x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
Delaware
|
22-2816046
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
|
9920
Belward Campus Drive, Rockville, MD
|
20850
|
|
(Address
of principal executive offices)
|
(Zip
code)
|
Large accelerated filer
¨
|
Accelerated filer
x
|
Non-accelerated filer
¨
(Do not check if a smaller reporting company)
|
Smaller reporting company
¨
|
|
Page No.
|
|
PART
I. FINANCIAL INFORMATION
|
||
Item
1.
|
Financial
Statements
|
|
Consolidated
Balance Sheets as of June 30, 2010 (unaudited) and December 31,
2009
|
1
|
|
Consolidated
Statements of Operations for the three and six months ended June 30, 2010
and 2009 (unaudited)
|
2
|
|
Consolidated
Statements of Cash Flows for the six months ended June 30, 2010 and 2009
(unaudited)
|
3
|
|
Notes
to the Consolidated Financial Statements (unaudited)
|
4
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
10
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
18
|
Item
4.
|
Controls
and Procedures
|
18
|
PART
II. OTHER INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
19
|
Item
1A.
|
Risk
Factors
|
19
|
Item
5.
|
Other
Information
|
19
|
Item
6.
|
Exhibits
|
19
|
SIGNATURES
|
21
|
June
30,
|
December
31,
|
|||||||
2010
|
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 9,446 | $ | 38,757 | ||||
Short-term
investments available-for-sale
|
17,340 | 4,193 | ||||||
Accounts
and other receivables
|
356 | 258 | ||||||
Prepaid
expenses and other current assets
|
452 | 1,295 | ||||||
Total
current assets
|
27,594 | 44,503 | ||||||
Property
and equipment, net
|
8,050 | 7,801 | ||||||
Goodwill
|
33,141 | 33,141 | ||||||
Other
non-current assets
|
160 | 160 | ||||||
Total
assets
|
$ | 68,945 | $ | 85,605 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 3,433 | $ | 2,098 | ||||
Accrued
expenses and other current liabilities
|
4,637 | 5,417 | ||||||
Current
portion of notes payable
|
80 | 80 | ||||||
Deferred
revenue
|
54 | 150 | ||||||
Deferred
rent
|
319 | 282 | ||||||
Total
current liabilities
|
8,523 | 8,027 | ||||||
Non-current
portion of notes payable
|
360 | 406 | ||||||
Deferred
rent
|
2,539 | 2,707 | ||||||
Total
liabilities
|
11,422 | 11,140 | ||||||
Commitments
and contingences
|
— | — | ||||||
Stockholders’
equity:
|
||||||||
Preferred
stock, $0.01 par value, 2,000,000 shares authorized; no shares issued and
outstanding
|
— | — | ||||||
Common
stock, $0.01 par value, 200,000,000 shares authorized; and 102,313,902
shares issued and 101,846,805 shares outstanding at June 30, 2010 and
100,717,890 shares issued and 100,262,460 shares outstanding at December
31, 2009
|
1,023 | 1,007 | ||||||
Additional
paid-in capital
|
354,776 | 350,810 | ||||||
Notes
receivable from former directors
|
(1,572 | ) | (1,572 | ) | ||||
Accumulated
deficit
|
(294,988 | ) | (274,150 | ) | ||||
Treasury
stock, 467,097 and 455,430 shares at June 30, 2010 and December 31, 2009,
respectively, cost basis
|
(2,450 | ) | (2,450 | ) | ||||
Accumulated
other comprehensive income
|
734 | 820 | ||||||
Total
stockholders’ equity
|
57,523 | 74,465 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 68,945 | $ | 85,605 |
For the Three Months
Ended
June
3
0
,
|
For the Six Months
Ended June
3
0
,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenue
|
$ | 7 | $ | 29 | $ | 117 | $ | 50 | ||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
6,327 | 5,297 | 15,356 | 9,563 | ||||||||||||
General
and administrative
|
3,148 | 2,562 | 5,683 | 5,454 | ||||||||||||
Total
operating expenses
|
