UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended March 31, 2011
OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from ________ to _________
Commission file number: 001-34637
ANTHERA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
(State or Other Jurisdiction of Incorporation or Organization)
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20-1852016
(I.R.S. Employer Identification No.)
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25801 Industrial Boulevard, Suite B
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Hayward, California
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94545
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(Address of Principal Executive Offices)
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(Zip Code)
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(510) 856-5600
(Registrants 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
þ
No
o
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
o
No
þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
þ
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes
o
No
þ
As of May 4, 2011, the number of outstanding shares of the registrants common stock, par
value $0.001 per share, was 32,974,267.
ANTHERA PHARMACEUTICALS, INC.
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2011
INDEX
2
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ANTHERA PHARMACEUTICALS, INC
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(unaudited)
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March 31,
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December 31,
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2011
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2010
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ASSETS
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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66,557,789
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$
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40,029,972
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Short term investments
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11,982,185
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23,350,922
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Prepaid expenses and other current assets
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1,231,693
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1,864,883
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Total current assets
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79,771,667
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65,245,777
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Property and equipment net
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1,325,478
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17,285
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Debt issuance costs
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348,230
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TOTAL
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$
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81,445,375
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$
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65,263,062
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LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)
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CURRENT LIABILITIES:
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Accounts payable
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$
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7,664,486
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$
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3,791,693
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Accrued
clinical studies
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8,159,476
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3,136,786
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Accrued liabilities
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475,473
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467,817
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Accrued payroll and related costs
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471,276
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609,086
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Total current liabilities
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16,770,711
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8,005,382
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Notes payable net of discount
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23,719,801
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Total liabilities
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40,490,512
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8,005,382
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Commitments and Contingencies
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Stockholders equity (deficit)
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Preferred stock, $0.001 par value, 5,000,000 shares
authorized, 0 shares issued and outstanding as of
March 31, 2011 and December 31, 2010
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Common stock, $0.001 par value, 95,000,000 shares
authorized; 32,909,914 and 32,853,032 shares issued
and outstanding as of March 31, 2011 and December
31, 2010, respectively
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32,909
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32,853
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Additional paid-in capital
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164,839,927
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162,919,216
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Accumulated comprehensive income (loss)
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291,499
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(50,622
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)
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Deficit accumulated the during the development stage
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(124,209,472
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)
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(105,643,767
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)
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Total stockholders equity
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40,954,863
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57,257,680
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TOTAL
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$
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81,445,375
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$
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65,263,062
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See accompanying notes to condensed financial statements.
3
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
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Cumulative
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Period from
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September 9,
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2004
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(Date of
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Inception) to
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Three Months Ended March 31,
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March 31,
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2011
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2010
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2011
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OPERATING EXPENSES:
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Research and development
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$
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16,316,758
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$
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5,241,814
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$
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97,097,481
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General and administrative
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2,339,882
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1,224,110
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18,558,298
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Total operating expenses
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18,656,640
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6,465,924
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115,655,779
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LOSS FROM OPERATIONS
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(18,656,640
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)
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(6,465,924
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)
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(115,655,779
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)
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OTHER INCOME (EXPENSE):
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Other expense and interest income, net
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90,935
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(841,377
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)
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(448,658
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)
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Mark-to-market adjustment of warrant liability
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|
|
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|
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(3,796,491
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)
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(3,796,491
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)
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Beneficial conversion features
|
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|
|
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(4,308,544
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)
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Total other income (expense)
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90,935
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(4,637,868
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)
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(8,553,693
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)
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NET LOSS
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$
|
(18,565,705
|
)
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$
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(11,103,792
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)
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$
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(124,209,472
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)
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Net loss per share basic and diluted
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$
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(0.56
|
)
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$
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(0.83
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)
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Weighted-average number of shares used in per
share calculation basic and diluted
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32,895,152
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13,344,231
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|
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|
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See accompanying notes to condensed financial statements.
4
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
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|
|
|
|
|
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September 9,
|
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
(Date of
|
|
|
|
|
|
|
|
|
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|
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Inception) to
|
|
|
|
Three Months Ended March 31,
|
|
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March 31,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
CASH FLOW FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(18,565,705
|
)
|
|
$
|
(11,103,792
|
)
|
|
$
|
(124,209,472
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
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|
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Depreciation
|
|
|
4,556
|
|
|
|
3,270
|
|
|
|
94,164
|
|
Amortization of premium/(discount) on short-term investments
|
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74,061
|
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|
|
|
|
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45,929
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Realized loss on short-term investments
|
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|
|
|
|
|
|
|
|
|
8,682
|
|
Realized gain from disposal of property and equipment
|
|
|
|
|
|
|
|
|
|
|
(214
|
)
|
Stock-based compensation expense
|
|
|
587,698
|
|
|
|
52,616
|
|
|
|
1,924,852
|
|
Issuance of common stock for consulting service
|
|
|
|
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|
|
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41,366
|
|
Issuance of preferred and common stock for service and license fee
|
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|
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3,500,000
|
|
|
|
5,750,000
|
|
Issuance of preferred stock in lieu of interest payment
|
|
|
|
|
|
|
173,194
|
|
|
|
330,575
|
|
Beneficial conversion feature
|
|
|
|
|
|
|
|
|
|
|
4,308,544
|
|
Amortization of discount on convertible promissory notes
|
|
|
|
|
|
|
540,993
|
|
|
|
677,715
|
|
Amortization of discount on term loan
|
|
|
15,095
|
|
|
|
|
|
|
|
15,095
|
|
Amortization of debt issuance costs
|
|
|
2,788
|
|
|
|
227,955
|
|
|
|
310,387
|
|
Mark-to-market adjustment on warrant liability
|
|
|
|
|
|
|
3,796,491
|
|
|
|
3,795,776
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other assets
|
|
|
633,190
|
|
|
|
(339,427
|
)
|
|
|
(1,231,695
|
)
|
Accounts payable
|
|
|
2,566,210
|
|
|
|
(103,890
|
)
|
|
|
6,615,264
|
|
Accrued
clinical studies
|
|
|
5,022,690
|
|
|
|
(242,336
|
)
|
|
|
8,159,476
|
|
Accrued liabilities
|
|
|
(56,626
|
)
|
|
|
(34,662
|
)
|
|
|
404,343
|
|
Accrued payroll and related costs
|
|
|
(137,810
|
)
|
|
|
25,922
|
|
|
|
471,276
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(9,853,853
|
)
|
|
|
(3,503,666
|
)
|
|
|
(92,487,937
|
)
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment purchases
|
|
|
|
|
|
|
(5,746
|
)
|
|
|
(107,079
|
)
|
Proceeds from disposal of property and equipment
|
|
|
|
|
|
|
|
|
|
|
400
|
|
Purchase of short-term investments
|
|
|
(1,996,000
|
)
|
|
|
|
|
|
|
(41,745,256
|
)
|
Proceeds from sale of short-term investments
|
|
|
13,318,014
|
|
|
|
|
|
|
|
29,850,146
|
|
Restricted cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
11,322,014
|
|
|
|
(5,746
|
)
|
|
|
(12,001,789
|
)
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of convertible notes
|
|
|
|
|
|
|
|
|
|
|
26,560,000
|
|
Proceeds from issuance of term loan
|
|
|
25,000,000
|
|
|
|
|
|
|
|
25,000,000
|
|
Payment of debt issuance costs
|
|
|
(291,500
|
)
|
|
|
(2,572
|
)
|
|
|
(599,099
|
)
|
Net proceeds from issuance of preferred stock
|
|
|
|
|
|
|
|
|
|
|
32,210,278
|
|
Payment of
financing costs for initial public and private offering
|
|
|
(13,818
|
)
|
|
|
(850,416
|
)
|
|
|
(3,533,957
|
)
|
Proceeds from issuance of common stock
|
|
|
|
|
|
|
57,202,972
|
|
|
|
90,789,015
|
|
Proceeds from issuance of common stock pursuant to employee stock purchase
plan
|
|
|
|
|
|
|
|
|
|
|
81,226
|
|
Proceeds from exercise of stock options
|
|
|
50,192
|
|
|
|
17,653
|
|
|
|
390,236
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
24,744,874
|
|
|
|
56,367,637
|
|
|
|
170,897,699
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash
|
|
|
314,782
|
|
|
|
|
|
|
|
149,816
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
26,527,817
|
|
|
|
52,858,225
|
|
|
|
66,557,789
|
|
CASH AND CASH EQUIVALENTS Beginning of period
|
|
|
40,029,972
|
|
|
|
3,803,384
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS End of period
|
|
$
|
66,557,789
|
|
|
$
|
56,661,609
|
|
|
$
|
66,557,789
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH DISCLOSURES OF CASH FLOW INFORMATION:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
|
|
|
$
|
|
|
|
$
|
15,229
|
|
|
|
|
|
|
|
|
|
|
|
Taxes paid
|
|
$
|
|
|
|
$
|
10,136
|
|
|
$
|
52,746
|
|
|
|
|
|
|
|
|
|
|
|
NONCASH INVESTING AND FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible promissory notes and accrued interest into
common stock, Series A-2 convertible preferred stock and Series B-2
convertible preferred stock
|
|
$
|
|
|
|
$
|
13,709,918
|
|
|
$
|
27,200,493
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial conversion feature
|
|
$
|
|
|
|
$
|
|
|
|
$
|
4,308,544
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized debt discount charged to equity in conjunction with conversion
of promissory notes into common stock
|
|
$
|
|
|
|
$
|
185,833
|
|
|
$
|
185,883
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of warrant and derivative liabilities to additional
paid-in capital
|
|
$
|
|
|
|
$
|
406,130
|
|
|
$
|
406,130
|
|
|
|
|
|
|
|
|
|
|
|
Issuance costs charged to equity
|
|
$
|
|
|
|
$
|
3,021,966
|
|
|
$
|
3,564,932
|
|
|
|
|
|
|
|
|
|
|
|
Accrued and deferred financing and debt issuance costs
|
|
$
|
78,700
|
|
|
$
|
982,504
|
|
|
$
|
78,700
|
|
|
|
|
|
|
|
|
|
|
|
Liability accrued for equipment purchases
|
|
$
|
1,312,748
|
|
|
$
|
|
|
|
$
|
1,312,748
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed financial statements.
5
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES
Organization
Anthera Pharmaceuticals, Inc. (the Company or Anthera) was incorporated on September 9,
2004 in the state of Delaware. During 2006, the Company opened its headquarters in San Mateo,
California, and subsequently moved to Hayward, California. Anthera is a biopharmaceutical company
focused on developing and commercializing therapeutics to treat serious diseases associated with
inflammation, including cardiovascular and autoimmune diseases. Two of the Companys primary
product candidates, varespladib and A-001, are inhibitors of the family of human enzymes known as
secretory phospholipase A
2
, or sPLA
2
. The Companys other primary product
candidate, A-623, targets elevated levels of B-cell activating factor, or BAFF. The Companys
activities since inception have consisted principally of acquiring product and technology rights,
raising capital, and performing research and development. Accordingly, the Company is considered to
be in the development stage as of March 31, 2011. Successful completion of the Companys
development programs and, ultimately, the attainment of profitable operations are dependent on
future events, including, among other things, its ability to access potential markets; secure
financing; develop a customer base; attract, retain and motivate qualified personnel; generate
revenues; and develop strategic alliances. Although management believes that the Company will be
able to successfully fund its operations, there can be no assurance that the Company will be able
to do so or that the Company will ever operate profitably.
From September 9, 2004 (Date of Inception) through March 31, 2010, the Company had an
accumulated a deficit of $124.2 million. During the three months ended March 31, 2011, the Company
incurred a net loss of $18.6 million and had negative cash flows from operations of $9.9 million.
The Company expects to continue to incur substantial losses and negative cash flows over the next
several years during its clinical development phase. To fully execute its business plan, the
Company will need to complete certain research and development activities and clinical studies.
Further, the Companys product candidates will require regulatory approval prior to
commercialization. These activities may span many years and require substantial expenditures to
complete and may ultimately be unsuccessful. Any delays in completing these activities could
adversely impact the Company. The Company plans to meet its capital requirements primarily through
issuances of equity securities, debt financing, and in the longer term, revenue from product sales.
Failure to generate revenue or raise additional capital would adversely affect the Companys
ability to achieve its intended business objectives.
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in conformity
with accounting principles generally accepted in the United States (U. S. GAAP) for interim
financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not contain all of the information and footnotes required for complete
financial statements. In the opinion of management, the accompanying unaudited condensed financial
statements reflect all adjustments, which include only normal recurring adjustments necessary to
present fairly the Companys interim consolidated financial information. The results for the three
months ended March 31, 2011 are not necessarily indicative of the results to be expected for the
year ending December 31, 2011 or for any other period. The condensed balance sheet as of December
31, 2010 has been derived from the audited financial statements as of that date but it does not
include all of the information and notes required by U.S. GAAP. The accompanying unaudited
condensed financial statements and notes thereto should be read in conjunction with the audited
financial statements and notes thereto included in our Annual Report on Form 10-K for the year
ended December 31, 2010, filed with the Securities and Exchange Commission (SEC) on March 7,
2011.
Significant Accounting Policies
There have been no changes in our significant accounting policies for the three month period
ended March 31, 2011, as compared to the significant accounting policies described in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2010.
Use of Estimates
The preparation of these financial statements in conformity with U.S. GAAP requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and
related disclosures. On an ongoing basis, management evaluates its estimates, including critical
accounting policies or estimates related to clinical trial accruals, our tax provision and
stock-based compensation. The Company bases its estimates on historical experience and on various
other market specific and other relevant
6
assumptions that it believes to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results may differ significantly from these
estimates.
2. NET LOSS PER SHARE
Basic net loss attributable to common stockholders per share is computed by dividing income
available to common stockholders by the weighted-average number of common shares outstanding during
the period. Shares issued during the period and shares reacquired during the period are weighted
for the portion of the period that they were outstanding. The computation of diluted net loss per
share is similar to the computation of basic net loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the
dilutive potential common shares had been issued. In addition, in computing the dilutive effect of
convertible securities, the numerator is adjusted to add back any convertible preferred dividends
and the after-tax amount of interest recognized in the period associated with any convertible debt.
The numerator also is adjusted for any other changes in income or loss that would result from the
assumed conversion of those potential common shares, such as profit-sharing expenses. Diluted net
loss per share is identical to basic net loss per share since common equivalent shares are excluded
from the calculation, as their effect is anti-dilutive.
The following table summarizes the Companys calculation of net loss per common share for the
three months ended March 31, 2011 and 2010:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2011
|
|
|
2010
|
|
Net loss per share
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(18,565,705
|
)
|
|
$
|
(11,103,792
|
)
|
Weighted-average common shares outstanding
|
|
|
32,917,289
|
|
|
|
13,357,149
|
|
Less: Weighted-average shares subject to repurchase
|
|
|
(22,137
|
)
|
|
|
(12,918
|
)
|
|
|
|
|
|
|
|
Total basic and diluted net loss per share
|
|
|
32,895,152
|
|
|
|
13,344,231
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.56
|
)
|
|
$
|
(0.83
|
)
|
|
|
|
|
|
|
|
The following table shows weighted-average historical dilutive common share equivalents
outstanding for the three months ended March 31, 2011 and 2010, which are not included in the above
calculation, as the effect of their inclusion is anti-dilutive during each period.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2011
|
|
|
2010
|
|
Options to purchase common stock
|
|
|
940,430
|
|
|
|
1,102,614
|
|
Common stock subject to repurchase
|
|
|
22,137
|
|
|
|
12,918
|
|
Warrants to purchase common stock
|
|
|
4,582,136
|
(2)
|
|
|
493,268
|
(1)
|
Restricted stock units
|
|
|
302,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,844,903
|
|
|
|
1,608,800
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
The warrants were exercised upon the closing of the Companys initial public offering (IPO) in March 2010.
|
|
(2)
|
|
Consists of 357,136 warrants which carry a contractual term of five years and terminate upon the earlier of
i) five years from the date of issuance, which will be July 17, 2014 or September 9, 2014, and ii) upon
certain corporate transactions; 4,200,000 warrants which carry a contractual term of five years expiring
September 24, 2015 and 25,000 warrants which carry a contractual term of seven years expiring March 25,
2018. Each of the warrants contains a customary net issuance feature, which allows the warrant holder to
pay the exercise price of the warrant by forfeiting a portion of the executed warrant shares with a value
equal to the aggregate exercise price.
|
7
3. CASH EQUIVALENTS AND INVESTMENTS
At March 31, 2011 and December 31, 2010, the amortized cost and estimated fair value of
investments is set forth in the following tables:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011
|
|
|
|
|
|
|
|
Gross
|
|
|
|
|
|
|
Amortized
|
|
|
Unrealized
|
|
|
Estimated
|
|
|
|
Cost
|
|
|
Losses
|
|
|
Fair Value
|
|
Cash
|
|
$
|
44,860,866
|
|
|
$
|
|
|
|
$
|
44,860,866
|
|
Money market funds
|
|
|
16,514,928
|
|
|
|
|
|
|
|
16,514,928
|
|
Certificates of deposit
|
|
|
11,989,000
|
|
|
|
(6,815
|
)
|
|
|
11,982,185
|
|
Investments in foreign sovereign debt
|
|
|
5,186,304
|
|
|
|
(4,309
|
)
|
|
|
5,181,995
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
78,551,098
|
|
|
|
(11,124
|
)
|
|
|
78,539,974
|
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash and cash equivalents
|
|
|
(66,562,098
|
)
|
|
|
4,309
|
|
|
|
(66,557,789
|
)
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
11,989,000
|
|
|
$
|
(6,815
|
)
|
|
$
|
11,982,185
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010
|
|
|
|
|
|
|
|
Gross
|
|
|
|
|
|
|
Amortized
|
|
|
Unrealized
|
|
|
Estimated
|
|
|
|
Cost
|
|
|
Losses
|
|
|
Fair Value
|
|
Cash
|
|
$
|
15,499,182
|
|
|
$
|
|
|
|
$
|
15,499,182
|
|
Money market funds
|
|
|
19,467,096
|
|
|
|
|
|
|
|
19,467,096
|
|
Certificates of deposit
|
|
|
14,478,000
|
|
|
|
(6,765
|
)
|
|
|
14,471,235
|
|
Corporate bonds
|
|
|
4,010,563
|
|
|
|
(83
|
)
|
|
|
4,010,480
|
|
Investments in foreign sovereign debt
|
|
|
10,017,010
|
|
|
|
(84,109
|
)
|
|
|
9,932,901
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
63,471,851
|
|
|
|
(90,957
|
)
|
|
|
63,380,894
|
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash and cash equivalents
|
|
|
(40,045,129
|
)
|
|
|
15,157
|
|
|
|
(40,029,972
|
)
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
23,426,722
|
|
|
$
|
(75,800
|
)
|
|
$
|
23,350,922
|
|
|
|
|
|
|
|
|
|
|
|
4. FAIR VALUE OF INSTRUMENTS
Pursuant to the accounting guidance for fair value measurement and its subsequent updates,
fair value is defined as the price that would be received to sell an asset or paid to transfer a
liability (i.e., the exit price) in an orderly transaction between market participants at the
measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair
value that minimizes the use of unobservable inputs by requiring the use of observable market data
when available. Observable inputs are inputs that market participants would use in pricing the
asset or liability based on active market data. Unobservable inputs are inputs that reflect the
assumptions market participants would use in pricing the asset or liability based on the best
information available in the circumstances.
The fair value hierarchy is broken down into the three input levels summarized below:
|
|
|
Level 1
Valuations are based on quoted prices in active markets for identical assets
or liabilities, and readily accessible by us at the reporting date. Examples of assets and
liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and
trading securities with quoted prices on active markets.
|
|
|
|
|
Level 2
Valuations based on inputs other than the quoted prices in active markets that
are observable either directly or indirectly in active markets. Examples of assets and
liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds,
commercial paper, certificates of deposit and over-the-counter derivatives.
|
|
|
|
|
Level 3
Valuations based on unobservable inputs in which there is little or no market
data, which require us to develop our own assumptions. Examples of assets and liabilities
utilizing Level 3 inputs are cost method investments, auction rate securities (ARS) and the
Primary Fund.
|
8
The following tables present the Companys fair value hierarchy for all its financial assets
(including those in cash and cash equivalents), by major security type measured at fair value on a
recurring basis as of March 31, 2011 and December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011
|
|
|
|
Estimated
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Money market funds
|
|
$
|
16,514,928
|
|
|
$
|
16,514,928
|
|
|
$
|
|
|
|
$
|
|
|
Certificates of deposit
|
|
|
11,982,185
|
|
|
|
|
|
|
|
11,982,185
|
|
|
|
|
|
Investments in foreign sovereign debt
|
|
|
5,181,995
|
|
|
|
|
|
|
|
5,181,995
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
33,679,108
|
|
|
$
|
16,514,928
|
|
|
$
|
17,164,180
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010
|
|
|
|
Estimated
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Money market funds
|
|
$
|
19,467,096
|
|
|
$
|
19,467,096
|
|
|
$
|
|
|
|
$
|
|
|
Certificates of deposit
|
|
|
14,471,235
|
|
|
|
|
|
|
|
14,471,235
|
|
|
|
|
|
Corporate bonds
|
|
|
4,010,480
|
|
|
|
|
|
|
|
4,010,480
|
|
|
|
|
|
Investments in foreign sovereign debt
|
|
|
9,932,901
|
|
|
|
|
|
|
|
9,932,901
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
47,881,712
|
|
|
$
|
19,467,096
|
|
|
$
|
28,414,616
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company did not have any non-financial assets or non-financial liabilities that were
required to be measured at fair value as of March 31, 2011 and December 31, 2010.
5. PROPERTY AND EQUIPMENT
Property and equipment are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2011
|
|
|
2010
|
|
Computers and software
|
|
$
|
77,318
|
|
|
$
|
77,318
|
|
Office equipment and furniture
|
|
|
16,730
|
|
|
|
16,730
|
|
Leasehold improvements
|
|
|
10,802
|
|
|
|
10,802
|
|
Construction in progress
|
|
|
1,312,749
|
|
|
|
|
|
|
|
|
|
|
|
|
Total property and equipment
|
|
|
1,417,599
|
|
|
|
104,850
|
|
Less accumulated depreciation
|
|
|
(92,121
|
)
|
|
|
(87,565
|
)
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
1,325,478
|
|
|
$
|
17,285
|
|
|
|
|
|
|
|
|
6. COMMITMENTS AND CONTINGENCIES
In July 2006, the Company entered into a license agreement with Shionogi & Co., Ltd. and Eli
Lilly and Company, or Eli Lilly, to develop and commercialize certain sPLA
2
inhibitors
for the treatment of inflammatory diseases. The agreement granted the Company commercialization
rights to Shionogi & Co., Ltd.s and Eli Lillys sPLA
2
inhibitors, including varespladib
and A-001. Under the terms of the agreement, the Companys license is worldwide, with the exception
of Japan where Shionogi & Co., Ltd. has retained rights. Pursuant to this license agreement, the
Company paid Shionogi & Co., Ltd. and Eli Lilly a one-time license initiation fee of $250,000 in
the aggregate. Additionally, in consideration for the licensed technology, the Company issued an
aggregate of 257,744 shares of Series A-2 convertible preferred stock at $5.14 per share and an
aggregate of 127,297 shares of Series B-1 convertible preferred stock at $7.28 per share with a
total aggregate value of $2.3 million to Shionogi & Co., Ltd. and Eli Lilly. As there is no future
alternative use for the technology, the Company recorded the initiation and license fees in
research and development expenses during 2006. In March 2010, the Company paid $1.75 million each
to Eli Lilly and Shionogi & Co., Ltd. in the form of the Companys common stock upon the
commencement of the Companys Phase 3 VISTA-16 study of varespladib.
The Company is obligated to make additional milestone payments of up to $97.5 million upon the
achievement of certain development and regulatory milestones. The Company is also obligated to pay
tiered royalties, which increase as a percentage from the mid-single digits to the low double
digits as net sales increase, on future net sales of products that are developed and approved as
defined by this collaboration. The Companys obligation to pay royalties with respect to each
licensed product in each country will expire upon the later of (a) 10 years following the date of
the first commercial sale of such licensed product in such country and (b) the first date on which
generic version(s) of the applicable licensed product achieve a total market share, in the
aggregate, of 25% or more of the total unit sales of wholesalers to pharmacies of licensed product and all generic
versions combined in the applicable country.
9
On December 18, 2007, the Company entered into with Amgen, Inc. (Amgen), a worldwide,
exclusive license agreement, or the Amgen Agreement, to develop and commercialize A-623 for the
treatment of systemic lupus erythematosus (lupus). Under the terms of the Amgen Agreement, the
Company paid a nonrefundable, upfront license fee of $6.0 million. As there is no future
alternative use for the technology, the Company expensed the license fee in research and
development expenses during 2007.
Under the terms of the Amgen Agreement, the Company is obligated to make additional milestone
payments to Amgen of up to $33.0 million upon the achievement of certain development and regulatory
milestones. The Company is also obligated to pay tiered royalties on future net sales of products,
ranging from the high single digits to the low double digits, which are developed and approved as
defined by this collaboration. The Companys royalty obligations as to a particular licensed
product will be payable, on a country-by-country and licensed product-by-licensed product basis,
for the longer of (a) the date of expiration of the last to expire valid claim within the licensed
patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product
by the Company or a sublicense in such country or (b) 10 years after the first commercial sale of
the applicable licensed product in the applicable country. There were no outstanding obligations
due to Amgen as of March 31, 2011.
7. COMPREHENSIVE LOSS
Comprehensive loss is comprised of net loss and certain changes in equity that are excluded
from net loss. Components of comprehensive loss include unrealized gains on available-for-sale
securities, and unrealized gains related to foreign currency transactions. The components of
comprehensive loss are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2011
|
|
|
2010
|
|
Net loss
|
|
$
|
(18,565,705
|
)
|
|
$
|
(11,103,792
|
)
|
Unrealized gain on available-for-sale securities
|
|
|
1,268
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
|
340,852
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$
|
(18,223,585
|
)
|
|
$
|
(11,103,792
|
)
|
|
|
|
|
|
|
|
8. DEBT FINANCING
Term Loan Agreement
Hercules Technology Growth Capital
In March 2011, the Company entered into a Loan and Security Agreement (Loan Agreement) with
Hercules Technology Growth Capital, Inc. and Hercules Technology II, L.P. (together, Hercules).
Under the terms of the Loan Agreement, the Company borrowed $25.0 million at an interest rate of
the higher of (i) 10.55% or (ii) 7.30% plus the prime rate as reported in the Wall Street Journal,
and issued to Hercules a secured term promissory note evidencing the loan. The loan is secured by
the Companys assets, excluding intellectual property. The Company will make interest only payments
for the initial 12 months, which will be extended an additional three months if (a) positive
biomarker analysis results are obtained from VISTA-16 Phase III FDA Clinical Trial on or before
July 31, 2011, and (b) full enrollment of the PEARL-SC Phase 2b FDA Clinical Trial is obtained on
or before March 31, 2012. The Company obtained positive biomarker analysis results on April 18,
2011. Thereafter, the loan will be repaid in 30 equal monthly installments of approximately
$952,000, at the initial interest rate. The Company will also be obligated to pay an end of the
term charge of $937,500, which will be expensed over the term of the
Loan Agreement using the effective interest rate.
The Loan Agreement limits both the seniority and amount of future debt the Company may incur.
The Company may be required to prepay the loan in the event of a change in control. In conjunction
with the loan, the Company issued a seven-year warrant to purchase 321,429 shares of the Companys
common stock at an exercise price of $6.00 per share. The warrant is immediately exercisable and
expires March 2018. The Company estimated the fair value of this warrant using the Black-Scholes
option valuation model with the following assumptions: expected term of seven years, a risk-free
interest rate of 2.87%, expected volatility of 63% and 0% expected dividend yield.
The Company applied the relative fair value method, described in ASC 470-20-30-1, to
allocate the $25.0 million proceeds received under the Loan Agreement between the loan and warrant.
The initial carrying amount
assigned to the loan was $23.7 million and was recorded as the Notes payable net of
discount on the Companys balance sheets. The fair value allocated to the warrant of $1.3 million
was recorded as an increase to additional paid-in capital in the Companys balance sheets. The
resulting $1.3 million discount from the $25.0 million par value of the loan will be amortized as
an additional interest expense over the term of the loan using the
effective interest rate method. At
March 31, 2011, this warrant remained outstanding and exercisable.
10
In connection with the Loan Agreement, the Company incurred note issuance costs of
approximately $370,200, which are recorded as long-term assets on the Companys balance sheet. The
note issuance costs are being amortized to interest expense over the term of the Loan Agreement
using the effective interest rate method.
9. STOCKHOLDERS EQUITY
Option Plans
At March 31, 2011, the Company had the following plans that give rise to share-based
compensation: (i) two stock option plans, the 2005 Equity and Incentive Plan (the 2005 Plan),
and the 2010 Stock Option and Incentive Plan (the 2010 Plan), and (ii) the 2010 Employee Stock
Purchase Plan. The terms of awards granted during the three months ended March 31, 2011 and the
methods for determining grant-date fair value of the awards were consistent with those described in
the financial statements included in the Companys Annual Report on Form 10-K for the year ended
December 31, 2010.
On January 1, 2011, in accordance with the 2010 Plan annual increase provisions, the
authorized shares in the 2010 Plan increased by 1,315,214.
The following table summarizes stock option activity under the Companys share-based
compensation plans for the three months ended March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
Weighted-
|
|
Average
|
|
|
|
|
|
|
|
|
Average
|
|
Remaining
|
|
Aggregate
|
|
|
Number of
|
|
Exercise
|
|
Contractual
|
|
Intrinsic
|
|
|
Options
|
|
Price
|
|
Life in Years
|
|
Value
|
Balance at December 31, 2010
|
|
|
1,275,991
|
|
|
$
|
1.26
|
|
|
|
7.07
|
|
|
$
|
4,700,543
|
|
Granted
|
|
|
988,000
|
|
|
$
|
5.03
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(35,747
|
)
|
|
$
|
1.40
|
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(13,313
|
)
|
|
$
|
2.72
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2011
|
|
|
2,214,931
|
|
|
$
|
2.93
|
|
|
|
8.02
|
|
|
$
|
8,471,231
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at March 31, 2011
|
|
|
1,080,275
|
|
|
$
|
1.08
|
|
|
|
6.50
|
|
|
$
|
6,141,662
|
|
Vested and expected to vest at March 31, 2011
|
|
|
2,214,931
|
|
|
$
|
2.93
|
|
|
|
8.02
|
|
|
$
|
8,471,231
|
|
The intrinsic value of stock options represents the difference between the exercise price of
stock options and the market price of our stock on that day for all in-the-money options.
