Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 June 30, 2006

 

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

For the transition period from              to             

Commission File No. 000-29089

 


Antigenics Inc.

(Exact Name of Registrant as Specified in its Charter)

 


 

Delaware   06-1562417
(State of Incorporation)   (I.R.S. Employer Identification Number)

630 Fifth Avenue, Suite 2100, New York, New York, 10111

(Address of Principal Executive Offices)

(212) 994-8200

(Registrant’s Telephone Number, including Area Code)

 


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

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

Large accelerated filer   ¨     Accelerated filer   x     Non-accelerated filer   ¨

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

Number of shares outstanding of the registrant’s Common Stock as of August 1, 2006: 45,844,392 shares.

 



Table of Contents

Antigenics Inc.

Quarterly Period Ended June 30, 2006

Table of Contents

 

          Page
   PART I — FINANCIAL INFORMATION   

Item 1.

  

Financial Statements:

  
  

Condensed Consolidated Balance Sheets as of June 30, 2006 and December 31, 2005 (Unaudited)

   2
  

Condensed Consolidated Statements of Operations for the Three and Six Months ended June 30, 2006 and 2005 (Unaudited)

   3
  

Condensed Consolidated Statements of Cash Flows for the Six Months ended June 30, 2006 and 2005 (Unaudited)

   4
  

Notes to Unaudited Condensed Consolidated Financial Statements

   5

Item 2.

  

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

   14

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

   28

Item 4.

  

Controls and Procedures

   28
   PART II — OTHER INFORMATION   

Item 1.

   Legal Proceedings    29

Item 1A.

   Risk Factors    30

Item 4.

   Submission of Matters to a Vote of Security Holders    48

Item 6.

   Exhibits    48

Signatures

   49

Exhibit Index

  

 

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Table of Contents

PART I — FINANCIAL INFORMATION

Item 1 — Financial Statements

ANTIGENICS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

    

June 30,

2006

   

December 31,

2005

 
ASSETS     

Cash and cash equivalents

   $ 19,415,170     $ 33,216,876  

Short-term investments

     12,451,774       28,530,650  

Accounts receivable

     —         45,586  

Inventories

     308,122       251,053  

Prepaid expenses

     2,157,030       1,665,308  

Restricted cash

     778,290       2,961,266  

Other current assets

     250,037       291,127  
                

Total current assets

     35,360,423       66,961,866  

Property and equipment, net of accumulated amortization and depreciation of $17,008,006 and $14,769,426 at June 30, 2006 and December 31, 2005, respectively

     20,644,780       23,350,246  

Goodwill

     2,572,203       2,572,203  

Core and developed technology, net of accumulated amortization of $5,877,687 and $5,324,055 at June 30, 2006 and December 31, 2005, respectively

     5,194,942       5,748,574  

Restricted cash

     —         21,912  

Debt issuance costs, net of accumulated amortization of $339,393 and $210,686 at June 30, 2006 and December 31, 2005, respectively

     1,653,349       1,782,056  

Other long-term assets

     3,704,698       3,713,760  
                

Total assets

   $ 69,130,395     $ 104,150,617  
                
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current portion, long-term debt

   $ 1,204,475     $ 4,125,913  

Accounts payable

     2,187,658       2,590,016  

Accrued liabilities

     9,232,927       12,291,085  

Other current liabilities

     581,806       138,367  
                

Total current liabilities

     13,206,866       19,145,381  

Long-term debt, less current portion

     —         43,823  

Convertible senior notes

     50,000,000       50,000,000  

Other long-term liabilities

     2,876,915       3,062,392  

Commitments and contingencies

STOCKHOLDERS’ EQUITY

    

Preferred stock, par value $0.01 per share; 25,000,000 shares authorized; Series A convertible preferred stock, par value $0.01 per share; 31,620 shares designated, issued and outstanding at June 30, 2006 and December 31, 2005, respectively; liquidation value of $31,817,625 at June 30, 2006 and December 31, 2005, respectively

     316       316  

Common stock, par value $0.01 per share; 100,000,000 shares authorized; 45,810,870 and 45,591,216 shares issued and outstanding at June 30, 2006 and December 31, 2005, respectively

     458,109       455,912  

Additional paid-in-capital

     441,926,253       441,497,317  

Deferred compensation

     —         (3,074 )

Accumulated other comprehensive loss

     (52,244 )     (88,103 )

Accumulated deficit

     (439,285,820 )     (409,963,347 )
                

Total stockholders’ equity

     3,046,614       31,899,021  
                

Total liabilities and stockholders’ equity

   $ 69,130,395     $ 104,150,617  
                

See accompanying notes to unaudited condensed consolidated financial statements.

 

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ANTIGENICS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the three and six months ended June 30, 2006 and 2005

(Unaudited)

 

    

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
     2006     2005     2006     2005  
     (Unaudited)  

Revenue

   $ 95,750     $ 84,689     $ 155,937     $ 205,052  

Operating expenses:

        

Research and development

     (7,866,261 )     (13,092,427 )     (16,376,172 )     (24,396,239 )

General and administrative

     (5,406,950 )     (7,470,987 )     (11,282,519 )     (14,271,078 )

Restructuring costs

     (645,123 )     (606,178 )     (1,374,293 )     (606,178 )
                                

Operating loss

     (13,822,584 )     (21,084,903 )     (28,877,047 )     (39,068,443 )

Other income (expense):

        

Non-operating income

     20,528       —         20,528       —    

Interest expense

     (737,663 )     (785,875 )     (1,475,236 )     (1,403,169 )

Interest income

     451,280       742,765       1,009,282       1,340,323  
                                

Net loss

     (14,088,439 )     (21,128,013 )     (29,322,473 )     (39,131,289 )

Dividends on series A convertible preferred stock

     (197,625 )     (197,625 )     (395,250 )     (395,250 )
                                

Net loss attributable to common stockholders

   $ (14,286,064 )   $ (21,325,638 )   $ (29,717,723 )   $ (39,526,539 )
                                

Per common share data, basic and diluted:

        

Net loss attributable to common stockholders

   $ (0.31 )   $ (0.47 )   $ (0.65 )   $ (0.87 )
                                

Weighted average number of common shares outstanding, basic and diluted

     45,857,600       45,564,011       45,800,814       45,563,392  
                                

See accompanying notes to unaudited condensed consolidated financial statements.

 

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ANTIGENICS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the six months ended June 30, 2006 and 2005

(Unaudited)

 

    

Six Months Ended

June 30,

 
     2006     2005  

Cash flows from operating activities:

    

Net loss

   $ (29,322,473 )   $ (39,131,289 )

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

    

Depreciation and amortization

     2,899,314       2,713,161  

Non-cash stock compensation

     805,973       (179,193 )

Write-off of property and equipment

     618,022       —    

Loss on sale of assets

     37,900       —    

Changes in operating assets and liabilities:

    

Accounts receivable

     45,586       (28,318 )

Inventories

     (57,069 )     (96,512 )

Prepaid expenses

     (491,722 )     (73,228 )

Accounts payable

     (402,358 )     (1,535,602 )

Accrued liabilities and other current liabilities

     (3,001,018 )     3,012,751  

Other operating assets and liabilities

     (60,328 )     520,297  
                

Net cash used in operating activities

     (28,928,173 )     (34,797,933 )
                

Cash flows from investing activities:

    

Proceeds from maturities of available-for-sale securities

     16,850,000       74,683,197  

Purchases of available-for-sale securities

     (735,265 )     (58,010,313 )

Investment in AGTC

     (75,000 )     (75,000 )

Distribution from AGTC

     —         123,169  

Proceeds from sale of property and equipment

     33,257       —    

Purchases of property and equipment

     (200,687 )     (2,074,945 )

Decrease in restricted cash

     2,204,888       1,459,506  
                

Net cash provided by investing activities

     18,077,193       16,105,614  
                

Cash flows from financing activities:

    

Proceeds from employee stock purchases and exercise of stock options

     409,785       202,153  

Payments of series A convertible preferred stock dividend

     (395,250 )     (395,250 )

Proceeds from long-term debt

     —         50,000,000  

Debt issuance costs

     —         (1,992,742 )

Repayments of long-term debt

     (2,965,261 )     (2,846,826 )
                

Net cash (used in) provided by financing activities

     (2,950,726 )     44,967,335  
                

Net (decrease) increase in cash and cash equivalents

     (13,801,706 )     26,275,016  

Cash and cash equivalents, beginning of period

     33,216,876       15,979,714  
                

Cash and cash equivalents, end of period

   $ 19,415,170     $ 42,254,730  
                

Supplemental cash flow information:

    

Cash paid for interest

   $ 1,369,942     $ 175,876  
                

See accompanying notes to unaudited condensed consolidated financial statements.

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2006

Note A — Organization and Basis of Presentation

Antigenics Inc. (including its subsidiaries, also referred to in this Quarterly Report on Form 10-Q as “Antigenics”, the “Company”, “we”, “us”, and “our”) is a biotechnology company developing technologies and products to treat cancers, infectious diseases and autoimmune disorders, primarily based on immunological approaches. Our most advanced product candidate is Oncophage ® (vitespen; formerly HSPPC-96), a personalized therapeutic cancer vaccine candidate that has been tested in several cancer indications, including in Phase 3 clinical trials for the treatment of renal cell carcinoma, the most common type of kidney cancer, and for metastatic melanoma. Oncophage has also been tested in Phase 2 and Phase 1 clinical trials in a range of indications as both monotherapy and in combination with other therapeutic agents. Our product candidate portfolio also includes (1) Aroplatin™ chemotherapeutic, a liposomal chemotherapeutic in a Phase 1 clinical trial for the treatment of solid tumors and B-cell lymphoma, (2) AG-707, a therapeutic vaccine program in a Phase 1 clinical trial for the treatment of genital herpes, (3) AU-801, a novel preclinical application of our proprietary heat shock protein technology as a treatment for autoimmune disorders, and (4) QS-21 Stimulon ® adjuvant (“QS-21”), an investigational adjuvant used in numerous vaccines including, but not limited to, hepatitis, lyme disease, human immunodeficiency virus (“HIV”), influenza, cancer, and malaria. Our related business activities include research and development, regulatory and clinical affairs, clinical manufacturing, business development, marketing and administrative functions that support these activities.

On March 24, 2006, we announced top-line results from part I of our Phase 3 study of Oncophage in renal cell carcinoma patients who are at high risk of recurrence after surgery, indicating that the trial did not meet its primary endpoint. The analysis was triggered based on the number of events (defined as recurrence of disease or death of a patient prior to recurrence) reported by study investigators. However, an independent review by the trial’s Clinical Events Committee revealed that a substantially smaller number of events had actually occurred. The analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint), and a trend against Oncophage for overall survival (a secondary endpoint); both findings were not statistically significant. The analysis of the overall survival endpoint is considered an interim assessment. At this time it is unclear as to why opposing trends were observed between recurrence-free survival and overall survival. There is no readily apparent adverse safety signal associated with the vaccine that we believe is contributing to this finding.

Based on these results, in April 2006, we commenced the implementation of a restructuring plan that refocused our programs and priorities resulting in the temporary discontinuation of all late-stage clinical programs and concentration on Phase 1 and preclinical programs, including those stated above for Aroplatin, AG-707, and AU-801. In addition, we terminated part II of the Phase 3 renal cell carcinoma trial and our Phase 2 trial of AG-858 for the treatment of chronic myelogenous leukemia. A combination study of Oncophage and ATRA-IV is also on hold pending review of the part I results. We continue to support and develop our QS-21 partnering collaborations, with the goal of generating royalties as early as 2010. To match these priorities, we eliminated 42 positions.

On June 5, 2006, we announced the updated results from our Phase 3 trial of Oncophage in metastatic melanoma and on June 7, 2006, we announced the results of an in-depth analysis of the data from part 1 of our Phase 3 trial of Oncophage in renal cell carcinoma. Based on these results, we decided to continue to collect survival data for our Phase 3 trial of Oncophage in renal cell carcinoma before making a decision regarding future pivotal clinical trials or seeking registration of Oncophage.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete annual consolidated financial statements. In the opinion of management, the financial statements include all normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results. All significant intercompany transactions and accounts have been eliminated in consolidation. Certain amounts previously reported have been reclassified in order to conform to the current period’s presentation. Operating results for the six-month period ended June 30, 2006 are not necessarily indicative of the results that may be expected for the year ending December 31, 2006. For further information, refer to the consolidated financial statements and footnotes thereto for the year ended December 31, 2005 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2006.

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and 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. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.

We have incurred annual operating losses since inception and, as a result, at June 30, 2006 have an accumulated deficit of $439.3 million. Our operations have been funded principally by sales of equity and convertible debt instruments. We believe that, based on our current plans and activities, our working capital resources at June 30, 2006 and estimated proceeds from collaborative agreements will be sufficient to satisfy our liquidity requirements through the first half of 2007. Satisfying our long-term liquidity needs may require the successful development and commercialization of product candidates and will require additional capital.

Our product candidates require substantial investment prior to commercialization, including investments in product development, conducting clinical trials, expanding manufacturing capacity, and obtaining approvals from regulatory agencies, as well as acceptance in the marketplace. Although we believe our patents, patent rights and patent applications are valid, the invalidation of our patents or failure of certain of our pending patent applications to issue as patents could have a material adverse effect upon our business. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaborative arrangements with academic and corporate collaborators and licensees and by entering into new collaborations. Our success depends, in part, on the success of these parties in performing research and preclinical and clinical testing. We compete with specialized biotechnology companies, major pharmaceutical companies, universities, and research institutions. Many of these competitors have substantially greater resources than we do.

Note B — Net Loss Per Share

Basic earnings or loss per common share (“EPS”) is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding and common shares issuable under our directors’ deferred compensation plan. Diluted EPS is calculated by dividing the net loss attributable to common stockholders by the weighted average common shares outstanding plus the dilutive effect of outstanding stock options, stock warrants, the series A convertible preferred stock, and the 5.25% Convertible Senior Notes due 2025. Because we have reported a net loss attributable to common stockholders for all periods, diluted EPS is the same as basic EPS as the effect of including the outstanding stock options, stock warrants, the convertible preferred stock, and the 5.25% Convertible Senior Notes due 2025 in the calculation would have reduced the net loss per common share. Therefore, the 6,246,692 outstanding stock options, the 8,910 outstanding stock warrants, the 31,620 outstanding shares of series A convertible preferred stock, and the 5.25% Convertible Senior Notes due 2025, are not included in the calculation of diluted net loss per common share.

Note C — Inventories

Inventories are stated at cost using the first-in, first-out method. The components of inventories are as follows.

 

    

June 30,

2006

  

December 31,

2005

Work in process

   $ 202,932    $ —  

Finished goods

     105,190      251,053
             
   $ 308,122    $ 251,053
             

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

Note D — Stock-Based Compensation

Our 1999 Equity Incentive Plan, as amended, (the 1999 equity plan) authorizes awards of incentive stock options within the meaning of Section 422 of the Internal Revenue Code, non-qualified stock options, restricted stock, and unrestricted stock for up to 10,000,000 shares of common stock (subject to adjustment for stock splits and similar capital changes and exclusive of options exchanged at the consummation of mergers) to employees and, in the case of non-qualified stock options, to consultants and directors as defined in the 1999 equity plan. The Board of Directors appointed the compensation committee to administer the 1999 equity plan.

 

Under the 1999 Employee Stock Purchase Plan (the “1999 ESPP”), employees may purchase shares of common stock at a discount from fair value. There are 300,000 shares of common stock reserved for issuance under the 1999 ESPP. The 1999 ESPP is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Internal Revenue Code. Rights to purchase common stock under the 1999 ESPP are granted at the discretion of the compensation committee, which determines the frequency and duration of individual offerings under the plan and the dates when stock may be purchased. Eligible employees participate voluntarily and may withdraw from any offering at any time before the stock is purchased. Participation terminates automatically upon termination of employment. The purchase price per share of common stock in an offering will not be less than 85% of the lesser of its fair value at the beginning of the offering period or on the applicable exercise date and may be paid through payroll deductions, periodic lump sum payments or a combination of both. The plan terminates on November 15, 2009. As of June 30, 2006, 184,218 shares of common stock have been purchased under the plan.

Effective June 11, 2003, our stockholders approved our Director’s Deferred Compensation Plan permitting each outside director to defer all, or a portion of, their cash compensation until their service as a director ends or until a specified date. There are 100,000 shares of our common stock reserved for issuance under this plan. As of June 30, 2006, no shares have been issued. The plan allows eligible directors to defer all, or a portion, of their cash compensation into a cash account or a stock account. Amounts deferred to a cash account will earn interest at the rate paid on one-year Treasury bills with interest added to the account annually. Amounts deferred to a stock account will be converted on a quarterly basis into a number of units representing shares of our common stock equal to the amount of compensation which the participant has elected to defer to the stock account divided by the applicable stock price for our common stock. The applicable price for our common stock is defined as the average of the closing price of our common stock for all trading days during the calendar quarter preceding the conversion date as reported by the Nasdaq National Market. Pursuant to this plan, 60,937 units, each representing a share of our common stock at an average common stock price of $5.83, were credited to participants’ stock accounts as of June 30, 2006. The compensation charges were immaterial for the periods presented.

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

The total compensation related to these plans was a net expense of $991,000 and $75,000 for the three months ended June 30, 2006 and 2005, respectively. For the six months ended June 30, 2006 and 2005, the total compensation related to these plans was a net expense of $806,000 and a net credit of $179,000, respectively.

Prior to January 1, 2006, we accounted for options granted to employees and directors in accordance with Accounting Principles Board (“APB”) Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations. As such, compensation cost was recorded on fixed stock option grants only if the fair value of the underlying stock exceeded the exercise price of the option at the date of grant and it was recognized on a straight-line basis over the vesting period and amounted to $6,000 and $38,000 for the three and six months ended June 30, 2005, respectively.

We provided pro forma disclosure amounts in accordance with the Financial Accounting Standards Board’s Statement of Financial Accounting Standards (“SFAS”) No. 148, Accounting for Stock-Based Compensation—Transition and Disclosure (“SFAS No. 148”), as if the fair value method defined by SFAS No. 123, Accounting for Stock-Based Compensation (“SFAS No. 123”) had been applied to our stock-based compensation plans.

Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS No. 123R, Share-Based Payment (“SFAS No. 123R”) for options granted to employees and directors, using the modified prospective transition method, and therefore have not restated results from prior periods. Under this method, stock-based compensation expense for the three and six months ended June 30, 2006 includes compensation expense for all stock-based options granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair value estimated in accordance with the original provision of SFAS No. 123. Compensation cost for all stock-based compensation awards granted after December 31, 2005 is based on the grant date fair value estimated in accordance with the provisions of SFAS No. 123R. Under the fair value recognition provisions of SFAS No. 123R, we recognized stock-based compensation net of an estimated forfeiture rate and only recognized compensation cost for those shares expected to vest on a straight-line prorated basis over the requisite service period of the award. In March 2005, the SEC issued Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment (“SAB No. 107”) regarding the SEC’s interpretation of SFAS No. 123R and the valuation of share-based payments for public companies. We have applied the provisions of SAB No. 107 in the adoption of SFAS No. 123R. The effect of adoption of the new standard for the three and six months ended June 30, 2006 related to stock options were additional non-cash expenses of $1.0 million ($0.02 per share, basic and diluted) and $1.1 million ($0.02 per share, basic and diluted), respectively.

Stock options granted to non-employees are accounted for based on the fair-value method of accounting in accordance with SFAS No. 123R and Emerging Issues Task Force (“EITF”) Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. As a result, the non-cash charge to operations for non-employee options with vesting or other performance criteria has affected each reporting period, until the non-employee options vested, by changes in the fair value of our common stock. The effect of these options for the three months ended June 30, 2006 and 2005, were a non-cash credit of $32,000 and a non-cash expense of $67,000, respectively. The effect of these options for the six months ended June 30, 2006 and 2005, were non-cash credits of $283,000 and $193,000, respectively.

Certain of our fully vested options granted to non-employees are outside the scope of SFAS No. 123R and are subject to EITF Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock , which requires the stock options held by certain non-employee consultants to be accounted for as liability awards. The fair value of these vested and unexercised awards was estimated using the Black-Scholes option pricing model and $1.7 million was reclassified from equity to a current liability as of January 1, 2006. The fair value of the award is remeasured at each financial statement date until the award is settled or expires. During the three and six months ended June 30, 2006, we recorded non-cash credits of $244,000 and $1.1 million, respectively, based on the remeasurement of these options. We also reclassified an additional liability of $64,000 during the six months ended June 30, 2006 based on the vesting of certain of these options. Non-employees exercised stock options to acquire 64,612 shares of common stock at an exercise price of $1.45 during the six months ended June 30,

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

2006 and the total liability of $216,000 as of the exercise dates was reclassified to equity. As of June 30, 2006, stock options to acquire approximately 876,000 shares of common stock held by non-employee consultants remained unexercised.

The following table illustrates the effect on net loss attributable to common stockholders and net loss attributable to common stockholders per common share, basic and diluted, had compensation cost for options granted to employees and directors and sold through our employee stock purchase plan been determined consistent with the fair value method of SFAS No. 123 (in thousands, except per share data):

 

    

Three Months

Ended
June 30, 2005

   

Six Months

Ended
June 30, 2005

 

Net loss attributable to common stockholders, as reported

   $ (21,326 )   $ (39,527 )

Add: stock-based employee and director compensation recognized under APB Opinion No. 25

     6       38  

Deduct: total stock-based employee and director compensation expense determined under the fair-value based method for all awards

     (1,854 )     (3,676 )
                

Pro forma net loss attributable to common stockholders

   $ (23,174 )   $ (43,165 )
                

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

    

As reported

   $ (0.47 )   $ (0.87 )
                

Pro forma

   $ (0.51 )   $ (0.95 )
                

In light of the new accounting guidance under SFAS No. 123R, we reevaluated our assumptions used in estimating the fair value of employee options granted. We also examined our historical pattern of option exercises in an effort to determine if there were any discernable activity patterns based on certain employee populations. From this analysis, we identified two employee populations. We used the Black-Scholes option pricing model to value the options for both of the employee populations as well as our options granted to members of our Board of Directors. The effects of applying SFAS No. 123R, for recognizing compensation cost under such pronouncement, may not be representative of the effects on our reported results of operations for future years.

All stock option grants are for a ten-year term and generally vest ratably over a four-year period. The fair value of each option granted during the periods is estimated on the date of grant with the following weighted average assumptions:

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2006     2005     2006     2005  

Expected volatility

   72 %   61 %   68 %   71 %

Expected term in years

   6     5     5     5  

Risk-free interest rate

   5.02 %   3.76 %   4.47 %   4.23 %

Dividend yield

   0 %   0 %   0 %   0 %

Expected volatility is based exclusively on historical volatility data of the Company’s stock. The expected term of stock options granted is based on historical data and other factors and represents the period of time that stock options are expected to be outstanding prior to exercise. The risk-free interest rate is based on U.S. Treasury strips with maturities that match the expected term on the date of grant.

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

The following table summarizes activity for options granted during the first six months of 2006:

 

     Options     Weighted
Average
Exercise
Price
  

Weighted
Average
Remaining
Contractual
Term

(in years)

   Aggregate
Intrinsic
Value

Outstanding December 31, 2005

   5,957,084     $ 8.75      

Granted

   1,399,300       4.87      

Exercised

   (185,660 )     1.47      

Forfeited

   (924,032 )     7.26      
              

Outstanding June 30, 2006

   6,246,692     $ 8.31    6.61    $ 147,532
              

Vested or expected to vest at June 30, 2006

   5,468,040     $ 8.59    6.32    $ 87,970
              

Exercisable at June 30, 2006

   2,978,702     $ 10.02    4.40    $ 11,354
              

The outstanding options at December 31, 2005 exclude 47,652 options granted to outside advisors with an exercise price which was determined based on the fair value of the underlying shares of common stock beginning on the second anniversary of the grant date as the options vest; these options vested prior to December 31, 1998 with an exercise price of approximately $11.17 per share and compensation expense was charged at such time. These options expired during the six months ended June 30, 2006.

The weighted average grant-date fair value of options granted during the six months ended June 30, 2006 and 2005 was $3.26 and $4.21, respectively.

The aggregate intrinsic value in the table above represents the difference between our closing stock price on the last trading day of the second quarter of fiscal 2006 and the exercise price, multiplied by the number of in-the-money options, that would have been received by the option holders had all option holders exercised their options on June 30, 2006. This amount changes based on the fair market value of our stock. The total intrinsic value of options exercised during the six months ended June 30, 2006, determined on the date of exercise, was $915,000.

During the first six months of 2006, all options were granted with exercise prices equal to the fair market value of the shares of common stock on the grant date.

As of June 30, 2006, $8.4 million of total unrecognized compensation cost related to stock options granted to employees and directors is expected to be recognized over a weighted-average period of three years.

At June 30, 2006, unrecognized expense for options granted to outside advisors for which performance (vesting) has not yet been completed but the exercise price of the option is known is approximately $333,000. Such amount is subject to change each reporting period based upon changes in the fair value of our common stock, expected volatility and the risk free interest rate until the outside advisor completes his or her performance under the option agreement.

During the three months ended March 31, 2006, 65,100 nonvested shares were issued with a weighted average grant date fair value of $5.13. No nonvested shares were outstanding as of January 1, 2006, no nonvested shares were vested, and 10,700 nonvested shares were forfeited during the six months ended June 30, 2006. As of June 30, 2006, there was $245,000 of unrecognized stock-based compensation expense related to these nonvested shares. That cost is expected to be recognized over a weighted-average period of two years.

Cash received from option exercises and purchases under the 1999 ESPP for the six months ended June 30, 2006 was $410,000. We issue new shares upon option exercises and purchases under the 1999 ESPP.

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

Note E — Comprehensive Loss

The following table provides the calculation of comprehensive loss for the three and six months ended June 30, 2006 and 2005 (in thousands):

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2006     2005     2006     2005  

Net loss

   $ (14,088 )   $ (21,128 )   $ (29,322 )   $ (39,131 )

Other comprehensive income:

        

Unrealized gain on available for sale securities, net

     18       64       36       47  
                                

Comprehensive loss

   $ (14,070 )   $ (21,064 )   $ (29,286 )   $ (39,084 )
                                

Note F — Commitments and Contingencies

On May 18, 2000, we committed $3.0 million to become a limited partner in a limited partnership called Applied Genomic Technology Capital Fund (“AGTC”), which invests principally in companies that apply genomic technologies and information in their offerings of products and services or that are engaged in research and development involving genomic technologies. Capital contributions to the limited partnership are made as requested by the general partner. Through June 30, 2006, we have invested approximately $2.6 million in AGTC, including $75,000 invested during the six months ended June 30, 2006. This investment is accounted for under the cost method, as our ownership interest is approximately 2%. In order to assess whether or not there has been an other than temporary decline in the value of this investment, we analyze several factors including: (1) the carrying value of the limited partnership’s investments in its portfolio companies, (2) how recently the investments in the portfolio companies have been made, (3) the post-financing valuations of those investments, (4) the level of uninvested capital held by the limited partnership, and (5) overall trends in venture capital valuations. Based on these analyses, during the six months ended June 30, 2006, we concluded that an other than temporary decline had not occurred and, therefore, have not reduced the carrying value of the asset. Our investment balance aggregated $2.1 million and $2.0 million at June 30, 2006 and December 31, 2005, respectively, and is included in other long-term assets. The general partner of the limited partnership is AGTC Partners, L.P. The management company for AGTC is NewcoGen Group Inc., which is a wholly owned subsidiary of Flagship Ventures Management, Inc. (“Flagship”). Noubar Afeyan, Ph.D., who is one of our directors, is Managing Partner and Chief Executive Officer of Flagship. In addition, until 2004, Garo H. Armen, Ph.D., our Chairman and Chief Executive Officer, was a director of NewcoGen Group Inc.

Antigenics, Garo Armen, and two investment banking firms that served as underwriters in our initial public offering have been named as defendants in a civil class action lawsuit filed on November 5, 2001 in the Federal District Court for the Southern District of New York on behalf of a class of purchasers of our stock between February 3, 2000 and December 6, 2000. Similar complaints were filed against about 300 other issuers, their underwriters, and in many instances their directors and officers. These cases have been coordinated under the caption In re Initial Public Offering Securities Litigation , Civ. No. 21 MC 92 (SAS), by order dated August 9, 2001. The suit against Antigenics and Dr. Armen alleges that the brokerage arms of the investment banking firms charged secret excessive commissions to certain of their customers in return for allocations of our stock in the offering. The suit also alleges that shares of our stock were allocated to certain of the investment banking firms’ customers based upon agreements by such customers to purchase additional shares of our stock in the secondary market. The complaint alleges that Antigenics is liable under Section 11 of the Securities Act of 1933, as amended (the “Securities Act”), and Dr. Armen is liable under Sections 11 and 15 of the Securities Act because our registration statement did not disclose these alleged practices. On April 19, 2002, the plaintiffs in this action filed an amended class action complaint, which contains new allegations. Again, similar amended complaints were filed with respect to the other companies. In addition to the claims in the earlier complaint, the amended complaint alleges that Antigenics and Dr. Armen violated Sections 10(b) and 20 of the Securities Exchange Act and SEC Rule 10b-5 by making false and misleading statements and/or omissions in order to inflate our stock price and conceal the investment banking firms’ alleged secret arrangements. The claims against Dr. Armen, in his individual capacity, have been dismissed without prejudice. On July 15, 2002, Antigenics and Dr. Armen joined the Issuer Defendants’ Motion to Dismiss the Consolidated Amended Complaints. By order of the Court, this motion set forth all “common

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

issues,” i.e., all grounds for dismissal common to all or a significant number of Issuer Defendants. The hearing on the Issuer Defendants’ Motion to Dismiss and the other Defendants’ motions to dismiss was held on November 1, 2002. On February 19, 2003, the Court issued its opinion and order on the Issuer Defendants’ Motion to Dismiss. The Court granted Antigenics’ motion to dismiss the Rule 10b-5 and Section 20 claims with leave to amend and denied our motion to dismiss the Section 11 and Section 15 claims. On June 14, 2004, papers formalizing a proposed settlement among the plaintiffs, Issuer Defendants, and insurers were presented to the Federal District Court for the Southern District of New York. On February 15, 2005, the Court granted preliminary approval of the settlement. On August 31, 2005, the Court issued an order confirming preliminary approval of the settlement. The settlement remains subject to a number of conditions, including final approval of the Court. If the settlement becomes effective, Antigenics anticipates that it will not incur significant out-of-pocket costs, after insurance. Accordingly, an accrual has not been recorded at June 30, 2006.

A third party has filed a notice of opposition to European patent EP 0750513 B1 which has claims relating to AG-702/707, to which we hold the exclusive license. We believe this patent claims valid subject matter and intend to defend the opposition. However, there is no guarantee that this patent will not be revoked or that we may not have to amend the claims.

Antigenics and our Chairman and Chief Executive Officer have been named as defendants in a purported class action complaint filed on June 16, 2006 in Federal District Court in New Mexico by Steven J. Tuckfelt on behalf of himself and all others similarly situated. As of August 8, 2006, the complaint has not been served on either defendant, and pending service of process, proceedings in the litigation do not commence. The complaint alleges that certain of our disclosures in connection with the conduct of the Oncophage Phase 3 renal cell carcinoma trial violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as well as includes purported claims for breach of fiduciary duty. While we believe that the complaint is without merit and plan to vigorously defend against the litigation should it proceed, litigation is uncertain. Regardless of the outcome, participation in this lawsuit diverts management’s time and attention from our business and may result in requiring us to pay legal fees and damages.

We currently are a party to other legal proceedings as well. While we currently believe that the ultimate outcome of any of these proceedings will not have a material adverse effect on our financial position, results of operations, or liquidity, litigation is subject to inherent uncertainty. Furthermore, litigation consumes both cash and management attention.

Note G — Restructurings

In June 2005, we took steps to improve our operating efficiency through the prioritization of our development portfolio and a streamlining of our infrastructure. Consequently, we eliminated 26 positions. We recorded severance charges of $606,000 related to the elimination of these positions.

In December 2005, we further updated our business strategy and refocused our programs and priorities, including the postponement and deceleration of a number of our projects. To match these priorities, we eliminated 65 positions. In addition to severance charges of $990,000 recorded in December 2005 related to the elimination of these positions, we recorded severance charges of $112,000 during the three months ended March 31, 2006. In April 2006, we commenced the implementation of a plan to further restructure, refocusing our programs and priorities with the goal of reducing our net cash burn rate and eliminated 42 additional positions. We recorded severance charges of $645,000 related to the elimination of these positions for the three months ended June 30, 2006.

A summary of severance and related costs is as follows (in thousands):

 

     Liability at
December 31, 2005
   Charge to
Operations
   Amount
Paid
    Liability at
June 30, 2006

Severance and payroll taxes

   $ 832    $ 649    $ (1,262 )   $ 219

Outplacement

     89      72      (128 )     33

Other

     33      36      (55 )     14
                            

Total

   $ 954    $ 757    $ (1,445 )   $ 266
                            

 

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ANTIGENICS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (continued)

During the three months ended March 31, 2006, we wrote-off certain assets that were determined to not be required for our updated business strategy. This resulted in additional restructuring charges of $617,000.

Note H — Subsequent Event

On July 6, 2006, we entered into expanded license and supply agreements with GlaxoSmithKline Biologicals SA for the use of QS-21, an investigational adjuvant used in numerous vaccines. Under the terms of the agreements, we have agreed to supply QS-21 through 2014. In addition, we agreed to transfer manufacturing technologies under the supply agreement. We will receive payments contingent upon successful milestone achievements, and royalties on net sales for a period of at least ten years after the first commercial sale under the supply agreement.

In order to meet our collaborative partners’ requirements for QS-21, we intend to design and build a manufacturing suite within our existing facility. We are currently in the process of determining the cost of this manufacturing suite and estimate that it will take 18 months to build and commission. The cost of the manufacturing suite is expected to be recovered out of revenues derived from the supply of QS-21 to our collaborative partners.

 

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

Overview

We are currently researching and/or developing product candidates to treat cancers, infectious diseases and autoimmune disorders. Since our inception in March 1994, our activities have primarily been associated with the development of our heat shock protein technology and our most advanced product candidate, Oncophage, a personalized therapeutic cancer vaccine. Our business activities have included product research and development, intellectual property prosecution, manufacturing therapeutic vaccines for clinical trials, regulatory and clinical affairs, corporate finance and development activities, marketing, and integration of our acquisitions.

We have incurred significant losses since our inception. As of June 30, 2006, we had an accumulated deficit of $439.3 million. Since our inception, we have financed our operations principally by sales of equity and convertible debt instruments. We believe that, based on our current plans and activities, our working capital resources at June 30, 2006 and estimated proceeds from collaborative agreements will be sufficient to satisfy our liquidity requirements through the first half of 2007. In addition, we expect, as we have in the past, to attempt to raise additional funds in advance of depleting our current funds. Satisfying long-term liquidity needs may require the successful commercialization of product candidates and will require additional capital.

As part of an effort to conserve funds, on December 6, 2005, we announced that we had refocused our programs and priorities, including the postponement and deceleration of a number of our projects. To match our updated business strategy, we also reduced our workforce by approximately 30% at that time.

On March 24, 2006, we announced top-line results from part I of our Phase 3 study of Oncophage in renal cell carcinoma patients who are at high risk of recurrence after surgery, indicating that the trial did not meet its primary endpoint. The analysis was triggered based on the number of events (defined as recurrence of disease or death of a patient prior to recurrence) reported by study investigators. However, an independent review by the trial’s Clinical Events Committee (“CEC”) revealed that a substantially smaller number of events had actually occurred. The analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint), and a trend against Oncophage for overall survival (a secondary endpoint); both findings were not statistically significant. The analysis of the overall survival endpoint is considered an interim assessment. At this time it is unclear as to why opposing trends were observed between recurrence-free survival and overall survival. There is no readily apparent adverse safety signal associated with the vaccine that we believe is contributing to this finding.

Based on these results, in April 2006, we implemented a restructuring plan that further refocused our programs and priorities resulting in the temporary discontinuation of all late-stage clinical programs and concentration on Phase 1 and preclinical programs, including Aroplatin for the treatment of solid tumors and B-cell lymphoma, AG-707 for the treatment of genital herpes, and AU-801 for autoimmune disorders. In addition, we terminated part II of the Phase 3 renal cell carcinoma trial and our Phase 2 trial of AG-858 for the treatment of chronic myelogenous leukemia (“CML”). A combination study of Oncophage and ATRA-IV is also on hold pending review of the part I results. We continue to support and develop our QS-21 Stimulon ® adjuvant (“QS-21”) partnering collaborations, with the goal of generating royalties as early as 2010. To match these priorities, we eliminated an additional 42 positions in April 2006.

We conducted an in-depth analysis of data from part I of our Phase 3 study of Oncophage in renal cell carcinoma during April and May 2006 and discussed the results with the U.S. Food and Drug Administration (the “FDA”) and a panel of experts in this medical field. On June 7, 2006, we announced the findings of the analysis. With regard to the primary endpoint, recurrence-free survival, this analysis revealed that in a subgroup of better-prognosis patients in the trial, there was a clinically significant improvement. The subgroup consisted of 361 patients, or 60% of the 604 patients in the full analysis set (“FAS”) population. As defined by FDA-issued guidance, the FAS is the set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle. It is derived from the set of all randomized subjects by minimal and justified elimination of subjects. In this case, patients with baseline disease were excluded from the FAS population. In this 361-patient subgroup, patients receiving Oncophage had a 43% decreased risk of recurrence compared with patients in the observation arm.

 

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Overall survival, the secondary endpoint, was also assessed in the 604 patients in the FAS patient population. The analysis, which is interim for the overall survival endpoint, indicated a trend against Oncophage. We believe that the data are also likely to have been influenced by missing information from patients who were lost to follow-up or withdrew consent.

Based on this analysis, additional data collection will be required to evaluate overall survival and the availability of such data is uncertain. The absence of such data could delay the initiation of future clinical studies. Moreover, even if such data is collected, it may continue to adversely affect our results, or the acceptability of the results, even if clinically meaningful, may not meet the requirements of regulatory authorities for submission and approval of a biologics application for product approval. Because the evidence of clinically significant improvement has been observed in a subgroup analysis and was not demonstrated in the pre-specified analysis of the primary and secondary endpoints of the Phase 3 study of Oncophage in renal cell carcinoma, this study alone would not be sufficient to support a biologics application for product approval. Further clinical studies must be conducted to demonstrate the safety and efficacy of Oncophage. We may not be able to secure additional financing to continue our clinical trials. If we cannot secure additional financing, we may become insolvent.

On July 6, 2006, we entered into expanded license and supply agreements with GlaxoSmithKline Biologicals SA (“GSK”) for the use of QS-21, an investigational adjuvant used in numerous vaccines. QS-21 is a key component included in several proprietary adjuvant systems. A number of vaccine candidates currently under development are formulated with adjuvant systems containing QS-21.

Under the terms of the agreements, we have agreed to supply QS-21 through 2014. In addition, we agreed to transfer manufacturing technologies under the supply agreement. We will receive payments contingent upon successful milestone achievements, and royalties on net sales for a period of at least ten years after the first commercial sale under the supply agreement.

