Regeneron Pharmaceuticals, Inc.
REGENERON PHARMACEUTICALS INC (Form: 10-Q, Received: 04/30/2009 07:01:08)

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 10-Q

  (Mark One)    
(X)        QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES  
  EXCHANGE ACT OF 1934    
 
  For the quarterly period ended   March 31, 2009    
  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 0-19034

REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

New York   13-3444607  
(State or other jurisdiction of   (I.R.S. Employer Identification No.)  
incorporation or organization)    

777 Old Saw Mill River Road    
Tarrytown, New York   10591-6707  
(Address of principal executive offices)   (Zip Code)  

(914) 347-7000
(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes X        No __

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes __       No __

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

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes __       No X

Number of shares outstanding of each of the registrant’s classes of common stock as of April 14, 2009:

Class of Common Stock   Number of Shares  
Class A Stock, $0.001 par value    2,246,698  
Common Stock, $0.001 par value   77,845,431  


REGENERON PHARMACEUTICALS, INC.
Table of Contents
March 31, 2009

      Page Numbers  
PART I        FINANCIAL INFORMATION    
 
Item 1   Financial Statements    
 
  Condensed balance sheets (unaudited) at March 31, 2009 and December 31, 2008   3  
   
  Condensed statements of operations (unaudited) for the three months ended March 31, 2009 and 2008     4  
   
  Condensed statement of stockholders’ equity (unaudited) for the three months ended March 31, 2009   5    
   
  Condensed statements of cash flows (unaudited) for the three months ended March 31, 2009 and 2008     6    
   
  Notes to condensed financial statements (unaudited)   7-10  
 
Item 2   Management's Discussion and Analysis of Financial Condition and Results of Operations   11-28    
   
Item 3   Quantitative and Qualitative Disclosures About Market Risk   29  
 
Item 4   Controls and Procedures   29  
 
PART II   OTHER INFORMATION    
 
Item 1   Legal Proceedings   29  
 
Item 1A   Risk Factors   29-44  
 
Item 6   Exhibits   44  
 
SIGNATURE PAGE   45  


PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS

REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS AT MARCH 31, 2009 AND DECEMBER 31, 2008 (Unaudited)
(In thousands, except share data)

      March 31,       December 31,
2009 2008
ASSETS
Current assets
       Cash and cash equivalents $ 199,097 $ 247,796
       Marketable securities 216,785 226,954
       Accounts receivable from the sanofi-aventis Group 44,576 33,302
       Accounts receivable - other 3,633 1,910
       Prepaid expenses and other current assets 19,700 11,480
              Total current assets 483,791 521,442
 
Restricted cash 1,650 1,650
Marketable securities 78,460 51,061
Property, plant, and equipment, at cost, net of accumulated
       depreciation and amortization 109,840 87,853
Other assets   7,680 8,032
              Total assets $ 681,421 $ 670,038
 
LIABILITIES and STOCKHOLDERS' EQUITY
Current liabilities
       Accounts payable and accrued expenses $ 44,832 $ 36,168
       Deferred revenue from sanofi-aventis, current portion 21,525 21,390
       Deferred revenue - other, current portion 36,756 26,114
              Total current liabilities 103,113 83,672
 
Deferred revenue from sanofi-aventis 100,474 105,586
Deferred revenue - other 54,364 56,835
Other long term liabilities 13,150 5,093
              Total liabilities 271,101 251,186
 
Commitments and contingencies
 
Stockholders' equity
       Preferred stock, $.01 par value; 30,000,000 shares authorized; issued and
              outstanding-none  
       Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized;    
              shares issued and outstanding - 2,246,698 in 2009 and 2,248,698 in 2008 2 2
       Common Stock, $.001 par value; 160,000,000 shares authorized;
              shares issued and outstanding - 77,841,540 in 2009 and 77,642,203 in 2008 78 78
       Additional paid-in capital   1,304,896   1,294,813
       Accumulated deficit (893,408 )     (875,927 )
       Accumulated other comprehensive loss (1,248 ) (114 )
              Total stockholders' equity 410,320 418,852
              Total liabilities and stockholders' equity $ 681,421 $ 670,038  

 


 

The accompanying notes are an integral part of the financial statements.

 
 

3


REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)

      Three months ended March 31,
2009       2008
Revenues
       Contract research and development from sanofi-aventis $ 49,660 $ 35,734
       Other contract research and development 11,430 10,649
       Technology licensing 10,000 10,000
       Net product sales 3,891  
74,981 56,383
 
Expenses
       Research and development 82,146 61,270
       Selling, general, and administrative 11,674 11,024
       Cost of goods sold 392
94,212 72,294
 
Loss from operations   (19,231 ) (15,911 )
 
Other income (expense)    
       Investment income   1,750   7,304
       Interest expense   (3,011 )
1,750 4,293
 
Net loss $ (17,481 ) $ (11,618 )
 
Net loss per share, basic and diluted $ (0.22 ) $ (0.15 )
 
Weighted average shares outstanding, basic and diluted 79,498 78,493  

 


 

The accompanying notes are an integral part of the financial statements.

 
 

4


REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY (Unaudited)
For the three months ended March 31, 2009
(In thousands)

                             Accumulated        
Additional Other Total
Class A Stock Common Stock Paid-in Accumulated Comprehensive Stockholders' Comprehensive
Shares Amount Shares Amount Capital Deficit Loss Equity Loss
Balance, December 31, 2008    2,249   $ 2 77,642 $ 78 $ 1,294,813 $ (875,927 ) $ (114 ) $ 418,852
Issuance of Common Stock in connection with
       exercise of stock options, net of shares tendered   117 1,038 1,038
Issuance of Common Stock in connection with  
       Company 401(k) Savings Plan contribution 81 1,391     1,391  
Conversion of Class A Stock to Common Stock (2 ) 2    
Stock-based compensation expense           7,654       7,654
Net loss   (17,481 ) (17,481 ) $ (17,481 )
Change in net unrealized loss on          
       marketable securities           (1,134 ) (1,134 )   (1,134 )
Balance, March 31, 2009 2,247 $ 2 77,842 $ 78 $ 1,304,896 $ (893,408 ) $ (1,248 ) $ 410,320 $ (18,615 )

 


 

The accompanying notes are an integral part of the financial statements.

 
 

5


REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands)

      Three months ended March 31,
2009       2008
Cash flows from operating activities
       Net loss $ (17,481 ) $ (11,618 )
       Adjustments to reconcile net loss to net cash used in
              operating activities
              Depreciation and amortization 2,724 2,946
              Non-cash compensation expense 7,654 8,286
              Changes in assets and liabilities  
                     Increase in accounts receivable   (12,997 ) (14,640 )
                     (Increase) decrease in prepaid expenses and other assets (8,611 ) 1,493
                     Increase in deferred revenue   3,194 3,200
                     Increase (decrease) in accounts payable, accrued expenses,
                            and other liabilities   15,318 (7,564 )
                                   Total adjustments 7,282 (6,279 )
                                   Net cash used in operating activities (10,199 ) (17,897 )
 
Cash flows from investing activities  
       Purchases of marketable securities (100,315 ) (91,518 )
       Sales or maturities of marketable securities 82,694 132,509
       Capital expenditures (21,917 ) (3,047 )
                                   Net cash (used in) provided by investing activities (39,538 ) 37,944
 
Cash flows from financing activities    
       Net proceeds from the issuance of Common Stock 1,038 1,903
                                   Net cash provided by financing activities 1,038 1,903
 
Net (decrease) increase in cash and cash equivalents (48,699 )   21,950
 
Cash and cash equivalents at beginning of period 247,796 498,925
 
Cash and cash equivalents at end of period $ 199,097 $ 520,875

 


 

The accompanying notes are an integral part of the financial statements.

 
 

6


REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)

(Unless otherwise noted, dollars in thousands, except per share data)

1. Interim Financial Statements

      The interim Condensed Financial Statements of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, these financial statements reflect all adjustments, consisting only of normal recurring accruals, necessary for a fair presentation of the Company’s financial position, results of operations, and cash flows for such periods. The results of operations for any interim periods are not necessarily indicative of the results for the full year. The December 31, 2008 Condensed Balance Sheet data were derived from audited financial statements, but do not include all disclosures required by accounting principles generally accepted in the United States of America. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008.

      Included in research and development expenses is the Company’s share of VEGF Trap-Eye development expenses incurred by Bayer HealthCare LLC, including the Company’s share of Bayer HealthCare’s estimated VEGF Trap-Eye development expenses for the most recent interim fiscal quarter. The Bayer HealthCare estimate is adjusted to agree with actual expenses for such quarter in the subsequent interim fiscal quarter.

      Effective in the first quarter of 2009, the estimated useful lives of laboratory and other equipment, which is a component of property, plant, and equipment, has been extended from 3 – 5 years to 3 – 10 years. The effect of this change in estimate was to lower depreciation expense by $0.2 million for the first quarter of 2009. There was no impact on the net loss per share as a result of this change in estimate.

2. ARCALYST ® (rilonacept) Product Revenue

      In February 2008, the Company received marketing approval from the FDA for ARCALYST for the treatment of CAPS. For the three months ended March 31, 2009, the Company recognized as revenue $3.9 million of ARCALYST net product sales for which the right of return no longer existed and rebates could be reasonably estimated. At March 31, 2009 and 2008, deferred revenue related to ARCALYST net product sales totaled $4.2 million and $0.8 million, respectively.

      Cost of goods sold related to ARCALYST sales totaled $0.4 million for the three months ended March 31, 2009 and consisted primarily of royalties. To date, ARCALYST shipments to the Company’s customers consisted of supplies of inventory manufactured and expensed prior to FDA approval of ARCALYST; therefore, the costs of these supplies were not included in costs of goods sold. At March 31, 2009, the Company had $0.3 million of inventoried work-in-process costs related to ARCALYST, which is included in prepaid expenses and other current assets. There were no capitalized inventory costs at December 31, 2008.

7


REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)

3. Per Share Data

      The Company’s basic and diluted net loss per share amounts have been computed by dividing net loss by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net loss per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. For the three months ended March 31, 2009 and 2008, the Company reported net losses; therefore, no common stock equivalents were included in the computation of diluted net loss per share for these periods, since such inclusion would have been antidilutive. The calculations of basic and diluted net loss per share are as follows:

Three Months Ended March 31,
     2009      2008
Net loss (Numerator)   $ (17,481 )   $ (11,618 )
 
Weighted-average shares, in thousands (Denominator) 79,498 78,493
 
Basic and diluted net loss per share $ (0.22 ) $ (0.15 )

      Shares issuable upon the exercise of stock options, vesting of restricted stock awards, and conversion of convertible debt, which have been excluded from the March 31, 2009 and 2008 diluted per share amounts because their effect would have been antidilutive, include the following:

Three months ended March 31,
     2009      2008
Stock Options:
       Weighted average number, in thousands 20,216 17,680
       Weighted average exercise price   $ 17.55 $ 17.16
 
Restricted Stock:
       Weighted average number, in thousands   500 500
 
Convertible Debt:    
       Weighted average number, in thousands   6,611
       Conversion price $ 30.25

4. Statement of Cash Flows

      Supplemental disclosure of noncash investing and financing activities:

      Included in accounts payable and accrued expenses at March 31, 2009 and December 31, 2008 were $9.8 million and $7.0 million, respectively, of accrued capital expenditures. Included in accounts payable and accrued expenses at March 31, 2008 and December 31, 2007 were $1.5 million and $1.7 million, respectively, of accrued capital expenditures.

      Included in accounts payable and accrued expenses at December 31, 2008 and 2007 were $1.5 million and $1.1 million, respectively, of accrued Company 401(k) Savings Plan contribution expense. In the first quarter of 2009 and 2008, the Company contributed 81,086 and 58,575 shares, respectively, of Common Stock to the 401(k) Savings Plan in satisfaction of these obligations.

      Included in marketable securities at March 31, 2009 and December 31, 2008 were $2.5 million and $1.7 million, respectively, of accrued interest income. Included in marketable securities at March 31, 2008 and December 31, 2007 were $2.1 million and $2.2 million, respectively, of accrued interest income.

8


REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)

5. Fair Value of Financial Assets

      The Company’s assets that are measured at fair value on a recurring basis, and subject to the disclosure requirements of Statement of Financial Accounting Standards No. (“SFAS”) 157, Fair Value Measurements , at March 31, 2009 and December 31, 2008, were as follows:

Fair Value Measurements at Reporting Date Using
Quoted Prices in Significant Other Significant
Fair Value at Active Markets for Observable Unobservable
March 31, Identical Assets Inputs Inputs
Description       2009       (Level 1)       (Level 2)       (Level 3)
Available-for-sale marketable securities $ 295,245 $ 3,138 $ 292,007 $ 100
 
Fair Value Measurements at Reporting Date Using
Quoted Prices in Significant Other Significant
Fair Value at   Active Markets for Observable Unobservable
December 31, Identical Assets Inputs Inputs
Description 2008 (Level 1) (Level 2) (Level 3)
Available-for-sale marketable securities   $ 278,015 $ 3,608   $ 247,307   $ 100

      There were no realized or unrealized gains or losses related to the Company’s Level 3 marketable securities for the three months ended March 31, 2009 and 2008. In addition, there were no purchases, sales, or maturities of Level 3 marketable securities, and no transfers of marketable securities between the Level 2 and Level 3 classifications, during the quarters ended March 31, 2009 and 2008.

      On a quarterly basis, the Company reviews its portfolio of marketable securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost are other-than-temporary. During the three months ended March 31, 2009 and 2008, the Company did not record any charges for other-than-temporary impairment of its marketable securities. However, the current economic environment, the deterioration in the credit quality of some of the issuers of securities that the Company holds, and the recent volatility of securities markets increase the risk that there could be further declines in the market value of marketable securities in the Company’s investment portfolio and that such declines could result in charges against income in future periods for other-than-temporary impairments, and such amounts could be material.

6. Accounts Payable and Accrued Expenses

      Accounts payable and accrued expenses as of March 31, 2009 and December 31, 2008 consist of the following:

March 31, December 31,
     2009      2008
Accounts payable $ 17,779 $ 6,268
Payable to Bayer HealthCare     9,799
Accrued payroll and related costs 8,352 5,948
Accrued clinical trial expense   6,558 4,273
Accrued property, plant, and equipment expenses   8,069 5,994
Accrued expenses, other 4,074 3,886
$ 44,832 $ 36,168

9


REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)

7. Comprehensive Loss

      The Company presents comprehensive income (loss) in accordance with SFAS 130, Reporting Comprehensive Income . Comprehensive loss of the Company includes net loss adjusted for the change in net unrealized gain (loss) on marketable securities. For the three months ended March 31, 2009 and 2008, the components of comprehensive loss are:

Three months ended March 31,
     2009      2008
Net loss $ (17,481 )   $ (11,618 )
Change in net unrealized gain (loss) on marketable securities   (1,134 ) 658  
       Total comprehensive loss $ (18,615 ) $ (10,960 )

8. Legal Matters

      From time to time, the Company is a party to legal proceedings in the course of its business. The Company does not expect any such current legal proceedings to have a material adverse effect on the Company’s business or financial condition.

9. Future Impact of Recently Issued Accounting Standards

      In April 2009, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position (“FSP”) FAS 107-1 and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments. This FSP amends SFAS 107, Disclosures about Fair Value of Financial Instruments, to require entities to provide disclosures about the fair value of financial instruments in interim financial information. This FSP also amends APB Opinion No. 28, Interim Financial Reporting, to require those disclosures in summarized financial information at interim reporting periods. In addition, an entity shall disclose in the body or in the accompanying notes of its summarized financial information for interim reporting periods and in its financial statements for annual reporting periods the fair value of all financial instruments for which it is practicable to estimate that value, whether recognized or not recognized in the statement of financial position, as required by SFAS 107. The Company is required to adopt FSP FAS 107-1 and APB 28-1 for the quarter ended June 30, 2009. Management does not anticipate that the adoption of FSP FAS 107-1 and APB 28-1 will have a material impact on the Company’s financial statements.

      In April 2009, the FASB issued FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments. This FSP changes existing guidance for determining whether an impairment to debt securities is other than temporary; replaces the existing requirement that management assert it has both the intent and ability to hold an impaired security until recovery with a requirement that management assert, ( a ) it does not have the intent to sell the security; and ( b ) it is more likely than not it will not have to sell the security before recovery of its cost basis; requires that an entity recognize noncredit losses on held-to-maturity debt securities in other comprehensive income and amortize that amount over the remaining life of the security in a prospective manner by offsetting the recorded value of the asset unless the security is subsequently sold or there are additional credit losses; and requires entities to present the total other-than-temporary impairment in the statement of earnings with an offset for the amount recognized in other comprehensive income. When adopting FSP FAS 115-2 and FAS 124-2, entities are required to record a cumulative-effect adjustment as of the beginning of the period of adoption to reclassify the noncredit component of a previously recognized other-temporary impairment from retained earnings to accumulated other comprehensive income if the entity does not intend to sell the security and it is not more likely than not that the entity will be required to sell the security before recovery. The Company is required to adopt FSP FAS 115-2 and FAS 124-2 for the quarter ended June 30, 2009. Management does not anticipate that the adoption of FSP FAS 115-2 and FAS 124-2 will have a material impact on the Company’s financial statements.

      In April 2009, the FASB issued FSP FAS 157-4, Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly. This FSP affirms that the objective of fair value when the market for an asset is not active is the price that would be received to sell the asset in an orderly transaction; clarifies and includes additional factors for determining whether there has been a significant decrease in market activity for an asset when the market for that asset is not active; and eliminates the proposed presumption that all transactions are distressed (not orderly) unless proven otherwise. The FSP instead requires an entity to base its conclusion about whether a transaction was not orderly on the weight of the evidence. The Company is required to adopt FSP FAS 157-4 for the quarter ended June 30, 2009. Management does not anticipate that the adoption of FSP FAS 157-4 will have a material impact on the Company’s financial statements.

10. Subsequent Event - Amendment to Operating Lease

      The Company leases laboratory and office facilities in Tarrytown, New York. In December 2006, the Company entered into a new agreement (which was amended in October 2007 and September 2008) to lease laboratory and office space at the Company’s current Tarrytown location, including space that is now under construction and expected to be completed in mid-2009 (the “new facilities”). The term of the lease commenced effective June 2008 and will expire in June 2024. In April 2009, the Company amended the operating lease agreement to increase the amount of space the Company will lease. As amended, the lease contains early termination options for the portion of the space that excludes the new facilities. Other terms and conditions, as previously described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008, remain unchanged. In connection with the lease amendment, in April 2009, the Company terminated an April 2008 sublease for space in Tarrytown, New York.

      In connection with the April 2009 amendment to the operating lease, the Company’s total estimated future minimum noncancelable lease commitments under operating leases, previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008, will increase to $9.4 million, $14.5 million, $14.7 million, $13.7 million, and $15.1 million for the years ended December 31, 2009, 2010, 2011, 2012, and 2013, respectively, and increase to $182.5 million, in the aggregate, for years subsequent to 2013.

10


ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

      The discussion below contains forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron Pharmaceuticals, Inc., and actual events or results may differ materially. These statements concern, among other things, the possible success and therapeutic applications of our product candidates and research programs, anticipated sales of our marketed product, the timing and nature of the clinical and research programs now underway or planned, and the future sources and uses of capital and our financial needs. These statements are made by us based on management's current beliefs and judgment. In evaluating such statements, stockholders and potential investors should specifically consider the various factors identified under the caption “Risk Factors” which could cause actual results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Overview

      Regeneron Pharmaceuticals, Inc. is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. We currently have one marketed product: ARCALYST ® (rilonacept) Injection for Subcutaneous Use, which is available for prescription in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. We also have six clinical development programs, including three late-stage clinical programs. Our late stage programs are aflibercept (VEGF Trap), which is being developed in oncology in collaboration with the sanofi-aventis Group, VEGF Trap-Eye, which is being developed in eye diseases using intraocular delivery in collaboration with Bayer HealthCare LLC, and ARCALYST, which is being developed for the treatment of gout. Our earlier stage clinical programs are REGN88, an antibody to the interleukin-6 receptor (IL-6R), which is being developed in rheumatoid arthritis, REGN421, an antibody to Delta-like ligand-4 (Dll4), which is being developed in oncology, and REGN475, an antibody to Nerve Growth Factor (NGF), which is being developed for the treatment of pain. All three of these antibodies are being developed in collaboration with sanofi-aventis.

      We expect that our next generation of product candidates will be based on our proprietary technologies for developing human monoclonal antibodies. Our antibody program is being conducted primarily in collaboration with sanofi-aventis. Our preclinical research programs are in the areas of oncology and angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain, and cardiovascular diseases.

      Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technology and combine that foundation with our clinical development and manufacturing capabilities to build a successful, integrated biopharmaceutical company. However, developing and commercializing new medicines entails significant risk and expense.

      We believe that our ability to develop product candidates is enhanced by the application of our VelociSuite TM technology platforms. Our discovery platforms are designed to identify specific genes of therapeutic interest for a particular disease or cell type and validate targets through high-throughput production of mammalian models. Our human monoclonal antibody technology ( VelocImmune ® ) and cell line expression technologies ( VelociMab TM ) may then be utilized to design and produce new product candidates directed against the disease target. Our first three antibody product candidates currently in clinical trials were developed using VelocImmune . Over the course of the next several years, we plan to advance an average of two to three new antibody product candidates into clinical development each year. We continue to invest in the development of enabling technologies to assist in our efforts to identify, develop, and commercialize new product candidates.

11


Commercial Product:

ARCALYST ® (rilonacept) – Cryopyrin-Associated Periodic Syndromes (CAPS)

      In February 2008, we received marketing approval from the U.S. Food and Drug Administration (FDA) for ARCALYST ® (rilonacept) Injection for Subcutaneous Use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. We shipped $10.7 million of ARCALYST to our distributors in 2008, and $4.3 million during the first quarter of 2009. ARCALYST is a protein-based product designed to bind the interleukin-1 (called IL-1) cytokine and prevent its interaction with cell surface receptors. ARCALYST is the only therapy approved in the United States for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. CAPS is caused by a range of mutations in the gene NLRP3 (formerly known as CIAS1 ) which encodes a protein named cryopyrin. In addition to FCAS and MWS, CAPS includes Neonatal Onset Multisystem Inflammatory Disease (NOMID). ARCALYST has not been studied for the treatment of NOMID.

      In March 2008, ARCALYST became available for prescription in the United States and we transitioned the patients who participated in the CAPS pivotal study from clinical study drug to commercial supplies. In 2009, we expect to ship $15-20 million of ARCALYST to our U.S. distributors. In July 2008, we submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for ARCALYST for the treatment of CAPS in the European Union.

Clinical Programs:

1. Aflibercept (VEGF Trap) – Oncology

      Aflibercept is a protein-based product candidate designed to bind all forms of Vascular Endothelial Growth Factor-A (called VEGF-A, also known as Vascular Permeability Factor or VPF) and the related Placental Growth Factor (called PlGF), and prevent their interaction with cell surface receptors. VEGF-A (and to a less validated degree, PlGF) is required for the growth of new blood vessels (a process known as angiogenesis) that are needed for tumors to grow and is a potent regulator of vascular permeability and leakage.

      Aflibercept is being developed globally in cancer indications in collaboration with sanofi-aventis. We and sanofi-aventis are enrolling patients in four Phase 3 trials that are evaluating combinations of aflibercept with standard chemotherapy regimens for the treatment of cancer. One trial is evaluating aflibercept as a 2 nd line treatment for metastatic colorectal cancer (called VELOUR) in combination with FOLFIRI (folinic acid (leucovorin), 5-fluorouracil, and irinotecan). A second trial is evaluating aflibercept as a 1 st line treatment for metastatic pancreatic cancer in combination with gemcitabine (VANILLA). A third trial is evaluating aflibercept as a 2 nd line treatment for metastatic non-small cell lung cancer in combination with docetaxel (VITAL). The fourth trial is evaluating aflibercept as a 1 st line treatment for metastatic androgen-independent prostate cancer in combination with docetaxel/prednisone (VENICE). All four trials are studying the current standard of chemotherapy care for the cancer being studied with and without aflibercept. At the end of the first quarter of 2009, each of the four Phase 3 trials was approximately one-half enrolled, and initial data from the Phase 3 program are expected are 2010. In addition, a Phase 2 study of aflibercept in 1st-line metastatic colorectal cancer in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (AFFIRM) began recruiting patients in January 2009.

      Aflibercept is also being studied in a Phase 2 single-agent study in advanced ovarian cancer (AOC) patients with symptomatic malignant ascites (SMA). This trial is now fully enrolled and initial data from this trial are expected by mid-2009. The FDA has granted Fast Track designation to aflibercept for the treatment of SMA.

      In addition, multiple exploratory studies are being conducted in conjunction with the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) evaluating aflibercept as a single agent or in combination with chemotherapy regimens in a variety of cancer indications.

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Aflibercept Collaboration with the sanofi-aventis Group

      We and sanofi-aventis U.S. (successor to Aventis Pharmaceuticals, Inc.) collaborate on the development and commercialization of aflibercept globally. Under the terms of our September 2003 collaboration agreement, as amended, we and sanofi-aventis will share co-promotion rights and profits on sales, if any, of aflibercept outside of Japan for disease indications included in our collaboration. In Japan, we are entitled to a royalty of approximately 35% on annual sales of aflibercept, subject to certain potential adjustments. We may also receive up to $400 million in milestone payments upon receipt of specified marketing approvals, including up to $360 million in milestone payments related to receipt of marketing approvals for up to eight aflibercept oncology and other indications in the United States or the European Union and up to $40 million related to receipt of marketing approvals for up to five oncology indications in Japan.

      Under the aflibercept collaboration agreement, as amended, agreed upon worldwide development expenses incurred by both companies during the term of the agreement will be funded by sanofi-aventis. If the collaboration becomes profitable, we will be obligated to reimburse sanofi-aventis for 50% of aflibercept development expenses in accordance with a formula based on the amount of development expenses and our share of the collaboration profits and Japan royalties, or at a faster rate at our option.

2. VEGF Trap-Eye – Ophthalmologic Diseases

      VEGF Trap-Eye is a specially purified and formulated form of VEGF Trap for use in intraocular applications. We and Bayer HealthCare are testing VEGF Trap-Eye in a Phase 3 program in patients with the neovascular form of age-related macular degeneration (wet AMD). We and Bayer HealthCare also initiated a Phase 2 study of VEGF Trap-Eye in patients with diabetic macular edema (DME) in late 2008. Wet AMD and diabetic retinopathy (which includes DME) are two of the leading causes of adult blindness in the developed world. In both conditions, severe visual loss is caused by a combination of retinal edema and neovascular proliferation. We and Bayer HealthCare have also announced plans to initiate a Phase 3 program later this year of VEGF Trap-Eye in the treatment of Central Retinal Vein Occlusion (CRVO). Dosing of the first patient in this Phase 3 program will entitle us to receive a $20.0 million milestone payment.

