x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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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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Delaware
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22-2816046
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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9920 Belward Campus Drive, Rockville, MD
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20850
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(Address of principal executive offices)
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(Zip code)
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
o
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PART I. FINANCIAL INFORMATION | Page No. | ||||
Item 1.
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Financial Statements
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||||
Balance Sheets as of June 30, 2011 (unaudited)
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|||||
and December 31, 2010
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1 | ||||
Statements of Operations for the three and six months ended
|
|||||
June 30, 2011 and 2010 (unaudited)
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2 | ||||
Statements of Cash Flows for the six months ended
|
|||||
June 30, 2011 and 2010 (unaudited)
|
3 | ||||
Notes to the Financial Statements (unaudited)
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4 | ||||
Item 2.
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Management’s Discussion and Analysis of Financial
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||||
Condition and Results of Operations
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11 | ||||
Item 3.
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Quantitative and Qualitative Disclosures about Market Risk
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22 | |||
Item 4.
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Controls and Procedures
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22 | |||
PART II. OTHER INFORMATION
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|||||
Item 1.
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Legal Proceedings
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23 | |||
Item 1A.
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Risk Factors
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23 | |||
Item 5.
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Other Information
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23 | |||
Item 6.
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Exhibits
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24 | |||
SIGNATURES
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25 |
June 30,
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December 31,
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|||||||
2011
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2010
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|||||||
(unaudited)
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|
|||||||
ASSETS
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||||||||
Current assets:
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||||||||
Cash and cash equivalents
|
$ | 13,092 | $ | 8,061 | ||||
Short-term investments available-for-sale
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9,229 | 23,615 | ||||||
Accounts receivables
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1,832 | 54 | ||||||
Unbilled receivables
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2,020 | — | ||||||
Prepaid expenses and other current assets
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2,243 | 1,607 | ||||||
Total current assets
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28,416 | 33,337 | ||||||
Property and equipment, net
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7,629 | 8,206 | ||||||
Goodwill
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33,141 | 33,141 | ||||||
Other non-current assets
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160 | 160 | ||||||
Total assets
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$ | 69,346 | $ | 74,844 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
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$ | 2,961 | $ | 3,572 | ||||
Accrued expenses and other current liabilities
|
3,110 | 6,273 | ||||||
Current portion of notes payable
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60 | 80 | ||||||
Deferred revenue
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2,500 | — | ||||||
Deferred rent
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364 | 341 | ||||||
Total current liabilities
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8,995 | 10,266 | ||||||
Warrant liability
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1,605 | 2,842 | ||||||
Non-current portion of notes payable
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300 | 320 | ||||||
Deferred rent
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2,175 | 2,366 | ||||||
Total liabilities
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13,075 | 15,794 | ||||||
Commitments and contingences
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— | — | ||||||
Stockholders’ equity:
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||||||||
Preferred stock, $0.01 par value, 2,000,000 shares authorized; no shares issued and outstanding
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— | — | ||||||
Common stock, $0.01 par value, 200,000,000 shares authorized; and 115,125,113 shares issued and 114,669,683 shares outstanding at June 30, 2011 and 111,492,014 shares issued and 111,036,584 shares outstanding at December 31, 2010
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1,151 | 1,115 | ||||||
Additional paid-in capital
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380,970 | 371,477 | ||||||
Notes receivable from former directors
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(1,572 | ) | (1,572 | ) | ||||
Accumulated deficit
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(322,738 | ) | (310,292 | ) | ||||
Treasury stock, 455,430 shares, cost basis
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(2,450 | ) | (2,450 | ) | ||||
Accumulated other comprehensive income
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910 | 772 | ||||||
Total stockholders’ equity
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56,271 | 59,050 | ||||||
Total liabilities and stockholders’ equity
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$ | 69,346 | $ | 74,844 | ||||
For the Three Months
Ended June 30,
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For the Six Months
Ended June 30,