We have the right to elect to manufacture some of our product candidates other than Oncophage and AG-707 in our own manufacturing facilities (e.g., QS-21 and Aroplatin). This would require the investment of substantial funds and the recruitment of qualified personnel in order to build, or lease and operate any new manufacturing facilities. We are only beginning to plan and develop clinical or commercial-scale manufacturing capabilities for our product candidates other than Oncophage and AG-707. In order to continue to develop our other product candidates, apply for regulatory approvals and commercialize these product candidates, we or our licensees or collaborators will need to develop, contract for or otherwise arrange for the necessary manufacturing capabilities. We currently rely and expect to continue to rely, upon third parties, potentially including our collaborators, to produce materials required for preclinical studies and clinical trials and for these product candidates. In order to meet our collaborative partners’ requirements for QS-21, we intend to design and build a manufacturing suite within our existing facility. We are currently in the process of determining the cost of this manufacturing suite and estimate that it will take 18 months to build and commission. The cost of the manufacturing suite is expected to be recovered out of revenues derived from the supply of QS-21 to our collaborative partners. A number of factors could cause production interruptions at our manufacturing facility or our contract manufacturers, including equipment malfunctions, labor or employment retention problems, natural disasters, power outages, terrorist activities, or disruptions in the operations of our suppliers. Alternatively, there is the possibility we may have excess manufacturing capacity if programs do not progress as planned.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements. Generally, these statements can be identified by the use of terms like “believe,” “expect,” “anticipate,” “plan,” “may,” “will,” “could,” “estimate,” “potential,” “opportunity,” “future,” “project,” and similar terms. Forward-looking statements include statements about generating royalty revenue from QS-21 as early as 2010, our timelines for performing and completing research, preclinical studies and clinical trials, timelines for releasing data from clinical trials, timelines for initiating new clinical trials, expectations regarding research, preclinical studies, clinical trials and regulatory processes, expectations regarding test results, future product research and development activities, the expected effectiveness of therapeutic drugs, vaccines, and combinations in treating diseases, applicability of our heat shock protein technology to multiple cancers and infectious diseases, competitive position, plans for regulatory filings, the sufficiency of our clinical trials in renal cell carcinoma and melanoma, or subgroup analyses of data from these trials, to support a biologics license application for product approval, possible receipt of future regulatory approvals, the performance of collaborative partners in, and revenue expectations from, our strategic license and partnering collaborations,

 

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expected liquidity and cash needs, plans for restructuring and reduction of our net cash burn rate (cash used in operating activities plus cash from investing activities and debt repayments), plans for sales and marketing, implementation of corporate strategy, and future financial performance. These forward-looking statements involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These risks and uncertainties include, among others, that clinical trials may not demonstrate that our products are both safe and more effective than current standards of care; that the subgroup analyses of our Oncophage clinical trials do not predict survival or efficacy of the product in future studies or use of Oncophage; that we may be unable to obtain the regulatory authorization necessary to conduct additional clinical trials; that we may not be able to enroll sufficient numbers of patients in our clinical trials; that we may be unable to obtain the regulatory review or approval necessary to commercialize our product candidates because the FDA or other regulatory agencies are not satisfied with our trial protocols or the results of our trials; that we may fail to adequately protect our intellectual property or that it is determined that we infringe on the intellectual property of others; our strategic licenses and partnering collaborations may not meet expectations; manufacturing problems may cause product development and launch delays and unanticipated costs; our ability to raise additional capital; our ability to attract and retain key employees; changes in financial markets, regulatory requirements, and geopolitical developments; and the solvency of counter-parties under material agreements, subleases, and general real estate risks.

We have included more detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business in Part II-Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.

Oncophage ® and Stimulon ® are registered trademarks of Antigenics and Aroplatin is a trademark of Antigenics. Gleevec ® is a registered trademark of Novartis AG. All rights reserved.

Historical Results of Operations

Three Months Ended June 30, 2006 Compared to the Three Months Ended June 30, 2005

Revenue: We generated $96,000 and $85,000 of research and development revenue during the three months ended June 30, 2006 and 2005, respectively. Revenues from research and development activities include revenues earned on shipments of QS-21 to our QS-21 licensees and license fees earned.

Research and Development: Research and development expenses include the costs associated with our internal research and development activities, including salaries and benefits, occupancy costs, clinical manufacturing costs, related administrative costs, and research and development conducted for us by outside advisors, such as sponsored university-based research partners, including the University of Connecticut Health Center, and clinical research organizations. Research and development expense decreased 40% to $7.9 million for the three months ended June 30, 2006 from $13.1 million for the three months ended June 30, 2005. The decrease was partially due to a $2.3 million reduction in payroll related expenses attributable to the workforce reductions in June and December 2005 and in April 2006. Clinical trial related expenses decreased $1.6 million due to the reduced activity in our Phase 3 trials. Other expenses decreased $1.3 million due to fewer ongoing projects and cost containment efforts.

General and Administrative: General and administrative expenses consist primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 28% to $5.4 million for the three months ended June 30, 2006 from $7.5 million for the three months ended June 30, 2005. This decrease is a reflection of our cost-cutting efforts. Specific cost reductions included a $1.3 million reduction in payroll and personnel related expenses due mainly to the workforce reductions in June and December 2005 and in April 2006, as well as decreased professional fees of $1.3 million. In addition, other expenses decreased $358,000. These reductions were partially offset by an increase in non-cash stock-based compensation expense of $851,000.

 

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Restructuring Costs: In June 2005, we took steps to improve our operating efficiency through the prioritization of our development portfolio and a streamlining of our infrastructure. Consequently, we eliminated 26 positions. We recorded severance charges of $606,000 related to the elimination of these positions.

In April 2006, we commenced the implementation of a plan to further restructure, refocusing our programs and priorities with the goal of reducing our net cash burn rate and eliminated 42 positions. We recorded severance charges of $645,000 related to the elimination of these positions.

Non-operating Income: Non-operating income of $21,000 represents income from the sale of excess assets.

Interest Expense: Interest expense decreased 6% to $738,000 for the three months ended June 30, 2006 from $786,000 for the three months ended June 30, 2005. This decrease results from the decrease in the average outstanding balance of our long-term debt.

Interest Income: Interest income decreased 39% to $451,000 for the three months ended June 30, 2006 from $743,000 for the same period in 2005. This decrease is primarily attributable to a decrease in cash, cash equivalents, and short-term investments, partially offset by a rise in interest rates earned on our cash, cash equivalents, and short-term investments. Our average interest rate increased from 2.8% for the three months ended June 30, 2005 to 4.8% for the three months ended June 30, 2006.

Six Months Ended June 30, 2006 Compared to the Six Months Ended June 30, 2005

Revenue: We generated $156,000 and $205,000 of research and development revenue during the six months ended June 30, 2006 and 2005, respectively. Revenues from research and development activities include revenues earned on shipments of QS-21 to our QS-21 licensees and license fees earned.

Research and Development: Research and development expenses include the costs associated with our internal research and development activities, including salaries and benefits, occupancy costs, clinical manufacturing costs, related administrative costs, and research and development conducted for us by outside advisors, such as sponsored university-based research partners, including the University of Connecticut Health Center, and clinical research organizations. Research and development expense decreased 33% to $16.4 million for the six months ended June 30, 2006 from $24.4 million for the six months ended June 30, 2005. The decrease was partially due to a $4.2 million reduction in payroll and personnel related expenses attributable to the workforce reductions in June and December 2005 and in April 2006. There was a decrease of $1.4 million due to reduced clinical trial activity. In addition, there was an increase in non-cash stock option credits of $472,000. Other expenses decreased $1.9 million due to fewer ongoing projects and cost containment efforts.

General and Administrative: General and administrative expenses consist primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 21% to $11.3 million for the six months ended June 30, 2006 from $14.3 million for the six months ended June 30, 2005. This decrease is a reflection of our cost-cutting efforts. Specific cost reductions included a $1.9 million reduction in payroll and personnel related expenses due mainly to the workforce reductions in June and December 2005 and in April 2006, as well as decreased professional fees of $1.8 million. In addition, other expenses decreased $686,000. These reductions were partially offset by an increase in non-cash stock-based compensation expense of $1.4 million.

Restructuring Costs: In June 2005, we took steps to improve our operating efficiency through the prioritization of our development portfolio and a streamlining of our infrastructure. Consequently, we eliminated 26 positions. We recorded severance charges of $606,000 related to the elimination of these positions.

In December 2005, we further updated our business strategy and refocused our programs and priorities, including the postponement and deceleration of a number of our projects. To match these priorities, we eliminated 65 positions. In addition to severance charges of $990,000 recorded in December 2005 related to the elimination of these positions, we recorded severance charges of $112,000 during the three months ended March 31, 2006. In April 2006, we commenced the implementation of a plan to further restructure, refocusing our programs and priorities with the goal of reducing our net cash burn rate and eliminated 42 additional positions. We recorded severance charges of $645,000 related to the elimination of these positions for the three months ended June 30, 2006 resulting

 

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in total severance charges of $757,000 for the six months ended June 30, 2006. In addition, during the three months ended March 31, 2006, we wrote-off certain assets that were determined to not be required for our updated business strategy. This resulted in impairment charges of $617,000 for the six months ended June 30, 2006.

Non-operating Income: Non-operating income of $21,000 represents income from the sale of excess assets.

Interest Expense: Interest expense increased 5% to $1.5 million for the six months ended June 30, 2006 from $1.4 million for the six months ended June 30, 2005. This increase relates to interest on our 5.25% convertible senior notes due 2025, which were issued on January 25, 2005, partially offset by a decrease in interest expense resulting from the decrease in the average outstanding balance of our long-term debt.

Interest Income: Interest income decreased 25% to $1.0 million for the six months ended June 30, 2006 from $1.3 million for the same period in 2005. This decrease is primarily attributable to a decrease in cash, cash equivalents, and short-term investments, partially offset by a rise in interest rates earned on our cash, cash equivalents, and short-term investments. Our average interest rate increased from 2.4% for the six months ended June 30, 2005 to 4.5% for the six months ended June 30, 2006.

Research and Development Programs

Prior to 2002, we did not track costs on a per project basis, and therefore have estimated the allocation of our total research and development costs to our largest research and development programs. During the first six months of 2006, these research and development programs consisted largely of five product candidates, Oncophage, AG-858, AG-707, Aroplatin, and QS-21, as indicated in the following table (in thousands).

 

Research and

Development Program

  

Product

  

Six Months
Ended
June 30,

2006

   Year Ended December 31,   

Prior to

2002

   Total
         2005    2004    2003    2002      

Heat Shock Proteins for Cancer

   Oncophage
& AG-858
   $ 13,171    $ 37,836    $ 35,462    $ 40,052    $ 31,046    $ 60,075    $ 217,642

Heat Shock Proteins for Infectious Diseases

   AG-702/707      976      3,001      2,682      2,376      1,248      2,820      13,103

Liposomal Cancer Treatments*

   Aroplatin      1,119      3,214      1,112      1,263      2,061      1,442      10,211

Vaccine Adjuvant

   QS-21      174      310      264      301      1,403      2,553      5,005

Other research and development programs

        936      2,719      2,198      2,272      1,720      5,830      15,675
                                                   

Total Research and Development Expenses

      $ 16,376    $ 47,080    $ 41,718    $ 46,264    $ 37,478    $ 72,720    $ 261,636
                                                   

* Prior to 2001, costs were incurred by Aronex Pharmaceuticals, Inc., a company we acquired in July 2001.

We have allocated direct and indirect costs to each program based on certain assumptions and our review of the status of each program, payroll related expenses, and other overhead costs based on estimated usage by each program. Our product candidates are in various stages of development as described below. Significant additional expenditures will be required if we complete our clinical trials, start new trials, apply for regulatory approvals, continue development of our technologies, expand our operations, and bring our product candidates to market. The eventual total cost of each clinical trial is dependent on a number of uncertainties such as trial design, length of the trial, number of clinical sites, and number of patients. The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain. Because the development of our most advanced product candidate, Oncophage, is subject to further evaluation and uncertain, and because AG-707 and Aroplatin are in early-stage clinical development, we are unable to reliably estimate the cost of completing our research and development programs, the timing of bringing such programs to market, and, therefore, when material cash inflows are likely to commence. Our collaborations involving QS-21 depend on our collaborative partners or licensees successfully completing clinical trials, our successful expansion of our manufacturing capacity to meet collaborative partner or licensee demand, and our collaborative partners or licensees obtaining regulatory approvals.

 

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Product Development Portfolio

Below is a table showing the status of our clinical trials.

 

Product

    

Phase 3

    

Phase 2

    

Phase 1/2

Trials Currently Enrolling Patients:

         

AG-707

              

Genital herpes

Aroplatin

              

Solid tumors/NHL (c)

Phase 3 Trials Undergoing Analysis:

         

Oncophage

    

Renal cell carcinoma Part I (a)(b)

         

Trials Closed to Enrollment:

         

Oncophage

    

Renal cell carcinoma Part II(a)(d)

    

Colorectal cancer

    

Pancreatic cancer

    

Metastatic melanoma (a)

    

Non-Hodgkin’s lymphoma (NHL)

    
         

Gastric cancer

    
         

Metastatic renal cell carcinoma

    
         

Lung cancer

    
         

Metastatic melanoma

    

Oncophage and ATRA-IV

         

Renal cell carcinoma (e)

AG-858

         

CML (a)(d)

    

Aroplatin

         

Colorectal cancer

    

Solid tumors


(a) These are multicenter trials conducted in the U.S. as well as internationally.
(b) This trial is closed to enrollment.
(c) Utilizing a new formulation.
(d) Trial has been terminated.
(e) Initiation of this study is on hold pending evaluation of the renal cell carcinoma part I data.

Oncophage

We started enrolling patients in our first clinical trial studying Oncophage in November 1997. To date, over 750 patients have been treated with Oncophage in our various clinical trials. We have ongoing Phase 2 trials in lung cancer and metastatic renal cell carcinoma, and we have completed enrollment in part I of a Phase 3 trial for renal cell carcinoma and a Phase 3 trial for metastatic melanoma. Because Oncophage is a novel therapeutic cancer vaccine that is personalized for each patient, meaning it is derived from the patient’s own tumor, it may experience a long regulatory review process and high development costs, either of which could delay or prevent our commercialization efforts. For additional information regarding regulatory risks and uncertainties, please read the risks identified under Part II-Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q.

On September 3, 2003, the FDA placed our Phase 3 Oncophage clinical trials on partial clinical hold because of inadequate data to support specifications for product purity, identity, potency and pH. With FDA consent, we continued to treat and monitor patients who were already enrolled in the trials as of that date. On October 22, 2003 we provided information in response to the FDA comments received, and on November 23, 2003, the agency lifted the partial clinical hold.

On December 22, 2003, we announced the result of the planned interim analysis of the data from our Phase 3 trial of Oncophage in renal cell carcinoma. Based on its review of the safety data, efficacy data, and other

 

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information regarding the trial, the independent Data Monitoring Committee (“DMC”) for the trial, a panel of cancer specialists who are reviewing the safety and conduct of the trial at regular intervals but are not otherwise involved in the study, recommended that the trial proceed as planned and did not require that we change the number of patients we planned to enroll in this trial for a successful analysis of part I of the Phase 3 trial. At the interim analysis, the DMC also declared the design and conduct of the trial sound and raised no safety concerns.

In July 2004, we held a meeting with the medical review team of the FDA for Oncophage in renal cell carcinoma. The medical review team is specifically focused on the review of issues related to patient safety, product efficacy, clinical protocols, and clinical development plans. The purpose of the meeting was to address issues surrounding the clinical development plan for product registration of Oncophage in renal cell carcinoma. The FDA expressed agreement with our overall proposed registration plan. This plan included our using data from part I of the Phase 3 trial as part of our product registration strategy as well as conducting a second part of the trial in a similar patient population. We commenced study initiation activities for part II of this trial in February 2005. The FDA has indicated that, by itself, part I of the trial is not sufficient to support a biologics license application, also known as a BLA, as they consider part II of the trial as potentially providing the definitive evidence of safety and efficacy.

During the quarter ended September 30, 2004, part I of our Phase 3 renal cell carcinoma trial was closed to enrollment. The protocol stipulates that analysis of this trial should occur when a pre-specified number of events occur. An event is defined as a recurrence of a patient’s renal cell carcinoma or the death of a patient prior to disease recurrence. All patients are reviewed for determination of disease recurrence, on a blinded basis and regardless of the clinical investigator’s assessment of the presence of disease recurrence, by an independent CEC comprised of expert radiologists and an expert oncologist.

On March 24, 2006, we announced top-line results from part I of our Phase 3 study of Oncophage in renal cell carcinoma patients who are at high risk of recurrence after surgery, indicating that the trial did not meet its primary endpoint. The analysis was triggered based on the number of events (defined as recurrence of disease or death of a patient prior to recurrence) reported by study investigators. However, an independent review by the trial’s CEC revealed that a substantially smaller number of events had actually occurred. The analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint), and a trend against Oncophage for overall survival (a secondary endpoint); both findings were not statistically significant. The analysis of the overall survival endpoint is considered an interim assessment. At this time it is unclear as to why opposing trends were observed between recurrence-free survival and overall survival. There is no readily apparent adverse safety signal associated with the vaccine that we believe is contributing to this finding.

We conducted an in-depth analysis of data from part I of our Phase 3 study of Oncophage in renal cell carcinoma in April and May 2006 and discussed the results with the FDA and a panel of experts in this medical field. On June 7, 2006, we announced the findings of the analysis. With regard to the primary endpoint, recurrence-free survival, this analysis revealed that in a subgroup of better-prognosis patients in the trial, there was a clinically significant improvement. The subgroup consisted of 361 patients, or 60% of the 604 patients in the FAS population. In this 361-patient subgroup, patients receiving Oncophage had a 43% decreased risk of recurrence compared with patients in the observation arm.

Overall survival, the secondary endpoint, was also assessed in the 604 patients in the FAS patient population. The analysis, which is interim for the overall survival endpoint, indicated a trend against Oncophage. We believe that the data are also likely to have been influenced by missing information from patients who were lost to follow-up or withdrew consent.

Because the evidence of clinically significant improvement has been observed in a subgroup analysis and was not demonstrated in the pre-specified analysis of the primary and secondary endpoints of the Phase 3 study of Oncophage in renal cell carcinoma, this study alone will not be sufficient to support a biologics application for product approval.

Based on this analysis, additional data collection will be required to evaluate overall survival and the availability of such data is uncertain. The absence of such data could delay the initiation of future clinical studies. Moreover, even if such data is collected, it may continue to adversely affect our results, or the acceptability of the results, even

 

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if clinically meaningful, may not meet the requirements of regulatory authorities for submission and approval of a biologics application for product approval. Further clinical studies must be conducted to demonstrate the safety and efficacy of Oncophage. We may not be able to secure additional financing to continue our clinical trials. If we cannot secure additional financing, we may become insolvent.

During the quarter ended September 30, 2004, we completed enrollment of our Phase 3 trial in metastatic melanoma. Our overall manufacturing success rate for this trial was approximately 70%. During 2004 we indicated that we did not believe this trial would qualify as registrational. In October 2005, we announced preliminary survival data from this trial and updated findings were presented on June 5, 2006 at the meeting of the American Society of Clinical Oncology. Overall, patients in the intent-to-treat Oncophage arm (M1a, b and c combined categories as defined by the American Joint Committee on Cancer) fared similarly to those in the physician’s choice arm in terms of survival, the primary endpoint. In a subgroup of patients who received at least ten injections of Oncophage, overall median survival increased by approximately 29% in the Oncophage treated arm as compared with those in the physician’s choice treatment arm (16.5 months versus 12.8 months). These findings also noted that in a subgroup of randomized stage IV M1a and M1b combined patients, who received at least ten doses of Oncophage vaccine, median survival increased by approximately 143% in the Oncophage-treated arm compared with those in the physician’s choice treatment arm (31.2 months versus 12.8 months). This analysis was not pre-specified. The physician’s choice treatment arm included the current array of therapies such as chemotherapeutics, biological agents and/or surgery. This overall survival analysis of the primary endpoint on an intent-to-treat basis was not statistically significant.

AG-858

In December 2002, we reported interim data from a pilot Phase 1 clinical trial conducted at the University of Connecticut School of Medicine using HSPPC-70, a purified HSP70 and its associated antigens, for the treatment of chronic myelogenous leukemia, or CML. In April 2003, we initiated a Phase 2 trial in CML combining AG-858, our HSP70 based product candidate, with Gleevec (imatinib mesylate, Novartis) in patients with CML unresponsive to medical treatment with Gleevec. In May 2004, we voluntarily placed enrollment of this study on hold to modify the cell collection procedure. The study resumed on July 24, 2004. Effective April 7, 2006, the study was terminated due to a change in our corporate priorities.

AG-707

The first potential off-the-shelf application of our HSP technology, AG-707, is an investigational therapeutic vaccine product candidate directed at the virus that causes genital herpes (herpes simplex virus type 2, or HSV-2). We initiated a proof-of principle Phase 1 trial for AG-702, a monovalent (single-antigen) vaccine and predecessor to AG-707, in the fourth quarter of 2001. AG-707 is a multivalent vaccine containing multiple synthetic HSV-2 peptides. Based on the results of completed toxicology studies and other pre-clinical activities, we submitted to the FDA an investigational new drug application (“IND”) for AG-707 during the second quarter of 2005 and in October 2005, initiated a Phase 1 clinical trial of AG-707. We do not anticipate further developing AG-702, given that AG-707 has a potential to benefit a larger number of patients with genital herpes.

Aroplatin

We initiated a Phase 2 trial with Aroplatin for advanced colorectal cancer unresponsive to medical treatment in 2002. This single-arm, open-label trial, conducted at the Arizona Cancer Center, was designed to evaluate the effect of Aroplatin alone in patients whose disease is not responsive to standard first-line cancer treatments (5-fluorouracil/leucovorin or capecitabine and irinotecan). In September 2003, the investigators presented findings from this trial at the European Cancer Conference, also known as ECCO. One out of the 15 evaluable patients demonstrated a partial clinical response and two experienced disease stabilization. Because this was a single-arm study without a comparator arm, statistical significance is not calculable. Researchers observed that Aroplatin appears well tolerated in this pretreated patient population. This trial is closed to enrollment.

 

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In January 2003, we also initiated at the John Wayne Cancer Center, in Santa Monica, California, a Phase 1/2 trial of Aroplatin for a variety of advanced solid tumors amenable to platinum therapy. This study is closed to enrollment.

We have developed a new formulation of Aroplatin, and completed a Good Laboratory Practices toxicology study comparing the old and new formulations of Aroplatin in 2005. The results from this study and studies describing characterization of the new formulation were submitted in an IND amendment to the FDA during the third quarter of 2005. We initiated a Phase 1, dose-escalation trial of the reformulated Aroplatin in solid malignancies and NHL (non-Hodgkin’s lymphoma) in October 2005. This study is currently enrolling patients.

QS-21

On July 6, 2006, we entered into expanded license and supply agreements with GSK for the use of QS-21, an investigational adjuvant used in numerous vaccines. QS-21 is a key component included in several proprietary adjuvant systems. A number of vaccine candidates currently under development are formulated with adjuvant systems containing QS-21.

Under the terms of the agreements, we have agreed to supply QS-21 through 2014. In addition, we agreed to transfer manufacturing technologies under the supply agreement. We will receive payments contingent upon successful milestone achievements, and royalties on net sales for a period of at least ten years after the first commercial sale under the supply agreement.

In order to meet our collaborative partners’ requirements for QS-21, we intend to design and build a manufacturing suite within our existing facility. We are currently in the process of determining the cost of this manufacturing suite and estimate that it will take 18 months to build and commission. The cost of the manufacturing suite is expected to be recovered out of revenues derived from the supply of QS-21 to our collaborative partners.

Liquidity and Capital Resources

We have incurred annual operating losses since inception, and, as of June 30, 2006, we had an accumulated deficit of $439.3 million. We expect to incur significant losses over the next several years if we continue our clinical trials, apply for regulatory approvals, continue development of our technologies, and expand our operations. Phase 3 trials are particularly expensive to conduct. Since our inception, we have financed our operations primarily through the sale of equity and convertible notes, interest income earned on cash, cash equivalents, and short-term investment balances, and debt provided through secured lines of credit. From our inception through June 30, 2006, we have raised aggregate net proceeds of $399.6 million through the sale of equity, the exercise of stock options and warrants, proceeds from our employee stock purchase plan, and the issuance of convertible notes, and borrowed $20.5 million under two credit facilities. At June 30, 2006, we had debt outstanding of approximately $51.2 million.

We believe that, based on our current plans and activities, our working capital resources at June 30, 2006 and estimated proceeds from collaborative agreements will be sufficient to satisfy our liquidity requirements through the first half of 2007. In June 2005, we took steps to improve our operating efficiency through the prioritization of our development portfolio and a streamlining of our infrastructure. Consequently, we eliminated 26 positions. During December 2005, we implemented a series of actions to reduce our net cash burn rate (cash used in operating activities plus cash from investing activities and debt repayments), and preserve our cash. These actions included eliminating 65 positions, additional cost saving activities, and a focusing and streamlining of our research and development activities. In April 2006, we expanded our restructuring plan to further conserve funds. This additional restructuring involves temporarily discontinuing all late-stage clinical programs and concentrating on Phase 1 and preclinical programs, including Aroplatin, AG-707, and AU-801. In addition, we continue to support and develop our QS-21 partnering collaborations, with the goal of generating royalties as early as 2010. These actions also included further reducing our headcount to approximately 130 at the time. As a result of these actions and based on our current plans and activities, we anticipate that our net cash burn rate will be between $30 million and $35 million, on an annualized basis, from July 2006 onwards. In order to fund our operations through 2007 and beyond, we will need to raise additional funds and may attempt to do so by: (1) out-licensing technologies or products to one or more collaborative partners, (2) renegotiating license agreements with current collaborative partners, (3) completing an outright sale of assets, (4) securing additional debt financing, and/or (5) completing offerings of equity securities. Our ability to successfully enter into any such arrangements is uncertain, and if funds are not available, or not available on terms acceptable to us, we may be required to revise our planned clinical trials, other development

 

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activities, capital expenditures, and/or the scale of our operations. We expect to attempt to raise additional funds in advance of depleting our current funds; however, we may not be able to raise funds or raise amounts sufficient to meet the long-term needs of the business. Satisfying long-term liquidity needs may require the successful commercialization of product candidates, and at this time, we cannot reliably estimate if or when that will occur, or if we will require additional capital as discussed above. Please see the “Forward-Looking Statements” section and the risks highlighted under Part II-Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q.

Our future cash requirements include, but are not limited to, supporting our clinical trial efforts and continuing our other research and development programs. Since inception we have entered into various agreements with institutions and clinical research organizations to conduct and monitor our current clinical studies. Under these agreements, subject to the enrollment of patients and performance by the applicable institution of certain services, we have estimated our payments to be $45.9 million over the term of the studies. Through June 30, 2006, approximately $43.8 million has been expensed as research and development expenses in the accompanying condensed consolidated statements of operations and $40.9 million has been paid related to these clinical studies. The timing of our expense recognition and future payments related to these agreements are subject to the enrollment of patients and performance by the applicable institution of certain services. In addition, we have entered into sponsored research agreements related to our product candidates that require payments of approximately $9.1 million, of which $5.6 million has been paid through June 30, 2006. The actual amounts we pay out related to these agreements, if any, will depend on a range of factors outside of our control, including the success of our preclinical and clinical development efforts with respect to product candidates being developed which incorporate the patents, the content and timing of decisions made by the United States Patent and Trademark Office (“USPTO”), the FDA and other regulatory authorities, the existence and scope of third-party intellectual property, the reimbursement and competitive landscape around such products, and other factors affecting operating results. We plan to enter into additional agreements, and we anticipate significant additional expenditures will be required to complete our clinical trials, apply for regulatory approvals, continue development of our technologies, and bring our product candidates to market. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaborative arrangements with academic and collaborative partners and licensees and by entering into new collaborations. As a result of our collaborative agreements, we will not completely control the efforts to attempt to bring those product candidates to market. We have various agreements, for example, with collaborative partners and/or licensees that allow the use of our QS-21 adjuvant in numerous vaccines. These agreements grant exclusive worldwide rights in some fields of use and co-exclusive or non-exclusive rights in others. These agreements generally provide us with rights to manufacture and supply QS-21 to the collaborative partner or licensee and also call for royalties to be paid to us on future sales of licensed vaccines that include QS-21, which may or may not be achieved. Significant investment in manufacturing capacity will be required to exercise our manufacturing and supply rights.

Our cash, cash equivalents, and short-term investments at June 30, 2006 were $31.9 million, a decrease of $29.9 million from December 31, 2005. In conjunction with our expanded license and supply agreements with GSK, we received a $3 million up-front non-refundable payment in July 2006. During the six months ended June 30, 2006, we used cash primarily to finance our operations, including our Oncophage clinical trials. Net cash used in operating activities for the six months ended June 30, 2006 and 2005 was $28.9 million and $34.8 million, respectively. The decrease resulted primarily from steps taken in June 2005 to improve our operating efficiency through the prioritization of our development portfolio and a streamlining of our infrastructure and, in December 2005, to further update our business strategy and refocus our programs and priorities, including the postponement and deceleration of a number of our projects. These combined steps resulted in the elimination of 91 positions. In addition, in April 2006, we implemented a restructuring plan that further refocused our programs and priorities resulting in the temporary discontinuation of all late-stage clinical programs and concentration on Phase 1 and preclinical programs, including Aroplatin for the treatment of solid tumors and B-cell lymphoma, AG-707 for the treatment of genital herpes, and AU-801 for autoimmune disorders. We also terminated part II of the Phase 3 renal cell carcinoma trial and our Phase 2 trial of AG-858 for the treatment of CML. A combination study of Oncophage and ATRA-IV is also on hold pending review of the part I results. We continue to support and develop our QS-21 partnering collaborations, with the goal of generating royalties as early as 2010. To match these priorities, we eliminated an additional 42 positions. Our future ability to generate cash from operations will depend on achieving regulatory approval of our product candidates, market acceptance of such product candidates, achieving benchmarks as defined in existing collaborative agreements, and our ability to enter into new collaborations. Please see the “Forward-Looking Statements” section and the risks highlighted under Part II-Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q.

 

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Net cash provided by investing activities for the six months ended June 30, 2006 was $18.1 million as compared to $16.1 million provided by investing activities for the six months ended June 30, 2005. During the six months ended June 30, 2006 we had net maturities of $16.1 million in short-term investments compared with net maturities of $16.7 million during the six months ended June 30, 2005. Additionally, our expenditures on equipment and furniture and fixtures decreased nearly $1.9 million to $201,000 for the six months ended June 30, 2006. We anticipate capital expenditures will increase during the remainder of 2006 as we begin construction on a new manufacturing suite for the production of QS-21. We also received $2.2 million during the six months ended June 30, 2006 from the release of restrictions on our restricted cash balance compared to $1.5 million during the six months ended June 30, 2005. We made contributions of $75,000 to Applied Genomic Technology Capital Fund (“AGTC”), a limited partnership, during each of the six month periods ended June 30, 2006 and 2005. In addition, during the six months ended June 30, 2005, we received a cash distribution from AGTC of $123,000. Our remaining commitment to AGTC as of June 30, 2006 is $375,000, with contributions made as requested by the general partner.

Net cash used in financing activities was $3.0 million for the six months ended June 30, 2006 as compared to net cash provided by financing activities of $45.0 million for the six months ended June 30, 2005. During the six months ended June 30, 2006 and 2005, exercises of stock options and proceeds from our employee stock purchase plan totaled $410,000 and $202,000, respectively. Repayments of long-term debt totaled $3.0 million during the six months ended June 30, 2006, compared to $2.8 million during the six months ended June 30, 2005.

In January 2005, we received net proceeds of approximately $48.0 million from the issuance of our convertible senior notes. In July 2003 we entered into a $17.1 million debt facility to finance the first phase of build-out of our Lexington facility. Through June 30, 2006, we have borrowed $17.0 million under this facility. Specific assets, including certain leasehold improvements and a cash security deposit (restricted cash) of $778,000, secure the loans drawn on the credit facility. At June 30, 2006, we had a $1.1 million debt balance under this credit facility.

Effective July 19, 2002, we sublet part of our Framingham manufacturing, research and development, and office space to GTC Biotherapeutics, Inc. (“GTC”), and we have leased related leasehold improvements and equipment under agreements that expire on December 31, 2006. GTC has an option to extend this lease until September 2010. Under the terms of our original lease, we are obligated to pay our landlord approximately 7% of our rental income. Effective March 17, 2004, we sublet an additional part of our Framingham manufacturing, research and development, and office space to PP Manufacturing, whose lease expires on September 30, 2010. As a result of the PP Manufacturing lease agreement, we amended our agreement with GTC effective March 16, 2004, adjusting the leaseable square footage. In addition, until February 2006 we sublet part of our Texas facility to two small private companies. In January 2006, we entered into a sublease for part of our New York office space with a private company under an agreement expiring in December 2006. We are contractually entitled to receive rental income of $827,000 during the six months ending December 31, 2006; $515,000 in 2007; $515,000 in 2008; $515,000 in 2009; and $386,000 in 2010. The collection of this income, however, is subject to uncertainty.

We are currently involved in certain legal proceedings as detailed in Note F of our notes to unaudited condensed consolidated financial statements. While we currently believe that the ultimate outcome of any of these proceedings will not have a material adverse effect on our financial position, results of operations, or liquidity, litigation is subject to inherent uncertainty. Furthermore, litigation consumes both cash and management attention.

Related Parties

As of June 30, 2006, we had invested approximately $2.6 million in a limited partnership, AGTC, and during the six months ended June 30, 2005, we received $123,000 as a distribution from this partnership. Our total capital commitment to AGTC is $3.0 million. The general partner of AGTC is AGTC Partners, L.P. The management company for AGTC is NewcoGen Group Inc., which is a wholly owned subsidiary of Flagship Venture Management, Inc. (“Flagship”). Noubar Afeyan, Ph.D., who is one of our directors, is the Managing Partner and Chief Executive Officer of Flagship. For additional details, refer to Note F of our notes to unaudited condensed consolidated financial statements. Garo H. Armen, Ph.D., our Chairman and Chief Executive Officer, was a director of NewcoGen Group Inc. until 2004.

 

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We currently have QS-21 license and supply agreements with Neuralab Limited, a wholly owned subsidiary of Elan Corporation, plc (“Elan”), for use of QS-21 with an antigen in the field of Alzheimer’s disease. Garo H. Armen, Ph.D., our Chairman and Chief Executive Officer, is a director of Elan and is a nominal employee of a different wholly owned subsidiary of Elan. For the six months ended June 30, 2006 and 2005, no revenues were earned under these agreements and, at June 30, 2006 and December 31, 2005, we had no amounts due to us under these agreements.

In March 1995, we entered into a consulting agreement with Dr. Pramod Srivastava, our scientific founder and one of our directors, and upon its expiration in March 2006, we entered into a new Consulting Agreement (the “Agreement”), effective March 28, 2006, with Dr. Srivastava. The Agreement with Dr. Srivastava has an initial term of five years and is automatically extended for successive terms of one year unless either party notifies the other at least 90 days prior to the expiration of the original or any extension term that this Agreement is not to be extended. The Agreement may be terminated without cause by us during its term, subject to the payment of compensation for twelve months at the then current rate provided for under the Agreement. In exchange for the timely performance of services, as defined in the Agreement, Dr. Srivastava is entitled to receive compensation to be established by the Compensation Committee of the Antigenics Board of Directors. For the twelve-month period ending March 31, 2007, Dr. Srivastava will receive $175,000. Dr. Srivastava is also eligible to receive an annual bonus and stock options at the discretion of the Compensation Committee of our Board of Directors.

In February 1998, we entered into a research agreement with the University of Connecticut Health Center (UConn) to fund research in Dr. Pramod Srivastava’s laboratory at UConn. Dr. Srivastava is a member of the faculty of the University of Connecticut School of Medicine. The research agreement was amended on December 30, 2003 to extend the term to December 31, 2008 and calls for payments to UConn totaling a minimum of approximately $6.8 million, payable quarterly at the rate of $337,500, contingent on the continuing employment of Dr. Srivastava by UConn. In return, we have an option to obtain an exclusive license to new inventions (as defined in the research agreement) subject to our payment to UConn of royalties at varying rates upon commercialization of a product utilizing technology discovered under the research agreement. In February 2005, we entered into a letter amendment agreement to pay UConn an additional one-time payment of $135,000 for additional costs associated with activities performed under the agreement in 2005.

In September 2004, we entered into a $60,000 one-year service agreement with Techsoft, Inc. d.b.a Medical Systems and NG Techsoft Pvt. Ltd. for data management services. Navin Gupta is the President and CEO of Techsoft, Inc. d.b.a Medical Systems, Director and Chairman of the Board of NG Techsoft Pvt Ltd. and is the spouse of Dr. Renu Gupta, our Senior Vice President of Development. This agreement was extended several times during 2005 to obtain additional data management and processing services and expired in May 2006. For the six months ended June 30, 2006, we expensed $125,000 under this agreement. At June 30, 2006, we had no amounts due under this agreement.

On October 22, 2004, we executed a letter of intent with Symphony Capital LLC for a potential transaction to provide funding for certain of our research programs. Mr. Mark Kessel, one of our directors, is a managing director of Symphony Capital LLC. During February 2005, we determined not to pursue this potential transaction. During 2004, we made payments to Symphony Capital LLC of $125,000 for development planning activities. During the year ended December 31, 2005, we paid $196,000 to Symphony Capital LLC for activities up to termination in February 2005. Dr. Alastair Wood, another director of ours, is a consultant to, and has a financial interest in Symphony Capital LLC.

 

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Critical Accounting Policies and Estimates

The Securities and Exchange Commission (“SEC”) defines “critical accounting policies” as those that require application of management’s most difficult, subjective, or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods.

The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and 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. We base those estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ from those estimates.

The following listing is not intended to be a comprehensive list of all of our accounting policies. Our significant accounting policies are described in Note 2 to our consolidated financial statements included in our Form 10-K for the year ended December 31, 2005 filed with the SEC on March 15, 2006. In many cases, the accounting treatment of a particular transaction is dictated by U.S. generally accepted accounting principles, with no need for our judgment in their application. There are also areas in which our judgment in selecting an available alternative would not produce a materially different result. We have identified the following as our critical accounting policies:

Research and Development

Research and development expenses include the costs associated with our internal research and development activities, including salaries and benefits, occupancy costs, clinical manufacturing costs, related administrative costs, and research and development conducted for us by outside advisors, such as sponsored university-based research partners, and clinical study partners. We account for our clinical study costs by estimating the total cost to treat a patient in each clinical trial and recognizing this cost based on estimates of when the patient receives treatment, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs, related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial and the length of the treatment period for each patient. As we become aware of the actual costs, we adjust our accrual; such a change in estimate may be a material change in our clinical study accrual, which could also materially affect our results of operations. Research and development costs are expensed as incurred and were $7.9 million and $13.1 million for the three months ended June 30, 2006 and 2005, respectively. Research and development costs were $16.4 million and $24.4 million for the six months ended June 30, 2006 and 2005, respectively.