Additional information related to our stock options is summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of
|
|
|
|
|
|
|
|
|
|
|
Inception) to
|
|
|
Three Months Ended March 31,
|
|
March 31,
|
|
|
2011
|
|
2010
|
|
2011
|
Intrinsic value of options exercised
|
|
$
|
151,680
|
|
|
$
|
126,868
|
|
|
$
|
979,879
|
|
Proceeds received from the exercise of stock options
|
|
$
|
50,192
|
|
|
$
|
17,653
|
|
|
$
|
395,343
|
|
Grant date fair value of options vested
|
|
$
|
130,465
|
|
|
$
|
36,683
|
|
|
$
|
953,099
|
|
As of March 31, 2011 there were 400,916 shares available for future issuance under the 2010
Plan.
Restricted Stock Units
The Company grants restricted stock unit awards under its 2010 Plan, as determined by the
Companys compensation committee, which are issued upon vesting. The restricted stock units granted
represent a right to receive shares of common stock at a future date determined in accordance with
the participants award agreement. An exercise price and monetary payment are not required for
receipt of restricted stock units or the shares issued in settlement of the award. Instead,
consideration is furnished in the form of the participants services to the Company. Substantially
all of the restricted stock units vest over four years.
11
The following table summarizes activity related to our restricted stock units:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
Grant
|
|
|
|
|
|
|
Date Fair
|
|
|
Shares
|
|
Value
|
Outstanding at December 31, 2010
|
|
|
302,500
|
|
|
$
|
5.13
|
|
Restricted stock units granted
|
|
|
10,000
|
|
|
$
|
4.88
|
|
Restricted stock units released
|
|
|
(10,000
|
)
|
|
$
|
4.88
|
|
Restricted stock units forfeitures and cancellations
|
|
|
(4,500
|
)
|
|
$
|
4.84
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2011
|
|
|
298,000
|
|
|
$
|
5.13
|
|
|
|
|
|
|
|
|
|
|
2010 Employee Stock Purchase Plan
Effective July 2010, under the 2010 Employee Stock Purchase Plan (the ESPP), eligible
employees of the Company may authorize the Company to deduct amounts from their compensation, which
amounts are used to enable the employees to purchase shares of the Companys common stock. The
Company initially reserved 100,000 shares of common stock for issuance thereunder plus on January
1, 2011 and each January 1 thereafter, the number of shares of stock reserved and available for
issuance under the Plan shall be cumulatively increased by the lesser of (i) one percent (1%) of
the number of shares of common stock issued and outstanding on the immediately preceding December
31 or (ii) 250,000 shares of common stock. On January 1, 2011, in accordance with the ESPPs
annual increase provisions, the authorized shares in the ESPP increased by 250,000.
The purchase price per share is 85% of the fair market value of the common stock as of the
first date or the ending date of the applicable semi-annual purchase period, whichever is less.
Purchases are generally made on the last trading day of each June and December. As of March 31,
2011, the Company received $27,723 in contributions for the ESPP. There were no shares issued
under the ESPP during the three month period ended March 31, 2011. As of March 31, 2011, 325,084
shares were available for future purchase under the ESPP.
Stock-Based Compensation
The employee stock-based compensation expense was determined using the Black-Scholes option
pricing model. Option pricing models require the input of subjective assumptions and these
assumptions can vary over time.
The estimated grant date fair values of the employee stock options and stock purchase rights
were calculated using the Black-Scholes option-pricing model with assumptions as follows:
Stock Option Plans
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of
|
|
|
|
|
|
|
|
|
|
|
Inception) to
|
|
|
Three Months
Ended March 31,
|
|
March 31,
|
|
|
2011
|
|
2010
|
|
2011
|
Expected Volatility
|
|
|
63
|
%
|
|
|
89
|
%
|
|
|
74
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
2.37
|
%
|
|
|
3.02
|
%
|
|
|
3.41
|
%
|
Expected Term (years)
|
|
|
6.25
|
|
|
|
6.25
|
|
|
|
6.25
|
|
12
ESPP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
2004 (Date of
|
|
|
|
|
|
|
Inception) to
|
|
|
Three Months ended
|
|
March 31,
|
|
|
March 31, 2011
|
|
2011
|
Expected Volatility
|
|
|
54
|
%
|
|
|
64
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
0.16
|
%
|
|
|
0.16
|
%
|
Expected Term (years)
|
|
|
0.5
|
|
|
|
0.5
|
|
Restricted Stock Units
Compensation cost for these awards is based on the closing price of the Companys common stock on
the date of grant and recognized as compensation expense on a straight-line basis over the
requisite service period.
Stock-Compensation Summary
Compensation cost for stock options granted to employees is based on the grant-date fair value
and is recognized over the vesting period of the applicable option on a straight-line basis. The
estimated per share weighted-average fair value of stock options granted to employees during the
three months ended March 31, 2011 and 2010 and for the period from September 4, 2004 (Date of
Inception) to March 31, 2011 was $3.02, $5.30 and $1.31 respectively.
Total stock-based compensation expense for equity awards granted to employees and
non-employees recognized was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of
|
|
|
|
|
|
|
|
|
|
|
|
Inception) to
|
|
|
|
Three Months Ended March 31,
|
|
|
March 31,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
Research and development
|
|
$
|
235,890
|
|
|
$
|
20,231
|
|
|
$
|
678,391
|
|
General and administrative
|
|
|
351,808
|
|
|
|
32,385
|
|
|
|
1,246,461
|
|
|
|
|
|
|
|
|
|
|
|
Total employee stock-based compensation
|
|
$
|
587,698
|
|
|
$
|
52,616
|
|
|
$
|
1,924,852
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2011, there was $3.1 million of unrecognized compensation expense related to
options. The unrecognized compensation expense will be amortized on a straight-line basis over a
weighted-average remaining period of 3.35 years. As of March 31, 2011, the unrecognized
compensation cost related to restricted stock unit awards was $1.2 million which will be amortized
on a straight-line basis over 2.48 years.
Nonemployee Stock-Based Compensation
In connection with share based awards granted to consultants, the Company recorded $48,800
(relating to restricted stock awards), $4,204, and $215,144 for nonemployee stock-based
compensation during the three months ended March 31, 2011 and 2010 and for the period from
September 9, 2004 (Date of Inception) to March 31, 2011, respectively. These amounts were based
upon the fair value of the vested portion of the grants. Amounts expensed during the remaining
vesting period will be determined based on the fair value at the time of vesting.
13
10. RELATED PARTY TRANSACTIONS
The Company engaged an outside service provider whose chief executive officer is a founder of
the Company and spouse of an officer of the Company, for clinical management services. In
consideration for the services rendered, the Company paid the following fees:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
(Date of
|
|
|
|
|
|
|
|
|
|
|
Inception) to
|
|
|
Three Months Ended March 31,
|
|
March 31,
|
|
|
2011
|
|
2010
|
|
2011
|
Project management fees
|
|
$
|
620,727
|
|
|
$
|
38,274
|
|
|
$
|
1,285,918
|
|
As of March 31, 2011, the Company had $828,935 payable to this organization for services
performed during the period compared to $519,386 payable as of December 31, 2010. We anticipate
this relationship to continue for the foreseeable future.
11. SUBSEQUENT EVENTS
In April 2011, the Company signed an extension and amendment to our lease agreement for our
operating facility. The lease commences August 2011 and will end September 2014. Total future
minimum lease payments over the life of the lease are $517,905.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report on
Form 10-Q
contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended (the Exchange Act), which are subject to the safe harbor created by
those sections. Forward-looking statements are based on our managements beliefs and assumptions
and on information currently available to our management. All statements other than statements of
historical factors are forward-looking statements for purposes of theses provisions. In some
cases you can identify forward-looking statements by terms such as may, will, should,
could, would, expect, plan, anticipate, believe, estimate, project, predict, and
potential, and similar expressions intended to identify forward-looking statements. Such
forward-looking statements are subject to risks, uncertainties and other important factors that
could cause actual results and the timing of certain events to differ materially from future
results expressed or implied by such forward-looking statements. Factors that could cause or
contribute to such differences include, but are not limited to, those identified below, and those
discussed in the section titled Risk Factors in this report. Furthermore, such forward-looking
statements speak only as of the date of this report. Except as required by law, we undertake no
obligation to update any forward-looking statements to reflect events or circumstances after the
date of such statements.
Overview
We are a biopharmaceutical company focused on developing and commercializing products to treat
serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. We
currently have one Phase 3 clinical program, varespladib, and two Phase 2 clinical programs, A-623
and A-001. Two of our product candidates, varespladib and A-001, are designed to inhibit a novel
enzyme target known as secretory phospholipase A
2
, or sPLA
2
. Elevated levels
of sPLA
2
have been implicated in a variety of acute inflammatory conditions, including
acute coronary syndrome and acute chest syndrome associated with sickle cell disease, as well as in
chronic diseases, including stable coronary artery disease. In addition, our Phase 2 product
candidate, A-623, targets elevated levels of B-cell activating factor, or BAFF, which has been
associated with a variety of B-cell mediated autoimmune diseases, including systemic lupus
erythematosus, or lupus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjögrens
Syndrome, Graves Disease and others.
We were incorporated and commenced operations in September 2004. Since our inception, we have
generated significant losses. As of March 31, 2011, we had an accumulated deficit of approximately
$124.2 million. As of the date of this filing, we have never generated any revenue and have
generated only interest income from cash and cash equivalents and short-term investments. We expect
to incur substantial and increasing losses for at least the next several years as we pursue the
development and commercialization of our product candidates.
14
To date, we have funded our operations through equity offerings, private placements of
convertible debt and debt financings, raising net proceeds of approximately $170.4 million. We will
need substantial additional financing to continue to develop our product candidates, obtain
regulatory approvals and to fund operating expenses, which we will seek to raise through public or
private equity or debt financings, collaborative or other arrangements with third parties or
through other sources of financing. We cannot assure you that such funds will be available on terms
favorable to us, if at all. In addition to the normal risks associated with development-stage
companies, we may never successfully complete development of any of our product candidates, obtain
adequate patent protection for our technology, obtain necessary government regulatory approval for
our product candidates or achieve commercial viability for any approved product candidates. In
addition, we may not be profitable even if we succeed in commercializing any of our product
candidates.
Revenue
To date, we have not generated any revenue. We do not expect to generate revenue unless or
until we obtain regulatory approval of, and commercialize, our product candidates or in- license
additional products that generate revenue. We intend to seek to generate revenue from a combination
of product sales, up-front fees and milestone payments in connection with collaborative or
strategic relationships and royalties resulting from the licensing of the commercial rights to our
intellectual property. We expect that any revenue we generate will fluctuate from quarter to
quarter as a result of the nature, timing and amount of milestone payments we may receive upon the
sale of our products, to the extent any are successfully commercialized, as well as any revenue we
may receive from our collaborative or strategic relationships.
Research and Development Expenses
Since our inception, we have focused our activities on our product candidate development
programs. We expense research and development costs as they are incurred. Research and development
expenses consist of personnel costs, including salaries, benefits and stock-based compensation,
clinical studies performed by contract research organizations, or CROs, materials and supplies,
licenses and fees and overhead allocations consisting of various administrative and
facilities-related costs. Research and development activities are also separated into three main
categories: licensing, clinical development and pharmaceutical development. Licensing costs consist
primarily of fees paid pursuant to license agreements. Historically, our clinical development costs
have included costs for preclinical and clinical studies. We expect to incur substantial clinical
development costs for our Phase 3 clinical study named VISTA- 16 for varespladib and for our Phase
2b clinical study named PEARL-SC for A-623, as well as for the development of our other product
candidates. Pharmaceutical development costs consist of expenses incurred relating to clinical
studies and product formulation and manufacturing.
We expense both internal and external research and development costs as incurred. We are
developing our product candidates in parallel, and we typically use our employee and infrastructure
resources across several projects. Thus, some of our research and development costs are not
attributable to an individually named project, but rather are allocated across our clinical stage
programs. These unallocated costs include salaries, stock-based compensation charges and related
fringe benefit costs for our employees (such as workers compensation and health insurance
premiums), consulting fees and travel.
The following table shows our total research and development expenses for the three months
ended March 31, 2011 and 2010 and for the period from September 9, 2004 (Date of Inception) through
March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Period
|
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of
|
|
|
|
|
|
|
|
|
|
|
|
Inception) to
|
|
|
|
Three Months Ended March 31,
|
|
|
March 31,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
Allocated costs:
|
|
|
|
|
|
|
|
|
|
|
|
|
A-001
|
|
$
|
24,255
|
|
|
$
|
91,729
|
|
|
$
|
6,532,613
|
(1)
|
Varespladib
|
|
|
9,323,210
|
|
|
|
4,252,849
|
(2)
|
|
|
56,413,723
|
(1)(2)(4)
|
A-623
|
|
|
5,680,193
|
|
|
|
304,950
|
|
|
|
17,650,085
|
(3)(5)
|
Unallocated costs
|
|
|
1,289,100
|
|
|
|
592,286
|
|
|
|
16,501,060
|
|
|
|
|
|
|
|
|
|
|
|
Total development
|
|
$
|
16,316,758
|
|
|
$
|
5,241,814
|
|
|
$
|
97,097,481
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Includes Qualifying Therapeutic Discovery Project Credit under Section 48D of approximately $244,000.
|
15
|
|
|
(2)
|
|
Includes milestone payments of $3.5 million pursuant to amendments to the license agreements with
each of Eli Lilly and Shionogi & Co. Ltd., which were paid in the form of shares of common stock.
|
|
(3)
|
|
Includes Qualifying Therapeutic Discovery Project Credit under Section 48D of approximately $488,000.
|
|
(4)
|
|
Includes license fees of $4.0 million pursuant to a license agreement with each of Eli Lilly and
Shionogi & Co. Ltd., which were paid in cash and shares of preferred stock in 2006.
|
|
(5)
|
|
Includes a one-time license initiation fee of $6.0 million pursuant to a license agreement with Amgen.
|
We expect our research and development expenses to increase significantly as we continue to
develop our product candidates. We began enrollment of patients in the VISTA-16 study of
varespladib for the treatment of patients experiencing acute coronary syndrome in June 2010. We
also initiated the PEARL-SC study of A-623 in July 2010. We intend to fund our clinical studies
with existing cash and proceeds from potential future debt and equity offerings.
We expect that a large percentage of our research and development expenses in the future will
be incurred in support of our current and future clinical development programs. These expenditures
are subject to numerous uncertainties in timing and cost to completion. As we obtain results from
clinical studies, we may elect to discontinue or delay clinical studies for certain product
candidates or programs in order to focus our resources on more promising product candidates or
programs. Completion of clinical studies may take several years or more, but the length of time
generally varies according to the type, complexity, novelty and intended use of a product
candidate. The cost of clinical studies may vary significantly over the life of a program as a
result of differences arising during clinical development, including:
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|
the number of sites included in the studies;
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|
|
|
|
the length of time required to enroll suitable patient subjects;
|
|
|
|
|
the number of patients that participate in the studies;
|
|
|
|
|
the number of doses that patients receive;
|
|
|
|
|
the drop-out or discontinuation rates of patients; and
|
|
|
|
|
the duration of patient follow-up.
|
Our expenses related to clinical studies are based on estimates of the services received and
efforts expended pursuant to contracts with multiple research institutions and clinical research
organizations that conduct and manage clinical studies on our behalf. The financial terms of these
agreements are subject to negotiation and vary from contract to contract and may result in uneven
payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed
fee or unit price. Payments under the contracts depend on factors such as the successful enrollment
of patients or the completion of clinical study milestones. Expenses related to clinical studies
generally are accrued based on contracted amounts and the achievement of milestones such as number
of patients enrolled. If timelines or contracts are modified based upon changes to the clinical
study design or scope of work to be performed, we modify our estimates of accrued expenses
accordingly on a prospective basis.
None of our product candidates has received U.S. Food and Drug Administration, or FDA, or
foreign regulatory marketing approval. In order to grant marketing approval, the FDA or foreign
regulatory agencies must conclude that clinical data establishes the safety and efficacy of our
product candidates and that the manufacturing facilities, processes and controls are adequate.
Despite our efforts, our product candidates may not offer therapeutic or other improvement over
existing, comparable drugs, be proven safe and effective in clinical studies, or meet applicable
regulatory standards.
As a result of the uncertainties discussed above, we are unable to determine the duration and
completion costs of our development projects or when and to what extent we will receive cash
inflows from the commercialization and sale of an approved product candidate, if ever.
16
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for employees in
executive and operational functions, including clinical, chemical manufacturing, regulatory,
finance and business development. Other significant costs include professional fees for legal
services, including legal services associated with obtaining and maintaining patents. We will
continue to incur significant general and administrative expenses as a public company, including
costs for insurance, costs related to the hiring of additional personnel, payment to outside
consultants, lawyers and accountants and complying with the corporate governance, internal controls
and similar requirements applicable to public companies.
Critical Accounting Policies and Estimates
Our managements discussion and analysis of our financial condition and results of operations
is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The
preparation of these financial statements requires us to make estimates and judgments that affect
the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these
estimates and judgments, including those described below. We base our estimates on our historical
experience and on various other assumptions that we believe to be reasonable under the
circumstances. These estimates and assumptions form the basis for making judgments about the
carrying values of assets and liabilities that are not readily apparent from other sources. Actual
results and experiences may differ materially from these estimates.
While our significant accounting policies are more fully described in the notes to the
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2010, we believe that the following accounting policies are the most critical to aid you in fully
understanding and evaluating our reported financial results and affect the more significant
judgments and estimates that we use in the preparation of our financial statements.
Accrued Clinical Expenses
We make estimates of our accrued expenses as of each balance sheet date in our financial
statements based on facts and circumstances known to us at that time. This process involves
reviewing open contracts and purchase orders, communicating with our applicable personnel to
identify services that have been performed on our behalf and estimating the level of service
performed and the associated cost incurred for the service when we have not yet been invoiced or
otherwise notified of actual cost. The majority of our service providers invoice us at least
monthly in arrears for services performed. We periodically confirm the accuracy of our estimates
with the service providers and make adjustments if necessary. Examples of estimated accrued
clinical expenses include:
|
|
|
fees paid to CROs in connection with clinical studies;
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|
|
|
|
fees paid to investigative sites in connection with clinical studies;
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|
|
|
|
fees paid to contract manufacturers in connection with the production of clinical study
materials; and
|
|
|
|
|
fees paid to vendors in connection with the preclinical development activities.
|
We base our expenses related to clinical studies on our estimates of the services received and
efforts expended pursuant to contracts with multiple research institutions and CROs that conduct
and manage clinical studies on our behalf. The financial terms of these agreements are subject to
negotiation, vary from contract to contract and may result in uneven payment flows. Payments under
some of these contracts depend on factors such as the successful enrollment of patients and the
completion of clinical study milestones. In accruing service fees, we estimate the time period over
which services will be performed and the level of effort to be expended in each period. If the
actual timing of the performance of services or the level of effort varies from our estimate, we
adjust the accrual accordingly. If we do not identify costs that we have begun to incur or if we
underestimate or overestimate the level of services performed or the costs of these services, our
actual expenses could differ from our estimates.
Stock-Based Compensation
Compensation costs related to all equity instruments are recognized at the grant-date fair
value of the awards. Additionally, we are required to include an estimate of the number of awards
that will be forfeited in calculating compensation costs, which are recognized over the requisite
service period of the awards on a straight-line basis. We account for stock-based compensation
using the Black-Scholes option pricing model to estimate the fair value of each option grant on the
date of grant. Black-Scholes option pricing model requires the input of highly subjective
assumptions, including the expected stock price volatility, expected term, and forfeiture rate. Any
changes in these highly subjective assumptions significantly impact stock-based compensation
expense.
17
Fair Value Measurements and Impairments
All of our available-for-sale investments are subject to periodic impairment review.
Investments are considered to be impaired when a decline in fair value is judged to be
other-than-temporary. This determination requires significant judgment. For publicly traded
investments, impairment is determined based upon the specific facts and circumstances present at
the time, including factors such as current economic and market conditions, the credit rating of
the securitys issuer, the length of time an investments fair value has been below our carrying
value, and our ability and intent to hold investments to maturity or for a period of time
sufficient to allow for any anticipated recovery in fair value. If an investments decline in fair
value, caused by factors other than changes in interest rates, is deemed to be
other-than-temporary, we reduce its carrying value to its estimated fair value, as determined based
on quoted market prices, liquidation values or other metrics.
Pursuant to the accounting guidance for fair value measurement and its subsequent updates,
fair value is defined as the price that would be received to sell an asset or paid to transfer a
liability (i.e., the exit price) in an orderly transaction between market participants at the
measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair
value that minimizes the use of unobservable inputs by requiring the use of observable market data
when available. Observable inputs are inputs that market participants would use in pricing the
asset or liability based on active market data. Unobservable inputs are inputs that reflect the
assumptions market participants would use in pricing the asset or liability based on the best
information available in the circumstances.
The fair value hierarchy is broken down into the three input levels summarized below:
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|
|
Level 1
Valuations are based on quoted prices in active markets for identical assets
or liabilities, and readily accessible by us at the reporting date. Examples of assets and
liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and
trading securities with quoted prices on active markets.
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|
|
|
Level 2
Valuations based on inputs other than the quoted prices in active markets that
are observable either directly or indirectly in active markets. Examples of assets and
liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds,
commercial paper, certificates of deposit and over-the-counter derivatives.
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|
|
|
|
Level 3
Valuations based on unobservable inputs in which there is little or no market
data, which require us to develop our own assumptions. Examples of assets and liabilities
utilizing Level 3 inputs are cost method investments, auction rate securities (ARS) and the
Primary Fund.
|
We measure our available-for-sale securities at fair value on a recurring basis.
Available-for-sale securities include U.S. Treasury securities, U.S. government agency bonds,
corporate bonds, commercial paper, money market funds and certificates of deposit. Where possible,
we utilize quoted market prices to measure and such items are classified as Level 1 in the
hierarchy. When quoted market prices for identical assets are unavailable, varying valuation
techniques are used. Such assets are classified as Level 2 or Level 3 in the hierarchy. We classify
items in Level 2 if investments are valued using observable inputs to quoted market prices,
benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with
reasonable levels of price transparency. We classify items in Level 3 if investments are valued
using a pricing model, based on unobservable inputs in the market or that require us to develop our
own assumptions. Our assessment of the significance of a particular input to the fair value
measurement in its entirety requires judgment and considers factors specific to the investment.
We are also exposed to market risk relating to our available-for-sale investments due to
uncertainties in the credit and capital markets. The fair value of our investments may change
significantly due to events and conditions in the credit and capital markets. These
securities/issuers could be subject to review for possible downgrade. Any downgrade in these credit
ratings may result in an additional decline in the estimated fair value of our investments. We
monitor and evaluate the accounting for our investment portfolio on a quarterly basis for
additional other-than-temporary impairment charges.
We actively review current investment ratings, company specific events, and general economic
conditions in managing our investments and determining whether there is a significant decline in
fair value that is other-than-temporary. As of March 31, 2011, our short-term in marketable
securities have been classified as available-for-sale and are carried at fair value.
Available-for-sale investments with original maturities of greater than three months at the date of
purchases are classified as short-term investments as these investments generally consist of
marketable securities that are intended to be available to meet current cash requirements.
Recognized gains and losses on available for sale investments during the three months ended
March 31, 2011 and 2010 were not material. Management determines the appropriate classification of
investments at the time of purchase and reevaluates the classification at each reporting date.
18
Results of Operations
Comparison of the three months ended March 31, 2011 and 2010
Research and development expenses.
Research and development expenses consist of personnel
costs for employees in clinical, chemical manufacturing and regulatory functions, clinical studies
performed by CROs, pharmaceutical development costs including product formulation and
manufacturing, preclinical costs, license fees and overhead allocations consisting of various
administrative and facilities-related costs.
Change in research and development expenses from the three months ended March 31, 2010 to 2011
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011
|
|
2010
|
|
$ Change
|
|
% Change
|
Research and development expense
|
|
$
|
16.3
|
|
|
$
|
5.2
|
|
|
$
|
11.1
|
|
|
|
213
|
%
|
The increase in research and development expenses from 2010 to 2011 was primarily attributable
to increased patient enrollment, CRO and manufacturing cost related to the launch of our Phase 3
clinical study of varespladib and Phase 2 clinical study of A-623, as well as increased headcount
to support these clinical studies.
General and administrative expenses.
General and administrative expenses consist of personnel
costs for employees in executive, business development and operational functions, professional
service fees including corporate legal fees, accountant fees and overhead allocations consisting of
various administrative and facilities-related costs.
Change in general and administrative expenses from the three months ended March 31, 2010 to
2011 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011
|
|
2010
|
|
$ Change
|
|
% Change
|
General and administrative expense
|
|
$
|
2.3
|
|
|
$
|
1.2
|
|
|
$
|
1.1
|
|
|
|
92
|
%
|
The increase in general and administrative expenses from 2010 to 2011 was primarily
attributable to increased headcount and professional services incurred in connection with our
financial audit and other costs associated with operating as a public company.
Other expense and interest income, net.
Other expense for the three months ended March 31,
2010 consists of primarily non-cash charge related to the amortization of discounts, mark-to-market
adjustment relating to warrants and embedded derivative associated with our convertible promissory
notes issued in July and September of 2009, which were converted into shares of our common stock
upon the closing of our IPO in March 2010. Other expense for the three months ended March 31, 2011
consists primarily of interest expense, amortization of note discount and note issuance costs, and
an end of term charge associated with our note issued under a Loan and Security Agreement with
Hercules in March 2011. Interest income consists of interest earned on our cash, cash equivalents
and short-term investments.
Change in other expense and interest income, net, from the three months ended March 31, 2010
to 2011 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011
|
|
2010
|
|
$ Change
|
|
% Change
|
Other expense and interest income, net
|
|
$
|
0.1
|
|
|
$
|
(0.8
|
)
|
|
$
|
0.9
|
|
|
|
113
|
%
|
Mark-to-market adjustment of warrant liability
|
|
|
|
|
|
|
(3.8
|
)
|
|
$
|
(3.8
|
)
|
|
|
100
|
%
|
The decrease in other expense and interest income, net, from 2011 to 2010 was primarily
attributable to a non-cash charge of $4.5 million recorded for the amortization of discounts on our
convertible promissory notes and the mark-to-market adjustment relating to warrants and embedded
derivative connected to these convertible promissory notes in 2010. The balance was offset by an
increase in interest income from 2010 to 2011 attributable to higher cash and investment balances
in 2011, resulting from proceeds received from our private placement in September 2010 and the debt
financing with Hercules in March 2011.
Liquidity and Capital Resources
To date, we have funded our operations primarily through private placements of preferred stock
and common stock, convertible and nonconvertible debt and our IPO. As of March 31, 2011, we had
received net proceeds of approximately $119.5 million from the sale of equity securities,
approximately $26.2 million from the issuance of convertible promissory notes, and approximately
$24.7 million from issuance of note payable. As of March 31, 2011, we had cash, cash equivalents
and short-term investments of approximately $78.5 million.
19
Cash, cash equivalents and investments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011
|
|
|
December 31, 2010
|
|
Cash and cash equivalents
|
|
$
|
66,557,789
|
|
|
$
|
40,029,972
|
|
Short-term investments
|
|
|
11,982,185
|
|
|
|
23,350,922
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
78,539,974
|
|
|
$
|
63,380,894
|
|
|
|
|
|
|
|
|
Our principal liquidity requirements are primarily to meet our working capital needs, support
ongoing business activities, research and development, and our capital expenditure needs.
In March 2011, we filed a shelf registration statement with the Securities and Exchange
Commission (SEC) under which we may issue up to $75.0 million in shares of common stock,
preferred stock, debt securities and/or warrants. As of March 31, 2011, no securities have been
issued.
Cash Flows
Three months ended March 31, 2011
For the three months ended March 31, 2011, we incurred a net loss of approximately $18.6
million.
Net cash used in operating activities was approximately $9.9 million. The net loss is higher
than cash used in operating activities by $8.7 million. The primary drivers for the difference
include increase of $5.0 million in clinical trial accruals which is based upon our estimated
clinical trial performance to date, increase in other operating liabilities of $3.0 million, and
adjustments for non-cash charges such as stock-based compensation of approximately $588,000.
Net cash provided by investing activities was approximately $11.3 million and was primarily
driven by the maturities of short-term investments during the period.
Net cash provided by financing activities was approximately $24.7 million and consisted
primarily of proceeds of $25 million received from the issuance of note payable with Hercules.
Three Months Ended March 31, 2010
For the three months ended March 31, 2010, we incurred a net loss of approximately $11.1
million.
Net cash used in operating activities was approximately $3.5 million. The net loss is higher
than cash used in operating activities by $7.6 million. The primary drivers for the difference are
the issuance of $3.5 million worth of common stock in lieu of cash milestone payments due to Eli
Lilly and Shionogi & Co., Ltd., and mark-to-market adjustments relating to warrant and derivative
liability of $3.8 million.
Net cash provided by financing activities was approximately $56.3 million and consisted
primarily of proceeds of $57.2 million received from the issuance of common stock at our IPO.
Contractual Obligations and Commitments
The Company has lease obligations consisting of operating lease in connection with a sublease
for our operating facility that commenced in October 2008 and expires July 2011 (which was
subsequently extended through September 2014 in April 2011), for approximately 7,800 square feet of
office space, and office equipment leases that commenced in October 2007 and will expire in June
2013.