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|||||||||||||||
2011
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2010
|
2011
|
2010
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|||||||||||||
Revenue
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$ | 3,001 | $ | 7 | $ | 3,835 | $ | 117 | ||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
5,584 | 6,327 | 10,998 | 15,356 | ||||||||||||
General and administrative
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3,338 | 3,148 | 6,188 | 5,683 | ||||||||||||
Total operating expenses
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8,922 | 9,475 | 17,186 | 21,039 | ||||||||||||
Loss from operations
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(5,921 | ) | (9,468 | ) | (13,351 | ) | (20,922 | ) | ||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
38 | 44 | 84 | 88 | ||||||||||||
Interest expense
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(2 | ) | (2 | ) | (4 | ) | (4 | ) | ||||||||
Change in fair value of warrant liability
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1,304 | 569 | 1,237 | 1,638 | ||||||||||||
Loss from operations before income tax
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(4,581 | ) | (8,857 | ) | (12,034 | ) | (19,200 | ) | ||||||||
Income tax expense
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412 | ― | 412 | ― | ||||||||||||
Net loss
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$ | (4,993 | ) | $ | (8,857 | ) | $ | (12,446 | ) | $ | (19,200 | ) | ||||
Basic and diluted net loss per share
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$ | (0.04 | ) | $ | (0.09 | ) | $ | (0.11 | ) | $ | (0.19 | ) | ||||
Basic and diluted weighted average number of common shares outstanding
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112,821 | 100,694 | 112,009 | 100,442 |
For the Six Months
Ended June 30,
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||||||||
2011
|
2010
|
|||||||
Operating Activities:
|
||||||||
Net loss:
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$ | (12,446 | ) | $ | (19,200 | ) | ||
Reconciliation of net loss to net cash used in operating activities:
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||||||||
Change in fair value of warrant liability
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(1,237 | ) | (1,638 | ) | ||||
Depreciation and amortization
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788 | 633 | ||||||
Amortization of net premiums on short-term investments
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231 | 66 | ||||||
Impairment of property and equipment
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— | 127 | ||||||
Deferred rent
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(168 | ) | (131 | ) | ||||
Non-cash stock-based compensation
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1,135 | 509 | ||||||
Changes in operating assets and liabilities:
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||||||||
Accounts receivables
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(1,778 | ) | (98 | ) | ||||
Unbilled receivables
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(2,020 | ) | — | |||||
Prepaid expenses and other current assets
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(636 | ) | 843 | |||||
Accounts payable and accrued expenses
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(3,808 | ) | 258 | |||||
Deferred revenue
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2,500 | (96 | ) | |||||
Net cash used in operating activities
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(17,439 | ) | (18,727 | ) | ||||
Investing Activities:
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||||||||
Capital expenditures
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(178 | ) | (712 | ) | ||||
Proceeds from maturities of short-term investments
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15,375 | 900 | ||||||
Purchases of short-term investments
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(1,082 | ) | (14,199 | ) | ||||
Net cash provided by (used in) by investing activities
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14,115 | (14,011 | ) | |||||
Financing Activities:
|
||||||||
Principal payments of notes payable
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(40 | ) | (46 | ) | ||||
Net proceeds from sales of common stock, net of offering costs of $0.2 million and $0.1 million, respectively
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8,280 | 3,060 | ||||||
Proceeds from the exercise of stock options
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115 | 413 | ||||||
Net cash provided by financing activities
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8,355 | 3,427 | ||||||
Net increase (decrease) in cash and cash equivalents
|
5,031 | (29,311 | ) | |||||
Cash and cash equivalents at beginning of period
|
8,061 | 38,757 | ||||||
Cash and cash equivalents at end of period
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$ | 13,092 | $ | 9,446 | ||||
Supplemental disclosure of non-cash activities:
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||||||||
Equipment purchases included in accounts payable
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$ | 34 | $ | 297 | ||||
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·
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Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
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·
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Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
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·
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Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions.
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Fair Value at June 30, 2011
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Fair Value at December 31, 2010
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|||||||||||||||||||||||
Assets
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Level 1
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Level 2
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Level 3
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Level 1
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Level 2
|
Level 3
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||||||||||||||||||
Corporate debt securities
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$ | — | $ | 9,229 | $ | — | $ | — | $ | 23,615 | $ | — | ||||||||||||
Total Short-term investments
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$ | — | $ | 9,229 | $ | — | $ | — | $ | 23,615 | $ | — | ||||||||||||
Liabilities
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||||||||||||||||||||||||
