UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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þ
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QUARTERLY REPORT UNDER SECTION 13 or 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For Quarterly Period Ended March 31, 2009
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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Commission File No. 0-26770
NOVAVAX, 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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22-2816046
(I.R.S. Employer
Identification No.)
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9920 Belward Campus Drive, Rockville, MD
(Address of principal executive offices)
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20850
(Zip code)
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(240) 268-2000
(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.
þ
Yes
o
No
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
o
Yes
o
No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definitions of large accelerated
flier, accelerated flier and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
o
Large accelerated filer
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þ
Accelerated filer
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o
Non-accelerated filer
(Do not check if a smaller reporting company)
|
o
Smaller reporting company
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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).
o
Yes
þ
No
The number of shares outstanding of each of the issuers classes of common stock, as of the latest
practicable date:
Shares of Common Stock Outstanding at May 5, 2009: 86,518,220
NOVAVAX, INC.
Form 10-Q
For the Quarters Ended March 31, 2009 and 2008 (unaudited)
Table of Contents
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PART I. FINANCIAL INFORMATION
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Item 1
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Financial Statements
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Consolidated Balance Sheets as of March 31, 2009 (unaudited) and
December 31, 2008
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1
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Consolidated Statements of Operations for the three-months ended
March 31, 2009 and 2008 (unaudited)
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2
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Consolidated Statements of Stockholders Equity as of March 31,
2009 (unaudited)
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3
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Consolidated Statements of Cash Flows for the three months ended
March 31, 2009 and 2008 (unaudited)
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4
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Notes to the Consolidated Financial Statements (unaudited)
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6
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Item 2
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Managements Discussion and Analysis of Financial Condition and Results
of Operations
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21
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Item 3
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Quantitative and Qualitative Disclosures about Market Risk
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32
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Item 4
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Controls and Procedures
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33
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PART II. OTHER INFORMATION
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Item 1
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Legal Proceedings
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34
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Item 1A
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Risk Factors
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34
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Item 6
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Exhibits
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34
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SIGNATURES
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i
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
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March 31,
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December 31,
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2009
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2008
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(unaudited)
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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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19,629
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$
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26,938
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Short-term investments classified as available for sale
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5,958
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6,962
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Accounts and other receivables, net of allowance for
doubtful accounts of $218 as of March 31, 2009 and
December 31, 2008
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61
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290
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Prepaid expenses and other current assets
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994
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774
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Current assets of discontinued operations
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132
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Total current assets
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26,642
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35,096
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Property and equipment, net
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8,019
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8,228
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Goodwill
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33,141
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33,141
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Other non-current assets
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160
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160
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Total assets
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$
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67,962
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$
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76,625
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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1,024
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1,750
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Accrued expenses and other current liabilities
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3,208
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2,969
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Current portion of notes payable
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385
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|
650
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Current liabilities of discontinued operations
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242
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|
Convertible notes, current
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21,881
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21,778
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Deferred rent
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334
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328
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Total current liabilities
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26,832
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27,717
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Non-current portion of notes payable
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468
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480
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Deferred rent
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2,868
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2,939
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Total liabilities
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30,168
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31,136
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Commitments and contingencies
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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, $0.01 par value, 100,000,000 shares
authorized; 69,310,521 shares issued and 68,855,091
shares outstanding at March 31, 2009 and 69,220,221
shares issued and 68,764,591 shares outstanding at
December 31, 2008
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693
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692
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Additional paid-in capital
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285,248
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284,595
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Notes receivable from directors
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(1,572
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)
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(1,572
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)
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Accumulated deficit
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(244,125
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)
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(235,776
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)
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Treasury stock, 455,430 shares at March 31, 2009 and
December 31, 2008, cost basis
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(2,450
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)
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(2,450
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)
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Total stockholders equity
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37,794
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45,489
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Total liabilities and stockholders equity
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$
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67,962
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$
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76,625
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The accompanying notes are an integral part of these consolidated financial statements.
1
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
(unaudited)
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Three months ended
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March 31,
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2009
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2008
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Revenues
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$
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21
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$
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458
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Operating costs and expenses:
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Research and development
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4,266
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4,434
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Selling, general and administrative
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2,892
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3,244
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Total operating costs and expenses
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7,158
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7,678
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Loss from continuing operations before other (expense) income, net
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(7,137
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)
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(7,220
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)
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Other (expense) income, net
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(1,212
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)
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|
117
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|
|
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|
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Loss from continuing operations
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(8,349
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)
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|
(7,103
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)
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Loss from discontinued operations
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(652
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)
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Net loss
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$
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(8,349
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)
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$
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(7,755
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)
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Basic and diluted net loss per share:
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Loss per share from continuing operations
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$
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(0.12
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)
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$
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(0.12
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)
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Loss per share from discontinued operations
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|
|
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(0.01
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)
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|
|
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Net loss per share
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$
|
(0.12
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)
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$
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(0.13
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)
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|
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|
|
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Basic and diluted weighted average number of common shares
outstanding
|
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68,692,455
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61,280,155
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|
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|
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The accompanying notes are an integral part of these consolidated financial statements.
2
NOVAVAX, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY
For the Three Months Ended March 31, 2009
(in thousands, except share information)
(unaudited)
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|
|
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|
|
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|
|
|
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|
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|
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|
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Additional
|
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Notes
|
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Total
|
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Common Stock
|
|
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Paid-in
|
|
|
Receivable
|
|
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Accumulated
|
|
|
Treasury
|
|
|
Stockholders
|
|
|
|
Shares
|
|
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Amount
|
|
|
Capital
|
|
|
From Directors
|
|
|
Deficit
|
|
|
Stock
|
|
|
Equity
|
|
Balance, December 31, 2008
|
|
|
69,220,021
|
|
|
$
|
692
|
|
|
$
|
284,595
|
|
|
$
|
(1,572
|
)
|
|
$
|
(235,776
|
)
|
|
$
|
(2,450
|
)
|
|
$
|
45,489
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash compensation costs
for stock options
|
|
|
|
|
|
|
|
|
|
|
350
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
350
|
|
Exercise of stock options
|
|
|
20,000
|
|
|
|
|
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35
|
|
Issuance of stock
|
|
|
70,500
|
|
|
|
1
|
|
|
|
121
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
122
|
|
Amortization of restricted
stock for
compensation
|
|
|
|
|
|
|
|
|
|
|
147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
147
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,349
|
)
|
|
|
|
|
|
|
(8,349
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2009
|
|
|
69,310,521
|
|
|
$
|
693
|
|
|
$
|
285,248
|
|
|
$
|
(1,572
|
)
|
|
$
|
(244,125
|
)
|
|
$
|
(2,450
|
)
|
|
$
|
37,794
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
3
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
|
March 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Operating Activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,349
|
)
|
|
$
|
(7,755
|
)
|
Plus net income from discontinued operations
|
|
|
|
|
|
|
652
|
|
|
|
|
|
|
|
|
Net loss from continuing operations
|
|
|
(8,349
|
)
|
|
|
(7,103
|
)
|
Reconciliation of net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
294
|
|
|
|
209
|
|
Amortization of debt discount
|
|
|
103
|
|
|
|
102
|
|
Loss on disposal of property and equipment
|
|
|
29
|
|
|
|
18
|
|
Amortization of net discounts on short-term investments
|
|
|
|
|
|
|
(147
|
)
|
Reserve for notes receivable and accrued interest
|
|
|
|
|
|
|
194
|
|
Amortization of deferred financing costs
|
|
|
64
|
|
|
|
65
|
|
Deferred rent
|
|
|
(66
|
)
|
|
|
(1
|
)
|
Impairment of short-term investments
|
|
|
879
|
|
|
|
|
|
Non-cash stock compensation
|
|
|
497
|
|
|
|
450
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts and other receivables
|
|
|
216
|
|
|
|
20
|
|
Inventory
|
|
|
(2
|
)
|
|
|
(18
|
)
|
Prepaid expenses and other current assets
|
|
|
(150
|
)
|
|
|
196
|
|
Accounts payable and accrued expenses
|
|
|
(242
|
)
|
|
|
(1,172
|
)
|
Other non-current assets
|
|
|
|
|
|
|
(28
|
)
|
|
|
|
|
|
|
|
Net cash used in operating activities from continuing operations
|
|
|
(6,727
|
)
|
|
|
(7,215
|
)
|
Net cash provided by operating activities from discontinued
operations
|
|
|
|
|
|
|
2,013
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(6,727
|
)
|
|
|
(5,202
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(63
|
)
|
|
|
(1,631
|
)
|
Proceeds from disposal of property and equipment
|
|
|
6
|
|
|
|
|
|
Purchases of short-term investments
|
|
|
|
|
|
|
(15,650
|
)
|
Proceeds from maturities of short-term investments
|
|
|
125
|
|
|
|
31,745
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities from continuing
operations
|
|
|
68
|
|
|
|
14,464
|
|
Net cash provided by investing activities from discontinued
operations
|
|
|
|
|
|
|
1,134
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
68
|
|
|
|
15,598
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities:
|
|
|
|
|
|
|
|
|
Principal payments of notes payable
|
|
|
(807
|
)
|
|
|
(658
|
)
|
Net proceeds from sales of common stock
|
|
|
122
|
|
|
|
|
|
Proceeds from the exercise of stock options
|
|
|
35
|
|
|
|
35
|
|
Bank overdraft
|
|
|
|
|
|
|
579
|
|
|
|
|
|
|
|
|
Net cash (used in) financing activities
|
|
|
(650
|
)
|
|
|
(44
|
)
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(7,309
|
)
|
|
|
10,352
|
|
Cash and cash equivalents at beginning of period
|
|
|
26,938
|
|
|
|
4,350
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
19,629
|
|
|
$
|
14,702
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash interest payments
|
|
$
|
523
|
|
|
$
|
688
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash activities:
|
|
|
|
|
|
|
|
|
Equipment purchases included in accounts payable
|
|
$
|
47
|
|
|
$
|
1,128
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
4
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Organization
Novavax, Inc., a Delaware corporation (Novavax or the Company), was incorporated in 1987,
and is a clinical-stage biopharmaceutical company focused on creating differentiated, value-added
vaccines that improve upon current preventive options for a range of infectious diseases. These
vaccines leverage the Companys virus-like-particle (VLP) platform technology coupled with a
unique, disposable production technology.
VLPs are genetically engineered three-dimensional nanostructures, which incorporate
immunologically important lipids and recombinant proteins. The Companys VLPs resemble the virus
but lack the genetic material to replicate the virus. The Companys proprietary production
technology uses insect cells rather then chicken eggs or mammalian cells. The Companys current
product targets include vaccines against the H5N1 and other subtypes of avian influenza with
pandemic potential, human seasonal influenza, Varicella Zoster (VZV), which causes Shingles, and
Respiratory Syncytial Virus (RSV).
Subsequent Events
Cadila Pharmaceuticals Ltd.
On March 31, 2009, the Company and Cadila Pharmaceuticals Ltd., a company incorporated under
the laws of India (Cadila), entered into a Joint Venture Agreement (the JVA) pursuant to which
the Company and Cadila formed CPL Biologicals Limited, a joint venture (the JV), of which 80%
will be owned by Cadila and 20% is owned by the Company. The JV must obtain approval from Indias
Foreign Investment Promotion Board (the FIPB) prior to issuing shares to Novavax. The JV will
develop and commercialize the Companys seasonal influenza virus-like-particle (VLP)-based vaccine
candidate and Cadilas therapeutic vaccine candidates against cancer as well as its adjuvants,
biogeneric products and other diagnostic products for the territory of India. Novavax will also
contribute to the JV technology for the development of several other VLP vaccine candidates against
diseases of public health concern in the territory, such as hepatitis E and chikungunya fever.
Cadila will contribute approximately $8 million over three years to support the JVs operations.
The JV will be responsible for clinical testing and registration of products that will be marketed
and sold in India.
The board of directors of the JV consists of five members, three of whom (including the
Chairman of the board) are nominated by Cadila and two of whom are nominated by Novavax. If the
board is not in unanimous agreement on an issue, the Chief Executive Officers (CEOs) of the
Company and Cadila will work to resolve the issue. If the CEOs cannot resolve the issue in five
business days, a vote by the majority of the board will decide. However, the approval of the
Company and Cadila, as shareholders of the JV, and the board of directors of the JV is required for
(1) the sale of all or most of the assets of the JV, (2) a change in control of the JV, (3) the
liquidation, dissolution, or winding up of the JV, (4) any occurrence of indebtedness that results
in the JV having a debt-to-equity ratio of 3-to-1 or greater, or (5) most amendments of the JVA or
the JVs Articles of Association.
The JV has the right to negotiate a definitive agreement for rights to certain future Novavax
products (other than RSV) and certain future Cadila products in each case for the territory of
India prior to Novavax or Cadila licensing such rights to a third party. Novavax has the right to
negotiate the licensing of vaccines developed by the joint venture using Novavaxs technology for
commercialization in every country except for India and vaccines developed by the joint venture
using Cadilas technology for commercialization in certain countries, including the United States.
In connection with the JVA, on March 31, 2009, the Company also entered into license
agreement, an option to enter into a license agreement, a technical services agreement and a supply
agreement with the JV.
Also on March 31, 2009, Novavax entered into a binding, non-cancellable Stock Purchase
Agreement (the SPA) with Satellite Overseas (Holdings) Limited (SOHL), a subsidiary of Cadila,
pursuant to which SOHL agreed to purchase 12.5 million shares of Company common stock, par value
$0.01 (the Common Stock) at the market price of $0.88 per share.
5
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The stock purchase was consummated on April 1, 2009. The Company raised gross proceeds of $11
million in the offering. The net proceeds to the Company from the sale of the Common Stock, after
deducting estimated offering expenses payable by the Company, was approximately $10.5 million.
The SPA provides that, as long as SOHL owns more than 5% of the Companys then-outstanding
Common Stock, SOHL may purchase a pro-rata portion of any Company Common Stock sale or issuance.
Under the SPA, certain issuances are exempt from SOHLs pre-emptive right, including shares issued
(1) as stock dividends, stock splits, or otherwise payable pro rata to all holders of Common Stock;
(2) to employees, officers, directors or consultants of the Company pursuant to an employee benefit
program; (3) upon the conversion or exercise of any options, warrants or other rights to purchase
Common Stock; and (4) as consideration for a merger, consolidation, purchase of assets, or in
connection with a joint venture or strategic partnership. However, any issuances pursuant to (4)
above, must be approved by a majority of the full board and, if the transaction exceeds 5% of the
Companys then issued and outstanding shares of Common Stock, the per share purchase price cannot
be less than $0.88.
Under the SPA, for so long as SOHL owns 5% of the Companys Common Stock, SOHL may designate
one member of the Companys board of directors.
Finally, on March 31, 2009, Novavax and Cadila entered into a Master Services Agreement (the
Master Services Agreement) pursuant to which Novavax may request services from Cadila in the
areas of biologics research, preclinical development, clinical development, process development,
manufacturing scale up, and general manufacturing related services in India. If, at the third
anniversary of the Master Services Agreement, the amount of services provided by Cadila is less
than $7.5 million, Novavax will pay Cadila a portion of the shortfall. Novavax will have to pay
Cadila the portion of the shortfall amount that is less than or equal to $2.0 million and 50% of
the portion of the shortfall amount that exceeds $2.0 million. When calculating the shortfall, the
amount of services provided by Cadila includes amounts that have been paid under all project plans,
the amounts that will be paid under ongoing executed project plans and amounts for services that
had been offered to Cadila, that Cadila was capable of performing, but exercised its right not to
accept such project. The term of the Master Services Agreement is five years, but may be terminated
by either party if there is a material breach that is not cured within 30 days of notice or, at any
time after three years, provided that 90 days prior notice is given to the other party.
As a result of the contribution of the intellectual property to the joint venture, the company
could recognize a taxable gain. Furthermore, since the Company has not analyzed whether it has had
a change in ownership under Internal Revenue Code section 382, a gain could result in a tax
liability to the Company since the Companys tax net operating losses could be limited by section
382.
At the Market Issuance
On January 12, 2009 the Company entered into an At Market Issuance Sales Agreement (the Sales
Agreement), with Wm Smith & Co. (Wm Smith), under which the Company may sell an aggregate of up
to $25.0 million in gross proceeds of the Companys common stock from time to time through Wm
Smith, as the agent for the offer and sale of the common stock. The board of directors has
authorized the sale of up to 12.5 million shares of common stock under the Sales Agreement. Based
on the trading price of the Companys common stock, the Company may not be able to raise the full
$25.0 million in gross proceeds permitted under the Sales Agreement. Wm Smith may sell the common
stock by any method permitted by law, including sales deemed to be an at the market offering as
defined in Rule 415 of the Securities Act, including without limitation sales made directly on
NASDAQ Global Market, on any other existing trading market for the common stock or to or through a
market maker. Wm Smith may also sell the common stock in privately negotiated transactions, subject
to the Companys prior approval. The Company will pay Wm Smith a commission equal to 3% of the
gross proceeds of the sales price of all common stock sold through it as sales agent under the
Sales Agreement. During the first quarter of 2009, the Company sold 70,500 shares and received net
proceeds in the amount of $121,457, under the Sales Agreement. As of
May 5, 2009, the Company sold approximately an
additional 3.1 million shares for net proceeds approximately of $7.5 million.
6
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Amendments to Convertible Notes
As of March 31, 2009, the Company had $22.0 million of senior convertible notes outstanding
(the Notes). The Notes carried a 4.75% coupon; are convertible into shares of Novavax common
stock at $4.00 per share; and mature on July 15, 2009. On April 29, 2009, the Company entered into
amendment agreements (the 2009 Amendments) with holders of the outstanding 4.75% Note
representing $17.0 million of the $22.0 million outstanding principal amount of the Notes to amend
the terms of the Notes to allow for early payment under specific terms described below.
The 2009 Amendments (i) provide for payment of $17.0 million aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of common stock that equals 30% of this principal amount divided
by $2.50. The Company paid $12.1 million in principal and accrued interest and issued 2,040,000
shares in accordance with the 2009 Amendments on April 29, 2009. After payment of this $17.0
million in principal amount, $5.0 million aggregate principal amount remains outstanding under the
Notes and will mature on July 15, 2009.
Under the terms of the Notes, Novavax, at its option, can pay up to 50% of the remaining $5.0
million outstanding Notes in Novavax common stock on the due date of July 15, 2009, subject to the
satisfaction of certain conditions, including, among other things, a requirement that the shares
issued upon conversion be registered or freely tradable without registration, that Novavaxs shares
of common stock have not been suspended from trading on NASDAQ Global Market during the applicable
measurement period and there is no threatened delisting or suspension, and that the Company is
otherwise in compliance with its agreements with the Note holders. The amount of shares that may
be issued at maturity may be subject to adjustment depending on the Note holders percentage
ownership of the Company on an as-converted basis and if the Companys stock price falls below
$2.00 during the measurement period. As a result, the Company will have to pay at least $2.5
million in cash to satisfy the remaining Notes on the due date unless the notes are converted into
common stock, redeemed or amended prior to July 15, 2009.
Liquidity Matters
The Company has incurred losses since its inception and as of March 31, 2009 has an
accumulated deficit of $244 million.
The Companys vaccine products currently under development or in clinical trials will require
significant additional research and development efforts, including extensive pre-clinical and
clinical testing and regulatory approval, prior to commercial use. There can be no assurance that
the Companys research and development efforts will be successful or that any potential products
will prove safe and effective in clinical trials. Even if developed, these vaccine products may
not receive regulatory approval or be successfully introduced and marketed at prices that would
permit the Company to operate profitably. The commercial launch of any vaccine product is subject
to certain risks including, but not limited to, manufacturing scale-up and market acceptance. The
Company does not expect to generate revenue in the near future.
At March 31, 2009 the Company had cash and cash equivalents totaling $19.6 million and auction
rate securities with a face value of $8.1 million and a fair value of $6.0 million. There has been
insufficient demand at auction for each of the Companys five auction rate securities. The Company
recorded impairment charges of $1.2 million in the fourth quarter of 2008 and $0.9 million during
the first quarter of 2009 due primarily to their illiquidity and believes the $6.0 million it has
recorded at March 31, 2009 represents their fair market value and the value the Company could
liquidate the investments for, if necessary. The Company is currently evaluating what purchase
price it could get for these securities currently, along with the risks and benefits of holding
versus selling these securities. Without liquidity of these auction rate securities, the Companys
cash position will be negatively affected.
7
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
During the three months ended March 31, 2009, the Company sold 70,500 shares of common stock
and received net proceeds in the amount of $121,457 pursuant to the Sales Agreement with Wm Smith.
On March 31, 2009, the Company entered into a non-cancellable binding Stock Purchase Agreement for
the sale of 12.5 million shares of common stock to a wholly-owned subsidiary of Cadila
Pharmaceuticals Ltd., at the market price of $0.88 per share for a net purchase price of $10.5
million (See
Subsequent Events At the Market Issuance and Cadila Pharmaceuticals, Ltd.
). These
proceeds were received on April 1, 2009.
As of May 5, 2009, the Company has sold approximately 3.1 million shares under the Sales
Agreement with Wm Smith for net proceeds of approximately $7.5 million.
As of March 31, 2009, the Company had $22.0 million of senior convertible notes outstanding
(the Notes). (See
Subsequent Events Amendments to Convertible Notes
).
The 2009 Amendments (i) provide for payment of $17.0 million aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of common stock that equals 30% of this principal amount divided
by $2.50. The Company paid $12.1 million in principal and accrued interest and issued 2,040,000
shares in accordance with the 2009 Amendments on April 29, 2009. After payment of this $17.0
million in principal amount, $5.0 million aggregate principal amount remains outstanding under the
Notes and will mature on July 15, 2009.
Based on the amount of funds on hand and the Companys proceeds from the Cadila transaction
and the sales of shares under the Sales Agreement with Wm Smith, the Company believes that its cash
and cash equivalents, excluding the value of its current illiquid auction rate securities, will be
sufficient to cover its estimated funding needs for at least twelve months. The Company is planning
to raise additional capital in order to continue its current level of operations and to pursue the
business plan beyond 2009. The Company has not, however, secured any additional commitments for
new financing at this time nor can it provide any assurance that new financing will be available on
commercially acceptable terms, if at all. If the Company is unable to immediately secure
additional capital, it will continue to assess its capital resources and the Company may be
required to downsize its operations, reduce general and administrative costs or delay or reduce the
scope of, or eliminate one or more of its product research and development programs, thereby
causing delays in the Companys efforts to introduce its future products to market.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim consolidated financial statements include the accounts of
the Company and its wholly owned subsidiary (Fielding Pharmaceutical Company). All significant
inter-company accounts and transactions have been eliminated in consolidation. They have been
prepared pursuant to the rules and regulations of the Securities and Exchange Commission. The
financial statements reflect all adjustments that are in the opinion of management, necessary for a
fair statement of such information. All such adjustments are of a normal recurring nature. Although
Novavax believes that the disclosures are adequate to make the information presented not
misleading, certain information and footnote disclosures, including a description of significant
accounting policies normally included in financial statements prepared in accordance with
accounting principles generally accepted in the United States of America, have been condensed or
omitted pursuant to such rules and regulations. Certain information and disclosures required by
accounting principles generally accepted in the United States for complete consolidated financial
statements are not included herein. The interim statements should be read in conjunction with the
financial statements and notes thereto included in the companys latest Annual Report on Form 10-K.
The results of operations for the three months ended March 31, 2009 are not necessarily indicative
of the results for any subsequent quarter or the entire fiscal year ending December 31, 2009.
Use of Estimates
The preparation of the consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires management to make estimates and
assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates.
8
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Cash and Cash Equivalents
Cash equivalents consist of highly liquid investments with original maturities of three months
or less from the date of purchase.
Net Loss per Share
The Company calculates net loss per share in accordance with SFAS No. 128,
Earnings per Share.
Basic loss per share is computed based on the weighted average number of common shares outstanding
during the period. The dilutive effect of common stock equivalents is included in the calculation
of diluted loss per share only when the effect of the inclusion would be dilutive. Outstanding
stock options with an exercise price above market, are excluded from the Companys diluted
computation as their effect would be anti-dilutive. For the three months ended March 31, 2009,
there were approximately 5.5 million outstanding stock options and 3.3 million outstanding warrants
that were excluded from the calculation of net loss per share. For the three months ended March 31,
2008, there were approximately 4.3 million outstanding stock options that were excluded from the
calculation of net loss per share.
Short-term investments
Short-term investments at March 31, 2009 and December 31, 2008 consist of investments in five
auction rate securities with a par value of $8.1 million and $8.2 million, respectively, and a fair
value of $6.0 million and $7.0 million, respectively. The Company recorded an other than temporary
impairment charge to other expenses related to these securities during the three months ended March
31, 2009 of $0.9 million as a result of the current turmoil in the credit markets and managements
belief these securities cannot presently be sold at par value, but are saleable at a discount from
their par value. The Company did not record any impairment charges during the three months ended
March 31, 2008. The auction rate securities are AAA-rated securities.
The Company has classified these securities as short-term investments and have accounted for
the investments in these securities as available for sale securities under the guidance of
Statement of Financial Accounting Standards,
Accounting for Certain Investments in Debt and Equity
Securities
(SFAS No. 115). Although the auction rate securities have variable interest rates,
which typically reset every 16 to 32 days through a competitive bidding process known as a Dutch
auction, they have long-term contractual maturities. These investments are classified within
current assets because the Company may need to liquidate these securities within the next year to
fund working capital requirements.
The available for sale securities are carried at fair value and unrealized gains and losses on
these securities, if determined to be temporary, are included in accumulated other comprehensive
income (loss) in stockholders equity. The Company assesses the recoverability of its
available-for-sale securities and, if impairment is indicated, the Company measures the amount of
such impairment by comparing the fair value to the carrying value. Other than temporary impairments
are included in the consolidated statements of operations. The impairment for the three months
ended March 31, 2009 was concluded to be other than temporary, thus the charge was recorded in the
consolidated statement of operations.
The Company had invested in auction rate securities for short periods of time as part of its
cash management program. Uncertainties in the credit markets have prevented the Company from
liquidating certain holdings of auction rate securities subsequent to December 31, 2008 as the
amount of securities submitted for sale during the auction has exceeded the amount of purchase
orders. Although an event of an auction failure does not necessarily mean that a security is
impaired, the Company considered various factors to assess the fair value and the classification of
the securities as short-term assets. Fair value was determined through independent valuation using
two valuation methods a discounted cash flow method and a market comparables method. Certain
factors used in these methods include, but are not limited to, comparable securities traded on
secondary markets, timing of the failed auction, specific security auction history, quality of
underlying collateral, rating of the security and the bond insurer, our ability and intent to
retain the securities for a period of time to allow for anticipated recovery in the market value,
and other factors.
9
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Interest and dividend income is recorded when earned and included in interest income.
Premiums and discounts, if any, on short-term investments are amortized or accreted to maturity and
included in interest income. The specific identification method is used in computing realized
gains and losses on sale of the Companys securities.
Fair Value Measurements
On January 1, 2008, the Company adopted SFAS No. 157,
Fair Value Measurements
(SFAS No.
157), which clarifies the definition of fair value, establishes a framework for measuring fair
value, and expends the disclosures on fair value measurements. In February 2008, the FASB issued
FSP 157-2 that deferred the effective date of SFAS No. 157 for one year for nonfinancial assets and
liabilities recorded at fair value on a non-recurring basis. SFAS No. 157 defines fair value as the
exchange price that would be received for an asset or paid to transfer a liability (an exit price)
in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. SFAS No. 157 also establishes a fair value
hierarchy which, as outlined below, requires an entity to maximize the use of observable inputs and
minimize the use of unobservable inputs when measuring fair value.
Level 1
Quoted prices in active markets for identical assets or liabilities. The Company does
not have any Level 1 assets as of March 31, 2009.
Level 2
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or
liabilities, or other inputs that are observable or can be corroborated by observable market data
for substantially the full term of the assets or liabilities. The Company considers its auction
rate securities to be Level 2 assets.
Level 3
Unobservable inputs that are supported by little or no market activity and that are
financial instruments whose value is determined using pricing models, discounted cash flow
methodologies, or similar techniques, as well as instruments for which the determination of fair
value requires significant judgment or estimation. The Companys Level 3 assets are composed of
goodwill.
If the inputs used to measure the financial assets and liabilities fall within the different
levels described above, the categorization is based on the lowest level input that is significant
to the fair value measurement of the instrument.
10
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Financial assets and liabilities measured at fair market value on a recurring basis as of
March 31, 2009 are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at
|
|
|
|
March 31, 2009 using
|
|
|
|
(in thousands)
|
|
|
|
Quoted Prices in
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
Active Markets
|
|
|
Other
|
|
|
Significant
|
|
|
|
|
|
|
For Identical
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
|
|
|
Assets
|
|
|
Inputs
|
|
|
Inputs
|
|
|
Assets
|
|
Assets
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
At Fair Value
|
|
Auction rate
securities
|
|
$
|
|
|
|
$
|
5,958
|
|
|
$
|
|
|
|
$
|
5,958
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
33,141
|
|
|
|
33,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
|
|
|
$
|
5,958
|
|
|
$
|
33,141
|
|
|
$
|
39,099
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment
Property and equipment are recorded at cost and are depreciated using the straight-line method
over the estimated useful lives of the assets, generally three to ten years.
Amortization of leasehold improvements is provided over the shorter of the estimated useful lives
of the improvements or the term of the respective lease. Repairs and maintenance costs are expensed
as incurred.
Property and equipment are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
(in thousands)
|
|
Construction in progress
|
|
$
|
1,219
|
|
|
$
|
5,394
|
|
Machinery and equipment
|
|
|
4,037
|
|
|
|
3,880
|
|
Leasehold improvements
|
|
|
4,523
|
|
|
|
637
|
|
Computer software and hardware
|
|
|
338
|
|
|
|
339
|
|
|
|
|
|
|
|
|
|
|
|
10,117
|
|
|
|
10,250
|
|
Less accumulated depreciation and amortization
|
|
|
(2,098
|
)
|
|
|
(2,022
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
8,019
|
|
|
$
|
8,228
|
|
|
|
|
|
|
|
|
Construction in progress is related to costs incurred in the construction of the Companys
Good Manufacturing Practice (GMP) pilot manufacturing facility, which started during the third
quarter of 2007. The GMP pilot manufacturing facility was ready for use in January 2009, when the
Company announced that all equipment in the pilot plant was installed and ready for operations
supporting scale-up and validation.
Goodwill and Other Intangible Assets
Goodwill originally results from certain business acquisitions. Assets acquired and
liabilities assumed are recorded at their fair values; the excess of the purchase price over the
identifiable net assets acquired is recorded as goodwill. In accordance with SFAS No. 142,
Goodwill
and Other Intangible Assets
(SFAS No. 142), goodwill is deemed to have an indefinite life and is
subject to impairment tests annually, or more frequently should indicators of impairment arise. The
Companys judgments regarding the existence of impairment indicators are primarily dependent on the
successful commercialization of its vaccine technologies, probability of success, growth and
profitability. Achievability of prospective results is subject to a great deal of risk and, because
events or circumstances may not occur as expected, differences between actual and expected results
may be material.
11
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Due to continued volatility in the financial and credit markets including the Companys stock
price, the Company determined it should perform an interim test for impairment of the Companys
goodwill as of March 31, 2009.
At March 31, 2009 and December 31, 2008, the Company used both the market approach and the
income approach to determine if the Company had an impairment of its goodwill. The income approach
was used as a confirming look to the market approach. The Company used a market approach to
determine the market value of capitalization of its single reporting unit. Step one of the
impairment test states that if the fair value of a reporting unit exceeds its carrying amount,
goodwill is considered not to be impaired. The Companys forecasts were used to create a risk
adjusted discounted cash flow analysis to indicate the market value capitalization. The fair value
of the Companys reporting unit was compared to the carrying amount of the reporting unit. Under
both approaches, the fair value of the reporting unit was higher than the carrying value, resulting
in no impairment recorded against goodwill at March 31, 2009.
Revenue Recognition
The Company recognizes revenue in accordance with the provisions of Staff Accounting Bulletin
No. 104,
Revenue Recognition
(SAB No. 104). For product sales, revenue is recognized when all of
the following criteria are met: persuasive evidence of an arrangement exists, delivery has
occurred, the sellers price to the buyer is fixed or determinable and collectability is reasonably
assured. The Company recognizes these sales, net of allowances for returns and rebates. The Company
estimates the amount of rebates and returns and records them as a liability and reduction of
revenue upon sale of the products. For upfront payments and licensing fees related to contract
research or technology, the Company follows the provisions of SAB No. 104 in determining if these
payments and fees represent the culmination of a separate earnings process or if they should be
deferred and recognized as revenue as earned over the life of the related agreement. Milestone
payments are recognized as revenue upon achievement of contract-specified events and when there are
no remaining performance obligations. Revenue earned under research contracts is recognized in
accordance with the terms and conditions of such contracts for reimbursement of costs incurred and
defined milestones.
Stock-Based Compensation
Stock Options
The Company accounts for its stock options in accordance with Statement of Financial
Accounting Standard No. 123 (revised),
Accounting for Stock-Based Compensation
(SFAS No. 123R).
This standard requires the Company to measure the cost of employee services received in exchange
for equity share options granted based on the grant-date fair value of the options. The cost is
recognized as compensation expense over the requisite service period (generally the vesting period)
of the options. Compensation cost included in operating expenses was $350,000 and $365,000 for the
three months ended March 31, 2009 and March 31, 2008, respectively.
As of March 31, 2009, there were 6,771,669 stock options outstanding with the aggregate fair
value of the remaining compensation cost of unvested options, as determined using a Black-Scholes
option valuation model, was approximately $345,471 (net of estimated forfeitures). This
unrecognized compensation cost of unvested options is expected to be recognized over a weighted
average period of 1.58 years. During the three months ended March 31, 2009, the Company granted
751,025 stock options, with a fair value of approximately $292,468 (net of estimated forfeitures),
and 65,734 options were forfeited. During the three months ended March 31, 2008, the Company
granted 784,150 options, with a fair value of approximately $1,072,000 (net of estimated
forfeitures), and 156,950 options were forfeited.
The weighted average fair value of stock options on the date of grant and the assumptions used
to estimate the fair value of stock options issued during the three months ended March 31, 2009 and
2008, using the Black-Scholes options valuation model, were as follows:
12
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 31,
|
|
|
2009
|
|
2008
|
Weighted average fair value of options granted
|
|
$
|
0.39
|
|
|
$
|
1.72
|
|
Expected life (years)
|
|
|
4.0 6.29
|
|
|
|
4.03 5.94
|
|
Expected volatility
|
|
|
85.68% 95.08
|
%
|
|
|
81.14% 89.34
|
%
|
Risk free interest rate
|
|
|
1.56% 2.27
|
%
|
|
|
2.37% 2.50
|
%%
|
Expected dividend
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Expected forfeiture rate
|
|
|
21.96
|
%
|
|
|
20.34
|
%
|
The expected life of options granted was based on the Companys historical share option
exercise experience using the historical expected term from the vesting date. The expected
volatility of the options granted during the three months ended March 31, 2009 and 2008 was
determined using historical volatilities based on stock prices over a look-back period
corresponding to the expected life. The risk-free interest rate was determined using the yield
available for zero-coupon U.S. government issues with a remaining term equal to the expected life
of the options. The forfeiture rate was determined using historical rates since the inception of
the plans. The Company has never paid a dividend, and as such the dividend yield is zero.
Restricted Stock
Non-cash compensation expense related to all restricted stock issued to employees and
directors has been recorded as compensation using the straight-line method of amortization. The
Company accounts for stock-based awards issued to non-employees in accordance with Emerging Issues
Task Force (EITF) Issue No. 96-18,
Accounting for Equity Instruments That are Issued to Other
than Employees for Acquiring, or in Conjunction with Selling Goods or Services.
For the three
months ended March 31, 2009, $147,000 of non-cash stock compensation expense was included in total
operating costs and expenses and additional paid-in capital was increased accordingly. For the
three months ended March 31, 2008, $85,000 of non-cash stock compensation expense was included in
total operating costs and expenses and additional paid in capital was increased accordingly.
Recent Accounting Pronouncements
In April 2009, the Financial Accounting Standards Board (FASB) issued FSP SFAS 141(R)-1,
Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from
Contingencies
, to amend the provisions related to the initial recognition and measurement,
subsequent measurement and disclosure of assets and liabilities arising from contingencies in a
business combination under SFAS 141(R). Under the new guidance, assets acquired and liabilities
assumed in a business combination that arise from contingencies should be recognized at fair value
on the acquisition date if fair value can be determined during the measurement period. If fair
value cannot be determined, companies should typically account for the acquired contingencies using
existing guidance. The Company is reviewing this pronouncement as it relates to its recent
agreement Joint Venture (JV) with Cadila Pharmaceuticals Ltd. The adoption of this pronouncement is
not expected to have a material effect on the Companys financial position and results from
operations.
In April 2009, the FASB issued FSP SFAS 157-4,
Determining Fair Value When the Volume and
Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying
Transactions That Are Not Orderly
which provides additional guidance for estimating fair value in
accordance with FASB Statement No. 157,
Fair Value Measurements
, when the volume and level of
activity for the asset or liability have significantly decreased. This FSP also includes guidance
on identifying circumstances that indicate a transaction is not orderly. This pronouncement is
effective for periods ending after June 15, 2009. The Company does not expect this pronouncement
to have a material effect on the Companys financial position and results of operations.
In April 2009, the FASB issued FSP SFAS 115-2 and SFAS 124-2,
Recognition and Presentation of
Other-Than-Temporary Impairments
, to amend the other-than-temporary impairment guidance in debt
securities to be based on intent to sell instead of ability to hold the security and to improve the
presentation and disclosure of other-than-temporary impairments on debt and equity securities in
the financial statements.
13
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
This pronouncement is effective for periods ending after June 15, 2009. The Company does not
expect this pronouncement to have a material effect on the Companys financial position and results
of operations.
In
April 2009, the FASB issued FSP FAS 107-1 and APB 28-1
Interim
Disclosures about Fair Value of Financial Instruments (FSP FAS
107)
, which amends SFAS No. 107, Disclosures about
Fair Value of Financial Instruments, to require disclosures
about fair value of financial instruments for interim reporting
periods of publicly traded companies as well as in annual financial
statements. This FSP also amends APB Opinion No. 28, Interim
Financial Reporting, to require those disclosures in summarized
financial information at interim reporting periods and is effective
for interim periods ending after June 15, 2009. The Company does
not believe this pronouncement will have a material impact on the
financial position and results of operations.
Significant Transactions
Graceway Agreements
In February 2008, the Company entered into an asset purchase agreement with Graceway
Pharmaceuticals, LLC (Graceway), pursuant to which Novavax sold Graceway its assets related to
Estrasorb in the United States, Canada and Mexico. The assets sold include certain patents related
to the micellar nanoparticle technology (the MNP Technology), trademarks, know-how, manufacturing
equipment, customer and supplier relations, goodwill and other assets. Novavax retained the rights
to commercialize Estrasorb outside of the United States, Canada and Mexico.
In February 2008, Novavax and Graceway also entered into a supply agreement, pursuant to which
Novavax agreed to manufacture additional units of Estrasorb with final delivery completed in August
2008. Graceway will pay a preset transfer price per unit of Estrasorb for the supply of this
product. Once Novavax delivered the required quantity of Estrasorb, Novavax cleaned the
manufacturing equipment and prepared the equipment for transport. Graceway removed the equipment
from the manufacturing facility and Novavax exited the facility in August 2008.
In February 2008, Novavax and Graceway also entered into a license agreement, pursuant to
which Graceway granted Novavax an exclusive, non-transferable (except for certain allowed
assignments and sublicenses), royalty-free, limited license to the patents and know-how that
Novavax sold to Graceway pursuant to the asset purchase agreement. The licensed grant allows
Novavax to make, use and sell licensed products and services in certain, limited fields. Upon
commencement of the Graceway agreement, the license and supply agreements with Allergan, Inc.,
successor-in-interest to Esprit Pharma, Inc., were terminated in February 2008 and October 2007,
respectively.
In connection with the closing of the transaction, Novavax received an upfront payment from
Graceway. The Company determined that the Graceway agreements should be accounted for as a single
arrangement with multiple elements as defined in EITF 00-21,
Revenue Arrangements with Multiple
Deliverables
(EITF 00-21). Under EITF 00-21, in an arrangement with multiple deliverables, the
delivered item(s) should be considered a separate unit of accounting if it has stand-alone value
and the fair value of the undelivered performance obligations can be determined. If the fair value
of the undelivered performance obligations can be determined, such obligations would be accounted
for separately as performed. If the fair value of undelivered performance obligations cannot be
determined, the arrangement is accounted for as a single unit of accounting. The Company evaluated
the deliverables related to the Graceway supply and asset purchase agreements under the criteria of
EITF 00-21 to determine whether they met the requirements for separation within a multi-element
arrangement.
14
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The Company concluded that the deliverables would not be treated as separate units of accounting as
there was no objective and reliable evidence of the fair value of the undelivered items related to
the manufacture of the additional Estrasorb lots and the cleaning and preparation of the equipment
under the terms of supply agreement. Accordingly, all revenue associated with the deliverables,
under both the supply and asset purchase agreement, was deferred and was not recognized until the
Companys obligations were completed in August 2008.
License Agreement with University of Massachusetts Medical School
Effective February 26, 2007, the Company entered into a worldwide agreement to exclusively
license a VLP technology from the University of Massachusetts Medical School (UMMS). Under the
agreement, the Company has the right to use this technology to develop VLP vaccines for the
prevention of any viral diseases in humans. As of March 31, 2009 and December 31, 2008, the Company
made payments to UMMS in an aggregate amount that is not material. In addition, the Company will
make certain payments based on development milestones as well as future royalties on any sales of
products that may be developed using the technology. The Company believes that all payments under
the UMMS agreement will not be material to the Company in the foreseeable future. The UMMS
agreement will remain effective as long as at least one claim of the licensed patent rights cover
the manufacture, sale or use of any product unless terminated sooner at the Companys option or by
UMMS for an uncured breach by Novavax.