On March 25, 2011, the Company entered into a Loan and Security Agreement (Loan Agreement)
with Hercules Technology Growth Capital, Inc. and Hercules Technology II, L.P. (together,
Hercules). Under the terms of the Loan Agreement, the Company borrowed $25.0 million at an
interest rate of the higher of (i) 10.55% or (ii) 7.30% plus the prime rate as reported in the Wall
Street Journal, and issued to Hercules a secured term promissory note evidencing the loan. The loan
is secured by the Companys assets, excluding intellectual property. The Company will make interest
only payments for the initial 12 months, which will be extended an additional three months if (a)
positive biomarker analysis results are obtained from VISTA-16 Phase III FDA Clinical Trial on or
20
before July 31, 2011, and (b) full enrollment of the PEARL-SC Phase 2b FDA Clinical Trial is
obtained on or before March 31, 2012. The Company obtained positive biomarker analysis results on
April 18, 2011. Thereafter, the loan will be repaid in 30 equal monthly installments of
approximately $952,000, at the initial interest rate. The Company will also be obligated to pay an
end of the term charge of $937,500, which will be expensed over the term of the Loan Agreement
using the effective interest rate.
The following table summarizes our estimated scheduled future minimum contractual obligations
and commitments as of March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
|
Less Than
|
|
|
|
|
|
|
|
|
|
|
After
|
|
|
|
Total
|
|
|
1 Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
5 Years
|
|
Operating lease obligations
|
|
$
|
30,402
|
|
|
$
|
26,502
|
|
|
$
|
3,900
|
|
|
$
|
|
|
|
$
|
|
|
Loan Agreement
|
|
$
|
32,061,628
|
|
|
$
|
2,505,625
|
|
|
$
|
29,556,003
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
32,092,030
|
|
|
$
|
2,532,127
|
|
|
$
|
29,559,903
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The above amounts exclude potential payments to be made under our license agreements to our
licensors that are based on the progress of our product candidates in development, as these
payments are not determinable. Under our license agreement with Eli Lilly and Shionogi & Co., Ltd.
to develop and commercialize certain sPLA
2
inhibitors, we are obligated to make
additional milestone payments upon the achievement of certain development, regulatory, and
commercial objectives. We are also obligated to pay royalties on future net sales of products that
are developed and approved as defined by this collaboration. Our obligation to pay royalties with
respect to each licensed product in each country will expire upon the later of (a) 10 years
following the date of the first commercial sale of such licensed product in such country, and (b)
the first date on which generic version(s) of the applicable licensed product achieve a total
market share, in the aggregate, of 25% or more of the total unit sales of wholesalers to pharmacies
of licensed product and all generic versions combined in the applicable country.
Also excluded from the table above
is the lease extension for the Companys facility and potential milestone payments on the development of
A-623. Under our license agreement with Amgen to develop and commercialize A-623, we are obligated
to make additional milestone payments upon the achievement of certain development, regulatory, and
commercial objectives. We are also obligated to pay royalties on future net sales of products that
are developed and approved as defined by this collaboration. Our royalty obligations as to a
particular licensed product will be payable, on a country-by-country and licensed
product-by-licensed product basis, for the longer of (a) the date of expiration of the last to
expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to
sell, or import of such licensed product by us or a sublicensee in such country, or (b) 10 years
after the first commercial sale of the applicable licensed product in the applicable country.
Funding Requirements
We expect to incur substantial expenses and generate significant operating losses as we
continue to advance our product candidates into preclinical studies and clinical studies and as we:
|
|
|
continue clinical development of varespladib;
|
|
|
|
|
continue clinical development of A-623;
|
|
|
|
|
hire additional clinical, scientific and management personnel; and
|
|
|
|
|
implement new operational, financial and management information systems.
|
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include the following:
|
|
|
the progress of preclinical development and clinical studies of our product candidates;
|
|
|
|
|
the time and costs involved in obtaining regulatory approvals;
|
|
|
|
|
delays that may be caused by evolving requirements of regulatory agencies;
|
|
|
|
|
the costs involved in filing and prosecuting patent applications and enforcing or
defending patent claims;
|
21
|
|
|
our ability to establish, enforce and maintain selected strategic alliances; and
|
|
|
|
|
the acquisition of technologies, product candidates and other business opportunities that
require financial commitments.
|
To date, we have not generated any revenue. We do not expect to generate commercial product
revenue unless or until we obtain regulatory approval of, and commercialize, our product
candidates. We expect our continuing operating losses to result in increases in cash used in
operations over the next several years. Our future capital requirements will depend on a number of
factors including the progress and results of our clinical studies, the costs, timing and outcome
of regulatory review of our product candidates, our revenue, if any, from successful development
and commercialization of our product candidates, the costs of commercialization activities, the
scope, progress, results and costs of preclinical development, laboratory testing and clinical
studies for other product candidates, the emergence of competing therapies and other market
developments, the costs of preparing, filing and prosecuting patent applications and maintaining,
enforcing and defending intellectual property rights, the extent to which we acquire or invest in
other product candidates and technologies, and our ability to establish collaborations and obtain
milestone, royalty or other payments from any collaborators.
We expect our existing resources as of the date of this report, to be sufficient to fund our
planned operations, including our continued product candidate development, for at least the next 12
months. However, we may require significant additional funds earlier than we currently expect to
conduct additional or extended clinical studies and seek regulatory approval of our product
candidates. Because of the numerous risks and uncertainties associated with the development and
commercialization of our product candidates, we are unable to estimate the amounts of increased
capital outlays and operating expenditures associated with our current and anticipated clinical
studies.
Additional funding may not be available to us on acceptable terms or at all. In addition, the
terms of any financing may adversely affect the holdings or the rights of our stockholders. For
example, if we raise additional funds by issuing equity securities or by selling debt securities,
if convertible, further dilution to our existing stockholders may result. To the extent our capital
resources are insufficient to meet our future capital requirements, we will need to finance our
future cash needs through public or private equity offerings, collaboration agreements, debt
financings or licensing arrangements.
If adequate funds are not available, we may be required to terminate, significantly modify or
delay our development programs, reduce our planned commercialization efforts, or obtain funds
through collaborators that may require us to relinquish rights to our technologies or product
candidates that we might otherwise seek to develop or commercialize independently. We may elect to
raise additional funds even before we need them if the conditions for raising capital are
favorable.
Off-Balance Sheet Arrangements
We do not currently have, nor have we ever had, any relationships with unconsolidated entities
or financial partnerships, such as entities often referred to as structured finance or special
purpose entities, established for the purpose of facilitating off-balance sheet arrangements or
other contractually narrow or limited purposes. In addition, we do not engage in trading activities
involving non-exchange traded contracts.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our primary exposure to market risk is interest income sensitivity, which is affected by
changes in the general level of U.S. interest rates. We are exposed to market risk related to
fluctuations in interest rates, market prices, and foreign currency exchange rates. However, since
a majority of our investments are in short-term certificates of deposit, FDIC-insured corporate
bonds and money market funds, we do not believe we are subject to any material market risk
exposure. As of March 31, 2011, we did not have any material derivative financial instruments. The
fair value of our marketable securities, including those included in cash equivalents and
short-term investments, was $33.7 million as of March 31, 2011.
Our investment policy is to limit credit exposure through diversification and investment in
highly rated securities. We actively review, along with our investment advisors, current investment
ratings, company specific events and general economic conditions in managing our investments and in
determining whether there is a significant decline in fair value that is other-than-temporary. We
will monitor and evaluate the accounting for our investment portfolio on a quarterly basis for
additional other-than-temporary impairment charges.
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ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive and financial officers,
evaluated the effectiveness of our disclosures controls and procedures, as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act, as of March 31, 2011. The term disclosure controls
and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls
and other procedures of a company that are designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SECs rules and forms.
Disclosure controls and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed by a company in the reports that it files or
submits under the Exchange Act is accumulated and communicated to the companys management,
including its principal executive and principal financial officers, as appropriate, to allow timely
decisions regarding required disclosure. Management recognizes that any controls and procedures, no
matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our disclosure
controls and procedures as of March 31, 2011, our principal executive officer and principal
financial officer concluded that, as of such date, our disclosure controls and procedures were
effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during the quarter ended
March 31, 2011 identified in connection with the evaluation required by Rule 13a-15(d) and
15d-15(d) of the Exchange Act 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 may be involved in routine legal proceedings, as well as demands, claims
and threatened litigation, which arise in the normal course of our business.
We believe there is no litigation pending that could, individually or in the aggregate, have a
material adverse effect on our results of operations or financial condition.
ITEM 1A. RISK FACTORS
You should carefully consider the risks described below, together with the other information
contained in this Quarterly Report on
Form 10-Q
, including the financial statements and the related
notes that appear in this report. We believe the risks described below are the risks that are
material to us as of the date of this report. If any of the following risks occur, our business,
financial condition, results of operations and future growth prospects would like be materially and
adversely affected. In these circumstances, the market price of our common stock could decline,
and you may lose all or part of your investment.
Risks Related to Our Financial Condition and Capital Requirements
We have incurred significant losses since our inception and anticipate that we will incur
continued significant losses for the foreseeable future.
We are a development stage company with only six years of operating history. We have focused
primarily on developing our three product candidates, varespladib, A-623 and varespladib sodium
(A-001). We have financed our operations exclusively through equity offerings, private placements
of convertible debt, and debt financings and we have incurred losses in each year since our
inception in September 2004. Our net losses were approximately $8.7 million in 2006, $25.7 million
in 2007, $18.1 million in 2008, $12.2 million in 2009, and $40.4 million in 2010 and $18.6 million
for the three months ended March 31, 2011. As of March 31, 2011, we had an accumulated deficit of
approximately $124.2 million. Substantially all of our losses resulted from costs incurred in
connection with our product development programs and from general and administrative costs
associated with our operations.
We expect to incur additional losses over the next several years, and these losses may
increase if we cannot generate revenues. Our historical losses, combined with expected future
losses, have had and will continue to have an adverse effect on our stockholders
equity and working capital. We expect our development expenses, as well as our clinical
product manufacturing expenses, to increase in connection with our pivotal Phase 3 clinical study
named VISTA-16 for varespladib, our Phase 2b clinical study named PEARL-SC for A-623 and other
clinical studies related to the development of A-623. In addition, we will incur additional costs
of operating as a
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public company and, if we obtain regulatory approval for any of our product candidates, we may
incur significant sales, marketing, in-licensing and outsourced manufacturing expenses as well as
continued product development expenses. As a result, we expect to continue to incur significant and
increasing losses for the foreseeable future.
We have never generated any revenue and may never be profitable.
Our ability to generate revenue and achieve profitability depends on our ability, alone or
with collaborators, to successfully complete the development of our product candidates, conduct
preclinical tests in animals and clinical studies in human beings, obtain the necessary regulatory
approvals for our product candidates and commercialize any approved products. We have not generated
any revenue from our development-stage product candidates, and we do not know when, or if, we will
generate any revenue. The commercial success of our development-stage product candidates will
depend on a number of factors, including, but not limited to, our ability to:
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obtain favorable results for and advance the development of our lead product candidate,
varespladib, for the treatment of acute coronary syndrome, including successfully launching
and completing the VISTA-16 study;
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obtain favorable results for and advance the development of our product candidate A-623
for the treatment of B-cell mediated autoimmune diseases, including successfully launching
and completing PEARL-SC or other clinical studies in patients with systemic lupus
erythematosus, or lupus, or other indications related to the development of A-623;
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obtain favorable results for and advance the development of our product candidate A-001
for the prevention of acute chest syndrome associated with sickle cell disease, including
completing a multi-center Phase 2 clinical study;
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successfully execute our planned preclinical studies in animals and clinical studies in
human beings for our other product candidates;
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obtain regulatory approval for varespladib, A-623, A-001 and our other product
candidates;
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if regulatory approvals are obtained, begin the commercial manufacturing of our product
candidates with our third-party manufacturers;
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launch commercial sales and effectively market our product candidates, either
independently or in strategic collaborations with third parties; and
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achieve broad market acceptance of our product candidates in the medical community and
with third-party payors.
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All of our product candidates are subject to the risks of failure inherent in the development
of therapeutics based on new technologies. Currently, we have three product candidates in clinical
development: varespladib, A-623 and A-001. These product candidates could fail in clinical studies
if we are unable to demonstrate that they are effective or if they cause unacceptable adverse
effects in the patients we treat. Failure of our product candidates in clinical studies would have
a material adverse effect on our ability to generate revenue or become profitable. If we are not
successful in achieving regulatory approval for our product candidates or are significantly delayed
in doing so, our business will be materially harmed.
Additionally, all of our other product candidates are in preclinical development. Our drug
discovery efforts may not produce any other viable or marketable product candidates. We do not
expect any of our potential product candidates to be commercially available until at least 2013.
Even if our product candidates are approved for commercial sale, the approved product
candidate may not gain market acceptance or achieve commercial success. Physicians, patients,
payors or the medical community in general may be unwilling to accept, utilize or recommend any of
our products. We would anticipate incurring significant costs associated with commercializing any
approved product. Even if we are able to generate product sales, which we cannot guarantee, we may
not achieve profitability soon thereafter, if ever. If we are unable to generate product revenues,
we will not become profitable and may be unable to continue operations without additional funding.
24
We will need substantial additional capital in the future to fund our operations. If additional
capital is not available, we will have to delay, reduce or cease operations.
We will need to raise substantial additional capital to fund our operations and to develop our
product candidates. Our future capital requirements could be substantial and will depend on many
factors including:
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the rate of progress of our Phase 3 clinical study named VISTA-16 study for varespladib
and our Phase 2b clinical study named PEARL-SC or other studies for A-623;
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the scope, size, rate of progress, results and costs of our preclinical studies, clinical
studies and other development activities for one or more of our other product candidates;
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manufacturing campaign of A-623 clinical matters, including formulation development and
enhancement;
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non-clinical activities that we may pursue parallel to clinical trials for each clinical
compound;
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the cost, timing and outcomes of regulatory proceedings;
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payments received under any strategic collaborations;
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the filing, prosecution and enforcement of patent claims;
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the costs associated with commercializing our product candidates if they receive
regulatory approval, including the cost and timing of developing sales and marketing
capabilities, or entering into strategic collaboration with others relating to the
commercialization of our product candidates; and
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revenues received from approved products, if any, in the future.
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As of the date of this report, we anticipate that our existing cash, cash equivalents and
short-term investments, will enable us to maintain our currently planned operations through at
least the next 12 months. Changing circumstances may cause us to consume capital significantly
faster than we currently anticipate. Additional financing may not be available when we need it or
may not be available on terms that are favorable to us. If adequate funds are not available to us
on a timely basis, or at all, we may be required to:
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terminate, reduce or delay preclinical studies, clinical studies or other development
activities for one or more of our product candidates; or
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terminate, reduce or delay our (i) establishment of sales and marketing capabilities,
(ii) pursuit of strategic collaborations with others relating to the sales, marketing and
commercialization of our product candidates or (iii) other activities that may be necessary
to commercialize our product candidates, if approved for sale.
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The timing of the milestone and royalty payments we are required to make to each of Eli Lilly and
Company, Shionogi & Co., Ltd. and Amgen Inc. is uncertain and could adversely affect our cash
flows and results of operations.
In July 2006, we entered into a license agreement with Eli Lilly and Company, or Eli Lilly,
and Shionogi & Co., Ltd. to develop and commercialize certain secretory phospholipase
A
2
, or sPLA
2
, inhibitors for the treatment of cardiovascular disease and
other diseases. Pursuant to our license agreement with them, we have an obligation to pay to each
of Eli Lilly and Shionogi & Co., Ltd. significant milestone and royalty payments based upon how we
develop and commercialize certain sPLA
2
inhibitors, including varespladib and A-001, and
our achievement of certain significant corporate, clinical and financial events. For varespladib,
we are required to pay up to $32.0 million upon achievement of certain approval and post-approval
sales milestones. For A-001, we are required to pay up to $3.0 million upon achievement of certain
clinical development milestones and up to $25.0 million upon achievement of certain approval and
post-approval sales milestones. For other product formulations that we are not currently
developing, we would be required to pay up to $2.0 million upon achievement of certain clinical
development milestones and up to $35.5 million upon achievement of certain approval and
post-approval sales milestones.
In addition, in December 2007, we entered into a license agreement with Amgen Inc., or Amgen,
pursuant to which we obtained an exclusive worldwide license to certain technology and compounds
relating to A-623. Pursuant to our license agreement with Amgen,
we are required to make various milestone payments upon our achievement of certain
development, regulatory and commercial objectives for any A-623 formulation. We are required to pay
up to $10.0 million upon achievement of certain pre-approval clinical
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development milestones and up to $23.0 million upon achievement of certain post-approval
milestones. We are also required to make tiered quarterly royalty payments on net sales, which
increase as a percentage from the high single digits to the low double digits as net sales
increase. The timing of our achievement of these events and corresponding milestone payments
becoming due to Eli Lilly, Shionogi & Co., Ltd. and Amgen is subject to factors relating to the
clinical and regulatory development and commercialization of certain sPLA
2
inhibitors or
A-623, as applicable, many of which are beyond our control. We may become obligated to make a
milestone payment during a period in which we do not have the cash on hand to make such payment,
which could require us to delay our clinical studies, curtail our operations, scale back our
commercialization and marketing efforts, seek funds to meet these obligations at terms unfavorable
to us or default on our license agreements, which could result in license termination.
Our limited operating history makes it difficult to evaluate our business and prospects.
We were incorporated in September 2004. Our operations to date have been limited to organizing
and staffing our company, acquiring product and technology rights, conducting product development
activities for our primary product candidates, varespladib, A-623 and A-001, and performing
research and development. We have not yet demonstrated an ability to obtain regulatory approval for
or commercialize a product candidate. Consequently, any predictions about our future performance
may not be as accurate as they could be if we had a history of successfully developing and
commercializing pharmaceutical products.
Risks Associated with Development and Commercialization of Our Product Candidates
We depend substantially on the success of our three primary product candidates, varespladib, A-623
and A-001, which are still under clinical development. We cannot assure you that these product
candidates or any of our other product candidates will receive regulatory approval or be
successfully commercialized.
To date, we have not obtained marketing approval for, or marketed, distributed or sold any
product candidates. The success of our business depends primarily upon our ability to develop and
commercialize our three primary product candidates successfully. Our lead product candidate is
varespladib, which has completed its Phase 2 clinical studies and for which we have received (i) an
agreement from the U.S. Food and Drug Administration, or FDA, on a Special Protocol Assessment, or
SPA, for the VISTA-16 Phase 3 study protocol, and (ii) scientific advice from the European
Medicines Agency on our European development strategy for varespladib. We initiated the VISTA-16
study for varespladib in June 2010.
Our next product candidate is A-623, which has completed several Phase 1 clinical studies and
recently began enrollment for our Phase 2b clinical study. In July 2010, we received clearance from
the FDA to begin recruitment of lupus patients into the PEARL-SC Phase 2b clinical study. In
November 2010, we placed a voluntary hold on the PEARL-SC study due to problems found with vials.
Patient enrollment in the study was temporarily suspended and dosing was discontinued in patients
who were enrolled in the study while we conducted an analysis of the problem. We resolved the
issues found with the vials in December 2010. After analysis, simulation and consultation with
industry experts, we determined that shipping on dry ice was the root cause of the issue. Shipping
logistics were modified and we reinitiated enrollment in PEARL-SC and dosing in January 2011. We
have received no reports of patient-related side effects or problems with drug administration that
could be attributed to the vial problem.
Our third product candidate, varespladib sodium (A-001), is an intravenously administered
inhibitor of sPLA
2
. We have completed a Phase 2 clinical study for the prevention of
acute chest syndrome associated with sickle cell disease. A pre-specified interim review of our
Phase 2 clinical study results by a Data Safety Monitoring Board, or DSMB, indicated A-001, at a
certain dose, reduced sPLA
2
activity by more than 80% from baseline within 48 hours.
Furthermore, the incidence of acute chest syndrome appeared to be related to the level of
sPLA
2
activity.
Our product candidates are prone to the risks of failure inherent in drug development. Before
obtaining regulatory approvals for the commercial sale of any product candidate for a target
indication, we must demonstrate with substantial evidence gathered in preclinical and
well-controlled clinical studies, and, with respect to approval in the United States, to the
satisfaction of the FDA and, with respect to approval in other countries, similar regulatory
authorities in those countries, that the product candidate is safe and effective for use for that
target indication and that the manufacturing facilities, processes and controls are adequate.
Despite our efforts, our product candidates may not:
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offer therapeutic or other improvement over existing, comparable therapeutics;
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be proven safe and effective in clinical studies;
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meet applicable regulatory standards;
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be capable of being produced in sufficient quantities at acceptable costs;
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be successfully commercialized; or
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obtain favorable reimbursement.
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We are not permitted to market our varespladib and A-001 product candidates in the United
States until we receive approval of a new drug application, or NDA, or with respect to our A-623
product candidate, approval of a biologics license application, or BLA, from the FDA, or in any
foreign countries until we receive the requisite approval from such countries. We have not
submitted an NDA or BLA or received marketing approval for any of our product candidates.
Preclinical testing and clinical studies are long, expensive and uncertain processes. We may
spend several years completing our testing for any particular product candidate, and failure can
occur at any stage. Negative or inconclusive results or adverse medical events during a clinical
study could also cause the FDA or us to terminate a clinical study or require that we repeat it or
conduct additional clinical studies. Additionally, data obtained from a clinical study are
susceptible to varying interpretations and the FDA or other regulatory authorities may interpret
the results of our clinical studies less favorably than we do. The FDA and equivalent foreign
regulatory agencies have substantial discretion in the approval process and may decide that our
data are insufficient to support a marketing application and require additional preclinical,
clinical or other studies.
Any termination or suspension of, or delays in the commencement or completion of, clinical testing
of our product candidates could result in increased costs to us, delay or limit our ability to
generate revenue and adversely affect our commercial prospects.
Delays in the commencement or completion of clinical testing could significantly affect our
product development costs. We do not know whether planned clinical studies will begin on time or be
completed on schedule, if at all. The commencement and completion of clinical studies can be
delayed for a number of reasons, including delays related to:
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obtaining regulatory approval to commence a clinical study or complying with conditions
imposed by a regulatory authority regarding the scope or design of a clinical study;
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reaching agreement on acceptable terms with prospective clinical research organizations,
or CROs, and study sites, the terms of which can be subject to extensive negotiation and may
vary significantly among different CROs and study sites;
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manufacturing, including manufacturing sufficient quantities of a product candidate or
other materials for use in clinical studies;
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obtaining institutional review board, or IRB, approval or the approval of other reviewing
entities to conduct a clinical study at a prospective site;
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recruiting and enrolling patients to participate in clinical studies for a variety of
reasons, including size of patient population, nature of clinical study protocol, the
availability of approved effective treatments for the relevant disease and competition from
other clinical study programs for similar indications;
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severe or unexpected drug-related adverse effects experienced by patients in a clinical
study; and
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retaining patients who have initiated a clinical study, but may withdraw due to treatment
protocol, adverse effects from the therapy, lack of efficacy from the treatment, personal
issues or who are lost to further follow-up.
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Clinical studies may also be delayed, suspended or terminated as a result of ambiguous or
negative interim results, or results that are inconsistent with earlier results. For example, while
an independent statistician has completed an analysis of various biomarkers of cardiovascular risk
and determined that treatment with once-daily varespladib met the pre-specified criteria for the
VISTA-16 study to proceed, an independent DSMB reviewing the clinical data from the VISTA-16 study
may recommend the clinical study discontinue based on safety and tolerability. In addition, a
clinical study may be suspended or terminated by us, the FDA, the IRB or other reviewing entity
overseeing the clinical study at issue, any of our clinical study sites with respect to that site,
or other regulatory authorities due to a number of factors, including:
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failure to conduct the clinical study in accordance with regulatory requirements or our
clinical protocols;
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inspection of the clinical study operations or study sites by the FDA or other regulatory
authorities resulting in the imposition of a clinical hold;
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unforeseen safety issues or any determination that a clinical study presents unacceptable
health risks; and
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lack of adequate funding to continue the clinical study, including the incurrence of
unforeseen costs due to enrollment delays, requirements to conduct additional clinical
studies and increased expenses associated with the services of our CROs and other third
parties.
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Product development costs to us and our collaborators will increase if we have delays in
testing or approval of our product candidates or if we need to perform more or larger clinical
studies than planned. For example, we may need to increase our sample size for our VISTA-16 study
for varespladib if the overall major adverse cardiovascular event, or MACE, rate is lower than
expected. We typically rely on third-party clinical investigators at medical institutions and
health care facilities to conduct our clinical studies and, as a result, we may face additional
delaying factors outside our control.
Additionally, changes in regulatory requirements and policies may occur and we may need to
amend clinical study protocols to reflect these changes. Amendments may require us to resubmit our
clinical study protocols to IRBs for reexamination, which may impact the costs, timing or
successful completion of a clinical study. If we experience delays in completion of, or if we, the
FDA or other regulatory authorities, the IRB or other reviewing entities, or any of our clinical
study sites suspend or terminate any of our clinical studies, the commercial prospects for our
product candidates may be harmed and our ability to generate product revenues will be delayed. In
addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in
the commencement or completion of, clinical studies may also ultimately lead to the denial of
regulatory approval of a product candidate. Also, if one or more clinical studies are delayed, our
competitors may be able to bring products to market before we do, and the commercial viability of
our product candidates could be significantly reduced.
The results of biomarker assays in earlier clinical studies in varespladib are not necessarily
predictive of future results, and therefore the results of biomarker assays in the VISTA-16 study
may not be similar to those observed previously.
Success in our Phase 2 clinical studies in lowering low-density lipoprotein cholesterol, or
LDL-C, C-reactive protein, or CRP, sPLA
2
and interleukin-6, or IL-6, during treatment
with varespladib does not ensure that later clinical studies, such as our VISTA-16 study, will
demonstrate similar reductions in these biomarkers. Each of these biomarkers has been associated
with an increased risk for secondary MACE following an acute coronary syndrome. Our inability to
demonstrate similar biomarker effects in our VISTA-16 study may reduce our ability to achieve our
primary endpoint to reduce MACE and to achieve regulatory approval of varespladib. Recently, an
independent statistician completed an analysis of various biomarkers of cardiovascular risk and
determined that treatment with once-daily varespladib met the pre-specified criteria for the study
to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment
effects versus placebo at relevant time points on a collection of biomarkers including: secretory
phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP),
interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less
than 70 mg/dL and CRP below 1.0 mg/L. Despite these interim results on biomarkers from VISTA-16,
those results do not necessarily equate with reductions in MACE.
Because the results of preclinical testing or earlier clinical studies are not necessarily
predictive of future results, varespladib, A-623, A-001 or any other product candidate we advance
into clinical studies may not have favorable results in later clinical studies or receive
regulatory approval.
Success in preclinical testing and early clinical studies does not ensure that later clinical
studies will generate adequate data to demonstrate the efficacy and safety of an investigational
drug or biologic. A number of companies in the pharmaceutical and biotechnology industries,
including those with greater resources and experience, have suffered significant setbacks in Phase
3 clinical studies, even after seeing promising results in earlier clinical studies. Despite the
results reported in earlier clinical studies for our product candidates, including varespladib,
A-623 and A-001, we do not know whether any Phase 3 or other clinical studies we may conduct will
demonstrate adequate efficacy and safety to result in regulatory approval to market any of our
product candidates. If later stage clinical studies do not produce favorable results, our ability
to achieve regulatory approval for any of our product candidates may be adversely impacted. Even if
we believe that our product candidates have performed satisfactorily in preclinical testing and
clinical studies, we may nonetheless fail to obtain FDA approval for our product candidates.
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If we breach the license agreements for our primary product candidates, we could lose the ability
to continue the development and commercialization of our primary product candidates.
We are party to an agreement with Eli Lilly and Shionogi & Co., Ltd. containing exclusive,
worldwide licenses, except for Japan, of the composition of matter, methods of making and methods
of use for certain sPLA
2
inhibitors. We are also party to an agreement with Amgen
containing exclusive, worldwide licenses of the composition of matter and methods of use for A-623.
These agreements require us to make timely milestone and royalty payments, provide regular
information, maintain the confidentiality of and indemnify Eli Lilly, Shionogi & Co., Ltd. and
Amgen under the terms of the agreements.
If we fail to meet these obligations, our licensors may terminate our exclusive licenses and
may be able to re-obtain licensed technology and aspects of any intellectual property controlled by
us that relate to the licensed technology that originated from the licensors. Our licensors could
effectively take control of the development and commercialization of varespladib, A-623 and A-001
after an uncured, material breach of our license agreements by us or if we voluntarily terminate
the agreements. While we would expect to exercise all rights and remedies available to us,
including seeking to cure any breach by us, and otherwise seek to preserve our rights under the
patents licensed to us, we may not be able to do so in a timely manner, at an acceptable cost or at
all. Any uncured, material breach under the licenses could result in our loss of exclusive rights
and may lead to a complete termination of our product development and any commercialization efforts
for varespladib, A-623 or A-001.
Our industry is subject to intense competition. If we are unable to compete effectively, our
product candidates may be rendered non-competitive or obsolete.
The pharmaceutical industry is highly competitive and subject to rapid and significant
technological change. Our potential competitors include large pharmaceutical and more established
biotechnology companies, specialty pharmaceutical and generic drug companies, academic
institutions, government agencies and other public and private research organizations that conduct
research, seek patent protection and establish collaborative arrangements for research,
development, manufacturing and commercialization. All of these competitors currently engage in,
have engaged in or may engage in the future in the development, manufacturing, marketing and
commercialization of pharmaceuticals and biotechnologies, some of which may compete with our
present or future product candidates. It is possible that any of these competitors could develop
technologies or products that would render our product candidates obsolete or non-competitive,
which could adversely affect our revenue potential. Key competitive factors affecting the
commercial success of our product candidates are likely to be efficacy, safety profile,
reliability, convenience of dosing, price and reimbursement.