Warrant liability
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$ | — | $ | — | $ | 1,605 | $ | — | $ | — | $ | 2,842 |
Fair Value Measurements of
Warrants Using Significant
Unobservable Inputs
(Level 3)
|
||||
Balance at December 31, 2010
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$ | 2,842 | ||
Change in fair value of Warrant liability
|
(1,237 | ) | ||
Balance at June 30, 2011
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$ | 1,605 |
June 30, 2011 | December 31, 2010 | |||||||||||||||||||||||||||||||
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
|||||||||||||||||||||||||
Auction rate securities
|
$ | 3,373 | $ | 912 | $ | — | $ | 4,285 | $ | 3,373 | $ | 773 | $ | — | $ | 4,146 | ||||||||||||||||
Corporate debt securities
|
4,946 | — | (2 | ) | 4,944 | 19,470 | — | (1 | ) | 19,469 | ||||||||||||||||||||||
Total
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$ | 8,319 | $ | 912 | $ | (2 | ) | $ | 9,229 | $ | 22,843 | $ | 773 | $ | (1 | ) | $ | 23,615 |
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Research and development
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$ | 150 | $ | 77 | $ | 273 | $ | 8 | ||||||||
General and administrative
|
553 | 348 | 862 | 501 | ||||||||||||
Total stock-based compensation expenses
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$ | 703 | $ | 425 | $ | 1,135 | $ | 509 |
2005 Stock Incentive
Plan
|
1995 Stock Option
Plan
|
|||||||||||||||
Stock
Options
|
Weighted-
Average
Exercise
Price
|
Stock
Options
|
Weighted-
Average
Exercise
Price
|
|||||||||||||
Outstanding at January 1, 2011
|
5,214,794 | $ | 2.34 | 579,850 | $ | 4.97 | ||||||||||
Granted
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2,857,400 | $ | 2.26 | — | $ | — | ||||||||||
Exercised
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(84,899 | ) | $ | 1.35 | — | $ | — | |||||||||
Canceled
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(571,680 | ) | $ | 2.37 | (55,200 | ) | $ | 8.87 | ||||||||
Outstanding at June 30, 2011
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7,415,615 | $ | 2.32 | 524,650 | $ | 4.58 | ||||||||||
Shares exercisable at June 30, 2011
|
3,461,147 | $ | 2.28 | 524,650 | $ | 4.58 | ||||||||||
Shares available for grant at June 30, 2011
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3,422,135 |
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
||||||
2011
|
2010
|
2011
|
2010
|
||||
Weighted-average fair value of stock options granted
|
$1.09
|
$1.68
|
$1.23
|
$1.64
|
|||
Risk-free interest rate
|
0.83%-1.91%
|
1.47%-2.33%
|
0.83%-1.91%
|
1.46%-2.89%
|
|||
Dividend yield
|
0%
|
0%
|
0%
|
0%
|
|||
Volatility
|
73.28%-80.02%
|
98.78%-108.02%
|
73.28%-80.48%
|
98.78%-108.02%
|
|||
Expected life (in years)
|
3.26-4.47
|
3.06-4.47
|
3.26-4.47
|
3.06-6.26
|
|||
Expected forfeiture rate
|
0-23.15%
|
21.07%
|
0-23.15%
|
21.07%
|
Number of
Shares
|
Per Share
Weighted-
Average
Grant-Date
Fair Value
|
|||||||
Outstanding at January 1, 2011
|
56,666 | $ | 2.47 | |||||
Restricted stock granted
|
— | $ | — | |||||
Restricted stock vested
|
(50,000 | ) | $ | 2.11 | ||||
Restricted stock forfeited
|
— | $ | — | |||||
Outstanding at June 30, 2011
|
6,666 | $ | 5.21 |
|
·
|
potential commercialization of our product candidates;
|
|
·
|
our expectation that we will have adequate capital resources available to operate at planned levels for at least the next twelve months;
|
|
·
|
our expectations for future revenue under the contract with the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA) and funding requirements and capital raising activity, including anticipated proceeds from our At Market Issuance Sales Agreement;
|
|
·
|
our expectations on financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding operating expenses, use of cash, and the fluctuations in expenses and capital requirements associated with pre-clinical studies, clinical trials and other research and development activities;
|
|
·
|
our expectations on clinical development and anticipated milestones, including under the contract with HHS BARDA and our RSV clinical trial;
|
|
·
|
our expectations that our trivalent seasonal influenza VLP vaccine could potentially address an unmet medical need in older adults;
|
|
·
|
our expectations regarding payments to Wyeth and UMMS;
|
|
·
|
our expectations for the use of results from our Pandemic H1N1 clinical trial in Mexico to support the development of our influenza vaccines in other countries, including the United States;
|
|
·
|
the impact of new accounting pronouncements; and
|
|
·
|
our expectations concerning payments under existing license agreements.
|
|
·
|
our ability to progress any vaccine candidates into pre-clinical studies or clinical trials;
|
|
·
|
the scope, initiation, rate and progress of our pre-clinical studies and clinical trials and other research and development activities;
|
|
·
|
clinical trial results;
|
|
·
|
even with positive data from pre-clinical studies or clinical trials, the vaccine candidate may not prove to be safe and efficacious;
|
|
·
|
decisions by regulatory agencies may delay or prevent our development programs or increase the costs of such programs;
|
|
·
|
regulatory approval is needed before any vaccines can be sold in or outside the United States and, to date, no governmental authority has approved any of our vaccine candidates for sale;
|
|
·
|
influenza is seasonal in nature, and if approval or commercial launch after approval is not timely in relation to the influenza season, we may not be able to manufacture or sell our influenza vaccines on terms favorable to us until the next influenza season, if at all;
|
|
·
|
RSV is a difficult disease to prevent and there is significant activity by many companies toward the development of a suitable vaccine;
|
|
·
|
we have not manufactured any of our vaccine candidates at a commercial level;
|
|
·
|
we utilize a unique manufacturing process and the scale-up of that process may prove difficult and/or costly;
|
|
·
|
our dependence on third parties to manufacture and distribute our vaccines;
|
|
·
|
risks associated with conducting business outside of the United States;
|
|
·
|
the cost and our ability of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
|
|
·
|
competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility;
|
|
·
|
our ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration;
|
|
·
|
our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financings or otherwise;
|
|
·
|
our ability to meet the significant requirements of a federal government contractor, which includes having appropriate accounting, project tracking and earned-value management systems implemented and operational, under our contract with HHS BARDA; and
|
|
·
|
other factors referenced herein.