License Agreement with Wyeth Holdings Corporation
On July 5, 2007, the Company entered into a License Agreement with Wyeth Holdings Corporation,
a subsidiary of Wyeth (Wyeth). The license is a non-exclusive, worldwide license to a family of
patent applications covering VLP technology for use in human vaccines in certain fields of use. The
agreement provides for an upfront payment, annual license fees, milestone payments and royalties on
any product sales. If each milestone is achieved for any particular product candidate, the Company
would be obligated to pay an aggregate of $14 million to Wyeth Holdings for each product candidate
developed and commercialized under the agreement. Achievement of each milestone is subject to many
risks, including those described in the Companys risk factors described in Item 1A of Part I of
the Companys Annual Report of Form 10-K for the year ended in December 31, 2008. Annual license maintenance fees under the Wyeth
Holdings agreement aggregate $0.3 million per year. The royalty to be paid by the Company under
the agreement, if a product is approved by the FDA for commercialization, will be based on single
digit percentage of net sales. Payments under the agreement to Wyeth as of March 31, 2009
aggregated $4.8 million and could aggregate up to an additional $0.3 million in 2009, depending on
the achievement of clinical development milestones. The agreement will remain effective as long as
at least one claim of the licensed patent rights cover the manufacture, sale or use of any product
unless terminated sooner at Novavaxs option or by Wyeth for an uncured breach by Novavax.
Notes Payable
Notes payable consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
(In thousands)
|
|
Note payable; insurance financing; bears
interest at 4.9% per annum; principal and
interest due in monthly installments of
$51,677 through September 2009
|
|
$
|
305
|
|
|
$
|
570
|
|
Notes payable; Opportunity Grant Funds;
non-interest bearing; principal only
payments due in monthly installments of
$6,666 through May 2012
|
|
|
240
|
|
|
|
260
|
|
Other
|
|
|
308
|
|
|
|
300
|
|
|
|
|
|
|
|
|
Total
|
|
|
853
|
|
|
|
1,130
|
|
Less current portion
|
|
|
(385
|
)
|
|
|
(650
|
)
|
|
|
|
|
|
|
|
Long-term portion
|
|
$
|
468
|
|
|
$
|
480
|
|
|
|
|
|
|
|
|
15
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Opportunity Grant Funds
In July 2005, the Company received a $400,000 Opportunity Grant from the Commonwealth of
Pennsylvania for the reimbursement of certain costs incurred in connection with the move of the
Companys corporate headquarters and product development activities to Malvern, Pennsylvania.
The Company announced in December 2006, that it had signed a long-term lease for its then new
corporate headquarters and research and development facility in Rockville, Maryland. As a result of
the Companys failure to comply with the conditions of the grant, the Department of Community &
Economic Development (DCED) of the Commonwealth of Pennsylvania requested that the Company repay
the full amount of the Opportunity Grant.
In April 2007, the Company entered into a Settlement and Release Agreement with the
Commonwealth of Pennsylvania, acting by and through DCED, whereby the Company agreed to repay the
sum of the original grant in 60 monthly installments starting on May 1, 2007. The loan was
reclassified to notes payable. The terms of the agreement stipulate the amount of the monthly
repayment to be $6,667 for 60 months. Interest does not accrue on the outstanding balance. During
the three months ended March 31, 2009 and 2008, the Company made payments totaling $20,000. The
$240,000 balance of the loan is included in notes payable at March 31, 2009.
Convertible Notes
Convertible notes consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(In thousands)
|
|
Note payable; 4.75% senior
convertible, issued July 19, 2004,
due July 15, 2009, currently
convertible by the holders into
4,029,304 shares of Novavax common
stock at $4.00 per share
|
|
$
|
22,000
|
|
|
$
|
22,000
|
|
Less: Discount
|
|
|
(119
|
)
|
|
|
(222
|
)
|
|
|
|
|
|
|
|
Note payable, net
|
|
$
|
21,881
|
|
|
$
|
21,778
|
|
|
|
|
|
|
|
|
As of March 31, 2009 and December 31, 2008, the Company had an aggregate principal amount of
$22.0 million of senior convertible notes outstanding (the Notes). The Notes carry a 4.75%
coupon; are convertible into shares of Novavax common stock at $4.00 per share; and mature in five
years on July 15, 2009. On June 15, 2007, the Company entered into amendment agreements (the 2007
Amendments) with each of the holders of the outstanding Notes to amend the terms of the Notes.
The 2007 Amendments (i) lowered the conversion price from $5.46 to $4.00 per share, (ii) eliminated
the holders right to require the Company to redeem the Notes if the weighted average price of the
Companys common stock is less than the conversion price on 30 of the 40 consecutive trading days
preceding July 19, 2007 or July 19, 2008 and (iii) mandated that the Notes be converted into
Company common stock if the weighted average price of the Companys common stock is greater than
$7.00 (a decrease from $9.56) in any 15 out of 30 consecutive trading days after July 19, 2007.
The Notes are also redeemable upon the occurrence of specified events of default as well as a
change of control (as that term is defined in the Notes) of Novavax. At March 31, 2009 and
December 31, 2008, the Company had accrued interest of $213,000 and $478,123, respectively,
relating to these Notes.
On April 29, 2009, the Company entered into amendment agreements (the 2009 Amendments) with
holders of the outstanding 4.75% Notes representing $17.0 million of the $22.0 million outstanding
principal amount of the Notes to amend the terms of the Notes to allow for early payment under
specific terms described below.
16
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The 2009 Amendments (i) provide for payment of $17,000,000 aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of Common Stock that equals 30% of this principal amount divided
by $2.50. On April 29, 2009, the Company paid $12.1 million in principal and accrued interest and
issued 2,040,000 shares of common stock in accordance with the terms of the 2009 Amendments. After
payment of this $17.0 million in principal amount, $5.0 million aggregate principal amount remains
outstanding under the Notes and will mature on July 15, 2009.
Under the terms of the Notes, Novavax, at its option, can pay up to 50% of the remaining $5.0
million outstanding Notes in Novavax common stock on the due date of July 15, 2009, subject to the
satisfaction of certain conditions, including, among other things, a requirement that the shares
issued upon conversion be registered or freely tradable without registration, that Novavaxs shares
of common stock have not been suspended from trading on NASDAQ Global Market during the applicable
measurement period and there is no threatened delisting or suspension, and that the Company is
otherwise in compliance with its agreements with the Note holders. The amount of shares that may
be issued at maturity may be subject to adjustment depending on the Note holders percentage
ownership of the Company on an as-converted basis and if the Companys stock price falls below
$2.00 during the measurement period. As a result, the Company will have to pay at least $2.5
million in cash to satisfy the Notes on the due date unless the Notes are converted into common
stock, redeemed or amended.
In connection with the 2007 Amendments, the Company recorded a debt discount of $852,000 and
increased additional paid-in capital accordingly. The debt discount is being amortized over the
remaining term of the Notes. Interest expense includes $102,000 related to the amortization of the
debt discount for the three months ended March 31, 2009 and 2008.
Operating Leases
Future minimum rental commitments under non-cancelable leases as of March 31, 2009 are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
|
|
|
|
|
|
|
Net Operating
|
|
Year
|
|
Leases
|
|
|
Sub-Leases
|
|
|
Leases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
$
|
1,701
|
|
|
$
|
248
|
|
|
$
|
1,453
|
|
2010
|
|
|
2,088
|
|
|
|
338
|
|
|
|
1,750
|
|
2011
|
|
|
2,087
|
|
|
|
259
|
|
|
|
1,828
|
|
2012
|
|
|
2,132
|
|
|
|
|
|
|
|
2,132
|
|
2013
|
|
|
2,179
|
|
|
|
|
|
|
|
2,179
|
|
Thereafter
|
|
|
6,399
|
|
|
|
|
|
|
|
6,399
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments
|
|
$
|
16,586
|
|
|
$
|
845
|
|
|
$
|
15,741
|
|
|
|
|
|
|
|
|
|
|
|
In April 2009, we negotiated an amendment to our sublease with PuriCore to expand the term of
the sublease until September 30, 2011, to expand the sublease premises to include all of the
approximately 32,900 rentable square feet and to grant PuriCore the option to renew the sublease
for an additional three-year term. We are currently awaiting the landlords approval of this
amendment, which is required before it can become effective.
Sales and Issuance of Common Stock
During the three months ended March 31, 2008, the Company received net proceeds of $35,000
from the exercise of 20,571 shares of common stock options, at a range of $1.34 to $2.67 per share.
During the three months ended March 31, 2009, the Company received net proceeds of $35,000 for
the exercise of 20,000 shares of common stock options at $1.75 per share.
17
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Income Taxes
The American Recovery and Reinvestment Act of 2009 was enacted and signed into law on February
17, 2009. The Act include the extension of a provision passed by the United States Congress in 2008
which allows companies to accelerate the recognition of a portion of research and development
(R&D) credits in lieu of bonus depreciation and convert the R&D credits carry forward into
currently refundable credits. The amount that may be converted is based on the amount invested in
property that would otherwise qualify for bonus depreciation and is capped at the lesser of 6% of
historic R&D credits or $30 million. The Company is evaluating the R&D credit provisions of the Act
but has not yet reached a decision whether it will forego the bonus depreciation to obtain any R&D
credit that may be refundable.
18
3. Discontinued Operations
In October 2007, the Company entered into agreements to terminate its supply agreements with
Allergan. In connection with the termination, the Company decided to wind down operations at its
manufacturing facility in Philadelphia, Pennsylvania. The results of operations for the
manufacturing facility are being reported as discontinued operations and the consolidated
statements of operations for prior periods have been adjusted to reflect this presentation.
The assets and liabilities related to the Companys manufacturing facility in Philadelphia,
Pennsylvania had identifiable cash flows that were largely independent of the cash flows of other
groups of assets and liabilities and the Company did not have a significant continuing involvement
beyond one year after the closing of the Graceway transaction.
Therefore, in accordance with Statement of Financial Accounting Standards No. 144,
Accounting
for the Impairment or Disposal of Long-Lived Assets
(SFAS No. 144), the accompanying consolidated
balance sheets report the assets and liabilities related to the Companys Philadelphia
manufacturing facility as discontinued operations in all periods presented, and the results of
operations have been classified as discontinued operations in the accompanying consolidated
statements of operations for all periods presented. The Company delivered the required quantity of
Estrrasorb as required under the Graceway agreements, and exited the facility in August 2008.
The following table presents summarized financial information for the Companys discontinued
manufacturing operations presented in the consolidated statements of operations for the three
months ended March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
Revenues
|
|
$
|
|
|
|
$
|
86
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
|
|
|
|
738
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
|
|
|
$
|
(652
|
)
|
|
|
|
|
|
|
|
The following table presents major classes of assets and liabilities that have been presented
as assets and liabilities of discontinued operations in the accompanying consolidated balance
sheets.
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
$
|
|
|
|
$
|
132
|
|
|
|
|
|
|
|
|
Current assets of discontinued operations
|
|
$
|
|
|
|
$
|
132
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
|
|
|
$
|
209
|
|
Accrued expenses and other liabilities
|
|
|
|
|
|
|
33
|
|
|
|
|
|
|
|
|
Current liabilities of discontinued operations
|
|
$
|
|
|
|
$
|
242
|
|
|
|
|
|
|
|
|
In February 2008, the Company completed the sale of certain assets used in the production of
Estrasorb to Graceway (See Note 2). As discussed above, the Company received an upfront payment
from Graceway in connection with the execution of the agreements. As part of the asset purchase
agreement, the Company transferred to Graceway, manufacturing equipment valued at $1.1 million
related to the production of Estrasorb on the closing date, which had been included as assets held
for sale in the Companys consolidated balance sheet.
19
4. Related Party Transactions
Effective April 1, 2009, the Board elected Rajiv I. Modi Ph.D., managing director of Cadila,
as a Class I director. Dr. Modi was elected to the board pursuant to the Stock Purchase Agreement
dated March 31, 2009 between Novavax and SOHL, a subsidiary of Cadila, which requires that, for so
long as SOHL owns 5% of the Companys Common Stock, SOHL may designate one member of the Board.
On March 31, 2009, Novavax entered into several material agreements with Cadila, SOHL and CPL
Biologicals Limited, the JV formed by the Company and Cadila, 80% of which will be owned by Cadila
(the JV). Cadila has committed to fund approximately $8 million of working capital to the JV over
three years. Dr. Modi serves as managing director of Cadila and his family has a substantial
ownership interest in Cadila and therefore he has an indirect material interest in these material
agreements further described below. Due to Dr. Modis interest in Cadila and the JV, he is not
independent as that term is defined in the NASDAQ listing standards.
As stated above, on March 31, 2009, Novavax entered into a Stock Purchase Agreement (the
SPA) with SOHL, pursuant to which SOHL agreed to purchase 12.5 million shares of Company Common
Stock at $0.88 per share, which closed on April 1, 2009. The Company raised gross proceeds of $11
million in the offering. The net proceeds to the Company from the sale of the Common Stock, after
deducting estimated offering expenses payable by the Company, is approximately $10.5 million. The
SPA provides that, as long as SOHL owns more than 5% of the Companys then-outstanding Common
Stock, SOHL may purchase a pro-rata portion of most Company Common Stock sales or issuances.
Finally, on March 31, 2009, Novavax and Cadila entered into a Master Services Agreement (the
Master Services Agreement) pursuant to which Novavax may request services from Cadila in the
areas of biologics research, preclinical development, clinical development, process development,
manufacturing scale up, and general manufacturing related services in India. If, at the third
anniversary of the Master Services Agreement, the amount of services provided by Cadila is less
than $7.5 million, Novavax will pay Cadila a portion of the shortfall. Novavax will have to pay
Cadila the portion of the shortfall amount that is equal to $2.0 million and 50% of the portion of
the shortfall amount that exceeds $2.0 million. When calculating the shortfall, the amount of
services provided by Cadila includes amounts that have been paid under all project plans, the
amounts that will be paid under ongoing executed project plans and amounts for services that had
been offered to Cadila, that Cadila was capable of performing, but exercised its right not to
accept such project.
The aggregate dollar value of the these agreements above is approximately $11 million for the
Stock Purchase Agreement, $7.5 million for the Master Services Agreement, and $8 million for the
Joint Venture Agreement.
On April 27, 2007 and effective as of March 31, 2007, the Company entered into a consulting
agreement with Mr. John Lambert, the Chairman of the Companys Board of Directors. The agreement
terminates on March 8, 2010, unless terminated sooner by either party upon 30 days written notice.
Under the agreement, Mr. Lambert is expected to devote one-third of his time to the Companys
activities. As a consultant, Mr. Lambert is required to work closely with the senior management of
the Company on matters related to clinical development of its vaccine products, including
manufacturing issues, FDA approval strategy and commercialization strategy. His annual compensation
is $220,000 in consideration for his consulting services. On March 6, 2008, the Company granted Mr.
Lambert 25,000 stock options under the 2005 Plan with a fair value of approximately $41,000. On
March 5, 2009, the Company granted Mr. Lambert 25,000 stock options under the 2005 plan with a fair
value of approximately, 10,000. For the three months ended March 31, 2009 and 2008, the Company
recorded consulting expenses for Mr. Lambert of $55,000 in accordance with the consulting
agreement.
On March 21, 2002, pursuant to the Novavax, Inc. 1995 Stock Option Plan, the Company approved
the payment of the exercise price of options by two of its directors, through the delivery of
full-recourse, interest-bearing promissory notes in the aggregate amount of $1,480,000. The
borrowings accrued interest at 5.07% per annum and were secured by an aggregate of 261,667 shares
of common stock owned by the directors. The notes were payable upon the earlier to occur of the
following: (i) the date on which the director ceases for any reason to be a director of the
Company, (ii) in whole, or in part, to the extent of net proceeds, upon the date on which the
director sells all or any portion of the pledged shares or (iii) payable in full on March 21, 2007.
20
In May 2006, one of these directors resigned from the Companys Board of Directors. Following
his resignation, the Company approved an extension of the former directors $448,000 note to
December 31, 2007 or earlier to the extent of the net proceeds of the pledged shares. In connection
with this extension, the former director executed a general release of all claims against the
Company.
On May 7, 2008, the Company and the former director entered into an Amended and Restated
Promissory Note and an Amended and Restated Pledge Agreement (the Amendment). The Amendment
restates the entire amount outstanding as of December 31, 2007, including accrued interest, or
$578,848, as the new outstanding principal amount. Furthermore, the Amendment extends the maturity
date of the note to June 30, 2009, permits the Company to sell the pledged shares if the market
price of the common stock as reported on NASDAQ Global Market exceeds certain targets, increases
the interest rate to 8.0% and stipulates quarterly payments beginning on June 30, 2008. The
Company received a first payment of $50,000 in July 2008 and a second payment of $5,000 in October
2008, with a balance due by December 31, 2008 of $45,000. In January 2009, the Company received an
additional payment of $10,000.
In March 2007, the second director resigned from the Board of Directors. In an agreement dated
May 7, 2007, the Board agreed to extend the note that was due March 21, 2007 to June 30, 2009 and
secured additional collateral in the form of a lien on certain outstanding stock options. Also
under the May 7, 2007 agreement, the Company has the right to exercise the stock options, sell the
acquired shares and the other shares held as collateral and use the proceeds to pay the debt, if
the share price exceeds $7.00 at any time during the period between May 7, 2007 and June 30, 2009.
As of December 31, 2007, the note and the corresponding accrued interest receivable totaling
$1,334,117 was included in non-current other assets in the accompanying consolidated balance sheet.
The note continues to accrue interest at 5.07% per annum and continues to be secured by 166,666
shares of common stock owned by the former director.
21
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Certain statements contained herein or as may otherwise be incorporated by reference herein
constitute forward-looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include, but are not limited to, statements
regarding product sales, future product development and related clinical trials, and future
research and development, including Food and Drug Administration approval. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors which may cause the
actual results, performance or achievements of the Company, or industry results, to be materially
different from those expressed or implied by such forward-looking statements.
Factors that may cause actual results to differ materially from the results discussed in the
forward-looking statements or historical experience include risks and uncertainties, including the
Companys ability to raise capital through public or private equity and/or debt financings; the
maturity of the convertible notes on July 15, 2009, the failure by Novavax to secure and maintain
relationships with collaborators; risks relating to the early stage of Novavaxs product candidates
under development; uncertainties relating to commencing clinical trials and their outcome; risks
relating to the supply and commercialization, if any, of Novavaxs proposed product candidates;
dependence on the efforts of third parties; dependence on intellectual property; competition for
clinical resources and patient enrollment from drug candidates in development by other companies
with greater resources and visibility and other factors referenced herein.
All forward-looking statements contained in this quarterly report are based on information
available to the Company on the date hereof, and the Company assumes no obligation to update any
such forward-looking statements, except as specifically required by law. Accordingly, past results
and trends should not be used to anticipate future results or trends.
Overview
Novavax, Inc., a Delaware corporation (Novavax or the Company), was incorporated in 1987,
and is a clinical-stage biopharmaceutical company focused on creating differentiated, value-added
vaccines that improve upon current preventive options for a range of infectious diseases. These
vaccines leverage the Companys virus-like-particle (VLP) platform technology coupled with a
unique, disposable production technology. The Company produces these VLP based, potent, recombinant
vaccines utilizing new and efficient manufacturing approaches.
VLPs are genetically engineered three-dimensional nanostructures, which incorporate
immunologically important lipids and recombinant proteins. Our VLPs resemble the virus but lack
the genetic material to replicate the virus. Our proprietary production technology uses insect
cells rather then chicken eggs or mammalian cells. The Companys current product targets include
vaccines against the H5N1 and other subtypes of avian influenza with pandemic potential, human
seasonal influenza, Varicella Zoster (VZV), which causes shingles, and a Respiratory Syncytial
Virus (RSV).
We made significant progress since 2007 in our vaccine that targets the H5N1 avian influenza
with pandemic potential. In December 2007, we announced favorable interim results for a Phase I
clinical trial which began in July 2007 for our pandemic influenza vaccine, that demonstrated
immunogenicity and safety. In August 2008, we received favorable results from a Phase I/IIa trial
which was conducted to gather additional patient immunogenicity and safety data, as well as to
determine a final dose, which demonstrated strong neutralizing antibody titers across all three
doses tested. Although the safety data are still blinded pending complete safety follow-up, there
were no serious adverse events reported. In February 2009, we announced that the vaccine induced
robust hemagglutination inhibition (HAI) responses, which have been shown to be important for
protection against influenza disease. In April 2009, we reported preclinical study results,
conducted by scientists from both the Centers for Disease Control and Prevention, and the Company
under a Collaborative Research and Development Agreement showing that an investigational H1N1 VLP
vaccine based on the 1918 Spanish influenza strain protected against both the Spanish flu and a
highly pathogenic H5N1 avian influenza strain. We have begun the work
on creating a VLP vaccine candidate against the 2009 H1N1 swine flu
virus and expect to complete production of the first batch of vaccine
within 12 weeks of receiving the protein sequences. This faster
cycle time from strain identification to first vaccine batch would
be another demonstration of our abilities to create strain specific vaccines
to potential pandemic influenza viruses. Over the past few years, we
have gone through the process of creating recombinant VLP vaccines
for multiple strains of influenza, both of seasonal as well as avian
strains. This experience and knowledge has prepared us to execute
this real life challenge.
We only intend to initiate further human clinical trials for our pandemic influenza vaccine,
which would be required for regulatory approval, with a collaborative partner.
22
We also progressed development of our VLP trivalent vaccine that targets seasonal influenza
virus in 2008 and 2007. In December 2008, we announced favorable safety and immunogenicity results
from our Phase IIa seasonal study in healthy adults which we commenced in September 2008 to
evaluate the safety and immunogenicity of different doses of our seasonal influenza vaccine. We
observed a slightly different safety profile (non-serious adverse events) from our Phase IIa trial
of our pandemic VLP vaccine, and are reviewing and analyzing the dose response curve as well as the
safety data from the healthy adult seasonal trial before commencing a seasonal influenza dose
ranging study in the elderly (
>
65 years of age) in the second half of 2009.
On May 5, 2009, we announced the initiation of enrollment in the second Phase II study of its
trivalent seasonal influenza VLP vaccine candidate. This clinical trial is designed to evaluate the
safety and immunogenicity of a broader range of vaccine doses and to provide data to help select
doses for future studies in older adults and a Phase III efficacy study. The Company plans to
report top-line immunogenicity and safety results from this study by the fourth quarter of this
year. We continue to seek a collaborative partner for our seasonal influenza vaccine upon completion
of additional Phase II clinical studies, which are expected to be completed by the end of 2009.
We have also developed vaccine candidates for both RSV and VZV, both of which are currently
being evaluated in preclinical studies. To date, preliminary data have shown that an RSV vaccine
candidate has shown positive results in two separate studies with mice. In December 2008, Novavax
and the University of Massachusetts jointly announced favorable results from a preclinical study to
evaluate the immunogenicity and efficacy of an RSV vaccine candidate in mice. The RSV VLP vaccine
induced strong antibody responses against RSV. In February 2009, we announced favorable results
from an RSV preclinical study performed in mice against the viral fusion (F) protein, which fuses
with cells in the respiratory tract and causes illness. A VZV vaccine candidate has also induced
antibody and T-cell responses. We plan on moving forward with further preclinical development of
both vaccines in 2009.
Our vaccine products currently under development or in clinical trials will require
significant additional research and development efforts, including extensive pre-clinical and
clinical testing and regulatory approval, prior to commercial use. There can be no assurance that
our research and development efforts will be successful or that any potential products will prove
to be safe and effective in clinical trials. Even if developed, these vaccine products may not
receive regulatory approval or be successfully introduced and marketed at prices that would permit
us to operate profitably. The commercial launch of any vaccine product is subject to certain risks
including but not limited to, manufacturing scale-up and market acceptance. No assurance can be
given that we can generate sufficient product revenue to become profitable or generate positive
cash flow from operations at all or on a sustained basis.
Subsequent Events
Cadila
Pharmaceuticals Ltd.
On March 31, 2009, Company and Cadila Pharmaceuticals Ltd., a company incorporated under the
laws of India (Cadila) entered into a Joint Venture Agreement (the JVA) pursuant to which the
Company and Cadila formed CPL Biologicals Limited, a joint venture (the JV), of which 80% will be
owned by Cadila and 20% is owned by the Company. The JV must obtain approval from Indias Foreign
Investment Promotion Board (the FIPB) prior to issuing shares to Novavax. The JV will develop and
commercialize our seasonal influenza virus-like-particle (VLP)-based vaccine candidate and Cadilas
therapeutic vaccine candidates against cancer as well as its adjuvants, biogeneric products and
other diagnostic products for the territory of India. We will also contribute to the JV technology
for the development of several other VLP vaccine candidates against diseases of public health
concern in the territory, such as hepatitis E and chikungunya fever. Cadila will contribute
approximately $8 million over three years to support the JVs operations. The JV will be
responsible for clinical testing and registration of products that will be marketed and sold in
India.
The board of directors of the JV consists of five members, three of whom (including the
Chairman of the board) are nominated by Cadila and two of whom are nominated by Novavax. If the
board is not in unanimous agreement on an issue, the Chief Executive Officers (CEOs) of the
Company and Cadila will work to resolve the issue. If the
CEOs cannot resolve the issue in five business days, a vote by the majority of the board will
decide. However, the approval of the Company and Cadila, as shareholders of the JV, and the board
of directors of the JV is required for (1) the sale of all or most of the assets of the JV, (2) a
change in control of the JV, (3) the liquidation, dissolution, or winding up of the JV, (4) any
occurrence of indebtedness that results in the JV having a debt-to-equity ratio of 3-to-1 or
greater, or (5) most amendments of the JVA or the JVs Articles of Association.
23
The JV has the right to negotiate a definitive agreement for rights to certain future Novavax
products (other than RSV) and certain future Cadila products in India prior to Novavax or Cadila
licensing such rights to a third party. Novavax has the right to negotiate the licensing of
vaccines developed by the joint venture using Novavaxs technology for commercialization in every
country except for India and vaccines developed by the joint venture using Cadilas technology for
commercialization in certain other countries, including the United States.
In connection with the JVA, on March 31, 2009, we also entered into license agreement, an
option to enter into a license agreement, a technical services agreement and a supply agreement
with the JV.
Also on March 31, 2009, we entered into a binding, non-cancellable Stock Purchase Agreement
(the SPA) with Satellite Overseas (Holdings) Limited (SOHL), a subsidiary of Cadila, pursuant
to which SOHL has agreed to purchase 12.5 million shares of our common stock, par value $0.01 (the
Common Stock) at the market price of $0.88 per share. We delivered the shares of Common Stock on
April 1, 2009. We raised gross proceeds of $11 million in the offering. The net proceeds to us from
the sale of the Common Stock, after deducting estimated offering expenses payable by us, is
approximately $10.5 million.
The SPA provides that, as long as SOHL owns more than 5% of the Companys then-outstanding
Common Stock, SOHL may purchase a pro-rata portion of any Company common stock sale issuance. Under
the SPA, certain issuances are exempt from SOHLs pre-emptive right, including shares issued (1) as
stock dividends, stock splits, or otherwise payable pro rata to all holders of Common Stock; (2) to
our employees, officers, directors or consultants pursuant to an employee benefit program; (3) upon
the conversion or exercise of any options, warrants or other rights to purchase Common Stock; and
(4) as consideration for a merger, consolidation, purchase of assets, or in connection with a joint
venture or strategic partnership. However, any issuances pursuant to (4) above, must be approved by
a majority of the full board and, if the transaction exceeds 5% of our then issued and outstanding
shares of Common Stock, the per share purchase price cannot be less than $0.88. Under the SPA, for
so long as SOHL owns 5% of our common stock, SOHL may designate one member of our board of
directors.
Finally, on March 31, 2009, Novavax and Cadila entered into a Master Services Agreement (the
Master Services Agreement) pursuant to which we may request services from Cadila in the areas of
biologics research, preclinical development, clinical development, process development,
manufacturing scale up, and general manufacturing related services in India. If, at the third
anniversary of the Master Services Agreement, the amount of services provided by Cadila is less
than $7.5 million, we will pay Cadila a portion of the shortfall. We will have to pay Cadila the
portion of the shortfall amount that is less than or equal to $2.0 million and 50% of the portion
of the shortfall amount that exceeds $2.0 million. When calculating the shortfall, the amount of
services provided by Cadila includes amounts that have been paid under all project plans, the
amounts that will be paid under ongoing executed project plans and amounts for services that had
been offered to Cadila, that Cadila was capable of performing, but exercised its right not to
accept such project. The term of the Master Services Agreement is five years, but may be terminated
by either party if there is a material breach that is not cured within 30 days of notice or, at any
time after three years, provided that 90 days prior notice is given to the other party.
At the Market Issuance
On January 12, 2009, we entered into an At Market Issuance Sales Agreement (the Sales
Agreement), with Wm Smith & Co. (Wm Smith), under which we may sell an aggregate of up to $25
million in gross proceeds of our common stock from time to time through Wm Smith, as the agent for
the offer and sale of the common stock. The Board of Directors has authorized the sale of up to
12,500,000 shares of common stock under the Sales Agreement. Based on the trading price of our
common stock, we may not be able to sell all 12,500,000 shares or we may not be able to raise the
full $25 million in gross proceeds permitted under the Sales Agreement. Wm Smith may sell the
common stock by any method permitted by law, including sales deemed to be an at the market
offering as defined in Rule 415 of the Securities Act, including without limitation sales made
directly on NASDAQ Global
Market, on any other existing trading market for the common stock or to or through a market maker.
Wm Smith may also sell the common stock in privately negotiated transactions, subject to our prior
approval. We will pay Wm Smith a commission equal to 3% of the gross proceeds of the sales price of
all common stock sold through it as sales agent under the Agreement. In the first quarter of 2009,
we sold 70,500 shares and received net proceeds in the amount of $121,457, under the Sales
Agreement. As of May 5, 2009, we sold approximately an additional 3.1 million shares for net
proceeds of approximately $7.5 million.
24
Amendments to Convertible Notes
On April 29, 2009, we entered into amendment agreements (the 2009 Amendments) with holders
of the outstanding 4.75% senior convertible notes (the Notes) representing $17.0 million of the
$22.0 million outstanding principal amount of the Notes to amend the terms of the Notes to allow
for early payment under specific terms described below.
The 2009 Amendments (i) provide for payment of $17,000,000 aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of Common Stock that equals 30% of this principal amount divided
by $2.50. On April 29, 2009, we paid $12.1 million in principal and accrued interest and issued
2,040,000 shares in accordance with the terms of the 2009 Amendments.
After payment of this $17.0 million in principal amount, $5.0 million aggregate principal
amount remains outstanding under the Notes and will mature on July 15, 2009. Under the terms of the
Notes, Novavax, at its option, can pay up to 50% of the remaining $5.0 million outstanding Notes in
Novavax common stock on the due date of July 15, 2009, subject to the satisfaction of certain
conditions, including, among other things, a requirement that the shares issued upon conversion be
registered or freely tradable without registration, that Novavaxs shares of common stock have not
been suspended from trading on NASDAQ Global Market during the applicable measurement period and
there is no threatened delisting or suspension, and that the Company is otherwise in compliance
with its agreements with the Note holders.
Significant Transactions in 2009 and 2008
Facility Exit Costs
In July 2008, we decided to consolidate our research and development and manufacturing
activities into our facility at Belward Campus Drive in Rockville, Maryland by closing our Taft
Court facility in Rockville, Maryland. The Taft Court location was used to support the
manufacturing requirements for early stage clinical trial materials for our VLP vaccine candidates.
Our new GMP pilot manufacturing facility located at our Belward Campus Drive location will be used
to support clinical trials and may also be used for future commercialization quantities of our VLP
vaccines. The move commenced in September 2008 and was completed on October 17, 2008. Our accrued
expenses on the consolidated balance sheet as of March 31, 2009 and December 31, 2008 include
$237,000 and $296,000, respectively, related to the remaining lease payments.
Graceway Agreements
In February 2008, we entered into an asset purchase agreement with Graceway Pharmaceuticals,
LLC (Graceway), pursuant to which Novavax sold Graceway its assets related to Estrasorb in the
United States, Canada and Mexico. The assets sold include certain patents related to the MNP
technology, trademarks, know-how, manufacturing equipment, customer and supplier relations,
goodwill and other assets. Novavax retained the rights to commercialize Estrasorb outside of the
United States, Canada and Mexico.
In February 2008, Novavax and Graceway also entered into a supply agreement, pursuant to which
Novavax had agreed to manufacture additional units of Estrasorb. Final delivery was made in July
2008. Graceway paid a preset transfer price per unit of Estrasorb for the supply of this product.
After we delivered the required quantity of Estrasorb, we were required to clean the manufacturing
equipment and prepare the equipment for transport. Graceway removed the equipment from the
manufacturing facility and we exited the facility in August 2008.
In February 2008, Novavax and Graceway also entered into a license agreement, pursuant to
which Graceway granted us an exclusive, non-transferable (except for certain allowed assignments
and sublicenses), royalty-free, limited license to the patents and know-how that Novavax sold to
Graceway pursuant to the asset purchase agreement. The licensed grant allows us to make, use and
sell licensed products and services in certain, limited fields.
25
The net cash proceeds from these transactions were in excess of $2.5 million. The license and
supply agreements with Allergan, Inc., successor-in-interest to Esprit Pharma, Inc., were
terminated in February 2008 and October 2007, respectively.
License Agreement with University of Massachusetts Medical School
Effective February 26, 2007, we entered into a worldwide agreement to exclusively license a
VLP technology from the University of Massachusetts Medical School (UMMS). Under the agreement,
we have the right to use this technology to develop VLP vaccines for the prevention of any viral
diseases in humans. As of March 31, 2009 and December 31, 2008, we made payments to UMMS in an
aggregate amount that is not material. In addition, we will make certain payments based on
development milestones as well as future royalties on any sales of products that may be developed
using the technology. We believe that all payments under the UMMS agreement will not be material to
us in the foreseeable future. The UMMS agreement will remain effective as long as at least one
claim of the licensed patent rights cover the manufacture, sale or use of any product unless
terminated sooner at our option or by UMMS for an uncured breach by Novavax.
License Agreement with Wyeth Holdings Corporation
On July 5, 2007, we entered into a License Agreement with Wyeth Holdings Corporation, a
subsidiary of Wyeth (Wyeth). The license is a non-exclusive, worldwide license to a family of
patent applications covering VLP technology for use in human vaccines in certain fields of use. The
agreement provides for an upfront payment, annual license fees, milestone payments and royalties on
any product sales. If each milestone is achieved for any particular product candidate, we would be
obligated to pay an aggregate of $14 million to Wyeth Holdings for each product candidate developed
and commercialized under the agreement. Achievement of each milestone is subject to many risks,
including those described in our Item IA of Part I of our annual report on Form 10-K for the year
ended December 31, 2008. Annual license
maintenance fees under the Wyeth Holdings agreement aggregate $0.3 million per year. The royalty
to be paid by us under the agreement, if a product is approved by the FDA for commercialization,
will be based on single digit percentage of net sales. Payments under the agreement to Wyeth as of
March 31, 2009 aggregated $4.8 million and could aggregate up to an additional $0.3 million in
2009, depending on the achievement of clinical development milestones. The agreement will remain
effective as long as at least one claim of the licensed patent rights cover the manufacture, sale
or use of any product unless terminated sooner at our option or by Wyeth for an uncured breach by
Novavax.
Sublease Agreement with PuriCore, Inc.
In April 2006, we entered into a sublease agreement with Sterilox Technologies, Inc. (now
known as PuriCore, Inc.) to sublease 20,469 square feet of the Companys Malvern, Pennsylvania
corporate headquarters at a premium price per square foot. The sublease, with a commencement date
of July 1, 2006, expires on September 30, 2009. This sublease resulted from our corporate move to
Rockville, Maryland. In October 2006, we entered into a lease for an additional 51,000 square feet
in Rockville, Maryland. Accordingly, in October 2006, we entered into an amendment to the Sublease
Agreement with PuriCore, Inc. to sublease an additional 7,500 square feet of the Malvern corporate
headquarters at a premium price per square foot. This amendment has a commencement date of October
25, 2006 and expires concurrent with the initial lease on September 30, 2009. In April 2009, we
negotiated an amendment to our sublease with PuriCore to expand the term of the sublease until
September 30, 2011, to expand the sublease premises to include all of the approximately 32,900
rentable square feet and to grant PuriCore the option to renew the sublease for an additional
three-year term. We are currently awaiting the landlords approval of this amendment, which is
required before it can become effective.
Notes with Former Directors
In March 2002, pursuant to the Novavax, Inc. 1995 Stock Option Plan, we approved the payment
of the exercise price of options by two of directors through the delivery of full-recourse,
interest-bearing promissory notes in the aggregate amount of $1,480,000. The notes were secured by
an aggregate of 261,667 shares of our common stock.
26
In May 2006, one of these directors resigned from our board of directors. Following his
resignation, we approved an extension of the former directors $448,000 note to be payable on
December 31, 2007, or earlier to the extent of the net proceeds from any sale of the pledged
shares. We entered into negotiations with the former director to extend the loan in January 2008.
On May 7, 2008 the Company and the former director entered into an Amended and Restated Promissory
Note and an Amended and Restated Pledge Agreement (the Amendment).
The Amendment restates the entire amount outstanding as of December 31, 2007, including
accrued interest, or $578,848, as the new outstanding principal amount. Furthermore, the Amendment
extends the maturity date of the note to June 30, 2009, permits us to sell the pledged shares if
the market price of the common stock as reported on NASDAQ Global Market exceeds certain targets,
increases the interest rate to 8.0% and stipulates quarterly payments beginning June 30, 2008. We
received the first payment of $50,000 in July 2008 for the first half of 2008 and a second payment
of $5,000 in October 2008, with a balance for the next payment due by December 31, 2008 of $45,000.
In January 2009, we received an additional payment of $10,000.
In March 2007, the other director resigned. Following his resignation, we approved an
extension of the former directors $1,031,668 note. The note continues to accrue interest at 5.07%
per annum and is secured by shares of common stock owned by the former director and is payable on
June 30, 2009, or earlier to the extent of the net proceeds from any sale of the pledged shares. In
addition, we have the option to sell the pledged shares on behalf of the former director at any
time that the market price of our common stock, as reported on NASDAQ Global Market, exceeds $7.00
per share.
We continue to actively work with these two individuals to collect the amounts outstanding and
reserve our rights to pursue the remedies available to us. Due to heightened sensitivity in the
current environment surrounding related-party transactions and the extensions of the maturity
dates, these transactions could be viewed negatively in the market and our stock price could be
negatively affected.
Critical Accounting Policies and Changes to Accounting Policies
Our discussion and analysis for our financial condition and results of operations are based
upon our consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States.
The preparation of our consolidated financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities and equity and disclosure of
contingent assets and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting period. These estimates, particularly estimates
relating to revenue recognition, allowance for doubtful accounts and rebates, accounting for stock
based compensation, goodwill, valuation of net deferred tax assets, and valuation of marketable
securities, have a material impact on our financial statements and are discussed in detail
throughout our analysis of the results of operations discussed below.
We base our estimates on historical experience and various other assumptions that we believe
are reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying value of assets, liabilities and equity that are not readily apparent from other
sources. Actual results and outcomes could differ from these estimates and assumptions.
For a more detailed explanation of the judgments made in these areas and a discussion of our
accounting estimates and policies, refer to
Critical Accounting Policies and Use of Estimates
included in Item 7 and
Summary of Significant Accounting Policies
(Note 2) included in Item 15 of
our Annual Report on Form 10-K for the year ended December 31, 2008. Since December 31, 2008,
there have been no significant changes to our critical accounting estimates and policies.
Recent Accounting Standards
In April 2009, the Financial Accounting Standards Board (FASB) issued FSP SFAS 141(R)-1,
Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from
Contingencies
, to amend the provisions related to the initial recognition and measurement,
subsequent measurement and disclosure of assets and liabilities arising from contingencies in a
business combination under SFAS 141(R).
27
Under the new guidance, assets acquired and liabilities
assumed in a business combination that arise from contingencies should be recognized at fair value
on the acquisition date if fair value can be determined during the measurement period. If fair
value cannot be determined, companies should typically account for the acquired contingencies using
existing guidance. We are reviewing this pronouncement as it relates
to our recent agreements with
Cadila Pharmaceuticals Ltd. The adoption of these pronouncements is not expected to have a
material effect on the Companys financial position and results from operations.
In April 2009, the FASB issued FSP SFAS 157-4,
Determining Fair Value When the Volume and
Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying
Transactions That Are Not Orderly
which provides additional guidance for estimating fair value in
accordance with FASB Statement No. 157,
Fair Value Measurements
, when the volume and level of
activity for the asset or liability have significantly decreased. This FSP also includes guidance
on identifying circumstances that indicate a transaction is not orderly. This pronouncement is
effective for periods ending after June 15, 2009. We do not expect this pronouncement to have a
material effect on our financial position and results of operations.
In April 2009, the FASB issued FSP SFAS 115-2 and SFAS 124-2,
Recognition and Presentation of
Other-Than-Temporary Impairments
, to amend the other-than-temporary impairment guidance in debt
securities to be based on intent to sell instead of ability to hold the security and to improve the
presentation and disclosure of other-than-temporary impairments on debt and equity securities in
the financial statements. This pronouncement is effective for periods ending after June 15, 2009.
We do not expect this pronouncement to have a material effect on our financial position and results
of operations.
Results of Operations
The following is a discussion of the historical consolidated financial condition and results
of operations of Novavax, Inc. and its wholly owned subsidiary and should be read in conjunction
with the consolidated financial statements and notes thereto set forth in this Quarterly Report on
Form 10-Q. Additional information concerning factors that could cause actual results to differ
materially from those in the Companys forward-looking statements is contained from time to time in
our SEC filings, including but not limited to our Annual Report on Form 10-K for the fiscal year
ended December 31, 2008.
Three months ended March 31, 2009 (Q1 2009) compared to the three months ended March 31, 2008
(Q1 2008): (Amounts in the tables are presented in thousands, except percentage changes and share and per share information)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1
|
|
|
Q1
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
21
|
|
|
$
|
458
|
|
|
$
|
(437
|
)
|
|
|
(95
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for the first quarter 2009 were $21,000 as compared to $458,000 in the comparable
period in 2008. The decrease in revenue from the comparable period in 2008 was principally due to
lower contract revenue. Contract research and development revenue is comprised of revenue from
government and commercial contracts and for the three months ended March 31, 2008 is comprised of
revenue from two National Institutes of Health (NIH) grants, one of which was completed in 2008.