      The Phase 3 trials in wet AMD, known as VIEW 1 and VIEW 2 ( V EGF Trap: I nvestigation of E fficacy and Safety in W et age-related macular degeneration), are comparing VEGF Trap-Eye and ranibizumab (Lucentis ® , a registered trademark of Genentech, Inc./Roche), an anti-angiogenic agent approved for use in wet AMD. VIEW 1 is being conducted in North America and VIEW 2 is being conducted in Europe, Asia Pacific, Japan, and Latin America. The VIEW 1 and VIEW 2 trials are both evaluating VEGF Trap-Eye doses of 0.5 mg and 2.0 mg at dosing intervals of four weeks and 2.0 mg at a dosing interval of eight weeks (after three monthly doses) compared with ranibizumab dosed according to its U.S. label, which specifies doses of 0.5 mg administered every four weeks over the first year. As-needed dosing (PRN) with both agents will be evaluated in the second year of the studies. We and Bayer Healthcare expect to complete enrollment of the VIEW 1 and VIEW 2 trials in 2009 and initial data are expected in late 2010.

      We and Bayer HealthCare have conducted a Phase 2 study in wet AMD which demonstrated that patients treated with VEGF Trap-Eye achieved durable improvements in visual acuity and retinal thickness for up to one year. Study results were reported at the 2008 annual meeting of the Retina Society.

      In this double-masked Phase 2 trial, known as CLEAR-IT 2, 157 patients were initially treated for 3 months with VEGF Trap-Eye: two groups received monthly doses of 0.5 or 2.0 mg (at weeks 0, 4, 8, and 12) and three groups received quarterly doses of 0.5, 2.0, or 4.0 mg (at baseline and week 12). Following the initial 3-month fixed-dosing phase, patients continued to receive VEGF Trap-Eye at the same dose on a PRN dosing schedule through one year, based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria.

      Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p<0.0001 versus baseline) and 5.4 letters (p<0.085 versus baseline), respectively, at the end of one year. The proportion of patients with vision of 20/40 or better (part of the legal minimum requirement for an unrestricted driver's license in the U.S.) increased from 23% at baseline to 45% at week 52 in patients initially treated with 2.0 mg monthly and from 16% at baseline to 47% at week 52 in patients initially treated with 0.5 mg monthly. Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg also achieved mean decreases in retinal thickness versus baseline of 143 microns (p<0.0001 versus baseline) and 125 microns (p<0.0001 versus baseline) at week 52, respectively.

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      After week 12 to week 52 in the PRN dosing period, patients initially dosed on a 2.0 mg monthly schedule received, on average, only 1.6 additional injections and those initially dosed on a 0.5 mg monthly schedule received, on average, 2.5 additional injections.

      While PRN dosing following a fixed quarterly dosing regimen (with dosing at baseline and week 12) also yielded improvements in visual acuity and retinal thickness versus baseline at week 52, the results generally were not as robust as those obtained with initial fixed monthly dosing.

      All patients who completed the one year CLEAR-IT 2 study were eligible to participate in an extension stage of the study. Eighteen month results of the extension stage are scheduled to be presented on May 4, 2009 at the 2009 Association for Research in Vision and Ophthalmology (ARVO) meeting. After receiving VEGF Trap-Eye for one year, the 117 patients who elected to enter the extension stage were dosed on a 2.0 mg PRN basis, irrespective of the dose at which they were treated earlier in the study. On a combined basis, for these 117 patients, the mean gain in visual acuity was 7.3 letters ( p <0.0001 versus baseline) at the 3-month primary endpoint of the original Phase 2 study, 8.4 letters ( p <0.0001 versus baseline) at one year, and 7.1 letters ( p <0.0001 versus baseline) at month 6 of the extension stage. Thus, after 18 months of dosing with VEGF Trap-Eye in the Phase 2 study, patients continued to maintain a highly significant improvement in visual acuity versus baseline, while receiving, on average, only 3.5 injections over the 15-month PRN dosing phase that extended from month 3 to month 18.

      Among all the patients in the Phase 2 wet AMD study, VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was one reported case of culture-negative endophthalmitis/uveitis in the study eye and two arterial thrombotic events; these were deemed not to be drug-related. Three deaths were reported—one patient with pancreatic cancer, one patient with squamous cell carcinoma of the lung, and one patient with pulmonary hypertension (a pre-existing condition). The most common adverse events were those typically associated with intravitreal injections and included conjunctival hemorrhage at the injection site and transient increased intraocular pressure following an injection.

      The recently initiated Phase 2 DME study, known as the DA VINCI study, is a double-masked, randomized, controlled trial that is evaluating four different VEGF Trap-Eye regimens versus laser treatment. The study is expected to complete enrollment of approximately 200 patients in the U.S., Canada, European Union, and Australia by the end of 2009. The patients in the study will be treated for 52 weeks followed by six additional months of safety evaluation. The primary efficacy endpoint is the change in best corrected visual acuity (BCVA) from baseline to week 24.

Collaboration with Bayer HealthCare

      In October 2006, we entered into a collaboration agreement with Bayer HealthCare for the global development and commercialization outside the United States of VEGF Trap-Eye. Under the agreement, we and Bayer HealthCare will collaborate on, and share the costs of, the development of VEGF Trap-Eye through an integrated global plan that encompasses wet AMD, DME, and other diseases and disorders. Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. If VEGF Trap-Eye is granted marketing authorization in a major market country outside the United States, we will be obligated to reimburse Bayer HealthCare for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits. Within the United States, we retain exclusive commercialization rights to VEGF Trap-Eye and are entitled to all profits from any such sales. We received an up-front payment of $75.0 million from Bayer HealthCare. In 2007, we received a $20.0 million milestone payment from Bayer HealthCare following dosing of the first patient in the Phase 3 study of VEGF Trap-Eye in wet AMD, and can earn up to $90 million in additional development and regulatory milestones related to the development of VEGF Trap-Eye and marketing approvals in major market countries outside the United States. We can also earn up to $135 million in sales milestones if total annual sales of VEGF Trap-Eye outside the United States achieve certain specified levels starting at $200 million.

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3. ARCALYST ® (rilonacept) – Inflammatory Diseases

      We are evaluating ARCALYST in gout, a disease where as in CAPS, IL-1 may play an important role in pain and inflammation. In September 2008, we announced the results of a Phase 2 study which evaluated the efficacy and safety of ARCALYST versus placebo in the prevention of gout flares induced by the initiation of urate-lowering drug therapy that is used to control gout. In this 83-patient, double-blind, placebo-controlled study, the mean number of flares per patient over the first 12 weeks of urate-lowering therapy was 0.79 with placebo and 0.15 with ARCALYST (p=0.0011), an 81% reduction. This was the primary endpoint of the study. All secondary endpoints also were met with statistical significance. In the first 12 weeks of treatment, 45.2% of patients treated with placebo experienced a gout flare and, of those, 47.4% had more than one flare. Among patients treated with ARCALYST, only 14.6% experienced a gout flare (p=0.0037 versus placebo) and none had more than one flare. Injection-site reaction was the most commonly reported adverse event with ARCALYST and no serious drug-related adverse events were reported.

      Gout is characterized by high blood levels of uric acid, a bodily waste product normally excreted by the kidneys. The uric acid can form crystals in the joints of the toes, ankles, knees, wrists, fingers, and elbows. Chronic treatment with uric acid-lowering medicines, such as allopurinol, is prescribed to eliminate the uric acid crystals and prevent reformation. During the first months of allopurinol therapy, while uric acid blood levels are being reduced, the break up of the uric acid crystals can result in stimulation of inflammatory mediators, including IL-1, resulting in acute flares of joint pain and inflammation. These painful flares generally persist for at least five days.

      During the first quarter of 2009, we initiated a Phase 3 clinical development program with ARCALYST for the treatment of gout. The program includes four clinical trials, three of which are currently enrolling patients. Two Phase 3 clinical trials (called PRE-SURGE 1 and PRE-SURGE 2) will evaluate ARCALYST versus placebo for the prevention of gout flares in patients initiating urate-lowering drug therapy. A third Phase 3 trial in acute gout (SURGE) will evaluate treatment with ARCALYST alone versus ARCALYST in combination with a non-steroidal anti-inflammatory drug (NSAID) versus an NSAID alone. The Phase 3 clinical development program also includes a separate placebo-controlled safety study (RE-SURGE). We expect to report initial data from the Phase 3 program in 2010.

      Under a March 2003 collaboration agreement with Novartis Pharma AG, we retain the right to elect to collaborate in the future development and commercialization of a Novartis IL-1 antibody which is in clinical development. Following completion of Phase 2 development and submission to us of a written report on the Novartis IL-1 antibody, we have the right, in consideration for an opt-in payment, to elect to co-develop and co-commercialize the Novartis IL-1 antibody in North America. If we elect to exercise this right, we are responsible for paying 45% of post-election North American development costs for the antibody product. In return, we are entitled to co-promote the Novartis IL-1 antibody, and to receive 45% of net profits on sales of the antibody product, in North America. Under certain circumstances, we are also entitled to receive royalties on sales of the Novartis IL-1 antibody in Europe. Under the collaboration agreement, Novartis has the right to elect to collaborate in the development and commercialization of a second generation IL-1 Trap following completion of its Phase 2 development, should we decide to clinically develop such a second generation product candidate. Novartis does not have any rights or options with respect to ARCALYST.

4. Monoclonal Antibodies

      We and sanofi-aventis are collaborating on the discovery, development, and commercialization of fully human monoclonal antibodies generated using our VelocImmune ® technology. The first therapeutic antibodies to enter clinical development under the collaboration are REGN88 and REGN475. REGN88, an antibody to the interleukin-6 receptor (IL-6R) is being evaluated in rheumatoid arthritis. REGN475, an antibody to Nerve Growth Factor (NGF) that binds NGF selectively without cross-reacting with other members of the neurotrophin family (such as neurotrophin-3, neurotrophin-4, and BDNF), is being developed for the treatment of pain. In addition, a Phase 1 trial is in the process of being initiated to evaluate REGN421, an antibody to Delta-like ligand-4 (Dll4), in patients with advanced malignancies. Over the course of the next several years, we and sanofi-aventis plan to advance an average of two to three new fully human monoclonal antibodies into clinical development each year.

Research and Development Technologies:

      One way that a cell communicates with other cells is by releasing specific signaling proteins, either locally or into the bloodstream. These proteins have distinct functions, and are classified into different “families” of molecules, such as peptide hormones, growth factors, and cytokines. All of these secreted (or signaling) proteins travel to and are recognized by another set of proteins, called “receptors,” which reside on the surface of responding cells. These secreted proteins impact many critical cellular and biological processes, causing diverse effects ranging from the regulation of growth of particular cell types, to inflammation mediated by white blood cells. Secreted proteins can at times be overactive and thus result in a variety of diseases. In these disease settings, blocking the action of secreted proteins can have clinical benefit.

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      Regeneron scientists have developed two different technologies to design protein therapeutics to block the action of specific secreted proteins. The first technology, termed the “Trap” technology, was used to generate our first approved product, ARCALYST ® (rilonacept), as well as aflibercept, and VEGF Trap-Eye, all of which are in Phase 3 clinical trials. These novel “Traps” are composed of fusions between two distinct receptor components and the constant region of an antibody molecule called the “Fc region”, resulting in high affinity product candidates. VelociSuite is our second technology platform and it is used for discovering, developing, and producing fully human monoclonal antibodies.

VelociSuite TM

      VelociSuite consists of VelocImmune ® , VelociGene ® , VelociMouse ® , and VelociMab TM . The VelocImmune mouse platform is utilized to produce fully human monoclonal antibodies. VelocImmune was generated by exploiting our VelociGene technology (see below), in a process in which six megabases of mouse immune gene loci were replaced, or “humanized,” with corresponding human immune gene loci. VelocImmune mice can be used to generate efficiently fully human monoclonal antibodies to targets of therapeutic interest. VelocImmune and our entire VelociSuite offer the potential to increase the speed and efficiency through which human monoclonal antibody therapeutics may be discovered and validated, thereby improving the overall efficiency of our early stage drug development activities. We are utilizing the VelocImmune technology to produce our next generation of drug candidates for preclinical and clinical development.

      Our VelociGene platform allows custom and precise manipulation of very large sequences of DNA to produce highly customized alterations of a specified target gene, or genes, and accelerates the production of knock-out and transgenic expression models without using either positive/negative selection or isogenic DNA. In producing knock-out models, a color or fluorescent marker may be substituted in place of the actual gene sequence, allowing for high-resolution visualization of precisely where the gene is active in the body, during normal body functioning, as well as in disease processes. For the optimization of pre-clinical development and toxicology programs, VelociGene offers the opportunity to humanize targets by replacing the mouse gene with the human homolog. Thus, VelociGene allows scientists to rapidly identify the physical and biological effects of deleting or over-expressing the target gene, as well as to characterize and test potential therapeutic molecules.

      The VelociMouse technology platform allows for the direct and immediate generation of genetically altered mice from embryonic stem cells (ES cells), thereby avoiding the lengthy process involved in generating and breeding knockout mice from chimeras. Mice generated through this method are normal and healthy and exhibit a 100% germ-line transmission. Furthermore, Regeneron’s VelociMice are suitable for direct phenotyping or other studies. We have also developed our VelociMab platform for the rapid screening of antibodies and rapid generation of expression cell lines for our Traps and our VelocImmune human monoclonal antibodies.

Antibody Collaboration with sanofi-aventis

      In November 2007, we and sanofi-aventis entered into a global, strategic collaboration to discover, develop, and commercialize fully human monoclonal antibodies. The collaboration is governed by a Discovery and Preclinical Development Agreement and a License and Collaboration Agreement. We received a non-refundable, up-front payment of $85.0 million from sanofi-aventis under the discovery agreement. In addition, sanofi-aventis is funding research at Regeneron to identify and validate potential drug discovery targets and develop fully human monoclonal antibodies against these targets. Sanofi-aventis funded approximately $75 million of research from the collaboration’s inception through December 31, 2008 and will fund up to $100 million per year in 2009 through 2012. Sanofi-aventis also has an option to extend the discovery program for up to an additional three years for further antibody development and preclinical activities. We will lead the design and conduct of research activities, including target identification and validation, antibody development, research and preclinical activities through filing of an Investigational New Drug Application, toxicology studies, and manufacture of preclinical and clinical supplies.

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      For each drug candidate identified under the discovery agreement, sanofi-aventis has the option to license rights to the candidate under the license agreement. If it elects to do so, sanofi-aventis will co-develop the drug candidate with us through product approval. Development costs will be shared between the companies, with sanofi-aventis generally funding drug candidate development costs up front. We are generally responsible for reimbursing sanofi-aventis for half of the total development costs for all collaboration products from our share of profits from commercialization of collaboration products to the extent they are sufficient for this purpose. Sanofi-aventis will lead commercialization activities for products developed under the license agreement, subject to our right to co-promote such products. The parties will equally share profits and losses from sales within the United States. The parties will share profits outside the United States on a sliding scale based on sales starting at 65% (sanofi-aventis)/35% (us) and ending at 55% (sanofi-aventis)/45% (us), and will share losses outside the United States at 55% (sanofi-aventis)/45% (us). In addition to profit sharing, we are entitled to receive up to $250 million in sales milestone payments, with milestone payments commencing after aggregate annual sales outside the United States exceed $1.0 billion on a rolling 12-month basis.

      In August 2008, we entered into an agreement with sanofi-aventis to use our VelociGene ® platform to supply sanofi-aventis with genetically modified mammalian models of gene function and disease. Sanofi-aventis will pay us a minimum of $21.5 million for the term of the agreement, which extends through December 2012, for knock-out and transgenic models of gene function for target genes identified by sanofi-aventis. Sanofi-aventis will use these models for its internal research programs that are outside of the scope of our antibody collaboration.

License Agreement with AstraZeneca

      In February 2007, we entered into a non-exclusive license agreement with AstraZeneca UK Limited that allows AstraZeneca to utilize our VelocImmune technology in its internal research programs to discover human monoclonal antibodies. Under the terms of the agreement, AstraZeneca made $20.0 million annual, non-refundable payments to us in February 2007, 2008, and 2009. AstraZeneca is required to make up to three additional annual payments of $20.0 million, subject to its ability to terminate the agreement after making the next additional payment or earlier if the technology does not meet minimum performance criteria. We are entitled to receive a mid-single-digit royalty on any future sales of antibody products discovered by AstraZeneca using our VelocImmune technology.

License Agreement with Astellas

      In March 2007, we entered into a non-exclusive license agreement with Astellas Pharma Inc. that allows Astellas to utilize our VelocImmune technology in its internal research programs to discover human monoclonal antibodies. Under the terms of the agreement, Astellas made two $20.0 million annual, non-refundable payments to us, one in April 2007 and the other in June 2008. Astellas is required to make up to four additional annual payments of $20.0 million, subject to its ability to terminate the agreement after making the first two additional payments or earlier if the technology does not meet minimum performance criteria. We are entitled to receive a mid-single-digit royalty on any future sales of antibody products discovered by Astellas using our VelocImmune technology.

Academic VelocImmune ® Investigators’ Program

      In September 2008, we entered into an agreement that will provide researchers at Columbia University Medical Center with access to our VelocImmune technology platform. In March 2009, we entered into a similar agreement with The University of Texas Southwestern Medical Center at Dallas. Under the agreements, scientists at these academic institutions will use VelocImmune mice to generate antibodies against their research targets and will conduct research to discover potential human therapeutics based on the antibodies. We have an exclusive option to license the antibodies for development and commercialization as therapeutic or diagnostic products and will pay to the appropriate institution a low single-digit royalty on ensuing product sales.

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National Institutes of Health Grant

      In September 2006, we were awarded a five-year grant from the National Institutes of Health (NIH) as part of the NIH’s Knockout Mouse Project. The goal of the Knockout Mouse Project is to build a comprehensive and broadly available resource of knockout mice to accelerate the understanding of gene function and human diseases. We are using our VelociGene ® technology to take aim at 3,500 of the most difficult genes to target and which are not currently the focus of other large-scale knockout mouse programs. We also agreed to grant a limited license to a consortium of research institutions, the other major participants in the Knockout Mouse Project, to use components of our VelociGene technology in the Knockout Mouse Project. We are generating a collection of targeting vectors and targeted mouse ES cells which can be used to produce knockout mice. These materials are available to academic researchers without charge. We will receive a fee for each targeted ES cell line or targeting construct made by us or the research consortium and transferred to commercial entities.

      Under the NIH grant, as amended in September 2008, we are entitled to receive a minimum of $24.5 million over the five-year period beginning September 2006, including $1.5 million to optimize our existing C57BL/6 ES cell line and its proprietary growth medium, both of which are being supplied to the research consortium for its use in the Knockout Mouse Project. We have the right to use, for any purpose, all materials generated by us and the research consortium.

Research Programs :

Oncology and Angiogenesis

      In many clinical settings, positively or negatively regulating blood vessel growth could have important therapeutic benefits, as could the repair of damaged and leaky vessels. VEGF was the first growth factor shown to be specific for blood vessels, by virtue of having its receptor specifically expressed on blood vessel cells. In 1994, we discovered a second family of angiogenic growth factors, termed angiopoietins, and we have received patents covering members of this family. Angiopoietins include naturally occurring positive and negative regulators of angiogenesis, as described in numerous scientific manuscripts published by our scientists and their collaborators. Angiopoietins are being evaluated in preclinical research by us and our academic collaborators. Our preclinical studies have revealed that VEGF and angiopoietins normally function in a coordinated and collaborative manner during blood vessel growth. Manipulation of both VEGF and angiopoietins seems to be of value in either promoting or blocking vessel growth. We have research programs focusing on several targets in the areas of oncology and angiogenesis.

      Tumors depend on the growth of new blood vessels (a process called “angiogenesis”) to support their continued growth. Therapies that block tumor angiogenesis, specifically those that block VEGF, the key initiator of tumor angiogenesis, recently have been validated in human cancer patients. However, anti-VEGF approaches do not work in all patients, and many tumors can become resistant to such therapies.

      In the December 21, 2006 issue of the journal Nature, we reported data from a preclinical study demonstrating that blocking an important cell signaling molecule, known as Delta-like ligand 4 (Dll4), inhibited the growth of experimental tumors by interfering with their ability to produce a functional blood supply. The inhibition of tumor growth was seen in a variety of tumor types, including those that were resistant to blockade of VEGF, suggesting a novel anti-angiogenesis therapeutic approach. We are in the process of initiating Phase 1 clinical development of a fully human monoclonal antibody to Dll4 that was discovered using our VelocImmune ® technology.

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Metabolic and Related Diseases

      Food intake and metabolism are regulated by complex interactions between diverse neural and hormonal signals that serve to maintain an optimal balance between energy intake, storage, and utilization. The hypothalamus, a small area at the base of the brain, is critically involved in integrating peripheral signals which reflect nutritional status and neural outputs which regulate appetite, food seeking behaviors, and energy expenditure. Metabolic disorders, such as type 2 diabetes, reflect a dysregulation in the systems which ordinarily tightly couple energy intake to energy expenditure. Our preclinical research program in this area encompasses the study of peripheral (hormonal) regulators of food intake and metabolism in health and disease. We have identified several targets in these therapeutic areas and are evaluating lead monoclonal antibodies in relevant preclinical models.

Muscle Diseases and Disorders

      Muscle atrophy occurs in many neuromuscular diseases and also when muscle is unused, as often occurs during prolonged hospital stays and during convalescence. Currently, physicians have few options to treat subjects with muscle atrophy or other muscle conditions which afflict millions of people globally. Thus, a treatment that has beneficial effects on skeletal muscle could have significant clinical benefit. Our muscle research program is currently focused on conducting in vivo and in vitro experiments with the objective of demonstrating and further understanding the molecular pathways involved in muscle atrophy and hypertrophy, and discovering therapeutic candidates that can modulate these pathways. We have several molecules in late stage research and are evaluating them for possible further development.

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Other Therapeutic Areas

      We also have research programs focusing on ophthalmology, inflammatory and immune diseases, bone and cartilage, pain, and cardiovascular diseases.

General

      Developing and commercializing new medicines entails significant risk and expense. Since inception we have not generated any significant sales or profits from the commercialization of ARCALYST or any of our other product candidates. Before significant revenues from the commercialization of ARCALYST or our other product candidates can be realized, we (or our collaborators) must overcome a number of hurdles which include successfully completing research and development and obtaining regulatory approval from the FDA and regulatory authorities in other countries. In addition, the biotechnology and pharmaceutical industries are rapidly evolving and highly competitive, and new developments may render our products and technologies uncompetitive or obsolete.

      From inception on January 8, 1988 through March 31, 2009, we had a cumulative loss of $893.4 million. In the absence of significant revenues from the commercialization of ARCALYST or our other product candidates or other sources, the amount, timing, nature, and source of which cannot be predicted, our losses will continue as we conduct our research and development activities. We expect to incur substantial losses over the next several years as we continue the clinical development of VEGF Trap-Eye and ARCALYST in other indications; advance new product candidates into clinical development from our existing research programs utilizing our technology for discovering fully human monoclonal antibodies; continue our research and development programs; and commercialize additional product candidates that receive regulatory approval, if any. Also, our activities may expand over time and require additional resources, and we expect our operating losses to be substantial over at least the next several years. Our losses may fluctuate from quarter to quarter and will depend on, among other factors, the progress of our research and development efforts, the timing of certain expenses, and the amount and timing of payments that we receive from collaborators.

      The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results. In our clinical programs, key events to date in 2009 and plans over the next 12 months are as follows:

      2009-10 Plans
Clinical Program       2009 Events to Date       (next 12 months)

ARCALYST ®
       (rilonacept; also
       known as IL-1 Trap)

  • Initiated patient enrollment in the Phase 3 program evaluating ARCALYST in the prevention of gout flares associated with the initiation of urate-lowering drug therapy and in the treatment of acute gout attacks
  • Continue enrollment in the Phase 3 program in gout
 

Aflibercept 
       (VEGF Trap –
       Oncology)

  • Initiated a Phase 2 1st-line study in metastatic colorectal cancer in combination with chemotherapy
  • Achieved approximately 50% enrollment in each of the Phase 3 studies
  • Report results of a Phase 2 single-agent study in SMA
  • Continue enrollment of the four Phase 3 studies
 

VEGF Trap-Eye
       (intravitreal injection)

  • Complete enrollment in VIEW 1 and VIEW 2 trials
  • Continue enrolling patients in the Phase 2 DME trial
  • Initiate a Phase 3 CRVO program
                 

Monoclonal
       Antibodies

  • Initiated a Phase 1 trial for REGN475 (anti-NGF) in healthy volunteers
  • Initiate a Phase 1 trial for REGN421(anti Dll4) in oncology
  • Report data from a Phase 1 trial of REGN88 (anti-IL-6R) in rheumatoid arthritis
  • Initiate multiple Phase 2 trials for REGN475 in pain indications
  • Advance additional antibody candidate(s) into clinical development 
 

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Results of Operations

Three Months Ended March 31, 2009 and 2008

Net Loss:

      Regeneron reported a net loss of $17.5 million, or $0.22 per share (basic and diluted), for the first quarter of 2009 compared to a net loss of $11.6 million, or $0.15 per share (basic and diluted), for the first quarter of 2008. The increase in our net loss was principally due to higher research and development expenses, as detailed below, partly offset by higher contract research and development revenue in connection with our antibody collaboration with sanofi-aventis and net product sales of ARCALYST ® (rilonacept) for the treatment of CAPS.

Revenues:

      Revenues for the three months ended March 31, 2009 and 2008 consist of the following:

(In millions)          2009        2008
Contract research & development revenue    
        Sanofi-aventis $ 49.6 $ 35.7
        Bayer HealthCare 10.0 9.0
        Other     1.5   1.7
               Total contract research & development revenue   61.1   46.4
Technology licensing revenue 10.0   10.0
Net product sales 3.9  
               Total revenue $ 75.0 $ 56.4

      The contract and research development revenue we earn from sanofi-aventis, as detailed below, consists primarily of reimbursement for research and development expenses and partly of the recognition of revenue related to non-refundable up-front payments of $105.0 million related to the aflibercept collaboration and $85.0 million related to the antibody collaboration.

Sanofi-aventis Contract Research & Development Revenue   Three months ended
(In millions)   March 31,
Aflibercept:        2009        2008
        Regeneron expense reimbursement $ 5.4 $ 11.7
        Recognition of deferred revenue related to up-front payments 2.5 2.1
               Total aflibercept 7.9   13.8
Antibody:      
        Regeneron expense reimbursement 38.4 19.3
        Recognition of deferred revenue related to up-front payment   2.6 2.6
        Recognition of revenue related to VelociGene ® agreement 0.7  
               Total antibody 41.7 21.9
Total sanofi-aventis contract research & development revenue $ 49.6 $ 35.7

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      Sanofi-aventis’ reimbursement of Regeneron’s aflibercept expenses decreased in the first quarter of 2009, compared to the same period in 2008, primarily due to lower costs related to manufacturing aflibercept clinical supplies. Recognition of deferred revenue related to sanofi-aventis’ up-front aflibercept payments increased in the first quarter of 2009 compared to the same period in 2008 due to shortening the estimated performance period over which this deferred revenue is being recognized, effective in the fourth quarter of 2008. As of March 31, 2009, $49.9 million of the original $105.0 million of up-front payments related to aflibercept was deferred and will be recognized as revenue in future periods.