|
Three Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change
2010 to
2011
|
||||||||||
Revenue:
|
||||||||||||
Total revenue
|
$ | 3,001 | $ | 7 | $ | 2,994 |
Three Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change
2010 to
2011
|
||||||||||
Operating Expenses:
|
||||||||||||
Research and development
|
$ | 5,584 | $ | 6,327 | $ | (743 | ) | |||||
General and administrative
|
3,338 | 3,148 | 190 | |||||||||
Total operating expenses
|
$ | 8,922 | $ | 9,475 | $ | (553 | ) |
Manufacturing
|
$ | 3.0 | ||
Vaccine Discovery
|
0.7 | |||
Clinical and Regulatory Affairs
|
1.9 | |||
Total research and development expenses
|
$ | 5.6 |
|
·
|
the number of patients who participate in the trials;
|
|
·
|
the number of sites included in the trials;
|
|
·
|
if trial locations are domestic, international or both;
|
|
·
|
the time to enroll patients;
|
|
·
|
the duration of treatment and follow-up;
|
|
·
|
the safety and efficacy profile of the vaccine candidate; and
|
|
·
|
the cost and timing of, and the ability to secure, regulatory approvals.
|
Three Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Other Income (Expense):
|
||||||||||||
Interest income
|
$ | 38 | $ | 44 | $ | (6 | ) | |||||
Interest expense
|
(2 | ) | (2 | ) | — | |||||||
Change in fair value of warrant liability
|
1,304 | 569 | 735 | |||||||||
Total other income (expense)
|
$ | 1,340 | $ | 611 | $ | (729 | ) |
Three Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Income Tax:
|
||||||||||||
Total income tax expense
|
$ | 412 | $ | — | $ | 412 |
Three Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Net Loss:
|
||||||||||||
Net loss
|
$ | (4,993 | ) | $ | (8,857 | ) | $ | 3,864 | ||||
Net loss per share
|
$ | (0.04 | ) | $ | (0.09 | ) | $ | 0.05 | ||||
Weighted shares outstanding
|
112,821 | 100,694 | 12,127 |
Six Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Revenue:
|
||||||||||||
Total revenue
|
$ | 3,835 | $ | 117 | $ | 3,718 |
Six Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Operating Expenses:
|
||||||||||||
Research and development
|
$ | 10,998 | $ | 15,356 | $ | (4,358 | ) | |||||
General and administrative
|
6,188 | 5,683 | 505 | |||||||||
Total operating expenses
|
$ | 17,186 | $ | 21,039 | $ | (3,853 | ) |
Manufacturing
|
$ | 6.1 | ||
Vaccine Discovery
|
1.6 | |||
Clinical and Regulatory Affairs
|
3.3 | |||
Total research and development expenses
|
$ | 11.0 |
Six Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Other Income (Expense):
|
||||||||||||
Interest income
|
$ | 84 | $ | 88 | $ | (4 | ) | |||||
Interest expense
|
(4 | ) | (4 | ) | — | |||||||
Change in fair value of warrant liability
|
1,237 | 1,638 | (401 | ) | ||||||||
Total other income (expense)
|
$ | 1,317 | $ | 1,722 | $ | (405 | ) |
Six Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Income Tax:
|
||||||||||||
Total income tax expense
|
$ | 412 | $ | — | $ | 412 |
Six Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to
2011
|
||||||||||
Net Loss:
|
||||||||||||
Net loss
|
$ | (12,446 | ) | $ | (19,200 | ) | $ | 6,754 | ||||
Net loss per share
|
$ | (0.11 | ) | $ | (0.19 | ) | $ | 0.08 | ||||
Weighted shares outstanding
|
112,009 | 100,442 | 11,567 |
Six Months Ended
June 30,
|
||||||||||||
2011
|
2010
|
Change 2010
to 2011
|
||||||||||
Summary of Cash Flows:
|
||||||||||||
Net cash (used in) provided by:
|
||||||||||||
Operating activities
|
$ | (17,439 | ) | $ | (18,727 | ) | $ | 1,288 | ||||
Investing activities
|
14,115 | (14,011 | ) | 28,126 | ||||||||
Financing activities
|
8,355 | 3,427 | 4,928 | |||||||||
Net increase (decrease) in cash and cash equivalents
|
5,031 | (29,311 | ) | 34,342 | ||||||||
Cash and cash equivalents at beginning of period
|
8,061 | 38,757 | (30,696 | ) | ||||||||
Cash and cash equivalents at end of period
|
$ | 13,092 | $ | 9,446 | $ | 3,646 |
10.1*
|
Novavax, Inc. Amended and Restated
2005 Stock Incentive Plan
|
10.2* ††
|
Employment Agreement between Novavax, Inc. and Stanley C. Erck dated June 22, 2011, effective as of April 19, 2011
|
14*
|
Novavax, Inc. Amended and Restated Code of Business Conduct and Ethics
|
31.1*
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
|
31.2*
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
|
32.1*
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
32.2*
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
NOVAVAX, INC.