Contract research and development revenue for the three months ended March 31, 2009 is comprised of
revenue from one NIH contract, which was completed in 2009.
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1
|
|
|
Q1
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
4,266
|
|
|
$
|
4,434
|
|
|
$
|
(168
|
)
|
|
|
(4
|
)%
|
General and administrative
|
|
|
2,892
|
|
|
|
3,244
|
|
|
|
(352
|
)
|
|
|
(11
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
7,158
|
|
|
$
|
7,678
|
|
|
$
|
(520
|
)
|
|
|
(7
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
Research and Development Expenses
Research and development costs decreased from $4.4 million in 2008 to $4.3 million in 2009, a
decrease of $0.1 million or 4%. Our research and development costs are incurred in support of the
development of VLP based vaccines. A portion of the decrease can be attributed to a $0.2 million
decrease in employee costs and a $0.1 million decrease associated with the closing of our Taft
Court facility. In October 2008, we consolidated our manufacturing operations into our facility at
Belward Campus Drive in Rockville, Maryland and accrued the remaining lease payments related to our
Taft Court facility.
These decreases were partially offset by a $0.1 million increase in outside testing costs
associated with the continuing preclinical testing, human clinical trials, process development,
manufacturing and quality-related programs and a $0.1 million increase in facility costs. The
increase in facility costs relate to increased rent and depreciation charges.
General and Administrative Expenses
General and administrative costs were $2.9 million in 2009 compared to $3.2 million in 2008.
The $0.3 million decrease in general and administrative costs can be attributed to a $0.1 million
decrease in employee costs and a $0.1 million decrease in facility costs associated with general
and administrative functions. General and administrative costs for the three months ended March 31,
2008 included $0.2 million related to the allowance established for two notes receivable from
former directors. During 2008, we determined that the notes receivable should be classified as a
reduction of equity. We have not recorded any reserved charges during the three months ended March
31, 2009. These decreases were partially offset by an increase of $0.1 million related to
professional fees associated with the preparation of SEC filings during the three months ended
March 31, 2009.
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1
|
|
|
Q1
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
$
|
104
|
|
|
$
|
543
|
|
|
$
|
(439
|
)
|
|
|
(81
|
)%
|
Interest expense
|
|
|
(437
|
)
|
|
|
(426
|
)
|
|
|
(11
|
)
|
|
|
(3
|
)%
|
Impairment loss on
short-term
investments
|
|
|
(879
|
)
|
|
|
|
|
|
|
(879
|
)
|
|
|
(100
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(1,212
|
)
|
|
$
|
117
|
|
|
$
|
(1,329
|
)
|
|
|
(1,136
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income was $0.1 million for 2009 compared to interest income of $0.5 million for
2008. The $0.4 million decrease in net interest income in the first quarter of 2009 as compared to
the quarter ended March 31, 2008, was principally due to a decrease in the average balance
outstanding for cash and short-term investments. The average cash and short-term investment
balances outstanding decreased as a result of our continuing investment in our research and
development activities surrounding our vaccine candidates. Interest expense for the three months
ended March 31, 2009 and 2008 primarily represents interest on the outstanding convertible debt of
$22.0 million and the amortization of the debt discount of $102,000. The debt discount resulted
from the amendment of our convertible notes in June 2007, which resulted in the recording of a debt
discount, which is being amortized over the remaining period of the notes. Additionally, we
recorded $0.9 as an impairment loss for the quarter ended March 31, 2009, related to an other than
temporary impairment loss on our auction rate securities.
Discontinued Operations:
In October 2007, we entered into agreements to terminate our supply agreements with Allergan,
successor-in-interest to Esprit. In connection with the termination, we decided to wind down
operations at our manufacturing facility in Philadelphia, Pennsylvania. The results of operations
for the manufacturing facility are being reported as discontinued operations. In August 2008, we
completed our final obligation to Graceway and exited the facility.
The following table presents summarized financial information for our discontinued operations
for the three months ended March 31, 2009 and 2008:
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1
|
|
|
Q1
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
|
|
|
$
|
86
|
|
|
$
|
(86
|
)
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of products sold
|
|
|
|
|
|
|
738
|
|
|
|
(738
|
)
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
|
|
|
$
|
652
|
|
|
$
|
(652
|
)
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded a loss from discontinued operations of $0.7 million for the three months ended
March 31, 2008. We recorded revenue from discontinued operations of $86,000 for 2008 from the sale
of Estrasorb.
Costs of products sold, which includes fixed idle capacity costs, were $0.7 million for the
three months ended March 31, 2008. Of the $0.7 million cost of products sold in 2008, $0.6 million
represented idle plant capacity costs at our manufacturing facility. The remaining $0.1 million
represented the cost of Estrasorb sales to Allergan. In accordance with the Supply Agreement with
Allergan, which terminated in February 2008, we were required to sell Estrasorb at a price that is
lower than our manufacturing costs.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1
|
|
|
Q1
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
$ Change
|
|
|
%Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,349
|
)
|
|
$
|
(7,755
|
)
|
|
$
|
(594
|
)
|
|
|
(8
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.12
|
)
|
|
$
|
(0.13
|
)
|
|
$
|
0.01
|
|
|
|
8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares
outstanding
|
|
|
68,692,455
|
|
|
|
61,280,155
|
|
|
|
6,952,264
|
|
|
|
11
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our net loss for the three months ended March 31, 2009 was $8.3 million, or 0.12 per share, as
compared to $7.8 million, or $0.13 per share, for the three months ended March 31, 2008, an
increase in the net loss of $0.6 million. The increase was principally due to the impairment loss
on short-term investments recorded for the three months ended March 31, 2009, and a decrease in
contract revenue, partially offset by a decrease in operating expenses.
Liquidity and Capital Resources
Our future capital requirements depend on numerous factors including but not limited to the
maturing of the remaining Notes on July 15, 2009, the commitments and progress of our research and
development programs, the progress of preclinical and clinical testing, the costs of filing,
prosecuting, defending and enforcing any patent claims and other intellectual property rights, and
manufacturing cost. We plan to continue to have multiple vaccines and products in various stages of
development and we believe our research and development as well as general and administrative
expenses and capital requirements will continue to increase. We will need to engage in capital
raising transactions in the near term. Future activities, particularly vaccine and product
development, are subject to our ability to raise funds through public or private financings using
equity and/or debt securities, or collaborative licensing and development arrangements with
industry partners and government agencies.
30
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31, 2009
|
|
|
|
(unaudited)
|
|
Summary of Cash Flows:
|
|
(In thousands)
|
|
Net cash (used in) provided by:
|
|
|
|
|
Operating activities
|
|
$
|
(6,727
|
)
|
Investing activities
|
|
|
68
|
|
Financing activities
|
|
|
(650
|
)
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents
|
|
|
(7,309
|
)
|
Cash and cash equivalents at beginning of period
|
|
|
26,938
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
19,629
|
|
|
|
|
|
As of March 31, 2009, we held $19.6 million in cash and investments as compared to $26.9
million at December 31, 2008. The $7.3 million decrease in cash and investments during 2008 was
primarily due to the operating loss of $8.3 million and
principal payments on debt of $0.9 million.
As of March 31, 2009, our working capital deficit was $0.2 million compared to $7.3 million surplus
as of December 31, 2008. This $7.5 million decrease primarily resulted from our net loss.
Additionally, our working capital was used for $0.8 million in principal payments on our
outstanding debt obligations for the three months ended March 31, 2009.
We will seek to raise additional capital through public or private equity and/or debt
financing. We intend to use the proceeds from these financing transactions to pay all or a portion
of the principal and interest due on the Notes and for general corporate purposes, including but
not limited to our internal research and development programs, such as preclinical and clinical
testing and studies for our vaccine and other product candidates, the development of new
technologies, capital improvements and general working capital. We will also seek to fund our
operations through licensing and development arrangements. There can be no assurance that we will
be able to obtain additional capital or, if such capital is available, that the terms of any
financing will be satisfactory to us. Any capital raised by an equity offering will likely be
substantially dilutive to the stockholders and any licensing or development arrangement may require
us to give up rights to a product or technology at less than its full potential value.
As of May 5, 2009, we have sold approximately 3.1 million shares of common stock and received
net proceeds of approximately $7.5 million pursuant to the sales agreement with Wm Smith. On March
31, 2009, we entered into a binding, non-cancellable stock purchase agreement to sell 12.5 million
shares to a wholly-owned subsidiary of Cadila for a market price of $0.88 per share. We closed
this transaction on April 1, 2009 and received net proceeds in the amount of $10.5 million.
As of March 31, 2009, we had $22.0 million of senior convertible notes outstanding (the
Notes). The Notes carry a 4.75% coupon; are convertible into shares of Novavax common stock at
$4.00 per share; and mature on July 15, 2009. We may require that the Notes be converted into our
common stock if the weighted average price of the our common stock is greater than $7.00 in any 15
out of 30 consecutive trading days after July 19, 2007. On April 29, 2009, we entered into
amendment agreements (the 2009 Amendments) with holders of the outstanding Notes representing
$17.0 million of the $22.0 million outstanding principal amount of the Notes to amend the terms of
the Notes to allow for early payment under specific terms described below.
The 2009 Amendments (i) provide for payment of $17.0 million aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) for the remaining portion of this principal amount to be paid
in that number of shares of Common Stock that equals 30% of this principal amount divided by $2.50.
Based on the amount of funds on hand, the proceeds from the Cadila transaction and the sale of
stock under the Wm Smith agreement, our intention to pay 50% of the remaining $5.0 million
outstanding Notes in Novavax common stock, and our planned business operations, we believe we will
have adequate capital resources to operate at planned levels for at least the next twelve months.
We are planning to raise additional capital in 2009 in order to continue our current level of
operations and to pursue the business plan beyond 2009. We have not, however, secured any
additional commitments for new financing at this time nor can we provide any assurance that new
financing will be available on commercially acceptable terms, if at all.
31
Any equity financing would cause significant dilution to our shareholders at current market prices.
If we are not able to secure additional capital, we will continue to assess our capital resources
and we may be required to downsize our operations, reduce general and administrative costs or to
delay or reduce the scope of, or eliminate one or more of
our product research and development programs, thereby causing delays in our efforts to introduce
our future products to market. Should we be unable to accomplish these activities, we may not be
able to continue our business.
Contractual Obligations and Commitments
We utilize different financing instruments, such as debt and operating leases, to finance
various equipment and facility needs. The following table summarizes our current financing
obligations and commitments (in thousands) as of March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than
|
|
|
1 - 3
|
|
|
4 - 5
|
|
|
More than
|
|
Commitments and Obligations
|
|
Total
|
|
|
1 Year
|
|
|
Years
|
|
|
Years
|
|
|
5 Years
|
|
|
|
(unaudited)
|
|
Convertible notes
|
|
$
|
22,000
|
|
|
$
|
22,000
|
*
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Operating leases
|
|
|
16,586
|
|
|
|
2,253
|
|
|
|
6,296
|
|
|
|
4,288
|
|
|
|
3,749
|
|
Notes payable
|
|
|
853
|
|
|
|
385
|
|
|
|
468
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total principal payments
|
|
|
39,439
|
|
|
|
24,638
|
|
|
|
6,764
|
|
|
|
4,288
|
|
|
|
3,749
|
|
Less: Subleases
|
|
|
(845
|
)
|
|
|
(328
|
)
|
|
|
(517
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
commitments and obligations
|
|
|
38,594
|
|
|
|
24,310
|
|
|
|
6,247
|
|
|
|
4,288
|
|
|
|
3,749
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
This is the gross obligation for the convertible notes at March 31, 2009.
|
On March 31, 2009, we entered into a Master Service Agreement with Cadila in which we may
request services from Cadila in areas of biologics research, preclinical development, clinical
development, process development, manufacturing scale up and general related services in India.
This commitment is for $7.5 million in services over the next three years. If, at the third
anniversary of the Master Service Agreement, the amount of services provided by Cadila is less than
$7.5 million, we will pay Cadilia a portion of the shortfall. We will have to pay Cadilia the
portion of the shortfall amount that is less than or equal to the shortfall amount that exceeds
$2.0 million and 50% of the portion of the shortfall that exceeds $2.0 million.
In April 2009, we negotiated an amendment to our sublease with PuriCore to expand the term of
the sublease until September 30, 2011, to expand the sublease premises to include all of the
approximately 32,900 rentable square feet and to grant PuriCore the option to renew the sublease
for an additional three-year term. We are currently awaiting the landlords approval of this
amendment, which is required before it can become effective.
32
In addition to the amounts reflected in the table above in the future, we may owe royalties
and other contingent payments to our collaborators or license holders based on the achievement
product sales, milestones and other specific objectives.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The primary objective of our investment activities is to preserve our capital until it is
required to fund operations while at the same time maximizing the income we receive from our
investments without significantly increasing risk. As of March 31, 2009, we had cash and cash
equivalents and short-term investments of $25.6 million as follows:
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
19.6 million
|
|
|
|
|
|
Short-term investments classified as available for sale
|
|
|
$
|
6.0 million
|
Our exposure to market risk is confined to our investment portfolio. As of March 31, 2009, our
short-term investments are classified as available for sale. We do not believe that a change in
the market rates of interest would have any significant impact on the realizable value of our
investment portfolio. Changes in interest rates may affect the investment income we earn on our
investments and, therefore, could impact our cash flows and results of operations.
Short-term investments at March 31, 2009 consist of investments in five auction rate
securities with a par value of $8.1 million and a fair value of $6.0 million. We recorded an
additional other than temporary impairment charge to operating related to these securities during
the first quarter of 2009 of $0.9 million because of the current turmoil in the credit markets and
managements belief these securities cannot presently be sold at par value but are saleable at a
discount from their par value.
We have classified these securities as short-term investments and have accounted for our
investments in these securities as available for sale securities under the guidance of Statement of
Financial Accounting Standards,
Accounting for Certain Investments in Debt and Equity Securities
(SFAS No. 115). Although the auction rate securities have variable interest rates which typically
reset every 16 to 32 days through a competitive bidding process known as a Dutch auction, they
have long-term contractual maturities. These investments are classified within current assets
because we may need to liquidate these securities within the next year.
The available for sale securities are carried at fair value and unrealized gains and losses on
these securities, if determined to be temporary, are included in accumulated other comprehensive
income (loss) in stockholders equity. We assess the recoverability of our available-for-sale
securities and, if impairment is indicated, we measure the amount of such impairment by comparing
the fair value to the carrying value. Other than temporary impairments are included in the
consolidated statements of operations. Our cumulative other than temporary impairment charges
approximate $2.1 million, which include an impairment charge of 1.2 million recorded in 2008.
We had invested in auction rate securities for short periods of time as part of our cash
management program. Recent uncertainties in the credit markets have prevented us from liquidating
certain holdings of auction rate securities subsequent to December 31, 2008 as the amount of
securities submitted for sale during the auction has exceeded the amount of the purchase orders.
Although an event of an auction failure does not necessarily mean that a security is impaired, we
considered various factors to assess the fair value and the classification of the securities as
short-term assets. Fair value was determined through an independent valuation using two valuation
methods - a discounted cash flow method and a market comparables method. Certain factors used in
these methods include, but are not necessary limited to, comparable securities traded on secondary
markets, timing of the failed auction, specific security auction history, quality of underlying
collateral, rating of the security and the bond insurer, our ability and intent to retain the
securities for a period of time to allow for anticipated recovery in the market value, and other
factors.
33
Interest and dividend income is recorded when earned and included in interest income.
Premiums and discounts, if any, on short-term investments are amortized or accreted to maturity and
included in interest income. The specific identification method is used in computing realized
gains and losses on sale of our securities.
We are headquartered in the United States where we conduct the vast majority of our business
activities. Accordingly, we have not had any material exposure to foreign currency rate
fluctuations.
At March 31, 2009, we had a total debt of $22.7 million, most of which bears interest at fixed
interest rates. We do not believe that it is exposed to any material interest rate risk as a result
of our borrowing activities.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Companys chief executive officer and interim principal accounting officer, who performs
functions similar to a principal financial officer, have reviewed and evaluated the effectiveness
of the Companys disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this
quarterly report. Based on that review and evaluation, which included the participation of
management and certain other employees of the Company, the chief executive officer and interim
principal accounting officer have concluded that the Companys current disclosure controls and
procedures, as designed and implemented, are effective.
Changes in Internal Control over Financial Reporting
The Companys management, including our principal executive officer and interim principal
accounting officer, has evaluated any changes in the Companys internal control over financial
reporting that occurred during the three months ended March 31, 2009, and has concluded that there
was no change that occurred during the quarter ended March 31, 2009 that has materially affected,
or is reasonably likely to materially affect, the Companys internal control over financial
reporting.
34
PART II. OTHER INFORMATION
Item 1 Legal Proceedings
The Company does not have any pending legal matters at this time.
Item 1A. Risk Factors
There are no material changes to the Companys risk factors as described in Item 1A of the
Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2008, as filed with the
SEC, other than as mentioned below.
Item 6 Exhibits
Confidential treatment has been requested for portions of exhibits marked with a double asterisk
(**).
|
|
|
10.1
|
|
Stock Purchase Agreement between Novavax, Inc. and Satellite Overseas (Holdings)
Limited, dated March 31, 2009
|
|
|
|
10.2
|
|
Registration Rights Agreement between Novavax, Inc. and Satellite Overseas
(Holdings) Limited, dated March 31, 2009
|
|
|
|
10.3**
|
|
Joint Venture Agreement between Novavax Inc. and Cadila Pharmaceuticals Limited, dated
March 31, 2009
|
|
|
|
10.4**
|
|
Master Services Agreement between Novavax, Inc. and Cadila Pharmaceuticals Limited,
dated March 31, 2009
|
|
|
|
10.5**
|
|
Supply Agreement between Novavax, Inc. and CPL Biologicals Limited, dated March 31,
2009
|
|
|
|
10.6**
|
|
Technical Services Agreement between Novavax, Inc. and CPL Biologicals Limited, dated
March 31, 2009
|
|
|
|
10.7**
|
|
Seasonal / Other License Agreement between Novavax, Inc. and CPL Biologicals Limited,
dated March 31, 2009
|
|
|
|
10.8**
|
|
Option to Obtain License between Novavax, Inc. and CPL Biologicals Limited, dated March
31, 2009
|
|
|
|
10.9
|
|
At the Market Issuance Sales
Agreement, dated January 12, 2009, by & between Novavax,
Inc. and Wm. Smith & Co. (Incorporated by reference to Exhibit
10.1 to the Companys Current Report on Form 8-K, filed
January 13, 2009)
|
|
|
|
10.10
|
|
Consulting Agreement of Len
Stigliano, effective January 28, 2009 (Incorporated by reference
to the Companys Current Report on Form 8-K, filed
February 20, 2009)
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a) or Rule
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of Interim Principal Accounting Officer (performing functions similar to a
principal financial officer) pursuant to Exchange Act Rule 13a-14(a) or Rule 15d-14(a), as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
35
|
|
|
32.1
|
|
Certification of Chief Executive Officer, pursuant to Exchange Act Rule 13a-14(a) or Rule
15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
|
|
|
|
32.2
|
|
Certification of Interim Principal Accounting Officer (performing functions similar to a
principal financial officer), pursuant to Exchange Act Rule 13a-14(a) or Rule 15d-14(b) and
Section 1350 of Chapter 63 of Title 18 of the United States Code as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002.*
|
|
|
|
*
|
|
This exhibit is not filed for purposes of Section 18 of the Securities Exchange Act of 1934,
and is not and should not be deemed to be incorporated by reference into any filing under the
Securities Act of 1933 or the Securities Exchange Act of 1934.
|
36
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
|
|
|
|
|
|
NOVAVAX, INC.
(Registrant)
|
|
Date: May 11, 2009
|
By:
|
/s/ Rahul Singhvi
|
|
|
|
Rahul Singhvi
|
|
|
|
President and Chief Executive
Officer
(Principal Executive Officer)
|
|
|
|
|
|
Date May 11, 2009
|
By:
|
/s/ Evdoxia E. Kopsidas
|
|
|
|
Evdoxia E. Kopsidas
|
|
|
|
Director of Finance and Interim Principal
Accounting Officer (performing functions
similar to a principal financial officer)
|
|
|
37
Exhibit 10.1
STOCK PURCHASE AGREEMENT
This Stock Purchase Agreement (this
Agreement
) is dated March 31, 2009, by and
between Satellite Overseas (Holdings) Limited (the
Investor
) and Novavax, Inc., a
Delaware corporation (the
Company
), whereby the parties agree as set forth herein.
Certain terms are defined in Section 10 of this Agreement.
WHEREAS
, the Company and the Investor have entered into an agreement (the JV Agreement) to
form a joint venture to develop and commercialize vaccines, including vaccines that leverage the
Companys VLP technology and vaccines based on Investors technology, for sale within the Indian
market and to establish local manufacturing capability in India based on the Companys novel
disposable vaccine production system under licensing rights to be obtained from the Company;
WHEREAS,
the Company and the Investor have entered into a Master Services Agreement under
which Investor and/or its affiliates will perform certain services for the Company; and
WHEREAS
, in connection with the anticipated joint venture, Investor has agreed to make an
equity investment in the Company, in accordance with the terms and conditions set forth in this
Agreement.
NOW, THEREFORE
, in consideration of the premises and the mutual promises herein made, and in
consideration of the representations, warranties, and covenants herein contained, the Parties agree
as follows.
1.
Subscription
.
(a) Investor agrees to buy and the Company agrees to sell and issue to Investor 12,500,000
shares (the
Shares
) of the Companys common stock, $0.01 par value per share (the
Common Stock
), for an aggregate purchase price of $11,000,000, at a per share purchase
price of $0.88 (the
Purchase Price
).
(b) The Shares have been registered on a Registration Statement on Form S-3, Registration
No. 333-138893 (the
Registration Statement
), which registration statement has been
declared effective by the Securities and Exchange Commission and is effective on the date hereof
(together with any registration statement filed by the Company pursuant to Rule 462(b) under the
Securities Act of 1933, as amended (the
Securities Act
)). A final prospectus supplement
will be delivered to the Investor as required by law.
(c) On the closing date, which, in accordance with Rule 15c6-1 promulgated under the
Securities Exchange Act of 1934, as amended, is expected to occur on or about March 31, 2009 (the
Closing Date
), upon satisfaction or waiver of all the conditions to closing set forth in
this Agreement, (i) the Purchase Price for the Shares purchased by the Investor will be delivered
by or on behalf of the Investor to the Company against delivery of the Shares, and (ii) the Company
shall cause its transfer agent to release to the Investor the number of Shares being purchased by
the Investor (such release shall be made through the facilities of The Depository Trust Companys
DWAC system). The provisions set forth in
Exhibit B
hereto shall be incorporated herein by
reference as if set forth fully herein.
2.
Representations, Warranties and Agreements of the Company
. The Company represents
and warrants to and agrees with Investor as of the date hereof and as of the Closing Date and any
other date specified below, that:
(a) The Company has been duly incorporated and has a valid existence and the authorization to
transact business as a corporation under the laws of the State of Delaware, with corporate power
and authority to own its properties and conduct its business as described in the Prospectus, and
has been duly qualified as a foreign corporation for the transaction of business and is in good
standing under the laws of each other jurisdiction in which it owns or leases properties or
conducts any business so as to require such qualification, except for such jurisdictions wherein
the failure to be so qualified and in good standing would not individually or in the aggregate have
a Material Adverse Effect.
(b) Each subsidiary of the Company has been duly incorporated and is validly existing as a
corporation in good standing under the laws of its jurisdiction of incorporation, with corporate
power and authority to own its properties and conduct its business as described in the Prospectus,
and has been duly qualified as a foreign corporation for the transaction of business and is in good
standing under the laws of each other jurisdiction in which it owns or leases properties or
conducts any business so as to require such qualification, except for such jurisdictions wherein
the failure to be so qualified and in good standing would not individually or in the aggregate have
a Material Adverse Effect. All subsidiaries and their respective jurisdictions of incorporation
are identified on
Schedule I
hereto. Except as disclosed in
Schedule I
, all of the
outstanding capital stock or other voting securities of each subsidiary is owned by the Company,
directly or indirectly, free and clear of any lien and free of any other limitation or restriction
(including any restriction on the right to vote, sell or otherwise dispose of such capital stock or
other voting securities). Other than the Companys 4.75% senior convertible notes (the
Convertible Notes
) and warrants to purchase 3,343,325 of Company Common Stock (the
2008 Warrants
), there are no outstanding (i) securities of the Company or any subsidiary
of the Company which are convertible into or exchangeable for shares of capital stock or voting
securities of any subsidiary of the Company or (ii) options or other rights to acquire from the
Company or any subsidiary of the Company, or other obligation of the Company or any subsidiary of
the Company to issue, any capital stock, voting securities or securities convertible into or
exchangeable for capital stock or voting securities of any subsidiary of the Company (collectively,
the
Subsidiary Securities
). There are no outstanding obligations of the Company or any
subsidiary of the Company to repurchase, redeem or otherwise acquire any outstanding Subsidiary
Securities.
(c) The execution, delivery and performance of this Agreement by the Company and the
consummation of the transactions contemplated hereby are within the corporate powers of the Company
and have been duly authorized by all necessary corporate action on the part of the Company, and the
Agreement, when duly executed and delivered by the Company, will constitute a valid and legally
binding instrument of the Company enforceable in accordance with its terms, except as enforcement
hereof may be limited by the effect of any applicable bankruptcy, insolvency, reorganization or
similar laws or court decisions affecting enforcement of creditors rights generally and except as
enforcement hereof is subject to general principles of equity (regardless of whether enforcement is
considered in a proceeding in equity or at law).
(d) The Shares have been duly authorized by the Company, and when issued and delivered by the
Company against payment therefor as contemplated by this Agreement, the Shares will (i) be validly
issued, fully paid and nonassessable, (ii) not be subject
Stock Purchase Agreement
2
to any statutory or contractual preemptive rights or other rights to subscribe for or purchase
or acquire any shares of Common Stock, which have not been waived or complied with, and (iii)
conform to the description of the Common Stock contained in the Prospectus. The capital stock of
the Company, including the Common Stock, conforms as to the legal matters to the description
thereof, if any, contained in the Registration Statement and the Prospectus, and as of the date
thereof, the Company had authorized capital stock as set forth therein. The Shares are in due and
proper form and the holders of Shares will not be subject to personal liability by reason of being
such holders.
(e) The execution and delivery of the Agreement does not, and the compliance by the Company
with the terms hereof will not, (i) violate the Certificate of Incorporation (as amended to date)
of the Company or the By-Laws (as amended to date) of the Company, (ii) result in a breach or
violation of any of the terms or provisions of, or constitute a default under, any indenture,
mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or
its subsidiary is bound, or (iii) result in a violation of, or failure to be in compliance with,
any applicable statute or any order, judgment, decree, rule or regulation of any court or
governmental, regulatory or self-regulatory agency or body having jurisdiction over the Company or
its subsidiary, except in the case of (ii) and (iii) where such breach, violation, default or the
failure to be in compliance would not have a Material Adverse Effect; and no consent, approval,
authorization, order, registration, filing or qualification of or with any such court or
governmental, regulatory or self-regulatory agency or body is required for the valid authorization,
execution, delivery and performance by the Company of the Agreement or the issuance of the Shares,
except for such consents, approvals, authorizations, registrations, filings or qualifications as
may be required under the Securities Act or state securities or blue sky laws and have been or
will be obtained and which have been or will be made in connection with the listing of the Shares
on the Nasdaq Global Market.
(f) The Company meets the requirements for the use of Form S-3 under the Securities Act for
the primary issuance of securities. The Registration Statement has been declared effective by the
Commission and at the time it became effective, and as of the date hereof, the Registration
Statement complied and complies with Rule 415 under the Securities Act. No stop order suspending
the effectiveness of the Registration Statement has been issued and no proceeding for that purpose
has been initiated or, to the Companys knowledge, threatened by the Commission. On the effective
date of the Registration Statement, the Registration Statement complied, on the date of the
Prospectus, the Prospectus will comply, and at the date of the Closing, the Registration Statement
and the Prospectus will comply, in all material respects with the applicable provisions of the
Securities Act and the applicable rules and regulations of the Commission thereunder; on the
effective date of the Registration Statement, the Registration Statement and the additional
information disclosed by the Company to the Investor in a document titled Investor Information
(the Investor Information) did not, on the date of the Prospectus, the Prospectus did not, and at
the date of the Closing, the Registration Statement and the Prospectus and the Investor
Information, will not, contain an untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary in order to make the statements therein, in light
of the circumstances under which they were made (with respect to the Prospectus), not misleading;
and when filed with the Commission, the documents incorporated by reference in the Registration
Statement and the Prospectus, complied or will comply in all material respects with the applicable
provisions of the Securities Exchange Act of 1934, as amended (the
Exchange Act
), and the
applicable rules and regulations of the Commission thereunder. There is no material document of a
character required to be described in the Registration Statement or the Prospectus or to be filed
as an exhibit to the Registration Statement
Stock Purchase Agreement
3
that is not described or filed as required. The Companys form 10-K for year ended 2008 will
not contain any material information that is not included in the Investor Information.
(g) The consolidated financial statements of the Company included or incorporated by reference
in the Registration Statement, the Prospectus and the Investor Information comply as to form with
the applicable accounting requirements of the Securities Act and have been prepared in conformity
with generally accepted accounting principles (except, with respect to the unaudited consolidated
financial statements and the accompanying footnotes which are subject to customary audit
adjustments) applied on a consistent basis, are consistent in all material respects with the books
and records of the Company, and accurately present in all material respects the consolidated
financial position, results of operations and cash flow of the Company and its subsidiary as of and
for the periods covered thereby. There are no other financial statements (historical or pro forma)
that are required to be included in the Registration Statement and the Prospectus.
(h) There are no material liabilities of the Company or any subsidiary of the Company of any
kind whatsoever, whether accrued, contingent, absolute, determined, determinable or otherwise, and
there is no existing condition, situation or set of circumstances which could reasonably be
expected to result in such a liability, other than liabilities disclosed in the consolidated
financial statements and financial schedules of the Company included or incorporated by reference
in the Registration Statement and the Prospectus, and other undisclosed liabilities which,
individually or in the aggregate, are not material to the Company and its subsidiary, taken as a
whole.
(i) Neither the Company nor its subsidiary has sustained, since the respective dates of the
latest audited financial statements included or incorporated by reference in the Registration
Statement and Prospectus, any material loss or interference with its business from fire, explosion,
flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or
governmental action, order or decree, otherwise than as disclosed in or contemplated by the
Registration Statement and Prospectus; and, since the respective dates as of which information is
given in the Registration Statement and Prospectus, there has not been any material change in the
capital stock or long-term debt of the Company or its subsidiary, the Company and its subsidiary
have not incurred any material liabilities or obligations, direct or contingent, nor entered into
any material transactions, except for entering into purchase orders in the ordinary course of
business, and there has not been any material adverse change in or affecting the general affairs,
assets, business, management, financial position or condition, stockholders equity or results of
operations of the Company and its subsidiary considered as a whole, otherwise than as disclosed in
the Registration Statement and Prospectus.
(j) Other than as disclosed in the Prospectus, there are no legal, governmental or regulatory
proceedings pending to which the Company or its subsidiary is a party or of which any material
property of the Company or its subsidiary is the subject which, taking into account the likelihood
of the outcome, the damages or other relief sought and other relevant factors, would individually
or in the aggregate reasonably be expected to have a Material Adverse Effect or adversely affect
the ability of the Company to issue and sell the Shares; to the best of the Companys knowledge, no
such proceedings are threatened or contemplated by governmental or regulatory authorities or
threatened by others.
(k) The Company and its subsidiary have good and marketable title to all the real property and
owns all other properties and assets, reflected as owned in the financial statements included or
incorporated by reference in the Registration Statement, the Prospectus
Stock Purchase Agreement
4
and the Investor Information, subject to no lien, mortgage, pledge, charge or encumbrance of
any kind except those, if any, reflected in such financial statements or which are not material to
the Company and its subsidiary taken as a whole. The Company and its subsidiary hold their
respective leased real and personal properties under valid and binding leases, except where the
failure to do so would not reasonably be expected to individually or in the aggregate have a
Material Adverse Effect.
(l) The Company has filed all necessary federal and state income and franchise tax returns and
has paid all taxes shown as due thereon or has filed all necessary extensions, and there is no tax
deficiency that has been, or to the knowledge of the Company might be, asserted against the Company
or any of its properties or assets that would in the aggregate or individually reasonably be
expected to have a Material Adverse Affect.
(m) There are no authorized options, warrants, preemptive rights, rights of first refusal or
other rights to purchase, or equity or debt securities convertible into or exchangeable or
exercisable for, any capital stock of the Company or its subsidiary other than the 2008 Warrants
and those accurately described in the Registration Statement and the Prospectus. There are no
holders or beneficial owners of securities of the Company having rights to registration thereof
whose securities have not been previously registered or who have not waived such rights with
respect to the registration of the Companys securities on the Registration Statement, except where
the failure to obtain such waiver would not individually or in the aggregate reasonably be expected
to have a Material Adverse Effect.
(n) Other than as disclosed in the Prospectus, the Company together with its subsidiary owns
and possesses all right, title and interest in and to, or, to the Companys knowledge, has duly
licensed from third parties, all patents, patent rights, trade secrets, inventions, know-how,
trademarks, trade names, copyrights, service marks and other proprietary rights (
Intellectual
Property
) material to the business of the Company and its subsidiary taken as a whole as
currently conducted and as described in the Prospectus. To the Companys knowledge and except as
would not individually or in the aggregate have a Material Adverse Effect, there is no infringement
or other violation by third parties of any of the Intellectual Property of the Company. Neither
the Company nor its subsidiary has received any notice of infringement or misappropriation from any
third party that has not been resolved or disposed of. Further, there is no pending or, to the
Companys knowledge and except as would not individually or in the aggregate have a Material
Adverse Effect, threatened action, suit, proceeding or claim by governmental authorities or others
that the Company is infringing a patent, and there is no pending or, to the Companys knowledge and
except as would not individually or in the aggregate have a Material Adverse Effect, threatened
legal or administrative proceeding relating to patents and patent applications of the Company,
other than proceedings initiated by the Company before the United States Patent and Trademark
Office and the patent offices of certain foreign jurisdictions which are in the ordinary course of
patent prosecution. To the Companys knowledge, the patent applications of the Company presently
on file disclose patentable subject matter, and the Company is not aware of any inventorship
challenges, any interference which has been declared or provoked, or any other material fact that
(i) would preclude the issuance of patents with respect to such applications, or (ii) would lead
outside patent counsel for the Company to reasonably conclude that such patents, when issued, would
not be valid and enforceable in accordance with applicable regulations.
(o) The Company conducts its business in compliance in all respects with applicable laws,
rules and regulations of governmental and regulatory bodies to which it is subject, except where
the failure to be in compliance would not have a Material Adverse Effect.
Stock Purchase Agreement
5
(p) All offers and sales of the Companys capital stock prior to the date hereof were at all
relevant times registered pursuant to the Securities Act or exempt from the registration
requirements of the Securities Act and were issued in compliance in all material respects with
applicable state securities or blue sky laws.
(q) The Company has filed with the Nasdaq Global Market a Notification of Listing of
Additional Shares with respect to the Shares required by the rules of the Nasdaq Global Market and
has not received a notice from the Nasdaq Global Market that such notification is insufficient.
The offer and sale of the Shares does not require stockholder approval under Rule 4350 of the
Nasdaq Stock Market Rules.
(r) Neither the Company nor its subsidiary nor, to the best of the Companys knowledge, any
employee or agent of the Company or its subsidiary, has (i) used any corporate funds for unlawful
contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii)
made any unlawful payment to foreign or domestic government officials or employees or to foreign or
domestic political parties or campaigns from corporate funds, (iii) violated any provision of the
Foreign Corrupt Practices Act of 1977, as amended, or (iv) made any other unlawful payment.
(s) There is no broker, finder or other party that is entitled to receive from the Company any
brokerage or finders fee or other fee or commission as a result of any transactions contemplated
by this Agreement.
(t) The Company maintains a system of internal accounting controls sufficient to provide
reasonable assurances that (i) transactions are executed in accordance with managements general or
specific authorization; (ii) transactions are recorded as necessary to permit preparation of
consolidated financial statements in conformity with generally accepted accounting principles and
to maintain accountability for assets; (iii) access to assets is permitted only in accordance with
managements general or specific authorization; and (iv) the recorded accountability for assets is
compared with existing assets at reasonable intervals and appropriate action is taken with respect
to any differences. Except as described in the Registration Statement and the Prospectus, since
the most recent audit of the effectiveness of the Companys internal control over financial
reporting, there has been (i) no material weakness in the Companys internal control over financial
reporting (whether or not remediated) and (ii) no change in the Companys internal control over
financial reporting that has materially affected, or is reasonably likely to materially affect, the
Companys internal control over financial reporting.
(u) The Company has established, maintains and evaluates disclosure controls and procedures
(as such term is defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act), which (i) are
designed to ensure that material information relating to the Company is made known to the Companys
principal executive officer and its principal financial officer by others within those entities,
particularly during the periods in which the periodic reports required under the Exchange Act are
being prepared, (ii) have been evaluated for effectiveness as of the end of the last fiscal period
covered by the Registration Statement; and (iii) such disclosure controls and procedures are
effective to perform the functions for which they were established. There are no significant
deficiencies and material weaknesses in the design or operation of internal controls which could
adversely affect the Companys ability to record, process, summarize, and report financial data to
management and the board of directors of the Company. The Company is not aware of any fraud,
whether or not material, that involves management or other employees who have a role in the
Companys internal controls; and since the date of the most recent evaluation of such disclosure
controls and procedures, there have been
Stock Purchase Agreement
6
no significant changes in internal controls or in other factors that could significantly
affect internal controls, including any corrective actions with regard to significant deficiencies
and material weaknesses.
(v) The Company and, to its knowledge, all of the Companys directors or officers, in their
capacities as such, is in compliance in all material respects with all applicable effective
provisions of the Sarbanes-Oxley Act and any related rules and regulations promulgated by the
Commission.
(w) The Company is not, nor after giving effect to the offering and sale of the Securities and
the application of the proceeds thereof as described in the Prospectus, will be, (i) required to
register as an investment company as defined in the Investment Company Act of 1940, as amended
(the
Investment Company Act
), and the rules and regulations of the Commission thereunder
or (ii) a business development company (as defined in Section 2(a)(48) of the Investment Company
Act).
(x) The Company maintains insurance in such amounts and covering such risks as it reasonably
considers to be adequate for the conduct of its business and the value of its properties and as is
customary for companies engaged in similar businesses in similar industries. All such insurance is
fully in force on the date hereof and will be fully in force as of the Closing Date. The Company
has no reason to believe that it will not be able to renew its existing insurance coverage as and
when such coverage expires or to obtain similar coverage from similar insurers as may be necessary
to continue its business at a cost that would not have a Material Adverse Effect.
(y) The Company has not sold or issued any securities that would be integrated with the
offering of the Securities contemplated by this Agreement pursuant to the Securities Act, the
published rules and regulations thereunder, or the interpretations thereof by the Commission.
(z) The section entitled Managements Discussion and Analysis of Financial Condition and
Results of OperationsCritical Accounting Policies and Estimates and Managements Discussion and
Analysis of Financial Condition and Results of OperationsCritical Accounting Policies and
Estimates for Discontinued Operations in the Companys most recent Annual Report on Form 10-K,
Quarterly Report on Form 10-Q and in the Investor Information accurately and fully describes (A)
the accounting policies that the Company believes are the most important in the portrayal of the
Companys financial condition and results of operations and that require managements most
difficult, subjective or complex judgments (
Critical Accounting Policies
); and (B) the
judgments and uncertainties affecting the application of Critical Accounting Policies.
(aa) Neither the Company nor, to the Companys knowledge, any of its officers, directors,
affiliates or controlling persons has taken or will take, directly or indirectly, any action
designed to cause or result in, or which has constituted or which might reasonably be expected to
constitute the stabilization or manipulation of the price of any security of the Company to
facilitate the sale or resale of the Shares.
(bb) No relationship, direct or indirect, exists between or among the Company on the one hand
and the directors, officers, stockholders, customers or suppliers of the Company on the other hand
which is required to be described in the Registration Statement and the Prospectus which has not
been so described. There are no outstanding loans, advances (except
Stock Purchase Agreement
7
normal advances for business expenses in the ordinary course of business) or guarantees or
indebtedness by the Company to, or for the benefit of, any of the current officers or directors of
the Company.
(cc) The Company has filed in a timely manner all reports required to be filed pursuant to
Sections 13(a), 13(e), 14 and 15(d) of the Exchange Act during the preceding 12 months (except to
the extent that Section 15(d) requires reports to be filed pursuant to Sections 13(d) and 13(g) of
the Exchange Act, which shall be governed by the next clause of this sentence); and the Company has
filed in a timely manner all reports required to be filed pursuant to Sections 13(d) and 13(g) of
the Exchange Act during the preceding 12 months, except where the failure to timely file could not
reasonably be expected individually or in the aggregate to have a Material Adverse Effect.
(dd) The Company and its subsidiary (a) are in compliance with any and all applicable foreign,
federal, state and local laws, orders, rules, regulations, directives, decrees and judgments
relating to the protection of human health and safety, the environment or hazardous or toxic
substances or wastes, pollutants or contaminants (
Environmental Laws
), (b) have received
all permits, licenses or other approvals required of them under applicable Environmental Laws to
conduct their business and the same are effective and in use on the date of this Agreement and (c)
are in compliance with all terms and conditions of any such permit, license or approval, except
where such noncompliance with Environmental Laws, failure to receive required permits, licenses or
other approvals or failure to comply with the terms and conditions of such permits, licenses or
approvals would not, individually or in the aggregate, result in a Material Adverse Effect. There
are no costs or liabilities associated with Environmental Laws (including, without limitation, any
capital or operating expenditures required for clean-up, closure of properties or compliance with
Environmental Laws or any permit, license or approval, any related constraints on operating
activities and any potential liabilities to third parties) which would, individually or in the
aggregate, result in a Material Adverse Effect.