The market for inflammatory disease therapeutics is especially large and competitive. All of
the sPLA
2
inhibitor compounds we are currently developing, if approved, will face
intense competition, either as monotherapies or in combination therapies. We are aware of other
companies with products in development that are being tested for anti-inflammatory benefits in
patients with acute coronary syndrome, such as Via Pharmaceuticals, Inc. and its 5-lipoxygenase, or
5-LO, inhibitor, which has been evaluated in Phase 2 clinical studies; and GlaxoSmithKline plc and
its product candidate, darapladib, which is a lipoprotein associated phospholipase A
2
,
or Lp-PLA
2
, inhibitor currently being evaluated in Phase 3 clinical studies. Although
there are no sPLA
2
inhibitor compounds currently approved by the FDA for the treatment
of acute chest syndrome associated with sickle cell disease, Droxia, or hydroxyurea, is approved
for the prevention of vaso-occlusive crisis, or VOC, in sickle cell disease and thus could reduce
the pool of patients with VOC at risk for acute chest syndrome. For lupus, Human Genome Sciences,
Inc.s and GlaxoSmithKline plcs BAFF antagonist monoclonal antibody, Benlysta, was recently
approved by the FDA for treatment of lupus. Further, we are aware of companies with other
products in development that are being tested for potential treatment of lupus, ZymoGenetics, Inc.
and Merck Serono S.A., whose dual BAFF/APRIL antagonist fusion protein, Atacicept, is in a Phase 3
clinical study for lupus; and Immunomedics, Inc. and UCB S.A., who recently reported favorable
results for their CD-22 antagonist humanized antibody, epratuzumab, which completed a Phase 2b
clinical study in lupus and has begun a Phase 3 study, and Eli Lillys anti-BLYS monoclonal
antibody, LY2127399, which has begun two Phase 3 studies.
Many of our potential competitors have substantially greater financial, technical and human
resources than we do and significantly greater experience in the discovery and development of drug
candidates, obtaining FDA and other regulatory approvals of products and the commercialization of
those products. Accordingly, our competitors may be more successful than we may be in obtaining FDA
approval for drugs and achieving widespread market acceptance. Our competitors drugs may be more
effective, have fewer adverse effects, be less expensive to develop and manufacture or be more
effectively marketed and sold than any product candidate we may commercialize and may render our
product candidates obsolete or non-competitive before we can recover the expenses of developing and
commercializing any of our product candidates. We anticipate that we will face intense and
increasing competition as new drugs enter the market and advanced technologies become available.
These entities may also establish collaborative or licensing
relationships with our competitors. Finally, the development of new treatment methods for the
diseases we are targeting could render our drugs non-competitive or obsolete. All of these factors
could adversely affect our business.
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Our product candidates may cause undesirable adverse effects or have other properties that could
delay or prevent their regulatory approval or limit the commercial profile of any approved label.
Undesirable adverse effects caused by our product candidates could cause us, IRBs or other
reviewing entities, clinical study sites, or regulatory authorities to interrupt, delay or halt
clinical studies and could result in the denial of regulatory approval by the FDA or other
regulatory authorities. Phase 2 clinical studies conducted by us with our product candidates have
generated differences in adverse effects and serious adverse events. The most common adverse
effects seen with any of our product candidates versus placebo include diarrhea, headache, nausea
and increases in alanine aminotransferase, which is an enzyme that indicates liver cell injury. The
most common serious adverse events seen with any of our product candidates include death, VOC and
congestive heart failure. While none of these serious adverse events were considered related to the
administration of our product candidates by the clinical investigators, if serious adverse events
that are considered related to our product candidates are observed in any Phase 3 clinical studies,
our ability to obtain regulatory approval for our product candidates may be adversely impacted.
Further, if any of our product candidates receives marketing approval and we or others later
discover, after approval and use in an increasing number of patients, that our products could have
adverse effect profiles that limit their usefulness or require their withdrawal (whether or not the
therapies showed the adverse effect profile in Phase 1 through Phase 3 clinical studies), a number
of potentially significant negative consequences could result, including:
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regulatory authorities may withdraw their approval of the product;
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regulatory authorities may require the addition of labeling statements, such as warnings
or contraindications;
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we may be required to change the way the product is administered, conduct additional
clinical studies or change the labeling of the product;
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
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Any of these events could prevent us from achieving or maintaining market acceptance of the
affected product candidate and could substantially increase the costs of commercializing our
product candidates.
After the completion of our clinical studies, we cannot predict whether or when we will obtain
regulatory approval to commercialize our product candidates and we cannot, therefore, predict the
timing of any future revenue from these product candidates.
Even if we project positive clinical results and file for regulatory approval, we cannot
commercialize any of our product candidates until the appropriate regulatory authorities have
reviewed and approved the applications for such product candidates. We cannot assure you that the
regulatory agencies will complete their review processes in a timely manner or that we will obtain
regulatory approval for any product candidate we develop. Satisfaction of regulatory requirements
typically takes many years, is dependent upon the type, complexity and novelty of the product and
requires the expenditure of substantial resources. In addition, we may experience delays or
rejections based upon additional government regulation from future legislation or administrative
action or changes in FDA policy during the period of product development, clinical studies and FDA
regulatory review.
Our agreement with the FDA on a SPA for our VISTA-16 study of varespladib for the potential
treatment of acute coronary syndrome does not guarantee any particular outcome from regulatory
review of the study or the product candidate.
The FDAs SPA process creates a written agreement between the sponsoring company and the FDA
regarding clinical study design and other clinical study issues that can be used to support
approval of a product candidate. The SPA is intended to provide assurance that if the agreed upon
clinical study protocols are followed and the clinical study endpoints are achieved, the data may
serve as the primary basis for an efficacy claim in support of an NDA. However, the SPA agreement
is not a guarantee of an approval of a product or any permissible claims about the product. In
particular, the SPA is not binding on the FDA if public health concerns unrecognized at the time of
the SPA agreement is entered into become evident, other new scientific concerns regarding product
safety or efficacy arise or if the sponsor company fails to comply with the agreed upon clinical
study protocols. Although we have an agreement with the FDA on an SPA for our VISTA-16 clinical
study of varespladib for the potential short-term (16-week) treatment of acute coronary syndrome,
we do not know how the FDA will interpret the commitments under our agreed upon SPA, how it will
interpret the data and results or whether it will approve our varespladib product candidate for the
short-term (16-week) treatment of acute coronary
30
syndrome. Regardless of our SPA agreement, we cannot guarantee any particular outcome from
regulatory review of our VISTA-16 study.
Even if our product candidates receive regulatory approval, they may still face future development
and regulatory difficulties.
Even if U.S. regulatory approval is obtained, the FDA may still impose significant
restrictions on a products indicated uses or marketing or impose ongoing requirements for
potentially costly post-approval studies or post-market surveillance. For example, the label
ultimately approved for varespladib, if any, may include restrictions on use. Further, the FDA has
indicated that long-term safety data on varespladib may need to be obtained as a post-market
requirement. Our product candidates will also be subject to ongoing FDA requirements governing the
labeling, packaging, storage, distribution, safety surveillance, advertising, promotion,
recordkeeping and reporting of safety and other post-market information. In addition, manufacturers
of drug products and their facilities are subject to continual review and periodic inspections by
the FDA and other regulatory authorities for compliance with current good manufacturing practices,
or cGMP, regulations. If we or a regulatory agency discovers previously unknown problems with a
product, such as adverse events of unanticipated severity or frequency, or problems with the
facility where the product is manufactured, a regulatory agency may impose restrictions on that
product, the manufacturing facility or us, including requiring recall or withdrawal of the product
from the market or suspension of manufacturing. If we, our product candidates or the manufacturing
facilities for our product candidates fail to comply with applicable regulatory requirements, a
regulatory agency may:
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issue warning letters or untitled letters;
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seek an injunction or impose civil or criminal penalties or monetary fines;
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suspend or withdraw regulatory approval;
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suspend any ongoing clinical studies;
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refuse to approve pending applications or supplements to applications filed by us;
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suspend or impose restrictions on operations, including costly new manufacturing
requirements; or
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seize or detain products, refuse to permit the import or export of products, or require
us to initiate a product recall.
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The occurrence of any event or penalty described above may inhibit our ability to
commercialize our products and generate revenue.
New legal and regulatory requirements could make it more difficult for us to obtain approvals for
our product candidates and could limit or make more burdensome our ability to commercialize any
approved products.
New federal legislation or regulatory requirements could affect the requirements for obtaining
regulatory approvals of our product candidates or otherwise limit our ability to commercialize any
approved products or subject our products to more rigorous post-approval requirements. For example,
the FDA Amendments Act of 2007, or FDAAA, granted the FDA new authority to impose post-approval
clinical study requirements, require safety-related changes to product labeling and require the
adoption of risk management plans, referred to in the legislation as risk evaluation and mitigation
strategies, or REMS. The REMS may include requirements for special labeling or medication guides
for patients, special communication plans to health care professionals, and restrictions on
distribution and use. Pursuant to the FDAAA, if the FDA makes the requisite findings, it might
require that a new product be used only by physicians with specified specialized training, only in
specified designated health care settings, or only in conjunction with special patient testing and
monitoring. The legislation also included the following: requirements for providing the public
information on ongoing clinical studies through a clinical study registry and for disclosing
clinical study results to the public through such registry; renewed requirements for conducting
clinical studies to generate information on the use of products in pediatric patients; and
substantial new penalties, for example, for false or misleading consumer advertisements. Other
proposals have been made to impose additional requirements on drug approvals, further expand
post-approval requirements, and restrict sales and promotional activities. The new legislation, and
the additional proposals if enacted, may make it more difficult or burdensome for us to obtain
approval of our product candidates, any approvals we receive may be more restrictive or be subject
to onerous post-approval requirements, our ability to successfully commercialize approved products
may be hindered and our business may be harmed as a result.
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If any of our product candidates for which we receive regulatory approval does not achieve broad
market acceptance, the revenue that we generate from its sales, if any, will be limited.
The commercial success of our product candidates for which we obtain marketing approval from
the FDA or other regulatory authorities will depend upon the acceptance of these products by the
medical community, including physicians, patients and health care payors. The degree of market
acceptance of any of our approved products will depend on a number of factors, including:
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demonstration of clinical safety and efficacy compared to other products;
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the relative convenience, ease of administration and acceptance by physicians and payors
of varespladib in the treatment of acute coronary syndrome, A-623 in the treatment of lupus
and A-001 in the prevention of acute chest syndrome associated with sickle cell disease;
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the prevalence and severity of any adverse effects;
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limitations or warnings contained in a products FDA-approved labeling;
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availability of alternative treatments, including, in the case of varespladib, a number
of competitive products being studied for anti-inflammatory benefits in patients with acute
coronary syndrome or expected to be commercially launched in the near future;
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pricing and cost-effectiveness;
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the effectiveness of our or any future collaborators sales and marketing strategies;
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our ability to obtain and maintain sufficient third-party coverage or reimbursement from
government health care programs, including Medicare and Medicaid; and
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the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
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If our product candidates are approved but do not achieve an adequate level of acceptance by
physicians, health care payors and patients, we may not generate sufficient revenue from these
products, and we may not become or remain profitable. In addition, our efforts to educate the
medical community and third-party payors on the benefits of our product candidates may require
significant resources and may never be successful.
Our future success depends on our ability to retain our chief executive officer and other key
executives and to attract, retain and motivate qualified personnel.
We are highly dependent on Mr. Paul F. Truex, our President and Chief Executive Officer, Dr.
Colin Hislop, our Senior Vice President and Chief Medical Officer and the other principal members
of our executive team. The loss of the services of any of these persons might impede the
achievement of our research, development and commercialization objectives. Recruiting and retaining
qualified scientific personnel and possibly sales and marketing personnel will also be critical to
our success. We may not be able to attract and retain these personnel on acceptable terms given the
competition among numerous pharmaceutical and biotechnology companies for similar personnel. We
also experience competition for the hiring of scientific personnel from universities and research
institutions. Failure to succeed in clinical studies may make it more challenging to recruit and
retain qualified scientific personnel. In addition, we rely on consultants and advisors, including
scientific and clinical advisors, to assist us in formulating our research and development and
commercialization strategy. Our consultants and advisors may be employed by employers other than us
and may have commitments under consulting or advisory contracts with other entities that may limit
their availability to us.
Recently enacted and future legislation or regulatory reform of the health care system in the
United States and foreign jurisdictions may affect our ability to sell our products profitably.
Our ability to commercialize our future products successfully, alone or with collaborators,
will depend in part on the extent to which reimbursement for the products will be available from
government and health administration authorities, private health insurers and other third-party
payors. The continuing efforts of the U.S. and foreign governments, insurance companies, managed
care organizations and other payors of health care services to contain or reduce health care costs
may adversely affect our ability to set prices for our products which we believe are fair, and our
ability to generate revenues and achieve and maintain profitability.
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Specifically, in both the United States and some foreign jurisdictions, there have been a
number of legislative and regulatory proposals to change the health care system in ways that could
affect our ability to sell our products profitably. In March 2010, President Obama signed into law
the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Reconciliation Act, or collectively, the Health Care Reform Law, a sweeping law intended to broaden
access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies
against fraud and abuse, add new transparency requirements for healthcare and health insurance
industries, impose new taxes and fees on the health industry and impose additional health policy
reforms.
We will not know the full effects of the Health Care Reform Law until applicable federal and
state agencies issue regulations or guidance under the new law. Although it is too early to
determine the effect of the Health Care Reform Law, the new law appears likely to continue the
pressure on pharmaceutical pricing, especially under the Medicare program, and also may increase
our regulatory burdens and operating costs. We expect further federal and state proposals and
health care reforms to continue to be proposed by legislators, which could limit the prices that
can be charged for the products we develop and may limit our commercial opportunity.
Also in the United States, the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, also called the Medicare Modernization Act, or MMA, changed the way Medicare covers and
pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by
the elderly and introduced a new reimbursement methodology based on average sales prices for drugs.
In addition, this legislation authorized Medicare Part D prescription drug plans to use formularies
where they can limit the number of drugs that will be covered in any therapeutic class. As a result
of this legislation and the expansion of federal coverage of drug products, we expect that there
will be additional pressure to contain and reduce costs. These cost reduction initiatives and other
provisions of this legislation could decrease the coverage and price that we receive for any
approved products and could seriously harm our business. While the MMA applies only to drug
benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and
payment limitations in setting their own reimbursement rates, and any reduction in reimbursement
that results from the MMA may result in a similar reduction in payments from private payors.
The continuing efforts of government and other third-party payors to contain or reduce the
costs of health care through various means may limit our commercial opportunity. It will be
time-consuming and expensive for us to go through the process of seeking reimbursement from
Medicare and private payors. Our products may not be considered cost-effective, and government and
third-party private health insurance coverage and reimbursement may not be available to patients
for any of our future products or sufficient to allow us to sell our products on a competitive and
profitable basis. Our results of operations could be adversely affected by the MMA, the Health Care
Reform Law, and additional prescription drug coverage legislation, by the possible effect of this
legislation on amounts that private insurers will pay and by other health care reforms that may be
enacted or adopted in the future. In addition, increasing emphasis on managed care in the United
States will continue to put pressure on the pricing of pharmaceutical products. Cost control
initiatives could decrease the price that we or any potential collaborators could receive for any
of our future products and could adversely affect our profitability.
In some foreign countries, including major markets in the European Union and Japan, the
pricing of prescription pharmaceuticals is subject to governmental control. In these countries,
pricing negotiations with governmental authorities can take six to 12 months or longer after the
receipt of regulatory marketing approval for a product. To obtain reimbursement or pricing approval
in some countries, we may be required to conduct a clinical study that compares the
cost-effectiveness of our product candidates to other available therapies. Such pharmacoeconomic
studies can be costly and the results uncertain. Our business could be harmed if reimbursement of
our products is unavailable or limited in scope or amount or if pricing is set at unsatisfactory
levels.
We face potential product liability exposure, and, if successful claims are brought against us, we
may incur substantial liability.
The use of our product candidates in clinical studies and the sale of any products for which
we obtain marketing approval expose us to the risk of product liability claims. Product liability
claims might be brought against us by consumers, health care providers, pharmaceutical companies or
others selling or otherwise coming into contact with our products. If we cannot successfully defend
ourselves against product liability claims, we could incur substantial liabilities. In addition,
regardless of merit or eventual outcome, product liability claims may result in:
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impairment of our business reputation;
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withdrawal of clinical study participants;
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costs of related litigation;
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distraction of managements attention from our primary business;
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substantial monetary awards to patients or other claimants;
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the inability to commercialize our product candidates; and
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decreased demand for our product candidates, if approved for commercial sale.
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Our product liability insurance coverage for our clinical studies may not be sufficient to
reimburse us for all expenses or losses we may suffer. Moreover, insurance coverage is becoming
increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a
reasonable cost or in sufficient amounts to protect us against losses due to liability. If and when
we obtain marketing approval for any of our product candidates, we intend to expand our insurance
coverage to include the sale of commercial products; however, we may be unable to obtain this
product liability insurance on commercially reasonable terms. On occasion, large judgments have
been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. A
successful product liability claim or series of claims brought against us could cause our stock
price to decline and, if judgments exceed our insurance coverage, could decrease our cash and
adversely affect our business.
If we use hazardous and biological materials in a manner that causes injury or violates applicable
law, we may be liable for damages.
Our research and development activities involve the controlled use of potentially hazardous
substances, including toxic chemical and biological materials. We could be held liable for any
contamination, injury or other damages resulting from these hazardous substances. In addition, our
operations produce hazardous waste products. While third parties are responsible for disposal of
our hazardous waste, we could be liable under environmental laws for any required cleanup of sites
at which our waste is disposed. Federal, state, foreign and local laws and regulations govern the
use, manufacture, storage, handling and disposal of these hazardous materials. If we fail to comply
with these laws and regulations at any time, or if they change, we may be subject to criminal
sanctions and substantial civil liabilities, which may harm our business. Even if we continue to
comply with all applicable laws and regulations regarding hazardous materials, we cannot eliminate
the risk of accidental contamination or discharge and our resultant liability for any injuries or
other damages caused by these accidents.
We rely on third parties to conduct, supervise and monitor our clinical studies, and those third
parties may perform in an unsatisfactory manner, such as by failing to meet established deadlines
for the completion of these clinical studies, or may harm our business if they suffer a
catastrophic event.
We rely on third parties such as CROs, medical institutions and clinical investigators to
enroll qualified patients and conduct, supervise and monitor our clinical studies. Our reliance on
these third parties for clinical development activities reduces our control over these activities.
Our reliance on these third parties, however, does not relieve us of our regulatory
responsibilities, including ensuring that our clinical studies are conducted in accordance with
good clinical practices, or GCP, and the investigational plan and protocols contained in the
relevant regulatory application, such as the investigational new drug application, or IND. In
addition, the CROs with whom we contract may not complete activities on schedule, or may not
conduct our preclinical studies or clinical studies in accordance with regulatory requirements or
our clinical study design. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, our efforts to obtain regulatory approvals for, and to
commercialize, our product candidates may be delayed or prevented. In addition, if a catastrophe
such as an earthquake, fire, flood or power loss should affect one of the third parties on which we
rely, our business prospects could be harmed. For example, if a central laboratory holding all of
our clinical study samples were to suffer a catastrophic loss of their facility, we would lose all
of our samples and would have to repeat our studies.
Any failure by our third-party manufacturers on which we rely to produce our preclinical and
clinical drug supplies and on which we intend to rely to produce commercial supplies of any
approved product candidates may delay or impair our ability to commercialize our product
candidates.
We have relied upon a small number of third-party manufacturers and active pharmaceutical
ingredient formulators for the manufacture of our material for preclinical and clinical testing
purposes and intend to continue to do so in the future. We also expect to rely upon third parties
to produce materials required for the commercial production of our product candidates if we succeed
in obtaining necessary regulatory approvals. If we are unable to arrange for third-party
manufacturing sources, or to do so on commercially reasonable terms, we may not be able to complete
development of our product candidates or market them.
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Reliance on third-party manufacturers entails risks to which we would not be subject if we
manufactured product candidates ourselves, including reliance on the third party for regulatory
compliance and quality assurance, the possibility of breach of the manufacturing agreement by the
third party because of factors beyond our control (including a failure to synthesize and
manufacture our product candidates in accordance with our product specifications) and the
possibility of termination or nonrenewal of the agreement by the third party, based on its own
business priorities, at a time that is costly or damaging to us. In addition, the FDA and other
regulatory authorities require that our product candidates be manufactured according to cGMP and
similar foreign standards. Any failure by our third-party manufacturers to comply with cGMP or
failure to scale up manufacturing processes, including any failure to deliver sufficient quantities
of product candidates in a timely manner, could lead to a delay in, or failure to obtain,
regulatory approval of any of our product candidates. In addition, such failure could be the basis
for action by the FDA to withdraw approvals for product candidates previously granted to us and for
other regulatory action, including recall or seizure, total or partial suspension of production or
injunction.
As part of our discussions to reactivate our US IND for A-623, we received a request from the
FDA for additional information regarding the characterization and qualification of the already
manufactured vials of A-623 and plans for any future manufactured vials of A-623 that we intend to
use in clinical studies. In response to this request, we provided the FDA additional analytical
data regarding all lots of previously manufactured A-623 to be utilized in the current PEARL-SC
clinical study. In addition, since new vials of A-623 will be manufactured at a new facility by our
partner Merck Biomanufacturing Network (recently acquired by Fujifilm ), we submitted a
comparability plan to the FDA on March 4, 2011 to establish appropriate comparability and
specifications requirements of newly manufactured vials of A-623 to be included in any future
clinical studies. We have had no comments to date. Should the FDA not agree with our comparability
protocol proposal or if we are unable to agree on the specifications for future A-623
manufacturing, further clinical development of A-623 beyond the PEARL-SC clinical study would be
substantially delayed and we would incur substantial additional expense.
We rely on our manufacturers to purchase from third-party suppliers the materials necessary to
produce our product candidates for our clinical studies. There are a small number of suppliers for
certain capital equipment and raw materials that we use to manufacture our drugs. Such suppliers
may not sell these raw materials to our manufacturers at the times we need them or on commercially
reasonable terms. We do not have any control over the process or timing of the acquisition of these
raw materials by our manufacturers. Moreover, we currently do not have any agreements for the
commercial production of these raw materials. Although we generally do not begin a clinical study
unless we believe we have a sufficient supply of a product candidate to complete the clinical
study, any significant delay in the supply of a product candidate or the raw material components
thereof for an ongoing clinical study due to the need to replace a third-party manufacturer could
considerably delay completion of our clinical studies, product testing and potential regulatory
approval of our product candidates. If our manufacturers or we are unable to purchase these raw
materials after regulatory approval has been obtained for our product candidates, the commercial
launch of our product candidates would be delayed or there would be a shortage in supply of such
product candidates, which would impair our ability to generate revenues from the sale of our
product candidates.
Because of the complex nature of our compounds, our manufacturers may not be able to
manufacture our compounds at a cost or in quantities or in a timely manner necessary to make
commercially successful products. If we successfully commercialize any of our drugs, we may be
required to establish large-scale commercial manufacturing capabilities. In addition, as our drug
development pipeline increases and matures, we will have a greater need for clinical study and
commercial manufacturing capacity. We have no experience manufacturing pharmaceutical products on a
commercial scale and some of these suppliers will need to increase their scale of production to
meet our projected needs for commercial manufacturing, the satisfaction of which on a timely basis
may not be met.
If we are unable to establish sales and marketing capabilities or enter into agreements with third
parties to market and sell our product candidates, we may be unable to generate any revenue.
We do not currently have an organization for the sales, marketing and distribution of
pharmaceutical products and the cost of establishing and maintaining such an organization may
exceed the cost-effectiveness of doing so. In order to market any products that may be approved by
the FDA, we must build our sales, marketing, managerial and other non-technical capabilities or
make arrangements with third parties to perform these services. If we are unable to establish
adequate sales, marketing and distribution capabilities, whether independently or with third
parties, we may not be able to generate product revenue and may not become profitable. We will be
competing with many companies that currently have extensive and well-funded marketing and sales
operations. Without an internal team or the support of a third party to perform marketing and sales
functions, we may be unable to compete successfully against these more established companies.
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Guidelines and recommendations published by various organizations may adversely affect the use of
any products for which we may receive regulatory approval.
Government agencies issue regulations and guidelines directly applicable to us and to our
product candidates. In addition, professional societies, practice management groups, private health
or science foundations and organizations involved in various diseases from time to time publish
guidelines or recommendations to the medical and patient communities. These various sorts of
recommendations may relate to such matters as product usage and use of related or competing
therapies. For example, organizations like the American Heart Association have made recommendations
about therapies in the cardiovascular therapeutics market. Changes to these recommendations or
other guidelines advocating alternative therapies could result in decreased use of any products for
which we may receive regulatory approval, which may adversely affect our results of operations.
Risks Related to Our Intellectual Property
If our or our licensors patent positions do not adequately protect our product candidates or any
future products, others could compete with us more directly, which would harm our business.
As of the date of this report, we hold a total of four pending U.S. non-provisional patent
applications, two pending U.S. provisional patent applications and two pending Patent Cooperation
Treaty, or PCT, patent applications. Another PCT application has entered the national phase in the
European Patent Office, the Eurasian Patent Organization and 17 other countries. We have also
entered into exclusive license agreements for certain composition of matter, method of use and
method of making patents and patent applications for certain of our development compounds. These
license agreements encompass (i) 13 U.S. patents, one pending U.S. non-provisional patent
application, five European, or EP, patents, one pending EP patent application, 20 non-EP foreign
patents and three pending non-EP foreign patent applications relating to varespladib and A-001;
(ii) more than 30 U.S. patents, one pending U.S. non-provisional patent application, five EP
patents, one pending EP patent application, 10 issued non-EP foreign patents and one pending non-EP
foreign patent applications relating to other sPLA
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inhibiting compounds including
A-003; and (iii) two U.S. patents, one pending U.S. non-provisional patent application, one EP
patent, two pending EP patent applications, eleven non-EP foreign patents and 13 non-EP foreign
patent applications relating to A-623. Our commercial success will depend in part on our and our
licensors ability to obtain additional patents and protect our existing patent positions,
particularly those patents for which we have secured exclusive rights, as well as our ability to
maintain adequate protection of other intellectual property for our technologies, product
candidates and any future products in the United States and other countries. If we or our licensors
do not adequately protect our intellectual property, competitors may be able to use our
technologies and erode or negate any competitive advantage we may have, which could materially harm
our business, negatively affect our position in the marketplace, limit our ability to commercialize
our product candidates and delay or render impossible our achievement of profitability. The laws of
some foreign countries do not protect our proprietary rights to the same extent as the laws of the
United States, and we may encounter significant problems in protecting our proprietary rights in
these countries.
The patent positions of biotechnology and pharmaceutical companies, including our patent
position, involve complex legal and factual questions, and, therefore, validity and enforceability
cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated or
circumvented. We and our licensors will be able to protect our proprietary rights from unauthorized
use by third parties only to the extent that our proprietary technologies, product candidates and
any future products are covered by valid and enforceable patents or are effectively maintained as
trade secrets.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure
that:
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we or our licensors were the first to make the inventions covered by each of our pending
patent applications;
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we or our licensors were the first to file patent applications for these inventions;
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others will not independently develop similar or alternative technologies or duplicate
any of our technologies;
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any of our or our licensors pending patent applications will result in issued patents;
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any of our or our licensors patents will be valid or enforceable;
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any patents issued to us or our licensors and collaborators will provide a basis for
commercially viable products, will provide us with any competitive advantages or will not be
challenged by third parties;
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we will develop additional proprietary technologies or product candidates that are
patentable; or
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the patents of others will not have an adverse effect on our business.
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We may be unable to adequately prevent disclosure of trade secrets and other proprietary
information.
We rely on trade secrets to protect our proprietary know-how and technological advances,
especially where we do not believe patent protection is appropriate or obtainable. However, trade
secrets are difficult to protect. We rely in part on confidentiality agreements with our employees,
consultants, outside scientific collaborators, sponsored researchers and other advisors to protect
our trade secrets and other proprietary information. These agreements may not effectively prevent
disclosure of confidential information and may not provide an adequate remedy in the event of
unauthorized disclosure of confidential information. In addition, others may independently discover
our trade secrets and proprietary information. Costly and time-consuming litigation could be
necessary to enforce and determine the scope of our proprietary rights. Failure to obtain or
maintain trade secret protection could enable competitors to use our proprietary information to
develop products that compete with our products or cause additional, material adverse effects upon
our competitive business position.
We license patent rights from third-party owners. If we, or such owners, do not properly maintain
or enforce the patents underlying such licenses, our competitive position and business prospects
will be harmed.
We have obtained exclusive, worldwide licenses, except for Japan, of the composition of
matter, methods of making and methods of use for certain sPLA
2
compounds from Eli Lilly
and Shionogi & Co., Ltd. In addition, we are party to a license agreement with Amgen that provides
exclusive and worldwide rights to develop and commercialize A-623, a novel BAFF inhibitor, as well
as non-exclusive rights to certain technology relating to peptibody compositions and formulations.
We may enter into additional licenses to third-party intellectual property in the future.
We depend in part on our licensors to protect the proprietary rights covering our in-licensed
sPLA
2
compounds and A-623, respectively. Our licensors are responsible for maintaining
certain issued patents and prosecuting certain patent applications. We have limited, if any,
control over the amount or timing of resources that our licensors devote on our behalf or the
priority they place on maintaining these patent rights and prosecuting these patent applications to
our advantage. Our licensors may also be notified of alleged infringement and be sued for
infringement of third-party patents or other proprietary rights. We may have limited, if any,
control or involvement over the defense of these claims, and our licensors could be subject to
injunctions and temporary or permanent exclusionary orders in the United States or other countries.
Our licensors are not obligated to defend or assist in our defense against third-party claims of
infringement. We have limited, if any, control over the amount or timing of resources, if any, that
our licensors devote on our behalf or the priority they place on defense of such third-party claims
of infringement.
Our success will depend in part on the ability of us or our licensors to obtain, maintain and
enforce patent protection for their intellectual property, in particular, those patents to which we
have secured exclusive rights. We or our licensors may not successfully prosecute the patent
applications which we have licensed. Even if patents issue in respect of these patent applications,
we or our licensors may fail to maintain these patents, may determine not to pursue litigation
against other companies that are infringing these patents or may pursue such litigation less
aggressively than we would. Without protection for the intellectual property we license, other
companies might be able to offer substantially identical products for sale, which could adversely
affect our competitive business position and harm our business prospects.