      In the first quarter of 2009, sanofi-aventis’ reimbursement of Regeneron’s antibody expenses consisted of $22.7 million under the discovery agreement and $15.7 million of development costs under the license agreement, compared to $15.1 million and $4.2 million, respectively, in the first quarter of 2008. Higher sanofi-aventis’ reimbursements in the first quarter of 2009 compared to the same period in 2008 were due to an increase in our research activities conducted under the discovery agreement and increases in our development activities for REGN88, REGN421, and REGN475 under the license agreement.

      Recognition of deferred revenue under the antibody collaboration related to sanofi-aventis’ $85.0 million up-front payment. As of March 31, 2009, $71.0 million of this up-front payment was deferred and will be recognized as revenue in future periods.

      As described above, in August, 2008, we entered into a separate VelociGene ® agreement with sanofi-aventis. For the three months ended March 31, 2009, we recognized $0.7 million of revenue related to this agreement.

      The contract research and development revenue we earn from Bayer HealthCare, as detailed below, consists partly of cost sharing of Regeneron VEGF Trap-Eye development expenses and partly of recognition of revenue related to a non-refundable $75.0 million up-front payment and $20.0 million non-substantive milestone payment.

  Three months ended
Bayer HealthCare Contract Research & Development Revenue   March 31,
(In millions)          2009        2008
Cost-sharing of Regeneron VEGF Trap-Eye development expenses $       7.5 $ 5.7
Recognition of deferred revenue related to up-front and milestone payments 2.5 3.3
       Total Bayer HealthCare contract research & development revenue $ 10.0 $ 9.0

      In the first quarter of 2009, cost-sharing of Regeneron VEGF Trap-Eye development expenses increased, compared to the same period in 2008, primarily due to higher clinical development costs in connection with our VIEW 1 trial in wet AMD and Phase 2 trial in DME. Recognition of deferred revenue related to Bayer’s up-front and milestone payments decreased in the first quarter of 2009 compared to the same period in 2008 due to an extension of the estimated performance period over which this deferred revenue is being recognized, effective in the fourth quarter of 2008. As of March 31, 2009, $64.2 million of the up-front licensing and milestone payments was deferred and will be recognized as revenue in future periods.

      Other contract research and development revenue in the first quarter of 2009 and 2008 includes $1.5 million and $1.1 million, respectively, in connection with our five-year grant from the NIH, which we were awarded in September 2006 as part of the NIH’s Knockout Mouse Project.

      In connection with our VelocImmune ® license agreements with AstraZeneca and Astellas, each of the $20.0 million annual, non-refundable payments are deferred upon receipt and recognized as revenue ratably over approximately the ensuing year of each agreement. In the first quarter of both 2009 and 2008, we recognized $10.0 million of technology licensing revenue related to these agreements.

      For the three months ended March 31, 2009, we recognized as revenue $3.9 million of ARCALYST ® (rilonacept) net product sales for which both the right of return no longer exists and rebates can be reasonably estimated. At March 31, 2009, deferred revenue related to ARCALYST net product sales totaled $4.2 million.

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Expenses:

      Total operating expenses increased to $94.2 million in the first quarter of 2009 from $72.3 million in the same period of 2008. Our average headcount increased to 938 in the first quarter of 2009 from 714 in the same period of 2008 principally as a result of our expanding research and development activities which are primarily attributable to the sanofi-aventis antibody collaboration.

      Operating expenses in the first quarter of 2009 and 2008 include a total of $7.7 million and $8.3 million, respectively, of non-cash compensation expense related to employee stock option and restricted stock awards (Non-cash Compensation Expense), as detailed below:

  For the three months ended March 31, 2009
Expenses before
  inclusion of Non-cash Non-cash  
Expenses   Compensation Compensation Expenses as
(In millions)          Expense        Expense        Reported
Research and development                  $ 77.4                               $ 4.7                       $ 82.1           
Selling, general, and administrative       8.7       3.0       11.7  
Cost of goods sold 0.4       0.4
       Total operating expenses $ 86.5 $ 7.7 $ 94.2

  For the three months ended March 31, 2008
Expenses before
  inclusion of Non-cash Non-cash  
Expenses   Compensation Compensation Expenses as
(In millions)          Expense        Expense        Reported
Research and development                    $ 56.4                             $ 4.9                         $ 61.3           
Selling, general, and administrative     7.6         3.4       11.0  
       Total operating expenses $ 64.0 $ 8.3 $ 72.3

Research and Development Expenses:

      Research and development expenses increased to $82.1 million in the first quarter of 2009 from $61.3 million in the same period of 2008. The following table summarizes the major categories of our research and development expenses for the three months ended March 31, 2009 and 2008:

  For the three months ended March 31,
Research and Development Expenses       Increase
(In millions)          2009        2008        (Decrease)
Payroll and benefits (1)                  $ 22.9                             $ 19.2            $ 3.7  
Clinical trial expenses 19.3   8.5            10.8           
Clinical manufacturing costs (2)   14.1   14.7 (0.6 )
Research and preclinical development costs     8.4   5.5   2.9  
Occupancy and other operating costs 10.4   6.8   3.6  
Cost-sharing of Bayer HealthCare VEGF          
       Trap-Eye development expenses (3) 7.0 6.6 0.4  
       Total research and development $ 82.1 $ 61.3 $ 20.8  

      (1)       Includes $4.0 million and $4.2 million of Non-cash Compensation Expense for the three months ended March 31, 2009 and 2008, respectively.
(2) Represents the full cost of manufacturing drug for use in research, preclinical development, and clinical trials, including related payroll and benefits, Non-cash Compensation Expense, manufacturing materials and supplies, depreciation, and occupancy costs of our Rensselaer manufacturing facility. Includes $0.7 million of Non-cash Compensation Expense for both the three months ended March 31, 2009 and 2008.
(3) Under our collaboration with Bayer HealthCare, in periods when Bayer HealthCare incurs VEGF Trap-Eye development expenses, we also recognize, as additional research and development expense, the portion of Bayer HealthCare’s VEGF Trap-Eye development expenses that we are obligated to reimburse.

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      Payroll and benefits increased principally due to the increase in employee headcount, as described above. Clinical trial expenses increased due primarily to higher costs related to our clinical development programs for (i) VEGF Trap-Eye, including our VIEW 1 trial in wet AMD and Phase 2 trial in DME, (ii) ARCALYST, related to our Phase 3 clinical development program in gout, and (iii) monoclonal antibodies, primarily related to REGN88 in rheumatoid arthritis. Clinical manufacturing costs decreased due to lower costs related to manufacturing aflibercept clinical supplies, partially offset by higher costs related to manufacturing clinical supplies of ARCALYST and monoclonal antibodies, including REGN88. Research and preclinical development costs increased primarily due to higher costs associated with our antibody programs. Occupancy and other operating costs increased principally in connection with our higher headcount, expanded research and development activities, and new operating lease for our Tarrytown, New York facilities, which commenced in June 2008. Cost-sharing of Bayer HealthCare’s VEGF Trap-Eye development expenses slightly increased primarily due to higher costs in connection with the VIEW 2 trial in wet AMD, which is being conducted by Bayer HealthCare.

      We budget our research and development costs by expense category, rather than by project. We also prepare estimates of research and development costs for projects in clinical development, which include direct costs and allocations of certain costs such as indirect labor, Non-cash Compensation Expense, and manufacturing and other costs related to activities that benefit multiple projects, and, under our collaboration with Bayer HealthCare, the portion of Bayer HealthCare’s VEGF Trap-Eye development expenses that we are obligated to reimburse. Our estimates of research and development costs for clinical development programs (including ARCALYST for the treatment of CAPS prior to receipt of marketing approval from the FDA in February 2008) are shown below:

Project Costs   For the three months ended March 31,
      Increase
(In millions)          2009        2008          (Decrease)
ARCALYST ® (rilonacept)                  $ 17.9                             $ 8.0                       $ 9.9           
Aflibercept       4.2 10.1 (5.9 )
VEGF Trap-Eye 20.8   16.6 4.2  
REGN88 9.0       3.8         5.2  
REGN421 and REGN475 4.9   4.9  
Other research programs & unallocated costs 25.3 22.8 2.5  
       Total research and development expenses $ 82.1 $ 61.3 $ 20.8  

      Drug development and approval in the United States is a multi-step process regulated by the FDA. The process begins with discovery and preclinical evaluation, leading up to the submission of an IND to the FDA which, if successful, allows the opportunity for study in humans, or clinical study, of the potential new drug. Clinical development typically involves three phases of study: Phase 1, 2, and 3. The most significant costs in clinical development are in Phase 3 clinical trials, as they tend to be the longest and largest studies in the drug development process. Following successful completion of Phase 3 clinical trials for a biological product, a biologics license application (or BLA) must be submitted to, and accepted by, the FDA, and the FDA must approve the BLA prior to commercialization of the drug. It is not uncommon for the FDA to request additional data following its review of a BLA, which can significantly increase the drug development timeline and expenses. We may elect either on our own, or at the request of the FDA, to conduct further studies that are referred to as Phase 3B and 4 studies. Phase 3B studies are initiated and either completed or substantially completed while the BLA is under FDA review. These studies are conducted under an IND. Phase 4 studies, also referred to as post-marketing studies, are studies that are initiated and conducted after the FDA has approved a product for marketing. In addition, as discovery research, preclinical development, and clinical programs progress, opportunities to expand development of drug candidates into new disease indications can emerge. We may elect to add such new disease indications to our development efforts (with the approval of our collaborator for joint development programs), thereby extending the period in which we will be developing a product. For example, we, and our collaborators where applicable, continue to explore further development of ARCALYST, aflibercept, and VEGF Trap-Eye in different disease indications.

      There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Item 1A, “Risk Factors” under “Risks Related to ARCALYST ® (rilonacept) and the Development of Our Product Candidates,” “Regulatory and Litigation Risks,” and “Risks Related to Commercialization of Products.” The lengthy process of seeking FDA approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business.

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      For these reasons and due to the variability in the costs necessary to develop a product and the uncertainties related to future indications to be studied, the estimated cost and scope of the projects, and our ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the total cost to bring our product candidates to market are not available. Similarly, we are currently unable to reasonably estimate if our product candidates will generate material product revenues and net cash inflows. In the first quarter of 2008, we received FDA approval for ARCALYST ® (rilonacept) for the treatment of CAPS, a group of rare, inherited auto-inflammatory diseases. These rare diseases affect a very small group of people. As a result, we can not predict whether the commercialization of ARCALYST in CAPS will result in a significant net cash benefit to us.

Selling, General, and Administrative Expenses:

      Selling, general, and administrative expenses increased to $11.7 million in the first quarter of 2009 from $11.0 million in the same period of 2008 due to (i) higher selling expenses related to ARCALYST, (ii) higher compensation expense due primarily to increases in administrative headcount to support our expanded research and development activities, and (iii) higher administrative facility-related costs arising principally in connection with our higher headcount and the new operating lease for our Tarrytown, New York facilities, which commenced in June 2008.

Cost of Goods Sold:

      In the third quarter of 2008, we began recognizing revenue and cost of goods sold from product sales of ARCALYST. We began capitalizing inventory costs associated with commercial supplies of ARCALYST subsequent to receipt of marketing approval from the FDA in February 2008. Costs for manufacturing supplies of ARCALYST prior to receipt of FDA approval were recognized as research and development expenses in the period that the costs were incurred. Therefore, these costs are not being included in cost of goods sold when revenue is recognized from the sale of those supplies of ARCALYST. Cost of goods sold for the first quarter of 2009 was $0.4 million and consisted primarily of royalty and other period costs related to ARCALYST commercial supplies.

Other Income and Expense:

      Investment income decreased to $1.8 million in the first quarter of 2009 from $7.3 million in the comparable quarter of 2008. The decrease in investment income was due to lower yields on, and lower balances of, cash and marketable securities in the first quarter of 2009 compared to the same quarter of 2008. Interest expense was $3.0 million in the first quarter of 2008 and related to $200.0 million of formerly outstanding 5.5% Convertible Senior Subordinated Notes which we either repurchased or repaid in full during 2008.

Liquidity and Capital Resources

      Since our inception in 1988, we have financed our operations primarily through offerings of our equity securities, a private placement of convertible debt (which was repurchased or repaid in 2008), purchases of our equity securities by our collaborators, including sanofi-aventis, revenue earned under our past and present research and development agreements, including our agreements with sanofi-aventis and Bayer HealthCare, our past contract manufacturing agreements, and our technology licensing agreements, ARCALYST product revenue, and investment income.

Three months ended March 31, 2009 and 2008

      At March 31, 2009, we had $496.0 million in cash, cash equivalents, restricted cash, and marketable securities compared with $527.5 million at December 31, 2008. In February 2009, we received a $20.0 million annual, non-refundable payment in connection with our non-exclusive license agreement with AstraZeneca.

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Cash Used in Operations:

      Net cash used in operations was $10.2 million in the first quarter of 2009 compared to $17.9 million in the first quarter of 2008. Our net losses of $17.5 million in the first quarter of 2009 and $11.6 million in the first quarter of 2008 included $7.7 million and $8.3 million, respectively, of Non-cash Compensation Expense.

      At March 31, 2009, accounts receivable increased by $13.0 million, compared to end-of-year 2008, primarily due to a higher receivable balance related to our antibody collaboration with sanofi-aventis. Also, prepaid expenses and other assets increased by $8.6 million at March 31, 2009 compared to end-of-year 2008 due primarily to higher prepaid clinical trial costs. At March 31, 2009, accounts payable, accrued expenses, and other liabilities increased by $15.3 million compared to end-of-year 2008. The increase was due primarily to higher liabilities for clinical trial and payroll costs, and capital expenditures, primarily for tenant improvements and related costs in connection with our new leased facilities in Tarrytown, New York, partially offset by a lower cost-sharing payment due to Bayer HealthCare in connection with the companies’ VEGF Trap-Eye collaboration.

      At March 31, 2008, accounts receivable increased by $14.6 million, compared to end-of-year 2007, primarily due to higher receivable balances related to our collaborations with sanofi-aventis. Accounts payable, accrued expenses, and other liabilities decreased by $7.6 million at March 31, 2008, compared to end-of-year 2007, due primarily to reductions in accrued payroll costs and the amount of the cost-sharing payment due to Bayer HealthCare in connection with the companies’ VEGF Trap-Eye collaboration.

Cash (Used in) Provided by Investing Activities:

      Net cash used in investing activities was $39.5 million in the first quarter of 2009 compared to net cash provided by investing activities of $37.9 million in the same period of 2008, due primarily to an increase in purchases of marketable securities net of sales or maturities. In the first quarter of 2009, purchases exceeded sales or maturities of marketable securities by $17.6 million, whereas in the first quarter of 2008, sales or maturities exceeded purchases of marketable securities by $41.0 million. In addition, cash used for capital expenditures totaled $21.9 million in the first three months of 2009, primarily for tenant improvements and related costs in connection with our new leased facilities in Tarrytown.

Cash Provided by Financing Activities:

      Cash provided by financing activities decreased to $1.0 million in the first quarter of 2009 from $1.9 million in the same period in 2008 due to a decrease in issuances of Common Stock in connection with exercises of employee stock options.

Fair Value of Marketable Securities:

      At March 31, 2009 and December 31, 2008, we held marketable securities whose aggregate fair value totaled $295.2 million and $278.0 million, respectively. The composition of our portfolio of marketable securities on these dates was as follows:

  March 31, 2009   December 31, 2008  
Investment type          Fair Value        Percent        Fair Value        Percent
U.S. Treasury securities $ 131.0 44 % $ 113.9 41 %
U.S. government agency securities 59.9 20 % 58.3 21 %
U.S. government-guaranteed corporate bonds   48.9 17 %   29.8   11 %
U.S. government guaranteed collateralized mortgage          
       obligations   11.3 4 %   17.4 6 %
Corporate bonds 32.1 11 % 37.1 13 %
Asset-backed securities 8.8 3 % 17.8 7 %
Other 3.2 1 % 3.7 1 %
       Total marketable securities $ 295.2 100 % $ 278.0 100 %

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      In addition, at March 31, 2009 and December 31, 2008, we had $200.8 million and $249.5 million, respectively, of cash, cash equivalents, and restricted cash, primarily held in money market funds that invest in U.S. government securities.

      During the first quarter of 2009, as marketable securities in our portfolio matured or paid down, we purchased primarily U.S. Treasury securities, U.S. government agency obligations and U.S. government-guaranteed debt. This shift toward higher quality securities, which we initiated in 2008, continues to reduce the risk profile, as well as the overall yield, of our portfolio. In particular, we continue to reduce the proportion of asset-backed securities and corporate bonds in our portfolio.

Capital Expenditures:

      Our additions to property, plant, and equipment totaled $24.7 million and $2.8 million for the first three months of 2009 and 2008, respectively. During the remainder of 2009, we expect to incur, primarily in connection with expanding our Rensselaer, New York manufacturing facilities and the new Tarrytown facilities approximately $80 to $90 million in capital expenditures of which up to approximately $50 million is reimbursable at our option from our landlord under the terms of our Tarrytown operating lease.

Amendment to Operating Lease – Tarrytown, New York Facilities:

      We currently lease approximately 248,000 square feet of laboratory and office facilities in Tarrytown, New York. In December 2006, we entered into a new operating lease agreement (as amended in October 2007 and September 2008) to lease approximately 348,000 square feet of laboratory and office space at our current Tarrytown location, including approximately 230,000 square feet in new facilities that are currently under construction and expected to be completed in mid-2009. The term of the lease commenced effective June 2008 and will expire in June 2024. In April 2009, we amended the operating lease agreement to increase the amount of space we will lease to approximately 389,500 square feet. As amended, the lease contains early termination options on approximately 159,500 square feet of space. Other terms and conditions, as previously described in our Annual Report on Form 10-K for the year ended December 31, 2008, remain unchanged. In connection with the lease amendment, in April 2009, we terminated a sublease for 16,200 square feet of space in Tarrytown, New York.

Funding Requirements:

      We expect to continue to incur substantial funding requirements primarily for research and development activities (including preclinical and clinical testing). Before taking into account reimbursements from collaborators, we currently anticipate that approximately 55-65% of our expenditures for 2009 will be directed toward the preclinical and clinical development of product candidates, including ARCALYST ® (rilonacept), aflibercept, VEGF Trap-Eye, and monoclonal antibodies (including REGN88, REGN421, and REGN475); approximately 15-20% of our expenditures for 2009 will be applied to our basic research and early preclinical activities and the remainder of our expenditures for 2009 will be used for the continued development of our novel technology platforms, capital expenditures, and general corporate purposes.

      We currently anticipate that in 2009 sales of ARCALYST for the treatment of CAPS will not materially enhance or otherwise materially impact our cash flows.

      In connection with the April 2009 amendment to our operating lease agreement in Tarrytown, New York, as described above, our funding requirements for operating leases, previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2008, will increase (i) from $9.1 million to $9.4 million for the year ending December 31, 2009, (ii) from $26.8 million to $29.2 million for the two-year period beginning January 1, 2010, (iii) from $27.2 million to $28.8 million for the two-year period beginning January 1, 2012, and (iv) from $167.0 million to $182.5 million for the fiscal years beginning January 1, 2014 and thereafter.

      The amount we need to fund operations will depend on various factors, including the status of competitive products, the success of our research and development programs, the potential future need to expand our professional and support staff and facilities, the status of patents and other intellectual property rights, the delay or failure of a clinical trial of any of our potential drug candidates, and the continuation, extent, and success of our collaborations with sanofi-aventis and Bayer HealthCare. Clinical trial costs are dependent, among other things, on the size and duration of trials, fees charged for services provided by clinical trial investigators and other third parties, the costs for manufacturing the product candidate for use in the trials, and for supplies, laboratory tests, and other expenses. The amount of funding that will be required for our clinical programs depends upon the results of our research and preclinical programs and early-stage clinical trials, regulatory requirements, the duration and results of clinical trials underway and of additional clinical trials that we decide to initiate, and the various factors that affect the cost of each trial as described above. Currently, we are required to remit royalties on product sales of ARCALYST for the treatment of CAPS. In the future, if we are able to successfully develop, market, and sell ARCALYST for other indications or certain of our product candidates, we may be required to pay royalties or otherwise share the profits generated on such sales in connection with our collaboration and licensing agreements.

      We expect that expenses related to the filing, prosecution, defense, and enforcement of patent and other intellectual property claims will continue to be substantial as a result of patent filings and prosecutions in the United States and foreign countries.

      We believe that our existing capital resources, including funding we are entitled to receive under our collaboration agreements, will enable us to meet operating needs through at least 2012. However, this is a forward-looking statement based on our current operating plan, and there may be a change in projected revenues or expenses that would lead to our capital being consumed significantly before such time. If there is insufficient capital to fund all of our planned operations and activities, we believe we would prioritize available capital to fund selected preclinical and clinical development programs.

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      Other than letters of credit totaling $1.7 million, including a $1.6 million letter of credit issued to our landlord in connection with our operating lease for facilities in Tarrytown, New York, as described above, we have no off-balance sheet arrangements. In addition, we do not guarantee the obligations of any other entity. As of March 31, 2009, we had no established banking arrangements through which we could obtain short-term financing or a line of credit. In the event we need additional financing for the operation of our business, we will consider collaborative arrangements and additional public or private financing, including additional equity financing. Factors influencing the availability of additional financing include our progress in product development, investor perception of our prospects, and the general condition of the financial markets. We may not be able to secure the necessary funding through new collaborative arrangements or additional public or private offerings. If we cannot raise adequate funds to satisfy our capital requirements, we may have to delay, scale-back, or eliminate certain of our research and development activities or future operations. This could materially harm our business.

Future Impact of Recently Issued Accounting Standards

      In April 2009, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position (“FSP”) FAS 107-1 and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments. This FSP amends SFAS 107, Disclosures about Fair Value of Financial Instruments, to require entities to provide disclosures about the fair value of financial instruments in interim financial information. This FSP also amends APB Opinion No. 28, Interim Financial Reporting, to require those disclosures in summarized financial information at interim reporting periods. In addition, an entity shall disclose in the body or in the accompanying notes of its summarized financial information for interim reporting periods and in its financial statements for annual reporting periods the fair value of all financial instruments for which it is practicable to estimate that value, whether recognized or not recognized in the statement of financial position, as required by SFAS 107. We are required to adopt FSP 107-1 and APB 28-1 for the quarter ended June 30, 2009. Management does not anticipate that the adoption of FSP 107-1 and APB 28-1 will have a material impact on our financial statements.

      In April 2009, the FASB issued FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments. This FSP changes existing guidance for determining whether an impairment to debt securities is other than temporary; replaces the existing requirement that management assert it has both the intent and ability to hold an impaired security until recovery with a requirement that management assert: ( a ) it does not have the intent to sell the security; and ( b ) it is more likely than not it will not have to sell the security before recovery of its cost basis; requires that an entity recognize noncredit losses on held-to-maturity debt securities in other comprehensive income and amortize that amount over the remaining life of the security in a prospective manner by offsetting the recorded value of the asset unless the security is subsequently sold or there are additional credit losses; and requires entities to present the total other-than-temporary impairment in the statement of earnings with an offset for the amount recognized in other comprehensive income. When adopting FSP FAS 115-2 and FAS 124-2, entities are required to record a cumulative-effect adjustment as of the beginning of the period of adoption to reclassify the noncredit component of a previously recognized other-temporary impairment from retained earnings to accumulated other comprehensive income if the entity does not intend to sell the security and it is not more likely than not that the entity will be required to sell the security before recovery. We are required to adopt FSP FAS 115-2 and FAS 124-2 for the quarter ended June 30, 2009. Management does not anticipate that the adoption of FSP FAS 115-2 and FAS 124-2 will have a material impact on our financial statements.

      In April 2009 the FASB issued FSP FAS 157-4, Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly. This FSP affirms that the objective of fair value when the market for an asset is not active is the price that would be received to sell the asset in an orderly transaction; clarifies and includes additional factors for determining whether there has been a significant decrease in market activity for an asset when the market for that asset is not active; and eliminates the proposed presumption that all transactions are distressed (not orderly) unless proven otherwise. The FSP instead requires entities to base its conclusion about whether a transaction was not orderly on the weight of the evidence. We are required to adopt FSP FAS 157-4 for the quarter ended June 30, 2009. Management does not anticipate that the adoption of FSP FAS 157-4 will have a material impact on our financial statements.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

Interest Rate Risk:

      Our earnings and cash flows are subject to fluctuations due to changes in interest rates primarily from our investment of available cash balances in investment grade corporate, asset-backed, and U.S. government securities. We do not believe we are materially exposed to changes in interest rates. Under our current policies, we do not use interest rate derivative instruments to manage exposure to interest rate changes. We estimated that a one percent unfavorable change in interest rates would result in approximately a $1.6 million and $1.8 million decrease in the fair value of our investment portfolio at March 31, 2009 and 2008, respectively.

Credit Quality Risk:

      We have an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. Nonetheless, deterioration of the credit quality of an investment security subsequent to purchase may subject us to the risk of not being able to recover the full principal value of the security. In 2007, we recognized a $5.9 million charge related to marketable securities from two issuers which we considered to be other than temporarily impaired in value. In 2008, an additional $0.7 million impairment charge was recognized related to one of these securities and a $1.8 million charge was recognized related to another marketable security which we considered to be other than temporarily impaired in value.

Item 4. Controls and Procedures

      Our management, with the participation of our chief executive officer and chief financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), as of the end of the period covered by this report. Based on this evaluation, our chief executive officer and chief financial officer each concluded that, as of the end of such period, our disclosure controls and procedures were effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in applicable rules and forms of the Securities and Exchange Commission, and is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure.

      There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2009 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

      From time to time, we are a party to legal proceedings in the course of our business. We do not expect any such current legal proceedings to have a material adverse effect on our business or financial condition.

ITEM 1A. RISK FACTORS

      We operate in an environment that involves a number of significant risks and uncertainties. We caution you to read the following risk factors, which have affected, and/or in the future could affect, our business, operating results, financial condition, and cash flows. The risks described below include forward-looking statements, and actual events and our actual results may differ substantially from those discussed in these forward-looking statements. Additional risks and uncertainties not currently known to us or that we currently deem immaterial may also impair our business operations. Furthermore, additional risks and uncertainties are described under other captions in this report and should be considered by our investors.

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Risks Related to Our Financial Results and Need for Additional Financing

We have had a history of operating losses and we may never achieve profitability. If we continue to incur operating losses, we may be unable to continue our operations.

      From inception on January 8, 1988 through March 31, 2009, we had a cumulative loss of $893.4 million. If we continue to incur operating losses and fail to become a profitable company, we may be unable to continue our operations. In the absence of substantial revenue from the sale of products or other sources, the amount, timing, nature or source of which cannot be predicted, our losses will continue as we conduct our research and development activities.

We may need additional funding in the future, which may not be available to us, and which may force us to delay, reduce or eliminate our product development programs or commercialization efforts.