Neither the Company nor its subsidiary is engaged in any unfair labor practice; except for
matters that would not, individually or in the aggregate, result in a Material Adverse Effect and
(i) there is (A) no unfair labor practice complaint pending or, to the Companys knowledge after
due inquiry, threatened against the Company or its subsidiary before the National Labor Relations
Board, and no grievance or arbitration proceeding arising out of or under collective bargaining
agreements is pending or threatened, (B) no strike, labor dispute, slowdown or stoppage pending or,
to the Companys knowledge after due inquiry, threatened against the Company or its subsidiary and
(C) no union representation dispute currently existing concerning the employees of the Company or
its subsidiary, and (ii) to the Companys knowledge (A) no union organizing activities are
currently taking place concerning the employees of the Company or its subsidiary and (B) there has
been no violation of any federal, state, local or foreign law relating to discrimination in the
hiring, promotion or pay of employees or any applicable wage or hour laws concerning the employees
of the Company or its subsidiary.
(ff) The Company and its subsidiary are in compliance in all material respects with all
applicable provisions of the Employee Retirement Income Security Act of 1974, as amended, including
the regulations thereunder (
ERISA
); no reportable event (as defined in ERISA) has
occurred with respect to any pension plan (as defined in ERISA) for which the Company or its
subsidiary would have any liability; neither the Company nor its subsidiary has incurred and does
not expect to incur liability under (i) Title IV of ERISA with respect to termination of, or
withdrawal from, any pension plan or (ii) Sections 412 or 4971 of the
Stock Purchase Agreement
8
Internal Revenue Code of 1986, as amended, including the regulations thereunder (the
Code
); and each pension plan for which the Company would have any liability that is
intended to be qualified under Section 401(a) of the Code is the subject of a favorable opinion or
determination letter issued by the Internal Revenue Service and nothing has occurred, whether by
action or by failure to act, which is reasonably expected to result in the revocation of such
determination letter.
(gg) Any statistical, industry-related and market-related data included or incorporated by
reference in the Registration Statement, the Prospectus and the Investor Information, are based on
or derived from sources that the Company reasonably and in good faith believes to be reliable and
accurate, and such data agree with the sources from which they are derived.
(hh) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or
sponsored by the Company or its subsidiary or in which the Company or its subsidiary or products or
product candidates have participated that are described in the Registration Statement and the
Prospectus were and, if still pending, are being conducted in accordance in all material respects
with all statutes, laws, rules and regulations administered by the Food and Drug Association
(
FDA
) and with standard medical and scientific research procedures. The descriptions in
the Registration Statement, the Prospectus and the Investor Information of the results of such
studies and tests are accurate and complete in all material respects and fairly present the
published data derived from such studies and tests. Neither the Company nor its subsidiary has
received any notices or other correspondence from the FDA with respect to any ongoing clinical or
pre-clinical studies or tests requiring the termination, suspension or material modification of
such studies or tests, which such termination, suspension or material modification would reasonably
be expected to result in a Material Adverse Effect. The Company and its subsidiary is in
compliance with all applicable laws, regulations, orders and decrees governing its business as
prescribed by the FDA except where noncompliance would not, singly or in the aggregate, result in a
Material Adverse Effect.
(ii) Other than as set forth on Schedule II attached hereto, as of the date of this Agreement,
the only outstanding indebtedness of the Company consists of (i) the Convertible Notes, which,
unless converted into Common Stock or amended, will be paid on or before July 19, 2009 with funds
then held by the Company, and (ii) ordinary course trade payables.
(jj) The board of directors of the Company has taken all actions necessary to be taken to
pre-approve the transactions contemplated by this Agreement such that (i) the restrictions
contained in Section 203 of the Delaware General Corporation Law (DGCL) applicable to a business
combination (as defined therein), and (ii) the applicable anti-takeover provisions contained in
the Companys Shareholder Rights Plan adopted on August 7, 2002 (the Shareholder Rights Plan)
will not apply to the execution, delivery or performance of this Agreement or the consummation of
the transactions contemplated by this Agreement.
3.
Investor Representations, Warranties and Acknowledgments
.
(a) The Investor represents and warrants that: (i) it has full right, power and authority to
enter into this Agreement and to perform all of its obligations hereunder; (ii) this Agreement has
been duly authorized and executed by the Investor and, when delivered in accordance with the terms
hereof, will constitute a valid and binding agreement of the Investor enforceable against the
Investor in accordance with its terms, except as such enforceability may
Stock Purchase Agreement
9
be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the
rights and remedies of creditors generally or subject to general principles of equity; (iii) the
execution and delivery of this Agreement and the consummation of the transactions contemplated
hereby do not result in a breach of (A) the Investors certificate of incorporation or by-laws (or
other governing documents), or (B) any material agreement or any law or regulation to which the
Investor is a party or by which any of its property or assets is bound; (iv) it has had full access
to the base prospectus included in the Registration Statement, the Prospectus and the Companys
periodic reports and other information incorporated by reference therein, and was able to read,
review, download and print such materials; (v) in making its investment decision in this offering,
the Investor and its advisors, if any, have relied solely on the Companys public filings with the
Securities and Exchange Commission and the Investor Information; (vi) it is knowledgeable,
sophisticated and experienced in making, and is qualified to make, decisions with respect to
investments in securities representing an investment decision like that involved in the purchase of
the Shares; (vii) except as set forth below, the Investor has had no position, office or other
material relationship within the past three years with the Company or persons known to it to be
affiliates of the Company and (viii), except as set forth below, the Investor is not a, and it has
no direct or indirect affiliation or association with any, National Association of Securities
Dealers, Inc. member as of the date hereof.
(If no exceptions, write none. If left blank, response will be deemed to be none.)
(b) The Investor also represents and warrants that, other than the transactions contemplated
hereunder, the Investor has not directly or indirectly, nor has any person acting on behalf of or
pursuant to any understanding with the Investor, executed any disposition, including short sales
as defined in Rule 200 of Regulation SHO under the Securities Exchange Act of 1934 (the
Short
Sales
), in the securities of the Company during the period commencing from the time that the
Investor first became aware of the proposed transactions contemplated hereunder until the date
hereof (
Discussion Time
). The Investor has maintained the confidentiality of all
disclosures made to it in connection with this transaction (including the existence and terms of
this transaction).
4.
Investor Covenant Regarding Short Sales and Confidentiality
. The Investor covenants
that neither it nor any affiliates acting on its behalf or pursuant to any understanding with it
will execute any Short Sales during the period after the Discussion Time and ending on the date the
transactions contemplated by this Agreement are publicly disclosed. The Investor covenants that
until such time as the transactions contemplated by this Agreement are publicly disclosed by the
Company through a press release, the Investor will maintain the confidentiality of all disclosures
made to it in connection with this transaction (including the existence and terms of this
transaction).
Stock Purchase Agreement
10
5.
Pre-emptive Right
.
(a) Except with respect to Exempt Issuances, for so long as Investor beneficially owns (as
determined under Rule 13d-3 of the Securities and Exchange Act of 1934, as amended) an aggregate
number of shares of Common Stock equal to or greater than five percent (5%) of the then issued and
outstanding shares of Common Stock (the
Threshold Amount
), the Company hereby grants
Investor the right to purchase its Pro-Rata Portion of any new Equity Securities that the Company
may from time to time propose to issue or sell to any party.
(b)
Additional Issuance Notices
. The Company shall give written notice (an
Issuance Notice
) of any proposed issuance or sale described in subsection (a) above to
the Investor. The Issuance Notice shall, if applicable, be accompanied by a written offer from any
prospective purchaser seeking to purchase Equity Securities, to the extent known to the Company at
the time, and shall set forth the material terms and conditions of the proposed issuance,
including, without limitation:
(i) the number and description of the new Equity Securities proposed to be issued and the
percentage of the Companys outstanding equity interests such issuance would represent;
(ii) the proposed issuance date; and
(iii) the proposed purchase price per share.
The Company shall provide written notice to Investor if the terms set forth in the Issuance Notice
are updated or changed in any material respect (a
Material Update
) as the details listed
in Sections 5(b)(i), (ii) and (iii) are known.
(c)
Exercise of Pre-emptive Rights
.
Investor shall, for a period of fifteen (15)
business days following the initial receipt of an Issuance Notice (the
Exercise Period
),
have the right to elect irrevocably to purchase up to its Pro Rata Portion of the new Equity
Securities at the purchase price and on the other terms set forth in the Issuance Notice by
delivering a written notice to the Company. If the Company provides a Material Update, the
Exercise Period shall be extended by five calendar days from the date of receipt of the Material
Update, if such extension is longer than the expiration of the Exercise Period. The closing of any
purchase by Investor shall be consummated concurrently with the consummation of the issuance or
sale described in the Issuance Notice;
provided, however
that, the closing of any purchase by
Investor may be extended beyond the closing of the transaction described in the Issuance Notice to
the extent necessary to obtain required government approvals and other required third party
approvals or consents (and the Company shall use its reasonable best efforts to obtain such
approvals and consents).
(d)
Sales to the Prospective Buyer
. If Investor fails to elect to purchase all or part
of its Pro Rata Portion allotment of the new Equity Securities described in the Issuance Notice
within the time period described in subsection (c), the Company shall be free to complete the
proposed issuance or sale of new Equity Securities described in the Issuance Notice at a price and
on other terms no less favorable to the Company than those set forth in the Issuance Notice. If the
Company does not enter into an agreement for the sale of such new Equity Securities within twenty
(20) business days after the expiration of the time period described in subsection (c), or if such
agreement is not consummated within sixty (60) days after the execution thereof, the pre-emptive
right provided hereunder shall be deemed to be revived and such new
Stock Purchase Agreement
11
Equity Securities shall not be issued or sold unless first reoffered to the Investor in
accordance with this
Section 5
.
6.
Board Seat
. During the period of time (the
Investor Board Representation
Period
) beginning on the date the Investor beneficially owns (as determined under Rule 13d-3
of the Securities Exchange Act of 1934, as amended) the Threshold Amount, and ending on the date
the Investor owns less than the Threshold Amount, the Investor may designate one member of the
Board (the
Investor Director
), who shall also serve on such committees of the Board as
designated by the Board. In connection therewith, the Company hereby agrees to create a vacancy
and appoint Dr. Rajiv I. Modi (the
Representative
) as a Class I director of the Company.
As a Class I director, the Representative will be subject to stockholder vote at the Annual Meeting
of Stockholders to be held in June 2011. The Company agrees to cause the Representative to be
nominated and recommended for reelection for so long as the Investor beneficially owns Common Stock
in excess of the Threshold Amount, and to promptly take any action as may be necessary after any
stockholder meeting to effect the first sentence of this Section 6. The Investor will cause the
Representative to supply any customary or required information and consents reasonably required by
the Company to be included in the Companys Proxy Statements and filings with the Commission under
the Securities Act and the Exchange Act of 1934. The Company agrees that in the event it receives
a request by the Investor to replace the Representative, the Company will reasonably cooperate with
Investor to effect such replacement provided that the replacement individual is reasonably
acceptable to the Board of Directors.
7.
Public Disclosure
. The Company shall (i) before the opening of trading on the
Nasdaq Global Market on the next trading day after the date hereof, issue a press release,
disclosing all material aspects of the transactions contemplated hereby, to the extent permitted by
applicable law, and (ii) make such other filings and notices in the manner and time required by the
Securities and Exchange Commission with respect to the transactions contemplated hereby. The
Company shall not identify the Investor by name in any press release or public filing, or otherwise
publicly disclose the Investors name, without the Investors prior written consent, unless
required by law or the rules and regulations of any self-regulatory organization or exchange to
which the Company or its securities are subject.
8.
Conditions
. The obligation of the Investor to purchase and acquire the Shares
hereunder shall be subject to the condition that all representations and warranties and other
statements of the Company shall be true and correct as of and on each of the date of this Agreement
and the date of the Closing, the condition that the Company shall have performed all of its
obligations hereunder theretofore to be performed, and the following additional conditions:
(a) The Prospectus shall have been filed with the Commission pursuant to Rule 424(b) under the
Securities Act within the applicable time period prescribed for such filing, no stop order
suspending the effectiveness of the Registration Statement or any part thereof shall have been
issued and no proceeding for that purpose shall have been initiated or threatened by the
Commission, and the Investor shall have received the Prospectus in accordance with the federal
securities laws.
(b) Prior to the Closing Date, there shall not have occurred any change, or any development
involving a prospective change, which would constitute a Material Adverse Effect, and that makes it
impracticable to market the Shares on the terms and in the manner contemplated in the Prospectus.
Stock Purchase Agreement
12
(c) No action shall have been taken and no statute, rule, regulation or order shall have been
enacted, adopted or issued by any governmental agency or body which would, as of the Closing Date,
prevent the issuance or sale of the Shares or materially and adversely affect or reasonably be
believed to materially and adversely affect the business or operations of the Company; and no
injunction, restraining order or order of any other nature by any federal or state court of
competent jurisdiction shall have been issued as of the Closing Date which would prevent the
issuance or sale of the Shares or materially and adversely affect or reasonably be believed to
materially and adversely affect the business or operations of the Company.
(d) The Investor shall have received from Ballard Spahr Andrews & Ingersoll, LLP, counsel to
the Company, such counsels written opinion and written statement, addressed to the Investor and
dated the Closing Date, in form and substance as set forth in
Exhibit B
.
(e) The Shares shall have been authorized for quotation on the Nasdaq Global Market, Inc.
(f) The JV Agreement and the agreements contemplated thereby, and the Services Agreement shall
have been executed and delivered by the parties thereto.
(g) The actions taken by the Companys board of directors to pre-approve the transactions
contemplated by this Agreement for purposes of Section 203 of the DGCL and the Companys
Shareholder Rights Agreement shall not have been amended or modified in any respect and remain in
full force and effect.
9.
Indemnification
.
(a)
Indemnification of the Investor
. The Company agrees to indemnify and hold harmless each
of the Investors and its owners, officers, directors, managers, members, agents, advisors,
successors and assigns (each, an
Indemnified Party
), against any losses, claims, damages
or liabilities, joint or several, to which such Indemnified Party may become subject, under the
Securities Act or otherwise (including in settlement of any litigation if such settlement is
effected with the written consent of the Company, insofar as such losses, claims, damages or
liabilities (or actions in respect thereof) arise out of or are based upon (i) an untrue statement
or alleged untrue statement of a material fact contained in the Registration Statement, including
the information deemed to be a part of the Registration Statement at the time of effectiveness and
at any subsequent time pursuant to Rules 430A and 430B of the Rules and Regulations promulgated
under the Securities Act, if applicable, any Preliminary Prospectus, the Prospectus, or any
amendment or supplement thereto (including any documents filed under the Exchange Act and deemed to
be incorporated by reference into the Prospectus), any Issuer Free Writing Prospectus or in any
materials or information provided to investors by, or with the approval of, the Company in
connection with the marketing of the offering of the Common Stock (
Marketing Materials
),
including any roadshow or investor presentations made to investors by the Company (whether in
person or electronically) or arise out of or are based upon the omission or alleged omission to
state therein a material fact required to be stated therein or necessary to make the statements
therein not misleading, and will reimburse each Indemnified Party for any legal or other expenses
reasonably incurred by it in connection with investigating or defending against such loss, claim,
damage, liability or action; or (ii) in whole or in part upon any inaccuracy in the representations
and warranties of the Company contained herein; or (iii) in whole or in part upon any failure of
the Company to perform their respective obligations hereunder or under law;
provided, however,
that
the
Stock Purchase Agreement
13
Company shall not be liable in any such case to the extent that any such loss, claim, damage,
liability or action arises out of or is based upon an untrue statement or alleged untrue statement
or omission or alleged omission made in the Prospectus Supplement in reliance upon and in
conformity with written information furnished to the Company by the Indemnified Party, specifically
for use in the preparation thereof.
In addition to their other obligations under this
Section 9(a)
, the Company agrees
that, as an interim measure during the pendency of any claim, action, investigation, inquiry or
other proceeding brought or threatened against the Indemnified Party and which arises out of or
based upon any statement or omission, or any alleged statement or omission, described in this
Section 9(a)
, they will reimburse each Indemnified Party on a monthly basis for all
reasonable legal fees or other expenses incurred in connection with investigating or defending any
such claim, action, investigation, inquiry or other proceeding, notwithstanding the absence of a
judicial determination as to the propriety and enforceability of the Companys obligation to
reimburse such Indemnified Party for such expenses and the possibility that such payments might
later be held to have been improper by a court of competent jurisdiction. To the extent that any
such interim reimbursement payment is so held to have been improper, each Indemnified Party that
received such payment shall promptly return it to the party or parties that made such payment,
together with interest, determined on the basis of the prime rate (or other commercial lending rate
for borrowers of the highest credit standing) announced from time to time by The Wall Street
Journal (the
Prime Rate
). Any such interim reimbursement payments which are not made to
an Indemnified Party within 30 days of a request for reimbursement shall bear interest at the Prime
Rate from the date of such request. This indemnity agreement shall be in addition to any
liabilities which the Company may otherwise have.
(b)
Notice and Procedures
. Promptly after receipt by an Indemnified Party under subsection (a)
above of notice of the commencement of any action, such Indemnified Party shall, if a claim in
respect thereof is to be made against the Company under such subsection, notify the Company in
writing of the commencement thereof; but the omission so to notify the Company shall not relieve
the Company from any liability that it may have to any Indemnified Party except to the extent the
Company has been materially prejudiced by such failure. In case any such action shall be brought
against any Indemnified Party, and it shall notify the Company of the commencement thereof, the
Company shall be entitled to participate in, and, to assume the defense thereof, with counsel
satisfactory to such Indemnified Party, and after notice from the Company to such Indemnified Party
of the Companys election so to assume the defense thereof, the Company shall not be liable to such
Indemnified Party under such subsection for any legal or other expenses subsequently incurred by
such Indemnified Party in connection with the defense thereof other than reasonable costs of
investigation;
provided, however
, that if, in the sole judgment of the Indemnified Party, it is
advisable for the Indemnified Party to be represented by separate counsel, the Indemnified Party
shall have the right to employ a single counsel to represent such Indemnified Party, in which event
the reasonable fees and expenses of such separate counsel shall be borne by the Company and
reimbursed to the Indemnified Party as incurred (in accordance with the provisions of the second
paragraph in subsection (a) above).
The Company under this
Section 9
shall not be liable for any settlement of any
proceeding effected without its written consent, but if settled with such consent or if there be a
final judgment for the plaintiff, the Company agrees to indemnify each Indemnified Party against
any loss, claim, damage, liability or expense by reason of such settlement or judgment.
Notwithstanding the foregoing sentence, if at any time an Indemnified Party shall have requested
the Company to reimburse such Indemnified Party for fees and expenses of counsel as contemplated by
this
Section 8
, the Company agrees that it shall be liable for any settlement of any
proceeding effected without its written consent if (i) such settlement is entered into more than
Stock Purchase Agreement
14
30 days after receipt by the Company of the aforesaid request and (ii) the Company shall not have
reimbursed the Indemnified Party in accordance with such request prior to the date of such
settlement. The Company shall not, without the prior written consent of the Indemnified Party,
effect any settlement, compromise or consent to the entry of judgment in any pending or threatened
action, suit or proceeding in respect of which any Indemnified Party is or could have been a party
and indemnity was or could have been sought hereunder by such Indemnified Party, unless such
settlement, compromise or consent (a) includes an unconditional release of such Indemnified Party
from all liability on claims that are the subject matter of such action, suit or proceeding and (b)
does not include a statement as to or an admission of fault, culpability or a failure to act by or
on behalf of any Indemnified Party.
(c)
Contribution; Limitation on Liability
. If the indemnification provided for in this
Section 9
is unavailable or insufficient to hold harmless an Indemnified Party under
subsection (a) above, then the Company shall contribute to the amount paid or payable by such
Indemnified Party as a result of the losses, claims, damages or liabilities referred to in
subsection (a) above, (i) in such proportion as is appropriate to reflect the relative benefits
received by the Company on the one hand and the Indemnified Party on the other from the offering of
the Shares or (ii) if the allocation provided by clause (i) above is not permitted by applicable
law, in such proportion as is appropriate to reflect not only the relative benefits referred to in
clause (i) above but also the relative fault of the Company on the one hand and the Indemnified
Party on the other in connection with the statements or omissions that resulted in such losses,
claims, damages or liabilities, as well as any other relevant equitable considerations. The
relative fault shall be determined by reference to, among other things, whether the untrue or
alleged untrue statement of a material fact or the omission or alleged omission to state a material
fact relates to information supplied by the Company or the Indemnified Party and the parties
relevant intent, knowledge, access to information and opportunity to correct or prevent such untrue
statement or omission. The Company and the Indemnified Party agree that it would not be just and
equitable if contributions pursuant to this
Section 9(c)
were to be determined by pro rata
allocation or by any other method of allocation which does not take account of the equitable
considerations referred to in the first sentence of this
Section 9(c)
. The amount paid by
an Indemnified Party as a result of the losses, claims, damages or liabilities referred to in the
first sentence of this
Section 9(c)
shall be deemed to include any legal or other expenses
reasonably incurred by such Indemnified Party in connection with investigating or defending against
any action or claim which is the subject of this
Section 9(c)
. Notwithstanding the
provisions of this
Section 9(c)
, no Indemnified Party shall be required to contribute any
amount in excess of the amount received by it (net of expenses) from the public sale of Shares
purchased by it pursuant to this Agreement. No person guilty of fraudulent misrepresentation
(within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from
any person who was not guilty of such fraudulent misrepresentation.
(d)
Non-Exclusive Remedies
.
The obligations of the Company under this
Section 9
shall
be in addition to any liability which the Company may otherwise have and shall extend, upon the
same terms and conditions, to each person, if any, who controls any Indemnified Party within the
meaning of the Securities Act. Each Indemnified Party shall also have all rights and remedies
available to it under the law and in equity, in addition to the rights and benefits of this
Section 9
.
Stock Purchase Agreement
15
(e)
Survival
. Except in the case of fraud, gross negligence or willful misconduct, the
provisions of this
Section 9
shall survive until the first anniversary of the Closing.
10.
Miscellaneous
.
(a)
Definitions
. As used herein, the following terms have the meanings indicated:
(i)
Commission
means the Securities and Exchange Commission.
(ii)
Exempt Issuances
means issuances in which Equity Securities are issued (i) as a
dividend, stock split or other distribution payable
pro rata
to all holders of Common Stock,
(ii) to employees, officers, directors or consultants of the Company pursuant to any employee
benefit plans or programs approved by the Board or any committee thereof, to the extent that the
total number of Equity Securities issuable pursuant to such plans or programs does not exceed 15%
of the shares of Common Stock outstanding on the date hereof, (iii) upon the conversion or exercise
of any options, warrants or other rights to purchase Common Stock (A) outstanding on the date
hereof or (B) issued in accordance with the foregoing clause (ii), (iv) as consideration for a
merger, consolidation or purchase of assets; and (v) in connection with any strategic partnership
or joint venture (the primary purpose of which is not to raise equity capital), provided that (A)
any transaction described in this clause (v) has been approved by a majority of the full Board of
Directors of the Company and (B) in any twelve (12)-month period, (I) the aggregate number of
Equity Securities issued in any transaction or series of related transactions described in this
clause (v) at a price per share of less than $0.88 (appropriately adjusted for any stock splits,
reverse stock splits, stock dividends, combinations, recapitalizations or the like, the Per Share
Purchase Price) shall not exceed 5% of the number of issued and outstanding shares of Common Stock
at the beginning of such period (the Initial Capitalization), and (II) the aggregate number of
Equity Securities issued in all transactions described in this clause (v) at a price per share less
than the Per Share Purchase Price shall not exceed 10% of the Initial Capitalization.
(iii)
Equity Securities
means any and all shares of Common Stock of the Company and
any securities of the Company convertible into, or exchangeable or exercisable for, such shares,
and options, warrants or other rights to acquire such shares or such convertible, exchangeable or
exercisable securities.
(iv)
Material Adverse Effect
means a material adverse effect on the results of
operations, assets, business, or financial condition of the Company and the its subsidiary, taken
as a whole, or a material adverse effect on the Companys ability to perform in any material
respect on a timely basis its obligations under the Transaction Documents or to consummate any
transactions contemplated by the Transaction Documents or the Prospectus.
(v)
Pro Rata Portion
means that portion of Equity Securities that equals the
proportion that the number of shares of Common Stock issued and held, or issuable upon the
conversion, exchange or exercise of any convertible, exchangeable or exercisable securities then
held, by the Investor bears to the total number of shares of Common Stock of the Company then
outstanding (assuming full conversion, exchange and exercise of all outstanding convertible,
exchangeable and exercisable securities).
Stock Purchase Agreement
16
(vi)
Prospectus
means the prospectus forming a part of the Registration Statement
and the prospectus supplement relating to the Offered Shares in the form first filed pursuant to
Rule 424(b) under the Securities Act, as amended (the
Securities Act
), as further amended
or supplemented prior to the execution of this Agreement, and shall include all information and
documents incorporated by reference in such prospectus.
(b) This Agreement constitutes the entire understanding and agreement between the parties with
respect to the subject matter hereof, and there are no agreements or understandings with respect to
the subject matter hereof which are not contained in this Agreement. Notwithstanding any
investigation made by any party to this Agreement, all covenants, agreements, representations and
warranties made by the Company and the Investor herein will survive the execution of this
Agreement, the delivery to the Investor of the Shares being purchased and the payment therefor
until the first anniversary of the Closing. This Agreement may be modified only in writing signed
by the parties hereto.
(c) This Agreement may be executed in any number of counterparts, all of which taken together
shall constitute one and the same instrument and shall become effective when counterparts have been
signed by each party and delivered to the other parties hereto, it being understood that all
parties need not sign the same counterpart. Execution may be made by delivery by facsimile, PDF or
other electronically transmitted means.
(d) The provisions of this Agreement are severable and, in the event that any court or
officials of any regulatory agency of competent jurisdiction shall determine that any one or more
of the provisions or part of the provisions contained in this Agreement shall, for any reason, be
held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provision or part of a provision of this Agreement and
this Agreement shall be reformed and construed as if such invalid or illegal or unenforceable
provision, or part of such provision, had never been contained herein, so that such provisions
would be valid, legal and enforceable to the maximum extent possible, so long as such construction
does not materially adversely effect the economic rights of either party hereto.
(e) All communications hereunder, except as may be otherwise specifically provided herein,
shall be in writing and shall be mailed, hand delivered, sent by a recognized overnight courier
service such as Federal Express, or sent via facsimile and confirmed by letter, to the party to
whom it is addressed at the following addresses or such other address as such party may advise the
other in writing:
To the Seller: as set forth on the signature page hereto.
To the Investor: as set forth on the signature page hereto.
All notices hereunder shall be effective upon receipt by the party to which it is addressed.
(f) This Agreement shall be governed by and interpreted in accordance with the laws of the
State of Delaware for contracts to be wholly performed in such state and without giving effect to
the principles thereof regarding the conflict of laws. To the extent determined by such court, the
prevailing party shall reimburse the other party for any reasonable legal fees and disbursements
incurred in enforcement of, or protection of any of its rights under this Agreement.
Stock Purchase Agreement
17
If the foregoing correctly sets forth our agreement, please confirm this by signing and
returning to us the duplicate copy of this Agreement.
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NOVAVAX, INC.
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By:
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/s/ Rahul Singhvi
Rahul Singhvi
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President and Chief Executive Officer
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Address for Notice:
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Novavax, Inc.
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9920 Belward Campus Drive
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Rockville, MD 20850
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Facsimile: 240-268-2128
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Email: rsinghvi@novavax.com
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Attention: Chief Executive Officer
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SATELLITE OVERSEAS (HOLDINGS) LIMITED
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By:
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/s/ Rajiv I. Modi
Rajiv I. Modi
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Director
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Address for Notice:
c/o Barleigh Wells Limited
7 Hill Street
Douglas, Isle of Man
Facsimile: +44 20 74905102
Email: PankajShah@LubbockFine.co.uk
Attention: Pankaj Shah
Exhibit 10.2
REGISTRATION RIGHTS AGREEMENT
This REGISTRATION RIGHTS AGREEMENT (this
Agreement
), dated as of March 31, 2009, by and
between Novavax, Inc., a Delaware corporation with its headquarters located at 9920 Belward Campus
Drive, Rockville, Maryland 20850 (the
Company
), and Satellite Overseas (Holdings) Limited
(together with its affiliates and any assignee or transferee of all of its rights hereunder, the
Investor
).
WHEREAS:
In connection with the Stock Purchase Agreement by and between the parties hereto of even date
herewith (the
Stock Purchase Agreement
), the Company has agreed, upon the terms and subject to
the conditions contained therein, to issue and sell to the Investor 12,500,000 shares (the
Shares
) of the Companys common stock, $0.01 par value per share (the
Common Stock
); and
To induce the Investor to execute and deliver the Stock Purchase Agreement, the Company has
agreed to provide certain registration rights under the Securities Act and applicable state
securities laws.
NOW, THEREFORE,
in consideration of the premises and the mutual covenants contained herein and
other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Company and the Investor hereby agree as follows:
1.
Definitions
. As used in this Agreement, the following terms shall have the
following meanings:
(a)
Affiliate
means, with respect to any individual, corporation, limited liability company,
partnership, association, trust, or any other entity (in each case, a
Person
), any other Person
which, directly or indirectly, controls, is controlled by or is under common control with such
Person.
(b)
Exchange Act
means the Securities Exchange Act of 1934, as amended, and the rules and
regulations promulgated thereunder.
(c)
Form S-3
means such form under the Securities Act as in effect on the date hereof or any
registration form under the Securities Act subsequently adopted by the SEC which permits inclusion
or incorporation of substantial information by reference to other documents filed by the Company
with the SEC.
(d)
SEC
means the Securities and Exchange Commission.
(e)
SEC Rule 144
means Rule 144 promulgated by the SEC under the Securities Act.
(f)
SEC Rule 145
means Rule 145 promulgated by the SEC under the Securities Act.
(g)
Securities Act
means the Securities Act of 1933, as amended, and the rules and
regulations promulgated thereunder.
2.
Registration Rights
(a)
Demand Registration Rights
.
(i) If the Company shall receive, at any time after December 31, 2009, a written demand from
the Investor that the Company file a registration statement under the Securities Act, then the
Company shall:
(1) as soon as practicable, but in any event within sixty (60) days of the receipt of such
request, file a registration statement under the Securities Act covering all of the Shares which
the Investor requests to be registered; and
(2) use its best efforts to cause such registration statement to be declared effective by the
SEC as soon as practicable.
(ii) Notwithstanding the foregoing, if the Company shall furnish to the Investor requesting a
registration statement pursuant to this
Section 2(a)
a certificate signed by the Chief
Executive Officer of the Company stating that in the good faith judgment of the board of directors
of the Company it would be materially detrimental to the Company and its stockholders for such
registration statement to become effective or to remain effective as long as such registration
statement would otherwise be required to remain effective because such action would (i) materially
interfere with a significant acquisition, corporate reorganization or other similar transaction
involving the Company, (ii) require premature disclosure of material information that the Company
has a bona fide business purpose for preserving as confidential or (iii) render the Company unable
to comply with requirements under the Securities Act or Exchange Act, the Company shall have the
right to defer taking action with respect to such filing for a period of not more than forty-five
(45) days after receipt of the request of the Investor;
provided
,
however
, that the
Company may not utilize this right more than twice in any twelve-month period and
provided
further that the Company shall not register any securities for the account of itself or any other
stockholder during any such forty-five (45) day period other than a registration statement relating
either to the sale of securities to employees of the Company pursuant to a stock option, stock
purchase or similar plan or an SEC Rule 145 transaction, a registration on any form that does not
include substantially the same information as would be required to be included in a registration
statement covering the sale of the Shares, or a registration in which the only Common Stock being
registered is Common Stock issuable upon conversion of debt securities that are also being
registered.
(iii) All expenses incurred in connection with a registration requested pursuant to this
Section 2(a)
shall be paid as set forth in
Section 2(f)
hereof.
(iv) Notwithstanding anything in this
Section 2(a)
to the contrary, the Company shall
only be required to consummate one (1) offering pursuant to this
Section 2(a)
during any
three (3) year period. A registration statement shall not be counted until such time as such
registration statement has been declared effective by the SEC (unless the Investor withdraws its
request for such registration (other than as a result of information
2
concerning the business or financial condition or prospects of the Company which is made known
to the Investor after the date on which such registration was requested) and elects not to pay the
registration expenses therefor pursuant to
Section 2(f)
.
(v) If the Investor intends to distribute the Shares covered by its request by means of an
underwriting, the Investor shall so advise the Company as part of its request.
(b)
Piggyback Registration
.
(i) If the Company proposes to register (including for this purpose a registration effected by
the Company for stockholders other than the Investor) any of its stock or other securities under
the Securities Act in connection with the public offering of such securities solely for cash (other
than a registration statement relating either to the sale of securities to employees of the Company
pursuant to a stock option, stock purchase or similar plan or an SEC Rule 145 transaction, a
registration on any form which does not include substantially the same information as would be
required to be included in a registration statement covering the sale of the Shares or a
registration in which the only Common Stock being registered is Common Stock issuable upon
conversion of debt securities which are also being registered) (a
Piggyback Registration
), the
Company shall, at such time, promptly give the Investor written notice of such registration. Upon
the written request of the Investor given within twenty (20) days after mailing of such notice by
the Company, the Company shall, subject to the provisions of
Section 2(e)
, cause to be
registered under the Securities Act all of the Shares that the Investor has requested to be
included in such Piggyback Registration. The Company shall pay the expenses of any such Piggyback
Registration as set forth in
Section 2(g)
hereof. The Company shall have the right to
terminate or withdraw any registration initiated by it under this
Section 2(b)
prior to the
effectiveness of such registration whether or not the Investor has elected to include Shares in
such registration. The expenses of such withdrawn registration shall be borne by the Company.
(ii) In the event that the Investor elects to participate in a Piggyback Registration that is
effected by the Company for a stockholder of the Company other than the Investor, the Investor
agrees to consider in good faith waiving its rights to participate in such Piggyback Registration
if the Company informs the Investor of its good faith opinion that the inclusion of the Shares in
such offering would be detrimental to the offering.
(c)
Obligations of the Company
. Whenever required under this
Section 2
to
effect the registration of any of the Shares, the Company shall, as expeditiously as reasonably
possible:
(i) prepare and file with the SEC a registration statement with respect to such Shares and use
its reasonable best efforts to cause such registration statement to become effective, and, upon the
request of the Investor, keep such registration statement effective for a period of up to one
hundred twenty (120) days or, if earlier, until the distribution contemplated in the registration
statement has been completed;
provided
,
however
, that (i) such 120-day period shall
be extended for a period of time equal to the period the Investor refrains from selling any
securities included in such registration at the request of an underwriter of
3
Common Stock (or other securities) of the Company and (ii) in the case of any registration of
the Shares on Form S-3 which are intended to be offered on a continuous or delayed basis, subject
to compliance with applicable SEC rules, such 120-day period shall be extended, if necessary, to
keep the registration statement effective until all such Shares are sold;
(ii) prepare and file with the SEC such amendments and supplements to such registration
statement and the prospectus used in connection with such registration statement as may be
necessary to comply with the provisions of the Securities Act with respect to the disposition of
all securities covered by such registration statement;
(iii) furnish to the Investor (a) a draft copy of the registration statement and (b) such
numbers of copies of a prospectus, including a preliminary prospectus, in conformity with the
requirements of the Securities Act, and such other documents as the Investor may reasonably request
in order to facilitate the disposition of Shares owned by it;
(iv) use its reasonable best efforts to register and qualify the securities covered by such
registration statement under such other securities or blue sky laws of such jurisdictions as shall
be reasonably requested by the Investor;
provided
that the Company shall not be required in
connection therewith or as a condition thereto to qualify to do business or to file a general
consent to service of process in any such states or jurisdictions, unless the Company is already
subject to service in such jurisdiction and except as may be required by the Securities Act;
(v) in the event of any underwritten public offering, enter into and perform its obligations
under an underwriting agreement, in usual and customary form, with the managing underwriter of such
offering;
(vi) provide a transfer agent and registrar for all Shares registered pursuant hereunder and a
CUSIP number for all such Shares, in each case not later than the effective date of such
registration;
(vii) notify the Investor, promptly after the Company receives notice thereof, of the time
when such registration statement has been declared effective or a supplement to any prospectus
forming a part of such registration statement has been filed;
(viii) after such registration statement becomes effective, notify the Investor of any request
by the SEC that the Company amend or supplement such registration statement or prospectus.
(ix) notify the Investor, at any time when a prospectus relating such registration statement
is required to be delivered under the Act, of (i) the issuance of any stop order by the SEC in
respect of such registration statement, or (ii) the happening of any event as a result of which the
prospectus included in such registration statement, as then in effect, includes an untrue statement
of a material fact or omits to state a material fact required to be stated therein or necessary to
make the statements therein not misleading in the light of the circumstances then existing;
4
(x) to the extent not already listed, cause all Shares registered hereunder to be listed on
each securities exchange on which similar securities issued by the Company are then listed; and
(xi) use its reasonable best efforts to furnish, at the request of the Investor, on the date
that Shares are delivered to the underwriters for sale in connection with an underwritten
registration pursuant to
Section 2(b)
, if such securities are being sold through
underwriters, or, if such securities are not being sold through underwriters, on the date that the
registration statement with respect to such Shares becomes effective, (i) an opinion, dated as of
such date, of the counsel representing the Company for the purposes of such registration, in form
and substance as is customarily given to underwriters in an underwritten public offering and
reasonably satisfactory to the Investor, addressed to the underwriters and to the Investor, and
(ii) a comfort letter dated as of such date from the independent certified public accountants of
the Company, in form and substance as is customarily given by independent certified public
accountants to underwriters in an underwritten public offering and reasonably satisfactory to the
Investor, addressed to the Investor,
provided
,
however
, that such comfort letter
shall be at the Investors own expense.
(d)
Furnish Information
. It shall be a condition precedent to the obligations of the
Company to take any action pursuant to this
Section 2
with respect to the Shares that the
Investor shall furnish to the Company such information regarding itself, the Shares held by it, and
the intended method of disposition of such securities as shall be reasonably required to effect the
registration of the Shares.
(e)
Underwriting Requirements
. In connection with any offering involving an
underwriting of shares of the Companys capital stock pursuant to
Section 2(b)
, the Company
shall not be required to include any of the Shares in such underwriting unless the Investor accepts
the terms of the underwriting as agreed upon between the Company and its underwriters. If the
total number of securities, including the Shares, requested by stockholders to be included in such
offering exceeds the amount of securities to be sold, other than by the Company, that the
underwriters determine in their reasonable discretion is compatible with the success of the
offering, then the Company shall be required to include in the offering only that number of such
securities, including the Shares, which the underwriters determine in their sole discretion will
not jeopardize the success of the offering , except that no securities held by the Investor shall
be excluded until all securities held by all other Persons other than the Company have been
excluded.
(f)
Expenses of Demand Registration
. All expenses, other than taxes, underwriting
discounts and commissions, incurred in connection with registrations, filings or qualifications
pursuant to
Section 2(a)
, including (without limitation) all registration, filing and
qualification fees (including blue sky fees), printers and accounting fees, fees and
disbursements of counsel for the Company and the reasonable fees and disbursements of one counsel
for the Investor shall be borne equally by the Company and the Investor; provided, however, that
the Investor shall not be required to pay any such expenses in excess of $20,000 per each
registration requested pursuant to
Section 2(a)
;
provided
further
, that the
Company shall not be required to pay for any expenses of any registration proceeding begun pursuant
to
Section 2(a)
if the registration request is subsequently withdrawn at the request of the
Investor; and
5
provided
further
,
however
, that if at the time of such withdrawal, the
Investor has learned of information concerning the business or financial condition or prospects of
the Company not known to the Investor at the time of its request and has withdrawn the request with
reasonable promptness after learning of such information, then the Investor shall not be required
to pay any of such expenses and shall retain its rights pursuant to
Section 2(a)
.
(g)
Expenses of Piggyback Registration
. The Company shall bear and pay all expenses
incurred in connection with any registration, filing or qualification of Shares with respect to the
registrations pursuant to
Section 2(b)
hereof for the Investor, including (without
limitation) all registration, filing, and qualification fees (including blue sky fees), printers
and accounting fees relating or apportionable thereto and the fees and disbursements, of counsel
for the Investor as selected by it, but excluding taxes, underwriting discounts and commissions
relating to Shares.
(h)
Indemnification
. In the event any Shares are included in a registration statement
under this
Section 2
:
(i) To the extent permitted by law, the Company will indemnify and hold harmless the Investor,
and the partners, members, officers, directors, and stockholders of the Investor; legal counsel and
accountants for the Investor; any underwriter (as defined in the Securities Act) for the Investor;
and each Person, if any, who controls the Investor or underwriter within the meaning of the
Securities Act or the Exchange Act, against any Damages (as defined below), and the Company will
pay to the Investor, underwriter, controlling Person, or other aforementioned Person any legal or
other expenses reasonably incurred by them in connection with investigating or defending any claim
or proceeding from which Damages may result, as such expenses are incurred;
provided
,
however
, that the indemnity agreement contained in this
Section 2(h)(i)
shall not
apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected
without the consent of the Company, which consent shall not be unreasonably withheld, nor shall the
Company be liable for any Damages to the extent that they arise out of or are based upon actions or
omissions made in reliance upon and in conformity with written information furnished by or on
behalf of the Investor, underwriter, controlling Person, or other aforementioned Person expressly
for use in connection with such registration.
(ii) To the extent permitted by law, the Investor will indemnify and hold harmless the
Company, and each of its directors, each of its officers who has signed the registration statement,
each Person (if any), who controls the Company within the meaning of the Securities Act, legal
counsel and accountants for the Company, and any underwriter (as defined in the Securities Act),
against any Damages, in each case only to the extent that such Damages arise out of or are based
upon actions or omissions made in reliance upon and in conformity with written information
furnished by or on behalf of the Investor expressly for use in connection with such registration;
and the Investor will pay to the Company and each other aforementioned Person any legal or other
expenses reasonably incurred by them in connection with investigating or defending any claim or
proceeding from which Damages may result, as such expenses are incurred;
provided
,
however
, that the indemnity agreement contained in this
Section 2(h)(ii)
shall not
apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected
without the consent of the Investor, which consent shall not be unreasonably withheld;
6
and
provided
further
that in no event shall the aggregate amounts payable by
the Investor by way of indemnity or contribution under
Sections 2(h)(ii)
and
2(h)(iv)
exceed the proceeds from the offering received by the Investor (net of any
underwriting discounts and commissions paid by the Investor), except in the case of fraud or
willful misconduct by the Investor.