If we do not obtain protection under the Hatch-Waxman Act and similar foreign legislation to
extend our licensed patent terms and to obtain market exclusivity for our product candidates, our
business will be materially harmed.
The United States Drug Price Competition and Patent Term Restoration Act of 1984, more
commonly known as the Hatch-Waxman Act, provides for an extension of patent term for drug
compounds for a period of up to five years to compensate for time spent in the regulatory approval
process. Assuming we gain a five-year patent term extension for each of our current product
candidates in clinical development, and that we continue to have rights under our license
agreements with respect to these product candidates, we would have exclusive rights to
varespladibs U.S. new chemical entity patent (the primary patent covering the compound as a new
composition of matter) until 2019 and to A-623s U.S. new chemical entity patent until 2027. In
Europe, similar legislative enactments allow patent terms in the European Union to be extended for
up to five years through the grant of a Supplementary Protection Certificate. Assuming we gain such
a five-year extension for each of our current product candidates in clinical development, and that
we continue to have rights under our license agreements with respect to these product candidates,
we would have exclusive rights to varespladibs European new chemical entity patents until 2020 and
to A-623s European new chemical
entity patents until 2027. In addition, since varespladib has not been previously approved in
the United States, varespladib could be eligible for up to five years of New Chemical Entity, or
NCE, exclusivity from the FDA. NCE exclusivity would prevent the FDA
37
from approving any generic competitor following NDA approval independent of the patent status of
varespladib. Further, since A-623 has not been previously approved, A-623 could be eligible for 12
years of data exclusivity from the FDA. During the data exclusivity period, competitors are barred
from relying on the innovator biologics safety and efficacy data to gain approval. Similarly, the
European Union provides that companies who receive regulatory approval for a new small molecule
compound or biologic will have a 10-year period of data exclusivity for that compound or biologic
(with the possibility of a further one-year extension) in most EU countries, beginning on the date
of such European regulatory approval, regardless of when the European new chemical entity patent
covering such compound expires. A generic version of the approved drug may not be marketed or sold
during such market exclusivity period. However, there is no assurance that we will receive the
extensions of our patents or other exclusive rights available under the Hatch-Waxman Act or similar
foreign legislation. If we fail to receive such Hatch-Waxman extensions or marketing exclusivity
rights or if we receive extensions that are materially shorter than expected, our ability to
prevent competitors from manufacturing, marketing and selling generic versions of our products will
be materially harmed.
Our current patent positions and license portfolio may not include all patent rights needed for
the full development and commercialization of our product candidates. We cannot be sure that
patent rights we may need in the future will be available for license to us on commercially
reasonable terms, or at all.
We typically develop our product candidates using compounds for which we have in-licensed and
original composition of matter patents and patents that claim the activities and methods for such
compounds production and use to the extent known at that time. As we learn more about the
mechanisms of action and new methods of manufacture and use of these product candidates, we may
file additional patent applications for these new inventions or we may need to ask our licensors to
file them. We may also need to license additional patent rights or other rights on compounds,
treatment methods or manufacturing processes because we learn that we need such rights during the
continuing development of our product candidates.
Although our in-licensed and original patents may prevent others from making, using or selling
similar products, they do not ensure that we will not infringe the patent rights of third parties.
We may not be aware of all patents or patent applications that may impact our ability to make, use
or sell any of our product candidates or proposed product candidates. For example, because we
sometimes identify the mechanism of action or molecular target of a given product candidate after
identifying its composition of matter and therapeutic use, we may not be aware until the mechanism
or target is further elucidated that a third party has an issued or pending patent claiming
biological activities or targets that may cover our product candidate. U.S. patent applications
filed after November 29, 2000 are confidential in the U.S. Patent and Trademark Office for the
first 18 months after such applications earliest priority date, and patent offices in non-U.S.
countries often publish patent applications for the first time six months or more after filing.
Furthermore, we may not be aware of published or granted conflicting patent rights. Any conflicts
resulting from patent applications and patents of others could significantly reduce the coverage of
our patents and limit our ability to obtain meaningful patent protection. If others obtain patents
with conflicting claims, we may need to obtain licenses to these patents or to develop or obtain
alternative technology.
We may not be able to obtain any licenses or other rights to patents, technology or know-how
from third parties necessary to conduct our business as described in this report and such licenses,
if available at all, may not be available on commercially reasonable terms. Any failure to obtain
such licenses could delay or prevent us from developing or commercializing our drug candidates or
proposed product candidates, which would harm our business. Litigation or patent interference
proceedings may be necessarily brought against third parties, as discussed below, to enforce any of
our patents or other proprietary rights or to determine the scope and validity or enforceability of
the proprietary rights of such third parties.
Litigation regarding patents, patent applications and other proprietary rights may be expensive
and time consuming. If we are involved in such litigation, it could cause delays in bringing
product candidates to market and harm our ability to operate.
Our commercial success will depend in part on our ability to manufacture, use, sell and offer
to sell our product candidates and proposed product candidates without infringing patents or other
proprietary rights of third parties. Although we are not currently aware of any litigation or other
proceedings or third-party claims of intellectual property infringement related to our product
candidates, the pharmaceutical industry is characterized by extensive litigation regarding patents
and other intellectual property rights. Other parties may obtain patents in the future and allege
that the use of our technologies infringes these patent claims or that we are employing their
proprietary technology without authorization. Likewise, third parties may challenge or infringe
upon our or our licensors existing or future patents.
Proceedings involving our patents or patent applications or those of others could result in
adverse decisions regarding the patentability of our inventions relating to our product candidates
or the enforceability, validity or scope of protection offered by our patents relating to our
product candidates.
38
Even if we are successful in these proceedings, we may incur substantial costs and divert
management time and attention in pursuing these proceedings. If we are unable to avoid infringing
the patent rights of others, we may be required to seek a license, defend an infringement action or
challenge the validity of the patents in court. Patent litigation is costly and time-consuming. We
may not have sufficient resources to bring these actions to a successful conclusion. In addition,
if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an
infringement action successfully or have our patents declared invalid, we may incur substantial
monetary damages; encounter significant delays in bringing our product candidates to market; or be
precluded from participating in the manufacture, use or sale of our product candidates or methods
of treatment requiring licenses.
Risks Related to the Securities Markets and Investment in Our Common Stock
Market volatility may affect our stock price and the value of your investment.
The market price for our common stock has been, and is likely to continue to be, volatile. In
addition, the market price of our common stock may fluctuate significantly in response to a number
of factors, most of which we cannot predict or control, including:
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plans for, progress in and results from clinical studies for varespladib, A-623, A-001
and our other product candidates;
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announcements of new products, services or technologies, commercial relationships,
acquisitions or other events by us or our competitors;
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developments concerning proprietary rights, including those pertaining to patents held by
Eli Lilly and Shionogi & Co., Ltd. concerning our sPLA
2
inhibitors and Amgen
concerning A-623;
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failure of any of our product candidates, if approved, to achieve commercial success;
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fluctuations in stock market prices and trading volumes of securities of similar
companies;
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general market conditions and overall fluctuations in U.S. equity markets;
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variations in our operating results, or the operating results of our competitors;
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changes in our financial guidance or securities analysts estimates of our financial
performance;
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changes in accounting principles;
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sales of large blocks of our common stock, including sales by our executive officers,
directors and significant stockholders;
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additions or departures of any of our key personnel;
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announcements related to litigation;
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changing legal or regulatory developments in the United States and other countries; and
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discussion of us or our stock price by the financial press and in online investor
communities.
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Although our common stock is listed for trading on the NASDAQ Global Market, our securities
have been relatively thinly traded. Investor trading patterns could serve to exacerbate the
volatility of the price of the stock. Accordingly, it may be difficult to sell shares of common
stock quickly without significantly depressing the value of the stock. Unless we are successful in
developing continued investor interest in our stock, sales of our stock could result in major
fluctuations in the price of the stock. In addition, the stock market in general, and The NASDAQ
Global Market in particular, have experienced substantial price and volume volatility that is often
seemingly unrelated to the operating performance of particular companies. These broad market
fluctuations may cause the trading price of our common stock to decline. In the past, securities
class action litigation has often been brought against a company after a period of volatility in
the market price of its common stock. We may become involved in this type of litigation in the
future. Any securities litigation claims brought against us could result in substantial expenses
and the diversion of our managements attention from our business.
Because a small number of our existing stockholders own a majority of our voting stock, your
ability to influence corporate matters will be limited.
Our executive officers, directors and greater than 5% stockholders, in the aggregate, own
approximately 75% of our outstanding common stock. As a result, such persons, acting together, will
have the ability to control our management and affairs and substantially
39
all matters submitted to our stockholders for approval, including the election and removal of
directors and approval of any significant transaction. These persons will also have the ability to
control our management and business affairs. This concentration of ownership may have the effect of
delaying, deferring or preventing a change in control, impeding a merger, consolidation, takeover
or other business combination involving us, or discouraging a potential acquirer from making a
tender offer or otherwise attempting to obtain control of our business, even if such a transaction
would benefit other stockholders.
Future sales of our common stock may cause our stock price to decline.
As of March 31, 2011, there were 32,926,100 shares of our common stock outstanding. In
addition, as of March 31, 2011, we had outstanding options to purchase shares of our common stock
and restricted stock units of 2,512,931 that, if exercised or released, will result in these
additional shares becoming available for sale. A large portion of these shares and outstanding
equity awards are held by a small number of persons and investment funds. Sales by these
stockholders or option holders of a substantial number of shares could significantly reduce the
market price of our common stock. Moreover, certain holders of shares of common stock will have
rights, subject to some conditions, to require us to file registration statements covering the
shares they currently hold, or to include these shares in registration statements that we may file
for ourselves or other stockholders.
We have registered all common stock that we may issue under our Amended and Restated 2010
Stock Option and Incentive Plan (the 2010 Plan) and our Employee Stock Purchase Plan (the
ESPP). As of March 31, 2011, an aggregate of 1,778,261 shares of our common stock has been
reserved for future issuance under the 2010 Plan, plus any shares reserved and unissued under our
2005 Equity Incentive Plan, and an aggregate of 350,000 shares has been reserved for future
issuance under our ESPP. These shares can be freely sold in the public market upon issuance. If a
large number of these shares are sold in the public market, the sales could reduce the trading
price of our common stock.
In addition, we have filed a universal shelf registration statement with the SEC on Form S-3
(File No. 333-172637) on March 7, 2011, which was declared effective on March 11, 2011, for the
proposed offering from time to time of up to $75.0 million of our securities, including common
stock, preferred stock, debt securities and/or warrants. We may issue securities in the future
pursuant to the shelf registration statement based on market conditions or other circumstances.
We may need to raise additional capital to fund our operations, which may cause dilution to our
existing stockholders, restrict our operations or require us to relinquish rights.
We may seek additional capital through a combination of private and public equity offerings,
debt financings and collaboration, strategic and licensing arrangements. To the extent that we
raise additional capital through the sale of equity or convertible debt securities, your ownership
interest may be diluted, and the terms may include liquidation or other preferences that adversely
affect your rights as a stockholder. Debt financing, if available, may involve agreements that
include covenants limiting or restricting our ability to take specific actions such as incurring
debt, making capital expenditures or declaring dividends. If we raise additional funds through
collaboration, strategic alliance and licensing arrangements with third parties, we may have to
relinquish valuable rights to our technologies or product candidates or grant licenses on terms
that are not favorable to us.
Operating as a public company increases our expenses and administrative burden.
As a public company, we incur significant legal, accounting and other expenses that we did not
incur as a private company. In addition, our administrative staff will be required to perform
additional tasks. For example, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well
as rules subsequently implemented by the SEC and The NASDAQ Global Market, impose various
requirements on public companies, including establishment and maintenance of effective disclosure
and financial controls and changes in corporate governance practices. We must also bear all of the
internal and external costs of preparing and distributing periodic public reports in compliance
with our obligations under the securities laws.
In particular, the Sarbanes-Oxley Act requires, among other things, that we maintain effective
internal control over financial reporting and disclosure controls and procedures. Commencing in
2011, we must perform system and process evaluation and testing of our internal control over
financial reporting to allow management and our independent registered public accounting firm to
report on the effectiveness of our internal control over financial reporting, as required by
Section 404 of the Sarbanes-Oxley Act. Our compliance with Section 404 will require that we incur
substantial accounting expense and expend significant management time on compliance-related issues.
Moreover, if we are not able to comply with the requirements of Section 404 in a timely manner, our
stock price could decline, and we could face sanctions, delisting or investigations by The NASDAQ
Global Market, or other material adverse effects on our business, reputation, results of
operations, financial condition or liquidity.
40
We do not intend to pay dividends on our common stock so any returns will be limited to the value
of our stock.
We have never declared or paid any cash dividend on our common stock. We currently anticipate
that we will retain future earnings for the development, operation and expansion of our business
and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return
to stockholders will therefore be limited to the value of their stock.
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition
of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our
stockholders to replace or remove our current management.
Provisions in our amended and restated certificate of incorporation and amended and restated
bylaws may delay or prevent an acquisition of us or a change in our management. These provisions
include:
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a classified and staggered board of directors whose members can only be dismissed for
cause;
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the prohibition on actions by written consent of our stockholders;
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the limitation on who may call a special meeting of stockholders;
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the establishment of advance notice requirements for nominations for election to our
board of directors or for proposing matters that can be acted upon at stockholder meetings;
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the ability of our board of directors to issue preferred stock without stockholder
approval, which would increase the number of outstanding shares and could thwart a takeover
attempt; and
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the requirement of at least 75% of the outstanding common stock to amend any of the
foregoing provisions.
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In addition, because we are incorporated in Delaware, we are governed by the provisions of
Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders
owning in excess of 15% of our outstanding voting stock to merge or combine with us. Although we
believe these provisions collectively provide for an opportunity to obtain greater value for
stockholders by requiring potential acquirors to negotiate with our board of directors, they would
apply even if an offer rejected by our board were considered beneficial by some stockholders. In
addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or
remove our current management by making it more difficult for stockholders to replace members of
our board of directors, which is responsible for appointing the members of our management.
Our ability to use our net operating loss carryforwards may be subject to limitation and may
result in increased future tax liability to us.
Generally, a change of more than 50% in the ownership of a corporations stock, by value, over
a three-year period constitutes an ownership change for U.S. federal income tax purposes. An
ownership change may limit a companys ability to use its net operating loss carryforwards
attributable to the period prior to such change. We have not performed a detailed analysis to
determine whether an ownership change under Section 382 of the Internal Revenue Code has occurred
after each of our previous private placements of preferred stock and convertible debt, or our
previous issuances of common stock, which if sufficient, taking into account prior or future shifts
in our ownership over a three-year period, could cause us to undergo an ownership change. As a
result, if we earn net taxable income, our ability to use our pre-change net operating loss
carryforwards to offset U.S. federal taxable income may become subject to limitations, which could
potentially result in increased future tax liability to us.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Previously reported in a Current Report on Form 8-K.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. (REMOVED AND RESERVED)
ITEM 5. OTHER INFORMATION
None.
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ITEM 6. EXHIBITS
The following exhibits are filed as part of this report:
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3.1
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Fifth Amended and Restated Certificate of Incorporation (filed as Exhibit 3.6 to
the registrants Registration Statement on Form S-1/A (File No. 333-161930) filed
with the SEC on February 3, 2010, and incorporated herein by reference).
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3.2
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Amended and Restated Bylaws (filed as Exhibit 3.7 to the registrants
Registration Statement on Form S-1/A (File No. 333-161930) filed with the SEC on
February 3, 2010, and incorporated herein by reference).
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10.1
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Second Addendum to Sublease by and between the Company and Millipore Corporation,
as a successor in interest to Guava Technologies, dated as of January 12, 2011
(filed as Exhibit 10.41 to the registrants Annual Report on Form 10-K filed with
the SEC on March 7, 2011, and incorporated herein by reference).
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10.2
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Loan and Security Agreement dated
March 25, 2011, by and between the Company, Hercules Technology
II, L.P. and Hercules Technology Growth Capital, Inc.,
(filed as Exhibit 10.1 to the registrants Current Report on Form 8-K filed with
the SEC on March 29, 2011, and incorporated herein by reference).
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10.3
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Form of Warrant Agreement dated March 25, 2011 (filed as Exhibit 10.2 to
registrants Current Report on Form 8-K filed with the SEC on March 29, 2011, and
incorporated herein by reference).
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10.4
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Lease by and between the Company and MEPT Mount Eden LLC, dated as of May 4, 2011.
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31.1
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Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule
15d-14(a) of the Securities Exchange Act of 1934, as amended.
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31.2
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Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule
15d-14(a) of the Securities Exchange Act of 1934, as amended.
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32.1
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Certification of Principal Executive Officer pursuant to Rule 13a-14(b) of the
Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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32.2
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Certification of Principal Financial Officer pursuant to Rule 13a-14(b) of the
Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as
adopted pursuant Section 906 of the Sarbanes-Oxley Act of 2002.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ANTHERA PHARMACEUTICALS, INC.
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May 13, 2011
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By:
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/s/ Paul F. Truex
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Paul F. Truex
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President and Chief Executive Officer
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May 13, 2011
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By:
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/s/ Christopher P. Lowe
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Christopher P. Lowe
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Chief Financial Officer
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43
EXHIBIT 10.4
LEASE
THIS LEASE (this
Lease
) is made as of May 4, 2011, by and between
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Landlord
MEPT Mount Eden LLC, a Delaware limited liability company
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and
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Tenant
Anthera Pharmaceuticals, a Delaware corporation
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SECTION 1: BASIC TERMS AND DEFINITIONS
Project
: Mt. Eden Business Park.
Building
: The building at 25801 Industrial Blvd., Hayward, CA, commonly known as Building
A and located on the real estate legally described on
Exhibit A
(the
Land
).
Premises
: The portion of the Building designated as Suite 200 and depicted on the plan
attached as
Exhibit B
.
Rentable Area of Premises
: 14,034 rentable square feet, measured in accordance with
ANSI/BOMA Z65.1-1996.
Rentable Area of Building
: 42,855 rentable square feet, measured in accordance with
ANSI/BOMA Z65.1-1996.
Tenants Pro Rata Share
: Thirty-Two and Seventy-Five Hundredths Percent (32.75%) which is
the Rentable Area of Premises divided by the Rentable Area of the Building.
Commencement Date
: August 1, 2011.
Lease Term
: Subject to the early termination right contained in Section 2.5 below,
commencing on the Commencement Date and ending on the last day of that calendar month which is
thirty-eight (38) months after the Commencement Date.
Base Rent
: The monthly amount of Base Rent and the portion of the Lease Term during which
such monthly amount of Base Rent is payable shall be determined from the following table:
(
Premises: 14,034 RSF
)
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Rate
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Applicable Portion of Lease Term
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Per/Rentable
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Monthly Base
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Beginning first day of
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Ending last day of
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Sq. Ft./Month
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Rent Installment
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Annual Base Rent
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Month 1
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Month 2
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$
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0.00
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(1)
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$
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0.00
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(1)
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$
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0.00
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(1)
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Month 3
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Month 12
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$
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0.99
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NNN
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$
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13,893.66
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$
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166,723.92
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Month 13
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Month 24
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$
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1.0197
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NNN
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$
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14,310.47
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$
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171,725.64
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Month 25
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Month 36
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$
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1.0503
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NNN
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$
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14,739.78
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$
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176,877.36
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Month 37
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Month 38
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$
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1.0818
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NNN
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$
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15,181.97
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$
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182,183.64
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(1)
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The Base Rent for the first two (2) months of the Lease Term shall be abated
and shall become immediately due and payable if at any time during the initial Lease Term, there is
an Event of Default by Tenant as described in Section 5.1.1 below. Tenant shall remain responsible
for Operating Costs Reimbursements during such period.
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Operating Costs Reimbursements Estimate for 2011
: Zero and 27/100 Dollars ($0.27) per
month.
Prepaid Rent
: Thirteen Thousand Eight Hundred Ninety-Three and 66/100 Dollars
($13,893.66).
Security Deposit
: Thirteen Thousand Eight Hundred Ninety-Three and 66/100 Dollars
($13,893.66).
1
Parking
: Three and one-half (3.5) non-reserved parking stalls per 1,000 rentable square
feet of the Premises for a total of approximately forty-nine (49) parking stalls, at no
additional charge. In addition, Tenant shall have the use of up to five (5) visitor parking
stalls located throughout the Project during the Lease Term and any extensions thereof.
Manager
: Simeon Commercial Properties, or its replacement as specified by written notice
from Landlord to Tenant.
Tenant Improvement Allowance
: Seventeen and 50/100 Dollars ($17.50) per rentable square
foot of the Premises, to be used as described in Paragraph 2.7 below.
Brokers
: Simeon Commercial Properties, a licensed broker, represents Landlord in this
transaction. Jones Lang LaSalle, a licensed broker, represents Tenant in this transaction.
SECTION 2: PREMISES AND TERM
2.1
Lease of Premises
. Landlord leases the Premises to Tenant, and Tenant leases the
Premises from Landlord, on the terms and conditions set forth in this Lease.
2.2
Rentable Areas
. The Rentable Areas of the Premises and the Building as specified in
Section 1 are final, conclusive and controlling for all purposes. A portion of the Building common
areas is included in the Rentable Area of the Premises.
2.3
Lease Term
. The Lease Term shall be for the period stated in the definition of that
term, unless earlier terminated as provided in this Lease.
2.4
Renewal Option
.
2.4.1 Tenant shall have the option to renew this Lease for one (1) additional extension term
of three (3) years. Such renewal option must be exercised, if at all, by written notice given by
Tenant to Landlord not later than six (6) months and not more than twelve (12) months prior to
expiration of the Lease Term. Timely delivery of notice of exercise of this renewal option shall
act to automatically extend the Lease Term for three years upon the same terms and conditions as
this Lease, except for the amount of Base Rent, which shall be calculated pursuant to this Section
and confirmed by a subsequent document executed by Landlord and Tenant. Notwithstanding the
foregoing, this renewal option shall be null and void and Tenant shall have no right to renew this
Lease if (i) on the date Tenant exercises such renewal option or as of the date immediately
preceding the commencement date of the renewal period, Tenant is in default beyond applicable
notice and cure periods of any of its obligations under this Lease; and (ii) at no time prior to
the expiration of the initial Lease Term shall there have been any assignment or subletting of the
Premises that shall remain in effect after the expiration of the initial Lease Term, except for
Permitted Transfers (as defined below).
2.4.2 If Tenant exercises this renewal option, then during the renewal period the Base Rent
payable by Tenant shall be the then Fair Market Rent for the Premises. For purposes of this
paragraph, the term Fair Market Rent shall mean the rental rate for comparable space for a
renewal term with an existing tenant, situated in comparable office and light warehouse buildings
in comparable business parks in the Hayward, California market area, taking into account tenant
improvement packages and any other customary concessions for renewals with existing tenants. Fair
Market Rent shall include the periodic rental increases, if any, that would be included for space
leased for the renewal period. The Fair Market Rent shall be negotiated by Landlord and Tenant
within the sixty (60) calendar day period commencing upon Landlords receipt of Tenants notice
exercising the renewal option.
2.4.3 If the parties cannot agree on the Fair Market Rent within the sixty (60) day period
after the date of Tenants notice to Landlord, Landlord shall, no more than fifteen (15) calendar
days thereafter, select an independent M.A.I. real estate appraiser (certified in the State of
California) with at least ten (10) years experience in the Hayward, California commercial real
estate market, who shall prepare a written appraisal of the Fair Market Rent using the assumptions
described in this paragraph. The appraisal report shall be completed and delivered to Tenant and
Landlord within fifteen (15) calendar days from the date Landlord selects the appraiser. Such
appraisers determination of Fair Market Rent shall be determinative unless Tenant disputes it as
provided in the next sentence. If Tenant disputes such appraisal, Tenant shall within ten (10)
calendar days following delivery of the appraisal report, deliver to Landlord written notice (a)
that Tenant disputes such appraisal report, and (b) of the identity of the appraiser selected by
Tenant meeting the qualifications set forth in this paragraph. The appraiser selected by Tenant
shall submit his appraisal report of the Fair Market Rent using the assumptions described in this
paragraph within fifteen (15) calendar days following the delivery of Tenants notice to
2
Landlord disputing the initial appraisal. If the two appraisals are within five percent (5%) of
each other (based on the higher number), the Fair Market Rent shall be the higher of the two
appraisals. If not, then within ten (10) calendar days after the delivery of the second appraisal,
the two appraisers shall appoint a third appraiser meeting the qualifications set forth in this
Section, and the third appraiser shall deliver his decision within ten (10) calendar days following
his selection and acceptance of the appraisal assignment. If the two appraisers fail to select a
third qualified appraiser, the third appraiser shall be appointed by the then presiding judge of
the county where the Premises are located upon application by either party. The third appraiser
shall be limited in authority to selecting, in his opinion, which of the two earlier appraisal
determinations best reflects the Fair Market Rent under the assumptions set forth in this
paragraph. The third appraiser must choose one of the two earlier appraisals, and, upon doing so,
the third appraisers determination shall be the controlling determination of the Fair Market Rent.
Each party shall pay the costs and fees of the appraiser it selected; if a third appraiser is
selected, the party whose appraisal is not selected to be the Fair Market Rent by said third
appraiser shall pay all of said appraisers costs and fees.
2.5
Termination Option
. Tenant shall have the one-time right to terminate this Lease
(
Termination Right
) as of the last day of the twenty-fourth (24th) month of the Lease
Term (the
Termination Date
) by providing Landlord with not less than nine (9) months
prior written notice. As a condition to the effectiveness of the Termination Right, Tenant must
satisfy all of the following requirements, satisfaction of which shall mean that the Lease will
terminate on the Termination Date with the same force and effect as if such date were the date
originally established in this Lease for the expiration of the Lease Term:
2.5.1 As of the date that Tenant notifies Landlord of Tenants exercise of this Termination
Right and as of the Termination Date, there shall be no monetary Event of Default (beyond the
expiration of all applicable notice and cure periods) by Tenant under this Lease and there shall
have occurred no act or omission which, with the passage of time or giving of notice, or both,
would become an Event of Default by Tenant under the Lease;
2.5.2 [Intentionally omitted];
2.5.3 At the time Tenant gives written notice to Landlord as provided for in subpart 2.5.1
above, Tenant shall have paid Landlord a termination fee, equal to the unamortized portions of the
Tenant Improvement Allowance and leasing commissions, which shall be amortized over the Lease Term
at an annual interest rate of 8%, and repayment of the initial two (2) months of abated rent. The
amount of the Tenant Improvement Allowance shall be set forth in a written notice from Landlord to
Tenant, as soon as the amount is determined; and
2.5.4 Upon termination of the Lease pursuant to this paragraph, Tenant shall surrender and
vacate the Premises to Landlord as provided for in this Lease. All rights and obligations of
Landlord and Tenant, unless expressly stated herein to survive the expiration or earlier
termination of this Lease, shall cease to exist as of the Termination Date.
2.6
Physical Condition of Premises
.
2.6.1 Tenant (a) accepts the Premises, the Building and the Project in its current
AS IS
condition, and (b) acknowledges that Tenant is not relying on any representations or warranties by
any person regarding the Premises or the Building except as specifically set forth in this Lease.
2.6.2 Landlord represents and warrants to Tenant that, (a) as of the Commencement Date and
for the first twelve (12) months of the Lease Term, all Building systems shall be operational and
in good condition and repair; (b) to Landlords actual knowledge, as of the date of this Lease the
Building and the Premises are in material compliance with all applicable Governmental Requirements;
(c) Landlord is the fee owner of the Building; and (d) as of the date of this Lease, Landlord has
no actual knowledge of any material defects in the Premises or the Building which would
unreasonably interfere with Tenants use and enjoyment of the Premises for the Permitted Use. In
the event of any breach of any of Landlords warranties in this Section 2.6.2, Landlord shall
promptly rectify the same at its sole cost and expense.
2.7
Tenant Improvement Allowance
.
2.7.1 Landlord shall provide a Tenant Improvement Allowance of Seventeen and 50/100 Dollars
($17.50) per rentable square feet for the Premises. The Tenant Improvement Allowance shall be
applied to the hard and soft construction costs incurred by Tenant, including but not limited to,
architectural services, cabling, furniture, electrical, signage, Tenants construction management
fees and any security system associated with the Premises and may used by Tenant to offset moving
costs. If the sum of Tenants actual hard and soft costs associated with the Tenant improvements
to the Premises is less than the Tenant Improvement Allowance, then up to Five and No/100 Dollars
($5.00) per rentable
3
square foot (such amount being the difference between the $17.50/RSF allowance and the amount
actually expended per rentable square feet) shall be applied as a credit against the Base Rent and
Operating Costs Reimbursements due immediately after the eighteenth (18th) month of the Lease Term.
2.7.2 At Tenants option, Landlord shall pay all or any portion of the Tenant Improvement
Allowance directly to third parties, including but not limited to, contractors, architects and
other consultants, based on billing invoices approved in advance in writing by Tenant.
2.8
Construction of Tenant Improvements
.
2.8.1 Tenant shall retain a licensed architect of its choice, subject to Landlords prior
written approval, to prepare the Plans and Specifications for the Tenant Improvements. The Plans
and Specifications shall be subject to Landlords approval, which approval shall not be
unreasonably delayed, provided that such Plans and Specifications comply with the requirements of
this paragraph.
2.8.2 Within one hundred eighty (180) days following the date of execution of the Lease by
Tenant, Tenant shall cause its architect to furnish to Landlord for Landlords approval space plans
sufficient to convey the architectural design of the Premises, including, without limitation, the
location of doors, partitions, electrical and telephone outlets, plumbing fixtures, heavy floor
loads and other special requirements (collectively, the
Space Plan
). If required by
Landlord, Tenants architect shall consult with Landlords engineer in preparing the Space Plan,
and incorporate such engineers requirements into the Space Plan. If Landlord fails to disapprove
the Space Plan within the ten (10) day period following its receipt of the Space Plan, the Space
Plan shall be deemed approved. If Landlord shall disapprove of any portion of the Space Plan
within such ten (10) day period, Landlord shall advise Tenant of the reasons therefor and shall
notify Tenant of the revisions to the Space Plan that are reasonably required by Landlord for the
purpose of obtaining approval. Tenant shall within seven (7) days submit to Landlord, for
Landlords approval, a redesign of the Space Plan, incorporating the revisions required by Landlord
or proposing alternatives for Landlords consideration, which shall be undertaken pursuant to the
process set forth above.