9,475 | 7,859 | 21,039 | 15,017 | ||||||||||||
Loss
from continuing operations
|
(9,468 | ) | (7,830 | ) | (20,922 | ) | (14,967 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
44 | 75 | 88 | 180 | ||||||||||||
Interest
expense
|
(2 | ) | (326 | ) | (4 | ) | (764 | ) | ||||||||
Impairment
of short-term investments
|
— | (459 | ) | — | (1,338 | ) | ||||||||||
Net
loss
|
$ | (9,426 | ) | $ | (8,540 | ) | $ | (20,838 | ) | $ | (16,889 | ) | ||||
Basic
and diluted net loss per share
|
$ | (0.09 | ) | $ | (0.10 | ) | $ | (0.21 | ) | $ | (0.22 | ) | ||||
Basic
and diluted weighted average number of common shares
outstanding
|
100,694 | 84,832 | 100,442 | 76,807 |
For the Six Months
Ended
June
3
0
,
|
||||||||
2010
|
2009
|
|||||||
Operating
Activities:
|
||||||||
Net
loss:
|
$ | (20,838 | ) | $ | (16,889 | ) | ||
Reconciliation
of net loss to net cash used in operating activities:
|
||||||||
Depreciation
and amortization
|
633 | 602 | ||||||
Amortization
of debt discount
|
— | 218 | ||||||
Amortization
of deferred financing costs
|
— | 145 | ||||||
Amortization
of short-term investments discount(premium)
|
66 | — | ||||||
Loss
on disposal of property and equipment
|
— | 28 | ||||||
Impairment
of property and equipment
|
127 | 21 | ||||||
Deferred
rent
|
(131 | ) | (137 | ) | ||||
Non-cash
stock-based compensation
|
509 | 854 | ||||||
Impairment
of short-term investments
|
— | 1,338 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
and other receivables
|
(98 | ) | 236 | |||||
Prepaid
expenses and other current assets
|
843 | (45 | ) | |||||
Accounts
payable and accrued expenses
|
258 | (398 | ) | |||||
Deferred
revenue
|
(96 | ) | — | |||||
Net
cash used in operating activities
|
(18,727 | ) | (14,027 | ) | ||||
Investing
Activities:
|
||||||||
Capital
expenditures
|
(712 | ) | (168 | ) | ||||
Proceeds
from disposal of property and equipment
|
— | 7 | ||||||
Proceeds
from maturities of short-term investments
|
900 | 125 | ||||||
Purchases
of short-term investments
|
(14,199 | ) | — | |||||
Net
cash used in investing activities
|
(14,011 | ) | (36 | ) | ||||
Financing
Activities:
|
||||||||
Principal
payments of notes payable
|
(46 | ) | (12,346 | ) | ||||
Net
proceeds from sales of common stock, net of offering costs of $0.1 million
and
$1.0 million, respectively
|
3,060 | 24,652 | ||||||
Proceeds
from the exercise of stock options
|
413 | 35 | ||||||
Net
cash provided by financing activities
|
3,427 | 12,341 | ||||||
Net
decrease in cash and cash equivalents
|
(29,311 | ) | (1,722 | ) | ||||
Cash
and cash equivalents at beginning of period
|
38,757 | 26,938 | ||||||
Cash
and cash equivalents at end of period
|
$ | 9,446 | $ | 25,216 | ||||
Supplemental
disclosure of non-cash activities:
|
||||||||
Equipment
purchases included in accounts payable
|
$ | 297 | $ | 84 | ||||
Payment
of notes payable through issuance of common stock
|
$ | — | $ | 5,100 | ||||
Supplemental
disclosure of cash flow information:
|
||||||||
Cash
interest payments
|
$ | — | $ | 761 |
|
·
|
Level
1: Observable inputs such as quoted prices (unadjusted) in active markets
for identical assets or
liabilities.
|
|
·
|
Level
2: Inputs other than quoted prices that are observable for the asset or
liability, either directly or indirectly. These include quoted prices for
similar assets or liabilities in active markets and quoted prices for
identical or similar assets or liabilities in markets that are not
active.
|
|
·
|
Level
3: Unobservable inputs that reflect the reporting entity’s own
assumptions.
