Arena Pharmaceuticals, Inc.
ARENA PHARMACEUTICALS INC (Form: 10-Q, Received: 11/09/2010 17:13:02)
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

 

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

For the quarterly period ended September 30, 2010

or

 

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

For the transition period from                to             

Commission File Number: 000-31161

 

 

ARENA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   23-2908305

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

6166 Nancy Ridge Drive, San Diego, CA   92121
(Address of principal executive offices)   (Zip Code)

858.453.7200

(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.     x   Yes     ¨   No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   ¨     No   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.

 

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

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

The number of shares of common stock outstanding as of the close of business on November 5, 2010:

 

Class

 

Number of Shares Outstanding

Common Stock, $0.0001 par value   121,411,502

 

 

 


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ARENA PHARMACEUTICALS, INC.

INDEX

 

PART I—FINANCIAL INFORMATION   
Item 1.    Financial Statements      1   
   Condensed Consolidated Balance Sheets — As of September 30, 2010 and December 31, 2009      1   
   Condensed Consolidated Statements of Operations — Three and Nine Months Ended September 30, 2010 and 2009      2   
   Condensed Consolidated Cash Flow Statements — Nine Months Ended September 30, 2010 and 2009      3   
   Notes to Unaudited Condensed Consolidated Financial Statements      4   
Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations      14   
Item 3.    Quantitative and Qualitative Disclosures About Market Risk      21   
Item 4.    Controls and Procedures      22   
PART II—OTHER INFORMATION   
Item 1.    Legal Proceedings      22   
Item 1A.    Risk Factors      22   
Item 6.    Exhibits      41   
Signatures      43   

In this report, “Arena Pharmaceuticals,” “Arena,” “we,” “us” and “our” refer to Arena Pharmaceuticals, Inc., and our wholly owned subsidiaries, unless the context otherwise provides.

Arena Pharmaceuticals ® , Arena ® and our corporate logo are registered service marks of Arena. CART™ and BRL Screening™ are unregistered service marks of Arena. Any other brand names or trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective holders.

 

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PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements.

Arena Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

 

     September 30,
2010
    December 31,
2009
 
     (Unaudited)     *  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 166,007      $ 94,733   

Short-term investments, available-for-sale

     10,529        20,716   

Accounts receivable

     1,972        1,415   

Prepaid expenses and other current assets

     3,274        4,409   
                

Total current assets

     181,782        121,273   

Land, property and equipment, net

     93,081        95,445   

Acquired technology and other intangibles, net

     12,126        13,123   

Other non-current assets

     6,051        6,437   
                

Total assets

   $ 293,040      $ 236,278   
                

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable and other accrued liabilities

   $ 5,368      $ 9,677   

Accrued compensation

     3,743        3,928   

Accrued clinical and preclinical study fees

     4,651        2,279   

Current portion of deferred revenues

     3,854        4,086   

Current portion of derivative liabilities

     280        —     

Current portion of note payable to Siegfried

     3,399        —     

Current portion of note payable to Deerfield **

     15,976        —     

Current portion of lease financing obligations

     925        717   
                

Total current liabilities

     38,196        20,687   

Deferred rent

     448        564   

Deferred revenues, less current portion

     45,192        —     

Derivative liabilities, less current portion

     1,505        6,642   

Note payable to Siegfried, less current portion

     6,489        9,143   

Note payable to Deerfield, less current portion **

     19,458        47,906   

Lease financing obligations, less current portion

     76,046        76,769   

Commitments and subsequent events

    

Stockholders’ equity:

    

Common stock

     12        10   

Additional paid-in capital

     1,085,918        961,269   

Treasury stock, at cost

     (23,070     (23,070

Accumulated other comprehensive income

     3,726        945   

Accumulated deficit

     (960,880     (864,587
                

Total stockholders’ equity

     105,706        74,567   
                

Total liabilities and stockholders’ equity

   $ 293,040      $ 236,278   
                

 

* The balance sheet data at December 31, 2009 has been derived from audited financial statements at that date. It does not include, however, all of the information and notes required by US generally accepted accounting principles for complete financial statements.
** The outstanding principal balance of the note payable to Deerfield was $60.0 million and $90.0 million at September 30, 2010 and December 31, 2009, respectively. See Note 5.

See accompanying notes to unaudited condensed consolidated financial statements.

 

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Arena Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

 

     Three months  ended
September 30,
    Nine months  ended
September 30,
 
     2010     2009     2010     2009  

Revenues:

        

Manufacturing services

   $ 1,846      $ 1,737      $ 5,258      $ 4,663   

Collaborative agreements

     5,783        882        7,343        3,042   
                                

Total revenues

     7,629        2,619        12,601        7,705   

Operating Expenses:

        

Cost of manufacturing services

     1,814        1,705        5,309        4,702   

Research and development

     20,155        22,147        58,971        88,972   

General and administrative

     6,862        5,423        20,636        18,725   

Restructuring charges

     —          —          —          3,324   

Amortization of acquired technology and other intangibles

     541        582        1,609        1,721   
                                

Total operating expenses

     29,372        29,857        86,525        117,444   
                                

Loss from operations

     (21,743     (27,238     (73,924     (109,739

Interest and Other Income (Expense):

        

Interest income

     107        75        338        291   

Interest expense

     (6,267     (7,339     (16,198     (10,991

Gain from valuation of derivative liabilities

     3,023        2,472        4,857        345   

Loss on extinguishment of debt

     (12,354     (2,479     (12,354     (2,479

Other

     968        (326     988        (859
                                

Total interest and other expense, net

     (14,523     (7,597     (22,369     (13,693
                                

Net loss

   $ (36,266   $ (34,835   $ (96,293   $ (123,432
                                

Net loss per share, basic and diluted

   $ (0.31   $ (0.38   $ (0.91   $ (1.51
                                

Shares used in calculating net loss per share, basic and diluted

     117,409        90,995        105,582        81,518   
                                

See accompanying notes to unaudited condensed consolidated financial statements.

 

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Arena Pharmaceuticals, Inc.

Condensed Consolidated Cash Flow Statements

(In thousands)

(Unaudited)

 

     Nine months  ended
September 30,
 
     2010     2009  

Operating Activities

    

Net loss

   $ (96,293   $ (123,432

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

    

Depreciation and amortization

     7,807        8,310   

Amortization of acquired technology and other intangibles

     1,609        1,721   

Share-based compensation

     4,320        5,366   

Deferred income tax provision

     —          401   

Gain from valuation of derivative liabilities

     (4,857     (345

Amortization of short-term investment premium

     —          69   

Amortization of prepaid financing costs

     462        278   

Accretion of note payable to Deerfield

     5,175        3,546   

Loss on extinguishment of debt

     12,354        2,479   

Accretion of note payable to Siegfried

     197        184   

(Gain) Loss on disposal of equipment

     (2     284   

Changes in assets and liabilities:

    

Accounts receivable

     (495     221   

Prepaid expenses and other assets

     973        (584

Accounts payable and accrued liabilities

     (2,945     (27,960

Deferred revenue

     44,960        —     

Deferred rent

     (116     (95
                

Net cash used in operating activities

     (26,851     (129,557

Investing Activities

    

Purchases of short-term investments, available-for-sale

     (1,195     (20,038

Proceeds from sales/maturities of short-term investments, available-for-sale

     11,207        35,696   

Purchases of land, property and equipment

     (3,711     (3,744

Proceeds from sale of equipment

     30        261   

Other non-current assets

     58        167   
                

Net cash provided by investing activities

     6,389        12,342   

Financing Activities

    

Principal payments on lease financing obligations

     (515     (445

Proceeds from issuance of note payable and related financial instruments to Deerfield

     —          96,865   

Principal payments on note payable to Deerfield

     (30,000     (10,000

Proceeds from lease financing

     —          15,000   

Proceeds from issuance of common stock

     120,331        65,121   
                

Net cash provided by financing activities

     89,816        166,541   

Effect of exchange rate changes on cash

     1,920        (680
                

Net increase in cash and cash equivalents

     71,274        48,646   

Cash and cash equivalents at beginning of period

     94,733        73,329   
                

Cash and cash equivalents at end of period

   $ 166,007      $ 121,975   
                

See accompanying notes to unaudited condensed consolidated financial statements.

 

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Notes to Unaudited Condensed Consolidated Financial Statements

1. Basis of Presentation and Recent Events

The accompanying unaudited condensed consolidated financial statements of Arena Pharmaceuticals, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our annual report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission, or SEC, from which we derived our balance sheet as of December 31, 2009. The accompanying financial statements have been prepared in accordance with US generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year.

The preparation of financial statements in accordance with GAAP requires our management to make estimates and assumptions that affect amounts reported in the financial statements and notes thereto. The amounts reported could differ under different estimates and assumptions.

During the second quarter of 2010, we identified an error in our consolidated financial statements as of and for the year ended December 31, 2009 and the three months ended March 31, 2010, which error was incorrectly applying the effective interest method to the accretion component of the debt discount on our note payable to Deerfield. As a result of the error, we overstated interest expense by $3.0 million and $1.3 million for the year ended December 31, 2009 and the three months ended March 31, 2010, respectively. The total interest expense on this note is comprised of such accretion and the 7.75% coupon rate applied to the outstanding and undiscounted principal balance. In accordance with relevant guidance, we evaluated the materiality of the error from a qualitative and quantitative perspective. Based on such evaluation, we concluded that correcting the cumulative error would be immaterial to the expected full year results for 2010 and correcting the error would not have had a material impact on any individual prior period financial statements or affect the trend of financial results. Accordingly, we recorded a non-cash adjustment during the second quarter of 2010 to reduce both the cumulative interest expense and the note payable to Deerfield by $4.3 million.

We have accumulated a large deficit since inception, and we expect that our losses will continue to be substantial for at least the short term. As of September 30, 2010, we had $176.5 million in cash and cash equivalents and short-term investments, which we believe will be sufficient to fund our operations for at least the next 12 months.

New Accounting Guidance

In April 2010, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2010-17, “Revenue Recognition—Milestone Method,” which provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research or development transactions in which one or more payments are contingent upon achieving uncertain future events. Under this guidance, we may recognize revenue contingent upon the achievement of a milestone in its entirety in the period in which the milestone is achieved, provided that the milestone meets all the criteria within the guidance to be considered substantive. However, under this guidance, we can elect to apply another appropriate accounting policy that results in the deferral of some portion of the arrangement consideration. This guidance is effective prospectively for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted. If we elect to adopt this standard, we do not expect the adoption of ASU 2010-17 to have a material impact on our consolidated financial statements.

In October 2009, the FASB issued ASU No. 2009-13, “Multiple-Deliverable Revenue Arrangements,” which provides guidance on recognizing revenue in arrangements with multiple deliverables. ASU 2009-13 addresses how to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting, how such deliverables should be separated and how the consideration should be allocated to one or more units of accounting. ASU 2009-13 is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted. We do not expect the adoption of ASU 2009-13 to have a material impact on our consolidated financial statements.

Recent Events

In October 2010, the US Food and Drug Administration, or FDA, issued a Complete Response Letter, or CRL, regarding our New Drug Application, or NDA, for lorcaserin. In the CRL, the FDA stated that it has completed its review of the NDA and determined that it cannot approve the application in its present form. The FDA also outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues. In September 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted nine to five that the available data do not demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long term in a population of overweight and obese individuals to allow marketing approval.

 

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2. Short-term Investments, Available-for-Sale

We define short-term investments as income-yielding securities that can be readily converted to cash, and classify such investments as available-for-sale. We carry these securities at fair value, and report unrealized gains and losses as a separate component of accumulated other comprehensive income or loss. Debt securities, if any, are adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, if any, is included in interest income. Realized gains and losses and declines in securities judged to be other than temporary are included in other income or expense. Securities sold are based on the specific identification method. Interest and dividends on available-for-sale securities are included in interest income.

The following table summarizes the investment categories comprising our available-for-sale securities at September 30, 2010 and December 31, 2009, in thousands:

 

     Maturity
in
Years
     Amortized
Cost
     Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Estimated
Fair
Value
 

September 30, 2010

             

US government and agency obligations

     Less than 1       $ 10,421       $ 108       $ —        $ 10,529   
                                     

Total available-for-sale securities

      $ 10,421       $ 108       $ —        $ 10,529   
                                     

December 31, 2009

             

US government and agency obligations

     Less than 1       $ 20,433       $ 404       $ (121 )   $ 20,716   
                                     

Total available-for-sale securities

      $ 20,433       $ 404       $ (121 )   $ 20,716   
                                     

3. Fair Value Disclosures

We measure our financial assets and liabilities at fair value, which is defined as the exit price, or the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.

We use the following three-level valuation hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value our financial assets and liabilities:

 

Level 1 -

  Observable inputs such as unadjusted quoted prices in active markets for identical instruments.

Level 2 -

  Quoted prices for similar instruments in active markets or inputs that are observable for the asset or liability, either directly or indirectly.

Level 3 -

  Unobservable inputs based on our assumptions.

The following table presents our valuation hierarchy for our financial assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2010, in thousands:

 

     Fair Value Measurements at September 30, 2010  
     Balance at
September 30,
2010
     Quoted
Prices in
Active
Markets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs
(Level 3)
 

Assets:

           

Money market funds and cash equivalents (1)

   $ 145,669       $ 145,669       $ —         $ —     

US government and agency obligations (2)

     10,529         10,529         —           —     

Liabilities:

           

Warrants and other derivative instruments

   $ 1,785       $ —         $ —         $ 1,785   

 

(1) Included in cash and cash equivalents on our condensed consolidated balance sheet.
(2) Included in short-term investments, available-for-sale on our condensed consolidated balance sheet.

 

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The following table presents our valuation hierarchy for our financial assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2009, in thousands:

 

     Fair Value Measurements at December 31, 2009  
     Balance at
December 31,
2009
     Quoted
Prices in
Active
Markets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs
(Level 3)
 

Assets:

           

Money market funds and cash equivalents (1)

   $ 86,857       $ 86,857       $ —         $ —     

US government and agency obligations (2)

     20,716         20,716         —           —     

Liabilities:

           

Warrants and other derivative instruments

   $ 6,642       $ —         $ —         $ 6,642   

 

(1) Included in cash and cash equivalents on our condensed consolidated balance sheet.
(2) Included in short-term investments, available-for-sale on our condensed consolidated balance sheet.

The following table presents the activity for our derivative liabilities, which are classified as Level 3 in our valuation hierarchy, during the three and nine months ended September 30, 2010, in thousands:

 

     Three months
ended
September 30,
2010
    Nine months
ended
September 30,
2010
 

Beginning balance

   $ 4,808      $ 6,642   

Gain from change in valuation of derivative liabilities

     (3,023     (4,857
                

Balance at September 30, 2010

   $ 1,785      $ 1,785   
                

4. Acquired Technology and Other Intangibles

In February 2001, we acquired Bunsen Rush Laboratories, Inc., for $15.0 million in cash and assumed $0.4 million in liabilities. We allocated $15.4 million to the patented Melanophore technology, our primary screening technology, acquired in such transaction. We are amortizing the Melanophore screening technology over its estimated useful life of 10 years, which we determined based on an analysis, as of the acquisition date, of the conditions in, and the economic outlook for, the pharmaceutical and biotechnology industries and the patent life of the technology.

In January 2008, we acquired from Siegfried Ltd, or Siegfried, certain assets, including manufacturing facility production licenses and an assembled workforce originally valued at $12.1 million and $1.6 million, respectively. We are amortizing the manufacturing facility production licenses, which are necessary for us to produce and package tablets and other dosage forms in such facility, over their estimated useful life of 20 years as of the acquisition date. We amortized the acquired workforce over its estimated benefit of two years, which was determined based on an analysis as of the acquisition date.

Acquired technology and other intangibles, net, consisted of the following at September 30, 2010, in thousands:

 

     Gross
Carrying
Amount
     Accumulated
Amortization
    Net
Carrying
Amount
 

Acquired Melanophore screening technology

   $ 15,378       $ (14,729   $ 649   

Acquired manufacturing facility production licenses

     13,307         (1,830     11,477   

Acquired workforce

     1,723         (1,723     —     
                         

Total acquired technology and other intangibles, net

   $ 30,408       $ (18,282   $ 12,126   
                         

 

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5. Note Payable to Deerfield

In July 2009, pursuant to a Facility Agreement we entered into in June 2009 with Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited, Deerfield Special Situations Fund, L.P., and Deerfield Special Situations Fund International Limited, or collectively Deerfield, Deerfield provided us with a $100.0 million secured loan and we issued Deerfield warrants to purchase an aggregate of 28,000,000 shares of our common stock at an exercise price of $5.42 per share. We refer to these warrants as the 2009 Warrants. We received net proceeds of $95.6 million from this loan.

On or before June 17, 2011, Deerfield may make a one-time election, which we refer to as the Deerfield Additional Loan Election, to loan us up to an additional $20.0 million under the Facility Agreement, with the additional loan maturing on the same date as the original loan, June 17, 2013. For each additional $1.0 million that Deerfield loans us under the Facility Agreement, we will issue Deerfield warrants for 280,000 shares of common stock at an exercise price of $5.42 per share. All of the warrants issued or issuable in connection with the Facility Agreement are exercisable until June 17, 2013.

Under certain circumstances, Deerfield also has the right to require us to accelerate principal payments under the loan. At any time we may prepay any or all of the outstanding principal at par, and we may be required to make the scheduled repayments earlier in connection with certain equity issuances.

In accordance with relevant guidance, we separately valued four components under the Facility Agreement at the July 2009 issuance date as follows:

 

  (1) The $100.0 million loan was valued at $47.9 million on a relative fair value basis, and was recorded as a long-term liability on our condensed consolidated balance sheet.

 

  (2) The 2009 Warrants to purchase an aggregate of 28,000,000 shares of our common stock, net of issuance costs, were valued at $39.1 million on a relative fair value basis. The relative fair value of these warrants was recorded as additional paid-in capital on our condensed consolidated balance sheet, and the resulting debt discount is being accreted to interest expense over the term of the loan or until paid using the effective interest rate method. These warrants were valued at the date of issuance using an option pricing model and the following assumptions: expected life of 3.95 years, risk-free interest rate of 2.0%, expected volatility of 66% and no dividend yield. Because these warrants are eligible for equity classification, no adjustments to the recorded value will be made on an ongoing basis.

 

  (3) The Deerfield Additional Loan Election, including the 5,600,000 contingently issuable warrants to purchase up to 5,600,000 shares of our common stock, was valued at $9.5 million. The Deerfield Additional Loan Election was classified as a liability on our condensed consolidated balance sheet and, accordingly, will be revalued on each subsequent balance sheet date until it is exercised or expires, with any changes in the fair value between reporting periods recorded in the interest and other income (expense) section of our condensed consolidated statements of operations (see Note 6). This allocation of proceeds under the Facility Agreement resulted in additional debt discount that is being accreted to interest expense over the term of the loan or until paid using the effective interest rate method.

 

  (4) Deerfield’s ability to accelerate principal payments under the loan was valued at $0.5 million. The acceleration right was classified as a liability on our condensed consolidated balance sheet and, accordingly, will be revalued on each subsequent balance sheet date until it is exercised or expires, with any changes in the fair value between reporting periods recorded in the interest and other income (expense) section of our condensed consolidated statements of operations (see Note 6). This allocation of proceeds under the Facility Agreement resulted in additional debt discount that is being accreted to interest expense over the term of the loan or until paid using the effective interest rate method.

The difference between the total recorded value of the note payable to Deerfield of $35.4 million and the $60.0 million outstanding principal balance of the loan as of September 30, 2010 represents the remaining debt discount, which will be accreted to interest expense over the term of the loan or until paid.

The loan matures on June 17, 2013, and the outstanding principal accrues interest at a rate of 7.75% per annum on the stated principal balance, payable quarterly in arrears. Total interest expense of $4.3 million and $10.4 million, including accretion of the debt discount attributable to the warrants and the other derivative financial instruments and amortization of capitalized issuance costs, was recognized in connection with this loan for the three and nine months ended September 30, 2010, respectively. The non-cash correction of prior period errors described in Note 1 resulted in a $3.0 million decrease to interest expense for the nine months ended September 30, 2010. At September 30, 2010, we expected interest expense of $9.8 million to be paid in cash over the remaining term of the loan. The effective annual interest rate on the loan is 38.4%.

As a result of the closing of our public offering of common stock in July 2009, we were required to repay Deerfield $10.0 million that was originally scheduled to be repaid in July 2010. In connection with this $10.0 million repayment, we retired a proportional share of the debt discount and issuance costs directly related to the repaid debt and recognized a non-cash loss on extinguishment of debt of $2.5 million in 2009.

 

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In June 2010, we entered into a Purchase and Exchange Agreement, or Purchase Agreement, with Deerfield, pursuant to which we sold Deerfield 11,000,000 shares of our common stock at a price of $3.23 per share, resulting in net proceeds to us of $35.5 million. Also pursuant to the Purchase Agreement, we exchanged 2009 Warrants to purchase an aggregate of 16,200,000 shares of our common stock at an exercise price of $5.42 per share for new warrants, which we refer to as the New Warrants, to purchase a like number of shares of our common stock at an exercise price of $3.45 per share. The New Warrants are exercisable beginning on December 7, 2010 and will remain exercisable until June 17, 2013, which is the same date the 2009 Warrants expire. Other than the exercise price and certain provisions related to cashless exercise and early termination of the warrants, the New Warrants contain substantially the same terms as the 2009 Warrants.

We valued the New Warrants at their June 7, 2010 issuance date using an option pricing model and the following assumptions: expected life of 3.03 years, risk-free interest rate of 1.2%, expected volatility of 72% and no dividend yield. We determined that the incremental value of the New Warrants was $5.5 million, which was recorded as a component of the stock issuance and warrant exchange under the Purchase Agreement in the stockholders’ equity section of our condensed consolidated balance sheet. Because the New Warrants are eligible for equity classification, no adjustments to the recorded value will be made on an ongoing basis.

In August 2010, we sold 8,955,224 shares of our common stock at a price of $6.70 per share in a registered direct public offering to Deerfield. As part of this transaction, we entered into an amendment to the Facility Agreement, pursuant to which (i) $30.0 million of the proceeds from this transaction was used to prepay the portion of the principal amount that we otherwise would have been required to repay in July 2012, and (ii) the $20.0 million principal repayment that we are currently required to make in July 2011 will be deferred until June 17, 2013 if the FDA approves our NDA for lorcaserin before the July 2011 repayment date. Net proceeds to us from this transaction, after prepayment of the $30.0 million, were approximately $30.0 million. In connection with this $30.0 million prepayment, we retired a proportional share of the debt discount and issuance costs directly related to the repaid debt and recognized a non-cash loss on extinguishment of debt of $12.4 million for the three and nine months ended September 30, 2010. In accordance with relevant guidance, we also evaluated whether this amendment constituted an extinguishment of debt resulting in extinguishment accounting or modification accounting. Based on our analysis, we determined that this amendment was not a substantial modification and, accordingly, we accounted for this amendment under modification accounting. Had extinguishment accounting been required, we would have recognized a gain or loss based on the difference between the carrying value of our note payable to Deerfield and its fair value.

Of the total $60.0 million of principal outstanding on the Deerfield loan at September 30, 2010, we are required to pay $20.0 million in July 2011 (unless such payment is deferred as discussed in the immediately preceding paragraph) and the remaining $40.0 million in June 2013.

6. Derivative Liabilities

In June 2006 and August 2008, we issued seven-year warrants, which we refer to as the Series B Warrants, to purchase 829,856 and 1,106,344 shares of our common stock, respectively, at an exercise price of $15.49 and $7.71 per share, respectively. The Series B Warrants are related to our Series B Convertible Preferred Stock, which we redeemed in 2008 and is no longer outstanding. The warrants contain an anti-dilution provision and, as a result of subsequent equity issuances at prices below the adjustment price of $6.72 defined in the warrants, as of September 30, 2010, the number of shares issuable upon exercise of the outstanding June 2006 and August 2008 Series B Warrants was increased to 1,046,781 and 1,398,346, respectively, and the exercise price was reduced to $12.28 and $6.10 per share, respectively.

In January 2009, we adopted amendments to the authoritative guidance related to contracts in an entity’s own equity. These amendments provide a two-step model to be applied in determining whether a financial instrument or an embedded feature in a financial instrument is indexed to an entity’s own stock that would qualify such financial instruments or embedded features for a scope exception. This scope exception specifies that a contract that would otherwise meet the definition of a derivative financial instrument would not be considered as such if the contract is both (i) indexed to the entity’s own stock and (ii) classified in the stockholders’ equity section of the balance sheet. Our adoption of these amendments resulted in the determination that our Series B Warrants are ineligible for equity classification as a result of provisions in the Series B Warrants that may result in an adjustment to the warrant exercise price. As such, upon adoption of these amendments, we recorded a $9.7 million adjustment to equity, a $2.1 million liability for the fair value of the Series B Warrants and a $7.6 million adjustment to the opening accumulated deficit balance as a cumulative effect of a change in accounting principle. We have revalued these warrants on each subsequent balance sheet date, and will continue to do so until they are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. The June 2006 Series B Warrants were valued at September 30, 2010 using an option pricing model and the following assumptions: expected life of 2.75 years, risk-free interest rate of 0.7%, expected volatility of 92% and no dividend yield. The August 2008 Series B Warrants were valued at September 30, 2010 using an option pricing model and the following assumptions: expected life of 4.87 years, risk-free interest rate of 1.3%, expected volatility of 77% and no dividend yield.

We separately valued the Deerfield Additional Loan Election, including the 5,600,000 contingently issuable warrants to purchase up to 5,600,000 shares of our common stock, as of the July 2009 issuance date of the Deerfield loan (see Note 5). The value of the Deerfield Additional Loan Election is classified as a liability on our condensed consolidated balance sheet and, accordingly, will be revalued on each subsequent balance sheet date until it is exercised or expires, with any changes in the fair value between reporting

 

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periods recorded as other income or expense. In July 2009, the Deerfield Additional Loan Election was valued using an option pricing model and the following assumptions: expected life of 1.45 to 1.95 years, risk-free interest rate of 2.0%, expected volatility of 66% and no dividend yield. At September 30, 2010, the Deerfield Additional Loan Election was revalued using an option pricing model and the following assumptions: expected life of 0.21 to 0.71 years, risk-free interest rate of 0.6%, expected volatility of 93% and no dividend yield.

We also separately valued Deerfield’s right to require us to accelerate principal payments on the Deerfield loan under certain circumstances at $0.5 million as of the July 2009 issuance date of the loan (see Note 5). The value of this acceleration right is classified as a liability on our condensed consolidated balance sheet and, accordingly, will be revalued on each subsequent balance sheet date until it is exercised or expires, with any changes in the fair value between reporting periods recorded as other income or expense. At the issuance date and at September 30, 2010, this acceleration right was valued using a discounted cash flow model.

Our derivative liabilities consisted of the following as of September 30, 2010 and December 31, 2009, in thousands:

 

     September 30,
2010
     December 31,
2009
 

Deerfield Additional Loan Election

   $ 280         —     
                 

Total current derivative liabilities

     280         —     
                 

Deerfield Additional Loan Election

     —         $ 3,831   

Series B Warrants

     978         2,386   

Deerfield acceleration right

     527         425   
                 

Total long-term derivative liabilities

     1,505         6,642   
                 

Total derivative liabilities

   $ 1,785       $ 6,642   
                 

The change in the fair value of our derivative liabilities is recorded in the interest and other income (expense) section of our condensed consolidated statements of operations. The following table presents the gain (loss) we recognized for the three and nine months ended September 30, 2010 and 2009, in thousands:

 

     Three months ended
September 30,
     Nine months ended
September 30,
 
     2010     2009      2010     2009  

Series B Warrants

   $ 1,175      $ 771       $ 1,408      $ (1,356

Deerfield Additional Loan Election

     1,915        1,687         3,551        1,687   

Deerfield acceleration right

     (67     14         (102     14   
                                 

Total gain due to revaluation of derivative liabilities

   $ 3,023      $ 2,472       $ 4,857      $ 345   
                                 

7. Marketing and Supply Agreement with Eisai, Inc.

In July 2010, our wholly owned subsidiary, Arena Pharmaceuticals GmbH, or Arena GmbH, entered into a marketing and supply agreement with Eisai Inc., or Eisai. Under this agreement, Arena GmbH granted Eisai exclusive rights to commercialize lorcaserin in the United States and its territories and possessions following the FDA’s approval of our NDA for lorcaserin. As part of the agreement, Arena GmbH will manufacture lorcaserin at our facility in Switzerland, and Eisai will purchase all of its requirements of lorcaserin from Arena GmbH.

We received a non-refundable, upfront payment of $50.0 million from Eisai, and, following regulatory approval of lorcaserin and upon the delivery of product supply for launch, may receive up to an additional $90.0 million depending on the label and timing of approval. We recorded the $50.0 million upfront payment as deferred revenues and will recognize it as revenue ratably over 13 years, which represents the period in which we expect to have significant involvement. Accordingly, at September 30, 2010, our condensed consolidated balance sheet included $3.8 million and $45.2 million for the current and non-current portion, respectively, of such deferred revenues. We recognized $1.0 million of revenue for the three and nine months ended September 30, 2010 related to the marketing and supply agreement with Eisai.

We will sell lorcaserin to Eisai for a purchase price starting at 31.5% of Eisai’s annual net product sales, and the purchase price will increase on a tiered basis to 36.5% on the portion of annual net product sales exceeding $750.0 million, subject to reduction in the event of generic competition and certain other circumstances. We are also eligible to receive up to an aggregate of $1.16 billion in purchase price adjustment payments based on Eisai’s annual net sales of lorcaserin, with the first and last amounts payable with

 

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annual net sales of $250.0 million and $2.5 billion, respectively. Of these purchase price adjustment payments, Eisai will pay us a total of $300.0 million for annual net sales of up to $1.0 billion. In addition, we are eligible to receive up to an additional $70.0 million in regulatory and development milestone payments.

Eisai and we will share equally the development expenses for any additional development work required by the FDA prior to approval of our NDA for lorcaserin. If the FDA requires development work following approval of lorcaserin, Eisai will bear 90% and we will bear 10% of the expenses for such work, except that Eisai and we will share equally the costs of certain pediatric or adolescent studies.

In determining the appropriate method of revenue recognition for the multiple elements comprising the marketing and supply agreement with Eisai, we considered a variety of factors, such as whether the elements are separable, whether there are determinable fair values and whether there is a unique earnings process associated with each element. We determined that the right to commercialize lorcaserin and the product development elements are required to be accounted for as a single bundled element, and, accordingly, the non-refundable, upfront payment will be recognized over the period in which we expect to have significant involvement in the arrangement, which we currently estimate to be 13 years. Revenue from milestones achieved, if any, will be recognized when earned, as long as (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of this agreement, (ii) the milestone represents the culmination of an earnings process, (iii) the milestone payment is non-refundable and (iv) our performance obligations after the milestone achievement will continue to be funded at a level comparable to the level before the milestone achievement.

Eisai and we have agreed to not commercialize outside of our marketing and supply agreement any product that competes with lorcaserin in the United States. Our marketing and supply agreement includes a stand-still provision limiting Eisai’s ability to acquire our securities and assets.