2.8.3 Tenant shall cause its architect to prepare from Tenants approved Space Plan, complete
Plans and Specifications within one hundred twenty (120) days after Landlord approves the Space
Plan. The Plans and Specifications shall (a) be compatible with the Building shell and with the
design, construction and equipment of the Building; (b) comply with all Governmental Requirements;
(c) comply with all applicable insurance regulations; and (d) be consistent with the approved Space
Plan. Tenant shall submit the Plans and Specifications for Landlords Approval in the same manner
and timeframe as provided in Subparagraph 2.8.2 above for approval by Landlord of Tenants Space
Plan.
2.8.4 Tenant shall complete the Tenant Improvements in accordance with the approved Plans and
Specifications and all applicable Governmental Requirements and in accordance with the provisions
of Paragraph 5.8 (
Work Performance and Responsible Contracting)
. Tenant shall provide an
exhibit depicting the intended Tenant Improvements to be attached as an exhibit to this Lease.
Landlord shall review and manage the construction of the Tenant Improvements for a construction
management fee of one and fifty percent (1.5%) of actual hard construction costs.
2.8.5 If Landlord requires performance or payment bonds, they shall be provided at Landlords
sole cost and expense, and shall not be funded from the Tenant Improvement Allowance.
2.8.6 All Tenant Improvements, regardless of which party constructed or paid for them, shall
become the property of Landlord and shall remain upon and be surrendered with the Premises on the
expiration or earlier termination of this Lease. Tenant shall not be responsible for any
restoration (or removal) of its initial Tenant Improvements completed in accordance with the
provisions of this Section 2.8 at the expiration of the Lease Term other than its Telecommunication
Facilities (as defined in Section 4.1.2).
2.9
Commencement Date
. The Commencement Date shall be August 1, 2011. Tenant agrees to
sign a Commencement Date Memorandum in the form of
Exhibit E
, when prepared by Landlord.
2.10
Use and Conduct of Business
.
2.10.1 The Premises are to be used only for general business office and research and
development uses (the
Permitted Uses
). Tenant shall, at its own cost and expense, obtain
and maintain any and all licenses, permits, and approvals necessary or appropriate for its
particular use, occupation and operation of the Premises for the Permitted Uses.
2.10.2 No act shall be done in or about the Premises that is unlawful or that will increase
the existing rate of insurance on the Land or Building. Tenant shall not commit or allow to be
committed or exist: (a) any waste upon the Premises, (b) any public or private nuisance, or (c) any
act or condition
4
which disturbs the quiet enjoyment of any other tenant in the Building, or materially and
unreasonably interferes in any way with the business of Landlord or any other tenant in the
Building.
2.11
Compliance with Governmental Requirements and Rules and Regulations
. Subject to
Section 4.2 below, Tenant shall comply with all Governmental Requirements relating to its
particular use, occupancy and operation of the Premises and shall observe such reasonable rules and
regulations as may be adopted and published by Landlord from time to time. Notwithstanding
anything to the contrary in this Lease, Tenant shall not be responsible for compliance with any
Governmental Requirements where such compliance would require capital expenditures, or is not
related specifically to Tenants use and occupancy of the Premises. For example, if any
Governmental Agency should require the Building or Premises to be structurally strengthened against
earthquake, or should require the removal of asbestos from the Premises and such measures are
imposed as a general requirement applicable to all tenants rather than as a condition to Tenants
specific use or occupancy of the Premises, such work shall be performed by Landlord and the cost
thereof shall be an Operating Costs to the extent provided in Section R1.4 of
Rider 1
hereto. Current Rules and Regulations are attached to this Lease as
Exhibit C
.
Governmental Requirements
are any and all statutes, ordinances, codes, laws, rules,
regulations, orders and directives of any Governmental Agency as now or later amended, promulgated
or issued and all current or future final orders, judgments or decrees of any court with
jurisdiction interpreting or enforcing any of the foregoing. A
Governmental Agency
is
the United States of America, the state in which the Land is located, any county, city, district,
municipality or other governmental subdivision, court or agency or quasi-governmental agency with
jurisdiction and any board, agency or authority associated with any such governmental entity.
2.12
Green Agency Ratings
. The Building may become certified under a Green Agency Rating
(as hereinafter defined) or operated pursuant to Landlords sustainable building practices, as the
same may be in effect or modified from time to time. Landlords sustainability practices address,
without limitation, whole building operations and maintenance issues including chemical use, indoor
air quality, energy efficiency, water efficiency, recycling programs, exterior maintenance
programs, and systems upgrades to meet green building energy, water, indoor air quality, and
lighting performance standards. Tenant will use good faith, commercially reasonable efforts not to
use or operate the Premises in a manner that will cause the Premises not to conform with Landlords
sustainability practices or the certification of the Building by a Green Agency Rating; provided,
however, Tenant may endeavor, at no cost or expense to Tenant, to follow such practices. Landlord
reserves the right to change electricity providers for the Building at any time and to purchase
green or renewable energy. To the extent commercially reasonable, all construction, maintenance
and repairs made by Tenant shall comply with Landlords sustainability practices and with the
minimum standards and specifications as outlined by the Green Agency Rating in addition to all
Governmental Requirements. Tenant shall use proven energy and carbon reduction measures, including
energy efficient bulbs in task lighting; use of lighting controls; daylighting measures to avoid
overlighting interior spaces; closing shades on the south side of the Building to avoid
over-heating the space; turning off lights and equipment at the end of the work day; and purchasing
Energy Star qualified equipment, including but not limited to lighting, office equipment, kitchen
equipment, vending and ice machines; and purchasing products certified by the U.S. EPAs WaterSense
program. As used herein, Green Agency Rating means any one or more of the following ratings, as
the same may be in effect or amended or supplemented from time to time: the U.S. EPAs Energy Star
rating and/or Design to Earn Energy Star, the Green Building Initiatives Green Globes for
Continual Improvement of Existing Buildings (Green Globes-CIEB), the U.S. Green Building Councils
Leadership in Energy and Environmental Design (LEED) rating system, LEED EBOM (existing buildings
operations and maintenance) and any applicable substitute third party or government mandated rating
systems
2.13
Relocation
. Intentionally omitted.
2.14
Holdover
. Base Rent shall increase on the expiration or termination of this Lease to
an amount equal to one hundred fifty percent (150%) of the Base Rent prevailing immediately prior
to the expiration or termination (a) if and for so long as Landlord has authorized Tenant to
holdover or (b) if Tenant wrongfully refuses to relinquish possession of the Premises upon such
expiration or termination. The increase in Base Rent under clause (b) of the preceding sentence is
an agreed increase in Base Rent, is not liquidated damages and shall not limit the right of
Landlord to recover direct and consequential damages for the Tenants violation of this paragraph
or to exercise other rights and remedies provided under applicable law for Tenants wrongful
refusal to surrender possession.
5
SECTION 3: BASE RENT, OPERATING COSTS REIMBURSEMENTS AND OTHER SUMS PAYABLE UNDER LEASE
3.1
Payment of Rental
. Tenant agrees to pay Base Rent, Operating Costs Reimbursements
(defined in
Rider 1
) and any other sum payable under this Lease to Landlord when due
without demand, deduction, credit, adjustment or offset of any kind. All such payments shall be in
lawful money of the United States and shall be paid to Landlord or to Manager or to such other
place as Landlord may from time to time designate in writing.
3.2
Base Rent
. On execution of this Lease, Tenant shall pay to Landlord the amount
specified in the definition of Prepaid Rent for the month specified in the definition of that term.
Monthly installments of Base Rent shall be paid, without demand and in advance, on or before the
first day of each calendar month during the Lease Term. The monthly Base Rent installment for any
partial month at the beginning or end of the Lease Term shall be prorated. Subject to abatement,
Base Rent for any partial month at the beginning of the Lease Term shall be paid by Tenant on the
Commencement Date.
3.3
Security Deposit
. All sums payable under this Lease (including Base Rent and Operating
Costs Reimbursements) shall be considered Rent and all rights and remedies available pursuant to
law for non-payment of rent shall apply. Tenant has deposited with Landlord or Manager the sum set
forth in the blank opposite the words Security Deposit in Section 1 of this Lease (the
Security Deposit
) to secure Tenants performance of this Lease. If Tenant defaults in
any payment or performance due under this Lease, Landlord, in its absolute discretion and without
prejudice in its other rights or remedies, may apply the Security Deposit, in whole or in part, to
the payment of sums due from Tenant as a result of such default. If such application cures the
default, Tenant shall within ten (10) days from demand, deposit with Landlord the sum necessary to
restore the Security Deposit to the specified amount. If Tenant has fully performed under this
Lease, the remainder of the Security Deposit shall be repaid to Tenant, without interest, within
thirty (30) days after the expiration of this Lease, such obligation of Landlord surviving the
expiration or earlier termination of this Lease. If the Land and the Building are sold or
transferred by Landlord, Tenant shall look solely to the successor Landlord for the return of the
remainder of the Security Deposit, provided Landlord has turned over or credited the amount of the
Security Deposit to such successor landlord.
3.4
Operating Costs Reimbursements
. The definition
Operating Costs
Reimbursements
and the provisions of this Lease applicable to Operating Costs Reimbursements
are set forth in
Rider 1
.
3.5
Late Charge
. If Tenant fails to make any payment of Base Rent, or other amount when
due under this Lease, a late charge is immediately due and payable by Tenant equal to five percent
(5%) of the amount of any such payment but Landlord will waive the late charge for the first such
failure occurring during any calendar year during the Lease Term. Landlord and Tenant agree that
this charge compensates Landlord for the administrative costs caused by the late payment.
3.6
Default Rate
. Any Base Rent, Operating Costs Reimbursements or other sum payable under
this Lease which is not paid when due shall bear interest at a rate equal to the lesser of: (a)
the published prime or reference rate then in effect at a national banking institution designated
by Landlord (the
Prime Rate
), plus two (2) percentage points, or (b) the maximum rate of
interest per annum permitted by applicable law (the
Default Rate
).
SECTION 4: SERVICES AND REPAIR
4.1
Utilities and Services
.
4.1.1 Tenant shall contract directly for all utilities and services to the Premises, including
the following: (a) electricity and gas; (b) heating, ventilation and air-conditioning services
(
HVAC
); (c) hot and cold domestic water, wastewater and sewage service at the points now
existing in the Premises or as specified for initial Tenant Improvements (where applicable); (d)
Telecommunication services; (e) cleaning and janitorial service; and (f) refuse/trash removal.
Tenant shall select the company or companies providing such utility and other services described in
this subparagraph.
4.1.2 Landlord will provide only a suitable connection for usual and customary voice telephone
and internet services at the designated locations in the Building. All connection, installation,
usage charges, maintenance and repair charges for such telephone service shall be Tenants
responsibility. Installation of Telecommunication Facilities beyond those specified as Landlords
responsibility under the first sentence shall be the responsibility of Tenant except to the extent
the Initial Tenant Improvements
6
include Telecommunication Facilities.
Telecommunication Facilities
are defined as
equipment, apparatus, installations, facilities and other materials utilized for the purposes of
electronic communication, whether wireless or wired, including cable, switches, conduit, sleeves
and wiring. Tenant shall be required to remove all Telecommunication Facilities, at Tenants
expense, on the expiration or earlier termination of the Lease in accordance with paragraph 5.3
(
Removal of Property
).
4.1.3 Tenant acknowledges that space on the Building rooftop and in Building risers, equipment
rooms and equipment closets is limited. Unless otherwise required by law, neither Tenant nor a
provider of telecommunication services to Tenant shall be entitled to locate or install
Telecommunication Facilities in, on or about the Building without first obtaining Landlords
advance, written consent (given in its reasonable discretion).
4.1.4 Landlord shall in no case be liable or in any way be responsible for damages (including
consequential damages) or the loss to Tenant of utilities or other services arising from the
failure of, diminution of or interruption of any kind to the Premises, unless (a) such interruption
in, deprivation of or reduction of any such service was caused by the gross negligence or willful
misconduct of Landlord, its agents or contractors or by the uncured breach of this Lease by
Landlord, and (b) any such claims are not covered by the business interruption insurance required
of Tenant by this Lease. To the extent that Landlord bears any responsibility for the foregoing,
Landlords responsibility and Tenants remedy shall be limited to an abatement in Base Rent for the
period beginning with (a) the day which is three (3) consecutive days after the date on which
Tenant delivers notice to Landlord of such interruption, deprivation or reduction and of the fact
that Tenant is being deprived of all reasonable use of the Premises and ending on (b) the date such
interruption, deprivation or reduction which is Landlords responsibility is no longer causing
Tenant to be deprived of all reasonable use of the Premises.
4.2
Maintenance and Repair by Landlord
. Subject to the paragraph 5.5 (
Damage or
Destruction
) and paragraph 5.6 (
Condemnation
), Landlord shall maintain the roof,
roof membrane, load-bearing and exterior walls and structural elements of the Building, public and
common areas of the Building, plate glass and the Building systems in good order and condition
subject to reasonable use and wear. The costs of such maintenance and repair are Operating Costs
as defined in subparagraph R1.4.1 of
Rider 1
. Landlord, at its sole cost, shall also be
responsible on an ongoing basis during the Lease Term for any necessary improvements to the
Building shell to comply with building code, the Americans With Disabilities Act of 1990
(
ADA
), and seismic requirements, provided such ADA compliance is not triggered by
Tenants Alterations during the Lease Term. These code compliance costs shall not be allocated as
Operating Costs of the Building or passed through to Tenant. In addition, Landlord, at its sole
cost and not as an Operating Cost, shall be responsible for the demising and separate metering of
all utilities and building systems.
4.3
Maintenance and Repair by Tenant
. Except as specified to be Landlords responsibility
under paragraph 4.1 (
Utilities and Services
) and paragraph 4.2 (
Maintenance and
Repair by Landlord
), and except for reasonable wear and tear, casualty and condemnation,
Tenant shall keep the Premises in good condition and repair. Notwithstanding the foregoing, in the
event that Tenant would be required by this Section to make a repair or replacement that would be
considered a capital improvement as determined in accordance with generally accepted accounting
principles, Landlord shall make such repair or replacement and charge Tenant, as an Operating Cost,
the cost thereof, provided that the cost of such repair or replacement shall be amortized over its
useful life and only the amortized portion of such cost shall be included in Operating Costs on a
monthly basis. Tenant shall be responsible for replacing light bulbs and ballasts within the
Premises. Tenant shall enter into all contracts for all repairs and services related to operating
the Premises. (See Paragraph 4.1 for additional responsibilities by Tenant.) Tenant agrees to
notify Landlord immediately if water or moisture conditions from any source (including leaks) are
discovered and to allow Landlord to evaluate and make recommendations and/or take appropriate
corrective action.
4.4
Common Areas/Security
. The common areas of the Building and the Project shall be under
Landlords sole management and control. Landlord has no duty or obligation to provide any security
services in, on or around the Premises, Land, Building or Project, and Tenant recognizes that
security services, if any, provided by Landlord will be for the sole benefit of Landlord and the
protection of Landlords property.
4.5.
Signage
. Tenant, at its sole cost and expense, shall have the right to the maximum
building top signage on the Premises and to Building, entry, and monument/directional signage in
accordance with
7
Landlords signage criteria without additional rental charges. All such signage shall be subject
to the reasonable approval of Landlord and any required Governmental Agencies.
SECTION 5:
OCCUPANCY PROVISIONS
5.1
Tenant Alterations
. Tenant shall not make or permit to be made any alterations,
additions, improvements or installations in or to the Premises (including Telecommunication
Facilities), or place signs or other displays visible from outside the Premises (individually and
collectively
Tenant Alterations
), without first obtaining the consent of Landlord which
may be withheld in Landlords reasonable discretion. If Landlord fails to respond to Tenants
request within fifteen (15) days after the receipt of Tenants request, Tenant shall give Landlord
a second notice. Landlords failure to respond to Tenants second notice within ten (10) days
after the receipt of Tenants request shall be deemed to be Landlords approval of the proposed
Tenant Alterations. Notwithstanding the foregoing, Tenant, without Landlords prior written
consent, but with prior notice thereto, shall be permitted to make non-structural Tenant
Alterations to the Building, provided that (a) Tenant shall deliver to Landlord in writing
approximately thirty (30) days prior to commencement of the Tenant Alterations a general
description of the Tenant Alterations Tenant intends to make, (b) the cost of such Tenant
Alteration does not exceed Twenty-Five Thousand and No/100 Dollars ($25,000.00) individually, (c)
Tenant shall notify Landlord in writing within thirty (30) days of completion of the Tenant
Alteration and deliver to Landlord a set of the plans and specifications therefor, either
as-built or marked to show construction changes made, and (d) Tenant shall, upon Landlords
request made within ten (10) days after the notice referred to in clause (c), remove the Tenant
Alteration at the termination of the Lease and restore the Premises to their condition prior to
such Tenant Alteration. Tenant shall deliver to Landlord complete plans and specifications for any
proposed Tenant Alterations and, if consent by Landlord is given, all such work shall be performed
at Tenants expense by Landlord or, with Landlords consent, by Tenant. Tenant shall be authorized
to perform Tenant Alterations only to the extent and under such terms and conditions as Landlord,
in its absolute discretion, shall specify which, in all events, shall include compliance with
paragraph 5.8 (
Work Performance and Responsible Contracting
). All Tenant Alterations
performed by Tenant shall be (1) completed in accordance with the plans and specifications approved
by Landlord; (2) completed in accordance with all Governmental Requirements; (3) carried out
promptly in a good and workmanlike manner; (4) of all new materials; and (5) free of defects in
materials and workmanship.
5.2
Surrender of Possession
. Tenant shall, at the expiration or earlier termination of
this Lease, surrender and deliver the Premises to Landlord (a) in as good condition as when
received by Tenant from Landlord or as later improved, reasonable use and wear, casualty and
condemnation excepted, and (b) free from any tenancy or occupancy by any person.
5.3
Removal of Property
. Upon the expiration or earlier termination of this Lease, Tenant
may remove its personal property, office supplies and office furniture and equipment if (a) such
items are readily moveable and are not attached to the Premises; (b) such removal is completed
prior to the expiration or earlier termination of this Lease; and (c) Tenant immediately repairs
all damage caused by or resulting from such removal. All Tenant Alterations shall become the
property of Landlord and shall remain upon and be surrendered with the Premises, unless Landlord
requires their removal at the time Landlord grants consent to the construction of such Tenant
Alterations. In no event shall Tenant have any obligation to remove the initial Tenant
Improvements (other than Telecommunication Facilities) at the expiration of the Lease as required
by Section 2.8 above. If removal is required, Tenant shall, at its sole cost and expense, remove
all (or such portion as Landlord shall designate) of the Tenant Alterations, repair any damages
resulting from such removal and return the Premises to the same condition as existed prior to such
Tenant Alterations.
5.4
Building Hours/Access
. Tenant shall have access to the Building seven (7) days per
week, twenty-four (24) hours per day, fifty-two (52) weeks a year. Tenant shall permit Landlord
and Landlords Affiliates (defined in paragraph 6.1) to enter into the Premises at any time on
reasonable prior written notice (no less than forty-eight (48) hours prior to such entry, except in
case of emergency in which case no notice shall be required) for the purposes of inspection or for
the purpose of repairing, altering or improving the Premises or the Building. When reasonably
necessary, Landlord may temporarily close Building or Land entrances, Building doors or other
facilities, but Landlord shall use good faith efforts to minimize disruption to Tenants business
and shall, in all cases, provide continued access to the Premises. Landlord shall have the right
on reasonable notice to enter the Premises during the last nine
8
(9) months of the Lease Term for the purpose of showing the Premises to prospective tenants and to
erect on the Premises a suitable sign indicating the Premises are available.
5.5
Damage or Destruction
.
5.5.1 If the Premises are damaged by fire, earthquake or other casualty (
Casualty
),
Tenant shall give immediate written notice to Landlord. If Landlord estimates that the damage can
be repaired to meet Tenants business needs within one hundred eighty (180) days after Landlord is
notified by Tenant of such damage and if there are sufficient insurance proceeds available to
repair such damage (net of any deductible), then Landlord shall proceed with reasonable diligence
to restore the Premises to substantially the condition which existed prior to the damage and this
Lease shall not terminate. If neither circumstance described in the previous sentence exists,
Landlord may elect, in its absolute discretion, to either: (a) terminate this Lease or (b) restore
the Premises to substantially the condition which existed prior to the damage and this Lease will
continue. Notice of Landlords election shall be delivered to Tenant within sixty (60) days after
the date Landlord receives written notice of the damage. Failure to deliver notice within the
specified period shall be treated as election not to restore. Tenant agrees to look to the
provider of Tenants insurance for coverage for the loss of Tenants use of the Premises and any
other related losses or damages incurred by Tenant during any reconstruction period following a
Casualty.
5.5.2 If the Building is damaged by Casualty and more than fifty percent (50%) of the Building
is rendered untenantable, without regard to whether the Premises are affected by such damage,
Landlord may, in its absolute discretion, elect to terminate this Lease by notice in writing to
Tenant within thirty (30) days after the date Landlord receives written notice of the damage. Such
notice shall be effective twenty (20) days after delivery to Tenant unless a later date is set
forth in Landlords notice.
5.5.3 Notwithstanding any provision to the contrary contained herein, (i) if Tenants use of
the Premises is substantially impaired for a period of more than one hundred eighty (180) days
after the date of Casualty, or during the last six (6) months of the Lease Term, then both Landlord
and Tenant shall have the right to terminate this Lease by written notice to the other party at any
time thereafter until Tenants use of the Premises is substantially restored, and (ii) if this
Lease is terminated by either Landlord or Tenant due to a Casualty, then Tenant shall not be
required to pay for any insurance deductibles relating to such Casualty as part of Landlords
insurance cost or otherwise.
5.6
Condemnation
. If more than fifty percent (50%) of the Premises, or such portions of
the Building as may be required for the Tenants reasonable use of the Premises, are taken by
eminent domain or by conveyance in lieu thereof, this Lease shall automatically terminate as of the
date the physical taking occurs, and all Base Rent, Operating Costs Reimbursements and other sums
payable under this Lease shall be paid to that date. In the case of a taking of a part of the
Premises or a portion of the Building not required for the Tenants reasonable use of the Premises,
this Lease shall continue in full force and effect and the Base Rent shall be equitably reduced
based on the proportion by which the floor area of the Premises is reduced, such reduction in Base
Rent to be effective as of the date the physical taking occurs. Operating Costs Reimbursements
payments may be redetermined as equitable under the circumstances. Landlord reserves all rights to
damages or awards for any taking by eminent domain relating to the Premises, Building, Land and the
unexpired term of this Lease. Tenant assigns to Landlord any right Tenant may have to such damages
or award and Tenant shall make no claim against Landlord for damages for termination of its
leasehold interest or interference with Tenants business. Tenant shall have the right, however,
to claim and recover from the condemning authority compensation for any loss to which Tenant may be
entitled for Tenants moving expenses or other relocation costs if they are awarded separately to
Tenant in the eminent domain proceedings and are not claimed by Tenant to be a part of the damages
recoverable by Landlord.
5.7
Liens
. Tenant shall have no authority, express or implied, to create or place any lien
or encumbrance of any kind or nature whatsoever upon the interest of Landlord or Tenant in the
Premises or to charge the rentals payable under this Lease for any Claims in favor of any person
dealing with Tenant, including those who may furnish materials or perform labor for any
construction or repairs. If any such lien or encumbrance is filed or recorded, Tenant shall cause
it to be released or otherwise removed within five (5) days by a means or method approved by
Landlord.
5.8
Work Performance and Responsible Contracting
.
5.8.1 Tenant acknowledges and agrees that all alterations, additions, improvements, repairs
and installations made to or on the Premises (including any Initial Improvements and any Tenant
Alterations) shall be performed subject to contractual requirements applicable for the entire
duration of
9
the contract that the prime contractor and each and every subcontractor of every tier shall (a) be
a party to or bound by a collective bargaining agreement applicable to the geographic area in which
the Land is located, applicable to the trade or trades in which the work under the contract is to
be performed and entered with one or more labor organizations affiliated with the Building and
Construction Trades Department of the AFL-CIO or with an independent, nationally recognized labor
organization or one of its affiliated locals, and (b) solely employ members of such labor
organizations to perform work within their respective jurisdictions. The previous sentence shall
apply whether it is Landlord or Tenant performing or contracting for any such alterations,
additions, improvements or installations. Waivers or exceptions to the requirement in this
sentence may be given only in writing by Landlord. Landlord hereby approves Skyline Construction
as the general contractor.
5.8.2 In addition to the requirements of the previous subparagraph, Tenant shall use
commercially reasonable efforts to contract for services to be performed in or about the Premises
with companies which are a Responsible Contractor. A
Responsible Contractor
is defined
as a contractor or subcontractor who pays workers a fair wage and Fair Benefits as evidenced by
payroll and employee records and who complies with a service-disabled veteran business policy.
Fair Benefits
are defined as including employer-paid family health care coverage, pension
benefits, and apprenticeship programs.
5.9
Estoppel Certificate
. On Landlords written request within ten (10) business days of
such request, Tenant shall timely complete, sign and deliver a certificate to an addressee
designated by Landlord stating (a) the material terms of this Lease, (b) whether any default
currently exists under the Lease, and (c) such other information as may reasonably be requested.
5.10
Utility Bills
. In order to assist Landlord in monitoring the energy efficiency of the
Building, on Landlords request, Tenant shall timely deliver to Landlord a copy of Tenants utility
bills for the Premises and such other information related to Tenants use of utilities as may
reasonably be requested.
5.11
Modification for Lender
. If, in connection with obtaining construction, interim or
permanent financing for the Building or Land, Landlords lender, if any, shall request reasonable
modifications to this Lease as a condition to such financing, Tenant will not unreasonably withhold
or delay its consent to such modifications;
provided that
, such modifications do not
increase the obligations of Tenant under this Lease or materially adversely affect Tenants rights
under this Lease.
5.12
Hazardous Substances
.
5.12.1 Landlord represents to Tenant that as of the execution date of this Lease, Landlord is
not aware of any Hazardous Substances prohibited by applicable Governmental Requirements located
in, on, or about the Premises, Building or the Project. Neither Tenant nor any of Tenants
Affiliates shall store, place, generate, manufacture, refine, handle, or locate on, in, under or
around the Land or Building any asbestos, PCBs, petroleum or petroleum-based chemicals or
substances, urea formaldehyde or any chemical, material, element, compound, solution, mixture,
substance or other matter of any kind whatsoever which is now or later defined, classified, listed,
designated or regulated as hazardous, toxic or radioactive by any Governmental Agency
(
Hazardous Substance
), except for storage, handling and use of reasonable quantities and
types of cleaning fluids, a generator with petroleum storage, office supplies and substances
necessary for Tenants drug research and development business in the Premises in the ordinary
course and the prudent conduct of Tenants business in the Premises and in accordance with
applicable law. Tenant agrees that (a) the storage, handling and use of such permitted Hazardous
Substances must at all times conform to all Governmental Requirements and to applicable fire,
safety and insurance requirements; (b) the types and quantities of permitted Hazardous Substances
which are stored in the Premises must be reasonable and appropriate to the nature and size of
Tenants operation in the Premises and reasonable and appropriate for a first-class building of the
same or similar use and in the same market area as the Building; and (c) no Hazardous Substance
shall be spilled or disposed of on, in, under or around the Land or Building or otherwise
discharged from the Premises or any area adjacent to the Land or Building. In no event will Tenant
be permitted to store, handle or use on, in, under or around the Premises any Hazardous Substance
which will increase the rate of fire or extended coverage insurance on the Land or Building,
unless: (1) such Hazardous Substance and the expected rate increase have been specifically
disclosed in writing to Landlord; (2) Tenant has agreed in writing to pay any rate increase related
to each such Hazardous Substance; and (3) Landlord has approved in writing each such Hazardous
Substance, which approval shall be subject to Landlords discretion.
5.12.2 Tenant shall indemnify, defend and hold harmless Landlord and Landlords Agents from
and against any and all Claims arising out of any breach of any provision of this paragraph, which
expenses shall also include laboratory testing fees, personal injury claims, clean-up costs and
10
environmental consultants fees; provided, the foregoing shall not apply to the extent of the gross
negligence or willful misconduct of Landlord, its agents, or contractors or the uncured breach of
this Lease by Landlord. Tenant agrees that Landlord may be irreparably harmed by Tenants breach
of this paragraph and that a specific performance action may appropriately be brought by Landlord;
provided that
, Landlords election to bring or not bring any such specific performance
action shall in no way limit, waive, impair or hinder Landlords other remedies against Tenant.
5.12.3 As of the execution date of this Lease, Tenant represents and warrants to Landlord
that, except as otherwise disclosed by Tenant to Landlord, Tenant has no intent to bring any
Hazardous Substances on, in or under the Premises except for the type and quantities authorized in
Section 5.12.1.
5.13
Access Laws
.
5.13.1 Landlord represents and warrants to Tenant that, as of the Commencement Date, to
Landlords actual knowledge, the Premises shall be in material compliance with the ADA (including
the Americans with Disabilities Act Accessibility Guidelines for Buildings and Facilities) and all
other Governmental Requirements relating to the foregoing (collectively,
Access Laws
).
5.13.2 Tenant agrees to notify Landlord immediately if Tenant receives notification or
otherwise becomes aware of: (a) any condition or situation on, in, under or around the Land or
Building which may constitute a violation of any Access Laws or (b) any threatened or actual lien,
action or notice that the Land or Building is not in compliance with any Access Laws. If Tenant is
responsible for such condition, situation, lien, action or notice under this paragraph, Tenants
notice to Landlord shall include a statement as to the actions Tenant proposes to take in response
to such condition, situation, lien, action or notice.