Investments

We classify investments in marketable securities at the time of purchase. At June 30, 2006, all marketable securities were classified as available-for-sale and as such, changes in the fair value of the available-for-sale securities are reported as a separate component of accumulated other comprehensive income (loss) until realized. If we were to classify future investments as trading securities rather than available-for-sale, our financial results would be subject to greater volatility. If declines in the fair value of available-for-sale securities are determined to be other than temporary, such losses would be recorded in the consolidated statement of operations.

Investments of less than 20% of the voting control of companies or other entities over whose operating and financial policies we do not have the power to exercise significant influence are accounted for by the cost method. We currently account for our investment in AGTC under the cost method and, as of June 30, 2006, we have included it in other long-term assets on the condensed consolidated balance sheet, as more fully disclosed in Note F of our notes to unaudited condensed consolidated financial statements included in this report. The general partner of AGTC determines the timing of our additional contributions. Our investment represents an approximate ownership interest of 2%. We continually assess the realizability of this investment. In order to assess whether or not there has been an other than temporary decline in the value of this investment, we analyze several factors including: (1) the carrying value of the limited partnership’s investments in its portfolio companies, (2) how recently the investments in the portfolio companies had been made, (3) the post-financing valuations of those investments, (4) the level of uninvested capital held by the limited partnership, and (5) the overall trend in venture capital valuations. Our investment balance aggregated $2.1 million and $2.0 million at June 30, 2006 and December 31, 2005, respectively.

 

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Revenue Recognition

Revenue from product sales is recognized at the time of product shipment. Revenue for services under research and development grants and contracts are recognized as the services are performed, or as clinical trial materials are provided. Non-refundable milestone payments that represent the completion of a separate earnings process are recognized as revenue when earned. License fees are recognized as they are earned.

Stock Option Accounting

Effective January 1, 2006, we adopted the fair value recognition provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123R, Share-Based Payment (“SFAS No. 123R”), using the modified prospective transition method, and therefore have not restated prior periods’ results. Our results of operations for the three and six months ended June 30, 2006 were impacted by the recognition of non-cash expense related to the fair value of our stock-based compensation awards. During the quarter ended June 30, 2006, we recorded a net charge of $991,000 related to stock-based compensation, of which a charge of $128,000 is included in research and development expense and a charge of $863,000 is included in general and administrative expense. For the six months ended June 30, 2006, we recorded a net charge of $806,000 related to stock-based compensation, of which a credit of $663,000 is included in research and development expense and a charge of $1.5 million is included in general and administrative expense. Stock-based compensation expense for the three and six months ended June 30, 2006 includes compensation expense for all stock-based options granted prior to, but not yet vested as of January 1, 2006, based on the grant date value estimated in accordance with the original provision of SFAS No. 123, Accounting for Stock-Based Compensation (“SFAS No 123”). In addition, stock-based compensation expense for the three and six months ended June 30, 2006 includes compensation expense for all stock-based options granted after January 1, 2006, based on the grant date fair value estimated in accordance with the provisions of SFAS No. 123R. Under the fair value recognition provisions of SFAS No. 123R, we recognize stock-based compensation net of an estimated forfeiture rate and only recognize compensation cost for those shares expected to vest on a straight-line prorated basis over the requisite service period of the award. In March 2005, the SEC issued Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment (“SAB No. 107”) regarding the SEC’s interpretation of SFAS No. 123R and the valuation of share-based payments for public companies. We have applied the provisions of SAB No. 107 in the adoption of SFAS No. 123R. See Note D of our notes to unaudited condensed consolidated financial statements for a further discussion on stock-based compensation.

Prior to the adoption of SFAS No. 123R, we accounted for options granted to employees and directors in accordance with Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations. As such, compensation cost was recorded on fixed stock option grants only if the current fair value of the underlying stock exceeded the exercise price of the option at the date of grant. In those situations, compensation expense was recognized on a straight-line basis over the vesting period.

Stock options granted to certain non-employees have been accounted for based on the fair-value method of accounting in accordance with SFAS No. 123R and Emerging Issues Task Force (“EITF”) Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. As a result, the non-cash charge to operations for non-employee options with vesting or other performance criteria has affected each reporting period, until the non-employee options vested, by changes in the fair value of our common stock. Effective January 1, 2006, under the provisions of EITF Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled, in a Company’s Own Stock , the change in fair value of vested options issued to non-employees will also affect each reporting period, until the options are exercised or expire.

Determining the appropriate fair value model and calculating the fair value of share-based payment awards require the input of highly subjective assumptions, including the expected life of the share-based payment awards and stock price volatility. The assumptions used in calculating the fair value of share-based payment awards represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our stock-based compensation expense could be materially different in the future. In addition, we are required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. If our actual forfeiture rate is materially different from our estimate, the stock-based compensation expense could be significantly different from what we have recorded in the current period. See Note D of our notes to unaudited condensed consolidated financial statements for a further discussion on stock-based compensation.

 

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Item 3 — Quantitative and Qualitative Disclosures About Market Risk

In the normal course of business, we are exposed to fluctuations in interest rates as we seek debt financing to make capital expenditures and invest excess cash and also foreign currency exchange rate fluctuation risk related to our transactions denominated in foreign currencies. We do not employ specific strategies, such as the use of derivative instruments or hedging, to manage these exposures. Our currency exposures vary, but are primarily concentrated in the Euro. Since the fiscal year ended December 31, 2005, there has been no material change with respect to our interest rate and foreign currency exposures or our approach toward those exposures. Further, we do not expect our market risk exposures to change in the near term.

We had cash, cash equivalents, and short-term investments at June 30, 2006 of approximately $31.9 million, which are exposed to the impact of interest rate changes and our interest income fluctuates as interest rates change. Due to the short-term nature of our investments in money market funds, corporate debt securities, taxable auction preferreds, and government-backed securities, our carrying value approximates the fair value of these investments at June 30, 2006, however, we are subject to investment risk.

We invest our cash, cash equivalents, and short-term investments in accordance with our Investment Policy. The primary objectives of our Investment Policy are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. Although our investments are subject to credit risk, our Investment Policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer or type of investment. Our investments are also subject to interest rate risk and will decrease in value if market interest rates increase. However, due to the conservative nature of our investments and relatively short duration, interest rate risk is mitigated. We do not invest in derivative financial instruments. Accordingly, we do not believe that there is any material market risk exposure with respect to derivative or other financial instruments that would require disclosure under this item.

Item 4 — Controls and Procedures

Evaluation of disclosure controls and procedures

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the Exchange Act). Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were functioning effectively as of the end of the period covered by this quarterly report to provide reasonable assurance that the Company can meet its disclosure obligations.

Changes in internal controls over financial reporting

During the quarter ended June 30, 2006, there was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II — OTHER INFORMATION

Item 1 — Legal Proceedings

Antigenics, our Chairman and Chief Executive Officer Garo Armen, and two investment banking firms that served as underwriters in our initial public offering have been named as defendants in a civil class action lawsuit filed on November 5, 2001 in the Federal District Court for the Southern District of New York on behalf of a class of purchasers of our stock between February 3, 2000 and December 6, 2000. Similar complaints were filed against about 300 other issuers, their underwriters, and in many instances their directors and officers. These cases have been coordinated under the caption In re Initial Public Offering Securities Litigation , Civ. No. 21 MC 92 (SAS), by order dated August 9, 2001. The suit against Antigenics and Dr. Armen alleges that the brokerage arms of the investment banking firms charged secret excessive commissions to certain of their customers in return for allocations of our stock in the offering. The suit also alleges that shares of our stock were allocated to certain of the investment banking firms’ customers based upon agreements by such customers to purchase additional shares of our stock in the secondary market. The complaint alleges that Antigenics is liable under Section 11 of the Securities Act of 1933, as amended (the “Securities Act”), and Dr. Armen is liable under Sections 11 and 15 of the Securities Act because our registration statement did not disclose these alleged practices. On April 19, 2002, the plaintiffs in this action filed an amended class action complaint, which contains new allegations. Again, similar amended complaints were filed with respect to the other companies. In addition to the claims in the earlier complaint, the amended complaint alleges that Antigenics and Dr. Armen violated Sections 10(b) and 20 of the Securities Exchange Act and SEC Rule 10b-5 by making false and misleading statements and/or omissions in order to inflate our stock price and conceal the investment banking firms’ alleged secret arrangements. The claims against Dr. Armen, in his individual capacity, have been dismissed without prejudice. On July 15, 2002, Antigenics and Dr. Armen joined the Issuer Defendants’ Motion to Dismiss the Consolidated Amended Complaints. By order of the Court, this motion set forth all “common issues,” i.e., all grounds for dismissal common to all or a significant number of Issuer Defendants. The hearing on the Issuer Defendants’ Motion to Dismiss and the other Defendants’ motions to dismiss was held on November 1, 2002. On February 19, 2003, the Court issued its opinion and order on the Issuer Defendants’ Motion to Dismiss. The Court granted Antigenics’ motion to dismiss the Rule 10b-5 and Section 20 claims with leave to amend and denied our motion to dismiss the Section 11 and Section 15 claims. On June 14, 2004, papers formalizing a proposed settlement among the plaintiffs, Issuer Defendants, and insurers were presented to the Federal District Court for the Southern District of New York. On February 15, 2005, the Court granted preliminary approval of the settlement. On August 31, 2005, the Court issued an order confirming preliminary approval of the settlement. The settlement remains subject to a number of conditions, including final approval of the Court. If the settlement becomes effective, Antigenics anticipates that it will not incur significant out-of-pocket costs, after insurance. Accordingly, an accrual has not been recorded at June 30, 2006.

A third party has filed a notice of opposition to European patent EP 0750513 B1 which has claims relating to AG-702/707, to which we hold the exclusive license. We believe this patent claims valid subject matter and intend to defend the opposition. However, there is no guarantee that this patent will not be revoked or that we may not have to amend the claims.

Antigenics and our Chairman and Chief Executive Officer have been named as defendants in a purported class action complaint filed on June 16, 2006 in Federal District Court in New Mexico by Steven J. Tuckfelt on behalf of himself and all others similarly situated. As of August 8, 2006, the complaint has not been served on either defendant, and pending service of process, proceedings in the litigation do not commence. The complaint alleges that certain of our disclosures in connection with the conduct of the Oncophage Phase 3 renal cell carcinoma trial violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as well as includes purported claims for breach of fiduciary duty. While we believe that the complaint is without merit and plan to vigorously defend against the litigation should it proceed, litigation is uncertain. Regardless of the outcome, participation in this lawsuit diverts management’s time and attention from our business and may result in requiring us to pay legal fees and damages.

We currently are a party to other legal proceedings as well. While we currently believe that the ultimate outcome of any of these proceedings will not have a material adverse effect on our financial position, results of operations, or liquidity, litigation is subject to inherent uncertainty. Furthermore, litigation consumes both cash and management attention.

 

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Item 1A. Risk Factors

Our future operating results could differ materially from the results described in this Quarterly Report on Form 10-Q due to the risks and uncertainties described below. We cannot assure investors that our assumptions and expectations will prove to have been correct. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements. See “Forward-Looking Statements” on page 15 of this Quarterly Report on Form 10-Q. Factors that could cause or contribute to such differences include those factors discussed below.

Risks Related to our Business

If we incur operating losses for longer than we expect, we may be unable to continue our operations.

From our inception through June 30, 2006, we have generated net losses totaling approximately $439.3 million. Our net losses for the six months ended June 30, 2006, and for the year ended December 31, 2005, were approximately $29.3 million and $74.1 million, respectively. We expect to incur significant losses over the next several years as we continue our clinical trials, apply for regulatory approvals, and continue development of our technologies. Furthermore, our ability to generate cash from operations is dependent on if and when we will be able to enter into strategic licensing and partnering relationships and/or commercialize our product candidates. Although we implemented cost-cutting measures late in 2005 and further cost-cutting measures in April 2006, the anticipated savings may not be at the levels estimated. If we incur operating losses for longer than we expect, we may be unable to continue our operations.

If we fail to obtain the capital necessary to fund our operations, we will be unable to advance our development programs and complete our clinical trials.

On June 30, 2006, we had approximately $31.9 million in cash, cash equivalents, and short-term investments. We believe that, based on our current plans and activities, our current working capital and estimated revenue from collaborative agreements will be sufficient to fund our planned development programs, clinical trials, and other operating activities through the first half of 2007. We plan to attempt to raise additional funds prior to that time. For the six months ended June 30, 2006, the sum of our average monthly cash used in operating activities plus our average monthly capital expenditures was approximately $4.9 million. Total capital expenditures for the six months ended June 30, 2006 were $201,000. We anticipate capital expenditures will increase during the remainder of 2006 as we begin construction on a new manufacturing suite for the production of QS-21. Since our inception, we have financed our operations principally by sales of equity and convertible debt instruments. In order to finance our future operations, we will be required to raise additional funds in the capital markets, through arrangements with collaborative partners, or from other sources. Additional financing, however, may not be available on favorable terms or at all. If we are unable to raise additional funds when we need them, we will be required to delay, reduce, or eliminate some or all of our development programs and some or all of our clinical trials, including the development programs and clinical trials supporting our product candidate, Oncophage. We also may be forced to license technologies to others under agreements that allocate to third parties substantial portions of the potential value of these technologies.

We have significant long-term debt, and we may not be able to make interest or principal payments when due.

As of June 30, 2006, our total long-term debt, excluding the current portion, was $50.0 million. Our 5.25% convertible senior notes due 2025 do not restrict our ability or the ability of our subsidiaries to incur additional indebtedness, including debt that effectively ranks senior to the notes. On each of February 1, 2012, February 1, 2015 and February 1, 2020, holders may require us to purchase their notes for cash equal to 100% of the principal amount of the notes, plus any accrued and unpaid interest. Holders may also require us to repurchase their notes upon a fundamental change, as defined, at a repurchase price, in cash, equal to 100% of the principal amount of the notes to be repurchased, plus any accrued and unpaid interest and, in some cases, an additional “make-whole” premium. Our ability to satisfy our obligations will depend upon our future performance, which is subject to many factors, including the factors identified in this “Risk Factors” section, and other factors beyond our control. If we are not able to generate sufficient cash flow from operations in the future to service our indebtedness, we may be required, among other things:

 

    to seek additional financing in the debt or equity markets;

 

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    to refinance or restructure all or a portion of our indebtedness, including the notes;

 

    to sell assets; and/or

 

    to reduce or delay planned expenditures on research and development and/or commercialization activities.

Such measures might not be sufficient to enable us to service our debt. In addition, any such financing, refinancing, or sale of assets might not be available on economically favorable terms.

To date, we have had negative cash flow from operations. For the six months ended June 30, 2006 and for the year ended December 31, 2005, net cash used in operating activities was approximately $28.9 million and $66.3 million, respectively. Assuming no additional interest-bearing debt is incurred and none of the notes are converted, redeemed, repurchased, or exchanged before February 1, 2012, our debt service requirements (payments of principal and interest) will be approximately $2.5 million during the six months ended December 31, 2006, $2.7 million during 2007 and $2.6 million annually during 2008 and thereafter until the notes are no longer outstanding.

Because part I of our Phase 3 trial in renal cell carcinoma did not achieve its primary endpoint, this trial would not be sufficient to support a biologics license application for product approval, and we would not expect to generate product revenue from sales of Oncophage until after the completion of additional clinical studies that demonstrate the safety and efficacy of Oncophage and the achievement of regulatory approval.

On March 24, 2006, we announced top-line results from part I of our Phase 3 study of Oncophage in renal cell carcinoma patients who are at high risk of recurrence after surgery, indicating that the trial did not meet its primary endpoint. The analysis was triggered based on the number of events (defined as recurrence of disease or death of a patient prior to recurrence) reported by study investigators. However, an independent review by the trial’s CEC revealed that a substantially smaller number of events had actually occurred. The analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint), and a trend against Oncophage for overall survival (a secondary endpoint); both findings were not statistically significant. The analysis of the overall survival endpoint is considered an interim assessment. At this time it is unclear as to why opposing trends were observed between recurrence-free survival and overall survival. There is no readily apparent adverse safety signal associated with the vaccine that we believe is contributing to this finding.

We conducted an in-depth analysis of data from part I of our Phase 3 study of Oncophage in renal cell carcinoma in April and May 2006 and discussed the results with the FDA and a panel of experts in this medical field. On June 7, 2006, we announced the findings of the analysis. With regard to the primary endpoint, recurrence-free survival, this analysis revealed that in a subgroup of better-prognosis patients in the trial, there was a clinically significant improvement. The subgroup consisted of 361 patients, or 60% of the 604 patients in the full analysis set (“FAS”) population. As defined by FDA-issued guidance, the FAS is the set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle. It is derived from the set of all randomized subjects by minimal and justified elimination of subjects. In this case, patients with baseline disease were excluded from the FAS population. In this 361-patient subgroup, patients receiving Oncophage had a 43% decreased risk of recurrence compared with patients in the observation arm.

Overall survival, the secondary endpoint, was also assessed in the 604 patients in the FAS patient population. The analysis, which is interim for the overall survival endpoint, indicated a trend against Oncophage. We believe that the data are also likely to have been influenced by missing information from patients who were lost to follow-up or withdrew consent.

Based on this analysis, additional data collection will be required to evaluate overall survival and the availability of such data is uncertain. The absence of such data could delay the initiation of future clinical studies. Moreover, even if such data is collected, it may continue to adversely affect our results, or the acceptability of the results, even if clinically meaningful, may not meet the requirements of regulatory authorities for submission and approval of a

 

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biologics application for product approval. Further clinical studies must be conducted to demonstrate the safety and efficacy of Oncophage. We may not be able to secure additional financing to continue our clinical trials. If we cannot secure additional financing, we may become insolvent.

Because the evidence of clinically significant improvement has been observed in a subgroup analysis and was not demonstrated in the pre-specified analysis of the primary and secondary endpoints of the Phase 3 study of Oncophage in renal cell carcinoma, this study alone will not be sufficient to support a biologics application for product approval.

Because the FDA has previously told us that part I of our Phase 3 trial in renal cell carcinoma, by itself, will not be sufficient to support a biologics license application for product approval, unless the FDA changes its position, and because of the results from part I, we do not expect the results of part I alone will provide substantial evidence in support of a future biologics license application that we ultimately may file with the FDA.

On September 3, 2003, the FDA placed our Phase 3 Oncophage clinical trials in renal cell carcinoma and in melanoma on partial clinical hold. The FDA’s written correspondence instituting the partial clinical hold indicated that Oncophage was not sufficiently characterized. On October 22, 2003, we submitted to the FDA additional specifications for purity, identity, potency and pH, which represent product characterization data, and on November 23, 2003, the FDA lifted the partial clinical hold. Even though the FDA lifted the partial clinical hold, the FDA informed us that, for purposes of part I of our Phase 3 trial in renal cell carcinoma and our Phase 3 trial in melanoma, Oncophage has been insufficiently characterized and that the results obtained with an insufficiently characterized product could not be used to provide efficacy data in support of a biologics license application, or BLA. The FDA deemed the Oncophage provided to patients before December 2003 to be insufficiently characterized because it had not undergone the full battery of tests required for drugs used in pivotal trials. Some of these tests, such as potency assays, were not fully developed until after September 2003. The imposition of the partial clinical hold prevented us from enrolling new patients in our Phase 3 clinical trials between September 3, 2003 and November 21, 2003. We believe that we addressed the comments the FDA raised in connection with the partial clinical hold. After the clinical hold was lifted, the FDA asked us to implement the use of potency assays to release vaccine lots for all trials of Oncophage, including our Phase 3 trials. Subsequently, we submitted, during 2004, our validation package to the FDA for the potency assays, and in May 2005 we successfully concluded discussions with the FDA. Validation of the assays refers, in general terms, to establishing the robustness and reproducibility of the assays on an ongoing basis and under various different conditions to demonstrate that the potency assays work consistently. The potency assays have been used to test product administered since December 2003, and we have performed tests on frozen stored portions of product administered to patients prior to December 2003. This data will be submitted to FDA as part of any BLA filing for Oncophage. We believe we have addressed all product characterization issues raised by the FDA to date.

Because the FDA indicated that, by itself, part I of our Phase 3 clinical trial in renal cell carcinoma was not sufficient to support a BLA filing, we expanded our clinical development plan by initiating a part II to this Phase 3 trial in a similar patient population. The FDA agreed with this registration plan, which was comprised of two components — part I and part II.

On March 24, 2006, we announced top-line results from part I of our Phase 3 renal cell carcinoma trial. The analysis was triggered based on the number of events reported by study investigators. However, an independent review by the trial’s CEC revealed that a substantially smaller number of events had actually occurred. The analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint), and a trend against Oncophage for overall survival (a secondary endpoint); both findings were not statistically significant. The analysis of the overall survival endpoint is considered an interim assessment. At this time it is unclear as to why opposing trends were observed between recurrence-free survival and overall survival. There is no readily apparent adverse safety signal associated with the vaccine that we believe is contributing to this finding.

Based on these results, we discontinued part II of our Phase 3 renal cell carcinoma trial and initiated an in-depth analysis of the data from part I of the Phase 3 renal cell carcinoma trial. This in-depth analysis found what we believe to be clinically meaningful improvement in recurrence-free survival in a subgroup of better-prognosis patients. However, the data relating to overall survival, which is an interim assessment, indicated a trend against Oncophage.

 

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Based on this analysis, additional data collection will be required to evaluate overall survival, and the availability of such data is uncertain. The absence of such data could delay the initiation of future clinical studies. Moreover, even if such data is collected, it may continue to adversely affect our results, or the acceptability of the results, even if clinically meaningful, may not meet the requirements of regulatory authorities for submission and approval of a biologics application for product approval. Further clinical studies must be conducted to demonstrate the safety and efficacy of Oncophage. We may not be able to secure additional financing to continue our clinical trials. If we cannot secure additional financing, we may become insolvent.

Because we expect additional Phase 3 clinical trials of Oncophage in the treatment of melanoma will be required prior to submitting a BLA for this indication, we will not commercialize Oncophage in this indication for several years, if ever.

During the quarter ended September 30, 2004, we completed enrollment of our Phase 3 trial in metastatic melanoma. Our overall manufacturing success rate for this trial was approximately 70%. During 2004 we indicated that we did not believe this trial would qualify as registrational. In October 2005, we announced preliminary survival data from this trial and updated findings were presented on June 5, 2006 at the meeting of the American Society of Clinical Oncology. Overall, patients in the intent-to-treat Oncophage arm (M1a, b and c combined categories as defined by the American Joint Committee on Cancer) fared similarly to those in the physician’s choice arm in terms of survival, the primary endpoint. In a subgroup of patients who received at least ten injections of Oncophage, overall median survival increased by approximately 29% in the Oncophage treated arm as compared with those in the physician’s choice treatment arm (16.5 months versus 12.8 months). These findings also noted that in a subgroup of randomized stage IV M1a and M1b combined patients, who received at least ten doses of Oncophage vaccine, median survival increased by approximately 143% in the Oncophage-treated arm compared with those in the physician’s choice treatment arm (31.2 months versus 12.8 months). This analysis was not pre-specified. The physician’s choice treatment arm included the current array of therapies such as chemotherapeutics, biological agents and/or surgery. This overall survival analysis of the primary endpoint on an intent-to-treat basis was not statistically significant.

Due to a relatively high failure rate in vaccine manufacturing, this study would not, by itself, be expected to support a BLA filing. Even if we had not experienced the high manufacturing failure rate, the FDA has indicated that this study, like part I of our Phase 3 renal cell carcinoma study, could not, by itself, support a BLA filing because the FDA views the Oncophage administered to patients in this study prior to December 2003 as insufficiently characterized. We have not yet had any specific discussions with the FDA regarding our clinical development plan for melanoma. Accordingly, we do not know the types of studies that the FDA will require to support a BLA filing. Even if the FDA were to indicate agreement with our clinical development plan, that plan may fail to support a BLA filing for many reasons, including failure of the trials to demonstrate that Oncophage is safe and effective in this indication, failure to conduct the studies in compliance with the clinical trial protocols, or a change in the FDA’s views.

Analysis of subgroups in clinical trials is generally hypothesis-generating, supportive of future clinical trials, and not generally supportive, alone, of registration or approval of a product.

The signals and trends observed in the Phase 3 renal cell carcinoma and melanoma trials of Oncophage are based on data analysis of subgroups that were not pre-specified endpoints in these studies. While the data might be suggestive of treatment effect, the results cannot be expected, alone, to support registration or approval of Oncophage. While the data provide important evidence that is useful for physicians in designing and conducting future clinical trials, additional evidence may be required to recruit physicians for future clinical research.

 

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We expect our commercial launch of Oncophage to be delayed, and it may be prevented, which would diminish our business prospects.

On March 24, 2006, we announced top-line results from part I of our Phase 3 renal cell carcinoma trial. The analysis was triggered based on the number of events reported by study investigators. However, an independent review by the trial’s CEC revealed that a substantially smaller number of events had actually occurred. The analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint), and a trend against Oncophage for overall survival (a secondary endpoint); both findings were not statistically significant. The analysis of the overall survival endpoint is considered an interim assessment. At this time it is unclear as to why opposing trends were observed between recurrence-free survival and overall survival. There is no readily apparent adverse safety signal associated with the vaccine that we believe is contributing to this finding.

Based on these results, we discontinued part II of our Phase 3 renal cell carcinoma trial and initiated an in-depth analysis of the data from part I of the Phase 3 renal cell carcinoma trial. This in-depth analysis found what we believe to be clinically meaningful improvement in recurrence-free survival in a subgroup of better prognosis patients. However, the data relating to overall survival, which is an interim assessment, indicated a trend against Oncophage.

Based on this analysis, additional data collection will be required to evaluate overall survival and the availability of such data is uncertain. The absence of such data could delay the initiation of future clinical studies. Moreover, even if such data is collected, it may continue to adversely affect our results, or the acceptability of the results, even if clinically meaningful, may not meet the requirements of regulatory authorities for submission and approval of a biologics application for product approval. Further clinical studies must be conducted to demonstrate the safety and efficacy of Oncophage. We may not be able to secure additional financing to continue our clinical trials. If we cannot secure additional financing, we may become insolvent.

During the quarter ended September 30, 2004, we completed enrollment of our Phase 3 trial in metastatic melanoma. Our overall manufacturing success rate for this trial was approximately 70%. During 2004 we indicated that we did not believe this trial would qualify as registrational. In October 2005, we announced preliminary survival data from this trial and updated findings were presented on June 5, 2006 at the meeting of the American Society of Clinical Oncology. Overall, patients in the intent-to-treat Oncophage arm (M1a, b and c combined categories as defined by the American Joint Committee on Cancer) fared similarly to those in the physician’s choice arm in terms of survival, the primary endpoint. In a subgroup of patients who received at least ten injections of Oncophage, overall median survival increased by approximately 29% in the Oncophage treated arm as compared with those in the physician’s choice treatment arm (16.5 months versus 12.8 months). These findings also noted that in a subgroup of randomized stage IV M1a and M1b combined patients, who received at least ten doses of Oncophage vaccine, median survival increased by approximately 143% in the Oncophage-treated arm compared with those in the physician’s choice treatment arm (31.2 months versus 12.8 months). This analysis was not pre-specified. The physician’s choice treatment arm included the current array of therapies such as chemotherapeutics, biological agents and/or surgery. This overall survival analysis of the primary endpoint on an intent-to-treat basis was not statistically significant. As we have previously stated, we believe this study will not, by itself support a BLA filing.

The drug development and approval process is uncertain, time-consuming and expensive.

The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain. It also can vary substantially based on the type, complexity, and novelty of the product. We must provide the FDA and foreign regulatory authorities with preclinical and clinical data demonstrating that our product candidates are safe and effective before they can be approved for commercial sale. Clinical development, including preclinical testing, is also a long, expensive, and uncertain process. It may take us several years to complete our testing, and failure can occur at any stage of testing. Interim results of preclinical or clinical studies do not necessarily predict their final results, and acceptable results in early studies might not be seen in later studies. Any preclinical or clinical test may fail to produce results satisfactory to the FDA. Preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval. Negative or inconclusive results from a preclinical study or clinical trial, adverse medical events during a clinical trial, or safety issues resulting from products of the same class of drug could require a preclinical study or clinical trial to be repeated or cause a program to be terminated, even if other studies or trials relating to the program are successful.

 

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Oncophage is a novel therapeutic cancer vaccine that is personalized for each patient, meaning it is derived from the patient’s own tumor. To date, the FDA has not approved any therapeutic cancer vaccines for commercial sale, and foreign regulatory agencies have approved only a limited number. Both the FDA and foreign regulatory agencies, including the European Medicines Agency responsible for product approvals in Europe, and Health Canada responsible for product approvals in Canada, have relatively little experience in reviewing personalized oncology therapies, and the partial clinical hold that the FDA had placed, and subsequently lifted, on our Phase 3 Oncophage clinical trials primarily related to product characterization issues partially associated with the personalized nature of Oncophage. Oncophage may experience a long regulatory review process and high development costs, either of which could delay or prevent our commercialization efforts. We have also initiated communications with regulatory health authorities in other jurisdictions to discuss requirements for the approval of Oncophage in renal cell carcinoma. As of June 30, 2006, we have spent approximately 12 years and $217.6 million on our research and development program in heat shock proteins for cancer.

To obtain regulatory approvals, we must, among other requirements, complete carefully controlled and well-designed preclinical studies and clinical trials demonstrating that a particular product candidate is safe and effective for the applicable disease. Several biotechnology companies have failed to obtain regulatory approvals because regulatory agencies were not satisfied with the structure or conduct of the preclinical studies and clinical trials or the ability to interpret the data from the trials; similar problems could delay or prevent us from obtaining approvals.

We may not complete our planned preclinical studies or clinical trials on schedule or at all. We may not be able to confirm the safety and efficacy of our potential drugs in long-term clinical trials, which may result in a delay or failure to commercialize our product candidates. The timing and success of a clinical trial is dependent on enrolling sufficient patients in a timely manner, avoiding serious or significant adverse patient reactions, and demonstrating efficacy of the product candidate in order to support a favorable risk versus benefit profile. Because we rely on third-party clinical investigators and contract research organizations to conduct our clinical trials, we may encounter delays outside our control, particularly if our relationships with any third-party clinical investigators or contract research organizations are adversarial. The timing and success of our clinical trials, in particular, are also dependent on the FDA and other regulatory agencies accepting each trial’s protocol, statistical analysis plan, product characterization tests, and clinical data. If we are unable to satisfy the FDA and other regulatory agencies with such matters, including the specific matters noted above, or our clinical trials yield inconclusive or negative results, we will be required to modify or expand the scope of our clinical studies or conduct additional studies to support BLA filings. In addition, the FDA may request additional information or data that is not readily available. Delays in our ability to respond to such an FDA request would delay, and failure to adequately address all FDA concerns would prevent, our commercialization efforts.

Also, we, or the FDA, might further delay or halt our clinical trials for various reasons, including but not limited to:

 

    we may fail to comply with extensive FDA regulations;

 

    a product candidate may not appear to be more effective than current therapies;

 

    a product candidate may have unforeseen, undesirable or significant adverse side effects, toxicities or other characteristics;

 

    the time required to determine whether a product candidate is effective may be longer than expected;

 

    we may be unable to adequately follow or evaluate patients after treatment with a product candidate;

 

    patients may die during a clinical trial because their disease is too advanced or because they experience medical problems that may not be related to the product candidate;

 

    sufficient numbers of patients may not enroll in our clinical trials; or

 

    we may be unable to produce sufficient quantities of a product candidate to complete the trial.

 

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Furthermore, regulatory authorities, including the FDA, may have varying interpretations of our preclinical and clinical trial data, which could delay, limit, or prevent regulatory approval or clearance. Any delays or difficulties in obtaining regulatory approvals or clearances for our product candidates may:

 

    adversely affect the marketing of any products we or our collaborators develop;

 

    impose significant additional costs on us or our collaborators;

 

    diminish any competitive advantages that we or our collaborators may attain; and

 

    limit our ability to receive royalties and generate revenue and profits.

If we are delayed in these activities or do not receive regulatory approval for our product candidates in a timely manner, we will have to incur additional development expense and, subject to securing additional financing, we will not be able to commercialize them in the timeframe anticipated, and, therefore, our business will suffer.

We must receive separate regulatory approvals for each of our product candidates for each type of disease indication before we can market and sell them in the United States or internationally.

We and our collaborators cannot sell any drug or vaccine until we receive regulatory approval from governmental authorities in the United States and from similar agencies in other jurisdictions. Oncophage and any other drug candidate could take a significantly longer time to gain regulatory approval than we expect or may never gain approval or may gain approval for only limited indications.

Even if we do receive regulatory approval for our product candidates, the FDA or international regulatory authorities will impose limitations on the indicated uses for which our products may be marketed or subsequently withdraw approval, or may take other actions against us or our products adverse to our business.

The FDA and international regulatory authorities generally approve products for particular indications. If an approval is for a limited indication, this limitation reduces the size of the potential market for that product. Product approvals, once granted, may be withdrawn if problems occur after initial marketing. Failure to comply with applicable FDA and other regulatory requirements can result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to renew marketing applications and criminal prosecution.

Delays enrolling patients in our studies will slow or prevent completion of clinical trials.

We have encountered in the past, and may encounter in the future, delays in initiating trial sites and in enrolling patients into our clinical trials. Future enrollment delays will postpone the dates by which we expect to complete the impacted trials and the potential receipt of regulatory approvals. If we fail to enroll sufficient numbers of patients in clinical trials, the trials may fail to demonstrate the efficacy of a product candidate at a statistically significant level. While such trials may help support our efforts to obtain marketing approval, they generally would not, by themselves, be sufficient for obtaining approval. In our cancer trials, enrollment difficulties may arise due to many factors, including the novel nature of our product candidates such as Oncophage, the identification of patients’ meeting the specific criteria for inclusion in our trials, the speed by which participating clinical trial sites review our protocol and allow enrollment, and any delay in contract negotiations between us and the participating clinical trial sites. In addition, we may encounter problems in our clinical trials due to increased pharmaceutical industry demand for clinical trial patients as well as limited patient availability due to the advanced disease state of the target patient population. Even if our patient enrollment is adequate, patients may die during a clinical trial if their disease is too advanced or because they experience problems that may be unrelated to the product candidate. A high dropout rate in a trial may undermine the ability to gain statistically significant data from the study.

 

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If new data from our research and development activities continues to modify our strategy, then we expect to continually adjust our projections of timelines and costs of programs; this uncertainty may depress the market price of our stock and increase our expenses.

Because we are focused on novel technologies, our research and development activities, including our preclinical studies and clinical trials, involve the ongoing discovery of new facts and the generation of new data, based on which we determine next steps for a relevant program. These developments are sometimes a daily occurrence and constitute the basis on which our business is conducted. We need to make determinations on an ongoing basis as to which of these facts or data will influence timelines and costs of programs. We may not always be able to make such judgments accurately, which may increase the costs we incur attempting to commercialize our product candidates. These issues are pronounced in our efforts to commercialize Oncophage, which represents an unprecedented approach to the treatment of cancer.

We may need to successfully address a number of technological challenges in order to complete development of our product candidates. Moreover, these product candidates may not be effective in treating any disease or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use.

Failure to enter into significant collaboration agreements may hinder our efforts to develop and commercialize our product candidates and will increase our need to rely on sales of securities to fund our operations.

We have been engaged in efforts to enter into collaborative partnering transactions, with a pharmaceutical or larger biotechnology company to assist us with global development and commercialization of our product candidates.

While we have been pursuing these business development efforts for several years, we have not negotiated a definitive agreement relating to the potential commercialization of Oncophage. Following the announcement in March 2006 that the results of part I of our Phase 3 trial in renal cell carcinoma did not achieve its primary endpoint, many larger companies may be unwilling to commit to a substantial agreement prior to receipt of additional clinical data. In the absence of such data, potential collaborative partners may demand economic terms that are unfavorable to us. Even if Oncophage generates favorable clinical data over the next several years, we may not be able to negotiate a transaction that provides us with favorable economic terms.

We have also been pursuing business development efforts to partner Aroplatin. Aroplatin is at an early stage of clinical development, and collaborative partners or licensees may defer such discussions until results from early clinical trials become available.

While some other biotechnology companies have negotiated large collaborations, we may not be able to negotiate any agreements with terms that replicate the terms negotiated by those other companies. We may not, for example, obtain significant upfront payments or substantial royalty rates. Some larger companies are skeptical of the commercial potential and profitability of a personalized product candidate like Oncophage or an early stage product like Aroplatin. If we fail to enter into such collaboration agreements, our efforts to develop and commercialize Oncophage or Aroplatin may be undermined. In addition, if we do not raise funds through collaboration agreements, we will need to rely on sales of additional securities to fund our operations. Sales of additional equity securities may substantially dilute the ownership of existing stockholders.

We may not receive significant royalty, milestone or manufacturing revenue payments from collaborators or licensees due to unsuccessful results in existing collaborations and licenses, failure to enter into future collaborations or license agreements or our inability to manufacture product supply requirements for our collaborators and licensees.

Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations. Our success depends on our ability to negotiate such agreements and on the success of the other parties in performing research and preclinical and clinical testing. Our collaborations involving QS-21, for example, depend on our

 

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collaborative partners or licensees successfully completing clinical trials, our successful expansion of our manufacturing capacity to meet collaborative partner or licensee demand, and our collaborative partners or licensees obtaining regulatory approvals.

These development activities frequently fail to produce marketable products. For example, in March 2002, Elan Corporation, plc and Wyeth-Ayerst Laboratories announced a decision to cease dosing patients in their Phase 2A clinical trial of their AN-1792 Alzheimer’s vaccine containing our QS-21 adjuvant after several patients experienced clinical signs consistent with inflammation in the central nervous system. Several of our agreements also require us to transfer important rights and regulatory compliance responsibilities to our collaborators and licensees. As a result of collaborative agreements, we will not control the nature, timing, or cost of bringing these product candidates to market. Our collaborators and licensees could choose not to devote resources to these arrangements or, under certain circumstances, may terminate these arrangements early. They may cease pursuing the programs or elect to collaborate with different companies. In addition, these collaborators and licensees, outside of their arrangements with us, may develop technologies or products that are competitive with those that we are developing. From time to time we may also become involved in disputes with our collaborators. As a result of these factors, our strategic collaborations may not yield revenue. In addition, we may be unable to enter into new collaborations or enter into new collaborations on favorable terms. Failure to generate significant revenue from collaborations would increase our need to fund our operations through sales of securities and could limit financial resources available for investment in manufacturing capacity expansion.

If we are unable to purify heat shock proteins from some cancer types, we may have difficulty successfully initiating clinical trials in new indications or completing our clinical trials and, even if we do successfully complete our clinical trials, the size of our potential market could decrease.