|
Fair Value Measurement at
June 30, 2010 using Fair Value Hierarchy
|
||||||||||||||||
Assets
|
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
||||||||||||
Cash and cash equivalents
|
$ | 9,446 | $ | — | $ | — | $ | 9,446 | ||||||||
Short-term
investments
|
— | 17,340 | — | 17,340 | ||||||||||||
Total
|
$ | 9,446 | $ | 17,340 | $ | — | $ | 26,786 |
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
|||||||||||||
Auction
rate securities
|
$ | 3,373 | $ | 747 | $ | — | $ | 4,120 | ||||||||
Corporate
debt securities
|
13,233 | — | (13 | ) | 13,220 | |||||||||||
Total
|
$ | 16,606 | $ | 747 | $ | (13 | ) | $ | 17,340 |
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Research
and development
|
$ | 77 | $ | 158 | $ | 8 | $ | 337 | ||||||||
General
and administrative
|
348 | 199 | 501 | 517 | ||||||||||||
Total
stock-based compensation expenses
|
$ | 425 | $ | 357 | $ | 509 | $ | 854 |
2005 Stock Incentive
Plan
|
1995 Stock Option
Plan
|
1995 Director Stock
Option Plan
|
||||||||||||||||||||||
Stock
Options
|
Weighted-
Average
Exercise
Price
|
Stock
Options
|
Weighted-
Average
Exercise
Price
|
Stock
Options
|
Weighted-
Average
Exercise
Price
|
|||||||||||||||||||
Outstanding
at January 1, 2010
|
4,878,675 | $ | 2.38 | 1,086,319 | $ | 5.72 | 30,000 | $ | 5.63 | |||||||||||||||
Granted
|
1,491,250 | $ | 2.39 | — | $ | — | — | $ | — | |||||||||||||||
Exercised
|
(193,675 | ) | $ | 1.62 | (45,000 | ) | $ | 2.21 | — | $ | — | |||||||||||||
Canceled
|
(781,057 | ) | $ | 2.67 | (461,469 | ) | $ | 7.04 | (30,000 | ) | $ | 5.63 | ||||||||||||
Outstanding
at June 30, 2010
|
5,395,193 | $ | 2.37 | 579,850 | $ | 4.97 | — | $ | — | |||||||||||||||
Shares
exercisable at June 30, 2010
|
2,450,630 | $ | 2.20 | 579,850 | $ | 4.97 | — | $ | — | |||||||||||||||
Shares
available for grant at June 30, 2010
|
2,480,523 |
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
||||||||
2010
|
2009
|
2010
|
2009
|
||||||
Weighted-average
fair value of stock
options
granted
|
$1.68 | $1.91 | $1.64 | $0.46 | |||||
Risk-free
interest rate
|
1.47%-2.33% | 2.09%-3.19% | 1.46%-2.89% | 1.56%-3.19% | |||||
Dividend
yield
|
0% | 0% | 0% | 0% | |||||
Volatility
|
98.78%-108.02% | 100.36%-111.83% | 98.78%-108.02% | 85.68%-111.83% | |||||
Expected
life (in years)
|
3.06-4.47 | 4.17-7.05 | 3.06-6.26 | 4.00-7.05 | |||||
Expected
forfeiture rate
|
21.07% | 21.96% | 21.07% | 21.96% |
Number of
Shares
|
Per Share
Weighted-
Average
Grant-Date
Fair Value
|
|||||||
Outstanding
at January 1, 2010
|
90,000 | $ | 3.04 | |||||
Restricted
stock granted
|
25,000 | $ | 2.38 | |||||
Restricted
stock vested
|
(28,333 | ) | $ | 2.77 | ||||
Restricted
stock forfeited
|
(11,667 | ) | $ | 2.77 | ||||
Outstanding
at June 30, 2010
|
75,000 | $ | 2.97 |
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
·
|
our
expectation that we will have adequate capital resources available to
operate at planned levels for at least the next twelve
months;
|
|
·
|
our
expectations for future funding requirements and capital raising activity,
including anticipated proceeds from our At Market Issuance Sales Agreement
with MLV;
|
|
·
|
our
expectations on financial or business performance, conditions or
strategies and other financial and business matters, including
expectations regarding operating expenses, use of cash, and the
fluctuations in expenses and capital requirements associated with
pre-clinical studies, clinical trials and other research and development
activities;
|
|
·
|
our
expectations on clinical development and anticipated milestones, including
a Department of Health and Human Services (HHS), Biomedical Advanced
Research and Development Authority (BARDA) contract and pursuing possible
registration of our H1N1 influenza VLP vaccine in the country of
Mexico;
|
·
|
our
expectations that our trivalent seasonal influenza VLP vaccine could
potentially address an unmet medical need in older
adults;
|
|
|
·
|
the
expected timing of the primary safety results from our second stage
clinical trial of our 2009 H1N1 influenza VLP vaccine in
Mexico;
|
|
·
|
our
expectations for the use of results from our clinical trial in Mexico to
support registration of our 2009 H1N1 influenza VLP vaccine in Mexico and
the development of vaccines in other countries, including the United
States;
|
|
·
|
our
expectations for the use of pre-clinical safety and efficacy studies to
support Investigational New Drug (IND)
application;
|
|
·
|
the
impact of new accounting pronouncements;
and
|
|
·
|
our
expectations concerning payments under existing license
agreements.