|
|||
Date: August 9, 2011
|
By:
|
/s/ Stanley C. Erck | |
President and Chief Executive Officer | |||
and Director | |||
(Principal Executive Officer)
|
|||
Date: August 9, 2011
|
By:
|
/s/ Frederick W. Driscoll
|
|
Vice President, Chief Financial Officer
|
|||
and Treasurer
|
|||
(Principal Financial and Accounting Officer)
|
|
Exhibit 10.1
|
1.
|
Purpose.
|
2.
|
Type of Stock Awards and Administration.
|
3.
|
Eligibility.
|
4.
|
Stock Subject to Plan.
|
5.
|
Stock Option Provisions.
|
6.
|
Special Provisions for Incentive Stock Options.
|
7.
|
Additional Provisions Related to Stock Options.
|
8.
|
Provisions of Stock Awards Other Than Options.
|
9.
|
General Restrictions.
|
10.
|
Rights as a Stockholder.
|
11.
|
Adjustment Provisions for Recapitalizations and Related Transactions
.
|
12.
|
Merger, Consolidation, Asset Sale, Liquidation, etc.
|
13.
|
No Special Employment Rights.
|
14.
|
Other Employee Benefits.
|
15.
|
Amendment of the Plan.
|
16.
|
Withholding.
|
17.
|
Effective Date and Duration of the Plan.
|
18.
|
Provision for Foreign Participants.
|
NOVAVAX, INC.
|
||
[SEAL]
|
||
By:
|
/s/
James F. Young
|
|
James F. Young, Ph.D.
|
||
Chairman of the Board of Directors
|
||
/s/
Stanley C. Erck
|
||
Stanley C. Erck
|
|
Exhibit 14
|
1. OBJECT AND SCOPE OF THIS CODE
|
1
|
2. OUR CORE VALUES
|
3
|
3. OUR BUSINESS PRACTICES
|
4
|
What You Can Do If You Have A Concern About Business Practices
|
5
|
Our Reporting and Non-Retaliation Policy
|
7
|
Our Principles
|
8
|
4. CONFLICTS OF INTEREST
|
9
|
In General
|
9
|
Receiving Gifts
|
10
|
Related Party Transactions
|
11
|
Outside Directorships
|
11
|
Director Transactions
|
11
|
Corporate Opportunities
|
12
|
Organizational Conflicts of Interest
|
12
|
Disclosure of Actual and Potential Conflicts
|
12
|
5. CONFIDENTIAL INFORMATION
|
14
|
In General
|
14
|
Third-Party Confidential Information
|
15
|
6. USE OF COMPANY ASSETS
|
16
|
7. INVENTIONS AND INTELLECTUAL PROPERTY
|
18
|
8. INSIDER TRADING
|
19
|
What Are the Limitations on Trading?
|
19
|
What is “Material Non-Public Information”?
|
19
|
Additional Requirements for “Insiders”
|
20
|
9. POLITICAL AND GOVERNMENT ACTIVITIES
|
22
|
Political Activities
|
22
|
Government Relations and Lobbying
|
22
|
10. PERSONAL CONDUCT
|
22
|
Equal Employment Opportunity
|
23
|
No Discrimination
|
23
|
No Harassment
|
23
|
Disability Accommodations
|
24
|
Safe Workplace
|
24
|
Drug-Free Workplace
|
25
|
Human Trafficking
|
25
|
11. FAIR COMPETITION
|
26
|
Sales and Marketing Practices
|
27
|
Competitive Information
|
12. ENVIRONMENT, HEALTH AND SAFETY
|
29
|
13. COMPLIANCE WITH LAWS
|
30
|
Bribes
|
30
|
Gratuities
|
30
|
Kickbacks
|
31
|
Prohibited Payment to Foreign Officials
|
31
|
Revolving Door – Discussing Employment with Government Employees
|
31
|
Procurement Information
|
32
|
Commissions, Percentages and Contingent Fees
|
32
|
Products
|
32
|
Classified Materials and Facilities
|
33
|
Export Laws
|
33
|
Boycott Requests
|
33
|
14. ACCURACY OF BOOKS, RECORDS AND ACCOUNTS
|
34
|
Record and Integrity
|
34
|
Accurate Billing Practices
|
34
|
Accurate Information for Investors
|
34
|
15. DISCLOSURE POLICIES AND COMMUNICATION WITH OUTSIDE PARTIES
|
36
|
Media and Investment Community
|
37
|
Our Investors
|
37
|
16. ADMINISTRATION OF THIS CODE
|
38
|
Distribution, Availability and Revisions
|
38
|
Approvals and Waivers
|
38
|
Signature and Acknowledgement
|
38
|
Ongoing Review of Compliance
|
39
|
Investigations and Disciplinary Actions
|
39
|
Important Disclaimers
|
41
|
17. NOVAVAX PERSONAL PLEDGE
|
42
|
|
·
|
honest and ethical conduct, including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships;
|
|
·
|
full, fair, accurate, timely and understandable disclosure in reports and documents that the Company files with, or submits to, regulatory agencies and in other public communications made by the Company;
|
|
·
|
compliance with applicable governmental laws, rules and regulations;
|
|
·
|
the prompt internal reporting of violations of the Code or applicable law to the appropriate person;
|
|
·
|
open communication and dealings with third parties; and
|
|
·
|
accountability for adherence to the Code.