Our ability to successfully develop and commercialize Oncophage for a particular cancer type depends on our ability to purify heat shock proteins from that type of cancer. If we experience difficulties in purifying heat shock proteins for a sufficiently large number of patients in our clinical trials, it may lower the probability of a successful analysis of the data from these trials and, ultimately, the ability to obtain FDA approval. Our overall manufacturing success rate for part I of our Phase 3 trial in renal cell carcinoma was 92%; for our Phase 3 trial in metastatic melanoma, it was 70%. Our inability to manufacture adequate amounts of Oncophage for approximately 30% of the patients randomized in the Oncophage treatment arm of the metastatic melanoma trial undermined the potential for the trial to meet its pre-specified clinical endpoints. To address this lower success rate for melanoma, we instituted an inhibitor process to avoid the breakdown of proteins. Subsequent to the implementation of this change, we successfully produced Oncophage for 18 of 23 patients, a success rate of approximately 78%, whereas previously we had produced Oncophage for 123 of 179 patients, a success rate of approximately 69%. The small sample size used subsequent to our process change may make the reported improvement in our manufacturing success unreliable as a predictor of future success.

We have successfully manufactured product for 100%, ten of ten, of the patients randomized to treatment in our Phase 2 lung cancer trial and 95%, 21 of 22 patients, randomized to treatment in our Phase 2 metastatic renal cell carcinoma trial. Based on our completed clinical trials to date, we have been able to manufacture Oncophage from 87% of the tumors delivered to our manufacturing facility; for melanoma (including our Phase 3 trial), 70%; for colorectal cancer, 98%; for gastric cancer, 81%; for lymphoma, 89%; and for pancreatic cancer, 46%. The relatively low rate for pancreatic cancer is due to the abundance of proteases in pancreatic tissue. Proteases are enzymes that break down proteins. These proteases may degrade the heat shock proteins during the purification process. We have made process development advances that have improved the manufacture of Oncophage from pancreatic tissue. In an expanded Phase 1 pancreatic cancer study, Oncophage was manufactured from five of five tumor samples (100%), bringing the aggregate success rate for this cancer type, which was previously 30%, to 46%.

We may encounter problems with other types of cancer as we expand our research. If we cannot overcome these problems, the number of cancer types that our heat shock protein product candidates could treat would be limited. In addition, if we commercialize our heat shock protein product candidates, we may face claims from patients for whom we are unable to produce a vaccine.

 

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Manufacturing problems may cause product launch delays and unanticipated costs.

If one of our product candidates or our licensees’ product candidates for which we hold manufacturing rights nears marketing approval or is approved for sale, we expect we would be required to manufacture substantially more than we have been required to manufacture for preclinical studies and clinical trials. We have no experience manufacturing products in commercial quantities, and we can provide no assurance that we will be able to do so successfully. We may experience higher manufacturing failure rates than we have in the past if and when we attempt to substantially increase production volume.

Furthermore, because Oncophage is a personalized biologic, it requires product characterization steps that are more onerous than those required for most chemical pharmaceuticals. Accordingly, we employ multiple steps to attempt to control the manufacturing processes. Minor deviations in these manufacturing processes could result in unacceptable changes in the vaccine that result in production failures.

We have the right to elect to manufacture some of our product candidates other than Oncophage and AG-707 in our own manufacturing facilities (e.g., QS-21 and Aroplatin). This would require the investment of substantial funds and the recruitment of qualified personnel in order to build, or lease and operate any new manufacturing facilities. We are only beginning to plan and develop clinical or commercial-scale manufacturing capabilities for our product candidates other than Oncophage and AG-707. In order to continue to develop our other product candidates, apply for regulatory approvals and commercialize these product candidates, we or our licensees or collaborators will need to develop, contract for or otherwise arrange for the necessary manufacturing capabilities. We currently rely and expect to continue to rely, upon third parties, potentially including our collaborators, to produce materials required for preclinical studies and clinical trials and for these product candidates. A number of factors could cause production interruptions at our manufacturing facility or our contract manufacturers, including equipment malfunctions, labor or employment retention problems, natural disasters, power outages, terrorist activities, or disruptions in the operations of our suppliers. Alternatively, there is the possibility we may have excess manufacturing capacity if programs do not progress as planned.

There are a limited number of contract manufacturers that operate under the FDA’s good manufacturing practices regulations capable of manufacturing our product candidates. If we are unable to do so ourselves or arrange for third-party manufacturing of these product candidates, or to do so on commercially reasonable terms, we may not be able to complete development of these product candidates or commercialize them ourselves or through our collaborative partners or licensees.

Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured products ourselves, including reliance on the third party for regulatory compliance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control and the possibility of termination or non-renewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.

Manufacturing is also subject to extensive government regulation. Regulatory authorities must approve the facilities in which human healthcare products are produced. In addition, facilities are subject to ongoing inspections and minor changes in manufacturing processes may require additional regulatory approvals, either of which could cause us to incur significant additional costs and lose revenue.

If we fail to sustain and further build our intellectual property rights, competitors will be able to take advantage of our research and development efforts to develop competing products.

If we are not able to protect our proprietary technology, trade secrets, and know-how, our competitors may use our inventions to develop competing products. We currently have exclusive rights to at least 81 issued U.S. patents and 117 foreign patents. We also have rights to at least 48 pending U.S. patent applications and 186 pending foreign patent applications. However, our patents may not protect us against our competitors. Our patent positions, and those of other pharmaceutical and biotechnology companies, are generally uncertain and involve complex legal, scientific and factual questions. The standards which the United States Patent and Trademark Office uses to grant patents, and the standards which courts use to interpret patents, are not always applied predictably or uniformly and

 

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can change, particularly as new technologies develop. Consequently, the level of protection, if any, that will be provided by our patents if we attempt to enforce them, and they are challenged, is uncertain. In addition, the type and extent of patent claims that will be issued to us in the future is uncertain. Any patents that are issued may not contain claims that permit us to stop competitors from using similar technology.

In addition to our patented technology, we also rely on unpatented technology, trade secrets, and confidential information. We may not be able to effectively protect our rights to this technology or information. Other parties may independently develop substantially equivalent information and techniques or otherwise gain access to or disclose our technology. We generally require each of our employees, consultants, collaborators, and certain contractors to execute a confidentiality agreement at the commencement of an employment, consulting, collaborative, or contractual relationship with us. However, these agreements may not provide effective protection of our technology or information or, in the event of unauthorized use or disclosure, they may not provide adequate remedies.

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to, or use, our technology.

If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company has the right to ask a court to rule that our patents are invalid and should not be enforced against that third party. These lawsuits are expensive and would consume time and other resources even if we were successful in stopping the infringement of our patents. In addition, there is a risk that the court will decide that our patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of our patents is upheld, the court will refuse to stop the other party on the grounds that such other party’s activities do not infringe our patents.

We may not have rights under some patents or patent applications related to some of our existing and proposed products or processes. Third parties may own or control these patents and patent applications in the United States and abroad. Therefore, in some cases, such as those described below, in order to develop, use, manufacture, sell or import some of our existing or proposed products or develop or use some of our existing or proposed processes, we or our collaborators may choose to seek, or be required to seek, licenses under third-party patents issued in the United States and abroad, or those that might issue from United States and foreign patent applications. In such an event, we likely would be required to pay license fees or royalties or both to the licensor. If licenses are not available to us on acceptable terms, we or our collaborators may not be able to exploit these products or processes.

Furthermore, a third party may claim that we are using inventions covered by such third party’s patents or other intellectual property rights and may go to court to stop us from engaging in our normal operations and activities. These lawsuits are expensive and would consume time and other resources. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court will order us to pay the other party substantial damages for having violated the other party’s patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. We know of patents issued to third parties relating to heat shock proteins and alleviation of symptoms of cancer, respectively. We have reviewed these patents, and we believe, as to each claim in those patents, that we either do not infringe the claim or that the claim is invalid. Moreover, patent holders sometimes send communications to a number of companies in related fields suggesting possible infringement, and we, like a number of biotechnology companies, have received this type of communication, including with respect to the third-party patents mentioned above, as well as a communication alleging infringement of a patent relating to certain gel-fiberglass structures. If we are sued for patent infringement, we would need to demonstrate that our products either do not infringe the patent claims of the relevant patent and/or that the patent claims are invalid, which we may not be able to do. Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Additionally, two of the patent applications licensed to us contain claims that are substantially the same as claims in a third-party patent relating to heat shock proteins. We have asked the United States Patent and Trademark Office to declare an interference with this third-party patent, U.S. Patent No. 6,713,608 which we believe is owned by the Science & Technology Corporation @ UNM (University of New Mexico). We believe that the invention of

 

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U.S. Patent No. 6,713,608 is the same as that of earlier-filed U.S. Patents No. 5,747,332, 6,066,716, and 6,433,141, which we believe are owned by the University of New Mexico and which were involved in a previous interference proceeding with one of those two applications. During that interference proceeding, we were awarded priority based upon our earlier effective filing date. Accordingly, we believe that the United States Patent and Trademark Office would declare an interference between our pending patent applications and this latest third-party patent and that the claims of U.S. Patent No. 6,713,608 would be deemed invalid. Although we believe that we should prevail against this third-party patent in an interference proceeding, there is no guarantee that that will be the outcome.

Additionally, a third party has filed a notice of opposition to European patent EP 0750513 B1 which has claims relating to AG-702/707, to which we hold the exclusive license. We believe this patent claims valid subject matter and intend to defend the opposition. However, there is no guarantee that this patent will not be revoked or that we may not have to amend the claims.

We may become involved in expensive patent litigation or other proceedings, which could result in our incurring substantial costs and expenses or substantial liability for damages or require us to stop our development and commercialization efforts.

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. We may become a party to patent litigation or other proceedings regarding intellectual property rights. Interference proceedings before the United States Patent and Trademark Office may be necessary to establish which party was the first to invent a particular invention.

The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the cost of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. If a patent litigation or other proceeding is resolved against us, we or our collaborators may be enjoined from using, manufacturing, selling or importing our products or processes without a license from the other party and we may be held liable for significant damages. We may not be able to obtain any required licenses on commercially acceptable terms or at all.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to enter into collaborations with other entities, obtain financing or compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.

Our patent protection for any compound or product that we seek to develop may be limited to a particular method of use or indication such that, if a third party were to obtain approval of the compound or product for use in another indication, we could be subject to competition arising from off-label use.

Although we generally seek the broadest patent protection available for our proprietary compounds, we may not be able to obtain patent protection for the actual composition of matter of any particular compound and may be limited to protecting a new method of use for the compound or otherwise restricted in our ability to prevent others from exploiting the compound. If we are unable to obtain patent protection for the actual composition of matter of any compound that we seek to develop and commercialize and must rely on method of use patent coverage, we would likely be unable to prevent others from manufacturing or marketing that compound for any use that is not protected by our patent rights. If a third party were to receive marketing approval for the compound for another use, physicians might nevertheless prescribe it for indications that are not described in the product’s labeling or approved by the FDA or other regulatory authorities. Even if we have patent protection of the prescribed indication, as a practical matter, we likely would have little recourse as a result of this off-label use. In that event, our revenues from the commercialization of the compound would likely be adversely affected.

If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.

We are a party to various license agreements under which we receive the right to practice and use important third party patent rights. We may enter into additional licenses in the future. Our existing licenses impose, and we expect future licenses will impose, various diligence, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with these obligations, the licensor may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed patents.

 

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If we fail to maintain positive relationships with particular individuals, we may be unable to successfully develop our product candidates, conduct clinical trials, and obtain financing.

Pramod K. Srivastava, Ph.D., a member of our Board of Directors, the Chairman of our Scientific and Medical Advisory Board, and a consultant to us, and Garo H. Armen, Ph.D., the Chairman of our Board of Directors and our Chief Executive Officer, who together founded Antigenics in 1994, have been, and continue to be, integral to building the Company and developing our technology. If either of these individuals decreases his contributions to the Company, our business could be adversely impacted.

Dr. Srivastava is not an employee of Antigenics and has other professional commitments. We sponsor research in Dr. Srivastava’s laboratory at the University of Connecticut Health Center in exchange for the right to license discoveries made in that laboratory with our funding. Dr. Srivastava is a member of the faculty of the University of Connecticut School of Medicine. The regulations and policies of the University of Connecticut Health Center govern the relationship between a faculty member and a commercial enterprise. These regulations and policies prohibit Dr. Srivastava from becoming our employee. Furthermore, the University of Connecticut may modify these regulations and policies in the future to further limit Dr. Srivastava’s relationship with us. Dr. Srivastava has a consulting agreement with Antigenics, which includes financial incentives for him to remain associated with us, but these may not prove sufficient to prevent him from severing his relationship with Antigenics, even during the time covered by the consulting agreement. The consulting agreement terminates in March 2011. In addition, this agreement does not restrict Dr. Srivastava’s ability to compete against us after his association with Antigenics is terminated. If Dr. Srivastava were to terminate his affiliation with us or devote less effort to advancing our technologies, we may not have access to future discoveries that could advance our technologies.

Effective December 1, 2005, the Company entered into an employment agreement (the “Agreement”) with Dr. Armen. Subject to earlier termination as provided in the Agreement, the Agreement shall have an original term of one year and shall be automatically extended thereafter for successive terms of one year each, unless either party provides notice to the other at least ninety days prior to the expiration of the original or any extension term. We do not carry key employee insurance policies for Dr. Armen or any other employee.

We also rely greatly on employing and retaining other highly trained and experienced senior management and scientific personnel. Since our manufacturing process is unique, our manufacturing and quality control personnel are very important. The competition for these and other qualified personnel in the biotechnology field is intense. If we are not able to attract and retain qualified scientific, technical, and managerial personnel, we probably will be unable to achieve our business objectives.

We may face litigation that could result in substantial damages and may divert management’s time and attention from our business.

Antigenics, our Chairman and Chief Executive Officer, Garo H. Armen, Ph.D., and two brokerage firms that served as underwriters in our initial public offering (“IPO”) have been named as defendants in a federal civil class action lawsuit. The suit alleges that the brokerage arms of the investment banking firms charged secret excessive commissions to certain of their customers in return for allocations of our IPO. The suit also alleges that shares of our stock were allocated to certain of the investment banking firms’ customers based upon agreements by such customers to purchase additional shares of our stock in the secondary market. To date, the plaintiffs have not asserted a specific amount of damages. We have submitted settlement papers with the Federal District Court for the Southern District of New York, which the court preliminarily approved. Regardless of the outcome, participation in this lawsuit diverts our management’s time and attention from our business and may result in requiring us to pay damages.

Antigenics and our Chairman and Chief Executive Officer have been named as defendants in a purported class action complaint filed on June 16, 2006 in Federal District Court in New Mexico by Steven J. Tuckfelt on behalf of himself and all others similarly situated. As of August 8, 2006, the complaint has not been served on either

 

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defendant, and pending service of process, proceedings in the litigation do not commence. The complaint alleges that certain of our disclosures in connection with the conduct of the Oncophage Phase 3 renal cell carcinoma trial violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as well as include purported claims for breach of fiduciary duty. While we believe that the complaint is without merit and plan to vigorously defend against the litigation should it proceed, litigation is uncertain. Regardless of the outcome, participation in this lawsuit diverts management’s time and attention from our business and may result in requiring us to pay legal fees and damages.

In addition, we are involved in other litigation and may become involved in additional litigation. Any such litigation could be expensive in terms of out-of-pocket costs and management time, and the outcome of any such litigation is uncertain.

If we fail to obtain adequate levels of reimbursement for our product candidates from third-party payers, the commercial potential of our product candidates will be significantly limited.

Our profitability will depend on the extent to which government authorities, private health insurance providers, and other organizations provide reimbursement for the cost of our product candidates. Many patients will not be capable of paying for our product candidates by themselves. A primary trend in the United States health care industry is toward cost containment. Large private payers, managed care organizations, group purchasing organizations, and similar organizations are exerting increasing influence on decisions regarding the use of particular treatments. Furthermore, many third-party payers limit reimbursement for newly approved health care products. Cost containment measures may prevent us from becoming profitable.

It is not clear that public and private insurance programs will determine that Oncophage or our other product candidates come within a category of items and services covered by their insurance plans. For example, although the federal Medicare program covers drugs and biological products, the program takes the position that the FDA’s treatment of a product as a drug or biologic does not require the Medicare program to treat the product in the same manner. Accordingly, it is possible that the Medicare program will not cover Oncophage or our other product candidates if they are approved for commercialization. It is also possible that there will be substantial delays in obtaining coverage of Oncophage or our other product candidates and that, if coverage is obtained, there may be significant restrictions on the circumstances in which there would be reimbursement. Where insurance coverage is available, there may be limits on the payment amount. Congress and the Medicare program periodically propose significant reductions in the Medicare reimbursement amounts for drugs and biologics. Such reductions could have a material adverse effect on sales of any of our product candidates that receive marketing approval. In December 2003, the President of the United States signed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The future impact of this legislation on our product candidates is uncertain. Effective January 1, 2004, Medicare payments for many drugs administered in physician’s offices were reduced significantly. This provision impacts many drugs used in cancer treatment by oncologists and urologists. The payment methodology changes in future years, and it is unclear how the payment methodology will impact reimbursement for Oncophage, if it receives regulatory approval, and incentives for physicians to recommend Oncophage relative to alternative therapies.

Our sales, marketing and commercial operations experience is limited and needs to be developed or acquired.

We have very limited experience in marketing and selling pharmaceutical products or in running commercial operations. In addition, for our personalized heat shock protein product candidates, we will need to develop specialized commercial operations to manage patient specific ordering, tracking, and control. There are few companies that have developed this expertise. We must either develop commercial operations and marketing capabilities and a sales force or enter into arrangements with third parties to perform such operations and/or market and sell any of our product candidates that are approved by regulatory authorities. We do not know whether we will be able to enter into commercial operations or marketing and sales agreements with others on acceptable terms, if at all. We may not be able to successfully develop our own commercial operations capabilities or sales and marketing force for drug candidates for which we have retained or elect to retain marketing or co-promotion rights. As we develop our own commercial operations or marketing and sales capability, we may be competing with other companies that currently have experienced and well-funded operations. Where we have licensed our products to third party collaborators or licensees, we will be dependent on their commercial operations, sales and marketing expertise and resources, and any revenues we receive from those products will depend primarily on the sales and marketing efforts of others.

 

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Product liability and other claims against us may reduce demand for our products or result in substantial damages.

We face an inherent risk of product liability exposure related to testing our product candidates in human clinical trials and will face even greater risks if we sell our product candidates commercially. An individual may bring a product liability claim against us if one of our product candidates causes, or merely appears to have caused, an injury. Product liability claims may result in:

 

    decreased demand for our product candidates;

 

    injury to our reputation;

 

    withdrawal of clinical trial volunteers;

 

    costs of related litigation; and

 

    substantial monetary awards to plaintiffs.

We manufacture Oncophage from a patient’s cancer cells, and a medical professional must inject Oncophage into the patient from which it was manufactured. A patient may sue us if we, a hospital, or a shipping company fails to deliver the removed cancer tissue or that patient’s Oncophage. We anticipate that the logistics of shipping will become more complex if the number of patients we treat increases, and it is possible that all shipments will not be made without incident. In addition, administration of Oncophage at a hospital poses risk of delivery to the wrong patient. Currently, we do not have insurance that covers loss of or damage to Oncophage, and we do not know whether insurance will be available to us at a reasonable price or at all. We have limited product liability coverage for clinical research use of product candidates. Our product liability policy provides $10 million aggregate coverage and $10 million per occurrence. This limited insurance coverage may be insufficient to fully cover us for future claims.

We may incur significant costs complying with environmental laws and regulations.

We use hazardous, infectious, and radioactive materials in our operations, which have the potential of being harmful to human health and safety or the environment. We store these hazardous (flammable, corrosive, toxic), infectious, and radioactive materials, and various wastes resulting from their use, at our facilities pending use and ultimate disposal. We are subject to a variety of federal, state, and local laws and regulations governing use, generation, storage, handling, and disposal of these materials. We may incur significant costs complying with both current and future environmental health and safety laws and regulations. In particular, we are subject to regulation by the Occupational Safety and Health Administration, the Environmental Protection Agency, the Drug Enforcement Agency, the Department of Transportation, the Centers for Disease Control and Prevention, the National Institutes of Health, the International Air Transportation Association, and various state and local agencies. At any time, one or more of the aforementioned agencies could adopt regulations that may affect our operations. We are also subject to regulation under the Toxic Substances Control Act and the Resource Conservation Development programs.

Although we believe that our current procedures and programs for handling, storage, and disposal of these materials comply with federal, state, and local laws and regulations, we cannot eliminate the risk of accidents involving contamination from these materials. Although we have limited pollution liability coverage ($2 million) and a workers’ compensation liability policy, in the event of an accident or accidental release, we could be held liable for resulting damages, which could be substantially in excess of any available insurance coverage and could substantially disrupt our business.

 

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Our competitors in the biotechnology and pharmaceutical industries may have superior products, manufacturing capability, or marketing expertise.

Our business may fail because we face intense competition from major pharmaceutical companies and specialized biotechnology companies engaged in the development of product candidates and other therapeutic products, including heat shock proteins directed at cancer, infectious diseases, and autoimmune disorders. Several of these companies have products that utilize similar technologies and/or personalized medicine techniques, such as Dendreon’s Sipuleucel-T, with Fast Track designation and currently in Phase 3 trials for prostate cancer, and Lapuleucel-T in Phase 1 trials for ovarian, colorectal and breast cancer, Stressgen’s HspE7 currently in or completed Phase 2 trials in HPV-related diseases, such as internal genital warts, recurrent respiratory papillomatosis and cervical dysplasia, AVAX’s AC Vaccine therapeutic platform vaccines in clinical trials for melanoma and non-small cell lung cancer and approved for sale in Switzerland for melanoma, Intracel’s OncoVax, currently approved for administration in the Netherlands, Switzerland and Israel and in a Phase 3 trial in the U.S. for colon cancer, Liponova’s Reniale, completed Phase 3 trials for renal cell carcinoma, Vical’s Allovectin with a special protocol assessment for a Phase 3 trial for metastatic melanoma, Favrille’s FavID currently in a Phase 3 trial for non-Hodgkin’s lymphoma (NHL), Accentia’s BiovaxID currently in a Phase 3 trial for NHL, Genitope’s MyVax in a Phase 3 trial for NHL, and Cell Genesys’ GVAX vaccines currently in trials for prostate (Phase 3), AML (Phase 1), pancreas (Phase 2), lung cancer (Phase 2), and myeloma (Phase 1). Patents have been issued in both the U.S. and Europe related to Stressgen’s heat shock protein technology.

More specifically, if we receive regulatory approvals, some of our product candidates will compete with FDA-approved therapies such as interleukin-2 and interferon-alpha for renal cell carcinoma and melanoma, which have generated substantial sales over a number of years. In addition, sorafenib tablets and sunitinib for the treatment of patients with advanced renal cell carcinoma, or kidney cancer, were recently approved by the FDA. Other product candidates, such as Aroplatin, may compete with existing approved chemotherapies or other chemotherapies that are in development. Several other platinum therapies are in development for a variety of diseases. The most advanced candidate is GPC Biotech’s satraplatin for second-line hormone-refractory prostate cancer, for which the company has filed a rolling new drug application based on the ongoing Phase 3 trial. Additionally, Poniard Pharmaceuticals’ picoplatin is in Phase 2 clinical trials. In addition, prior to regulatory approval, we may compete for access to patients with other products in clinical development, with products approved for use in the indications we are studying, or with off-label use of products in the indications we are studying. We anticipate that we will face increased competition in the future as new companies enter markets we seek to address and scientific developments surrounding immunotherapy and other traditional cancer therapies continue to accelerate.

Additionally, many of our competitors, including large pharmaceutical companies, have greater financial and human resources and more experience than we do. Our competitors may:

 

    commercialize their product candidates sooner than we commercialize our own;

 

    develop safer or more effective therapeutic drugs or preventive vaccines and other therapeutic products;

 

    implement more effective approaches to sales and marketing and capture our potential market share;

 

    establish superior intellectual property positions;

 

    discover technologies that may result in medical insights or breakthroughs, which render our drugs or vaccines obsolete, possibly before they generate any revenue; or

 

    adversely affect our ability to recruit patients for our clinical trials.

Risks Related to our Common Stock

Our officers and directors may be able to block proposals for a change in control.

Antigenics Holdings L.L.C. is a holding company that owns shares of our common stock and, as of June 30, 2006, Antigenics Holdings L.L.C. controlled approximately 24% of our outstanding common stock. Due to this concentration of ownership, Antigenics Holdings L.L.C. may be able to prevail on all matters requiring a stockholder vote, including:

 

    the election of directors;

 

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    the amendment of our organizational documents; or

 

    the approval of a merger, sale of assets, or other major corporate transaction.

Certain of our directors and officers, including our Chief Executive Officer, directly and indirectly own approximately 70% of Antigenics Holdings L.L.C. and, if they elect to act together, can control Antigenics Holdings L.L.C. In addition, several of our directors and officers directly and indirectly own approximately 5% of our outstanding common stock.

A single, otherwise unaffiliated, stockholder holds a substantial percentage of our outstanding capital stock.

According to publicly filed documents, Mr. Brad M. Kelley beneficially owns 5,546,240 shares of our outstanding common stock and 31,620 shares of our series A convertible preferred stock. The shares of preferred stock are currently convertible at any time into 2,000,000 shares of common stock at an initial conversion price of $15.81, are non-voting, and carry a 2.5% annual dividend yield. If Mr. Kelley had converted all of the shares of preferred stock on June 30, 2006, he would have held approximately 16% of our outstanding common stock. We currently have a right of first refusal agreement with Mr. Kelley that provides us with limited rights to purchase certain of Mr. Kelley’s shares if he proposes to sell them to a third party.

Mr. Kelley’s substantial ownership position provides him with the ability to substantially influence the outcome of matters submitted to our stockholders for approval. Furthermore, collectively, Mr. Kelley and Antigenics Holdings L.L.C. control approximately 36% of our outstanding common stock as of June 30, 2006, providing substantial ability, if they vote in the same manner, to determine the outcome of matters submitted to a stockholder vote. If Mr. Kelley were to convert all of his preferred stock into common stock, the combined percentage would increase to 39%. Additional purchases of our common stock by Mr. Kelley also would increase both his own percentage of outstanding voting rights and the percentage combined with Antigenics Holdings L.L.C. (Mr. Kelley’s shares of preferred stock do not carry voting rights; the common stock issuable upon conversion, however, carries the same voting rights as other shares of common stock).

Provisions in our organizational documents could prevent or frustrate attempts by stockholders to replace our current management.

Our certificate of incorporation and bylaws contain provisions that could make it more difficult for a third party to acquire us without consent of our Board of Directors. Our certificate of incorporation provides for a staggered board and removal of directors only for cause. Accordingly, stockholders may elect only a minority of our board at any annual meeting, which may have the effect of delaying or preventing changes in management. In addition, under our certificate of incorporation, our Board of Directors may issue additional shares of preferred stock and determine the terms of those shares of stock without any further action by our stockholders. Our issuance of additional preferred stock could make it more difficult for a third party to acquire a majority of our outstanding voting stock and thereby effect a change in the composition of our Board of Directors. Our certificate of incorporation also provides that our stockholders may not take action by written consent. Our bylaws require advance notice of stockholder proposals and director nominations and permit only our President or a majority of the Board of Directors to call a special stockholder meeting. These provisions may have the effect of preventing or hindering attempts by our stockholders to replace our current management. In addition, Delaware law prohibits a corporation from engaging in a business combination with any holder of 15% or more of its capital stock until the holder has held the stock for three years unless, among other possibilities, the Board of Directors approves the transaction. Our Board of Directors may use this provision to prevent changes in our management. Also, under applicable Delaware law, our Board of Directors may adopt additional anti-takeover measures in the future.

 

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Our stock has low trading volume and its public trading price has been volatile.

Between our initial public offering on February 4, 2000 and June 30, 2006 and for the twelve months ended June 30, 2006, the sale price of our common stock has fluctuated between $1.67 and $52.63 per share and $1.67 and $7.22 per share, respectively, with an average daily trading volume for the six months ended June 30, 2006 of approximately 535,000 shares. The market has experienced significant price and volume fluctuations that are often unrelated to the operating performance of individual companies. In addition to general market volatility, many factors may have a significant adverse effect on the market price of our stock, including:

 

    continuing operating losses, which we expect over the next several years as we continue our clinical trials;

 

    announcements of decisions made by public officials;

 

    results of our preclinical and clinical trials;

 

    announcements of technological innovations or new commercial products by our competitors;

 

    developments concerning proprietary rights, including patent and litigation matters;

 

    publicity regarding actual or potential results with respect to product candidates under development by us or by our competitors;

 

    regulatory developments; and

 

    quarterly fluctuations in our financial results.

The sale of a significant number of shares could cause the market price of our stock to decline.

The sale by us or the resale by stockholders of a significant number of shares of our common stock could cause the market price of our common stock to decline. As of June 30, 2006, we had approximately 45,811,000 shares of common stock outstanding. All of these shares are eligible for sale on the NASDAQ Global Market, although certain of the shares are subject to sales volume and other limitations.

We have filed registration statements to permit the sale of 10,436,831 shares of common stock under our equity incentive plan and certain equity plans that we assumed in the acquisitions of Aquila Biopharmaceuticals, Inc. and Aronex Pharmaceuticals, Inc. We have also filed a registration statement to permit the sale of 300,000 shares of common stock under our employee stock purchase plan. We have also filed a registration statement to permit the sale of 100,000 shares of common stock under our directors’ deferred compensation plan. As of June 30, 2006, options to purchase approximately 6,247,000 shares of our common stock with a weighted average exercise price per share of $8.31 were outstanding. Many of these options are subject to vesting that generally occurs over a period of up to five years following the date of grant. As of June 30, 2006, warrants to purchase approximately 8,910 shares of our common stock with a weighted average exercise price per share of $54.71 were outstanding. The market price of our common stock may decrease based on the expectation of such sales. On August 12, 2004, we filed a registration statement with respect to an aggregate of $100 million of our common stock, preferred stock, and debt. That registration statement has become effective, and we may offer and sell any of those securities from time to time. On May 24, 2005, we filed a registration statement with respect to an aggregate of $50 million of 5.25% Convertible Senior Notes due 2025 and 4,645,115 shares of our common stock that would be issued upon conversion of the notes, subject to adjustment for any stock split, stock dividend, or any other event or transaction that results in an increase in the number of shares issuable upon conversion of the notes. That registration statement has become effective, and those notes and shares may be offered and sold from time to time by the selling security holders listed in the related prospectus. The market price of our common stock may decrease based on investor expectations that we will issue a substantial number of shares of common stock or securities convertible into common stock at low prices.

 

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Because we are a relatively small public company, we have been disproportionately negatively impacted by the Sarbanes-Oxley Act of 2002 and related regulations, which have increased our costs and required additional management resources.

The Sarbanes-Oxley Act of 2002, which became law in July 2002, has required changes in some of our corporate governance, securities disclosure, and compliance practices. In response to the requirements of that Act, the SEC and the NASDAQ have promulgated new rules and listing standards covering a variety of subjects. Compliance with these new rules and listing standards significantly increased our legal, financial, and accounting costs, which we expect to increase as we expand our operations. In addition, the requirements have taxed a significant amount of management’s and the Board of Directors’ time and resources. Likewise, these developments have made it more difficult for us to attract and retain qualified members of our Board of Directors, particularly independent directors, or qualified executive officers. Because we are a relatively small public company, we expect to be disproportionately negatively impacted by these changes in securities laws and regulations, which have increased our costs and required additional management resources.

Our internal control over financial reporting (as defined in Rules 13a-15 of the Exchange Act of 1934, as amended) is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect all deficiencies or weaknesses in our financial reporting. While our management has concluded in our annual report on Form 10-K for the year ended December 31, 2005 that there were no material weaknesses in our internal control over financial reporting as of December 31, 2005, our procedures are subject to the risk that our controls may become inadequate because of changes in conditions or as a result of a deterioration in compliance with such procedures. No assurance is given that our procedures and processes for detecting weaknesses in our internal control over financial reporting will be effective.

Item 4 — Submission of Matters to a Vote of Security Holders

At the Annual Meeting of Stockholders held on June 14, 2006, Antigenics’ stockholders voted as follows:

To elect the following nominees to the Board of Directors:

 

Nominee

 

Total Vote “FOR”

 

Total Vote “WITHHELD”

Margaret M. Eisen

  39,617,874   606,525

Wadih Jordan

  39,613,767   610,632

All received a plurality of the votes cast by stockholders entitled to vote thereon and, therefore, Ms. Eisen and Mr. Jordan were elected to the Board of Directors for terms of three years. In addition, the terms in office of Dr. Afeyan, Dr. Armen, Mr. AtLee, Mr. Dechaene, Mr. Kessel, Dr. Srivastava, and Dr. Wood, continued after the meeting.

To amend our 1999 Equity Incentive Plan to allow for unrestricted stock awards:

 

Total Vote “FOR”

 

Total Vote “AGAINST”

 

Total Vote “ABSTAIN”

22,088,456

  1,100,758   112,360

Item 6 — Exhibits

The Exhibits listed in the Exhibit Index are included in this Report.

 

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ANTIGENICS 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.

 

A NTIGENICS I NC .

/s/ G ARO H. A RMEN , PH.D.

Garo H. Armen, Ph.D.
Chairman and Chief Executive Officer

/s/ P ETER T HORNTON

Peter Thornton
Chief Financial Officer

Date: August 9, 2006

 

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EXHIBIT INDEX

 

Exhibit No.

  

Description

3.1

  

Amended and Restated Certificate of Incorporation of Antigenics. Filed as Exhibit 3.1 to our

Current Report on Form 8-K (File No. 0-29089) dated June 10, 2002 and incorporated herein by reference.

3.2

   Amended and Restated By-laws of Antigenics Inc. Filed as Exhibit 3.2 to our Current Report on Form 8-K (File No. 0-29089) dated June 10, 2002 and incorporated herein by reference.

10.1

   License Agreement By and Between Antigenics, Inc. and GlaxoSmithKline Biologicals SA dated July 6, 2006. (2)

10.2

   Manufacturing Technology Transfer and Supply Agreement By and Between Antigenics, Inc. and GlaxoSmithKline Biologicals SA dated July 6, 2006. (2)

31.1

   Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.

31.2

   Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.

32.1(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. Submitted herewith.

(1) This certification accompanies the Quarterly Report on Form 10-Q and is not filed as part of it.
(2) Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

50

Confidential

Exhibit 10.1

LICENSE AGREEMENT

BY AND BETWEEN

ANTIGENICS, INC., A MASSACHUSETTS CORPORATION

AND

GLAXOSMITHKLINE BIOLOGICALS SA


Confidential

 

LICENSE AGREEMENT

This License Agreement (this “ Agreement ”) is made effective this 6th day of July, 2006 (“ Effective Date ”) by and between Antigenics, Inc., a Massachusetts corporation and wholly owned subsidiary of Antigenics, Inc., a Delaware corporation, having offices at 3 Forbes Road, Lexington, MA 02421 (“ Antigenics MA ”), and GlaxoSmithKline Biologicals SA, a Belgian company, having an address at 89 rue de l’Institut, 1330 Rixensart Belgium (“ GSK ”) (each singularly a “ Party ” and collectively the “ Parties ”).

WHEREAS, Antigenics MA and GSK are parties to that certain License, Development, and Supply Agreement entered into effective September 11, 1992 between Cambridge Biotech Corporation (predecessor to Antigenics MA) and Smithkline Beecham p.l.c. (predecessor to GlaxoSmithKline plc, an Affiliate of GSK) (as amended, the “ Prior Agreement ”); and

WHEREAS, GSK has an interest in gaining certain manufacturing rights for QS-21 and restructuring its partnering arrangement with Antigenics MA;

WHEREAS, Antigenics MA has an interest in expanding its collaborative relationship with GSK;

WHEREAS, GSK and Antigenics MA now desire to terminate and supercede the Prior Agreement with this Agreement and the Supply Agreement (as hereinafter defined);

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

1. Definitions .

The following terms, whether used in the singular or the plural, shall have the following meanings for purposes of this Agreement:

1.1 “ Affiliate ” means any corporation, firm, partnership or other entity, which controls, is controlled by or is under common control with a Party. For purposes of this Section 1.1, “control” means direct or indirect ownership of fifty percent (50%) or more, or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction, of the outstanding stock or other voting rights entitled to elect directors thereof or the ability to otherwise control the management of the corporation, firm, partnership or other entity.

1.2 “ Annual Update ” means the annual update of GSK’s development and commercialization efforts including the [**] and plans of [**] activities in each [**], [**] of [**] of QS-21 in the [**] under evaluation for each [**] in each [**], [**] and [**] dates and [**] and [**] dates with respect to each [**] in the [**], as prepared by GSK and presented to and discussed with Antigenics MA during an annual meeting in accordance with this Agreement.

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

1


Confidential

 

1.3 “ BLA ” means a Biologics License Application or similar application (including without limitation a New Drug Application) filed with the FDA, or any comparable filing in any non-US jurisdiction with any relevant Regulatory Authority.

1.4 “ BMF ” means Antigenics MA’s FDA biologics master file for QS-21.

1.5 “ Business Day ” means a day on which banking institutions in both Brussels, Belgium and Boston, Massachusetts are open for business.

1.6 “ Co-exclusive Vaccine ” means any prophylactic and/or therapeutic Vaccine product for the sole purpose of eliciting an immune response to one or more antigens directed to any indication listed on Exhibit B attached hereto and incorporated herein, solely or in combination with other indications listed on Exhibit C and D attached hereto, formulated and delivered in combination with QS-21 with or without other adjuvants. For the sake of clarity, Co-exclusive Vaccines shall specifically exclude any and all (i) formulations of QS-21 with [**] or with [**] (provided however that said exclusion shall not [**] from [**] or [**] with [**] and/or [**] by GSK), and/or (ii) uses of QS-21 without an antigen, including without limitation, combinations where antigens are not present.

1.7 “ Combination Vaccines ” means Licensed Vaccines formulated in combination with one or more Other Vaccine Product(s) (as defined in Section 1.22 below).

1.8 “ Commercially Reasonable Efforts ” means efforts in accordance with GSK’s scientific, medical, legal and business judgment and consistent with the efforts used by GSK for its own internal products and by similar companies in the biotechnology and pharmaceutical industries for products of similar commercial value, status and market potential under similar market conditions.

1.9 “ Confidential Information ” has the meaning set forth in Article 9 hereof.

1.10 “ Exclusive Vaccine ” means any prophylactic and/or therapeutic Vaccine product for the sole purpose of eliciting an immune response to one or more antigens directed to any indication listed on Exhibit C attached hereto and incorporated herein, solely or in combination with other indications listed on Exhibit B and D attached hereto, formulated and delivered in combination with QS-21. For the sake of clarity, Exclusive Vaccines shall specifically exclude any and all (i) formulations of QS-21 with [**] or with [**] (provided, however that said exclusion shall not [**] from [**] or [**], [**] with [**] and/or [**] or [**] by GSK), and/or (ii) uses of QS-21 without an antigen, including without limitation, combinations where antigens are not present.

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

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

2


Confidential

 

1.12 “ First Commercial Sale ” means the date of first commercial sale of a Licensed Vaccine by GSK or its Affiliates or Third Party Sublicensees anywhere in the world.

1.13 “ Gross Sales ” has the meaning set forth in Section 1.22 below.