|
|
·
|
our
ability to progress any product candidates into pre-clinical studies or
clinical trials;
|
|
·
|
the
scope, initiation, rate and progress of our pre-clinical studies and
clinical trials and other research and development
activities;
|
|
·
|
clinical
trial results;
|
|
·
|
even
with positive data from pre-clinical studies or clinical trials, the
product candidate may not prove to be safe and
efficacious;
|
|
·
|
regulatory
approval is needed before any vaccines can be sold in or outside the
United States and, to date, no governmental authority has approved any of
our vaccine candidates for sale;
|
|
·
|
influenza
is seasonal in nature, and if approval or commercial launch after approval
is not timely in relation to the influenza season, we may not be able to
manufacture or sell our influenza vaccines on terms favorable to us until
the next influenza season, if at
all;
|
|
·
|
we
have not manufactured any of our vaccine candidates at a commercial
level;
|
|
·
|
we
utilize a unique manufacturing process and the scale-up of that process
may prove difficult and/or
costly;
|
|
·
|
our
dependence on third parties to manufacture and distribute our
vaccines;
|
|
·
|
risks
associated with conducting business outside of the United
States;
|
|
·
|
the
cost and our ability of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property
rights;
|
|
·
|
competition
for clinical resources and patient enrollment from drug candidates in
development by other companies with greater resources and
visibility;
|
|
·
|
our
ability to enter into future collaborations with industry partners and the
terms, timing and success of any such
collaboration;
|
|
·
|
our
ability to obtain adequate financing in the future through product
licensing, co-promotional arrangements, public or private equity or debt
financings or otherwise;
|
|
·
|
our
ability to win any government contracts/grants, including from BARDA, in a
timely manner or at all; and
|
|
·
|
other
factors referenced herein.
|
Three Months Ended
June 30,
|
||||||||||||
20
10
|
200
9
|
Change
2009 to
20
10
|
||||||||||
Revenue:
|
||||||||||||
Total
revenue
|
$ | 7 | $ | 29 | $ | 22 |
Three Months Ended
June 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Operating
Expenses:
|
||||||||||||
Research
and development
|
$ | 6,327 | $ | 5,297 | $ | 1,030 | ||||||
General
and administrative
|
3,148 | 2,562 | 586 | |||||||||
Total
operating expenses
|
$ | 9,475 | $ | 7,859 | $ | 1,616 |
Three Months Ended
June 30,
|
||||||||||||
20
10
|
200
9
|
Change
2009 to
20
10
|
||||||||||
Other
Income (Expense):
|
||||||||||||
Interest
income
|
$ | 44 | $ | 75 | $ | (31 | ) | |||||
Interest
expense
|
(2 | ) | (326 | ) | 324 | |||||||
Impairment
of short-term investments
|
— | (459 | ) | 459 | ||||||||
Total
other income (expense)
|
$ | 42 | $ | (710 | ) | $ | 752 |
Three Months Ended
June 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Net
Loss:
|
||||||||||||
Net
loss
|
$ | (9,426 | ) | $ | (8,540 | ) | $ | (886 | ) | |||
Net
loss per share
|
$ | (0.09 | ) | $ | (0.10 | ) | $ | 0.01 | ||||
Weighted
shares outstanding
|
100,694 | 84,832 | 15,862 |
Six Months Ended
June 30,
|
||||||||||||
20
10
|
200
9
|
Change
2009 to
20
10
|
||||||||||
Revenue:
|
||||||||||||
Total
revenue
|
$ | 117 | $ | 50 | $ | 67 |
Six Months Ended
June 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Operating
Expenses:
|
||||||||||||
Research
and development
|
$ | 15,356 | $ | 9,563 | $ | 5,793 | ||||||
General
and administrative
|
5,683 | 5,454 | 229 | |||||||||
Total
operating expenses
|
$ | 21,039 | $ | 15,017 | $ | 6,022 |
Six Months Ended
June 30,
|
||||||||||||
20
10
|
200
9
|
Change
2009 to
20
10
|
||||||||||
Other
Income (Expense):
|
||||||||||||
Interest
income
|
$ | 88 | $ | 180 | $ | (92 | ) | |||||
Interest
expense
|
(4 | ) | (764 | ) | 760 | |||||||
Impairment
of short-term investments
|
— | (1,338 | ) | 1,338 | ||||||||
Total
other income (expense)
|
$ | 84 | $ | (1,922 | ) | $ | 2,006 |
Six Months Ended
June 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Net
Loss:
|
||||||||||||
Net
loss
|
$ | (20,838 | ) | $ | (16,889 | ) | $ | (3,949 | ) | |||
Net
loss per share
|
$ | (0.21 | ) | $ | (0.22 | ) | $ | 0.01 | ||||
Weighted
shares outstanding
|
100,442 | 76,807 | 23,635 |
Six Months Ended
June 30,
|
||||||||||||
2010
|
2009
|
Change 2009
to 2010
|
||||||||||
Summary
of Cash Flows:
|
||||||||||||
Net
cash (used in) provided by:
|
||||||||||||
Operating
activities
|
$ | (18,727 | ) | $ | (14,027 | ) | $ | (4,700 | ) | |||
Investing
activities
|
(14,011 | ) | (36 | ) | (13,975 | ) | ||||||
Financing
activities
|
3,427 | 12,341 | (8,914 | ) | ||||||||
Net
decrease in cash and cash equivalents
|
(29,311 | ) | (1,722 | ) | (27,589 | ) | ||||||
Cash
and cash equivalents at beginning of period
|
38,757 | 26,938 | 11,819 | |||||||||
Cash
and cash equivalents at end of period
|
$ | 9,446 | $ | 25,216 | $ | (15,770 | ) |
Item
3.