      We will need to expend substantial resources for research and development, including costs associated with clinical testing of our product candidates. We believe our existing capital resources, including funding we are entitled to receive under our collaboration agreements, will enable us to meet operating needs through at least 2012; however, one or more of our collaboration agreements may terminate, our projected revenue may decrease, or our expenses may increase and that would lead to our capital being consumed significantly before such time. We may require additional financing in the future and we may not be able to raise such additional funds. If we are able to obtain additional financing through the sale of equity or convertible debt securities, such sales may be dilutive to our shareholders. Debt financing arrangements may require us to pledge certain assets or enter into covenants that would restrict our business activities or our ability to incur further indebtedness and may contain other terms that are not favorable to our shareholders. If we are unable to raise sufficient funds to complete the development of our product candidates, we may face delay, reduction or elimination of our research and development programs or preclinical or clinical trials, in which case our business, financial condition or results of operations may be materially harmed.

The value of our investment portfolio, which includes cash, cash equivalents, and marketable securities, is influenced by varying economic and market conditions. A decrease in the value of an asset in our investment portfolio or a default by the issuer may result in our inability to recover the principal we invested and/or a recognition of a loss charged against income.

      As of March 31, 2009, cash, cash equivalents, restricted cash, and marketable securities totaled $496.0 million and represented 73% of our total assets. We have invested available cash balances primarily in money market funds and U.S. Treasury, U.S. government agency, corporate, and asset-backed securities. We consider assets classified as marketable securities to be “available-for-sale,” as defined by Statement of Financial Accounting Standards No. (SFAS) 115, Accounting for Certain Investments in Debt and Equity Securities . Marketable securities totaled $295.2 million at March 31, 2009, are carried at fair value, and the unrealized gains and losses are included in other accumulated comprehensive income (loss) as a separate component of stockholders’ equity. If the decline in the value of a security in our investment portfolio is deemed to be other-than-temporary, we write down the security to its current fair value and recognize a loss that is charged against income. For example, during the year ended December 31, 2008, we recorded charges for other-than-temporary impairments totaling $2.5 million related to two marketable securities in our investment portfolio. The current economic environment, the deterioration in the credit quality of some of the issuers of securities that we hold, and the recent volatility of securities markets increase the risk that we may not recover the principal we invested and/or there may be further declines in the market value of securities in our investment portfolio. As a result, we may incur additional charges against income in future periods for other-than-temporary impairments or realized losses upon a security’s sale or maturity, and such amounts may be material.

Risks Related to ARCALYST ® (rilonacept) and the Development of Our Product Candidates

Successful development of any of our product candidates is highly uncertain.

      Only a small minority of all research and development programs ultimately result in commercially successful drugs. Even if clinical trials demonstrate safety and effectiveness of any of our product candidates for a specific disease and the necessary regulatory approvals are obtained, the commercial success of any of our product candidates will depend upon their acceptance by patients, the medical community, and third-party payers and on our partners’ ability to successfully manufacture and commercialize our product candidates. Our product candidates are delivered either by intravenous infusion or by intravitreal or subcutaneous injections, which are generally less well received by patients than tablet or capsule delivery. If our products are not successfully commercialized, we will not be able to recover the significant investment we have made in developing such products and our business would be severely harmed.

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      We are studying aflibercept, VEGF Trap-Eye, ARCALYST ® (rilonacept), and our antibody candidates in a wide variety of indications. Many of these current trials are exploratory studies designed to identify what diseases and uses, if any, are best suited for our product candidates. It is likely that our product candidates will not demonstrate the requisite efficacy and/or safety profile to support continued development for most of the indications that are being, or are planned to be, studied. In fact, our product candidates may not demonstrate the requisite efficacy and safety profile to support the continued development for any of the indications or uses.

Clinical trials required for our product candidates are expensive and time-consuming, and their outcome is highly uncertain. If any of our drug trials are delayed or yield unfavorable results, we will have to delay or may be unable to obtain regulatory approval for our product candidates.

      We must conduct extensive testing of our product candidates before we can obtain regulatory approval to market and sell them. We need to conduct both preclinical animal testing and human clinical trials. Conducting these trials is a lengthy, time-consuming, and expensive process. These tests and trials may not achieve favorable results for many reasons, including, among others, failure of the product candidate to demonstrate safety or efficacy, the development of serious or life-threatening adverse events (or side effects) caused by or connected with exposure to the product candidate, difficulty in enrolling and maintaining subjects in the clinical trial, lack of sufficient supplies of the product candidate or comparator drug, and the failure of clinical investigators, trial monitors and other consultants, or trial subjects to comply with the trial plan or protocol. A clinical trial may fail because it did not include a sufficient number of patients to detect the endpoint being measured or reach statistical significance. A clinical trial may also fail because the dose(s) of the investigational drug included in the trial were either too low or too high to determine the optimal effect of the investigational drug in the disease setting.

      We will need to reevaluate any drug candidate that does not test favorably and either conduct new trials, which are expensive and time consuming, or abandon the drug development program. Even if we obtain positive results from preclinical or clinical trials, we may not achieve the same success in future trials. Many companies in the biopharmaceutical industry, including us, have suffered significant setbacks in clinical trials, even after promising results have been obtained in earlier trials. The failure of clinical trials to demonstrate safety and effectiveness for the desired indication(s) could harm the development of our product candidate(s), and our business, financial condition, and results of operations may be materially harmed.

Serious complications or side effects have occurred, and may continue to occur, in connection with the use of our approved product and in clinical trials of some of our product candidates which could cause our regulatory approval to be revoked or otherwise negatively affected or lead to delay or discontinuation of development of our product candidates which could severely harm our business.

      During the conduct of clinical trials, patients report changes in their health, including illnesses, injuries, and discomforts, to their study doctor. Often, it is not possible to determine whether or not the drug candidate being studied caused these conditions. Various illnesses, injuries, and discomforts have been reported from time-to-time during clinical trials of our product candidates. It is possible as we test our drug candidates in larger, longer, and more extensive clinical programs, illnesses, injuries, and discomforts that were observed in earlier trials, as well as conditions that did not occur or went undetected in smaller previous trials, will be reported by patients. Many times, side effects are only detectable after investigational drugs are tested in large scale, Phase 3 clinical trials or, in some cases, after they are made available to patients after approval. If additional clinical experience indicates that any of our product candidates has many side effects or causes serious or life-threatening side effects, the development of the product candidate may fail or be delayed, which would severely harm our business.

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      Our aflibercept (VEGF Trap) is being studied for the potential treatment of certain types of cancer and our VEGF Trap-Eye candidate is being studied in diseases of the eye. There are many potential safety concerns associated with significant blockade of vascular endothelial growth factor, or VEGF, that may limit our ability to successfully develop aflibercept and VEGF Trap-Eye. These serious and potentially life-threatening risks, based on clinical and preclinical experience of VEGF inhibitors, include bleeding, intestinal perforation, hypertension, proteinuria, heart attack, and stroke. In addition, patients given infusions of any protein, including VEGF Trap delivered through intravenous administration, may develop severe hypersensitivity reactions or infusion reactions. Other VEGF blockers have reported side effects that became evident only after large scale trials or after marketing approval and large number of patients were treated. These and other complications or side effects could harm the development of aflibercept for the treatment of cancer or VEGF Trap-Eye for the treatment of diseases of the eye.

      We have tested ARCALYST in only a small number of patients with CAPS. As more patients begin to use our product and as we test it in new disease settings, new risks and side effects associated with ARCALYST may be discovered, and risks previously viewed as inconsequential could be determined to be significant. Like cytokine antagonists such as Kineret ® (Amgen, Inc.), Enbrel ® (Immunex Corporation), and Remicade ® (Centocor, Inc.), ARCALYST affects the immune defense system of the body by blocking some of its functions. Therefore, ARCALYST may interfere with the body’s ability to fight infections. Treatment with Kineret (Amgen), a medication that works through the inhibition of IL-1, has been associated with an increased risk of serious infections, and serious, life threatening infections have been reported in patients taking ARCALYST. These or other complications or side effects could cause regulatory authorities to revoke approvals of ARCALYST. Alternatively, we may be required to conduct additional clinical trials, make changes in the labeling of our product, or limit or abandon our efforts to develop ARCALYST in new disease settings. These side effects may also result in a reduction, or even the elimination, of sales of ARCALYST in approved indications.

ARCALYST ® (rilonacept) and our product candidates in development are recombinant proteins that could cause an immune response, resulting in the creation of harmful or neutralizing antibodies against the therapeutic protein.

      In addition to the safety, efficacy, manufacturing, and regulatory hurdles faced by our product candidates, the administration of recombinant proteins frequently causes an immune response, resulting in the creation of antibodies against the therapeutic protein. The antibodies can have no effect or can totally neutralize the effectiveness of the protein, or require that higher doses be used to obtain a therapeutic effect. In some cases, the antibody can cross react with the patient’s own proteins, resulting in an “auto-immune” type disease. Whether antibodies will be created can often not be predicted from preclinical or clinical experiments, and their detection or appearance is often delayed, so that there can be no assurance that neutralizing antibodies will not be detected at a later date, in some cases even after pivotal clinical trials have been completed. Antibodies directed against the receptor domains of rilonacept were detected in patients with CAPS after treatment with ARCALYST. Nineteen of 55 subjects (35%) who received ARCALYST for at least 6 weeks tested positive for treatment-emerging binding antibodies on at least one occasion. To date, no side effects related to antibodies were observed in these subjects and there were no observed effects on drug efficacy or drug levels. It is possible that as we continue to test aflibercept and VEGF Trap-Eye with more sensitive assays in different patient populations and larger clinical trials, we will find that subjects given aflibercept and VEGF Trap-Eye develop antibodies to these product candidates, and may also experience side effects related to the antibodies, which could adversely impact the development of such candidates.

We may be unable to formulate or manufacture our product candidates in a way that is suitable for clinical or commercial use.

      Changes in product formulations and manufacturing processes may be required as product candidates progress in clinical development and are ultimately commercialized. If we are unable to develop suitable product formulations or manufacturing processes to support large scale clinical testing of our product candidates, including aflibercept, VEGF Trap-Eye, and our antibody candidates, we may be unable to supply necessary materials for our clinical trials, which would delay the development of our product candidates. Similarly, if we are unable to supply sufficient quantities of our product or develop product formulations suitable for commercial use, we will not be able to successfully commercialize our product candidates.

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Risks Related to Intellectual Property

If we cannot protect the confidentiality of our trade secrets or our patents are insufficient to protect our proprietary rights, our business and competitive position will be harmed.

      Our business requires using sensitive and proprietary technology and other information that we protect as trade secrets. We seek to prevent improper disclosure of these trade secrets through confidentiality agreements. If our trade secrets are improperly exposed, either by our own employees or our collaborators, it would help our competitors and adversely affect our business. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. The patent position of biotechnology companies involves complex legal and factual questions and, therefore, enforceability cannot be predicted with certainty. Our patents may be challenged, invalidated, or circumvented. Patent applications filed outside the United States may be challenged by third parties who file an opposition. Such opposition proceedings are increasingly common in the European Union and are costly to defend. We have patent applications that are being opposed and it is likely that we will need to defend additional patent applications in the future. Our patent rights may not provide us with a proprietary position or competitive advantages against competitors. Furthermore, even if the outcome is favorable to us, the enforcement of our intellectual property rights can be extremely expensive and time consuming.

We may be restricted in our development and/or commercialization activities by, and could be subject to damage awards if we are found to have infringed, third party patents or other proprietary rights.

      Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Other parties may allege that they have blocking patents to our products in clinical development, either because they claim to hold proprietary rights to the composition of a product or the way it is manufactured or used. Moreover, other parties may allege that they have blocking patents to antibody products made using our VelocImmune ® technology, either because of the way the antibodies are discovered or produced or because of a proprietary position covering an antibody or the antibody’s target.

      We are aware of patents and pending applications owned by Genentech/Roche that claim certain chimeric VEGF receptor compositions. Although we do not believe that aflibercept or VEGF Trap-Eye infringes any valid claim in these patents or patent applications, Genentech/Roche could initiate a lawsuit for patent infringement and assert that its patents are valid and cover aflibercept or VEGF Trap-Eye. Genentech/Roche may be motivated to initiate such a lawsuit at some point in an effort to impair our ability to develop and sell aflibercept or VEGF Trap-Eye, which represent potential competitive threats to Genentech/Roche’s VEGF-binding products and product candidates. An adverse determination by a court in any such potential patent litigation would likely materially harm our business by requiring us to seek a license, which may not be available, or resulting in our inability to manufacture, develop and sell aflibercept or VEGF Trap-Eye or in a damage award.

      We are aware of patents and pending applications owned by Roche that claim antibodies to the interleukin-6 receptor and methods of treating rheumatoid arthritis with such antibodies. We are developing REGN88, an antibody to the interleukin-6 receptor, for the treatment of rheumatoid arthritis. Although we do not believe that REGN88 infringes any valid claim in these patents or patent applications, Roche could initiate a lawsuit for patent infringement and assert its patents are valid and cover REGN88.

      We are aware of a U.S. patent jointly owned by Genentech/Roche and City of Hope relating to the production of recombinant antibodies in host cells. We currently produce our antibody product candidates using recombinant antibodies from host cells and may choose to produce additional antibody product candidates in this manner. Neither ARCALYST ® (rilonacept), aflibercept, nor VEGF Trap-Eye are recombinant antibodies. If any of our antibody product candidates are produced in a manner subject to valid claims in the Genentech/Roche patent, then we may need to obtain a license from Genentech/Roche, should one be available. Genentech/Roche has licensed this patent to several different companies under confidential license agreements. If we desire a license for any of our antibody product candidates and are unable to obtain a license on commercially reasonable terms or at all, we may be restricted in our ability to use Genentech/Roche’s techniques to make recombinant antibodies in or to import them into the United States.

      Further, we are aware of a number of other third party patent applications that, if granted, with claims as currently drafted, may cover our current or planned activities. We cannot assure you that our products and/or actions in manufacturing and selling our product candidates will not infringe such patents.

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      Any patent holders could sue us for damages and seek to prevent us from manufacturing, selling, or developing our drug candidates, and a court may find that we are infringing validly issued patents of third parties. In the event that the manufacture, use, or sale of any of our clinical candidates infringes on the patents or violates other proprietary rights of third parties, we may be prevented from pursuing product development, manufacturing, and commercialization of our drugs and may be required to pay costly damages. Such a result may materially harm our business, financial condition, and results of operations. Legal disputes are likely to be costly and time consuming to defend.

      We seek to obtain licenses to patents when, in our judgment, such licenses are needed. If any licenses are required, we may not be able to obtain such licenses on commercially reasonable terms, if at all. The failure to obtain any such license could prevent us from developing or commercializing any one or more of our product candidates, which could severely harm our business.

Regulatory and Litigation Risks

If we do not obtain regulatory approval for our product candidates, we will not be able to market or sell them.

      We cannot sell or market products without regulatory approval. Although we obtained regulatory approval for ARCALYST ® (rilonacept) for the treatment of CAPS in the United States, we may be unable to obtain regulatory approval of ARCALYST in any other country or in any other indication. Regulatory agencies outside the United States may require additional information or data with respect to any future submission for ARCALYST for the treatment of CAPS.

      If we do not obtain and maintain regulatory approval for our product candidates, including ARCALYST for the treatment of diseases other than CAPS, the value of our company and our results of operations will be harmed. In the United States, we must obtain and maintain approval from the United States Food and Drug Administration (FDA) for each drug we intend to sell. Obtaining FDA approval is typically a lengthy and expensive process, and approval is highly uncertain. Foreign governments also regulate drugs distributed in their country and approval in any country is likely to be a lengthy and expensive process, and approval is highly uncertain. Except for the FDA approval of ARCALYST for the treatment of CAPS, none of our product candidates has ever received regulatory approval to be marketed and sold in the United States or any other country. We may never receive regulatory approval for any of our product candidates.

      Before approving a new drug or biologic product, the FDA requires that the facilities at which the product will be manufactured be in compliance with current good manufacturing practices, or cGMP requirements. Manufacturing product candidates in compliance with these regulatory requirements is complex, time-consuming, and expensive. To be successful, our products must be manufactured for development, following approval, in commercial quantities, in compliance with regulatory requirements, and at competitive costs. If we or any of our product collaborators or third-party manufacturers, product packagers, or labelers are unable to maintain regulatory compliance, the FDA can impose regulatory sanctions, including, among other things, refusal to approve a pending application for a new drug or biologic product, or revocation of a pre-existing approval. As a result, our business, financial condition, and results of operations may be materially harmed.

      In addition to the FDA and other regulatory agency regulations in the United States, we are subject to a variety of foreign regulatory requirements governing human clinical trials, manufacturing, marketing and approval of drugs, and commercial sale and distribution of drugs in foreign countries. The foreign regulatory approval process includes all of the risks associated with FDA approval as well as country specific regulations. Whether or not we obtain FDA approval for a product in the United States, we must obtain approval by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of ARCALYST for the treatment of CAPS or any of our product candidates in those countries.

If the testing or use of our products harms people, we could be subject to costly and damaging product liability claims.

      The testing, manufacturing, marketing, and sale of drugs for use in people expose us to product liability risk. Any informed consent or waivers obtained from people who sign up for our clinical trials may not protect us from liability or the cost of litigation. We may be subject to claims by CAPS patients who use ARCALYST that they have been injured by a side effect associated with the drug. Our product liability insurance may not cover all potential liabilities or may not completely cover any liability arising from any such litigation. Moreover, we may not have access to liability insurance or be able to maintain our insurance on acceptable terms.

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If we market and sell ARCALYST ® (rilonacept) in a way that violates federal or state fraud and abuse laws, we may be subject to civil or criminal penalties.

      In addition to FDA and related regulatory requirements, we are subject to health care “fraud and abuse” laws, such as the federal False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations. Federal and state anti-kickback laws prohibit, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any health care item or service reimbursable under Medicare, Medicaid, or other federally or state financed health care programs.

      Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. Pharmaceutical companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in promotion for uses that the FDA has not approved, or off-label uses, that caused claims to be submitted to Medicaid for non-covered off-label uses; and submitting inflated best price information to the Medicaid Rebate program.

      The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payer. Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, criminal fines, and imprisonment.

      Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which would also harm our financial condition. Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws.

      In recent years, several states and localities, including California, the District of Columbia, Massachusetts, Maine, Minnesota, Nevada, New Mexico, Vermont, and West Virginia, have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, and file periodic reports with the state or make periodic public disclosures on sales, marketing, pricing, clinical trials, and other activities. Similar legislation is being considered in other states. Many of these requirements are new and uncertain, and the penalties for failure to comply with these requirements are unclear. Nonetheless, if we are found not to be in full compliance with these laws, we could face enforcement action and fines and other penalties, and could receive adverse publicity.

Our operations may involve hazardous materials and are subject to environmental, health, and safety laws and regulations. We may incur substantial liability arising from our activities involving the use of hazardous materials.

      As a biopharmaceutical company with significant manufacturing operations, we are subject to extensive environmental, health, and safety laws and regulations, including those governing the use of hazardous materials. Our research and development and manufacturing activities involve the controlled use of chemicals, viruses, radioactive compounds, and other hazardous materials. The cost of compliance with environmental, health, and safety regulations is substantial. If an accident involving these materials or an environmental discharge were to occur, we could be held liable for any resulting damages, or face regulatory actions, which could exceed our resources or insurance coverage.

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Changes in the securities laws and regulations have increased, and are likely to continue to increase, our costs.

      The Sarbanes-Oxley Act of 2002, which became law in July 2002, has required changes in some of our corporate governance, securities disclosure and compliance practices. In response to the requirements of that Act, the SEC and the NASDAQ Stock Market have promulgated rules and listing standards covering a variety of subjects. Compliance with these rules and listing standards has increased our legal costs, and significantly increased our accounting and auditing costs, and we expect these costs to continue. These developments may make it more difficult and more expensive for us to obtain directors’ and officers’ liability insurance. Likewise, these developments may make it more difficult for us to attract and retain qualified members of our board of directors, particularly independent directors, or qualified executive officers.

In future years, if we are unable to conclude that our internal control over financial reporting is effective, the market value of our Common Stock could be adversely affected.

      As directed by Section 404 of the Sarbanes-Oxley Act of 2002, the SEC adopted rules requiring public companies to include a report of management on the Company’s internal control over financial reporting in their annual reports on Form 10-K that contains an assessment by management of the effectiveness of our internal control over financial reporting. In addition, the independent registered public accounting firm auditing our financial statements must attest to and report on the effectiveness of our internal control over financial reporting. Our independent registered public accounting firm provided us with an unqualified report as to the effectiveness of our internal control over financial reporting as of December 31, 2008, which report is included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2008. However, we cannot assure you that management or our independent registered public accounting firm will be able to provide such an unqualified report as of future year-ends. In this event, investors could lose confidence in the reliability of our financial statements, which could result in a decrease in the market value of our Common Stock. In addition, if it is determined that deficiencies in the design or operation of internal controls exist and that they are reasonably likely to adversely affect our ability to record, process, summarize, and report financial information, we would likely incur additional costs to remediate these deficiencies and the costs of such remediation could be material.

Changes in laws and regulations affecting the healthcare industry could adversely affect our business.

      All aspects of our business, including research and development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation and regulation. Changes in applicable federal and state laws and agency regulations could have a material adverse effect on our business. These include:

  • changes in the FDA and foreign regulatory processes for new therapeutics that may delay or prevent the approval of any of our current or future product candidates;
  • new laws, regulations, or judicial decisions related to healthcare availability or the payment for healthcare products and services, including prescription drugs, that would make it more difficult for us to market and sell products once they are approved by the FDA or foreign regulatory agencies; and
  • changes in FDA and foreign regulations that may require additional safety monitoring prior to or after the introduction of new products to market, which could materially increase our costs of doing business.

      The enactment in the United States of the Medicare Prescription Drug Improvement and Modernization Act of 2003 and possible legislation which could ease the entry of competing follow-on biologics into the marketplace are examples of changes and possible changes in laws that could adversely affect our business.

Risks Related to Our Reliance on Third Parties

If our antibody collaboration with sanofi-aventis is terminated, our business operations and our ability to discover, develop, manufacture, and commercialize our pipeline of product candidates in the time expected, or at all, would be materially harmed.

      We rely heavily on the funding from sanofi-aventis to support our target discovery and antibody research and development programs. Sanofi-aventis has committed to pay up to $400 million between 2009 and 2012 to fund our efforts to identify and validate drug discovery targets and pre-clinically develop fully human monoclonal antibodies against such targets. In addition, sanofi-aventis funds almost all of the development expenses incurred by both companies in connection with the clinical development of antibodies that sanofi-aventis elects to co-develop with us. We rely on sanofi-aventis to fund these activities. In addition, with respect to those antibodies that sanofi-aventis elects to co-develop with us, such as REGN88, REGN421, and REGN475, we rely on sanofi-aventis to lead much of the clinical development efforts and assist with obtaining regulatory approval, particularly outside the United States. We also rely on sanofi-aventis to lead the commercialization efforts to support all of the antibody products that are co-developed by sanofi-aventis and us. If sanofi-aventis does not elect to co-develop the antibodies that we discover or opts-out of their development, we would be required to fund and oversee on our own the clinical trials, any regulatory responsibilities, and the ensuing commercialization efforts to support our antibody products. If sanofi-aventis terminates the antibody collaboration or fails to comply with its payment obligations thereunder, our business, financial condition, and results of operations would be materially harmed. We would be required to either expend substantially more resources than we have anticipated to support our research and development efforts, which could require us to seek additional funding that might not be available on favorable terms or at all, or materially cut back on such activities. While we cannot assure you that any of the antibodies from this collaboration will ever be successfully developed and commercialized, if sanofi-aventis does not perform its obligations with respect to antibodies that it elects to co-develop, our ability to develop, manufacture, and commercialize these antibody product candidates will be significantly adversely affected.

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If our collaboration with sanofi-aventis for aflibercept (VEGF Trap) is terminated, or sanofi-aventis materially breaches its obligations thereunder, our business operations and financial condition, and our ability to develop, manufacture, and commercialize aflibercept in the time expected, or at all, would be materially harmed.

      We rely heavily on sanofi-aventis to lead much of the development of aflibercept. Sanofi-aventis funds all of the development expenses incurred by both companies in connection with the aflibercept program. If the aflibercept program continues, we will rely on sanofi-aventis to assist with funding the aflibercept program, provide commercial manufacturing capacity, enroll and monitor clinical trials, obtain regulatory approval, particularly outside the United States, and lead the commercialization of aflibercept. While we cannot assure you that aflibercept will ever be successfully developed and commercialized, if sanofi-aventis does not perform its obligations in a timely manner, or at all, our ability to develop, manufacture, and commercialize aflibercept in cancer indications will be significantly adversely affected. Sanofi-aventis has the right to terminate its collaboration agreement with us at any time upon twelve months advance notice. If sanofi-aventis were to terminate its collaboration agreement with us, we would not have the resources or skills to replace those of our partner, which could require us to seek additional funding that might not be available on favorable terms or at all, and could cause significant delays in the development and/or manufacture of aflibercept and result in substantial additional costs to us. We have limited commercial capabilities and would have to develop or outsource these capabilities. Termination of the sanofi-aventis collaboration agreement for aflibercept would create substantial new and additional risks to the successful development and commercialization of aflibercept.

If our collaboration with Bayer HealthCare for VEGF Trap-Eye is terminated, or Bayer HealthCare materially breaches its obligations thereunder, our business, operations and financial condition, and our ability to develop and commercialize VEGF Trap-Eye in the time expected, or at all, would be materially harmed.

      We rely heavily on Bayer HealthCare to assist with the development of VEGF Trap-Eye. Under our agreement with them, Bayer HealthCare is required to fund approximately half of the development expenses incurred by both companies in connection with the global VEGF Trap-Eye development program. If the VEGF Trap-Eye program continues, we will rely on Bayer HealthCare to assist with funding the VEGF Trap-Eye development program, lead the development of VEGF Trap-Eye outside the United States, obtain regulatory approval outside the United States, and provide all sales, marketing and commercial support for the product outside the United States. In particular, Bayer HealthCare has responsibility for selling VEGF Trap-Eye outside the United States using its sales force. While we cannot assure you that VEGF Trap-Eye will ever be successfully developed and commercialized, if Bayer HealthCare does not perform its obligations in a timely manner, or at all, our ability to develop, manufacture, and commercialize VEGF Trap-Eye outside the United States will be significantly adversely affected. Bayer HealthCare has the right to terminate its collaboration agreement with us at any time upon six or twelve months advance notice, depending on the circumstances giving rise to termination. If Bayer HealthCare were to terminate its collaboration agreement with us, we would not have the resources or skills to replace those of our partner, which could require us to seek additional funding that might not be available on favorable terms or at all, and could cause significant delays in the development and/or commercialization of VEGF Trap-Eye outside the United States and result in substantial additional costs to us. We have limited commercial capabilities and would have to develop or outsource these capabilities outside the United States. Termination of the Bayer HealthCare collaboration agreement would create substantial new and additional risks to the successful development and commercialization of VEGF Trap-Eye.

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Our collaborators and service providers may fail to perform adequately in their efforts to support the development, manufacture, and commercialization of ARCALYST ® (rilonacept) and our drug candidates.