1.14 “ GSK Invention ” means any invention or discovery (a) which is conceived or reduced to practice by or on behalf of GSK, its Affiliates or Third Party Sublicensees at any time up to the [**] anniversary of the [**] hereof as a result of the practice of the Licensed Patent Rights or the use of QS-21 pursuant to this Agreement, the Supply Agreement, and/or the Prior Agreement and (b) in so far as it is related to QS-21 and in so far as it is not related to (i) [**], (ii) [**], (iii) [**] and/or (iv) any other [**], and (c) that would block the making, using, or selling of QS-21 in Antigenics MA’s or its Affiliates’ [**] based [**].

1.15 “ GSK Patent Rights ” means any U.S. or foreign patent applications, provisional patent applications and patents issuing therefrom worldwide, together with any extensions, registrations, confirmations, reissues, continuations, divisions, continuations-in-part, reexamination certificates, confirmations, registrations, revalidations, additions, substitutions, or renewals thereof and any patents anywhere in the world claiming the priority date of any of the foregoing, in each case owned or controlled by GSK, its Affiliates, licensees or sublicensees (and for which GSK has the right to grant licenses or sublicenses hereunder) to the extent claiming, covering or directed to the subject matter of a GSK Invention.

1.16 “ Licensed Indications ” means the Vaccine indications identified in Exhibits B, C, and D for which GSK has rights with respect to Exclusive Vaccines, Co-exclusive Vaccines, or Non-exclusive Vaccines.

1.17 “ Licensed Know-how ” means all tangible and intangible information and data owned or controlled by Antigenics MA (and for which Antigenics MA has the right to grant licenses during the Term), which are not generally known, which relate to QS-21, which are substantial and have been identified or summarized in writing by Antigenics MA, and which are necessary for GSK to develop, make, use, sell, offer for sale and import Licensed Vaccines or to practice the Licensed Patent Rights. In no event shall Know-how include any information or know-how of Antigenics MA related to the manufacture of QS-21, it being the understanding of the Parties that such information and know-how shall be the subject of the Supply Agreement.

1.18 “ Licensed Patent Rights ” means (i) United States Patent No.’s [**], and (ii) PCT Publication No.[**] and US Patent Application USSN [**] ((ii), collectively, the “[ **] Patents”) , together with (iii) any patents issuing from any continuations, continuations-in-part (to the extent that the claims are directed to subject matter specifically disclosed in (i) or (ii)), divisionals, substitutions, reissues, reexaminations or extensions of the Patents, and any foreign counterparts or equivalents of the foregoing. Also included in the definition of Licensed Patent Rights are any patents or patent applications which generically or specifically claim any improvements in so far as such improvements are [**] to [**] and in so far as such improvements are not [**] to [**](other than [**]) of Antigenics MA or its Affiliates which are

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

3


Confidential

 

conceived or reduced to practice by Antigenics MA, its Affiliates, licensees or sublicensees at any time up to the [**] of the Effective Date hereof, and which are owned or controlled by Antigenics MA, its Affiliates, licensees or sublicensees and for which Antigenics MA has the right to grant licenses during the Term. For the avoidance of doubt, and notwithstanding the foregoing, the Parties agree that Licensed Patent Rights do not include (i) patents or patent applications relating to the compounds derived by or on behalf of Antigenics MA from QS-21 designed for drug delivery instead of immune response potentiation, or (ii) patents or patent applications relating to immunomodulation without an antigen, or (iii) patent applications claiming manufacturing processes for QS-21 it being the understanding of the Parties that the grant to GSK of a license to such patent applications claiming manufacturing processes for QS-21 is the subject of the Supply Agreement. The current Licensed Patent Rights are listed on Exhibit I.

1.19 “ Licensed Technology ” means QS-21 and Licensed Know-how.

1.20 “ Licensed Vaccine(s) ” means Exclusive Vaccines, Co-Exclusive Vaccines, and Non-Exclusive Vaccines.

1.21 “ Marketing Approval ” means approval received from the FDA or any comparable approval in any non-US jurisdiction with any relevant Regulatory Authority granting the right to commercialize Licensed Vaccines (but specifically independent of pricing or reimbursement considerations, where applicable).

1.22 “ Net Sales ” means the amount billed or invoiced on arms length sales of Licensed Vaccines by GSK or its Affiliates or Third Party Sublicensees to Third Parties including its distributors under this Agreement (“ Gross Sales ”) less deductions duly documented for (i) normal and customary trade, quantity and cash discounts and non-affiliated broker’s, distributor’s or agent’s commissions actually allowed and taken; (ii) amounts repaid or credited by reason of rejection or return or retroactive price reduction; (iii) to the extent separately stated on purchase or sales orders, invoices, or other documents of sale, sales and excise taxes and duties levied on and/or other governmental charges made as to production, sale, importation, transportation, delivery or use paid by or on behalf of GSK or its Affiliates or Third Party Sublicensees]; (iv) transportation costs including insurance; (v) the [**] determined as [**] of [**] and other special [**] and/or [**] and [**] with Licensed Vaccines; (vi) any [**] to [**] on [**] provided however that [**] under [**] shall not exceed [**] of [**] and (vii) contributions and payments required by the [**] to be made pursuant to the [**], specifically with respect to any of the [**], which [**] and [**] have been [**] on to the [**] and are [**] in the [**] of [**] and which are not [**], provided however that deductions under this subparagraph (vii) and subparagraph (v) shall not [**] of [**] in the [**]. Sales between or among GSK and its Affiliates or Third Party Sublicensees shall be excluded from the computation of Net Sales except where the Affiliates or Third Party Sublicensees are end users, but Net Sales shall include the subsequent final sales to Third Parties by the Affiliates or Third Party Sublicensees.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Confidential

 

For the avoidance of doubt, in the event GSK gets any indirect financial interest, income or other consideration back from the subsequent sales of GSK distributors to Third Parties, such financial interest, income or consideration shall be included as Net Sales hereunder. In addition, in the event that GSK has entered into a distribution agreement with a Third Party in form that is in economic and business substance a sublicense relationship and not a traditional distribution relationship in such country or countries, then such distributor shall be treated as a Sublicensee for purposes of calculating Net Sales, Sublicense Revenues, and royalties hereunder.

If GSK or any of its Affiliates or Third Party Sublicensees makes any transfer of Licensed Vaccines to Third Parties for consideration other than monetary value or as part of a multi-product transaction, such transfer will be considered a sale hereunder for Net Sales, accounting and royalty purposes. Net Sales for any such transfers will be determined on a country by country basis and will be the average price of “arms length” sales of Licensed Vaccines by GSK or its Affiliates or Third Party Sublicensees in such country during the royalty reporting period in which such transfer occurs or, if no such “arms length” sales occurred in such country during such period, during the last period in which such “arms length” sales occurred. If no “arms length” sales have occurred in a particular country, Net Sales for any such transfer in such country will be the average price of “arms length” sales of Licensed Vaccines in all countries in the Territory by GSK, its Affiliates or Third Party Sublicensees.

If Licensed Vaccine(s) is (are) sold as part of a Combination Vaccine, Net Sales for purposes of determining royalties on Licensed Vaccine(s) in the Combination Vaccine shall be calculated by [**] of the [**] (as determined in accordance with the provisions of this Section) by the [**], where [**] is the [**] of the Licensed Vaccine(s) [**] in the [**] and [**] and [**] is the [**] of the [**] in the [**] in the [**] and [**].

In the event that no such separate sales are made of the Licensed Vaccine or Other Vaccine Product(s) in such Combination Vaccine in the relevant country during the royalty period in question, then Net Sales for purposes of determining royalties on Licensed Vaccine(s) in the Combination Vaccine shall be calculated by [**] of the [**] (as determined in accordance with the provisions of this Section) by the [**], where [**] is the [**] of the Licensed Vaccine(s) [**] in [**] within the [**] and [**], and [**] is the [**] of the [**] in such [**] within the [**] and [**].

In the event that no such separate sales are made of the Licensed Vaccines or any of the Other Licensed Vaccines in such Combination Vaccine in the relevant countries within the same geographical region and similar economic profile during the royalty period in question, Net Sales, for the purposes of determining royalty payments royalties on Licensed Vaccine(s) in the Combination Vaccine shall be calculated as [**] in [**] the [**] provided that in the event the Parties are [**] to [**] to [**] on [**] after [**], then [**] shall be [**] for [**] to an [**] to the [**] shall be [**].

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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1.23 “ Non-exclusive Vaccine ” means any prophylactic and/or therapeutic Vaccine product for the sole purpose of eliciting an immune response to one or more antigens directed to any indication listed on Exhibit D attached hereto and incorporated herein, solely or in combination with other indications listed on Exhibits B and C , formulated and delivered in combination with QS-21 with or without other adjuvants. For the sake of clarity, Non-exclusive Vaccines shall specifically exclude any and all (i) formulations of QS-21 with [**] or with [**] (provided however that said exclusion shall not [**] from [**] or [**], Non-exclusive Vaccines with [**] and/or [**] or [**] by GSK), and/or (ii) uses of QS-21 without an antigen, including without limitation, combinations where antigens are not present and/or (iii) any [**] containing [**] (whether alone or in combination with each other) for the prevention and/or treatment of human cancers.

1.24 “ Other Vaccine Product ” means any vaccine product, other than a Licensed Vaccine, which is [**] with [**] and [**] when [**] with the [**] as [**] by [**] to [**].

1.25 “ QS-21 ” means a substantially pure saponin adjuvant isolated from crude Quillaja saponaria tree extract and referred to as QS-21, a Stimulon ® adjuvant.

1.26 “ Regulatory Authority ” means the U.S. or foreign government agency or health authority that regulates and grants recommendations for approvals for the manufacture and sale of pharmaceutical products.

1.27 “ Steering Committee ” has the meaning set forth in the Supply Agreement.

1.28 “ Sublicensee ” means any Affiliate or Third Party to whom GSK grants a sublicense of any of the license rights granted to GSK hereunder pursuant to the terms and conditions of this Agreement.

1.29 “ Sublicense Revenue ” means any [**] and [**], and/or [**] by [**] from a [**] treated as a [**] in accordance with Section 1.22 in consideration for the sublicense rights to QS-21 granted GSK under this Agreement. In the event that GSK grants a sublicense to the rights granted by Antigenics MA hereunder in addition to a sublicense to other GSK technologies, then a [**] of any such [**] shall be [**] by [**] as [**] for the [**] to [**] under the [**] and/or[**] hereunder by [**]. GSK shall share with Antigenics MA the relevant portions of such sublicense terms and Antigenics MA shall treat such information as Confidential Information in accordance with this Agreement. In the event of a dispute regarding such allocation, the matter shall be resolved under Section 12.1.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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1.30 “ Supply Agreement ” shall have the meaning set forth in Section 6.1 hereof.

1.31 “ Term ” has the meaning set forth in Section 10.1 hereof.

1.32 “ Territory ” means the world.

1.33 “ Third Party ” means any entity other than the Parties to this Agreement or their respective Affiliates.

1.34 “ Vaccine ” means a preparation in finished form (not requiring any further processing or packaging prior to sale to the end user).

1.35 “ Valid Claim ” means a claim of an issued, unexpired patent, or a claim of a pending patent application, included within the Licensed Patent Rights, which has not been held invalid, unpatentable or unenforceable in an unappealed or unappealable decision of a court or other governmental body of competent jurisdiction, which has not been rendered unenforceable through disclaimer or otherwise, and which has not been lost through an interference proceeding, provided that if any pending patent application is pending for more than [**], it shall cease to be within the definition of Valid Claim unless and until it issues.

2. License .

2.1 License Grant to GSK Subject to the terms and conditions of this Agreement, Antigenics MA hereby grants to GSK during the Term:

(a) an exclusive license (even as to Antigenics MA), with the right to sublicense solely as set forth in Section 2.2 below, under the Licensed Patent Rights to use QS-21 to develop, make, have made, use, sell, offer for sale, keep and import Exclusive Vaccines within the Territory;

(b) a co-exclusive license (with either Antigenics MA or a sole sublicense of Antigenics MA in each country or group of countries), with the right to sublicense solely as set forth in Section 2.2 below, under the Licensed Patent Rights to use QS-21 to develop, make, have made, use, sell, offer for sale, keep and import Co-exclusive Vaccines within the Territory;

(c) a non-exclusive license, with the right to sublicense solely as set forth in Section 2.2 below, under the Licensed Patent Rights to use QS-21 to develop, make, have made, use, sell, offer for sale, keep and import Non-exclusive Vaccines within the Territory;

(d) an exclusive license (even as to Antigenics MA), with the right to sublicense solely as set forth in Section 2.2 below, under the [**] Patents to develop, make, have made, use, sell, offer for sale, keep and import Licensed Vaccines in the Licensed Indication of cancer within the Territory; and

(e) a non-exclusive license, with the right to sublicense solely as set forth in Section 2.2 below, under the Licensed Technology to use QS-21 to develop, make, have made, use, sell, offer for sale, keep and import Licensed Vaccines within the Territory.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Confidential

 

Notwithstanding the foregoing, the license rights granted to GSK under subsections (a) through (e) of this Section 2.2 expressly exclude any rights under the Licensed Patent Rights or Licensed Technology to develop, make, have made, use, sell, offer for sale, keep and import any vaccine products containing [**] (whether alone or in combination with each other) for the prevention and/or treatment of human cancers.

Nothing in this Agreement shall restrict GSK’s ability to exploit its own technology or to carry out research outside the Licensed Indications, provided however that nothing in this Agreement shall be construed as Antigenics MA granting GSK or its Affiliates or other Sublicensees (a) any affirmative right to use the Licensed Technology or Licensed Patent Rights outside the Licensed Indications, including without limitation, combinations of Licensed Vaccines with other Vaccine Products, or (b) any right to manufacture (or have made) QS-21 for use in the research, development or commercialization of Licensed Vaccines, it being the understanding of the Parties that the provision of such a manufacturing right is the subject of the Supply Agreement.

2.2 Sublicensing . GSK shall have the right to grant sublicenses to (a) Affiliates and/or (b) Third Parties who receive a license to the Licensed Indications, to the license rights granted to GSK in Section 2.1 above, subject to the following terms and conditions:

(a) GSK may grant sublicenses to Affiliates and/or Third Parties:

(i) for Exclusive Vaccines [**] provided that the Sublicensee will practice the Licensed Patent Rights and Licensed Technology only to the extent granted to GSK under this Agreement and GSK and the Sublicensee will comply with the remaining provisions of this Section 2.2.

(ii) for Co- exclusive and Non- exclusive Vaccines [**] provided that the Sublicensee will practice the Licensed Patent Rights and Licensed Technology only in the applicable country and only to the extent granted to GSK under this Agreement; and that GSK and the Sublicensee will comply with the remaining provisions of this Section 2.2.

(b) GSK and (i) each Affiliate Sublicensee will sign a side letter under which the Affiliate Sublicensee will agree to be bound by the terms of this Agreement; and (ii) each Third Party Sublicensee shall enter into a written agreement subject to, consistent with, and not to extend beyond the scope of GSK’s rights and obligations under, and the terms and conditions of, this Agreement, which written sublicense agreement shall require the Third Party Sublicensee to agree to be bound by and comply with provisions that are consistent with the provisions of this Agreement. In addition, each such side letter or sublicense agreement shall require the Affiliate and/or Third Party Sublicensee, at the election of Antigenics MA (to be made by Antigenics MA upon notice from GSK at the time the side letter or sublicense agreement is entered into) to either (i) [**] to [**] by the [**] and [**] of, and the [**] of [**] under, the [**] or (ii) [**] a [**] within a [**] after the [**] of the [**], pursuant to which the

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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[**] shall be [**] to [**] from [**], or a [**] of [**] (either [**] or [**] as may be [**] by [**]) all of its [**] of [**] and [**] or its [**] will [**] to [**] such [**] (up to [**]), provided that after the [**] (as defined in the [**]), any such [**] shall have the right to [**] (if [**] a [**] to [**] in accordance with the [**]) or [**] its [**] from [**]. In addition and notwithstanding the foregoing, GSK may grant sublicenses to Affiliate subsidiaries controlled by GSK without entering into a written side letter or sublicense agreement with such subsidiaries, provided that GSK shall and hereby guarantees and remains primarily responsible for the performance of such subsidiaries in accordance with this Agreement and the Supply Agreement.

(c) GSK shall remain responsible for compliance by any Sublicensee receiving a sublicense hereunder with all terms and conditions of this Agreement relevant to such Sublicensee. GSK shall promptly provide Antigenics MA with a copy of the relevant provisions of such agreement entered into with any Sublicensee, which are reasonably necessary for Antigenics MA to verify consistency with the terms of this Agreement and/or Antigenics MA’s rights hereunder.

(d) Should this Agreement terminate for any reason, at GSK’s request and provided that GSK’s Third Party Sublicensee continues to comply with the provisions of the written agreement to be entered into pursuant to Section 2.2 (c) above, the sublicense shall survive provided that Antigenics MA shall be substituted for GSK and become the direct licensor of GSK’s Third Party Sublicensee, provided that Antigenics MA has approved or has not reasonably objected to such written agreement. In no event shall Antigenics MA have greater obligations under any such written agreement than Antigenics MA has under this Agreement.

In addition, and for the avoidance of doubt notwithstanding the foregoing provisions, GSK, its Affiliates and Sublicensees shall have the right to collaborate with Third Parties for the development of Licensed Vaccines and/or to engage with a Third Party to carry out clinical trials in the ordinary course of business to develop Licensed Vaccines and to engage Third Party distributors in the ordinary course of business to sell Licensed Vaccines in accordance with this Agreement without Antigenics MA’s further consent and without a formal sublicense agreement, provided that such arrangements do not otherwise compromise Antigenics MA’s (or its Affiliates) rights under this Agreement or the Supply Agreement.

2.3 Non-Assertion . GSK covenants and agrees not to assert against Antigenics MA, its Affiliates or licensees or sublicensees any claim for [**] with [**] to [**] falling within the GSK Patent Rights. To the extent that GSK grants any sublicenses for the performance of GSK’s rights or obligations hereunder, GSK shall obtain the same non-assertion covenant and agreement for Antigenic MA, its Affiliates or licenseese or sublicensees from its Sublicensees, whether Affiliates or Third Party Sublicensees (in the side letter or sublicense agreement, as applicable), and Antigenics MA and its Affiliates and licensees and sublicensees shall be expressly acknowledged as third party beneficiaries under such non-assertion provisions.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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2.4 No Other Rights . Except for the express licenses granted pursuant to this Article 2, no license, express or implied, is granted by either Party to the other Party under any intellectual property rights owned or controlled by such Party.

2.5 Conversion . GSK shall have the right to convert the license to Exclusive Vaccines into a non-exclusive or co-exclusive license and to convert the license to Co-Exclusive Vaccines into a non-exclusive license upon notification to Antigenics MA [**] from the [**] as described in Section [**] or [**] as appropriate.

3. Consideration to Antigenics MA .

3.1 Milestone Payments . As partial consideration for the license rights granted to GSK pursuant to this Agreement, GSK shall make one-time, non-refundable, non-creditable development milestone payments to Antigenics MA within [**] after achievement of each of the [**] milestones by GSK or its Sublicensees set forth below as follows:

 

Milestone

  

[**] Licensed
Vaccine [**]

[**] of [**] in any country of the Territory

   US [**]

[**] of [**] in any country of the Territory

   US [**]

GSK shall notify Antigenics MA within [**] of the achievement of any of the above [**] milestones and Antigenics MA shall send the corresponding invoices to GSK to the address specified in Section 12.12 or to such other address as may be later specified by GSK below to the attention of GSK’s Licensing Manager.

3.2 Royalties . As further consideration for the license rights granted to GSK hereunder, commencing with the First Commercial Sale of Licensed Vaccines by GSK or its Sublicensees, for each Licensed Vaccine whose manufacture, use, sale, offer for sale, or importation would, absent the license rights granted to GSK hereunder, infringe one or more Valid Claims of the Licensed Patent Rights, the following royalties shall apply and be payable on Net Sales in countries where such Licensed Vaccine is covered by a Valid Claim of the Licensed Patent Rights in the country of sale:

(a) [**] for (i) Exclusive Vaccines, or (ii) any other Licensed Vaccines for use in the Licensed Indication of cancer covered by a Valid Claim of a [**] Patent, provided however that in the event that a [**] has a [**] (as defined below) in a [**], then the royalty rate on Licensed Vaccines covered by a Valid Claim of a [**] Patents would be [**] in [**], and provided further that in the event that [**] has a [**] in a [**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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[**], then the royalty rate on Licensed Vaccines covered by a Valid Claim of a [**] Patents would be [**] in [**];

(b) [**] for Co-exclusive Vaccines; and

(c) [**] for Non-exclusive Vaccines.

As used herein, [**] means a Vaccine product for use in the [**] covered by the [**] Patent for use in the [**] covered by the [**] Patent. For the avoidance of doubt, Antigenics MA shall not be authorized to grant to any Third Party, as of the Effective Date, any further license under [**] Patent for use in [**] and [**].

Except as specifically provided herein, the foregoing royalties shall not be subject to any reductions, including without limitation, for Third Party patent rights, Third Party competing products, or the like. In addition, in the event that any Licensed Vaccine (including any Combination Vaccine) contains antigens in Licensed Indications identified in more than one of Exhibits B, C and D then [**].

3.3 Sublicense Revenue . In addition to the royalties payable under Section 3.2 above, GSK shall pay to Antigenics MA [**] of any Sublicense Revenue received by GSK. These Sublicense Revenue payments shall be nonrefundable and payable [**] after GSK receives the relevant payment.

4. Payments, Reports and Records .

4.1 First Commercial Sale . GSK shall notify Antigenics MA of the occurrence of the First Commercial Sale of each therapeutic Licensed Vaccine and each prophylactic Licensed Vaccine in the first country of the Territory within [**] of its occurrence.

4.2 Payments . Commencing with the First Commercial Sale of the first Licensed Vaccine in any country, GSK shall furnish to Antigenics MA a written report within [**] showing, on a country-by-country basis: (i) Gross Sales by GSK and its Affiliates and Third Party Sublicensees during the reporting period listed by country; (ii) the Net Sales of all such Licensed Vaccines sold, and qualifying deductions as described in Section 1.22, listed by category of deductions; (iii) the royalties payable in United States dollars which shall have accrued hereunder in respect of such sales; (iv) withholding taxes, if any, required by law to be deducted in respect of such sales, as applicable; (v) the exchange rates used in determining the amount of United States dollars as provided in Section 4.4 below; and (vi) the Sublicense Revenue payments paid or payable for such period. All royalty payments shown to have accrued to Antigenics MA by each report provided for under this Section shall be due and payable on the date such report is due. If no payments are due for any reporting period hereunder, GSK shall so report. All payments to Antigenics MA under this Agreement shall be made in United States dollars by check payable to “Antigenics, Inc.” or, if requested by Antigenics MA, by wire transfer to an account designated by Antigenics MA.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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4.3 Withholding Taxes . All royalty payments are exclusive of all federal, state, local and foreign taxes, levies, and assessments, duties, customs and similar charges. GSK shall be responsible for any and all such applicable charges incident to the payments to Antigenics MA under this Agreement, other than taxes on Antigenics MA’s income. When Antigenics MA has the legal obligation to collect such taxes, the appropriate amount shall be paid by GSK (by adding such amount to the payment to Antigenics MA under Section 4.2), unless GSK provides Antigenics MA with a valid tax exemption certificate authorized by the appropriate taxing authority. In the event that GSK is required by applicable law to make deductions or withholdings from payments to Antigenics MA hereunder, then GSK shall pay such additional amounts to Antigenics MA as may be necessary to assure that the actual amount received by Antigenics MA after deduction or withholding shall equal the amount that would have been received if such deduction or withholding were not required.

4.4 Exchange Rates . If GSK (or its Affiliates or Third Party Sublicensees ) receives revenues from the sale of Licensed Vaccines in currency other than United States dollars, revenues shall be converted to United States dollars at the conversion rate for foreign currency as published in the The Wall Street Journal , published on the last Business Day of the applicable calendar quarter.

4.5 GSK’s Recordkeeping and Inspection . After the date of First Commercial Sale of the first Licensed Vaccine, GSK shall keep, and shall cause its Affiliates and Third Party Sublicensees to keep, for at least [**] records of all sales of Licensed Vaccines in sufficient detail to permit Antigenics MA to confirm the accuracy of GSK’s royalty and Sublicense Revenue payment calculations. At the request of Antigenics MA, upon at least [**] prior written notice to GSK or its Affiliate or Third Party Sublicensee and at the expense of Antigenics MA (except as otherwise provided below), GSK or its Affiliate or Third Party Sublicensee shall permit an experienced, independent certified public accountant selected by Antigenics MA and reasonably acceptable to GSK or its Affiliate or Third Party Sublicensee to inspect, during regular business hours, any such records of GSK or its Affiliate or Third Party Sublicensee for the then-preceding [**] solely to the extent necessary to verify such calculations provided that such inspection shall not take place more often than once a year, and shall not cover such records for more than the preceding [**] and shall not cover the same records more than once unless this is reasonably necessary for confirming the accuracy of existing records. Results of any such inspection shall be made available to both Parties. If such inspection reveals a deficiency in the calculation of royalties and/or Sublicense Revenue payments resulting in an underpayment to Antigenics MA by [**], GSK shall pay all costs and expenses of such inspection if such inspection reveals an overpayment of royalties and/or Sublicense Revenue payments to the benefit of Antigenics MA of [**], Antigenics MA shall refund to GSK any overpaid amounts within [**] after results of such inspection become available. Any deficiencies found shall be payable by GSK within [**] of receipt of invoice from Antigenics MA.

4.6 Interest on Late Payments . Any payment not timely made shall bear interest at a rate equal to [**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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5. Annual Update, Diligence and Related Responsibilities .

5.1 Annual Update . GSK agrees to use its Commercially Reasonable Efforts to conduct its development activities substantially in accordance with the Annual Update prepared by GSK consistent with this Agreement. A copy of the Annual Update will be provided to Antigenics MA each year, with a copy to the Steering Committee for their annual review and discussion. The initial Annual Update is attached hereto as Exhibit A . GSK will use, and will ensure that its Sublicensees use, Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the development activities set forth in the Annual Update, in each case in good scientific manner and in compliance with applicable laws, rules, regulations, and guidelines. In addition, by or promptly after execution of this Agreement, GSK will provide Antigenics MA with a summary of results achieved as part of its development programs with respect to [**]. In addition, GSK shall provide Antigenics MA with a detailed status update and development plan for its QS-21 activities in the Licensed Indications of [**] within [**] of the [**] of the Effective Date. Information provided hereunder shall be treated as Confidential Information in accordance with this Agreement.

5.2 Diligence . GSK shall use Commercially Reasonable Efforts to develop and commercialize the Licensed Vaccines in the Territory. In addition to such development and commercialization efforts, GSK will use Commercially Reasonable Efforts to provide appropriate medical affairs personnel to support the Licensed Vaccines in the Territory during the Term. GSK’s development and commercialization activities will be consistent with the Annual Update. For sake of clarity, it is hereby understood that nothing contained in this Agreement require GSK to pursue the development or commercialization of all Licensed Vaccines at the same time.

5.3 Diligence Inquiry . If Antigenics MA believes that GSK has failed to apply Commercially Reasonable Efforts to commercialize the Licensed Vaccines as provided in Section 5.2 above, it will notify GSK in writing, and within thirty (30) days of receipt of such notice, GSK will submit a report to Antigenics MA containing sufficient detail to allow Antigenics MA to verify GSK’s compliance. If, after receiving the report, Antigenics MA is not satisfied that GSK has complied with its diligence requirements as described above, Antigenics MA may convene a Special Meeting of the Steering Committee, attended by appropriate representatives from each Party’s business, research and development, commercial and/or legal departments, as provided in Section 5.4 below to address the matter.

5.4 Special Meeting of Steering Committee . If Antigenics MA believes that GSK has failed to comply with its diligence obligations under this Article 5, then Antigenics MA may, by written notice to GSK, convene a special meeting of the Steering Committee to discuss the matter (a “ Special Meeting ”). Such notice may include a general statement of the areas of concern to Antigenics MA. The Parties will convene the Special Meeting no later than [**] after such notice is given. At the Special Meeting, the Steering Committee will discuss the areas of concern to Antigenics MA and the additional actions (if any) GSK could

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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take to address such concerns. If, after a Special Meeting, the Parties still disagree on whether GSK has complied with its diligence requirement under the Annual Update, then [**]. If GSK agrees that additional actions need to be taken, GSK will provide Antigenics MA with a proposal within [**] describing the actions that GSK proposes to take to meet such obligation. If Antigenics MA then notifies GSK in writing that Antigenics MA agrees that such proposal describes actions sufficient to meet such obligation, then GSK will carry out the actions described in such proposal. If Antigenics MA disagrees with GSK as to the sufficiency of the actions described in such proposal to meet such obligation, and the Parties are unable to resolve such disagreement within [**]. Any agreed proposal will be deemed to constitute an amendment to the relevant Annual Update.

5.5 Cessation of Activities . Without in any way limiting the foregoing, if GSK elects to stop the development or commercialization of Licensed Vaccines in all countries, GSK shall promptly [**], and thereafter, [**].

5.6 Compliance . GSK shall comply, and shall cause its Sublicensees to comply, with all applicable federal and state laws, rules, regulations and guidelines and the provisions of Section 2.3 of the Supply Agreement in connection with its performance under this Agreement and the development and commercialization of Licensed Vaccines.

5.7 Cooperation of Antigenics MA . Antigenics MA shall cooperate with and assist GSK in the preparation and filing of information with respect to QS-21 for use in any regulatory filings throughout the Territory with respect to any Licensed Vaccine as provided for under the Supply Agreement.

5.8 Exchange of Safety Information .

(a) During the Term of this Agreement, each Party shall use customary pharmacovigilance processes relevant to manufacture or use of a pharmaceutical grade bulk drug substance to monitor and promptly disclose to the other Party information of which it becomes aware regarding any actual or potential significant safety issue relating to QS-21. For these purposes, the term “significant safety issue” includes, without limitation, the following events (or events likely to result in the following):

(i) The suspension or termination of a clinical trial or clinical trial program for QS-21 due to an actual or potential safety issue relating to administration or utilization of QS-21 either alone or as a component of a Licensed Vaccine or other product;

(ii) the suspension, revocation or variation of a Marketing Approval or a regulatory authorization (such as a clinical trial authorization) for QS-21 due to an actual or potential safety issue relating to administration or utilization of QS-21 either alone or as a component of a Licensed Vaccine or other product;

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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(iii) the voluntary withdrawal of QS-21 or a Licensed Vaccine or other product from the market due to an actual or potential safety issue relating to QS-21;

(iv) a change to the protocol of a clinical trial in which the QS-21 is being used due to an actual or potential safety issue relating to the utilization or administration of QS-21 either alone or as a component of a Licensed Vaccine or other product;

(v) a change to the Marketing Approval by way of a restriction of the indications, in the indicated patient population, in the circumstances of use or administration, or a change to the contraindications, precautions and/or warnings of a Licensed Vaccine or other product, provided, however, such change is prompted by an actual or potential safety issue relating to administration or utilization of QS-21 either alone or as a component of a Licensed Vaccine or other product;

(vi) an indication of lack of efficacy of QS-21 where this could lead to a significant health hazard to the exposed patient population;

(vii) issuance of a Dear Doctor or Dear Healthcare Provider letter (or equivalent communication) relating to a safety issue associated with the administration or utilization of QS-21 either alone or as a component of a Licensed Vaccine or other product;

(viii) an adverse effect upon the overall balance of benefits and risks afforded by QS-21 such that it could lead to a significant change in the evaluation of that balance.

Such information shall be communicated no later than three (3) business days following the occurrence of such an event.

(b) Each Party shall promptly notify the other Party of the receipt of an enquiry from a regulatory authority regarding an actual or potential significant safety issue associated with QS-21 when administered either alone or as a component of a Licensed Vaccine or other product. For these purposes, the term “significant safety issue” includes, without limitation, the events listed in Sections 5.8 (a)(i)-(viii). Such notification shall be provided within five (5) business days of receiving the enquiry.

(c) The Party receiving the query shall submit the response it considers appropriate and shall simultaneously provide a copy thereof to the other Party. For avoidance of doubt, GSK shall have the right to provide such response and related safety information for such purposes to its Sublicenses, and Antigenics MA shall have the right to provide such response and related safety information for such purposes to its Affiliates and QS-21 licensees and QS-21 customers.

 

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6. Supply Agreement .

The Parties acknowledge and agree that, pursuant to a separate Manufacturing Technology Transfer and Supply Agreement to be executed by the Parties contemporaneously with this Agreement (the “ Supply Agreement ”), Antigenics MA shall transfer certain QS-21 manufacturing rights to GSK on commercially reasonable terms and conditions in line with the Supply Agreement. Under the Supply Agreement, GSK shall have the right to manufacture its own supply of QS-21, subject to Antigenics MA’s retained rights. GSK shall not manufacture or have any Third Party or Affiliate manufacture QS-21 except in accordance with this Agreement and the Supply Agreement.

7. Representations and Warranties; Disclaimer .

7.1 Representations and Warranties of GSK . GSK represents, warrants and covenants to Antigenics MA as follows:

(a) GSK is a corporation duly organized, validly existing and in good standing under the laws of Belgium. GSK has all requisite corporate power to own and operate its properties and assets and to carry on its business as presently being conducted and as proposed to be conducted. GSK has, and will have on all relevant dates, all requisite legal and corporate power to execute and deliver this Agreement, and to carry out and perform its obligations under the terms of this Agreement; and

(b) the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate GSK corporate action. The performance by GSK of any of the terms and conditions of this Agreement on its part to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a party.

(c) In addition, without admitting any fault, GSK represents, warrants and covenants that is has abandoned or will timely abandon and not pursue in the future any of the patents or patent applications listed on Exhibit E attached hereto and incorporated herein.

7.2 Representations and Warranties of Antigenics MA . Antigenics MA represents, warrants and covenants to GSK as follows:

(a) Antigenics MA is a corporation duly organized, validly existing and in good standing under the laws of the Commonwealth of Massachusetts. Antigenics MA has all requisite corporate power to own and operate its properties and assets and to carry on its business as presently being conducted and as proposed to be conducted. Antigenics MA has, and will have on all relevant dates, all requisite legal and corporate power to execute and deliver this Agreement and to carry out and perform its obligations under this Agreement.

(b) the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate Antigenics MA corporate action. The performance by Antigenics MA of any of the terms and conditions of this Agreement on its part to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a party, and that Antigenics

 

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MA has not entered and will not enter into any agreement with a Third Party which would conflict with or be in breach of the rights granted to GSK hereunder. Antigenics MA has the full right and legal capacity to provide in the Territory all rights to the Licensed Technology and Licensed Patent Rights in the Licensed Indications granted to GSK hereunder.

(c) to its knowledge as of the Effective Date, all relevant intellectual property rights of Antigenics MA or its Affiliates [**] for [**] to [**] and [**] in accordance with this Agreement are [**] either in [**] or in [**].

(d) to its knowledge as of the Effective Date, Antigenics MA owns the right, title and interest in the Licensed Patent Rights set forth in Exhibit I , or otherwise has the right to grant the licenses hereunder to such Licensed Patent Rights, and in the Licensed Know-how provided to GSK and that it otherwise has the right to enter into this Agreement. [**].

(e) Nothing in this Agreement shall be construed as a warranty that Licensed Patent Rights are valid or enforceable. Antigenics MA hereby represents that it has no present actual knowledge from which it can be inferred that Licensed Patent Rights are invalid.

(f) Antigenics MA warrants and represents that it has no present actual knowledge of the existence of any pre-clinical or clinical data or information concerning QS21 which suggests that there may exist quality, toxicity, safety and/or efficacy concerns which may materially impair the utility and/or safety of QS21.

7.3 Disclaimer of Warranty . EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, ANTIGENICS MA MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS INCLUDING WITHOUT LIMITATION WARRANTIES OF THE VALIDITY OR ENFORCEABILITY OF THE LICENSED PATENT RIGHTS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT OF ANY THIRD PARTY PATENTS OR PROPRIETARY RIGHTS. ALL UNIFORM COMMERCIAL CODE WARRANTIES AND UNITED NATIONS CONVENTION ON THE INTERNATIONAL SALE OF GOODS WARRANTIES ARE EXPRESSLY DISCLAIMED BY ANTIGENICS MA.

8. Liability .

8.1 Indemnification by GSK . GSK shall indemnify, defend and hold harmless Antigenics MA and its Affiliates and its and their respective directors, officers, employees and agents, and its and their respective successors and/or heirs (current and former) and assigns (the “ Antigenics MA Indemnitees ”) against any liability, damage, loss, cost or expense (including reasonable legal fees and expenses of litigation) (collectively, “ Liabilities ”) suffered, incurred by or imposed upon any such Antigenics MA Indemnitees resulting from any Third Party claim,

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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demand, suit, action or judgment (hereinafter collectively referred to as “Claims”) (including without limitation, arising from any theory of product liability (including without limitation actions in the form of tort, warranty or strict liability)) to the extent arising out of or resulting from the development, manufacture, use, sale, offer for sale, importation or exportation of any Licensed Vaccine, or otherwise resulting from activities undertaken by or on behalf of GSK hereunder or under the Prior Agreement including resulting from Third Party allegation that a Combination Vaccine breached or infringed the Third Party’s rights granted by Antigenics MA to that Third Party, except to the extent (if any) that such Liability is attributable to (a) the negligence or intentional misconduct of any Antigenics MA Indemnitee, or (b) the failure of QS-21 delivered by or on behalf of Antigenics MA to meet the specifications set forth in the Supply Agreement at the time of shipment thereunder.

8.2 Indemnification by Antigenics MA . Antigenics MA agrees to indemnify, defend and hold harmless GSK, its Affiliates and its and their respective directors, officers, employees and agents, and its and their respective successors and/or heirs (current and former) and assigns (the “ GSK Indemnitees ”) against any and all Liabilities suffered, incurred by or imposed upon any such GSK Indemnitees in connection with any Third Party Claim (including without limitation, arising from any theory of product liability (including without limitation actions in the form of tort, warranty or strict liability)) to the extent arising from or resulting out of Antigenics MA’s negligence or intentional misconduct, except to the extent (if any) that such Liability is attributable to the negligence or intentional misconduct of any GSK Indemnitee.

