peregrine_10q-013109.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
ý
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For
the quarterly period ended January 31,
2009
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For the transition period from
_______________ to
_______________
|
Commission
file number: 0-17085
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
|
|
95-3698422
|
(State or other jurisdiction
of
incorporation or
organization)
|
|
(I.R.S.
Employer
Identification
No.)
|
|
|
|
14282 Franklin Avenue, Tustin,
California
|
|
92780-7017
|
(Address of principal
executive offices)
|
|
(Zip
Code)
|
(714)
508-6000
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes ý No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one)
|
Large Accelerated
Filer o |
Accelerated
Filer ý |
|
Non- Accelerated
Filer o |
Smaller reporting
company o |
|
|
|
Indicate
by checkmark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act).
Yes o No ý
As of
January 31, 2009, there were 226,210,617 shares of common stock, $0.001 par
value, outstanding.
PEREGRINE
PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
|
|
Page
No.
|
|
|
|
|
Item
1.
|
Consolidated
Financial Statements (unaudited):
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
1
|
|
Condensed
Consolidated Statements of Operations
|
|
3
|
|
Condensed
Consolidated Statements of Cash Flows
|
|
4
|
|
Notes
to Condensed Consolidated Financial Statements
|
|
5
|
|
|
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
16
|
|
Company
Overview
|
|
16
|
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
|
27
|
|
|
|
|
Item
4.
|
Controls
and Procedures
|
|
27
|
|
|
|
PART
II - OTHER INFORMATION
|
|
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
|
27
|
|
|
|
|
Item
1A.
|
Risk
Factors
|
|
28
|
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
43
|
|
|
|
|
Item
3.
|
Defaults
upon Senior Securities
|
|
43
|
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
|
43
|
|
|
|
|
Item
5.
|
Other
Information
|
|
43
|
|
|
|
|
Item
6.
|
Exhibits
|
|
43
|
SIGNATURES
|
|
44
|
The terms “we,” “us,” “our,” “the Company,” and “Peregrine,” as used in this Report on Form 10-Q refers to Peregrine
Pharmaceuticals, Inc. and its wholly owned subsidiary, Avid Bioservices,
Inc.
PART I - FINANCIAL
INFORMATION
ITEM
1. CONSOLIDATED FINANCIAL
STATEMENTS
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
JANUARY
31,
2009
|
|
|
APRIL
30,
2008
|
|
|
|
Unaudited
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
10,850,000 |
|
|
$ |
15,130,000 |
|
Trade
and other receivables
|
|
|
1,990,000 |
|
|
|
605,000 |
|
Government
contract receivables
|
|
|
362,000 |
|
|
|
- |
|
Inventories,
net
|
|
|
5,547,000 |
|
|
|
2,900,000 |
|
Debt
issuance costs, current portion
|
|
|
248,000 |
|
|
|
- |
|
Prepaid
expenses and other current assets
|
|
|
685,000 |
|
|
|
1,208,000 |
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
19,682,000 |
|
|
|
19,843,000 |
|
|
|
|
|
|
|
|
|
|
PROPERTY:
|
|
|
|
|
|
|
|
|
Leasehold
improvements
|
|
|
675,000 |
|
|
|
669,000 |
|
Laboratory
equipment
|
|
|
4,205,000 |
|
|
|
4,140,000 |
|
Furniture,
fixtures and office equipment
|
|
|
901,000 |
|
|
|
919,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
5,781,000 |
|
|
|
5,728,000 |
|
Less
accumulated depreciation and amortization
|
|
|
(3,982,000 |
) |
|
|
(3,670,000 |
) |
|
|
|
|
|
|
|
|
|
Property, net
|
|
|
1,799,000 |
|
|
|
2,058,000 |
|
|
|
|
|
|
|
|
|
|
OTHER
ASSETS:
|
|
|
|
|
|
|
|
|
Debt
issuance costs, less current portion
|
|
|
189,000 |
|
|
|
- |
|
Other
assets
|
|
|
1,156,000 |
|
|
|
1,156,000 |
|
|
|
|
|
|
|
|
|
|
Total other
assets
|
|
|
1,345,000 |
|
|
|
1,156,000 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$ |
22,826,000 |
|
|
$ |
23,057,000 |
|
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
|
|
JANUARY
31,
2009
|
|
|
APRIL
30,
2008
|
|
|
|
Unaudited
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
2,886,000 |
|
|
$ |
2,060,000 |
|
Accrued
clinical trial site fees
|
|
|
744,000 |
|
|
|
237,000 |
|
Accrued
legal and accounting fees
|
|
|
247,000 |
|
|
|
450,000 |
|
Accrued
royalties and license fees
|
|
|
123,000 |
|
|
|
222,000 |
|
Accrued
payroll and related costs
|
|
|
1,010,000 |
|
|
|
1,084,000 |
|
Capital
lease obligation, current portion
|
|
|
21,000 |
|
|
|
22,000 |
|
Notes
payable, current portion and net of discount
|
|
|
948,000 |
|
|
|
- |
|
Deferred
revenue
|
|
|
4,805,000 |
|
|
|
2,196,000 |
|
Deferred
government contract revenue
|
|
|
3,262,000 |
|
|
|
- |
|
Customer
deposits
|
|
|
706,000 |
|
|
|
838,000 |
|
Other
current liabilities
|
|
|
459,000 |
|
|
|
331,000 |
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
15,211,000 |
|
|
|
7,440,000 |
|
|
|
|
|
|
|
|
|
|
Capital
lease obligation, less current portion
|
|
|
6,000 |
|
|
|
22,000 |
|
Notes
payable, less current portion and net of discount
|
|
|
3,667,000 |
|
|
|
- |
|
Other
long-term liabilities
|
|
|
150,000 |
|
|
|
- |
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Preferred
stock-$0.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
|
|
- |
|
|
|
- |
|
Common
stock-$0.001 par value; authorized 325,000,000 shares;
outstanding – 226,210,617 and 226,210,617,
respectively
|
|
|
226,000 |
|
|
|
226,000 |
|
Additional
paid-in capital
|
|
|
247,317,000 |
|
|
|
246,205,000 |
|
Accumulated
deficit
|
|
|
(243,751,000 |
) |
|
|
(230,836,000 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
|
3,792,000 |
|
|
|
15,595,000 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
$ |
22,826,000 |
|
|
$ |
23,057,000 |
|
See
accompanying notes to condensed consolidated financial
statements
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
THREE
MONTHS ENDED
|
|
|
NINE
MONTHS ENDED
|
|
|
|
January
31,
2009
|
|
|
January
31,
2008
|
|
|
January
31,
2009
|
|
|
January
31,
2008
|
|
|
|
Unaudited
|
|
|
Unaudited
|
|
|
Unaudited
|
|
|
Unaudited
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
manufacturing revenue
|
|
$ |
5,778,000 |
|
|
$ |
1,662,000 |
|
|
$ |
7,954,000 |
|
|
$ |
5,146,000 |
|
Government
contract revenue
|
|
|
1,048,000 |
|
|
|
- |
|
|
|
2,330,000 |
|
|
|
- |
|
License
revenue
|
|
|
- |
|
|
|
13,000 |
|
|
|
- |
|
|
|
46,000 |
|
Total
revenues
|
|
|
6,826,000 |
|
|
|
1,675,000 |
|
|
|
10,284,000 |
|
|
|
5,192,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS
AND EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of contract manufacturing
|
|
|
4,106,000 |
|
|
|
1,289,000 |
|
|
|
5,672,000 |
|
|
|
3,872,000 |
|
Research
and development
|
|
|
4,465,000 |
|
|
|
4,941,000 |
|
|
|
12,834,000 |
|
|
|
13,665,000 |
|
Selling,
general and administrative
|
|
|
1,489,000 |
|
|
|
1,847,000 |
|
|
|
4,722,000 |
|
|
|
5,498,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
costs and expenses
|
|
|
10,060,000 |
|
|
|
8,077,000 |
|
|
|
23,228,000 |
|
|
|
23,035,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(3,234,000 |
) |
|
|
(6,402,000 |
) |
|
|
(12,944,000 |
) |
|
|
(17,843,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income
|
|
|
37,000 |
|
|
|
259,000 |
|
|
|
165,000 |
|
|
|
851,000 |
|
Interest
and other expense
|
|
|
(135,000 |
) |
|
|
(11,000 |
) |
|
|
(136,000 |
) |
|
|
(25,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$ |
(3,332,000 |
) |
|
$ |
(6,154,000 |
) |
|
$ |
(12,915,000 |
) |
|
$ |
(17,017,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE COMMON
SHARES OUTSTANDING:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and Diluted
|
|
|
226,210,617 |
|
|
|
226,210,617 |
|
|
|
226,210,617 |
|
|
|
219,497,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
See
accompanying notes to condensed consolidated financial
statements
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
NINE
MONTHS ENDED JANUARY 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
Unaudited
|
|
|
Unaudited
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(12,915,000 |
) |
|
$ |
(17,017,000 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
385,000 |
|
|
|
353,000 |
|
Share-based
compensation
|
|
|
698,000 |
|
|
|
627,000 |
|
Amortization
of expenses paid in shares of common stock
|
|
|
255,000 |
|
|
|
- |
|
Amortization
of discount on notes payable and debt issuance costs
|
|
|
61,000 |
|
|
|
- |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Trade
and other receivables
|
|
|
(1,385,000 |
) |
|
|
(566,000 |
) |
Government
contract receivables
|
|
|
(362,000 |
) |
|
|
- |
|
Inventories,
net
|
|
|
(2,647,000 |
) |
|
|
(478,000 |
) |
Prepaid
expenses and other current assets
|
|
|
268,000 |
|
|
|
(135,000 |
) |
Accounts
payable
|
|
|
826,000 |
|
|
|
704,000 |
|
Accrued
clinical trial site fees
|
|
|
507,000 |
|
|
|
16,000 |
|
Accrued
payroll and related costs
|
|
|
(74,000 |
) |
|
|
(16,000 |
) |
Deferred
revenue
|
|
|
2,609,000 |
|
|
|
370,000 |
|
Deferred
government contract revenue
|
|
|
3,262,000 |
|
|
|
- |
|
Customer
deposits
|
|
|
(132,000 |
) |
|
|
336,000 |
|
Other
accrued expenses and current liabilities
|
|
|
(24,000 |
) |
|
|
(197,000 |
) |
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities
|
|
|
(8,668,000 |
) |
|
|
(16,003,000 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Refund
of security deposits on notes payable
|
|
|
- |
|
|
|
150,000 |
|
Property
acquisitions
|
|
|
(126,000 |
) |
|
|
(314,000 |
) |
Increase
in other assets
|
|
|
- |
|
|
|
(410,000 |
) |
|
|
|
|
|
|
|
|
|
Net cash used in investing
activities
|
|
|
(126,000 |
) |
|
|
(574,000 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of common stock, net of issuance costs
of $1,641,000
|
|
|
- |
|
|
|
20,932,000 |
|
Proceeds
from issuance of notes payable, net of issuance costs
of $469,000
|
|
|
4,531,000 |
|
|
|
- |
|
Principal
payments on notes payable
|
|
|
- |
|
|
|
(323,000 |
) |
Principal
payments on capital leases
|
|
|
(17,000 |
) |
|
|
(13,000 |
) |
Net cash provided by financing
activities
|
|
|
4,514,000 |
|
|
|
20,596,000 |
|
|
|
|
|
|
|
|
|
|
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
(4,280,000 |
) |
|
|
4,019,000 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS,
beginning of period
|
|
|
15,130,000 |
|
|
|
16,044,000 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH
EQUIVALENTS, end of period
|
|
$ |
10,850,000 |
|
|
$ |
20,063,000 |
|
|
|
|
|
|
|
|
|
|
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Applied
security deposit on payoff of notes payable to GE
Capital
|
|
$ |
- |
|
|
$ |
175,000 |
|
Fair
market value of warrants issued in connection with notes payable |
|
$ |
414,000 |
|
|
$ |
- |
|
See
accompanying notes to condensed consolidated financial
statements
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
1. BASIS
OF PRESENTATION
The accompanying interim condensed
consolidated financial statements include the accounts of Peregrine
Pharmaceuticals, Inc. (“Peregrine”), a clinical stage biopharmaceutical company
developing monoclonal antibodies (“MAb”) for the treatment of cancer and
serious viral infections, and its wholly owned subsidiary, Avid Bioservices,
Inc. (“Avid”), a bio-manufacturing company engaged in providing contract
manufacturing services for Peregrine and outside customers on a fee-for-service
basis (collectively, the “Company”). All intercompany balances and
transactions have been eliminated.
In addition, the accompanying interim
condensed consolidated financial statements are unaudited; however they contain
all adjustments (consisting only of normal recurring adjustments) which, in the
opinion of management, are necessary to present fairly the condensed
consolidated financial position of the Company at January 31, 2009, and the
condensed consolidated results of our operations and our condensed consolidated
cash flows for the three and nine month periods ended January 31, 2009 and
2008. We prepared the condensed consolidated financial statements
following the requirements of the Securities and Exchange Commission (or SEC)
for interim reporting. As permitted under those rules, certain
footnotes or other financial information that are normally required by U.S.
generally accepted accounting principles (or GAAP) can be condensed or
omitted. Although we believe that the disclosures in the financial
statements are adequate to make the information presented herein not misleading,
the information included in this quarterly report on Form 10-Q should be read in
conjunction with the consolidated financial statements and accompanying notes
included in our Annual Report on Form 10-K for the year ended April 30,
2008. Results of operations for interim periods covered by this
quarterly report on Form 10-Q may not necessarily be indicative of results of
operations for the full fiscal year.
Going Concern – Our interim
condensed consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the satisfaction
of liabilities in the normal course of business. The financial
statements do not include any adjustments relating to the recoverability of the
recorded assets or the classification of liabilities that may be necessary
should it be determined that we are unable to continue as a going
concern.
At
January 31, 2009, we had $10,850,000 in cash and cash equivalents. We
have expended substantial funds on the research, development and clinical trials
of our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2008, 2007 and 2006 amounted
to $23,176,000, $20,796,000, and $17,061,000, respectively. Unless
and until we are able to generate sufficient revenues from Avid’s contract
manufacturing services and/or from the sale and/or licensing of our products
under development, we expect such losses to continue for the foreseeable
future.
Therefore,
our ability to continue our clinical trials and development efforts is highly
dependent on the amount of cash and cash equivalents on hand combined with our
ability to raise additional capital to support our future
operations.
We will
need to raise additional capital through one or more methods, including but not
limited to, issuing additional equity or debt, in order to support the costs of
our research and development programs.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Regarding
possible issuance of equity to raise additional capital, as of January 31, 2009,
we had 4,851,454 shares available under an existing effective Form S-3
registration statement for possible future registered transactions provided,
however, we issue these shares prior to April 12, 2009 (the expiration date of
this registration statement). In addition, we filed a separate shelf
registration statement on Form S-3, File Number 333-139975, under which we may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While we
will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to Avid to complete the research,
development, and clinical testing of our product candidates. Based on
our current projections, which include projected revenues under signed contracts
with existing customers of Avid, combined with the projected revenues from our
government contract, we believe we have sufficient cash on hand combined with
amounts expected to be received from Avid customers and from our government
contract to meet our obligations as they become due through at least the second
quarter of our fiscal year 2010 ending October 31, 2009. There are a
number of uncertainties associated with our financial projections, including but
not limited to, termination of contracts and technical challenges, which could
reduce or delay our future projected cash-inflows. In addition, under
the Loan Agreement, in the event our contract with the Defense Threat Reduction
Agency is terminated or canceled for any reason, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessable by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
second quarter of our fiscal year 2010 unless we raise additional
capital. The uncertainties surrounding our future cash inflows have
raised substantial doubt regarding our ability to continue as a going
concern.
2. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Revenue Recognition – We
currently derive revenues primarily from contract manufacturing services
provided by Avid and from services performed under a government contract awarded
to Peregrine through the Transformational Medical Technologies Initiative (TMTI)
of the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) that
was signed on June 30, 2008.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
We recognize revenues pursuant to the
SEC’s Staff Accounting Bulletin No. 104 (“SAB No. 104”), Revenue
Recognition. In accordance with SAB No. 104, revenue is
generally realized or realizable and earned when (i) persuasive evidence of an
arrangement exists, (ii) delivery has occurred or services have been rendered,
(iii) the seller's price to the buyer is fixed or determinable, and (iv)
collectibility is reasonably assured.
In addition, we comply with Emerging
Issues Task Force (“EITF”) Issue No. 00-21, Revenue Arrangements with Multiple
Deliverables, EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent, and Accounting Research Bulletin No. 43
Chapter 11, Government
Contracts.
Revenues associated with contract
manufacturing services provided by Avid are generally recognized once the
service has been provided and/or upon shipment of the product to the
customer. We also record a provision for estimated contract losses,
if any, in the period during which they are determined.
Our
contract with the DTRA is a “cost-plus-fixed-fee”
contract. Reimbursable costs under the contract primarily
include direct labor, subcontract costs, materials, equipment, travel, indirect
costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is recognized as we perform the underlying
research and development activities. However, progress payments
associated with contract manufacturing services performed under the DTRA
contract are classified as Deferred Government Contract Revenue and are
recognized as revenue upon delivery or transfer of legal title of the product to
the DTRA.
Allowance for Doubtful
Accounts –
We continually monitor our allowance for doubtful accounts for all
receivables. A considerable amount of judgment is required in
assessing the ultimate realization of these receivables and we estimate an
allowance for doubtful accounts based on these factors at that point in
time. As of January 31, 2009, based on our analysis of our accounts
receivable balances and based on historical collectibility of receivables from
our current customers, we determined no allowance for doubtful accounts was
necessary.
Inventories – Inventories are
stated at the lower of cost or market and primarily include raw materials,
direct labor and overhead costs associated with our wholly owned
subsidiary, Avid. Inventories consist of the following at January 31,
2009 and April 30, 2008:
|
|
January
31,
2009
|
|
|
April
30,
2008
|
|
Raw
materials
|
|
$ |
2,176,000 |
|
|
$ |
1,115,000 |
|
Work-in-process
|
|
|
3,371,000 |
|
|
|
1,785,000 |
|
Total
inventories, net
|
|
$ |
5,547,000 |
|
|
$ |
2,900,000 |
|
Comprehensive Loss –
Comprehensive loss is equal to net loss for all periods presented.
Reclassification – Certain
amounts in the fiscal year 2008 condensed consolidated financial statements have
been reclassified to conform to the current year presentation.
Customer Deposits – Customer
deposits primarily represent advance billings and/or advance payments received
from customers prior to the initiation of contract manufacturing
services.
Basic and Dilutive Net Loss Per
Common Share – Basic and dilutive net loss per common share are
calculated in accordance with Statement of Financial Accounting Standards No.
128, Earnings per
Share. Basic net loss per common share is computed by dividing
our net loss by the weighted average number of common shares outstanding during
the period excluding the dilutive effects of options and
warrants. Diluted net loss per common share is computed by dividing
the net loss by the sum of the weighted average number of common shares
outstanding during the period plus the potential dilutive effects of options and
warrants outstanding during the period calculated in accordance with the
treasury stock method, but are excluded if their effect is
anti-dilutive. Because the impact of options and warrants are
anti-dilutive during periods of net loss, there was no difference between basic
and diluted loss per share amounts for the three and nine months ended January
31, 2009 and 2008.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
The calculation of weighted average
diluted shares outstanding excludes the dilutive effect of options and warrants
to purchase up to 209,136 and 132,286 shares of common stock for the three and
nine months ended January 31, 2009, respectively, and 357,542 and 722,641
shares of common stock for the three and nine months ended January 31, 2008,
respectively, since the impact of such options and warrants are anti-dilutive
during periods of net loss.
The calculation of weighted average
diluted shares outstanding also excludes weighted average outstanding options
and warrants to purchase up to 12,790,740 and 13,101,259 shares of common stock
for the three and nine months ended January 31, 2009, respectively, and
11,193,227 and 10,530,120 shares of common stock for the three and nine months
ended January 31, 2008, respectively, as the exercise prices of those options
were greater than the average market price of our common stock during the
respective periods, resulting in an anti-dilutive effect.