      We depend upon third-party collaborators, including sanofi-aventis, Bayer HealthCare, and service providers such as clinical research organizations, outside testing laboratories, clinical investigator sites, and third-party manufacturers and product packagers and labelers, to assist us in the manufacture and development of our product candidates. If any of our existing collaborators or service providers breaches or terminates its agreement with us or does not perform its development or manufacturing services under an agreement in a timely manner or at all, we could experience additional costs, delays, and difficulties in the manufacture, development, or ultimate commercialization of our product candidates.

      We rely on third party service providers to support the distribution of ARCALYST and many other related activities in connection with the commercialization of ARCALYST for the treatment of CAPS. We cannot be certain that these third parties will perform adequately. If these service providers do not perform their services adequately, our efforts to market and sell ARCALYST for the treatment of CAPS will not be successful.

Risks Related to the Manufacture of Our Product Candidates

We have limited manufacturing capacity, which could inhibit our ability to successfully develop or commercialize our drugs.

      Our manufacturing facility is likely to be inadequate to produce sufficient quantities of product for commercial sale. We intend to rely on our corporate collaborators, as well as contract manufacturers, to produce the large quantities of drug material needed for commercialization of our products. We rely entirely on third-party manufacturers for filling and finishing services. We will have to depend on these manufacturers to deliver material on a timely basis and to comply with regulatory requirements. If we are unable to supply sufficient material on acceptable terms, or if we should encounter delays or difficulties in our relationships with our corporate collaborators or contract manufacturers, our business, financial condition, and results of operations may be materially harmed.

      We must expand our own manufacturing capacity to support the planned growth of our clinical pipeline. Moreover, we may expand our manufacturing capacity to support commercial production of active pharmaceutical ingredients, or API, for our product candidates. This will require substantial additional expenditures, and we will need to hire and train significant numbers of employees and managerial personnel to staff our facility. Start-up costs can be large and scale-up entails significant risks related to process development and manufacturing yields. We may be unable to develop manufacturing facilities that are sufficient to produce drug material for clinical trials or commercial use. This may delay our clinical development plans and interfere with our efforts to commercialize our products. In addition, we may be unable to secure adequate filling and finishing services to support our products. As a result, our business, financial condition, and results of operations may be materially harmed.

      We may be unable to obtain key raw materials and supplies for the manufacture of ARCALYST and our product candidates. In addition, we may face difficulties in developing or acquiring production technology and managerial personnel to manufacture sufficient quantities of our product candidates at reasonable costs and in compliance with applicable quality assurance and environmental regulations and governmental permitting requirements.

If any of our clinical programs are discontinued, we may face costs related to the unused capacity at our manufacturing facilities.

      We have large-scale manufacturing operations in Rensselaer, New York. We use our facilities to produce bulk product for clinical and preclinical candidates for ourselves and our collaborations. If our clinical candidates are discontinued, we will have to absorb one hundred percent of related overhead costs and inefficiencies.

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Third-party supply failures or a business interruption at our manufacturing facility in Rensselaer, New York could adversely affect our ability to supply our products.

      We manufacture all of our bulk drug materials for ARCALYST and our product candidates at our manufacturing facility in Rensselaer, New York. We would be unable to supply our product requirements if we were to cease production due to regulatory requirements or action, business interruptions, labor shortages or disputes, contaminations, or other problems at the facility.

      Certain raw materials necessary for manufacturing and formulation of ARCALYST and our product candidates are provided by single-source unaffiliated third-party suppliers. In addition, we rely on certain third parties to perform filling, finishing, distribution, and other services related to the manufacture of our products. We would be unable to obtain these raw materials or services for an indeterminate period of time if any of these third-parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services to us for any reason, including due to regulatory requirements or action, adverse financial developments at or affecting the supplier, business interruptions, or labor shortages or disputes. This, in turn, could materially and adversely affect our ability to manufacture or supply ARCALYST or our product candidates for use in clinical trials, which could materially and adversely affect our business and future prospects.

      Also, certain of the raw materials required in the manufacturing and the formulation of our clinical candidates may be derived from biological sources, including mammalian tissues, bovine serum, and human serum albumin. There are certain European regulatory restrictions on using these biological source materials. If we are required to substitute for these sources to comply with European regulatory requirements, our clinical development activities may be delayed or interrupted.

Risks Related to Commercialization of Products

If we are unable to establish sales, marketing, and distribution capabilities, or enter into agreements with third parties to do so, we will be unable to successfully market and sell future products.

      We are marketing and selling ARCALYST for the treatment of CAPS ourselves in the United States, primarily through third party service providers. We have no sales or distribution personnel in the United States and have only a small staff with commercial capabilities. We have no sales, marketing, commercial, or distribution capabilities outside the United States. If we are unable to obtain those capabilities, either by developing our own organizations or entering into agreements with service providers, even if our current or future product candidates receive marketing approval, we will not be able to successfully sell those products. In that event, we will not be able to generate significant revenue, even if our product candidates are approved. We cannot guarantee that we will be able to hire the qualified sales and marketing personnel we need or that we will be able to enter into marketing or distribution agreements with third-party providers on acceptable terms, if at all. Under the terms of our collaboration agreement with sanofi-aventis, we currently rely on sanofi-aventis for sales, marketing, and distribution of aflibercept in cancer indications, should it be approved in the future by regulatory authorities for marketing. We will have to rely on a third party or devote significant resources to develop our own sales, marketing, and distribution capabilities for our other product candidates, including VEGF Trap-Eye in the United States, and we may be unsuccessful in developing our own sales, marketing, and distribution organization.

There may be too few patients with CAPS to profitably commercialize ARCALYST ® (rilonacept) in this indication.

      Our only approved product is ARCALYST for the treatment of CAPS, a group of rare, inherited auto-inflammatory diseases. These rare diseases affect a very small group of people. The incidence of CAPS has been reported to be approximately 1 in 1,000,000 people in the United States. Although the incidence rate of CAPS in Europe has not been reported, it is known to be a rare set of diseases. As a result, there may be too few patients with CAPS to profitably commercialize ARCALYST in this indication.

Even if our product candidates are approved for marketing, their commercial success is highly uncertain because our competitors have received approval for products with a similar mechanism of action, and competitors may get to the marketplace with better or lower cost drugs.

      There is substantial competition in the biotechnology and pharmaceutical industries from pharmaceutical, biotechnology, and chemical companies. Many of our competitors have substantially greater research, preclinical and clinical product development and manufacturing capabilities, and financial, marketing, and human resources than we do. Our smaller competitors may also enhance their competitive position if they acquire or discover patentable inventions, form collaborative arrangements, or merge with large pharmaceutical companies. Even if we achieve product commercialization, our competitors have achieved, and may continue to achieve, product commercialization before our products are approved for marketing and sale.

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      Genentech/Roche has an approved VEGF antagonist, Avastin ® (bevacizumab), on the market for treating certain cancers and many different pharmaceutical and biotechnology companies are working to develop competing VEGF antagonists, including Novartis, Amgen, Imclone/Eli Lilly, Pfizer, AstraZeneca, and GlaxoSmithKline plc. Many of these molecules are farther along in development than aflibercept and may offer competitive advantages over our molecule. Each of Pfizer and Onyx Pharmaceuticals, (together with its partner Bayer HealthCare) has received approval from the FDA to market and sell an oral medication that targets tumor cell growth and new vasculature formation that fuels the growth of tumors. The marketing approvals for Genentech/Roche’s VEGF antagonist, Avastin, and their extensive, ongoing clinical development plan for Avastin in other cancer indications, make it more difficult for us to enroll patients in clinical trials to support aflibercept and to obtain regulatory approval of aflibercept in these cancer settings. This may delay or impair our ability to successfully develop and commercialize aflibercept. In addition, even if aflibercept is ever approved for sale for the treatment of certain cancers, it will be difficult for our drug to compete against Avastin (Genentech/Roche) and the FDA approved kinase inhibitors, because doctors and patients will have significant experience using these medicines. In addition, an oral medication may be considerably less expensive for patients than a biologic medication, providing a competitive advantage to companies that market such products.

      The market for eye disease products is also very competitive. Novartis and Genentech/Roche are collaborating on the commercialization and further development of a VEGF antibody fragment, ranibizumab (Lucentis ® ), for the treatment of age-related macular degeneration (wet AMD) and other eye indications that was approved by the FDA in June 2006. Many other companies are working on the development of product candidates for the potential treatment of wet AMD and DME that act by blocking VEGF, VEGF receptors, and through the use of small interfering ribonucleic acids (siRNAs) that modulate gene expression. In addition, ophthalmologists are using off-label a third-party reformatted version of Genentech/Roche’s approved VEGF antagonist, Avastin ® , with success for the treatment of wet AMD. The National Eye Institute is conducting a Phase 3 trial comparing Lucentis (Genentech/Roche) to Avastin (Genentech/Roche) in the treatment of wet AMD. The marketing approval of Lucentis (Genentech/Roche) and the potential off-label use of Avastin (Genentech/Roche) make it more difficult for us to enroll patients in our clinical trials and successfully develop VEGF Trap-Eye. Even if VEGF Trap-Eye is ever approved for sale for the treatment of eye diseases, it may be difficult for our drug to compete against Lucentis (Genentech/Roche), because doctors and patients will have significant experience using this medicine. Moreover, the relatively low cost of therapy with Avastin (Genentech/Roche) in patients with wet AMD presents a further competitive challenge in this indication.

      The availability of highly effective FDA approved TNF-antagonists such as Enbrel ® (Immunex), Remicade ® (Centocor), and Humira ® (Abbott Laboratories), and the IL-1 receptor antagonist Kineret ® (Amgen), and other marketed therapies makes it more difficult to successfully develop and commercialize ARCALYST ® (rilonacept). This is one of the reasons we discontinued the development of ARCALYST in adult rheumatoid arthritis. In addition, even if ARCALYST is ever approved for sale in indications where TNF-antagonists are approved, it will be difficult for our drug to compete against these FDA approved TNF-antagonists because doctors and patients will have significant experience using these effective medicines. Moreover, in such indications these approved therapeutics may offer competitive advantages over ARCALYST, such as requiring fewer injections.

      There are both small molecules and antibodies in development by other companies that are designed to block the synthesis of interleukin-1 or inhibit the signaling of interleukin-1. For example, Eli Lilly, Xoma, and Novartis are each developing antibodies to interleukin-1 and Amgen is developing an antibody to the interleukin-1 receptor. Novartis has filed applications in the U.S. and Europe seeking regulatory approval of its IL-1 antibody in CAPS. Novartis is also developing its IL-1 antibody in gout and other inflammatory diseases. Novartis has stated that its IL-1 antibody demonstrated long-lasting clinical remission in patients with CAPS and that its clinical candidate could develop into a major therapeutic advance in the treatment of CAPS. Novartis’ IL-1 antibody and these other drug candidates could offer competitive advantages over ARCALYST. The successful development of these competing molecules could impair our ability to successfully commercialize ARCALYST.

      We have plans to develop ARCALYST for the treatment of certain gout indications. Currently, inexpensive, oral therapies such as analgesics and other non-steroidal anti-inflammatory drugs are used as the standard of care to treat the symptoms of these gout diseases. These established, inexpensive, orally delivered drugs may make it difficult for us to successfully commercialize ARCALYST in these diseases.

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The successful commercialization of ARCALYST ® (rilonacept) and our product candidates will depend on obtaining coverage and reimbursement for use of these products from third-party payers and these payers may not agree to cover or reimburse for use of our products.

      Our product candidates, if commercialized, may be significantly more expensive than traditional drug treatments. For example, we have announced plans to initiate a Phase 3 program studying the use of ARCALYST for the treatment of certain gout indications. Patients suffering from these gout indications are currently treated with inexpensive therapies, including non-steroidal anti-inflammatory drugs. These existing treatment options are likely to be considerably less expensive and may be preferable to a biologic medication for some patients. Our future revenues and profitability will be adversely affected if United States and foreign governmental, private third-party insurers and payers, and other third-party payers, including Medicare and Medicaid, do not agree to defray or reimburse the cost of our products to the patients. If these entities refuse to provide coverage and reimbursement with respect to our products or provide an insufficient level of coverage and reimbursement, our products may be too costly for many patients to afford them, and physicians may not prescribe them. Many third-party payers cover only selected drugs, making drugs that are not preferred by such payer more expensive for patients, and require prior authorization or failure on another type of treatment before covering a particular drug. Payers may especially impose these obstacles to coverage on higher-priced drugs, as our product candidates are likely to be.

      We market and sell ARCALYST in the United States for the treatment of a group of rare genetic disorders called CAPS. There may be too few patients with CAPS to profitably commercialize ARCALYST. Physicians may not prescribe ARCALYST, and CAPS patients may not be able to afford ARCALYST, if third party payers do not agree to reimburse the cost of ARCALYST therapy and this would adversely affect our ability to commercialize ARCALYST profitably.

      In addition to potential restrictions on coverage, the amount of reimbursement for our products may also reduce our profitability. In the United States, there have been, and we expect will continue to be, actions and proposals to control and reduce healthcare costs. Government and other third-party payers are challenging the prices charged for healthcare products and increasingly limiting, and attempting to limit, both coverage and level of reimbursement for prescription drugs.

      Since ARCALYST and our product candidates in clinical development, will likely be too expensive for most patients to afford without health insurance coverage, if our products are unable to obtain adequate coverage and reimbursement by third-party payers our ability to successfully commercialize our product candidates may be adversely impacted. Any limitation on the use of our products or any decrease in the price of our products will have a material adverse effect on our ability to achieve profitability.

      In certain foreign countries, pricing, coverage, and level of reimbursement of prescription drugs are subject to governmental control, and we may be unable to negotiate coverage, pricing, and reimbursement on terms that are favorable to us. In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Our results of operations may suffer if we are unable to market our products in foreign countries or if coverage and reimbursement for our products in foreign countries is limited.

Risk Related to Employees

We are dependent on our key personnel and if we cannot recruit and retain leaders in our research, development, manufacturing, and commercial organizations, our business will be harmed.

      We are highly dependent on certain of our executive officers. If we are not able to retain any of these persons or our Chairman, our business may suffer. In particular, we depend on the services of P. Roy Vagelos, M.D., the Chairman of our board of directors, Leonard Schleifer, M.D., Ph.D., our President and Chief Executive Officer, George D. Yancopoulos, M.D., Ph.D., our Executive Vice President, Chief Scientific Officer and President, Regeneron Research Laboratories, and Neil Stahl, Ph.D., our Senior Vice President, Research and Development Sciences. There is intense competition in the biotechnology industry for qualified scientists and managerial personnel in the development, manufacture, and commercialization of drugs. We may not be able to continue to attract and retain the qualified personnel necessary for developing our business.

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Our move to new facilities in mid-2009 could lead to disruptions in our business operations.

      We plan to move most of our laboratories and headquarters to new facilities in mid-2009. There is a risk that this physical move could lead to damage to equipment or other business assets or the loss of important data, or that we could encounter problems with our new facilities, which could disrupt or delay our business operations.

Risks Related to Our Common Stock

Our stock price is extremely volatile.

      There has been significant volatility in our stock price and generally in the market prices of biotechnology companies’ securities. Various factors and events may have a significant impact on the market price of our Common Stock. These factors include, by way of example:

  • progress, delays, or adverse results in clinical trials;
  • announcement of technological innovations or product candidates by us or competitors;
  • fluctuations in our operating results;
  • third party claims that our products or technologies infringe their party patents;
  • public concern as to the safety or effectiveness of ARCALYST ® (rilonacept) or any of our product candidates;
  • developments in our relationship with collaborative partners;
  • developments in the biotechnology industry or in government regulation of healthcare;
  • large sales of our common stock by our executive officers, directors, or significant shareholders;
  • arrivals and departures of key personnel; and
  • general market conditions.

      The trading price of our Common Stock has been, and could continue to be, subject to wide fluctuations in response to these and other factors, including the sale or attempted sale of a large amount of our Common Stock in the market. Broad market fluctuations may also adversely affect the market price of our Common Stock.

Future sales of our Common Stock by our significant shareholders or us may depress our stock price and impair our ability to raise funds in new share offerings.

      A small number of our shareholders beneficially own a substantial amount of our Common Stock. As of April 14, 2009, our five largest shareholders plus Leonard S. Schleifer, M.D. Ph.D., our Chief Executive Officer, beneficially owned 52.5% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of April 14, 2009. As of April 14, 2009, sanofi-aventis beneficially owned 14,799,552 shares of Common Stock, representing approximately 19.0% of the shares of Common Stock then outstanding. Under our investor agreement with sanofi-aventis, sanofi-aventis may not sell these shares until December 20, 2012 except under limited circumstances and subject to earlier termination of these restrictions upon the occurrence of certain events. Notwithstanding these restrictions, if sanofi-aventis, or our other significant shareholders or we, sell substantial amounts of our Common Stock in the public market, or the perception that such sales may occur exists, the market price of our Common Stock could fall. Sales of Common Stock by our significant shareholders, including sanofi-aventis, also might make it more difficult for us to raise funds by selling equity or equity-related securities in the future at a time and price that we deem appropriate.

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Our existing shareholders may be able to exert significant influence over matters requiring shareholder approval.

      Holders of Class A Stock, who are generally the shareholders who purchased their stock from us before our initial public offering, are entitled to ten votes per share, while holders of Common Stock are entitled to one vote per share. As of April 14, 2009, holders of Class A Stock held 22.4% of the combined voting power of all shares of Common Stock and Class A Stock then outstanding, plus any voting power associated with any shares of Common Stock beneficially owned by such Class A Stock holders. These shareholders, if acting together, would be in a position to significantly influence the election of our directors and to effect or prevent certain corporate transactions that require majority or supermajority approval of the combined classes, including mergers and other business combinations. This may result in us taking corporate actions that you may not consider to be in your best interest and may affect the price of our Common Stock. As of April 14, 2009:

  • our current executive officers and directors beneficially owned 13.3% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options held by such persons which are exercisable within 60 days of April 14, 2009, and 28.2% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by such persons which are exercisable within 60 days of April 14, 2009; and
     
  • our five largest shareholders plus Leonard S. Schleifer, M.D., Ph.D., our Chief Executive Officer, beneficially owned 52.5% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of April 14, 2009. In addition, these six shareholders held 57.2% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of April 14, 2009.

      Pursuant to an investor agreement, sanofi-aventis has agreed to vote its shares, at sanofi-aventis’ election, either as recommended by our board of directors or proportionally with the votes cast by our other shareholders, except with respect to certain change of control transactions, liquidation or dissolution, stock issuances equal to or exceeding 10% of the then outstanding shares or voting rights of Common Stock and Class A Stock, and new equity compensation plans or amendments if not materially consistent with our historical equity compensation practices.

The anti-takeover effects of provisions of our charter, by-laws, and of New York corporate law and the contractual “standstill” provisions in our investor agreement with sanofi-aventis, could deter, delay, or prevent an acquisition or other “change in control” of us and could adversely affect the price of our Common Stock.

      Our amended and restated certificate of incorporation, our by-laws and the New York Business Corporation Law contain various provisions that could have the effect of delaying or preventing a change in control of our company or our management that shareholders may consider favorable or beneficial. Some of these provisions could discourage proxy contests and make it more difficult for you and other shareholders to elect directors and take other corporate actions. These provisions could also limit the price that investors might be willing to pay in the future for shares of our Common Stock. These provisions include:

  • authorization to issue “blank check” preferred stock, which is preferred stock that can be created and issued by the board of directors without prior shareholder approval, with rights senior to those of our common shareholders;
  • a staggered board of directors, so that it would take three successive annual meetings to replace all of our directors;
  • a requirement that removal of directors may only be effected for cause and only upon the affirmative vote of at least eighty percent (80%) of the outstanding shares entitled to vote for directors, as well as a requirement that any vacancy on the board of directors may be filled only by the remaining directors;
  • any action required or permitted to be taken at any meeting of shareholders may be taken without a meeting, only if, prior to such action, all of our shareholders consent, the effect of which is to require that shareholder action may only be taken at a duly convened meeting;
  • any shareholder seeking to bring business before an annual meeting of shareholders must provide timely notice of this intention in writing and meet various other requirements; and
  • under the New York Business Corporation Law, in addition to certain restrictions which may apply to “business combinations” involving the Company and an “interested shareholder”, a plan of merger or consolidation of the Company must be approved by two-thirds of the votes of all outstanding shares entitled to vote thereon. See the risk factor immediately above captioned “Our existing shareholders may be able to exert significant influence over matters requiring shareholder approval.”

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      Until the later of the fifth anniversaries of the expiration or earlier termination of our antibody collaboration agreements with sanofi-aventis or our aflibercept collaboration with sanofi-aventis, sanofi-aventis will be bound by certain "standstill" provisions, which contractually prohibit sanofi-aventis from acquiring more than certain specified percentages of our Class A Stock and Common Stock (taken together) or otherwise seeking to obtain control of the Company.

      In addition, we have a Change in Control Severance Plan and our Chief Executive Officer has an employment agreement that provides severance benefits in the event our officers are terminated as a result of a change in control of the Company. Many of our stock options issued under our Amended and Restated 2000 Long-Term Incentive Plan may become fully vested in connection with a “change in control” of our company, as defined in the plan.

ITEM 6. EXHIBITS

      (a) Exhibits

Exhibit
        Number Description  
10.1               -  

Form of option agreement and related notice of grant for use in connection with the grant of time based vesting stock options to the Registrant's non-employee directors and executive officers.

   
10.2 -

Form of option agreement and related notice of grant for use in connection with the grant of performance based vesting stock options to the Registrant's executive officers.

 
10.3 - Third Amendment to lease, by and between BMR-Landmark at Eastview  LLC and Regeneron Pharmaceuticals, Inc., entered into as of April 29, 2009.
 
31.1 -

Certification of CEO pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.

 
31.2 -

Certification of CFO pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.

 
32 -

Certification of CEO and CFO pursuant to 18 U.S.C. Section 1350.


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SIGNATURE

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.

Regeneron Pharmaceuticals, Inc.

 
Date: April 30, 2009

By: 

/s/ Murray A. Goldberg

 
Murray A. Goldberg
Senior Vice President, Finance & Administration,
Chief Financial Officer, Treasurer, and
Assistant Secretary
(Principal Financial Officer and
Duly Authorized Officer)

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Exhibit 10.1

   
  Regeneron Pharmaceuticals, Inc.  
  ID: [            ]  
Notice of Grant of Stock Options   777 Old Saw Mill River Road  
and Option Agreement for Time Vesting   Tarrytown, New York 10591  
Option Awards          
 
 
[OPTIONEE NAME]   Option Number:     [            ]  
[OPTIONEE ADDRESS   Plan:     04    
  ID     [            ]  
 

Effective <date> (the Grant Date) you have been granted a [Non-Qualified Stock Option] [Incentive Stock Option] to buy [     ] shares of Regeneron Pharmaceuticals, Inc. (the Company) stock at [$     ] per share.

The total option price of the shares granted is [$     ].

[Shares in each period will become fully vested on the date shown.

[Shares       Vest Type       Full Vest       Expiration Date  
**   On Vest Date     [__/__/__]**   [10 years from Grant Date]  
**     On Vest Date   [__/__/__]**     [10 years from Grant Date]  
**   On Vest Date   [__/__/__]**   [10 years from Grant Date]  
**   On Vest Date   [__/__/__]**   [10 years from Grant Date]]  
   
The [Non-Qualified Stock Option] [Incentive Stock Option] expires on [           ]*** (the “Expiration Date”).
 
 
You and the Company agree that these options are granted under and governed by the terms and conditions of the Company’s Amended and Restated 2000 Long-Term Incentive Plan and the enclosed Option Agreement, both of which are attached and made a part of this document.
 
 
____________________
 
**    Options for executive officers will vest in approximately equal annual 25% installments. Full Vest Dates will occur on the first, second, third and fourth anniversaries of the Grant Date. Options for non-employee directors will vest in approximately equal annual 33-1/3% installments. Full Vest Dates will occur on the first, second, and third anniversaries of the Grant Date.
 
*** Date to be 10 years from the Grant Date.
 


REGENERON PHARMACEUTICALS, INC.
OPTION AGREEMENT
PURSUANT TO THE
2000 LONG-TERM INCENTIVE PLAN

           THIS AGREEMENT, made as of the date on the Notice of Grant of Stock Options , by and between Regeneron Pharmaceuticals, Inc., a New York corporation (the "Company"), and the employee (or member of the Board of Directors) named on the Notice of Grant of Stock Options (the "Grantee");

           WHEREAS, the Grantee is an employee or member of the Board of Directors of the Company and the Company desires to afford the Grantee the opportunity to acquire or enlarge the Grantee's stock ownership in the Company so that the Grantee may have a direct proprietary interest in the Company's success; and

           WHEREAS, the Committee administering the 2000 Long-Term Incentive Plan (as amended from time to time, the "Plan") has granted (as of the effective date of grant specified in the Notice of Grant of Stock Options ) to the Grantee a Stock Option to purchase the number of shares of the Company's Common Stock ($.001 par value) (the "Common Stock") as set forth in the Notice of Grant of Stock Options .

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

      1. Grant of Award. Pursuant to Section 7 of the Plan, the Company grants to the Grantee, subject to the terms and conditions of the Plan and subject further to the terms and conditions set forth here, the option to purchase from the Company all or any part of an aggregate of shares of Common Stock at the purchase price per share (the "Option") as shown on the Notice of Grant of Stock Options . No part of the Option granted hereby is intended to qualify as an Incentive Stock Option under Section 422 of the Internal Revenue Code of 1986, as amended (the "Code").

      2. Vesting; Exercise. (a) The Option is exercisable in installments as provided on the Notice of Grant of Stock Options . To the extent that the Option has become exercisable with respect to the number of shares of Common Stock as provided on the Notice of Grant of Stock Options and subject to the terms and conditions of the Plan, including without limitation, Section 7(c)(1) & (2), the Option may thereafter be exercised by the Grantee, in whole or in part, at any time or from time to time prior to the expiration of the Option in accordance with the requirements set forth in Section 7(c)(3) of the Plan, including, without limitation, the filing of such written form of exercise notice as may be provided by the Company, and in accordance with applicable tax and other laws. In addition to the methods of payment described in Section 7(c)(3) of the Plan, the Grantee shall be eligible to pay for shares of Common Stock purchased upon the exercise of the Option by directing the Company to withhold shares of Common Stock that would otherwise be issued pursuant to the Option exercise having a Fair Market Value (as measured on the date of exercise) equal to the Option exercise price. The Company shall have the right to require the Grantee in connection with the exercise of the Option to remit to the Company in cash an amount sufficient to satisfy any federal, state and local withholding tax requirements related thereto.

      (b) The Notice of Grant of Stock Options indicates each date upon which the Grantee shall be entitled to exercise the Option with respect to the number of shares of Common Stock granted as indicated provided that the Grantee has not incurred a termination of employment or service with the Company and all Subsidiaries (collectively, the Company and all Subsidiaries shall be referred to herein as the "Employer" and no termination of employment or service shall be deemed to take place unless the Grantee is no longer employed by or providing service to the Employer) prior to such date. There shall be no proportionate or partial vesting in the periods between the Full Vest Dates specified in the Notice of Grant of Stock Options and all vesting shall occur only on the Full Vest Dates. Except as otherwise provided in any employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date specified in the Notice of Grant of Stock Options , or as may be otherwise determined by the Committee in accordance with Section 7(e) of the Plan, no vesting shall occur after such date as the Grantee ceases to be employed by the Employer (or providing services as a member of the Board of Directors, as the case may be) and all unvested Options shall be forfeited at such time.