|
Quantitative
and Qualitative Disclosures About Market
Risk
|
Item 4.
|
Controls and
Procedures
|
Item
1.
|
Legal
Proceedings
|
Item
5.
|
Other
Information
|
Item
6.
|
Exhibits
|
10.49*
**
|
Amendment
No. 1 to License Agreement, effective as of March 17, 2010, between the
Company and Wyeth Holdings Corporation
|
10.50*
††
|
Consulting
Agreement, dated as of April 1, 2010, between the Company and John
Lambert
|
10.51
††
|
Employment
Agreement of Mark O. Thornton dated May 6, 2010 (Incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed May 25,
2010)
|
10.52
††
|
Employment
Agreement of Stanley C. Erck dated as of February 15, 2010 (Incorporated
by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K,
filed June 1, 2010)
|
10.53
††
|
Amendment
to Amended and Restated Employment Agreement of Rahul Singhvi dated May
27, 2010 (Incorporated by reference to Exhibit 10.2 to the Company’s
Current Report on Form 8-K, filed June 1, 2010)
|
10.54
††
|
Employment
Agreement of Gregory Glenn dated July 1, 2010 (Incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed July 6,
2010)
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31.1*
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Certification
of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the
Securities Exchange Act
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31.2*
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Certification
of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the
Securities Exchange Act
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32.1*
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Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
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32.2*
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Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
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NOVAVAX,
INC.
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Date:
August 6, 2010
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By:
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/s/ Rahul Singhvi
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President and Chief Executive Officer | ||
and Director | ||
(Principal Executive Officer) | ||
Date:
August 6, 2010
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By:
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/s/ Frederick W.
Driscoll
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Vice President, Chief Financial Officer | ||
and Treasurer | ||
(Principal Financial and Accounting Officer) |
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1.
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The
H1N1 Product is a Product for Pandemic Flu for purposes of the
Agreement. Notwithstanding the provisions of Section 3.1.4 of
the Agreement to the contrary but subject to paragraphs 2 and 3 below, no
milestone payment shall be due for receipt of [**********] of the H1N1
Product in Mexico for H1N1 influenza, and the milestone payment due within
thirty (30) days after [**********] of the H1N1 Product in Mexico for H1N1
influenza shall be [**********].
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2.
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In
the event that the H1N1 Product receives [**********] for H1N1 influenza
in Mexico (the “Mexico Trigger Event”), in addition to the royalties
payable pursuant to Section 3.1.6 of the Agreement, Novavax shall pay or
cause to be paid to Wyeth, pursuant to Section 3.4 of the Agreement, a
separate royalty equal to [**********] of all [**********] of the H1N1
Product in Mexico for H1N1 influenza by Novavax or any of its Affiliates
or permitted sublicensees (such additional, separate royalty payments are
referred to as the “Additional Royalties”) until such time as Novavax and
its Affiliates and permitted sublicensees have paid to Wyeth Additional
Royalties in the aggregate amount of [**********], subject to paragraph 3
below.
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3.
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In
the event that the H1N1 Product receives [**********] for H1N1 influenza
in any jurisdiction other than Mexico at any time after the Mexico Trigger
Event when Novavax has paid to Wyeth Additional Royalties pursuant to
paragraph 2 above in an aggregate amount less than [**********], Novavax
shall, within thirty (30) days after such [**********], pay to Wyeth an
amount (the “H1N1 [**********] Makeup Amount”) equal to (a) [**********]
minus
(b)
the aggregate amount of Additional Royalties paid to Wyeth pursuant to
paragraph 2 above through the date of such [**********]. Upon
payment of the H1N1 [**********] Makeup Amount, Novavax and its Affiliates
and permitted sublicenses shall have no further obligation to pay any
Additional Royalties to Wyeth.