(iii) Promptly after receipt by an indemnified party under this
Section 2(h)
of notice
of the commencement of any action (including any governmental action) for which a party may be
entitled to indemnification hereunder, such indemnified party will, if a claim in respect thereof
is to be made against any indemnifying party under this
Section 2(h)
, give the indemnifying
party notice of the commencement thereof. The indemnifying party shall have the right to
participate in such action and, to the extent the indemnifying party so desires, participate
jointly with any other indemnifying party to which notice has been given, and to assume the defense
thereof with counsel mutually satisfactory to the parties;
provided
,
however
, that
an indemnified party (together with all other indemnified parties that may be represented without
conflict by one counsel) shall have the right to retain one separate counsel, with the fees and
expenses to be paid by the indemnifying party, if representation of such indemnified party by the
counsel retained by the indemnifying party would be inappropriate due to actual or potential
differing interests between such indemnified party and any other party represented by such counsel
in such action. The failure to give notice to the indemnifying party within a reasonable time of
the commencement of any such action shall relieve such indemnifying party of any liability to the
indemnified party under this
Section 2(h)
, to the extent that such failure materially
prejudices the indemnifying partys ability to defend such action. The failure to give notice to
the indemnifying party will not relieve it of any liability that it may have to any indemnified
party otherwise than under this
Section 2(h)
.
(iv) In order to provide for just and equitable contribution to joint liability under the
Securities Act in any case in which either (i) any party otherwise entitled to indemnification
hereunder makes a claim for indemnification pursuant to this
Section 2(h)
but it is
judicially determined (by the entry of a final judgment or decree by a court of competent
jurisdiction and the expiration of time to appeal or the denial of the last right of appeal) that
such indemnification may not be enforced in such case, notwithstanding the fact that this
Section 2(h)
provides for indemnification in such case, or (ii) contribution under the
Securities Act may be required on the part of any party hereto for which indemnification is
provided under this
Section 2(h)
, then, and in each such case, such parties will contribute
to the aggregate losses, claims, damages, liabilities, or expenses to which they may be subject
(after contribution from others) in such proportion as is appropriate to reflect the relative fault
of each of the indemnifying party and the indemnified party in connection with the statements,
omissions, or other actions that resulted in such loss, claim, damage, liability, or expense, as
well as to reflect any other relevant equitable considerations. The relative fault of the
indemnifying party and of the indemnified party shall be determined by reference to, among other
things, whether the untrue or allegedly untrue statement of a material fact, or the omission or
alleged omission of a material fact, relates to information supplied by the indemnifying party or
by the indemnified party and the parties relative intent, knowledge, access to information, and
opportunity to correct or prevent such statement or omission;
provided
,
however
,
that, in any such case, (x) the Investor will be required to contribute any amount in excess of the
public offering price of all such Shares offered and sold by the Investor pursuant to such
registration statement and (y) no Person guilty of fraudulent misrepresentation (within the meaning
of Section 11(f) of the Securities Act) will be
7
entitled to contribution from any Person who was not guilty of such fraudulent
misrepresentation; and
provided
further
that in no event shall the Investors
liability pursuant to this
Section 2(h)(iv)
, when combined with the amounts paid or payable
by the Investor pursuant to
Section 2(h)(ii)
, exceed the proceeds from the offering
received by the Investor (net of any underwriting discounts and selling commissions paid by the
Investor), except in the case of willful misconduct or fraud by the Investor.
(v) Unless otherwise superseded by an underwriting agreement entered into in connection with
the underwritten public offering, the obligations of the Company and the Investor under this
Section 2(h)
shall survive the completion of any offering of Shares in a registration
statement under this
Section 2
, and otherwise and shall survive the termination of this
Agreement.
(vi) As used in this
Section 2
,
Damages
means any loss, damage, or liability (joint
or several) to which a Person may become subject under the Securities Act, the Exchange Act, or
other federal or state law, insofar as such loss, damage, or liability (or any action in respect
thereof) arises out of or is based upon (i) any untrue statement or alleged untrue statement of a
material fact contained in any registration statement of the Company, including any preliminary
prospectus or final prospectus contained therein or any amendments or supplements thereto; (ii) an
omission or alleged omission to state therein a material fact required to be stated therein, or
necessary to make the statements therein not misleading; or (iii) any violation or alleged
violation by the indemnifying party (or any of its agents or Affiliates) of the Securities Act, the
Exchange Act, any state securities law, or any rule or regulation promulgated under the Securities
Act, the Exchange Act, or any state securities law.
(i)
Reports Under Exchange Act
. With a view to making available to the Investor the
benefits of SEC Rule 144 promulgated under the Securities Act and any other rule or regulation of
the SEC that may at any time permit the Investor to sell securities of the Company to the public
without registration or pursuant to a registration on Form S-3, the Company agrees to:
(i) make and keep public information available, as those terms are understood and defined in
SEC Rule 144, at all times after the effective date of the first registration statement filed by
the Company for the offering of its securities to the general public so long as the Company is
subject to the periodic reporting requirements under Sections 13 or 15(d) of the Exchange Act;
(ii) file with the SEC in a timely manner all reports and other documents required of the
Company under the Securities Act and the Exchange Act; and
(iii) furnish to the Investor, so long as the Investor owns Shares, forthwith upon request (i)
a written statement by the Company that it has complied with the reporting requirements of SEC Rule
144, the Securities Act and the Exchange Act (at any time after it has become subject to such
reporting requirements), or that it qualifies as a registrant whose securities may be resold
pursuant to Form S-3 (at any time after it so qualifies), (ii) a copy of the most recent annual or
quarterly report of the Company and such other reports and documents so filed by the Company, and
(iii) such other information as may be reasonably
8
requested in availing the Investor of any rule or regulation of the SEC which permits the
selling of any such securities without registration or pursuant to Form S-3 (at any time after the
Company so qualifies to use such form).
(j)
Assignment of Registration Rights
. The Investor may not assign the rights under
this Agreement to any Person that is not an Affiliate of the Investor.
(k)
Lockup Agreement
. In any underwritten registration in which the Investor
participates, the Investor shall execute a reasonable and customary lockup agreement as required
by the underwriters; provided, however, that such agreement is no more restrictive than the form of
agreement required by the underwriters of the other participants in the offering and the directors
and officers of the Company.
(l)
Limitation on Subsequent Registration Rights
. From and after the date of this
Agreement, the Company shall not, without the prior written consent of the Investor, enter into any
agreement with any holder or prospective holder of any securities of the Company that would allow
such holder or prospective holder to include such securities in any registration filed under
Section 2(b)
, unless under the terms of such agreement, such holder or prospective holder
may include such securities in any such registration only to the extent that the inclusion of such
securities will not reduce the number of Shares held by the Investor that are included.
(m)
Termination of Registration Rights
. The rights set forth in this
Article
2
shall terminate on the first date on which all Shares held by the Investor and its Affiliates
may be sold in any ninety (90) day period without registration in compliance with SEC Rule 144.
3.
Miscellaneous
.
(a)
Governing Law
. This Agreement shall be governed by and construed in accordance
with the internal laws of the State of Delaware, without regard to its principles of conflicts of
laws.
(b)
Counterparts
. This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument. This Agreement may also be executed and delivered by facsimile signature and in two or
more counterparts, each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
(c)
Titles and Subtitles
. The titles and subtitles used in this Agreement are used
for convenience only and are not to be considered in construing or interpreting this Agreement.
(d)
Notices
. All notices and other communications given or made pursuant to this
Agreement shall be in writing and shall be deemed effectively given: (a) upon personal delivery to
the party to be notified; (b) when sent by confirmed facsimile if sent during normal business hours
of the recipient, and if not sent during normal business hours, then on the next business day; (c)
five (5) days after having been sent by registered or certified mail, return receipt requested,
postage prepaid; or (d) two (2) business days after deposit with a nationally
9
recognized overnight courier, specifying next day delivery, with written verification of
receipt. All communications shall be sent to the respective parties at their address or facsimile
number as set forth on the signature page hereto, or to such facsimile number or address as
subsequently modified by written notice given in accordance with this
Section 3(d)
. If
notice is given to the Company, a copy shall also be sent to Ballard Spahr Andrews & Ingersoll,
LLP, Attn: Jennifer Miller, Esq., 1735 Market Street, 51
st
Floor, Philadelphia, PA
19103, facsimile (215) 864-8999. If notice is given to the Investor, a copy shall also be sent to
Morrison & Foerster, LLP, Attn: Nicholas J. Spiliotes, Esq., 2000 Pennsylvania Avenue N.W., Suite
5500, Washington, DC 20006, facsimile (202) 887-0763.
(e)
Amendments and Waivers
. Any term of this Agreement may be amended and the
observance of any term of this Agreement may be waived (either generally or in a particular
instance, and either retroactively or prospectively) only with the written consent of the Company
and the Investor.
(f)
Severability
. The invalidity or unenforceability of any provision hereof shall in
no way affect the validity or enforceability of any other provision.
(g)
Aggregation of Stock
. All Shares held or acquired by an Affiliate of an Investor
shall be aggregated together for the purpose of determining the availability of any rights under
this Agreement.
(h)
Entire Agreement
. This Agreement constitutes the full and entire understanding
and agreement between the parties with respect to the subject matter hereof, and any other written
or oral agreement relating to the subject matter hereof existing between the parties is expressly
canceled.
(i)
Delays or Omissions
. No delay or omission to exercise any right, power or remedy
accruing to any party under this Agreement, upon any breach or default of any other party under
this Agreement, shall impair any such right, power or remedy of such non-breaching or
non-defaulting party nor shall it be construed to be a waiver of any such breach or default, or an
acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any
waiver of any single breach or default be deemed a waiver of any other breach or default
theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or
character on the part of any party of any breach or default under this Agreement, or any waiver on
the part of any party of any provisions or conditions of this Agreement, must be in writing and
shall be effective only to the extent specifically set forth in such writing. All remedies, either
under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not
alternative.
[Signature Page Follows]
10
IN WITNESS WHEREOF, the parties have executed this Registration Rights Agreement as of the
date first above written.
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Novavax, Inc.
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By:
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/s/ Rahul Singhvi
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Rahul Singhvi
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President and Chief Executive Officer
9920 Belward Campus Drive
Rockville, Maryland 20850
Fax No.: 240-268-2128
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Satellite Overseas (Holdings) Limited
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By:
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/s/ Rajiv I. Modi
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Rajiv I. Modi
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Director
c/o Barleigh Wells Limited,
7 Hill Street,
Douglas, Isle of Man,
United Kingdom Im1 1EF
Fax No.: +44 20 7491 5102
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Registration Rights Agreement
Exhibit 10.4
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
MASTER SERVICES AGREEMENT
This Master Services Agreement, dated as of March 31, 2009 (the Effective Date), is between
Cadila Pharmaceuticals Limited, a company incorporated under the laws of India having its
registered office at Cadila Corporate Campus, Sarkhej Dholka Road, Bhat, Ahmedabad-382210,
Gujarat, India (Cadila), and Novavax, Inc., a Delaware corporation having its principal place of
business at 9920 Belward Campus Drive, Rockville, Maryland, 20850, United States (Novavax).
1.
Description of Services.
1.1
General
. This Master Services Agreement contemplates that Novavax may request
various services from Cadila from time to time in the areas of biologics research, preclinical
development, clinical development, process development and manufacturing scale up and general
manufacturing related services in India, and that the provision of such periodic services by Cadila
shall be governed by this Agreement.
1.2
Project Plans
.
Novavax shall request services from Cadila by means of one or more written Services Requests, which
shall set forth a description of the desired services, timeline for completion, and any other
information that Novavax believes is relevant to the requested services. Novavax and Cadila will
confer as necessary for Cadila to understand the details of the requested services. Cadila shall
promptly respond to Novavax with a Project Estimate that sets forth an estimated cost and timeline
for the requested services. In March 2009 Novavax visited the Cadila Campus in Ahmedabad to
conduct due diligence of Cadila personnel and facilities, and understand Cadilas capabilities of
performing the desired services at the required level of performance and Novavax was generally
satisfied with Cadilas capabilities to perform the desired services. Novavax may request minor
changes in procedures, equipment or similar to enhance the performance capabilities of a project by
Cadila from time to time. Novavax may also consider other service providers for the desired
services. Novavax will remit the initial Services Request within sixty (60) days of execution of
this Agreement. The Project Plans as may be approved by the parties will be attached hereto as
Exhibit A (Project Plans) forming part of this Agreement within sixty (60) days of Cadilas receipt
of the initial Service Request.
Novavax shall issue Services Requests to Cadila and Cadila shall then promptly prepare a detailed
draft Project Plan that describes the services, cost and payment schedule based on fully loaded
actual costs (including escalated costs, if any) plus [* * *], timelines, primary contacts,
scheduled teleconferences and meetings, and deliverables. Novavax and Cadila will then work
together to finalize the Project Plan for approval and final agreement by both the parties. In
addition, if the services require the use of tangible research materials (e.g., biological or
chemical materials) provided by Novavax, the Project Plan shall contain a description of such
materials, delivery arrangements, timelines, and special treatment instructions (if any). Each
Project Plan shall become effective after execution by both parties. The services described in
each executed
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Project Plan shall be defined as Services under this Agreement. Each Project Plan shall
constitute an addendum to this Agreement, and shall therefore be governed by and incorporated into
the terms of this Agreement.
Cadila will assign a qualified Project Manager to each Project Plan who shall be named in the
Project Plan. The Project Manager will coordinate performance of the Project Plan and all
communication between Cadila and Novavax regarding the Project Plan.
2.
Performance by Cadila
.
Cadila shall diligently perform the Services according to the applicable Project Plan using
commercially reasonable efforts. Novavax shall timely provide Cadila with any materials specified
in the applicable Project Plan and shall timely furnish Cadila with any information or additional
materials as reasonably requested by Cadila for the performance of the Services. Cadila shall not
be responsible for any delays caused by Novavax. If Novavax delays a Project Plan or desires to
reschedule a Project Plan, Cadila will use good faith efforts to accommodate the needs of Novavax,
but makes no commitment to commence or complete the Services under the Project Plan on the
original schedule. Cadila shall conduct the Services in a professional manner consistent with
applicable industry standards and consistent with all applicable Indian laws and regulations and
United States federal Food and Drug Administration regulations, including Good Laboratory Practices
(GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
3.
Records and Reports
.
Cadila shall prepare and maintain complete and accurate records containing all results generated by
Cadila in the performance of the Services (the Project Results). Cadila shall meet with Novavax
by teleconference and furnish Novavax with interim reports of the Project Results periodically as
provided in the applicable Project Plan, or as otherwise agreed by the parties. After the Services
are completed under a Project Plan, Cadila shall provide Novavax with a final report on the Project
Results in accordance with the requirements of the applicable Project Plan.
4.
Payment by Novavax; Guaranty of Services
.
Novavax shall pay to Cadila the costs of the Services in accordance with the fees on the schedule
set forth in the applicable Project Plan. All amounts shall be due and payable within thirty (30)
days after invoice by Cadila. All payments shall be made in US dollars unless otherwise agreed by
the parties. If the actual costs of the Services under a Project Plan exceed the estimated costs
as included in the Project Plan, then Novavax shall pay the actual costs; provided, however, that
Cadila shall not incur nor invoice any costs in excess of [* * *] of the estimated cost in the
Project Plan without the prior written consent of Novavax. If any amount payable under this
Agreement is not paid when due and payable, Cadila reserves the right, without prejudice to its
other rights and remedies, to charge interest on such amount at the rate of [* * *] per annum. In
2
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
addition, Cadila may suspend its performance of the Services under all Project Plans if any amounts
due and payable by Novavax have not been timely paid.
It is the intent of the parties that, during the first three years of the term of this Agreement
(the Services Period), Novavax will have engaged Cadila to perform Services hereunder that will
in the aggregate equal $7.5 million in fees paid to Cadila. If, at the end of the Services Period,
the Services Amount (defined below) does not equal or exceed $7.5 million, then Novavax shall pay
Cadila an amount (the Final Amount) equal to the sum of (a) the portion of the Shortfall Amount
that is less than or equal to $2.0 million, plus (b) the product of fifty percent (50%) times the
portion, if any, of the Shortfall Amount that exceeds $2.0 million. For purposes of this Section 4
and Section 9.2,
Services Amount
equals the sum of (A) the amounts paid under all Project
Plans, and (B) amounts to be paid under executed Project Plans if the Services under such Project
Plans are completed as provided therein, and (C) any amounts that would have been paid for services
under a reasonable Service Request provided to Cadila under this Agreement, which Service Request
(i) concerns legitimate products or projects within Novavaxs scope of its own business and (ii)
involves services that Cadila is reasonably able to provide within its scope of resources and
expertise, but for the fact that Cadila exercised its right not to prepare a Project Estimate or
agree to a Project Plan reasonably offered to Cadila by Novavax containing terms substantially
consistent with those contained in Cadilas Project Estimate therefor (which amounts shall be
reasonably determined based on amounts that would be reasonably charged for such services had
Cadila actually provided a Project Estimate and the parties had entered into a Project Plan
therefor); and
Shortfall Amount
equals the difference between $7.5 million and the
Services Amount.
5.
Ownership of Work Product
.
5.1
Disclosures
. Cadila will promptly notify Novavax of any invention, discovery,
improvement, formula, know-how, design, process or technique, whether patentable or not, which is
conceived or reduced to practice by Cadila in the course of Cadilas performance of Services.
5.2
Novavax Ownership
. Except as set forth in Section 5.3, Novavax shall have sole
ownership of all right, title, and interest in and to all (a) Project Results, and (b) inventions,
discoveries, improvements, formulas, know-how, designs, processes and techniques, whether or not
patentable, patent rights, copyrights, and any other intellectual property rights (all the
foregoing, collectively, IP Rights) directed or specific to Novavaxs VLP vaccines, Novavaxs VLP
platform or the particular products or programs of Novavax described in the Project Plan (Novavax
Technology) conceived or reduced to practice by Cadila in the course of performance of the
Services, and (c) IP Rights directed or specific to Novavax Technology conceived or reduced to
practice jointly by Cadila and Novavax in the course of performance of the Services (collectively,
the Novavax IP Rights). Cadila hereby assigns, transfers, and conveys to Novavax all right,
title, and interest in the Novavax IP Rights (subject, as applicable, to the license granted by
Novavax to the joint venture to be formed under the Joint Venture Agreement between Novavax and
Cadila). Cadila further agrees to execute any documents and
3
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
to provide Novavax with any other assistance that is reasonably necessary for Novavax to
perfect and enjoy its rights under this Section.
5.3
Cadila Ownership; Non-Exclusive License
. Novavax acknowledges that, in the course
of providing Services, Cadila (solely or jointly with Novavax) may conceive of, or reduce to
practice, IP Rights in the course of performance of the Services that are not directed to or
specific to the Novavax Technology, including, without limitation, any improvements to Cadilas
existing technologies or capabilities (collectively, Cadila IP Rights). Therefore,
notwithstanding the provisions of Section 5.2, Cadila shall have sole ownership of all Cadila IP
Rights. Novavax hereby assigns, transfers, and conveys to Cadila all right, title, and interest in
Cadila IP Rights. Novavax further agrees to execute any documents and to provide Cadila with any
other assistance that is reasonably necessary for Cadila to perfect and enjoy its rights under this
Section. Cadila hereby grants to Novavax a fully paid, nonexclusive right and license to use any
Cadila IP Rights in connection with the research, development, manufacture and sale of Novavax
vaccine products anywhere in the world. Except as expressly provided herein, Cadila retains all of
its rights, title and interest in, to and under its intellectual property, technology and other
assets, and no transfer of ownership or license is provided hereunder with respect thereto (by
implication or otherwise), except as expressly provided for herein.
6.
Confidential Information
.
6.1
Confidential Information
means any confidential or proprietary information
furnished by one party (the Disclosing Party) to the other party (the Receiving Party) in
connection with any Services Request or Project Plan or otherwise in connection with the
performance of Services hereunder, any information within the Project Results and any Novavax IP
Rights and any Cadila Improvements and Cadila IP Rights. All information within the Project
Results, other than Cadila Improvements and Cadila IP Rights, shall be the Confidential Information
of Novavax and Novavax shall be deemed the Disclosing Party with respect to such information. All
information relating to Cadila Improvements and Cadila IP Rights shall be the Confidential
Information of Cadila and Cadila shall be deemed the Disclosing Party with respect to such
information. Such Confidential Information may include, without limitation, trade secrets,
know-how, inventions, product or technical data or specifications, testing methods, and research
and development activities and results.
6.2
Restrictions
. During the term of this Agreement and thereafter for a period of
ten (10) years, the Receiving Party shall (i) maintain all Confidential Information in strict
confidence, except that the Receiving Party may disclose or permit the disclosure of any
Confidential Information to its directors, officers, employees, consultants, and advisors who are
obligated to maintain the confidential nature of such Confidential Information and who need to know
such Confidential Information for the purposes of this Agreement; (ii) use all Confidential
Information solely for the purposes of this Agreement (or any other agreements entered into by the
parties); and (iii) allow its directors, officers, employees, consultants, and advisors to
reproduce the Confidential Information only to the extent necessary to fulfill the purposes of this
Agreement, with all such reproductions being considered Confidential Information.
4
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
6.3
Exceptions
. The obligations of the Receiving Party under Section 6.2 above shall
not apply to the extent that the Receiving Party can demonstrate by written records that certain
Confidential Information (i) was in the public domain prior to the time of its disclosure under
this Agreement; (ii) entered the public domain after the time of its disclosure under this
Agreement through means other than an unauthorized disclosure resulting from an act or omission by
the Receiving Party; (iii) was independently developed or discovered by the Receiving Party without
use of the Confidential Information; or (iv) is or was disclosed to the Receiving Party at any
time, whether prior to or after the time of its disclosure under this Agreement, by a third party
having no fiduciary relationship with the Disclosing Party and having no obligation of
confidentiality with respect to such Confidential Information. The parties shall be permitted to
disclose Confidential Information if such information is required to be disclosed to comply with
applicable laws or regulations, or with a court or administrative order, provided that the
Disclosing Party receives reasonable prior written notice of such disclosure and the party who
wishes to disclose the Confidential Information under this provision shall have cooperated with the
Disclosing Party to seek to avoid or limit the disclosure or to obtain confidential treatment of
its disclosure.
6.4
Ownership and Return
. The Receiving Party acknowledges that the Disclosing Party
(or any third party entrusting its own information to the Disclosing Party) claims ownership of its
Confidential Information in the possession of the Receiving Party. Upon the expiration or
termination of this Agreement, or earlier at the request of the Disclosing Party, the Receiving
Party shall return to the Disclosing Party all originals, copies, and summaries of documents,
materials, and other tangible manifestations of Confidential Information in the possession or
control of the Receiving Party (unless and to the extent continued use thereof is expressly
authorized by another agreement entered into by the parties), except that the Receiving Party may
retain one copy of the Confidential Information in the possession of its legal counsel solely for
the purpose of monitoring its obligations under this Agreement.
7.
Proprietary Materials
.
7.1
Proprietary Materials
shall mean any tangible chemical, biological, or physical
research materials furnished by Novavax to Cadila in connection with this Agreement. Proprietary
Materials shall also include other materials derived by Cadila in the performance of Services
hereunder from the original materials, including without limitation any progeny derived from a cell
line and substances routinely purified from any source material included in the original materials.
Except as expressly provided herein, Novavax retains all of its rights, title and interest in, to
and under the Proprietary Materials, and no transfer of ownership or license is provided hereunder
with respect thereto (by implication or otherwise), except as expressly provided for herein.
7.2
Limited Use
. Cadila shall (and shall have the right to) use Proprietary Materials
solely for the purpose of providing the Services as requested by Novavax.
5
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
7.3
Limited Disposition
. Cadila shall not transfer or distribute any Proprietary
Materials to any third party without the prior written consent of Novavax.
7.4
Return of Proprietary Materials
. Upon the termination of this Agreement, or
earlier at the request of Novavax, Cadila shall at the instruction of Novavax either destroy or
return any unused Proprietary Materials that remain in its possession. If materials are destroyed,
Cadila shall provide Novavax with a certificate of an officer of Cadila as to such destruction.
7.5
Instructions Regarding Proprietary Materials
. Cadila represents and warrants that
it will follow any reasonable instructions, directions, or protocols from Novavax regarding the
Proprietary Materials specified by Novavax in any Project Plan hereunder and Cadila will not
administer or allow or facilitate administration of any such Proprietary Materials to any human
unless expressly directed or permitted to do so (including in any Project Plan).
8.
Term and Termination
.
8.1
Term
. This Agreement shall commence on the Effective Date and shall remain in
effect for a period of five (5) years, unless earlier terminated as provided in this Article.
8.2
Termination for Breach
. In the event that either party commits a material breach
of its obligations under this Agreement and fails to cure that breach within thirty (30) days after
receiving written notice thereof (which notice must contain a reasonably detailed description of
the alleged breach with appropriate supporting documentation), the other party may terminate this
Agreement effectively immediately without additional notice. If Novavax terminates this Agreement
for breach by Cadila, then Novavaxs obligation to pay the Final Amount shall also terminate. To
the extent that Cadila disagrees with Novavaxs position that Cadila is in breach or did not
adequately cure such breach, then the dispute resolution provisions of Sections 9.6 and 9.7 will
apply to resolutions of that disagreement to determine whether or not Novavax has a right to
terminate under this Section 8.2.
8.3
Voluntary Termination of this Agreement
. After the third anniversary of this
Agreement, either party may terminate this Agreement for any reason upon ninety (90) days written
notice to the other party; provided, however, that if Novavax terminates this Agreement before the
end of the Services Period, then the effective date of the termination shall be considered the end
of the Services Period and Novavax shall pay any Final Amount that may be due.
8.4
Effect of Termination
. Any termination of this Agreement shall trigger a
termination of any ongoing Services and Project Plans, unless the parties specifically provide
otherwise. In the event of termination of this Agreement, Cadila shall, to the extent practicable,
immediately cease work on all Project Plans and use reasonable efforts to wind down the services
thereunder as cost effectively as possible, unless otherwise instructed by Novavax. Cadila shall
send a final invoice to Novavax for work performed and for any non-cancellable or non-refundable
commitments. Cadila shall use commercially reasonable efforts to mitigate costs. After Cadila
receives the full final payment, Cadila will transfer to Novavax the Project
6
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Results as of the termination date, but Cadila shall have no obligation to deliver a final
report or to organize, interpret, or analyze any of the Project Results if such work is not already
completed.
8.5
Survival
. The following provisions shall survive the expiration or termination of
this Agreement: Articles 5, 6, and 7; Sections 9.6, 9.7, 9.8, 9.9, and 9.10.
8.6
Termination of Project Plans
. Novavax may terminate one or more Project Plans,
rather than the entire Agreement, upon ninety (90) days written notice to Cadila. In such event,
(a) any unpaid amounts under such Project Plan shall be excluded from calculation of the Final
Amount under Section 4 (i.e., no such unpaid amounts shall be subtracted from the $5.5 million in
calculating the Final Amount), and (b) Cadila will use reasonable efforts to wind down the Services
under the Project Plan(s) that were terminated as cost-effectively as possible unless otherwise
instructed by Novavax. Cadila shall send a final invoice to Novavax for work performed and for any
non-cancellable or non-refundable commitments. Cadila shall use commercially reasonable efforts to
mitigate costs. After Cadila receives the full final payment, Cadila will transfer to Novavax the
Project Results as of the termination date, but Cadila shall have no obligation to deliver a final
report or to organize, interpret, or analyze any of the Project Results if such work is not already
completed.
9.
Miscellaneous
.
9.1
Independent Contractor
. For the purposes of this Agreement, each party is an
independent contractor and not an agent or employee of the other party. This Agreement shall not
be deemed to create a joint venture or partnership between the parties. Neither party shall have
authority to make any statements, representations, or commitments of any kind, or to take any
action which shall be binding on the other party, except as may be explicitly provided for in this
Agreement or authorized in writing by the other party.
9.2
Force Majeure
. Neither party will be responsible for delays or failures in
performance resulting from causes beyond the reasonable control of such party (except for any delay
or failure to pay amounts due hereunder), including without limitation fire, explosion, flood, war,
strike, or riot, provided that the nonperforming party uses commercially reasonable efforts to
avoid or remove such causes of nonperformance and continues performance under this Agreement with
reasonable dispatch whenever such causes are removed. Either party shall have the right to
immediately terminate this Agreement should such force majeure event continue for more than ninety
(90) days. If, at the time of such a termination, the Services Amount (defined in Section 4) does
not equal or exceed a pro rata portion of $5.5 million (taking into consideration the time between
the Effective Date and such termination versus the three year Services Period (the Pro Rata
Amount)) plus $2.0 million, then Novavax shall pay Cadila an amount (the FM Final Amount) equal
to the sum of (a) the portion of the FM Shortfall Amount that is less than or equal to $2.0
million, plus (b) the product of fifty percent (50%) times the portion, if any, of the FM Shortfall
Amount that exceeds 2.0 million. For purposes of this
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EXCHANGE COMMISSION.
Section 9.2,
FM Shortfall Amount
equals the difference between the Pro Rata Amount
and the Services Amount.
9.3
Headings
. All headings are for convenience only and shall not affect the meaning
of any provision of this Agreement.
9.4
Assignment
. This Agreement may not be assigned by either party without the prior
written consent of the other party, except that a party may assign this Agreement to an affiliate
or to a successor in connection with the merger, consolidation, or sale of all or substantially all
of its assets or that portion of its business to which this Agreement relates.
9.5
Amendment
. This Agreement may be amended, supplemented, or otherwise modified
only by means of a written instrument signed by authorized representatives of both parties. Any
waiver of any rights or failure to act in a specific instance shall relate only to such instance
and shall not be construed as an agreement to waive any rights or fail to act in any other
instance, whether or not similar.
9.6
Governing Law
. This Agreement shall be governed by and construed in accordance
with the laws of England, irrespective of any conflicts of law principles. The U.N. Convention on
the Sale of Goods shall not apply to this Agreement.
9.7
Arbitration
. The parties recognize that disputes as to certain matters may from
time to time arise during the course of performance of this Agreement. It is the objective of the
parties to establish procedures to facilitate the resolution of disputes arising under this
Agreement in an expedient manner by mutual cooperation and without resort to litigation.
(a) The parties will refer any dispute, controversy or claim under, arising out of or
relating to the validity, construction, enforceability or performance of this Agreement to
the most senior management of each party who will attempt in good faith to resolve the
dispute.
(b) After senior management of the parties have attempted in good faith to resolve the
dispute, and resolution is not obtained within thirty (30) days of eithers partys referral
of such dispute to senior management, either party may initiate resolution of any dispute,
controversy or claim only by final binding arbitration administered by the International
Chamber of Commerce (ICC) and in accordance with the provisions of the ICC Rules of
Arbitration (or such other reputable arbitration organization as the parties may mutually
agree in writing). Any such arbitration will be conducted in London, in the English
language.
(c) Notwithstanding anything to the contrary in this Section 9.7, either party has the
right to seek temporary injunctive relief or any other equitable remedy (collectively, the
Equitable Claims) in any court of competent jurisdiction as may be available to such party
under the laws applicable to such jurisdiction.
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(d) The arbitration will be presided over by one arbitrator mutually agreed to by the
parties. If the parties are unable to agree to a single arbitrator, then there will be
three arbitrators, one chosen by Cadila, one chosen by Novavax and the third chosen by the
first two arbitrators..
(e) The substantive laws of England will govern the resolution of all disputes,
controversies and claims under, arising out of or relating to the validity, construction,
enforceability or performance of this agreement and any related remedies.
(f) Each party will abide by any arbitral award rendered pursuant to this Section 9.7.
If a party resists enforcement of an arbitral award, any costs, fees or taxes incident to
enforcement will be charged against that party to the extent permitted by law. Each part
will bear its own legal fees for arbitration, and the arbitrator(s) will assess their costs,
fees and expenses against the party losing the arbitration.
9.8
Notices
. Any notices required or permitted under this Agreement shall be in
writing, shall specifically refer to this Agreement, and shall be sent by recognized international
overnight courier, confirmed facsimile transmission, or confirmed electronic mail. All notices
under this Agreement shall be deemed effective upon receipt. The parties will designate their
respective contact information below, which information is subject to change immediately upon
written notice to the other party in the manner provided in this Section.
9.9
Indemnification; Insurance
.
Cadila shall indemnify, defend, and hold harmless Novavax
and its affiliates, directors,
officers, employees, and agents against any and all losses, costs, expenses, and damages, including
but not limited to reasonable attorneys fees and costs of investigation, arising out of any third
party suit, action or proceeding and attributable to the negligence or willful misconduct of Cadila
or arising out of Cadilas failure to perform the Services in compliance with the terms and
conditions of this Agreement.
Novavax shall indemnify, defend, and hold harmless Cadila and its affiliates, directors, officers,
employees, and agents against any and all losses, costs, expenses, and damages, including but not
limited to reasonable attorneys fees and costs of investigation, arising out of any third party
suit, action or proceeding and attributable to the negligence or willful misconduct of Novavax in
connection with its obligations under this Agreement or to the use, development, manufacture or
commercialization by or for Novavax or any licensee of any Novavax IP Rights, or any products or
services utilizing or covered by the same.
Any party seeking indemnification under this Agreement shall provide prompt written notice to the
indemnifying party identifying the claim or potential claim giving rise to the indemnification;
provided that failure to provide such notice shall not remove the obligation to indemnify unless
and to the extent such failure prejudices the indemnifying party. The indemnifying party shall
have the right to assume the defense of any claims that are the subject of indemnification at its
expense, provided that if there are defenses available to the indemnified party in conflict with
the
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EXCHANGE COMMISSION.
indemnifying partys defense, then the indemnified party may retain its own counsel at the
indemnifying partys expense. No party shall settle or compromise any claim for which
indemnification has been requested without the prior approval of the other party.
Each party shall secure and maintain in full force and effect throughout the performance of each
Project Plan policies of general liability, product liability and other insurance having policy
limits, deductibles and other terms appropriate to the conduct of the Services and the partys
business and to cover the liability that could arise under this Agreement and this Section 9.9
specifically.
9.10
Warranties
.
Each of Cadila and Novavax represents and warrants that (a) they each shall use commercially
reasonable efforts to perform their respective obligations under this Agreement, and (b) the
execution, delivery and performance of this Agreement has been duly authorized and, upon execution
and delivery, will be enforceable against Cadila or Novavax, as the case may be, in accordance with
the terms and conditions of this Agreement. Moreover, Cadila will comply with all applicable
Indian laws and regulations and the United States Federal Food, Drug and Cosmetic Act and the
regulations promulgated thereunder, including GLP, GMP and GCP, in its performance of Services
hereunder.
Except as expressly set forth herein, NEITHER PARTY MAKES ANY OTHER REPRESENTATION OR WARRANTY,
EXPRESS OR IMPLIED, OF ANY KIND INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR PARTICULAR PURPOSE, OR ANY WARRANTIES WITH RESPECT TO THE SERVICES PROVIDED PURSUANT TO
THIS AGREEMENT.
9.11
Limitation of Liability
. In no event shall either party, including its
employees, agents, or representatives, be liable for any consequential, incidental, special,
exemplary, or punitive damages, including any loss of profit, business, or goodwill. This
limitation shall apply regardless of whether such liability arises from a claim based upon
contract, warranty, tort, or any other theory of liability (including negligence).
9.12
Severability
. In the event that any provision of this Agreement shall be held
invalid or unenforceable for any reason, such invalidity or unenforceability shall not affect any
other provision of this Agreement, and the parties shall negotiate in good faith to modify the
Agreement to preserve (to the extent possible) their original intent.
9.13
Integration
. This Agreement, the Project Plans and all Exhibits attached hereto
constitutes the entire agreement between the parties with respect to its subject matter and
supersedes all prior agreements or understandings between the parties relating to its subject
matter.
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EXCHANGE COMMISSION.
9.14
Use of Names
. Neither party shall use the name of the other party or the names
of the employees of the other party in any advertising or sales promotional material or in any
publication without the prior written permission of such party.
[Signature Page Follows]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized representatives as of the date first written above.
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NOVAVAX, INC.
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CADILA PHARMACEUTICALS LIMITED
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By:
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/s/ Rahul Singhvi
Rahul Singhvi
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By:
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/s/ Rajiv I. Modi
Rajiv I. Modi
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President and Chief Executive Officer
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Managing Director
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EXCHANGE COMMISSION.
EXHIBIT A
PROJECT PLANS
[Project Plans, upon approval by the parties as set forth in Section 1.2, will be attached hereto
as Exhibit A documents and become incorporated into the Agreement]
Exhibit 10.6
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
TECHNICAL SERVICES AGREEMENT
This Technical Services Agreement
(the Agreement) is made as of March 31, 2009 (the
Execution Date), by and between
Novavax, Inc.
, a Delaware corporation having an address
at 9920 Belward Campus Drive, Rockville, Maryland 20850, United States of America (Novavax)
and
CPL Biologicals Limited, a limited company incorporated under the laws of India having
an address at Cadila Corporate Campus, Sarkhej-Dholka Road, Bhat, Ahmedabad 382210, Gujarat,
India
(Company).
Novavax and Company are sometimes referred to herein each individually
as a Party and collectively as the Parties.
RECITALS
Whereas
, the Company, a joint venture formed pursuant to a Joint Venture Agreement
dated as of the date hereof (the Joint Venture Agreement) between Novavax and Cadila
Pharmaceuticals Limited, organized under the laws of India (Cadila), was formed for developing,
manufacturing, marketing and selling certain pharmaceutical and medicinal products to cater the
needs of the market in India;
Whereas
, Novavax and Cadila intend that Company will establish U.S. and India cGMP
acceptable manufacturing facilities (the Manufacturing Facilities) in India and the structure for
developing, producing, marketing and selling pharmaceutical products either directly or through
partners / contractors as further described in the Joint Venture Agreement;
Whereas
, Novavax has granted the Company a license to certain of Novavaxs Patents
and Know-How for the Company to develop and commercialize Novavax Products under the Novavax
Licenses (as each such term is defined in the Joint Venture Agreement); and
Whereas
,
Novavax has significant subject matter expertise in biologics, preclinical
development, clinical development, process development and manufacturing scale up and general
manufacturing related services.
Now, Therefore
,
in consideration of the foregoing premises and the mutual covenants
set forth below, and for other good and valuable consideration, the receipt of which is hereby
acknowledged, Novavax and Company hereby agree as follows:
ARTICLE 1
DEFINITIONS
Section 1.1. References in the body of this Agreement to Sections will refer to the sections
of this Agreement. In addition, as used herein, the following initially capitalized terms will
have the following meanings:
(a) Affiliate means any corporation or other business entity controlled by, controlling, or
under common control with a Party, with control (for purposes of this Section 1.1) meaning (a)
direct or indirect beneficial ownership of fifty percent (50%) or
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EXCHANGE COMMISSION.
more of the voting stock (or, in the case of a non-corporate entity, of the equity interests
with the power to direct the management and policies) of such corporation or other business entity,
or (b) possession, directly or indirectly, of the power to direct, or cause the direction of, the
management and policies of such corporation or other business entity, whether through the ownership
of voting securities, by contract, or otherwise; provided that for purposes of this Agreement,
Novavax and Cadila shall not be deemed to be an Affiliate of Company.
(b) Bankruptcy Event means, with respect to a specified Person, (i) the filing by such
Person in any court or agency, pursuant to any statute or regulation of any state or country, a
petition in bankruptcy or insolvency or for reorganization or for an the appointment of a receiver
or trustee of such other Party or of its assets, (ii) the filing against such Person of an
involuntary petition for any bankruptcy or insolvency proceeding which petition is not dismissed
within sixty (60) days after filing, (iii) the making by such Person of an assignment for the
benefit of its creditors, (iv) the taking of possession of a substantial part of the assets of such
Person by a lien holder or other encumbrancer, or (v) the levy or enforcement of any distress,
execution or other process upon or against a substantial part of the assets of such Person.
(c) Business Day means any day other than a Saturday, Sunday or other day on which the
principal commercial banks located in Mumbai, India are not open for business during normal
business hours.
(d) Company Indemnitee has the meaning set forth in Section 6.2.
(e) Consulting Services shall mean the services set forth in Section 2.3.
(f) Development and Regulatory Services shall mean the services set forth in Section 2.2.
(g) Effective Date means the date on which the condition precedent set forth in Article 7 is
first satisfied.
(h) Governmental Authority means any court, agency, department or other instrumentality of
any foreign, federal, state, county, city or other political subdivision.
(i) Improvements means any enhancements or modifications in the production process
concerning Novavax Products.
(j) Indeminitee means a Company Indemnitee or Novavax Indemnitee, as applicable.
(k) Indemnitor means the Company or Novavax, as applicable.
(l) Joint Venture Agreement has the meaning set forth in the Recitals.
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(m) Know-How means any tangible and intangible (a) techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods, protocols, processes, formulas,
knowledge, know-how, skill, experience, records, documents, data and results (including
pharmacological, toxicological, non-clinical and clinical test data and results), analytical and
quality control data, results or descriptions, software and algorithms and (b) compositions of
matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
(n) Laws means applicable laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of the United States and India.
(o) Losses has the meaning set forth in Section 6.1.
(p) Manufacturing Facilities has the meaning set forth in the Recitals.
(q) Manufacturing Services shall mean the services set forth in Section 2.1.
(r) Novavax Indemnitee has the meaning set forth in Section 6.1.
(s) Novavax Licenses has the meaning set forth in the Recitals.
(t) Novavax Product has the meaning set forth in the Joint Venture Agreement.