      (c) Notwithstanding anything herein (except the following sentence) or in the Notice of Grant of Stock Options to the contrary, the Option shall be fully vested on the date of termination of the Grantee’s employment with the Employer (or services as a member of the Board of Directors) if the Grantee’s employment with the Employer (or services a member of the Board of Directors) is terminated on or within two years after the occurrence of a Change in Control by the Employer (other than for Cause) or by the Grantee for Good Reason. Except as otherwise provided in any employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options , if the application of the provision in the foregoing sentence, similar provisions in other stock option or restricted stock grants, and other payments and benefits payable to the Grantee upon termination of employment (or service as member of the Board of Directors) (collectively, the “Company Payments”) would result in the Grantee being subject to the excise tax payable under Internal Revenue Code Section 4999 (the “Excise Tax”), the amount of any Company Payments shall be automatically reduced to an amount one dollar less than an amount that would subject the Grantee to the Excise Tax; provided , however , that the reduction shall occur only if the reduced Company Payments received by the Grantee (after taking into account further reductions for applicable federal, state and local income, social security and other taxes) would be greater than the unreduced Company Payments to be received by the Grantee minus (i) the Excise Tax payable with respect to such Company Payments and (ii) all applicable federal, state and local income, social security and other taxes on such Company Payments. If the Company Payments are to be reduced in accordance with the foregoing, the Company Payments shall be reduced as mutually agreed between the Employer and the Grantee or, in the event the parties cannot agree, in the following order (1) acceleration of vesting of any option where the exercise price exceeds the fair market value of the underlying shares at the time the acceleration would otherwise occur, (2) any lump sum severance based on a multiple of base salary or bonus, (3) any other cash amounts payable to the Grantee, (4) any benefits valued as parachute payments, and (5) acceleration of vesting of any equity not covered by (1) above.

      3. Option Term. (a) Except as otherwise provided in the next sentence or in the Plan, the Option shall expire on the tenth anniversary of the grant of the Option as shown on the Notice of Grant of Stock Options . In the event of termination of employment or service with the Employer, except as set forth in any employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options , or as may be otherwise determined by the Committee in accordance with Section 7(e) of the Plan, the vested portion of the Option shall expire on the earlier of (i) the tenth anniversary of this grant, or (ii)(A) subject to (E) below, three months after such termination if such termination is for any reason other than death, retirement, or long-term disability, (B) the tenth anniversary of this grant if such termination is due to the Grantee's retirement, (C) one year after the termination if such termination is due to the Grantee's death or long-term disability, (D) the occurrence of the Cause event if such termination is for Cause or Cause existed at the time of such termination (whether then known or later discovered) or (E) one year after such termination if such termination is at any time within two years after the occurrence of a Change in Control and is by the Employer without Cause or by the Grantee for Good Reason.

      (b) For purposes of this Agreement, "Cause" shall mean (i) in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Company and the Grantee on the date of grant specified in the Notice of Grant of Stock Options (or where there is such an agreement or plan but it does not define “cause” (or words of like import)) (A) the willful and continued failure by the Grantee substantially to perform his or her duties and obligations to the Employer, including without limitation, repeated refusal to follow the reasonable directions of the Employer, knowing violation of law in the course of performance of the duties of the Grantee's employment with the Employer, repeated absences from work without a reasonable excuse, and intoxication with alcohol or illegal drugs while on the Employer's premises during regular business hours (other than any such failure resulting from his or her incapacity due to physical or mental illness); (B) fraud or material dishonesty against the Employer; or (C) a conviction or plea of guilty or nolo contendere to a felony or a crime involving material dishonesty or (ii) in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options that defines “cause” (or words of like import), as defined under such agreement or plan. For purposes of this Section 3(b), no act, or failure to act, on a Grantee's part shall be considered "willful" unless done, or omitted to be done, by the Grantee in bad faith and without reasonable belief that his or her action or omission was in the best interest of the Employer. Any determination of Cause made prior to a Change in Control shall be made by the Committee in its sole discretion.


      (c) For purposes of this Agreement, “Good Reason” shall mean (i) in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options (or where there is such an agreement or plan but it does not define “good reason” (or words of like import)) a termination of employment by the Grantee within one hundred twenty (120) days after the occurrence of one of the following events after the occurrence of a Change in Control unless such events are fully corrected in all material respects by the Employer within thirty (30) days following written notification by the Grantee to the Employer that Grantee intends to terminate his employment hereunder for one of the reasons set forth below: (A) (1) any material diminution in the Grantee’s duties and responsibilities from that which exists immediately prior to a Change in Control (except in each case in connection with the termination of the Grantee’s employment for Cause or as a result of the Grantee’s death, or temporarily as a result of the Grantee’s illness or other absence), or (2) the assignment to the Grantee of duties and responsibilities materially inconsistent with the position held by the Grantee; (B) any material breach by the Employer of any material provision of any written agreement with the Grantee or failure to timely pay any compensation obligation to the Grantee; (C) a reduction in the Grantee’s annual base salary or target bonus opportunity (if any) from that which exists immediately prior to a Change in Control; or (D) if the Grantee is based at the Employer’s principal executive office, any relocation therefrom or, in any event, a relocation of the Grantee’s primary office of more than fifty (50) miles from the location immediately prior to a Change in Control; or (ii) in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options that defines “good reason” (or words of like import), as defined under such agreement or plan.

      4. Restrictions on Transfer of Option. The Option granted hereby shall not be transferable other than by will or by the laws of descent and distribution. During the lifetime of the Grantee, this Option shall be exercisable only by the Grantee. In addition, except as otherwise provided in this Agreement, the Option shall not be assigned, negotiated, pledged or hypothecated in any way (whether by operation of law or otherwise), and the Option shall not be subject to execution, attachment or similar process. Upon any other attempt to transfer, assign, negotiate, pledge or hypothecate the Option, or in the event of any levy upon the option by reason of any execution, attachment, or similar process contrary to the provisions hereof, the Option shall immediately become null and void. Notwithstanding the foregoing provisions of this Section 4, subject to the approval of the Committee in its sole and absolute discretion and to any conditions that the Committee may prescribe, the Grantee may, upon providing written notice to the Company, elect to transfer the Option to members of his or her immediate family, including, but not limited to, children, grandchildren and spouse or to trusts for the benefit of such immediate family members or to partnerships in which such family members are the only partners; provided, however, that no such transfer may be made in exchange for consideration.

      5. Rights of a Stockholder. The Grantee shall have no rights as a stockholder with respect to any shares of Common Stock subject to this Option prior to the date of issuance to the Grantee of a certificate or certificates for such shares. No adjustment shall be made for dividends in cash or other property, distributions, or other rights with respect to such shares for which the record date is prior to the date upon which the Grantee shall become the holder of record therefor.

      6. Compliance with Law and Regulations. This award and any obligation of the Company hereunder shall be subject to all applicable federal, state and local laws, rules and regulations and to such approvals by any government or regulatory agency as may be required. The Company shall be under no obligation to effect the registration pursuant to federal securities laws of any interests in the Plan or any shares of Common Stock to be issued hereunder or to effect similar compliance under any state laws. The Company shall not be obligated to cause to be issued or delivered any certificates evidencing shares of Common Stock pursuant to this Agreement unless and until the Company is advised by its counsel that the issuance and delivery of such certificates is in compliance with all applicable laws, regulations of governmental authority and the requirements of any securities exchange on which shares of Common Stock are traded. The Committee may require, as a condition of the issuance and delivery of certificates evidencing shares of Common Stock pursuant to the terms hereof, that the recipient of such shares make such agreements and representations, and that such certificates bear such legends, as the Committee, in its sole discretion, deems necessary or desirable. Except to the extent preempted by any applicable federal law, this Agreement shall be construed and administered in accordance with the laws of the State of New York without reference to its principles of conflicts of law.


      7. Grantee Bound by Plan. The Grantee acknowledges receipt of a copy of the Plan and agrees to be bound by all the terms and provisions thereof. The Plan is incorporated herein by reference, and any capitalized term used but not defined herein shall have the same meaning as in the Plan. To the extent that this Agreement is silent with respect to, or in any way inconsistent with, the terms of the Plan, the provisions of the Plan shall govern and this Agreement shall be deemed to be modified accordingly.

      8. Notices. Any notice or communication given hereunder shall be in writing and shall be deemed given when delivered in person, or by United States mail, at the following addresses: (i) if to the Employer, to: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, Attention: Secretary, and (ii) if to the Grantee, to: the Grantee at Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, or, if the Grantee has terminated employment or service, to the last address for the Grantee indicated in the records of the Employer, or such other address as the relevant party shall specify at any time hereafter in accordance with this Section 8.

      9. No Obligation to Continue Employment. This Agreement does not guarantee that the Employer will employ the Grantee for any specified time period, nor does it modify in any respect the Grantee's employment or compensation.


Exhibit 10.2

 
  Regeneron Pharmaceuticals, Inc.  
  ID: [            ]  
Notice of Grant of Stock Options   777 Old Saw Mill River Road  
and Option Agreement for Performance   Tarrytown, New York 10591     
Vesting Option Awards          
 
 
[OPTIONEE NAME]   Option Number:     [            ]  
[OPTIONEE ADDRESS   Plan:     04    
  ID     [            ]  
 

Effective <date> (the Grant Date) you have been granted a Non-Qualified Stock Option to buy [     ] shares of Regeneron Pharmaceuticals, Inc. (the Company) stock at [$     ] per share.

The total option price of the shares granted is [$     ].

Stock options granted pursuant to this award will be eligible to vest on [           ]*. The number of stock options that will vest on that date will be determined based on the total number of points that are earned according to the table below during the period commencing on [           ] and ending on [           ]* (the Performance Measurement Period):

Total Points   Stock Options to Vest on [            ] *  
[            ] or less   0  
[            ]     [            ]    
[            ]   [            ]    
[            ]     [            ]    
[            ]     [            ]  
[            ]   [            ]  
[            ] or more   [            ]  

Total points in the table set forth above will be calculated based on the following criteria as achieved during the Performance Measurement Period:

[Description of performance criteria and allocation of points for achieving specific milestones]


[For the avoidance of doubt, points may be earned upon achievement of the specified criteria by or on behalf of the Company or any subsidiary of the Company, including by any other entity pursuant to or in connection with any license or collaboration agreement under which such entity has rights to develop the Drug Candidate.]

[Notwithstanding the foregoing, if [insert certain criteria] have not been achieved during the Performance Measurement Period, then the number of stock options from this award that will vest on [          ]* may not exceed [          ] unless otherwise determined by the Compensation Committee or there is an acceleration of this stock option award following a Change in Control pursuant to any employment agreement, change in control agreement or similar agreement in effect between the Grantee and the Company.

Notwithstanding anything to the contrary set forth herein, the Compensation Committee of the Board of Directors of the Company shall have the discretion to cause or accelerate the vesting of any or all of the stock options granted pursuant to this award.

The Compensation Committee of the Board of Directors of the Company shall have the authority in its sole discretion to determine whether the criteria required for earning the points in the table set forth above were achieved.

The Non-Qualified Stock Option expires on [10 years from the Grant Date].

 
You and the Company agree that these options are granted under and governed by the terms and conditions of the Company’s Amended and Restated 2000 Long-Term Incentive Plan and the enclosed Option Agreement, both of which are attached and made a part of this document.
 
 
____________________

*    This date will be the last day of the Performance Measurement Period.
 

REGENERON PHARMACEUTICALS, INC.
OPTION AGREEMENT
PURSUANT TO THE
2000 LONG-TERM INCENTIVE PLAN

           THIS AGREEMENT, made as of the date on the Notice of Grant of Stock Options , by and between Regeneron Pharmaceuticals, Inc., a New York corporation (the "Company"), and the employee [(or member of the Board of Directors)]* named on the Notice of Grant of Stock Options (the "Grantee");

           WHEREAS, the Grantee is an employee [or member of the Board of Directors]* of the Company and the Company desires to afford the Grantee the opportunity to acquire or enlarge the Grantee's stock ownership in the Company so that the Grantee may have a direct proprietary interest in the Company's success; and

           WHEREAS, the Committee administering the 2000 Long-Term Incentive Plan (as amended from time to time, the "Plan") has granted (as of the effective date of grant specified in the Notice of Grant of Stock Options ) to the Grantee a Stock Option to purchase the number of shares of the Company's Common Stock ($.001 par value) (the "Common Stock") as set forth in the Notice of Grant of Stock Options .

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

      1. Grant of Award. Pursuant to Section 7 of the Plan, the Company grants to the Grantee, subject to the terms and conditions of the Plan and subject further to the terms and conditions set forth here, the option to purchase from the Company all or any part of an aggregate of shares of Common Stock at the purchase price per share (the "Option") as shown on the Notice of Grant of Stock Options . [No part of the Option granted hereby is intended to qualify as an Incentive Stock Option under Section 422 of the Internal Revenue Code of 1986, as amended (the "Code").]* [Notwithstanding the foregoing, the Option will not qualify as an Incentive Stock Option, among other events, (i) if the Grantee disposes of the Common Stock acquired pursuant to the Option at any time during the two year period following the date of this Agreement or the one year period following the date on which the Option is exercised, or (ii) if the Grantee is not employed by the Company or a subsidiary of the Company within the meaning of Section 424 of the Code (a "Subsidiary") at all times during the period beginning on the date of this Agreement and ending on the day three months before the date of exercise of the Option, or (iii) to the extent the aggregate fair market value (determined as of the time the Option is granted) of the stock subject to Incentive Stock Options which become exercisable for the first time in any calendar year exceeds $100,000. To the extent that the Option does not qualify as an Incentive Stock Option, it shall constitute a separate Non-Qualified Stock Option.]**

      2. Vesting; Exercise. (a) The Option is exercisable in installments as provided on the Notice of Grant of Stock Options . To the extent that the Option has become exercisable with respect to the number of shares of Common Stock as provided on the Notice of Grant of Stock Options and subject to the terms and conditions of the Plan, including without limitation, Section 7(c)(1) & (2), the Option may thereafter be exercised by the Grantee, in whole or in part, at any time or from time to time prior to the expiration of the Option in accordance with the requirements set forth in Section 7(c)(3) of the Plan, including, without limitation, the filing of such written form of exercise notice as may be provided by the Company, and in accordance with applicable tax and other laws. [In addition to the methods of payment described in Section 7(c)(3) of the Plan, the Grantee shall be eligible to pay for shares of Common Stock purchased upon the exercise of the Option by directing the Company to withhold shares of Common Stock that would otherwise be issued pursuant to the Option exercise having a Fair Market Value (as measured on the date of exercise) equal to the Option exercise price.]* The Company shall have the right to require the Grantee in connection with the exercise of the Option to remit to the Company in cash an amount sufficient to satisfy any federal, state and local withholding tax requirements related thereto.

      (b) The Notice of Grant of Stock Options indicates each date upon which the Grantee shall be entitled to exercise the Option with respect to the number of shares of Common Stock granted as indicated provided that the Grantee has not incurred a termination of employment or service with the Company and all Subsidiaries (collectively, the Company and all Subsidiaries shall be referred to herein as the "Employer" and no termination of employment or service shall be deemed to take place unless the Grantee is no longer employed by or providing service to the Employer) prior to such date. There shall be no proportionate or partial vesting in the periods between the Full Vest Dates specified in the Notice of Grant of Stock Options and all vesting shall occur only on the Full Vest Dates. Except as otherwise provided in any employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date specified in the Notice of Grant of Stock Options , or as may be otherwise determined by the Committee in accordance with Section 7(e) of the Plan, no vesting shall occur after such date as the Grantee ceases to be employed by the Employer [(or providing services as a member of the Board of Directors, as the case may be)]* and all unvested Options shall be forfeited at such time.


      (c) Notwithstanding anything herein (except the following sentence) or in the Notice of Grant of Stock Options to the contrary, the Option shall be fully vested on the date of termination of the Grantee’s employment with the Employer [(or services as a member of the Board of Directors)]* if the Grantee’s employment with the Employer [(or services a member of the Board of Directors)]* is terminated on or within two years after the occurrence of a Change in Control by the Employer (other than for Cause) or by the Grantee for Good Reason. Except as otherwise provided in any employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options , if the application of the provision in the foregoing sentence, similar provisions in other stock option or restricted stock grants, and other payments and benefits payable to the Grantee upon termination of employment [(or service as member of the Board of Directors)]* (collectively, the “Company Payments”) would result in the Grantee being subject to the excise tax payable under Internal Revenue Code Section 4999 (the “Excise Tax”), the amount of any Company Payments shall be automatically reduced to an amount one dollar less than an amount that would subject the Grantee to the Excise Tax; provided , however , that the reduction shall occur only if the reduced Company Payments received by the Grantee (after taking into account further reductions for applicable federal, state and local income, social security and other taxes) would be greater than the unreduced Company Payments to be received by the Grantee minus (i) the Excise Tax payable with respect to such Company Payments and (ii) all applicable federal, state and local income, social security and other taxes on such Company Payments. If the Company Payments are to be reduced in accordance with the foregoing, the Company Payments shall be reduced as mutually agreed between the Employer and the Grantee or, in the event the parties cannot agree, in the following order (1) acceleration of vesting of any option where the exercise price exceeds the fair market value of the underlying shares at the time the acceleration would otherwise occur, (2) any lump sum severance based on a multiple of base salary or bonus, (3) any other cash amounts payable to the Grantee, (4) any benefits valued as parachute payments, and (5) acceleration of vesting of any equity not covered by (1) above.

      3. Option Term. (a) Except as otherwise provided in the next sentence or in the Plan, the Option shall expire on the tenth anniversary of the grant of the Option as shown on the Notice of Grant of Stock Options . In the event of termination of employment or service with the Employer, except as set forth in any employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options , or as may be otherwise determined by the Committee in accordance with Section 7(e) of the Plan, the vested portion of the Option shall expire on the earlier of (i) the tenth anniversary of this grant, or (ii)(A) subject to (E) below, three months after such termination if such termination is for any reason other than death, retirement, or long-term disability, (B) the tenth anniversary of this grant if such termination is due to the Grantee's retirement, (C) one year after the termination if such termination is due to the Grantee's death or long-term disability, (D) the occurrence of the Cause event if such termination is for Cause or Cause existed at the time of such termination (whether then known or later discovered) or (E) one year after such termination if such termination is at any time within two years after the occurrence of a Change in Control and is by the Employer without Cause or by the Grantee for Good Reason.

      (b) For purposes of this Agreement, "Cause" shall mean (i) in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Company and the Grantee on the date of grant specified in the Notice of Grant of Stock Options (or where there is such an agreement or plan but it does not define “cause” (or words of like import)) (A) the willful and continued failure by the Grantee substantially to perform his or her duties and obligations to the Employer, including without limitation, repeated refusal to follow the reasonable directions of the Employer, knowing violation of law in the course of performance of the duties of the Grantee's employment with the Employer, repeated absences from work without a reasonable excuse, and intoxication with alcohol or illegal drugs while on the Employer's premises during regular business hours (other than any such failure resulting from his or her incapacity due to physical or mental illness); (B) fraud or material dishonesty against the Employer; or (C) a conviction or plea of guilty or nolo contendere to a felony or a crime involving material dishonesty or (ii) in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options that defines “cause” (or words of like import), as defined under such agreement or plan. For purposes of this Section 3(b), no act, or failure to act, on a Grantee's part shall be considered "willful" unless done, or omitted to be done, by the Grantee in bad faith and without reasonable belief that his or her action or omission was in the best interest of the Employer. Any determination of Cause made prior to a Change in Control shall be made by the Committee in its sole discretion.


      (c) For purposes of this Agreement, “Good Reason” shall mean (i) in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options (or where there is such an agreement or plan but it does not define “good reason” (or words of like import)) a termination of employment by the Grantee within one hundred twenty (120) days after the occurrence of one of the following events after the occurrence of a Change in Control unless such events are fully corrected in all material respects by the Employer within thirty (30) days following written notification by the Grantee to the Employer that Grantee intends to terminate his employment hereunder for one of the reasons set forth below: (A) (1) any material diminution in the Grantee’s duties and responsibilities from that which exists immediately prior to a Change in Control (except in each case in connection with the termination of the Grantee’s employment for Cause or as a result of the Grantee’s death, or temporarily as a result of the Grantee’s illness or other absence), or (2) the assignment to the Grantee of duties and responsibilities materially inconsistent with the position held by the Grantee; (B) any material breach by the Employer of any material provision of any written agreement with the Grantee or failure to timely pay any compensation obligation to the Grantee; (C) a reduction in the Grantee’s annual base salary or target bonus opportunity (if any) from that which exists immediately prior to a Change in Control; or (D) if the Grantee is based at the Employer’s principal executive office, any relocation therefrom or, in any event, a relocation of the Grantee’s primary office of more than fifty (50) miles from the location immediately prior to a Change in Control; or (ii) in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement or plan in effect between the Employer and the Grantee on the date of grant specified in the Notice of Grant of Stock Options that defines “good reason” (or words of like import), as defined under such agreement or plan.

      4. Restrictions on Transfer of Option. The Option granted hereby shall not be transferable other than by will or by the laws of descent and distribution. During the lifetime of the Grantee, this Option shall be exercisable only by the Grantee. In addition, except as otherwise provided in this Agreement, the Option shall not be assigned, negotiated, pledged or hypothecated in any way (whether by operation of law or otherwise), and the Option shall not be subject to execution, attachment or similar process. Upon any other attempt to transfer, assign, negotiate, pledge or hypothecate the Option, or in the event of any levy upon the option by reason of any execution, attachment, or similar process contrary to the provisions hereof, the Option shall immediately become null and void. Notwithstanding the foregoing provisions of this Section 4, subject to the approval of the Committee in its sole and absolute discretion and to any conditions that the Committee may prescribe, the Grantee may, upon providing written notice to the Company, elect to transfer the Option to members of his or her immediate family, including, but not limited to, children, grandchildren and spouse or to trusts for the benefit of such immediate family members or to partnerships in which such family members are the only partners; provided, however, that no such transfer may be made in exchange for consideration.

      5. Rights of a Stockholder. The Grantee shall have no rights as a stockholder with respect to any shares of Common Stock subject to this Option prior to the date of issuance to the Grantee of a certificate or certificates for such shares. No adjustment shall be made for dividends in cash or other property, distributions, or other rights with respect to such shares for which the record date is prior to the date upon which the Grantee shall become the holder of record therefor.


      6. Compliance with Law and Regulations. This award and any obligation of the Company hereunder shall be subject to all applicable federal, state and local laws, rules and regulations and to such approvals by any government or regulatory agency as may be required. The Company shall be under no obligation to effect the registration pursuant to federal securities laws of any interests in the Plan or any shares of Common Stock to be issued hereunder or to effect similar compliance under any state laws. The Company shall not be obligated to cause to be issued or delivered any certificates evidencing shares of Common Stock pursuant to this Agreement unless and until the Company is advised by its counsel that the issuance and delivery of such certificates is in compliance with all applicable laws, regulations of governmental authority and the requirements of any securities exchange on which shares of Common Stock are traded. The Committee may require, as a condition of the issuance and delivery of certificates evidencing shares of Common Stock pursuant to the terms hereof, that the recipient of such shares make such agreements and representations, and that such certificates bear such legends, as the Committee, in its sole discretion, deems necessary or desirable. Except to the extent preempted by any applicable federal law, this Agreement shall be construed and administered in accordance with the laws of the State of New York without reference to its principles of conflicts of law.

      7. Grantee Bound by Plan. The Grantee acknowledges receipt of a copy of the Plan and agrees to be bound by all the terms and provisions thereof. The Plan is incorporated herein by reference, and any capitalized term used but not defined herein shall have the same meaning as in the Plan. To the extent that this Agreement is silent with respect to, or in any way inconsistent with, the terms of the Plan, the provisions of the Plan shall govern and this Agreement shall be deemed to be modified accordingly.

      8. Notices. Any notice or communication given hereunder shall be in writing and shall be deemed given when delivered in person, or by United States mail, at the following addresses: (i) if to the Employer, to: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, Attention: Secretary, and (ii) if to the Grantee, to: the Grantee at Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, or, if the Grantee has terminated employment or service, to the last address for the Grantee indicated in the records of the Employer, or such other address as the relevant party shall specify at any time hereafter in accordance with this Section 8.

      9. No Obligation to Continue Employment. This Agreement does not guarantee that the Employer will employ the Grantee for any specified time period, nor does it modify in any respect the Grantee's employment or compensation.

____________________

*    For Non-Qualified Stock Option Awards.
**    For Incentive Stock Option Awards.
 

Exhibit 10.3

THIRD AMENDMENT TO LEASE

      THIS THIRD AMENDMENT TO LEASE (this “ Amendment ”) is entered into as of this 29 th day of April, 2009 (“ Execution Date ”), by and between BMR-LANDMARK AT EASTVIEW LLC, a Delaware limited liability company (“ Landlord ”), and REGENERON PHARMACEUTICALS, INC., a New York corporation (“ Tenant ”).

RECITALS

      A. WHEREAS, Landlord and Tenant entered into that certain Lease dated as of December 21, 2006 (the “ Original Lease ”), as amended by that certain First Amendment to Lease dated as of October 24, 2007 (the “ First Amendment ”), and that certain Second Amendment to Lease dated as of September 30, 2008 (the “ Second Amendment ” and, collectively with the Original Lease and the First Amendment, and as the same may have been further amended, supplemented or otherwise modified from time to time, the “ Lease ”), whereby Tenant leases certain premises (the “ Premises ”) from Landlord at 735, 745, 765 and 777 Old Saw Mill River Road in Tarrytown, New York (collectively, the “ Buildings ”, and each a “ Building ”);

      B. WHEREAS, Emisphere Technologies, Inc. (“ Emisphere ”), leases certain space from Landlord at 765 Old Saw Mill River Road (the “ 765 Building ”) pursuant to that certain Lease dated as of March 31, 1997, as the same may have been amended, supplemented or otherwise modified from time to time, the “ Emisphere Lease ”);

      C. WHEREAS, Emisphere, as sublessor, subleases to Tenant, as sublessee, approximately 13,652 rentable square feet of space (the “ Regeneron Sublease Premises ”) in the Quad I & II Premises (as defined below) pursuant to that certain Sublease Agreement dated as of April 15, 2008 (the “ Regeneron Sublease ”);

      D. WHEREAS, Emisphere, as sublessor, subleases to PsychoGenics Inc. (“ PsychoGenics ”), as sublessee, approximately 2,275 rentable square feet of space (the “ PsychoGenics Premises ”) in the Quad III & IV Premises (as defined below) pursuant to that certain Sublease dated as of January __[sic], 2008 (the “ PsychoGenics Sublease ”);

      E. WHEREAS, as of the date hereof, Landlord and Emisphere have terminated the Emisphere Lease and, consequently, the Regeneron Sublease and PsychoGenics Sublease have been terminated;

      F. WHEREAS, Tenant desires to continue to occupy and lease directly from Landlord the Regeneron Sublease Premises, to surrender certain other space within the Buildings and to lease additional space in the 765 Building from Landlord; and

      G. WHEREAS, Landlord and Tenant desire to modify and amend the Lease only in the respects and on the conditions hereinafter stated.