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4.
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Nothing
herein shall affect the obligations of Novavax, its Affiliates and its
permitted sublicensees to make any payments to Wyeth under Section 3.1.3
or 3.1.4 of the Agreement for any Product other than the H1N1 Product or
for any indication for the H1N1 Product other than H1N1
influenza.
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5.
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In
all other respects the Agreement shall remain in full force and
effect.
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NOVAVAX,
INC.
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WYETH
HOLDINGS
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CORPORATION
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By:
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/s/ Rahul Singhvi
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By:
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/s/ Arthur J. Cohn
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Name:
Rahul Singhvi, Sc.D.
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Name: Arthur
J. Cohn
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Title:
President and CEO
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Title: Vice
President
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1.
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Engagement
.
Upon the
terms and subject to the conditions set forth in this Agreement, Novavax
hereby agrees to engage Consultant as an independent contractor, to render
services to and on behalf of Novavax and Consultant hereby agrees to
render such services to and on behalf of
Novavax.
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2.
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Consultant
Services
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The
Consultant shall provide the services described in
Exhibit A
(the
“Services”).
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3.
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Provisions
of Services – Prior
Approval
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3.1
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Production of
Deliverables
. Consultant’s performance of Services shall
only include the completion and delivery of deliverables that may be set
forth on
Exhibit
A
(“Deliverables”). Novavax shall not be liable to
Consultant for the cost of any Deliverables not performed pursuant to
Novavax’s request for or assent to the production of such Deliverables in
writing.
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3.2
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Meetings
. Consultant
shall attend meetings at Novavax or elsewhere pursuant to the written
agreement of Novavax and Consultant, identifying the location and timing
of the meeting. Novavax shall be liable for Consultant’s fees
and related expenses only for attendance at meetings mutually agreed to in
writing by both parties.
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4.
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Fees and
Invoicing.
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4.1
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Fees
.
In full
consideration of the provision of the Services and the obligations
undertaken pursuant to this Agreement, Novavax agrees to pay Consultant at
the rate of $375 per hour up to the initial 8 hours in a particular day
and capped at $3000 per day for any work in excess of 8
hours.
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4.2
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Expenses
.
Novavax shall reimburse Consultant for the reasonable transportation costs
and related expenses incurred by Consultant in connection with the
Services that are approved in advance by Novavax, payable upon receipt of
invoice with copies of receipts for such expenses. Novavax will provide
reimbursement for legitimate, approved business related expenses. These
include business class travel (via British Airways or other similar
airlines), meals, hotel, rental car, use of own car, telephone, and other
items. Consultant shall submit itemized documentation and receipts to
Novavax at the time reimbursement is requested. Such documentation will be
audited to ensure that charges are reasonable and customary. Consultant
shall bear the cost of all other expenses incurred by Consultant in
connection with the performance of the Services, unless otherwise agreed
in writing.
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4.3
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Invoicing
. No
later than thirty (30) days after the end of each calendar quarter,
Consultant shall provide Novavax with an invoice detailing all time spent
by Consultant in performing the Services, the expenses incurred by
Consultant in connection therewith that were approved by Novavax, and the
total amount due to Consultant. The invoices shall provide a narrative
description of the activity performed, the time spent by Consultant
performing such activities, and shall contain such other information in
such detail as Novavax may reasonably request. Subject to the terms and
conditions set forth herein, Novavax shall pay all amounts due hereunder,
and not disputed in good faith, within thirty (30) days after its receipt
of such invoice.
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4.4
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Relationship of the
Parties
. The relationship of the Consultant to the Company
hereunder is that of independent contractor. Nothing herein shall be
deemed to create any partnership, association or joint venture between the
parties. Consultant shall not be construed for any purpose to be an
employee subject to the control and direction of the Company or any of its
affiliates. Consultant shall not be entitled to any of the benefits,
coverages or privileges, including, without limitation, social security,
unemployment, medical or pension payments, made available to employees of
the Company. The Consultant shall have sole responsibility, subject to
rules promulgated by the U.S. Internal Revenue Service (the “IRS”), for
the proper reporting and payment of any and all applicable U. S. taxes due
on payments made to the Consultant by the Company
hereunder.
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5.
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Term
and Termination
.
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5.1
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Term and
Termination
. This Agreement shall commence on the date
set forth above and expire twelve (12) months thereafter, unless
terminated earlier as set forth in this Paragraph 5.1. Upon
mutual written agreement no later than thirty (30) days before the
anniversary of the Effective Date, this agreement may be renewed for
additional twelve (12) month
periods.