Unless terminated earlier, our marketing and supply agreement will continue in effect until terminated by Eisai following the later of the expiration of all issued lorcaserin patents for the United States and 12 years after the first commercial sale of lorcaserin in the United States. Either party has the right to terminate this agreement early in certain circumstances, including (i) if the other party is in material breach, (ii) for certain commercialization concerns and (iii) for certain intellectual property infringement. Eisai also has the right to terminate this agreement early in certain circumstances, including (a) if sales of generic equivalents of lorcaserin in the United States exceed sales of lorcaserin in the United States (based on volume) and (b) if Eisai is acquired by a company that has a product that competes with lorcaserin.

8. Warrants

As part of our June 2010 sale of common stock to Deerfield that resulted in net proceeds to us of $35.5 million (see Note 5), we exchanged 16,200,000 of the 2009 Warrants to purchase shares of our common stock at an exercise price of $5.42 per share for New Warrants to purchase a like number of shares of our common stock at an exercise price of $3.45 per share.

The following table summarizes our outstanding warrants as of September 30, 2010:

 

     Balance Sheet
Classification
     Number of
Warrants
     Exercise
Price
     Expiration
Date
 

Deerfield New Warrants

     Equity         16,200,000       $ 3.45         June 17, 2013   

Deerfield 2009 Warrants

     Equity         11,800,000       $ 5.42         June 17, 2013   

August 2008 Series B Warrants

     Liability         1,398,346       $ 6.10         August 14, 2015   

June 2006 Series B Warrants

     Liability         1,046,781       $ 12.28         June 30, 2013   
                 

Total number of warrants outstanding

        30,445,127         
                 

9. Share-based Activity

Share-based Compensation

We use the Black-Scholes option pricing model to estimate the grant-date fair value of share-based awards in determining our share-based compensation expense. In June 2009, our stockholders approved our 2009 Long-Term Incentive Plan and, concurrently, our 2006 Long-Term Incentive Plan, as amended, was terminated. The table below sets forth the weighted-average assumptions and estimated fair value of stock options we granted under these plans during the three and nine months ended September 30, 2010 and 2009:

 

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     Three months ended
September 30,
    Nine months ended
September 30,
 
     2010     2009     2010     2009  

Risk-free interest rate

     2.1     2.8     2.4     2.0

Dividend yield

     0     0     0     0

Expected volatility

     80     80     72     86

Expected life (years)

     5.76        5.72        5.76        5.72   

Weighted-average estimated fair value per share of stock options granted

   $ 2.71      $ 3.06      $ 2.07      $ 2.87   

In June 2009, our stockholders also approved our 2009 Employee Stock Purchase Plan and, concurrently, our 2001 Employee Stock Purchase Plan, as amended, was terminated. The table below sets forth the weighted-average assumptions and estimated fair value of the options to purchase stock granted under these plans for multiple offering periods during the three and nine months ended September 30, 2010 and 2009:

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2010     2009     2010     2009  

Risk-free interest rate

     0.1% - 1.9     0.1% - 4.2     0.1% - 2.8     0.1% - 5.1

Dividend yield

     0     0     0     0

Expected volatility

     63% - 83     53% - 82     57% - 83     53% - 82

Expected life (years)

     0.25 - 2.0        0.25 - 2.0        0.25 - 2.0        0.25 - 2.0   

Weighted-average estimated fair value per share of options granted under our employee stock purchase plans

   $ 1.41 - 2.28      $ 1.45 - 4.70      $ 1.41 -2.64      $ 1.45 - 4.70   

Expected volatility is based on a combination of 75% historical volatility of our common stock and 25% market-based implied volatilities from traded options on our common stock, with historical volatility being more heavily weighted due to the historically low volume of traded options on our common stock. The expected life of options is determined based on historical experience of similar awards, giving consideration to the contractual terms of the share-based awards, vesting schedules and post-vesting terminations. The risk-free interest rates are based on the US Treasury yield curve, with a remaining term approximately equal to the expected term used in the option pricing model.

Forfeitures are estimated at the time of option grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Based on historical experience, forfeitures of unvested options were estimated to be 7.0% at September 30, 2010 and 8.5% at September 30, 2009. If actual forfeitures vary from estimates, we will recognize the difference in compensation expense in the period the actual forfeitures occur or when stock options vest.

We recognized share-based compensation expense as follows, in thousands, except per share data:

 

     Three months ended
September 30,
     Nine months ended
September 30,
 
     2010      2009      2010      2009  

Research and development

   $ 826       $ 1,054       $ 2,611       $ 2,878   

General and administrative

     364         571         1,709         2,182   

Restructuring charges

     —           —           —           306   
                                   

Total share-based compensation expense and impact on net loss

   $ 1,190       $ 1,625       $ 4,320       $ 5,366   
                                   

Impact on net loss per share, basic and diluted

   $ 0.01       $ 0.02       $ 0.04       $ 0.06   
                                   

 

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Share-based Award Activity

The following table summarizes our stock option activity during the nine months ended September 30, 2010:

 

     Options     Weighted-
Average 
Exercise Price
 

Outstanding at January 1, 2010

     7,226,824      $ 8.94   

Granted

     1,641,337        3.25   

Exercised

     (51,655     1.05   

Forfeited/cancelled/expired

     (552,927     10.63   
                

Outstanding at September 30, 2010

     8,263,579      $ 7.74   
                

The following table summarizes activity with respect to our performance-based restricted stock unit awards during the nine months ended September 30, 2010:

 

     Performance
Units
    Weighted-
Average 
Grant-Date
Fair Value
 

Outstanding at January 1, 2010

     1,714,350      $ 12.44   

Granted

     —          —     

Vested

     —          —     

Forfeited/cancelled

     (24,700     7.94   
                

Outstanding at September 30, 2010

     1,689,650      $ 12.50   
                

10. Concentration of Credit Risk and Major Customers

Financial instruments, which potentially subject us to concentrations of credit risk, consist primarily of cash, cash equivalents and short-term investments. We limit our exposure to credit loss by placing our cash and investments in US government, agency and government-sponsored enterprise obligations and in corporate debt instruments that are rated investment grade, in accordance with our board-approved investment policy.

We manufacture drug products for Siegfried under a manufacturing services agreement, and all of our manufacturing services revenues are attributable to Siegfried.

Percentages of our total revenues derived from our manufacturing services agreement and from our most significant collaborators for the periods presented are as follows:

 

     Three months ended
September 30,
    Nine months ended
September 30,
 

Source of revenue

   2010     2009     2010     2009  

Collaboration with TaiGen Biotechnology Co., Ltd.

     53.1     —          32.1     —     

Manufacturing services agreement with Siegfried

     24.2     66.3     41.7     60.5

Collaboration with Eisai

     12.6     —          7.6     —     

Collaboration with Ortho-McNeil-Janssen Pharmaceuticals, Inc.

     10.0     33.1     15.3     39.0

11. Net Loss Per Share

We compute basic and diluted net loss per share using the weighted-average number of shares of common stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of our common stock subject to repurchase or forfeiture for the three and nine months ended September 30, 2010 or 2009.

 

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Because we are in a net loss position, we have excluded outstanding unvested performance-based restricted stock unit awards, which are subject to forfeiture, warrants and stock options, as well as unvested restricted stock in our deferred compensation plan, from our calculation of diluted net loss per share for the three and nine months ended September 30, 2010 and 2009 because these securities are antidilutive. The table below presents our securities that would otherwise be included in our diluted net loss per share at September 30, 2010 and 2009.

 

     September 30,  
     2010      2009  

Warrants

     30,445,127         30,138,263   

Stock options

     8,263,579         7,249,561   

Performance-based restricted stock unit awards

     1,689,650         1,717,850   

Unvested restricted stock

     84,169         101,669   
                 

Total

     40,482,525         39,207,343   
                 

Had they been dilutive, these securities would have been included in our computation of diluted net loss per share.

12. Comprehensive Income (Loss)

We report all components of comprehensive income (loss), including foreign currency translation gain and loss and unrealized gains and losses on investment securities, in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Below is a reconciliation, in thousands, of our net loss to comprehensive loss for all periods presented.

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2010     2009     2010     2009  

Net loss

   $ (36,266   $ (34,835   $ (96,293   $ (123,432

Foreign currency translation gain

     3,677        1,348        2,956        507   

Unrealized gain (loss) on available-for-sale securities and other investments, net of taxes

     (679     462        (176     433   
                                

Comprehensive loss

   $ (33,268   $ (33,025   $ (93,513   $ (122,492
                                

13. Legal Proceedings

Beginning September 20, 2010, a number of complaints were filed in the US District Court for the Southern District of California against us and certain of our current and former employees and directors on behalf of certain purchasers of our common stock. The complaints have been brought as purported stockholder class actions, and, in general, include allegations that we and certain of our current and former employees and directors violated federal securities laws by making materially false and misleading statements regarding our lorcaserin trials, thereby artificially inflating the price of our common stock. The plaintiffs are seeking unspecified monetary damages and other relief. We expect that all class action complaints filed to date will be transferred to a single court. We then expect the court to consolidate the actions, appoint a lead plaintiff and order the lead plaintiff to file a consolidated complaint. We intend to vigorously defend against the claims advanced, and intend to file a motion to dismiss the consolidated complaint.

On September 24, 2010, a stockholder derivative complaint was filed in the Superior Court of California for the County of San Diego against certain of our current and former employees and directors, and other stockholder derivative complaints were subsequently filed in state court. On October 19, 2010, the Superior Court ordered the pending state derivative complaints be consolidated. The Superior Court also ordered that later filed, related derivative complaints be consolidated as well. On October 6, 2010, a stockholder derivative suit was filed in the US District Court for the Southern District of California. Thereafter, a number of other stockholder derivative actions were filed in federal court. Plaintiffs in the first two federal stockholder derivative actions filed a motion to consolidate the two actions and appoint lead counsel. A hearing on the motion to consolidate has been scheduled for December 17, 2010. The state and federal stockholder derivative actions are hereinafter collectively referred to as the Derivative Actions. The complaints in the Derivative Actions allege breaches of fiduciary duties by the defendants and other violations of law. In general, the complaints allege that certain of our current and former employees and directors caused or allowed for the dissemination of materially false and misleading statements regarding our lorcaserin trials, thereby artificially inflating the price of our common stock. The plaintiffs are seeking unspecified monetary damages and other relief, including reforms and improvements to our corporate governance and internal procedures. We have not yet responded to the Derivative Actions, but intend to vigorously defend against the claims advanced and to seek dismissal of the Derivative Actions.

 

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14. Subsequent Events

We have evaluated subsequent events after the balance sheet date of September 30, 2010 and up to the date we filed this report.

On October 22, 2010, the FDA issued a CRL regarding our NDA for lorcaserin. In the CRL, the FDA stated that it has completed its review of the NDA and determined that it cannot approve the application in its present form. The FDA also outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues.

On November 4, 2010, we announced that following the completion of a Phase 1 clinical trial program for APD597, Ortho-McNeil-Janssen Pharmaceuticals, Inc., decided not to advance APD597 and notified us that it is terminating our collaboration, effective December 28, 2010. APD597 is a GPR119 agonist intended for the treatment of type 2 diabetes, which, along with other compounds and intellectual property, will revert to us upon termination of the collaboration. The Phase 1 program provided evidence for incretin stimulation (GLP-1, GIP and PYY) and reductions in post-meal glucose increases with APD597 alone and in combination with sitagliptin, a DPP-4 inhibitor.

On November 9, 2010, we announced top-line results from the lorcaserin BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial that demonstrate statistically significant weight loss and improved HbA1c in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three primary efficacy endpoints.

 

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

This discussion and analysis should be read in conjunction with our financial statements and notes thereto included in this quarterly report on Form 10-Q, or Quarterly Report, and the audited consolidated financial statements and notes thereto included in our annual report on Form 10-K for the year ended December 31, 2009, or 2009 Annual Report, as filed with the Securities and Exchange Commission, or SEC. Operating results are not necessarily indicative of results that may occur in future periods.

This Quarterly Report includes forward-looking statements, which involve a number of risks and uncertainties. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Readers of this Quarterly Report are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Quarterly Report was filed with the SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business, and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, the risk factors identified in our SEC reports, including this Quarterly Report. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements.

OVERVIEW AND RECENT DEVELOPMENTS

We are a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Our most advanced drug candidate, lorcaserin hydrochloride or lorcaserin, is intended for weight management. Arena Pharmaceuticals GmbH, or Arena GmbH, our wholly owned subsidiary, has granted Eisai Inc., or Eisai, exclusive rights to market and distribute lorcaserin in the United States following the US Food and Drug Administration, or FDA, approval of our New Drug Application, or NDA, for lorcaserin.

Our recent developments include:

Lorcaserin

 

   

Announced top-line results from the lorcaserin BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial that demonstrate statistically significant weight loss and improved HbA1c in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three primary efficacy endpoints.

 

   

The FDA issued a Complete Response Letter, or CRL, regarding our NDA for lorcaserin. In the CRL, the FDA stated that it has completed its review of the NDA and determined that it cannot approve the application in its present form. The FDA also outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues. Prior to issuance of the CRL, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted nine to five that the

 

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available data do not demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long term in a population of overweight and obese individuals to allow marketing approval.

 

   

Results from a lorcaserin mechanism of action study conducted at the Pennington Biomedical Research Center were presented at Obesity 2010, the 28th Annual Scientific Meeting of The Obesity Society. The data presented showed that lorcaserin reduces energy intake and appetite, and causes weight loss without stimulating energy expenditure.

 

   

The FDA completed the Pre-Approval Inspection of our drug product manufacturing facility in Switzerland and classified the inspection as No Action Indicated.

 

   

Results from our two-year, pivotal Phase 3 BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial were published in the July 15, 2010, issue of the New England Journal of Medicine . The data presented in the article show that lorcaserin used in conjunction with behavioral modification caused significantly greater weight loss and improved maintenance of weight loss compared to placebo. The data also indicated that lorcaserin improved values for biomarkers that may be predictive of future cardiovascular events, including lipid levels, insulin resistance, levels of inflammatory markers and blood pressure.

 

   

Arena GmbH entered into a marketing and supply agreement with Eisai for the commercialization of lorcaserin in the United States following FDA approval of our NDA for lorcaserin. Under the terms of the agreement, we received a non-refundable, upfront payment of $50.0 million from Eisai.

Other

 

   

Announced that following the completion of a Phase 1 clinical trial program for APD597, Ortho-McNeil-Janssen Pharmaceuticals, Inc., decided not to advance APD597 and notified us that it is terminating our collaboration, effective December 28, 2010. APD597 is a GPR119 agonist intended for the treatment of type 2 diabetes, which, along with other compounds and intellectual property, will revert to us upon termination of the collaboration. The Phase 1 program provided evidence for incretin stimulation (GLP-1, GIP and PYY) and reductions in post-meal glucose increases with APD597 alone and in combination with sitagliptin, a DPP-4 inhibitor.

 

   

Announced results from a Phase 1 clinical trial of APD916, a novel drug candidate we discovered that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy. In this randomized, double-blind, placebo-controlled trial in 24 healthy volunteers, APD916 demonstrated dose-proportional pharmacokinetic exposure over the tested dose range.

 

   

Received gross proceeds of approximately $60.0 million from the sale of 8,955,224 shares of our common stock to certain Deerfield entities at a price of $6.70 per share. As part of the transaction, we amended our June 2009 Facility Agreement with Deerfield pursuant to which $30.0 million of the proceeds from this transaction was used to prepay the portion of the principal amount that we otherwise would have been required to repay in July 2012.

We refer you to our previously filed Current Reports on Form 8-K for a more complete discussion of these developments.

RESULTS OF OPERATIONS

We are providing the following summary of our revenues, research and development expenses and general and administrative expenses to supplement the more detailed discussion below. The dollar values in the following tables are in millions.

Revenues

 

     Three months  ended
September 30,
     Nine months  ended
September 30,
 

Source of revenue

   2010      2009      2010      2009  

Manufacturing services

   $ 1.8       $ 1.7       $ 5.3       $ 4.7   

Collaborative agreements

     5.8         0.9         7.3         3.0   
                                   

Total revenues

   $ 7.6       $ 2.6       $ 12.6       $ 7.7   
                                   

Research and development expenses

 

     Three months  ended
September 30,
     Nine months  ended
September 30,
 

Type of expense

   2010      2009      2010      2009  

Salary and other personnel costs (excluding non-cash share-based compensation)

   $ 8.1       $ 7.7       $ 25.1       $ 27.3   

External clinical and preclinical study fees and expenses

     5.7         7.7         14.0         39.8   

Facility and equipment costs

     3.5         3.8         10.9         11.7   

 

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     Three months  ended
September 30,
     Nine months  ended
September 30,
 

Type of expense

   2010      2009      2010      2009  

Research supplies

     1.0         0.8         2.9         3.7   

Non-cash share-based compensation

     0.9         1.0         2.6         2.9   

Other

     1.0         1.1         3.5         3.6   
                                   

Total research and development expenses

   $ 20.2       $ 22.1       $ 59.0       $ 89.0   
                                   

General and administrative expenses

 

     Three months  ended
September 30,
     Nine months  ended
September 30,
 

Type of expense

   2010      2009      2010      2009  

Legal, accounting and other professional fees

   $ 2.7       $ 1.7       $ 7.0       $ 6.0   

Salary and other personnel costs (excluding non-cash share-based compensation)

     2.3         1.9         7.0         6.5   

Facility and equipment costs

     1.0         0.8         2.8         2.7   

Non-cash share-based compensation

     0.4         0.6         1.7         2.2   

Other

     0.5         0.4         2.1         1.3   
                                   

Total general and administrative expenses

   $ 6.9       $ 5.4       $ 20.6       $ 18.7   
                                   

THREE MONTHS ENDED SEPTEMBER 30, 2010 AND 2009

Revenues. We recognized total revenues of $7.6 million for the three months ended September 30, 2010, compared to $2.6 million for the three months ended September 30, 2009. Our revenues for the three months ended September 30, 2010 included (i) $4.0 million of previously deferred non-cash revenues recognized from our license agreement with TaiGen Biotechnology Co., Ltd., or TaiGen, (ii) $1.8 million recognized under our manufacturing services agreement with Siegfried, (iii) $1.0 million recognized from amortization of the $50.0 million non-refundable, upfront payment we received in July 2010 under our marketing and supply agreement with Eisai and (iv) $0.8 million recognized for patent activities from our collaboration with Ortho-McNeil-Janssen Pharmaceuticals, Inc., or Ortho-McNeil-Janssen. Our revenues for the three months ended September 30, 2009 included $1.7 million recognized under our manufacturing services agreement with Siegfried and $0.9 million recognized for patent activities, primarily related to the Ortho-McNeil-Janssen collaboration. On October 29, 2010, Ortho-McNeil-Janssen notified us that, effective December 28, 2010, it is terminating our collaboration.

We expect that our 2010 revenues will primarily consist of amortization of the $50.0 million non-refundable, upfront payment we received from Eisai, reimbursement for patent activities from Ortho-McNeil-Janssen, recognition of non-cash deferred revenues from our license agreement with TaiGen and revenue under our manufacturing services agreement with Siegfried. Under such Siegfried agreement, until at least December 31, 2010, Siegfried may sub-contract to us the manufacture of certain drug products it previously manufactured for its customers, and we agreed to perform such manufacturing up to certain specified amounts. Under such agreement, Siegfried guarantees a minimum level of cost absorption through the end of 2010, which we will record as revenues, of CHF 6.6 million, or approximately $6.8 million, for the full year ending December 31, 2010. We expect to exceed this minimum for 2010. After December 31, 2010, Siegfried can request under such agreement for us to manufacture drug products, but we will no longer be obligated to perform such manufacturing. In the fourth quarter of 2010, we expect to recognize $1.0 million from amortization of the $50.0 million non-refundable, upfront payment we received from Eisai and recorded as deferred revenues. Following the termination of our collaboration with Ortho-McNeil-Janssen, they will no longer reimburse us for patent activities, and, accordingly, we will no longer recognize such revenues.

Revenues from collaborators for milestones that may be achieved in the future are difficult to predict, and, in the case of our marketing and supply agreement with Eisai, depend in large part on whether we receive US marketing approval for lorcaserin. We may recognize in the short term up to an additional $90.0 million in revenues from Eisai following regulatory approval of our NDA for lorcaserin and upon the delivery of product supply for launch, depending on the label and timing of approval. Our revenues may vary significantly from quarter to quarter and year to year. We expect that any significant revenues for at least the short term will depend on whether and when we receive US marketing approval for lorcaserin, enter into any agreements to commercialize lorcaserin outside of the United States and collaborate on any of our other current or future drug candidates. Ultimately, we expect our revenues in the long term to primarily depend upon the regulatory approval and commercialization of our drug candidates.

Cost of manufacturing services. Cost of manufacturing services is comprised of direct costs associated with manufacturing drug products for Siegfried under our manufacturing services agreement, including related salaries, other personnel costs and machinery

 

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depreciation costs. We recognized cost of manufacturing services of $1.8 million for the three months ended September 30, 2010, compared to $1.7 million for the three months ended September 30, 2009.

Research and development expenses. Research and development expenses, which account for the majority of our expenses, consist primarily of salaries and other personnel costs, clinical trial costs (including payments to contract research organizations, or CROs), preclinical study fees, manufacturing costs for non-commercial products, costs for the development of our earlier-stage programs and technologies, research supply costs and facility and equipment costs. We expense research and development costs to operations as they are incurred when these expenditures relate to our research and development efforts and have no alternative future uses. Other than external expenses for our clinical and preclinical programs, we generally do not track our research and development expenses by project; rather, we track such expenses by the type of cost incurred.

Research and development expenses decreased by $1.9 million to $20.2 million for the three months ended September 30, 2010, from $22.1 million for the three months ended September 30, 2009. This was primarily due to a $2.0 million decrease in external clinical and preclinical study fees and expenses due to completing our lorcaserin pivotal Phase 3 clinical trials. We expect that our 2010 research and development expenses will be significantly lower than the 2009 level due to completion of our lorcaserin pivotal Phase 3 trials.

We expect to incur manufacturing costs for lorcaserin in the short term as we prepare for the launch of lorcaserin following FDA approval and that such costs will be substantial if the FDA approves our NDA for lorcaserin. However, if the NDA for lorcaserin is approved, we will begin to record our lorcaserin manufacturing costs as cost of goods sold as the related inventory is sold, instead of as part of our research and development expenses. Pre-launch inventory manufactured is being charged to expense until we believe that the likelihood of approval is such that we should begin recording the production costs related to the inventory produced as an asset.

Substantially all of the $5.7 million of total external clinical and preclinical study fees and expenses noted in the table above for the three months ended September 30, 2010 related to our lorcaserin program. Included in the $7.7 million total external clinical and preclinical study fees and expenses noted in the table above for the three months ended September 30, 2009 was $7.4 million related to our lorcaserin program.

General and administrative expenses. General and administrative expenses increased by $1.5 million to $6.9 million for the three months ended September 30, 2010, from $5.4 million for the three months ended September 30, 2009. This increase was primarily due to an increase of $1.0 million in legal fees, primarily patent legal fees. We expect that our 2010 general and administrative expenses will be higher than the 2009 level as a result of market research expenses related to lorcaserin and increased legal fees. We expect our expenses for legal fees to increase in the short term due to ongoing litigation, but we expect that any costs exceeding our deductible for defending against these claims will largely be covered by insurance.

Amortization of acquired technology and other intangibles. We recognized $0.5 million for amortization of acquired technology and other intangibles for the three months ended September 30, 2010, compared to $0.6 million for the three months ended September 30, 2009. The amortization expense recognized for the three months ended September 30, 2010 relates to the manufacturing facility production licenses we acquired in January 2008, which are being amortized over their estimated useful life of 20 years, and the Melanophore screening technology, our primary screening technology, which is being amortized over its estimated useful life of 10 years. Using the exchange rate in effect on September 30, 2010, we expect to record amortization expense of $0.2 million in the remaining quarter of 2010 and $0.7 million per year through 2027 for the manufacturing facility production licenses. We also expect to record amortization expense related to our Melanophore screening technology of $0.4 million in the remaining quarter of 2010 and the remaining amount of $0.3 million in the first quarter of 2011. We amortized the workforce we acquired from Siegfried in January 2008 through the end of 2009 over its estimated benefit of two years.

Interest and other income (expense), net. Total interest and other expense, net, increased by $6.9 million to $14.5 million for the three months ended September 30, 2010, from $7.6 million for the three months ended September 30, 2009. This increase was primarily due to an increase of $9.9 million in our non-cash loss on extinguishment of debt, which was partially offset by (i) a $1.1 million decrease in interest expense, primarily due to the lower outstanding principal balance on the Deerfield loan, (ii) a $0.9 million gain on investments and (iii) a $0.6 million non-cash gain due to the revaluation of our derivative liabilities. The interest expense recognized for the three months ended September 30, 2010 includes interest of $1.5 million paid to Deerfield in cash. We expect that our interest expense will continue to be substantial as a result of the Deerfield loan and, to a lesser degree, payments on our lease financing obligations.

NINE MONTHS ENDED SEPTEMBER 30, 2010 AND 2009

Revenues. We recognized revenues of $12.6 million during the nine months ended September 30, 2010, compared to $7.7 million during the nine months ended September 30, 2009. Our revenues for the nine months ended September 30, 2010 included (i) $5.3 million recognized under our manufacturing services agreement with Siegfried, (ii) $4.0 million of previously deferred revenues recognized from our license agreement with TaiGen, (iii) $1.9 million recognized for patent activities, primarily related to our

 

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collaboration with Ortho-McNeil-Janssen, (iv) $1.0 million recognized from amortization of the $50.0 million non-refundable, upfront payment we received from Eisai in July 2010 and (v) $0.4 million recognized related to a license agreement with GlaxoSmithKline LLC and GlaxoSmithKline Research & Development Limited, or collectively GSK, for their use of our Melanophore screening technology. Our revenues for the nine months ended September 30, 2009 included $4.7 million recognized under our manufacturing services agreement with Siegfried and $3.0 million recognized for patent activities, primarily related to the Ortho-McNeil-Janssen collaboration.

Cost of contract manufacturing. We recognized cost of manufacturing services of $5.3 million and $4.7 million for the nine months ended September 30, 2010 and 2009, respectively.

Research and development expenses. Research and development expenses decreased $30.0 million to $59.0 million for the nine months ended September 30, 2010, from $89.0 million for the nine months ended September 30, 2009. This was primarily due to decreases of (i) $25.8 million in external clinical and preclinical study fees and expenses primarily due to completing our pivotal Phase 3 clinical trials for lorcaserin, (ii) $2.2 million in salary and personnel costs as a result of our June 2009 workforce reduction and (iii) $0.8 million in both facility and equipment costs and research supplies. Included in the $14.0 million of total external clinical and preclinical study fees and expenses for the nine months ended September 30, 2010 was $12.8 million related to our lorcaserin program, $0.5 million related to our APD916 program for the treatment of narcolepsy with cataplexy, and $0.4 million related to our APD811 program for the treatment of pulmonary arterial hypertension. Included in the $39.8 million of total external clinical and preclinical study fees and expenses for the nine months ended September 30, 2009 was $38.4 million related to lorcaserin, $0.6 million related to APD811 and $0.4 million related to APD125, which we previously studied for insomnia.

General and administrative expenses. General and administrative expenses increased $1.9 million to $20.6 million for the nine months ended September 30, 2010, from $18.7 million for the nine months ended September 30, 2009. This was primarily due to increases of $0.9 million in legal fees, primarily corporate legal fees, and $0.8 million in marketing research expenses.

Amortization of acquired technology and other intangibles. We recognized $1.6 million for amortization of acquired technology and other intangibles for the nine months ended September 30, 2010, compared to $1.7 million for the nine months ended September 30, 2009.

Interest and other income (expense), net. Total interest and other expense, net, increased by $8.7 million to $22.4 million for the nine months ended September 30, 2010, from $13.7 million for the nine months ended September 30, 2009. This increase was primarily due to an increase of $9.9 million in our loss on extinguishment of debt and a $5.2 million increase in interest expense related to our Deerfield loan. These increases were partially offset by a $4.5 million gain due to the revaluation of our derivative liabilities and a $0.9 million gain on investments. The interest expense recognized for the nine months ended September 30, 2010 includes interest of $5.0 million we paid Deerfield in cash and the non-cash correction of prior period errors described in the notes to our financial statements herein, which resulted in a $3.0 million decrease to interest expense in the second quarter of 2010.

LIQUIDITY AND CAPITAL RESOURCES

Short term

Our sources of liquidity include our cash balances and short-term investments. As of September 30, 2010, we had $176.5 million in cash and cash equivalents and short-term investments, which we believe will be sufficient to fund our operations for at least the next 12 months. Other potential sources of liquidity in the short term include (i) entering into additional commercialization agreements for lorcaserin or a collaborative agreement for one of our other drug candidates or programs, (ii) equity, debt or other financing, (iii) the sale of facilities we own, (iv) payments from our collaborators and (v) revenues based on Eisai’s annual net sales of lorcaserin if we receive marketing approval. In addition, on or before June 17, 2011, Deerfield can make a one-time election to loan us up to an additional $20.0 million under similar terms as the initial $100.0 million loan.

To date, we have obtained cash and funded our operations primarily through the sale of common and preferred stock, the issuance of a note and related financial instruments, payments from collaborators and sale leaseback transactions. Although we will continue to be opportunistic in our efforts to obtain cash, there is no guarantee that additional funding will be available or that, if available, such funding will be adequate or available on terms that we or our stockholders view as favorable. In addition, as a result of our outstanding loan with Deerfield, our ability to engage in financing transactions is subject to certain limitations and certain financing transactions, if consummated, may accelerate our repayment obligations to Deerfield.

In October 2010, the FDA issued a CRL regarding our NDA for lorcaserin. In the CRL, the FDA stated that it has completed its review of the NDA and determined that it cannot approve the application in its present form. The FDA also outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues. Our marketing and supply agreement with Eisai provides that Eisai and we will share equally the development expenses for any additional development work required by the FDA prior to approval of lorcaserin, and we intend to work with Eisai in responding to the CRL. We expect that the cost of any additional external development expenses that we incur in connection with such response will be substantially less than the external development expenses we have incurred for lorcaserin thus far in 2010.

 

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In January 2008, we entered into strategic cooperation agreements with Siegfried that are primarily related to the manufacturing of lorcaserin, and which are necessary for lorcaserin’s commercialization. We paid CHF 21.8 million, or $19.6 million, of the cash purchase price in January 2008, and are scheduled to pay the remaining cash portion of the purchase price of CHF 10.0 million in three equal installments, with the first payment of CHF 3.3 million scheduled to be paid in January 2011.

Although our September 30, 2010 consolidated balance sheet reflects a total balance of $35.4 million for our note payable to Deerfield due to the requirement to separately value the components of the note, warrants and related financial instruments, the principal balance outstanding on this loan was $60.0 million at September 30, 2010. The earlier of the two remaining principal repayments on the Deerfield loan of $20.0 million is scheduled to be repaid in July 2011. As part of our August 2010 sale of common stock to Deerfield, we amended the Facility Agreement we entered into in June 2009, pursuant to which this $20.0 million principal repayment currently required to be made in July 2011 will be deferred until June 17, 2013, provided that we receive FDA approval of our NDA for lorcaserin before the July 2011 repayment date.