8.3 Notice and Cooperation . Any Antigenics MA Indemnitee or GSK Indemnitee (each an “ Indemnitee ”) intending to claim indemnification under this Article 7 shall promptly notify the other Party (the “Indemnifying Party”) of any Claim after the Indemnitee is aware thereof, setting forth the nature of the Claim and the basis for indemnification hereunder, and the Indemnifying Party shall assume, at its sole cost and expense, the defense of the Claim with counsel mutually satisfactory to the Parties; provided, however, that any Indemnitee shall have the right to retain its own counsel reasonably acceptable to the Indemnifying Party, at the expense of the Indemnifying Party, if representation of such Indemnitee by the counsel retained by the Indemnifying Party would be inappropriate because of actual or potential differences in the interests of such Indemnitee and any other Party represented by such counsel. The Indemnitee shall cooperate fully with the Indemnifying Party in such defense and will permit the Indemnifying Party to conduct and control such defense and disposition of such Claim including all decisions relative to litigation, appeal and settlement provided that (i) the Indemnifying Party agrees to keep the Indemnitee informed of the progress in the defense and disposition of such Claim and to consult with the Indemnitee with regard to any proposed settlement; and (ii) the Indemnifying Party agrees not to enter into any settlement which would have a material adverse effect on the other Party without prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. This indemnity agreement shall not apply to amounts paid in settlement of any Liability if such settlement is effected without the consent of the Indemnifying Party, which consent shall not be withheld unreasonably. The failure to deliver notice to the Indemnifying Party promptly after the Indemnitee receives notice of or otherwise becomes aware of any such Claim, if prejudicial to its ability to defend such Claim, shall relieve the Indemnifying Party of any liability to the Indemnitee under this indemnity agreement.

 

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8.4 LIMITATION OF LIABILITY . EXCEPT A) WITH RESPECT TO LIABILITY RELATING TO THIRD PARTY CLAIMS UNDER SECTIONS 8.1 OR 8.2, B) LIABILITY FOR BREACH OF ARTICLE 9, AND C) CLAIMS FOR MISUSE, MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY, IT IS AGREED BY THE PARTIES THAT NEITHER PARTY NOR ITS AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR ANY SPECIAL, CONSEQUENTIAL, INDIRECT, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES (OTHER THAN REVENUES COMPRISING ROYALTIES OR OTHER PAYMENTS TO BE EARNED AND PAID TO A PARTY BY THE OTHER PARTY UNDER THIS AGREEMENT) OR PROFITS RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME.

8.5 Insurance . During the Term and for a period of [**] after the [**] of Licensed Vaccine by GSK, its Affiliates, Third Party Sublicensees or distributors, GSK shall either self-insure through a GlaxoSmithKline plc program, or obtain and carry, and shall cause its Sublicensees to obtain and carry, in full force and effect product liability insurance in amounts which are reasonable and customary in the pharmaceutical industry for similar products. Upon request by Antigenics MA, GSK shall provide, and shall cause its Sublicensees to provide, Antigenics MA with appropriate certificates of insurance unless GSK is self-insured.

9. Confidentiality .

9.1 “ Confidential Information ” shall mean any technical, scientific or business information furnished by or on behalf of one Party or its Affiliates (the “ Disclosing Party ”) to the other Party or its Affiliates (the “ Receiving Party ”) in connection with this Agreement, the Supply Agreement or the Prior Agreement, or the activities contemplated hereunder and thereunder, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in oral, written, electronic or other form. The terms of this Agreement shall be considered Confidential Information of both Parties, subject to the provisions of this Article 9 and Section 12.6. Confidential Information shall not include information that:

(a) is generally available in the public domain or thereafter becomes available to the public through no act of the Receiving Party; or

(b) was independently known to the Receiving Party prior to receipt thereof or was discovered independently by an employee of the Receiving Party who had no access to the information supplied by or on behalf of the Disclosing Party; or

(c) was made available to the Receiving Party as a matter of lawful right by a Third Party who had no obligations of confidentiality to the Disclosing Party.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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9.2 Obligations . The Receiving Party agrees that it shall not, without the prior written consent of the Disclosing Party, directly or indirectly:

(a) make any use, of any portion of the Confidential Information of the Disclosing Party for purposes other than those set forth in this Agreement;

(b) disclose or transfer any portion of the Confidential Information to any person, except that the Receiving Party may disclose or permit the disclosure of Confidential Information to its Affiliates and sublicensees and subcontractors and partners and its and their respective directors, officers, employees, consultants, and advisors, and investors and potential investors in connection with a general financing transaction, who have an ethical or fiduciary duty to the Receiving Party or are otherwise obligated to maintain the confidential nature of such Confidential Information and who need to know such Confidential Information for the purposes set forth in this Agreement or for other legitimate business purposes;

Notwithstanding the above, the Receiving Party may disclose Confidential Information of the Disclosing Party when required by applicable laws or government rules or regulations (including without limitation, applicable securities regulations), provided that to the extent reasonably possible, the Receiving Party provides reasonable prior written notice of such disclosure to the Disclosing Party and takes reasonable efforts to avoid and/or minimize the extent of disclosure.

9.3 Upon expiration or termination of this Agreement and upon request of the Disclosing Party, all copies of any Disclosing Party’s Confidential Information shall be returned to the Disclosing Party, except that each Receiving Party may retain one (1) copy of the Confidential Information received hereunder in the possession of its legal counsel, solely for monitoring its obligations under this Agreement.

9.4 No option, license, or conveyance of such rights, express or implied, is granted to the Receiving Party in connection with any Confidential Information disclosed by the Disclosing Party, except for the express licenses granted in Article 2. If any such rights are to be granted to the Receiving Party, such grant shall be expressly set forth in a separate written instrument.

10. Term and Termination .

10.1 Term . This Agreement shall commence as of the Effective Date and, unless sooner terminated as provided in this Article 10, shall expire upon the later of (i) the expiration of the last to expire of Valid Claims of the Licensed Patent Rights or (ii) the date royalties and other payments are no longer payable by GSK to Antigenics MA under Article 3 hereof (the “ Term ”).

10.2 Material Breach . Failure by either Party to comply with any of the material obligations or representations or warranties contained in this Agreement shall entitle the other Party to give to the Party in default written notice specifying the nature of the default and requiring it to cure such default. If such default is not cured within thirty (30) days for payments or sixty (60) days for other material breaches after the receipt of such notice, the notifying Party shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement

 

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and in addition to any other remedies available to it by law or in equity, to terminate this Agreement effective upon written notice to the other Party. The right of a Party to terminate this Agreement, as hereinabove provided, shall not be affected in any way by its waiver or failure to take action with respect to any previous default. For the purposes of this Section, a material breach of the Supply Agreement by one Party shall be deemed a material breach and default of this Agreement by such Party, and shall entitle the other Party to give notice of default under this Section. In addition, Antigenics MA shall have the right to terminate this Agreement and/or the Supply Agreement immediately upon written notice to GSK in the event that GSK or its Affiliates challenge, or direct or assist a Third Party to challenge, the validity, patentability or enforceability of, or otherwise oppose any, Licensed Patent Rights.

10.3 Termination by GSK . GSK may terminate this Agreement, in whole or in part on a Licensed Vaccine by Licensed Vaccine basis, or on Licensed Patent Right by Licensed Patent Right basis, or on a country-by-country basis or for the whole Territory without cause, by giving [** ] prior written notice to Antigenics MA.

10.4 Termination or Continuation for Bankruptcy of Antigenics MA .

(a) GSK may terminate this Agreement if, at any time, Antigenics MA shall file in any court or agency pursuant to any statute or regulation of (the United States or of) any (individual) state or (foreign) country, a petition in bankruptcy or insolvency or for reorganisation or for an arrangement or for the appointment of a receiver or trustee of the party or of its assets, or if Antigenics MA proposes a written agreement of composition or extension of its debts, or if Antigenics MA shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed [**] after the filing thereof, or if Antigenics MA shall propose or be a party to any dissolution or liquidation, or if Antigenics MA shall make an assignment for the benefit of creditors.

(b) In the alternative, notwithstanding the bankruptcy of Antigenics MA or the impairment of performance by Antigenics MA of its obligations under this Agreement as a result of bankruptcy or insolvency of Antigenics MA, GSK shall be entitled to retain the licenses granted herein in lieu of termination of this Agreement. For the purposes of this Agreement all rights and licenses granted under or pursuant to any Section of this Agreement are rights to “intellectual property” (as defined in Section 101(35A) of Bankruptcy Code). Antigenics MA hereby acknowledges that (i) Licensed Patent Rights and Licensed Know-How, (ii) the Manufacturing Technology (as defined in the Supply Agreement), and (iii) the Manufacturing Technology Package (as defined in the Supply Agreement), in each case, that relate to such intellectual property, constitute “embodiments” of such intellectual property pursuant to Section 365(n) of the Bankruptcy Code. Antigenics MA agrees not to interfere with GSK’s exercise, pursuant to Section 365(n) of the Bankruptcy Code, of rights to intellectual property granted hereunder and embodiments thereof and agrees to use reasonable efforts to assist GSK to obtain such intellectual property and embodiments thereof in the possession or control of Third Parties as reasonably necessary for GSK to exercise such rights pursuant to Section 365(n) of the Bankruptcy Code.

(c) Effect of Termination . Any expiration or termination of this Agreement shall not relieve either Party from any obligation which accrued prior to such expiration or

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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termination. The provisions of Articles 6, 7, 8, and 9, and Sections 2.3, 3.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1 (for the term of the Supply Agreement), 5.8 (for the term of the Supply Agreement), 11.1, 11.2(a) (first sentence only), 11.2(b), 12.1, 12.5, 12.6, 12.8, 12.11, and 12.12 and this Section 10.4 (c) shall survive expiration or termination of this Agreement for any reason. In addition, unless this Agreement is sooner terminated as provided in this Article 10, upon expiration of the Term of this Agreement pursuant to Section 10.1 above, the license rights granted to GSK under Section 2.1 (and the sublicense rights granted under Section 2.2) shall be deemed royalty-free, non-exclusive and perpetual. Any sublicense agreement reviewed and approved or not reasonably objected by Antigenics MA between GSK and a Third Party Sublicensee shall survive termination of this Agreement in accordance with Section 2.2 (d) provided and for so long as the Sublicensee continues to meet its contractual obligations. In that case the Third Party Sublicensee shall become a direct licensee of Antigenics MA. In addition, in the event that GSK terminates this Agreement in its entirety in accordance with Section 10.3 hereof (other than for a “significant safety issue” (as defined in Section 5.8) relating to QS-21, as reasonably demonstrated by GSK), and the aggregate effect of such termination(s) is such as to reduce GSK’s projected supply requirements for QS-21 under the Supply Agreement by more than [**], and if at the time of such termination(s) Antigenics MA shall have made irrevocable commitments for the establishment of capacity to supply GSK’s requirements, GSK shall pay Antigenics MA a [**] to [**] for such excess capacity. Such payment shall be [**] and paid by GSK within [**] of [**].

11. Patent Rights .

11.1 Inventions . Title to any inventions will follow inventorship, as determined in accordance with United States laws of inventorship and written evidence of the Parties. Designation of inventors on any patent application is a matter of law and will be solely within the discretion of qualified patent counsel of Antigenics MA and GSK. Notwithstanding the foregoing, in the event that GSK breaches the representation, warranty and covenant contained in Section 7.1(c) of this Agreement, then in addition to any right or remedy Antigenics MA may have available hereunder, or in law or equity, GSK shall assign and hereby does assign one half (1/2) undivided interest in and to any patent rights pursued in violation of Section 7.1(c) to Antigenics MA or its designee.

11.2 Patent Prosecution .

(a) Licensed Patent Rights . Antigenics MA, by counsel it selects, shall have the sole right, but not the obligation, to prosecute and maintain the Licensed Patent Rights in Antigenics MA’s name and in countries designated by Antigenics MA at the sole discretion of Antigenics MA. If Antigenics MA intends to abandon or otherwise cause or allow any of the Licensed Patents Rights to be forfeited, it shall inform GSK reasonably in advance and GSK shall have the right but no obligation to assume responsibility for the prosecution and maintenance of any such Licensed Patent Right claiming [**] in Antigenics MA’s name, subject to, and consistent with, Antigenics MA contractual obligations to Third Parties.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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(b) GSK Inventions . GSK, by counsel it selects, shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain any GSK Patent Rights in GSK’s name and in countries designated by GSK at the sole discretion of GSK.

11.3 Third Party Infringement . Each Party shall promptly notify the other Party in writing of any alleged infringement of the Licensed Patent Rights and/or of any declaratory judgment actions brought against the Licensed Patent Rights, and of any available evidence thereof. Antigenics MA shall have the sole right, but not the obligation, under its own control [**], to prosecute any Third Party infringement of the Licensed Patent Rights and/or to defend the Licensed Patent Rights in any declaratory judgment action brought by a Third Party which alleges [**]. Antigenics MA may enter into any settlement, consent judgment or other voluntary final disposition of any infringement or declaratory judgment action hereunder without the prior written consent of GSK provided that [**].

11.4 Infringement Allegations . In the event that a Third Party asserts or alleges that a Licensed Vaccine manufactured or sold by GSK infringes a patent or other proprietary right of such Third Party (other than actions relating solely to the Licensed Patent Rights, such as actions alleging that the Licensed Patent Rights are dominated by Third Party patent rights or declaratory judgment actions brought against the Licensed Patent Rights), GSK shall have the right but not the obligation to assume the defense of such claim. Antigenics MA may participate in the defense of such claim through counsel of its own choosing and at its sole expense if any such claim relates to or would in any way affect the Licensed Technology or Licensed Patent Rights. In the event that Antigenics MA receives notice of such assertion or allegation, Antigenics MA shall notify GSK of such allegation or assertion. GSK may enter into any settlement, consent judgment, or other voluntary final disposition of any infringement action under this Section 11.4 that impacts or affects GSK’s ability to manufacture, use, sell, offer to sell, or import Licensed Vaccines pursuant to the license rights granted hereunder under the Licensed Patent Rights without the prior written consent of Antigenics MA, except if any such settlement, consent judgment, or other voluntary final disposition will affect the Licensed Technology or Licensed Patent Rights in any manner (including without limitation, the validity, enforceability, or use of the Licensed Technology or Licensed Patent Rights), in which case GSK shall obtain the prior written consent of Antigenics MA, which consent shall not be unreasonably withheld or delayed.

11.5 Antigenics MA and GSK shall recover their respective actual out-of-pocket expenses, or equitable proportions thereof, associated with any litigation or settlement thereof from any recovery made by any Party. Any excess amount shall be shared between the Parties with GSK receiving [**] and Antigenics MA receiving [**] of such excess.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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12. Miscellaneous .

12.1 Dispute Resolution . Except for the right of any Party to apply to a court of competent jurisdiction for a temporary restraining order, a preliminary injunction or other equitable relief to preserve the status quo or prevent irreparable harm, any dispute, other than disputes regarding the construction, validity or enforcement of patents, arising between the Parties relating to, arising out of or in any way connected with this Agreement or any term or condition hereof, or the performance by either Party of its obligations hereunder, whether before or after termination of this Agreement, shall be resolved as follows:

(a) If the dispute cannot be resolved by the Parties through their duly authorized representatives within [**] (or the Steering Committee, if applicable), the Chief Executive Officer of GSK (or his designee) and the Chief Executive Office of Antigenics, Inc., a Delaware corporation, the parent corporation of Antigenics MA (or his designee) shall meet in person at a mutually acceptable time and location or by means of telephone or video conference within [**] of the matter being referred to them.

(b) If the Chief Executive Officer of GSK (or his designee) and the Chief Executive Officer of Antigenics, Inc. (or his designee) fail to first meet within [**] of the matter being referred to them, or if the dispute can not be resolved by the Chief Executive Officer of GSK (or his designee) and the Chief Executive Officer of Antigenics, Inc. (or his designee) within [**] of the matter being referred to them, then either Party may bring such matter in a federal or state court in the State of Delaware, to whose exclusive jurisdiction both Parties hereto consent.

12.2 No Partnership . Nothing in this Agreement is intended or shall be deemed to constitute a partnership, distributorship, agency, employer-employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein.

12.3 Assignments . This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided, however , that, GSK may, without such consent, assign this Agreement and any of its right or obligations hereunder to its Affiliates or in connection with the transfer or sale of all or substantially all of the portion of its business to which this Agreement relates, or in the event of its merger or consolidation or reorganization or change in control; provided, further, that the assigning Party shall deliver written notice of any such permitted assignment to the other Party. This Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any attempted assignment not in accordance with this Section shall be void.

12.4 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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12.5 No Name or Trademark Rights . Except as otherwise expressly provided herein, or expressly set forth in the Supply Agreement, no right, express or implied, is granted by this Agreement to use in any manner the names “Antigenics, Inc.,” “GlaxoSmithkline plc.” or any contraction thereof or any other trade name or trademark of Antigenics MA or GSK in connection with the performance of this Agreement. In addition, GSK agrees not use or apply for registration of any trademarks, tradedresses or tradenames pertaining to QS-21 (as opposed to trademarks pertaining to Licensed Vaccines) in the Territory without Antigenics MA’s prior consent, which consent shall not be unreasonably withheld where the use of such trademarks, tradedresses or tradenames is required by applicable laws or regulations, provided that such use by GSK is consistent with both Party’s internal trademark strategy.

12.6 Public Announcements . Upon the execution of this Agreement, Antigenics MA (through its parent corporation, Antigenics, Inc.) shall be entitled to issue a press release regarding the subject matter of this Agreement and the Supply Agreement which [**] is attached hereto as Exhibit G . After such initial press release, [**] issue a press release or public announcement relating to this Agreement or the Supply Agreement [**] Antigenics MA and its Affiliates shall have the right to disclose the information set forth on Exhibit H without any further review and approval by GSK, provided that Exhibit H may be updated from time to time by mutual agreement of the Parties (including without limitation, [**] such [**] with [**]), or [**] where a [**] in [**] would [**] any [**]. In the event that [**] or its [**] intends to [**] or [**] regarding the [**] and/or [**] of [**] (e.g., [**] of a [**] or [**] of a [**] (or similar [**] of a [**] and of a [**], or any [**] or [**] under [**] or the [**] that would be [**] to be [**] to [**], each a “[**]”). [**] shall [**] to [**] to [**] a [**] pertaining to [**]. [**] shall be [**] a [**] of such [**] pertaining to [**] at least [**] the [**] to [**], and [**] shall [**] into [**], including [**] to [**] if [**] or [**] any [**] with respect to [**]. In addition, in the event that [**] does not [**] any [**] or [**] as contemplated in the foregoing sentence, [**] shall [**] the [**] or [**] regarding (a) the [**] of any [**], and/or (b) [**] under this Agreement or [**] and [**], provided that [**] pertaining to [**] at least [**] the [**] to [**] and [**], and [**] takes [**] into [**], including [**] to [**] with or otherwise [**] with respect to [**]. [**] shall [**] within [**] of [**] of a [**] to [**] to [**] hereunder. In addition and

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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[**], and [**] and/or [**] shall have the right to make press releases or other public disclosures [**], to the extent a press release or other public disclosure is required by applicable laws or regulations, including US securities laws, provided that, to the extent reasonably practical, [**] or [**] provides [**] of such release or disclosure.

12.7 Force Majeure . If any default or delay occurs which prevents or materially impairs a Party’s performance and is due to a cause beyond the Party’s reasonable control, including but not limited to any act of god, flood, fire, explosion, earthquake, casualty, accident, war, revolution, terrorist acts, civil commotion, blockade or embargo, injunction, law, proclamation, order, regulation or governmental demand, or acts, omissions or delays in acting by any Regulatory Authority, the affected Party promptly shall notify the other Party in writing of such cause and shall exercise diligent efforts to resume performance under this Agreement as soon as possible. Neither Party shall be liable to the other Party for any loss or damage due to such cause. Neither Party may terminate this Agreement because of such default or delay, unless such event continues unabated for a period of six (6) months, in which case the Party disadvantaged by such default or delay may, at its option, terminate this Agreement upon written notice to the other Party.

12.8 Entire Agreement of the Parties, Amendments .

(a) This Agreement, including the Exhibits attached hereto which are incorporated herein, and the Supply Agreement, constitute and contain the entire understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether verbal or written, between the Parties respecting the subject matter hereof and thereof, including without limitation, the Prior Agreement. In addition and for the avoidance of doubt, the Parties hereby agree that except for [**] described in subsection (b) of this Section 12.8, the Prior Agreement is terminated and fully superseded by this Agreement and the Supply Agreement as of the Effective Date of this Agreement. Notwithstanding any provision to the contrary in the Prior Agreement, and except for [**] described in subsection (b) of this Section 12.8, no provision contained in that agreement shall survive termination thereof. Notwithstanding the foregoing, each Party hereby agrees that, except for [**] described in subsection (b) of this Section 12.8, [**] which [**] the other [**] under the [**] of the [**], by [**] of any [**] of the [**] out of any [**] or [**] prior to [**] of [**], is [**] or [**] hereby. No other waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each of the Parties.

(b) The [**] as of [**] of [**], a [**] between the Parties [**] the [**] with respect to the [**] that [**] including those [**] were or may be [**] in the future and/or [**] in [**] of the [**] of the [**], and that if such [**] are

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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[**] to be [**], that [**] would [**] have [**] in [**]. [**] such [**] and the [**] by [**]. The Parties have [**] this [**] and the [**] the [**] of the [**], and shall be [**] to [**] pursuant to the [**] of the [**], modified as follows:

(i) The [**] of [**] hereunder [**] on or before [**] following the [**]of [**] and any [**] is [**] to [**] for the [**] of such [**].

(ii) The Parties agree that the [**] or [**] to be [**] shall be [**] in the [**] of [**] and [**] to [**] the [**] and [**] of the [**]. The Parties further agree [**] in [**], should a [**], to [**] a [**] in lieu of a [**] of [**] to [**]; provided that if [**] cannot [**] within [**] of [**] of the [**], the provisions for [**] a [**] under Section [**] of [**] shall apply. The Parties agree to [**] as a [**] for such [**].

12.9 Severability . If any provision of this Agreement, or part thereof, is found by a proper authority to be unenforceable, that provision, or part thereof, shall be stricken and the remainder of this Agreement will continue in full force and effect; provided, however, that the Parties shall renegotiate an acceptable replacement provision so as to accomplish, as nearly as possible, the original intent of the Parties.

12.10 Captions . The captions to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.

12.11 Applicable Law; Governing Language . This Agreement shall be governed and construed in accordance with the laws of the State of Delaware, without regard to conflicts of laws principles. This Agreement has been prepared in the English language and the English language shall control its interpretation. All consents, notices, reports and other written documents to be delivered or provided by a Party under this Agreement shall be in the English language, and in the event of any conflict between the provisions of any document and the English language translation thereof, the terms of the English language translation shall control.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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12.12 Notices and Deliveries . Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed given (a) when delivered personally, (b) three (3) Business Days after having been sent by registered or certified mail, return receipt requested, postage prepaid; or (c) one (1) day after deposit with a commercial express courier specifying next day delivery, with written verification or receipt, as follows:

 

If to Antigenics MA, to:

   Antigenics, Inc.
  

3 Forbes Road

  

Lexington MA 02421 U.S.A.

  

Attention: Vice President, Business Development

with copy to:

  

Antigenics, Inc.

  

3 Forbes Road

  

Lexington MA 02421 U.S.A.

  

Attention: Legal Department

If to GSK, to:

  

GlaxoSmithKline Biologicals SA

  

89 rue de l’Institut

  

B-1330 Rixensart, BELGIUM

  

Attention: President and General Manager

with a copy to:

  

GlaxoSmithKline Biologicals SA

  

89 rue de l’Institut

  

B-1330 Rixensart, BELGIUM

  

Attention: Legal Department

However, all invoices shall be sent by Antigenics MA to GSK’s Licensing Manager, Account Department, GlaxoSmithKline Biologicals SA, 89 rue de l’Institut, B-1330 Rixensart, Belgium or at such other address GSK may later designate in writing.

12.13 Counterparts . This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[The remainder of this page is intentionally left blank.]

 

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be signed by their respective corporate officers, duly authorized as of the day and year first above written.

Antigenics, Inc., a Massachusetts corporation and wholly owned subsidiary of Antigenics, Inc., a Delaware corporation

 

By:

  /s/ P.Thornton

Name:

  Peter Thornton

Title:

  Chief Financial Officer

GlaxoSmithKline Biologicals SA

By:   /s/ Jean Stephenne
Name:   Jean Stephenne
Title:   President, General Manager

 

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Confidential

 

Exhibit A

Annual Update

M AY 2006 –

INDICATIVE NON-BINDING DATES

 

L ICENSED V ACCINE

  

S TATUS

  

BLA

  

A PPROVAL

[**]

   [**]    [**]    [**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit B

Co-exclusive Vaccines

For the Prophylaxis or Treatments of:

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit C

Exclusive Vaccines

For the Prophylaxis or Treatments of:

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit D

Non- exclusive Vaccines

For the Prophylaxis or Treatments of:

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit E

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit F

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit G

Press Release

DRAFT, NOT FOR IMMEDIATE RELEASE

 

  

Sunny Uberoi

Media Relations

917.443.3325

suberoi@antigenics.com

  

Shalini Sharp

Investor Relations

800.962.2436

ir@antigenics.com

ANTIGENICS ANNOUNCES EXPANSION OF ITS LICENSE AND SUPPLY AGREEMENT

WITH GLAXOSMITHKLINE BIOLOGICALS FOR QS-21 STIMULON ® ADJUVANT

Conference Call to be Held Today at XX ET

NEW YORK – July XX, 2006 – Antigenics Inc. (NASDAQ: AGEN) today announced that the company has signed expanded license and supply agreements for the use of QS-21 Stimulon ® adjuvant with GlaxoSmithKline Biologicals, a vaccine division of GlaxoSmithKline (GSK). QS-21 is a key component included in several of GSK’s proprietary adjuvant systems. A number of GSK’s vaccine candidates currently under development are formulated with GSK’s proprietary adjuvant systems containing QS-21.

Under the terms of the agreements, GSK will purchase a percentage of its QS-21 supply requirements from Antigenics through 2014. Antigenics will also transfer manufacturing technologies to GSK under the supply agreement. GSK will make payments contingent upon successful milestone achievements, and will pay royalties to Antigenics on net sales for a period of at least 10 years after first commercial sale under the supply agreement.

“We are delighted to announce this transaction with GlaxoSmithKline,” said Garo H. Armen, PhD, chairman and CEO of Antigenics. “GSK is the world’s leading developer of preventive vaccines and novel cancer immunotherapeutics and Antigenics’ QS-21 offers GSK one of the most potent and widely used immunostimulants in development. These agreements represent an important strategic collaboration for both companies.”

 

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Confidential

 

About QS-21

QS-21 is the leading member of the Stimulon family of adjuvants developed by Antigenics, and has been shown to stimulate both antibody (humoral) as well as cellular immune responses. Published clinical studies have shown QS-21 to be significantly more effective in stimulating antibody responses than aluminum adjuvants, the only adjuvants used in approved vaccines in the United States today. QS-21 has not only become a critical component in the development of preventative vaccine formulations across a wide variety of infectious diseases, but may also be essential in enabling a new generation of therapeutic vaccines to treat cancer and degenerative disorders.

QS-21–based vaccines are being evaluated in more than 50 different indications through commercial partnerships with pharmaceutical companies, academic institutions and Antigenics’ internal programs. A number of pharmaceutical and biotechnology companies have licensed QS-21, including GlaxoSmithKline plc, Elan Corporation, plc, Wyeth, Pharmexa A/S and Advanced BioScience Laboratories, Inc.

Conference Call Information

Antigenics executives will host a conference call at XXX a.m. ET today. To access the live call, dial XXX (domestic) or XXX (international); the access code is XXX. The call will also be webcast and will be accessible from the company’s website at www.antigenics.com/webcast/. A replay will be available approximately two hours after the call through midnight ET on XXX. The replay number is XXX (domestic) or XXX (international), and the access code is XXX. The replay will also be available on the company’s website approximately two hours after the live call.

About Antigenics

Antigenics is working to develop treatments for cancers, infectious diseases and autoimmune disorders. The company’s investigational product portfolio includes Oncophage ® (vitespen), a patient-specific therapeutic cancer vaccine being evaluated in several indications; Aroplatin™, a liposomal, third-generation platinum chemotherapeutic; ATRA-IV, a liposomal retinoic acid; AG-707, a therapeutic vaccine for the treatment of genital herpes; AU-801, a preclinical program targeting autoimmune disorders; and QS-21, an adjuvant being evaluated by Antigenics’ corporate partners in several late-stage clinical trials. For more information, please visit www.antigenics.com.

[ANTIGENICS WILL INSERT LEGAL DISCLAIMER]

 

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Confidential

 

Exhibit H

Certain Statements Pre-Approved for Public Disclosure

 

    A number of pharmaceutical and biotechnology companies have licensed QS-21, including GlaxoSmithKline, Elan Corporation, Wyeth, Pharmexa A/S and Advanced BioScience Laboratories, Inc.

 

    Antigenics signed expanded license and supply agreements for the use of QS-21 Stimulon ® adjuvant with GlaxoSmithKline.

 

    QS-21 is a key component included in several of GSK’s proprietary adjuvant systems.

 

    Several GSK proprietary adjuvant systems containing QS-21 are included in a number of GSK of GSK’s vaccine candidates currently under development.

 

    Under the terms of the agreements, GSK will purchase a percentage of its QS-21 supply requirements from Antigenics through 2014.

 

    Antigenics will also transfer manufacturing technologies to GSK under the supply agreement.

 

    GSK will make payments contingent upon successful milestone achievements, and will pay royalties to Antigenics on net sales for at least 10 years after first commercial sale under the supply agreement.

 

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Confidential

 

Exhibit I

Current Licensed Patent Rights

 

Country

  

Serial/Application No.

  

Filed

  

Title

  

Status

  

Expiration

[**]

  

[**]

  

[**]

  

[**]

  

[**]

  

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i

Confidential

Exhibit 10.2

MANUFACTURING TECHNOLOGY TRANSFER AND SUPPLY AGREEMENT

BY AND BETWEEN

ANTIGENICS, INC., A MASSACHUSETTS CORPORATION

AND

GLAXOSMITHKLINE BIOLOGICALS SA


Confidential

 

MANUFACTURING TECHNOLOGY TRANSFER AND SUPPLY AGREEMENT

This Manufacturing Technology Transfer and Supply Agreement (this “ Agreement ”) is made effective this 6th day of July, 2006 (“ Effective Date ”) by and between Antigenics Inc., a Massachusetts corporation and wholly owned subsidiary of Antigenics Inc., a Delaware corporation, having offices at 3 Forbes Road, Lexington, MA 02421 (“ Antigenics MA ”), and GlaxoSmithKline Biologicals SA, a Belgian company, having an address at 89 rue de l’Institut, 1330 Rixensart, Belgium (“ GSK ”) (each singularly a “ Party ” and collectively the “ Parties ”).

WHEREAS, Antigenics MA and GSK are parties to that certain License, Development, and Supply Agreement entered into effective September 11, 1992 between Cambridge Biotech Corporation (predecessor to Antigenics MA) and Smithkline Beecham p.l.c. (predecessor to GlaxoSmithKline plc an Affiliate of GSK) (as amended, the “ Prior Agreement ”); and

WHEREAS, GSK has an interest in gaining certain manufacturing rights for QS-21 and restructuring its partnering arrangement with Antigenics MA;

WHEREAS, Antigenics MA has an interest in expanding its collaborative relationship with GSK;

WHEREAS, GSK and Antigenics MA now desire to terminate and supercede the Prior Agreement with this Agreement and the License Agreement (as hereinafter defined);

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

1. Definitions .

The following terms, whether used in the singular or the plural, shall have the following meanings for purposes of this Agreement:

1.1 “ Affiliate ” means any corporation, firm, partnership or other entity, which controls, is controlled by or is under common control with a Party. For purposes of this Section 1.1, “control” means direct or indirect ownership of fifty percent (50%) or more, or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction, of the outstanding stock or other voting rights entitled to elect directors thereof or the ability to otherwise control the management of the corporation, firm, partnership or other entity.

1.2 “ BMF ” means Antigenics MA’s FDA biologics master file(s) for QS-21.

1.3 “ Business Day ” means a day on which banking institutions in both Brussels, Belgium and Boston, Massachusetts are open for business.

 

1


Confidential

 

1.4 “ cGMP ” means the current European Guidelines, ICH Guidelines and United States Good Manufacturing Practices for Finished Pharmaceuticals pursuant to 21 C.F.R. 210 et seq., as amended from time to time.

1.5 “ cGMP Consistency Lots ” means minimum of [**]commercial grade process validation runs for Antigenics MA’s facility, Manufactured in accordance with the Specifications.

1.6 “ Completion of the [**]of the [**] ” means (a) [**] of all [**] of the [**] by [**] to [**] in accordance with Section [**] and (b) performance of a [**] in accordance with [**] and [**] of [**] at [**] in accordance with [**] and [**] of [**] at [**] , of one (1) [**] of [**] (which [**] is [**] without any [**] from the [**] which would [**] and [**] of [**]) , in accordance with the [**], which [**] shall be [**] the [**] to [**] in [**] with [**], for the [**] of [**] and [**] the [**] of the [**]. For avoidance of doubt, Completion of the [**] of the [**] does not require [**] and [**] of [**].

1.7 “ Confidential Information ” has the meaning set forth in Article 9 hereof.

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

1.9 “ First Commercial Sale ” means the date of first commercial sale of a QS-21 Vaccine by GSK or its Affiliates or Third Party Sublicensees or distributors anywhere in the Territory.

1.10 “ Fully Burdened Costs ” means: (a) in the case where Antigenics MA Manufactures QS-21 for supply to GSK hereunder, the total cost to Manufacture by Antigenics MA and/or its Affiliates hereunder, which total cost shall include direct and indirect labor costs, direct material costs (including without limitation, raw materials, lab supplies and other materials used directly in Manufacturing QS-21) and indirect material costs (including without limitation shipping materials (driven by shipments not batches), stability materials, batch record materials, sundry supplies to support QS-21 Manufacture, record keeping, stationary, incidental supplies etc.) calculated in accordance with Generally Accepted Accounting Principles (“GAAP”), and Other Overhead Costs calculated in accordance with GAAP [**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

2


Confidential

 

[**]; or (b) in the case where Antigenics MA engages a Third Party to Manufacture QS-21 on its behalf for supply to GSK hereunder, the actual cost to Antigenics MA to have QS-21 Manufactured and supplied by such Third Party, including without limitation, direct and indirect costs borne by Antigenics MA for any internal quality assurance, quality control, fill/finish, packaging, shipping, and/or delivery, in each case as duly documented by Antigenics. For either (a) or (b) above, Fully Burdened Costs shall also include direct and indirect costs incurred by Antigenics MA as a result of Antigenics MA fulfilling its Manufacturing and supply obligations pursuant to this Agreement, but shall specifically exclude any costs or expenses otherwise payable or reimbursable by GSK hereunder. Antigenics MA’s estimated Fully Burdened Costs under (b) above, based on [**] Manufacture of a [**] batch of QS-21 for [**], are detailed hereto as Exhibit D attached hereto. Antigenics MA’s estimated Fully Burdened Cost details shall be updated annually (or semi-annually upon the request of GSK) by Antigenics MA and shall be [**].

1.11 “ Gross Sales ” has the meaning set forth in Section 1.25 below.

1.12 “ License Agreement ” means the license agreement by and between Antigenics MA and GSK entered into contemporaneously with this Agreement and providing GSK with license rights under certain intellectual property to use QS-21 (as defined below) to develop, make, have made, use, sell, offer for sale and import certain products containing QS-21.

1.13 “ Licensed Indications ” means the Vaccine indications licensed to GSK pursuant to the License Agreement.

1.14 “ Licensed Vaccines ” means the Vaccines for which GSK has license rights under the License Agreement.

1.15 “ Manufacture or Manufacturing ” means the storage, production, purification, handling, materials procurement, processing, testing, packaging and release of QS-21 in accordance with this Agreement.

1.16 “ Manufacturing Capacity ” means Antigenics MA’s or its Affiliates or authorized Third Party manufacturer’s capacity for QS-21 Manufacture for [**] and [**] as set forth on Exhibit C attached hereto and incorporated herein, or such higher capacity as Antigenics MA may advise GSK from time to time in writing.

1.17 “ Manufacturing Improvements ” means any development, enhancement, improvement, invention, modification, or derivative (whether or not patentable) necessary for or actually applied to the Manufacture of QS-21 that is made, discovered, conceived or reduced to practice by or on behalf of GSK or its Affiliates in the course of the further development or Manufacturing of QS-21 at any time during the [**] of this Agreement or by Antigenics MA or its Affiliates in the course of the further

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Confidential

 

development or Manufacture of QS-21 at any time during the [**] of this Agreement. For the avoidance of doubt, Manufacturing Improvements specifically exclude any development, enhancement, improvement, invention, modification, or derivative (whether or not patentable) relating to [**] (as opposed to [**]) or [**] or [**] or [**] of [**] with a [**] other [**] or any other [**] of a [**].

1.18 “ Manufacturing Technology ” means (i) United States Patent No. [**] (the “[**] Patent”) , together with any patents issuing from any continuations, continuations-in-part (to the extent that the claims therein are directed to subject matter disclosed in the [**] Patent), divisionals, substitutions, reissues, reexaminations or extensions of the [**] Patent, and any foreign counterparts or equivalents of the foregoing, and (ii) the technical and regulatory information contained in the Manufacturing Technology Package, and (iii) any know-how owned or controlled by Antigenics MA (with the right to grant licenses or sublicenses hereunder) existing as of the Effective Date that are necessary or reasonably useful for the Manufacture of QS-21 and (iv) any Manufacturing Improvements owned or controlled by Antigenics MA or its Affiliates (with the right to grant licenses or sublicenses hereunder) whether or not claimed by a patent filed by Antigenics MA.

1.19 “ Manufacturing Technology Package ” means all relevant technical and regulatory information on QS-21 and the QS-21 Manufacturing process owned and/or controlled by Antigenics MA (with the right to transfer to GSK BIO), as listed under the heading “Phase 1: Transfer of Enabling Technology (Manufacturing Technology Package)” in the Manufacturing Technology Transfer Plan.

1.20 “ Manufacturing Technology Transfer Royalty ” has the meaning set forth in Section 5.3 hereof.

1.21 “ Manufacturing Technology Transfer Plan ” means the written transfer plan agreed to between and signed by both Parties contemporaneously with this Agreement, which forms an integral part hereof, which will set forth the activities of each Party relating to the transfer of the Manufacturing Technology to GSK and the objectives, criteria, milestones and timelines relating to each Party’s Manufacturing activities hereunder including without limitation, cooperation of the Parties to ensure [**] between the Parties and timelines for [**] of [**] as further described therein, and as may be updated from time to time until completion of all contemplated activities.

1.22 “ Manufacturing Transition Date ” means January 1, 2012, unless another date is agreed to between the Parties for GSK to begin Manufacturing itself in accordance with Section 2.5 and 3.2 (the “ Manufacturing Transition Date ”).

1.23 “ Marketing Approval ” means approval received from the FDA or any comparable approval in any non-US jurisdiction with any relevant Regulatory Authority granting the right to commercialize QS-21 Vaccines (but specifically independent of pricing or reimbursement considerations, where applicable).

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Confidential

 

1.24 “ Minimum Purchase Requirement ” has the meaning set forth in Section 3.4(a) hereof.