5.13.3 Tenant shall not alter or permit any assignee or subtenant or any other person to alter
the Premises in any manner which would violate any Access Laws or increase Landlords
responsibilities for compliance with Access Laws, without the prior approval of the Landlord, which
shall not be unreasonably withheld provided that such Tenant Alteration complies with the
provisions of Section 5.1 above and Tenant causes compliance with Access Laws. In connection with
any such approval, Landlord may require a certificate of compliance with Access Laws from an
architect, engineer or other person acceptable to Landlord. Tenant agrees to pay the reasonable
fees incurred by such architect, engineer or other third party in connection with the issuance of
such certificate of compliance. Landlords consent to any proposed Tenant Alteration shall (a) not
relieve Tenant of its obligations or indemnities contained in this paragraph or this Lease or (b)
be construed as a warranty that such proposed alteration complies with any Access Law.
5.13.4 Tenant shall be solely responsible for all costs and expenses relating to or incurred
in connection with bringing the Premises, the Building, or the common areas of the Building into
compliance with Access Laws, if and to the extent such noncompliance arises out of or relates to:
(1) Tenants specific use of the Premises, including the hiring of employees; (2) any Tenant
Alterations to the Premises; or (3) any Tenant Improvements constructed in the Premises at the
request of Tenant.
5.13.5 Landlord shall be responsible for all costs and expenses relating to or incurred in
connection with bringing the common areas of the Building into compliance with Access Laws, unless
such costs and expenses are Tenants responsibility as provided in the preceding subparagraph.
5.13.6 Tenant agrees to indemnify, defend and hold harmless Landlord and Landlords Affiliates from
and against any and all claims arising out of or relating to any failure of Tenant or Tenants
Affiliates to comply with Tenants obligations under this paragraph.
5.13.7 Subject to Section 4.2 above, the provisions of this paragraph shall supersede any
other provisions in this Lease regarding Access Laws, to the extent inconsistent with the
provisions of any other paragraphs.
5.14
Subordination
. Tenant subordinates this Lease and all rights of Tenant under this
Lease to any mortgage, deed of trust, ground lease or vendors lien, or similar instrument which
may from time to time be placed upon the Premises (and all renewals, modifications, replacements
and extensions of such encumbrances), and each such mortgage, deed of trust, ground lease or lien
or other instrument shall be superior to and prior to this Lease. Notwithstanding the foregoing,
the holder or beneficiary of such mortgage, deed of trust, ground lease, vendors lien or similar
instrument shall have the right to subordinate or cause to be subordinated any such mortgage, deed
of trust, ground lease, vendors lien or similar instrument to this Lease or to execute a
non-disturbance agreement in favor of Tenant on the standard form utilized by such lender or ground
lessor. At the request of Landlord, the holder of such mortgage or deed of trust or any ground
lessor, Tenant shall
execute, acknowledge and deliver promptly in recordable form any customary instrument or
subordination agreement that Landlord or such holder
11
may request, provided that the agreement contains a commercially reasonable non-disturbance and
attornment agreement and does not materially increase Tenants obligations or decrease its rights
under this Lease. Tenant further covenants and agrees that if the lender or ground lessor acquires
the Premises as a purchaser at any foreclosure sale or otherwise, Tenant shall recognize and attorn
to such party as landlord under this Lease, and shall make all payments required hereunder to such
new landlord without deduction or set-off and, upon the request of such purchaser or other
successor, execute, deliver and acknowledge documents confirming such attornment. Tenant waives
the provisions of any law or regulation, now or hereafter in effect, which may give or purport to
give Tenant any right to terminate or otherwise adversely affect this Lease or the obligations of
Tenant hereunder in the event that any such foreclosure or termination or other proceeding is
prosecuted or completed.
SECTION 6:
INSURANCE AND INDEMNIFICATION
6.1
Indemnification
. Tenant shall indemnify, defend and hold harmless Landlord, Landlords
Affiliates and the Manager from and against any and all Claims made against such persons, arising
solely out of (a) the possession, use or occupancy of the Premises or the business conducted in the
Premises, (b) any act, omission or actionable neglect of Tenant or Tenants Affiliates, or (c) any
breach or default under this Lease by Tenant or by any Tenants Affiliates. Tenants obligations
under the previous sentence shall not apply to the extent the Claim arises from intentional
misconduct by or actionable neglect of Landlord or Landlords Affiliates or uncured breach of this
Lease by Landlord.
Landlords Affiliates
are (i) the trustee of and, the investment
advisor to the Landlord and (ii) employees of the foregoing.
Tenants Affiliates
are all
officers, partners, contractors, employees and invitees of Tenant.
Claims
is an
individual and collective reference to any and all claims, demands, damages, injuries, losses,
liens, liabilities, penalties, fines, lawsuits, actions, and other proceedings and expenses
(including attorneys fees and expenses incurred in connection with the proceeding, whether at
trial or on appeal).
6.2
Tenant Insurance
.
6.2.1 Tenant shall, throughout the Lease Term, at its own expense, keep and maintain in full
force and effect each and every one of the following policies, each of which shall be endorsed as
needed to provide that the insurance afforded by these policies is primary and that all insurance
carried by Landlord is strictly excess and secondary and shall not contribute with Tenants
liability insurance:
(a) A policy of commercial general liability insurance, including a contractual liability
endorsement covering Tenants obligations under the paragraph captioned Indemnification, insuring
against claims of bodily injury and death or property damage or loss with a combined single limit
at the Commencement Date of this Lease of not less than Two Million Dollars ($2,000,000.00) per
occurrence and location. Tenant shall include Landlord, Manager, Landlords investment advisor,
and at Landlords request, Landlords mortgage lender(s) as additional insureds. The limit shall
be reasonably increased during the Lease Term at Landlords request.
(b) Special Form property insurance (which is commonly called all risk) covering Initial
Tenant Improvements, Tenant Alterations, and any and all furniture, fixtures, equipment, inventory,
improvements and other property in or about the Premises which is not owned by Landlord, for the
then, entire current replacement cost of such property.
(c) Business interruption insurance in an amount sufficient to cover costs, damages, lost
income, expenses, Base Rent, Operating Costs Reimbursements and all other sums payable under this
Lease, should any or all of the Premises not be usable for a period of up to twelve (12) months.
(d) A policy of workers compensation insurance if and as required by applicable law and
employers liability insurance with limits of no less than One Million and No/100 Dollars
($1,000,000.00).
(e) In the event Tenant acquires company automobiles, a policy of comprehensive automobile
liability insurance, including loading and unloading, and covering owned and hired vehicles with
limits of no less than One Million Dollars ($1,000,000.00) per occurrence.
6.2.2 All insurance policies required under this paragraph shall be with companies having a
rating according to Bests Insurance Key Rating Guide for Property Casualties of no less than A-
Class VIII. Each policy shall provide that it is not subject to cancellation, lapse or reduction
in coverage except after thirty (30) days written notice to Landlord. Tenant shall deliver to
Landlord, prior to the Commencement Date and, from time to time thereafter, certificates evidencing
the existence and amounts of all such policies and, on Landlords request, copies of such insurance
policies. There shall be
12
no deductible amount applicable with respect to the insurance policy requirements in part (a) of
the previous subparagraph unless approved in advance by Landlord. Deductibles under policies
procured under the requirements of clause (b) of subparagraph 6.2.1 must be reasonable and
customary. There shall be no self-insured retention with respect to the requirements in either
part (a) or (b) of the previous subparagraph unless approved in advance by Landlord.
6.2.3 If Tenant fails to acquire or maintain any insurance or provide evidence of insurance
required by this paragraph, Landlord may, but shall not be required to, obtain such insurance or
evidence and the costs associated with obtaining such insurance or evidence shall be payable by
Tenant to Landlord on demand.
6.3
Landlords Insurance
. Landlord shall, throughout the Lease Term, keep and maintain in
full force and effect:
(a) Commercial general liability insurance, insuring against claims of bodily injury and death
or property damage or loss with a combined single limit at the Commencement Date of not less than
One Million Dollars ($1,000,000.00) per occurrence and Two Million Dollars ($2,000,000.00) general
aggregate, which policy shall be payable on an occurrence rather than a claims made basis.
(b) Special Form property insurance (which is commonly called all risk) covering the
Building and Landlords personal property, if any, located on the Land for the then, current
replacement value of such property.
(c) Landlord may, but shall not be required to, maintain other types of insurance as Landlord
deems appropriate, including property insurance coverage for earthquakes and floods in such amounts
as Landlord deems appropriate.
6.4
Waiver of Subrogation
. Notwithstanding anything in this Lease to the contrary,
Landlord and Tenant each waive and release the other from any and all Claims or any loss or damage
that may occur to the Land, Building, Premises, or personal property located on or in the described
Premises, by reason of Casualty, but only to the extent of deductibles specified in the insurance
policies plus the insurance proceeds paid to such party under its policies of insurance or, if it
fails to maintain the required policies, the insurance proceeds that would have been paid to such
party if it had maintained such policies.
SECTION 7:
ASSIGNMENT AND SUBLETTING
7.1
Assignment and Subletting by Tenant
. Except for Permitted Transfers, Tenant shall not
have the right, directly or indirectly (by change of control or otherwise) to assign, transfer,
mortgage or encumber this Lease in whole or in part, nor sublet the whole or any part of the
Premises, nor allow the occupancy of all or any part of the Premises by another, without first
obtaining Landlords consent, which consent may not be unreasonably withheld or delayed. Neither
Landlords demand for Recapture under paragraph 7.2 (
Recapture
) or Landlords
conditioning of its consent under paragraph 7.3 (
Landlord Share of Revenue Surplus
) shall
be deemed unreasonable. No sublease or assignment , including one to which Landlord has consented,
shall release Tenant from its obligations under this Lease.
7.2
Recapture
. Landlord shall have the right to recapture all or the applicable portion of
the Premises proposed to be assigned or sublet by giving written notice of Landlords intention to
exercise such right within fifteen (15) days after delivery of Tenants request that Landlord
consent to assignment or subletting (
Recapture
). The Recapture shall be effective on the
earlier of (a) the date Tenant proposed to assign or sublet or (b) the last day of a calendar month
which is at least sixty (60) days after delivery of Tenants request that Landlords consent to the
assignment or subletting. On the effective date of the Recapture, this Lease shall be terminated
as to the Premises or the portion of the Premises subject to the Recapture. Notwithstanding the
first sentence of this subparagraph, Landlord shall have no right to Recapture the Premises or
applicable portion thereof if: (a) Tenants proposed assignment or sublet is a Permitted Transfer
or to an affiliate or wholly-owned subsidiary or is to a reorganized entity under which no change
in ownership has occurred, or (b) Tenants proposed assignment or sublet, together with any
previous assignments and/or sublets in effect as of the date of Tenants request, encompass in the
aggregate net rentable area equal to or less than fifty percent (50%) of the total net rentable
area of Premises.
7.3
Landlord Share of Revenue Surplus
. Landlord may elect to condition its consent to an
assignment or subletting on this paragraph. If Landlord so gives conditional consent, Tenant shall
pay to Landlord if, as and when received by Tenant, fifty percent (50%) of the consideration
received by Tenant for the assignment or subletting (after deduction of leasing commissions,
attorneys fees, tenant
13
improvement allowances, and other reasonable costs of assignment or subletting) to the extent that
consideration exceeds Tenants obligations under this Lease for the same portion of the Lease Term.
If the sublet is for other than the entirety of the Premises, Tenants obligation under this Lease
shall be prorated based on the area subleased as compared to the Rentable Area of the Premises.
7.4
Permitted Transfers
. Notwithstanding anything to the contrary in subparagraph 7.1, but
subject to the other provisions of this paragraph, Tenant may assign this Lease or sublet the
Premises or any portion thereof (a
Permitted Transfer
), without Landlords consent: (a)
to any partnership, corporation or other entity which controls, is controlled by, or is under
common control with Tenant (control being defined for such purposes as ownership of 50% or more of
all of the voting stock of a corporation or 50% or more of the voting legal or equitable interest
in any other business entity, and the power to direct the management and operations of the relevant
entity) (an
Affiliate
) or (b) to any partnership, corporation or other entity resulting
from a merger or consolidation with Tenant or which acquires all or substantially all of Tenants
assets (through a transfer of assets or equity interests in Tenant) as a going concern and such
assets include substantial assets other than this Lease (a
Successor
); or (c) to any
entity engaged in a joint venture with Tenant,
provided that,
(i) Landlord receives at
least ten (10) days prior written notice of the assignment or subletting, in which Tenant shall
expressly confirm that Tenant remains primarily liable (together with the assignee in the event of
an assignment) for all of the obligations of Tenant under this Lease, (ii) in the case of a
subletting or assignment to an Affiliate, the Affiliate remains an Affiliate for the duration of
the subletting or the balance of the term in the event of an assignment,, (iii) Landlord receives a
fully executed coy of the assignment or sublease agreement between Tenant and the Affiliate or
Successor at least ten (10) days prior to the effective date of such assignment or sublease, in
which the Affiliate or Successor, as the case may be, assumes (in the event of an assignment) all
of Tenants obligations under the Lease, and agrees (in the event of a sublease) that such
subtenant will, at Landlords election, attorn directly to Landlord in the event that this Lease is
terminated for any reason, and (iv) in the case of an assignment, the essential purpose of such
assignment is to transfer an active, ongoing business with substantial assets in addition to this
Lease, and, in the case of an assignment or sublease, the transaction is for legitimate business
purposes unrelated to this Lease and the transaction is not a subterfuge by Tenant to avoid its
obligations under this Lease or the restrictions on assignment and subletting contained herein. In
addition, a sale or transfer of the capital stock of Tenant shall be deemed a Permitted Transfer if
(1) such sale or transfer occurs in connection with any bona fide financing or capitalization for
the benefit of Tenant, or (2) Tenant is or becomes a publicly traded corporation. Landlord shall
no right to any sums or other economic consideration resulting from any Permitted Transfer.
Additionally, any rights that are personal to Tenant shall also accrue to any Permitted Transferee.
7.5
Assignment by Landlord
. Landlord shall have the right to transfer and assign, in whole
or in part, its rights and obligations under this Lease and in any and all of the Land or Building.
If Landlord sells or transfers any or all of the Building, Landlord and Landlords Affiliates
shall, upon consummation of such transfer be released automatically from any liability under this
Lease for obligations to be performed or observed after the date of the transfer. After the
effective date of the transfer, Tenant must look solely to Landlords successor-in-interest.
SECTION 8: DEFAULT AND REMEDIES
8.1
Events of Default
.
8.1.1 The occurrence of any one or more of the following events shall constitute a material
default and breach of this Lease by Tenant (
Event of Default
):
(a) vacation or abandonment of all or any portion of the Premises without continued payment
when due of Base Rent and Operating Costs Reimbursements and other sums due under this Lease;
(b) failure by Tenant to make any payment of Base Rent, Operating Costs Reimbursements or any
other sum payable by Tenant under this Lease within three (3) days after its due date, or, in the
case of the first such failure during a calendar year of the Lease Term, within three (3) days
after written notice to Tenant of such failure;
(c) failure by Tenant to observe or perform any covenant or condition of this Lease, other
than the making of Base Rent, Operating Costs Reimbursements and other payments, where such failure
continues for a period of twenty (20) days after written notice from Landlord; provided, however,
14
that if the nature of Tenants obligation is such that more than the specified period required
for performance, then Tenant shall not be in default if Tenant commences performance within such
period and thereafter diligently prosecutes it to completion;
(d) the failure of Tenant to surrender possession of the Premises at the expiration or earlier
termination of this Lease in the condition required by this Lease;
(e) (1) the making by Tenant of any general assignment or general arrangement for the benefit
of creditors; (2) the filing by or against Tenant of a petition in bankruptcy, including
reorganization or arrangement, unless, in the case of a petition filed against Tenant, it is
dismissed within sixty (60) days; (3) the appointment of a trustee or receiver to take possession
of substantially all of Tenants assets located in the Premises or of Tenants interest in this
Lease; (4) any execution, levy, attachment or other process of law against any property of Tenant
or Tenants interest in this Lease, unless it is dismissed within sixty (60) days; (5) adjudication
that Tenant is bankrupt; (6) the making by Tenant of a transfer in fraud of creditors; or (7) the
failure of Tenant to generally pay its debts as they become due;
(f) any information furnished by or on behalf of Tenant to Landlord in connection with this
Lease is determined to have been materially false, or misleading and Tenant knew of same; or
(g) if a letter of credit is required under the Credit Enhancement Rider to this Lease, a
failure of the Tenant to deliver that letter of credit within the time period specified.
8.1.2 If a petition in bankruptcy is filed by or against Tenant, and if this Lease is treated
as an unexpired lease under applicable bankruptcy law, then Tenant shall neither attempt nor
cause any trustee to attempt to extend the time period specified by the Bankruptcy Act for the
assumption or rejection of this Lease.
8.2
Remedies
.
8.2.1 If any Event of Default occurs, Landlord may at any time after such occurrence, with or
without notice or demand except as stated in this paragraph, and without limiting Landlord in the
exercise of any other right or remedy which Landlord may have by reason of such Event of Default,
exercise the rights and remedies, either singularly or in combination, specified or described in
the subparagraphs of this paragraph.
8.2.2 Landlord may terminate this Lease and all rights of Tenant under this Lease, either
immediately or at some later date, by giving Tenant written notice that this Lease is terminated.
If Landlord so terminates this Lease, then Landlord may recover from Tenant the sum of:
(a) the unpaid Base Rent, Operating Costs Reimbursements and all other sums payable under this
Lease which have been earned up to and including the date of termination; plus
(b) interest at the Default Rate on the sum stated in clause (a); plus
(c) the amount by which (i) the unpaid Base Rent, Operating Costs Reimbursements and all other
sums payable under this Lease which would have been earned after termination until the time of
award exceeds (ii) the amount of such rental loss, if any, as Tenant affirmatively proves could
have been reasonably avoided during such time period, together with interest on such resulting
difference at the Default Rate; plus
(d) the amount by which (i) the aggregate of the unpaid Base Rent, Operating Costs
Reimbursements and all other sums payable under this Lease for the balance of the Lease Term after
the time of award exceeds (ii) the amount of such rental loss, if any, as Tenant affirmatively
proves could be reasonably avoided, with such resulting difference being discounted to present
value at the time of the award at the Prime Rate in existence at such time; plus
(e) any other amount necessary to compensate Landlord for the detriment proximately caused by
Tenants failure to perform Tenants obligations under this Lease or which, in the ordinary course
of things, would be likely to result from such failure, including, leasing commissions, tenant
improvement costs, renovation costs and advertising costs.
8.2.3 Landlord shall also have the right, with or without terminating this Lease, to re-enter
the Premises and remove all persons and property from the Premises. Landlord may cause property so
removed from the Premises to be stored in a public warehouse or elsewhere at the expense, for the
account of, and at the risk of Tenant.
8.2.4 Landlord shall also have the right, without terminating this Lease, to accelerate and
recover from Tenant the sum of all unpaid Base Rent, Operating Costs Reimbursements and all other
sums payable under the then remaining term of the Lease, discounting such amount to present value
at the Prime Rate.
15
8.2.5 If Tenant vacates, abandons or surrenders the Premises without Landlords consent, or if
Landlord re-enters the Premises as provided in subparagraph 8.2.3 or takes possession of the
Premises pursuant to legal or notice proceedings, then, if Landlord does not elect to terminate
this Lease, Landlord may, from time to time, without terminating this Lease, either (a) recover all
Base Rent, Operating Costs Reimbursements and all other sums payable under this Lease as they
become due or (b) relet the Premises or any part of the Premises on behalf of Tenant for such term
or terms, at such rent or rents and pursuant to such other provisions as Landlord, in its sole
discretion, may deem advisable, all with the right, at Tenants cost, to make alterations and
repairs to the Premises and recover any deficiency from Tenant as set forth in subparagraph 8.2.6.
8.2.6 If Landlord relets the Premises without terminating this Lease, Landlord shall apply the
revenue from such reletting to Landlords costs and Tenants obligations in such order as Landlord
deems appropriate. Should revenue from letting during any month be less than the sum of the Base
Rent, Operating Costs Reimbursements and other sums payable under this Lease and Landlords
expenditures for the Premises during such month, Tenant shall be obligated to pay such deficiency
to Landlord as and when such deficiency arises.
8.3
Right to Perform
. If Tenant shall fail to pay any sum of money, other than Base Rent
or Operating Costs Reimbursements, required to be paid by it under this Lease or shall fail to
perform any other act on its part to be performed under this Lease, and such failure shall continue
for ten (10) days after written notice of such failure by Landlord, Landlord may, but shall not be
obligated to, and without waiving or releasing Tenant from any obligations, make such payment or
perform such other act on Tenants part to be made or performed as provided in this Lease.
Landlord shall have all rights and remedies for recovery of any sum or for the cost of such
performance as specified in this Lease.
8.4
Landlords Default
. Landlord shall not be in default under this Lease unless Landlord
fails to perform obligations required of Landlord within thirty (30) days after written notice is
delivered by Tenant to Landlord specifying the obligation which Landlord has failed to perform;
provided, however
, that if the nature of Landlords obligation is such that more than the
specified period required for performance, then Landlord shall not be in default if Landlord
commences performance within such period and thereafter diligently prosecutes it to completion.
Tenant waives the benefit of any laws granting it the right to perform Landlords obligation, a
lien upon the property of Landlord or upon rent due Landlord, or the right to terminate this Lease
or withhold rent.
8.5
Limitation on Recourse
. Liability with respect to the entry and performance of this
Lease by or on behalf of Landlord or any other obligation of Landlord, however it may arise, shall
be asserted and enforced only against Landlords estate and equity interest in the Building and
proceeds therefrom and from insurance. Neither Landlord nor any of Landlords Affiliates shall
have any personal liability in the event of any Claim against any of them arising out of or in
connection with this Lease, the relationship of Landlord and Tenant or Tenants use of the
Premises. Any and all personal liability, if any, beyond that which may be asserted under this
paragraph, is expressly waived and released by Tenant and by all persons claiming by, through or
under Tenant.
SECTION 9: MISCELLANEOUS PROVISIONS
9.1
Notices
. All notices, demands, consents, approvals, statements and communications
required or permitted under this Lease shall be in writing and shall be addressed to a party at the
addresses set forth opposite that partys signature, or to such other address as either party may
specify by written notice, given in accordance with this paragraph. Unless otherwise specified
opposite Tenants signature, Tenants notice address shall be changed to the address of the
Premises after the Commencement Date. All such communications shall be transmitted by personal
delivery, reputable express or courier service, or United States Postal Service, postage prepaid.
All such communications shall be deemed delivered and effective on the earlier of (a) the date
received or refused for delivery, or (b) three (3) calendar days after having been deposited in the
United States Postal Service, postage prepaid.
9.2
Attorneys Fees and Expenses
. In the event that (a) either party requires the services
of an attorney in connection with enforcing the terms of this Lease, (b) suit is brought for the
enforcement of this Lease or the exercise of rights and remedies afforded by this Lease or under
law, or (c) proceedings are held in bankruptcy, then the substantially prevailing party shall be
entitled to a reasonable sum for attorneys and paralegals fees, expenses and court costs,
including those relating to any appeal.
16
9.3
Successors; Joint and Several Liability
. All of the covenants and conditions contained
in this Lease shall apply to and be binding upon Landlord and Tenant and their respective heirs,
executors, administrators, permitted successors and permitted assigns. In the event that more than
one person or organization is included in the term
Tenant
, then each such person or
organization shall be jointly and severally liable for all obligations of Tenant under this Lease.
9.4
Choice of Law
. This Lease shall be construed and governed by the laws of the state in
which the Land is located.
9.5
Offer to Lease
. The submission of this Lease in a draft form to Tenant or its broker
or other agent does not constitute an offer to Tenant to lease the Premises. This Lease shall have
no force or effect until it is executed and delivered by both Tenant and Landlord.
9.6
Force Majeure
. In the event that either party shall be delayed, hindered in or
prevented from the performance of any act or obligation required under this Lease by reason of acts
of God, strikes, lockouts, labor troubles or disputes, inability to procure or shortage of
materials or labor, failure of power or utilities, delay in transportation, fire, vandalism,
accident, flood, severe weather, other casualty, Governmental Requirements (including mandated
changes in the Plans and Specifications or the Tenant Improvements resulting from changes in
pertinent Governmental Requirements or interpretations thereof), riot, insurrection, civil
commotion, sabotage, explosion, war, natural or local emergency, acts or omissions of others,
including the other party, or other reasons of a similar or dissimilar nature not solely the fault
of, or under the exclusive control of, Landlord, then performance of such act or obligation (other
than Tenants rental obligations under this Lease) shall be excused for the period of the delay and
the period for the performance of any such act or obligation shall be extended for the period
equivalent to the period of such delay.
9.7
Interpretation
. Headings or captions shall in no way define, limit or otherwise affect
the construction or interpretation of this Lease. Whenever a provision of this Lease uses the
terms include or including, that term shall not be limiting but shall be construed as
illustrative. This Lease shall be given a fair and reasonable interpretation of the words
contained in it without any weight being given to whether a provision was drafted by one party or
its counsel. Unless otherwise specified, whenever this Lease requires a consent or approval, the
decision shall be reached in good faith discretion of the party entitled to give such consent or
approval.
9.8
Prior Agreement and Amendments
. This Lease contains all of the agreements of the
parties to this Lease with respect to any matter covered or mentioned in this Lease. No prior
agreement, understanding or statement pertaining to any such matter shall be effective for any
purpose. No provision of this Lease may be amended or added to except by an agreement in writing
signed by the parties to this Lease.
9.9
Time of Essence
. Time is of the essence with respect to the performance of this Lease.
9.10
Survival of Obligations
. Notwithstanding anything contained in this Lease to the
contrary or the expiration or earlier termination of this Lease, any and all obligations of either
party accruing prior to the expiration or termination of this Lease shall survive the expiration or
earlier termination of this Lease, and either party shall promptly perform all such obligations
whether or not this Lease has expired or terminated.
9.11
Landlords Authorized Agents
. Notwithstanding anything contained in the Lease to the
contrary, including the definition of Landlords Agents, MEPT Edgemoor REIT LLC (the manager of
Landlord) and Bentall Kennedy (U.S.) Limited Partnership (the authorized signatory of MEPT Edgemoor
REIT LLC) are the only entities authorized to amend, renew or terminate this Lease, to compromise
any of Landlords claims under this Lease or to bind Landlord in any manner with respect to this
Lease. Neither the Manager nor any leasing agent or broker shall be considered an authorized agent
of Landlord for such purposes.
9.12
Tenant Certification
. Tenant certifies that it is not acting, directly or indirectly,
for or on behalf of any person, group, entity, or nation named as a terrorist, Specially
Designated National and Blocked Person, or other banned or blocked person, group, entity, nation,
or transaction pursuant to any law, order, rule or regulation that is enforced or administered by
the Office of Foreign Assets Control. Tenant is not entering this Lease, directly or indirectly on
behalf of, or instigating or facilitating this Lease, directly or indirectly on behalf of, any such
person, group, entity or nation.
ADDITIONAL DEFINED TERMS CROSS REFERENCE TABLE
17
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ADA
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Paragraph 4.2 (
Maintenance and Repair by
Landlord
)
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Affiliate
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Paragraph 7.4 (
Permitted Transfers
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Casualty
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Subparagraph 5.5.1
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Claims
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Paragraph 6.1 (
Indemnification
)
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Fair Benefits
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Subparagraph 5.8.2
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Governmental Agency
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Paragraph 2.11 (
Compliance with Governmental
Requirements and Rules and Regulations
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Governmental Requirements
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Paragraph 2.11 (
Compliance with Governmental
Requirements and Rules and Regulations
)
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HVAC
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Subparagraph 4.1.1
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Land
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Definition of Building and also
Exhibit A
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Landlords Affiliates
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Paragraph 6.1 (
Indemnification
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Permitted Transfer
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Paragraph 7.4 (
Permitted Transfers
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Permitted Uses
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Subparagraph 2.10.1
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Recapture
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Paragraph 7.2 (
Recapture
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Responsible Contractor
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Subparagraph 5.8.2
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Successor
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Paragraph 7.4 (
Permitted Transfers
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Telecommunication Facilities
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Subparagraph 4.1.2
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Tenant Affiliates
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Paragraph 6.1 (
Indemnification
)
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Tenant Alterations
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Paragraph 5.1 (
Tenant Alterations
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LISTING OF EXHIBITS
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Exhibit A
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Legal Description of the Land
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Exhibit B
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Drawing Showing Location and Configuration of the Premises
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Exhibit C
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Rules and Regulations
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Exhibit D
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Commencement Date Memorandum Form
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LISTING OF RIDERS
Rider 1:
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Operating Costs Reimbursements
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18
This Lease has been executed the day and year set forth on the first page of this Lease
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Designated Address for Landlord:
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LANDLORD:
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MEPT Mount Eden LLC
c/o Bentall Kennedy (U.S.) Limited Partnership
Attn: Dir. of Asset Management MEPT
1215 Fourth Avenue, Suite 2400
Seattle, WA 98161
Facsimile: 206-682-4769
and to:
MEPT Mount Eden LLC
c/o Bentall Kennedy (U.S.) Limited Partnership
Attn: Dir. of Asset Management MEPT
7315 Wisconsin Ave., Ste. 350 West
Bethesda, MD 20814
Facsimile: 301-656-9339
and to:
MEPT Mount Eden LLC
c/o NewTower Trust Company
Attn: President/MEPT or Patrick O. Mayberry
3 Bethesda Metro Center, Suite 1600
Bethesda, MD 20814
Facsimile: 240-235-9961
Designated Address for Tenant:
Anthera Pharmaceuticals
Attn:
Facsimile:
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MEPT Mount Eden LLC, a Delaware limited
liability company
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By:
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MEPT Edgemoor REIT LLC, a Delaware
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limited liability company, its sole member
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By:
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Bentall Kennedy (U.S.) Limited
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Partnership, its Authorized Signatory
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By:
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Bentall Kennedy (U.S.) G.P. LLC, its
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General Partner
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By:
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/s/ Michael R. McCormick
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Name: Michael R. McCormick
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Its: Senior Vice President
5-4-11
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TENANT:
Anthera Pharmaceuticals, a Delaware corporation
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By:
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/s/ Chris Lowe
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Name:
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Chris Lowe
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Its:
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CBO
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15
EXHIBIT A to Lease
LEGAL DESCRIPTION OF LAND
Ex. A
1
EXHIBIT A
REAL PROPERTY SITUATED IN THE STATE OF CALIFORNIA, COUNTY OF ALAMEDA, CITY OF HAYWARD MORE
PARTICULARLY DESCRIBED AS FOLLOWS:
ALL THAT PORTION OF THOSE CERTAIN PARCELS OF LAND DESCRIBED IN THE GRANT DEEDS FROM JENJIURO
SHIBATA TO MT. EDEN NURSERY COMPANY RECORDED ON DECEMBER 10, 1990, RECORDERS SERIES NO. 111089
AND PEARL CRYER ET. AL. TO MT. EDEN NURSERY COMPANY RECORDED ON DECEMBER 14, 1965 IN REEL 1701 AT
IMAGE 977 AND WILLIAM ZENKLUSEN TO MT. EDEN NURSERY COMPANY, RECORDED ON JUNE 29, 1967, IN REEL
1990, AT IMAGE 740 AND FROM PETER BEDFORD ET UX TO MOUNT EDEN NURSERY
COMPANY ON AUGUST 17, 1976
IN REEL 4488 AT IMAGE 15 OFFICIAL RECORDS OF SAID COUNTY MORE PARTICULARLY DESCRIBED AS FOLLOWS:
COMMENCING AT A CONCRETE STREET MONUMENT IN INDUSTRIAL BOULEVARD ALSO KNOWN AS COUNTY ROAD NO.