AGREEMENT

      NOW, THEREFORE, Landlord and Tenant, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree as follows:

      1. Definitions . For purposes of this Amendment, capitalized terms shall have the meanings ascribed to them in the Lease unless otherwise defined herein. The Lease, as amended by this Amendment, is referred to herein as the “ Amended Lease .”

      2. Swap Premises . Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord (y) as of the Execution Date, the Regeneron Sublease Premises, and (z) as of May 1, 2009 (the “ Swap Premises Commencement Date ”), the portions of the following premises that are not part of the Regeneron Sublease Premises. The Quad I & II Premises and Quad III & IV Premises (including the Regeneron Sublease Premises) are referred to herein collectively as the “ Swap Premises .” The Swap Premises consist of approximately 77,178 rentable square feet.

           a. Quad I Premises . Approximately 13,462 rentable square feet of space located on the second floor of the 765 Building, as shown on Exhibit A attached hereto (the “ Quad I Premises ”);

           b. Quad II Premises . Approximately 22,219 rentable square feet of space located on the second floor of the 765 Building, as shown on Exhibit A attached hereto (the “ Quad II Premises ” and, collectively with the Quad I Premises, the “ Quad I & II Premises ”);

           c. Quad III Premises . Approximately 20,748 rentable square feet of space located on the second floor of the 765 Building, as shown on Exhibit A attached hereto (the “ Quad III Premises ”); and

           d. Quad IV Premises . Approximately 20,749 rentable square feet of space located on the second floor of the 765 Building, as shown on Exhibit A attached hereto (the “ Quad IV Premises ” and, collectively with the Quad III Premises, the “ Quad III & IV Premises ”).

      3. Surrender Premises . The parties acknowledge that, as part of the Additional Premises, Tenant currently leases approximately 35,681 rentable square feet in the North portion of the Building located at 777 Old Saw Mill River Road, as shown on Exhibit B attached hereto (the “ Surrender Premises ”). The Additional Premises less the Surrender Premises shall be referred to herein as the “ Modified Additional Premises. ” Notwithstanding anything to the contrary in the Lease, the Term for the Surrender Premises shall expire on August 31, 2009, and Landlord and Tenant shall be released from each of their respective obligations under the Lease with respect to the Surrender Premises (including the payment of Rent), except for those obligations that expressly survive the expiration or earlier termination of the Lease.

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      4. Tenant’s Pro Rata Shares . From and after the Execution Date until the Swap Premises Commencement Date, (a) the Premises shall be deemed to include the Regeneron Sublease Premises, (b) Tenant’s Pro Rate Share of the 765 Building shall increase from 15.25% to 22.94%, (c) Tenant’s Pro Rata Share of the Existing Project (based on Retained Premises, Additional Premises and Regeneron Sublease Premises only) shall increase from 15.75% to 17.57%, and (iv) Tenant’s Pro Rata Share of the Entire Project shall increase from 31.29% to 32.52%. From and after the Swap Premises Commencement Date, Section 2.2 of the Lease is hereby deleted and replaced in its entirety with the following:

The Premises, the Buildings, and certain related terms are defined as follows. In these definitions, each Rentable Area is expressed in rentable square footage. Rentable Area and Tenant’s Pro Rata Shares are all subject to adjustment under this Lease, including under Section 9.2 .

Definition or Provision   Means the Following (As of the Swap  
  Premises Commencement Date)  
Premises Retained Premises, New Premises, Additional Premises, and Swap Premises
Buildings 735 Building, 745 Building, 765 Building and 777 Building
Rentable Area of Premises   389,529  
Rentable Area of Buildings   117,935 for 735 Building  
  111,708 for 745 Building  
  177,203 for 765 Building  
  311,104 for 777 Building  
Rentable Area of Existing Project   751,648  
Rentable Area of New Project   360,520  
Rentable Area of Entire Project   1,112,168  
Tenant’s Pro Rata Share of Buildings   100% of 735 Building  
  100% of 745 Building  
  58.80 % of 765 Building  
  17.90% of 777 Building  
Tenant’s Pro Rata Share of the Existing Project   21.27%  
(Based on Retained Premises, Additional    
Premises and Swap Premises only)    
Tenant’s Pro Rata Share of the New Project   63.70%  
(Based on New Premises only)    
Tenant’s Pro Rata Share of Entire Project   35.02%  

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5. Rent .

      a. Basic Annual Rent . Commencing as of (i) the Swap Premises Commencement Date with respect to the Quad I Premises and (ii) September 1, 2009, with respect to the remainder of the Swap Premises (the relevant dates in (i) and (ii), the “ Swap

Premises Rent Commencement Date ”), and continuing through the Term, Tenant shall pay Landlord Basic Annual Rent for the Swap Premises (“ Swap Premises Basic Annual Rent ”) in the following amounts (in addition to Rent otherwise due under the Lease) and in accordance with the terms for payment of Basic Annual Rent set forth in the Lease:

Quad I Premises
Date Rentable Per Rentable Total Annual Total Monthly
  s.f. s.f.    
    Annually    
Swap Premises 13,462 $26.50 $356,743.00 (to $29,728.58
Commencement Date –     be prorated)  
August 31, 2009        
September 1, 2009 – June 30, 13,462 $28.00 $376,936.00 (to $31,411.33
2010     be prorated)  
July 1, 2010 – remainder of 13,462 Swap Premises Basic Annual Rent to increase
the Term   annually every July 1 by 2.5% of the then-current
    Swap Premises Basic Annual Rent applicable to
    Quad I Premises
Quad II Premises
Date Rentable Per Rentable Total Annual Total Monthly
  s.f. s.f.    
    Annually    
Swap Premises Rent 22,219 $28.00 $622,132.00 $51,844.33
Commencement Date – June        
30, 2010        
July 1, 2010 – remainder of 22,219 Swap Premises Basic Annual Rent to increase
the Term   annually every July 1 by 2.5% of the then-current
    Swap Premises Basic Annual Rent applicable to
    Quad II Premises
Quad III Premises
Date Rentable Per Rentable Total Annual Total Monthly
  s.f. s.f.    
    Annually    
Swap Premises Rent 20,748 $26.50 $549,822 (to be $45,818
Commencement Date – June     prorated)  
30, 2010        
July 1, 2010–June 30, 2011 20,748 $27.16 $563,515.68 $46,959.64
July 1, 2011–June 30, 2012 20,748 $27.84 $577,624.32 $48,135.36
July 1, 2012–June 30, 2013 20,748 $28.00 $580,944 $48,412.00

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July 1, 2013–June 30, 2014 20,748 $28.00 $580,944 $48,412.00
July 1, 2014–remainder of 20,748 Swap Premises Basic Annual Rent to increase
Term   annually every July 1 by 2.5% of the then-current
    Swap Premises Basic Annual Rent applicable to
    Quad III Premises
Quad IV Premises
Date Rentable Per Rentable Total Annual Total Monthly
  s.f. s.f.    
    Annually    
Swap Premises Rent 20,749 $26.50 $549,848.50 (to $45,820.71
Commencement Date – June     be prorated)  
30, 2010        
July 1, 2010–June 30, 2011 20,749 $27.16 $563,542.84 $46,961.90
July 1, 2011–June 30, 2012 20,749 $27.84 $577,652.16 $48,137.68
July 1, 2012–June 30, 2013 20,749 $28.00 $580,972.00 $48,414.33
July 1, 2013–June 30, 2014 20,749 $28.00 $580,972.00 $48,414.33
July 1, 2014–remainder of 20,749 Swap Premises Basic Annual Rent to increase
Term   annually every July 1 by 2.5% of the then-current
    Swap Premises Basic Annual Rent applicable to
    Quad IV Premises

           b. Operating Expenses .

                i. In addition to Swap Premises Basic Annual Rent, commencing as of the Swap Premises Rent Commencement Date, Tenant shall pay to Landlord as Additional Rent, at times specified in the Amended Lease, Tenant’s Pro Rata Share of Operating Expenses with respect to the applicable portion of the Swap Premises.

                ii. Notwithstanding anything in the Amended Lease to the contrary, and solely with respect to the Quad II Premises and the Quad III & IV Premises, commencing as of the Swap Premises Commencement Date and continuing until (but not including) the Swap Premises Rent Commencement Date, Tenant shall pay to Landlord monthly, on the first day of each month as Additional Rent, a fixed amount of One Hundred Twenty Thousand Five Hundred Dollars ($120,500). The parties hereby agree and confirm that the foregoing amount shall be the sole obligation of Tenant with respect to Operating Expenses for the Quad II Premises and the Quad III & IV Premises during such period.

                iii. For the avoidance of doubt, HVAC for the Additional Premises and the Swap Premises shall be calculated in the same manner as provided in the Amended Lease with respect to the Retained Premises.

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      6. Rent Credit . Tenant shall be entitled to the following Rent credits:

           a. Effective as of December 1, 2009, a Rent credit equal to Five Hundred Thousand Dollars ($500,000) to be applied against any portion of Rent due to Landlord under the Amended Lease; and

           b. Effective as of December 1, 2012, a Rent credit equal to One Million Fifty Thousand Three Hundred Dollars ($1,050,300) to be applied against any portion of Rent due to Landlord under the Amended Lease (except that the foregoing credit shall not be applicable to cure a monetary default of Tenant).

      7. Swap Premises Term Expiration Date . The Term for the Swap Premises shall expire on the Term Expiration Date for the New Premises, subject to (a) Tenant’s option to extend the Term of the Lease as provided in Article 44 of the Lease (as amended by this Amendment), and (b) Tenant’s termination options set forth in Section 13 below.

      8. Lease Extension Options . From and after the Swap Premises Commencement Date, the first paragraph of Article 44 of the Lease is hereby deleted and replaced with the following:

44. Option to Extend Term . Tenant shall have three (3) options (each, an “ Option ”) to extend the Term of this Lease (and, in each case, the Term Expiration Date) by five (5) years, in each case on the same terms and conditions as this Lease, except as provided below. If Tenant desires to exercise any Option, Tenant must do so by giving Landlord written notice of such exercise at least one (1) year before the Term would otherwise expire. Tenant may exercise its Option to extend the Term only as to any one or more of the following: (a) the entire Retained Premises, (b) the entire New Whole Building Premises, (c) the entire New Multiple Tenant Building Premises, (d) the Modified Additional Premises or (e) the Swap Premises. If Tenant fails to exercise an Option with respect to less than all of the Premises and the time to do so has lapsed (or if a Retained Premises Early Termination or a termination pursuant to a Swap Premises Termination Option (as defined below)has occurred), then Tenant shall no longer have an Option with respect to those portions of the Premises for which it failed to exercise an Option. Tenant’s Options for the remaining Premises shall remain in full force and effect.

      9. Delivery of Possession .

           a. Tenant acknowledges that it is currently in possession of and occupies the Regeneron Sublease Premises. Landlord shall deliver to Tenant (i) on the Execution Date, the Regeneron Sublease Premises for construction of the Swap Premises Tenant Improvements (as defined below), and (ii) on the Swap Premises Commencement Date, the remainder of the Swap Premises for possession, occupancy and construction of the Swap Premises Tenant Improvements. As of each such date, Tenant’s possession and occupancy of the applicable portions of the Swap Premises shall be governed by and pursuant to the Amended Lease; provided , however, that Tenant shall have no obligation to pay Swap Premises Basic Annual Rent with respect to its occupancy and possession of the Swap Premises prior to the applicable Swap Premises Rent Commencement Date. Landlord shall permit Tenant, accompanied by an employee of Landlord, to enter the portion of the Swap Premises that is not the Regeneron Sublease Premises at a time mutually acceptable to Landlord and Tenant (but in no event more than three (3) days prior to the Swap Premises Commencement Date) for the purpose of Tenant planning its move into the Swap Premises.

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           b. If Landlord fails to deliver all or a portion of the Swap Premises to Tenant on the Swap Premises Commencement Date (such portion, the “ Late Delivery Premises ”), then Tenant shall not be obligated to pay Base Rent or Operating Expenses with respect to the Late Delivery Premises until Landlord delivers the Late Delivery Premises to Tenant.

      10. Tenant Improvements .

           a. Landlord shall make available to Tenant a tenant improvement allowance of Ten Dollars ($10) per rentable square foot of the Quad I & II Premises (the “ Quad I & II Premises TI Allowance ”) at any time after the Swap Premises Commencement Date until such time as Tenant has exercised a Quad I & II Termination Option (as defined below). Further, Landlord shall make available to Tenant a tenant improvement allowance of Twenty Dollars ($20) per rentable square foot of the Quad III & IV Premises (the “ Quad III & IV Premises TI Allowance ”). Up to Ten Dollars ($10) per rentable square foot of the Quad III & IV Premises TI Allowance (the “ Phase 1 Quad III & IV Premises TI Allowance ”) shall be available to Tenant at any time after the Swap Premises Rent Commencement Date. The balance of the Quad III & IV Premises TI Allowance (not to exceed an additional Ten Dollars ($10) per rentable square foot (the “ Phase 2 Quad III & IV Premises TI Allowance ”)) shall be available to Tenant at any time during the Term after June 30, 2013; provided that Tenant has not exercised a Quad III & IV Termination Option (as defined below). If Tenant has exercised a Quad III & IV Termination Option with respect to the Quad III Premises or the Quad IV Premises only, then Tenant shall still be entitled to its pro rata amount of the Phase 2 Quad III & IV Premises TI Allowance allocable to the non-terminated portion of the Quad III & IV Premises.

           b. The Quad I & II Tenant Improvement Allowance and the Quad III & IV Tenant Improvement Allowance (collectively, the “ Swap Premises TI Allowance ”) shall be disbursed in the same manner as the Base TI Allowance under the applicable provisions of Article 5 of the Lease, including, without limitation, the Disbursement Conditions, in order to finance improvements to the Swap Premises consistent with the provisions of the Lease and the Permitted Use (such improvements, the “ Swap Premises Tenant Improvements ”). Tenant shall be responsible for performing and completing the Swap Premises Tenant Improvements, and Tenant shall pay Landlord a construction oversight fee of two and one-half percent (2.5%) of the total cost of the Swap Premises Tenant Improvements, including, without limitation, the Swap Premises TI Allowance to the extent disbursed to Tenant, which construction oversight fee may be paid out of the Swap Premises TI Allowance.

      11. Reduction in Additional Premises TI Allowance . The Additional Premises TI Allowance, as set forth in Section 10 of the Second Amendment, is hereby reduced by Three Hundred Fifty-Six Thousand Eight Hundred Ten Dollars ($356,810). For the avoidance of doubt, Landlord and Tenant acknowledge that the reduction in the Additional Premises TI Allowance results from Tenant surrendering the Surrender Premises, and that Tenant shall continue to have available to it, to the extent not previously disbursed, Ten Dollars ($10) per rentable square foot of the Modified Additional Premises.

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      12. Parking . The parties acknowledge that, in accordance with the Lease, Tenant shall be entitled to its pro rata share of unreserved parking spaces on the South side of the Entire Project with respect to the Swap Premises. As of the Swap Premises Rent Commencement Date, Tenant shall be entitled to an additional two (2) parking spaces per thousand (1,000) rentable square feet of Swap Premises. In addition, Tenant’s pro rata share of unreserved parking spaces on the North side of the Entire Project shall be reduced proportionately to reflect Tenant’s surrendering of the Surrender Premises.

      13. Termination Options :

           a. Tenant shall be entitled to terminate the Lease with respect to (i) the entire Quad III Premises, (ii) the entire Quad IV Premises or (iii) the entire Quad III & IV Premises (each, a “ Quad III & IV Termination Option ,” and collectively, the “ Quad III & IV Termination Options ”). In each case, upon not less than eighteen (18) months’ prior written notice to Landlord, effective as of (l) June 30, 2013, upon payment to Landlord of Fifteen and 57/100 Dollars ($15.57) per rentable square foot of terminated space, (m) June 30, 2014, upon payment to Landlord of Fourteen and 16/100 Dollars ($14.16) per rentable square foot of terminated space, (n) December 31, 2015, upon payment to Landlord of Twelve and 03/100 Dollars ($12.03) per rentable square foot of terminated space, or (o) December 31, 2016, upon payment to Landlord of Ten and 62/100 Dollars ($10.62) per square foot of terminated space. If Tenant terminates less than all of the Quad III & IV Premises prior to June 30, 2014, then Tenant’s right to exercise its remaining Quad III & IV Termination Options with respect to the portion of the Quad III & IV Premises not terminated shall survive until June 30, 2015 (i.e., eighteen (18) months prior to the last termination date). If Tenant receives any portion of the Phase 2 Quad III & IV Premises TI Allowance, then the payment required to terminate the Quad III & IV Premises shall increase by the unamortized portion of the Phase 2 Quad III & IV TI Allowance allocable to the terminated portion or portions of the Quad III & IV Premises as of the applicable termination date using straight-line amortization (such amortization period to commence as of the Swap Premises Rent Commencement Date). If Tenant timely exercises a Quad III & IV Termination Option, then Tenant shall (y) surrender the applicable Premises to Landlord on the applicable surrender date in the condition required by the Amended Lease for surrendering Premises upon the expiration or earlier termination of the Term, and (z) if less than all of the Quad III & IV Premises are terminated by Tenant, demise the terminated Premises at its expense, such demising to be performed in accordance with Applicable Laws. Nothing in the foregoing clause (z) shall be deemed to require Tenant to perform any work to conform the terminated portion of the Premises with Applicable Laws (other than the demising thereof), except as may be expressly required by the Amended Lease.

           b. Additionally, Tenant shall be entitled to terminate the Lease with respect to the entire Quad I & II Premises (the “ Quad I & II Termination Option ” and, together with the Quad III & IV Premises Termination Options, the “ Swap Premises Termination Options ”) upon not less than eighteen (18) months’ prior written notice to Landlord, effective as of (a) June 30, 2014, upon payment to Landlord of Twenty-Nine and 45/100s Dollars ($29.45) per rentable square foot of terminated space, (b) December 31, 2015, upon payment to Landlord of Twenty and 02/100s Dollars ($20.02) per rentable square foot of terminated space, or (c) December 31, 2016 upon payment to Landlord of Ten and 50/100s Dollars ($10.50) per square foot of terminated space.

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      14. Emisphere Lease; Regeneron Sublease .

           a. Landlord represents and warrants that, as of the date hereof, Landlord and Emisphere have executed a lease termination agreement (the “ Emisphere Termination Agreement ”) that terminated the Emisphere Lease, except for those provisions that, by their express terms, survive the expiration or earlier termination thereof. Landlord shall use commercially reasonable efforts to enforce any obligations of Emisphere under the Emisphere Termination Agreement to the extent necessary to deliver the Swap Premises to Tenant on the Swap Premises Commencement Date. In addition, Landlord agrees that it shall provide copies of any cleaning records, surveys, swipes or other reports that it obtains from Emisphere as a result of the Emisphere Termination Agreement regarding the presence of Hazardous Materials in the Swap Premises.

           b. Landlord represents and warrants that, to its knowledge, as of the Execution Date, no Hazardous Materials exist in the Swap Premises in violation of Applicable Laws.

           c. Tenant hereby represents and warrants to Landlord that, with respect to the Regeneron Sublease, (a) Tenant has not prepaid to Emisphere more than one (1) month’s Rent, (b) Landlord shall have no liability for any security deposits or other amounts Tenant has paid to Emisphere, (c) Tenant shall look solely to Emisphere (not Landlord) for reimbursement of any prepaid Rent or return of any security deposit and (d) to its knowledge, there are no defaults, or conditions existing that with the passage of time may become a default, whether on behalf of Tenant or Emisphere.

      15. Condition of Premises . Tenant acknowledges that (a) it is in possession of and is fully familiar with the condition of that portion of the Swap Premises occupied by Tenant pursuant to the Regeneron Sublease, (b) is familiar with the condition of the remainder of the Swap Premises and, notwithstanding anything contained in the Amended Lease to the contrary, agrees to take the Swap Premises in its condition “as is” as of the Swap Premises Commencement Date; provided , however, that Landlord shall deliver the Swap Premises (other than the Regeneron Sublease Premises) in broom clean condition, taking into account that Tenant has entered into a separate agreement with Emisphere to have those certain items of Emisphere’s personal property set forth in the attached Exhibit C (the “ Emisphere FF&E ”) remain in the Swap Premises after the termination of the Emisphere Lease. Landlord shall have no liability with respect to the Emisphere FF&E, except to the extent that the same form a part of the Buildings or the Common Areas and Landlord would otherwise be required to repair and maintain the same pursuant to Section 19.1 of the Amended Lease, in which case Landlord shall be obligated to fulfill such repair and maintenance obligations. For the avoidance of doubt, Landlord and Tenant agree that: (y) Landlord shall have no liability for the existence or condition of the Emisphere FF&E as of the Swap Premises Commencement Date and (z) the following items being left in the Swap Premises by Emisphere shall constitute and form a part of the Building: base building HVAC systems, elevators, restrooms, and exhaust fans and stacks.

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      16. Hazardous Materials . From and after the Swap Premises Commencement Date, the second to last sentence of Section 40.1 of the Lease shall be deleted and replaced in its entirety with the following:

Landlord acknowledges that Tenant shall not be responsible for environmental conditions or contamination now or hereafter existing on, under or in the Entire Project, in the New Whole Building, in the New Multiple Tenant Building, in the Retained Premises, in the Additional Premises or in the Swap Premises caused by Landlord or tenants other than Tenant or by third parties in the Entire Project prior to the Execution Date or after such date, or for environmental conditions or contamination coming from off-site so long as Tenant, Tenant’s Affiliates, its permitted sublessees or its agents did not cause or contribute to such environmental conditions or contamination.

      17. PsychoGenics License Agreement . Landlord and Tenant acknowledge that Tenant, as an accommodation to Landlord, intends to enter into a license agreement with PsychoGenics Inc. in substantially the form attached hereto as Exhibit D (the “ PsychoGenics License Agreement ”). Landlord, Tenant and PsychoGenics shall, prior to execution of the PsychoGenics License Agreement, enter into a consent to the PsychoGenics License Agreement on Landlord’s customary form, a copy of which has been provided to Tenant prior to the date hereof.

      18. Broker . Each of Landlord and Tenant represents and warrants to the other that it has not dealt with any broker or agent in the negotiation for or the obtaining of this Amendment, other than Studley (“ Broker ”), and each agrees to indemnify, defend and hold the other harmless from any and all cost or liability for compensation claimed by any such broker or agent, other than Broker, employed or engaged by it or claiming to have been employed or engaged by it. Broker is entitled to a leasing commission in connection with this Amendment, and Landlord shall pay such commission to Broker pursuant to a separate agreement between Landlord and Broker, which commission shall be calculated on the rentable square footage of the Quad III & IV Premises only.

      19. No Default; Authority; Non-Contravention . Each of Landlord and Tenant represents, warrants and covenants that, to the best of its respective knowledge, neither Landlord nor Tenant is in default of any of its respective obligations under the Lease and no event has occurred that, with the passage of time or the giving of notice (or both), would constitute a default by either Landlord or Tenant thereunder. Each of Landlord and Tenant further represents, warrants and covenants that it has the full power and authority to execute, deliver and comply with the terms of this Amendment, and doing so will not conflict with or result in the violation of or default under any provision of any agreement or other instrument to which it is a party (including without limitation, with respect to Landlord, the Emisphere Lease and the Emisphere Termination Agreement).

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      20. Effect of Amendment . Except as modified by this Amendment, the Lease and all the covenants, agreements, terms, provisions and conditions thereof shall remain in full force and effect and are hereby ratified and affirmed. The covenants, agreements, terms, provisions and conditions contained in this Amendment shall bind and inure to the benefit of the parties hereto and their respective successors and, except as otherwise provided in the Lease, their respective assigns. In the event of any conflict between the terms contained in this Amendment and the Lease, the terms herein contained shall supersede and control the obligations and liabilities of the parties. From and after the date hereof, the term “Lease” as used in the Lease shall mean the Lease, as modified by this Amendment.

      21. Miscellaneous . This Amendment becomes effective only upon execution and delivery hereof by Landlord and Tenant. The captions of the paragraphs and subparagraphs in this Amendment are included solely for convenience and shall not be considered or given any effect in construing the provisions hereof. All exhibits hereto are incorporated herein by reference.

      22. Counterparts . This Amendment may be executed in one or more counterparts that, when taken together, shall constitute one original.

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]

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      IN WITNESS WHEREOF, Landlord and Tenant have hereunto set their hands as of the date and year first above written, and acknowledge that they possess the requisite authority to enter into this transaction and to execute this Amendment.

LANDLORD :

BMR-LANDMARK AT EASTVIEW LLC,
a Delaware limited liability company
 

By:   /s/ Kevin M Simonsen    
Name:   Kevin M. Simonsen    
Title:   VP, Real Estate Counsel    

TENANT :

REGENERON PHARMACEUTICALS, INC.,
a New York corporation
 

By:   /s/ Murray A. Goldberg    
Name:   Murray A. Goldberg    
Title:   Senior Vice President, Finance & Administration and Chief Financial Officer  


EXHIBIT A

SWAP PREMISES

[DIAGRAM]

 

 

 

 

 

 


EXHIBIT B

SURRENDER PREMISES

[Diagram ]

 

 

 

 

 

 


EXHIBIT C

EMISPHERE FF&E

Item   Qty.  
VWR double-door refrigerator   1  
Revco laboratory freezer   1  
Fisher Scientific Isotemp Plus, double door   1  
NuAire biological safety cabinet   2  
Ice machine   1  
Misc. stainless steel tables   14  
Mobile benches   15  
Bedding dump station   1  
Narcotics safe   1  
Flammable cabinets   10  
Corrosive & acid cabinets   3  
Cagewasher   1  
Lab casework, incl. fume hoods   throughout  
Cold room   1  
Downdraft table   1  
Animal watering system   1  
Liebert air handling system in data center   1  
Office furniture (not including chairs)   throughout  

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EXHIBIT D

FORM OF PSYCHOGENICS LICENSE AGREEMENT

LICENSE AGREEMENT

      This LICENSE AGREEMENT (this “ Agreement ”) is made as of this ___ day of April, 2009 (the “ Effective Date ”) by and between REGENERON PHARMACEUTICALS, INC. (“ Licensor ”) and PSYCHOGENICS INC. (“ Licensee ”).

BACKGROUND

      A. The Licensor is a tenant in the Building located at 765 Old Saw Mill River Road (the “ Building ”), located within the project the (“ Project ”) known as The Landmark at Eastview, in the Towns of Mt. Pleasant and Greenburgh, New York. As tenant, Licensor has entered into a lease (as amended, supplemented or modified, the “ Lease ”) with BMR-Landmark at Eastview, LLC (the “ Landlord ”) for certain premises within the Project and, as of the Effective Date, is entering into an amendment of the Lease (the “ Amendment ”) to lease from Landlord additional premises thereunder, comprising approximately 77,178 rentable square feet in the Building (the “ Leased Premises ”).