Recent Accounting
Pronouncements - In September 2006, the Financial Accounting Standards
Board (“FASB”) issued Statement of Financial Accounting Standards No. 157
(“SFAS No. 157”), Fair Value
Measurements, which defines fair value, establishes a framework for
measuring fair value under GAAP, and expands disclosures about fair value
measurements. SFAS No. 157 establishes a three-level hierarchy that
prioritizes the inputs used to measure fair value. The hierarchy
defines the three levels of inputs to measure fair value, as
follows:
·
|
Level
1 – Quoted prices in active markets for identical assets or
liabilities.
|
·
|
Level
2 – Observable inputs other than quoted prices included in Level 1, such
as assets or liabilities whose value are based on quoted market prices in
markets where trading occurs infrequently or whose values are based on
quoted prices of instruments with similar attributes in active
markets.
|
·
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and significant to the overall fair value
measurement.
|
We adopted SFAS No. 157 on
May 1, 2008, which did not have a material impact on our consolidated financial
statements as we currently do not have any Level 2 or Level 3 financial assets
or liabilities and cash and cash equivalents are carried at fair value based on
quoted market prices for identical securities (Level 1 input).
In February 2007, the FASB issued
Statement of Financial Accounting Standards No. 159 (“SFAS No. 159”), The Fair Value Option for Financial
Assets and Financial Liabilities – Including an amendment of FASB statement No.
115. SFAS No. 159 permits entities to choose to measure many
financial instruments and certain other items at fair value. If the
fair value method is selected, a business entity shall report unrealized gains
and losses on elected items in earnings at each subsequent reporting
date. The standard also establishes presentation and disclosure
requirements designed to facilitate comparisons between companies that choose
different measurement attributes for similar types of assets and
liabilities. We adopted SFAS No. 159 on May 1, 2008, which did not
have a material impact on our consolidated financial statements as the fair
value option was not elected for any of our financial assets or financial
liabilities.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
In June 2007, the FASB ratified EITF
Issue No. 07-3 (“EITF No. 07-3”), Accounting for Non-Refundable
Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities, which requires nonrefundable advance payments for
goods and services that will be used or rendered for future research and
development activities be deferred and capitalized. These amounts
will be recognized as expense in the period that the related goods are delivered
or the related services are performed. We adopted the provisions of
EITF No. 07-3 on May 1, 2008, which did not have a material impact on
our consolidated financial statements.
In November 2007, the FASB ratified
EITF Issue 07-01 (“EITF No. 07-01”), Accounting for Collaborative
Arrangements, which defines collaborative arrangements and requires that
revenues and costs incurred with third parties that do not participate in the
collaborative arrangements be reported in the statement of operations gross or
net pursuant to the guidance in EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent. Classification of payments
made between participants of a collaborative arrangement are to be based on
other applicable authoritative accounting literature or, in the absence of other
applicable authoritative accounting literature, based on analogy to
authoritative accounting literature or a reasonable, rational, and consistently
applied accounting policy election. EITF No. 07-01 will be
effective for fiscal years beginning after December 15, 2008, which we
would be required to implement no later than May 1, 2009, and applied as a
change in accounting principal to all prior periods retrospectively for all
collaborative arrangements existing as of the effective date. We have
not yet evaluated the potential impact of adopting EITF No. 07-01 on our
consolidated financial statements.
We account for stock options granted
under our equity compensation plans in accordance with Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment (Revised
2004). SFAS No. 123R requires the recognition of compensation
expense, using a fair value based method, for costs related to all share-based
payments including grants of employee stock options. In addition,
SFAS No. 123R requires companies to estimate the fair value of share-based
payment awards on the date of grant using an option-pricing
model. The value of the portion of the award that is ultimately
expected to vest is recognized as expense on a straight-line basis over the
requisite service periods (typically 2 to 4 years).
The fair value of each option grant is
estimated using the Black-Scholes option valuation model. The use of
a valuation model requires us to make certain estimates and assumptions with
respect to selected model inputs including estimated stock price volatility,
risk-free interest rate, expected dividends and projected employee stock option
exercise behaviors. In addition, SFAS No. 123R requires forfeitures to be
estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Total share-based compensation expense
related to employee stock option grants for the three and nine-month periods
ended January 31, 2009 and 2008 are included in the accompanying condensed
consolidated statements of operations as follows:
|
|
Three
Months Ended
January
31,
|
|
|
Nine
Months Ended
January
31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Research
and development
|
|
$ |
106,000 |
|
|
$ |
147,000 |
|
|
$ |
370,000 |
|
|
$ |
416,000 |
|
Selling,
general and administrative
|
|
|
97,000 |
|
|
|
84,000 |
|
|
|
320,000 |
|
|
|
196,000 |
|
Total
|
|
$ |
203,000 |
|
|
$ |
231,000 |
|
|
$ |
690,000 |
|
|
$ |
612,000 |
|
As of
January 31, 2009, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,314,000. This cost is expected to be
recognized over a weighted average vesting period of 2.17 years based on current
assumptions.
Periodically, we grant stock options to
non-employee consultants. The fair value of options granted to
non-employees are measured utilizing the Black-Scholes option valuation model
and are amortized over the estimated period of service or related vesting period
in accordance with EITF 96-18, Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. Share-based compensation expense
recorded during the three and nine months ended January 31, 2009 associated with
non-employees amounted to
$2,000 and $8,000,
respectively. Share-based compensation expense recorded during the
three and nine months ended January 31, 2008 associated with non-employees
amounted to $1,000 and $15,000, respectively.
4. GOVERNMENT
CONTRACT
On June 30, 2008, we were awarded a
five-year contract potentially worth up to $44.4 million to test and develop
bavituximab and an equivalent fully human antibody as potential broad-spectrum
treatments for viral hemorrhagic fever infections. The initial
contract was awarded through the Transformational Medical Technologies
Initiative (TMTI) of the U.S. Department of Defense's Defense Threat Reduction
Agency (DTRA). This federal contract is expected to provide us with
up to $22.3 million in funding over a 24-month base period, with $14.3
million having been appropriated through the current federal fiscal year
ending September 30, 2009. The remainder of the $22.3 million in
funding is expected to be appropriated over the remainder of the two-year base
period ending June 29, 2010. Subject to the progress of the program
and budgetary considerations in future years, the contract can be extended
beyond the base period to cover up to $44.4 million in funding over the
five-year contract period through three one-year option terms. Work
under this contract commenced on June 30, 2008 and direct costs associated with
the contract are included in research and development expense in the
accompanying condensed consolidated statements of operations.
5. NOTE
PAYABLE
On December 9, 2008, we
entered into a loan and security agreement pursuant to which we have the ability
to borrow up to $10,000,000 (“Loan Agreement”) with MidCap Financial LLC and
BlueCrest Capital Finance, L.P. On December 19, 2008, we received
initial funding of $5,000,000. In addition, we have an option, which
expires on June 30, 2009, to borrow a second tranche in the amount of $5,000,000
upon the satisfaction of certain clinical and financial conditions as
set forth in the Loan Agreement. As
of January 31, 2009, we had met all clinical conditions under the Loan
Agreement, however, we had not met the required financial
conditions. In order for us to meet the financial conditions and
receive the second tranche of $5,000,000 under the Loan Agreement (provided we
are not otherwise in default of any of our obligations under the Loan
Agreement), we must raise at least $7,500,000 in gross proceeds from the
issuance of new equity or obtain a defined amount in net proceeds from the
potential sale of our wholly owned subsidiary, Avid Bioservices, no later than
the expiration of the option.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Under the
Loan Agreement, the outstanding principal balance each month will bear interest
at the then current thirty (30) day LIBOR rate (set at a floor of 3%) plus
9%. The Loan Agreement allows for interest-only payments during the
initial six (6) months or until July 2009 followed by thirty (30) equal monthly
principal payments plus interest. The Loan Agreement, which is
secured by generally all assets of the Company, contains customary covenants
that, among other things, generally restricts our ability to incur additional
indebtedness. In addition, the Loan Agreement contains a covenant,
whereby if our contract with the Defense Threat Reduction Agency (Note 4) is
terminated while the loan is outstanding, we would be required to set aside cash
and cash equivalents in an amount equal to at least 80% of the outstanding loan
balance in a secured account over which we will not be permitted to make
withdrawals or otherwise exercise control. Moreover,
the Loan Agreement includes a Material Adverse Change clause whereby if there is
a material impairment in the priority of lenders’ lien in the collateral or in
the value of such collateral, or if we encounter a material adverse change in
our business, operations, or condition (financial or otherwise), or a material
impairment of the prospect of repayment of any portion of the loan, then an
event of default can be invoked by the lender.
The terms
of the Loan Agreement also include a provision for warrant coverage equal to 10%
of each tranche amount divided by the warrant exercise price. The warrant
exercise price was calculated based on the average closing price of our common
stock for the 20-day period prior to the date of the Loan
Agreement. The warrants are exercisable immediately, include
piggy-back registration rights, and have a five-year term. In
connection with the first tranche advance of $5,000,000, we issued MidCap
Financial LLC and BlueCrest Capital Finance, L.P. warrants of 1,184,433 and
507,614, respectively, to purchase an aggregate of 1,692,047 shares of our
common stock at an exercise price of $0.2955 per share. At the date
of the first tranche advance, the fair value of the warrants was $414,000, and
this amount was credited to additional paid-in capital and reduced the carrying
value of the debt, reflected as a debt discount in the accompanying condensed
consolidated financial statements. The debt discount is being
amortized as a non-cash interest expense over the term of the outstanding loan
using the effective interest method. The fair value of the warrants
was determined using the Black-Scholes model with the following
assumptions: estimated volatility of 70.72%; risk free interest rate
of 2.00%; an expected life of five years; and no dividend yield.
In
connection with the Loan Agreement, we also incurred $469,000 in financing fees
and legal costs related to closing the Loan Agreement. These fees and
costs are classified as debt issuance costs, and the short-term and long-term
portions of these costs are included in current assets and other long-term
assets, respectively, in the accompanying condensed consolidated financial
statements and are being amortized as a non-cash interest expense over the term
of the outstanding loan using the effective interest method. Included
in debt issuance costs is a final payment fee of $150,000, which is due and
payable on the maturity date of the outstanding loan balance, and is equal to 3%
of the total amount funded under the Loan Agreement. The final
payment fee payable of $150,000 is classified as other long-term liabilities in
the accompanying condensed consolidated financial statements.
As of
January 31, 2009, we will make the following principal payments in the years
ending April 30:
2009
|
|
$ |
- |
|
2010
|
|
|
1,667,000 |
|
2011
|
|
|
2,000,000 |
|
2012
|
|
|
1,333,000 |
|
Total
|
|
$ |
5,000,000 |
|
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
6. STOCKHOLDERS’
EQUITY
On June
28, 2007, we entered into a Securities Purchase Agreement with several
institutional investors whereby we sold 30,000,000 shares of our common stock in
exchange for gross proceeds of $22,500,000. After deducting placement
agent fees, legal fees and other costs associated with the offering, we received
net proceeds of $20,859,000. The shares of common stock were issued
from our shelf registration statement on Form S-3, File Number 333-139975
(“January 2007 Shelf”), which allows us to issue, in one or more offerings,
shares of common stock for proceeds up to $30,000,000. As of January
31, 2009, we could potentially raise up to $7,500,000 in remaining gross
proceeds under the January 2007 Shelf.
In
addition, as of January 31, 2009, an aggregate of 4,851,454 shares of common
stock were available for issuance under an existing effective shelf registration
statement, provided, however, we issue these shares prior to April 12, 2009 (the
expiration date of this registration statement).
As of January 31, 2009, we have
reserved 22,002,346 additional shares of our common stock which may be issued
under our shelf registration statement, stock option plans and outstanding
warrants, excluding shares of common stock that could potentially be issued
under the January 2007 Shelf, as further described in the following
table:
|
|
Number
of Shares
Reserved
|
|
Shares
of common stock reserved for issuance under one registration
statement
|
|
|
4,851,454 |
|
Shares
of common stock reserved for issuance upon exercise of outstanding
options
|
|
|
14,199,500 |
|
Shares
of common stock reserved for future option grants under our Option
Plans
|
|
|
1,259,345 |
|
Shares
of common stock reserved for issuance under outstanding warrant
arrangements
|
|
|
1,692,047 |
|
Total shares of common stock
reserved for issuance
|
|
|
22,002,346 |
|
7. WARRANTS
During
December 2008, we issued 1,692,047 warrants in connection with the loan and
security agreement we entered into on December 9, 2008 (Note 5). The
warrants, which are exercisable immediately, have an exercise price of $0.2955,
include piggy-back registration rights, and have a five-year term.
During
the nine months ended January 31, 2009, no warrants were exercised. During the
nine months ended January 31, 2008, warrants to purchase 53,416 shares of our
common stock were exercised for net proceeds of $46,000.
As of
January 31, 2009, warrants to purchase up to 1,692,047 shares of our common
stock were issued and outstanding at an exercise price of $0.2955 per share and
expire in December 2013.
8. SEGMENT
REPORTING
Our
business is organized into two reportable operating
segments. Peregrine is engaged in the research and development of
monoclonal antibody-based therapies for the treatment of cancer and serious
viral infections. Avid is engaged in providing contract manufacturing
services for Peregrine and outside customers on a fee-for-service
basis.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
The
accounting policies of the operating segments are the same as those described in
Note 2. We primarily evaluate the performance of our contract
manufacturing services segment based on gross profit or
loss. However, our products in the research and development segment
are not evaluated based on gross profit or loss, but rather based on scientific
progress of the technologies. As such, gross profit is only provided
for our contract manufacturing services segment in the below
table. All revenues shown below are derived from transactions with
external customers.
Segment
information for the three-month periods is summarized as follows:
|
|
Three
Months Ended January 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Contract
manufacturing services revenue
|
|
$ |
5,778,000 |
|
|
$ |
1,662,000 |
|
Cost
of contract manufacturing services
|
|
|
4,106,000 |
|
|
|
1,289,000 |
|
Gross
profit
|
|
|
1,672,000 |
|
|
|
373,000 |
|
|
|
|
|
|
|
|
|
|
Revenues
from products in research and development
|
|
|
1,048,000 |
|
|
|
13,000 |
|
Research
and development expense
|
|
|
(4,465,000 |
) |
|
|
(4,941,000 |
) |
Selling,
general and administrative expense
|
|
|
(1,489,000 |
) |
|
|
(1,847,000 |
) |
Other
income (expense), net
|
|
|
(98,000 |
) |
|
|
248,000 |
|
Net
loss
|
|
$ |
(3,332,000 |
) |
|
$ |
(6,154,000 |
) |
|
|
|
|
|
|
|
|
|
Revenues
generated from our contract manufacturing services segment were from the
following customers:
|
|
Three
Months Ended January 31,
|
|
|
|
2009
|
|
|
2008
|
|
Customer
revenues as a % of revenues:
|
|
|
|
|
|
|
|
|
United
States (customer A)
|
|
|
43% |
|
|
|
|
90% |
|
|
United
States (customer B)
|
|
|
26% |
|
|
|
|
0% |
|
|
Germany
(one customer)
|
|
|
28% |
|
|
|
|
10% |
|
|
Other
customers
|
|
|
3% |
|
|
|
|
0% |
|
|
Total
customer revenues as a % of revenues
|
|
|
100% |
|
|
|
|
100% |
|
|
Segment
information for the nine-month periods is summarized as follows:
|
|
Nine
Months Ended January 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Contract
manufacturing services revenue
|
|
$ |
7,954,000 |
|
|
$ |
5,146,000 |
|
Cost
of contract manufacturing services
|
|
|
5,672,000 |
|
|
|
3,872,000 |
|
Gross
profit
|
|
|
2,282,000 |
|
|
|
1,274,000 |
|
|
|
|
|
|
|
|
|
|
Revenues
from products in research and development
|
|
|
2,330,000 |
|
|
|
46,000 |
|
Research
and development expense
|
|
|
(12,834,000 |
) |
|
|
(13,665,000 |
) |
Selling,
general and administrative expense
|
|
|
(4,722,000 |
) |
|
|
(5,498,000 |
) |
Other
income (expense), net
|
|
|
29,000 |
|
|
|
826,000 |
|
Net
loss
|
|
$ |
(12,915,000 |
) |
|
$ |
(17,017,00 |
) |
|
|
|
|
|
|
|
|
|
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Revenues
generated from our contract manufacturing services segment were from the
following customers:
|
|
Nine
Months Ended January 31,
|
|
|
|
2009
|
|
|
2008
|
|
Customer
revenues as a % of revenues:
|
|
|
|
|
|
|
|
|
United
States (customer A)
|
|
|
56% |
|
|
|
|
86% |
|
|
United
States (customer B)
|
|
|
20% |
|
|
|
|
3% |
|
|
Germany
(one customer)
|
|
|
22% |
|
|
|
|
6% |
|
|
Other
customers
|
|
|
2% |
|
|
|
|
5% |
|
|
Total
customer revenues as a % of revenues
|
|
|
100% |
|
|
|
|
100% |
|
|
Revenues
generated from our products in our research and development segment during the
three and nine months ended January 31, 2009 were from revenues earned under the
government contract with the DTRA (Note 4). Revenues generated from
our products in our research and development segment during the three and nine
months ended January 31, 2008 were from an annual license fee and the amortized
portion of an up-front license fee received under a license
agreement.
Our
long-lived assets consist of leasehold improvements, laboratory equipment, and
furniture, fixtures and computer equipment and are net of accumulated
depreciation. Long-lived assets by segment consist of the
following:
|
|
January
31,
2009
|
|
|
April
30,
2008
|
|
Long-lived
Assets, net:
|
|
|
|
|
|
|
Contract
manufacturing services
|
|
$ |
1,633,000 |
|
|
$ |
1,825,000 |
|
Products
in research and development
|
|
|
166,000 |
|
|
|
233,000 |
|
Total
long-lived assets, net
|
|
$ |
1,799,000 |
|
|
$ |
2,058,000 |
|
In the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. We currently are not aware of any such
legal proceedings or claims that we believe will have, individually or in the
aggregate, a material adverse effect on our business, operating results or cash
flows. However, we did file or are involved with the following
lawsuits:
On
January 12, 2007, we filed a complaint in the Superior Court of the State of
California for the County of Orange against Cancer Therapeutics Laboratories
(“CTL”). The original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai Medipharm Biotech Co.,
Ltd. (“Shanghai Medipharm”) and its related entities. The lawsuit
alleges claims for breach of contract, interference with contractual relations,
declaratory relief, and injunctive relief against the
defendants. Peregrine's claims stem from a 1995 license agreement
with CTL, and two amendments thereto (collectively referred to as the "License
Agreement"). Peregrine claims that CTL breached the License Agreement
by, among other things, (i) not sharing with Peregrine all inventions,
technology, know-how, patents and other information, derived and/or developed in
the People’s Republic of China and/or at the CTL laboratory, as was required
under the License Agreement; (ii) not splitting revenue appropriately with
Peregrine as required under the License Agreement; (iii) utilizing Peregrine's
licensed technologies outside of the People’s Republic of China; and (iv)
failing to enter a sublicense agreement with a Chinese sponsor obligating the
Chinese sponsor to comply with the terms and obligations in the License
Agreement. Peregrine further alleges that Medibiotech Co., Inc. and
Shanghai Medipharm ("Medipharm Entities") interfered with the License Agreement,
leading to CTL's breaches. This interference by the Medipharm
Entities includes: 1) posturing Shanghai Medipharm as the designated sublicensee
under the License Agreement, without binding any of the Medipharm
Entities to the terms and obligations of an appropriate sublicense
agreement called for under the License Agreement; 2) entering into a license
agreement with Alan Epstein, M.D. ("Epstein License Agreement") instead of CTL;
3) restricting the information CTL was allowed to provide to Peregrine, thereby
prohibiting CTL from providing to Peregrine all information required under the
License Agreement; and 4) providing compensation to CTL, and its principals, so
that CTL would enter agreements that prohibited CTL from performing under the
License Agreement.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
On March
28, 2007, CTL filed a cross-complaint, which has been amended three times,
alleging that the Company breached the Agreement by improperly terminating the
Agreement and double-licensing the technology licensed to CTL to another party,
interfered with CTL’s agreements with various Medipharm Entities and unjust
enrichment. CTL’s cross-complaint, which seeks $20 million in
damages, is in part predicated on the existence of a sublicense agreement
between CTL and Shanghai Medipharm. We are challenging the
cross-complaint on the basis that not only did CTL fail to allege an agreement
with which the Company interfered, they have been unable to produce the alleged
sublicense agreement with Shanghai Medipharm despite our repeated demands, and
they have not suffered any compensable damages.