We are continuing to fund activities in support of the further development, approval and commercialization of lorcaserin, and, at the same time, selectively advancing other drug candidates and programs in our research and development pipeline, which may include clinical development. We expect that our research and development expenditures will continue to be high in 2010, but substantially less than they were in 2009. We expect to incur manufacturing costs for lorcaserin as we prepare for the potential launch of lorcaserin and that such costs will be substantial if the FDA approves our NDA for lorcaserin.

We will continue to monitor and evaluate the level of our research, development and manufacturing expenditures, and may further adjust such expenditures based upon a variety of factors, such as our available cash, our ability to obtain additional cash, the results and progress in our lorcaserin and earlier-stage programs, the time and costs related to clinical trials and regulatory decisions, as well as the global economic environment.

Long term

We will need substantial cash to achieve our objectives of discovering, developing and commercializing drugs, which typically take many years and potentially several hundreds of millions of dollars to develop. We do not have adequate internal liquidity to meet these objectives in the long term. To do so, we will need to obtain significant funds under our current collaborative agreements, continue seeking collaborators for our drug candidates and programs and look to other external sources of liquidity, which may include the public and private financial markets.

With respect to lorcaserin, we expect to continue to incur substantial costs, including manufacturing costs, prior to and after receiving marketing approval for lorcaserin, if ever. If lorcaserin is approved for marketing in the United States, we expect Eisai to commercialize lorcaserin under our marketing and supply agreement. With respect to commercializing lorcaserin outside of the United States, we will need additional funds or a collaborative or other agreement with one or more pharmaceutical companies.

In addition to the public and private financial markets, potential sources of liquidity in the long term include revenues based on Eisai’s annual net sales of lorcaserin and milestone and other payments under our marketing and supply agreement, milestone and royalty payments from other existing and future collaborators and revenues from sales of any drugs we commercialize on our own. The length of time that our current cash and cash equivalents, short-term investments and any available borrowings will sustain our operations will be based on, among other things, our prioritization decisions regarding funding for our programs, progress in our clinical and earlier-stage programs, the time and costs related to current and future clinical trials and regulatory decisions, our research, development, manufacturing and commercialization costs (including personnel costs), our progress in any programs under collaborations, costs associated with intellectual property, our capital expenditures, and costs associated with securing any in-licensing opportunities. Any significant shortfall in funding may result in us reducing our development and/or research activities, which, in turn, would affect our development pipeline and ability to obtain cash in the future. If we determine it is advisable to raise additional funds, we do not know whether adequate funding will be available to us or, if available, that such funding will be available on acceptable terms.

The final principal repayment on the Deerfield loan of $40.0 million is scheduled to be repaid in June 2013. At any time we may prepay any or all of the outstanding principal of the Deerfield loan at par, and we may be required to make the scheduled repayments earlier in connection with certain equity issuances. In addition, we are required to make mandatory prepayments of the loan under certain circumstances.

We evaluate from time to time potential acquisitions and in-licensing and other opportunities. Any such transaction may impact our liquidity as well as affect our expenses if, for example, our operating expenses increase as a result of such license or acquisition or we use our cash to finance the license or acquisition. In each of January 2012 and January 2013, we are scheduled to pay Siegfried CHF 3.3 million for the final two installments for the drug product facility assets we acquired in January 2008.

 

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Sources and Uses of Our Cash

Net cash used in operating activities decreased by $102.7 million to $26.9 million comparing the nine months ended September 30, 2010 and 2009. This decrease resulted from our lower net loss comparing these periods, primarily due to completing our lorcaserin pivotal Phase 3 trials in 2009, as well as changes in our operating assets and liabilities, primarily receipt of a $50.0 million non-refundable, upfront payment from Eisai.

Net cash of $6.4 million was provided by investing activities during the nine months ended September 30, 2010, and was primarily attributable to net proceeds of $10.0 million from our short-term investments, which were partially offset by $3.7 million used for equipment and improvements to our facilities. Net cash of $12.3 million was provided by investing activities during the nine months ended September 30, 2009, and was primarily attributable to net proceeds of $15.7 million from our short-term investments, which were partially offset by $3.7 million used for equipment and improvements to our facilities. We expect that our capital expenditures in 2010 will be lower than in 2009 primarily as a result of lower capital expenditures for our manufacturing facility in Switzerland.

Net cash of $89.8 million was provided by financing activities during the nine months ended September 30, 2010, primarily due to net proceeds of $35.5 million from the sale of 11.0 million shares of common stock and the exchange of warrants to Deerfield, net proceeds of $30.0 million, after the $30.0 million principal prepayment, from the sale of approximately 9.0 million shares of common stock to Deerfield and net proceeds of $24.2 million from the sale of approximately 8.3 million shares of common stock under an equity financing commitment we had with Azimuth Opportunity Ltd, or Azimuth. Net cash provided by financing activities was $166.5 million during the nine months ended September 30, 2009, and was primarily attributable to net financing proceeds of $96.9 million from the issuance of a note and related financial instruments to Deerfield, net proceeds of $49.7 million from the sale of 12.5 million shares of common stock, $15.0 million in proceeds related to a lease financing and net proceeds of $14.7 million from the sale of approximately 5.7 million shares of common stock under the equity financing commitment with Azimuth.

CRITICAL ACCOUNTING POLICIES AND MANAGEMENT ESTIMATES

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

Our critical accounting policies include:

Revenue recognition. Our revenues to date have been generated primarily through collaborative agreements and a manufacturing services agreement. Our collaborative agreements have included upfront payments, research funding and milestone achievements. We defer non-refundable upfront payments under our collaborations and recognize them over the period in which we have significant involvement or perform services, using various factors specific to each collaboration. Amounts we receive for research funding for a specified number of full-time researchers are recognized as revenue as the services are performed. Revenue from a milestone achievement is recognized when earned, as evidenced by acknowledgment from our collaborator, provided that (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement, (ii) the milestone represents the culmination of an earnings process, (iii) the milestone payment is non-refundable and (iv) our performance obligations after the milestone achievement will continue to be funded by our collaborator at a level comparable to the level before the milestone achievement. If all of these criteria are not met, the milestone achievement is recognized over the remaining minimum period of our performance obligations under the agreement. Any advance payments we receive in excess of amounts earned are classified as deferred revenues until earned.

We manufacture drug products under a manufacturing services agreement for a single customer, Siegfried. Upon Siegfried’s acceptance of drug products manufactured by us, we recognize manufacturing services revenues at agreed upon prices for such drug products. We have also contracted with Siegfried for them to provide us with administrative and other services in exchange for a fee paid to Siegfried. We determined that we are receiving an identifiable benefit for these services from Siegfried, and are recording such fees in the operating expense section of our consolidated statement of operations.

Clinical trial expenses. We accrue clinical trial expenses based on work performed. In determining the amount to accrue, we rely on estimates of total costs incurred based on the enrollment of subjects, the completion of trials and other events. We follow this method because we believe reasonably dependable estimates of the costs applicable to various stages of a clinical trial can be made. However, the actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending on a number of factors. Differences between the actual clinical trial costs and the estimated clinical trial costs that we have accrued in any prior period are

 

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recorded in the subsequent period in which the actual costs become known. Historically, these differences have not been material; however, material differences could occur in the future.

Derivative liabilities. We account for our warrants and other derivative financial instruments as either equity or liabilities based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded as additional paid-in capital on our consolidated balance sheet and no further adjustments to their valuation are made. Some of our warrants were determined to be ineligible for equity classification because of provisions that may result in an adjustment to their exercise price. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on our consolidated balance sheet at their fair value on the date of issuance and will be revalued on each subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. We estimate the fair value of these liabilities using option pricing models that are based on the individual characteristics of the warrants or instruments on the valuation date, as well as assumptions for expected volatility, expected life and risk-free interest rate. Changes in the assumptions used could have a material impact on the resulting fair value.

Share-based compensation. We recognize compensation expense for all of our share-based awards based on the grant-date fair value. We determine the grant-date fair value of share-based awards by using the Black-Scholes option pricing model, which is affected by our stock price on the date of grant, as well as assumptions regarding other subjective variables. These assumptions include, but are not limited to, our expected stock price volatility over the term of the awards, the risk-free interest rate and the expected term of awards. Changes in the assumptions used could have a material impact on the compensation expense we recognize.

As compensation expense recognized is based on awards ultimately expected to vest, we reduce the expense recognized based on an estimated forfeiture rate at the time of grant. If actual forfeitures vary from estimates, we will recognize the difference in compensation expense in the period the actual forfeitures occur or when options vest.

Accounting for lease financing obligations. We account for our sale and leaseback transactions using the financing method because our options to repurchase these properties in the future are considered continued involvement requiring such method. Under the financing method, the book value of the properties and related accumulated depreciation remain on our balance sheet and no sale is recognized. Instead, the sales price of the properties is recorded as a financing obligation, and a portion of each lease payment is recorded as interest expense. We estimated the borrowing rate that we use to impute interest expense on our lease payments.

The above listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particular transaction is specifically dictated by GAAP. See our audited consolidated financial statements and notes thereto included in our 2009 Annual Report, which contain additional accounting policies and other disclosures required by GAAP.

New Accounting Guidance

In April 2010, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2010-17, “Revenue Recognition—Milestone Method,” which provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research or development transactions in which one or more payments are contingent upon achieving uncertain future events. Under this guidance, we may recognize revenue contingent upon the achievement of a milestone in its entirety in the period in which the milestone is achieved, provided that the milestone meets all the criteria within the guidance to be considered substantive. However, under this guidance, we can make an accounting policy election to apply another appropriate accounting policy that results in the deferral of some portion of the arrangement consideration. This guidance is effective prospectively for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted. If we elect to adopt this standard, we do not expect the adoption of ASU 2010-17 to have a material impact on our consolidated financial statements.

In October 2009, the FASB issued ASU No. 2009-13, “Multiple-Deliverable Revenue Arrangements,” which provides guidance on recognizing revenue in arrangements with multiple deliverables. ASU 2009-13 addresses how to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting, how such deliverables should be separated and how the consideration should be allocated to one or more units of accounting. ASU 2009-13 is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted. We do not expect the adoption of ASU 2009-13 to have a material impact on our consolidated financial statements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

There have been no material changes from the information we included in this section of our annual report on Form 10-K for the year ended December 31, 2009.

 

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Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures. Based on an evaluation carried out as of the end of the period covered by this quarterly report, under the supervision and with the participation of our management, including our President and Chief Executive Officer and Vice President, Finance and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, our President and Chief Executive Officer and Vice President, Finance and Chief Financial Officer have concluded that, as of the end of such period, our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934) were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting. During the third quarter of 2010, we completed the implementation of the financial and purchasing modules of an Enterprise Resource Planning, or ERP, system. As a result of this implementation, certain controls were modified to supplement and complement our existing internal control over financial reporting.

Except as described above, there was no change in our internal control over financial reporting that occurred during the quarter covered by this quarterly report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings.

Beginning September 20, 2010, a number of complaints were filed in the US District Court for the Southern District of California against us and certain of our current and former employees and directors on behalf of certain purchasers of our common stock. The complaints have been brought as purported stockholder class actions, and, in general, include allegations that we and certain of our current and former employees and directors violated federal securities laws by making materially false and misleading statements regarding our lorcaserin trials, thereby artificially inflating the price of our common stock. The plaintiffs are seeking unspecified monetary damages and other relief. We expect that all class action complaints filed to date will be transferred to a single court. We then expect the court to consolidate the actions, appoint a lead plaintiff and order the lead plaintiff to file a consolidated complaint. We intend to vigorously defend against the claims advanced, and intend to file a motion to dismiss the consolidated complaint.

On September 24, 2010, a stockholder derivative complaint was filed in the Superior Court of California for the County of San Diego against certain of our current and former employees and directors, and other stockholder derivative complaints were subsequently filed in state court. On October 19, 2010, the Superior Court ordered the pending state derivative complaints be consolidated. The Superior Court also ordered that later filed, related derivative complaints be consolidated as well. On October 6, 2010, a stockholder derivative suit was filed in the US District Court for the Southern District of California. Thereafter, a number of other stockholder derivative actions were filed in federal court. Plaintiffs in the first two federal stockholder derivative actions filed a motion to consolidate the two actions and appoint lead counsel. A hearing on the motion to consolidate has been scheduled for December 17, 2010. The state and federal stockholder derivative actions are hereinafter collectively referred to as the Derivative Actions. The complaints in the Derivative Actions allege breaches of fiduciary duties by the defendants and other violations of law. In general, the complaints allege that certain of our current and former employees and directors caused or allowed for the dissemination of materially false and misleading statements regarding our lorcaserin trials, thereby artificially inflating the price of our common stock. The plaintiffs are seeking unspecified monetary damages and other relief, including reforms and improvements to our corporate governance and internal procedures. We have not yet responded to the Derivative Actions, but intend to vigorously defend against the claims advanced and to seek dismissal of the Derivative Actions.

 

Item 1A. Risk Factors.

RISK FACTORS

Investment in our stock involves a high degree of risk. You should consider carefully the risks described below, together with other information in this quarterly report on Form 10-Q and our other public filings, before making investment decisions regarding our stock. If any of the following events actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.

The risk factors set forth below with an asterisk (*) before the title are new risk factors or risk factors containing substantive changes, including any material changes, from the risk factors previously disclosed in Item 1A to Part I of our annual report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission.

 

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Risks Relating to Our Business

*We will need additional funds to conduct our planned research, development and commercialization efforts, we may not be able to obtain such funds and we may never become profitable.

We have accumulated a large deficit since inception that has primarily resulted from the significant research and development expenditures we have made in seeking to identify and validate new drug targets and develop compounds that could become marketed drugs. We expect that our losses will continue to be substantial for at least the short term and that our operating expenses will also continue to be substantial, even if we are successful in advancing lorcaserin, including under our marketing and supply agreement with Eisai Inc., or Eisai, or our other compounds and drug candidates, independently or with another company.

We do not have any commercially available drugs, and may not have adequate funds to develop our compounds into marketed drugs. It takes many years and potentially hundreds of millions of dollars to successfully develop a preclinical or early clinical compound into a marketed drug, and our efforts may not result in any marketed drugs.

Our wholly owned subsidiary, Arena Pharmaceuticals GmbH, or Arena GmbH, has entered into a marketing and supply agreement with Eisai for the commercialization of our most advanced drug candidate, lorcaserin, in the United States and its territories and possessions following approval by the US Food and Drug Administration, or FDA, of our lorcaserin New Drug Application, or NDA. We will need additional funds or a collaborative or other agreement with a pharmaceutical company or companies to commercialize lorcaserin outside of the United States, and we may not be able to secure adequate funding or find a pharmaceutical company to commercialize lorcaserin outside the United States at all or on terms you or we believe are favorable. Even if we receive approval of our lorcaserin NDA and commence commercialization of lorcaserin under our marketing and supply agreement with Eisai, we cannot assure you that any additional payments we receive under such agreement will be sufficient to conduct our planned research and development and other activities or to result in profitability. We also believe that it may be difficult for us to obtain additional financing or enter into strategic relationships on terms that we or third parties, including investors, analysts, or potential collaborators, view as acceptable, if at all. We may need additional funding even if we enter into such a relationship. If adequate funding is not available, we may eliminate or postpone or scale back some or all of our research or development programs or delay the advancement of one or more of such programs. Any such reductions may adversely impact our lorcaserin development and commercialization timeline or narrow or slow the development of our pipeline, which we believe would reduce our opportunities for success and result in a decline in the market price of our common stock.

*The current global economic environment poses severe challenges to our business strategy, which relies on access to capital from the markets or collaborators, and creates other financial risks for us.

The global economy, including credit markets and the financial services industry, has been experiencing a period of substantial turmoil and uncertainty. These conditions have generally made equity and debt financing more difficult to obtain, and may negatively impact our ability to complete financing transactions. The duration and severity of these conditions is uncertain, as is the extent to which they may adversely affect our business and the business of current and prospective vendors or our distributors, licensees and collaborators, which we sometimes refer to generally as our collaborators. If the global economy does not improve or worsens, we may be unable to secure additional funding to sustain our operations or to find suitable collaborators to advance our internal programs, even if we achieve positive results from our research and development or business development efforts.

From time to time, we may maintain a portfolio of investments in marketable debt securities, which are recorded at fair value. Although we have established investment guidelines relative to diversification and maturity with the objectives of maintaining safety of principal and liquidity, we rely on credit rating agencies to help evaluate the riskiness of investments, and such agencies may not accurately predict such risk. In addition, such agencies may reduce the credit quality of our individual holdings, which could adversely affect their value. Lower credit quality and other market events, such as changes in interest rates and further deterioration in the credit markets, may have an adverse effect on the fair value of our investment holdings and cash position.

*We are focusing a significant portion of our activities and resources on lorcaserin and depend on its marketing approval and commercial success.

We are focusing a significant portion of our near-term activities and resources on lorcaserin, and we believe a significant portion of the value of our company relates to our ability to obtain marketing approval for and commercialize this drug candidate. The marketing approval and successful commercialization of lorcaserin is subject to many risks, including the risks discussed in other risk factors. If the results of clinical trials and preclinical studies of lorcaserin, our and regulatory authorities’ actions and decisions affecting lorcaserin, the anticipated or actual timing and plan for commercializing lorcaserin, or, ultimately, the market acceptance of lorcaserin do not meet our, your, analysts’ or others’ expectations, the market price of our common stock could decline significantly.

In September 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted nine to five that the available data do not demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long term in a population of overweight and obese individuals to allow marketing approval. In addition, in October 2010, the FDA issued a Complete Response Letter, or CRL, regarding our NDA for lorcaserin. In the CRL, the FDA stated that it has completed its review of the NDA and

 

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determined that it cannot approve the application in its present form. The FDA also outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues.

The non-clinical issues identified by the FDA included diagnostic uncertainty in the classification of mammary masses in female rats, unresolved exposure-response relationship for lorcaserin-emergent mammary adenocarcinoma, and unidentified mode of action and unclear safety margin for lorcaserin-emergent brain astrocytoma. The CRL included the following requests related to the non-clinical issues: provide a detailed accounting of all slides prepared from female rats that contributed to mammary tumor incidence data in each update to the FDA and to the final study report; in consultation with the FDA, identify an independent pathologist or group of pathologists to re-adjudicate all mammary and lung tissues (neoplastic and nonneoplastic lesions) from all female rats; demonstrate that the apparent increase in aggressiveness of adenocarcinoma in rats administered lorcaserin is reasonably irrelevant to human risk assessment; and provide additional data/information regarding the distribution of lorcaserin to the CNS in animals and human subjects that would clarify or provide a better estimate of astrocytoma exposure margins. With respect to the clinical reasons, the FDA stated in the CRL that the weight-loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes is marginal and recommended that we submit the final study report of our BLOOM-DM trial. The FDA also stated in the CRL that in the event evidence cannot be provided to alleviate concern regarding clinical relevance of the tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin’s benefit-to-risk profile. In addition, the FDA requested in the CRL that we include a safety update in our response that includes data from all non-clinical and clinical studies/trials of lorcaserin.

Our response to the CRL may require additional preclinical studies or clinical trials, may not be submitted in a timely manner or the data and other information provided or learned in connection with such response may not be satisfactory to the FDA. The FDA may request additional information or have additional recommendations prior to approval of our NDA for lorcaserin and lorcaserin may never receive marketing approval from the FDA or any other regulatory agency.

*Our ability to generate significant revenues, for at least the short term, depends upon the regulatory approval of lorcaserin, the commercialization of lorcaserin, activities and payments under the marketing and supply agreement with Eisai and our entry into new collaborations.

We expect that, for at least the short term, our ability to generate significant revenues will depend on the regulatory approval of lorcaserin, the success of Eisai in commercializing lorcaserin, if approved, in the United States, and our ability to enter into new collaborations. Future revenues under our marketing and supply agreement with Eisai will depend on the achievement of milestones under the agreement and Eisai’s commercialization of lorcaserin, and we may receive no additional revenues from Eisai if our NDA for lorcaserin is not approved by the FDA or further development of lorcaserin is unfavorable. In addition, we intend to commercialize lorcaserin outside of the United States with one or more pharmaceutical companies or independently. Lorcaserin may not be approved for sale outside of the United States, and, even if it is approved, we or our collaborators may not be successful in commercializing lorcaserin outside of the United States.

We cannot guarantee that any development, approval or sales milestones in our existing or future collaborations will be achieved in the future, or that we will receive any payments for the achievement of any milestones or product sales. In addition, our marketing and supply agreement with Eisai may be terminated early in certain circumstances, in which case we may not receive milestone or other payments under the agreement.

Moreover, our ability to enter into new collaborations may depend on the outcomes of our preclinical and clinical testing. We do not control these outcomes. In addition, even if our testing is successful, pharmaceutical companies may not enter into agreements with us on terms that we believe are acceptable until we have advanced our drug candidates into the clinic and, possibly, through later-stage clinical trials, approval or successful commercialization, if at all. With respect to lorcaserin, our ability to enter into additional collaborative agreements may also depend on the FDA’s approval of our NDA for lorcaserin as well as our interactions with, and decisions by, regulatory agencies outside of the United States.

*We are dependent on the marketing and supply agreement with Eisai to commercialize lorcaserin in the United States and, if applicable, to further develop lorcaserin, and the failure to maintain such agreement, or poor performance under such agreement, could negatively impact our business.

Pursuant to the terms of our marketing and supply agreement with Eisai, Arena GmbH granted Eisai exclusive rights to commercialize lorcaserin in the United States and its territories and possessions following approval by the FDA of our lorcaserin NDA.

Our ability to generate payments from Eisai substantially depends on the regulatory approval and market acceptance of lorcaserin in the United States. Eisai has primary responsibility for the marketing and sale of lorcaserin in the United States and responsibility for compliance with certain US regulatory requirements, and we have limited control over the amount and timing of resources that Eisai will dedicate to the commercialization of lorcaserin.

We are subject to a number of other risks associated with our dependence on our marketing and supply agreement, including:

 

   

Eisai may not comply with applicable regulatory guidelines with respect to commercializing lorcaserin, which could adversely impact sales or any development of lorcaserin;

 

   

there could be disagreements regarding the agreement that delay or terminate the commercialization or development of lorcaserin, delay or eliminate potential payments under the agreement or increase our costs under the agreement; or

 

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Eisai may not perform as expected, including with regard to making payments under the agreement, and such agreement may not provide adequate protection or may not be effectively enforced.

Eisai and we each have the right to terminate the agreement in certain circumstances. Eisai and we could also agree to amend the terms of the agreement, and we or others, including investors and analysts, may not view the amendments as favorable. If the agreement is terminated early, we may not be able to find another company for the commercialization of lorcaserin in the United States and further development of lorcaserin on acceptable terms, if at all, and even if we elected to pursue continued commercialization or further development of lorcaserin on our own, we might not have the funds, or otherwise be able, to do so successfully.

We may enter into additional agreements for the commercialization of lorcaserin or other of our drug candidates, and may be similarly dependent on the performance of third parties with similar risk.

*We and certain of our current and former employees and directors have been named as defendants in litigation that could result in substantial costs and divert management’s attention.

Beginning September 20, 2010, a number of complaints were filed in the US District Court for the Southern District of California against us and certain of our current and former employees and directors on behalf of certain purchasers of our common stock. The complaints have been brought as purported stockholder class actions, and in general include allegations that we and certain of our current and former employees and directors violated federal securities laws by making materially false and misleading statements regarding our lorcaserin trials, thereby artificially inflating the price of our common stock. The plaintiffs are seeking unspecified monetary damages and other relief. Several derivative lawsuits also have been filed in federal and state courts.

We intend to vigorously defend these lawsuits. There is, however, no guarantee that we will be successful. Also, our insurance coverage may be insufficient, our assets may be insufficient to cover any amounts that exceed our insurance coverage, and we may have to pay damage awards or otherwise may enter into settlement arrangements in connection with such claims. Any such payments or settlement arrangements could have material adverse effects on our business, operating results or financial condition. Even if the plaintiffs’ claims are not successful, this litigation could result in substantial costs and significantly and adversely impact our reputation and divert management’s attention and resources, which could have a material adverse effect on our business, operating results or financial condition. In addition, such lawsuits may make it more difficult to finance our operations.

*Our stock price could decline significantly based on the results and timing of clinical trials and preclinical studies of, and decisions affecting, our most advanced drug candidates.

The results and timing of clinical trials and preclinical studies can affect our stock price. Preclinical studies include experiments performed in test tubes, in animals, or in cells or tissues from humans or animals. These studies, which are sometimes referred to as non-clinical studies, include all drug studies except those conducted in human subjects, and may occur before or after initiation of clinical trials for a particular compound. Results of clinical trials and preclinical studies of lorcaserin or our other drug candidates may not be viewed favorably by us or third parties, including investors, analysts, current or potential collaborators, the academic and medical communities, and regulators. The same may be true of how we design the development programs of our most advanced drug candidates and regulatory decisions (including by us or regulatory authorities) affecting those development programs. Stock prices of companies in our industry have declined significantly when such results and decisions were unfavorable or perceived negatively or when a drug candidate did not otherwise meet expectations.

From time to time we have drug programs in clinical trials. In addition to successfully completing clinical trials, to conduct long-term clinical trials and gain regulatory approval to commercialize drug candidates, regulatory authorities require that all drug candidates complete short- and long-term preclinical toxicity and carcinogenicity studies. These preclinical, animal studies are required to help us and regulatory authorities assess the potential risk that drug candidates may be toxic or cause cancer in humans. The results of clinical trials and preclinical studies are uncertain and subject to different interpretations, and the design of these trials and studies (which may change significantly and be more expensive than anticipated depending on results and regulatory decisions) may also be viewed negatively by us, regulatory authorities or other third parties and adversely impact the development and opportunities for regulatory approval and commercialization of our drug candidates and those under collaborative agreements.

For example, we conducted long-term carcinogenicity preclinical studies of lorcaserin. The FDA identified in the CRL for lorcaserin issues related to such studies. We intend to provide in our response to the CRL data and other information to support our view related to such issues, but the FDA may disagree with our view or impose conditions that could delay or preclude approval of our lorcaserin NDA.

We may not be successful in advancing our programs on our projected timetable, if at all. Failure to initiate or delays in the development programs for any of our drug candidates, or unfavorable results or decisions or negative perceptions regarding any of such programs, could cause our stock price to decline significantly. This is particularly the case with respect to lorcaserin.

 

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We may report top-line data from time to time, which is based on a preliminary analysis of then available efficacy and safety data, and such findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.

*We have significant indebtedness and debt service obligations as a result of our Deerfield secured loan, which may adversely affect our cash flow, cash position and stock price.

In July 2009, we received under a facility agreement, or the Facility Agreement, a $100.0 million loan from Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited, Deerfield Special Situations Fund, L.P., and Deerfield Special Situations Fund International Limited, or collectively Deerfield, which substantially increased our total debt and debt service obligations. This loan matures on June 17, 2013, and the outstanding principal accrues interest at a rate of 7.75% per annum on the stated principal balance, payable quarterly in arrears. Our remaining required principal repayments are $20.0 million in July 2011 and $40 million at maturity. In August 2010, Deerfield and we amended the Facility Agreement such that the $20 million principal repayment required to be made in July 2011 will be deferred until June 17, 2013 if we receive FDA approval to market and sell lorcaserin before such July 2011 repayment date.

We may be required to make the scheduled repayments earlier in connection with certain equity issuances. For example, we were required to repay $10.0 million, which was initially required to be repaid in July 2010, in connection with the closing of our July 2009 public offering. In addition, we are required to make mandatory prepayments on the loan upon certain changes of control and in the event we issue equity securities (other than certain exempted issuances) at a price of less than $2.00 per share. The Facility Agreement also places certain restrictions on our business, including our ability to incur additional indebtedness and to undertake certain business transactions.

On or before June 17, 2011, Deerfield may elect to provide us with an additional loan in a principal amount of up to $20.0 million under similar terms as the $100.0 million loan, with the additional loan also maturing on June 17, 2013.

In the future, if we are unable to generate cash from operations sufficient to meet these debt obligations, we will need to obtain additional funds from other sources, which may include one or more financings. However, we may be unable to obtain sufficient additional funds when we need them on favorable terms or at all. The sale of equity or convertible debt securities in the future may be dilutive to our stockholders, and debt-financing arrangements may require us to enter into covenants that would further restrict certain business activities or our ability to incur additional indebtedness, and may contain other terms that are not favorable to our stockholders or us.

Also, if we are unable to generate cash from operations or obtain additional funds from other sources sufficient to meet these debt obligations, or we need to use existing cash to fund these debt obligations, we may have to delay or curtail some or all of our research, development and commercialization programs or sell or license some or all of our assets. Our indebtedness could have significant additional negative consequences, including, without limitation:

 

   

increasing our vulnerability to general adverse economic conditions;

 

   

limiting our ability to obtain additional funds; and

 

   

placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.

If an event of default occurs under our loan documents, including in certain circumstances under the warrants issued in connection with the loan transaction, the lenders may declare the outstanding principal balance and accrued but unpaid interest owed to them immediately due and payable, which would have a material adverse affect on our financial position. We may not have sufficient cash to satisfy this obligation. Also, if a default occurs under our secured loan, and we are unable to repay the lenders, the lenders could seek to enforce their rights under their security interests in our assets. If this were to happen, we may lose or be forced to sell some or all of our assets to satisfy our debt, which could cause our business to fail.

*If we do not commercialize lorcaserin outside of the United States with one or more pharmaceutical companies or raise additional funds, we may have to commercialize lorcaserin outside of the United States on our own and curtail certain of our activities.

We expect to commercialize lorcaserin outside of the United States, following regulatory approval, with one or more pharmaceutical companies or independently. We may not be able to enter into agreements to commercialize lorcaserin outside of the United States on acceptable terms, if at all. If we are unable to enter into such agreements, and we develop our own capabilities to commercialize lorcaserin outside of the United States, we may require additional capital to develop such capabilities and the marketing and sale of lorcaserin outside of the United States may be delayed or limited. Even if we were able to develop our own commercialization capabilities, we have not previously commercialized a drug, and our limited experience may make us less effective at marketing and

 

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selling lorcaserin than a pharmaceutical company. Our lack of corporate experience and adequate resources may impede our efforts to successfully commercialize lorcaserin.

We face competition in our search for pharmaceutical companies to commercialize lorcaserin outside of the United States. In addition, if our competitors are able to establish commercialization arrangements with companies who have substantially greater resources than we have (or, with respect to commercializing lorcaserin in the United States, Eisai has), our competitors may be more successful in marketing and selling their drugs, and our ability to successfully commercialize our drug candidates will be limited.

*Our drug candidates are subject to extensive regulation, and we may not receive required regulatory approvals, or timely approvals, for any of our drug candidates.