8085, SAID MONUMENT BEING SHOWN ON THAT CERTAIN MAP ENTITLED PARCEL MAP NO. 2144, FILED IN THE
OFFICE OF THE RECORDER OF SAID COUNTY ON JULY 7, 1977 IN BOOK 97 OF PARCEL MAPS AT PAGE 93 AS
MARKING A POINT OF CURVATURE OF SAID INDUSTRIAL BOULEVARD, SAID MONUMENT ALSO BEING AT THE
NORTHERN TERMINUS OF THAT COURSE SHOWN AS N 49°5151 W 426.13 MON-MON;
THENCE FROM SAID POINT OF
COMMENCEMENT SOUTH 50°1527 WEST
34.00 FEET TO THE SOUTHWESTERN LINE OF SAID INDUSTRIAL BOULEVARD;
THENCE ALONG SAID LINE ALONG THE
ARC OF A NON-TANGENT 1246.00 FOOT RADIUS CURVE TO THE LEFT, FROM
WHICH THE CENTER OF SAID CURVE BEARS NORTH 50°1505
EAST, THROUGH A CENTRAL ANGLE OF 1°1223 AN
ARC DISTANCE OF 26.23 FEET TO THE MOST NORTHERN CORNER OF SAID
CERTAIN PARCEL OF LAND (RE: 4488
IM 15) SAID CORNER BEING THE POINT OF BEGINNING OF THIS DESCRIPTION;
THENCE CONTINUING ALONG SAID LINE SAID LINE ALSO BEING THE NORTHEASTERN LINE OF SAID CERTAIN
PARCEL OF LAND (RE: 4448 IM 15) ALONG THE ARC OF SAID 1246.00 FOOT RADIUS CURVE, THROUGH A
CENTRAL ANGLE OF 6°5034 AN ARC DISTANCE OF 148.81 FEET TO THE NORTHERN LINE OF SAID CERTAIN
PARCEL OF LAND (SERIES NO. 111089), SAID LINE ALSO BEING THE NORTHERN LINE OF THAT CERTAIN GRANT
OF RIGHT OF WAY FROM MT. EDEN NURSERY COMPANY TO ALAMEDA COUNTY
RECORDED ON MARCH 23, 1961 IN REEL
289 AT IMAGE 322 OFFICIAL RECORDS OF SAID COUNTY;
THENCE LEAVING SAID SOUTHWESTERN LINE AND ALONG THE NORTHERN, WESTERN AND SOUTHWESTERN LINES OF
SAID GRANT OF RIGHT OF WAY (RE:289 IM 322) THE FOLLOWING THREE (3) COURSES:
1)
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SOUTH 89°3438 WEST 145.79 FEET;
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2)
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ALONG THE ARC OF A NON-TANGENT 1154.00 FOOT RADIUS CURVE TO THE LEFT, FROM WHICH POINT THE
CENTER OF SAID CURVE BEARS NORTH 36°4747 EAST, THROUGH A CENTRAL ANGLE OF 6°1203 AN ARC
DISTANCE OF 124.89 FEET;
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3)
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SOUTH 2°5732 EAST 109.72 FEET TO THE NORTHWESTERN CORNER OF SAID CERTAIN PARCEL OF LAND
(RE: 1701 IM 977) SAID CORNER ALSO BEING ON SAID SOUTHEASTERN LINE OF INDUSTRIAL BOULEVARD;
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THENCE ALONG SAID SOUTHEASTERN LINE OF INDUSTRIAL BOULEVARD, SAID LINE ALSO BEING THE NORTH
EASTERN LINES OF SAID CERTAIN PARCELS OF LAND (RE: 1701 IM 977) AND (RE: 1990 IM 740) SOUTH
59°5947 EAST 62.47 FEET TO A POINT OF CURVATURE;
THENCE ALONG THE ARC OF A TANGENT 1154.00 FOOT RADIUS CURVE TO THE RIGHT THROUGH A CENTRAL ANGLE
OF 14°5536 AN ARC DISTANCE OF 300.58 FEET;
THENCE
LEAVING SAID LINE SOUTH 54°2412 WEST 394.84 FEET;
THENCE SOUTH 35°3548 EAST 354.97 FEET TO THE NORTHERN RIGHT OF WAY LINE OF WEST JACKSON
FREEWAY;
THENCE ALONG SAID LINE THE FOLLOWING FOUR (4) COURSES:
1.
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ALONG THE ARC OF A NON-TANGENT 250.02 FOOT RADIUS CURVE TO THE LEFT, FROM WHICH POINT THE
CENTER OF SAID CURVE BEARS NORTH 67°4410 WEST, THROUGH A CENTRAL ANGLE OF 16°5145
AN ARC DISTANCE OF 73.58 FEET;
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2.
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SOUTH 5°2335 WEST 157.55 FEET;
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3.
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ALONG THE ARC OF A TANGENT 180.01 FOOT RADIUS CURVE TO THE RIGHT, THROUGH A CENTRAL ANGLE
OF 31°1244 AN ARC DISTANCE OF 98.06 FEET;
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4.
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SOUTH 63°5214 WEST 453.49 FEET TO THE NORTHWESTERN RIGHT OF WAY LINE OF THE SOUTHERN
PACIFIC RAILROAD;
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THENCE ALONG SAID NORTHWESTERN LINE, ALONG THE ARC OF A NON-TANGENT 5700.00 FOOT RADIUS CURVE TO
THE RIGHT, THROUGH A CENTRAL ANGLE OF 0°3052 AN ARC DISTANCE OF 51.18 FEET;
THENCE NORTH 35°3548 WEST 1173.48 FEET TO THE NORTHERN LINE OF SAID CERTAIN PARCEL
OF LAND;
THENCE ALONG SAID LINE AND THE WESTERLY PROLONGATION THEREOF NORTH 845.77 FEET TO THE POINT OF
BEGINNING AND CONTAINING 1,098,286 SQUARE FEET OF LAND MORE OR LESS.
EXHIBIT B to Lease
DRAWING SHOWING LOCATION AND CONFIGURATION OF THE PREMISES
Ex. B
1
EXHIBIT C to Lease
RULES AND REGULATIONS
Notwithstanding anything to the contrary contained in this Exhibit, if any rule or regulation is in
conflict with any term, covenant or condition of this Lease, this Lease shall prevail. In
addition, no such rule or regulation, or any subsequent amendment thereto adopted by Landlord,
shall in any way alter, reduce or adversely affect any of Tenants rights or enlarge Tenants
obligations under this Lease. Following a written request from Tenant, Landlord shall use
commercially reasonable efforts to enforce the rules and regulations against other tenants of the
Building.
1. No sign, placard, picture, advertisement, name or notice shall be installed or displayed on
any part of the outside or inside of the Building or Land without the prior written consent of the
Landlord or as otherwise expressly provided in the Lease. Landlord shall have the right to remove,
at Tenants expense and without notice, any sign installed or displayed in violation of this rule.
All approved signs or lettering on doors and walls shall be printed, painted, affixed or inscribed
at the expense of Tenant by a person chosen by Landlord.
2. If Landlord objects in writing to any curtains, blinds, shades, screens or hanging plants
or other similar objects attached to or used in connection with any window or door of the Premises,
Tenant shall immediately discontinue such use. No awning shall be permitted on any part of the
Premises. Tenant shall not place anything against or near glass partitions or doors or windows
which may appear unsightly from outside the Premises.
3. Tenant shall not obstruct any sidewalk, halls, passages, exits, entrances, elevators,
escalators, or stairways of the Building. The halls, passages, exits, entrances, elevators,
escalators and stairways are not open to the general public. Landlord shall in all cases retain
the right to control and prevent access to such areas of all persons whose presence in the judgment
of Landlord would be prejudicial to the safety, character, reputation and interest of the Land,
Building and the Buildings tenants; provided that, nothing in this Lease contained shall be
construed to prevent such access to persons with whom any Tenant normally deals in the ordinary
course of its business, unless such persons are engaged in illegal activities. Tenant shall not go
upon the roof of the Building.
4. The directory of the Building, if any, will be provided exclusively for the display of the
name and location of tenants only, and Landlord reserves the right to exclude any other names
therefrom.
5. Landlord will furnish Tenant, free of charge, two (2) keys to each door lock in the
Premises. Landlord may make a reasonable charge for any additional keys. Tenant shall not make or
have made additional keys, and Tenant shall not alter any lock or install a new additional lock or
bolt on any door of its Premises without Landlords prior approval. Tenant, upon the termination
of its tenancy, shall deliver to Landlord the keys of all doors which have been furnished to
Tenant, and in the event of loss of any keys so furnished, shall pay Landlord therefor.
6 The Building shall be accessible seven (7) days a week, twenty-four (24) hours per day.
7. If Tenant requires
Telecommunication Services, computer circuits, burglar alarm or similar services
or other utility services, it shall first obtain Landlords approval of the construction or
installation of such services. Application for such services shall be made in accordance with the
procedure prescribed by Landlord in Section 5.1 of the Lease.
8. Tenant shall not place a load upon any floor of the Premises which exceeds the load per
square foot which such floor was designed to carry and which is allowed by Governmental
Requirements. Landlord shall have the right to prescribe the weight, size and position of all
equipment, materials, furniture or other property brought into the Building. Heavy objects shall,
if considered necessary by Landlord, stand on such platforms as determined by Landlord to be
necessary to properly distribute the weight. Business machines and mechanical equipment belonging
to Tenant, which cause noise or vibration that may be transmitted to the structure of the Building
or to any space in the Building or to any other tenant in the Building, shall be placed and
maintained by Tenant, at Tenants expense, on vibration eliminators or other devices sufficient to
eliminate noise or vibration. The persons employed to move such equipment in or out of the
Building must be reasonably acceptable to Landlord. Landlord will not be responsible for loss of,
or damage to, any such equipment or other property from any cause, and all
Ex. C
1
damage done to the Building by maintaining or moving such equipment or other property shall be
repaired at the expense of Tenant.
9. Tenant shall not use or keep in the Premises any kerosene, gasoline or inflammable or
combustible fluid or material other than those limited quantities permitted by the Lease. Tenant
shall not use or permit to be used in the Premises any foul or noxious gas or substance, or permit
or allow the Premises to be occupied or used in a manner offensive or objectionable to Landlord or
other occupants of the Building by reason of noise, odors or vibrations nor shall Tenant bring into
or keep in or about the Premises any birds or animals.
10. Tenant shall not use any method of heating or air-conditioning other than that supplied by
Landlord.
11. Tenant shall not waste any utility provided by Landlord and agrees to cooperate fully with
Landlord to assure the most effective operation of the Buildings heating and air-conditioning and
to comply with any governmental energy-saving rules, laws or regulations of which Tenant has actual
notice.
12. Landlord reserves the right, exercisable without notice and without liability to Tenant,
to change the name and street address of the Building.
13. Landlord reserves the right to exclude from the Building between the hours of 6 p.m. and 7
a.m. the following day, or such other hours as may be established from time to time by Landlord,
and on Sundays and legal holidays, any person unless that person is known to the person or employee
in charge of the Building and has a pass or is properly identified. Tenant shall be responsible
for all persons for whom it requests passes and shall be liable to Landlord for all acts of such
persons. Landlord shall not be liable for damages for any error with regard to the admission to or
exclusion from the Building of any person. Landlord reserves the right to prevent access to the
Building in case of invasion, mob, riot, public excitement or other commotion by closing the doors
or by other appropriate action.
14. Tenant shall close and lock the doors of its Premises and entirely shut off all water
faucets or other water apparatus, and electricity, gas or air outlets before Tenant and its
employees leave the Premises. Tenant shall be responsible for any damage or injuries sustained by
other tenants or occupants of the Building or by Landlord for noncompliance with this rule.
15. Tenant shall not obtain for use on the Premises ice, drinking water, food, beverage, towel
or other similar services, except at such hours and under such regulations as may be fixed by
Landlord.
16. The toilet rooms, toilets, urinals, wash bowls and other apparatus shall not be used for
any purpose other than that for which they were constructed and no foreign substance of any kind
whatsoever shall be deposited in them. Subject to available insurance, the expenses of any
breakage, stoppage or damage resulting from the violation of this rule shall be borne by Tenant if
it or its employees or invitees shall have caused it.
17. Tenant shall not sell, or permit the sale at retail, of newspapers, magazines,
periodicals, theater tickets or any other goods or merchandise to the general public in or on the
Premises. Tenant shall not make any room-to-room solicitation of business from other tenants in
the Building. Tenant shall not use the Premises for any business or activity other than that
specifically provided for in the Lease.
18. Tenant shall not install any radio or television antenna, loudspeaker or other device on
the roof or exterior walls of the Building. Tenant shall not interfere with radio or television
broadcasting or reception from or in the Building or elsewhere. Other than the usual and customary
cellular telephones, and computer wifi. Tenant shall not install or utilize any wireless
Telecommunication Facilities, including antenna and satellite receiver dishes within the Premises
or on, in, or about the Building without first obtaining Landlords prior written consent and
Landlord at its option may require the entry of a supplemental agreement with respect to such
construction or installation. Tenant shall comply with all instructions for installation and shall
pay or shall cause to be paid the entire cost of such installations. Application for such
facilities shall be made in the same manner and shall be subject to the same requirements as
specified for Telecommunication Services and Telecommunication Facilities in the paragraph of the
Lease entitled Utilities. Supplemental rules and regulations may be promulgated by Landlord
specifying the form of and information to be included with the application and establishing
procedures, regulations and controls with respect to the installation and use of such wireless
Telecommunication Facilities.
19. Landlord reserves the right to direct electricians as to where and how telephone and
telegraph wires are to be introduced to the Premises. Tenant shall not cut or bore holes for
wires. Tenant shall not affix any floor covering to the floor of the Premises in any manner except
as approved by Landlord. Tenant shall repair any damage resulting from noncompliance with this
rule.
Ex. C
2
20. Tenant shall not install, maintain or operate upon the Premises any vending machine
without the written consent of Landlord.
21. Canvassing, soliciting and distribution of handbills or any other written material, and
peddling in the Building or Land are prohibited, and Tenant shall cooperate to prevent the same.
22. Landlord reserves the right to exclude or expel from the Building and Land any person who,
in Landlords judgment, is intoxicated, under the influence of liquor or drugs or in violation of
any of these Rules and Regulations.
23. Tenant shall store all of its trash and garbage within the Premises. Tenant shall not
place in any trash box or receptacle any material which cannot be disposed of in the ordinary and
customary manner of trash and garbage disposal. All garbage and refuse disposal shall be made in
accordance with directions issued from time to time by Landlord.
24. The Premises shall not be used for lodging or any improper or immoral or objectionable
purpose. No cooking shall be done or permitted by Tenant, except that use by Tenant of
Underwriters Laboratory approved equipment for brewing coffee, tea, hot chocolate and similar
beverages and a microwave for heating food shall be permitted; provided that, such equipment and
its use is in accordance with all Governmental Requirements.
25. Tenant shall not use in the Premises or in the public halls of the Building any hand truck
except those equipped with rubber tires and side guards or such other material-handling equipment
as Landlord may approve. Tenant shall not bring any other vehicles of any kind into the Building.
26. Without the prior written consent of Landlord, Tenant shall not use the name of the
Building in connection with or in promoting or advertising the business of Tenant except as
Tenants address.
27. Tenant shall comply with all safety, fire protection and evacuation procedures and
regulations established by Landlord or any governmental agency.
28. Tenant assumes any and all responsibility for protecting the Premises from theft, robbery
and pilferage, which includes keeping doors locked and other means of entry to the Premises closed.
29. The requirements of Tenant will be attended to only upon appropriate application to the
Manager of the Building by an authorized individual. Employees of Landlord are not required to
perform any work or do anything outside of their regular duties unless under special instructions
from Landlord, and no employee of Landlord is required to admit Tenant to any space other than the
Premises without specific instructions from Landlord.
30. Tenant shall not park its vehicles in any parking areas designated by Landlord as areas
for parking by visitors to the Building or Land. Tenant shall not leave vehicles in the parking
areas overnight nor park any vehicles in the Building parking areas other than automobiles,
motorcycles, motor driven or nonmotor driven bicycles or four-wheeled trucks.
31. Landlord may waive on a non-discriminatory basis any one or more of these Rules and
Regulations for the benefit of Tenant or any other tenant, but no such waiver by Landlord shall be
construed as a waiver of such Rules and Regulations in favor of any other person, nor prevent
Landlord from thereafter revoking such waiver and enforcing any such Rules and Regulations against
any or all of the tenants of the Building.
32. These Rules and Regulations are in addition to, and shall not be construed to in any way
modify or amend, in whole or in part, the covenants and conditions of any lease of premises in the
Building. If any provision of these Rules and Regulations conflicts with any provision of the
Lease, the terms of the Lease shall prevail.
33. Landlord reserves the right to make such other and reasonable Rules and Regulations as, in
its judgment, may from time to time be needed for safety and security, the care and cleanliness of
the Building and Land, the preservation of good order in the Building and the maintenance or
enhancement of the value of the Building as a rental property. Tenant agrees to abide by all the
Rules and Regulations stated in this exhibit and any additional rules and regulations which are so
made by Landlord.
34. Tenant shall be responsible for the observance of all of the foregoing rules by Tenant and
Tenants Agents.
Ex. C
3
EXHIBIT D to Lease
COMMENCEMENT DATE MEMORANDUM FORM
MEPT Mount Eden LLC, a Delaware limited liability company, as Landlord, and Anthera
Pharmaceuticals, a Delaware corporation, as Tenant, executed that Lease dated as of
________________________, 2011 (the Lease).
The Lease contemplates that this document shall be delivered and executed as set forth in the
paragraph entitled Lease Memorandum. This Lease Memorandum shall become part of the Lease.
Landlord and Tenant agree as follows:
1. The Commencement Date of the Lease is _____________________________.
2. The end of the Lease Term and the date on which this Lease will expire is
_____________________.
3. The Lease is in full force and effect as of the date of this Lease Memorandum. By
execution of this Lease Memorandum, Tenant confirms that as of the date of the Lease Memorandum (a)
Tenant has no claims against Landlord and (b) Landlord has fulfilled all of its obligations under
the Lease required to be fulfilled by Landlord as of the date hereof.
4. Tenants Pro Rata Share is ________________ percent (_________%).
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MEPT Mount Eden LLC, a Delaware limited liability company
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Anthera Pharmaceuticals, a Delaware corporation
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By: MEPT Edgemoor REIT LLC, a
Delaware limited liability
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By:
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company, its sole member
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Name:
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Its:
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By: Bentall Kennedy (U.S.) Limited Partnership, its Authorized Signatory
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By: Bentall Kennedy (U.S.) G.P. LLC, its General Partner
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Ex. D
Rider 1
Operating Costs Reimbursements
R1.1
Operating Costs Reimbursements Payments
. Tenant agrees to pay, in addition to Base
Rent, sums computed and payable in accordance with this Rider (
Operating Costs
Reimbursements
). As the context requires, the term Operating Costs Reimbursements shall
include the Operating Costs Reimbursements Estimate payments.
R1.2
Operating Costs Reimbursements Estimate Payments
. Landlord shall prepare and furnish
to Tenant an estimate of the Operating Costs Reimbursements computed in accordance with paragraphs
R1.3 through R1.6 (
Operating Costs Reimbursements Estimate
) (a) on about the Commencement
Date, (b) in advance of the beginning of each calendar year during the Lease Term and (c) from time
to time during the Lease Term. Tenant shall pay one-twelfth (1/12
th
) of the current
Operating Costs Reimbursements Estimate in advance on or before the first day of each calendar
month of the Lease Term. If the applicable blank on the first page of this Lease is filled in, the
amount in it shall be the Operating Cost Reimbursement Estimate as of the Commencement Date.
R1.3
Computation of Operating Costs Reimbursements
. The Operating Costs Reimbursements
shall equal the product of (a) Tenants Pro Rata Share multiplied by (b) the difference between
Operating Costs minus the Operating Cost Base Amount. These capitalized terms are defined later in
paragraph 1.4 of this Rider. The determination and computation of the Operating Costs
Reimbursements shall be made by Landlord. After the close of each calendar year, Landlord shall
deliver to Tenant a written statement setting forth the Operating Costs Reimbursements payable for
the preceding calendar year. If the Operating Costs Reimbursements exceed the Operating Costs
Reimbursements Estimate paid by Tenant, Tenant shall pay the amount of such excess to Landlord with
twenty (20) days after delivery of such statement to Tenant. If such statement shows the Operating
Costs Reimbursements to be less than the Operating Costs Reimbursements Estimate paid by Tenant,
then the amount of such overpayment shall be paid by Landlord to Tenant within twenty (20) days
following the date of such statement or, at Landlords option, shall be credited toward future
installment(s) of Operating Costs Reimbursements Estimate.
R1.4
Definitions
.
R1.4.1
Operating Costs
. Subject to Section R1.4.3 below, all costs and
expenses paid or incurred by Landlord for maintaining, operating, owning and repairing any or all
of the Land, Building, Premises, related improvements and the personal property used in conjunction
with such Land, Building, Premises and related improvements. Without limiting the generality of
the previous sentence, a few of the categories of costs and expense intended to be included in
Operating Costs are (a) Taxes as defined later in this paragraph; (b) premiums and other
obligations associated with Landlords insurance program; (c) property management fees with respect
to this Lease not to exceed two percent (2.0%) of the Base Rent; (d) amortization of capital
improvements installed or constructed other than in connection with the original construction of
this Building and (e) other costs or expense which are customarily accounted for as an expense of
ownership or operation. See Paragraph 4.2 (
Maintenance and Repair by Landlord
) for the
treatment of code compliance costs. If less than ninety-five percent (95%) of the Building is
occupied by tenants during the calendar year, then Operating Costs which vary based on occupancy
shall include all additional costs and expenses that Landlord reasonably determines would have been
incurred had ninety-five percent (95%) occupancy prevailed during the calendar year.
R1.4.2
Taxes
. Taxes means all ad valorem taxes and governmental and private
assessments which are levied, assessed, imposed or become due and payable with respect to the Land
and the Building and associated improvements. Notwithstanding the foregoing, Taxes shall not
include:
(i) any franchise, estate, gift, inheritance, net income, or excess profits tax imposed upon
Landlord ,or a penalty fee imposed as a result of Landlords failure to pay Taxes when due; and
(ii) any increases in real property taxes and/or assessments that result from new
construction or a change of ownership of the Building, or the Land (and for purposes hereof,
new
Rider 1
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construction or a change of ownership shall have the same meaning as in Part 0.5 of Division 1
of the California Revenue and Taxation Code or any amendments or successor statutes to those
sections.
R1.4.3
Exclusions to Operating Costs
. Notwithstanding the foregoing
provisions of this Rider, the following are specifically excluded from the definition of Operating
Costs and Tenant shall have no obligation to pay directly or reimburse Landlord for all or any
portion of the following except to the extent any of the following are caused by the actions or
inactions of Tenant, or result from the failure of Tenant to comply with the terms of this Lease:
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(i)
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costs incurred because Landlord actually violated the terms and conditions of
this Lease or any other lease for premises within the Building, if any;
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(ii)
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legal and auditing fees (other than those fees reasonably incurred in
connection with the maintenance and operation of all or any portion the Building),
leasing commissions, advertising expenses, and other costs incurred in connection with
the original leasing of the Property or future re-leasing of any portion of the
Building;
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(iii)
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depreciation of the Building or any other improvements situated within the
Project;
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(iv)
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any items for which Landlord is actually reimbursed by insurance or by direct
reimbursement by Tenant or any other party;
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(v)
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costs of repairs or other work necessitated by fire, windstorm or other
casualty (excluding any deductibles) and/or costs of repair or other work necessitated
by the exercise of the right of eminent domain to the extent insurance proceeds or a
condemnation award, as applicable, is actually received by Landlord for such purposes;
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(vi)
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any interest or payments on any financing for the Building, interest and
penalties incurred as a result of Landlords late payment of any invoice and any bad
debt loss, rent loss or reserves for same;
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(vii)
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overhead and profit increment paid to Landlord or to subsidiaries or
affiliates of Landlord for goods and/or services to the extent the same exceeds the
costs of such by unaffiliated third parties on a competitive basis; or any costs
included in Operating Costs representing an amount paid to a person, firm, corporation
or other entity related to Landlord which is in excess of the amount which would have
been paid in the absence of such relationship;
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(viii)
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any payments under a ground lease or master lease;
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(ix)
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costs of correcting any building code or other violations which were violations
prior to the Commencement Date; and
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(x)
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costs incurred in the investigation and/or remediation of Hazardous Materials
which either existed on the Land prior to the Commencement Date or were brought onto
the Property by Landlord, its agents, employee or contractors.
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Additionally, to the extent any of the foregoing items described above constitute capital repairs
or replacements under generally accepted accounting principles, consistently applied, then only the
amortizing portion of such capital repairs or replacements shall constitute Operating Costs; such
amortization shall be over the useful life of the applicable repair or replacement, and shall
employ an interest rate equal to the sum of that rate quoted by Wells Fargo Bank, N.T. & S.A. from
time to time as its prime rate, plus two percent (2%).
R1.5
Audit Rights
. Landlord shall maintain records concerning estimated and actual
Operating Costs Reimbursements to the Premises for no less than twelve (12) months following the
period covered by the statement or statements furnished Tenant, after which time Landlord may
dispose of such records. Provided that Tenant is not then in default of its obligation to pay Base
Rent, Operating Costs Reimbursements or other payments required to be made by it under this Lease
and provided that Tenant is not otherwise in default under this Lease, Tenant may, at Tenants sole
cost and expense, cause a Qualified Person (defined below) to inspect Landlords records. Such
inspection, if any, shall be conducted no more than once each year, during Landlords normal
business hours within ninety (90) calendar days after receipt of Landlords written statement of
Operating Costs Reimbursements allocable to the Premises for the previous year, upon first
furnishing Landlord at least twenty (20) calendar days prior written notice. Any errors disclosed
by the review shall be promptly corrected by Landlord; provided,
Rider 1
2
however, that if Landlord disagrees with any such claimed errors, Landlord shall have the right to
cause another review to be made by an auditor of Landlords choice. In the event the results of
the review of records (taking into account, if applicable, the results of any additional review
caused by Landlord) reveal that Tenant has overpaid obligations for a preceding period, the amount
of such overpayment shall be credited against Tenants subsequent installment of Base Rent,
Operating Costs Reimbursements or other payments due to Landlord under the Lease. In the event
that such results show that Tenant has underpaid its obligations for a preceding period, the amount
of such underpayment shall be paid by Tenant to Landlord with the next succeeding installment
obligation of estimated Operating Costs Reimbursements allocable to the Premises. If the actual
Operating Costs Reimbursements allocable to the Premises for any given year were improperly
computed and if the actual Operating Costs Reimbursements allocable to the Premises are overstated
by more than 5%, Landlord shall reimburse Tenant for the cost of its audit. For purposes of this
subparagraph, the term Qualified Person means an accountant or other person experienced in
accounting for income and expenses of office projects, who is engaged solely by Tenant on terms
which do not entail any compensation based or measured in any way upon any savings in Operating
Costs Reimbursements or reduction in Operating Costs Reimbursements allocable to the Premises
achieved through the inspection process described in this subparagraph.
R.1.6
End of Term
. If this Lease shall terminate on a day other than the last day of a
calendar year, (a) Landlord shall estimate the Operating Costs Reimbursements for such partial year
predicated on the most recent reliable information available to Landlord; (b) the amount determined
under clause (a) of this sentence shall be prorated by multiplying such amount by a fraction, the
numerator of which is the number of days within the Lease Term in such year and the denominator of
which is 360; (c) if the clause (b) amount exceeds the Operating Costs Reimbursements Estimate paid
by Tenant for the last year in the Lease Term, then Tenant shall pay the excess to Landlord within
ten (10) days after Landlords delivery to Tenant of a statement for such excess; and (d) if the
Operating Costs Reimbursements Estimate paid by Tenant for the last year in the Lease Term exceeds
the clause (b) amount, then Landlord shall refund to Tenant the excess within such ten (10) day
period if Tenant is not then in default of any of its obligations under this Lease.
R1.7
Taxes Based on Rent
. If a rental tax, gross receipts tax or sales tax on rent is
imposed on Landlord, Tenant shall, as Operating Costs Reimbursements, pay or reimburse Landlord, an
amount equal to all such taxes computed on the Base Rent and Operating Costs Reimbursements payable
under this Lease. If such taxes are payable other than at monthly intervals, Tenant shall pay
one-twelfth (1/12
th
) of the annual tax amount with each installment of Base Rent.
Rider 1
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