On
February 22, 2008, Medibiotech Co., Inc. (“Medibiotech”) filed a cross-complaint
alleging, as a third party beneficiary, that the Company breached the Agreement
by double-licensing the technology licensed to CTL to another party,
intentionally interfered with a prospective economic advantage, and unjust
enrichment. Medibiotech’s subsidiary, Shanghai Medipharm filed an
almost identical cross-complaint on February 17, 2009. These
cross-complaints, each seek $30 million in damages, in part predicated on
Medibiotech and Shanghai Medipharm being the “Chinese Sponsor” under the
Agreement. We intend to bring pre-trial motions in an attempt to
dispose of these cross-complaints.
The
discovery phase on the aforementioned cases is still ongoing. Until
we complete the discovery phase and our objections are considered, we cannot
estimate the magnitude of the claims of the parties against each other or
probable outcome of the litigation.
ITEM
2.
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
|
This Quarterly Report on Form 10-Q
contains “forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, which represent our projections, estimates,
expectations or beliefs concerning among other things, financial items that
relate to management’s future plans or objectives or to our future economic and
financial performance. In some cases, you can identify these
statements by terminology such as “may”, “should”, “plans”, “believe”, “will”,
“anticipate”, “estimate”, “expect” “project”, or “intend”, including their
opposites or similar phrases or expressions. You should be aware that
these statements are projections or estimates as to future events and are
subject to a number of factors that may tend to influence the accuracy of the
statements. These forward-looking statements should not be regarded
as a representation by the Company or any other person that the events or plans
of the Company will be achieved. You should not unduly rely on these
forward-looking statements, which speak only as of the date of this Quarterly
Report. We undertake no obligation to publicly revise any
forward-looking statement to reflect circumstances or events after the date of
this Quarterly Report or to reflect the occurrence of unanticipated events. You
should, however, review the factors and risks we describe in the reports we file
from time to time with the Securities and Exchange Commission (“SEC”)
after the date of this Quarterly Report. Actual results may differ
materially from any forward looking statement.
Company
Overview
We are a clinical stage
biopharmaceutical company developing monoclonal antibodies for the
treatment of cancer and hepatitis C virus (“HCV”) infection. We are
advancing three separate clinical programs with our first-in-class compounds
bavituximab and Cotara® that employ our two platform
technologies: Anti-Phosphatidylserine (“Anti-PS”) therapeutics and
Tumor Necrosis Therapy (“TNT”). Our lead Anti-PS product,
bavituximab, is being evaluated under two separate clinical programs for the
treatment of solid cancers and hepatitis C virus (“HCV”)
infection. Under our TNT technology platform, our lead candidate
Cotara®, is advancing through two clinical studies for the treatment of patients
with brain cancer.
We are
organized into two reportable operating segments: (i) Peregrine, the parent
company, is engaged in the research and development of monoclonal antibody
products for the treatment of cancer and serious viral infections and (ii) Avid
Bioservices, Inc., (“Avid”) a wholly owned subsidiary, is engaged in providing
contract manufacturing services for Peregrine and outside customers on a
fee-for-service basis.
Going
Concern
The Company’s consolidated financial
statements have been prepared on a going concern basis, which contemplates the
realization of assets and the satisfaction of liabilities in the normal course
of business. The financial statements do not include any adjustments
relating to the recoverability of the recorded assets or the classification of
liabilities that may be necessary should it be determined that we are unable to
continue as a going concern.
At
January 31, 2009, we had $10,850,000 in cash and cash equivalents. We
have expended substantial funds on the research, development and clinical trials
of our product candidates, and funding the operations of our wholly owned
subsidiary, Avid Bioservices, Inc. As a result, we have historically
experienced negative cash flows from operations since our inception and we
expect to continue to experience negative cash flows from operations for the
foreseeable future. Our net losses incurred during the past three
fiscal years ended April 30, 2008, 2007 and 2006 amounted to $23,176,000,
$20,796,000, and $17,061,000, respectively. Unless and until we are
able to generate sufficient revenues from Avid’s contract manufacturing services
and/or from the sale and/or licensing of our products under development, we
expect such losses to continue for the foreseeable future.
Therefore,
our ability to continue our clinical trials and development efforts is highly
dependent on the amount of cash and cash equivalents on hand combined with our
ability to raise additional capital to support our future
operations. As discussed in Note 1 to the condensed consolidated
financial statements, there exists substantial doubt regarding our ability to
continue as a going concern.
We will
need to raise additional capital through one or more methods, including but not
limited to, issuing additional equity or debt, in order to support the costs of
our research and development programs.
Regarding
possible issuance of equity to raise additional capital, as of January 31, 2009,
we had 4,851,454 shares available under an existing effective Form S-3
registration statement for possible future registered transactions provided,
however, we issue these shares prior to April 12, 2009 (the expiration date of
this registration statement). In addition, we filed a separate shelf
registration statement on Form S-3, File Number 333-139975, under which we may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While we
will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to Avid to complete the research,
development, and clinical testing of our product candidates. Based on our current
projections, which include projected revenues under signed contracts with
existing customers of Avid Bioservices,
Inc.,
combined with the projected revenues from our government contract, we believe we
have sufficient cash on hand combined with amounts expected to be received from
Avid customers and from our government contract to meet our obligations as they
become due through at least the second fiscal quarter of our
fiscal year 2010 ending October 31,
2009. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of contracts
and technical challenges, which could reduce or delay our future projected
cash-inflows. In addition, under the Loan Agreement, in the
event our contract with the Defense Threat Reduction Agency is terminated or
canceled for any reason, we would be required to set aside cash and cash
equivalents in an amount equal to 80% of the outstanding loan balance in a
restricted collateral account non-accessable by us. In the event our
projected cash-inflows are reduced or delayed or if we default on a loan
covenant that limits our access to our available cash on hand, we might not have
sufficient capital to operate our business through the second quarter of our
fiscal year 2010 unless we raise additional capital. The
uncertainties surrounding our future cash inflows have raised substantial doubt
regarding our ability to continue as a going concern.
Clinical
Trial Programs
The following represents a summary of
our ongoing clinical trial programs:
Product
|
Indication
|
Trial
Design
|
Trial
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
I monotherapy repeat dose safety study designed to treat up to 28
patients.
|
Patient
enrollment is continuing in this study.
|
Bavituximab
plus docetaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
has been expanded to treat up to a total of 46 patients because six or
more objective tumor responses were observed in the initial 15
patients.
|
Patient
enrollment for the first 15 patients in Stage A is
complete. The pre-specified number of objective tumor responses
was obtained in Stage A. Stage B enrollment is continuing for
this study.
|
Bavituximab
plus carboplatin and paclitaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
may be expanded to treat up to a total of 46 patients because promising
results were observed in the initial 15 patients.
|
Patient
enrollment for the first 15 patients in Stage A is
complete. The pre-specified number of objective tumor responses
was obtained in Stage A. Clinical data is continuing to be
collected on the initial 15 patients.
|
Bavituximab
plus carboplatin and paclitaxel
|
Non-small
cell lung cancer (NSCLC)
|
Phase
II study designed to treat 21 patients initially. Study may be expanded to
treat up to a total of 49 patients because promising results were observed
in the initial 21 patients.
|
Patient
enrollment for the first 21 patients in Stage A is
complete. The pre-specified number of objective tumor responses
was obtained in Stage A. Clinical data is continuing to be
collected on the initial 21 patients.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
Patient
enrollment is continuing in this study.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Phase
II safety and efficacy study to treat up to 40 patients at first
relapse.
|
Patient
enrollment is continuing in this study.
|
Bavituximab
|
Chronic
hepatitis C virus (“HCV”) infection co-infected with HIV
|
Phase
Ib repeat dose safety study designed to treat up to 24
patients.
|
Patient
enrollment is continuing in this
study.
|
Results
of Operations
The following table compares the
unaudited condensed consolidated statements of operations for the three and
nine-month periods ended January 31, 2009 and 2008. This table
provides you with an overview of the changes in the condensed consolidated
statements of operations for the comparative periods, which are further
discussed below.
|
|
Three
Months Ended
January
31,
|
|
|
Nine
Months Ended
January
31,
|
|
|
|
2009
|
|
|
2008
|
|
|
$
Change
|
|
|
2009
|
|
|
2008
|
|
|
$
Change
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
manufacturing revenue
|
|
$ |
5,778,000 |
|
|
$ |
1,662,000 |
|
|
$ |
4,116,000 |
|
|
$ |
7,954,000 |
|
|
$ |
5,146,000 |
|
|
$ |
2,808,000 |
|
Government
contract revenue
|
|
|
1,048,000 |
|
|
|
- |
|
|
|
1,048,000 |
|
|
|
2,330,000 |
|
|
|
- |
|
|
|
2,330,000 |
|
License
revenue
|
|
|
- |
|
|
|
13,000 |
|
|
|
(13,000 |
) |
|
|
- |
|
|
|
46,000 |
|
|
|
(46,000 |
) |
Total
revenues
|
|
|
6,826,000 |
|
|
|
1,675,000 |
|
|
|
5,151,000 |
|
|
|
10,284,000 |
|
|
|
5,192,000 |
|
|
|
5,092,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COST
AND EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of contract manufacturing
|
|
|
4,106,000 |
|
|
|
1,289,000 |
|
|
|
2,817,000 |
|
|
|
5,672,000 |
|
|
|
3,872,000 |
|
|
|
1,800,000 |
|
Research
and development
|
|
|
4,465,000 |
|
|
|
4,941,000 |
|
|
|
(476,000 |
) |
|
|
12,834,000 |
|
|
|
13,665,000 |
|
|
|
(831,000 |
) |
Selling,
general and administrative
|
|
|
1,489,000 |
|
|
|
1,847,000 |
|
|
|
(358,000 |
) |
|
|
4,722,000 |
|
|
|
5,498,000 |
|
|
|
(776,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
cost and expenses
|
|
|
10,060,0000 |
|
|
|
8,077,000 |
|
|
|
1,983,000 |
|
|
|
23,228,000 |
|
|
|
23,035,000 |
|
|
|
193,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(3,234,000 |
) |
|
|
(6,402,000 |
) |
|
|
3,168,000 |
|
|
|
(12,944,000 |
) |
|
|
(17,843,000 |
) |
|
|
4,899,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income
|
|
|
37,000 |
|
|
|
259,000 |
|
|
|
(222,000 |
) |
|
|
165,000 |
|
|
|
851,000 |
|
|
|
(686,000 |
) |
Interest
and other expense
|
|
|
(135,000 |
) |
|
|
(11,000 |
) |
|
|
(124,000 |
) |
|
|
(136,000 |
) |
|
|
(25,000 |
) |
|
|
(111,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$ |
(3,332,000 |
) |
|
$ |
(6,154,000 |
) |
|
$ |
2,822,000 |
|
|
$ |
(12,915,000 |
) |
|
$ |
(17,017,000 |
) |
|
$ |
4,102,000 |
|
Results
of operations for interim periods covered by this quarterly report on Form 10-Q
may not necessarily be indicative of results of operations for the full fiscal
year.
Contract Manufacturing
Revenue.
Three and
nine months: The increases in contract manufacturing revenue of
$4,116,000 and $2,808,000 during the three and nine months ended January 31,
2009, respectively, compared to the same periods in the prior year were
primarily due to increases in services provided to unrelated entities on a
fee-for-service basis including an increase in the number of completed
manufacturing runs utilizing our larger capacity bioreactors compared to the
same three and nine-month periods in the prior year.
We expect
to continue to generate contract manufacturing revenue during the remainder of
the current fiscal year based on the anticipated completion of in-process
customer related projects and the anticipated demand for Avid’s services under
signed and outstanding proposals.
Government
Contract Revenue.
Three and
nine months: The increases in government contract manufacturing revenue of
$1,048,000 and $2,330,000 during the three and nine months ended January 31,
2009, respectively, compared to the same periods in the prior year is related to
research and development services performed under our government contract with
the Defense Threat Reduction Agency (DTRA), a division of the Department of
Defense, which commenced during the current fiscal year.
We expect
to continue to generate government contract revenue associated with our contract
with the DTRA, which was awarded to us on June 30, 2008 and is a five-year
contract potentially worth up to $44.4 million to test and develop bavituximab
and an equivalent fully human antibody as potential broad-spectrum treatments
for viral hemorrhagic fever infections. The initial contract was
awarded through the Transformational Medical Technologies Initiative (TMTI) of
the U.S. Department of Defense's Defense Threat Reduction Agency
(DTRA). This contract is expected to provide us with up to
$22.3 million in funding over a 24-month base period, with $14.3 million
having been appropriated through the current federal fiscal year ending
September 30, 2009. The remainder of the $22.3 million in funding is
expected to be appropriated over the remainder of the two-year base period
ending June 29, 2010. Subject to the progress of the program and
budgetary considerations in future years, the contract can be extended beyond
the base period to cover up to $44.4 million in funding over the five-year
contract period through three one-year option terms.
Cost of Contract
Manufacturing.
Three and
Nine Months: The increases in cost of contract manufacturing of
$2,817,000 and $1,800,000 during the three and nine months ended January 31,
2009, respectively, compared to the same periods in the prior year are primarily
related to the current year three and nine-month increases in contract
manufacturing revenue. We expect to continue to incur contract
manufacturing costs during the remainder of the current fiscal year based on the
anticipated completion of customer projects under our current contract
manufacturing agreements.
Research and
Development Expenses.
Three and
Nine Months: The decreases in research and development (“R&D”)
expenses of $476,000 and $831,000 during the three and nine months ended January
31, 2009 compared to the same periods in the prior year were primarily due to
the following changes associated with each of our following platform
technologies under development:
Technology
Platform
|
|
R&D
Expenses –
Three
Months
Ended
January 31,
|
|
|
R&D
Expenses –
Nine
Months
Ended
January 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
$
Change
|
|
|
2009
|
|
|
2008
|
|
|
$
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anti-PS
Immunotherapeutics
(bavituximab)
|
|
$ |
3,378,000 |
|
|
$ |
2,943,000 |
|
|
$ |
435,000 |
|
|
$ |
9,479,000 |
|
|
$ |
8,158,000 |
|
|
$ |
1,321,000 |
|
TNT
(Cotara®)
|
|
|
1,050,000 |
|
|
|
1,065,000 |
|
|
|
(15,000 |
) |
|
|
3,164,000 |
|
|
|
2,742,000 |
|
|
|
422,000 |
|
VTA
and Anti-Angiogenesis Agents
|
|
|
33,000 |
|
|
|
767,000 |
|
|
|
(734,000 |
) |
|
|
171,000 |
|
|
|
2,266,000 |
|
|
|
(2,095,000 |
) |
VEA
|
|
|
4,000 |
|
|
|
166,000 |
|
|
|
(162,000 |
) |
|
|
20,000 |
|
|
|
499,000 |
|
|
|
(479,000 |
) |
Total
R&D Expenses
|
|
$ |
4,465,000 |
|
|
$ |
4,941,000 |
|
|
$ |
(476,000 |
) |
|
$ |
12,834,000 |
|
|
$ |
13,665,000 |
|
|
$ |
(831,000 |
) |
o
|
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) – The increase in
Anti-PS Immunotherapeutics program expenses of $435,000 and $1,321,000
during the three and nine months ended January 31, 2009, respectively,
compared to the same periods in the prior year is primarily due to an
increase in clinical trial expenses to support the advancement of four
clinical trials using bavituximab for the treatment of solid tumors and
one clinical trial for the treatment of HCV patients co-infected with
HIV. The increase in Anti-PS Immunotherapeutics program
expenses was further supplemented with an increase in R&D expenses
directly associated with increased efforts to advance the development of
bavituximab and a fully human antibody as potential broad-spectrum
treatments for viral hemorrhagic fever infections under our federal
contract with the U.S. Department of Defense’s Defense Threat Reduction
Agency (DTRA), which was awarded to us on June 30,
2008.
|
o
|
Tumor Necrosis Therapy (“TNT”)
(Cotara®) – TNT program expenses for the three months ended January
31, 2009 remained in line with the same period in the prior year
decreasing slightly by $15,000. TNT program expenses for the
nine months ended January 31, 2009 increased $422,000 compared to the same
period in the prior year primarily due to increases in clinical trial and
payroll expenses to support the continued advancement of our two ongoing
Cotara® clinical trials for the treatment of brain
cancer.
|
o
|
Vascular Targeting Agents
(“VTAs”) and Anti-Angiogenesis Agents – The decrease in
VTA and Anti-Angiogenesis Agents program expenses of $734,000 and
$2,095,000 during the three and nine months ended January 31, 2009,
respectively, compared to the same periods in the prior year is primarily
due to our efforts to significantly curtail our development expenses
associated with this program while focusing our efforts on seeking
partners to further advance these
technologies.
|
o
|
Vasopermeation Enhancement
Agents (“VEAs”) – The decrease in VEA program expenses of $162,000
and $479,000 during the three and nine months ended January 31, 2009,
respectively, compared to the same periods in the prior year is primarily
due to our efforts to significantly curtail our development expenses
associated with this program while focusing our efforts on seeking
partners to further advance this
technology.
|
Looking
beyond the current fiscal year, it is extremely difficult for us to reasonably
estimate all future research and development costs associated with each of our
technologies due to the number of unknowns and uncertainties associated with
pre-clinical and clinical trial development. These unknown variables
and uncertainties include, but are not limited to:
·
|
the
uncertainty of future clinical trial
results;
|
·
|
the
uncertainty of the ultimate number of patients to be treated in any
current or future clinical trial;
|
·
|
the
uncertainty of the U.S. Food and Drug Administration allowing our studies
to move forward from Phase I clinical studies to Phase II and Phase III
clinical studies;
|
·
|
the
uncertainty of the rate at which patients are enrolled into any current or
future study. Any delays in clinical trials could significantly
increase the cost of the study and would extend the estimated completion
dates;
|
·
|
the
uncertainty of terms related to potential future partnering or licensing
arrangements;
|
·
|
the
uncertainty of protocol changes and modifications in the design of our
clinical trial studies, which may increase or decrease our future costs;
and
|
·
|
The
uncertainty of our ability to raise additional capital to support our
future research and development efforts beyond the second quarter of our
fiscal year 2010 ending October 31,
2009.
|
We or our
potential partners will need to do additional development and clinical testing
prior to seeking any regulatory approval for commercialization of our product
candidates as all of our products are in discovery, pre-clinical or clinical
development. Testing, manufacturing, commercialization, advertising,
promotion, exporting, and marketing, among other things, of our proposed
products are subject to extensive regulation by governmental authorities in the
United States and other countries. The testing and approval process
requires substantial time, effort, and financial resources, and we cannot
guarantee that any approval will be granted on a timely basis, if at
all. Companies in the pharmaceutical and biotechnology industries
have suffered significant setbacks in conducting advanced human clinical trials,
even after obtaining promising results in earlier
trials. Furthermore, the United States Food and Drug Administration
may suspend clinical trials at any time on various grounds, including a finding
that the subjects or patients are being exposed to an unacceptable health
risk. Even if regulatory approval of a product is granted, such
approval may entail limitations on the indicated uses for which it may be
marketed. Accordingly, we or our potential partners may experience
difficulties and delays in obtaining necessary governmental clearances and
approvals to market our products.
Selling, General and Administrative
Expenses.
Selling,
general and administrative expenses consist primarily of payroll and related
expenses, director fees, legal and accounting fees, share-based compensation
expense, investor and public relation fees, insurance, and other expenses
relating to the general management, administration, and business development
activities of the Company.