The preclinical, clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, marketing and distribution, and other possible activities relating to our drug candidates are, and any resulting drugs will be, subject to extensive regulation by the FDA and other regulatory agencies in the United States. Failure to comply with FDA and other applicable regulatory requirements may, either before or after product approval, if any, subject our company to administrative or judicially imposed sanctions.

Neither collaborators nor we are permitted to market a drug candidate in the United States until the particular drug candidate is approved for marketing by the FDA. Specific preclinical data, chemistry, manufacturing and controls data, a proposed clinical trial protocol and other information must be submitted to the FDA as part of an investigational new drug, or IND, application, and clinical trials may commence only after the IND application becomes effective. None of our drug candidates has received marketing approval. To market a new drug in the United States, we must submit to the FDA and obtain FDA approval of an NDA. An NDA must be supported by extensive clinical and preclinical data, as well as extensive information regarding chemistry, manufacturing and controls to demonstrate the safety and effectiveness of the drug candidate. Following its review of an NDA, the FDA may approve the NDA or issue a CRL.

Obtaining approval of an NDA can be a lengthy, expensive and uncertain process. As part of the Prescription Drug User Fee Act, or PDUFA, the FDA has a goal to review and act on a percentage of all submissions in a given time frame. The FDA’s review goals are subject to change, and it is unknown whether any particular FDA review will be completed within the FDA’s review goals or will be delayed. Moreover, the duration of the FDA’s review may depend on the number and types of other submissions with the FDA around the same time period. The review of such other submissions may impact the regulatory review of our submissions related to lorcaserin. Furthermore, any drug that acts on the central nervous system, or CNS, such as lorcaserin, has the potential to be scheduled as a controlled substance by the Drug Enforcement Administration of the US Department of Justice, or DEA. DEA scheduling is an independent process that can delay drug launch beyond an NDA approval date. The FDA stated in the CRL for lorcaserin that it would recommend placement of lorcaserin in Schedule IV of the Controlled Substance Act based on its review of the materials submitted in the NDA. The CRL provided the opportunity to complete additional preclinical studies that may lead to a different recommendation. If lorcaserin were to be scheduled in a more tightly controlled category, such scheduling could negatively impact the ability or willingness to prescribe or dispense lorcaserin, the likelihood that a patient will use it and other aspects of our ability to commercialize it.

Regulatory approval of an NDA or NDA supplement is not guaranteed. The number and types of preclinical studies and clinical trials that will be required for FDA approval varies depending on the drug candidate, the disease or condition that the drug candidate is designed to target and the regulations applicable to any particular drug candidate. Despite the time and expense exerted in preclinical and clinical studies, failure can occur at any stage, and we could encounter problems that cause us to abandon clinical trials or to repeat or perform additional preclinical studies and clinical trials. The FDA can delay, limit or deny approval of a drug candidate for many reasons, including:

 

   

a drug candidate may not be deemed adequately safe and effective;

 

   

FDA officials may not find the data from preclinical studies and clinical trials sufficient. For example, the FDA in the CRL for lorcaserin identified issues that indicate that the FDA may not find the data from preclinical studies and clinical trials for lorcaserin sufficient to approve our NDA for lorcaserin;

 

   

the FDA’s interpretation and our interpretation of data from preclinical studies and clinical trials may differ significantly. For example, the FDA in the CRL for lorcaserin identified issues that indicate that the FDA may disagree with our interpretation of certain preclinical studies;

 

   

our or our collaborators’ failure to comply with applicable FDA and other regulatory requirements, including those identified in other risk factors;

 

   

the FDA may not approve the manufacturing processes or facilities;

 

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the FDA may change its approval policies or adopt new regulations; or

 

   

the FDA may not accept an NDA or other submission due to, among other reasons, the content or formatting of the submission.

With respect to lorcaserin, the FDA draft guidance document “Developing Products for Weight Management” dated February 2007 provides two alternate benchmarks for the development of drugs for the indication of weight management. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of patients who lose at least 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant. While we believe the results of our pivotal Phase 3 clinical trials of lorcaserin satisfy the latter of the two alternate efficacy benchmarks, the FDA may disagree with our view, not follow its draft guidance or impose other approval conditions that could delay or preclude approval of our lorcaserin NDA. For example, the FDA stated in the CRL for lorcaserin that the weight loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes is marginal and recommended that we submit the final study report of our BLOOM-DM trial. The FDA also stated in the CRL that in the event evidence cannot be provided to alleviate the FDA’s concern regarding the clinical relevance of certain tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin’s benefit-to-risk profile.

With the exception of the NDA we submitted for lorcaserin in December 2009, we have not previously submitted NDAs to the FDA. We have also not previously submitted a response to a CRL. This lack of corporate experience may impede our ability to obtain FDA approval in a timely manner, if at all, for lorcaserin or our other drug candidates for which development and commercialization are our responsibility. Even if we believe that data collected from our preclinical studies and clinical trials of our drug candidates are promising and that our information and procedures regarding chemistry, manufacturing and controls are sufficient, our data may not be sufficient to support approval by the FDA or any other US or foreign regulatory authority, or regulatory interpretation of these data and procedures may be unfavorable. In addition, we believe that the regulatory review of NDAs for drug candidates intended for widespread use by a large proportion of the general population is becoming increasingly focused on safety. In this regard, it is possible that some of our drug candidates, including lorcaserin, will be subject to increased scrutiny to show adequate safety than would drug candidates for more acute or life-threatening diseases such as cancer. Even if approved, drug candidates may not be approved for all indications requested and such approval may be subject to limitations on the indicated uses for which the drug may be marketed, restricted distribution methods or other limitations, such as those required by a Risk Evaluation and Mitigation Strategies, or REMS. Our business and reputation may be harmed by any failure or significant delay in receiving regulatory approval for the sale of any drugs resulting from our drug candidates. As a result, we cannot predict when or whether regulatory approval will be obtained for any drug we develop.

To market any drugs outside of the United States, we and current or future collaborators must comply with numerous and varying regulatory requirements of other countries. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks associated with FDA approval as well as additional risks, some of which may be unanticipated. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such approval could have the same adverse effects associated with regulatory approval in the United States, including the risk that our drug candidates may not be approved for all indications requested and that such approval may be subject to limitations on the indicated uses for which the drug may be marketed.

*Even if any of our drug candidates receives regulatory approval, our drug candidates will still be subject to extensive post-marketing regulation.

If we or collaborators receive regulatory approval for our drug candidates in the United States or other jurisdictions, we and our collaborators will also be subject to ongoing obligations and continued regulatory review from the FDA and other applicable regulatory agencies, such as continued adverse event reporting requirements. There may also be additional FDA post-marketing obligations, all of which may result in significant expense and limit the ability to commercialize such drugs in the United States or other jurisdictions.

If any of our drug candidates receive US regulatory approval or approval in other jurisdictions, the FDA or other regulatory agencies may also require that the sponsor of the NDA conduct additional clinical trials to further assess the drug after NDA approval under a post-approval commitment. Such additional studies may be costly and may impact the commercialization of the drug. The FDA or other regulatory agencies may also impose significant restrictions on the indicated uses for which such drug may be marketed.

If the FDA or other regulatory agencies approve any of our drug candidates, the labeling, packaging, adverse event reporting, storage, advertising and promotion for the drug will be subject to extensive regulatory requirements. We and the manufacturers of our products

 

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are also required to comply with Current Good Manufacturing Practices, or CGMPs, regulations, which include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation. Further, regulatory agencies must approve these manufacturing facilities before they can be used to manufacture our products, and these facilities are subject to ongoing regulatory inspections. In addition, regulatory agencies subject a drug, its manufacturer and the manufacturer’s facilities to continual review and inspections. The subsequent discovery of previously unknown problems with a drug, including adverse events of unanticipated severity or frequency, or problems with the facility where the drug is manufactured, may result in restrictions on the marketing of that drug, up to and including withdrawal of the drug from the market. In the United States, the DEA and comparable state-level agencies also heavily regulate the manufacturing, holding, processing, security, recordkeeping and distribution of drugs that are considered controlled substances. If any of our drug candidates are scheduled by the DEA as controlled substances (due to abuse potential), we will become subject to the DEA’s regulations. The FDA stated in the CRL for lorcaserin that it would recommend placement of lorcaserin in Schedule IV of the Controlled Substance Act based on its review of the materials submitted in the NDA. The CRL provided the opportunity to complete additional preclinical studies that may lead to a different recommendation. The DEA periodically inspects facilities for compliance with its rules and regulations. If our manufacturing facilities or those of our suppliers fail to comply with applicable regulatory requirements, it could result in regulatory action and additional costs to us. Failure to comply with applicable FDA and other regulatory requirements may, either before or after product approval, if any, subject our company to administrative or judicially imposed sanctions, including:

 

   

issuance of Form 483 notices or Warning Letters by the FDA or other regulatory agencies;

 

   

imposition of fines and other civil penalties;

 

   

criminal prosecutions;

 

   

injunctions, suspensions or revocations of regulatory approvals;

 

   

suspension of any ongoing clinical trials;

 

   

total or partial suspension of manufacturing;

 

   

delays in commercialization;

 

   

refusal by the FDA to approve pending applications or supplements to approved applications filed by us or collaborators;

 

   

refusals to permit drugs to be imported into or exported from the United States;

 

   

restrictions on operations, including costly new manufacturing requirements; and

 

   

product recalls or seizures.

The FDA’s and other regulatory agencies’ policies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of our drug candidates or further restrict or regulate post-approval activities. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we or our collaborators might not be permitted to market our drugs and our business could suffer.

*Even if we receive regulatory approval to commercialize our drug candidates, our ability to generate revenues from any resulting products will be subject to a variety of risks, many of which are out of our control.

Even if our drug candidates obtain regulatory approval, resulting products may not gain market acceptance among physicians, patients, healthcare payers or the medical community. We believe that the degree of market acceptance and our ability to generate revenues from such products will depend on a number of factors, including:

 

   

timing of market introduction of our drugs and competitive drugs;

 

   

actual and perceived efficacy and safety of our drug candidates;

 

   

prevalence and severity of any side effects;

 

   

potential or perceived advantages or disadvantages over alternative treatments;

 

   

strength of sales, marketing and distribution support;

 

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price of our future products, both in absolute terms and relative to alternative treatments;

 

   

the effect of current and future healthcare laws on our drug candidates;

 

   

availability of coverage and reimbursement from government and other third-party payers; and

 

   

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

If our approved drugs, if any, fail to achieve market acceptance, we may not be able to generate significant revenue to achieve or sustain profitability.

In addition, if lorcaserin is approved for marketing, regulatory authorities may determine that lorcaserin will be a scheduled drug if it is found to have abuse potential or for other reasons. Based on our interpretation of a formal abuse potential clinical trial we conducted, lorcaserin’s clinical safety profile and certain other factors, we believe that lorcaserin has a limited abuse potential. The FDA stated in the CRL for lorcaserin that it would recommend placement of lorcaserin in Schedule IV of the Controlled Substance Act based on its review of the materials submitted in the NDA. The CRL provided the opportunity to complete additional preclinical studies that may lead to a different recommendation. If lorcaserin were to be scheduled in a more tightly controlled category, such scheduling could negatively impact the ability to prescribe lorcaserin, a patient’s willingness to use it and other aspects of our ability to commercialize it.

*Our development and commercialization of lorcaserin may be adversely impacted by cardiovascular side effects previously associated with fenfluramine and dexfenfluramine.

We developed lorcaserin to more selectively stimulate the serotonin 2C receptor because we believe this may avoid the cardiovascular side effects associated with fenfluramine and dexfenfluramine (often used in combination with phentermine, the combination of which was commonly referred to as “fen-phen”). These two drugs were serotonin-releasing agents and non-selective serotonin receptor agonists, and were withdrawn from the market in 1997 after reported incidences of heart valve disease and pulmonary hypertension associated with their usage. We may not be correct in our belief that more selectively stimulating the serotonin 2C receptor will avoid these undesired side effects or lorcaserin’s selectivity profile may not be adequate to avoid these side effects. Moreover, the potential relationship between the activity of lorcaserin and the activity of fenfluramine and dexfenfluramine may result in increased FDA regulatory scrutiny of the safety of lorcaserin and may raise potential adverse publicity in the marketplace, which could affect clinical enrollment or sales if lorcaserin is approved for commercialization. We have completed two large pivotal Phase 3 lorcaserin trials of one and two years’ duration, which we believe showed no apparent effects on heart valves or pulmonary artery pressures. We plan to submit to the FDA the results of our one-year BLOOM-DM trial of lorcaserin, which include additional data relating to heart valves and pulmonary artery pressures. We cannot guarantee that the FDA will agree with our view of the data relating to heart valves and pulmonary artery pressures. The FDA may request additional data or other information or analysis, or decline to approve our NDA for lorcaserin.

*The development programs for our drug candidates are expensive, time consuming, uncertain and susceptible to change, interruption, delay or termination.

Drug development programs are very expensive, time consuming and difficult to design and implement. Our drug candidates are in various stages of research and development and are prone to the risks of failure inherent in drug development. Clinical trials and preclinical studies are needed to demonstrate that drug candidates are safe and effective to the satisfaction of the FDA and similar non-US regulatory authorities. These trials are expensive and uncertain processes that take years to complete. Failure can occur at any stage of the process, and successful early clinical or preclinical trials do not ensure that later trials or studies will be successful. In addition, the commencement or completion of our planned clinical trials could be substantially delayed or prevented by several factors, including:

 

   

limited number of, and competition for, suitable patients required for enrollment in our clinical trials;

 

   

limited number of, and competition for, suitable sites to conduct our clinical trials;

 

   

delay or failure to obtain FDA approval or agreement to commence a clinical trial;

 

   

delay or failure to obtain sufficient supplies of our drug candidates for our clinical trials;

 

   

delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or investigators; and

 

   

delay or failure to obtain institutional review board, or IRB, approval to conduct a clinical trial at a prospective site.

 

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Even if the results of our development programs are favorable, the development programs of our most advanced drug candidates, including those being developed by current or future collaborators, may take significantly longer than expected to complete. In addition, the FDA, other regulatory authorities, collaborators, or we may suspend, delay or terminate our development programs at any time for various reasons, including:

 

   

lack of effectiveness of any drug candidate during clinical trials;

 

   

side effects experienced by study participants or other safety issues;

 

   

slower than expected rates of patient recruitment and enrollment or lower than expected patient retention rates;

 

   

delays or inability to manufacture or obtain sufficient quantities of materials for use in clinical trials;

 

   

inadequacy of or changes in our manufacturing process or compound formulation;

 

   

delays in obtaining regulatory approvals to commence a study, or “clinical holds,” or delays requiring suspension or termination of a study by a regulatory authority, such as the FDA, after a study is commenced;

 

   

changes in applicable regulatory policies and regulations;

 

   

delays in identifying and reaching agreement on acceptable terms with prospective clinical trial sites;

 

   

uncertainty regarding proper dosing;

 

   

unfavorable results from ongoing clinical trials and preclinical studies;

 

   

failure of our clinical research organizations to comply with all regulatory and contractual requirements or otherwise perform their services in a timely or acceptable manner;

 

   

scheduling conflicts with participating clinicians and clinical institutions;

 

   

failure to design appropriate clinical trial protocols;

 

   

insufficient data to support regulatory approval;

 

   

termination of clinical trials by one or more clinical trial sites;

 

   

inability or unwillingness of medical investigators to follow our clinical protocols;

 

   

difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data;

 

   

lack of sufficient funding to continue clinical trials and preclinical studies; or

 

   

changes in business priorities or perceptions of the value of the program.

There is typically a high rate of attrition from the failure of drug candidates proceeding through clinical trials, and many companies have experienced significant setbacks in advanced development programs even after promising results in earlier studies or trials. We have experienced setbacks in our internal and partnered development programs and may experience additional setbacks in the future. If we or our collaborators abandon or are delayed in our development efforts related to lorcaserin or any other drug candidate, we may not be able to generate sufficient revenues to continue our operations at the current level or become profitable, our reputation in the industry and in the investment community would likely be significantly damaged, additional funding may not be available to us or may not be available on terms you or we believe are favorable, and our stock price would likely decrease significantly.

*The results of preclinical studies and completed clinical trials are not necessarily predictive of future results, and our current drug candidates may not have favorable results in later studies or trials.

Preclinical studies and Phase 1 and Phase 2 clinical trials are not primarily designed to test the efficacy of a drug candidate, but rather to test safety, to study pharmacokinetics and pharmacodynamics, and to understand the drug candidate’s side effects at various doses and schedules. Favorable results in our early studies or trials may not be repeated in later studies or trials, including continuing preclinical studies and large-scale clinical trials, and our drug candidates in later-stage trials may fail to show desired safety and efficacy despite having progressed through earlier-stage trials. Unfavorable results from ongoing preclinical studies or clinical trials

 

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could result in delays, modifications or abandonment of ongoing or future clinical trials, or abandonment of a clinical program. Preclinical and clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or commercialization. For example, the FDA in the CRL for lorcaserin identified issues that indicate that the FDA may disagree with our interpretation of certain preclinical studies. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated or terminated, or a clinical program to be abandoned.

Many of our research and development programs are in early stages of development, and may not result in the commencement of clinical trials.

Many of our research and development programs are in the discovery or preclinical stage of development. The process of discovering compounds with therapeutic potential is expensive, time consuming and unpredictable. Similarly, the process of conducting preclinical studies of compounds that we discover requires the commitment of a substantial amount of our technical and financial resources and personnel. We may not discover additional compounds with therapeutic potential, and any of our preclinical compounds may not result in the commencement of clinical trials. We cannot be certain that results sufficiently favorable to justify commencement of Phase 1 clinical trials will be obtained in these preclinical investigations. Even if such favorable preclinical results are obtained, our financial resources may not allow us to commence Phase 1 clinical trials. If we are unable to identify and develop new drug candidates, we may not be able to maintain a clinical development pipeline or generate revenues.

We may participate in new strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.

From time to time we consider strategic transactions, such as out-licensing or in-licensing of compounds or technologies, acquisitions of companies and asset purchases. Additional potential transactions we may consider include a variety of different business arrangements, including strategic collaborations, joint ventures, spin-offs, restructurings, divestitures, business combinations and investments. In addition, another entity may pursue us as an acquisition target. Any such transactions may require us to incur non-recurring or other charges, may increase our near- and long-term expenditures and may pose significant integration challenges, require additional expertise or disrupt our management or business, which could harm our operations and financial results.

As part of an effort to enter into significant transactions, we conduct business, legal and financial due diligence with the goal of identifying and evaluating material risks involved in the transaction. Despite our efforts, we ultimately may be unsuccessful in ascertaining or evaluating all such risks and, as a result, might not realize the intended advantages of the transaction. If we fail to realize the expected benefits from any transaction we may consummate, whether as a result of unidentified risks, integration difficulties, regulatory setbacks or other events, our business, results of operations and financial condition could be adversely affected.

Drug discovery and development is intensely competitive in the therapeutic areas on which we focus. If our competitors develop treatments that are approved faster, marketed better, less expensive or demonstrated to be more effective or safer than our drug candidates, our commercial opportunities will be reduced or eliminated.

Many of the drugs our collaborators or we are attempting to discover and develop would compete with existing therapies. In addition, many companies are pursuing the development of new drugs that target the same diseases and conditions that we target. Many of our competitors, particularly large pharmaceutical companies, have substantially greater research, development and marketing capabilities and greater financial, scientific and human resources than we do. Companies that complete clinical trials, obtain required regulatory agency approvals and commence commercial sale of their drugs before we do for the same indication may achieve a significant competitive advantage, including certain patent and FDA marketing exclusivity rights. In addition, our competitors may develop drugs with fewer side effects, more desirable characteristics (such as route of administration or frequency of dosing) or better efficacy than our drug candidates or drugs, if any, for the same indication. Our competitors may also market generic or other drugs that compete with our drugs at a lower price than our drugs, which may negatively impact our drug sales, if any. Any results from our research and development efforts, or from our joint efforts with our existing or any future collaborators, may not compete successfully with existing or newly discovered products or therapies.

*Collaborative relationships may lead to disputes and delays in drug development and commercialization, and we may not realize the full commercial potential of our drug candidates.

We have had conflicts with collaborators and may in the future have conflicts with our prospective, current or past collaborators, such as conflicts concerning the interpretation of preclinical or clinical data, the achievement of milestone or other payments, the ownership of intellectual property, or research and development or commercialization strategy. Collaborators may stop supporting our drug candidates or drugs if they develop or obtain rights to competing drug candidates or drugs. In addition, collaborators may fail to effectively develop or commercialize our drug candidates, which may result in us not realizing the full commercial potential of our drug candidates. If any conflicts arise with Eisai or any other prospective, current or past collaborator, such collaborator may act in a manner that is adverse to our interests. Any such disagreement could result in one or more of the following, each of which could delay, or lead to termination of, development or commercialization of our drug candidates, and in turn prevent us from generating revenues:

 

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unwillingness on the part of a collaborator to pay us research funding, milestone payments, royalties or other payments that we believe are due to us under a collaboration;

 

   

uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

 

   

unwillingness on the part of a collaborator to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;

 

   

slowing or cessation of a collaborator’s research, development or commercialization efforts with respect to our drug candidates; or

 

   

litigation or arbitration.

*Setbacks and consolidation in the pharmaceutical and biotechnology industries and inadequate third-party coverage and reimbursement could make entering into agreements with pharmaceutical companies to collaborate or commercialize our drugs more difficult and diminish our revenues.

Setbacks in the pharmaceutical and biotechnology industries, such as those caused by safety concerns relating to drugs like Meridia, Avandia, Vioxx and Celebrex, or drug candidates, as well as competition from generic drugs, litigation, and industry consolidation, may have an adverse effect on us. For example, the FDA may be more cautious in approving our drug candidates based on safety concerns relating to these or other drugs or drug candidates, or pharmaceutical companies may be less willing to enter into new collaborations or continue existing collaborations if they are integrating a new operation as a result of a merger or acquisition or if their therapeutic areas of focus change following a merger.

Moreover, our and our collaborators’ ability to commercialize any of our drugs that may be approved will depend in part on government regulation and the availability of coverage and adequate reimbursement from third-party payers, including private health insurers and government payers, such as the Medicaid and Medicare programs, increases in government-run, single-payer health insurance plans and compulsory licenses of drugs. Government and third-party payers are increasingly attempting to contain healthcare costs by limiting coverage and reimbursement levels for new drugs. In addition, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Act, or collectively, PPACA, was passed, which will significantly affect the pharmaceutical industry. In addition to extending coverage to patients otherwise uninsured, PPACA includes, among several other provisions relating to pharmaceuticals, measures that impose a new nondeductible fee on certain branded drugs based on market share in government health care programs, increases in rebates for government programs such as Medicaid, and the creation of a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. Many of the details regarding the implementation of PPACA are yet to be determined, and we cannot predict with certainty whether or to what extent such implementation or adoption of reforms may impair our business. Given the continuing discussion regarding the cost of healthcare, managed care, universal healthcare coverage and other healthcare issues, we also cannot predict with certainty what additional healthcare initiatives, if any, will be implemented or the effect any future legislation or regulation will have on our business. PPACA and any additional legislation or regulations may limit our commercial opportunities by reducing the amount a potential collaborator is willing to pay to license our programs or drug candidates in the future due to a reduction in the potential revenues from drug sales. Moreover, legislation and regulations affecting the pricing of pharmaceuticals may change before regulatory agencies approve our drug candidates for marketing. Adoption of such legislation and regulations could further limit pricing approvals for, and reimbursement of, drugs. A government or third-party payer decision not to approve pricing for, or provide adequate coverage and reimbursements of, our drugs, if any, could limit market acceptance of such drugs.

*We rely on other companies, including third-party manufacturers, and we or such other companies may encounter failures or difficulties that could delay the clinical development or regulatory approval of our drug candidates, or their ultimate commercial production if approved.

We and third parties manufacture our drug candidates. We do not have manufacturing facilities that can produce sufficient quantities of active pharmaceutical ingredient, or API, and finished drug product for large-scale clinical trials. Accordingly, we must either develop such facilities, which will require substantial additional funds, or rely, at least to some extent, on third-party manufacturers for the production of drug candidates. Furthermore, should we obtain FDA approval for any of our drug candidates, we expect to rely, at least to some extent, on third-party manufacturers for commercial production. Our dependence on others for the manufacture of our drug candidates may adversely affect our ability to develop and deliver such drug candidates on a timely and competitive basis.

Any performance failure on the part of us or a third-party manufacturer could delay clinical development, regulatory approval or, ultimately, sales of our drug candidates. We or third-party manufacturers may encounter difficulties involving production yields, regulatory compliance, lot release, quality control and quality assurance, as well as shortages of qualified personnel. Approval of our drug candidates could be delayed, limited or denied if the FDA does not approve our or a third-party manufacturer’s processes or

 

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facilities. Moreover, the ability to adequately and timely manufacture and supply drug candidates is dependent on the uninterrupted and efficient operation of the manufacturing facilities, which is impacted by many manufacturing variables including:

 

   

availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier;

 

   

capacity of our facilities or those of our contract manufacturers;

 

   

facility contamination by microorganisms or viruses or cross contamination;

 

   

compliance with regulatory requirements, including Form 483 notices and Warning Letters;

 

   

changes in forecasts of future demand;

 

   

timing and actual number of production runs;

 

   

production success rates and bulk drug yields; and

 

   

timing and outcome of product quality testing.

In addition, we or our third-party manufacturers may encounter delays and problems in manufacturing our drug candidates or drugs for a variety of reasons, including accidents during operation, failure of equipment, delays in receiving materials, natural or other disasters, political or governmental changes, or other factors inherent in operating complex manufacturing facilities. Supply chain management is complex, and involves sourcing from a number of different companies and foreign countries. Commercially available starting materials, reagents and excipients may become scarce or more expensive to procure, and we may not be able to obtain favorable terms in agreements with subcontractors. We or our third-party manufacturers may not be able to operate our respective manufacturing facilities in a cost-effective manner or in a time frame that is consistent with our expected future manufacturing needs. If we or our third-party manufacturers cease or interrupt production or if our third-party manufacturers and other service providers fail to supply materials, products or services to us for any reason, such interruption could delay progress on our programs, or interrupt the commercial supply, with the potential for additional costs and lost revenues. If this were to occur, we may also need to seek alternative means to fulfill our manufacturing needs.

We may not be able to enter into agreements for the manufacture of our drug candidates with manufacturers whose facilities and procedures comply with applicable law. Manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the DEA and corresponding state and foreign authorities to ensure strict compliance with CGMP and other applicable government regulations and corresponding foreign standards. We do not have control over a third-party manufacturer’s compliance with these regulations and standards. In addition, Arena GmbH has contracted with Siegfried Ltd, or Siegfried, to provide safety, health and environmental services and assess compliance, train personnel and oversee Arena GmbH’s compliance with the applicable safety, health and environmental regulations. We are, therefore, relying at least in part on Siegfried’s judgment, experience and expertise. If we or one of our manufacturers fail to maintain compliance, we or they could be subject to civil or criminal penalties, the production of our drug candidates could be interrupted or suspended, or our product could be recalled or withdrawn, resulting in delays, additional costs and potentially lost revenues.

We rely on third parties to conduct our clinical trials and many of our preclinical studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, our drug candidates may not advance in a timely manner or at all.

In the course of our discovery, preclinical testing and clinical trials, we rely on third parties, including laboratories, investigators, clinical research organizations and manufacturers, to perform critical services for us. For example, we rely on third parties to conduct our clinical trials and many of our preclinical studies. Clinical research organizations are responsible for many aspects of the trials, including finding and enrolling subjects for testing and administering the trials. Although we rely on these third parties to conduct our clinical trials, we are responsible for ensuring that each of our clinical trials is conducted in accordance with its investigational plan and protocol. Moreover, the FDA and foreign regulatory authorities require us to comply with regulations and standards, commonly referred to as good clinical practices, or GCPs, for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials. Our reliance on third parties does not relieve us of these responsibilities and requirements. These third parties may not be available when we need them or, if they are available, may not comply with all regulatory and contractual requirements or may not otherwise perform their services in a timely or acceptable manner, and we may need to enter into new arrangements with alternative third parties and our clinical trials may be extended, delayed or terminated. These independent third parties may also have relationships with other commercial entities, some of which may compete with us. In addition, if such third parties fail to perform their obligations in compliance with our clinical trial protocols or GCPs, our clinical trials may not

 

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meet regulatory requirements or may need to be repeated. As a result of our dependence on third parties, we may face delays or failures outside of our direct control. These risks also apply to the development activities of collaborators, and we do not control their research and development, clinical trial or regulatory activities.

*Our efforts will be seriously jeopardized if we are unable to retain and attract key and other employees.

Our success depends on the continued contributions of our principal management, development and scientific personnel, and the ability to hire and retain key and other personnel, particularly in the area of clinical development. We face competition for such personnel, and we believe that recent developments, including our receipt of the CRL for lorcaserin, pending and possible future litigation involving us and our relatively low stock price, may impact our ability to hire and retain key and other personnel. The loss of services of any principal member of our management or scientific staff or other personnel, particularly Jack Lief, our Chairman, President and Chief Executive Officer, and Dominic P. Behan, Ph.D., our Senior Vice President and Chief Scientific Officer, could adversely impact our operations and ability to raise additional capital. To our knowledge, neither Mr. Lief nor Dr. Behan plans to leave, retire or otherwise disassociate with us in the near future.

*We may incur substantial liabilities for any product liability claims or otherwise as a drug product manufacturer.

We develop, test and manufacture drugs that are used by humans. We face an inherent risk of product liability exposure related to the testing of our drug candidates in clinical trials, and will face an even greater risk if we sell our own drugs commercially. In addition, under our marketing and supply agreement with Eisai, Arena GmbH has agreed to indemnify Eisai for certain losses resulting from product liability claims, except to the extent caused by Eisai’s negligence, willful misconduct, or violation of law or Eisai’s breach of such agreement.

Whether or not we are ultimately successful in any product liability or related litigation, such litigation would consume substantial amounts of our financial and managerial resources, and might result in adverse publicity, all of which would impair our business. In addition, damages awarded in a product liability action could be substantial and could have a negative impact on our financial condition.

An individual may bring a liability claim against us if one of our drug candidates or drugs causes, or merely appears to have caused, an injury. Regardless of merit or eventual outcome, liability claims may result in:

 

   

decreased demand for our drug;

 

   

injury to our reputation;

 

   

withdrawal of clinical trial subjects;

 

   

costs of related litigation;

 

   

substantial monetary awards to subjects or other claimants;

 

   

loss of revenues; and

 

   

the inability to commercialize our drug candidates.

We have limited product liability insurance that covers our clinical trials. We intend to expand our insurance coverage to include the sale of drugs if marketing approval is obtained for any of our drug candidates. However, insurance coverage is increasingly expensive. We may not be able to obtain or maintain insurance coverage at a reasonable cost, and we may not have insurance coverage that will be adequate to satisfy any liability that may arise, which could have an adverse effect on our capital sources and financial condition.

Arena GmbH manufactures drug products for Siegfried and will manufacture lorcaserin for Eisai if lorcaserin is approved. In addition to product liability, Arena GmbH is subject to liability for non-performance, product recalls and breaches of the agreements with Siegfried and Eisai.