|
|
·
|
reporting violations or potential violations of this Code, other Company policies and procedures, or applicable law that the employee reasonably believes to have occurred;
|
|
·
|
making complaints regarding accounting, internal accounting controls or auditing matters or voicing concerns regarding questionable accounting or auditing matters that the employee reasonably believes to have occurred;
|
|
·
|
disclosing information to a government or law enforcement agency, where the employee has reasonable cause to believe that the information discloses a violation or possible violation of foreign, federal, state or local law or regulation; or
|
|
·
|
providing or causing information to be provided, filing or causing to be filed, testifying, participating in a proceeding filed or about to be filed, or otherwise assisting in an investigation or proceeding regarding any conduct that the employee reasonably believes involves a violation of this Code or applicable law, including criminal laws regarding securities law violations or fraud, any rule or regulation of the Securities and Exchange Commission (“SEC”) or any provision of law relating to fraud against shareholders.
|
Question:
If I do raise a business conduct or ethics issue, will I get in trouble?
Answer:
No - as long as you honestly have a concern or issue, you will not be reprimanded or disciplined for raising an issue. Quite the contrary, as a Novavax employee you have an obligation to question situations with which you are uncomfortable and seek assistance.
|
|
·
|
unduly using your influence or position to cause Novavax to employ, engage in a business transaction or enter into a contract with your relatives (including your spouse, parents, grandparents, children, siblings, in-laws or life partner), friends, or a company in which you or your relatives or friends has, directly or indirectly, an interest;
|
|
·
|
using material, non-public Novavax, vendor, customer, partner or competitor information for personal gain (including securities transactions based on such information);
|
|
·
|
serving as a director or advisory board member of any current or likely competitor of Novavax, or accepting such positions with any organization or governmental agency with which we do or may do business;
|
|
·
|
soliciting or receiving any gift in violation of this policy;
|
|
·
|
making or accepting gifts, loans, meals, entertainment or services from or to vendors, customers, partners, competitors or others seeking to do business with Novavax that are not reasonable and of modest value (generally, not exceeding $100), or that do not support the legitimate business interests of the Company;
|
|
·
|
having outside employment that interferes with the employee’s performance, ability to act in Novavax’s best interests, or comply with Company policies, or requires the employee to use confidential information or Company assets, or otherwise creates a conflict or the appearance of impropriety;
|
|
·
|
having more than a modest financial interest in Novavax’s vendors, customers, partners or competitors, whether such entities are public or private; and
|
|
·
|
competing, or preparing to compete, with the Company while still employed by the Company.
|
Question:
My spouse’s company is bidding on a contract with a subsidiary of Novavax. Although I select vendors for projects in my own business unit, I have no decision-making authority in the subsidiary where my spouse’s company is competing on the bid. Do I need to report this?
Answer:
Yes. Even though you may not have direct control over the outcome of the bid, the fact that your spouse has connections to the Company might give the appearance of a conflict of interest.
|
·
Financial information and projections
·
Human resource information, including employee files and salary information
·
Formulations and prototypes
·
License and partnering agreements
·
Regulatory plans
·
Production processes and schedules
·
Customer lists and information
·
Business methods
·
Strategic plans and budgets
·
Planned business acquisitions or divestitures
·
Advertising and marketing strategies
|
·
Quality data
·
Manufacturing processes, techniques and layouts
·
Competitive information held by the Company
·
Market data
·
R&D information, data, proposals & plans
·
Product ideas
·
Inventions & discoveries, whether patentable or not
·
Pre-Clinical R&D information and data
·
Clinical R&D protocols, information and data
|
·
Office supplies, including telephones and cell phones
·
Computers, including software and computer files
·
Office and laboratory equipment
·
Facilities
·
Building access cards
|
·
Confidential information
·
Communications systems (including voicemail, e-mail, the Internet and the Novavax intranet)
·
An employee’s time at work and work-product
|
|
·
|
does not affect your job performance or disrupt others;
|
|
·
|
is truly occasional in nature;
|
|
·
|
does not result in any additional expense to Novavax;
|
|
·
|
does not knowingly access or transmit material containing derogatory, racial, gender or religious comments, sexual content, offensive language, material which would negatively reflect upon Novavax or be likely to offend co-workers, or contents prohibited by law or regulation; and
|
|
·
|
is not used to carry on any form of business activity outside of the course of your duties with Novavax - without Novavax approval.
|
Question:
My co-worker uses Company e-mail to arrange her social life. I think this is an inappropriate use of Company assets but she disagrees. Who is right?