Three and Nine Months: The
decreases in selling, general and administrative expenses of $358,000 and
$776,000 during the three and nine months ended January 31, 2009, respectively,
compared to the same periods in the prior year are primarily due to decreases in
travel and related expenses, corporate legal fees and payroll and related
expenses. Travel and related expenses decreased $162,000 and $349,000
during the current year three and nine-month periods, respectively, primarily
due to a decrease in business development efforts in the U.S. and abroad and
decreased participation in corporate and investor relation activities compared
to the prior year in an effort to curtail corporate and business development
related expenditures. Corporate legal fees decreased $108,000 and
$279,000 during the current year three and nine-month periods, respectively,
primarily due to an overall decrease in legal fees associated with general
corporate matters. Payroll and related expenses decreased $60,000 and
$111,000 during the current year three and nine-month periods, respectively,
primarily due to a decrease in compensation and related expenses. In
addition, we incurred incremental decreases in other general corporate related
expenses primarily associated with facility related expenses and public relation
fees. These decreases in selling, general and administrative expenses
were offset with increases in non-cash stock based compensation expenses of
$13,000 and $123,000 during the three and nine-month periods, respectively,
associated with the amortization of the fair value of options granted to
employees.
Interest and
Other Income.
Three and
Nine Months: The decreases in interest and other income of $222,000
and $686,000 during the three and nine months ended January 31, 2009,
respectively, compared to the same periods in the prior year was primarily due
to decreases in interest income as a result of a lower average cash balance on
hand combined with lower prevailing interest rates during the current year
compared to the prior year.
Interest and
Other Expense.
Three and Nine Months: The
increases in interest and other expense of $124,000 and $111,000 during the
three and nine months ended January 31, 2009, respectively, compared to the same
periods in the prior year was primarily due to increases in interest expense
associated with the loan and security agreement we entered into during December
2008 combined with increases in non-cash interest expense regarding the
amortization of the loan and security agreement discount associated with the
fair value of detachable warrants and related debt issuance costs.
Critical
Accounting Policies
The
methods, estimates, and judgments we use in applying our most critical
accounting policies have a significant impact on the results we report in our
condensed consolidated financial statements. We evaluate our estimates and
judgments on an ongoing basis. We base our estimates on historical
experience and on assumptions that we believe to be reasonable under the
circumstances. Our experience and assumptions form the basis for our
judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may vary from
what we anticipate and different assumptions or estimates about the future could
change our reported results. We believe the following accounting
policies are the most critical to us, in that they are important to the
portrayal of our financial statements and they require our most difficult,
subjective or complex judgments in the preparation of our condensed consolidated
financial statements:
Revenue
Recognition
We
recognize revenues pursuant to the SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition. In accordance with SAB No. 104, revenue is
generally realized or realizable and earned when (i) persuasive evidence of an
arrangement exists, (ii) delivery has occurred or services have been rendered,
(iii) the seller's price to the buyer is fixed or determinable, and (iv)
collectibility is reasonably assured.
We also
comply with Financial Accounting Standards Board’s Emerging Issues Task Force
No. 00-21 (“EITF 00-21”), Revenue Arrangements with Multiple
Deliverables. In accordance with EITF 00-21, we recognize
revenue for delivered elements only when the delivered element has stand-alone
value and we have objective and reliable evidence of fair value for each
undelivered element. If the fair value of any undelivered element
included in a multiple element arrangement cannot be objectively determined,
revenue is deferred until all elements are delivered and services have been
performed, or until fair value can objectively be determined for any remaining
undelivered elements.
In July 2000, the Emerging Issues Task
Force (“EITF”) released Issue 99-19 (“EITF 99-19”), Reporting Revenue
Gross as a Principal versus Net as an Agent. EITF 99-19 summarized the
EITF’s views on when revenue should be recorded at the gross amount billed to a
customer because it has earned revenue from the sale of goods or services, or
the net amount retained (the amount billed to the customer less the amount paid
to a supplier) because it has earned a fee or commission. In
addition, the EITF released Issue 00-10 (“EITF 00-10”), Accounting for
Shipping and Handling Fees and Costs, and Issue 01-14 (“EITF 01-14”), Income Statement
Characterization of Reimbursements Received for “Out-of-Pocket” Expenses
Incurred. EITF
00-10 summarized the EITF’s views on how the seller of goods should classify in
the income statement amounts billed to a customer for shipping and handling and
the costs associated with shipping and handling. EITF 01-14
summarized the EITF’s views on when the reimbursement of out-of-pocket expenses
should be characterized as revenue or as a reduction of expenses
incurred. Our revenue recognition policies are in compliance with
EITF 99-19, EITF 00-10 and EITF 01-14 whereby we record revenue for the gross
amount billed to customers (the cost of raw materials, supplies, and shipping,
plus the related handling mark-up fee) and we record the cost of the amounts
billed as cost of sales as we act as a principal in these
transactions.
Revenues
associated with contract manufacturing services provided by Avid are generally
recognized once the service has been provided and/or upon shipment of the
product to the customer. We also record a provision for estimated
contract losses, if any, in the period in which they are
determined.
Revenues
associated with licensing agreements primarily consist of nonrefundable up-front
license fees and milestone payments. Revenues under licensing
agreements are recognized based on the performance requirements of the
agreement. Nonrefundable up-front license fees received under license
agreements, whereby continued performance or future obligations are considered
inconsequential to the relevant licensed technology, are generally recognized as
revenue upon delivery of the technology. Nonrefundable up-front
license fees, whereby we have an ongoing involvement or performance obligations,
are recorded as deferred revenue and recognized as revenue over the term of the
performance obligation or relevant agreement. Milestone payments are
generally recognized as revenue upon completion of the milestone assuming there
are no other continuing obligations. Under some license agreements,
the obligation period may not be contractually defined. Under these
circumstances, we must exercise judgment in estimating the period of time over
which certain deliverables will be provided to enable the licensee to practice
the license.
Revenues
associated with our government contract are recognized in accordance with
Accounting Research Bulletin No. 43 Chapter 11, Government
Contracts. Our government contract with the Defense Threat
Reduction Agency (DTRA), a division of the Department of Defense, is a
“cost-plus-fixed-fee” contract. Reimbursable costs under the contract
primarily include direct labor, subcontract costs, materials, equipment, travel,
indirect costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is recognized as we perform the underlying
research and development activities. However, progress payments
associated with contract manufacturing services performed under the DTRA
contract are classified as Deferred Government Contract Revenue and are
recognized as revenue upon delivery or transfer of legal title of the product to
the DTRA.
Share-based
Compensation Expense
We
currently maintain four equity compensation plans which provide for the granting
of options to our employees to purchase shares of our common stock at exercise
prices not less than the fair market value of our common stock at the date of
grant. The granting of options are share-based payments and are
subject to the fair value recognition provisions of Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment (Revised
2004), which requires the recognition of compensation expense, using a
fair value based method, for costs related to all share-based payments including
grants of employee stock options.
The fair value of each option grant is
estimated using the Black-Scholes option valuation model and are amortized as
compensation expense on a straight-line basis over the requisite service periods
of the awards, which is generally the vesting period (typically 2 to 4
years). Use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model
inputs. Expected volatility is based on daily historical volatility
of our stock covering the estimated expected term. The expected term
of options granted prior to November 1, 2007 was based on the expected time to
exercise using the “simplified” method allowable under the Security and Exchange
Commission’s Staff Accounting Bulletin No. 107 (“SAB No.
107”). Effective November 1, 2007, the expected term reflects actual
historical exercise activity and assumptions regarding future exercise activity
of unexercised, outstanding options and is applied to all option grants
subsequent to October 31, 2007. The risk-free interest rate is based
on U.S. Treasury notes with terms within the contractual life of the option at
the time of grant. In addition, SFAS No. 123R requires forfeitures to
be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates.
Our loss
from operations for the three and nine-month periods ended January 31, 2009
included share-based compensation expense of $203,000 and $690,000,
respectively. Our loss from operations for the three and nine-month
periods ended January 31, 2008 included share-based compensation expense of
$231,000 and $612,000, respectively. We believe that non-cash
share-based compensation expense for the remaining three months of fiscal year
2009 may be up to approximately $161,000 based on actual shares granted and
unvested as of January 31, 2009. However, the actual expense may
differ materially from this estimate as a result of changes in a number of
factors that affect the amount of non-cash compensation expense, including the
number of options granted by our Board of Directors during the remainder of the
fiscal year, the price of our common stock on the date of grant, the volatility
of our stock price, the estimate of the expected life of options granted and the
risk-free interest rates.
As of January 31, 2009, the total
estimated unrecognized compensation cost related to non-vested stock options was
$1,314,000. This cost is expected to be recognized over a weighted
average period of 2.17 years.
Allowance
for Doubtful Accounts
We
continually monitor our allowance for doubtful accounts for all
receivables. A considerable amount of judgment is required in
assessing the ultimate realization of these receivables and we estimate an
allowance for doubtful accounts based on these factors at that point in
time. As of January 31, 2009, based on our analysis of our accounts
receivable balances and based on historical collectibility of receivables from
our current customers, we determined no allowance for doubtful accounts was
necessary.
Liquidity
and Capital Resources
At
January 31, 2009, we had $10,850,000 in cash and cash equivalents. We
have expended substantial funds on the research, development and clinical trials
of our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2008, 2007 and 2006 amounted
to $23,176,000, $20,796,000, and $17,061,000, respectively. Unless
and until we are able to generate sufficient revenues from Avid’s contract
manufacturing services and/or from the sale and/or licensing of our products
under development, we expect such losses to continue for the foreseeable
future.
Therefore, our ability to continue our
clinical trials and development efforts is highly dependent on the amount of
cash and cash equivalents on hand combined with our ability to raise additional
capital to support our future operations. As discussed in Note 1 to
the condensed consolidated financial statements, there exists substantial doubt
regarding our ability to continue as a going concern.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
Regarding possible issuance of equity
to raise additional capital, as of January 31, 2009, we had 4,851,454 shares
available under an existing effective Form S-3 registration statement for
possible future registered transactions provided, however, we issue these shares
prior to April 12, 2009 (the expiration date of this registration
statement). In addition, we filed a separate shelf registration
statement on Form S-3, File Number 333-139975, under which we may issue, from
time to time, in one or more offerings, shares of our common stock for remaining
gross proceeds of up to $7,500,000.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While we
will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to Avid to complete the research,
development, and clinical testing of our product candidates. Based on
our current projections, which include projected revenues under signed contracts
with existing customers of Avid, combined with the projected revenues from our
government contract, we believe we have sufficient cash on hand combined with
amounts expected to be received from Avid customers and from our government
contract to meet our obligations as they become due through at least the second
quarter of our fiscal year 2010 ending October 31, 2009. There are a
number of uncertainties associated with our financial projections, including but
not limited to, termination of contracts and technical challenges, which could
reduce or delay our future projected cash-inflows. In addition, under
the Loan Agreement, in the event our contract with the Defense Threat Reduction
Agency is terminated or canceled for any reason, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessable by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
second quarter of our fiscal year 2010 unless we raise additional
capital. The uncertainties surrounding our future cash inflows have
raised substantial doubt regarding our ability to continue as a going
concern.
Significant components of the changes
in cash flows from operating, investing, and financing activities for the nine
months ended January 31, 2009 compared to the same prior year period are as
follows:
Cash Used In Operating
Activities. Cash used in operating activities is primarily
driven by changes in our net loss. However, cash used in operating
activities generally differs from our reported net loss as a result of non-cash
operating expenses or differences in the timing of cash flows as reflected in
the changes in operating assets and liabilities. During the nine
months ended January 31, 2009, cash used in operating activities decreased
$7,335,000 to $8,668,000 compared to $16,003,000 for the nine months ended
January 31, 2008. This decrease in net cash used in operating
activities was primarily due to a decrease of $4,521,000 in our net loss
reported in the current nine-month period after taking into consideration
non-cash operating expenses. This amount was supplemented by a net
change in operating assets and payment or reduction of liabilities in the
aggregate amount of $2,814,000. The decrease in our current
nine-month period net loss was primarily due to current period increases in
contract manufacturing revenue and government contract revenue combined with
decreases in cost of contract manufacturing, research and development expenses
and selling, general and administrative expenses.
The
changes in operating activities as a result of non-cash operating expenses or
differences in the timing of cash flows as reflected by the changes in operating
assets and liabilities are as follows:
|
|
NINE
MONTHS ENDED
|
|
|
|
January
31,
2009
|
|
|
January
31,
2008
|
|
Net
loss, as reported
|
|
$ |
(12,915,000 |
) |
|
$ |
(17,017,000 |
) |
Less
non-cash expenses and adjustments to net loss:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
385,000 |
|
|
|
353,000 |
|
Share-based
compensation
|
|
|
698,000 |
|
|
|
627,000 |
|
Amortization
of expenses paid in shares of common
stock
|
|
|
255,000 |
|
|
|
- |
|
Amortization
of discount on notes payable and debt
issuance costs
|
|
|
61,000 |
|
|
|
- |
|
Net
cash used in operating activities before changes in operating assets and
liabilities
|
|
$ |
(11,516,000 |
) |
|
$ |
(16,037,000 |
) |
Net
change in operating assets and liabilities
|
|
$ |
2,848,000 |
|
|
$ |
34,000 |
|
Net
cash used in operating activities
|
|
$ |
(8,668,000 |
) |
|
$ |
(16,003,000 |
) |
Cash Used In Investing
Activities. Net cash used in investing activities decreased
$448,000 to $126,000 for the nine months ended January 31, 2009 compared to net
cash used of $574,000 for the nine months ended January 31,
2008. This decrease was primarily due to a decrease in cash outflows
associated with other assets of $410,000 combined with a $188,000 decrease in
property acquisitions. The decrease in other assets of $410,000 was
primarily due to prior year progress payments of $413,000 made on certain
property related improvements associated with our manufacturing
facility. These decreases were offset by the prior year receipt of
$150,000 in net security deposits from GE Capital Corporation during the prior
year period upon the payment in full of various note payable
amounts.
Cash Provided By Financing
Activities. Net cash provided by financing activities
decreased $16,082,000 for the nine months ended January 31, 2009 compared to the
same prior year period. During the nine months ended January 31,
2009, we received net proceeds of $4,531,000 from notes payable under a loan and
security agreement we entered into on December 9, 2008, net of debt issuance
costs in the amount of $469,000. In addition, principal payments on
capital leases were $17,000 for the nine months ended January 31, 2009 compared
to capital lease and notes payable principal payments of $336,000 paid in the
same prior year period, or a decrease of $319,000. In addition,
during the nine months ended January 31, 2008, we received $20,932,000 from the
sale of common stock. In the prior year period, we entered into a
securities purchase agreement whereby we sold and issued a total of 30,000,000
shares of our common stock in exchange for net proceeds of
$20,859,000. This amount was supplemented with net proceeds of
$73,000 from the exercise of stock options and warrants.
Commitments
At January 31, 2009, we had no material
capital commitments.
ITEM
3.
|
QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Changes in United States interest rates
would affect the interest earned on our cash and cash equivalents and interest
expense on our outstanding notes payable, however, they would not have an affect
on our capital leases, which have fixed interest rates and terms.
Based on our overall cash and cash
equivalents interest rate exposure at January 31, 2009, a near-term change in
interest rates, based on historical movements, would not have a material adverse
effect on our financial position or results of operations.
At
January 31, 2009, we had an outstanding notes payable balance of $5,000,000
under a loan and security agreement, which bear interest at a monthly variable
rate equal to the then current thirty (30) day LIBOR rate (set at a floor of 3%)
plus 9%, which may expose us to market risk due to changes in interest
rates. However, based on current LIBOR interest rates, which are
currently under the minimum floor set at 3% under our loan and security
agreement and based on historical movements in LIBOR rates, we believe a
near-term change in interest rates would not have a material adverse effect on
our financial position or results of operations.
ITEM
4.
|
CONTROLS AND
PROCEDURES
|
The Company maintains disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are
designed to ensure that information required to be disclosed in its reports
filed under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and forms, and that such
information is accumulated and communicated to our management, including its
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow
timely decisions regarding required disclosure. In designing and
evaluating the disclosure controls and procedures, management recognized that
any controls and procedures, no matter how well designed and operated, can
provide only reasonable assurance of achieving the desired control objectives,
and management necessarily was required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
The
Company carried out an evaluation, under the supervision and with the
participation of management, including its Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of its
disclosure controls and procedures as of January 31, 2009, the end of the period
covered by this Quarterly Report. Based on that evaluation, the
Company’s Chief Executive Officer and Chief Financial Officer concluded that its
disclosure controls and procedures were effective at the reasonable assurance
level as of January 31, 2009.
There were no significant changes in
the Company’s internal controls over financial reporting, during the quarter
ended January 31, 2009, that have materially affected, or are reasonably likely
to materially affect, the Company’s internal controls over financial
reporting.
PART II OTHER
INFORMATION
ITEM
1.
|
LEGAL
PROCEEDINGS.
|
In the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. We currently are not aware of any such
legal proceedings or claim that we believe will have, individually or in the
aggregate, a material adverse effect on our business, operating results or cash
flows. However, we did file or are involved with the following
lawsuits:
On
January 12, 2007, we filed a complaint in the Superior Court of the State of
California for the County of Orange against Cancer Therapeutics Laboratories
(“CTL”). The original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai Medipharm Biotech Co.,
Ltd. (“Shanghai Medipharm”) and its related entities. The lawsuit
alleges claims for breach of contract, interference with contractual relations,
declaratory relief, and injunctive relief against the
defendants. Peregrine's claims stem from a 1995 license agreement
with CTL, and two amendments thereto (collectively referred to as the "License
Agreement"). Peregrine claims that CTL breached the License Agreement
by, among other things, (i) not sharing with Peregrine all inventions,
technology, know-how, patents and other information, derived and/or developed in
the People’s Republic of China and/or at the CTL laboratory, as was required
under the License Agreement; (ii) not splitting revenue appropriately with
Peregrine as required under the License Agreement; (iii) utilizing Peregrine's
licensed technologies outside of the People’s Republic of China; and (iv)
failing to enter a sublicense agreement with a Chinese sponsor obligating the
Chinese sponsor to comply with the terms and obligations in the License
Agreement. Peregrine further alleges that Medibiotech Co., Inc. and
Shanghai Medipharm ("Medipharm Entities") interfered with the License Agreement,
leading to CTL's breaches. This interference by the Medipharm
Entities includes: 1) posturing Shanghai Medipharm as the designated sublicensee
under the License Agreement, without binding any of the Medipharm
Entities to the terms and obligations of an appropriate sublicense
agreement called for under the License Agreement; 2) entering into a license
agreement with Alan Epstein, M.D. ("Epstein License Agreement") instead of CTL;
3) restricting the information CTL was allowed to provide to Peregrine, thereby
prohibiting CTL from providing to Peregrine all information required under the
License Agreement; and 4) providing compensation to CTL, and its principals, so
that CTL would enter agreements that prohibited CTL from performing under the
License Agreement.
On March
28, 2007, CTL filed a cross-complaint, which has been amended three times,
alleging that the Company breached the Agreement by improperly terminating the
Agreement and double-licensing the technology licensed to CTL to another party,
interfered with CTL’s agreements with various Medipharm Entities and unjust
enrichment. CTL’s cross-complaint, which seeks $20 million in
damages, is in part predicated on the existence of a sublicense agreement
between CTL and Shanghai Medipharm. We are challenging the
cross-complaint on the basis that not only did CTL fail to allege an agreement
with which the Company interfered, they have been unable to produce the alleged
sublicense agreement with Shanghai Medipharm despite our repeated demands, and
they have not suffered any compensable damages.
On
February 22, 2008, Medibiotech Co., Inc. (“Medibiotech”) filed a cross-complaint
alleging, as a third party beneficiary, that the Company breached the Agreement
by double-licensing the technology licensed to CTL to another party,
intentionally interfered with a prospective economic advantage, and unjust
enrichment. Medibiotech’s subsidiary, Shanghai Medipharm filed an
almost identical cross-complaint on February 17, 2009. These
cross-complaints, each seek $30 million in damages, in part predicated on
Medibiotech and Shanghai Medipharm being the “Chinese Sponsor” under the
Agreement. We intend to bring pre-trial motions in an attempt to
dispose of these cross-complaints.
The
discovery phase on the aforementioned cases is still ongoing. Until
we complete the discovery phase and our objections are considered, we cannot
estimate the magnitude of the claims of the parties against each other or
probable outcome of the litigation.
The following risk factors below
update, and should be considered in addition to, the risk factors previously
disclosed by us in Part 1, Item 1A of our Annual Report for the fiscal year
ended April 30, 2008.