*We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

If we obtain FDA approval for any of our drug candidates to commercialize those drugs in the United States, our operations may be directly or indirectly subject to various state and federal fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and federal False Claims Act. These laws may impact, among other things, the sales, marketing and education programs for our drugs.

 

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The federal Anti-Kickback Statute prohibits persons from knowingly and willingly soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated. The Anti-Kickback Statute is broad and, despite a series of narrow safe harbors, prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. Penalties for violations of the federal Anti-Kickback Statute include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs.

The federal False Claims Act prohibits persons from knowingly filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. The frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of pharmaceutical, medical device and other healthcare companies to have to defend a False Claims Act action. When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Various states have also enacted laws modeled after the federal False Claims Act.

We are unable to predict whether we could be subject to actions under any of these or other fraud and abuse laws, or the impact of such actions. If we are found to be in violation of any of the laws described above and other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from government healthcare reimbursement programs and the curtailment or restructuring of our operations, all of which could have a material adverse effect on our business and results of operations.

*We may not be able to effectively integrate or manage our international operations and such difficulty could adversely affect our stock price, business operations, financial condition and results of operations.

The headquarters of our operations outside of the United States is in Switzerland. Activities conducted at this location include manufacturing, quality control, quality assurance, development of manufacturing processes, qualifying suppliers and otherwise managing the global supply chain, regulatory strategy and compliance, distribution of finished products, and European strategic planning and development. There are significant risks associated with foreign operations, including, but not limited to, compliance with local laws and regulations, the protection of our intellectual property, the ability to integrate our corporate culture with local customs and cultures, the distraction to our management, foreign currency exchange rates and the impact of shifts in the US and local economies on those rates, and integration of our policies and procedures, including disclosure controls and procedures and internal control over financial reporting, with our international operations.

We use biological materials, hazardous materials, chemicals and radioactive compounds.

Our research and development and manufacturing activities involve the use of potentially harmful biological materials as well as materials, chemicals and various radioactive compounds that could be hazardous to human health and safety or the environment. These materials and various wastes resulting from their use are stored at our facility pending ultimate use and disposal. We cannot completely eliminate the risk of contamination, which could cause:

 

   

interruption of our research and development or manufacturing efforts;

 

   

injury to our employees and others;

 

   

environmental damage resulting in costly clean up; and

 

   

liabilities under domestic or foreign federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products.

In such an event, we may be held liable for any resulting damages, and any such liability could exceed our resources. Although we carry insurance in amounts and type that we consider commercially reasonable, we cannot be certain that the coverage or coverage limits of our insurance policies will be adequate and we do not have insurance coverage for losses relating to an interruption of our research and development efforts caused by contamination.

 

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Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.

Our US operations, including laboratories, offices and a chemical development facility, are located in the same business park in San Diego. We also have a drug product facility in Zofingen, Switzerland, and we expect that at least for the foreseeable future that this facility will be the sole location for the manufacturing of lorcaserin finished drug product. We depend on our facilities and on collaborators, contractors and vendors for the continued operation of our business, some of whom are located in Europe and Asia. Natural disasters or other catastrophic events, including interruptions in the supply of natural resources, political and governmental changes, severe weather conditions, wildfires and other fires, explosions, actions of animal rights activists, terrorist attacks, earthquakes and wars could disrupt our operations or those of our collaborators, contractors and vendors. Even though we believe we carry commercially reasonable business interruption and liability insurance, and our contractors may carry liability insurance that protect us in certain events, we might suffer losses as a result of business interruptions that exceed the coverage available under our and our contractors’ insurance policies or for which we or our contractors do not have coverage. For example, we are not insured against a terrorist attack. Any natural disaster or catastrophic event could have a significant negative impact on our operations and financial results. Moreover, any such event could delay our research and development programs and adversely affect, which may include stopping, our commercial production.

Our executive officers and directors may sell shares of their stock, and these sales could adversely affect our stock price.

Sales of our stock by our executive officers and directors, or the perception that such sales may occur, could adversely affect the market price of our stock. Our executive officers and directors may sell stock in the future, either as part, or outside, of trading plans under Securities and Exchange Commission, or SEC, Rule 10b5-1.

Currency fluctuations may negatively affect our financial condition.

We primarily spend and generate cash in US dollars, and present our consolidated financial statements in US dollars. However, a portion of our expected and potential payments and receipts under our agreements are in foreign currencies, including Swiss francs. For example, payments and receipts under our asset purchase agreement, manufacturing services agreement and long-term API manufacturing agreement with Siegfried are required to be paid in Swiss francs. A fluctuation of the exchange rates of foreign currencies versus the US dollar may, thus, adversely affect our financial results, including cash balances, expenses and revenues. We may enter into hedging transactions to try to reduce our foreign currency exposure in the future, but there is no assurance that such transactions will occur or be successful.

Laws, rules and regulations relating to public companies may be costly and impact our ability to attract and retain directors and executive officers.

Laws and regulations affecting public companies, including rules adopted by the SEC and by the NASDAQ Global Market, as well as the laws and regulations of foreign governments, may result in increased costs to us, particularly as we continue to develop the required capabilities in the United States and abroad to commercialize our products. These laws, rules and regulations could make it more difficult or costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on our board committees or as executive officers. We cannot estimate accurately the amount or timing of additional costs we may incur to respond to these laws, rules and regulations.

Risks Relating to Our Intellectual Property

*Our success is dependent on intellectual property rights held by us and third parties and our interest in these rights is complex and uncertain.

Our success will depend on our own and on current or future collaborators’ abilities to obtain, secure and defend patents. In particular, the patents directed to our most advanced drug candidates and other compounds discovered using our technologies or that are otherwise part of our collaborations are important to commercializing drugs. We have numerous US and foreign patent applications pending for our technologies. There is no assurance that any of our patent applications will issue, or that any of the patents will be enforceable or will cover a drug or other commercially significant technology or method, or that the patents will be held to be valid for their expected terms.

The procedures for obtaining a patent in the United States and in most foreign countries are complex. These procedures require an analysis of the scientific technology related to the invention and many sophisticated legal issues. Obtaining patent rights outside the United States often requires the translation of highly technical documents and an improper translation may lead to the loss of, or otherwise jeopardize, the patent protection of our inventions. Ensuring adequate quality of translators and foreign patent attorneys is often very challenging. Consequently, the process for having our pending patent applications issue as patents will be difficult, complex and time consuming. Our patent position is very uncertain and we do not know when, or if, we will obtain additional patents

 

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for our technologies, or if the scope of the patents obtained will be sufficient to protect our drugs, or be considered sufficient by parties reviewing our patent positions pursuant to a potential licensing or financing transaction.

In addition, other entities may challenge the validity or enforceability of our patents and patent applications in litigation or administrative proceedings. Even the issuance of a patent is not conclusive as to its validity or enforceability. We cannot make assurances as to how much protection, if any, will be given to our patents if we attempt to enforce them or they are challenged. It is possible that a competitor or a generic pharmaceutical provider may successfully challenge our patents and those challenges may result in reduction or elimination of our patents’ coverage.

We also rely on confidentiality agreements and trade secrets to protect our technologies. However, such information is difficult to protect. We require our employees to contractually agree not to improperly use our confidential information or disclose it to others, but we may be unable to determine if our employees have conformed or will conform to their legal obligations under these agreements. We also enter into confidentiality agreements with prospective collaborators, collaborators, service providers and consultants, but we may not be able to adequately protect our trade secrets or other proprietary information in the event of any unauthorized use or disclosure or the lawful development by others of this information. Many of our employees and consultants were, and many of them may currently be, parties to confidentiality agreements with other pharmaceutical and biotechnology companies, and the use of our technologies could violate these agreements. In addition, third parties may independently discover our trade secrets or proprietary information.

Some of our academic institution licensors, research collaborators and scientific advisors have rights to publish data and information to which we have rights. We generally seek to prevent our collaborators from disclosing scientific discoveries before we have the opportunity to file patent applications on such discoveries. In some of our collaborations, we do not control our collaborators’ ability to disclose their own discoveries under the collaboration and in some of our academic collaborations we are limited to relatively short periods to review a proposed publication and file a patent application. If we cannot maintain the confidentiality of our technologies and other confidential information in connection with our collaborations, our ability to receive patent protection or protect our proprietary information will be impaired.

The US Congress has recently considered, and may again consider, changes to federal patent laws on several issues including, but not limited to: (i) the information that can be used to determine whether an invention is not new and, therefore, not patentable, (ii) the limits on the independent administrative rulemaking authority of the US Patent and Trademark Office, (iii) the duties of patent applicants to disclose information that relates to their applications, (iv) whether, under what circumstances, and how many times a third party can challenge an issued US patent before the US Patent and Trademark Office, (v) whether and under what circumstances patent owners can lose their ability to enforce their patents in the United States based on their failure to disclose certain information relating to their inventions, and (vi) how damages for patent infringement may be reduced based on a number of factors, including the similarity of a patented invention to preexisting technologies.

We believe that the United States is by far the largest single market for pharmaceuticals in the world. Because of the critical nature of patent rights to our industry, changes in US patent laws could have a profound effect on our future profits, if any. Several of the patent law changes that are being considered could significantly weaken patent protections in the United States in general. They may also have a disproportionately large negative impact on our industry in particular, as well as tilt the balance of market control and distribution of profits between the manufacturers of patented pharmaceutical products and the manufacturers of generic pharmaceutical products towards the generics manufacturers. At present there is considerable uncertainty as to which patent laws will be changed and exactly how changes to the patent laws will ultimately be enforced by the courts.

A dispute regarding the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be costly and result in delays or termination of our future research, development, manufacturing and sales activities.

Our commercial success also depends upon our ability to develop and manufacture our drug candidates and market and sell drugs, if any, and conduct our research and development activities without infringing or misappropriating the proprietary rights of others. There are many patents and patent applications filed, and that may be filed, by others relating to drug discovery and development programs that could be determined to be similar, identical or superior to ours or our licensors or collaborators. We may be exposed to future litigation by others based on claims that our drug candidates, technologies or activities infringe the intellectual property rights of others. Numerous US and foreign issued patents and pending patent applications owned by others exist in the area of GPCRs, including some which purport to allow the patent holder to control the use of all drugs that modulate a particular drug target or GPCR, regardless of whether the infringing drug bears any structural resemblance to a chemical compound known to the patent holder at the time of patent filing. Numerous US and foreign issued patents and pending patent applications owned by others also exist in the therapeutic areas in, and for the therapeutic targets for, which we are developing drugs. There are also numerous issued patents and patent applications to chemical compounds or synthetic processes that may be necessary or useful to use in our research, development, manufacturing or commercialization activities. These could materially affect our ability to develop our drug candidates or manufacture, import or sell drugs, and our activities, or those of our licensors or collaborators, could be determined to infringe these patents. Because patent applications can take many years to issue, there may be currently pending applications, unknown to us, which may later result in issued patents that our drug candidates or technologies may infringe. There also may be existing patents, of which

 

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we are not aware, that our drug candidates or technologies may infringe. Further, there may be issued patents or pending patent applications in fields relevant to our business, of which we are or may become aware, that we believe (i) are invalid or we do not infringe; (ii) relate to immaterial portions of our overall drug discovery, development, manufacturing and commercialization efforts; or (iii) in the case of pending patent applications, the resulting patent would not be granted or, if granted, would not likely be enforced in a manner that would materially impact such efforts. We cannot assure you that others holding any of these patents or patent applications will not assert infringement claims against us for damages or seek to enjoin our activities. We also cannot assure you that, in the event of litigation, we will be able to successfully assert any belief we may have as to non-infringement, invalidity or immateriality, or that any infringement claims will be resolved in our favor.

In addition, others may infringe or misappropriate our proprietary rights, and we may have to institute costly legal action to protect our intellectual property rights. We may not be able to afford the costs of enforcing or defending our intellectual property rights against others.

Other organizations, companies and individuals are seeking proprietary positions on genomics information that overlap with the government-sponsored project to sequence the human genome. Our activities, or those of our licensors or collaborators, could be affected by conflicting positions that may exist between any overlapping genomics information made available publicly as a result of the government-sponsored project and genomics information that other organizations, companies or individuals consider to be proprietary. There could also be significant litigation and other administrative proceedings in our industry that affect us regarding patent and other intellectual property rights. Any legal action or administrative action against us, or our collaborators, claiming damages or seeking to enjoin commercial activities relating to our drug discovery, development, manufacturing and commercialization activities could:

 

   

require us, or our collaborators, to obtain a license to continue to use, manufacture or market the affected drugs, methods or processes, which may not be available on commercially reasonable terms, if at all;

 

   

prevent us from importing, making, using, selling or offering to sell the subject matter claimed in patents held by others and subject us to potential liability for damages;

 

   

consume a substantial portion of our managerial, scientific and financial resources; or

 

   

be costly, regardless of the outcome.

Furthermore, because of the substantial amount of pre-trial document and witness discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the trading price of our common stock.

We have been contacted from time to time by third parties regarding their intellectual property rights, sometimes asserting that we may need a license to use their technologies. If we fail to obtain any required licenses or make any necessary changes to our technologies, we may be unable to develop or commercialize some or all of our drug candidates.

We cannot protect our intellectual property rights throughout the world.

Filing, prosecuting, defending and enforcing patents on all of our drug discovery technologies and all of our potential drug candidates throughout the world would be prohibitively expensive. Competitors may use our technologies to develop their own drugs in jurisdictions where we have not obtained patent protection. These drugs may compete with our drugs, if any, and may not be covered by any of our patent claims or other intellectual property rights. The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties (for example, the patent owner has failed to “work” the invention in that country or the third party has patented improvements). In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent. Compulsory licensing of life-saving drugs is also becoming increasingly popular in developing countries either through direct legislation or international initiatives. Such compulsory licenses could be extended to include some of our drug candidates, which could limit our potential revenue opportunities. Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the aggressive enforcement of patents and other intellectual property protection, particularly those relating to biotechnology and/or pharmaceuticals, which makes it difficult for us to stop the infringement of our patents. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

 

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Risks Relating to Our Securities

*Our stock price will likely be volatile, and your investment in our stock could decline in value.

Our stock price has fluctuated historically. From January 1, 2008 to October 29, 2010, the market price of our stock was as low as $1.45 per share and as high as $8.68 per share.

Very few drug candidates being tested will ultimately receive FDA approval, and companies in our industry may experience a significant drop in stock price based on a clinical trial result or regulatory action. Our stock price may fluctuate significantly depending on a variety of factors, including:

 

   

regulatory actions affecting lorcaserin, including those relating to our response to the CRL for lorcaserin, or other drug candidates or drugs;

 

   

discussions or recommendations affecting lorcaserin or other drug candidates or drugs by FDA advisory committees or other reviewers of preclinical or clinical data or other information related to lorcaserin or other drug candidates or drugs;

 

   

the success or failure of our clinical-stage development programs or other results or decisions affecting the development of our drug candidates;

 

   

the timing of the discovery of drug leads and the development of our drug candidates;

 

   

the modification or termination of an existing collaboration or the entrance into, or failure to enter into, a new collaboration;

 

   

the timing and receipt by us of milestone or other payments or failing to achieve and receive the same;

 

   

changes in our research and development budget or the research and development budgets of our existing or potential collaborators;

 

   

the introduction, development or withdrawal of drug candidates or drugs by others that target the same diseases and conditions that we or our collaborators target or the introduction of new drug discovery techniques;

 

   

the success or failure of our or a perceived competitor’s drug candidate or drug;

 

   

expenses related to, and the results of, litigation, other disputes and other proceedings;

 

   

financing strategy or decisions;

 

   

developments in intellectual property rights or related announcements;

 

   

capital market conditions; and

 

   

accounting changes.

We are not able to control many of these factors. If our financial or scientific results in a particular period do not meet stockholders’ or analysts’ expectations, our stock price may decline and such decline could be significant.

*There are a substantial number of shares of our common stock eligible for future sale in the public market, and the sale of these shares could cause the market price of our common stock to fall.

There were 121,411,502 shares of our common stock outstanding as of October 29, 2010. We also had outstanding as of October 29, 2010 a seven-year warrant issued in June 2006 to purchase 1,046,781 shares of our common stock at an exercise price of $12.28 per share and a seven-year warrant issued in August 2008 to purchase 1,398,346 shares of our common stock at an exercise price of $6.10 per share. Such warrants were adjusted as a result of certain equity sales following their issuance to decrease the exercise price and increase the number of shares issuable upon exercise of the warrants. Certain future equity issuances below the pre-defined warrant adjustment price may result in additional adjustments to any such warrants then outstanding.

We also had outstanding as of October 29, 2010, warrants we issued to Deerfield to purchase 16,200,000 and 11,800,000 shares of our common stock at per share exercise prices of $3.45 and $5.42, respectively. In certain circumstances we may be obligated to issue Deerfield additional warrants to purchase up to 5,600,000 shares of common stock at an exercise price of $5.42 per share. All of these warrants are or will be exercisable until June 17, 2013.

 

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In addition to our outstanding warrants, as of October 29, 2010, there were (i) options to purchase 8,255,629 shares of our common stock outstanding under our equity incentive plans at a weighted-average exercise price of $7.74 per share, (ii) 1,687,150 performance-based restricted stock unit awards outstanding under our 2006 Long-Term Incentive Plan, as amended, (iii) 5,527,681 additional shares of common stock remaining issuable under our 2009 Long-Term Incentive Plan, (iv) 930,950 shares of common stock remaining issuable under our 2009 Employee Stock Purchase Plan, and (v) 84,169 shares of common stock remaining issuable under our Deferred Compensation Plan.

The shares described above, when issued, will be available for immediate resale in the public market. The market price of our common stock could decline as a result of such resales due to the increased number of shares available for sale in the market.

*Any future equity or debt issuances by us may have dilutive or adverse effects on our existing stockholders.

We have primarily financed our operations, and we expect to continue to finance our operations, by issuing and selling our common stock or securities convertible into or exercisable for shares of our common stock. In light of our need for additional funding, we may issue additional shares of common stock or convertible securities that could dilute your ownership in our company and may include terms that give new investors rights that are superior to yours. Moreover, any issuances by us of equity securities may be at or below the prevailing market price of our common stock and in any event may have a dilutive impact on your ownership interest, which could cause the market price of our common stock to decline. In addition, we may also raise additional funds through the incurrence of debt, and the holders of any debt we may issue would have rights superior to your rights in the event we are not successful and are forced to seek the protection of bankruptcy laws. For example, in July 2009 we issued debt to Deerfield that is secured by our assets, and Deerfield’s right to repayment would be senior to your rights to receive any proceeds from a liquidation in bankruptcy or otherwise.

The holders of our common stock and other securities may take actions that are contrary to your interests, including selling their stock.

A small number of our stockholders hold or have rights to acquire a significant amount of our outstanding stock. These stockholders may support competing transactions and have interests that are different from yours. In addition, sales of a large number of shares of our stock by these large stockholders or other stockholders within a short period of time could adversely affect our stock price.

We may also be involved with disagreements with the holders of our stock, warrants or other securities in the future. Such disagreements may lead to litigation which may be expensive and consume management’s time, or involve settlements, the terms of which may not be favorable to us.

Our rights agreement and certain provisions in our charter documents and Delaware law could delay or prevent a change in management or a takeover attempt that you may consider to be in your best interest.

We have adopted certain anti-takeover provisions, including a stockholders’ rights agreement, dated as of October 30, 2002, between us and Computershare Trust Company, Inc., as Rights Agent, as amended. The rights agreement will cause substantial dilution to any person who attempts to acquire us in a manner or on terms not approved by our board of directors.

The rights agreement, as well as other provisions in our certificate of incorporation and bylaws and under Delaware law, could delay or prevent the removal of directors and other management and could make more difficult a merger, tender offer or proxy contest involving us that you may consider to be in your best interest. For example, these provisions:

 

   

allow our board of directors to issue preferred stock without stockholder approval;

 

   

limit who can call a special meeting of stockholders;

 

   

eliminate stockholder action by written consent; and

 

   

establish advance notice requirements for nomination for election to the board of directors or for proposing matters to be acted upon at stockholders meetings.

 

Item 6. Exhibits.

 

EXHIBIT
NO.

 

DESCRIPTION

  3.1

  Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 3.1 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2002, filed with the Securities and Exchange Commission on August 14, 2002, Commission File No. 000-31161)

  3.2

  Certificate of Amendment of the Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 28, 2006, Commission File No. 333-135398)

 

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EXHIBIT
NO.

 

DESCRIPTION

  3.3

  Certificate of Amendment No. 2 of the Fifth Amended and Restated Certificate of Incorporation of Arena, as amended (incorporated by reference to Exhibit 4.3 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 30, 2009, Commission File No. 333-160329)

  3.4

  Amended and Restated Bylaws of Arena (incorporated by reference to Exhibit 3.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on October 4, 2007, Commission File No. 000-31161)

  3.5

  Certificate of Designations of Series A Junior Participating Preferred Stock of Arena, dated November 4, 2002 (incorporated by reference to Exhibit 3.3 to Arena’s quarterly report on Form 10-Q for the quarter ended September 30, 2002, filed with the Securities and Exchange Commission on November 14, 2002, Commission File No. 000-31161)

  3.6

  Certificate of Designations of Series B-1 Convertible Preferred Stock and Series B-2 Convertible Preferred Stock of Arena, dated December 24, 2003 (incorporated by reference to Exhibit 3.1 to Arena’s report on Form 8-K filed with the Securities and Exchange Commission on December 30, 2003, Commission File No. 000-31161)

  4.1

  Rights Agreement, dated October 30, 2002, between Arena and Computershare Trust Company, Inc. (incorporated by reference to Exhibit 4.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on November 1, 2002, Commission File No. 000-31161)

  4.2

  Amendment No. 1, dated December 24, 2003, to Rights Agreement, dated October 30, 2002, between Arena and Computershare Trust Company, Inc. (incorporated by reference to Exhibit 4.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on December 30, 2003, Commission File No. 000-31161)

  4.3

  Amendment No. 2, dated November 16, 2006, to Rights Agreement, dated October 30, 2002, between Arena and Computershare Trust Company, Inc. (incorporated by reference to Exhibit 4.3 to Amendment No. 2 to Arena’s registration statement on Form 8-A filed with the Securities and Exchange Commission on November 16, 2006, Commission File No. 000-31161)

  4.4

 

Form of common stock certificate (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on

Form S-1, as amended, filed with the Securities and Exchange Commission on July 19, 2000, Commission File No. 333-35944)

10.1+

  Marketing and Supply Agreement, dated July 1, 2010, by and between Arena Pharmaceuticals GmbH and Eisai Inc.

10.2

  Securities Purchase Agreement, dated August 5, 2010, by and among Arena and Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited, Deerfield Special Situations Fund, L.P. and Deerfield Special Situations Fund International Limited, or collectively Deerfield (incorporated by reference to Exhibit 99.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 6, 2010, Commission File No. 000-31161)

10.3

  Amendment to Facility Agreement, dated August 5, 2010, by and between Arena and Deerfield (incorporated by reference to Exhibit 99.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 6, 2010, Commission File No. 000-31161)

31.1

  Certification of Chief Executive Officer pursuant to Rule 13a-14(A) promulgated under the Securities Exchange Act of 1934

31.2

  Certification of Chief Financial Officer pursuant to Rule 13a-14(A) promulgated under the Securities Exchange Act of 1934

32.1

  Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) promulgated under the Securities Exchange Act of 1934

 

+ Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.

 

42


Table of Contents

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: November 9, 2010     ARENA PHARMACEUTICALS, INC.
    By:  

/s/ Jack Lief

      Jack Lief
      President and Chief Executive Officer (principal executive officer authorized to sign on behalf of the registrant)
    By:  

/s/ Robert E. Hoffman

      Robert E. Hoffman
      Vice President, Finance and Chief Financial Officer (principal financial and chief accounting officer authorized to sign on behalf of the registrant)

 

43


Table of Contents

 

EXHIBIT INDEX

 

EXHIBIT
NO.

 

DESCRIPTION

  3.1   Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 3.1 to Arena’s quarterly report on Form 10-Q for the quarter ended June 30, 2002, filed with the Securities and Exchange Commission on August 14, 2002, Commission File No. 000-31161)
  3.2   Certificate of Amendment of the Fifth Amended and Restated Certificate of Incorporation of Arena (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 28, 2006, Commission File No. 333-135398)
  3.3   Certificate of Amendment No. 2 of the Fifth Amended and Restated Certificate of Incorporation of Arena, as amended (incorporated by reference to Exhibit 4.3 to Arena’s registration statement on Form S-8 filed with the Securities and Exchange Commission on June 30, 2009, Commission File No. 333-160329)
  3.4   Amended and Restated Bylaws of Arena (incorporated by reference to Exhibit 3.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on October 4, 2007, Commission File No. 000-31161)
  3.5   Certificate of Designations of Series A Junior Participating Preferred Stock of Arena, dated November 4, 2002 (incorporated by reference to Exhibit 3.3 to Arena’s quarterly report on Form 10-Q for the quarter ended September 30, 2002, filed with the Securities and Exchange Commission on November 14, 2002, Commission File No. 000-31161)
  3.6   Certificate of Designations of Series B-1 Convertible Preferred Stock and Series B-2 Convertible Preferred Stock of Arena, dated December 24, 2003 (incorporated by reference to Exhibit 3.1 to Arena’s report on Form 8-K filed with the Securities and Exchange Commission on December 30, 2003, Commission File No. 000-31161)
  4.1   Rights Agreement, dated October 30, 2002, between Arena and Computershare Trust Company, Inc. (incorporated by reference to Exhibit 4.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on November 1, 2002, Commission File No. 000-31161)
  4.2   Amendment No. 1, dated December 24, 2003, to Rights Agreement, dated October 30, 2002, between Arena and Computershare Trust Company, Inc. (incorporated by reference to Exhibit 4.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on December 30, 2003, Commission File No. 000-31161)
  4.3   Amendment No. 2, dated November 16, 2006, to Rights Agreement, dated October 30, 2002, between Arena and Computershare Trust Company, Inc. (incorporated by reference to Exhibit 4.3 to Amendment No. 2 to Arena’s registration statement on Form 8-A filed with the Securities and Exchange Commission on November 16, 2006, Commission File No. 000-31161)
  4.4  

Form of common stock certificate (incorporated by reference to Exhibit 4.2 to Arena’s registration statement on

Form S-1, as amended, filed with the Securities and Exchange Commission on July 19, 2000, Commission File No. 333-35944)

10.1+   Marketing and Supply Agreement, dated July 1, 2010, by and between Arena Pharmaceuticals GmbH and Eisai Inc.
10.2   Securities Purchase Agreement, dated August 5, 2010, by and among Arena and Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited, Deerfield Special Situations Fund, L.P. and Deerfield Special Situations Fund International Limited, or collectively Deerfield (incorporated by reference to Exhibit 99.1 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 6, 2010, Commission File No. 000-31161)
10.3   Amendment to Facility Agreement, dated August 5, 2010, by and between Arena and Deerfield (incorporated by reference to Exhibit 99.2 to Arena’s current report on Form 8-K filed with the Securities and Exchange Commission on August 6, 2010, Commission File No. 000-31161)
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(A) promulgated under the Securities Exchange Act of 1934
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(A) promulgated under the Securities Exchange Act of 1934
32.1   Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) promulgated under the Securities Exchange Act of 1934

 

+ Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.

 

44

 

Exhibit 10.1

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

CONFIDENTIAL

EXECUTION COPY

Marketing and Supply Agreement

by and between

Arena Pharmaceuticals GmbH

and

Eisai Inc.

July 1, 2010


 

TABLE OF CONTENTS

 

ARTICLE 1.

   DEFINITIONS      1   

ARTICLE 2.

   EXCLUSIVE DISTRIBUTORSHIP      18   

2.1.

   Appointment of Eisai as Exclusive Distributor in Territory      18   

2.2.

   Supply of Product for Distributorship      18   

2.3.

   Negative Covenants      18   

2.4.

   Non-Compete Covenants      20   

2.5.

   OTC Covenant      22   

ARTICLE 3.

   PRODUCT DEVELOPMENT AND REGULATORY ACTIVITIES      22   

3.1.

   Overview of Product Development      22   

3.2.

   Further Development of the Initial Product      23   

3.3.

   Selection and Development of Additional Products      25   

3.4.

   Development Plans      26   

3.5.

   Conduct of Development Activities      27   

3.6.

   Development Expenses      28   

3.7.

   Non-Development Plan Development      31   

3.8.

   Use of Subcontractors      32   

3.9.

   Materials Transfer      33   

3.10.

   Initial Product Regulatory Activities      33   

3.11.

   Additional Products Regulatory Activities      34   

3.12.

   Regulatory Cooperation of the Parties      35   

3.13.

   Communications Outside the Territory      36   

3.14.

   Regulatory Filings; Arena’s Right of Reference      36   

3.15.

   Pharmacovigilance      37   

3.16.

   Subcontracting Medical Education Activities      37   

 

ii


ARTICLE 4.

   MANAGEMENT OF DEVELOPMENT      38   

4.1.

   Joint Development Committee      38   

4.2.

   Joint Development Committee Membership; Procedure      39   

4.3.

   Meetings      40   

4.4.

   Decision-making of Joint Development Committee      40   

4.5.

   Scope of Governance      41   

ARTICLE 5.

   COMMERCIALIZATION OF PRODUCTS      41   

5.1.

   Commercialization Rights and Responsibility      41   

5.2.

   Eisai Commercialization Responsibilities      41   

5.3.

   Commercialization Plans and Communication      42   

5.4.

   Eisai Commercialization Commitments      43   

5.5.

   Commercialization Standards of Conduct      43   

5.6.

   Limited Licenses      44   

5.7.

   Commercialization by Arena      44   

5.8.

   Recalls      45   

5.9.

   Co-Promotion      45   

5.10.

   Returned Product      45   

ARTICLE 6.

   MANUFACTURE AND SUPPLY      46   

6.1.

   Manufacture and Supply Commitment      46   

6.2.

   Forecasting and Ordering      46   

6.3.

   Delivery and Purchase      48   

6.4.

   Negotiation Regarding Supply of Raw Materials      48   

6.5.

   Labeling and Packaging      48   

6.6.

   Second Source      49   

6.7.

   Quality Agreement      49   

 

iii


6.8.

   Quality Control      49   

6.9.

   Certificates      49   

6.10.

   Quality Audits      49   

6.11.

   Acceptance/Rejection      50   

6.12.

   Dispute Regarding Rejection      50   

6.13.

   Product Warranty      50   

6.14.

   Facility Licenses; Storage      51   

6.15.

   Inspection by Eisai      51   

6.16.

   Regulatory Inspections      51   

6.17.

   Supply Problems      53   

6.18.

   Product Shortage      53   

6.19.

   Safety Stock; Inventory      53   

6.20.

   Commitment to Optimize Supply Relationship      54   

ARTICLE 7.

   PAYMENTS      55   

7.1.

   Initial Payment      55   

7.2.

   Milestone Payments      55   

7.3.

   Product Purchase Price Payments for Commercial Supply of Product      56   

7.4.

   Product Purchase Price Adjustment Payments      59   

7.5.