Answer:
It depends. If your friend occasionally uses e-mail to contact friends or schedule social events, this is not a violation of policy or an abuse of Novavax resources. However, if her use of e-mail for personal reasons is prolonged and affecting her productivity, it is inappropriate and she should stop.
|
|
·
|
Patents – protect inventions by permitting inventors to exclude or prevent others from making, using or selling their inventions. Employees should report the unauthorized use of the Company’s patents and notify the Company if they have an invention that needs patent protection.
|
|
·
|
Copyrights – protect works of original authorship such as articles, drawings, photographs, video, music, audiotapes and software. Generally, copyrights prohibit others from copying or downloading the works without consent. Employees should ensure that other parties’ use of Novavax’s copyrights is only pursuant to the proper authorization.
|
|
·
|
Trademarks and service marks – protect words, names and symbols that help consumers recognize a product or service and distinguish it from those of competitors. The use of Novavax’s trademarks and service marks must be properly authorized or licensed.
|
|
·
|
Trade secrets – include valuable information that creates a competitive advantage for Novavax by being kept confidential. Examples include information about customers, research and development data, and financial, planning, marketing or strategic information. Employees should treat trade secrets as confidential information and safeguard them from unauthorized disclosure or use.
|
|
·
|
financial results for the quarter or year
|
|
·
|
financial forecasts and budgets
|
|
·
|
possible mergers, acquisitions, joint ventures or business development transactions
|
|
·
|
gain or loss of a substantial customer, supplier or contract
|
|
·
|
major financing developments
|
|
·
|
major personnel changes
|
|
·
|
major patent or product developments
|
|
·
|
major litigation developments
|
|
·
|
information and results regarding pre-clinical & clinical trials
|
|
·
|
inventions & discoveries, whether patentable or not
|
Question:
What if an insider has material non-public information about Novavax?
Answer:
When any Novavax insider knows material information about the Company that has not been made public, they are prohibited from three activities:
·
trading in Novavax’s securities for their own account or for the account of another (including any trust of which they are a trustee);
·
having anyone else trade for them in Novavax’s securities; and
·
disclosing the information to anyone else who might then trade or in turn “tip” another person who trades.
Neither the insiders nor anyone acting on their behalf nor anyone who learns the information from them can trade. This prohibition continues whenever and for as long as the information continues to be material and non-public. This prohibition extends not just to securities of Novavax but also to those of other companies with which we are involved.
|
Question:
A member of my team often makes disparaging remarks about other team members, in particular one who suffers from a physical disability. She does not believe this it is a problem because she never makes the remarks in the person’s presence, but I have to work with her on a daily basis and I find it offensive. What should I do?
Answer:
Every member of your team deserves respect. The preferred course of action is to clearly tell the co-worker that you find the remarks offensive and ask her to stop. Novavax considers such remarks inappropriate for our professional work environment. If she does not cease the conduct, you can ask a member of management to take appropriate action.
|
|
·
|
all antitrust rules and regulations, including rules against agreements or understandings between Novavax and its competitors that affect the process, terms or conditions of sale;
|
|
·
|
prohibitions against unfair methods of competition and unfair and deceptive acts or practices in commerce;
|
|
·
|
all foreign corrupt practices laws, including those making illegal any offer, payment, promise to pay or authorization to pay any money, gift or anything of value to foreign officials, political parties or candidates for improper purposes; and
|
|
·
|
laws governing trade, boycotts, customs, embargoes and export controls.
|
|
·
|
agree with a competitor to fix prices or share pricing information;
|
|
·
|
illegally favor one customer over another; or
|
|
·
|
attend trade association meetings held for improper purposes, such as to discuss setting prices or allocating markets or territories among competitors.
|
Question:
If I do not talk about specific price levels, can I agree with a competitor not to engage in a price war?