If
We Cannot Obtain Additional Funding, Our Product Development And
Commercialization Efforts May Be Reduced Or Discontinued And We May Not Be Able
To Continue Operations.
At January 31, 2009, we had $10,850,000
in cash and cash equivalents. We have expended substantial funds on
the research, development and clinical trials of our product candidates, and
funding the operations of Avid. As a result, we have historically
experienced negative cash flows from operations since our inception and we
expect to continue to experience negative cash flows from operations for the
foreseeable future. Our net losses incurred during the past three
fiscal years ended April 30, 2008, 2007 and 2006 amounted to $23,176,000,
$20,796,000, and $17,061,000, respectively. Unless and until we are
able to generate sufficient revenues from Avid’s contract manufacturing services
and/or from the sale and/or licensing of our products under development, we
expect such losses to continue for the foreseeable future.
Therefore, our ability to continue our
clinical trials and development efforts is highly dependent on the amount of
cash and cash equivalents on hand combined with our ability to raise additional
capital to support our future operations. As discussed in Note 1 to
the condensed consolidated financial statements, there exists substantial doubt
regarding our ability to continue as a going concern.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
Regarding
possible issuance of equity to raise additional capital, as of January 31, 2009,
we had 4,851,454 shares available under an existing effective Form S-3
registration statement for possible future registered transactions provided,
however, we issue these shares prior to April 12, 2009 (the expiration date of
this registration statement). In addition, we filed a separate shelf
registration statement on Form S-3, File Number 333-139975, under which we may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While we
will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to Avid to complete the research,
development, and clinical testing of our product candidates. Based on
our current projections, which include projected revenues under signed contracts
with existing customers of Avid, combined with the projected revenues from our
government contract, we believe we have sufficient cash on hand combined with
amounts expected to be received from Avid customers and from our government
contract to meet our obligations as they become due through at least the second
quarter of our fiscal year 2010 ending October 31, 2009. There are a
number of uncertainties associated with our financial projections, including but
not limited to, termination of contracts and technical challenges, which could
reduce or delay our future projected cash-inflows. In addition, under
the Loan Agreement, in the event our contract with the Defense Threat Reduction
Agency is terminated or canceled for any reason, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessable by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
second quarter of our fiscal year 2010 unless we raise additional
capital. The uncertainties surrounding our future cash inflows have
raised substantial doubt regarding our ability to continue as a going
concern.
Our Outstanding
Indebtedness To MidCap Finacial LLC and BlueCrest Capital Finance, L.P. Imposes
Certain Restrictions On How We Conduct Our Business. In Addition, All
Of Our Assets, Including Our Intellectual Property, Are Pledged To Secure This
Indebtedness. If We Fail To Meet Our Obligations To The Lenders, Our
Payment Obligations May Be Accelerated And The Collateral Securing The Debt May
Be Sold To Satisfy These Obligations.
Pursuant
to a Loan and Security Agreement dated December 9, 2008 (the “Loan
Agreement”), MidCap Financial LLC and BlueCrest Capital Finance, L.P. (the
“Lenders”) have provided us a three-year, $5,000,000 working capital loan, which
funded on December 19, 2008 and may be increased to $10,000,000 upon our
attainment of certain additional clinical and financial conditions by June 30,
2009 as outlined in the Loan Agreement. As collateral to secure our
repayment obligations to the Lenders, we and our wholly-owned subsidiary, Avid
Bioservices, Inc., have granted the Lenders a first priority security interest
in generally all of our respective assets, including our intellectual
property.
The
Loan Agreement contains various covenants that restrict our operating
flexibility. Pursuant to the Loan Agreement, we may not, among other
things:
·
|
incur
additional indebtedness, except for certain permitted indebtedness.
Permitted indebtedness is defined to include accounts payable incurred in
the ordinary course of business, leases of equipment or property incurred
in the ordinary course of business not to exceed in the aggregate $100,000
outstanding at any one time;
|
·
|
incur
additional liens on any of our assets except for certain permitted
liens including but not limited to non-exclusive licenses of our
intellectual property in the ordinary course of business and exclusive
licenses of intellectual property provided they are approved by our board
of directors and do not involve bavituximab or
Cotara;
|
·
|
Make
any payment of subordinated debt, except as permitted under the applicable
subordination or intercreditor
agreement;
|
·
|
merge
with or acquire any other entity, or sell all or substantially all of our
assets, except as permitted under the Loan
Agreement;
|
·
|
pay
dividends (other than stock dividends) to our
shareholders;
|
·
|
redeem
any outstanding shares of our common stock or any outstanding options or
warrants to purchase shares of our common stock except in connection with
a share repurchase pursuant to which we offer to pay our then existing
shareholders not more than
$250,000;
|
·
|
enter
into transactions with affiliates other than on arms-length terms;
and
|
·
|
make
any change in any of our business objectives, purposes and operations
which has or could be reasonably expected to have a material adverse
effect on our business.
|
These
provisions could have important consequences for us, including (i) making
it more difficult for us to obtain additional debt financing from another
lender, or obtain new debt financing on terms favorable to us, because a new
lender will have to be willing to be subordinate to the lenders,
(ii) causing us to use a portion of our available cash for debt repayment
and service rather than other perceived needs and/or (iii) impacting our
ability to take advantage of significant, perceived business
opportunities. Our failure to timely repay our obligations under the
Loan Agreement or meet the covenants set forth in the Loan Agreement could give
rise to a default under the agreement. In the event of an uncured default, the
Loan Agreement provides that all amounts owed to the lender may be declared are
immediately due and payable and that the Lenders have the right to enforce their
security interest in the assets securing the Loan Agreement. In such event, the
Lenders could take possession of any or all of our assets in which they hold a
security interest, and dispose of those assets to the extent necessary to pay
off our debts, which would materially harm our business.
In
The Event Our Contract With The DTRA Is Terminated, Our Loan Requires Us To
Place A Significant Amount Of Our Cash In A Restricted Bank
Account.
Under the terms of the Loan Agreement,
if our contract with the Defense Threat Reduction Agency is terminated while any
principal balance of the loan is outstanding, we will be required to at all
times thereafter maintain cash and cash equivalents in an amount of at least
eighty percent (80%) of the then outstanding principal balance of the loan in a
restricted account over which we will not be permitted to make withdrawals or
otherwise exercise control.
We
Have Had Significant Losses And We Anticipate Future Losses.
We have incurred net losses in most
fiscal years since we began operations in 1981. The following table
represents net losses incurred for the nine months ended January 31, 2009 and
for each of the past three fiscal years:
|
Net Loss |
Nine months ended
January 31, 2009 (unaudited) |
$12,915,000 |
Fiscal Year
2008 |
$23,176,000 |
Fiscal Year
2007 |
$20,796,000 |
Fiscal Year
2006 |
$17,061,000 |
As of
January 31, 2009, we had an accumulated deficit of
$243,751,000. While we expect to continue to generate revenues from
Avid’s contract manufacturing services, in order to achieve and sustain
profitable operations, we must successfully develop and obtain regulatory
approval for our products, either alone or with others, and must also
manufacture, introduce, market and sell our products. The costs
associated with clinical trials and product manufacturing is very expensive and
the time frame necessary to achieve market success for our products is long and
uncertain. We do not expect to generate product or royalty revenues
for at least the next two years, and we may never generate product and/or
royalty revenues sufficient to become profitable or to sustain
profitability.
The Sale Of
Substantial Shares Of Our Common Stock May Depress Our Stock Price.
As of January 31, 2009, there were
226,210,617
shares of our common stock outstanding. Substantially all of these
shares are eligible for trading in the public market, subject in some cases to
volume and other limitations. The market price of our common stock
may decline if our common stockholders sell a large number of shares of our
common stock in the public market, or the market perceives that such sales may
occur.
We could also issue up to 22,002,346
additional shares of our common stock that are reserved for future issuance
under our shelf registration statements, stock option plans and for outstanding
warrants, as further described in the following table:
|
|
Number
of Shares
of
Common Stock
Reserved
For Issuance
|
|
Shares
reserved for issuance under one effective shelf registration
statement
|
|
|
4,851,454 |
|
|
Common
shares reserved for issuance upon exercise of outstanding options
or
reserved
for future option grants under our stock incentive plans
|
|
|
15,458,845 |
|
|
Common
shares issuable upon exercise of outstanding warrants
|
|
|
1,692,047 |
|
|
Total
|
|
|
22,002,346 |
|
|
In addition, the above table does not
include shares of common stock that we have available to issue from the
registration statement we filed during January 2007 on Form S-3, File Number
333-139975, under which we may issue, from time to time, in one or more
offerings, shares of our common stock for remaining gross proceeds of up to
$7,500,000.
Of the total options and warrants
outstanding as of January 31, 2009, 5,885,770 would be considered dilutive to
stockholders because we would receive an amount per share which is less than the
market price of our common stock at January 31, 2009.
In addition, we will need to raise
substantial additional capital in the future to fund our
operations. If we raise additional funds by issuing equity
securities, the market price of our securities may decline and our existing
stockholders may experience significant dilution.
Current
Economic Conditions And Capital Markets Are In A Period Of Disruption And
Instability Which Could Adversely Affect Our Ability To Access The Capital
Markets, And Thus Adversely Affect Our Business And Liquidity.
The
current economic conditions and financial crisis have had, and will continue to
have, a negative impact on our ability to access the capital markets, and thus
have a negative impact on our business and liquidity. The shortage of liquidity
and credit combined with recent substantial losses in worldwide equity markets
could lead to an extended worldwide recession. We may face
significant challenges if conditions in the capital markets do not
improve. Our ability to access the capital markets has been and
continues to be severely restricted at a time when we need to access such
markets, which could have a negative impact on our business plans, including our
pre-clinical studies and clinical trial schedules and other research and
development activities. Even if we are able to raise capital, it may
not be at a price or on terms that are favorable to us. We cannot
predict the occurrence of future disruptions or how long the current conditions
may continue.
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock.
The market price of our common stock
and the market prices of securities of companies in the biotechnology sector
have generally been highly volatile and are likely to continue to be highly
volatile.
The following table shows the high and
low sales price and trading volume of our common stock for each quarter in the
three fiscal years ended April 30, 2008, and our three fiscal quarters ended
January 31, 2009:
|
|
Common
Stock
Sales
Price
|
|
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
|
|
|
High
|
|
|
Low
|
|
|
High
|
|
|
Low
|
|
Fiscal
Year 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended January 31, 2009
|
|
$ |
0.47 |
|
|
$ |
0.22 |
|
|
|
1,298 |
|
|
|
93 |
|
Quarter
Ended October 31, 2008
|
|
$ |
0.40 |
|
|
$ |
0.23 |
|
|
|
1,318 |
|
|
|
77 |
|
Quarter
Ended July 31, 2008
|
|
$ |
0.53 |
|
|
$ |
0.31 |
|
|
|
2,997 |
|
|
|
103 |
|
Fiscal
Year 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2008
|
|
$ |
0.73 |
|
|
$ |
0.35 |
|
|
|
3,846 |
|
|
|
130 |
|
Quarter
Ended January 31, 2008
|
|
$ |
0.65 |
|
|
$ |
0.35 |
|
|
|
3,111 |
|
|
|
140 |
|
Quarter
Ended October 31, 2007
|
|
$ |
0.79 |
|
|
$ |
0.54 |
|
|
|
2,631 |
|
|
|
169 |
|
Quarter
Ended July 31, 2007
|
|
$ |
1.40 |
|
|
$ |
0.72 |
|
|
|
21,653 |
|
|
|
237 |
|
Fiscal
Year 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2007
|
|
$ |
1.26 |
|
|
$ |
0.86 |
|
|
|
6,214 |
|
|
|
408 |
|
Quarter
Ended January 31, 2007
|
|
$ |
1.39 |
|
|
$ |
1.09 |
|
|
|
4,299 |
|
|
|
203 |
|
Quarter
Ended October 31, 2006
|
|
$ |
1.48 |
|
|
$ |
1.12 |
|
|
|
3,761 |
|
|
|
277 |
|
Quarter
Ended July 31, 2006
|
|
$ |
1.99 |
|
|
$ |
1.30 |
|
|
|
23,790 |
|
|
|
429 |
|
Fiscal
Year 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2006
|
|
$ |
1.76 |
|
|
$ |
1.20 |
|
|
|
9,922 |
|
|
|
391 |
|
Quarter
Ended January 31, 2006
|
|
$ |
1.40 |
|
|
$ |
0.88 |
|
|
|
12,152 |
|
|
|
251 |
|
Quarter
Ended October 31, 2005
|
|
$ |
1.28 |
|
|
$ |
0.91 |
|
|
|
4,619 |
|
|
|
156 |
|
Quarter
Ended July 31, 2005
|
|
$ |
1.31 |
|
|
$ |
0.92 |
|
|
|
7,715 |
|
|
|
178 |
|
The
market price of our common stock may be significantly impacted by many factors,
including, but not limited to:
·
|
announcements
of technological innovations or new commercial products by us or our
competitors;
|
·
|
publicity
regarding actual or potential clinical trial results relating to products
under development by us or our
competitors;
|
·
|
our
financial results or that of our competitors, including our abilities to
continue as a going concern;
|
·
|
the
offering and sale of shares of our common stock at a discount under an
equity transaction;
|
·
|
changes
in our capital structure, including but not limited to any potential
reverse stock split;
|
·
|
published
reports by securities analysts;
|
·
|
announcements
of licensing agreements, joint ventures, strategic alliances, and any
other transaction that involves the sale or use of our technologies or
competitive technologies;
|
·
|
developments
and/or disputes concerning our patent or proprietary
rights;
|
·
|
regulatory
developments and product safety
concerns;
|
·
|
general
stock trends in the biotechnology and pharmaceutical industry
sectors;
|
·
|
public
concerns as to the safety and effectiveness of our
products;
|
·
|
economic
trends and other external factors, including but not limited to, interest
rate fluctuations, economic recession, inflation, foreign market trends,
national crisis, and disasters; and
|
·
|
healthcare
reimbursement reform and cost-containment measures implemented by
government agencies.
|
These and
other external factors have caused and may continue to cause the market price
and demand for our common stock to fluctuate substantially, which may limit or
prevent investors from readily selling their shares of common stock, and may
otherwise negatively affect the liquidity of our common stock.
The
Liquidity Of Our Common Stock Will Be Adversely Affected If Our Common Stock Is
Delisted From The Nasdaq Capital Market.
Our common stock is presently traded on
The Nasdaq Capital Market. To maintain inclusion on The Nasdaq
Capital Market, we must continue to meet the following six listing
requirements:
|
1.
|
Net
tangible assets of at least $2,500,000 or market capitalization of at
least $35,000,000 or net income of at least $500,000 in either our latest
fiscal year or in two of our last three fiscal
years;
|
|
2.
|
Public
float of at least 500,000 shares;
|
|
3.
|
Market
value of our public float of at least
$1,000,000;
|
|
4.
|
A
minimum closing bid price of $1.00 per share of common stock, without
falling below this minimum bid price for a period of thirty consecutive
trading days;
|
|
5.
|
At
least two market makers; and
|
|
6.
|
At
least 300 stockholders, each holding at least 100 shares of common
stock.
|
On July 25, 2007, we received a
deficiency notice from The NASDAQ Stock Market notifying us that we had not met
the $1.00 minimum closing bid price requirement for thirty consecutive trading
days as required under NASDAQ listing rules. According to the NASDAQ
notice, we were automatically afforded an initial “compliance period” of 180
calendar days, or until January 22, 2008, to regain compliance with this
requirement. After the initial 180 calendar day period, we remained
noncompliant with the minimum closing bid price requirement but because we were
in compliance with all other initial listing requirements, we were afforded an
additional “compliance period” of 180 calendar days, or until July 21,
2008. Because we did not regain compliance, i.e., the closing bid
price of the Company’s common stock did not meet or exceed $1.00 per share for a
minimum of ten (10) consecutive business days prior to July 21, 2008, on July
22, 2008 we received a notice from The NASDAQ Stock Market indicating that we
were not in compliance with the minimum bid price requirement for continued
listing, and as a result our common stock is subject to delisting. On
July 28, 2008, we requested a hearing with the NASDAQ Listing Qualifications
Panel (“Panel”) to review the delisting determination. Our request
for a hearing stayed the delisting pending a decision by the
Panel. The oral hearing took place September 4, 2008 at which we
presented to the Panel our definitive plan to achieve and sustain long-term
compliance with the listing requirements of the NASDAQ Capital
Market. On September 16, 2008, we received a letter from the NASDAQ
Stock Market informing us that the Panel had determined to grant our request to
remain listed, subject to the condition that on or before January 20, 2009, we
must evidence a closing bid price for our common stock of $1.00 or more for a
minimum of ten prior consecutive trading days.
On October 21, 2008, we conducted our
2008 annual meeting of stockholders at which our stockholders approved an
amendment to our certificate of incorporation to effect a reverse stock split of
the outstanding shares of our common stock at a ratio to be determined by our
Board of Directors within a range of three-for-one and
ten-for-one. Subsequent to our annual meeting of stockholders, NASDAQ
Stock Market suspended the bid price and market value of publicly held shares
continued listing requirements through April 17, 2009. As a result of
this suspension, the exception granted to us by the Panel, which required us to
demonstrate compliance with the closing minimum bid price requirement by January
20, 2009, has been extended to July 27, 2009.
We intend
to pursue all available options to ensure our continued listing on the Nasdaq
Stock Market, including, if necessary, effecting the reverse stock split of our
outstanding common stock previously approved by our
stockholders. Although we currently meet all other Nasdaq listing
requirements, the market price of our common stock has generally been highly
volatile and we cannot guarantee that we will be able to regain compliance with
the minimum closing bid price requirement within the required compliance
period. If we fail to regain compliance with the minimum closing bid
price requirement or fail to comply with any other of The Nasdaq Capital Market
listing requirements, the market value of our common stock could fall and
holders of common stock would likely find it more difficult to dispose of the
common stock.
If our
common stock is delisted, we would apply to have our common stock quoted on the
over-the-counter electronic bulletin board. Upon any such delisting,
our common stock would become subject to the regulations of the Securities and
Exchange Commission relating to the market for penny stocks. A penny
stock, as defined by the Penny Stock Reform Act, is any equity security not
traded on a national securities exchange that has a market price of less than
$5.00 per share. The penny stock regulations generally require that a
disclosure schedule explaining the penny stock market and the risks associated
therewith be delivered to purchasers of penny stocks and impose various sales
practice requirements on broker-dealers who sell penny stocks to persons other
than established customers and accredited investors. The
broker-dealer must make a suitability determination for each purchaser and
receive the purchaser’s written agreement prior to the sale. In
addition, the broker-dealer must make certain mandated disclosures, including
the actual sale or purchase price and actual bid offer quotations, as well as
the compensation to be received by the broker-dealer and certain associated
persons. The regulations applicable to penny stocks may severely
affect the market liquidity for our common stock and could limit your ability to
sell your securities in the secondary market.
If
We Effect A Reverse Stock Split, The Liquidity of Our Common Stock And Market
Capitalization Could Be Adversely Affected.
A reverse
stock split is often viewed negatively by the market and, consequently, can lead
to a decrease in our overall market capitalization. If the per share
market price does not increase proportionately as a result of the reverse split,
then the value of our company as measured by our market capitalization will be
reduced, perhaps significantly. In addition, because the reverse
split will significantly reduce the number of shares of our common stock that
are outstanding, the liquidity of our common stock could be adversely affected
and you may find it more difficult to purchase or sell shares of our common
stock.
Successful
Development Of Our Products Is Uncertain. To Date, No Revenues Have
Been Generated From The Commercial Sale Of Our Products And Our Products May Not
Generate Revenues In The Future.
Our
development of current and future product candidates is subject to the risks of
failure inherent in the development of new pharmaceutical products and products
based on new technologies. These risks include:
·
|
delays
in product development, clinical testing or
manufacturing;
|
·
|
unplanned
expenditures in product development, clinical testing or
manufacturing;
|
·
|
failure
in clinical trials or failure to receive regulatory
approvals;
|
·
|
emergence
of superior or equivalent products;
|
·
|
inability
to manufacture on our own, or through others, product candidates on a
commercial scale;
|
·
|
inability
to market products due to third party proprietary rights;
and
|
·
|
failure
to achieve market acceptance.
|
Because
of these risks, our research and development efforts or those of our partners
may not result in any commercially viable products. If significant
portions of these development efforts are not successfully completed, required
regulatory approvals are not obtained, or any approved products are not
commercially successful, our business, financial condition and results of
operations may be materially harmed.