1.25 “ Net Sales ” means the amount billed or invoiced on arms length sales of QS-21 Vaccines by GSK, its Affiliates or Third Party Sublicensees to Third Parties including its distributors (“ Gross Sales ”) less deductions duly documented for (i) normal and customary trade, quantity and cash discounts and non-affiliated broker’s, distributor’s or agent’s commissions actually allowed and taken; (ii) amounts repaid or credited by reason of rejection or return or retroactive price reduction; (iii) to the extent separately stated on purchase or sales orders, invoices, or other documents of sale, sales and excise taxes and duties levied on and/or other governmental charges made as to production, sale, importation, transportation, delivery or use paid by or on behalf of GSK or its Affiliates or Third Party Sublicensees; (iv) transportation costs including insurance; and (v) the [**] determined as [**] of [**] and other special [**] and/or [**] and [**] with Licensed Vaccines; (vi) any [**] to [**] on [**], provided however that [**] under [**] shall not exceed [**] of [**]; and (vii) contributions and payments required by the [**] to be made pursuant to the [**], specifically with respect to any of [**], and which [**] and [**] have been [**] on to the [**] and are [**] in the [**] of [**] and which are not [**], provided however that deductions under this subparagraph (vii) and subparagraph (v) shall not exceed [**] of [**] in the [**]. Sales between or among GSK and its Affiliates or Third Party Sublicensees shall be excluded from the computation of Net Sales except where the Affiliates or Third Party Sublicensees are end users, but Net Sales shall include the subsequent final sales to Third Parties by the Affiliates or Third Party Sublicensees.

For the avoidance of doubt, in the event GSK gets any indirect financial interest, income or other consideration back from the subsequent QS-21 Vaccines sales of GSK distributors to Third Parties, such financial interest, income or consideration shall be included as Net Sales. In addition, in the event that GSK has entered into a distribution agreement with a Third Party and which distribution agreement is in a form that is in economic and business substance a sublicense relationship and not a traditional distribution relationship in such country or countries, then such distributor shall be treated as a Sublicensee for purposes of calculating Net Sales and royalties hereunder.

If GSK or any of its Affiliates or Third Party Sublicensees makes any transfer of QS-21 Vaccines to Third Parties for consideration other than monetary value or as part of a multi-product transaction, such transfer will be considered a sale hereunder for Net Sales, accounting and royalty purposes. Net Sales for any such transfers will be determined on a country by country basis and will be the average price of “arms length” sales of QS-21 Vaccines by GSK or its Affiliates or Third Party Sublicensees s in such country during the

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Confidential

 

royalty reporting period in which such transfer occurs or, if no such “arms length” sales occurred in such country during such period, during the last period in which such “arms length” sales occurred. If no “arms length” sales have occurred in a particular country, Net Sales for any such transfer in such country will be the average price of “arms length” sales of QS-21 Vaccines in all countries in the Territory by GSK, its Affiliates or Third Party Sublicensees.

If QS-21 Vaccine(s) is (are) sold as part of a Combination Vaccine (as hereinafter defined), Net Sales for purposes of determining royalties on QS-21 Vaccine(s) in the Combination Vaccine shall be calculated by [**] of the [**] (as determined in accordance with the provisions of this Section) by the [**], where [**] is the [**] of the QS-21 Vaccine(s) [**] in the [**] and [**]) and [**] is the [**] of the [**] in the [**] in the [**] and [**]).

As used herein, “ Combination Vaccine ” means QS-21 Vaccines formulated in combination with one or more Other Vaccine Product(s). As used herein, “ Other Vaccine Product ” means a vaccine product, other than a QS-21 Vaccine, which is [**] with [**] and [**] when [**] with the [**], as [**] by [**] to [**].

In the event that no such separate sales are made of the QS-21 Vaccine or Other Vaccine Product(s) in such Combination Vaccine in the relevant country during the royalty period in question, then by [**] of the [**] (as determined in accordance with the provisions of this Section) by the [**], where [**] is the [**] of the [**] in [**] within the [**] and [**], and [**] is the [**] of the [**] in such [**] within the [**] and [**].

In the event that no such separate sales are made of the QS-21 Vaccines or any of the Other Vaccine Products in such Combination Vaccine in the relevant countries within the same geographical region and similar economic profile during the royalty period in question, Net Sales, for the purposes of determining royalty payments, shall be calculated as [**] in [**] the [**], provided that in the event the Parties are [**] to [**] to [**] on [**] after [**], then [**] shall be [**] for [**] to an [**] to the [**] shall be [**].

1.26 “ Other Costs ” means the costs incurred and paid by Antigenics MA and/or its Affiliates for the execution of the Manufacturing Technology Transfer Plan, activities under [**] hereof, and related activities, as such costs shall be set forth in an “Other Costs Budget” to be established and agreed by the Steering Committee within [**] after the execution of this Agreement, and which shall include without limitation: (i) the direct and indirect labor costs (including personnel time of Antigenics

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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MA’s or its Affiliates’ employees (charged at an FTE rate of [**]), and any consultation services or cooperation charged [**], provided by or on behalf of Antigenics MA or its Affiliates in accordance with the Manufacturing Technology Transfer Plan and (ii) direct and indirect material costs. Other Costs specifically excludes Antigenics MA’s Fully Burdened Costs of Manufacturing QS-21 Vaccine otherwise chargeable to GSK under this Agreement.

1.27 “ Other Overhead Costs ” for purposes of determining Fully Burdened Costs, means appropriate [**] and [**] of [**] related to QS-21 Manufacturing activities.

1.28 “ Quality Agreement ” means the Quality Agreement entered into between the Parties contemporaneously with this Agreement, as may be revised by the Parties from time to time and which forms an integral part hereof.

1.29 “ QS-21 ” means a substantially pure saponin adjuvant isolated from crude Quillaja saponaria tree extract and referred to as QS-21, a Stimulon ® adjuvant.

1.30 “ QS-21 Vaccine(s) ” means, during the term of the License Agreement, the Licensed Vaccines, and after expiration of a Valid Claim of the Licensed Patent Rights covering the applicable Vaccine product, QS-21 Vaccines means any Vaccine product of GSK or its Affiliates or Third Party Sublicensees formulated using QS-21.

1.31 “ Regulatory Authority ” means the U.S. or foreign government agency or health authority that regulates and grants recommendations for approvals for the manufacture and sale of pharmaceutical products.

1.32 “ Release ” has the meaning set forth in Section 4.1 hereof.

1.33 “ Specifications ” means the applicable release specifications for QS-21 agreed to by the Parties and set out in Exhibit A attached hereto and incorporated herein, as may be amended from time to time by mutual agreement of the Parties.

1.34 “ Steering Committee ” means the Steering Committee established in accordance with this Agreement.

1.35 “ Sublicensee ” means any Affiliate or Third Party to whom GSK grants a sublicense of any of the license rights granted to GSK pursuant to the terms and conditions of the License Agreement.

1.36 “ Term ” has the meaning set forth in Section 8.1 hereof.

1.37 “ Territory ” means the world.

1.38 “ Third Party ” means any entity other than the Parties to this Agreement or their respective Affiliates.

1.39 “ Vaccine ” means a preparation in finished form (not requiring any further processing or packaging prior to sale to the end user).

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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2. Steering Committee, Manufacturing Technology Transfer, Cooperation and License Rights .

2.1 General . Antigenics MA will transfer the Manufacturing Technology Package to GSK in accordance with the Manufacturing Technology Transfer Plan, and both Parties will perform their respective activities under and in accordance with the Manufacturing Technology Transfer Plan in order to facilitate [**] between the two Parties.

2.2 Steering Committee .

(a) As soon as reasonably practicable after the Effective Date, Antigenics MA and GSK BIO will establish a steering committee (the “ Steering Committee ”), to oversee the activities to be undertaken pursuant to this Agreement. The Steering Committee will facilitate communication between the Parties and provide a forum to review any technology transfer, supply and manufacturing matters pertaining to QS-21. The Steering Committee shall consist of three (3) individuals appointed by each Party or such other number of representatives the Parties may mutually agree upon and may also include additional representatives from the Parties, as mutually agreed, on an ad-hoc basis and shall be co-chaired by GSK and Antigenics MA. The co-chairs will coordinate agendas and minute-taking for meetings of the Steering Committee. Each Party may replace its Steering Committee representatives at any time upon written notice to the other Party provided that, in the [**] and will [**] to any [**]. The Steering Committee may establish certain ad hoc sub-committees which consider certain matters, including without limitation, one or more sub-committees (consisting of at least one (1) individual from each Party) to address (i) technical matters in dispute that have not been resolved under the Quality Agreement and (ii) repetitive, specific cGMP issues.

(b) The Steering Committee shall meet (in person, or by teleconference or videoconference as agreed by the Parties) at least [**] during the first [**] and thereafter [**] (or more frequently as the Parties mutually agree is appropriate, or as determined by [**] during any period of Antigenics MA’s inability to supply under Section 3.5(c), on such dates and at such times as the Parties shall agree. The Steering Committee (itself or through one or more sub-committes as contemplated in Section 2.2(a) above) will, among other things (i) oversee the Manufacturing Technology transfer; (ii) review and manage the Manufacturing relationship hereunder, including without limitation, review the Manufacturing requirements for QS-21 for GSK, (iii) discuss and review for Antigenics MA’s reasonable consideration, the [**], discuss

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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and review validation plans for Manufacturing, QC testing and facilities, and coordinate efforts to ensure [**] between the two Parties; (iv) establish the Other Costs Budget as described in Section 1.26 above), and (v) address such other matters as may be agreed to between the Parties including open matters that may exist at the level of the sub-committees. All information provided to Antigenics MA pursuant to this Section shall be considered the Confidential Information of GSK in accordance with Article 9; provided, however , that GSK grants permission to Antigenics MA to (i) disclose such information as may be necessary or reasonably useful to comply with any applicable laws, rules, regulations, or guidelines, including to reference and submit any such information to the FDA and other relevant Regulatory Authorities and for inclusion in the QS-21 BMF or comparable filing, subject to GSK’s confidential obligations to Third Parties. All information provided to GSK pursuant to this Section shall be considered the Confidential Information of Antigenics MA in accordance with Article 9, provided however that Antigenics MA grants permission to GSK to disclose such information as may be necessary or reasonably useful to comply with any applicable laws, rules, regulations, or guidelines, including to reference and submit any such information to the FDA and other relevant Regulatory Authorities and for securing product license applications with respect to QS-21 Vaccines, subject to Antigenics MA’s confidential obligations to Third Parties.

(c) Subject to Section 10.1 below, the Steering Committee will operate by consensus, and each Party will consider the other Party’s input in good faith, provided however that [**] shall [**] in [**] on the [**] with [**] with respect to [**], provided that (x) [**] shall not [**] in [**] that [**] in [**] to a [**] or other [**], or [**] in [**] between [**] and [**] or [**] hereunder); and (y) without in any way limiting (x), GSK shall indemnify and hold harmless Antigenics MA from any liability incurred by Antigenics MA as a result of [**].

2.3 Manufacturing Technology Transfer Plan, Manufacturing Technology Transfer Team and Manufacturing Technology Package .

(a) Manufacturing Technology Transfer Plan . Antigenics MA will use commercially reasonable efforts to execute the Manufacturing Technology Transfer Plan (and to [**] to execute its activities under the Manufacturing Technology Transfer Plan), in an efficient and timely manner and in accordance with schedule as set forth in the Manufacturing Technology Transfer Plan. In particular, Antigenics MA will [**] under the Manufacturing Technology Transfer Package (other than the [**]) within [**] after the Effective Date and the Parties shall use commercially reasonable efforts to complete the Phase 1 of the Manufacturing Technology Transfer Plan with the goal of reaching Completion of the Transfer of the Manufacturing Technology Package by the later of [**] or [**].

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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(b) Establishment of Manufacturing Technology Transfer Team . As soon as practicable after the Effective Date and until completion of the Manufacturing Technology Transfer Plan, GSK and Antigenics MA shall establish a Manufacturing Technology Transfer Team comprised at least of four (4) representatives designated by GSK and at least four (4) representatives designated by Antigenics MA; provided that GSK and Antigenics MA may designate an equal number of additional representatives from time to time. Each Party shall make its initial designation of its representatives not later than [**] after the Effective Date. Either Party may change its designees to the Manufacturing Technology Team at any time upon written notice to the other Party. Each representative shall have appropriate skills and competencies for its role on the team.

(c) Contact Persons . The Parties will identify contact persons to serve as the primary contacts for and day-to-day management of the coordination, delivery and receipt of the Manufacturing Technology under the Manufacturing Technology Transfer Plan.

(d) Transfer of the Manufacturing Technology Package . Antigenics MA shall notify GSK in writing of the Completion of the Transfer of the Manufacturing Technology Package, and provide reasonable evidence of such completion in accordance with any delivery criteria set forth in the Manufacturing Technology Transfer Plan, which shall constitute reasonable evidence for the purpose of determining whether the transfer is complete. GSK shall have [**] to either agree upon the Completion of the Transfer of the Manufacturing Technology Package and in that case GSK shall [**] described in [**] in accordance with the provisions of [**] or identify any deficiencies, and in the latter case shall promptly provide Antigenics MA with written notice thereof and the Parties shall promptly discuss such issue. Each Party shall use reasonable efforts, if applicable, to timely address any such deficiencies that were specified in writing. Upon correction of such noticed failures, Antigenics MA shall notify GSK BIO in writing. In the event of any disagreement of the Parties regarding the Completion of the Transfer of the Manufacturing Technology Package by Antigenics MA, the matter shall be referred to the Steering Committee for resolution. If the Steering Committee is unable to resolve the matter within [**] of such referral, the matter shall be resolved in accordance with the dispute resolution provisions in Section 10.1 hereof. In any case, [**] shall only be [**] described in [**] upon resolution of the Completion of the Transfer of the Manufacturing Technology Package issue either [**] or as will be decided under Section 10.1 hereof.

(e) Other Costs . GSK BIO shall reimburse Antigenics MA monthly for the Other Costs incurred by Antigenics MA in accordance with the Other Costs Budget to be established by the Steering Committee, within [**] of receipt of duly documented invoices from Antigenics MA.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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2.4 Regulatory Cooperation .

(a) Access to Regulatory Documents and Communications . GSK will have the right to cross-reference the BMF. As part of the Manufacturing Technology Transfer Plan, Antigenics MA shall provide GSK with a redacted copy of the BMF. In addition, each Party shall promptly send the other Party a copy of any material notices, material reports, and other material communications it has received from any Regulatory Authority or other governmental entity concerning QS-21. Antigenics MA will discuss with GSK any material documents relating to Manufacturing matters for the QS-21 Vaccines pertaining to the QS-21 that Antigenics MA receives from, or intends to submit to the Regulatory Authorities in the Territory in line with Section 5.8 of the License Agreement and GSK will discuss with Antigenics MA any material documents relating to Manufacturing matters for the QS-21 Vaccines pertaining to the QS-21 that GSK receives from, or intends to submit to the Regulatory Authorities in the Territory in line with Section 5.8 of the License Agreement but only to the extent these documents relate to the subject matter described in Section 2.2 (c) (x) above. Upon GSK’s reasonable request, Antigenics MA will provide GSK with regulatory support as reasonably necessary for development and licensure of GSK QS-21 Vaccines. Likewise, upon GSK’s reasonable request, Antigenics MA will reasonably cooperate with GSK in support of all regulatory filings involving QS-21, including participation in meetings with Regulatory Authorities as appropriate. In addition, Antigenics MA will authorize and reasonably cooperate with GSK to prepare any visit or inspection requested by Regulatory Authorities.

(b) Changes to Manufacturing Processes . Any changes to Manufacturing processes shall be handled pursuant to the provisions of the Quality Agreement and Section 2.8 of this Agreement.

(c) Adverse Events Reporting . GSK shall be responsible for reporting all safety related events from studies of QS-21 Vaccines to the appropriate Regulatory Authorities and agencies according to the applicable local regulations, including without limitation, the regulations outlined in 21 CFR 312.32 (and other applicable international regulations). GSK and Antigenics MA shall keep each other informed of any serious adverse reactions, or other significant, unusual or unexpected safety findings related to QS-21 as provided for in Section 5.8 of the License Agreement.

(d) Compliance . Notwithstanding the foregoing and for the avoidance of doubt, (i) GSK shall comply, and shall cause its Sublicensees to comply, with all applicable federal and state laws, rules, regulations and guidelines in connection with its performance under this Agreement and the development and commercialization of QS-21 Vaccines; and (ii) Antigenics MA shall comply, and shall cause its Affiliates and Third Party Manufacturer (other than the contract manufacturer selected by the Steering Committee, whose compliance shall be the joint responsibility of Antigenics MA and GSK) to comply, with the Specifications, the cGMP and other applicable federal and State laws, rules and regulations in connection with its performance under this Agreement and the Manufacture of QS-21. Without limiting the generality of the foregoing, GSK shall use Commercially Reasonable Efforts (as such term is defined in the License Agreement) to ensure compliance with all applicable product safety, product

 

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testing, product labeling, package marking, and product advertising laws and regulations and International Conference on Harmonisation (ICH) Guidelines. GSK shall be solely responsible for diligently obtaining all required and/or necessary Regulatory Authority authorizations and approvals to develop, Manufacture and commercialize QS-21 Vaccines hereunder and under the License Agreement.

(e) Product Recalls . Any products recalls will be handled pursuant to the terms of the Quality Agreement.

2.5 License Grant to GSK .

(a) Subject to the terms and conditions of this Agreement (including without limitation, the provisions of Article 4 below and the retained rights of Antigenics MA set forth in Sections 3.1 and 3.2 below), Antigenics MA hereby grants to GSK a [**] right and license (with the right to grant sublicenses to its Affiliates and Sublicensees as defined in the License Agreement, subject to the provisions of Section 2.5(c) below) to [**] for the sole purpose of [**]. To the extent that Antigenics MA subcontracts or sublicenses with its Affiliates or Third Parties to Manufacture hereunder, Antigenics MA shall obtain the right under the intellectual property rights of such Affiliate or Third Party related to the Manufacture of QS-21, with the right to grant sublicenses to GSK and its Affiliates (and such license shall be further sublicensable by GSK to its Affiliates and Sublicensees, subject to the provisions of Section 2.5(c) below), to use any such intellectual property necessary for or actually applied to the Manufacture of QS-21 that is discovered or developed by such Affiliate or Third Party to preserve the license granted to GSK and its Affiliates in this Section.

(b) Notwithstanding the provisions of Section 2.5(a) above, Antigenics MA hereby retains the right and has the obligation to Manufacture QS-21 for GSK, its Affiliates, and Sublicensees (subject to Section 2.5(c) below), as set forth in Sections 3.1, 3.2 and 3.3 below. For the avoidance of doubt, nothing in this Section 2.5 shall be construed to prevent Antigenics MA from Manufacturing or having Manufactured QS-21 for itself or any other parties. For the Term of this Agreement, GSK agrees to Manufacture or have Manufactured QS-21 solely in accordance with this Agreement, and for the term of the License Agreement and thereafter to use QS-21 solely to develop, make, have made, use, sell, offer for sale and import QS-21 Vaccines.

(c) GSK may grant sublicenses to Sublicensees provided that:

(i) the Sublicensee will practice the Manufacturing Technology only to the extent granted to GSK under this Agreement;

(ii) GSK and each Affiliate Sublicensee will sign a [**] under which the Affiliate Sublicensee will agree to be bound by the terms of this Agreement;

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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(iii) GSK and each Third Party Sublicensee shall enter into a written agreement subject to, consistent with, and not to extend beyond the scope of GSK’s rights under, and the terms and conditions of, this Agreement, or provide for Sublicensee obligations inconsistent with or less than GSK’s obligations under this Agreement, and which written agreement shall require the Third Party Sublicensee to agree to be bound by and comply with provisions that are consistent with the provisions of this Agreement;

(iv) each such side letter or sublicense agreement shall require the Affiliate and/or Third Party Sublicensee, at the election of Antigenics MA (to be made by Antigenics MA upon notice from GSK at the time the side letter or sublicense agreement is entered into) to either (i)[**] to [**] by the [**] and [**] of, and the [**] of [**] under, [**] or (ii) [**] a [**] within a reasonable time after the [**] of the [**] , pursuant to which the [**] shall be [**] to [**] from [**] , or a [**] (either [**] or [**] as may be agreed to by Antigenics MA) [**] of [**] and [**] or [**] will [**] such [**] (subject to [**]), provided that [**], any [**] shall [**];

(v) GSK shall remain responsible for compliance by any Sublicensee receiving a sublicense hereunder with all terms and conditions of this Agreement relevant to such Sublicensee. GSK shall promptly provide Antigenics MA with a copy of the relevant provisions of such agreement entered into with any Third Party Sublicensee redacted as may be deemed appropriate by GSK for confidentiality or legal reason; and

(vi) in addition and notwithstanding the foregoing, GSK may grant sublicenses to Affiliate subsidiaries controlled by GSK without entering into a written [**] or sublicense agreement with such subsidiaries, provided that GSK shall and hereby guarantees and remains primarily responsible for the performance of such subsidiaries in accordance with this Agreement.

Should this Agreement terminate for any reason, at GSK’s request (or Antigenics MA’s election in the event this Agreement and the licenses granted to GSK hereunder are terminated by Antigenics MA for GSK’s material breach in accordance with Section 8.4(c)), and provided that GSK’s Third Party Sublicensee continues to comply with the provisions of the written agreement to be entered into pursuant to this Section, the Third Party Sublicense shall survive, provided that Antigenics MA shall be substituted for GSK and become the direct licensor of GSK’s Third Party Sublicensee, provided that Antigenics MA has approved or has not reasonably objected to such written agreement. However, Antigenics MA shall assume no obligations of GSK under such written agreement, other than the obligation to grant the Manufacturing rights contemplated in this Section 2.5, unless Antigenics MA otherwise agrees.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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2.6 License Grant to Antigenics MA . Subject to the terms and conditions of this Agreement, GSK shall grant and hereby grants to Antigenics MA and its Affiliates a [**], right and license, with the right to grant sublicenses, to any [**] (whether or not patented or patentable) to make or have made QS-21. For the avoidance of doubt, nothing in this Section 2.6 shall be construed as granting Antigenics MA any right to [**] or any right to [**] or to [**]. To the extent that GSK subcontracts or sublicenses with its Affiliates or Third Parties for the performance of GSK’s rights or obligations hereunder in accordance with this Agreement, GSK shall obtain the right under the intellectual property rights of such Affiliate or Third Party related to the Manufacture of QS-21, with the right to grant sublicenses to Antigenics MA and its Affiliates (and such license shall be further sublicensable by Antigenics MA), to use any such intellectual property necessary for or actually applied to [**] that is discovered or developed by such Affiliate or Third Party to preserve the license granted to Antigenics MA and its Affiliates in this Section.

2.7 No Other Rights . Except for the express licenses granted pursuant to this Article 2, no license, express or implied, is granted by either Party to the other Party under any intellectual property or other rights owned or controlled by such Party pursuant to this Agreement.

2.8 Disclosure of Manufacturing Improvements . For the avoidance of doubt, no obligations on either Party to disclose Manufacturing Technology are implied by the license grants set forth herein, and the only Manufacturing Technology disclosure obligations under this Agreement are the specific disclosure and reporting obligations expressly set forth in this Agreement, the Quality Agreement or the Manufacturing Technology Transfer Plan. The Parties agree that each Party will promptly disclose to the other Party those Manufacturing Improvements that are modifications, improvements or other changes to the Manufacturing process that may reasonably affect the yield, scale, cost or efficiency of the Manufacturing process, and shall cooperate with the other Party to enable the other Party to practice such modifications, improvements or other changes in its Manufacturing processes in accordance with such other Party’s rights under this Agreement.

3. Manufacture and Supply by Antigenics MA .

3.1 Initial Supply . Subject to the terms and conditions contained in this Agreement, until the Manufacturing Transition Date, GSK agrees to purchase solely from Antigenics MA or it Affiliates (or a Third Party manufacturer approved by GSK, such approval not to be unreasonably withheld or delayed), and Antigenics MA or its Affiliates (or a Third Party manufacturer approved by GSK, such approval not to be unreasonably withheld or delayed) agrees to supply GSK and its Sublicensees with one hundred percent (100%) of their initial requirements of QS-21 (subject to the Manufacturing Capacity) for use solely in the development, marketing and sale of QS-21 Vaccines in the Territory. In the event that GSK’s requirements for QS-21 exceed the Manufacturing Capacity, the Parties will work together to increase the Manufacturing

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Capacity as set forth in Exhibit C. Antigenics MA shall use commercially reasonable efforts to Manufacture and supply Commercial Grade cGMP quality of QS-21 (in accordance with Specifications of Exhibit A with a target of [**]) no later than [**], provided that GSK shall reasonably cooperate with Antigenics MA to that end in accordance with Antigenics MA reasonable request and reasonable timeline. Thereafter, Antigenics MA will only supply Commercial Grade cGMP QS-21 to GSK.

3.2 Future Supply . Commencing on the Manufacturing Transition Date and subject to the terms and conditions contained in this Agreement, GSK agrees to purchase solely from Antigenics MA or its Affiliates (or a Third Party manufacturer approved by GSK, such approval not to be unreasonably withheld or delayed), and Antigenics MA (itself or through an Affiliate or a Third Party manufacturer approved by GSK, such approval not to be unreasonably withheld or delayed) retains the right and has the obligation, to Manufacture, [**] percent [**] of GSK’s and its Affiliates and, if requested by GSK in accordance with this Agreement, Third Party Sublicensees’ requirements of QS-21 (subject to the Manufacturing Capacity) for use solely in the development, marketing and sale of QS-21 Vaccines in the Territory, up to [**] per year for three (3) years after the Manufacturing Transition Date. In the event that GSK’s requirements for QS-21 exceed [**] per year during such three year period, the Parties will discuss in good faith the potential for increasing the [**] cap hereunder. Beyond that period, at either Party’s request, the Parties will discuss in good faith, the possibility of extending the QS-21 supply by Antigenics MA to GSK.

3.3 Supply to GSK’s Sublicensees . Prior to supplying any Sublicensee under the License Agreement with QS-21 supplied to GSK hereunder, GSK shall enter into a written agreement with such Sublicensee pursuant to which such Sublicensee acknowledges and agrees to be subject and subordinate to the provisions of this Agreement (but specifically excluding the right of such Sublicensee to Manufacture or have Third Parties Manufacture QS-21 prior to [**]). In accordance with Section [**], Antigenics MA may [**].

3.4 Forecasts and Purchase Orders . GSK shall issue forecasts and firm purchase orders for its requirements of QS-21 as follows:

(a) Annual Forecasts . Attached hereto as Exhibit B and incorporated herein is GSK’s indicative forecasts of the quantity of QS-21 it expects to require for 2006- 2014 in a form substantially similar to the table included in Exhibit B-1 attached hereto. These long-term forecasts shall be updated by GSK no later than [**] of each year for the remaining years under this Agreement. GSK shall be obligated to order within the immediately following calendar year not less than [**] percent [**] of the quantity of QS-21 specified in the forecast provided in accordance with the foregoing sentence, and in no event less that the purchase requirement set forth in Sections 3.1 or 3.2 above (as applicable) (the “ Minimum Purchase Requirement ”). In the

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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event that GSK does not comply with the foregoing provisions of this Section 3.4(a) and delays providing its annual forecast by [**] of a particular calendar year, then Antigenics MA shall notify GSK of its failure to provide such forecast, and in the event that GSK does not furnish such forecast within [**] of receipt of such notice, then Antigenics MA retains the right, but not the obligation, to (i) make the Minimum Purchase Requirement for the immediately following calendar year equal to one hundred percent (100%) of the amount set forth in the last annual forecast received from GSK pursuant to this Section 3.4(a), or (ii) provide GSK with its estimation of what Antigenics MA believes to be GSK’s minimum purchase requirements for such period, and GSK shall have [**] from receipt thereof to provide an update of this estimate.

(b) Rolling Forecasts . Not later than the first day of each calendar quarter, GSK shall provide Antigenics MA with a rolling quarterly forecast of the quantity of QS-21 that it expects to require and purchase from Antigenics MA for the following next [**] calendar quarters, which shall be no less than its Minimum Purchase Requirement (as defined above), and shall be binding on GSK for hundred percent (100%) as to the first [**] quarters, be binding on GSK for [**] of the quantities of QS-21 forecasted for the next [**] quarters, and be non-binding on GSK as to the remaining [**] calendar quarters. In the event that GSK does not comply with the provisions of this Section 3.4(b) and fails or delays to provide its forecasts hereunder, then Antigenics MA will notify GSK and GSK shall have [**] to comply with its obligations, otherwise Antigenics MA may elect to fill the purchase order(s) to be placed in accordance with Section 3.4(c) below for any of the quarters of the concerned forecast, but is not obligated to do so.

(c) Firm Purchase Orders . Not later than [**] prior to the beginning of [**], GSK shall provide Antigenics MA with a firm purchase order for the quantity of QS-21 it intends to purchase hereunder during such [**]. Each firm purchase order shall specify the quantity of QS-21 to be ordered. Such firm purchase order commits GSK to purchase [**] percent [**] of the quantity of QS-21 set forth in the purchase order during that [**]. In the event that GSK does not comply with the foregoing provisions of this Section and delays ordering or does not submit a purchase order for a particular [**] in a given [**], then Antigenics MA may notify GSK and GSK shall have [**] to comply with its purchase order obligations (and Antigenics MA shall have an additional [**] to supply GSK beyond the period specified in Section 3.4(d) below). In case of GSK’s failure to do so, Antigenics MA retains the right to deliver to, and charge GSK for, QS-21 in such [**] in the amount equal to [**], where A equals the [**] for the applicable [**], B equals the [**], and C equals the number of [**] (including the [**] at issue).

(d) Delivery . Antigenics MA shall deliver within [**] of the applicable [**] (the “ Contractual Delivery Date ”), and in accordance with

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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the Specifications,[**] of the quantity of QS-21 set forth in the applicable firm purchase order (subject to the Manufacturing Capacity) for the applicable calendar quarter. Such QS-21 shall not [**]; provided, however, that Antigenics MA may make delivery of any firm purchase order that is for less than the Minimum Purchase Requirement, subject to payment by GSK of the [**] of the [**] up to the [**], and shall have the right to reject that portion of any firm purchase order that exceeds [**] percent [**] of the QS-21 amount set forth in the corresponding last non-binding forecast for that calendar quarter, or any purchase order that is otherwise inconsistent with the requirements of this Agreement. If Antigenics MA determines that any firm purchase order submitted by GSK, and not rejected by Antigenics MA hereunder, cannot be filled by the Contractual Delivery Date, including, without limitation, as a result of a supply failure by a Third Party manufacturer, Antigenics MA shall notify GSK in writing promptly upon making such determination. In such case, the Parties will work together, in good faith, to identify an appropriate resolution to the supply problem. If the Parties cannot reach an agreement on an appropriate resolution to the problem within [**] of bringing this to the attention of the Steering Committee for resolution, then at either Party’s written request but without prejudice to Section 3.5(c), resolution of the problem will be governed by the [**]. Notwithstanding the foregoing or any other provision of this Agreement, in the event GSK orders QS-21 for any [**] in an amount greater than [**] percent [**] of the quantity ordered in the firm purchase order for the immediately preceding [**], Antigenics MA will use commercially reasonable efforts to meet the order, but shall be deemed to have met the order if it supplies by the Contractual Delivery Date [**] percent [**] of the quantities ordered in the firm purchase order for the immediately preceding [**]. In calculating [**] percent [**] of the quantities ordered in firm purchase orders for the [**], the Parties shall exclude quantities ordered in the preceding [**] in excess of that which Antigenics MA must supply in order to have been deemed to have met the order. Although Antigenics MA may upon request from GSK agree from time to time in its sole discretion to deliver QS-21 in [**], any such agreement in a given instance shall in no event obligate Antigenics MA to deliver subsequent future orders of QS-21 in any [**] but the [**].

(e) Shipping . Each order of QS-21 shall be shipped F.O.B. Antigenics MA’s facilities (U.C.C. terms) or, in the event Antigenics MA has a Third Party Manufacture QS-21 in accordance with this Agreement, then at Antigenics MA’s discretion, F.O.B. the Third Party’s facilities. Shipping will be according to the purchase order and to any other specific written instructions of GSK reasonably acceptable to Antigenics MA or its Third Party manufacturer (or if no written instructions are given, by a common carrier selected by Antigenics MA and reasonably agreeable to GSK, taking into consideration the specific nature of QS-21). Title to and risk of loss for any order of QS-21 purchased by GSK shall pass to GSK upon the common carrier taking possession and control of the order of QS-21. Unless otherwise agreed to between the Parties, all QS-21 shall be [**].

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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and in accordance with shipping instructions provided by GSK to Antigenics MA from time to time.

(f) All forecasts and purchase orders to be provided by GSK to Antigenics MA hereunder may be transmitted to Antigenics MA via email, provided that Antigenics MA confirms receipt thereof within [**]. In the event that Antigenics MA does not confirm receipt within [**], GSK shall contact Antigenics MA to ensure that Antigenics MA received such email, or in the alternative, GSK may provide such forecast or purchase order via the notice requirements of Section 10.12 of this Agreement.

3.5 Supply Controls .

(a) [**]. Without limiting in any way [**] under this Agreement, [**] may [**], either [**] at [**] or [**], to [**] consistent with the terms of this Agreement. In the event that [**] in connection with Section 3.5(c) below, then [**] will [**] with [**] in its efforts, consistent with the terms of this Agreement. In the event [**] so requests in the future, the Parties will discuss in good faith the possibility of [**] by such [**] on [**].

(b) [**]. In the event that [**] with a [**] (other than [**], the [**] (or [**] (either as the [**]), [**] shall be [**] to [**] on [**], and [**] shall [**] to [**]. Such [**] shall [**] shall be an [**] of such [**] thereunder, including with [**]. In addition, each [**] shall [**], in substance, that, in the event that [**], or any other [**] pursuant to the [**] or any other [**] (collectively, the [**]), shall [**] to [**] or [**] (collectively, [**]) such [**], then the [**] shall (i) timely [**] any and all [**] (if any) thereunder, pursuant to [**] or any other [**], and (ii) to the extent that [**] effectively [**] the [**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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[**]. The [**] may [**] such [**] as Antigenics MA and [**] to, [**] the [**] of the [**] prior to [**] of such [**] and provided that such [**] do not [**] under this Agreement or the [**].

(c) Antigenics MA Inability to Supply . Antigenics MA shall use commercially reasonable efforts to supply GSK with quantities of QS-21 ordered pursuant to Section 3.3 (c) above. As soon as Antigenics MA determines it will be unable to deliver to GSK the quantities of QS-21 ordered with respect to any particular calendar quarter, Antigenics MA shall immediately notify GSK, and GSK shall then have the right to secure (whether through [**] or [**]) such quantities of QS-21 that Antigenics MA is unable to fill for the time period that Antigenics MA is unable to meet such GSK orders [**]. In the event that GSK engages a Third Party to Manufacture as a result of Antigenics MA’s inability to supply hereunder, then Antigenics MA will cooperate with such Third Party in its efforts, consistent with the terms of this Agreement.

4. Antigenics MA Supply .

4.1 Documentation with Deliveries . Antigenics MA shall provide, or shall cause any Third Party manufacturer in accordance with this Agreement to provide, to GSK, together with each shipment of QS-21, all documentation set forth in the Quality Agreement, documenting the quality control authorized release of such shipment in accordance with the terms and conditions of the Quality Agreement (the “ Release ”).

4.2 Testing and Acceptance . GSK shall have [**] days after the delivery to GSK of the order of QS-21 supplied hereunder to determine whether the QS-21 conforms to the Specifications and order quantity. GSK will be deemed to have acknowledged that an order of QS-21 conforms to the Specifications and order quantity and is accepted, unless GSK rejects the QS-21 order by giving written notice of non-conformity to Antigenics MA within such [**] day period. If GSK determines that the QS-21 order fails to meet the Specifications, or that there is a shortage in the quantity delivered, it shall promptly so notify Antigenics MA in writing within such [**] day period. Any such notice shall specify the reason, with supporting documentation, for the non-conformity or the details of any quantity shortage, as the case may be. In the event that Antigenics MA agrees that an order of QS-21 is non-conforming with the Specifications or that there was a shortage in quantity delivered, Antigenics MA shall, at its own cost (including shipping) use commercially reasonable efforts to replace the non-conforming quantities of QS-21 or make up the shortage, as soon as reasonably possible. If Antigenics MA does not agree that the particular order of QS-21 fails to meet the Specifications or that it delivered a shortage of QS-21, it shall notify GSK and the Parties (through the Steering Committee) shall try to negotiate a mutually satisfactory resolution of their differences. Should a dispute over the

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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conformity of a QS-21 order persist beyond [**] days after Antigenics MA’s notice to GSK of disagreement, a representative sample of the QS-21 at issue shall be submitted to an independent testing laboratory designated by GSK and reasonably agreeable to Antigenics MA for testing against the Specifications. The test results obtained from such laboratory shall be final and binding on the Parties. The cost of such test shall be borne by the Party whose results disagree with those of the independent laboratory. Where the test results demonstrate that the QS-21 order fails to meet any of the Specifications, Antigenics MA shall replace the non-conforming quantities of QS-21 at no additional cost to GSK as soon as reasonably possible after receipt of such results. The provisions of this Section shall not apply to any QS-21 damaged or lost in transit after delivery by Antigenics MA to the common carrier, which shall be the responsibility of GSK.

4.3 Sample Testing and Records . Sample testing and record retention shall be in accordance with the Quality Agreement.

4.4 Inspections . During the Term of this Agreement, and subject to the last sentence of this Section 4.4, Antigenics MA shall permit a reasonable number of GSK employees or agents reasonably acceptable to Antigenics MA, as GSK may reasonably from time to time request, at least once a year (and [**] if [**]), access to Antigenics MA’s QS-21 manufacturing facilities during normal business hours for the purpose of Manufacturing and quality control compliance reviews and inspections (at each Party’s own cost and expense), subject to the remaining provisions of this Section 4.4. GSK agrees that prior to any such employee or agent visitor entering such QS-21 manufacturing facilities, GSK will provide Antigenics MA with (a) written notice of the visit at least [**] days in advance for routine annual audits, and (b) reasonable advance notice, and in no event less then [**] notice for [**]. In addition, GSK will obtain from such employees or agents a binding confidentiality agreement in a form acceptable to Antigenics MA in advance of any visit and that these audits do not take place more often than reasonably necessary. The Parties agree that Antigenics MA may refuse access to or eject any GSK employee or agent if Antigenics MA reasonably believes, and can reasonably demonstrate to GSK that it has grounds for such belief, that such employee or agent is or may be a security risk to Antigenics MA or does not meet Antigenics MA’s safety or security requirements. Antigenics MA shall have no liability under this Agreement for refusing access to or ejecting such individual(s). GSK further agrees to protect, defend, indemnify, and hold harmless Antigenics MA and its officers, directors, employees, agents and assignees, from all demands, claims, actions, liability, loss, damage, costs and expenses including reasonable attorney’s fees, arising out of any claims for personal injury or property damage caused by a GSK employee or agent while visiting such QS-21 manufacturing facilities. Notwithstanding the foregoing, if GSK’s request to inspect the QS-21 manufacturing facilities as contemplated hereunder conflicts with any Third Party rights to which Antigenics MA has Manufacture or supply obligations, the Parties will work together, in good faith, to identify an appropriate resolution to the conflict. Further notwithstanding the foregoing, in the event that Antigenics MA has a Third Party Manufacture and supply QS-21 to Antigenics MA, for subsequent supply to GSK pursuant to this Agreement, Antigenics MA shall [**] [**] with respect to [**].