(u) Patents mean any and all (a) issued patents and inventors certificates in the Territory
and re-examinations, reissues, renewals, extensions, registrations, substitutions, supplementary
protection certificates and term restorations with respect to any of the foregoing, and (b) pending
applications for patents and inventors certificates in the Territory and patents that issue
therefrom, including, without limitation, provisional applications, continuations,
continuations-in-part, divisional and substitute applications with respect to any of the foregoing.
(v) Regulatory Approval means any and all approvals (including supplements, amendments, pre-
and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations
of any national, supra-national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, that are necessary for the manufacture,
distribution, use or sale of a Novavax Product in a regulatory jurisdiction in the Territory.
(w) Services means Consulting Services, Development and Regulatory Services and Technology
Transfer Services.
(x) Technology Transfer Services means the Manufacturing Services and other technology
transfer services described in Section 2.1:
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EXCHANGE COMMISSION.
(y) Territory means India.
(z) Third Party means a person or entity other than (a) Novavax, (b) Company, (c) an
Affiliate of Novavax or (d) an Affiliate of Company.
ARTICLE 2
SERVICES
Section 2.1.
Technology Transfer Services
.
(a) Promptly after the Effective Date (but in any event within sixty (60) days thereof),
Novavax shall disclose and provide to the Company the Know-How set forth on
Exhibit 1
(the
Manufacturing Know-How) and any other relevant manufacturing-related Know How licensed to the
Company by Novavax to allow the Company to establish a Manufacturing Facility for Novavax Products.
As reasonably requested by the Company, Novavax shall disclose and provide to the Company any
Improvements to the Manufacturing Know-How made by Novavax.
(b) To effectuate the transfer and implementation of the Manufacturing Know-How and the
establishment of the Manufacturing Facility for Novavax Products, Novavax shall provide the
Manufacturing Services set forth on
Exhibit 2
. As soon as practicable after the date of
this Agreement, the Representative and the Company shall develop a reasonable schedule pursuant to
which the Manufacturing Services will be provided.
(c) Promptly after the Effective Date (but in any event within sixty (60) days thereof), and
thereafter as reasonably requested by the Company, Novavax shall disclose and provide to the
Company any Know-How licensed to the Company by Novavax under the Novavax Licenses (which is not
addressed in Section 2.1(a) above), and shall provide reasonable assistance and cooperation to the
Company for the purpose of effectively transferring such Know-How and enabling the Company to use
such Know-How within the scope of the Novavax Licenses.
Section 2.2.
Development and Regulatory Services
.
(a) To assist the Company in developing and obtaining Regulatory Approval for Novavax Products
in the Territory, Novavax shall provide the Development and Regulatory Services set forth on
Exhibit 3
.
(b) The Company and the Representative shall coordinate the execution and delivery of the
Development and Regulatory Services. The Development and Regulatory Services shall be provided at
reasonable times as shall be mutually agreed to by the Company and the Representative.
Section 2.3.
Consulting Services
.
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(a) At the Companys request, Novavax may provide consulting services to Company in the areas
of biologics, preclinical development, clinical development, process development, manufacturing
scale up and general manufacturing related services and any other areas in which Novavax has
subject matter expertise.
(b) Upon the Companys request for and upon Novavaxs agreement to provide such Consulting
Services, the Company and the Representative shall develop a description of the desired Consulting
Services and a plan for completing the requested Consulting Services, including an outline of the
level of staffing required and an estimated timeline for completion.
Section 2.4.
Novavax Representative
. Novavax designates James Robinson (the
Representative) as the Companys primary contact for all Services provided under this Agreement
and Novavax shall make such Representative reasonably available to the Company. The Company shall
direct all high-level communications regarding the Services and this Agreement to the
Representative. Novavax may substitute the Representative at any time upon notice to the Company.
Section 2.5.
Impracticability
. Novavax shall not be obligated to provide any Service
to the extent the performance of such Service becomes commercially impracticable as a result of
events or circumstances outside of the control of Novavax, including, to the extent the performance
of such Services would require Novavax to breach any applicable Law or could reasonably be expected
to result in the breach of any applicable contract, license, or other agreement; provided however,
that Novavax represents and warrants to Company that, as of the date of this Agreement, Novavax has
no knowledge of any event or circumstance that would cause the performance of Services to violate
any applicable Law or could reasonably be expected to result in the breach of any applicable
contract, license or other agreement. Novavax shall provide Company with reasonable notice of the
occurrence of any event which would cause Novavax to curtail or cease any Service pursuant to this
Section 2.5.
Section 2.6.
Rights to Know-How
. Novavax shall retain all of its right, title and
interest in any Know-How provided to the Company hereunder, subject to the Novavax Licenses.
Company shall use such Know-How solely in accordance with the terms and conditions of such Novavax
Licenses. New developments derived by the Company from the Know-How provided by Novavax hereunder
shall be subject to the terms and conditions of the Novavax License with respect thereto, if and to
the extent applicable.
ARTICLE 3
EXPENSES
Section 3.1.
Expenses
. The Company shall reimburse Novavax for its reasonable
out-of-pocket expenses incurred in connection with the performance of the Services hereunder,
including travel.
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EXCHANGE COMMISSION.
Section 3.2.
Invoices
. By the tenth business day of each month, Novavax shall submit
to the Company a report (the
Invoice
) showing a list of all out-of-pocket expenses
incurred in performance of the Services during the preceding month.
Section 3.3.
Payment Dates
. The Company shall pay all Invoices within thirty (30)
days of receipt. Late payments shall bear interest at the lesser of [* * *] per annum or the
maximum rate allowed by applicable Law. All payments due under this Agreement will be made in U.S.
dollars by wire transfer to a bank account designated by Novavax.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES
Section 4.1.
Mutual Warranties
. Each of Novavax and Company hereby represents,
warrants and covenants to the other as of the Execution Date that:
(a) it has full corporate power and authority to enter into this Agreement and to carry out
the provisions hereof, and this Agreement is legally binding upon it and enforceable in accordance
with its terms.
(b) the execution, delivery and performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party or by which it may
be bound, nor violate any Law of any governmental authority having jurisdiction over it;
(c) all necessary consents, approvals and authorizations of all governmental authorities and
other persons required to be obtained by such Party to enter into, or perform its obligations
under, this Agreement have been obtained.
Section 4.2.
DISCLAIMER OF WARRANTIES
. Novavax represents that it will use
commercially reasonable efforts to provide a high standard of professional service. However,
Novavax, as a provider of such services, cannot guarantee success, thus, except as expressly set
forth herein, THE SERVICES AND KNOW-HOW PROVIDED BY NOVAVAX HEREUNDER, AND THE IMPROVEMENTS
KNOW-HOW PROVIDED BY THE COMPANY HEREUNDER, ARE PROVIDED AS IS. EACH PARTY EXPRESSLY DISCLAIMS
ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES
OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING,
USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT.
ARTICLE 5
CONFIDENTIALITY
The Parties anticipate that under this Agreement each Party will provide confidential and/or
proprietary information to the other Party and that the use and disclosure of such
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information shall be governed by Article 18 of the Joint Venture Agreement which is hereby
incorporated by reference.
ARTICLE 6
INDEMNIFICATION
Section 6.1.
Indemnification by Company
. Company will indemnify, defend and hold
harmless Novavax, its affiliates, directors, officers, and employees (each a Novavax Indemnitee)
from and against any and all liability, loss, damage or expense (including without limitation
reasonable attorneys fees) it may suffer as the result of Third Party claims, demands, actions and
proceedings brought against it (collectively, Losses) to the extent such Losses result from the
use of the Products by Company or any human subject in a clinical trial, or which arise out of
Companys making, testing, using or selling products or processes incorporating the Products;
except to the extent that Novavax is obligated to indemnify Company as provided below.
Section 6.2.
Indemnification by Novavax
. Novavax will indemnify, defend and hold
harmless Company, its affiliates, directors, officers, and employees (each a Company Indemnitee)
from and against any and all Losses which arise out of the gross negligence, willful misconduct or
breach of a covenant, representation or warranty in this Agreement by Novavax, its affiliates or
employees.
Section 6.3.
Procedures
. Indemnitors agreement to indemnify, defend and hold
harmless an Indemnitee is conditioned on Indemnitee (a) providing prompt written notice of any
claim giving rise to an indemnification obligation hereunder but only if a failure to so notify
causes prejudicial harm to the Indemnitors ability to defend, (b) permitting Indemnitor to assume
full responsibility to investigate, prepare for and defend against any such claim, (c) providing
reasonable assistance in the defense of such claim at Indemnitors reasonable expense, and (d) not
compromising or settling such claim without Indemnitors advance written consent
Section 6.4.
LIMITATION OF LIABILITY
. EXCEPT TO THE EXTENT (A) SUCH PARTY MAY BE
REQUIRED TO INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 6, OR (B) OF A BREACH OF A PARTYS
RESPONSIBILITIES PURSUANT TO ARTICLE 5, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES WILL BE LIABLE
TO THE OTHER PARTY FOR ANY SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS
AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE.
ARTICLE 7
CONDITION PRECEDENT
This Agreement, including the obligations and benefits herein, shall only become effective if,
and shall automatically become effective upon, satisfaction of the following condition precedent;
provided that such condition is satisfied before [* * *]:
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Obtain the approval of the Foreign Investment Promotion Board for the issuance to Novavax of
[* * *] shares of Company.
If the foregoing occurs before [* * *], the first Party receiving documented evidence thereof
shall notify the other and include in such notice the date thereof which date shall thereupon be
the Effective Date hereunder.
ARTICLE 8
TERM
Section 8.1.
Term
. The initial term of this Agreement is four years commencing on
March 31, 2009, and unless terminated earlier pursuant to Section 8.2 or 8.3, shall continue until
March 31, 2013 (the Initial Term). This Agreement shall automatically renew for successive
additional one-year periods (each a Renewal Term) unless either party gives the other party
written notice of their intention to terminate the Agreement at least thirty (30) days prior to the
end of any such term (each Renewal Term and the Initial Term shall collectively be referred to
herein as the Term).
Section 8.2.
Termination by Novavax
. Novavax shall have the right to terminate this
Agreement upon the happening of any of the following events:
(a) Company fails to pay or cause to be paid any material sum which has become due to Novavax
under this Agreement and has not cured such failure to pay within thirty (30) days after written
notice from Novavax to Company identifying such payment failure;
(b) Company is in material breach of or default under this Agreement other than any payment
obligation referred to in clause (a) above and has not cured such breach or default within ninety
(90) days after written notice from Novavax to Company specifying the nature of such breach or
default; and
(c) Immediately upon notice to Company if a Bankruptcy Event occurs with respect to Company.
Section 8.3.
Termination by Company
. Company may terminate this Agreement if Novavax
is in material breach of or default under this Agreement and has not cured such breach or default
within ninety (90) days after written notice from Company to Novavax specifying the nature of such
breach or default.
Section 8.4.
Termination Upon Dissolution of Company
. This Agreement will terminate
automatically upon the dissolution, winding up, or liquidation of the Company.
Section 8.5.
Termination Upon Termination of the Joint Venture Agreement
. This
Agreement will terminate automatically if Novavax terminates the Joint Venture Agreement by
providing a Notice of Termination under and pursuant to Section 11.2 of the Joint Venture Agreement
8
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Section 8.6.
Consequences of Termination
. Upon termination of this Agreement by
Company pursuant to Section 8.3, Company will remain liable for the payment of any outstanding
Invoices pursuant to Section 3.5, but may offset such payment obligations by any contract damages
that are determined to be due to Company pursuant to Section 9.2. Upon termination of this
Agreement by Novavax pursuant to Section 8.2, all outstanding Invoices shall be due and payable
immediately and shall bear interest at a rate of the lesser of [* * *] per annum and the maximum
rate permitted by applicable Law. Termination of this Agreement shall be without prejudice to or
limitation on any other remedies or any accrued obligations of either Party. In addition, Articles
5, 6, 8.6 and 9 and any necessary definitions in Article 1 will survive any termination or
expiration of this Agreement.
ARTICLE 9
MISCELLANEOUS
Section 9.1.
Governing Law
. This Agreement shall be governed by and construed in
accordance with the laws of India.
Section 9.2.
Dispute Resolution
. Any dispute arising between the Parties out of or in
connection with the implementation or interpretation of this Agreement shall, if not settled
amicably within ninety (90) days from the date that the dispute arose, be finally settled by three
(3) arbitrators. Each Party shall be entitled to appoint one (1) arbitrator and the two (2) so
appointed shall appoint the third arbitrator in accordance with the Indian Arbitration and
Conciliation Act, 1996. It is hereby agreed that Part I of the Indian Arbitration and Conciliation
Act, 1996 shall not apply to the arbitration under this Agreement. The language of the arbitration
proceedings shall be English and its place shall be Singapore. The arbitral award or determination
shall be final and subject to no appeal and shall deal with the question of costs of arbitration
and all matters related thereto.
The Parties agree that it would be impossible or inadequate to measure and calculate their damages
from any breach of the Agreement though great and irreparable. Accordingly, each Party agrees that
if the other Party breaches this Agreement, the non-breaching party will have available, in
addition to any other right or remedy available, the right to obtain an injunction from a court of
competent jurisdiction restraining such breach or threatened breach and specific performance of any
provision of this Agreement.
Section 9.3.
Force Majeure
. Neither party will be responsible for delays or failures
in performance resulting from causes beyond the reasonable control of such party (except for any
delay or failure to pay amounts due hereunder), including without limitation fire, explosion,
flood, war, strike, or riot, provided that the nonperforming party uses commercially reasonable
efforts to avoid or remove such causes of nonperformance and continues performance under this
Agreement with reasonable dispatch whenever such causes are removed. Either party shall have the
right to immediately terminate this Agreement should such force majeure event continue for more
than ninety (90) days.
9
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Section 9.4.
Notices
. Any notice, request, demand, waiver, consent, approval or other
communication permitted or required under this Agreement (
"
Notice
"
) will be in writing, will refer
specifically to this Agreement and will be deemed given only if sent by electronic mail (with
receipt confirmed), facsimile transmission (with transmission confirmed) or by an internationally
recognized delivery service that maintains records of delivery, addressed to the Parties at their
respective addresses specified in this Section 9.4 or to such other address as the Party to whom
notice is to be given may have provided to the other Party in accordance with this Section 9.4.
Any notice delivered by electronic mail or facsimile will be confirmed by a hard copy delivered as
soon as practicable thereafter by an internationally recognized overnight delivery service. Such
Notice will be deemed to have been given on the second Business Day (at the place of delivery)
after deposit with an internationally recognized delivery service. This Section 9.4 is not
intended to govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
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If to Novavax:
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Novavax, Inc.
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9920 Belward Campus Drive
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Rockville, Maryland 20850
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Attn: Ray Hage, Senior Vice President
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Email: Rhage@Novavax.com
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Facsimile No.: 240-268-2122
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If to Company:
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CPL Biologicals Limited
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Cadila Corporate Campus
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Sarkhej-Dholka Road
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Bhat, Ahmedabad 382210
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Gujarat, India
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Attn: Dr. Rajiv I. Modi, Managing Director
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Email: rimodi@cadilapharma.co.in
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Facsimile No.: +91 (02718) 225031
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Section 9.5.
Third Party Contractors
. The Parties will perform their obligations
under this Agreement as Third Party contractors and nothing contained in this Agreement will be
construed to be inconsistent with such relationship or status. This Agreement will not constitute,
create or in any way be interpreted as a joint venture or partnership of any kind.
Section 9.6.
Headings
. The headings for each article and section in this Agreement
have been inserted for convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular article or section.
Section 9.7.
No Strict Construction
. This Agreement has been prepared jointly and
will not be strictly construed against either Party.
10
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Section 9.8.
Ambiguities
. Ambiguities and uncertainties in this Agreement, if any,
will not be interpreted against either Party, irrespective of which Party may be deemed to have
caused the ambiguity or uncertainty to exist.
Section 9.9.
English Language
. All notices required or permitted to be given
hereunder, and all written, electronic, oral or other communications between the Parties regarding
this Agreement will be in the English language. This Agreement is in the English language only,
which language will be controlling in all respects, and all versions hereof in any other language
will be for accommodation only and will not be binding upon the Parties.
Section 9.10.
Amendment and Waiver
. No amendment or waiver of any provision of this
Agreement, and no consent to any departure therefrom, shall be effective unless the same shall be
in writing and signed by an authorized representative of each Party, and such waiver or consent
shall be effective only for the specific purpose for which it is given. No failure on the part of
a Party to exercise, and no delay in exercising, any right hereunder shall operate as a waiver
thereof; nor shall any single or partial exercise of any right hereunder preclude any other or
further exercise thereof or the exercise of any other right. The remedies provided for in this
Agreement are cumulative and are not exclusive of any remedies provided for by law.
Section 9.11.
Severability
. If any of the provisions of this Agreement are found to be
inconsistent with, or void under, applicable laws, the validity of the remaining provisions shall
not thereby be affected. In such a case the Parties shall re-negotiate the ineffective provision
in good faith in order to replace it with a provision affording the same rights, obligations and
economic benefits to the Parties as the ineffective provision.
Section 9.12.
Entire Agreement
. This Agreement and the documents executed and
delivered on the date hereof pursuant hereto or in connection herewith, contain the entire
agreement among the Parties with respect to the matters addressed herein and therein and supersede
all prior representations, inducements, promises or agreements, oral or otherwise, which are not
embodied herein or therein.
Section 9.13.
Assignment
.
(a) Novavax may not assign this Agreement, in whole or in part, without the advance written
consent of the Company; provided, however, that this Agreement shall be automatically assigned to
Novavaxs successor in connection with the acquisition, merger or sale of Novavax or the sale,
transfer, lease, assignment or disposal of all or substantially all of the property or assets of
Novavax, whether by way of a single transaction or a series of related transactions, and such
successor shall be fully bound by the terms and conditions hereof.
(b) The Company may not assign this Agreement, in whole or in part, without the advance
written consent of Novavax; provided, however, that this Agreement shall be automatically assigned
to the Companys successor in connection with the sale, transfer, lease, assignment or disposal of
all or substantially all of the property or assets of the Company ,
11
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
whether by way of a single transaction or a series of related transactions, including a Change
in Control of the Company (as that term is defined in Schedule II of the Joint Venture Agreement),
and such successor shall be fully bound by the terms and conditions hereof; provided that any such
automatic assignment by Company within the scope of Schedule II of the Joint Venture Agreement
shall only be effective if such transaction was approved by Novavax under and pursuant to the Joint
Venture Agreement for so long as such approval rights of Novavax under the Joint Venture Agreement
have not been terminated.
(c) Any assignment or purported assignment by either Party in violation of this Section 9.13
will be null and void..
Section 9.14.
Counterparts
. This Agreement may be executed in one or more identical
counterparts, each of which will be deemed to be an original, and which collectively will be deemed
to be one and the same instrument.
[Signature Page to Follow]
12
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
In Witness Whereof,
the Parties have by duly authorized persons executed this
Technical Services Agreement as of the Execution Date.
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Novavax, Inc.
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CPL Biologicals Limited
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By:
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/s/ Rahul Singhvi
Rahul Singhvi
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By:
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/s/ Rajiv I. Modi
Rajiv I. Modi
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President and CEO
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Managing Director
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[Signature Page to Technical Services Agreement]
Exhibit 10.7
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
SEASONAL / OTHER LICENSE AGREEMENT
This License Agreement
(the
Agreement
) is executed this March 31, 2009 (the
"
Execution Date
), to be effective as set forth in Article 4, by and between
Novavax,
Inc.
, a Delaware corporation having an address at 9920 Belward Campus Drive, Rockville,
Maryland 20850, United States of America (
Novavax
) and
CPL Biologicals Limited
, a
limited company incorporated under the laws of India having an address at Cadila Corporate
Campus, Sarkhej-Dholka Road, Bhat, Ahmedabad 382210, Gujarat, India
(
Company
).
Novavax and Company are sometimes referred to herein each individually as a Party and
collectively as the Parties.
RECITALS
Whereas,
Novavax is a specialty biopharmaceutical company engaged in the research,
development and commercialization of its virus like particle technology into vaccine products for
the prevention of infectious diseases such as seasonal influenza and other infectious diseases;
Whereas,
Novavax Controls the Licensed Rights, as defined below;
Whereas,
Company wishes to obtain a license under the Licensed Rights, to practice
the processes included or claimed in the Licensed Rights and to Develop and Commercialize Licensed
Products; and
Whereas,
Novavax is willing to grant such license on the terms and conditions of this
Agreement.
Now, Therefore,
in consideration of the foregoing premises and the mutual covenants
set forth below, and for other good and valuable consideration, the receipt of which is hereby
acknowledged, Novavax and Company hereby agree as follows:
ARTICLE 1
DEFINITIONS
References in the body of this Agreement to Sections will refer to the sections of this
Agreement. In addition, as used herein, the following initially capitalized terms will have the
following meanings:
1.1 Affiliate
means any corporation or other business entity controlled by, controlling, or
under common control with a Party, with
control
(for purposes of this Section 1.1 only) meaning
(a) direct or indirect beneficial ownership of fifty percent (50%) or more of the voting stock (or,
in the case of a non-corporate entity, of the equity interests with the power to direct the
management and policies) of such corporation or other business entity, or (b) possession, directly
or indirectly, of the power to direct, or cause the direction of, the management and policies of
such corporation or other business entity, whether through the ownership of voting securities,
1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
by contract, or otherwise; provided that for purposes of this Agreement, Novavax and Cadila
Pharmaceuticals Limited shall not be deemed to be an Affiliate of Company.
1.2 Business Day
means any day other than a Saturday, Sunday or other day on which the
principal commercial banks located in Mumbai, India and Washington, DC, United States are not open
for business during normal business hours.
1.3 Commercialize or Commercialization
means all activities that are undertaken to prepare
for launch before Regulatory Approval (including pricing and reimbursement approvals) undertaken
after Regulatory Approval for a particular Licensed Product and that relate to the commercial
marketing and sale of such Licensed Product including advertising, sales, marketing, promotion,
distribution, and phase IV clinical trials.
1.4 Control
means, with respect to any intellectual property right, that a Party owns or has
a license to such item or right, and has the ability to grant a license or sublicense in or to such
right without violating the terms of any agreement or other arrangement with any Third Party
existing at the time that this Agreement first requires such Party to grant the other Party such
license or sublicense, provided that, for the avoidance of doubt, if the ability to grant such
license or sublicense without violating the terms of any such agreement or other arrangement arises
after such time, the license or sublicense shall be deemed granted hereunder at such later date.
1.5 Develop or Development
means the performance of all non-clinical, pre-clinical and
clinical development, manufacturing and regulatory activities for a Licensed Product that are
required to obtain Regulatory Approval of a Licensed Product in the Territory.
1.6 Developed Know-How
has the meaning in Section 5.1.
1.7 Effective Date
means the date on which the condition precedent set forth in Article 4 is
first satisfied.
1.8 Governmental Authority
means any applicable court, agency, department or other
instrumentality of any foreign, federal, state, county, city or other political subdivision.
1.9 IND
means a U.S. Food and Drug Administration investigational new drug application, or
its foreign equivalent.
1.10 Joint Venture Agreement
means the Joint Venture Agreement by and between Novavax and
Cadila Pharmaceuticals Limited, dated March 31, 2009.
1.11 Know-How
means all tangible and intangible (a) techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods, protocols, processes, formulas,
knowledge, know-how, skill, experience, records, documents, data and results (including
pharmacological, toxicological, non-clinical and clinical test data and results), analytical and
quality control data, results or descriptions, software and algorithms and (b) compositions of
matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
2
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
1.12 Laws
means all applicable laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any federal, national, multinational, state, provincial,
or other political subdivision, domestic or foreign.
1.13 Licensed Product
means (a) Novavaxs current trivalent, intra-muscular seasonal
influenza vaccine containing a virus like particle (VLP) consisting of an avian influenza M1
protein or influenza M1 protein containing an avian influenza M1 L-domain sequence and a seasonal
influenza HA and seasonal influenza NA described in the U.S. IND No. BB-IND 13787 and appropriate
diluent(s) wherein the seasonal HA and seasonal NA under the IND are recommended by the World
Health Organization (WHO) Collaborating Centers for Reference and Research on Influenza located at
the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, (
Seasonal Influenza
Licensed Product
) and (b) vaccines consisting of a virus like particle (VLP) consisting of an
avian influenza M1 protein or influenza M1 protein containing an avian influenza M1 L-domain
sequence and one or more antigens from (i) chikun gunya virus, (ii) [* * *] dengue fever), (iii)
hepatitis E [* * *] (
Other Products
), together with, in each case of both (a) and (b), any minor
modifications thereto including, by way of example but not limitation, changes to any excipient,
changes arising from a change in manufacturing process, or change in dosage, or substitution of one
or more seasonal influenza HAs and/or NAs designated by the CDC for seasonal influenza HAs and/or
NAs designated by the corresponding authority in India (e.g., the WHO in India). Licensed Product
shall include any Other Product used in combination with another active ingredient, antigen or
adjuvant. [* * *] Licensed Product shall include the trivalent, intra-muscular seasonal influenza
vaccine containing a virus like particle (VLP) consisting of an avian influenza M1 protein or
influenza M1 protein containing an avian influenza M1 L-domain sequence and a seasonal influenza HA
and seasonal influenza NA that Novavax launches for commercial sale in the United States after
Regulatory Approval of such vaccine; it being understood that for so long as (but only for so long
as) such vaccine is being developed in clinical trials by or for Novavax in support for commercial
launch in the United States, such vaccine shall be deemed a Licensed Product hereunder prior to
commercial launch (for the purpose of allowing the Company to develop and launch such product in
the Territory in accordance with the terms and conditions of this Agreement promptly following its
launch by Novavax in the United States).
1.14 Licensed Rights
means the Novavax Patents and any and all Know-How, including any
Developed Know-How, owned or Controlled by Novavax at any time during the term of this Agreement
which is used or embodied in, or useful for developing or manufacturing, any Licensed Products,
including, without limitation, Know-How regarding Novavaxs proprietary baculovirus insect cell
expression and manufacturing system and improvements thereto.
1.15 Novavax Patents
means any and all Patents in the Territory owned or Controlled by
Novavax at any time during the term of this Agreement covering or claiming a Licensed Product
and/or the manufacture or use thereof including, without limitation, the Patents listed on
Schedule 1
.
1.16 Patent
means any and all (a) issued patents and inventors certificates and
re-examinations, reissues, renewals, extensions, registrations, substitutions, supplementary
protection certificates and term restorations with respect to any of the foregoing, and (b) pending
3
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
applications for patents and inventors certificates and patents that issue therefrom,
including, without limitation, provisional applications, continuations, continuations-in-part,
divisional and substitute applications with respect to any of the foregoing.
1.17
"
Program Data
means (a) research, preclinical, clinical, manufacturing and similar data,
information, material and results, (b) regulatory filings and approvals, and (c) sales and
marketing information.
1.18 Regulatory Approval
means any and all approvals (including supplements, amendments,
pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, that are necessary for the
manufacture, distribution, use or widespread sale of a Licensed Product in a regulatory
jurisdiction in the Territory.
1.19 Regulatory Authority
means any Governmental Authority with responsibility for granting
any licenses or approvals necessary for the marketing and sale of pharmaceutical products in the
Territory.
1.20 Regulatory Documentation
means, with respect to a Licensed Product, all Regulatory
Filings and supporting documents created, submitted to a Regulatory Authority, and all data
contained therein, including, without limitation, any Investigational New Drug Application, New
Drug Application, Marketing Authorization Application, foreign counterparts thereof, Investigators
Brochures, drug master files, correspondence to and from a Regulatory Authority, minutes from
teleconferences with Regulatory Authorities, registrations and licenses, regulatory drug lists,
advertising and promotion documents shared with Regulatory Authorities, adverse event files,
complaint files and manufacturing records.
1.21 Regulatory Filing
means the foreign counterparts of an Investigation New Drug
Application, New Drug Application, Marketing Authorization Application and any other filings
required by Regulatory Authorities relating to the study, Development, manufacture or
Commercialization of any Licensed Product in the Territory.
1.22 Technical Services Agreement
means that certain Technical Services Agreement between
Novavax and Company dated as of the date hereof.
1.23 Territory
means India.
1.24 Third Party
means a person or entity other than (a) Novavax, (b) Company, (c) an
Affiliate of Novavax or (d) an Affiliate of Company.
1.25 U.S.
means the United States of America.
4
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 2
LICENSES
2.1 License Grant to Company.
Novavax hereby grants to Company an exclusive, fully paid-up,
royalty-free (except as expressly set forth in Section 2.7), non-transferable, right and license
under the Licensed Rights during the term of this Agreement to (a) research, develop, use, sell,
have sold, offer to sell and import Licensed Products in the Territory, and (b) make (and have made
solely by Cadila or an Affiliate of Cadila, subject to Novavaxs approval described below) Licensed
Products in the Territory solely to develop, use, sell, have sold, offer to sell and import
Licensed Products in the Territory. The foregoing license shall be exclusive for Licensed Products
in the Territory, even as to Novavax, provided that Novavax retains the right to perform its
obligations under this Agreement, the Technical Services Agreement and any other agreement between
Company and Novavax.
Novavax shall be reasonable in granting or withholding its approval to permit Cadila or an
Affiliate of Cadila to make Licensed Products in the Territory. Novavaxs approval shall be
subject to its consideration of, among other things, any documentation or agreement surrounding
such manufacturing of the Licensed Product (which, in any case, shall be solely for the benefit of
the Company), the safeguards in place with regard to any such manufacturing, the protection of the
Licensed Rights, and Novavaxs ability to conduct reasonable due diligence on any Affiliate of
Cadila. In no event does the license grant to the Company under this Section 2.1 permit the
Company to have Licensed Products made by a Third Party.
2.2 License Grant to Novavax.
The Company hereby grants to Novavax a fully paid-up,
royalty-free exclusive right and license under Developed Know-How owned or Controlled by the
Company, including any Patents that issue therefrom, to (a) research, develop, use, sell, have
sold, offer to sell and import (i) Seasonal Influenza Licensed Products and (ii) other seasonal
influenza vaccines outside the Territory, and (b) make and have made (i) Seasonal Influenza
Licensed Products and other seasonal influenza vaccines outside the Territory solely to develop,
use, sell, have sold, offer to sell and import Seasonal Influenza Products outside the Territory.
For clarity, the license grant to Novavax under this Section 2.2 does not include the right
research, develop, use, make, have made, sell, have sold, offer to sell and import the Other
Products outside the Territory.
2.3 Sublicenses.
Company shall not sublicense the Licensed Rights to any Third Party without
the prior written consent of Novavax, which consent may be withheld in its sole discretion. Upon
execution of a sublicense, after receipt of Novavax consent, Company will notify Novavax of the
execution of the sublicense and provide a copy to Novavax promptly following execution thereof.
2.4 No Implied Rights or Licenses.
No right or license, other than those expressly set forth
in this Agreement are granted to either party hereunder, and no additional rights will be deemed
granted to either party by implication, estoppel or otherwise. All rights not expressly granted by
either party to the other hereunder are reserved.
5
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
2.5 Research Data; Right of Reference.
(a) Company shall keep complete and accurate notes, accounts and records of all Program Data
with respect to Licensed Products, including the manufacture thereof. Novavax shall have the right
to access, use and reference for its Development and Commercialization of its products outside the
Territory Program Data related to Licensed Products in the possession or control of the Company.
The Company shall provide such cooperation and assistance as reasonably requested by Novavax from
time to time to effectuate the foregoing, including, without limitation by providing access to and
disclosure of Program Data to Novavax and by providing such authorization and consents required for
reference to regulatory filings and approvals.
(b) Company shall have the right to access, use and reference for its Development and
Commercialization of Licensed Products in the Territory Program Data related to Licensed Products
in the possession or control of Novavax. Novavax shall provide such cooperation and assistance as
reasonably requested by Company from time to time to effectuate the foregoing, including, without
limitation by providing access to and disclosure of Program Data to Company and by providing such
authorization and consents required for reference to regulatory filings and approvals.
2.6 Grey Market.
The Parties reasonably cooperate to formulate and implement reasonable
precautions designed to prevent Licensed Products made or sold by or for such Party or its
respective Affiliates and permitted sublicensees from being sold outside of its respective
territory (i.e., outside the Territory for the Company and inside the Territory for Novavax).
Further, each Party will take reasonable measures so that its distributors, Affiliates and
wholesalers to whom the Company or Novavax provides its respective Licensed Products are aware of
the respective territorial limitations.
2.7 Third Party License Agreements.
The license granted under Section 2.1 may be subject to
applicable terms and conditions of a license agreement with a Third Party, under which any Licensed
Rights are sublicensed to the Company hereunder by Novavax (each a
Third Party License
Agreement
). Novavax shall be responsible for maintaining the Third Party License Agreements
and for any payments owed by Novavax thereunder; provided, however, that if a royalty is owed on
sales of Licensed Product by or for the Company in the Territory under such Third Party License
Agreement, such payments will be paid by Company.
2.8 Combination Products Reservation.
Novavax shall not, directly or indirectly, (i) engage
in, promote, or finance the research, development, or commercialization of, or (ii) grant any
license, or any similar rights with respect to, to a Third Party, in each case of (i) and (ii), a
Licensed Product in combination with another active ingredient, antigen or adjuvant in the
Territory.
6
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 3
LICENSED PRODUCT DEVELOPMENT AND COMMERCIALIZATION
3.1 Development and Commercialization of Licensed Products.
(a)
General.
Company will have sole responsibility, at Companys sole expense, for all
Development and Commercialization of Licensed Products in the Territory in accordance with the
terms of this Agreement.
(b)
Development and Commercialization of Seasonal Influenza Licensed Products.
Prior to [* *
*], Company shall present to Novavax for its written approval Development plans for the Seasonal
Influenza Licensed Product which shall specify preclinical studies (including a toxicology program
and other preclinical testing), human clinical trials, manufacturing scale up, Regulatory Approval
strategy and any other significant Development activities, that Company plans to perform to obtain
Regulatory Approval of such Licensed Products in the Territory (the
Seasonal Development Plans
).
Novavax may reasonably request adjustments to activities described in such Development plans as a
condition to granting its approval. In no event shall Company materially alter a Seasonal
Development Plan without Novavaxs prior written consent. Company shall conduct Development of
such Licensed Products in a manner that is materially consistent with the Seasonal Development
Plans. All clinical trial protocols for Seasonal Influenza Licensed Products conducted by Company
shall require the prior written approval of Novavax. Prior to [* * *] Company shall present to
Novavax for its written approval a plan to Commercialize the Seasonal Influenza Licensed Product
which shall specify a multi-year marketing and public relations strategy, operational plans to
implement such strategies and any other significant Commercialization activities (the
Seasonal
Commercialization Plan
). Novavax may reasonably request adjustments to the Commercialization plan
as a condition to granting its approval. In no event shall Company materially alter the Seasonal
Commercialization Plan without Novavaxs prior written consent. Company shall conduct
Commercialization of such Licensed Products in a manner that is materially consistent with the
Seasonal Commercialization Plan. Novavax acknowledges that the Licensed Products are being
contributed by Novavax to the Company in accordance with the Joint Venture Agreement and that if
the Company cannot Develop and Commercialize such Licensed Products it will not obtain the value of
such contribution. Company acknowledges that Novavax (or its affiliates or licensees) are
Developing and Commercializing Licensed Products outside the Territory and Companys activities
could raise safety concerns and have an impact on Novavaxs activities including the Regulatory
Approval and regulatory profile of an approved Licensed Product outside the Territory.
Accordingly, taking into account Novavaxs and Companys respective interests including, without
limitation, as provided in the two preceding sentences, Novavax shall not unreasonably withhold,
delay or condition any of its consents or approvals hereunder.
(c)
Development and Commercialization of Other Products.
Before beginning any Development or
Commercialization activities with respect to an Other Product, Company shall present to Novavax
Development plans and Commercialization plans, as the case may be, for such Other Product and
material alterations to such plans. Novavax may review and comment on such Other Product
Development plans and Commercialization plans and material
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
alterations to such plans and Company will consider in good faith the reasonable comments of
Novavax. Company shall conduct Development and Commercialization of such Other Product in a manner
that is materially consistent with such Other Product Development plans and Commercialization
plans.
3.2 Regulatory Affairs.
Company will be responsible for developing Regulatory Documentation
and preparing and submitting Regulatory Filings, seeking Regulatory Approvals, and maintaining
Regulatory Approvals for Licensed Products in the Territory. As set forth in the Technical
Services Agreement, Novavax will cooperate with Company in preparing and filing all such reports.
3.3 Manufacture and Supply.
Company will be responsible for the manufacture of Licensed
Product in the Territory and for all costs associated therewith. Certain amount of supply of
preclinical and clinical supply of Licensed Product will be made under the Supply Agreement, dated
as of March 31, 2009, between Company and Novavax (the
Supply Agreement
).
3.4 Adverse Event Reporting.
Company will maintain a record of all non-medical and medical
Licensed Product-related complaints and reports of Adverse Events in the Territory with respect to
any Licensed Product Developed or Commercialized by the Company. At the request of either party,
Novavax and the Company shall enter into reasonable and customary pharmacovigilance agreement with
respect to sharing of adverse event data and information for Licensed Products as required to
comply with applicable laws and regulations.
3.5 Development and Commercial Reporting.
During the Term of this Agreement, Company will
provide a half-yearly written progress report to Novavax summarizing the Development and
Commercialization of Licensed Product(s) during the prior six months. Each such progress report
will be provided to Novavax by Company no later than March 1
st
or September
1
st
(as the case may be) of each year following the Effective Date.
3.6 Minor Modifications; Intent.
During the Term of this Agreement, Novavax will promptly
provide Company with details of any minor modifications it makes to the Seasonal Influenza Licensed
Product as Novavax develops it for Regulatory Approval. [* * *]
ARTICLE 4
CONDITION PRECEDENT
This Agreement, including the license grants, obligations and benefits herein, shall only
become effective if, and shall automatically become effective upon, satisfaction of the following
condition precedent; provided that such condition is satisfied before [* * *]:
Obtain the approval of the Foreign Investment Promotion Board for the issuance to Novavax of
[* * *] shares of Company.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
If the foregoing occurs before [* * *], the first Party receiving documented evidence thereof
shall notify the other and include in such notice the date thereof which date shall thereupon be
the Effective Date hereunder.
ARTICLE 5
INTELLECTUAL PROPERTY
5.1 Disclosure.
During the Term, the Parties will promptly disclose to one another all
Know-How (whether patentable or not) developed, conceived or reduced to practice during the
Development, manufacture or Commercialization of a Licensed Product which is regarding or directed
to a Licensed Product (
Developed Know-How
). Novavax shall also disclose to the Company any
Know-How within the Licensed Rights obtained, licensed or generated after the Effective Date which
is not included within the Developed Know-How.
5.2 Ownership.
Novavax shall own all Developed Know-How and any other intellectual property
that is conceived and reduced to practice solely by Novavax. The Company shall own all Developed
Know-How and any other intellectual property that is conceived and reduced to practice solely by
Company. Novavax and the Company shall jointly own in accordance with U.S. Laws regarding joint
ownership of the applicable type of intellectual property, all Developed Know-How and any other
intellectual property that is conceived or reduced to practice by Novavax and Company jointly.
5.3 Prosecution and Maintenance of Patents.
Novavax shall have the sole and exclusive right
and authority to control the filing, prosecution, maintenance, and renewal of all Novavax Patents
and any Patents that result from Developed Know-How which is owned by Novavax or jointly owned as
provided in Section 5.2, at its own expense. Company shall have the sole and exclusive right and
authority to control the filing, prosecution, maintenance and renewal of any Patents that result
from Developed Know-How owned by Company as provided in Section 5.2. With respect to any such
Patents in the Territory and with respect to any such Patents that are subject to the license
granted to Novavax in Section 2.2 anywhere in the world (the
ROW Patents
), the prosecuting party
shall (i) provide the other party with copies of all material filings, documentation and
correspondence from, sent to or filed with patent offices in the Territory or anywhere in the world
for the ROW Patents, and (ii) provide the other party with a reasonable opportunity to comment upon
all filings and actions with such patent offices in advance of submissions to such patent offices.
For purposes of this Section 5.3, filing, prosecution and maintenance of patents shall be deemed
to include, without limitation, appeals to administrative or judicial entities having jurisdiction
over patentability, the conduct of interferences or oppositions, and/or requests for
re-examinations, reissues or extensions of patent terms.
5.4 Abandoned Patents.
In the event the prosecuting party determines not to initiate patent
prosecution for any particular patentable Developed Know-How invention or to cease prosecution or
maintenance of, or otherwise abandon, any Patents that are the subject of Section 5.3 in the
Territory, or with respect to ROW Patents anywhere in the world (which the prosecuting party may do
in its sole discretion), the prosecuting party shall provide reasonable prior written notice to the
other party sufficient for the other party to timely initiate or take over the prosecution
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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
and maintenance of such Patent and timely file any required documents and responses with the
relevant government patent office in the Territory, or with respect to ROW Patents anywhere in the
world, with respect thereto, and the other party may elect (in its sole discretion) to prosecute
and maintain such Patent, at the other partys sole expense. In such event, upon the request of
and, at the expense of the other party, the prosecuting party shall assign to the other party all
of its right, title and interest in, to and under such Patent which the prosecuting party has
decided to abandon and provide reasonable cooperation to the other party with respect thereto
(including, without limitation, providing necessary information and executing relevant documents).
5.5 Enforcement of Patents.
(a)
Infringement by Third Parties.