   Non-Commercial Product Purchase Price      61   

7.6.

   Payment Method; Currency      61   

7.7.

   Necessary Third Party IP      61   

7.8.

   Taxes      62   

7.9.

   Records      62   

7.10.

   Audits      62   

7.11.

   Payment Due Dates; Late Payments      63   

 

iv


ARTICLE 8.

   CONFIDENTIALITY      64   

8.1.

   Product Information      64   

8.2.

   Confidential Information      64   

8.3.

   Exceptions      65   

8.4.

   Permitted Disclosures      66   

8.5.

   Confidentiality of this Agreement and its Terms      67   

8.6.

   Public Announcements      67   

8.7.

   Use of Name      68   

8.8.

   Publication of the Product Information      68   

8.9.

   Stand-Still      69   

ARTICLE 9.

   PATENT PROSECUTION AND ENFORCEMENT      71   

9.1.

   Ownership of Intellectual Property      71   

9.2.

   Patent Prosecution and Maintenance      71   

9.3.

   Infringement by Third Parties      73   

9.4.

   Infringement of Third Party Rights      74   

9.5.

   Invalidity or Unenforceability Defenses or Actions      75   

9.6.

   Consent for Settlement      76   

9.7.

   Patent Term Extensions      76   

9.8.

   Orange Book Listing      76   

9.9.

   Product Trademarks      77   

ARTICLE 10.

   REPRESENTATIONS, WARRANTIES AND COVENANTS      78   

10.1.

   Mutual Representations, Warranties and Covenants      78   

10.2.

   Representations, Warranties and Covenants of Arena      79   

10.3.

   Representations, Warranties and Covenants of Eisai      82   

10.4.

   Disclaimer      83   

 

v


ARTICLE 11.

   INDEMNIFICATION; PRODUCT LIABILITY CLAIMS      83   

11.1.

   Indemnification of Arena      83   

11.2.

   Indemnification of Eisai      83   

11.3.

   Procedure      84   

11.4.

   Insurance      86   

ARTICLE 12.

   TERM AND TERMINATION      86   

12.1.

   Term      86   

12.2.

   Early Termination      86   

12.3.

   Termination for Commercialization Concerns      87   

12.4.

   Termination for Third Party Infringement      88   

12.5.

   Eisai Termination for Non-Compete Reasons      88   

12.6.

   Other Arena Termination Right      88   

12.7.

   Adjudication of Material Breach      89   

ARTICLE 13.

   EFFECT OF TERMINATION      91   

13.1.

   Accrued Obligations      91   

13.2.

   Effects of Termination      91   

13.3.

   Return of Confidential Information      93   

13.4.

   Rights in Bankruptcy      93   

13.5.

   Survival      93   

ARTICLE 14.

   DISPUTE RESOLUTION AND GOVERNING LAW      94   

14.1.

   Dispute Resolution Process      94   

14.2.

   Governing Law; Litigation; Exclusive Venue and Service      94   

ARTICLE 15.

   GENERAL PROVISIONS      95   

15.1.

   Force Majeure      95   

15.2.

   Waiver of Breach      95   

 

vi


15.3.

   Further Actions      95   

15.4.

   Performance by Affiliates or Subcontractors      95   

15.5.

   Modification      96   

15.6.

   Severability      96   

15.7.

   Entire Agreement      96   

15.8.

   Language      97   

15.9.

   Notices      97   

15.10.

   Assignment      97   

15.11.

   No Partnership or Joint Venture      98   

15.12.

   Interpretation      98   

15.13.

   References      98   

15.14.

   Counterparts; Electronic Signature Pages      99   

15.15.

   Limitation of Liability      99   

15.16.

   Equitable Relief; Specific Performance      99   

15.17.

   No Benefit to Third Parties      99   

15.18.

   Cumulative Rights      99   

ARTICLE 16.

   COMPLIANCE WITH LAW      100   

16.1.

   Generally      100   

16.2.

   Securities Laws      100   

16.3.

   Certain Payments      100   
List of Exhibits      

Exhibit A - Compound Structure

Exhibit B - Existing Arena Patents

 

vii


MARKETING AND SUPPLY AGREEMENT

This M ARKETING AND S UPPLY A GREEMENT ( this Agreement ”) is entered into as of July 1, 2010 (the “ Effective Date ”) by and between A RENA P HARMACEUTICALS G MB H , a company organized under the laws of Switzerland having a principal place of business at Untere Brühlstrasse 4, 4800, Zofingen, Switzerland ( Arena ”), and E ISAI I NC . , a company organized under the laws of Delaware having a principal place of business at 100 Tice Blvd., Woodcliff Lake, New Jersey 07677 ( Eisai ”). Each of Arena and Eisai may be referred to in this Agreement individually as a “ Party ” and collectively as the “ Parties ”.

WHEREAS

A. Arena is developing a product containing lorcaserin hydrochloride hemihydrate for weight loss or weight maintenance, among other potential indications. Arena owns or controls certain patents, know-how and other intellectual property relating to such product;

B. Arena wishes to obtain a distributor that will promote, market, sell and distribute such product (and potentially other pharmaceutical products containing lorcaserin) within the United States;

C. Eisai has the ability to promote, market, sell and distribute such product within the United States and wishes to be Arena’s exclusive distributor within the United States, and Arena is willing to grant to Eisai such exclusive distribution rights on the terms and conditions set forth in this Agreement; and

D. Arena agrees to manufacture (or have manufactured) and sell to Eisai such product for such commercialization activities in the United States, on the terms and conditions set forth in this Agreement;

NOW, THEREFORE , in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Arena and Eisai, intending to be legally bound, hereby agree as follows:

Article 1.

DEFINITIONS

As used in this Agreement, the following capitalized terms have the meanings set out in this Article 1.

1.1. Additional Product ” means a pharmaceutical product (in any specific dosage form or mode of administration) that contains the Compound or a Related Compound as an active pharmaceutical agent and is added to the scope of this Agreement by agreement of the Parties as provided in Section 3.3 for development for a particular Indication(s) (which product may also include, if agreed, one or more other active pharmaceutical agents). For clarity, the Initial Formulation as indicated for any Indication other than the Indications that, as of the Effective


Date, are the subject of the Initial Product NDA (as the label resulting from such Initial Product NDA may be expanded or amended based upon any clinical data resulting from the BLOOM-DM Trial or any clinical data specific to the Initial Product existing as of the Effective Date), shall constitute an Additional Product, if the Parties agree under Section 3.3 to develop such Initial Formulation for such additional Indication(s).

1.2. Affiliate ” of a Party means any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Party, as the case may be, but for only so long as such control exists. As used in this definition, the term “control” (with correlative meanings for the terms “controlled by” and “under common control with”) means (a) direct or indirect beneficial ownership of more than 50% of the voting share capital or other equity interest in such Party able to elect the directors or management of such Party or (b) the power to direct the management and policies of such Party by contract or otherwise.

1.3. Agreement ” has the meaning set forth in the opening paragraph hereto.

1.4. Applicable Laws ” means the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits (including Regulatory Approvals) of or from any court, arbitrator, Regulatory Authority or other governmental agency or authority having jurisdiction over or related to the subject activity or item as they may be in effect from time to time.

1.5. Arena ” has the meaning set forth in the opening paragraph hereto.

1.6. Arena ex-US Distributor ” means a licensee, collaborator or distributor engaged by Arena or any of its Affiliates to market, promote or sell a Product or other Compound Product or Related Product in a country or countries outside the Territory. For clarity, any such licensee, collaborator or distributor shall constitute an Arena ex-US Distributor only during the term of such engagement.

1.7. Arena Indemnitees ” has the meaning set forth in Section 11.1.

1.8. Arena Independent Know-How ” means all Know-How that is Confidential Information of Arena and that is discovered, identified, conceived, reduced to practice or otherwise made by or on behalf of Arena or any of its Affiliates, or by any Arena ex-US Distributor and Controlled by Arena or any of its Affiliates, after the Effective Date in the course of any Non-Development Plan Development or other work conducted outside of a Development Plan; provided, that Arena has notified Eisai of such Know-How pursuant to Section 3.7(b) and such Know-How has not become Arena Know-How pursuant to Section 3.7(b).

1.9. Arena Know-How ” means all Know-How that (a) is Controlled by Arena or any of its Affiliates, including any Know-How of an Arena ex-US Distributor that is Controlled by Arena or any of its Affiliates, as of the Effective Date or at any time during the Term, (b) is necessary or useful for the development or Commercialization by Eisai of the Initial Product or an

 

2


Additional Product in the Territory in accordance with this Agreement, but excluding all Arena Independent Know-How and Program Know-How and (c) that is Confidential Information of Arena.

1.10. Arena Patent ” means any Patent pending or issued in the Territory that is Controlled by Arena or any of its Affiliates as of the Effective Date or at any time during the Term and that claims (a) the Compound, or a product containing the Compound, as a composition of matter, or (b) a method of use of the Compound or a product containing the Compound, but excluding (x) all claims of any such Patent that do not involve or relate to a Compound, a Compound Product or the development or Commercialization thereof and (y) any Program Patents.

1.11. Arena US ” means Arena Pharmaceuticals, Inc., an Affiliate of Arena.

1.12. Auditor ” has the meaning set forth in Section 7.10(a).

1.13. Batch ” means the total amount of a particular Finished Product resulting from one complete production run conducted by or on behalf of Arena using the applicable Master Batch Records and Manufacturing SOPs.

1.14. Batch Records ” means, with respect to a particular production run conducted by or on behalf of Arena for manufacturing one Batch of a particular Finished Product, the completed batch records, in the form of the Master Batch Records, for such production run containing all the relevant manufacturing details and information for the run, including any deviations.

1.15. BLOOM-DM Trial ” means the Phase 3 clinical trial of the Initial Product referred to as “Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus” and identified as clinical protocol APD356-010, entitled “A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients with Type 2 Diabetes Mellitus Managed with Oral Hypoglycemic Agent(s).”

1.16. Board of Directors ” has the meaning set forth in the definition of “Change of Control”.

1.17. Calendar Quarter ” means a period of three consecutive months during a Calendar Year beginning on and including January 1 st , April 1 st , July 1 st or October 1 st ; provided, that the last Calendar Quarter shall end on the last day of the Term.

1.18. Calendar Year ” means a period of 12 consecutive months beginning on and including January 1 st ; provided, that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs, and the last Calendar Year shall end on the last day of the Term.

1.19. Certificate of Analysis ” means a written certificate of analysis, in reasonable and customary form, which confirms that the quantity of the applicable Finished Product, manufactured by or on behalf of Arena and delivered by Arena to Eisai under Article 6, has been

 

3


tested in accordance with the applicable Product Acceptance Tests and meets the warranty set forth in Section 6.13. The Certificate of Analysis will include the results of all Product Acceptance Tests performed by or on behalf of Arena on the particular Batch of such Finished Product.

1.20. Chairman ” means the chairman of the Joint Development Committee.

1.21. Change of Control ” means, with respect to either Party, the occurrence of any of the following:

(a) any “person” or “group” (as such terms are defined below) is or becomes the “beneficial owner” (as defined below), directly or indirectly, in a transaction or series of related transactions, of shares of capital stock or other interests (including partnership or LLC membership interests) of such Party (or any of its Controlling Affiliates) then-outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (“ Voting Stock ”) (or its Controlling Affiliate, as applicable) of such Party representing 50% or more of the total voting power of all outstanding classes of Voting Stock of such Party (or its Controlling Affiliate, as applicable); or

(b) such Party (or any of its Controlling Affiliates) enters into a merger, consolidation or other form of business combination, share exchange, reorganization, recapitalization or other similar extraordinary transaction with another Person (whether or not such Party (or its Controlling Affiliate, as applicable) is the surviving entity) and as a result of such merger, consolidation or other form of business combination, share exchange, reorganization, recapitalization or similar extraordinary transaction (i) the members of the board of directors or similar governing body (as the case may be, “ Board of Directors ”) of such Party (or its Controlling Affiliate, as applicable) immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party (or its Controlling Affiliate, as applicable) or, if not such Party (or its Controlling Affiliate, as applicable), such surviving Person immediately following such transaction or (ii) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party (or its Controlling Affiliate, as applicable) immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person immediately following such transaction; or

(c) such Party (or any of its Controlling Affiliates) sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of the consolidated total assets of such Party and its Affiliates.

For the purpose of this definition: (x) “person” and “group” have the meanings given such terms under Section 13(d)(3) and 14(d)(2) of the Exchange Act and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the Exchange Act; (y) “beneficial owner” shall be determined in accordance with Rule 13d-3 under the Exchange Act; and (z) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial ownership”.

 

4


 

1.22. Commercial Approval ” has the meaning set forth in Section 7.2.

1.23. Commercial Strategy ” has the meaning set forth in Section 5.2(a).

1.24. Commercial Year ” means each period of 12 consecutive months beginning on (a) the first day of the first full month that occurs after the date of the First Commercial Sale of the first Product in the Territory and (b) each anniversary of the date specified in the foregoing clause (a); provided, that the first Commercial Year of the Term shall also include the period beginning on and including the date of the First Commercial Sale of the first Product in the Territory and ending on the day immediately prior to the first day of the first full month that occurs after the date of the First Commercial Sale of the first Product in the Territory, and the last Commercial Year shall end on the last day of the Term.

1.25. Commercialization ” means marketing, promoting, detailing, offering for sale, selling, importing and distributing in the Territory the applicable Product, and other similar activities related to the commercial sale of the Product in the Territory, but excluding for clarity all activities relating to research, development or manufacturing of Product or Finished Product. When used as a verb, “ Commercializing ” means to engage in Commercialization and “ Commercialize ” and “ Commercialized ” have corresponding meanings.

1.26. Commercially Reasonable Efforts ” means, with respect to a particular Party’s specific obligations under this Agreement with respect to a Product at the relevant point in time, that level of efforts and application of resources that is consistent with the usual practice followed by that Party in conducting similar activities, in the exercise of its reasonable scientific, business or regulatory judgment, but in no event less than the level of efforts and resources consistent with the commercially reasonable practices of the research-based pharmaceutical industry in the Territory, relating to other prescription pharmaceutical products owned or licensed by it or to which it has exclusive rights that have market potential and are at a stage of development or product life similar to the applicable Product, taking into account the anticipated or, if applicable, actual Patent coverage and the nature and extent of such Product’s market exclusivity (including Patent coverage and regulatory exclusivity), the likelihood of Regulatory Approval of such Product, the safety and efficacy of such Product, the cost to develop such Product, such Product’s profile, the competitiveness of the marketplace with respect to such Product, the proprietary position of such Product, the regulatory structure involved with respect to such Product, the profitability of such Product (including pricing and reimbursement status and the amounts of marketing and promotional expenditures) and other relevant factors, including comparative technical, legal, scientific, or medical factors.

1.27. Competing Product ” means a pharmaceutical product, other than a Product, that is approved for sale by a Regulatory Authority for a weight loss, weight management, obesity or, subject to the time limitations in Section 2.4(a), addiction disorder Indication.

1.28. Competing Program ” has the meaning set forth in Section 2.4(b).

1.29. Compound ” means the compound known as (R)-8-chloro-1-methyl-2,3,4,5-

 

5


tetrahydro-1H-3-benzazepine, the structure of which is set forth in Exhibit A , in the hydrochloride hemihydrate form, or any other specific pharmaceutically acceptable salt, hydrate, solvate or crystalline polymorph of such compound.

1.30. Compound Product ” means a pharmaceutical product (in any specific dosage form or mode of administration) that contains the Compound as an active pharmaceutical agent (which product may also include one or more other active pharmaceutical agents).

1.31. Confidential Information ” has the meaning set forth in Section 8.2.

1.32. Control ” (including any variations such as “ Controlled ” and “ Controlling ”), in the context of Materials, Patents, Know-How or regulatory filings (including specific Confidential Information), means that the applicable Party owns or has a license to such Materials, Patents, Know-How or regulatory filings and has the ability to grant to the other Party the applicable license (or sublicense, as applicable) or right to use such Materials, Patents, Know-How or regulatory filings under this Agreement without violating the terms of an agreement with a Third Party.

1.33. Controlling Affiliate ” means, with respect to a Party, an Affiliate of such Party that controls (within the meaning given under the definition of “Affiliate”) such Party.

1.34. Cost Overrun ” has the meaning set forth in Section 3.6(c)(i).

1.35. Development Data ” means, with respect to clinical trials and other development work conducted on a Product, all data, results, information and other Know-How generated from or related to such clinical trials and development work, including preclinical, non-clinical and clinical data, reports and information, protocols, statistical analysis plans, methods, and Batch Records for all products used in such work.

1.36. Development Expenses ” means (a) a Party’s (or its Affiliate’s) FTE costs at the applicable FTE Rates, and all costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with GAAP) by a Party or any of its Affiliates, in each case, in conducting the clinical trials and other development work assigned to such Party in accordance with the applicable Development Plan and (b) Finished Product COGS with respect to clinical supply of the applicable Finished Product used in such clinical trials and other development work in accordance with the applicable Development Plan.

1.37. Development Plan ” means, with respect to a specific Product, the plan for conducting the clinical trials and other development work (including any preclinical and non-clinical studies) to generate data for use in obtaining, maintaining, enhancing or expanding Regulatory Approval of such Product, as such plan is approved, and amended (if applicable), by the JDC pursuant to Section 4.1.

1.38. Disclosing Party ” has the meaning set forth in Section 8.2.

1.39. Dispute ” has the meaning set forth in Section 12.7(a).

 

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1.40. ECI ” has the meaning set forth in the definition of “FTE Rate”.

1.41. Effective Date ” has the meaning set forth in the opening paragraph of this Agreement.

1.42. Eisai ” has the meaning set forth in the opening paragraph hereto.

1.43. Eisai Indemnitees ” has the meaning set forth in Section 11.2.

1.44. Eisai Know-How ” means any and all Know-How that is Confidential Information of Eisai and that is discovered, identified, conceived, reduced to practice or otherwise made, as necessary to establish authorship, inventorship or ownership under applicable United States law as such law exists as of the Effective Date irrespective of where such discovering, identifying, conception, reduction to practice or other making occurs, solely by one or more employees of or consultants to Eisai or any of its Affiliates in the course of or as a result of or related to the Commercialization activities under this Agreement to the extent such Know-How does not relate predominantly to the Commercialization of a Product and is predominantly applicable to the marketing, promoting, detailing, offering for sale, selling, distributing, or conducting other similar activities related to the commercial sale of pharmaceutical products generally.

1.45. Escalation Notice ” has the meaning set forth in Section 4.4(b).

1.46. Estimated Price ” has the meaning set forth in Section 7.3(c).

1.47. Ex-Territory Development ” has the meaning set forth in Section 3.2(c)(i).

1.48. Excess Order ” has the meaning set forth in Section 6.2(b).

1.49. Exchange Act ” means the Securities Exchange Act of 1934, as it may be amended from time to time.

1.50. Excluded Claim ” has the meaning set forth in Section 12.7(j).

1.51. Excluded List ” means any of the Department of Health and Human Service’s List of Excluded Individuals/Entities or the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs.

1.52. Existing Arena Patents ” has the meaning set forth in Section 10.2(a).

1.53. Facility ” has the meaning set forth in Section 6.14.

1.54. Facility Licenses ” has the meaning set forth in Section 6.14.

1.55. FCPA ” has the meaning set forth in Section 5.5(a).

1.56. FDA ” means the United States Food and Drug Administration or its successor.

1.57. FFDCA ” means the United States Federal Food, Drug, and Cosmetic Act, 21

 

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U.S.C. 301, et. seq., as it may be amended from time to time, and the rules, regulations, guidances, guidelines, and requirements promulgated or issued thereunder.

1.58. Field Infringement ” has the meaning set forth in Section 9.3(b).

1.59. Finished Product ” means, with respect to a particular Product, (a) if such Product is to be sold to end-users, such Product in final form ready for sale to the end user in the Territory, (b) if such Product is to be used for clinical trials or other development work, such Product in final form ready for such clinical trials or other development work, (c) if such Product is to be used as a sample, such Product in final form ready for distribution as a sample in the Territory or (d) if such Product is to be used as part of a compassionate use, named patient use or indigent patient program in the Territory, such Product in final form ready for such compassionate use, named patient use or indigent patient program, in each case ((a) - (d)), in appropriate final packaging and labeling.

1.60. Finished Product COGS ” means, with respect to a Finished Product, the fully-burdened aggregate reasonable direct and indirect costs and expenses incurred and recorded by Arena in manufacturing such Finished Product consisting solely of: (a) direct labor costs (salaries, wages, employee benefits, overtime costs and shift premiums); (b) direct materials (including raw materials and intermediates and packaging) costs; (c) operating costs of facilities and equipment (including start up and cleaning costs of production); (d) quality, release and in-process control costs; (e) charges for reasonable spoilage, scrap or rework costs; (f) amounts (without markup) that are paid to a Third Party, Eisai, or an Affiliate of Eisai in connection with the manufacture of such Finished Product or any component thereof; and (g) the reasonable allocation of Facility overhead, both fixed and variable, to such manufacturing operation (including the allocable costs of administrators and managers overseeing manufacturing and production), in each case ((a) through (g)), to the extent specifically identifiable to the manufacture of such Finished Product as determined in accordance with GAAP.

1.61. First Commercial Sale ” means, on a Product-by-Product basis, the first bona fide , arm’s length sale of a Product by Eisai or any of its Affiliates to a Third Party in the Territory. Sales of a Product for registration samples, compassionate use sales, named patient use, inter-company transfers to Affiliates of Eisai and the like shall not constitute a First Commercial Sale.

1.62. Fiscal Semester ” means a period of six consecutive months during a Fiscal Year beginning on and including April 1 st or October 1 st ; provided, that the first Fiscal Semester of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of April 1 st or October 1 st after the Effective Date, and the last Fiscal Semester shall end on the last day of the Term.

1.63. Fiscal Year ” means a period of 12 consecutive months beginning on and including April 1st; provided, that the first Fiscal Year of the Term shall commence on the Effective Date and end on March 31, 2011, and the last Fiscal Year shall end on the last day of the Term.

1.64. Forecast ” has the meaning set forth in Section 6.2(a).

 

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1.65. Force Majeure ” has the meaning set forth in Section 15.1.

1.66. FTE ” means the equivalent of the work of one employee full time for one Calendar Year (consisting of a total of 1880 hours per Calendar Year) of work under Development Plans. Any employee who devotes fewer than 1880 hours per Calendar Year on work under Development Plans shall be treated as an FTE on a pro-rata basis calculated by dividing the actual number of hours worked by such employee under Development Plans during such Calendar Year by 1880. FTE efforts shall not include the work of general corporate or administrative personnel.

1.67. FTE Rate ” means the FTE personnel cost incurred by a Party in connection with the development of Products under Development Plans, which shall initially be at an annual rate of (a) US$[…***…] per FTE for director or equivalent level or above, (b) US$[…***…] per FTE for scientist or equivalent level or above, and (c) US$[…***…] per FTE below scientist or equivalent level. Commencing January 1, 2011, each above FTE Rate shall adjust annually, effective January 1 of the applicable Calendar Year, to reflect any year-to-year percentage increase or decrease (as the case may be) in the U.S. Bureau of Labor Statistics Employee Cost Index (“ ECI ”) (based on the change in the ECI from the most recent index available as of the Effective Date to the most recent index available as of the date of the calculation of such adjusted FTE Rate).

1.68. GAAP ” means generally accepted accounting principles in the Territory, or internationally, as appropriate, consistently applied, and means international financial reporting standards (“ IFRS ”) at such time as IFRS becomes the generally accepted accounting standard and Applicable Laws require that a Party use IFRS.

1.69. Generic Version ” means, with respect to a particular Product, a product sold (i) by a Third Party (who is not authorized by Eisai or any of its Affiliates and who neither Arena nor any of its Affiliates has authorized at Eisai’s request) or (ii) by Arena, any of its Affiliates or any Third Party authorized by Arena or any of its Affiliates (provided that the foregoing shall in no way be deemed or construed to limit Arena’s obligations under Section 2.3(a)) that, in each case ((i) or (ii)), (a) contains as an active pharmaceutical agent the same Compound or Related Compound that such Product contains as an active pharmaceutical agent, and (b) has been approved for sales introduction into interstate commerce in the Territory by reference to the Regulatory Approval for such Product pursuant to Section 505(b)(2) or 505(j) of the FFDCA, but excluding for clarity any Products sold by Eisai or any of its Affiliates during the Term.

1.70. Good Clinical Practices ” or “ GCP ” means the then-current standards, practices and procedures promulgated or endorsed by the FDA for designing, conducting, recording, analyzing and reporting clinical trials that involve the participation of human subjects, including as set forth in 21 C.F.R. parts 50, 54, 56 and 312 and in the ICH guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” and comparable regulatory standards, practices and procedures in jurisdictions outside the Territory, as they may be updated from time to time.

1.71. Good Laboratory Practices ” or “ GLP ” means the then-current good laboratory

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practice standards promulgated or endorsed by the FDA for nonclinical laboratory studies that support or are intended to support applications to conduct research on human subjects or to obtain regulatory approval, including as set forth in 21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside the Territory, as they may be updated from time to time.

1.72. Good Manufacturing Practices ” or “ GMP ” means the then-current good manufacturing practices required by the FDA, as set forth in the FFDCA for the manufacture and testing of pharmaceutical materials, including as set forth in 21 U.S.C. section 351 and 21 C.F.R. Parts 210 and 211, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the Territory, as they may be updated from time to time. Good Manufacturing Practices shall include applicable quality guidelines promulgated under the ICH.

1.73. ICC ” has the meaning set forth in Section 12.7(a).

1.74. ICC Rules ” has the meaning set forth in Section 12.7(a).

1.75. ICH ” means the International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use).

1.76. IND ” means an Investigational New Drug Application (including any amendments thereto) filed with the FDA pursuant to 21 C.F.R. §312 before commencement of clinical trials of a pharmaceutical product.

1.77. Indemnitee ” has the meaning set forth in Section 11.3(a).

1.78. Indemnitor ” has the meaning set forth in Section 11.3(a).

1.79. Indication ” means the diagnosis, treatment, prevention or amelioration of any disease or condition for which an NDA or similar regulatory filing may be filed and approved.

1.80. Initial Formulation ” means the pharmaceutical product in solid, oral tablet form containing the Compound as its sole active pharmaceutical agent as described in the Initial Product NDA as of the Effective Date.

1.81. Initial Product ” means the Initial Formulation as indicated for the Indication(s) that, as of the Effective Date, is (are) the subject of the Initial Product NDA (as the label resulting from such Initial Product NDA may be expanded or amended based upon any clinical data resulting from the BLOOM-DM Trial or any clinical data specific to the Initial Product existing as of the Effective Date).

1.82. Initial Product NDA ” means NDA22529.

1.83. Joint Development Committee ” or “ JDC ” has the meaning set forth in Section 4.1(a).

1.84. Know-How ” means all tangible and intangible scientific, technical, trade,

 

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financial or business information and materials, including compounds, compositions of matter, formulations, techniques, processes, methods, trade secrets, formulae, procedures, tests, data, results, analyses, documentation, reports, information (including pharmacological, toxicological, non-clinical (including chemistry, manufacturing and control)), and clinical test design, methods, protocols, data, results, analyses, and conclusions, quality assurance and quality control information, regulatory documentation, information and submissions pertaining to, or made in association with, filings with any Regulatory Authority, product life cycle management strategies, knowledge, know-how, skill, and experience, and all other discoveries, developments, inventions (whether or not confidential, proprietary, patented or patentable), and tangible embodiments of any of the foregoing.

1.85. Knowledge ” means, with respect to a particular statement to which such term is attributed, that none of the applicable Party’s or any of its Affiliates’ respective employees with the title of vice president or higher or in-house general counsel are aware of any facts or information that make such statement untrue after performing a reasonably diligent investigation with respect to such statement.

1.86. Launch Quantity ” has the meaning set forth in Section 7.2.

1.87. Losses ” has the meaning set forth in Section 11.1.

1.88. Manufacturing SOPs ” means, with respect to a particular Finished Product being supplied by Arena to Eisai under Article 6, the specific methods, techniques, processes and standard operating procedures (including Quality Control Procedures) that are used by or on behalf of Arena in manufacturing such Finished Product.

1.89. Manufacturing Working Group ” has the meaning set forth in Section 6.20.

1.90. Marketing Activities ” has the meaning set forth in Section 5.2(b).

1.91. Master Batch Records ” means the master batch records for Arena’s (or its designee’s) manufacturing of a specific Finished Product, as established in accordance with the Quality Agreement, including the applicable Manufacturing SOPs, the in-process testing and QA/QC testing for such Finished Product, which records are to be used in the manufacture by or on behalf of Arena of such Finished Product for supply to Eisai under Article 6.

1.92. Materials ” has the meaning set forth in Section 3.9.

1.93. Minimum Order Quantity ” has the meaning set forth in Section 6.2(a).

1.94. NDA ” means a New Drug Application as described in 21 C.F.R. § 314.50, et seq., and all amendments and supplements thereto, that is filed with the FDA, including all documents, data, and other information concerning the applicable product filed therewith.

1.95. Negative Covenant Period ” means the period that begins on the Effective Date and ends on the last day of the first Calendar Quarter commencing after the Patent Expiry Date in which the aggregate units of all Generic Versions of all Products sold in the Territory during such

 

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Calendar Quarter exceed […***…]% of the aggregate units of all Products and all Generic Versions of all Products sold in the Territory during such Calendar Quarter.

1.96. Net Sales ” means, with respect to a Product during any period, the gross invoiced sales price in US Dollars for all quantities of such Product sold by Eisai or any of its Affiliates to a Third Party during such period, less the following deductions to the extent actually incurred, allowed, or paid with respect to such sale by the selling party, using GAAP applied on a consistent basis:

(a) sales taxes or other taxes included in the gross invoiced sales price;

(b) credits or allowances given or made for rejection, recall or return of previously sold Product, in amounts not exceeding usual and customary reductions, or billing errors with respect to such Product;

(c) Retroactive Price Discounts;

(d) costs of outbound freight, insurance, and other transportation charges directly related to the distribution of such Product to the purchaser, to the extent separately set forth in the applicable invoice;

(e) quantity, cash and other trade discounts, or inventory management fees, including those generated as a result of distributor service agreements, in amounts not exceeding usual and customary discounts and fees; and

(f) rebates, credits, and chargeback payments (or the equivalent thereof) granted to managed health care organizations, wholesalers, or to federal, state, local and other governments, including their agencies, purchasers, or reimbursers, or to trade customers, in amounts not exceeding usual and customary amounts and calculated in accordance with GAAP.