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(a)
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Novavax
may terminate this Agreement before its expiration or any specific
Services for any reason upon thirty (30) days advance written notice to
Consultant.
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(b)
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Consultant
may terminate this Agreement and/or any specific Services if Novavax is in
default of any of its material obligations set forth herein, and such
breach is not cured within thirty (30) days after Novavax’s receipt of a
written notice from Consultant that describes such breach in reasonable
detail.
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5.2
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Duties Upon
Termination
. Upon termination of this Agreement for any
reason, the Consultant shall promptly deliver to Novavax all Confidential
Information and all copies thereof and immediately cease all use of
Confidential Information and the Intellectual Work
Product.
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6.
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Confidential
Information
.
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6.1
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Without
the express prior written consent of Novavax, Consultant shall only use
for the purpose of rendering the Services and shall not disclose or use
any Confidential Information (as defined below) of Novavax for
Consultant’s direct or indirect benefit or the direct or indirect benefit
of any third party, and Consultant shall maintain, both during and for
seven years after Consultant’s engagement, the confidentiality of all
Confidential Information of Novavax. The term "Confidential Information"
shall include all information disclosed to Consultant by Novavax including
without limitation: trade secrets, know-how, patent applications or
patentable improvements thereto, biomedical technology, inventions,
writings, blueprints, computer programs, documents, engineering
specifications, diagrams, charts, models, research studies, assays,
marketing studies, process descriptions, manufacturing processes,
projections, information relating to customers, suppliers, distributors,
licensees, profits, costs, pricing or tooling, and all other materials or
information relating to or dealing with the business operations,
technologies or activities of Novavax, whether written, oral, electronic
or visual, tangible or intangible, whether machine readable or otherwise
and shall also include the existence of any relationship between Novavax
and Consultant, including but not limited to the terms of this Agreement
and the terms of the engagement by Novavax of Consultant;
and all information and
materials prepared by Consultant in the course of, relating to or arising
out of his engagement by Novavax, or prepared by any other Novavax
employee or contractor for Novavax or its customers. Failure to mark any
of the Confidential Information as confidential or proprietary shall not
affect its status as Confidential Information under the terms of this
Agreement.
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6.2
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At
Novavax’s request, Consultant shall immediately: (i) discontinue all use
of all Confidential Information; (ii) return to Novavax all materials then
in Consultant’s possession or subject to its control that contain
Confidential Information, including all copies thereof and all summaries,
analyses and notes thereon; (iii) erase or destroy all Confidential
Information contained in computer memory or data storage apparatus under
the ownership or control of Consultant; and (iv) warrant in writing to
Novavax that Consultant has taken all actions described in the foregoing
Subparagraphs 6.2(i)-(iii).
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6.3
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The
restrictions set forth in this Section 6 shall not apply to Confidential
Information that:
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(a)
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is
rightfully in the possession of the receiving party prior to the date of
the disclosure of such information to the receiving party by the
disclosing party;
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(b)
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is
in the public domain prior to the date of the disclosure of such
information to the receiving party by the disclosing
party;
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(c)
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becomes
part of the public domain by publication or by any other means except an
unauthorized act or omission on the part of the receiving party or its
employees, consultants or advisors;
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(d)
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is
or was supplied to the receiving party on a non-confidential basis by a
third party who is under no obligation to the disclosing party to maintain
such information in confidence. Specific information disclosed
as part of the Confidential Information shall not be deemed to be in the
public domain or in the prior possession of Consultant merely because it
is embraced by more general information in the public domain or in the
prior possession of Consultant.
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6.4
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Securities
Trading
. Consultant further agrees that it will conform
in all respects to the securities and trading policies of Company and with
the laws and regulations governing activities including, buying, selling
or otherwise trading securities of the Company. Consultant
shall consult with the Chief Financial Officer of Company as to when such
trading shall be permitted.
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7.
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Property
Rights
. All work produced hereunder, including, without limitation,
all inventions, ideas, creations, designs, discoveries, developments,
techniques, expressions, improvements, computer programs, specifications,
operating instructions and all other documentation, data or other work
product related to the Services provided by the Consultant under this
Agreement (whether patentable or subject to copyright, or not), which are
first conceived, made or otherwise originated or acquired or first
actually constructively reduced to practice during the Term or within six
(6) months following the expiration or termination of the Term, whether
preliminary or final, and on whatever media rendered (collectively, the
“Work Product”), shall be deemed work made for hire and made in the course
of services rendered for the Company and shall be the sole and exclusive
property of the Company. The Company shall have the sole, absolute and
unlimited right throughout the world to protect by patent or copyright,
and to make, have made, use, reconstruct, repair, modify reproduce,
publish, distribute and sell the Work Product, in whole or in part, or
combine the Work Product with other matter, or not use the Work Product at
all, as it sees fit. To the extent that title to the Work Product may not
be considered work for hire, the Consultant irrevocably agrees to transfer
and assign to the Company in perpetuity all worldwide right, title and
interest in and to the patent rights, copyrights, trade secrets and other
proprietary rights (including, without limitation, applications for
registrations thereof) in, and ownership of, the Work Product that the
Consultant may have, as and when such rights arise. The Consultant further
agrees that it will execute, and will cause its applicable employees to
execute, all documents necessary to enable the Company to protect and
record its ownership of the Work
Product.