In the event that Novavax or the Company becomes aware of
or has reasonable suspicions of third party activities in the Territory that could constitute
infringement of the Novavax Patents or Patents that issue from Developed Know-How in the Territory,
or with respect to ROW Patents anywhere in the world, or misappropriation of the Novavax Know-How
or Developed Know-How in the Territory, or with respect to Developed Know-How any that is subject
to the license granted to Novavax in Section 2.2 anywhere in the world (
ROW Know-How
), then such
party shall promptly notify the other parties of such third party activities, including
identification of the third party and delineation of the facts relating to such third party
activities. The Company shall have the right (but shall not be obligated) to enforce the Novavax
Patents, Novavax Know-How and Developed Know-How against any actual or alleged infringement or
misappropriation thereof in the Territory by a third party (by bringing a suit, action or
proceeding against such third party), at the Companys sole expense. Novavax shall have the right
(but shall not be obligated) to enforce the ROW Patents and ROW Know-How within the scope of the
licenses granted to Novavax in Section 2.2 against any actual or alleged infringement or
misappropriation thereof outside the Territory by a third party (by bringing a suit, action or
proceeding against such third party), at Novavaxs sole expense. If the Company does not enforce
the Novavax Patents or Know-How by (i) one hundred (100) days following the notice of alleged
infringement or (ii) thirty (30) days before the time limit, if any, set forth in the appropriate
laws and regulations for the filing of such an action, whichever comes first, then Novavax shall
have the right (but not the obligation) to enforce the Novavax Patents and Novavax Know-How against
any actual or alleged infringement or misappropriation thereof in the Territory by a third party
(by bringing a suit, action or proceeding against such party), at Novavaxs sole expense. The
non-prosecuting party shall reasonably cooperate with the prosecuting party in such enforcement
activities, at the prosecuting partys expense, including by agreeing to be named as a party to (or
bringing in its own name) such suit, action or proceeding for the benefit of the non-prosecuting
party if required for such enforcement action to proceed. The prosecuting party shall keep the
non-prosecuting party reasonably informed regarding any such enforcement action and shall consider
in good faith the reasonable comments and suggestions of the non-prosecuting party related to such
suit, action or proceeding. All recoveries received by the prosecuting party from any such
enforcement action shall be retained by the prosecuting party.
(b)
Challenge by Third Parties.
Novavax and Company will each notify the other Party in
writing within ten (10) Business Days of learning of any alleged or threatened opposition,
reexamination request, action for declaratory judgment, nullity action, interference or
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
other attack upon the validity, title or enforceability of the Licensed Rights or the ROW
Patents or ROW Know-How by a Third Party. Owner of the subject Patent will have the right (but not
the obligation) to defend any such challenge in the Territory. If the owner of the subject Patent
commences a defense against the alleged or threatened challenge (i) within sixty (60) days
following the detection of the alleged challenge, or (ii) ten (10) Business Days before the time
limit, if any, set forth in appropriate Laws and regulations for making a filing in defense of such
a challenge, whichever comes first, then the owner of the subject Patent will so notify the other
party promptly. Notwithstanding the foregoing, if any such action for declaratory judgment,
nullity action, or other attack upon the validity, title or enforceability of the Licensed Right
includes or will include counterclaims of infringement of the Licensed Rights, ROW Patents or ROW
Know-How by the Third Party, control of such action or other attack shall be governed by Section
5.5(a).
ARTICLE 6
CONFIDENTIALITY; PUBLICATION
6.1 Confidentiality
. The Parties anticipate that under this Agreement each Party will provide
confidential and/or proprietary information to the other Party and that the use and disclosure of
such information shall be governed by Article 18 of the Joint Venture Agreement which is hereby
incorporated by reference.
6.2 Publication.
(a) Each Party shall have the right to publish the data and results related to Licensed
Products, subject to the rest of this Section 6.2. Prior to public disclosure or submission for
publication of a proposed publication describing the results of any scientific or clinical activity
relating to a Licensed Product, the Party proposing such publication shall send the other Party by
expedited delivery a copy of the proposed publication to be submitted and shall allow the other
Party a reasonable time period (but not more than sixty (60) days from the date of confirmed
receipt) in which to determine whether the proposed publication contains subject matter for which
patent protection should be sought (prior to publication of such proposed publication) for the
purpose of protecting an invention, or whether the proposed publication contains the Confidential
Information of such other Party, or whether the proposed publication contains information that is
reasonably likely to have a material adverse impact on the development or commercialization of
Licensed Products. Following the expiration of applicable time period for review, the Party
proposing such publication shall be free to submit such proposed publication for publication and
publish or otherwise disclose to the public such scientific or clinical results, subject to the
procedures set forth in Section 6.2(b).
(b) If the Party reviewing such publication believes that the subject matter of the proposed
publication by the other Party contains Confidential Information of the Party or a patentable
invention owned by the Party or in which it otherwise has exclusive rights hereunder, then prior to
the expiration of the applicable time period for review, such Party shall notify the Party
proposing such publication in writing of such belief. On receipt of written notice from the other
Party that such proposed publication contains its Confidential Information, the Party
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
proposing publication shall remove such Confidential Information from such proposed
publication prior to any publication thereof, unless the other Party agrees otherwise in writing.
On receipt of written notice from the other Party that such proposed publication contains a
patentable invention owned by it or in which it otherwise has exclusive rights hereunder, the Party
proposing publication shall delay public disclosure of such information or submission of the
proposed publication for an additional period of thirty (30) days to permit preparation and filing
of a patent application on such invention. The Party proposing publication shall thereafter be
free to publish or disclose such information.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
7.1 Mutual Warranties.
Each of Novavax and Company hereby represents, warrants and covenants
to the other as of the Execution Date that:
(a) it has full corporate power and authority to enter into this Agreement and to carry out
the provisions hereof, and this Agreement is legally binding upon it and enforceable in accordance
with its terms.
(b) the execution, delivery and performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party or by which it may
be bound, nor violate any Law of any governmental authority having jurisdiction over it;
(c) it has not granted, and during the Term it will not grant, any right to any Third Party
that would conflict with the rights granted to the other Party hereunder. It has (or will have at
the time performance is due) maintained and will maintain and keep in full force and effect all
agreements necessary to perform its obligations hereunder; and
(d) all necessary consents, approvals and authorizations of all governmental authorities and
other persons required to be obtained by such Party to enter into, or perform its obligations
under, this Agreement have been obtained.
7.2 Representations by Novavax.
In addition to the representations and warranties made in
Section 7.1, Novavax hereby represents, warrants and covenants to Company that:
(a) as of the Execution Date, the Licensed Rights are subsisting and are not the
subject of any interference, re-issue, re-exam, opposition or appeal proceedings;
(b) as of the Execution Date, no Third Party has filed, pursued or maintained or, to
the best of its knowledge, threatened in writing to file, pursue or maintain any claim,
lawsuit, charge or other action involving any Licensed Right including any claim, lawsuit,
charge, or action alleging that any Licensed Right is invalid or unenforceable;
12
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(c) as of the Execution Date and to the best of its knowledge, all employees and agents
of Novavax who have performed any activities on its behalf in connection with research
regarding the Licensed Rights have properly assigned to Novavax the whole of their rights in
any intellectual property made, discovered or developed by them as a result of such
research, and no Third Party has any rights to any such intellectual property;
(d) as of the Effective Date, the Licensed Rights are free and clear of any liens,
charges, encumbrances or rights of others, to possession or use that may interfere with
Novavaxs possession or use under this Agreement;
(e) as of the Effective Date, it has sufficient rights to grant the licenses granted to
the Company hereunder; and
(f) as of the Effective Date, all third party agreements licensing any Licensed Rights
to Novavax, which are sublicensed to the Company hereunder, are currently in full force and
effect, and it has not received notice of material breach or termination thereof.
7.3 DISCLAIMER OF WARRANTIES
. Except as expressly set forth herein, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE
OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the
generality of the foregoing, each Party expressly does not warrant, and disclaims any warranties
with regards to: (a) the success of any study or test commenced under this Agreement, (b) the
safety or usefulness for any purpose of the technology or Materials it provides or discovers under
this Agreement; and/or (c) the validity, enforceability, or non-infringement of any intellectual
property rights or technology it provides or licenses to the other Party under this Agreement.
ARTICLE 8
INDEMNIFICATION
8.1 Indemnification by Company.
Company will indemnify, defend and hold harmless Novavax, its
affiliates, directors, officers and employees (each a
Novavax Indemnitee
) from and against any
and all liability, loss, damage or expense (including without limitation reasonable attorneys fees)
it may suffer as the result of Third Party claims, demands, actions and proceedings brought against
it (collectively,
Losses
) to the extent such Losses result from the (a) negligence or willful
misconduct by Company, its Affiliates, employees, agents, or Third Party contractors, or (b)
manufacture, use, sale, or offer for sale of a Licensed Product in the Territory due to a design
defect or a manufacturing defect, including but not limited to, a Loss related to the death of or
injury to a Third Party. Companys obligation to indemnify Novavax pursuant to this Section 8.1
will not apply to the extent of any Loss that arises from the (i) material breach by Novavax of its
representations, warranties or covenants contained within this Agreement, (ii) negligence or
willful misconduct of any Novavax Indemnitee, or (iii) a manufacturing defect of Licensed Product
supplied by Novavax under the Supply Agreement.
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
8.2 Indemnification by Novavax.
Novavax will indemnify, defend and hold harmless Company,
its affiliates, directors, officers and employees (each a
Company Indemnitee
) from and against
any and all Losses to the extent such Losses result from the (a) negligence or willful misconduct
by Novavax, its Affiliates, employees, agents or Third Party contractors, or (b) manufacture, use,
sale, or offer for sale of a Licensed Product outside the Territory due to a design defect or a
manufacturing defect, including but not limited to, a Loss related to the death of or injury to a
Third Party. Novavaxs obligation to indemnify the Company Indemnitee pursuant to this Section 8.2
will not apply to the extent of any Loss that arises from the (i) material breach by Company of its
representations, warranties or covenants contained within this Agreement or (ii) negligence or
willful misconduct of any Company Indemnitee.
8.3 Procedures.
Indemnitors agreement to indemnify, defend and hold harmless an Indemnitee
is conditioned on Indemnitee (a) providing prompt written notice of any claim giving rise to an
indemnification obligation hereunder but only if a failure to so notify causes prejudicial harm to
the Indemnitors ability to defend, (b) permitting Indemnitor to assume full responsibility to
investigate, prepare for and defend against any such claim, (c) providing reasonable assistance in
the defense of such claim at Indemnitors reasonable expense, and (d) not compromising or settling
such claim without Indemnitors advance written consent.
8.4 Insurance.
Each Party will maintain comprehensive general liability insurance coverage,
including products liability, in amounts it reasonably determines are appropriate with respect to
the Development and Commercialization of Licensed Products in its respective territory.
8.5 Limitation of Liability.
EXCEPT TO THE EXTENT (A) SUCH PARTY MAY BE REQUIRED TO
INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 8, OR (B) AS REGARDS A BREACH OF A PARTYS
RESPONSIBILITIES PURSUANT TO ARTICLE 6, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES WILL BE LIABLE
TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR
ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS
AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.
ARTICLE 9
TERM; BREACH
9.1 Term and Termination.
The term of this Agreement will commence on the Execution Date and
will continue until (a) the Company provides sixty (60) days prior written notice of termination to
Novavax, (b) the Parties mutually agree in writing to terminate the Agreement, or (c) Novavax
terminates the Joint Venture Agreement by providing a Notice of Termination under and pursuant to
Section 11.2 of the Joint Venture Agreement. In no event shall either Party have the right to
terminate this Agreement based upon any breach by the other Party, and to the extent that any right
to terminate is provided under any Laws, the Parties hereby waive such right.
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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
9.2 Breach and Remedies.
In addition to any remedies available under any laws, the following
remedies shall be available to a party in the event of the following breaches
(a) In the event that Section 2.6 is materially breached by either party, the non-breaching
party shall be entitled to damages equal to its lost profit from lost sales of Licensed Products in
or out of the Territory (as applicable) due to the grey market breach.
(b) In the event that Company (i) materially alters a Seasonal Development Plan or Seasonal
Commercialization Plan for Seasonal Influenza Licensed Product without Novavaxs prior written
consent, or (ii) initiates a clinical trial of Seasonal Influenza Licensed Product without
Novavaxs approval or materially deviates from an approved clinical trial protocol for Seasonal
Influenza Licensed Product without the prior written consent of Novavax, then Novavax shall have
right to obtain injunctive relief with respect to such breach before any court of competent
jurisdiction in accordance with Section 10.3.
9.3 Survival.
The following provisions of this Agreement shall survive expiration or
termination of this Agreement for any reason: Article 8 and Sections 6.1 and 7.3. In the event
that this Agreement is terminated under 9.1(c), the license grant under Section 2.2 shall survive
as a fully paid, exclusive license solely under Developed Know-how owned or Controlled by Company,
including any Patents that issue therefrom, as of the effective date of termination (i.e.,
excluding any intellectual property developed or acquired after such date of termination).
ARTICLE 10
DISPUTE RESOLUTION
10.1 Disputes.
The Parties recognize that disputes as to certain matters may from time to
time arise during the Term which relate to either Partys rights and/or obligations hereunder. It
is the objective of the Parties to establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in
this Article 10 if and when a dispute arises under this Agreement.
10.2 Arbitration.
Any dispute arising between the Parties out of or in connection with the
implementation or interpretation of this Agreement shall, if not settled amicably within ninety
(90) days from the date that the dispute arose, be finally settled by three (3) arbitrators. Each
Party shall be entitled to appoint one (1) arbitrator and the two (2) so appointed shall appoint
the third arbitrator in accordance with the Indian Arbitration and Conciliation Act, 1996. It is
hereby agreed that Part I of the Indian Arbitration and Conciliation Act, 1996 (except for the
provisions of Section 9 thereof) shall not apply to the arbitration under this Agreement. The
language of the arbitration proceedings shall be English and its place shall be Singapore. The
arbitral award or determination shall be final and subject to no appeal and shall deal with the
question of costs of arbitration and all matters related thereto.
The Parties agree that it would be impossible or inadequate to measure and calculate their damages
from any breach of the Agreement though great and irreparable. Accordingly, each Party agrees
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that if the other Party breaches this Agreement, the non-breaching party will have available, in
addition to any other right or remedy available, the right to obtain an injunction from a court of
competent jurisdiction restraining such breach or threatened breach and specific performance of any
provision of this Agreement.
10.3 Equitable Claims.
Notwithstanding anything to the contrary in this Article 10, either
Party has the right to seek temporary injunctive relief or any other interim equitable remedy in
any court of competent jurisdiction as may be available to such Party under the laws applicable to
such jurisdiction that may be necessary to protect the rights or property of that Party until such
time as any dispute underlying such temporary injunctive relief or any other interim equitable
remedy has been resolved in accordance with Section 10.2.
10.4 Governing Law.
The substantive laws of India will govern the resolution of all disputes,
controversies and claims under, arising out of or relating to the validity, construction,
enforceability or performance of this Agreement and any related remedies, without giving effect to
any choice of law rules.
10.5 Award.
Each Party will abide by any arbitral award rendered pursuant to this Article 10.
If a Party resists enforcement of an arbitral award, any costs, fees or taxes incident to
enforcement will be charged against that Party to the extent permitted by Law. Each Party will
bear its own legal fees for arbitration, and the arbitrator(s) will assess their costs, fees and
expenses against the Party losing the arbitration.
10.6 Injunctive Relief.
If a Party makes a sufficient showing under the rules and standards
set forth in the rules of civil procedure and applicable Law, the arbitrator may, and the Parties
will abide by, injunctive measures after either Party submits in writing for arbitration claims
requiring immediate relief. Notwithstanding the foregoing, and in accordance with Section 10.3, a
Party will also be free at any time to bring an Equitable Claim to any court of competent
jurisdiction without submitting such request to an arbitrator.
10.7 Confidentiality.
Any arbitration proceeding, including without limitation the existence
of any dispute submitted to arbitration and any arbitral award or decision, will be Confidential
Information of both Parties, and the arbitrator(s) will issue appropriate protective orders to
safeguard each Partys Confidential Information, provided that such Confidential Information may be
disclosed solely as necessary in connection with the enforcement of an arbitral award or as
otherwise required by Law (subject to Section 6.3).
ARTICLE 11
MISCELLANEOUS
11.1 Entire Agreement.
This Agreement (including its Exhibits) sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings between the
Parties with respect to the subject matter hereof and supersedes and terminates all prior
agreements and understanding between the Parties with respect to such subject matter. No
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EXCHANGE COMMISSION.
subsequent alteration, amendment, change or addition to this Agreement will be binding upon
the Parties unless reduced to writing and signed by the respective authorized officers of the
Parties.
11.2 Third Party Contractors.
The Parties will perform their obligations under this Agreement
as Third Party contractors and nothing contained in this Agreement will be construed to be
inconsistent with such relationship or status. This Agreement will not constitute, create or in
any way be interpreted as a joint venture or partnership of any kind.
11.3 Notices.
Any notice, request, demand, waiver, consent, approval or other communication
permitted or required under this Agreement (
Notice
) will be in writing, will refer specifically
to this Agreement and will be deemed given only if sent by electronic mail (with receipt
confirmed), facsimile transmission (with transmission confirmed) or by an internationally
recognized delivery service that maintains records of delivery, addressed to the Parties at their
respective addresses specified in this Section 11.3 or to such other address as the Party to whom
notice is to be given may have provided to the other Party in accordance with this Section 11.3.
Any notice delivered by electronic mail or facsimile will be confirmed by a hard copy delivered as
soon as practicable thereafter by an internationally recognized overnight delivery service. Such
Notice will be deemed to have been given on the second Business Day (at the place of delivery)
after deposit with an internationally recognized delivery service. This Section 11.3 is not
intended to govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
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If to Novavax:
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Novavax, Inc.
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9920 Belaward Campus Drive
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Rockville Maryland 20850
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Attn: Ray Hage, Senior Vice President
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Email: Rhage@Novavax.com
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Facsimile No.: 240-268-2122
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If to Company:
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CPL Biologicals Limited
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Cadila Corporate Campus
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Sarkhej-Dholka Road
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Bhat, Ahmedabad 382210
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Gujarat, India
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Attn: Dr. Rajiv I. Modi, Managing Director
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Email: rimodi@cadilapharma.co.in
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Facsimile No.: +91 (02718) 225031
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11.4 Assignment.
(a) Novavax may not assign this Agreement, in whole or in part, without the advance written
consent of the Company; provided, however, that this Agreement shall be automatically assigned to
Novavaxs successor in connection with the acquisition, merger or sale of Novavax or the sale,
transfer, lease, assignment or disposal of all or substantially all of the
17
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
property or assets of Novavax, whether by way of a single transaction or a series of related
transactions, and such successor shall be fully bound by the terms and conditions hereof.
(b) The Company may not assign this Agreement, in whole or in part, without the advance
written consent of Novavax; provided, however, that this Agreement shall be automatically assigned
to the Companys successor in connection with the sale, transfer, lease, assignment or disposal of
all or substantially all of the property or assets of the Company , whether by way of a single
transaction or a series of related transactions, including a Change in Control of the Company (as
that term is defined in Schedule II of the Joint Venture Agreement), and such successor shall be
fully bound by the terms and conditions hereof; provided that any such automatic assignment by
Company within the scope of Schedule II of the Joint Venture Agreement shall only be effective if
such transaction was approved by Novavax under and pursuant to the Joint Venture Agreement for so
long as such approval rights of Novavax under the Joint Venture Agreement have not been terminated.
(c) Any assignment or purported assignment by either Party in violation of this Section 11.4
will be null and void.
11.5 Force Majeure.
Both Parties will be excused from the performance of their obligations
under this Agreement (except for the obligation to pay money) to the extent that such performance
is prevented by force majeure and the nonperforming Party promptly provides notice of the
prevention to the other Party. Such excuse will be continued so long as the condition constituting
force majeure continues and the nonperforming Party takes reasonable efforts to remove the
condition. For purposes of this Agreement, force majeure will include conditions beyond the
control of the Parties, including without limitation, an act of God, voluntary or involuntary
compliance with any regulation, Law or order of any government, war, civil commotion, labor strike
or lock-out, acts of terrorism, epidemic, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake, storm or like
catastrophe.
11.6 Headings.
The headings for each article and section in this Agreement have been inserted
for convenience of reference only and are not intended to limit or expand on the meaning of the
language contained in the particular article or section.
11.7 No Strict Construction.
This Agreement has been prepared jointly and will not be
strictly construed against either Party.
11.8 Ambiguities.
Ambiguities and uncertainties in this Agreement, if any, will not be
interpreted against either Party, irrespective of which Party may be deemed to have caused the
ambiguity or uncertainty to exist.
11.9 English Language.
All notices required or permitted to be given hereunder, and all
written, electronic, oral or other communications between the Parties regarding this Agreement will
be in the English language. This Agreement is in the English language only, which language will be
controlling in all respects, and all versions hereof in any other language will be for
accommodation only and will not be binding upon the Parties.
18
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
11.10 No Waiver.
Any delay in enforcing a Partys rights under this Agreement or any waiver
as to a particular default or other matter will not constitute a waiver of such Partys rights to
the future enforcement of its rights under this Agreement, excepting only as to an express written
and signed waiver as to a particular matter for a particular period of time.
11.11 Severability.
If one or more of the provisions in this Agreement are deemed
unenforceable by Law, then such provision will be deemed stricken from this Agreement and the
remaining provisions will continue in full force and effect and shall be interpreted to give full
effect to the commercial agreement between the Parties.
11.12 Counterparts.
This Agreement may be executed in one or more identical counterparts,
each of which will be deemed to be an original, and which collectively will be deemed to be one and
the same instrument.
[Signature Page to Follow]
19
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
In Witness Whereof,
the Parties have by duly authorized persons executed this License
Agreement as of the Execution Date.
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Novavax, Inc.
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CPL Biologicals Limited
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By:
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/s/ Rahul Singhvi
Rahul Singhvi
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By:
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/s/ Rajiv I. Modi
Rajiv I. Modi
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President and CEO
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Managing Director
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[Signature Page to Seasonal / Other License Agreement]
Exhibit 10.8
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
OPTION TO OBTAIN LICENSE
This Option Agreement
(the
Agreement
) is effective this March 31, 2009 (the
Effective Date
), by and between
Novavax, Inc.
, a Delaware corporation having an address
at 9920 Belward Campus Drive, Rockville, Maryland 20850, United States of America (
Novavax
)
and
CPL Biologicals Limited
, a limited company incorporated under the laws of India having
an address at Cadila Corporate Campus, Sarkhej-Dholka Road, Bhat, Ahmedabad 382210, Gujarat,
India
(
Company
).
Novavax and Company are sometimes referred to herein each individually
as a Party and collectively as the Parties.
RECITALS
Whereas,
Novavax is a specialty biopharmaceutical company engaged in the research,
development and commercialization of its virus like particle technology into vaccine products for
the prevention of infectious diseases such as influenza and other infectious diseases;
Whereas,
Company wishes to obtain an option to obtain a license to Novavaxs pandemic
influenza vaccine product when and if the same comes under the Control of Novavax in the Territory;
and
Whereas,
Novavax is willing to grant such option as partial consideration for shares
of Company in accordance with the Joint Venture Agreement.
Now, Therefore,
in consideration of the foregoing premises and the mutual covenants
set forth below, and for other good and valuable consideration, the receipt of which is hereby
acknowledged, Novavax and Company hereby agree as follows:
ARTICLE 1
DEFINITIONS
References in the body of this Agreement to Sections will refer to the sections of this
Agreement. In addition, as used herein, the following initially capitalized terms will have the
following meanings:
1.1 Affiliate
means any corporation or other business entity controlled by, controlling, or
under common control with a Party, with
control
(for purposes of this Section 1.1 only) meaning
(a) direct or indirect beneficial ownership of fifty percent (50%) or more of the voting stock (or,
in the case of a non-corporate entity, of the equity interests with the power to direct the
management and policies) of such corporation or other business entity, or (b) possession, directly
or indirectly, of the power to direct, or cause the direction of, the management and policies of
such corporation or other business entity, whether through the ownership of voting securities, by
contract, or otherwise; provided that for purposes of this Agreement, Novavax and Cadila
Pharmaceuticals Limited shall not be deemed to be an Affiliate of Company.
1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
1.2 Business Day
means any day other than a Saturday, Sunday or other day on which the
principal commercial banks located in Mumbai, India and Washington, DC, United States are not open
for business during normal business hours.
1.3 Control
means, with respect to any intellectual property right, that a Party owns or has
a license to such item or right, and has the ability to grant a license or sublicense in or to such
right without violating the terms of any agreement or other arrangement with any Third Party
existing at the time that this Agreement first requires such Party to grant the other Party such
license or sublicense, provided that, for the avoidance of doubt, if the ability to grant such
license or sublicense without violating the terms of any such agreement or other arrangement arises
after such time, the license or sublicense shall be deemed granted hereunder at such later date.
1.4 Joint Venture Agreement
means the Joint Venture Agreement by and between Novavax and
Cadila Pharmaceuticals Limited, dated March 31, 2009.
1.5 Know-How
means all tangible and intangible (a) techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods, protocols, processes, formulas,
knowledge, know-how, skill, experience, records, documents, data and results (including
pharmacological, toxicological, non-clinical and clinical test data and results), analytical and
quality control data, results or descriptions, software and algorithms and (b) compositions of
matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
1.6 Laws
means all applicable laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any federal, national, multinational, state, provincial,
or other political subdivision, domestic or foreign.
1.7 Licensed Product
means Novavaxs current intra-muscular pandemic influenza vaccine
containing a virus like particle (VLP) consisting of an avian influenza M1 protein or influenza M1
protein containing an avian influenza M1 L-domain sequence and a pandemic influenza HA and pandemic
influenza NA described in the U.S. IND No. BB-IND 13419 wherein the pandemic HA and pandemic NA
under the IND are classified as pandemic by the World Health Organization (WHO) Collaborating
Centers for Reference and Research on Influenza located at the Centers for Disease Control and
Prevention (CDC) in Atlanta, Georgia, together with any minor modifications thereto including, by
way of example but not limitation, changes to any excipient, changes arising from a change in
manufacturing process, or change in dosage. [* * *] Licensed Product shall include the pandemic
influenza vaccine containing a virus like particle (VLP) consisting of an avian influenza M1
protein or an influenza M1 protein containing an avian influenza M1 L-domain sequence and a
pandemic influenza HA and pandemic influenza NA that is launched by or for Novavax for commercial
sale in the United States after Regulatory Approval of such vaccine; ; it being understood that for
so long as (but only for so long as) such vaccine is being developed in clinical trials by or for
Novavax in support for commercial launch in the United States, such vaccine shall be deemed a
Licensed Product hereunder prior to commercial launch (for the purpose of allowing the Company to
develop and launch such product in the Territory in accordance with the terms and conditions of
this Agreement promptly following its launch by Novavax in the United States).
2
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
1.8 Licensed Rights
means the Novavax Patents and any and all Know-How, including any
Developed Know-How, owned or Controlled by Novavax at any time during the term of this Agreement
which is used or embodied in, or useful for developing or manufacturing, any Licensed Product.
1.9 Novavax Patents
means any and all Patents in the Territory owned or Controlled by
Novavax at any time during the term of this Agreement covering or claiming a Licensed Product
and/or the manufacture or use thereof including, without limitation, the Patents listed on
Schedule 1
.
1.10 Patent
means any and all (a) issued patents and inventors certificates and
re-examinations, reissues, renewals, extensions, registrations, substitutions, supplementary
protection certificates and term restorations with respect to any of the foregoing, and (b) pending
applications for patents and inventors certificates and patents that issue therefrom, including,
without limitation, provisional applications, continuations, continuations in part, divisional and
substitute applications with respect to any of the foregoing.
1.11 Territory
means India.
1.12 Third Party
means a person or entity other than (a) Novavax, (b) Company, (c) an
Affiliate of Novavax or (d) an Affiliate of Company.
ARTICLE 2
OPTION
2.1 Option Grant to Company.
Novavax hereby grants to Company an exclusive, fully paid-up,
royalty-free (except as expressly provided in the License Agreement) non-transferable, right and
option to obtain an exclusive license in the Territory (the Option) under the form of License
Agreement attached hereto as Exhibit A that has been executed by Novavax, exercisable at Companys
option and sole discretion, upon the later of (a) the approval of the Foreign Investment Promotion
Board for the issuance to Novavax of 120,000,000 shares of Company and (b) the earlier of
termination or expiration (the
Exercise Trigger Date
) of the Third Party agreement to which a
portion of the technology that is the subject of the License Agreement is subject. Novavax shall
promptly provide notice to Company upon occurrence of the Exercise Trigger Date having been met
together with reasonable documentation establishing that the Exercise Trigger Date has been met
(the
Trigger Notice
)
2.2 Exercise of Option.
At any time after the Exercise Trigger Date for two (2) years of
Company having received the Trigger Notice, Company may exercise the Option by sending a written
notice to Novavax, along with a fully executed copy of such License Agreement.
2.3 Effectiveness of License.
Immediately upon receipt of the signed Notice and fully
executed License by Novavax, the License Agreement shall become immediately and automatically
effective as of such date.
3
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
2.4 No Implied Rights or Licenses.
No right or license, other than those expressly set forth
in this Agreement, are granted to either party hereunder, and no additional rights will be deemed
granted to either party by implication, estoppel or otherwise. All rights not expressly granted by
either party to the other hereunder are reserved.
ARTICLE 3
CONFIDENTIALITY
The Parties anticipate that under this Agreement each Party will provide confidential and/or
proprietary information to the other Party and that the use and disclosure of such information
shall be governed by Article 18 of the Joint Venture Agreement which is hereby incorporated by
reference.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES
4.1 Mutual Warranties.
Each of Novavax and Company hereby represents, warrants and covenants
to the other as of the Effective Date that:
(a) it has full corporate power and authority to enter into this Agreement and to carry out
the provisions hereof, and this Agreement is legally binding upon it and enforceable in accordance
with its terms.
(b) the execution, delivery and performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party or by which it may
be bound, nor violate any Law of any governmental authority having jurisdiction over it; and
(c) all necessary consents, approvals and authorizations of all governmental authorities and
other persons required to be obtained by such Party to enter into, or perform its obligations
under, this Agreement have been obtained.
4.2 Representations by Novavax.
In addition to the representations and warranties made in
Section 4.1, Novavax hereby represents, warrants and covenants to Company that:
(a) as of the Effective Date, the Licensed Rights are subsisting and are not the
subject of any interference, re-issue, re-exam, opposition or appeal proceedings;
(b) as of the Effective Date and the Exercise Trigger Date, no Third Party has or will
have filed, pursued or maintained or, to the best of its knowledge, threatened in writing to
file, pursue or maintain any claim, lawsuit, charge or other action involving any Licensed
Right including any claim, lawsuit, charge, or action alleging that any Licensed Right is
invalid or unenforceable;
4
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(c) as of the Effective Date and to the best of its knowledge, all employees and agents
of Novavax who have performed any activities on its behalf in connection with research
regarding the Licensed Rights have properly assigned to Novavax the whole of their rights in
any intellectual property made, discovered or developed by them as a result of such
research, and no Third Party has any rights to any such intellectual property;
(d) as of the Exercise Trigger Date, the Licensed Rights will be free and clear of any
liens, charges, encumbrances or rights of others, to possession or use that may interfere
with Novavaxs possession or use under this Agreement;
(e) as of the Exercise Trigger Date, it will have sufficient rights to grant the
licenses granted to the Company hereunder;
(f) as of the Effective Date and the Exercise Trigger Date, it has not granted, and
during the Term it will not grant, any right to any Third Party that would conflict with the
rights granted to the other Party hereunder. It has (or will have at the time performance
is due) maintained and will maintain and keep in full force and effect all agreements
necessary to perform its obligations hereunder; and
(g) as of the Effective Date and the Exercise Trigger Date, all third party agreements
licensing any Licensed Rights to Novavax, which are sublicensed to the Company hereunder,
are currently in full force and effect, and it has not received notice of material breach or
termination thereof.
4.3 DISCLAIMER OF WARRANTIES
. Except as expressly set forth herein, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE
OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the
generality of the foregoing, each Party expressly does not warrant, and disclaims any warranties
with regards to: (a) the success of any study or test commenced under this Agreement, (b) the
safety or usefulness for any purpose of the technology or Materials it provides or discovers under
this Agreement; and/or (c) the validity, enforceability, or non-infringement of any intellectual
property rights or technology it provides or licenses to the other Party under this Agreement.
ARTICLE 5
INDEMNIFICATION
5.1 Indemnification by Novavax.
Novavax will indemnify, defend and hold harmless Company, its
Affiliates, directors, officers and employees (each a
Company Indemnitee
) from and against any
and all liability, loss, damage or expense (including without limitation reasonable attorneys fees)
it may suffer as the result of Third Party claims, demands, actions and proceedings brought against
it (collectively,
Losses
) to the extent such Losses result from the negligence or willful
misconduct by Novavax, its Affiliates, employees, agents or Third Party contractors.
5
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Novavaxs obligation to indemnify the Company Indemnitee pursuant to this Section 5.1 will not
apply to the extent of any Loss that arises from the (i) material breach by Company of its
representations, warranties or covenants contained within this Agreement or (ii) negligence or
willful misconduct of any Company Indemnitee.
5.2 Procedures.
Indemnitors agreement to indemnify, defend and hold harmless an Indemnitee
is conditioned on Indemnitee (a) providing prompt written notice of any claim giving rise to an
indemnification obligation hereunder but only if a failure to so notify causes prejudicial harm to
the Indemnitors ability to defend, (b) permitting Indemnitor to assume full responsibility to
investigate, prepare for and defend against any such claim, (c) providing reasonable assistance in
the defense of such claim at Indemnitors reasonable expense, and (d) not compromising or settling
such claim without Indemnitors advance written consent.
5.3 Limitation of Liability.
EXCEPT AS REGARDS A BREACH OF A PARTYS
RESPONSIBILITIES PURSUANT TO ARTICLE 3, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES WILL BE LIABLE
TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR
ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS
AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.
ARTICLE 6
TERM
6.1 Term and Termination.
The term of this Agreement will commence on the Effective Date and
will continue until (a) expiration of the Option as provided in Section 2.2, (b) the Parties
mutually agree in writing to terminate the Agreement, or (c) Novavax terminates the Joint Venture
Agreement by providing a Notice of Termination under and pursuant to Section 11.2 of the Joint
Venture Agreement (the
Term
).
ARTICLE 7
DISPUTE RESOLUTION
7.1 Disputes.
The Parties recognize that disputes as to certain matters may from time to time
arise during the Term which relate to either Partys rights and/or obligations hereunder. It is
the objective of the Parties to establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in
this Article 7 if and when a dispute arises under this Agreement.
7.2 Arbitration.
Any dispute arising between the Parties out of or in connection with the
implementation or interpretation of this Agreement shall, if not settled amicably within ninety
(90) days from the date that the dispute arose, be finally settled by three (3) arbitrators. Each
Party
6
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
shall be entitled to appoint one (1) arbitrator and the two (2) so appointed shall appoint the
third arbitrator in accordance with the Indian Arbitration and Conciliation Act, 1996. It is
hereby agreed that Part I of the Indian Arbitration and Conciliation Act, 1996 (except for the
provisions of Section 9 thereof) shall not apply to the arbitration under this Agreement. The
language of the arbitration proceedings shall be English and its place shall be Singapore. The
arbitral award or determination shall be final and subject to no appeal and shall deal with the
question of costs of arbitration and all matters related thereto.
7.3 Equitable Claims.
Notwithstanding anything to the contrary in this Article 7, either
Party has the right to seek temporary injunctive relief or any other interim equitable remedy in
any court of competent jurisdiction as may be available to such Party under the laws applicable to
such jurisdiction that may be necessary to protect the rights or property of that Party until such
time as any dispute underlying such temporary injunctive relief or any other interim equitable
remedy has been resolved in accordance with Section 7.2.
7.4 Governing Law.
The substantive laws of India will govern the resolution of all disputes,
controversies and claims under, arising out of or relating to the validity, construction,
enforceability or performance of this Agreement and any related remedies, without giving effect to
any choice of law rules.
7.5 Award.
Each Party will abide by any arbitral award rendered pursuant to this Article 7.
If a Party resists enforcement of an arbitral award, any costs, fees or taxes incident to
enforcement will be charged against that Party to the extent permitted by Law. Each Party will
bear its own legal fees for arbitration, and the arbitrator(s) will assess their costs, fees and
expenses against the Party losing the arbitration.
7.6 Injunctive Relief.
If a Party makes a sufficient showing under the rules and standards
set forth in the rules of civil procedure and applicable Law, the arbitrator may, and the Parties
will abide by, injunctive measures after either Party submits in writing for arbitration claims
requiring immediate relief. Notwithstanding the foregoing, and in accordance with Section 7.3, a
Party will also be free at any time to bring an Equitable Claim to any court of competent
jurisdiction without submitting such request to an arbitrator.
7.7 Confidentiality.
Any arbitration proceeding, including without limitation the existence
of any dispute submitted to arbitration and any arbitral award or decision, will be Confidential
Information of both Parties, and the arbitrator(s) will issue appropriate protective orders to
safeguard each Partys Confidential Information, provided that such Confidential Information may be
disclosed solely as necessary in connection with the enforcement of an arbitral award or as
otherwise required by Law (subject to Section 7.3).
ARTICLE 8
MISCELLANEOUS
8.1 Entire Agreement.
This Agreement (including its Exhibits) sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings
7
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
between the Parties with respect to the subject matter hereof and supersedes and terminates
all prior agreements and understanding between the Parties with respect to such subject matter. No
subsequent alteration, amendment, change or addition to this Agreement will be binding upon the
Parties unless reduced to writing and signed by the respective authorized officers of the Parties.
8.2 Third Party Contractors.
The Parties will perform their obligations under this Agreement
as Third Party contractors and nothing contained in this Agreement will be construed to be
inconsistent with such relationship or status. This Agreement will not constitute, create or in
any way be interpreted as a joint venture or partnership of any kind.
8.3 Notices.
Any notice, request, demand, waiver, consent, approval or other communication
permitted or required under this Agreement (
Notice
) will be in writing, will refer specifically
to this Agreement and will be deemed given only if sent by electronic mail (with receipt
confirmed), facsimile transmission (with transmission confirmed) or by an internationally
recognized delivery service that maintains records of delivery, addressed to the Parties at their
respective addresses specified in this Section 8.3 or to such other address as the Party to whom
notice is to be given may have provided to the other Party in accordance with this Section 8.3.
Any notice delivered by electronic mail or facsimile will be confirmed by a hard copy delivered as
soon as practicable thereafter by an internationally recognized overnight delivery service. Such
Notice will be deemed to have been given on the second Business Day (at the place of delivery)
after deposit with an internationally recognized delivery service. This Section 8.3 is not
intended to govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
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|
If to Novavax:
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|
Novavax, Inc.
|
|
|
9920 Belaward Campus Drive
|
|
|
Rockville Maryland 20850
|
|
|
Attn: Ray Hage, Senior Vice President
|
|
|
Email: Rhage@Novavax.com
|
|
|
Facsimile No.: 240-268-2122
|
|
|
|
If to Company:
|
|
CPL Biologicals Limited
|
|
|
Cadila Corporate Campus
|
|
|
Sarkhej-Dholka Road
|
|
|
Bhat, Ahmedabad 382210
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|
|
Gujarat, India
|
|
|
Attn: Dr. Rajiv I. Modi, Managing Director
|
|
|
Email: rimodi@cadilapharma.co.in
|
|
|
Facsimile No.: +91 (02718) 225031
|
8.4 Assignment.
(a) Novavax may not assign this Agreement, in whole or in part, without the advance written
consent of the Company; provided, however, that this Agreement shall be automatically assigned to
Novavaxs successor in connection with the acquisition, merger or sale of Novavax or the sale,
transfer, lease, assignment or disposal of all or substantially all of the
8
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
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property or assets of Novavax, whether by way of a single transaction or a series of related
transactions, and such successor shall be fully bound by the terms and conditions hereof.
(b) The Company may not assign this Agreement, in whole or in part, without the advance
written consent of Novavax; provided, however, that this Agreement shall be automatically assigned
to the Companys successor in connection with the sale, transfer, lease, assignment or disposal of
all or substantially all of the property or assets of the Company , whether by way of a single
transaction or a series of related transactions, including a Change in Control of the Company (as
that term is defined in Schedule II of the Joint Venture Agreement), and such successor shall be
fully bound by the terms and conditions hereof; provided that any such automatic assignment by
Company within the scope of Schedule II of the Joint Venture Agreement shall only be effective if
such transaction was approved by Novavax under and pursuant to the Joint Venture Agreement for so
long as such approval rights of Novavax under the Joint Venture Agreement have not been terminated.
(c) Any assignment or purported assignment by either Party in violation of this Section 8.4
will be null and void.
8.5 Headings.
The headings for each article and section in this Agreement have been inserted
for convenience of reference only and are not intended to limit or expand on the meaning of the
language contained in the particular article or section.
8.6 No Strict Construction.
This Agreement has been prepared jointly and will not be strictly
construed against either Party.
8.7 Ambiguities.
Ambiguities and uncertainties in this Agreement, if any, will not be
interpreted against either Party, irrespective of which Party may be deemed to have caused the
ambiguity or uncertainty to exist.
8.8 English Language.
All notices required or permitted to be given hereunder, and all
written, electronic, oral or other communications between the Parties regarding this Agreement will
be in the English language. This Agreement is in the English language only, which language will be
controlling in all respects, and all versions hereof in any other language will be for
accommodation only and will not be binding upon the Parties.
8.9 No Waiver.
Any delay in enforcing a Partys rights under this Agreement or any waiver as
to a particular default or other matter will not constitute a waiver of such Partys rights to the
future enforcement of its rights under this Agreement, excepting only as to an express written and
signed waiver as to a particular matter for a particular period of time.
8.10 Severability.
If one or more of the provisions in this Agreement are deemed
unenforceable by Law, then such provision will be deemed stricken from this Agreement and the
remaining provisions will continue in full force and effect and shall be interpreted to give full
effect to the commercial agreement between the Parties.
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8.11 Counterparts.
This Agreement may be executed in one or more identical counterparts, each
of which will be deemed to be an original, and which collectively will be deemed to be one and the
same instrument.
[Signature Page to Follow]
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In Witness Whereof,
the Parties have by duly authorized persons executed this License
Agreement as of the Effective Date.
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Novavax, Inc.
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CPL Biologicals Limited
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By:
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/s/ Rahul Singhvi
Rahul Singhvi
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By:
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/s/ Rajiv I. Modi
Rajiv I. Modi
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President and Chief Executive Officer
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Managing Director
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[Signature Page to License Agreement]
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Exhibit A
Form of License Agreement executed by Novavax
LICENSE AGREEMENT
This License Agreement
(the
Agreement
) is executed this March 31, 2009 (the
Execution Date
), to be effective as set forth in Article 4, by and between
Novavax,
Inc.