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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4.5 Exchange of information . Antigenics MA and GSK shall fully cooperate to achieve acceptance of Antigenics MA facilities by Regulatory Authorities, and to exchange information about lots produced by the Parties in accordance with this Agreement, the Quality Agreement and the Manufacturing Technology Transfer Plan.

5. Consideration to Antigenics MA .

5.1 Upfront Payment . As partial consideration for the Manufacturing Technology rights transferred to GSK pursuant to this Agreement, and Antigenics MA’s agreement to provide expertise in connection therewith in accordance with this Agreement, GSK shall make a non-refundable, non-creditable upfront payment to Antigenics MA within [**] from execution of this Agreement in the amount of [**] dollars (US$[**]).

5.2 Milestone Payments . As further consideration for the Manufacturing Technology rights transferred to GSK pursuant to this Agreement, and Antigenics MA’s agreement to provide expertise in connection therewith in accordance with this Agreement, GSK shall pay Antigenics MA the following milestone payments within [**] of achievement of the applicable milestone events:

 

Milestone Event

  

Milestone
Payment

(a) Upon [**]

   US $[**]

(b) Upon [**]

   US $[**]

5.3 Manufacturing Technology Transfer Royalty . As further consideration for the Manufacturing Technology rights transferred to GSK pursuant to this Agreement, and Antigenics MA’s agreement to provide expertise in connection therewith in accordance with this Agreement, commencing with the First Commercial Sale of QS-21 Vaccines by GSK or its Affiliates or Third Party Sublicensees or distributors, GSK shall pay Antigenics MA a Manufacturing Technology transfer royalty (“ Manufacturing Technology Transfer Royalty ”) of [**] percent [**] of Net Sales throughout the Territory.

This Manufacturing Technology Transfer Royalty obligation shall apply: (i) with respect to prophylactic QS-21 Vaccines for ten (10) years after the First Commercial Sale of the first prophylactic QS-21 Vaccine in a Major Market Country (as defined below); and (ii) with respect to therapeutic QS-21 Vaccines for ten (10) years after the First Commercial Sale of the first therapeutic QS-21 Vaccine in a Major Market Country.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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In addition and notwithstanding the foregoing, in no event shall the foregoing Manufacturing Technology Transfer Royalty obligation apply with respect to QS-21 Vaccines in the [**] for less than [**] years after the First Commercial Sale of the first prophylactic or first therapeutic [**]; and in no event shall the foregoing Manufacturing Technology Transfer Royalty obligation apply with respect to QS-21 Vaccines in the [**] for less than [**] years after the First Commercial Sale of the first prophylactic or first therapeutic [**].

As used herein, “ Major Market Country ” means the countries of the United States, France, Germany, Italy, the United Kingdom, Canada, Spain, Australia, Japan and, in the case of a Licensed Vaccine for the Licensed Indication of [**].

The foregoing Manufacturing Technology Transfer Royalty shall not be subject to any reductions.

5.4 QS-21 Supply Transfer Pricing . As consideration for Antigenics MA agreeing to supply GSK with QS-21 under this Agreement, GSK shall pay Antigenics MA a transfer price of [**] percent ([**]%) of the Fully Burdened Costs for QS-21 delivered hereunder up to [**], and thereafter GSK shall pay Antigenics MA a transfer price of [**] percent ([**]%) of the Fully Burdened Costs for QS-21 delivered hereunder. Antigenics MA shall invoice GSK upon delivery to the common carrier and GSK shall pay Antigenics MA in U.S. dollars (USD) within [**] days of the invoice date unless rejected by GSK under Section 4.2 for each order of QS-21.

5.5 Other Costs . GSK shall reimburse Antigenics MA for Other Costs in accordance with Section 2.3(e) hereof.

5.6 GSK Audit Rights . At the request of GSK, upon at least [**] prior written notice to Antigenics MA and at the expense of GSK (except as otherwise provided below), Antigenics MA shall permit an experienced, independent certified public accountant selected by GSK and reasonably acceptable to Antigenics MA to inspect, during regular business hours, any such records of Antigenics MA for the then-preceding [**] solely to the extent necessary to verify Fully Burden Costs provided that such inspection shall not take place more often than once a year, and shall not cover such records for more than the preceding [**] and shall not cover the same records more than once unless this is reasonably necessary for confirming the accuracy of existing records. Results of any such inspection shall be made available to both Parties.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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6. Payments, Reports and Records .

6.1 First Commercial Sale . GSK shall notify Antigenics MA of the occurrence of the First Commercial Sale of each therapeutic QS-21 Vaccine and each prophylactic QS-21 Vaccine in each country within [**] days of its occurrence.

6.2 Payments . Commencing with the First Commercial Sale of the first QS-21 Vaccine in any country, GSK shall furnish to Antigenics MA a written report within [**] showing, on a country-by-country basis: (i) Gross Sales by GSK and its Affiliates and Third Party Sublicensees during the reporting period; (ii) the Net Sales of all such QS-21 Vaccines sold, and qualifying discounts as described in Section 1.25, listed by category of deductions; (iii) the Manufacturing Technology Transfer Royalties payable in United States dollars which shall have accrued hereunder in respect of such sales; (iv) withholding taxes, if any, required by law to be deducted in respect of such sales, as applicable; and (v) the exchange rates used in determining the amount of United States dollars. All Manufacturing Technology Transfer Royalty payments shown to have accrued to Antigenics MA by each report provided for under this Section shall be due and payable on the date such report is due. If no payments are due for any reporting period hereunder, GSK shall so report. All payments to Antigenics MA under this Agreement shall be made in United States dollars by check payable to “Antigenics Inc.” or, if requested by Antigenics MA, by wire transfer to an account designated by Antigenics MA.

6.3 Withholding Taxes . All royalty payments are exclusive of all federal, state, local and foreign taxes, levies, and assessments, duties, customs and similar charges. GSK shall be responsible for any and all such applicable charges incident to the payments to Antigenics MA under this Agreement, other than taxes on Antigenics MA’s income. When Antigenics MA has the legal obligation to collect such taxes, the appropriate amount shall be paid by GSK (by adding such amount to the payment otherwise due to Antigenics MA), unless GSK provides Antigenics MA with a valid tax exemption certificate authorized by the appropriate taxing authority. In the event that GSK is required by applicable law to make deductions or withholdings from payments to Antigenics MA hereunder, then GSK shall pay such additional amounts to Antigenics MA as may be necessary to assure that the actual amount received by Antigenics MA after deduction or withholding shall equal the amount that would have been received if such deduction or withholding were not required.

6.4 Exchange Rates . If GSK (or its Affiliates or Third Party Sublicensees) receives revenues from the sale of QS-21 Vaccines in currency other than United States dollars, revenues shall be converted to United States dollars at the conversion rate for foreign currency as published in the eastern edition of The Wall Street Journal published on the last Business Day of the applicable calendar quarter.

6.5 GSK’s Recordkeeping and Inspection . After the date of First Commercial Sale of the first QS-21 Vaccine, GSK shall keep, and shall cause its Affiliates and Third Party Sublicensees to keep, for at least [**], records of all sales of QS-21 Vaccines in sufficient detail to permit Antigenics MA to confirm (i) the accuracy of GSK’s Manufacturing Technology Transfer Royalty payment calculations and (ii) the

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Minimum Purchase Requirements. At the request of Antigenics MA, upon at least [**] prior written notice to GSK or its Affiliates or Third Party Sublicensees and at the expense of Antigenics MA (except as otherwise provided below), GSK or its Affiliates or Third Party Sublicensees shall permit an experienced, independent certified public accountant selected by Antigenics MA and reasonably acceptable to GSK or its Affiliates or Third Party Sublicensees to inspect, during regular business hours, any such records of GSK or its Affiliates or Third Party Sublicensees for the then-preceding [**] solely to the extent necessary to verify such calculations provided that such inspection shall not take place more often than once a year, and shall not cover such records for more than the preceding [**]. Results of any such inspection shall be made available to both Parties. If such inspection reveals a deficiency in the calculation of Manufacturing Technology Transfer Royalty payments or Minimum Purchase Requirements resulting in an underpayment to Antigenics MA by [**] or more, GSK shall pay all costs and expenses of such inspection. Any deficiencies found shall be payable by GSK within [**] of receipt of invoice from Antigenics MA. If such inspection reveals an overpayment of Manufacturing Technology Transfer Royalty payments or Minimum Purchase Requirements resulting in an underpayment to Antigenics MA by [**] or more, Antigenics MA shall refund to GSK any overpaid amounts within [**] after results of such inspection become available.

6.6 Interest on Late Payments . Any payment not timely made shall bear interest at a rate equal to [**].

7. Indemnification and Warranties .

7.1 Indemnification by GSK . GSK shall indemnify, defend, and hold harmless Antigenics MA and its Affiliates and their respective directors, officers, employees, and agents, and its and their respective successors, heirs (current and former) and assigns (the “ Antigenics MA Indemnitees ”) from and against any and all loss, liability, damage, cost, or expense (including reasonable legal fees and expenses of litigation) (collectively, “ Liabilities ”) suffered, incurred by, or imposed upon any such Antigenics MA Indemnitee, resulting from any Third Party claims, demands, suits, actions, or judgments (collectively referred to hereafter as “Claims”) to the extent arising out of or resulting from (i) the development, pre-clinical or clinical testing, Manufacture, use, sale, offer for sale, or importation of QS-21 Vaccines, including without limitation, the Manufacture of QS-21 for use therein, (ii) GSK’s breach of any representation, warranty or covenant of GSK hereunder, or (iii) the negligence or intentional misconduct of GSK, in each case except to the extent such Liability is attributable (a) to the negligence or intentional misconduct of Antigenics MA, or (b) the failure of QS-21 delivered by Antigenics MA to meet the Specifications at the time of shipment hereunder.

7.2 Indemnification by Antigenics MA . Antigenics MA shall indemnify, defend, and hold harmless GSK and its Affiliates and its and their respective directors, officers,

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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employees, and agents, and its and their respective successors, heirs (current and former) and assigns (the “ GSK Indemnitees ”) from and against any and all Liabilities suffered, incurred by, or imposed upon any such GSK Indemnitee, resulting from any Third Party Claims to the extent arising out of or resulting from (i) the failure of QS-21 to conform to the Specifications at the time of shipment hereunder, or (ii) Antigenics MA’s breach of any representation, warranty or covenant hereunder, or (iii) the negligence or intentional misconduct of Antigenics MA, in each case except to the extent such Liability is attributable to the negligence or intentional misconduct of GSK.

7.3 Conditions on Indemnification . Any Antigenics MA Indemnitee or GSK Indemnitee (each an “ Indemnitee ”) intending to claim indemnification under this Article 7 shall promptly notify the other Party (the “ Indemnifying Party ”) of any Claim after the Indemnitee is aware thereof, setting forth the nature of the Claim and the basis for indemnification hereunder, and the Indemnifying Party shall assume, at its sole cost and expense, the defense of the Claim with counsel mutually satisfactory to the Parties; provided, however, that any Indemnitee shall have the right to retain its own counsel reasonably acceptable to the Indemnifying Party, at the expense of the Indemnifying Party, if representation of such Indemnitee by the counsel retained by the Indemnifying Party would be inappropriate because of actual or potential differences in the interests of such Indemnitee and any other Party represented by such counsel. The Indemnitee shall cooperate fully with the Indemnifying Party in such defense and will permit the Indemnifying Party to conduct and control such defense and disposition of such Claim (including all decisions relative to litigation, appeal and settlement), provided that (i) the Indemnifying Party agrees to keep the Indemnitee informed of the progress in the defense and disposition of such Claim and to consult with the Indemnitee with regard to any proposed settlement, and (ii) the Indemnifying Party agrees not to enter into any settlement which would have a material adverse effect on the other Party without prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. This indemnity agreement shall not apply to amounts paid in settlement of any Liability if such settlement is effected without the consent of the Indemnifying Party, which consent shall not be withheld unreasonably. The failure to deliver notice to the Indemnifying Party promptly after the Indemnitee receives notice of or otherwise becomes aware of any such Claim, if prejudicial to its ability to defend such Claim, shall relieve the Indemnifying Party of any liability to the Indemnitee under this indemnity agreement.

7.4 Insurance . During the Term of this Agreement and for a period of [**] after the [**] of QS-21 Vaccines by GSK, its Affiliates or Third Party Sublicensees or its or their distributors, GSK shall, at its discretion, either self-insure through a GlaxoSmithKline plc program, or obtain and carry, and shall cause its Sublicensees to obtain and carry, in full force and effect product liability insurance in amounts which are reasonable and customary in the pharmaceutical industry for similar products. GSK shall provide Antigenics MA with appropriate certificates of insurance from time to time as requested by Antigenics MA unless GSK is self-insured. During the Term of this Agreement and for a period of [**], after the [**] of QS-21 to GSK its Affiliates

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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or Third Party Sublicensees, Antigenics shall at its discretion, either self-insure through an Antigenics Inc. (parent corporation) program, or obtain and carry, and shall cause its Sublicensees to obtain and carry, in full force and effect product liability insurance in amounts which are reasonable and customary in the pharmaceutical industry for similar products. Antigenics MA shall provide GSK with appropriate certificates of insurance from time to time as requested by GSK unless Antigenics MA is self-insured.

7.5 Representation and Warranties of GSK . GSK represents, warrants, and covenants to Antigenics MA as follows:

(a) GSK is a corporation duly organized, validly existing and in good standing under the laws of Belgium. GSK has, and will have on all relevant dates, all requisite corporate power to own and operate its properties and assets and to carry on its business as presently being conducted and as proposed to be conducted. GSK has, and will have on all relevant dates, all requisite legal and corporate power to execute and deliver this Agreement, and to carry out and perform its obligations under the terms of this Agreement;

(b) the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate GSK corporate action;

(c) the performance by GSK of any of the terms and conditions of this Agreement on its part to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a party; and

(d) GSK will Manufacture, purchase and use, QS-21 and formulate, package and distribute the QS-21 Vaccines for marketing and sale in the Territory solely in accordance with this Agreement and the License Agreement, and applicable laws, rules, regulations, and guidelines.

7.6 Representation and Warranties of Antigenics MA . Antigenics MA represents and warrants to GSK as follows:

(a) Antigenics MA is a corporation duly organized, validly existing and in good standing under the laws of the Commonwealth of Massachusetts. Antigenics MA has all requisite corporate power to own and operate its properties and assets and to carry on its business as presently being conducted and as proposed to be conducted. Antigenics MA has, and will have on all relevant dates, all requisite legal and corporate power to execute and deliver this Agreement;

(b) the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate Antigenics MA corporate action;

 

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(c) the performance by Antigenics MA of any of the terms and conditions of this Agreement on its part to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a party;

(d) Antigenics MA shall Manufacture, or have Manufactured, QS-21 supplied to GSK hereunder in conformity with the Specifications and applicable laws, rules, regulations, and guidelines;

(e) the Manufacturing Technology Package will contain all relevant technological and regulatory information regarding QS-21 and QS-21 Manufacturing Process known to Antigenics MA that is necessary to manufacture QS-21 in accordance with the Specifications applicable as of the Effective Date; and

(f) to the best of Antigenics MA’s knowledge as of the Effective Date, there are no patents owned by Antigenics MA or its Affiliates, other than as defined in Section 1.18, that would be infringed by GSK in practicing the right and licenses granted under this Agreement to Manufacture QS-21 in accordance with the Specifications applicable as of the Effective Date.

7.7 LIMITATION OF LIABILITY . EXCEPT A) WITH RESPECT TO LIABILITY RELATING TO THIRD PARTY CLAIMS UNDER SECTIONS 7.1 OR 7.2, B) LIABILITY FOR BREACH OF ARTICLE 9 AND C) CLAIMS FOR MISUSE, MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY, IT IS AGREED BY THE PARTIES THAT NEITHER PARTY NOR ITS AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR ANY SPECIAL, CONSEQUENTIAL, INDIRECT, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES (OTHER THAN REVENUES COMPRISING ROYALTIES OR OTHER PAYMENTS TO BE EARNED AND PAID TO A PARTY BY THE OTHER PARTY UNDER THIS AGREEMENT) OR PROFITS RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME.

7.8 DISCLAIMER OF WARRANTY . EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN SECTION 7.6 HEREOF, ANTIGENICS MA MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE QS-21 MANUFACTURED AND SUPPLIED HEREUNDER, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT OF ANY THIRD PARTY PATENTS OR PROPRIETARY RIGHTS. ALL UNIFORM COMMERCIAL CODE WARRANTIES AND UNITED NATIONS CONVENTION ON THE INTERNATIONAL SALE OF GOODS WARRANTIES ARE EXPRESSLY DISCLAIMED BY ANTIGENICS MA.

 

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8. Term And Termination .

8.1 Term . Unless otherwise terminated pursuant to the terms hereof or by separate written agreement between the Parties, the term of this Agreement (the “ Term ”) shall begin on the Effective Date and shall remain in full force and effect until expiration of the royalty obligations provided under Section 5.3 above. After that, GSK shall have a [**] license under the Manufacturing Technology to Manufacture QS-21 for use in any QS-21 Vaccines [**] under this Agreement, unless earlier terminated in accordance with Section 8.2 below.

8.2 Material Breach . If either Party materially breaches any obligation, representation or warranty contained in this Agreement, the other Party shall be entitled to give to the Party in default written notice specifying the nature of the default and requiring it to cure such default. If such default is not cured within [**] days for payments or [**] days after the receipt of such notice, the notifying Party shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement and in addition to any other remedies available to it by law or in equity, to terminate this Agreement effective upon written notice to the other Party. The right of a Party to terminate this Agreement, as hereinabove provided, shall not be affected in any way by its waiver or failure to take action with respect to any previous default. For the purposes of this Section, a material breach of [**] by one Party shall be deemed a material breach and default of this Agreement by such Party, and shall entitle the other Party to give notice of default under this Section. In addition, Antigenics MA shall have the right to terminate this Agreement and/or [**] immediately upon written notice to GSK in the event that GSK or its Affiliates challenge, or direct or assist a Third Party to challenge, the validity, patentability or enforceability of, or otherwise oppose any, Licensed Patent Rights (as defined in the License Agreement) or the Manufacturing Technology.

8.3 Termination Or Continuation for Bankruptcy of Antigenics MA.

(a) GSK may terminate this Agreement if, at any time, Antigenics MA shall file in any court or agency pursuant to any statute or regulation of (the United States or of) any (individual) state or (foreign) country, a petition in bankruptcy or insolvency or for reorganisation or for an arrangement or for the appointment of a receiver or trustee of the party or of its assets, or if Antigenics MA proposes a written agreement of composition or extension of its debts, or if Antigenics MA shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed [**] days after the filing thereof, or if Antigenics MA shall propose or be a party to any dissolution or liquidation, or if Antigenics MA shall make an assignment for the benefit of creditors.

(b) All rights and licenses granted under or pursuant to this Agreement by Antigenics MA are, and shall otherwise be deemed to be, for purposes of Article 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Article 101 of the U.S. Bankruptcy Code so long as such rights do not conflict with any

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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of the terms of this Agreement. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Antigenics MA under the U.S. Bankruptcy Code, GSK shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Manufacturing Technology and any such intellectual property and all embodiments of intellectual property consistent with Article 365(n) of the U.S. Bankruptcy Code, and same, if not already in its possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon its written request therefore, unless Antigenics MA elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of Antigenics MA upon written request therefore by GSK. All such Manufacturing Technology and intellectual property so delivered shall remain subject to the use and confidentiality restrictions set forth in Article 9 of this Agreement and [**].

8.4 Effects of Termination .

(a) Orders in Progress . In the event of expiration of this Agreement, Antigenics MA shall at GSK’s request or otherwise at its election, fill any purchase orders for QS-21 that were made by GSK and accepted by Antigenics MA prior to such date, and GSK shall pay Antigenics MA for any QS-21 supplied by Antigenics MA hereunder. In addition, in the event of early termination of this Agreement, Antigenics MA retains the right but not the obligation to fill any purchase orders for QS-21 that were made by GSK and accepted by Antigenics MA prior to such date, and GSK shall pay Antigenics MA for any QS-21 supplied by Antigenics MA hereunder. In either such an event, and in addition to the provisions set forth in Section 8.4(b) and (c) below, the provisions of Sections 3.4(d) and (e) and 4.1 shall remain in full force and effect until the Parties have fulfilled their respective obligations with respect to such orders.

(b) Termination or expiration of this Agreement, for any reason, shall not deprive or relieve either Party hereto, of any right, remedy, or obligation accrued hereunder prior to termination or expiration, and shall not effect any other rights accrued in any way under separate agreements between the Parties.

(c) The provisions of Articles 6 (with respect to outstanding payment obligations), 7, and 9, and Sections 2.6, 4.1 and 4.2 (with respect to deliveries made prior to the date of expiration or termination or thereafter in accordance with Section 8.4(a) above) 4.3, 5.2, 5.3 (with respect to Net Sales of QS-21 Vaccines made prior to the date of expiration or termination), 5.4 (with respect to deliveries made prior to the date of expiration or termination or thereafter in accordance with Section 8.4(a) above), 5.6, 8.1, 8.4, 10.1, 10.5, 10.6 (for so long as payment obligations survive the termination or expiration of this Agreement), 10.8, 10.11, and 10.12 shall survive expiration or termination of this Agreement for any reason. In addition, (i) the provisions of Sections 2.5, 5.3 and Article 6 (with respect to payment obligations under Section 5.3) shall survive termination of this Agreement for any reason, other than termination by Antigenics MA for GSK’s material breach, unless Antigenics MA elects otherwise in the case of such material breach. Furthermore, in the event this Agreement is terminated by GSK under Section 8.2 for material breach of Antigenics MA (as agreed to by Antigenics

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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MA or finally resolved in accordance with the Dispute Resolution provisions of Section 10.1 of this Agreement), and, prior to such termination, Antigenics MA incorporated a Manufacturing Improvement covered by a Valid Claim (as defined in the License Agreement) of a patent or patent application of GSK into the Manufacturing process of QS-21 at the request of GSK that results in a reduction in the Fully Burdened Costs of greater than [**], then the [**] to [**] by [**] under Section [**] above shall (a) [**] be [**] a [**] at a [**], and the Parties shall [**] a [**] as [**] for [**] (which [**] shall [**] a [**] of the [**] in the [**], and (b) [**] with respect to [**] not [**] by a [**].

9. Confidentiality .

9.1 “ Confidential Information ” shall mean any technical, scientific or business information furnished by or on behalf of one Party or its Affiliates (the “ Disclosing Party ”) to the other Party or its Affiliates (the “ Receiving Party ”) in connection with this Agreement, the License Agreement or the Prior Agreement, or the activities contemplated hereunder and thereunder, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in oral, written, electronic or other form. The terms of this Agreement shall be considered Confidential Information of both Parties, subject to the provisions of this Article 9 and Section 10.6. Confidential Information shall not include information that:

(a) is generally available in the public domain or thereafter becomes available to the public through no act of the Receiving Party; or

(b) was independently known to the Receiving Party prior to receipt thereof or was discovered independently by an employee of the Receiving Party who had no access to the information supplied by or on behalf of the Disclosing Party; or

(c) was made available to the Receiving Party as a matter of lawful right by a Third Party who had no obligations of confidentiality to the Disclosing Party.

9.2 Obligations . The Receiving Party agrees that it shall not, without the prior written consent of the Disclosing Party, directly or indirectly:

(a) make any use, including but not limited to any research, commercial or potentially commercial use thereof, of any portion of the Confidential Information of the Disclosing Party for purposes other than those set forth in this Agreement; or

(b) duplicate, disseminate, disclose or transfer any portion of the Confidential Information to any person, except that the Receiving Party may disclose or permit the disclosure of Confidential Information to its Affiliates and sublicensees and its and their respective directors, officers, employees, consultants, and advisors, and investors and potential investors in connection with a general financing transaction, and, (i) in the case of GSK, to Third Party (ies) (solely for the purpose of [**]) as

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

30


Confidential

 

may be useful or necessary to establish the [**] and (ii) in the case of Antigenics MA, to Third Party(ies) contract manufacturers as may be useful or necessary to Manufacture for Antigenics MA as contemplated in this Agreement, in any case, who have an ethical or fiduciary duty to the Receiving Party or are otherwise obligated to maintain the confidential nature of such Confidential Information and who need to know such Confidential Information for the purposes set forth in this Agreement, or for other legitimate business purposes;

Notwithstanding the above, the Receiving Party may disclose Confidential Information of the Disclosing Party when required by applicable laws or government rules or regulations (including without limitation, applicable securities regulations), provided that to the extent reasonably possible, the Receiving Party provides reasonable prior written notice of such disclosure to the Disclosing Party and takes reasonable efforts to avoid and/or minimize the extent of disclosure.

9.3 Upon expiration or termination of this Agreement and upon request of the Disclosing Party, all copies of any Disclosing Party’s Confidential Information (other than the Manufacturing Technology in the case of expiration) shall be returned to the Disclosing Party, except that each Receiving Party may retain one (1) copy of the Confidential Information received hereunder in the possession of its legal counsel, solely for monitoring its obligations under this Agreement.

9.4 No option, license, or conveyance of such rights, express or implied, is granted to the Receiving Party in connection with any Confidential Information disclosed by the Disclosing Party, except for the express licenses granted in Article 2. If any such rights are to be granted to the Receiving Party, such grant shall be expressly set forth in a separate written instrument.

10. Miscellaneous .

10.1 Dispute Resolution . Except for the right of any Party to apply to a court of competent jurisdiction for a temporary restraining order, a preliminary injunction or other equitable relief to preserve the status quo or prevent irreparable harm, any dispute, other than disputes regarding the construction, validity or enforcement of patents, arising between the Parties relating to, arising out of or in any way connected with this Agreement or any term or condition hereof, or the performance by either Party of its obligations hereunder, whether before or after termination of this Agreement, shall be resolved as follows:

(a) If the dispute cannot be resolved by the Parties through their duly authorized representatives (or the Steering Committee, if applicable) within [**], the Chief Executive Officer of GSK (or his designee) and the Chief Executive Office of Antigenics, Inc., a Delaware corporation, the parent corporation of Antigenics MA (or his designee) shall meet in person at a mutually acceptable time and location or by means of telephone or video conference within [**] of the matter being referred to them.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

31


Confidential

 

(b) If the Chief Executive Officer of GSK (or his designee) and the Chief Executive Officer of Antigenics, Inc. (or his designee) fail to first meet within [**] of the matter being referred to them, or if the dispute can not be resolved by the Chief Executive Officer of GSK (or his designee) and the Chief Executive Officer of Antigenics, Inc. (or his designee) within [**] of the matter being referred to them, then either Party may bring such matter in a federal or state court in the State of Delaware to whose exclusive jurisdiction both Parties hereto consent.

(c) Notwithstanding the foregoing, in the event there is a disagreement between the Parties as to whether [**] under applicable [**] and [**] from [**] or other [**], such dispute shall be resolved by an independent panel of experts (the “[**] Panel”). The [**] Panel shall be composed of one (1) member if the Parties can agree on the sole member within [**]. Otherwise, it shall be composed of one (1) member appointed by Antigenics MA, one (1) member appointed by GSK and a third member appointed by the agreement of first two (2) members. In order to be eligible for appointment to the [**] Panel, a person must be independent in all respects from both Antigenics MA and GSK and have the [**]. The Parties shall identify their respective appointees within [**] following notice by one Party to the other of a [**] dispute. The first two (2) members so appointed will have an additional [**] to choose the third member. Antigenics MA and GSK shall share equally any cost involved in the engagement and services of such third member. The Quality Panel shall determine whether, in light of all circumstances, including without limitation, [**], the [**] the above referred [**]. Notwithstanding the foregoing, the Parties may, by agreement, identify a more specific or relevant [**] for the [**] Panel to consider in resolving a particular dispute. The [**] Panel shall make its determination as soon as reasonably possible, but no later than [**] after referral of the dispute to the [**] Panel by the Parties. Decisions of the [**] Panel shall be made by [**] vote of the members and shall be announced, with such reasoning as the [**] Panel, in its sole discretion, shall determine to be appropriate, in a document delivered on the same date to both Parties.

10.2 No Partnership . Nothing in this Agreement is intended or shall be deemed to constitute a partnership, distributorship, agency, employer-employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein.

10.3 Assignments . This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided, however , that, GSK may, without such consent, assign this Agreement and any of its right or obligations hereunder to its Affiliates or in connection with the transfer or sale of all or substantially all of the portion of its business to which this Agreement relates, or in the event of its merger or consolidation or reorganization or change in control; provided, further, that the assigning Party shall deliver written notice of any such permitted assignment to the other

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

32


Confidential

 

Party. This Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any attempted assignment not in accordance with this Section 10.3 shall be void.

10.4 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

10.5 No Name or Trademark Rights . Except as otherwise expressly provided herein, or expressly set forth in the License Agreement, no right, express or implied, is granted by this Agreement to use in any manner the names “Antigenics Inc.,” “GlaxoSmithkline plc.” or any contraction thereof or any other trade name or trademark of Antigenics MA or GSK in connection with the performance of this Agreement. In addition, GSK agrees not use or apply for registration of any trademarks, tradedresses or tradenames pertaining to QS-21 (as opposed to trademarks pertaining to QS-21 Vaccines) in the Territory without Antigenics MA’s prior consent, which consent shall not be unreasonably withheld where the use of such trademarks, tradedresses or tradenames is required by applicable laws or regulations, provided that such use by GSK is consistent with both Party’s internal trademark policies.

10.6 Public Announcements . Press releases and public announcements regarding the subject matter of this Agreement shall be made in accordance with the provisions of [**].

10.7 Force Majeure . If any default or delay occurs which prevents or materially impairs a Party’s performance and is due to a cause beyond the Party’s reasonable control, including but not limited to any act of god, flood, fire, explosion, earthquake, casualty, accident, war, revolution, terrorist acts, civil commotion, blockade or embargo, injunction, law, proclamation, order, regulation or governmental demand, or acts, omissions or delays in acting by any Regulatory Authority, the affected Party promptly shall notify the other Party in writing of such cause and shall exercise diligent efforts to resume performance under this Agreement as soon as possible. Neither Party shall be liable to the other Party for any loss or damage due to such cause. Neither Party may terminate this Agreement because of such default or delay, unless such event continues unabated for a period of six (6) months, in which case the Party disadvantaged by such default or delay may, at its option, terminate this Agreement upon written notice to the other Party.

10.8 Entire Agreement of the Parties, Amendments . This Agreement, including the Exhibits attached hereto which are incorporated herein, and the License Agreement, Quality Agreement, and Manufacturing Technology Transfer Plan, constitute and contain the entire understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether verbal or written, between the Parties respecting the subject matter hereof and thereof, including without limitation, the Prior Agreement. In the event of any inconsistency between this

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

33


Confidential

 

Agreement and the Quality Agreement or the Manufacturing Technology Transfer Plan, the provisions of the Quality Agreement or the Manufacturing Technology Transfer Plan shall prevail. In addition and for the avoidance of doubt, the Parties hereby agree that the Prior Agreement is terminated and fully superseded by this Agreement and the License Agreement as of the Effective Date of this Agreement. Notwithstanding any provision to the contrary in the Prior Agreement, no provision contained in that agreement shall survive termination thereof. Notwithstanding the foregoing, each Party hereby agrees that all actions, suits, damages, or claims which either of them may have against the other arising under the terms of the Prior Agreement, by reason of any breach of the Prior Agreement arising out of any act or failure to act prior to the Effective Date of this Agreement, is waived or released hereby. No other waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each of the Parties. The foregoing provisions of this Section 10.8 is subject to, and in no way diminishes, the rights of the Parties under Section [**] of the [**] with respect to the [**] (as defined in the [**]).

10.9 Severability . If any provision of this Agreement, or part thereof, is found by a proper authority to be unenforceable, that provision, or part thereof, shall be stricken and the remainder of this Agreement will continue in full force and effect; provided, however, that the Parties shall renegotiate an acceptable replacement provision so as to accomplish, as nearly as possible, the original intent of the Parties.

10.10 Captions . The captions to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.

10.11 Applicable Law; Governing Language . This Agreement shall be governed and construed in accordance with the laws of the State of Delaware, without regard to conflicts of laws principles. This Agreement has been prepared in the English language and the English language shall control its interpretation. All consents, notices, reports and other written documents to be delivered or provided by a Party under this Agreement shall be in the English language, and in the event of any conflict between the provisions of any document and the English language translation thereof, the terms of the English language translation shall control.

10.12 Notices and Deliveries . Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed given (a) when delivered personally, (b) three (3) Business Days after having been sent by registered or certified mail, return receipt requested, postage prepaid; or (c) one (1) day after deposit with a commercial express courier specifying next day delivery, with written verification or receipt, as follows:

 

If to Antigenics MA, to:    Antigenics Inc.
   3 Forbes Road
   Lexington MA 02421 U.S.A.
   Attention: Vice President, Business Development

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

34


Confidential

 

with copy to:    Antigenics Inc.
   3 Forbes Road
   Lexington MA 02421 U.S.A.
   Attention: Legal Department
If to GSK, to:    GlaxoSmithKline Biologicals SA
   89 rue de l’Institut
   B-1330 Rixensart, BELGIUM
   Attention: President and General Manager
with a copy to:    GlaxoSmithKline Biologicals SA
   89 rue de l’Institut
   B-1330 Rixensart, BELGIUM
   Attention: Legal Department

However, all invoices shall be sent by Antigenics MA to GSK’s Licensing Manager, Account Department, GlaxoSmithKline Biologicals SA, 89 rue de l’Institut, B-1330 Rixensart, Belgium or at such other address GSK may later designate in writing.

10.13 Counterparts . This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

10.14 [**]. During the term of [**] under [**], [**] shall [**] and [**] to [**] to a [**] identified on Exhibit E (an “[**]”), the [**] to [**] its [**] (outside the scope of the [**]), without [**] with [**]. Upon request [**] following [**] of such [**], the [**] the [**] and [**] under which [**] would [**], which, upon [**], shall [**] the [**] of the [**] and [**] of [**] to [**] for [**]. In the event that the [**] have [**] such [**] and [**] within [**] after the [**] pursuant to which [**] would [**] shall be [**] or otherwise [**] to [**] the [**] to [**] the [**], without [**], and [**] any [**] that [**]. It is understood that [**] only [**] hereunder [**] in such [**] with the [**], and that [**] is not [**] to [**] any [**] if [**]. Notwithstanding the foregoing, in no event shall the provisions of this Section apply with respect to (i) any [**] relating to [**] or [**] of [**] or [**] or [**] of the [**] of [**] or [**], or (ii)

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

35


Confidential

 

any [**]with any [**] other than with the [**].

The remainder of this page is intentionally left blank.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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Confidential

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be signed by their respective corporate officers, duly authorized as of the day and year first above written.

Antigenics Inc., a Massachusetts corporation and wholly owned subsidiary of Antigenics Inc., a Delaware corporation

 

By:   /s/ P. Thornton
Name:   Peter Thornton
Title:   Chief Financial Officer
GlaxoSmithKline Biologicals SA
By:   /s/ Jean Stephenne
Name:   Jean Stephenne
Title:   President, General Manager

 

37


Confidential

 

Exhibit A

Specifications

[**] Specifications

QS-21 shall be produced and released according to Manufacturing methods and applicable [**].

The release criteria and specifications are set in the Quality Agreement.

[**] Specifications

QS-21 shall be produced and released in [**], in accordance with [**] methods of Manufacturing [**].

The release criteria and specifications are set in the current Quality Agreement.

The Parties agree that the [**] Specifications shall apply to Antigenics MA’s supply obligations hereunder until such time as the Parties agree that the [**] Specifications apply in accordance with the Manufacturing Technology Transfer Plan.

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit B

GSK’s QS-21 Forecasts

Q2 2006: [**]

Q3 2006: [**]

Q4 2006: [**]

Q1 2007: [**]

Q2 2007: [**]

Q3 2007: [**]

Q4 2007: [**]

2008: [**] per [**] ([**] per year)

2009: [**] per [**] ([**] per year)

2010: [**] per [**] ([**] per year)

2011: [**] per [**] ([**] per year)

2012-2014: [**] per [**] ([**] per year)

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit B-1

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit C

Manufacturing Capacity

 

Quarter/year

   [**]   Antigenics MA

Q3/2006

  

[**]   

  [**]

Q4/2006

   [**]      [**]

Q1/2007

  

[**]  a

  [**]

Q2/2007

   [**]  b   [**]

Q3/2007

   [**] b   [**]

Q4/2007

  

[**] b *

  [**]

Q1/2008

   [**] b *   [**]

Q2/2008

   [**] b *      [**]  c
[**]

 

a [**] can be [**] to [**] with an [**] and [**] from [**] of the [**].

 

b [**] can be [**] from [**] to [**] with an [**] and [**] from [**] of the [**].

 

* [**] with [**] to [**].

 

c [**] can be [**] with an [**] and [**] from [**] of the [**].

For deliveries to be made from the last week of [**] onwards, the Manufacturing Capacity can be increased to [**], with [**] and [**] from [**]. In addition, for deliveries to be made from the last week of [**] onwards, Manufacturing Capacity can be increased either (A) to [**] with an [**] and [**] from [**], or (B) to [**] with an [**] and [**], in each case, provided that in no event shall GSK’s requests for QS-21 [**].

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit D

Estimated Fully Burdened Costs per MG – QS-21 – May 2005:

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

i


Confidential

 

Exhibit E

[**]

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

ii

Exhibit 31.1

Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended

I, Garo H. Armen, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of Antigenics Inc.;

 

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

 

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

 

  4. The Registrant’s other certifying officer 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 quarterly report is being prepared;

 

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

 

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

 

  d. disclosed in this quarterly report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

 

  5. The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors:

 

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

 

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

 

Date: August 9, 2006  

/s/ Garo H. Armen, Ph.D.

  Garo H. Armen, Ph.D.
  Chief Executive Officer

Exhibit 31.2

Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended

I, Peter Thornton, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of Antigenics Inc.;

 

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

 

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

 

  4. The Registrant’s other certifying officer 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 quarterly report is being prepared;

 

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

 

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

 

  d. disclosed in this quarterly report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

 

  5. The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors:

 

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

 

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

 

Date: August 9, 2006  

/s/ Peter Thornton

  Peter Thornton
  Chief Financial Officer

Exhibit 32.1

Certification

Pursuant to 18 U.S.C. Section 1350,

As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Quarterly Report on Form 10-Q of Antigenics Inc. (the “Company”) for the quarterly period ended June 30, 2006 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned to his knowledge hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

 

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

 

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

 

/s/ Garo H. Armen, Ph.D.

Garo H. Armen, Ph.D.
Chief Executive Officer

/s/ Peter Thornton

Peter Thornton
Chief Financial Officer

August 9, 2006

A signed original of this written statement required by Section 906 has been provided to Antigenics Inc. and will be retained by Antigenics Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

The foregoing certification is being furnished to the Securities and Exchange Commission as an exhibit to the Form 10-Q for the period ended June 30, 2006, and should not be considered filed as part of the Form 10-Q.