Because
we have not begun the commercial sale of any of our products, our revenue and
profit potential is unproven and our limited operating history makes it
difficult for an investor to evaluate our business and prospects. Our
technology may not result in any meaningful benefits to our current or potential
partners. No revenues have been generated from the commercial sale of
our products, and our products may not generate revenues in the
future. Our business and prospects should be considered in light of
the heightened risks and unexpected expenses and problems we may face as a
company in an early stage of development in a new and rapidly evolving
industry.
Our
Product Development Efforts May Not Be Successful.
Our
product candidates have not received regulatory approval and are generally in
research, pre-clinical and various clinical stages of development. If
the results from any of the clinical trials are poor, those results may
adversely affect our ability to raise additional capital or obtain regulatory
approval to conduct additional clinical trials, which will affect our ability to
continue full-scale research and development for our antibody
technologies. In addition, our product candidates may take longer
than anticipated to progress through clinical trials, or patient enrollment in
the clinical trials may be delayed or prolonged significantly, thus delaying the
clinical trials. Patient enrollment is a function of many factors,
including the size of the patient population, the nature of the protocol, the
proximity of patients to the clinical sites, and the eligibility criteria for
the study. In addition, because our Cotara® product currently in
clinical trials represents a departure from more commonly used methods for
cancer treatment, potential patients and their doctors may be inclined to use
conventional therapies, such as chemotherapy, rather than enroll patients in our
clinical study.
Clinical
Trials Required For Our Product Candidates Are Expensive And Time
Consuming, And Their Outcome Is
Uncertain.
|
In order
to obtain FDA approval to market a new drug product, we or our potential
partners must demonstrate proof of safety and efficacy in humans. To
meet these requirements, we or our potential partners will have to conduct
extensive pre-clinical testing and “adequate and well-controlled” clinical
trials. Conducting clinical trials is a lengthy, time-consuming and
expensive process. The length of time may vary substantially
according to the type, complexity, novelty and intended use of the product
candidate, and often can be several years or more per trial. Delays
associated with products for which we are directly conducting pre-clinical or
clinical trials may cause us to incur additional operating
expenses. Moreover, we may continue to be affected by delays
associated with the pre-clinical testing and clinical trials of certain product
candidates conducted by our partners over which we have no
control. The commencement and rate of completion of clinical trials
may be delayed by many factors, including, for example:
·
|
obtaining
regulatory approval to commence a clinical
trial;
|
·
|
reaching
agreement on acceptable terms with prospective contract research
organizations, or CROs, and trial sites, the terms of which can be subject
to extensive negotiation and may vary significantly among different CROs
and trial sites;
|
·
|
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
·
|
the
inability of patients to meet FDA or other regulatory authorities imposed
protocol requirements;
|
·
|
the
inability to retain patients who have initiated a clinical trial but may
be prone to withdraw due to various clinical or personal reasons, or who
are lost to further follow-up;
|
·
|
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices, or cGMPs, for use in clinical
trials;
|
·
|
the
need or desire to modify our manufacturing
processes;
|
·
|
the
inability to adequately observe patients after
treatment;
|
·
|
changes
in regulatory requirements for clinical
trials;
|
·
|
the
lack of effectiveness during the clinical
trials;
|
·
|
unforeseen
safety issues;
|
·
|
delays,
suspension, or termination of the clinical trials due to the institutional
review board responsible for overseeing the study at a particular study
site; and
|
·
|
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
|
Even if
we obtain positive results from pre-clinical or initial clinical trials, we may
not achieve the same success in future trials. Clinical trials may
not demonstrate statistically sufficient safety and effectiveness to obtain the
requisite regulatory approvals for product candidates employing our
technology.
Clinical
trials that we conduct or that third-parties conduct on our behalf may not
demonstrate sufficient safety and efficacy to obtain the requisite regulatory
approvals for any of our product candidates. We expect to commence
new clinical trials from time to time in the course of our business as our
product development work continues. The failure of clinical trials to
demonstrate safety and effectiveness for our desired indications could harm the
development of that product candidate as well as other product
candidates. Any change in, or termination of, our clinical trials
could materially harm our business, financial condition and results of
operations.
Our
International Clinical Trials May Be Delayed Or Otherwise Adversely Impacted By
Social, Political And Economic Factors Affecting The Particular Foreign
Country.
We are
presently conducting clinical trials in India and the Republic of
Georgia. Our ability to successfully initiate, enroll and complete a
clinical trial in either country, or in any future foreign country in which we
may initiate a clinical trial, are subject to numerous risks unique to
conducting business in foreign countries, including:
·
|
difficulty
in establishing or managing relationships with clinical research
organizations and physicians;
|
·
|
different
standards for the conduct of clinical trials and/or health care
reimbursement;
|
·
|
our
inability to locate qualified local consultants, physicians, and
partners;
|
·
|
the
potential burden of complying with a variety of foreign laws, medical
standards and regulatory requirements, including the regulation of
pharmaceutical products and treatment;
and
|
·
|
general
geopolitical risks, such as political and economic instability, and
changes in diplomatic and trade
relations.
|
Because
we will be conducting a number of our Phase II clinical trials in India and the
Republic of Georgia and potentially other foreign countries, any disruption to
our international clinical trial program could significantly delay our product
development efforts. In addition, doing business in the Republic of
Georgia, which is in Eastern Europe, involves other significant risks which
could materially and adversely affect our business as there remains a high
degree of political instability in many parts of Eastern Europe.
Success
In Early Clinical Trials May Not Be Indicative Of Results Obtained In Later
Trials.
A number
of new drugs and biologics have shown promising results in initial clinical
trials, but subsequently failed to establish sufficient safety and effectiveness
data to obtain necessary regulatory approvals. Data obtained from
pre-clinical and clinical activities are subject to varying interpretations,
which may delay, limit or prevent regulatory approval.
Positive
results from our pre-clinical studies, Phase I and the first stage of our Phase
II clinical trials should not be relied upon as evidence that later or
larger-scale clinical trials will succeed. The Phase I studies we
have completed to date have been designed to primarily assess safety in a small
number of patients. In addition, while we have completed the first
stage of all three of our Phase II studies, and obtained positive results with
respect to our primary endpoints, our Phase II trials are open-label, Simon
two-stage design trials to evaluate the safety and efficacy on bavituximab in
combination with chemotherapy drugs in a limited number of
patients. The limited results we have obtained, and will obtain in
the Phase II trials, may not predict results for any future studies and also may
not predict future therapeutic benefit. We will be required to
demonstrate through larger-scale clinical trials that bavituximab and Cotara®
are safe and effective for use in a diverse population before we can seek
regulatory approval for their commercial sale. There is typically an
extremely high rate of attrition from the failure of drug candidates proceeding
through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be Profitable.
Even if bavituximab, Cotara®, or any
future product candidate is approved for commercial sale by the FDA or other
regulatory authorities, the degree of market acceptance of any approved product
candidate by physicians, healthcare professionals and third-party payors and our
profitability and growth will depend on a number of factors,
including:
·
|
our
ability to provide acceptable evidence of safety and
efficacy;
|
·
|
relative
convenience and ease of
administration;
|
·
|
the
prevalence and severity of any adverse side
effects;
|
·
|
availability
of alternative treatments;
|
·
|
pricing
and cost effectiveness;
|
·
|
effectiveness
of our or our collaborators’ sales and marketing strategy;
and
|
·
|
our
ability to obtain sufficient third-party insurance coverage or
reimbursement.
|
In
addition, if bavituximab, Cotara®, or any future product candidate that we
discover and develop does not provide a treatment regimen that is more
beneficial than the current standard of care or otherwise provide patient
benefit, that product likely will not be accepted favorably by the
market. If any products we may develop do not achieve market
acceptance, then we may not generate sufficient revenue to achieve or maintain
profitability.
In
addition, even if our products achieve market acceptance, we may not be able to
maintain that market acceptance over time if new products or technologies are
introduced that are more favorably received than our products, are more cost
effective or render our products obsolete.
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We have
completed Phase I and Phase I/II studies with Cotara® for the treatment of brain
cancer. In addition, we are currently conducting a dose confirmation
and dosimetry clinical trial in patients with recurrent glioblastoma multiforme
(“GBM”) in the U.S. We are also currently conducting a Phase II
safety and efficacy study in India using a single administration of the drug
through an optimized delivery method. Taken together, the
current U.S. study along with data collected from the Phase II safety and
efficacy study in India should provide the safety, dosimetry and efficacy data
that will support the final design of the larger Phase III
study. Once we complete these two Cotara® studies for the treatment
of GBM, substantial financial resources will be needed to complete the final
part of the trial and any additional supportive clinical studies necessary for
potential product approval. We do not presently have the financial
resources internally to complete the larger Phase III study. We
therefore intend to continue to seek a licensing or funding partner for Cotara®,
and hope that the data from the U.S. and the Phase II study in India will
enhance our opportunities of finding such partner. If a partner is
not found for this technology, we may not be able to advance the project past
its current state of development. Because there are a limited number
of companies which have the financial resources, the internal infrastructure,
the technical capability and the marketing infrastructure to develop and market
a radiopharmaceutical based oncology drug, we may not find a suitable partnering
candidate for Cotara®. We also cannot ensure that we will be able to
find a suitable licensing partner for this technology. Furthermore,
we cannot ensure that if we do find a suitable licensing partner, the financial
terms that they propose will be acceptable to the Company.
Our
Dependency On Our Radiolabeling Suppliers May Negatively Impact Our Ability To
Complete Clinical Trials And Market Our Products.
We have
procured our antibody radioactive isotope combination services (“radiolabeling”)
for Cotara® with Iso-tex Diagnostics, Inc. for all U.S. clinical trials and with
the Board of Radiation & Isotope Technology (“BRIT”) for our Phase II study
in India. If either of these suppliers is unable to continue to
qualify its respective facility or radiolabel and supply our antibody in a
timely manner, our current clinical trials using radiolabeling technology could
be adversely affected and significantly delayed. While there are
other suppliers for radioactive isotope combination services in the U.S., our
clinical trial would be delayed for up to twelve to eighteen months because it
may take that amount of time to certify a new facility under current Good
Manufacturing Practices and qualify the product, plus we would incur significant
costs to transfer our technology to another vendor. In addition, the
number of facilities that can perform these radiolabeling services is very
limited. Prior to commercial distribution of any of our products, if
approved, we will be required to identify and contract with a company for
commercial antibody manufacturing and radioactive isotope combination
services. An antibody that has been combined with a radioactive
isotope, such as Iodine-131, cannot be stored for long periods of time, as it
must be used within one week of being radiolabeled to be
effective. Accordingly, any change in our existing or future
contractual relationships with, or an interruption in supply from, any such
third-party service provider or antibody supplier could negatively impact our
ability to complete ongoing clinical trials conducted by us or a potential
licensing partner.
Our
Manufacturing Facilities May Not Continue To Meet Regulatory Requirements And
Have Limited Capacity.
Before
approving a new drug or biologic product, the FDA requires that the facilities
at which the product will be manufactured be in compliance with current Good
Manufacturing Practices, or cGMP requirements. To be successful, our
therapeutic products must be manufactured for development and, following
approval, in commercial quantities, in compliance with regulatory requirements
and at acceptable costs. Currently, we manufacture all pre-clinical
and clinical material through Avid Bioservices, our wholly owned
subsidiary. While we believe our current facilities are adequate for
the manufacturing of product candidates for clinical trials, our facilities may
not be adequate to produce sufficient quantities of any products for commercial
sale.
If we are
unable to establish and maintain a manufacturing facility or secure third-party
manufacturing capacity within our planned time frame and cost parameters, the
development and sales of our products, if approved, may be materially
harmed.
We may
also encounter problems with the following:
·
|
quality
control and quality assurance;
|
·
|
shortages
of qualified personnel;
|
·
|
compliance
with FDA or other regulatory authorities regulations, including the
demonstration of purity and
potency;
|
·
|
changes
in FDA or other regulatory authorities
requirements;
|
·
|
production
costs; and/or
|
·
|
development
of advanced manufacturing techniques and process
controls.
|
In
addition, we or any third-party manufacturer will be required to register the
manufacturing facilities with the FDA and other regulatory authorities, provided
it had not already registered. The facilities will be subject to
inspections confirming compliance with cGMP or other regulations. If
any of our third-party manufacturers or we fail to maintain regulatory
compliance, the FDA can impose regulatory sanctions including, among other
things, refusal to approve a pending application for a new drug product or
biologic product, or revocation of a pre-existing approval. As a
result, our business, financial condition and results of operations may be
materially harmed.
We
Currently Depend On a Government Contract To Partially Fund Our Research And
Development Efforts. If Our Current Government Funding Is Reduced Or
Delayed, Our Drug Development Efforts May Be Negatively Affected.
On June
30, 2008, we were awarded up to a five-year contract potentially worth up to
$44.4 million to test and develop bavituximab and an equivalent fully human
antibody as potential broad-spectrum treatments for viral hemorrhagic fever
infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (TMTI) of the U.S. Department
of Defense's Defense Threat Reduction Agency (DTRA). This federal
contract is expected to provide us with up to $22.3 million in funding over
a 24-month base period, with $14.3 million having been appropriated through the
current federal fiscal year ending September 30, 2009. The remainder
of the $22.3 million in funding is expected to be appropriated over the
remainder of the two-year base period ending June 29, 2010. Subject
to the progress of the program and budgetary considerations in future years, the
contract can be extended beyond the base period to cover up to $44.4 million in
funding over the five-year contract period. Work under this contract
commenced on June 30, 2008. If we do not receive the expected funding
under this contract, we may not be able to develop therapeutics to treat
hemorrhagic fever virus infection nor otherwise receive the other indirect
benefits that may be derived from receipt of the full funding under this
contract.
Federal
government contracts contain provisions giving government customers a variety of
rights that are unfavorable to us, including the ability to terminate a contract
at any time for convenience.
Federal
government contracts, such as our contract with the DTRA, contain provisions,
and are subject to laws and regulations, that give the government rights and
remedies not typically found in commercial contracts. These provisions may allow
the government to:
·
|
Reduce,
cancel, or otherwise modify our contracts or related
subcontract agreements;
|
·
|
Decline
to exercise an option to renew a multi-year
contract;
|
·
|
Claim
rights in products and systems produced by
us;
|
·
|
Prohibit
future procurement awards with a particular agency as a result of a
finding of an organizational conflict of interest based upon prior related
work performed for the agency that would give a contractor an unfair
advantage over competing
contractors;
|
·
|
Subject
the award of contracts to protest by competitors, which may require the
contracting federal agency or department to suspend our performance
pending the outcome of the protest;
|
·
|
Suspend
or debar us from doing business with the federal government or with a
governmental agency; and
|
·
|
Control
or prohibit the export of our products and
services.
|
If the
government terminates our contract for convenience, we may recover only our
incurred or committed costs, settlement expenses and profit on work completed
prior to the termination. If the government terminates our contract for default,
we may not recover even those amounts, and instead may be liable for excess
costs incurred by the government in procuring undelivered items and services
from another source. If the DTRA were to unexpectedly terminate or cancel, or
decline to exercise the option to extend our contract beyond the base period,
our revenues, product development efforts and operating results would be
materially harmed.
We
May Have Significant Product Liability Exposure Because We Maintain Only Limited
Product Liability Insurance.
We face
an inherent business risk of exposure to product liability claims in the event
that the administration of one of our drugs during a clinical trial adversely
affects or causes the death of a patient. Although we maintain
product liability insurance for clinical studies in the amount of $3,000,000 per
occurrence or $3,000,000 in the aggregate on a claims-made basis, this coverage
may not be adequate. Product liability insurance is expensive,
difficult to obtain and may not be available in the future on acceptable terms,
if at all. Our inability to obtain sufficient insurance coverage on
reasonable terms or to otherwise protect against potential product liability
claims in excess of our insurance coverage, if any, or a product recall, could
negatively impact our financial position and results of operations.
In
addition, the contract manufacturing services that we offer through Avid expose
us to an inherent risk of liability as the antibodies or other substances
manufactured by Avid, at the request and to the specifications of our customers,
could possibly cause adverse effects or have product defects. We
obtain agreements from our customers indemnifying and defending us from any
potential liability arising from such risk. There can be no assurance
that such indemnification agreements will adequately protect us against
potential claims relating to such contract manufacturing services or protect us
from being named in a possible lawsuit. Although Avid has procured
insurance coverage, there is no guarantee that we will be able to maintain our
existing coverage or obtain additional coverage on commercially reasonable
terms, or at all, or that such insurance will provide adequate coverage against
all potential claims to which we might be exposed. A partially
successful or completely uninsured claim against Avid would have a material
adverse effect on our consolidated operations.
If
We Are Unable To Obtain, Protect And Enforce Our Patent Rights, We May Be Unable
To Effectively Protect Or Exploit Our Proprietary Technology, Inventions And
Improvements.
Our
success depends in part on our ability to obtain, protect and enforce
commercially valuable patents. We try to protect our proprietary
positions by filing United States and foreign patent applications related to our
proprietary technology, inventions and improvements that are important to
developing our business. However, if we fail to obtain and maintain
patent protection for our proprietary technology, inventions and improvements,
our competitors could develop and commercialize products that would otherwise
infringe upon our patents.
Our
patent position is generally uncertain and involves complex legal and factual
questions. Legal standards relating to the validity and scope of
claims in the biotechnology and biopharmaceutical fields are still
evolving. Accordingly, the degree of future protection for our patent
rights is uncertain. The risks and uncertainties that we face with
respect to our patents include the following:
·
|
the
pending patent applications we have filed or to which we have exclusive
rights may not result in issued patents or may take longer than we expect
to result in issued patents;
|
·
|
the
claims of any patents that issue may not provide meaningful
protection;
|
·
|
we
may be unable to develop additional proprietary technologies that are
patentable;
|
·
|
the
patents licensed or issued to us may not provide a competitive
advantage;
|
·
|
other
parties may challenge patents licensed or issued to
us;
|
·
|
disputes
may arise regarding the invention and corresponding ownership rights in
inventions and know-how resulting from the joint creation or use of
intellectual property by us, our licensors, corporate partners and other
scientific collaborators; and
|
·
|
other
parties may design around our patented
technologies.
|
We
May Become Involved In Lawsuits To Protect Or Enforce Our Patents That Would Be
Expensive And Time Consuming.
In order
to protect or enforce our patent rights, we may initiate patent litigation
against third parties. In addition, we may become subject to
interference or opposition proceedings conducted in patent and trademark offices
to determine the priority and patentability of inventions. The
defense of intellectual property rights, including patent rights through
lawsuits, interference or opposition proceedings, and other legal and
administrative proceedings, would be costly and divert our technical and
management personnel from their normal responsibilities. An adverse
determination of any litigation or defense proceedings could put our pending
patent applications at risk of not being issued.
Furthermore, because of the substantial
amount of discovery required in connection with intellectual property
litigation, there is a risk that some of our confidential information could be
compromised by disclosure during this type of litigation. For
example, during the course of this kind of litigation, confidential information
may be inadvertently disclosed in the form of documents or testimony in
connection with discovery requests, depositions or trial
testimony. This disclosure could have a material adverse effect on
our business and our financial results.
We
May Not Be Able To Compete With Our Competitors In The Biotechnology Industry
Because Many Of Them Have Greater Resources Than We Do And They Are Further
Along In Their Development Efforts.
The pharmaceutical and biotechnology
industry is intensely competitive and subject to rapid and significant
technological change. Many of the drugs that we are attempting to
discover or develop will be competing with existing therapies. In
addition, we are aware of several pharmaceutical and biotechnology companies
actively engaged in research and development of antibody-based products that
have commenced clinical trials with, or have successfully commercialized,
antibody products. Some or all of these companies may have greater
financial resources, larger technical staffs, and larger research budgets than
we have, as well as greater experience in developing products and running
clinical trials. We expect to continue to experience significant and
increasing levels of competition in the future. In addition, there
may be other companies which are currently developing competitive technologies
and products or which may in the future develop technologies and products that
are comparable or superior to our technologies and products.