, a Delaware corporation having an address at 9920 Belward Campus Drive, Rockville,
Maryland 20850, United States of America (
Novavax
) and
CPL Biologicals Limited
, a
limited company incorporated under the laws of India having an address at Cadila Corporate
Campus, Sarkhej-Dholka Road, Bhat, Ahmedabad 382210, Gujarat, India
(
Company
).
Novavax and Company are sometimes referred to herein each individually as a Party and
collectively as the Parties.
RECITALS
Whereas,
Novavax is a specialty biopharmaceutical company engaged in the research,
development and commercialization of its virus like particle technology into vaccine products for
the prevention of infectious diseases such as influenza and other infectious diseases;
Whereas,
on the Effective Date, Novavax will Control the Licensed Rights, as defined
below;
Whereas,
Company wishes to obtain a license as of the Effective Date under the
Licensed Rights, to practice the processes included or claimed in the Licensed Rights and to
Develop and Commercialize Licensed Product; and
Whereas,
Novavax is willing to grant such license on the terms and conditions of this
Agreement.
Now, Therefore,
in consideration of the foregoing premises and the mutual covenants
set forth below, and for other good and valuable consideration, the receipt of which is hereby
acknowledged, Novavax and Company hereby agree as follows:
ARTICLE 1
DEFINITIONS
References in the body of this Agreement to Sections will refer to the sections of this
Agreement. In addition, as used herein, the following initially capitalized terms will have the
following meanings:
1.1 Affiliate
means any corporation or other business entity controlled by, controlling, or
under common control with a Party, with
control
(for purposes of this Section 1.1 only) meaning
(a) direct or indirect beneficial ownership of fifty percent (50%) or more of the
1
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voting stock (or, in the case of a non-corporate entity, of the equity interests with the
power to direct the management and policies) of such corporation or other business entity, or (b)
possession, directly or indirectly, of the power to direct, or cause the direction of, the
management and policies of such corporation or other business entity, whether through the ownership
of voting securities, by contract, or otherwise; provided that for purposes of this Agreement,
Novavax and Cadila Pharmaceuticals Limited shall not be deemed to be an Affiliate of Company.
1.2 Business Day
means any day other than a Saturday, Sunday or other day on which the
principal commercial banks located in Mumbai, India and Washington, DC, United States are not open
for business during normal business hours.
1.3 Commercialize or Commercialization
means all activities that are undertaken to prepare
for launch before Regulatory Approval (including pricing and reimbursement approvals) undertaken
after Regulatory Approval for a particular Licensed Product and that relate to the commercial
marketing and sale of such Licensed Product including advertising, sales, marketing, promotion,
distribution, and phase IV clinical trials.
1.4 Control
means, with respect to any intellectual property right, that a Party owns or has
a license to such item or right, and has the ability to grant a license or sublicense in or to such
right without violating the terms of any agreement or other arrangement with any Third Party
existing at the time that this Agreement first requires such Party to grant the other Party such
license or sublicense, provided that, for the avoidance of doubt, if the ability to grant such
license or sublicense without violating the terms of any such agreement or other arrangement arises
after such time, the license or sublicense shall be deemed granted hereunder at such later date.
1.5 Develop or Development
means the performance of all non-clinical, pre-clinical and
clinical development, manufacturing and regulatory activities for a Licensed Product that are
required to obtain Regulatory Approval of a Licensed Product in the Territory.
1.6 Developed Know-How
has the meaning in Section 5.1.
1.7 Effective Date
means the date on which the condition precedent set forth in Article 4 is
first satisfied.
1.8 Governmental Authority
means any applicable court, agency, department or other
instrumentality of any foreign, federal, state, county, city or other political subdivision.
1.9 IND
means a U.S. Food and Drug Administration investigational new drug application, or
its foreign equivalent.
1.10 Joint Venture Agreement
means the Joint Venture Agreement by and between Novavax and
Cadila Pharmaceuticals Limited, dated March 31, 2009.
1.11 Know-How
means all tangible and intangible (a) techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods, protocols, processes, formulas,
knowledge, know-how, skill, experience, records, documents, data and results
2
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(including pharmacological, toxicological, non-clinical and clinical test data and results),
analytical and quality control data, results or descriptions, software and algorithms and
(b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or
chemical material.
1.12 Laws
means all applicable laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any federal, national, multinational, state, provincial,
or other political subdivision, domestic or foreign.
1.13 Licensed Product
means Novavaxs current intra-muscular pandemic influenza vaccine
containing a virus like particle (VLP) consisting of an avian influenza M1 protein or an influenza
M1 protein containing an avian influenza M1 L-domain sequence and a pandemic influenza HA and
pandemic influenza NA described in the U.S. IND No. BB-IND 13419 wherein the pandemic HA and
pandemic NA under the IND are classified as pandemic by the World Health Organization (WHO)
Collaborating Centers for Reference and Research on Influenza located at the Centers for Disease
Control and Prevention (CDC) in Atlanta, Georgia, together with any minor modifications thereto
including, by way of example but not limitation, changes to any excipient, changes arising from a
change in manufacturing process, or change in dosage. [* * *] Licensed Product shall include the
pandemic influenza vaccine containing a virus like particle (VLP) consisting of an avian influenza
M1 protein or an influenza M1 protein containing an avian influenza M1 L-domain sequence and a
pandemic influenza HA and pandemic influenza NA that is launched by or for Novavax for commercial
sale in the United States after Regulatory Approval of such vaccine; it being understood that for
so long as (but only for so long as) such vaccine is being developed in clinical trials by or for
Novavax in support for commercial launch in the United States, such vaccine shall be deemed a
Licensed Product hereunder prior to commercial launch (for the purpose of allowing the Company to
develop and launch such product in the Territory in accordance with the terms and conditions of
this Agreement promptly following its launch by Novavax in the United States).
1.14 Licensed Rights
means the Novavax Patents and any and all Know-How, including any
Developed Know-How, owned or Controlled by Novavax at any time during the term of this Agreement
which is used or embodied in, or useful for developing or manufacturing, any Licensed Product,
including, without limitation, Know-How regarding Novavaxs proprietary baculovirus insect cell
expression and manufacturing system and improvements thereto.
1.15 Novavax Patents
means any and all Patents in the Territory owned or Controlled by
Novavax at any time during the term of this Agreement covering or claiming a Licensed Product
and/or the manufacture or use thereof including, without limitation, the Patents listed on
Schedule 1
.
1.16 Patent
means any and all (a) issued patents and inventors certificates and
re-examinations, reissues, renewals, extensions, registrations, substitutions, supplementary
protection certificates and term restorations with respect to any of the foregoing, and (b) pending
applications for patents and inventors certificates and patents that issue therefrom, including,
without limitation, provisional applications, continuations, continuations in part, divisional and
substitute applications with respect to any of the foregoing.
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1.17
Program Data
means (a) research, preclinical, clinical, manufacturing and similar data,
information, material and results, (b) regulatory filings and approvals, and (c) sales and
marketing information.
1.18 Regulatory Approval
means any and all approvals (including supplements, amendments,
pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, that are necessary for the
manufacture, distribution, use or widespread sale of a Licensed Product in a regulatory
jurisdiction in the Territory.
1.19 Regulatory Authority
means any Governmental Authority with responsibility for granting
any licenses or approvals necessary for the marketing and sale of pharmaceutical products in the
Territory.
1.20 Regulatory Documentation
means, with respect to a Licensed Product, all Regulatory
Filings and supporting documents created, submitted to a Regulatory Authority, and all data
contained therein, including, without limitation, any Investigational New Drug Application, New
Drug Application, Marketing Authorization Application, foreign counterparts thereof, Investigators
Brochures, drug master files, correspondence to and from a Regulatory Authority, minutes from
teleconferences with Regulatory Authorities, registrations and licenses, regulatory drug lists,
advertising and promotion documents shared with Regulatory Authorities, adverse event files,
complaint files and manufacturing records.
1.21 Regulatory Filing
means the foreign counterparts of an Investigation New Drug
Application, New Drug Application, Marketing Authorization Application and any other filings
required by Regulatory Authorities relating to the study, Development, manufacture or
Commercialization of any Licensed Product in the Territory.
1.22 Technical Services Agreement
means that certain Technical Services Agreement between
Novavax and Company dated as of the date hereof.
1.23 Territory
means India.
1.24 Third Party
means a person or entity other than (a) Novavax, (b) Company, (c) an
Affiliate of Novavax or (d) an Affiliate of Company.
1.25 U.S.
means the United States of America.
ARTICLE 2
LICENSES
2.1 License Grant to Company.
Novavax hereby grants to Company an exclusive, fully paid-up,
royalty-free (except as expressly set forth in Section 2.7), non-transferable, right and license
under the Licensed Rights during the term of this Agreement to (a) research, develop, use,
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sell, have sold, offer to sell and import Licensed Product in the Territory, and (b) make (and
have made solely by Cadila or an Affiliate of Cadila, subject to Novavaxs approval described
below) Licensed Product in the Territory solely to develop, use, sell, have sold, offer to sell and
import Licensed Product in the Territory. The foregoing license shall be exclusive for Licensed
Product in the Territory, even as to Novavax, provided that Novavax retains the right to perform
its obligations under this Agreement, the Technical Services Agreement and any other agreement
between Company and Novavax.
Novavax shall be reasonable in granting or withholding its approval to permit Cadila or an
Affiliate of Cadila to make Licensed Product in the Territory. Novavaxs approval shall be subject
to its consideration of, among other things, any documentation or agreement surrounding such
manufacturing of the Licensed Product (which, in any case, shall be solely for the benefit of the
Company), the safeguards in place with regard to any such manufacturing, the protection of the
Licensed Rights, and Novavaxs ability to conduct reasonable due diligence on any Affiliate of
Cadila. In no event does the license grant to the Company under this Section 2.1 permit the
Company to have Licensed Product made by a Third Party
2.2 License Grant to Novavax.
The Company hereby grants to Novavax a fully paid-up,
royalty-free exclusive right and license under Developed Know-How owned or Controlled by the
Company, including any Patents that issue therefrom, to (a) research, develop, use, sell, have
sold, offer to sell and import non-seasonal influenza vaccines outside the Territory, and (b) make
and have made non-seasonal influenza vaccines outside the Territory solely to develop, use, sell,
have sold, offer to sell and import non-seasonal influenza vaccines outside the Territory.
2.3 Sublicenses.
Company shall not sublicense the Licensed Rights to any Third Party without
the prior written consent of Novavax, which consent may be withheld in its sole discretion. Upon
execution of a sublicense, after receipt of Novavax consent, Company will notify Novavax of the
execution of the sublicense and provide a copy to Novavax promptly following execution thereof.
2.4 No Implied Rights or Licenses.
No right or license, other than those expressly set forth
in this Agreement are granted to either party hereunder, and no additional rights will be deemed
granted to either party by implication, estoppel or otherwise. All rights not expressly granted by
either party to the other hereunder are reserved.
2.5 Research Data; Right of Reference.
(a) Company shall keep complete and accurate notes, accounts and records of all Program Data
with respect to Licensed Product, including the manufacture thereof. Novavax shall have the right
to access, use and reference for its Development and Commercialization of its products outside the
Territory Program Data related to Licensed Product in the possession or control of the Company.
The Company shall provide such cooperation and assistance as reasonably requested by Novavax from
time to time to effectuate the foregoing, including, without limitation by providing access to and
disclosure of Program Data to Novavax and by providing such authorization and consents required for
reference to regulatory filings and approvals.
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(b) Company shall have the right to access, use and reference for its Development and
Commercialization of Licensed Product in the Territory Program Data related to Licensed Product in
the possession or control of Novavax. Novavax shall provide such cooperation and assistance as
reasonably requested by Company from time to time to effectuate the foregoing, including, without
limitation by providing access to and disclosure of Program Data to Company and by providing such
authorization and consents required for reference to regulatory filings and approvals.
2.6 Grey Market.
The Parties reasonably cooperate to formulate and implement reasonable
precautions designed to prevent Licensed Product made or sold by or for such Party or its
respective Affiliates and permitted sublicensees from being sold outside of its respective
territory (i.e., outside the Territory for the Company and inside the Territory for Novavax).
Further, each Party will take reasonable measures so that its distributors, Affiliates and
wholesalers to whom the Company or Novavax provides its respective Licensed Product are aware of
the respective territorial limitations.
2.7 Third Party License Agreements.
The license granted under Section 2.1 may be subject to
applicable terms and conditions of a license agreement with a Third Party, under which any Licensed
Rights are sublicensed to the Company hereunder by Novavax (each a
Third Party License
Agreement
). Novavax shall be responsible for maintaining the Third Party License Agreements
and for any payments owed by Novavax thereunder; provided, however, that if a royalty is owed on
sales of Licensed Product by or for the Company in the Territory under such Third Party License
Agreement, such payments will be paid by Company.
2.8 Combination Products Reservation.
Novavax shall not, directly or indirectly, (i) engage
in, promote, or finance the research, development, or commercialization of, or (ii) grant any
license, or any similar rights with respect to, to a Third Party, in each case of (i) and (ii), a
Licensed Product in combination with another active ingredient, antigen or adjuvant in the
Territory.
ARTICLE 3
LICENSED PRODUCT DEVELOPMENT AND COMMERCIALIZATION
3.1 Development and Commercialization of Licensed Product.
(a)
General.
Company will have sole responsibility, at Companys sole expense, for all
Development and Commercialization of Licensed Product in the Territory in accordance with the terms
of this Agreement.
(b)
Development and Commercialization of Licensed Product.
Within [* * *] days of the
Effective Date, Company shall present to Novavax for its written approval Development plans for the
Licensed Product which shall specify preclinical studies (including a toxicology program and other
preclinical testing), human clinical trials, manufacturing scale up, Regulatory Approval strategy
and any other significant Development activities, that Company plans to perform to obtain
Regulatory Approval of such Licensed Product in the Territory (the
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Development Plans
). Novavax may reasonably request adjustments to activities described in
such Development plans as a condition to granting its approval. In no event shall Company
materially alter a Development Plan without Novavaxs prior written consent. Company shall conduct
Development of such Licensed Product in a manner that is materially consistent with the Development
Plans. All clinical trial protocols for Licensed Product conducted by Company shall require the
prior written approval of Novavax. At least [* * *] prior to anticipated commercial launch,
Company shall present to Novavax for its written approval a plan to Commercialize the Licensed
Product which shall specify a multi-year marketing and public relations strategy, operational plans
to implement such strategies and any other significant Commercialization activities (the
Commercialization Plan
). Novavax may reasonably request adjustments to the Commercialization
plan as a condition to granting its approval. In no event shall Company materially alter the
Commercialization Plan without Novavaxs prior written consent. Company shall conduct
Commercialization of such Licensed Product in a manner that is materially consistent with the
Commercialization Plan. Novavax acknowledges that the Licensed Product is being contributed by
Novavax to the Company in accordance with the Joint Venture Agreement and that if the Company
cannot Develop and Commercialize such Licensed Product it will not obtain the value of such
contribution. Company acknowledges that Novavax (or its affiliates or licensees) are Developing
and Commercializing Licensed Product outside the Territory and Companys activities could raise
safety concerns and have an impact on Novavaxs activities including the Regulatory Approval and
regulatory profile of an approved product outside the Territory. Accordingly, taking into account
Novavaxs and Companys respective interests including, without limitation, as provided in the two
preceding sentences, Novavax shall not unreasonably withhold, delay or condition any of its
consents or approvals hereunder.
3.2 Regulatory Affairs.
Company will be responsible for developing Regulatory Documentation
and preparing and submitting Regulatory Filings, seeking Regulatory Approvals, and maintaining
Regulatory Approvals for Licensed Product in the Territory. As set forth in the Technical Services
Agreement, Novavax will cooperate with Company in preparing and filing all such reports.
3.3 Manufacture and Supply.
Company will be responsible for the manufacture of Licensed
Product in the Territory and for all costs associated therewith. Certain amount of supply of
preclinical and clinical supply of Licensed Product will be made under the Supply Agreement, dated
as of March 31, 2009, between Company and Novavax (the
Supply Agreement
).
3.4 Adverse Event Reporting.
Company will maintain a record of all non-medical and medical
Licensed Product-related complaints and reports of Adverse Events in the Territory with respect to
any Licensed Product Developed or Commercialized by the Company. At the request of either party,
Novavax and the Company shall enter into reasonable and customary pharmacovigilance agreement with
respect to sharing of adverse event data and information for Licensed Product as required to comply
with applicable laws and regulations.
3.5 Development and Commercial Reporting.
During the Term of this Agreement, Company will
provide a half-yearly written progress report to Novavax summarizing the Development and
Commercialization of Licensed Product(s) during the prior six months. Each
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such progress report will be provided to Novavax by Company no later than March 1
st
or September 1
st
(as the case may be) of each year following the Effective Date.
3.6 Minor Modifications; Intent.
During the Term of this Agreement, Novavax will promptly
provide Company with details of any minor modifications it makes to the Licensed Product as Novavax
develops it for Regulatory Approval. [* * *]
ARTICLE 4
CONDITION PRECEDENT
This Agreement, including the license grants, obligations and benefits herein, shall only
become effective if, and shall automatically become effective upon, exercise and delivery of the
option granted by Novavax to Company in accordance with the Joint Venture Agreement and that
certain Option to Obtain License dated as of March31, 2009, unless earlier terminated.
ARTICLE 5
INTELLECTUAL PROPERTY
5.1 Disclosure.
During the Term, the Parties will promptly disclose to one another all
Know-How (whether patentable or not) developed, conceived or reduced to practice during the
Development, manufacture or Commercialization of a Licensed Product which is regarding or directed
to a Licensed Product (
Developed Know-How
). Novavax shall also disclose to the Company any
Know-How within the Licensed Rights obtained, licensed or generated after the Effective Date which
is not included within the Developed Know-How.
5.2 Ownership.
Novavax shall own all Developed Know-How and any other intellectual property
that is conceived and reduced to practice solely by Novavax. The Company shall own all Developed
Know-How and any other intellectual property that is conceived and reduced to practice solely by
Company. Novavax and the Company shall jointly own in accordance with U.S. Laws regarding joint
ownership of the applicable type of intellectual property, all Developed Know-How and any other
intellectual property that is conceived or reduced to practice by Novavax and Company jointly.
5.3 Prosecution and Maintenance of Patents.
Novavax shall have the sole and exclusive right
and authority to control the filing, prosecution, maintenance, and renewal of all Novavax Patents
and any Patents that result from Developed Know-How which is owned by Novavax or jointly owned as
provided in Section 5.2, at its own expense. Company shall have the sole and exclusive right and
authority to control the filing, prosecution, maintenance and renewal of any Patents that result
from Developed Know-How owned by Company as provided in Section 5.2. With respect to any such
Patents in the Territory and with respect to any such Patents that are subject to the license
granted to Novavax in Section 2.2 anywhere in the world (the
ROW Patents
), the prosecuting party
shall (i) provide the other party with copies of all material filings, documentation and
correspondence from, sent to or filed with patent offices in the Territory or anywhere in the world
for the ROW Patents, and (ii) provide the other party with a reasonable
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opportunity to comment upon all filings and actions with such patent offices in advance of
submissions to such patent offices. For purposes of this Section 5.3, filing, prosecution and
maintenance of patents shall be deemed to include, without limitation, appeals to administrative
or judicial entities having jurisdiction over patentability, the conduct of interferences or
oppositions, and/or requests for re-examinations, reissues or extensions of patent terms.
5.4 Abandoned Patents.
In the event the prosecuting party determines not to initiate patent
prosecution for any particular patentable Developed Know-How invention or to cease prosecution or
maintenance of, or otherwise abandon, any Patents that are the subject of Section 5.3 in the
Territory, or with respect to ROW Patents anywhere in the world (which the prosecuting party may do
in its sole discretion), the prosecuting party shall provide reasonable prior written notice to the
other party sufficient for the other party to timely initiate or take over the prosecution and
maintenance of such Patent and timely file any required documents and responses with the relevant
government patent office in the Territory, or with respect to ROW Patents anywhere in the world,
with respect thereto, and the other party may elect (in its sole discretion) to prosecute and
maintain such Patent, at the other partys sole expense. In such event, upon the request of and,
at the expense of the other party, the prosecuting party shall assign to the other party all of its
right, title and interest in, to and under such Patent which the prosecuting party has decided to
abandon and provide reasonable cooperation to the other party with respect thereto (including,
without limitation, providing necessary information and executing relevant documents).
5.5 Enforcement of Patents.
(a)
Infringement by Third Parties.
In the event that Novavax or the Company becomes aware of
or has reasonable suspicions of third party activities in the Territory that could constitute
infringement of the Novavax Patents or Patents that issue from Developed Know-How in the Territory,
or with respect to ROW Patents anywhere in the world, or misappropriation of the Novavax Know-How
or Developed Know-How in the Territory, or with respect to Developed Know-How any that is subject
to the license granted to Novavax in Section 2.2 anywhere in the world (
ROW Know-How
), then such
party shall promptly notify the other parties of such third party activities, including
identification of the third party and delineation of the facts relating to such third party
activities. The Company shall have the right (but shall not be obligated) to enforce the Novavax
Patents, Novavax Know-How and Developed Know-How against any actual or alleged infringement or
misappropriation thereof in the Territory by a third party (by bringing a suit, action or
proceeding against such third party), at the Companys sole expense. Novavax shall have the right
(but shall not be obligated) to enforce the ROW Patents and ROW Know-How within the scope of the
licenses granted to Novavax in Section 2.2 against any actual or alleged infringement or
misappropriation thereof outside the Territory by a third party (by bringing a suit, action or
proceeding against such third party), at Novavaxs sole expense. If the Company does not enforce
the Novavax Patents or Know-How by (i) one hundred (100) days following the notice of alleged
infringement or (ii) thirty (30) days before the time limit, if any, set forth in the appropriate
laws and regulations for the filing of such an action, whichever comes first, then Novavax shall
have the right (but not the obligation) to enforce the Novavax Patents and Novavax Know-How against
any actual or alleged infringement or misappropriation thereof in the Territory by a third party
(by bringing a suit, action or proceeding against such party), at
9
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Novavaxs sole expense. The non-prosecuting party shall reasonably cooperate with the
prosecuting party in such enforcement activities, at the prosecuting partys expense, including by
agreeing to be named as a party to (or bringing in its own name) such suit, action or proceeding
for the benefit of the non-prosecuting party if required for such enforcement action to proceed.
The prosecuting party shall keep the non-prosecuting party reasonably informed regarding any such
enforcement action and shall consider in good faith the reasonable comments and suggestions of the
non-prosecuting party related to such suit, action or proceeding. All recoveries received by the
prosecuting party from any such enforcement action shall be retained by the prosecuting party.
(b)
Challenge by Third Parties.
Novavax and Company will each notify the other Party in
writing within ten (10) Business Days of learning of any alleged or threatened opposition,
reexamination request, action for declaratory judgment, nullity action, interference or other
attack upon the validity, title or enforceability of the Licensed Rights or the ROW Patents or ROW
Know-How by a Third Party. Owner of the subject Patent will have the right (but not the
obligation) to defend any such challenge in the Territory. If the owner of the subject Patent
commences a defense against the alleged or threatened challenge (i) within sixty (60) days
following the detection of the alleged challenge, or (ii) ten (10) Business Days before the time
limit, if any, set forth in appropriate Laws and regulations for making a filing in defense of such
a challenge, whichever comes first, then the owner of the subject Patent will so notify the other
party promptly. Notwithstanding the foregoing, if any such action for declaratory judgment,
nullity action, or other attack upon the validity, title or enforceability of the Licensed Right
includes or will include counterclaims of infringement of the Licensed Rights, ROW Patents or ROW
Know-How by the Third Party, control of such action or other attack shall be governed by Section
5.5(a).
ARTICLE 6
CONFIDENTIALITY; PUBLICATION
6.1 Confidentiality
. The Parties anticipate that under this Agreement each Party will provide
confidential and/or proprietary information to the other Party and that the use and disclosure of
such information shall be governed by Article 18 of the Joint Venture Agreement which is hereby
incorporated by reference.
6.2 Publication.
(a) Each Party shall have the right to publish the data and results related to Licensed
Product, subject to the rest of this Section 6.2. Prior to public disclosure or submission for
publication of a proposed publication describing the results of any scientific or clinical activity
relating to a Licensed Product, the Party proposing such publication shall send the other Party by
expedited delivery a copy of the proposed publication to be submitted and shall allow the other
Party a reasonable time period (but not more than sixty (60) days from the date of confirmed
receipt) in which to determine whether the proposed publication contains subject matter for which
patent protection should be sought (prior to publication of such proposed publication) for the
purpose of protecting an invention, or whether the proposed publication contains the Confidential
Information of such other Party, or whether the proposed publication contains information that is
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
reasonably likely to have a material adverse impact on the development or commercialization of
Licensed Product. Following the expiration of applicable time period for review, the Party
proposing such publication shall be free to submit such proposed publication for publication and
publish or otherwise disclose to the public such scientific or clinical results, subject to the
procedures set forth in Section 6.2(b).
(b) If the Party reviewing such publication believes that the subject matter of the proposed
publication by the other Party contains Confidential Information of the Party or a patentable
invention owned by the Party or in which it otherwise has exclusive rights hereunder, then prior to
the expiration of the applicable time period for review, such Party shall notify the Party
proposing such publication in writing of such belief. On receipt of written notice from the other
Party that such proposed publication contains its Confidential Information, the Party proposing
publication shall remove such Confidential Information from such proposed publication prior to any
publication thereof, unless the other Party agrees otherwise in writing. On receipt of written
notice from the other Party that such proposed publication contains a patentable invention owned by
it or in which it otherwise has exclusive rights hereunder, the Party proposing publication shall
delay public disclosure of such information or submission of the proposed publication for an
additional period of thirty (30) days to permit preparation and filing of a patent application on
such invention. The Party proposing publication shall thereafter be free to publish or disclose
such information.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
7.1 Mutual Warranties.
Each of Novavax and Company hereby represents, warrants and covenants
to the other as of the Execution Date that:
(a) it has full corporate power and authority to enter into this Agreement and to carry out
the provisions hereof, and this Agreement is legally binding upon it and enforceable in accordance
with its terms.
(b) the execution, delivery and performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party or by which it may
be bound, nor violate any Law of any governmental authority having jurisdiction over it;
(c) it has not granted, and during the Term it will not grant, any right to any Third Party
that would conflict with the rights granted to the other Party hereunder. It has (or will have at
the time performance is due) maintained and will maintain and keep in full force and effect all
agreements necessary to perform its obligations hereunder; and
(d) all necessary consents, approvals and authorizations of all governmental authorities and
other persons required to be obtained by such Party to enter into, or perform its obligations
under, this Agreement have been obtained.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
7.2 Representations by Novavax.
In addition to the representations and warranties made in
Section 7.1, Novavax hereby represents, warrants and covenants to Company that:
(a) as of the Execution Date, the Licensed Rights are subsisting and are not the
subject of any interference, re-issue, re-exam, opposition or appeal proceedings;
(b) as of the Execution Date, no Third Party has filed, pursued or maintained or, to
the best of its knowledge, threatened in writing to file, pursue or maintain any claim,
lawsuit, charge or other action involving any Licensed Right including any claim, lawsuit,
charge, or action alleging that any Licensed Right is invalid or unenforceable;
(c) as of the Execution Date and to the best of its knowledge, all employees and agents
of Novavax who have performed any activities on its behalf in connection with research
regarding the Licensed Rights have properly assigned to Novavax the whole of their rights in
any intellectual property made, discovered or developed by them as a result of such
research, and no Third Party has any rights to any such intellectual property;
(d) as of the Effective Date, the Licensed Rights are free and clear of any liens,
charges, encumbrances or rights of others, to possession or use that may interfere with
Novavaxs possession or use under this Agreement;
(e) as of the Effective Date, it has sufficient rights to grant the licenses granted to
the Company hereunder; and
(f) as of the Effective Date, all third party agreements licensing any Licensed Rights
to Novavax, which are sublicensed to the Company hereunder, are currently in full force and
effect, and it has not received notice of material breach or termination thereof.
7.3 DISCLAIMER OF WARRANTIES
. Except as expressly set forth herein, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE
OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the
generality of the foregoing, each Party expressly does not warrant, and disclaims any warranties
with regards to: (a) the success of any study or test commenced under this Agreement, (b) the
safety or usefulness for any purpose of the technology or Materials it provides or discovers under
this Agreement; and/or (c) the validity, enforceability, or non-infringement of any intellectual
property rights or technology it provides or licenses to the other Party under this Agreement.
ARTICLE 8
INDEMNIFICATION
8.1 Indemnification by Company.
Company will indemnify, defend and hold harmless Novavax, its
affiliates, directors, officers and employees (each a
Novavax Indemnitee
)
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
from and against any and all liability, loss, damage or expense (including without limitation
reasonable attorneys fees) it may suffer as the result of Third Party claims, demands, actions and
proceedings brought against it (collectively,
Losses
) to the extent such Losses result from the
(a) negligence or willful misconduct by Company, its Affiliates, employees, agents, or Third Party
contractors, or (b) manufacture, use, sale, or offer for sale of a Licensed Product in the
Territory due to a design defect or a manufacturing defect, including but not limited to, a Loss
related to the death of or injury to a Third Party. Companys obligation to indemnify Novavax
pursuant to this Section 8.1 will not apply to the extent of any Loss that arises from the (i)
material breach by Novavax of its representations, warranties or covenants contained within this
Agreement, (ii) negligence or willful misconduct of any Novavax Indemnitee, or (iii) a
manufacturing defect of Licensed Product supplied by Novavax under the Supply Agreement.
8.2 Indemnification by Novavax.
Novavax will indemnify, defend and hold harmless Company,
its affiliates, directors, officers and employees (each a
Company Indemnitee
) from and against
any and all Losses to the extent such Losses result from the (a) negligence or willful misconduct
by Novavax, its Affiliates, employees, agents or Third Party contractors, or (b) manufacture, use,
sale, or offer for sale of a Licensed Product outside the Territory due to a design defect or a
manufacturing defect, including but not limited to, a Loss related to the death of or injury to a
Third Party. Novavaxs obligation to indemnify the Company Indemnitee pursuant to this Section 8.2
will not apply to the extent of any Loss that arises from the (i) material breach by Company of its
representations, warranties or covenants contained within this Agreement or (ii) negligence or
willful misconduct of any Company Indemnitee.
8.3 Procedures.
Indemnitors agreement to indemnify, defend and hold harmless an Indemnitee
is conditioned on Indemnitee (a) providing prompt written notice of any claim giving rise to an
indemnification obligation hereunder but only if a failure to so notify causes prejudicial harm to
the Indemnitors ability to defend, (b) permitting Indemnitor to assume full responsibility to
investigate, prepare for and defend against any such claim, (c) providing reasonable assistance in
the defense of such claim at Indemnitors reasonable expense, and (d) not compromising or settling
such claim without Indemnitors advance written consent.
8.4 Insurance.
Each Party will maintain comprehensive general liability insurance coverage,
including products liability, in amounts it reasonably determines are appropriate with respect to
the Development and Commercialization of Licensed Product in its respective territory.
8.5 Limitation of Liability.
EXCEPT TO THE EXTENT (A) SUCH PARTY MAY BE REQUIRED TO
INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 8, OR (B) AS REGARDS A BREACH OF A PARTYS
RESPONSIBILITIES PURSUANT TO ARTICLE 6, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES WILL BE LIABLE
TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR
ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS
AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 9
TERM; BREACH
9.1 Term and Termination.
The term of this Agreement will commence on the Execution Date and
will continue until (a) the Company provides sixty (60) days prior written notice of termination to
Novavax, (b) the Parties mutually agree in writing to terminate the Agreement, or (c) Novavax
terminates the Joint Venture Agreement by providing a Notice of Termination under and pursuant to
Section 11.2 of the Joint Venture Agreement. In no event shall either Party have the right to
terminate this Agreement based upon any breach by the other Party, and to the extent that any right
to terminate is provided under any Laws, the Parties hereby waive such right.
9.2 Breach and Remedies.
In addition to any remedies available under any laws, the following
remedies shall be available to a party in the event of the following breaches
(a) In the event that Section 2.6 is materially breached by either party, the non-breaching
party shall be entitled to damages equal to its lost profit from lost sales of Licensed Product in
or out of the Territory (as applicable) due to the grey market breach.
(b) In the event that Company (i) materially alters a Development Plan or Commercialization
Plan for Licensed Product without Novavaxs prior written consent, or (ii) initiates a clinical
trial of Licensed Product without Novavaxs approval or materially deviates from an approved
clinical trial protocol for Licensed Product without the prior written consent of Novavax, then
Novavax shall have right to obtain injunctive relief with respect to such breach before any court
of competent jurisdiction in accordance with Section 10.3.
9.3 Survival.
The following provisions of this Agreement shall survive expiration or
termination of this Agreement for any reason: Article 8 and Sections 6.1 and 7.3. In the event
that this Agreement is terminated under 9.1(c), the license grant under Section 2.2 shall survive
as a fully paid, exclusive license solely under Developed Know-how owned or Controlled by Company,
including any Patents that issue therefrom, as of the effective date of termination (i.e.,
excluding any intellectual property developed or acquired after such date of termination).
ARTICLE 10
DISPUTE RESOLUTION
10.1 Disputes.
The Parties recognize that disputes as to certain matters may from time to
time arise during the Term which relate to either Partys rights and/or obligations hereunder. It
is the objective of the Parties to establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in
this Article 10 if and when a dispute arises under this Agreement.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
10.2 Arbitration.
Any dispute arising between the Parties out of or in connection with the
implementation or interpretation of this Agreement shall, if not settled amicably within ninety
(90) days from the date that the dispute arose, be finally settled by three (3) arbitrators. Each
Party shall be entitled to appoint one (1) arbitrator and the two (2) so appointed shall appoint
the third arbitrator in accordance with the Indian Arbitration and Conciliation Act, 1996. It is
hereby agreed that Part I of the Indian Arbitration and Conciliation Act, 1996 (except for the
provisions of Section 9 thereof) shall not apply to the arbitration under this Agreement. The
language of the arbitration proceedings shall be English and its place shall be Singapore. The
arbitral award or determination shall be final and subject to no appeal and shall deal with the
question of costs of arbitration and all matters related thereto.
The Parties agree that it would be impossible or inadequate to measure and calculate their damages
from any breach of the Agreement though great and irreparable. Accordingly, each Party agrees that
if the other Party breaches this Agreement, the non-breaching party will have available, in
addition to any other right or remedy available, the right to obtain an injunction from a court of
competent jurisdiction restraining such breach or threatened breach and specific performance of any
provision of this Agreement.
10.3 Equitable Claims.
Notwithstanding anything to the contrary in this Article 10, either
Party has the right to seek temporary injunctive relief or any other interim equitable remedy in
any court of competent jurisdiction as may be available to such Party under the laws applicable to
such jurisdiction that may be necessary to protect the rights or property of that Party until such
time as any dispute underlying such temporary injunctive relief or any other interim equitable
remedy has been resolved in accordance with Section 10.2.
10.4 Governing Law.
The substantive laws of India will govern the resolution of all disputes,
controversies and claims under, arising out of or relating to the validity, construction,
enforceability or performance of this Agreement and any related remedies, without giving effect to
any choice of law rules.
10.5 Award.
Each Party will abide by any arbitral award rendered pursuant to this Article 10.
If a Party resists enforcement of an arbitral award, any costs, fees or taxes incident to
enforcement will be charged against that Party to the extent permitted by Law. Each Party will
bear its own legal fees for arbitration, and the arbitrator(s) will assess their costs, fees and
expenses against the Party losing the arbitration.
10.6 Injunctive Relief.
If a Party makes a sufficient showing under the rules and standards
set forth in the rules of civil procedure and applicable Law, the arbitrator may, and the Parties
will abide by, injunctive measures after either Party submits in writing for arbitration claims
requiring immediate relief. Notwithstanding the foregoing, and in accordance with Section 10.3, a
Party will also be free at any time to bring an Equitable Claim to any court of competent
jurisdiction without submitting such request to an arbitrator.
10.7 Confidentiality.
Any arbitration proceeding, including without limitation the existence
of any dispute submitted to arbitration and any arbitral award or decision, will be Confidential
Information of both Parties, and the arbitrator(s) will issue appropriate protective
15
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
orders to safeguard each Partys Confidential Information, provided that such Confidential
Information may be disclosed solely as necessary in connection with the enforcement of an arbitral
award or as otherwise required by Law (subject to Section 6.3).
ARTICLE 11
MISCELLANEOUS
11.1 Entire Agreement.
This Agreement (including its Exhibits) sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings between the
Parties with respect to the subject matter hereof and supersedes and terminates all prior
agreements and understanding between the Parties with respect to such subject matter. No
subsequent alteration, amendment, change or addition to this Agreement will be binding upon the
Parties unless reduced to writing and signed by the respective authorized officers of the Parties.
11.2 Third Party Contractors.
The Parties will perform their obligations under this Agreement
as Third Party contractors and nothing contained in this Agreement will be construed to be
inconsistent with such relationship or status. This Agreement will not constitute, create or in
any way be interpreted as a joint venture or partnership of any kind.
11.3 Notices.
Any notice, request, demand, waiver, consent, approval or other communication
permitted or required under this Agreement (
Notice
) will be in writing, will refer specifically
to this Agreement and will be deemed given only if sent by electronic mail (with receipt
confirmed), facsimile transmission (with transmission confirmed) or by an internationally
recognized delivery service that maintains records of delivery, addressed to the Parties at their
respective addresses specified in this Section 11.3 or to such other address as the Party to whom
notice is to be given may have provided to the other Party in accordance with this Section 11.3.
Any notice delivered by electronic mail or facsimile will be confirmed by a hard copy delivered as
soon as practicable thereafter by an internationally recognized overnight delivery service. Such
Notice will be deemed to have been given on the second Business Day (at the place of delivery)
after deposit with an internationally recognized delivery service. This Section 11.3 is not
intended to govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
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If to Novavax:
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Novavax, Inc.
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9920 Belaward Campus Drive
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Rockville Maryland 20850
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Attn: Ray Hage, Senior Vice President
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Email: Rhage@Novavax.com
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Facsimile No.: 240-268-2122
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If to Company:
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CPL Biologicals Limited
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Cadila Corporate Campus
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Sarkhej-Dholka Road
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Bhat, Ahmedabad 382210
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Gujarat, India
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Attn: Dr. Rajiv I. Modi, Managing Director
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Email: rimodi@cadilapharma.co.in
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Facsimile No.: +91 (02718) 225031
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11.4 Assignment.
(a) Novavax may not assign this Agreement, in whole or in part, without the advance written
consent of the Company; provided, however, that this Agreement shall be automatically assigned to
Novavaxs successor in connection with the acquisition, merger or sale of Novavax or the sale,
transfer, lease, assignment or disposal of all or substantially all of the property or assets of
Novavax, whether by way of a single transaction or a series of related transactions, and such
successor shall be fully bound by the terms and conditions hereof.
(b) The Company may not assign this Agreement, in whole or in part, without the advance
written consent of Novavax; provided, however, that this Agreement shall be automatically assigned
to the Companys successor in connection with the sale, transfer, lease, assignment or disposal of
all or substantially all of the property or assets of the Company , whether by way of a single
transaction or a series of related transactions, including a Change in Control of the Company (as
that term is defined in Schedule II of the Joint Venture Agreement), and such successor shall be
fully bound by the terms and conditions hereof; provided that any such automatic assignment by
Company within the scope of Schedule II of the Joint Venture Agreement shall only be effective if
such transaction was approved by Novavax under and pursuant to the Joint Venture Agreement for so
long as such approval rights of Novavax under the Joint Venture Agreement have not been terminated.
(c) Any assignment or purported assignment by either Party in violation of this Section 11.4
will be null and void.
11.5 Force Majeure.
Both Parties will be excused from the performance of their obligations
under this Agreement (except for the obligation to pay money) to the extent that such performance
is prevented by force majeure and the nonperforming Party promptly provides notice of the
prevention to the other Party. Such excuse will be continued so long as the condition constituting
force majeure continues and the nonperforming Party takes reasonable efforts to remove the
condition. For purposes of this Agreement, force majeure will include conditions beyond the
control of the Parties, including without limitation, an act of God, voluntary or involuntary
compliance with any regulation, Law or order of any government, war, civil commotion, labor strike
or lock-out, acts of terrorism, epidemic, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake, storm or like
catastrophe.
11.6 Headings.
The headings for each article and section in this Agreement have been inserted
for convenience of reference only and are not intended to limit or expand on the meaning of the
language contained in the particular article or section.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
11.7 No Strict Construction.
This Agreement has been prepared jointly and will not be
strictly construed against either Party.
11.8 Ambiguities.
Ambiguities and uncertainties in this Agreement, if any, will not be
interpreted against either Party, irrespective of which Party may be deemed to have caused the
ambiguity or uncertainty to exist.
11.9 English Language.
All notices required or permitted to be given hereunder, and all
written, electronic, oral or other communications between the Parties regarding this Agreement will
be in the English language. This Agreement is in the English language only, which language will be
controlling in all respects, and all versions hereof in any other language will be for
accommodation only and will not be binding upon the Parties.
11.10 No Waiver.
Any delay in enforcing a Partys rights under this Agreement or any waiver
as to a particular default or other matter will not constitute a waiver of such Partys rights to
the future enforcement of its rights under this Agreement, excepting only as to an express written
and signed waiver as to a particular matter for a particular period of time.
11.11 Severability.
If one or more of the provisions in this Agreement are deemed
unenforceable by Law, then such provision will be deemed stricken from this Agreement and the
remaining provisions will continue in full force and effect and shall be interpreted to give full
effect to the commercial agreement between the Parties.
11.12 Counterparts.
This Agreement may be executed in one or more identical counterparts,
each of which will be deemed to be an original, and which collectively will be deemed to be one and
the same instrument.
[Signature Page to Follow]
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
In Witness Whereof,
the Parties have by duly authorized persons executed this License
Agreement as of the Execution Date.
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Novavax, Inc.
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CPL Biologicals Limited
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By:
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/s/ Rahul Singhvi
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By:
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Rahul Singhvi
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Rajiv I. Modi
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President and Chief
Executive Officer
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Managing Director
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[Signature Page to License Agreement]