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8.
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Authority
to Contract
.
The Company represents
and warrants to Consultant that the execution and delivery of this
Agreement and the performance of the provisions hereof have been duly
authorized by all necessary action on its part, that this Agreement has
been duly and validly executed and delivered by it, that this Agreement
constitutes a valid and legally binding agreement enforceable against it
in accordance with its terms. Consultant represents and warrants to the
Company that this Agreement has been duly and validly executed and
delivered by him or her, that this Agreement constitutes a valid and
legally binding agreement enforceable against him or her in accordance
with its terms, and that neither the execution and delivery of this
Agreement nor the performance of the provisions hereof constitute or will
constitute a violation of any contract, or other agreement or relationship
to which he or she is a party or by which he or she is
bound.
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9.
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Debarment.
Consultant has not been debarred under the provisions of the Generic Drug
Enforcement Act of 1992, including without limitation, 21 U.S.C. Section
335a. If at any time during the term of this Agreement Consultant (a)
becomes debarred, or (b) receives notice of action or threat of action
with respect to its debarment, Consultant shall notify Novavax
immediately. In the event that Consultant becomes debarred as set forth
above, this Agreement shall automatically terminate upon receipt of such
notice without any further action or notice. In the event that Consultant
receives notice of action as set forth above, Novavax shall have the right
to terminate this Agreement
immediately.
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10.
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Governing
Law
. This Agreement shall be construed and enforced in
accordance with the laws of the State of Maryland, without regard to the
conflict of law principles of Maryland or any other
jurisdiction.
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11.
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Equitable
Relief
. In the event that any provision of Section 6 or
7 shall be declared by a court of competent jurisdiction to exceed the
maximum time period or areas such court deems reasonable and enforceable,
said time period and/or areas of restriction shall be deemed to become and
thereafter be the maximum time period and/or areas which such court deems
reasonable and enforceable. Consultant recognizes and agrees
that the Company’s remedy at law for any breach of the provisions of
Sections 6 or 7 hereof would be inadequate, and Consultant agrees that for
breach of such provisions, the Company shall, in addition to such other
remedies as may be available to it at law or in equity or as provided in
this Agreement, be entitled to injunctive relief and to enforce its rights
by an action for specific
performance.
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12.
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Miscellaneous
.
This Agreement and the Exhibit attached hereto (which is incorporated
herein by reference) contains the entire agreement and understanding of
the parties relating to the subject matter hereof and merges and
supersedes all prior discussions, agreements and understandings of every
nature between them. This Agreement may not be changed or modified, except
by an agreement in writing signed by both of the parties hereto. The
waiver of the breach of any term or provision of this Agreement shall not
operate as or be construed to be a waiver of any other or subsequent
breach of this Agreement. The obligations of Consultant as set forth
herein, other than Consultant’s obligations to perform the Services, shall
survive the termination of Consultant’s engagement with Novavax. Novavax
may assign this Agreement to, and this Agreement shall bind and inure to
the benefit of, any parent, subsidiary, affiliate or successor of Novavax.
This Agreement shall not be assignable by Consultant. This Agreement may
be executed in any number of counterparts, and each such counterpart shall
be deemed to be an original instrument, but all such counterparts together
shall constitute but one agreement.
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NOVAVAX,
INC.
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By:
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/s/ Frederick W.
Driscoll
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Name:
Frederick W. Driscoll
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Title:
Vice President, Chief Financial Officer and Treasurer
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John
Lambert:
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/s/ John Lambert
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a)
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designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
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b)
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designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
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c)
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evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluations;
and
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d)
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disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting; and
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By:
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/s/ Rahul Singhvi
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President
and Chief Executive Officer
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By:
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/s/ Frederick W.
Driscoll
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Vice
President, Chief Financial Officer and
Treasurer
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By:
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/s/ Rahul Singhvi
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President and Chief Executive Officer |
By:
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/s/ Frederick W.
Driscoll
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Vice
President, Chief Financial Officer and
Treasurer
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