We are conducting the Cotara® dose
confirmation and dosimetry clinical trial for the treatment of recurrent
glioblastoma multiforme (“GBM”), the most aggressive form of brain
cancer. Approved treatments for brain cancer include the Gliadel®
Wafer (polifeprosan 20 with carmustine implant) from MGI Pharma, Inc. and
Temodar® (temozolomide) from Schering-Plough Corporation. Gliadel® is
inserted in the tumor cavity following surgery and releases a chemotherapeutic
agent over time. Temodar® is administered orally to patients with
brain cancer.
Because Cotara® targets brain tumors
from the inside out, it is a novel treatment dissimilar from other drugs in
development for this disease. Some products in development may
compete with Cotara® should they become approved for marketing. These
products include, but are not limited to: 131I-TM601,
a radiolabeled chlorotoxin peptide being developed by TransMolecular, Inc.,
Neuradiab, a radiolabeled anti-tenascin monoclonal antibody sponsored by Bradmer
Pharmaceuticals, CDX-110, a peptide vaccine under development by Celldex,
cilengitide, an integrin-targeting peptide being evaluated by Merk KGaA, and
cediranib, a VEGFR tyrosine kinase inibitor being developed by
AstraZeneca. In addition, oncology products marketed for other
indications such as Gleevec® (Novartis), Tarceva® (Genentech/OSI), Avastin®
(Genentech) and Nexavar® (Bayer), are being tested in clinical trials for the
treatment of brain cancer.
Bavituximab is currently in clinical
trials for the treatment of advanced solid cancers. There are a
number of possible competitors with approved or developmental targeted agents
used in combination with standard chemotherapy for the treatment of
cancer, including but not limited to, Avastin® by Genentech, Inc., Gleevec®
by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and Genentech, Inc., Erbitux®
by ImClone Systems Incorporated and Bristol-Myers Squibb Company, Rituxan® and
Herceptin® by Genentech, Inc., and Vectibix™ by Amgen. There are a
significant number of companies developing cancer therapeutics using a variety
of targeted and non-targeted approaches. A direct comparison of these
potential competitors will not be possible until bavituximab advances to
later-stage clinical trials.
In addition, we are evaluating
bavituximab for the treatment of HCV. Bavituximab is a first-in-class
approach for the treatment of HCV. We are aware of no other products
in development targeting phosphatidylserine as a potential therapy for
HCV. There are a number of companies that have products approved and
on the market for the treatment of HCV, including but not limited
to: Peg-Intron® (pegylated interferon-alpha-2b), Rebetol®
(ribavirin), and Intron-A (interferon-alpha-2a), which are marketed by
Schering-Plough Corporation, and Pegasys® (pegylated interferon-alpha-2a),
Copegus® (ribavirin USP) and Roferon-A® (interferon-alpha-2a), which are
marketed by Roche Pharmaceuticals, and Infergen® (interferon alfacon-1) now
marketed by Three Rivers Pharmaceuticals, LLC. First line treatment
for HCV has changed little since alpha interferon was first introduced in
1991. The current standard of care for HCV includes a combination of
an alpha interferon (pegylated or non-pegylated) with ribavirin. This
combination therapy is generally associated with considerable toxicity including
flu-like symptoms, hematologic changes and central nervous system side effects
including depression. It is not uncommon for patients to discontinue
alpha interferon therapy because they are unable to tolerate the side effects of
the treatment.
Future treatments for HCV are likely to
include a combination of these existing products used as adjuncts with products
now in development. Later-stage developmental treatments include
improvements to existing therapies, such as Albuferon™ (albumin interferon) from
Human Genome Sciences, Inc. Other developmental approaches include,
but are not limited to, protease inhibitors such as telaprevir from Vertex
Pharmaceuticals Incorporated and boceprevir from Schering-Plough
Corporation.
Avid
Bioservices, Our subsidiary, Is exposed To Risks Resulting From Its Small
Customer Base.
A
significant portion of Avid Bioservices’ revenues have historically been derived
from a small customer base. These customers typically do not enter
into long-term contracts because their need for drug supply depends on a variety
of factors, including the drug’s stage of development, their financial
resources, and, with respect to commercial drugs, demand for the drug in the
market. Our results of operations could be adversely affected if
revenue from any one of our primary customers is significantly reduced or
eliminated
If
We Lose Qualified Management And Scientific Personnel Or Are Unable To Attract
And Retain Such Personnel, We May Be Unable To Successfully Develop Our Products
Or We May Be Significantly Delayed In Developing Our Products.
Our
success is dependent, in part, upon a limited number of key executive officers,
each of whom is an at-will employee, and also upon our scientific
researchers. For example, because of his extensive understanding of
our technologies and product development programs, the loss of Mr. Steven W.
King, our President & Chief Executive Officer and Director, would adversely
affect our development efforts and clinical trial programs during the six to
twelve month period that we estimate it would take to find and train a qualified
replacement.
We also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical
personnel. We face intense competition in our recruiting activities,
including competition from larger companies with greater
resources. We do not know if we will be successful in attracting or
retaining skilled personnel. The loss of certain key employees or our
inability to attract and retain other qualified employees could negatively
affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to
protect stockholders against unsolicited attempts to acquire control of us that
do not offer a fair price to our stockholders as determined by our Board of
Directors. Under the plan, the acquisition of 15% or more of our
outstanding common stock by any person or group, unless approved by our board of
directors, will trigger the right of our stockholders (other than the acquiror
of 15% or more of our common stock) to acquire additional shares of our common
stock, and, in certain cases, the stock of the potential acquiror, at a 50%
discount to market price, thus significantly increasing the acquisition cost to
a potential acquiror. In addition, our certificate of incorporation
and by-laws contain certain additional anti-takeover protective
devices. For example,
·
|
no
stockholder action may be taken without a meeting, without prior notice
and without a vote; solicitations by consent are thus
prohibited;
|
·
|
special
meetings of stockholders may be called only by our Board of Directors;
and
|
·
|
our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares, of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into a large
number of shares of common stock could prevent a potential acquiror from
gaining effective economic or voting
control.
|
Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these
provisions may frustrate or prevent any attempts by our stockholders to replace
or remove our current management by making it more difficult for stockholders to
replace members of our Board of Directors, which is responsible for appointing
the members of our management.
ITEM
2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS.
None.
|
ITEM
3.
|
DEFAULTS
UPON SENIOR
SECURITIES. None.
|
ITEM
4.
|
SUBMISSION OF MATTERS TO A VOTE OF
SECURITY
HOLDERS. None
|
|
10.111
|
Loan
and Security Agreement dated December 9, 2008 between Registrant and
BlueCrest Capital Finance, L.P.
|
|
10.112
|
Secured
Term Promissory Note dated December 19, 2008 between Registrant and
BlueCrest Capital Finance, L.P.
|
|
10.113
|
Secured
Term Promissory Note dated December 19, 2008 between Registrant and MidCap
Funding I, LLC.
|
|
10.114
|
Intellectual
Property Security Agreement dated December 19, 2008 between Avid
Bioservices, Inc. and MidCap Funding I,
LLC.
|
|
10.115
|
Intellectual
Property Security Agreement dated December 19, 2008 between Registrant and
MidCap Funding I, LLC.
|
|
10.116
|
Warrant to
purchase 507,614 shares of Common Stock of Registrant issued to BlueCrest
Capital Finance, L.P. dated December 9,
2008.
|
|
10.117
|
Warrant
to purchase 1,184,433 shares of Common Stock of Registrant issued to
MidCap Funding I, LLC dated December 9,
2008.
|
|
|
Certification
of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the Registrant has duly caused this report to
be signed on its behalf by the undersigned thereunto duly
authorized.
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
Date: March 11, 2009 |
By:
/s/
STEVEN
W. KING |
|
|
|
Steven
W. King
President,
Chief Executive Officer, and Director
|
|
|
|
|
|
|
|
|
|
|
Date: March 11, 2009 |
By: /s/ PAUL J.
LYTLE |
|
|
|
Paul
J. Lytle
Chief
Financial Officer
(signed
both as an
officer
duly authorized to sign on
behalf
of the Registrant and principal
financial
officer and chief accounting
officer)
|
|
44
peregrine_10q-ex10111.htm
Exhibit 10.111
LOAN
AND SECURITY AGREEMENT
THIS LOAN AND SECURITY
AGREEMENT (this “Agreement”) dated as of
December 9, 2008 (the “Effective Date”) among BLUECREST CAPITAL FINANCE,
L.P., a Delaware limited
partnership (“BlueCrest”), the other Lenders
listed on Schedule 1.1 hereof and otherwise party hereto, and BlueCrest in its
capacity as agent for the Lenders (the “Agent”), BlueCrest in its
capacity as lead arranger (in such capacity, the “Arranger”), and PEREGRINE PHARMACEUTICALS,
INC., a Delaware corporation (“Peregrine”), and AVID BIOSERVICES, INC., a
Delaware corporation (“Avid,” and together with
Peregrine, jointly and severally, individually and collectively, referred to as
“Borrower”), provides
the terms on which Lenders shall lend to Borrower and Borrower shall repay
Lenders. The parties agree as follows:
1
ACCOUNTING AND OTHER
TERMS
Accounting
terms not defined in this Agreement shall be construed following
GAAP. Calculations and determinations must be made following
GAAP. Capitalized terms not otherwise defined in this Agreement shall
have the meanings set forth in Section 13. All other terms
contained in this Agreement, unless otherwise indicated, shall have the meaning
provided by the Code to the extent such terms are defined therein.
2
LOAN AND TERMS OF
PAYMENT
2.1
Promise to
Pay. Borrower hereby unconditionally promises to pay Lenders
the outstanding principal amount of all Credit Extensions and accrued and unpaid
interest thereon as and when due in accordance with this Agreement.
2.1.1
Growth Capital
Advances.
(a) Availability. Subject
to the terms and conditions of this Agreement, during the Growth Capital Draw
Period, Lenders agree, severally and not jointly, to make advances to Borrower
(each a “Growth Capital
Advance” and, collectively, the “Growth Capital Advances”) not
exceeding the Growth Capital Line according to each Lender's pro-rata share of
the Growth Capital Line (based upon the respective Commitment Percentage of each
Lender). After repayment, no Growth Capital Advance may be
reborrowed. The Growth Capital Advances shall be available in two
tranches. The first tranche (“Tranche One”) shall be in an
amount equal to Five Million Dollars ($5,000,000) and shall be advanced within
ten (10) calendar days after the Effective Date. The second tranche
(“Tranche Two”) shall be
in an amount equal to Five Million Dollars ($5,000,000) and shall be available
to be advanced only within the fifteen (15) Business Day period following the
satisfaction of the following conditions, but shall not be advanced after the
Growth Capital Commitment Termination Date:
(i) Peregrine
receives (in cash) at least (x) $7,500,000 in gross proceeds from the
issuance of new equity after the Effective Date or (y) ********** in net proceeds from the
sale of Avid;
(ii) the
interim results from either (x) the Phase II bavituximab and carboplatin breast
cancer study or (y) the Phase II bavituximab and carboplatin lung cancer study
meet the predetermined response rate sufficient to continue Stage B enrollment
as specified in the respective clinical protocol for such study, and proven to
the reasonable satisfaction of Agent; and
(iii) no
Default or Event of Default has occurred or is continuing.
(c) Repayment. Commencing
on the seventh (7th)
Interest Payment Date for each Growth Capital Advance, and on each Interest
Payment Date thereafter, Borrower shall pay to Lenders as a principal payment
under such Growth Capital Advance outstanding an amount equal to the
“Amortization Payment” (defined below) as an amortization payment in respect of
such Growth Capital Advance. The term “Amortization Payment” means
the principal payment based upon a straight-line amortization of equal monthly
principal payments through the Growth Capital Line Maturity Date. The
final payment of all unpaid principal and accrued interest is due and payable in
full on the Growth Capital Line Maturity Date.
(d) Mandatory Prepayment Upon an
Acceleration. If the Growth Capital Advances are accelerated
following the occurrence of an Event of Default, Borrower shall immediately pay
to Lenders an amount equal to the sum of (i) all outstanding principal plus
accrued and unpaid interest, (ii) the Final Payment, (iii) the Prepayment Fee,
and (iv) all other sums, if any, that shall have become due and payable,
including interest at the Default Rate with respect to any past due
amounts.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(e) Permitted Prepayment of
Growth Capital Advances. So long as no Event of Default
has occurred and is continuing, Borrower shall have the option to prepay all,
but not less than all, of the Growth Capital Advances advanced by Lenders under
this Agreement, provided Borrower (i) delivers written notice to Agent of its
election to prepay the Growth Capital Advances at least thirty (30) days prior
to such prepayment, and (ii) pays to Lenders, on the date of such prepayment (A)
all outstanding principal plus accrued and unpaid interest, (B) the Final
Payment, (C) the Prepayment Fee, and (D) all other sums, if any, that
shall have become due and payable, including interest at the Default Rate with
respect to any past due amounts. Notwithstanding the foregoing,
Lenders shall waive fifty percent (50%) of the Prepayment Fee in the event
Borrower refinances all of the Obligations within thirty (30) days after
Lenders’ demand for Borrower to pay increased costs or additional costs pursuant
to Section 2.4 hereof.
2.2 Payment of Interest on the Credit
Extensions.
(a) Computation of
Interest. Interest on the Credit Extensions and all fees
payable hereunder shall be computed on the basis of a 360-day year and the
actual number of days elapsed in the period during which such interest
accrues. In computing interest on any Credit Extension, the date of
the making of such Credit Extension shall be included and the date of payment
shall be excluded; provided, however, that if any Credit Extension is repaid on
the same day on which it is made, such day shall be included in computing
interest on such Credit Extension.
(b) Interest
Payments. Subject to the provisions of Sections 2.2(c) and 3.5
below, each Growth Capital Advance shall bear interest on the outstanding
principal amount thereof from the date when made until paid in full at a rate
per annum equal to (i) the greater of (A) the LIBOR Rate in effect for the
applicable Interest Period or (B) three percent (3%), plus (ii) the LIBOR Rate
Margin, adjusted on the first day of each Interest Period and fixed for the
duration of each such Interest Period. Pursuant to the terms hereof,
interest on each Growth Capital Advance shall be paid in arrears on each
Interest Payment Date. Interest shall also be paid on the date of any
prepayment of any Growth Capital Advance pursuant to this Agreement for the
portion of any Growth Capital Advance so prepaid and upon payment (including
prepayment) in full thereof. All accrued but unpaid interest on the
Growth Capital Advances shall be due and payable on the Growth Capital Line
Maturity Date.
(c) Default
Interest. After and during the continuation of an Event of
Default, Obligations shall bear interest of five percent (5.00%) above the rate
that is otherwise applicable thereto (the “Default
Rate”). Payment or acceptance of the increased interest rate
provided in this Section 2.2(c) is not a permitted alternative to timely
payment and shall not constitute a waiver of any Event of Default or otherwise
prejudice or limit any rights or remedies of Agent or Lenders.
(d) Debit of
Accounts. Lenders may debit any of Borrower’s deposit
accounts, including the Designated Deposit Account, for principal and interest
payments when due, or any other amounts Borrower owes Lenders under the Loan
Documents, when due. These debits shall not constitute a
set-off.
(e) Payments. Unless
otherwise provided, interest is payable monthly on each Interest Payment
Date. Payments of principal and/or interest received after 12:00 noon
Eastern time are considered received at the opening of business on the next
Business Day. When a payment is due on a day that is not a Business
Day, the payment is due the next Business Day and additional fees or interest,
as applicable, shall continue to accrue. All payments to be made by
Borrower hereunder or under any other Loan Document, including payments of
principal and interest made hereunder and pursuant to any other Loan Document,
and all fees, expenses, indemnities and reimbursements, shall be made without
set-off, recoupment or counterclaim, in lawful money of the United States and in
immediately available funds. All payments required under this
Agreement are to be made directly to Lenders.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(f) Maximum Lawful
Rate. In no event shall the interest charged hereunder, with
respect to the notes (if any) or any other obligations of Borrower under any
Loan Documents exceed the maximum amount permitted under the Laws of the State
of Maryland or of any other applicable jurisdiction. Notwithstanding
anything to the contrary herein or elsewhere, if at any time the rate of
interest payable hereunder or under any note or other Loan Document (the “Stated Rate”) would exceed the
highest rate of interest permitted under any applicable Law to be charged (the
“Maximum Lawful Rate”),
then for so long as the Maximum Lawful Rate would be so exceeded, the rate of
interest payable shall be equal to the Maximum Lawful Rate; provided, however, that if at
any time thereafter the Stated Rate is less than the Maximum Lawful Rate,
Borrower shall, to the extent permitted by Law, continue to pay interest at the
Maximum Lawful Rate until such time as the total interest received is equal to
the total interest which would have been received had the Stated Rate been (but
for the operation of this provision) the interest rate
payable. Thereafter, the interest rate payable shall be the Stated
Rate unless and until the Stated Rate again would exceed the Maximum Lawful
Rate, in which event this provision shall again apply. In no event
shall the total interest received by any Lender exceed the amount which it could
lawfully have received, had the interest been calculated for the full term
hereof at the Maximum Lawful Rate. If, notwithstanding the prior
sentence, any Lender has received interest hereunder in excess of the Maximum
Lawful Rate, such excess amount shall be applied to the reduction of the
principal balance of the Growth Capital Advances or to other amounts (other than
interest) payable hereunder, and if no such principal or other amounts are then
outstanding, such excess or part thereof remaining shall be paid to
Borrower. In computing interest payable with reference to the Maximum
Lawful Rate applicable to any Lender, such interest shall be calculated at a
daily rate equal to the Maximum Lawful Rate divided by the number of days
in the year in which such calculation is made.
2.3 Fees. Borrower
shall pay to Lenders:
(a) Commitment
Fee. A fully earned, non-refundable commitment fee of (i)
$50,000 in regard to Tranche One, due and payable on the Effective Date, and
(ii) $50,000 in regard to Tranche Two (the “Tranche Two Commitment Fee”) due and
payable on the earliest to occur of (A) the funding of Tranche Two or (B) June
30, 2009 (if the condition in Section 2.1.1(a)(ii) has been met prior to such
date); provided, however, that the Tranche Two Commitment Fee shall be waived if
the condition in Section 2.1.1(a)(ii) has not been met prior to June 30,
2009;
(b) Prepayment
Fee. The Prepayment Fee, when due hereunder;
(c) Final
Payment. The Final Payment, when due hereunder;
and
(d) Lenders'
Expenses. All Lenders' Expenses (including reasonable
attorneys’ fees and expenses, plus expenses, for documentation and negotiation
of this Agreement) incurred through and after the Effective Date, within ten
(10) Business Days following written demand therefor, net of the $50,000 deposit
previously paid by Borrower.
2.4 Additional
Costs. If any new Law or regulation increases Lender’s costs
or reduces its income for any loan, Borrower shall pay the increase in cost or
reduction in income or additional expense; provided, however, that Borrower
shall not be liable for any amount attributable to any period before 180 days
prior to the date Agent notifies Borrower of such increased
costs. Each Lender agrees that it shall allocate any increased costs
among its customers similarly affected in good faith and in a manner consistent
with such Lender's customary practice.