      B. Prior to the date hereof, Licensee occupied an approximately 2,275 rentable square foot portion of the Leased Premises as more precisely described and designated on Exhibit A attached hereto and made a part hereof (the “ License Area ”) pursuant to a sublease (the “ Sublease ”), by and between Licensee, as subtenant and Emisphere Technologies Inc., as sublessor, which Sublease has been terminated as of the date hereof. Licensee desires to continue to occupy the License Area and, in furtherance thereof, to obtain a license from the Licensor for the temporary occupancy of the License Area. Licensor is willing to grant a license to Licensee, all subject to the terms and conditions set forth in this Agreement.

TERMS

      NOW THEREFORE, in consideration of the mutual promises and agreements set forth herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Licensor hereby grants to Licensee a license (the “ License ”)to use the Licensed Area, subject to the following conditions:

      1. License Area . Licensor hereby grants to Licensee a non-transferable right and revocable license for the temporary use of the License Area. Nothing in this Agreement shall be construed to create any relationship between the parties other than that of licensor and licensee.

      2. Term . The term of the License (the “ Term ”) shall commence on May 1, 2009 (the “ Commencement Date ”) and shall expire on January 15, 2010, unless sooner terminated as provided in this Agreement (the “ Expiration Date ”). If Licensee remains in the License Area after the Expiration Date, then, in addition to all other remedies Licensor may have at law, in equity or under this Agreement, Licensee shall be deemed to be a licensee at sufferance only and the License Fee (as such term is defined in paragraph 4 below) shall be increased to two hundred percent (200%) of the License Fee (as such term is defined below). If Licensee fails to surrender and vacate the License Area upon the termination or expiration of this Agreement, then Licensee shall indemnify, defend and hold Licensor harmless from and against all loss and liability, including, without limitation, all costs to remove Licensee’s personal property and any claims made by any succeeding licensee, subtenant, or any other occupant founded on or resulting from such failure to surrender or vacate, including, without limitation, any attorneys’ fees, disbursements or other costs associated therewith.

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      3. Use . Licensee shall occupy and use the License Area during the term of this Agreement for the sole purposes of general, administrative, and executive use in rooms 721, 722 and 723, and laboratory use in Rooms 724, 726 and 727, and no other purpose without Licensor’s prior written consent.

      4. Fees .

           A. Licensee shall pay to Licensor a monthly license fee of Eight Thousand, Six Hundred Twenty-Six and 40/100 Dollars ($8,626.40) (the “ Fixed Fee ”), provided that the following additional amounts shall also be due hereunder: (i) for the payment due on September 1, 2009 an additional amount equal to One Thousand, Two Hundred Sixty-Three and 35/100 Dollars ($1,263.35), and (ii) for the payment due on January 1, 2009, an additional amount equal to One Hundred Ninety-Seven and 12/100 Dollars ($197.12) (such additional amounts, together with the Fixed Fee, the “ License Fee ”).

           B. The License Fee for the month of May, 2009 shall be paid by Licensee on the date of the full execution of this Agreement, and thereafter, the License Fee shall be payable in advance on a monthly basis during the Term, on the first day of each month commencing on June 1, 2009, without notice, demand, set-off, claim, or counterclaim, by check or money order, made payable to Licensor at Licensor’s address set forth below. If the first month or the last month of the Term shall be partial months, the License Fee for any such partial month shall be prorated on a daily basis.

      5. Security Deposit . Licensee has deposited with Licensor a security deposit in the amount of Twenty Thousand Dollars ($20,000) (the “ Security Deposit ”), which sum shall be held by Licensor as security for the faithful performance by Licensee of all of the terms, covenants and conditions of this Agreement to be kept and performed by Licensee during the term. If Licensee defaults with respect to any provision of this Agreement, including, but not limited to, any provision relating to the payment of the License Fee, then Licensor may (but shall not be required to) use, apply or retain all or any part of the Security Deposit for the payment of any License Fees or any other sum in default, or to compensate Licensor for any other loss or damage that Licensor may suffer by reason of Licensee's default. If any portion of the Security Deposit is so used or applied, then Licensee shall, within ten (10) days following demand therefor, deposit cash with Licensor in an amount sufficient to restore the Security Deposit to its original amount, and Licensee's failure to do so shall be a material breach of this Agreement. Licensor shall not be required to keep this Security Deposit separate from its general funds, and Licensee shall not be entitled to interest on the Security Deposit. In the event of bankruptcy or other debtor-creditor proceedings against Licensee, the Security Deposit shall be deemed to be applied first to the payment of License Fee and other charges due Licensor for all periods prior to the filing of such proceedings. If Licensee shall fully and faithfully perform every provision of this Agreement to be performed by it, then the Security Deposit, or any balance thereof, shall be returned to Licensee within thirty (30) days after the expiration or earlier termination of this Agreement.

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      6. Late Charges . Late payment by Licensee to Licensor of the License Fee or any other sums due shall cause Licensor to incur costs not contemplated by this Agreement, the exact amount of which shall be extremely difficult and impracticable to ascertain. Such costs include, but are not limited to, processing and accounting charges and late charges that may be imposed on Licensor by the terms of its Lease. Therefore, if any installment of License Fee or other fees due from Licensee pursuant to this Agreement is not received by Licensor within five (5) days after the date such payment is due, Licensee shall pay to Licensor an additional sum of six percent (6%) of the overdue amount as a late charge. The parties agree that this late charge represents a fair and reasonable estimate of the costs that Licensor shall incur by reason of late payment by Licensee. In addition to the late charge, amounts not paid when due shall bear interest from the fifth (5 th ) day after the date due until paid at the lesser of (a) twelve percent (12%) per annum or (b) the maximum rate permitted by applicable laws.

      7. Common Areas . Licensee shall have the right, subject to the provisions of this License, to use, without additional charge, on a non-exclusive basis, the common areas leased by Licensor pursuant to the Lease and the areas of the Leased Premises specified as “common areas” in the attached Exhibit A . Licensee shall be responsible for any and all damage caused by Licensee or its employees, agents and invitees in or to such common areas. Licensee shall not permit any of its files, furniture, personal property or other matters to be placed in such common areas, and shall keep such common areas free of debris and refuse. In addition to the foregoing, Licensee shall be entitled to access to the portion of the Leased Premises specified as “restricted access area” in the attached Exhibit A . Access to such restricted access areas shall be permitted only if (i) a representative of Licensor is present at all times during such access, and (ii) such access is solely for the purpose of allowing Licensee to use the elevator. Licensee agrees that it shall make available a representative for the purpose of such access during reasonable business hours and upon one (1) business days’ advance notice, provided that Licensor shall use reasonable efforts (but shall not be obligated) to provide a representative on shorter notice, should exigent circumstances require the same.

      8. Licensee’s Maintenance; No Improvements . Licensee shall at all times maintain the License Area, and any equipment or property used or installed by Licensee in the License Area, in good, clean and safe condition, free of all debris and trash. Licensee shall not make any improvements, alterations or changes of any kind to the License Area without Licensor’s prior written approval. In addition to all of Licensor’s remedies under this Agreement, if (a) Licensee does not maintain the License Area as required under this Section or (b) repairs or replacement of any portion of the License Area is made necessary by any act, omission or negligence of Licensee or its agents, employees or invitees, then Licensor may make such repairs or provide such maintenance without liability to Licensee for any loss or damage to Licensee or its merchandise, fixtures or other property, or to Licensee’s business by reason of such repairs or maintenance. Further, upon completion of any such repairs or maintenance, Licensee shall pay upon demand, as additional License Fee, one hundred percent of Licensor’s costs for making such repairs or providing such maintenance, evidenced by invoices, together with Licensor’s administrative costs related thereto, which administrative costs the parties agree to be an amount equal to twenty percent (20%) of the total cost of such repair. Licensee shall not make any changes, alterations, installations, additions or improvements to the License Area without first obtaining the written consent of Licensor, which consent may be granted or withheld in the sole discretion of Licensor.

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     9. Hazardous Materials . Licensee shall not cause or permit any Hazardous Materials (as hereinafter defined) to be brought upon, kept or used in or about the License Area, the Building or the Project in violation of Applicable Laws (as hereinafter defined) by Licensee, its agents, employees, contractors or invitees. If Licensee breaches such obligation, or if the presence of Hazardous Materials as a result of such a breach results in contamination of the License Area, the Leased Premises, the Building, the Project or any adjacent property, or if contamination of the License Area, the Leased Premises, the Building, the Project or any adjacent property by Hazardous Materials otherwise occurs during the Term or any extension or renewal hereof or holding over hereunder due to such breach by Licensee, then Licensee shall indemnify, save, defend and hold Licensor, its agents and contractors harmless from and against any and all losses, costs, damages or judgments (including sums paid in settlement, attorneys’ fees, consultants’ fees and experts’ fees) that arise during or after the Term as a result of such breach or contamination. This indemnification of Licensor by Licensee includes, without limitation, costs incurred in connection with any investigation of site conditions or any cleanup, remedial, removal or restoration work required by any federal, state, regional, local or municipal governmental authority, agency or subdivision (collectively, the “ Governmental Authorities ”) because of Hazardous Materials present in the air, soil or groundwater above, on or under the License Area, the Leased Premises, the Building, the Project or any adjacent property. Without limiting the foregoing, if the presence of any Hazardous Materials in, on, under or about the License Area, the Leased Premises, the Building, the Project or any adjacent property caused or permitted by Licensee results in any contamination of the License Area, the Leased Premises, the Building, the Project or any adjacent property, then Licensee shall promptly take all actions at its sole cost and expense as are necessary to return the License Area, the Leased Premises, the Building, the Project and any adjacent property to their respective condition existing prior to the time of such contamination; provided that Licensor’s written approval and the written approval of Landlord of such action shall first be obtained, which approval Licensor shall not unreasonably withhold; and provided, further, that it shall be reasonable for Licensor to withhold its consent if (i) Landlord withholds such consent, or (ii) such actions could have a material adverse long-term or short-term effect on the License Area, the Leased Premises, the Building, the Project or any adjacent property. Licensor acknowledges that Licensee shall not be responsible for environmental conditions or contamination now or hereafter existing on, under or in the License Area, the Leased Premises, the Building or the Project, or for environmental conditions or contamination coming from off site, to the extent the same was not caused or contributed to by Licensee, Licensee’s affiliates, or their agents. Licensee’s obligations under this paragraph shall survive the Expiration Date. During any period of time needed by Licensee or Licensor after the Expiration Date to complete the removal from the License Area of any such Hazardous Materials, Licensee shall continue to pay License Fee for the affected area(s) in accordance with this Agreement, which License Fee shall be pro-rated daily. As used herein, the term “Hazardous Material” means any hazardous or toxic substance, material or waste that is so designated by Applicable Laws and/or becomes regulated by any Governmental Authority.

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      10. Damage and Repairs . Any damage, destruction, graffiti or debris around, to, or on the License Area, the Leased Premises, the Building or the Project caused by Licensee, its agents, employees or invitees shall be Licensee’s responsibility. If Licensee fails to repair, clean or replace any such damage or debris within two (2) days of Licensor’s demand to do so, then Licensor may make such repairs, clean-up or replacement. Upon completion of any such repairs, clean-up or replacement, Licensee shall pay upon demand, as additional License Fee, one hundred percent (100%) of Licensor’s costs for making such repairs or providing such clean-up or replacement, evidenced by invoices, together with Licensor’s administrative costs related thereto, which administrative costs the parties agree to be an amount equal one twenty percent (20%) of the total cost of such repairs, clean-up or replacement. Any damage to the License Area caused directly by Licensor shall be Licensor’s responsibility to repair and maintain.

      11. Fire and Casualty Damage . If the License Area is rendered partially or wholly untenantable by fire or other casualty, this License shall terminate as to such affected License Area as of the date of such fire or casualty as if that date had been originally fixed in this Agreement for the Expiration Date for the affected License Area.

      12. Transfer and Assignment . Licensee shall have no right to assign or transfer this License or rights arising under this License. Any assignment by operation of law or otherwise shall be deemed a prohibited assignment hereunder. In the event of a transfer or such assignment, this License shall automatically terminate and thereafter shall be considered null and void.

      13. Inspections . Provided that Licensor uses reasonable efforts not to interfere with Licensee’s use of the Licensed Area, Licensor shall have the right to enter the License Area at any reasonable time for the following purposes: (a) to ascertain the condition of the License Area; (b) to determine whether Licensee is diligently fulfilling Licensee’s responsibilities under this License, or; (c) to do any other act or thing which Licensor deems reasonably necessary to preserve the Licensed Area or to comply with its obligations hereunder or under the Lease.

      14. Termination of Agreement . On the Expiration Date, Licensee shall (a) return the License Area to Licensor in good, sanitary and satisfactory condition and (b) remove its equipment and any other of its property from the License Area, the Leased Premises, the Building and the Project, unless otherwise agreed to by Licensor. Licensee acknowledges and agrees that it shall reimburse Licensor upon demand for one hundred percent (100%) of Licensor’s costs to repair any damage caused by such removal by Licensee, evidenced by invoices, together with Licensor’s administrative costs related thereto, which administrative costs the parties agree to be an amount equal to twenty percent (20%) of the total costs such repair. Any equipment or property not removed within two (2) days of the date of termination or expiration of this Agreement shall be deemed abandoned by Licensee, and Licensor shall have the right, but not the obligation, to remove and dispose of such abandoned equipment or property at Licensee’s sole cost and risk, and Licensor shall be entitle to Licensor’s administrative costs related thereto, which administrative costs the parties agree to be an amount equal to twenty percent (20%) of the total costs such removal and disposal.

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      15. Personal Property Taxes . Licensee shall pay all sales and use taxes, if any, imposed as a result of Licensee’s business conducted on the License Area and all taxes assessed against property of Licensee situated thereon during the Term.

      16. Compliance with Laws; Liens . Licensee shall at all times observe and comply with all federal, state and local laws, ordinances, rules, regulations and code requirements (collectively, the “ Applicable Laws ”). Licensee shall obtain all permits and licenses for the operation of its business at the Building or its use or occupancy of the License Area and shall comply with all current and future rules and regulations of Landlord for tenants or licensees of the Leased Premises, the Building, or the Project. Licensee shall at all times maintain sufficient supervision and control of its employees and invitees. Licensee shall not (a) obstruct the free flow of pedestrian or vehicular traffic in any area of the Property, (b) harm the License Area, commit any waste, create a nuisance or make any use of the License Area that is offensive or (c) act or fail to act in any manner that could result in injury or harm to any person in or about the Property. Licensee shall, and shall instruct its employees, agents and invitees to, act in accordance with Landlord’s rules and regulations as they may be promulgated by Landlord from time to time, provided Licensee is given copies thereof. Licensee shall keep the License Area free and clear of any mechanics’ liens and other liens. Nothing in this Agreement shall be construed as consent on the part of Licensor to subject the Leased Premises, the Building or the Project to any lien or liability under the lien laws of the State of New York.

      17. Insurance . Licensee shall, at all times during the Term, and at its own cost and expense, procure and continue in force insurance in the amounts and on the terms set forth in this Section 17. Said insurance shall name Landlord and Licensor as additional insureds and shall be subject to reasonable approval of Licensor and Landlord. Licensee shall obtain from the insurance companies, or cause the insurance companies to furnish, certificates of coverage. The delivery of proof of such insurance is a condition precedent to this Agreement. All certificates of insurance shall provide that the insurer will provide Licensor twenty (20) days notice of cancellation of or any change of said policies by certified mail, return receipt requested or via established overnight courier. In the event Licensee shall fail to comply with any or all of the provisions of this paragraph, Licensor is hereby authorized to purchase said insurance and charge Licensee for the premiums of same and any other costs incurred thereon, and such sums shall be deemed additional License Fee and may be collected by Licensor as such in the next ensuing installment of License Fee. At a minimum, Licensee shall procure Comprehensive General Liability Insurance, in the broadest form available in New York State, with a minimum amount of $3,000,000 combined single limit and which shall contain personal injury liability, fire damage liability on real property (with sublimits for such events in amounts no less than the minimum amount of $3,000,000), Workers Compensation Insurance, and such other insurance as was required pursuant to the Sublease.

      Licensee agrees to use commercially reasonable efforts to include in each of its policies insuring against loss, damage or destruction by fire or other casualty, a waiver of the insurer’s right of subrogation against Licensor. If such waiver shall not be, or shall cease to be, obtainable without additional charge, or is otherwise not available at all, Licensee shall promptly so notify Licensor. In such case, if the other party shall so elect and shall pay the insurer’s additional charge therefore, such waiver shall be included in the policy.

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      18. Consent of Landlord . This Agreement is subject to the written consent of Landlord (the “ Consent ”), which consent shall be evidenced by Landlord’s customary form of consent, with such changes as may be agreed to by the parties thereto. In the event Landlord rejects this Agreement, neither party shall have any rights against the other, and this Agreement shall be deemed null and void.

      19. Utilities, Services . Licensor shall use commercially reasonable efforts to cause Landlord to furnish the License Area with all services required by the Lease to the extent Licensee was receiving the same pursuant to the Sublease. Licensor shall not be liable to Licensee for any loss, injury or damage to persons or property caused by or resulting from any variation, failure, or interruption of any services or utilities to be provided by Landlord under the Lease due to any cause whatsoever. Licensee’s use or occupancy of the License Area shall not in any manner (i) cause the design loads for the Building or the systems providing exhaust, heating, cooling, ventilation, electrical, life safety, water, sewer or other utility or safety services to be exceeded or (ii) adversely affect the Building or the operation of said systems in the License Area, the Leased Premises or the Building or cause deterioration or damage to the Building or such systems.

      20. Access and Parking . Licensee and its agents, employees and invitees may have access to the License Area during its above term twenty-four (24) hours a day. Licensee agrees that it shall not park in any reserved spot on the Property or in front of any roll access/loading doors to the other buildings. Licensee must also keep a fire lane available around the Building. Any costs or liability associated with enforcing this parking access shall be Licensee’s or violator’s sole responsibility.

      21. Default . Any failure by Licensee to perform any term or condition of this Agreement shall constitute a default under this Agreement and, in such event, Licensor may exercise any remedy available to it under this Agreement, at law or in equity. Without limiting the foregoing, in the event any such default is not cured within forty-eight (48) hours of Licensor’s notice to Licensee thereof, Licensor may, at its option, terminate this Agreement and revoke the license granted hereby. Licensee shall reimburse Licensor for any and all costs and expenses (including attorneys’ fees and costs) that Licensor incurs in connection with enforcing Licensee’s obligations under this Agreement.

      22. Limitation of Recovery; Waiver . There shall be no personal liability of Licensor with respect to any of the terms of this Agreement. In the event of any breach or default by Licensor under this Agreement, Licensee shall look solely to the equity of Licensor in the Building for satisfaction of Licensee’s remedies. Licensee releases and waives all right of recovery that it might otherwise have against Licensor, or other tenants or licensees of the Building, and their respective agents and employees, by reason of any loss or damage resulting from any recovery, claim, action or cause of action against Licensor, damage or injury or other occurrence no matter how caused, to the extent the same is either covered by Licensee’s insurance (assuming no deductible) or would have been covered had Licensee complied with the requirements of this Agreement.

      23. Entire Agreement . Other than Licensee’s lease agreement with Licensor, this Agreement contains the entire agreement between the parties and all prior understandings and agreements between the parties are merged into this Agreement. This Agreement may be modified only by a writing signed by both of the parties hereto.

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      24. Acceptance of License Area . By taking possession of the License Area, Licensee shall be deemed to have inspected the License Area and accepted the License Area “as is” in its present condition. Licensee acknowledges and agrees that neither Licensor, nor any employee, agent nor representative of Licensor, has made any representation or warranty, express or implied, of any kind as to the condition of the License Area or its suitability for Licensee’s proposed use. Licensee further acknowledges and agrees that Licensor has no obligation to improve, maintain or repair the License Area unless said obligation is expressly set forth in this Agreement.

      25. Waiver of Responsibility; Indemnification . Licensee shall assume liability for, and shall indemnify, defend and hold harmless Licensor and its shareholders, members, officers, directors, employees, contractors, subcontractors, agents, customers, mortgagees, lenders and invitees from and against any and all liabilities, obligations, losses, fines, damages, claims, demands, judgments, penalties, expenses (including, without limitation, attorneys’ fees and costs) arising, directly or indirectly, from (a) any labor dispute involving Licensee or its contractors or agents, (b) the use or enjoyment of the License Area or the Project by Licensee or its contractors, agents, employees and/or customers or invitees, (c) injury to or death of any person or persons, or damage to or destruction of any property (including, without limitation, the cost of investigation, removal or remedial action and disposal of any Hazardous Materials) occurring in, on or about the License Area or (d) a breach of this Agreement by Licensee or any act or omission of Licensee or its agents, employees or contractors (“ Claims ”). Notwithstanding anything to the contrary in this Section, nothing in this Section shall relieve Licensor from responsibility for its proportionate share of fault attributable to its negligence in causing any Claims. To the maximum extent permitted by law, Licensee’s activities on and use of the License Area and the Property shall be at Licensee’s sole risk. Licensee’s obligations under this Section shall survive the Expiration Date.

      26. Representations and Warranties .

      A. Licensee represents and warrants to Licensor that, as of the Effective Date, the Sublease has been terminated and Licensee waives all rights of possession and occupancy of any portion of the Leased Premises pursuant thereto.

      27. Licensor hereby represents and warrants to Licensee that (i) as of the Effective Date, the Lease and the Amendment are in full force and effect and grant to Licensor a leasehold interest in and to the Leased Premises, and (ii) the Amendment does not materially modify the Lease with respect to Licensee's obligations under the Consent. Licensor shall provide Licensee with a fully-executed copy of the Amendment within five (5) business days of the date on which the same is made a part of the public record.

      28. Signage . Licensee is responsible for all of Licensee’s signage. All signage must be pre-approved in writing by Licensor and Landlord and hand-written signs are not permitted.

      29. Miscellaneous.

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      A. Whenever under this License Agreement provision is made for any demand, notice, requests or declaration of any kind, or where it is deemed desirable or necessary by either party to give or serve any such notice, demand, request or declaration to the other party, it shall be in writing and such notices shall be deemed given when personally delivered, or the next business day after delivery to a reputable overnight delivery service such as Federal Express or United Parcel Service to the following addresses:

To the Licensor at:

REGENERON PHARMACEUTICALS, INC.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Attn: General Counsel

with copy to:

REGENERON PHARMACEUTICALS, INC.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Attn: Joanne Deyo, Vice President Facilities

To Licensee at:

PSYCHOGENICS INC.
765 Old Saw Mill River Road
Tarrytown, New York 10591
Attn: William Fasnacht, CFO/COO

      B. The terms, provisions and covenants and conditions contained in this License shall apply to, inure to the benefit of, and be binding upon, the parties hereto and upon their respective heirs, legal representatives, successors and permitted assigns.

      C. All obligations of Licensee hereunder not fully performed as of the Expiration Date shall survive the Expiration Date.

      D. Licensor and Licensee agree to indemnify the other for any claims made by any other brokers arising under the acts of such party.

      E. Licensee represents that it has used no broker in connection with this transaction.

      F. This Agreement may be signed in counterparts; each, when taken together, shall constitute one instrument.

      G. If any term, provision or condition of this License shall, to any extent, be finally adjudicated to be invalid or unenforceable, the remainder of this License (or the application of such term, provision or condition to persons or circumstances other than those in respect of which it is finally adjudicated to be invalid or unenforceable) shall not be affected thereby and each and every other term, provision and condition of this License shall be valid and enforceable to the fullest extent permitted by law.

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      H. Licensee shall pay to Licensor all costs and expenses, including reasonable attorneys’ fees and costs, incurred by Licensor in connection with any action between Licensor and Licensee arising out of this License or incurred by Licensor as a result of any litigation to which Licensor becomes a party as a result of this License or Licensee’s use and occupancy of the Licensed Area or any portion thereof.

      I. Licensor and Licensee waive trial by jury in the event of any action, proceeding or counterclaim brought by either Licensor or Licensee against the other in connection with this License.

      J. If Licensee fails timely to perform any of its duties under this License, Licensor shall have the right (but not the obligation), after the expiration of any grace or notice and cure period elsewhere under this License expressly granted to Licensee for the performance of such duty, to perform such duty on behalf and at the expense of Licensee (but only upon prior notice to Licensee), and all sums expended or expenses incurred by Licensor in performing such duty together with Licensor’s administrative costs related thereto, which administrative costs the parties agree to be an amount equal to twenty percent (20%) of Licensor’s cost of performing such duty, shall be deemed to be additional License Fee under this License and shall be due and payable upon demand by Licensor.

      K. This Agreement shall be governed by, and construed and interpreted in accordance with New York law, without regard to conflicts of law principles.

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      IN WITNESS WHEREOF, Licensor and Licensee have hereunto set their hands as of the date and year first above written, and acknowledge that they possess the requisite authority to enter into this transaction and to execute this Agreement.

LICENSOR :

REGENERON PHARMACEUTICALS, INC.,
a New York corporation

By:      
Name:   Murray A. Goldberg  
Title:   Senior Vice President,  
  Finance & Administration  
  and Chief Financial Officer  

LICENSEE :

PSYCHOGENICS INC.,
a Delaware corporation

By:      
Name:   William Fasnacht  
Title:   CFO/COO  


EXHIBIT A

LICENSE AREA

[Diagram ]

 

 

 

 

 

 


Exhibit 31.1

Certification of CEO Pursuant to
Rule 13a-14(a) under the Securities Exchange Act
of 1934, as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002

I, Leonard S. Schleifer, certify that:

1.         I have reviewed this quarterly report on Form 10-Q of Regeneron Pharmaceuticals, Inc.;  
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
  a)       Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
Date: April 30, 2009   /s/ LEONARD S. SCHLEIFER  
  Leonard S. Schleifer, M.D., Ph.D.  
  President and Chief Executive Officer  


Exhibit 31.2

Certification of CFO Pursuant to
Rule 13a-14(a) under the Securities Exchange Act
of 1934, as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002

I, Murray A. Goldberg, certify that:

1.         I have reviewed this quarterly report on Form 10-Q of Regeneron Pharmaceuticals, Inc.;  
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
  a)       Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
Date: April 30, 2009   /s/ MURRAY A. GOLDBERG  
  Murray A. Goldberg
  Senior Vice President, Finance & Administration,
  Chief Financial Officer, Treasurer, and
  Assistant Secretary


Exhibit 32

Certification of CEO and CFO Pursuant to
18 U.S.C. Section 1350,
As Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Quarterly Report of Regeneron Pharmaceuticals, Inc. (the "Company") on Form 10-Q for the quarterly period ended March 31, 2009 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), Leonard S. Schleifer, M.D., Ph.D., as Chief Executive Officer of the Company, and Murray A. Goldberg, as Chief Financial Officer of the Company, each hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to the best of his knowledge, that:

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

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

/s/ LEONARD S. SCHLEIFER  
Leonard S. Schleifer, M.D., Ph.D.  
Chief Executive Officer  
April 30, 2009  
    
 
 
/s/ MURRAY A. GOLDBERG  
Murray A. Goldberg  
Chief Financial Officer  
April 30, 2009