Answer:
No. Any agreement between competitors that directly relates to the prices they charge is a violation of fair competition laws, regardless of whether specific prices are a part of the agreement.
|
|
·
|
illegally influence the judgment or conduct, or ensure a desired outcome or action, of any individual, customer, company or company representative;
|
|
·
|
win or retain business, or influence any act or decision of any government official, political party, candidate for political office or official of a public or international organization; or
|
|
·
|
gain an improper advantage.
|
|
·
|
fair competition,
|
|
·
|
antitrust policies,
|
|
·
|
proprietary information and data, and
|
|
·
|
confidential relationships between employees and employers.
|
|
·
|
tradeshows and medical conferences
|
|
·
|
literature searches
|
|
·
|
discussions with customers
|
|
·
|
competitive brochures and other widely distributed information
|
|
·
|
market data
|
|
·
|
provide and maintain facilities and operations where health and safety are promoted and hazards are controlled;
|
|
·
|
manage facilities and operations such that their potential impacts on the environment are controlled and minimized;
|
|
·
|
comply with applicable environmental, health and safety legal requirements; and
|
|
·
|
provide environmental, health and safety training and education for all Novavax employees as appropriate.
|
|
·
|
provide information in accordance with generally accepted accounting principles (GAAP) that is accurate, complete, reliable, objective, relevant and timely for data and disclosures in reports and documents that Novavax files with, or submits to, government and regulatory authorities, internal management review and in other public communications;
|
|
·
|
to the best of your knowledge, conduct business in compliance with the laws, rules and regulations of applicable governments, and other appropriate private and public regulatory agencies;
|
|
·
|
act in good faith, responsibly, with due care, competence and diligence, and without allowing one’s independent judgment to be subordinated in the execution of your financial duties;
|
|
·
|
respect the confidentiality of information acquired in the course of your work except when authorized or otherwise legally obligated to disclose, and do not use confidential information for personal advantage;
|
|
·
|
to the extent estimates and accruals are necessary in Company reports and records, ensure they are based on good faith judgment and supported by appropriate documentation.
|
|
·
|
never falsify any document, distort the true nature of any transaction or manipulate financial accounts, records or reports, whether that of Novavax, a customer, a partner or other third-party;
|
|
·
|
include supporting documentation for all transactions;
|
|
·
|
cooperate with any investigations or inquiries into the accuracy and timeliness of financial records;
|
|
·
|
promptly report to the CFO or Chairman of the Audit Committee any material information of which you may become aware that affects the disclosures made by the Company in our public filings, or that concerns either deficiencies in the design or operation of internal control which could adversely affect Novavax’s ability to record, process, summarize and report financial data, material weaknesses in internal controls, or fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s financial reporting, disclosures or internal controls; and
|
|
·
|
promptly report to the Chairman of the Audit Committee of the Board (in the case of the CEO or the CFO) or to your supervisor (in the case of other employees with financial reporting responsibilities) any activity that the individual believes to be a violation of law, business ethics or of any provisions of this Code, including any transaction or relationship that reasonably could be expected to give rise to a conflict of interest.
|
Question:
I do not have the time to check all of the invoices and expense reports that come across my desk. Surely, it is the responsibility of the individual who prepared them or the employee who submitted them to me to make sure that they are correct. Am I right in my assumption?
Answer:
No. Accurate records are everyone’s responsibility. If you are approving an invoice or expense report, you are responsible for its accuracy.
|
Question:
I received a call from a reporter who is looking for information that is within the scope of my job. What should I do?
Answer:
The prudent course of action in this case is to redirect the reporter to the Company’s Investor Relations department, CEO or CFO.
|
|
·
|
committing, authorizing or directing an illegal act or violation of this Code;
|
|
·
|
failing to exercise proper compliance oversight or tolerating illegal conduct, if acting as a supervisor.
|
|
·
|
failing to report illegal or improper conduct of which he or she directly knows or observes.
|
|
·
|
refusing to cooperate with an investigation, including deliberately withholding relevant information or knowingly providing false information concerning a violation of this Code or applicable laws and regulations.
|
|
·
|
discouraging another individual from reporting a violation of law or this Code.
|
|
·
|
retaliating against or condoning retaliation against an individual who reports a violation or assists in an investigation of a suspected violation.
|
|
·
|
I have received a copy of Novavax’s Code of Business Conduct and Ethics (the “Code”);
|
|
·
|
I have read, understand and will act consistent with the Code and any of its future revisions;
|
|
·
|
If I have questions regarding the content or interpretation of the Code, I will bring them to the attention of my supervisor; and
|
|
·
|
If I observe or suspect a violation of the Code or any business practice or legal or ethical standard, I will report it in accordance with this Code.
|
Employee Signature:
|
|
Date:
|
|
||
Employee Name:
|
|
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c)
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluations; and
|
|
d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
Date: August 9, 2011
|
By:
|
/s/ Stanley C. Erck
|
President and Chief Executive Officer
|
Date: August 9, 2011
|
By:
|
/s/ Frederick W. Driscoll
|
Vice President, Chief Financial Officer and
Treasurer
|
Date: August 9, 2011
|
By:
|
/s/ Stanley C. Erck
|
President and Chief Executive Officer
|
Date: August 9, 2011
|
By:
|
/s/ Frederick W. Driscoll
|
Vice President, Chief Financial Officer and Treasurer
|