In no event shall any particular amount of deduction, identified above, be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions). Each of the above deductions shall be substantially consistent with Eisai’s internal accounting policies as consistently applied by Eisai and its Affiliates in the Territory across its products at the time of sale. In no event shall the deductions with respect to Retroactive Price Discounts for any Calendar Quarter exceed 3% of the amount arrived at after deducting the items described in clauses (a), (b), (d), (e) and (f) above from the gross invoiced sales price in US Dollars for all quantities of such Product sold by Eisai or any of its Affiliates to a Third Party in the Territory during such Calendar Quarter; provided that any deductions for Retroactive Price Discounts not taken in any Calendar Quarter pursuant to this sentence shall be carried forward and applied in future Calendar Quarters. Eisai shall not, and shall cause its Affiliates not to, use any Product as a loss leader or otherwise unfairly or inappropriately discount the gross invoiced sales price of a Product in a manner that is intended to benefit, or provide an incentive to enhance sales of, any other pharmaceutical product sold by Eisai or any of its Affiliates. Sales of a Product between Eisai and any of its Affiliates for resale shall be excluded from the computation of Net Sales, but the subsequent resale of such Product to a Third Party shall be included within the computation of Net Sales.

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Notwithstanding anything to the contrary herein, the transfer, disposal or use of Product, without consideration, for marketing, regulatory, development or charitable purposes, such as clinical trials, preclinical trials, compassionate use, named patient use, or indigent patient programs, shall not be deemed a sale hereunder.

1.97. Non-Compete Period ” has the meaning set forth in Section 2.4(a).

1.98. Non-Conforming Finished Product ” has the meaning set forth in Section 6.11.

1.99. Non-Development Plan Development ” has the meaning set forth in Section 3.7.

1.100. Non-Required Development ” has the meaning set forth in Section 3.2(b)(i).

1.101. Notice Date ” has the meaning set forth in Section 12.7(b).

1.102. “[…***…]” has the meaning set forth in Section 3.3(e).

1.103. Order Acceptance ” has the meaning set forth in Section 6.2(b).

1.104. Order Commitment ” has the meaning set forth in Section 6.2(a).

1.105. OTC Product ” has the meaning set forth in Section 2.5.

1.106. Panel ” has the meaning set forth in Section 12.7(b).

1.107. Paragraph IV Notice ” has the meaning set forth in Section 9.3(c).

1.108. Party ” and “ Parties ” has the meaning set forth in the opening paragraph of this Agreement.

1.109. Patent(s) ” means (a) all patents, certificates of invention, applications for certificates of invention, priority patent filings and patent applications, including provisional patent applications, and (b) any renewal, division, continuation (in whole or in part), or request for continued examination of any of such patents, certificates of invention and patent applications, and any all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing.

1.110. Patent Expiry Date ” means the later of (a) the date on which the last issued Arena Patent expires and (b) 12 years after the First Commercial Sale of the first Product in the Territory.

1.111. Patent Term Extension ” means any term extensions, supplementary protection certificates, regulatory exclusivity and equivalents thereof offering patent protection beyond the initial term with respect to any issued Patents.

1.112. Payee Party ” has the meaning set forth in Section 7.8.

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1.113. Paying Party ” has the meaning set forth in Section 7.8.

1.114. Payment ” has the meaning set forth in Section 7.8.

1.115. Payment Report ” has the meaning set forth in Section 3.6(b).

1.116. Permissible Cost Overrun ” has the meaning set forth in Section 3.6(c)(ii).

1.117. Person ” means any individual, corporation, partnership, limited liability company, trust, governmental entity, or other legal entity of any nature whatsoever.

1.118. Post-Approval Required Development ” has the meaning set forth in Section 3.2.(a).

1.119. Pre-Approval Required Development ” has the meaning set forth in Section 3.2.(a).

1.120. Product ” means each of (a) the Initial Product and (b) each Additional Product.

1.121. Product Acceptance Tests ” means, with respect to a particular Finished Product being supplied by Arena to Eisai under Article 6, the specific tests (including release tests) to be used to determine whether such Finished Product manufactured by or on behalf of Arena conforms to the warranty set forth in Section 6.13, which tests the Parties shall establish (and amend from time to time if required) in accordance with the terms of the Quality Agreement.

1.122. Product Information ” has the meaning set forth in Section 8.1.

1.123. Product Liability Claim ” means any Third Party Claim brought against any Arena Indemnitee or Eisai Indemnitee arising from, based on or occurring as a result of personal injury, death or property damage (to the extent resulting from personal injury or death) caused by or resulting from the use of a Product (other than a Generic Version of such Product sold by Eisai or any of its Affiliates), except to the extent caused by or resulting from the actual negligence or actual willful misconduct of or actual violation of Applicable Laws by Eisai or any of its Affiliates or its or their subcontractors in performing any activity contemplated by this Agreement or any actual breach or actual default by Eisai (or any of its Affiliates) of this Agreement, the Quality Agreement or the PV Agreement.

1.124. Product Purchase Price ” has the meaning set forth in Section 7.3(a).

1.125. Product Purchase Price Adjustment Payment ” has the meaning set forth in Section 7.4.

1.126. Product Trademark ” has the meaning set forth in Section 9.9(a).

1.127. Program Know-How ” means any and all Know-How discovered, identified, conceived, reduced to practice or otherwise made, as necessary to establish authorship, inventorship or ownership under applicable United States law as such law exists as of the

 

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Effective Date irrespective of where such discovering, identifying, conception, reduction to practice or other making occurs, in the course of or as a result of or related to the development activities under this Agreement, including pursuant to a Development Plan, or any Commercialization activities to the extent such Know-How relates predominantly to the Commercialization of a Product and is not predominately applicable to the marketing, promoting, detailing, offering for sale, selling, distributing, or conducting other similar activities related to the commercial sale of pharmaceutical products generally (a) solely by one or more employees of or consultants to Arena or any of its Affiliates, (b) solely by one or more employees of or consultants to Eisai or any of its Affiliates, or (c) jointly by one or more employees of or consultants to Arena or any of its Affiliates, on the one hand, and one or more employees of or consultants to Eisai or any of its Affiliates, on the other hand; but excluding all Know-How discovered, identified, conceived, reduced to practice or otherwise made by or on behalf of Arena or any of its Affiliates pursuant to (x) any manufacturing activity relating to Compound or Product, or (y) any activities outside of a Development Plan.

1.128. Program Patent ” means any Patent that claims or covers any invention within the Program Know-How.

1.129. Proposed Product ” means (a) the Initial Formulation developed (or proposed to be developed) for Indication(s) that, as of the Effective Date, are not the subject of the Initial Product NDA (as the label resulting from such Initial Product NDA may be expanded or amended based upon any clinical data resulting from the BLOOM-DM Trial or any clinical data specific to the Initial Product existing as of the Effective Date) or (b) any pharmaceutical product containing the Compound or a Related Compound other than the Initial Product (including a pharmaceutical product that contains the Compound or a Related Compound as an active pharmaceutical agent together with one or more other active pharmaceutical agents).

1.130. Proposed Response ” has the meaning set forth in Section 6.16(b).

1.131. Purchase Order ” means a written order submitted by Eisai to Arena, in a form reasonably acceptable to Arena, for Arena to manufacture (or have manufactured) and deliver, and Eisai to purchase, a specific quantity of a particular Finished Product, as provided in Section 6.2(b).

1.132. PV Agreement ” means the pharmacovigilance agreement to be entered into by the Parties as provided in Section 3.15.

1.133. Quality Agreement ” means the agreement containing or referring to the agreed policies, procedures, and standards, which shall be customary and reasonable, by which the Parties will coordinate and implement the operational and quality assurance activities needed to efficiently achieve regulatory compliance objectives with respect to manufacturing and supply by Arena of the Finished Products.

1.134. Quality Control Procedures ” has the meaning set forth in Section 6.8.

1.135. Quarterly Report ” has the meaning set forth in Section 3.6(b).

 

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1.136. Receiving Party ” has the meaning set forth in Section 8.2.

1.137. Recipient ” has the meaning set forth in Section 8.2.

1.138. Reconciliation Payment ” has the meaning set forth in Section 7.3(c).

1.139. Regulatory Approval ” means, with respect to a Product, approval by the FDA of the NDA covering such Product in the Territory and, if applicable, all necessary approvals or authorizations by the U.S. Drug Enforcement Administration (or its successor) necessary to sell such Product in the Territory.

1.140. Regulatory Authority ” means any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity whose review, approval or authorization is necessary for the manufacture, packaging, use, storage, import, export, distribution, promotion, marketing, offer for sale or sale of a Product. In the event that after the Effective Date governmental approval becomes required for pricing or reimbursement for a Product in the Territory to be reimbursed by national health insurance (or its local equivalent), “Regulatory Authority” shall also include any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity whose approval or authorization of pricing or reimbursement is required.

1.141. Regulatory Filings ” means all applications, approvals, licenses, notifications, registrations, submissions and authorizations made to or received from a Regulatory Authority in the Territory necessary for the development, manufacture or commercialization of a pharmaceutical product, including any INDs, NDAs and Regulatory Approvals.

1.142. Regulatory Standards ” has the meaning set forth in Section 6.8.

1.143. Related Compound ” means (a) any known prodrug, known metabolite (having similar physiological activity as the Compound), or racemate or other optically active form of the Compound ( other than the Compound itself), (b) any free acid form or free base form of the Compound ( other than the Compound itself), (c) any compound that is claimed by claim 1 of U.S. Patent No. 6,953,787 and acts primarily as a 5HT2C agonist and has physiological activity similar to the Compound, or (d) any compound that is claimed by International Patent Publication No. WO 2005/003096 (as such claims are published as of the Effective Date).

1.144. Related Product ” means any pharmaceutical product that contains a Related Compound as a pharmaceutically active agent.

1.145. Remainder Period ” means the period during the Term after the Negative Covenant Period ends.

1.146. Responsible Party ” means (a) the Party designated, in the applicable Development Plan, as responsible for conducting the clinical trials or other development work (including regulatory activities) under such Development Plan in the Territory, or (b) with respect to regulatory activities in the Territory for a Product, the NDA holder for such Product after Regulatory Approval of such Product.

 

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1.147. Retroactive Price Discount ” means, with respect to a Product, a discount for such Product provided for in a contract entered into by Eisai or any of its Affiliates during any period stipulating a discounted contract price for such Product that is effective for Product purchased prior to the execution of such contract.

1.148. Safety Stock ” means, with respect to a Product and for each month during the Term commencing three months after the First Commercial Sale of such Product in the Territory, a quantity of the applicable Finished Product (as defined in Section 1.59(a)) equal to the aggregate quantity of such Finished Product forecasted to be ordered for the three months following such month in the Forecast most recently submitted by Eisai prior to such month, which Finished Product to qualify as Safety Stock during such month (a) must have been released pursuant to the Quality Agreement and (b) must meet the requirements of the warranty set forth in Section 6.13 at all times during such month.

1.149. SEC ” has the meaning set forth in Section 8.6(a).

1.150. Second Source ” has the meaning set forth in Section 6.6.

1.151. Senior Executives ” has the meaning set forth in Section 4.4(c).

1.152. Specifications ” means, with respect to a particular Finished Product, the specifications, characteristics, qualities and labeling and packaging requirements established in writing for such Finished Product, in accordance with the Quality Agreement and in conformance with the NDA for the applicable Product and Applicable Laws, with which such Finished Product must conform (including release criteria and associated analytical methods) when delivered by Arena to Eisai under Article 6, and as the same may be amended from time to time under the terms of the Quality Agreement.

1.153. Stand-Still Period ” has the meaning set forth in Section 8.9(a).

1.154. Subcommittee ” has the meaning set forth in Section 4.4(c).

1.155. Term ” has the meaning set forth in Section 12.1.

1.156. Territory ” means the United States of America and its territories and possessions, including Puerto Rico and the District of Columbia.

1.157. Testing Laboratory ” has the meaning set forth in Section 6.12.

1.158. Third Party ” means any Person other than Arena, Eisai and their respective Affiliates.

1.159. Third Party Claim ” has the meaning set forth in Section 11.1.

1.160. Trademark ” means any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered.

 

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1.161. U.S. Package Insert ” means, with respect to a Product in the Territory, (a) any display of written, printed or graphic matter affixed upon the immediate container, outside container, wrapper or other packaging of such Product in the Territory or (b) any written, printed or graphic material on or within the package from which such Product is to be dispensed in the Territory.

1.162. Voting Stock ” has the meaning set forth in the definition of “Change of Control”.

1.163. Wind-down Period ” means any period after the date of termination of this Agreement during which the Parties are required to wind-down or transition development activities pursuant to Section 13.2(a) and, if applicable, Eisai is required to wind-down Commercialization activities pursuant to Section 13.2(e).

Article 2.

EXCLUSIVE DISTRIBUTORSHIP

2.1. Appointment of Eisai as Exclusive Distributor in Territory. Subject to the terms and conditions of this Agreement, Arena hereby appoints Eisai (a) during the Negative Covenant Period, as the exclusive distributor of the Initial Product and any and all Additional Products in the Territory and grants to Eisai during the Negative Covenant Period the exclusive rights to Commercialize the Initial Product and any and all Additional Products in the Territory and (b) during the Remainder Period, as the exclusive distributor of the Initial Product and any and all Additional Products in the Territory under the Product Trademarks and grants to Eisai during the Remainder Period the exclusive rights to Commercialize the Initial Product and any and all Additional Products in the Territory under the Product Trademarks. Eisai shall have the exclusive right to invoice and book (x) during the Negative Covenant Period, all Product sales in the Territory and (y) during the Remainder Period, all sales of Product sold under the Product Trademarks in the Territory. As between the Parties, Arena and its Affiliates shall retain the exclusive right to commercialize Products outside the Territory.

2.2. Supply of Product for Distributorship. Arena shall supply (or have supplied) to Eisai, and Eisai shall purchase exclusively from Arena, its requirements of the Initial Product (and, if applicable, each Additional Product) for sale by Eisai or its Affiliates in the Territory pursuant to Section 2.1, subject to and under the provisions of Article 6. Eisai shall purchase all such amounts of Product supplied by Arena under the payment provisions of Section 7.3 and Section 7.4.

2.3. Negative Covenants.

(a) Arena hereby covenants and agrees that during the Negative Covenant Period it shall not, and shall cause its Affiliates not to (i) (A) file an NDA, a BLA or any equivalent thereof for, market, promote, detail, offer for sale, sell, distribute or conduct any other similar activities related to the commercial sale of, any Compound Product or Related Product in the Territory or (B) knowingly sell any Product or other Compound Product or Related Product to any Person outside the Territory that Arena or any of its Affiliates knows intends to resell such

 

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Product or other Compound Product or Related Product inside the Territory, (ii) license, authorize, appoint or assist any Third Party to (A) file an NDA, a BLA or any equivalent thereof for, market, promote, detail, offer for sale, sell, distribute or conduct any other similar activities related to the commercial sale of, any Compound Product or Related Product in the Territory or (B) knowingly sell any Product or other Compound Product or Related Product to any Person outside the Territory that such Third Party knows intends to resell such Product or other Compound Product or Related Product inside the Territory. During the Negative Covenant Period, Arena shall, and shall cause its Affiliates and each Arena ex-US Distributor (for so long as such Arena ex-US Distributor remains an Arena ex-US Distributor) to, use Commercially Reasonable Efforts to prevent Third Parties from reselling the Products or other Compound Products or Related Products inside the Territory, including by obtaining from each Arena ex-US Distributor an undertaking at least as restrictive as the foregoing clause (i)(B) is with respect to Arena and using Commercially Reasonable Efforts to enforce each such undertaking. If Arena receives any order for a Product from a prospective purchaser located in the Territory, Arena shall promptly notify Eisai in writing. Arena shall not accept any such orders. Subject to Section 2.3(c), the foregoing shall not restrict Arena or its Affiliates or Arena ex-US Distributors from conducting any research or development, including clinical development, of Compound Products or Related Products.

(b) Notwithstanding anything in this Agreement to the contrary, Eisai acknowledges and agrees that certain advertising, promotion or marketing of the Products or other Compound Products or Related Products, including the advertising, promotion and marketing of the Products or other Compound Products or Related Products through the use of the internet and pan-regional print advertisements and at conferences and seminars held outside the Territory, may reach Persons in the Territory, and Arena shall not be in breach of this Agreement so long as (i) the objective of such advertising, promotion or marketing is to reach Persons outside the Territory or otherwise to promote sales of the Products or other Compound Products or Related Products (as applicable) outside the Territory, and (ii) the receipt by Persons located inside the Territory of such advertising, promotion or marketing of the Products or other Compound Products or Related Products is merely incidental to the objectives of such advertising, promotion or marketing. In the event that Arena (or any of its Affiliates or Arena ex-US Distributors) desires to attend and give presentations (including seminars, “poster-board” presentations, and industry booths) regarding the Products or other Compound Products or Related Products at conferences or seminars and the like in the Territory, Arena shall notify the JDC of such desire and the JDC (or any applicable Subcommittee) shall review and discuss such proposed presentation; provided, that (A) Arena shall not, and shall cause its Affiliates and Arena ex-US Distributors not to, attend or give any such presentations in the Territory without the prior written consent of Eisai, which consent shall not be unreasonably conditioned, withheld or delayed and (B) any such presentation shall comply with Applicable Laws and be consistent with the applicable rules and regulations of the applicable conference or seminar. Further, Eisai acknowledges that certain Products sold to distributors outside the Territory and intended for resale to end users outside the Territory may end up being resold (through, for example, an internet sales channel) to end users in the Territory, and that Arena shall not be in breach of this Agreement based on such resales so long as Arena (or any of its Affiliates) does not authorize such resales into the Territory and complies with its obligations set forth in Section 2.3(a).

 

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(c) Arena hereby covenants and agrees that it shall not, and it shall cause its Affiliates and the Arena ex-US Distributors not to, conduct any clinical trials or other material development work with respect to a Compound Product or a Related Product outside the Territory without first complying with the provisions of Section 3.2(c) or Section 3.3, as applicable.

(d) Eisai hereby covenants and agrees that it shall not, and it shall cause its Affiliates not to, purchase any Compound or Related Compound from any Third Party, or market, promote, detail, offer for sale, sell, distribute or conduct other similar activities related to the commercial sale of any Compound Product or Related Product during the Term that was not purchased from Arena.

(e) Eisai hereby covenants and agrees that it shall not, and shall cause its Affiliates not to, either directly or indirectly, market, promote, detail, offer for sale, sell or distribute, or conduct any other similar activities related to the commercial sale of, any Product or Related Product in countries outside the Territory. As to such countries outside the Territory, Eisai shall not, and shall cause its Affiliates not to: (i) engage in any advertising or promotional activities relating to any such Product or Related Product directed primarily to customers or other buyers or users of such Product or Related Product located in such countries; or (ii) solicit orders from any prospective purchaser located in such countries. Eisai hereby covenants and agrees that it shall not, and shall cause its Affiliates not to, knowingly sell any Product or Related Product to any Person inside the Territory that Eisai or any of its Affiliates, as applicable, knows intends to resell such Product or Related Product outside the Territory. If Eisai receives any order for any such Product or Related Product from a prospective purchaser located in a country outside the Territory, Eisai shall promptly notify Arena in writing. Eisai shall not accept any such orders. Notwithstanding anything in this Agreement to the contrary, Arena acknowledges and agrees that certain advertising, promotion or marketing of the Products, including the advertising, promotion and marketing of the Products through the use of the internet and pan-regional print advertisements and at conferences and seminars held in the Territory, may reach Persons outside the Territory, and Eisai shall not be in breach of this Agreement so long as (1) the objective of such advertising, promotion or marketing is to reach Persons within the Territory or otherwise to promote sales of the Products within the Territory, and (2) the receipt by Persons located outside the Territory of such advertising, promotion or marketing of the Product is merely incidental to the objectives of such advertising, promotion or marketing. Eisai shall not, and shall cause its Affiliates not to, conduct any medical affairs activities, including attending and giving presentations at conferences and seminars and the like (including “poster-board” presentations and industry booths), with respect to any Product or Related Product outside the Territory without the prior written consent of Arena, which consent shall not be unreasonably conditioned, withheld or delayed.

2.4. Non-Compete Covenants.

(a) Each Party shall not, and shall cause its Affiliates not to, file an NDA, a BLA or any equivalent thereof for, market, promote, detail, offer for sale, sell or distribute, or conduct other similar activities related to the commercial sale of, a Competing Product in the Territory during the period commencing on the Effective Date and ending 12 years after the First

 

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Commercial Sale of the first Product (the “ Non-Compete Period ”); provided that a product that receives Regulatory Approval for an addiction disorder Indication shall no longer be deemed a Competing Product ( provided that such product does not otherwise meet the definition of “Competing Product”) upon the later of (i) five years after the Effective Date and (ii) if the Parties agree during such five-year period to develop an Additional Product for an addiction disorder Indication, the date when the Parties are no longer developing (i.e., have not conducted any activity under a Development Plan for six months) or Commercializing any Additional Product for an addiction disorder Indication under this Agreement.

(b) Notwithstanding Section 2.4(a), Arena shall not be in breach of Section 2.4(a) by virtue of any Person filing an NDA, a BLA or any equivalent thereof for, marketing, promoting, detailing, offering for sale, selling or distributing, or conducting other similar activities related to the commercial sale of, any Competing Product in the Territory (a “ Competing Program ”), which Person becomes an Affiliate of Arena through a Change of Control of Arena during the Non-Compete Period; provided, that Arena notifies Eisai in writing promptly after the closing of such Change of Control of Arena. In the event of any such Change of Control of Arena during the Non-Compete Period where such Affiliate has a Competing Program, if such Affiliate does not cease such Competing Program entirely (whether by a divestiture of such Competing Program in a transaction where Arena and its Affiliates retain no interest in the divested Competing Program, or otherwise) within six months after such Change of Control, then after the end of such six-month period (during which Arena or such Affiliate, as the case may be, shall be permitted to file an NDA, a BLA or any equivalent thereof for, market, promote, detail, offer for sale, sell and distribute, and conduct other similar activities related to the commercial sale of, the applicable Competing Product in the Territory) Eisai shall have final decision-making authority with respect to all decisions regarding each Development Plan pursuant to Section 4.4(b) for so long as such Competing Program continues, including whether or not to enter into such Development Plan, except that Eisai may not (i) obligate Arena to (A) perform any clinical trials or development work other than the Pre-Approval Required Development and the Post-Approval Required Development or (B) perform or fund any clinical trials or other development work for which a Development Plan does not exist as of the date of such Change of Control or (ii) amend any existing Development Plan in a manner that imposes additional economic obligations on Arena.

(c) Notwithstanding Section 2.4(a), if Eisai would violate the provisions of Section 2.4(a) by virtue of (i) any Person having a Competing Program becoming an Affiliate of Eisai during the Non-Compete Period through a Change of Control of Eisai, then Eisai shall, at its election: (A) terminate this Agreement upon 90 days’ notice to Arena (which notice, if given, must be given within 60 days after such Change of Control) or (B) cease entirely, or cause its applicable Affiliate to cease entirely, such Competing Program (whether by a divestiture of such Competing Program in a transaction where Eisai and its Affiliates retain no interest in the divested Competing Program, or otherwise) within six months after such Change of Control; provided, that in any case Eisai or such Affiliate, as the case may be, shall be permitted to file an NDA, a BLA or any equivalent thereof for, market, promote, detail, offer for sale, sell or distribute, and conduct other similar activities related to the commercial sale of, the applicable Competing Product in the Territory during such six-month period; and provided, further, that Eisai’s obligations under Article 5 shall remain in effect during such six-month period, or (ii) (A)

 

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any Person having a Competing Program becoming an Affiliate of Eisai during the Non-Compete Period through an acquisition of such Person by Eisai or any of its Affiliates or a merger or consolidation with such Person (including merger by a subsidiary of such Person) by Eisai or any of its Affiliates, which transaction does not result in a Change of Control of Eisai or (B) the acquisition by Eisai or any of its Affiliates of all or substantially all of the assets of a Person having a Competing Program, then in each case ((A) and (B)) Eisai shall cease entirely, or cause its applicable Affiliate to cease entirely, such Competing Program (whether by a divestiture of such Competing Program in a transaction where Eisai and its Affiliates retain no interest in the divested Competing Program, or otherwise) within six months after such transaction; provided, that in any case Eisai or such Affiliate, as the case may be, shall be permitted to file an NDA, a BLA or any equivalent thereof for, market, promote, detail, offer for sale, sell or distribute, and conduct other similar activities related to the commercial sale of, the applicable Competing Product in the Territory during such six-month period; and provided, further, that Eisai’s obligations under Article 5 shall remain in effect during such six-month period, and in each case ((i) and (ii)) Eisai shall not be in breach of Section 2.4(a) if it complies with the terms of this Section 2.4(c).

2.5. OTC Covenant. In the event that after the Negative Covenant Period Arena desires to market, promote, offer for sale, sell, import or distribute in the Territory any Product to be sold directly to consumers without a prescription or other authorization from a physician, nurse practitioner, pharmacist, physician assistant or other healthcare provider (such Product, an “ OTC Product ”) either itself or through an Affiliate or Third Party, then Arena shall notify Eisai of such desire, and if Eisai desires to obtain the rights to market, promote, offer for sale, sell, import or distribute such OTC Product in the Territory, then Eisai shall notify Arena thereof within 30 days after receipt of such notice from Arena and the Parties shall in good faith seek to reach agreement, within 180 days after Eisai so notifies Arena, on the terms under which Eisai would have the rights to market, promote, offer for sale, sell, import or distribute such OTC Product in the Territory, provided that it is understood that neither Party shall have any obligation to enter into any such agreement except on terms that are acceptable to such Party, or to continue such negotiations beyond the end of such period. If the Parties do not enter into such an agreement within such 180-day period, then, notwithstanding anything to the contrary in this Agreement, Arena shall have the right to market, promote, offer for sale, sell, import or distribute such OTC Product in the Territory either itself or through an Affiliate or Third Party without obligation to Eisai; provided, that such OTC Product is not sold under a Product Trademark.

Article 3.

PRODUCT DEVELOPMENT AND REGULATORY ACTIVITIES

3.1. Overview of Product Development. Arena US has filed the Initial Product NDA with the FDA, and Arena shall be responsible (as provided in Section 3.10(a)) for conducting, or causing Arena US to conduct, the regulatory activities with respect to the FDA for the Initial Product through achievement of initial Regulatory Approval for the Initial Product. If the FDA requires additional clinical trials or other development work on the Initial Product to obtain or maintain such Regulatory Approval (such as a required Phase 4 clinical trial or outcome study), or if the Parties agree to conduct other additional clinical trials or other development work on the

 

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Initial Product after such Regulatory Approval (such as to expand the labeling for the Initial Product in the Territory), such clinical trials or other development work shall be conducted as provided in Section 3.2(a) and (b), respectively. Further, if the Parties agree, pursuant to Section 3.3, to develop an Additional Product, any clinical trials and other development work with respect to such Additional Product shall be conducted by the Parties pursuant to a Development Plan established by the Parties for such Additional Product under Section 3.4 and shall be funded by the Parties according to the Parties’ agreement under Section 3.3 with respect to such Additional Product.

3.2. Further Development of the Initial Product.

(a) Required Development. If (i) the FDA requires that additional clinical trials or other development work be conducted on the Initial Product as a condition of and prior to approving the Initial Product NDA (such required clinical trials or other development work, “ Pre-Approval Required Development ”) or (ii) the FDA requires additional clinical trials or other development work on the Initial Product after approval of the Initial Product NDA to obtain or maintain such Regulatory Approval in the Territory (such required clinical trials or other development work, “ Post-Approval Required Development ”), the holder of the Initial Product NDA (or one of its Affiliates) shall notify the other Party of such Pre-Approval Required Development or Post-Approval Required Development, as applicable, and the Parties shall, through the JDC, promptly meet to discuss in good faith and seek to agree on the Development Plan (consistent with Section 3.4) for such Pre-Approval Required Development or Post-Approval Required Development, as applicable; provided, that, unless the Parties otherwise agree in writing: (W) Arena shall be obligated to conduct, or cause one of its Affiliates to conduct, such Pre-Approval Required Development or Post-Approval Required Development, as applicable; (X) subject to Section 4.4(b), Arena shall have final decision-making authority with respect to the Development Plan for such Pre-Approval Required Development or Post-Approval Required Development, as applicable, if the Senior Executives are any unable to resolve any dispute with respect thereto pursuant to Section 4.4(b), except that the Development Expenses with respect to such Pre-Approval Required Development or Post-Approval Required Development, as applicable, shall be allocated between the Parties as set forth in clause (Y) or clause (Z) below, as applicable, and except that if Eisai does not approve the use of Arena FTEs (such approval not to be unreasonably conditioned, withheld or delayed), Arena shall have the right to use such FTEs at its own expense in conducting such development work, with the costs of such FTEs not included in Development Expenses; (Y) the Parties shall share equally the Development Expenses with respect to any Pre-Approval Required Development; and (Z) Eisai shall bear 90% and Arena shall bear 10% of the Development Expenses with respect to any Post-Approval Required Development (including any required Phase 4 clinical trial or outcomes studies), except that the Parties shall share equally the Development Expenses with respect to pediatric or adolescent studies under Section 505A of the FFDCA (21 U.S.C. § 335a). For clarity, pediatric or adolescent studies under Section 505A of the FFDCA (21 U.S.C. § 335a) with respect to the Initial Product shall be deemed Post-Approval Required Development. Notwithstanding the foregoing, Arena shall be solely responsible for conducting, at its sole expense, the BLOOM-DM Trial and shall use Commercially Reasonable Efforts to achieve database lock for the BLOOM-DM Trial as soon as reasonably practicable after the Effective Date. Arena shall, or shall cause one of its Affiliates to, report the results of all clinical trials

 

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with respect to a Compound or a Product commenced by Arena or any of its Affiliates prior to the Effective Date to the appropriate registry or database (e.g., clinicaltrials.gov) in accordance with Applicable Laws. No Development Plan shall be required for the BLOOM-DM Trial.

(b) Non-Required Development.

(i) If either Party desires to conduct additional clinical trials or other development work on the Initial Product to enhance or expand the Regulatory Approval for the Initial Product in the Territory beyond the scope of the Initial Product NDA (but not for a new Indication), or for the purpose of enhancing scientific knowledge and understanding of the clinical utility of the Initial Product, or for any other appropriate purposes that is not Pre-Approval Required Development or Post-Approval Required Development (“ Non-Required Development ”), the Party desiring to conduct such Non-Required Development shall promptly notify the other Party, and the Parties shall promptly meet to discuss in good faith and seek to agree on the terms under which the Parties would conduct such Non-Required Development, including (A) the Parties’ responsibilities for conducting such Non-Required Development and (B) the sharing of Development Expenses with respect to such Non-Required Development and, if the Parties agree on such terms, the Parties shall, through the JDC, establish a Development Plan for such Non-Required Development consistent with Section 3.4. For clarity, development of the Initial Formulation for Indications other than the Indications that, as of the Effective Date, are the subject of the Initial Product NDA shall not be considered Non-Required Development and shall instead, to the extent agreed under Section 3.3, be considered development of an Additional Product; provided that a label expansion or amendment for the Initial Product based on results of the BLOOM-DM Trial or any clinical data specific to the Initial Product existing as of the Effective Date shall not be considered an Additional Product.

(ii) If the Parties, through the JDC, fail to agree on a Development Plan covering any Non-Required Development within a reasonable time period (not to exceed 90 days after notice from the applicable Party), Arena shall have the right, but not the obligation, to conduct such Non-Required Development at its own expense and in its sole discretion subject to Section 3.7.

(iii) Neither Party shall be required to conduct or fund any Non-Required Development, except as set forth in a Development Plan.

(c) For Use Outside the Territory.

(i) If Arena (or any of its Affiliates, Arena ex-US Distributors or other Third Party on behalf of Arena) intends to conduct any clinical trials or other development work on the Initial Product for use in obtaining, maintaining, or expanding the registration, labeling or regulatory approval for the Initial Product in any country or jurisdiction outside the Territory, or for the purpose of enhancing scientific knowledge and understanding of the clinical utility of the Initial Product, or for any other appropriate purposes (“ Ex-Territory Development ”), Arena shall provide written notice, including a reasonable summary of such proposed clinical trials or other development work, of such Ex-Territory Development to Eisai.

 

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(ii) If requested by Eisai, the Parties shall promptly meet to discuss in good faith and seek to agree on the terms under which Eisai would participate in such Ex-Territory Development, including (A) the Parties’ responsibilities for conducting such Ex-Territory Development and (B) the sharing of Development Expenses with respect to such Ex-Territory Development and, if the Parties agree on such terms, the Parties shall establish, through the JDC, a Development Plan for such Ex-Territory Development consistent with Section 3.4.

3.3. Selection and Development of Additional Products.

(a) If Arena, any of its Affiliates, or any actual or potential Arena ex-US Distributor, clinically develops (or intends to initiate clinical development of) a Proposed Product anywhere in the world, then Arena shall give Eisai written notice describing such Proposed Product and, to the extent Arena or its applicable Affiliate has the right to do so under any applicable agreement with an actual or potential Arena ex-US Distributor, the intended development plan with respect thereto in reasonable detail.

(b) If Eisai desires that the Parties clinically develop a Proposed Product so that Eisai would obtain the rights under this Agreement to Commercialize such Proposed Product (if approved) in the Territory, then Eisai shall give Arena written notice describing such Proposed Product and the intended development plan with respect thereto in reasonable detail. Arena shall have the right to disclose such intended development plan to its Affiliates and Arena ex-US Distributors.

(c) If, (i) with respect to Section 3.3(a), Eisai desires to obtain the rights under this Agreement to Commercialize such Proposed Product (if approved) in the Territory or (ii) with respect to Section 3.3(b), Arena desires that the Parties clinically develop such Proposed Product, then in either case ((i) or (ii)), on written request from Eisai (with respect to Section 3.3(a)) or Arena (with respect to Section 3.3(b)), as applicable, the Parties shall, subject to Section 3.3(e) and Section 3.3(f) (if applicable), negotiate reasonably and in good faith and seek to agree on the terms under which such Proposed Product would become an Additional Product, including (A) the terms of the development of such Proposed Product, including (1) the Parties’ responsibilities for conducting the development of such Proposed Product and (2) the sharing of Development Expenses with respect thereto and (B) if such Proposed Product receives Regulatory Approval in the Territory, the terms pursuant to which Arena would grant Eisai the exclusive right to Commercialize such Proposed Product in the Territory, which terms shall be consistent with Section 3.3(e) and Section 3.3(f) (if applicable) and otherwise commercially reasonable given the product opportunity. If the Parties agree on such terms, the terms shall be reflected in a written amendment to this Agreement entered into by both Parties pursuant to Section 15.5, and upon the effectiveness of such amendment, such Proposed Product shall be deemed an Additional Product. It is understood and agreed that, notwithstanding the foregoing, Arena is bound by the terms of Section 2.3, whether or not the Parties agree on any amendment concerning any such Proposed Product.

(d) With respect to each Additional Product, the Parties shall, through the JDC, promptly establish the Development Plan covering the clinical trials and other development work for such Additional Product in the Territory through Regulatory Approval, which

 

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Development Plan shall include an agreed allocation of sharing by the Parties of the applicable Development Expenses.

(e) If the Parties agree to a Development Plan with respect to an Additional Product that (i) is a Product in a […***…] that contains the Compound as its sole active pharmaceutical agent (the “[…***…]”) or (ii) if approved, would be the first Additional Product that receives Regulatory Approval in the Territory for an Indication […***…], in each case ((i) and (ii)), the Parties shall share equally the Development Expenses incurred by the Parties under each such Development Plan.

(f) The Product Purchase Price payable by Eisai to Arena with respect to the […***…] and the first Additional Product that receives Regulatory Approval in the Territory for an Indication […***…] shall be the same percentage of Net Sales of such Product as the Product Purchase Price payable with respect to the Initial Product (unless such Additional Product contains a proprietary active pharmaceutical agent of Arena or Eisai in addition to the Compound), and no milestones other than those set forth in Section 7.2 as of the Effective Date shall be payable with respect thereto.

(g) Subject to Section 2.3, if the Parties fail to agree under Section 3.3(c) on the terms under which a Proposed Product would become an Additional Product within a reasonable time period (not to exceed 90 days after receipt of notice under Section 3.3(a) or Section 3.3(b), as applicable), Arena (including its Affiliates or Arena ex-US Distributors) shall have the right, but not the obligation, to perform any clinical trials or other development work with respect to such Proposed Product, subject to Section 3.7.

3.4. Development Plans.

(a) Any clinical studies or other development work to be conducted by the Parties under this Agreement on the Initial Product or an Additional Product shall be conducted pursuant to an agreed Development Plan established under this Section 3.4. Each such Development Plan shall: (i) describe in appropriate detail the clinical trials or other development work to be conducted (including the protocol, the statistical analysis plan and related documents for any clinical trials); (ii) allocate to each Party the specific clinical trials or other development work to be conducted by such Party; (iii) identify whether clinical trials and other development work will be conducted by a Party’s FTEs or by a contract research organization or other Third Party (and, if applicable, which Party shall have the responsibility for managing and supervising such contract research organization or other Third Party); (iv) establish a timeline and budget for such clinical trials or other development work; (v) allocate to each Party the regulatory activities to be performed by such Party; (vi) allocate the safety reporting responsibilities with respect to any clinical trial included in such Development Plan; and (vii) address any other material matter relating to such clinical trials or other development work.

(b) The Parties shall discuss and establish each such Development Plan through the JDC, and the Parties shall in all cases seek in good faith to establish Development Plans that provide for maximum efficiency in the worldwide development of the applicable Products, with the goal of obtaining quickly and efficiently the clinical data (for each Product)

***Confidential Treatment Requested

 

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that is useful, both in the Territory and in countries and jurisdictions outside the Territory, in seeking registrations and regulatory approvals of such Product; provided, that, Eisai shall have no obligation with respect to the costs and expenses for clinical trials and development work for a Product to the extent related solely to countries and jurisdictions outside the Territory, unless agreed to by Eisai pursuant to Section 3.2(c)(ii) or Section 3.3(c).

(c) The JDC also shall review and consider the existing Development Plans, in light of the clinical trials and other development work conducted, and discuss and seek to agree on any needed or appropriate changes or modifications to the Development Plans on an ongoing basis, and in no event less frequently than once each Calendar Quarter. All material changes to the Development Plans shall be subject to approval by the JDC.

3.5. Conduct of Development Activities.

(a) Compliance with Development Plan and Applicable Laws. Each Party shall conduct the clinical trials and other development work for which it is the Responsible Party under each Development Plan (i) in accordance with the applicable Development Plan (including the applicable budget contained therein, except as otherwise provided in Section 3.6(c)) and this Agreement and (ii) in compliance with all Applicable Laws and in accordance with GLP and GCP under the Applicable Laws of the country in which such activities are conducted. The Responsible Party with respect to a clinical trial conducted under a Development Plan shall (or, if the Responsible Party is not the sponsor of such clinical trial, the Responsible Party shall cause the sponsor of such clinical trial to) register such clinical trial on and report the results of such clinical trial to the appropriate registry or database (e.g., clinicaltrials.gov) in accordance with Applicable Laws.

(b) Diligence. Each Party shall use Commercially Reasonable Efforts to conduct and complete the clinical trials and other development work for which it is the Responsible Party under each Development Plan in order to achieve the goals of such Development Plan in accordance with the timelines specified therein and substantially within the established budget. Without limiting the foregoing, each Party shall proceed diligently and in a timely manner with respect to the clinical trials and other development work for which it is the Responsible Party under each Development Plan by using its good faith efforts to allocate sufficient time, effort, equipment and facilities to such clinical trials and other development work and to use personnel with sufficient skills and experience as are required to accomplish such clinical trials and other development work in accordance with such Development Plan and the terms and conditions of this Agreement.

(c) Information Regarding Development Activities. Each Party shall maintain, or cause to be maintained, records of the clinical trials and other development work for which it is the Responsible Party, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved by or on behalf of such Party in the performance of such clinical trials and other development work under the Development Plans. Each Party shall retain such records for at least five years after the Term, or for such longer period as may be required by Applicable Laws. Each Party shall keep the other Party appropriately informed of the status and results of the

 

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clinical trials and other development work with respect to each Product for which it is the Responsible Party under any Development Plan. Upon reasonable request by a Party, without limiting the foregoing, the other Party shall provide the requesting Party, according to a reasonable time frame, with summaries of data and results and other Program Know-How resulting from such clinical trials or other development work and, if requested by the requesting Party, shall provide access to all supporting data and results and other Program Know-How generated or obtained in the course of such other Party’s performance of the clinical trials or other development work for which such other Party is the Responsible Party under any Development Plan. Upon reasonable prior written notice, each Party shall have the right to inspect and copy any such records and notebooks reflecting the work done and results achieved under a Development Plan by or on behalf of the other Party or its Affiliates in the performance of such other Party’s clinical trials and other development work with respect to Compounds, Related Compounds or Products.

(d) Limited License. Subject to the terms and conditions of this Agreement, Arena hereby grants to Eisai and its Affiliates a non-exclusive, royalty-free, limited license in the Territory under the applicable Arena Know-How and Program Know-How solely as necessary to conduct the clinical trials and other development work under the Development Plans for which Eisai is the Responsible Party to develop each Product for use in the Territory pursuant to this Agreement, and to perform the regulatory activities for the Products in the Territory for which Eisai is the Responsible Party.

3.6. Development Expenses.

(a) Sharing of Expenses. With respect to all clinical trials and other development work conducted by the Parties under a Development Plan, each Party shall be responsible for its agreed share of all Development Expenses incurred by the Parties under such Development Plan, to the extent such Development Expenses are, subject to Section 3.6(c), in accordance with the budget in such Development Plan (or are otherwise agreed in writing by the Parties to be included within such cost sharing).

(b) Payment. Within 15 days after the end of each Calendar Quarter, each Party shall provide a written report (each, a “ Quarterly Report ”) to the other Party setting forth in reasonable detail the Development Expenses (together with the evidence supporting such Development Expenses) incurred by such Party during such Calendar Quarter in conducting the clinical trials and other development work for which it is the Responsible Party under each Development Plan. Within 10 days after each Party has provided the other Party its Quarterly Report for a Calendar Quarter, the Parties shall confer and agree on a written report based upon the Quarterly Reports for such Calendar Quarter (each, a “ Payment Report ”) setting forth the amount payable by Eisai to Arena or the amount payable by Arena to Eisai, so that each of the Parties has borne its respective share (as set forth in the applicable Development Plan) of all the Development Expenses incurred by the Parties in such Calendar Quarter. The applicable Party shall pay the amount shown to be due to the other Party as set forth in the Payment Report within 20 days after the Parties agree on such Payment Report.

(c) Cost Overruns.

 

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(i) Each Party shall promptly inform the JDC upon such Party’s determining that it is likely to overspend the budgeted costs and expenses set forth in a Development Plan for any Calendar Year with respect to any clinical trials or other development work for which it is the Responsible Party (such overspend, a “ Cost Overrun ”) and the JDC shall promptly hold an an-hoc meeting and shall discuss reasonably and in good faith what steps to take to address the Cost Overrun (which may include modifying the Development Plan to reduce the costs appropriately or increasing the budget for such clinical trial or other development work so that there is no longer a Cost Overrun). To the extent that any such anticipated Cost Overrun is caused by matters outside of such Responsible Party’s reasonable control (including, for example, changes in circumstances, regulatory delays, inaccuracies in the original development budget for the tasks or in the assumptions on which the budget was based), then such Responsible Party shall also include in its notice to the JDC of such Cost Overrun, the cause(s) of such anticipated Cost Overrun, and the JDC shall discuss such budget issue in good faith and seek to modify the applicable Development Plan in a manner so that there is no longer a Cost Overrun. Any resulting modifications to the applicable budget in a Development Plan approved by the JDC to address a Cost Overrun shall be included as an amendment to the budget in such Development Plan. Each Party shall not knowingly perform, and shall not have the obligation to perform, any clinical trials or development work that likely will result in a Cost Overrun until such issue and related expenditure have been reviewed and approved by the JDC; provided that if a Party determines after commencing an activity that cannot reasonably be ceased (such as an ongoing clinical trial that cannot be interrupted without jeopardizing the well-being of any subject in such clinical trial or the timing or integrity of such trial), that a Cost Overrun is likely for such activity, such Party shall have the right to continue such activity upon notice to the JDC, and the JDC shall attempt in good faith to address such Cost Overrun as soon as reasonably practicable.

(ii) Permissible Cost Overrun ” means, with respect to any clinical trial or other development work, a Cost Overrun (i) that either (A) does not exceed 10% of the budgeted costs and expenses set forth in the Development Plan for such clinical trial or other development work for the applicable Calendar Year or (B) was outside the reasonable control of the Responsible Party with respect to such clinical trial or other development work and not attributable to a failure by such Responsible Party to use Commercially Reasonable Efforts or did not result from the failure of such Responsible Party to adequately supervise a Third Party performing such clinical trial or other development work or from other negligence on the part of such Responsible Party with respect to such clinical trial or other development work and (ii) of which the Responsible Party with respect thereto promptly notifies the other Party and uses reasonable efforts to mitigate the size of such Cost Overrun. If and to the extent a Party experiences a Permissible Cost Overrun with respect to any clinical trials or other development work for which it is the Responsible Party, the Parties shall share such Permissible Cost Overrun in the same proportion as the Parties share Development Expenses under the applicable Development Plan. To the extent that any Cost Overrun is not a Permissible Cost Overrun, such Cost Overrun shall be solely borne by the Responsible Party with respect to such clinical trial or other development work. If there is a dispute as to whether any Cost Overrun (X) is attributable to a Party or (Y) represents a Permissible Cost Overrun, then at the election of either Party, such dispute shall be submitted to the JDC for resolution pursuant to Section 4.4(b).

 

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(iii) In the event that a Permissible Cost Overrun with respect to a clinical trial or other development work exceeds 20% of the budgeted costs and expenses set forth in the Development Plan for such clinical trial or other development work for the applicable Calendar Year, then the Party that is not the Responsible Party with respect to such clinical trial or other development work may elect not to continue funding its share of the Permissible Cost Overrun that exceeds 20% of the budgeted costs and expenses set forth in the Development Plan for such clinical trial or other development work for the applicable Calendar Year upon written notice to the Responsible Party, in which case the Responsible Party shall have the option, in its sole discretion, to either (A) continue to conduct such clinical trial or other development work and be solely responsible for the portion of the Permissible Cost Overrun that exceeds 20% of the budgeted costs and expenses set forth in the Development Plan for such clinical trial or other development work or (B) cease conducting such clinical trial or other development work, in which case the Parties shall share the reasonable and documented costs and expenses of winding-down such clinical trial or other development work in the same proportion as the Parties’ share the Development Expenses with respect thereto.

(d) Records. Each Party shall keep, and cause its Affiliates to keep, complete, true and accurate books of accounts and records of Development Expenses incurred by such Party for the purpose of confirming the proper allocation of Development Expenses pursuant to Section 3.6(a). Such books and records shall be kept for such period of time required by Applicable Laws, but no less than at least five years following the end of the Calendar Quarter to which they pertain. Such records shall be subject to audit in accordance with Section 3.6(e).

(e) Audit. Each Party shall have the right to cause an independent, certified public accounting firm of international recognition reasonably acceptable to the other Party to audit the other Party’s records relating to Development Expenses to confirm the amount of the Development Expenses reflected in the Quarterly Reports and the related Payment Reports. Such audit right may be exercised during normal business hours upon reasonable prior written notice to the audited Party; provided that such audit right may be exercised no more than once in any 12 month period, no more than once with regard to any given Calendar Quarter and no later than five years after the end of the Calendar Quarter to be audited, and shall be conducted so as to not unreasonably interfere with the audited Party’s business. The audited Party shall not be obligated to provide the public accounting firm any records until the public accounting firm executes a confidentiality agreement in a form reasonably acceptable to the audited Party. The public accounting firm shall disclose to the auditing Party only whether any reports made or amounts paid under this Agreement are correct and details concerning any discrepancies. The public accounting firm shall send a copy of the report to the audited Party at the same time it is sent to the auditing Party. If such audit concludes that additional payments were owed or that excess payments were made during the audited period, then Arena or Eisai, as applicable, shall pay the other Party an appropriate adjustment payment to achieve the applicable allocation of the Development Expenses set forth in the Development Plans within 30 days after the date on which such audit is completed and the public accounting firm notifies each Party of the conclusions thereof. The auditing Party shall bear the full cost of such audit unless such audit discloses an over-reporting by the audited Party of more than 5% of the amount of Development Expenses for a given Calendar Quarter for the clinical trials and other development work for

 

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which the audited Party is the Responsible Party, in which case, the audited Party shall bear the reasonable and documented cost of such audit.

3.7. Non-Development Plan Development. With respect to any clinical trials or other development work with respect to a Compound Product or Related Product that is conducted by or on behalf of Arena or any of its Affiliates (or any Arena ex-US Distributor) anywhere in the world outside the scope of a Development Plan (“ Non-Development Plan Development ”):

(a) Prior to the commencement of any Non-Development Plan Development, and to the extent Arena has the right to do so under any applicable agreement with an Arena ex-US Distributor, Arena shall provide the JDC a high-level development plan with respect to such Non-Development Plan Development, and the JDC shall promptly hold an ad-hoc meeting to review and discuss such plan. Arena shall in good faith seek to address any reasonable issues that Eisai’s members on the JDC may raise with respect to possible issues that such Non-Development Plan Development could reasonably be expected to cause to Eisai’s development or Commercialization of the Products in the Territory. Following such JDC meeting, Arena (and its Affiliates and Arena ex-US Distributors) shall have and retain the right to conduct the applicable Non-Development Plan Development in or outside the Territory.

(b) Arena shall notify Eisai of any Know-How Controlled by Arena or any of its Affiliates, including any Know-How made by an Arena ex-US Distributor and Controlled by Arena or any of its Affiliates, resulting from any Non-Development Plan Development and if, at any time during the Term, Eisai desires to use any such Know-How in the Territory, Eisai shall notify Arena, and the Parties shall meet and discuss in good faith and seek to agree on reasonable payments to Arena for the use of such Know-How by Eisai. If the Parties reach such agreement, such Know-How shall constitute Arena Know-How. If Eisai does not so notify Arena, or if the Parties do not reach agreement, then such Know-How shall constitute Arena Independent Know-How and, subject to clause (c) below, Eisai shall not have the right to use any Arena Independent Know-How.

(c) Notwithstanding clause (b) above, Arena hereby grants Eisai and its Affiliates a royalty-free (i) right to use any Arena Independent Know-How with respect to the Initial Product and right to reference any regulatory filings Controlled by Arena or any of its Affiliates that are made by Arena, its Affiliates, or any Arena ex-US Distributors with respect to the Initial Product outside the Territory, in each case, solely to maintain the Initial Product NDA or as otherwise required by Regulatory Authorities in the Territory; provided that, except as provided otherwise pursuant to Section 3.7(b) or with the consent of Arena, Eisai shall not have the right to use any Arena Independent Know-How or reference any such regulatory filings to obtain any Regulatory Approval for the Initial Product for any Indications that are not the subject of the Initial Product NDA as of the Effective Date and (ii) right to use any Arena Independent Know-How with respect to any Additional Product and right to reference any regulatory filings Controlled by Arena or any of its Affiliates that are made by Arena, its Affiliates, or any Arena ex-US Distributors with respect to the Additional Product outside the Territory, in each case, solely to maintain any NDA for such Additional Product that resulted from clinical trials or other development work conducted under a Development Plan or as otherwise required by Regulatory Authorities in the Territory; provided that, except as provided otherwise pursuant to Section

 

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3.7(b) or with the consent of Arena, Eisai shall not have the right to use any Arena Independent Know-How or reference any such regulatory filings to obtain any Regulatory Approval for any Additional Product for any Indications that are not the subject of any NDA or any amendment or supplement to any NDA that resulted from the clinical trials or other development work conducted under a Development Plan.

(d) Arena shall, within 30 days after the end of each Calendar Quarter and to the extent Arena has the right to do so under any applicable agreement with an Arena ex-US Distributor, provide Eisai with a written report that summarizes the status and results of any Non-Development Plan Development that occurred during such Calendar Quarter. Without limiting the foregoing, upon request by Eisai, Arena shall promptly provide Eisai with summaries of data and results generated or obtained in the course of the performance of any Non-Development Plan Development.

(e) Eisai, at Arena’s expense, shall reasonably cooperate with Arena in facilitating communications between Arena and Regulatory Authorities in the Territory with respect to any Non-Development Plan Development.

(f) With respect to any agreement entered into by Arena or any of its Affiliates with an Arena ex-US Distributor, Arena shall, and shall cause any such Affiliate to, use Commercially Reasonable Efforts to include in any such agreement terms and conditions that permit Arena to make the disclosures to Eisai contemplated by Section 3.3(a), Section 3.7(a), Section 3.7(d) and Section 3.14(b).

(g) With respect to any clinical trial conducted in the course of any Non-Development Plan Development, Arena shall (or if Arena is not the sponsor of such clinical trial, Arena shall cause the sponsor of such clinical trial to) register such clinical trial on and report the results of such clinical trial to the appropriate registry or database (e.g., clinicaltrials.gov) in accordance with Applicable Laws.

3.8. Use of Subcontractors. Each Party may subcontract some of the clinical trials and other development work for which it is the Responsible Party under a Development Plan to one or more subcontractors, to the extent permitted under the Development Plan; provided, that: (a) none of the other Party’s rights hereunder are diminished or otherwise adversely affected as a result of such subcontracting, (b) the subcontractor undertakes in writing obligations of confidentiality and non-use that are no less stringent than those undertaken by the Parties pursuant to Article 8, (c) the applicable agreement with such subcontractor assigns all Know-How developed by such subcontractor under the applicable agreement to the applicable Party or its designee, and requires that all employees of such subcontractor be under written obligation to assign without any additional compensation all such Know-How to the applicable Party or its designee, (d) the subcontractor does not have the right to further subcontract such clinical trials or other development work unless agreed by the JDC, (e) the subcontracting Party shall remain responsible and liable for the performance by any subcontractor of its obligations under this Agreement, and (f) such permitted subcontracting shall not relieve the Responsible Party of any liability or obligation under this Agreement, except to the extent satisfactorily performed by such subcontractor. In the event a Party performs any of the clinical trials or other development work

 

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for which it is the Responsible Party under a Development Plan through a subcontractor, then such Party shall at all times be fully responsible for the performance and payment of such subcontractor.

3.9. Materials Transfer. In order to facilitate the clinical trials and other development work contemplated by this Agreement, either Party may provide to the other Party certain biological materials or chemical compounds (other than Compound or Product) Controlled by the supplying Party (collectively, “ Materials ”) for use by the other Party in furtherance of such clinical trials or other development work. Except as otherwise provided for under this Agreement, all such Materials delivered to the other Party will remain the sole property of the supplying Party. The receiving Party shall: (a) only use such Materials in furtherance of the clinical trials and other development work for which it is the Responsible Party under a Development Plan, (b) not use or deliver any Materials to or for the benefit of any Third Party, except for subcontractors pursuant to Section 3.8, without the prior written consent of the supplying Party, and (c) use the Materials in compliance with all Applicable Laws. The Parties shall use the Materials supplied under this Agreement with prudence and appropriate caution in any experimental work because not all of their characteristics may be known. Except as otherwise expressly set forth in this Agreement, THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.

3.10. Initial Product Regulatory Activities.

(a) Initial Regulatory Activities. All regulatory activities for obtaining the initial Regulatory Approval of the Initial Product in the Territory shall be conducted by Arena or Arena US; provided, that Arena shall ensure that Eisai is involved in the planning and conduct of such activities and the decisions with respect thereto and shall in good faith seek to reach agreement with Eisai on all material FDA communications and decisions with respect to such activities, including discussions with any Regulatory Authority and any decisions regarding the labeling of, and any risk evaluation and mitigation strategies with respect to, the Initial Product in the Territory, including (i) timely informing Eisai of any scheduled meetings with Regulatory Authorities in the Territory with respect to the initial Regulatory Approval of the Initial Product as soon as practicably possible and (ii) using all reasonable efforts to ensure that Eisai is afforded the opportunity to participate in such meetings; provided that (x) Eisai shall timely cooperate with Arena with respect to all such activities, including responding promptly to all of Arena’s reasonable requests for information and comments, and (y) in no event shall Arena be required to undertake any specific activities to seek or consider Eisai’s input or include Eisai in any Regulatory Authority meetings to the extent such input or inclusion could reasonably be expected to materially delay Arena’s regulatory activities or receipt of the initial Regulatory Approval of the Initial Product. Upon FDA approval of the Initial Product NDA, Arena shall cause Arena US to transfer the Initial Product NDA to Eisai and to provide to the FDA (with a copy to Eisai) a letter indicating that ownership and a copy of all applicable documents with respect to the Initial Product NDA have been transferred to Eisai pursuant to 21 C.F.R. 314.72. Arena shall thereafter use diligent efforts to provide Eisai a copy of the applicable documents,

 

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and Eisai shall use diligent efforts to provide to the FDA commitments to all applicable regulatory requirements relevant to the Initial Product NDA pursuant to the applicable regulations.

(b) Additional Regulatory Activities. After transfer of the Initial Product NDA to Eisai, all regulatory activities relating to the Initial Product NDA shall be conducted by Eisai, and Eisai shall ensure that Arena or Arena US are fully involved in the planning and conduct of such activities and decisions with respect thereto and shall in good faith seek to reach agreement with Arena or Arena US on all FDA communications and decisions with respect to such activities, including discussions with any Regulatory Authority and any decisions regarding the labeling of, and any risk evaluation and mitigation strategies with respect to, the Initial Product in the Territory, including (i) timely informing Arena or Arena US of any scheduled meetings with Regulatory Authorities in the Territory with respect to such activities as soon as practicably possible and (ii) using all reasonable efforts to ensure that Arena or Arena US is afforded the opportunity to participate in such meetings; provided that Arena shall timely cooperate with Eisai with respect to all such activities, including responding promptly to all of Eisai’s reasonable requests for information and comments.

(c) Information Transfer. In addition to the information required to be provided to the other Party in other provisions of this Agreement, each Party shall timely provide the other Party with (i) copies of all written correspondence with the Regulatory Authorities in the Territory regarding the Initial Product for use in the Territory, and (ii) a written summary of all oral communications with the Regulatory Authorities in the Territory regarding the Initial Product.

(d) Compliance . Each Party shall conduct all of those regulatory activities in the Territory for which it is the Responsible Party under a Development Plan with respect to the Initial Product, and all other regulatory activities it conducts with respect to the Initial Product for the Territory, in compliance with all Applicable Laws.

3.11. Additional Products Regulatory Activities.

(a) For each Additional Product, the Parties shall designate, in the Development Plan for such Additional Product, which Party shall be the Responsible Party with respect to FDA regulatory activities and filing and seeking Regulatory Approval for such Additional Product in the Territory, through obtaining Regulatory Approval for such Additional Product. Each Party shall conduct such regulatory activities in the Territory for which it is the Responsible Party in accordance with the applicable Development Plan (including the budget set forth therein, except as otherwise provided in Section 3.6(c)). The Party that is the Responsible Party with respect to seeking Regulatory Approval of an Additional Product in the Territory shall use Commercially Reasonable Efforts to obtain such Regulatory Approval.

(b) Each Party shall be responsible for funding the Development Expenses for the regulatory activities for obtaining Regulatory Approval in the Territory for a particular Additional Product in accordance with the agreed cost sharing for Development Expenses for such Additional Product as set forth in the Development Plan for such Additional Product.

 

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(c) The Responsible Party for the regulatory activities with respect to an Additional Product shall ensure that the other Party is fully involved in the planning and conduct of such activities and decisions with respect thereto and shall in good faith seek to reach agreement with such other Party on all FDA communications and decisions with respect to such activities, including: (i) timely informing the other Party of any scheduled meetings with Regulatory Authorities in the Territory as soon as practicably possible and (ii) using all reasonable efforts to ensure that such other Party is afforded the opportunity to participate in such meetings.

(d) If Arena is the Responsible Party with respect to obtaining Regulatory Approval of an Additional Product in the Territory, upon receipt of such Regulatory Approval Arena shall, or shall cause its applicable Affiliate to, transfer such Regulatory Approval to Eisai and provide to the FDA a letter indicating that ownership and a copy of all applicable documents with respect to such Regulatory Approval have been transferred to Eisai pursuant to 21 C.F.R. 314.72. Arena shall thereafter use diligent efforts to provide Eisai a copy of the applicable documents, and Eisai shall use diligent efforts to provide to the FDA commitments to all applicable regulatory requirements relevant to such Regulatory Approval pursuant to the applicable regulations.

(e) In addition to the information required to be provided to the other Party in other provisions of this Agreement, each Party shall timely provide the other Party with (i) copies of all written correspondence with the Regulatory Authorities in the Territory regarding any Additional Product for use in the Territory, and (ii) a written summary of all oral communications with the Regulatory Authorities in the Territory regarding any Additional Product.

(f) Each Party shall conduct all of those regulatory activities for which it is the Responsible Party under a Development Plan with respect to an Additional Product, and all other regulatory activities it conducts with respect to an Additional Product for the Territory, in compliance with all Applicable Laws of the country in which such activities are conducted.

3.12. Regulatory Cooperation of the Parties.

(a) Arena shall cooperate with any reasonable requests for assistance from Eisai with respect to obtaining any Regulatory Approval of a Product for which Eisai is the Responsible Party with respect to obtaining such Regulatory Approval under a Development Plan and maintaining any Regulatory Approval of a Product that is held by Eisai, including by:

(i) making its employees, consultants and other staff available upon reasonable notice during normal business hours to attend meetings with Regulatory Authorities concerning the applicable Products; and

(ii) disclosing and making available to Eisai, in a reasonable form as Eisai may reasonably request, all manufacturing and quality control data, chemistry, manufacturing and controls data and other information related to the applicable Product and the

 

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manufacturing process therefor as is reasonably necessary or desirable to prepare, file, obtain and maintain any such Regulatory Approval.

(b) Eisai shall cooperate with any reasonable requests for assistance from Arena with respect to obtaining any Regulatory Approval of a Product for which Arena is the Responsible Party with respect to obtaining such Regulatory Approval under a Development Plan and maintaining any Regulatory Approval of a Product that is held by Arena or any of its Affiliates, and obtaining any registration or other regulatory approval of a Product or other Compound Product or Related Product o