2.5 Payments and
Taxes. Any and all payments made by Borrower under this
Agreement or any Loan Documents shall be made free and clear of and without
deduction for any and all present or future taxes, levies, imposts, duties,
deductions, withholdings, assessments, fees or other charges imposed by any
governmental authority (including any interest, additions to tax or penalties
applicable thereto) other than any taxes imposed on or measured by any Lender’s
overall net income and franchise taxes imposed on it (in lieu of net income
taxes), by a jurisdiction (or any political subdivision thereof) as a result of
any Lender being organized or resident, conducting business (other than a
business deemed to arise from such Lender having executed, delivered or
performed its obligations or received a payment under, or enforced, or otherwise
with respect to, this Agreement or any Loan Documents) or having its principal
office in such jurisdiction (“Indemnified
Taxes”). If any Indemnified Taxes shall be required by Law to
be withheld or deducted from or in respect of any sum payable under this
Agreement or any Loan Documents to any Lender (w) an additional amount shall be
payable as may be necessary so that, after making all required withholdings or
deductions (including withholdings or deductions applicable to additional sums
payable under this Section) such Lender receives an amount equal to the sum it
would have received had no such withholdings or deductions been made, (x)
Borrower shall make such withholdings or deductions, (y) Borrower shall pay the
full amount withheld or deducted to the relevant taxing authority or other
authority in accordance with applicable Law and (z) Borrower shall deliver to
such Lender evidence of such payment. Borrower’s obligation hereunder
shall survive the termination of this Agreement.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
3
CONDITIONS OF
LOANS
3.1
Conditions Precedent to
Initial Credit Extension. Each Lender’s obligation to make the
initial Credit Extension is subject to the condition precedent that Borrower
shall consent to or shall have delivered, in form and substance satisfactory to
Lenders, such documents, and completion of such other matters, as Lenders may
reasonably deem necessary or appropriate, including, without
limitation:
(a) Agent
shall have received duly executed original signatures to the Loan Documents to
which Borrower is a party;
(b) Agent
shall have received duly executed original signatures to the Control
Agreement[s];
(c) Agent
shall have received Operating Documents and a good standing certificate of
Borrower certified by the Secretary of State of the State of Delaware as of a
date no earlier than thirty (30) days prior to the Effective Date;
(d) Agent
shall have received duly executed original signatures to the completed Borrowing
Resolutions for Borrower;
(e) Agent
shall have received certified copies, dated as of a recent date, of financing
statement searches, as Agent shall request, accompanied by written evidence
(including any UCC termination statements) that the Liens indicated in any such
financing statements either constitute Permitted Liens or have been or, in
connection with the initial Credit Extension, will be terminated or
released;
(f) Agent
shall have received the Perfection Certificate executed by
Borrower;
(g) Agent
shall have received a legal opinion of Borrower’s counsel dated as of the
Effective Date together with the duly executed original signatures
thereto;
(h) BlueCrest
shall have (i) assigned to another Lender (the “Assignee Lender”) a seventy
percent (70%) Commitment Percentage under the Growth Capital Line and all
rights, remedies and obligations in connection therewith, and resigned as Agent
and agreed to permit such Assignee Lender to become the Agent and Arranger;
(i) Agent
shall have received payment of the fees and Lenders' Expenses then due as
specified in Section 2.3 hereof; and
(j) Agent
shall have received evidence, satisfactory to Agent, that all Liens set forth in
clause (l) of the definition of “Permitted Liens” have been
terminated.
3.2 Conditions Precedent to all Credit
Extensions. The obligation of each Lender to make each Credit
Extension, including the initial Credit Extension, is subject to the
following:
(a) (i)
Agent’s receipt of a promissory note or promissory notes, as the case may be, in
substantially the form agreed upon by the parties hereto as of the Effective
Date, executed by Borrower in favor of each Lender (one promissory note per
Lender) with a face amount equal to the portion of the applicable Credit
Extension to be funded by the applicable Lender, and (ii) except as otherwise
provided in Section 3.4, timely receipt of an executed Advance Request
Form;
(b) the
representations and warranties in Section 5 shall be true, correct and complete
in all material respects on the date of the Advance Request Form and on the
Funding Date of each Credit Extension; provided, however, that such materiality
qualifier shall not be applicable to any representations and warranties that
already are qualified or modified by materiality in the text thereof; and
provided, further that those representations and warranties expressly referring
to a specific date shall be true, accurate and complete in all material respects
as of such date, and no Default or Event of Default shall have occurred and be
continuing or result from the Credit Extension. Each Credit Extension
is Borrower’s representation and warranty on that date that the representations
and warranties in Section 5 remain true in all material respects; provided,
however, that such materiality qualifier shall not be applicable to any
representations and warranties that already are qualified or modified by
materiality in the text thereof; and provided, further that those
representations and warranties expressly referring to a specific date shall be
true, accurate and complete in all material respects as of such date;
and
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(c) in
such Lender’s sole discretion, there has not been any material impairment in the
general affairs, management, results of operation, financial condition or the
prospect of repayment of the Obligations, nor has there been any material
adverse deviation by Borrower from the most recent business plan of Borrower
presented to and accepted by Agent.
3.3 Covenant to
Deliver. Borrower agrees to deliver to Agent each item
required to be delivered to Agent under this Agreement as a condition to any
Credit Extension. Borrower expressly agrees that the extension of a
Credit Extension prior to the receipt by Agent of any such item shall not
constitute a waiver by Lenders of Borrower’s obligation to deliver such item,
and any such extension in the absence of a required item shall be in Agent’s
sole discretion.
3.4 Procedures for
Borrowing. Subject to the prior satisfaction of all other
applicable conditions to the making of a Growth Capital Advance set forth in
this Agreement, to obtain a Growth Capital Advance, Borrower shall notify Agent
(which notice shall be irrevocable) by electronic mail, facsimile, or telephone
by 12:00 noon Eastern time five (5) Business Days prior to the date the Growth
Capital Advance is to be made. Together with any such electronic or
facsimile notification, Borrower shall deliver to Agent by electronic mail or
facsimile a completed Advance Request Form executed by a Responsible Officer or
his or her designee. Upon receipt of an Advance Request Form, Agent
shall promptly provide a copy of the same to each Lender. Agent may
rely on any telephone notice given by a person whom such Agent believes is a
Responsible Officer or designee. On the Funding Date, each Lender
shall credit and/or transfer (as applicable) to Borrower's Designated Deposit
Account, an amount equal to its Commitment Percentage multiplied by the amount
of the Growth Capital Advance. Each Lender may make Growth Capital
Advances under this Agreement based on instructions from a Responsible Officer
or his or her designee or without instructions if the Growth Capital Advances
are necessary to meet Obligations which have become due.
3.5 Special Provisions Governing Growth
Capital Advances.
Notwithstanding
any other provision of this Agreement to the contrary, the following provisions
shall govern with respect to the matters covered:
(a) Determination of Applicable
Interest Rate. As soon as practicable on each Interest Rate
Determination Date, Agent shall determine (which determination shall, absent
manifest error in calculation, be final, conclusive and binding upon all
parties) the interest rate that shall apply to the Growth Capital Advances for
which an interest rate is then being determined for the applicable Interest
Period and shall promptly give notice thereof (in writing or by telephone
confirmed in writing) to Borrower.
(b) No Breakage
Fees. Borrower shall not incur any breakage fees associated
with the prepayment of Growth Capital Advances on a day that is not the last day
of the relevant Interest Period.
(c) Inability to Determine
Applicable Interest Rate. In the event that Agent shall have
determined (which determination shall be final and conclusive and binding upon
all parties hereto), on any Interest Rate Determination Date with respect to any
Growth Capital Advance, that adequate and fair means do not exist for
ascertaining the interest rate applicable to such Growth Capital Advance on the
basis provided for in the definition of LIBOR Rate, then Agent may select a
comparable replacement index and corresponding margin.
4
CREATION
OF SECURITY INTEREST
4.1 Grant of Security
Interest. Borrower hereby grants Agent, for the ratable
benefit of the Lenders, to secure the payment and performance in full of all of
the Obligations, a continuing security interest in, and pledges to Agent, for
the ratable benefit of the Lenders, the Collateral, wherever located, whether
now owned or hereafter acquired or arising, and all proceeds and products
thereof. Borrower represents, warrants, and covenants that the
security interest granted herein is and shall at all times continue to be a
first priority security interest in the Collateral (subject only to Permitted
Liens that may have superior priority under this Agreement). If
Borrower shall acquire a commercial tort claim (as defined in the Code),
Borrower shall promptly notify Agent in a writing signed by Borrower of the
general details thereof (and further details as may be required by Agent) and
grant to Agent, for the ratable benefit of the Lenders, in such writing a
security interest therein and in the proceeds thereof, all upon the terms of
this Agreement, with such writing to be in form and substance reasonably
satisfactory to Agent. If this Agreement is terminated, Agent’s Lien
in the Collateral shall continue until the Obligations are repaid in full in
cash. Upon payment in full in cash of the Obligations and at such
time as the Lenders' obligation to make Credit Extensions has terminated, the
Agent, at Borrower’s sole cost and expense, shall release its Liens in the
Collateral and all rights therein shall revert to Borrower.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
4.2 Authorization to File Financing
Statements. Borrower hereby authorizes Agent to file financing
statements, without notice to Borrower, with all appropriate jurisdictions to
perfect or protect Agent’s and each Lender's interest or rights
hereunder, including a notice that any disposition of the Collateral, by either
Borrower or any other Person, shall be deemed to violate the rights of the Agent
and the Lenders under the Code.
5
REPRESENTATIONS AND
WARRANTIES
Borrower
represents and warrants as follows:
5.1 Due Organization and
Authorization. Borrower and each of its Subsidiaries, if any,
are duly existing and in good standing, as Registered Organizations in their
respective jurisdictions of formation and are qualified and licensed to do
business and are in good standing in any jurisdiction in which the conduct of
their business or their ownership of property requires that they be qualified
except where the failure to do so could not reasonably be expected to have a
material adverse effect on Borrower’s business. In connection with
this Agreement, Borrower has delivered to Agent a completed perfection
certificate signed
by Borrower (the “Perfection Certificate”). Borrower represents and
warrants that (a) Borrower’s exact legal name is that indicated on the
Perfection Certificate and on the signature page hereof; (b) Borrower is an
organization of the type and is organized in the jurisdiction set forth in the
Perfection Certificate; (c) the Perfection Certificate accurately sets forth
Borrower’s organizational identification number or accurately states that
Borrower has none; (d) the Perfection Certificate accurately sets forth
Borrower’s place of business, or, if more than one, its chief executive office
as well as Borrower’s mailing address (if different than its chief executive
office); (e) Borrower (and each of its predecessors) has not, in the past
five (5) years, changed its jurisdiction of formation, organizational structure
or type (except for changes to its authorized capital and the establishment of a
stockholders’ rights plan), or any organizational number assigned by its
jurisdiction; and (f) all other information set forth on the Perfection
Certificate pertaining to Borrower and each of its Subsidiaries is accurate and
complete (it being understood and agreed that Borrower may from time to time
update certain information in the Perfection Certificate after the Effective
Date to the extent permitted by one or more specific provisions in this
Agreement). If Borrower is not now a Registered Organization but
later becomes one, Borrower shall promptly notify Agent of such occurrence and
provide Agent with Borrower’s organizational identification number.
The
execution, delivery and performance by Borrower of the Loan Documents to which
it is a party have been duly authorized, and do not (i) conflict with any of
Borrower’s organizational documents, (ii) contravene, conflict with, constitute
a default under or violate any material Requirement of Law, (iii) contravene,
conflict or violate any applicable order, writ, judgment, injunction, decree,
determination or award of any Governmental Authority by which Borrower or any of
its Subsidiaries or any of their property or assets may be bound or affected,
(iv) require any action by, filing, registration, or qualification with, or
Governmental Approval from, any Governmental Authority (except such Governmental
Approvals which have already been obtained and are in full force and effect) or
are being obtained pursuant to Section 6.1(b), or (v) nor constitute an event of
default under any material agreement by which Borrower is
bound. Borrower is not in default under any agreement to which it is
a party or by which it is bound in which the default could reasonably be
expected to have a
material adverse effect on Borrower’s business.
5.2 Collateral.
(a) Borrower
has good title to, has rights in, and the power to transfer each item of the
Collateral upon which it purports to grant a Lien hereunder, free and clear of
any and all Liens except Permitted Liens. Borrower has no Collateral
Accounts other than the Collateral Accounts with Agent, the Collateral Accounts,
if any, described in the Perfection Certificate, or of which Borrower has given
Agent notice and taken such actions as are necessary to give Agent for the
ratable benefit of all Lenders a perfected security interest
therein.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(b) The
Collateral is not in the possession of any third party bailee (such as a
warehouse) except as otherwise provided in the Perfection
Certificate. None of the components of the Collateral shall be
maintained at locations other than as provided in the Perfection Certificate or
as Borrower has given Agent notice pursuant to Section 7.2. In the
event that Borrower, after the date hereof, intends to store or otherwise
deliver any portion of the Collateral to a bailee, then Borrower will first
receive the written consent of Agent and such bailee must execute and deliver a
bailee agreement in form and substance satisfactory to Agent in its sole
discretion.
(c) All
Inventory is in all material respects of good and marketable quality, free from
material defects.
(d) All
of Borrower’s Material Intellectual Property, including all licenses under which
Borrower is the licensee of any such Material Intellectual Property owned by
another Person, are set forth on Schedule 5.2. Such Schedule 5.2
indicates in each case the expiration date of such Material Intellectual
Property and whether such Material Intellectual Property (or application
therefor) is owned or licensed by Borrower, and in the case of any such licensed
Material Intellectual Property, lists the name and address of the licensor and
the name and date of the agreement pursuant to which such item of Material
Intellectual Property is licensed, the expiration date of such license and the
expiration date of the underlying Material Intellectual Property, whether or not
such license is an exclusive license and whether there are any purported
restrictions in such license on the ability to Borrower to grant a security
interest in and/or to transfer any of its rights as a licensee under such
license.
5.3 Litigation. Except
as set forth in Schedule 5.3 and except for actions or proceedings in regard to
which Agent has received notice under Section 6.2(a)(iv), there are no actions
or proceedings pending or, to the knowledge of the Responsible Officers,
threatened in writing by or against Borrower or any of its Subsidiaries
involving more than One Hundred Thousand Dollars ($100,000.00).
5.4 No Material Deviation in Financial
Statements. All consolidated financial statements for Borrower
and any of its Subsidiaries delivered to Agent fairly present, in conformity
with GAAP, in all material respects Borrower’s consolidated financial condition
and Borrower’s consolidated results of operations. There has not been
any material deterioration in Borrower’s consolidated financial condition since
the date of the most recent financial statements submitted to
Agent.
5.5 Solvency. The fair
salable value of Borrower’s assets (including goodwill minus disposition costs)
exceeds the fair value of its liabilities; Borrower is not left with
unreasonably small capital after the transactions in this Agreement; and
Borrower is able to pay its debts (including trade debts) as they
mature.
5.6 Regulatory
Compliance. Borrower is not an “investment company” or a
company “controlled” by an “investment company” or a “subsidiary” of an
“investment company” under the Investment Company Act of
1940. Borrower is not engaged in extending credit for margin stock
(under Regulations T and U of the Federal Reserve Board of
Governors). Borrower has complied in all material respects with the
Federal Fair Labor Standards Act. Neither Borrower nor any of its
Subsidiaries is a “holding company” or an “affiliate” or a “holding company” or
a “subsidiary company” of a “holding company” as each term is defined and used
in the Public Utility Holding Company Act of 2005. Borrower has not
violated any Laws, ordinances or rules, the violation of which could reasonably
be expected to have a material adverse effect on its business. None
of Borrower’s or any of its Subsidiaries’ properties or assets has been used by
Borrower or any Subsidiary or, to the best of Borrower’s knowledge, by previous
Persons, in disposing, producing, storing, treating, or transporting any
hazardous substance other than legally. Borrower has obtained all
Required Permits, or has contracted with third parties holding Required Permits,
necessary for compliance with all Laws and all such Required Permits are
current. Borrower and each of its Subsidiaries have obtained all
consents, approvals and authorizations of, made all declarations or filings
with, and given all notices to, all Governmental Authorities that are necessary
to continue their respective businesses as currently conducted.
None of
the Borrower, its Affiliates or any of their respective agents acting or
benefiting in any capacity in connection with the transactions contemplated by
this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engages in or
conspires to engage in any transaction that evades or avoids, or has the purpose
of evading or avoiding or attempts to violate, any of the prohibitions set forth
in any Anti-Terrorism Law, or (iii) is a Blocked Person. Neither
Borrower nor, to the knowledge of Borrower, any of its Affiliates or agents
acting or benefiting in any capacity in connection with the transactions
contemplated by this Agreement, (x) conducts any business or engages in making
or receiving any contribution of funds, goods or services to or for the benefit
of any Blocked Person, or (y) deals in, or otherwise engages in any transaction
relating to, any property or interest in property blocked pursuant to Executive
Order No. 13224, any similar executive order or other Anti-Terrorism
Law.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
5.7 Subsidiaries;
Investments. Borrower does not own any stock, partnership
interest or other equity securities except for Permitted
Investments.
5.8 Tax Returns and Payments; Pension
Contributions. Borrower has timely filed all required tax
returns and reports (including those relating to employee tax withholding,
social security and unemployment taxes), and Borrower and its Subsidiaries have
timely paid all foreign, federal, state and local taxes, assessments, deposits
and contributions owed by Borrower. Borrower may defer payment of any
contested taxes, provided that Borrower (a) in good faith contests its
obligation to pay the taxes by appropriate proceedings promptly and diligently
instituted and conducted, (b) notifies Agent in writing of the commencement of,
and any material development in, the proceedings, (c) posts bonds or takes any
other steps required to prevent the governmental authority levying such
contested taxes from obtaining a Lien upon any of the Collateral that is other
than a “Permitted Lien”. Borrower is unaware of any claims or
adjustments proposed for any of Borrower's prior tax years which could result in
additional taxes becoming due and payable by Borrower. Borrower has
paid all amounts necessary to fund all present pension, profit sharing and
deferred compensation plans in accordance with their terms, and Borrower has not
withdrawn from participation in, and has not permitted partial or complete
termination of, or permitted the occurrence of any other event with respect to,
any such plan which could reasonably be expected to result in any liability of
Borrower, including any liability to the Pension Benefit Guaranty Corporation or
its successors or any other governmental agency.
5.9 Use of
Proceeds. Borrower shall use the proceeds of the Credit
Extensions solely as working capital
5.10 Full Disclosure. No
written representation, warranty or other statement of Borrower in any
certificate or written statement given to Agent or any Lender, as of the date
such representation, warranty, or other statement was made, taken together with
all such written certificates and written statements given to Agent or any
Lender, contains any untrue statement of a material fact or omits to state a
material fact necessary to make the statements contained in the certificates or
statements not misleading (it being recognized that the projections and
forecasts provided by Borrower in good faith and based upon reasonable
assumptions are not viewed as facts and that actual results during the period or
periods covered by such projections and forecasts may differ from the projected
or forecasted results).
5.11 Regulatory
Developments.
(a) All
Products and all Required Permits are listed on Schedule 5.11 (as updated from
time to time pursuant to Section 6.2(d)), and Borrower has delivered to Agent a
copy of all Required Permits to the extent requested by Agent pursuant to
Section 6.2(d);
(b) Without
limiting the generality of Section 5.6 above, with respect to any Product being
tested or manufactured by Borrower, Borrower has received, and such Product is
the subject of, all Required Permits needed in connection with the testing or
manufacture of such Product as such testing is currently being conducted by or
on behalf of Borrower, and Borrower has not received any notice from any
applicable Governmental Authority, specifically including the FDA, that such
Governmental Authority is conducting an investigation or review of (A)
Borrower’s manufacturing facilities and processes for such Product which have
disclosed any material deficiencies or violations of Laws and/or the Required
Permits related to the manufacture of such Product, or (B) any such Required
Permit or that any such Required Permit has been revoked or withdrawn, nor has
any such Governmental Authority issued any order or recommendation stating that
the development, testing and/or manufacturing of such Product by Borrower should
cease;
(c) Without
limiting the generality of Section 5.6 above, with respect to any Product
marketed or sold by Borrower, Borrower shall have received, and such Product is
the subject of, all Required Permits needed in connection with the marketing and
sales of such Product as currently being marketed or sold by Borrower, and
Borrower has not received any notice from any applicable Governmental Authority,
specifically including the FDA, that such Governmental Authority is conducting
an investigation or review of any such Required Permit or approval or that any
such Required Permit has been revoked or withdrawn, nor has any such
Governmental Authority issued any order or recommendation stating that such
marketing or sales of such Product cease or that such Product be withdrawn from
the marketplace;
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(d) Without
limiting the generality of Section 5.6 above, (i) there have been no adverse
clinical test results which could cause a Material Adverse Change, and (ii)
there have been no Product recalls or voluntary Product withdrawals from any
market; and
(e) Borrower
has not (since the Effective Date) experienced any significant failures in their
manufacturing of any Product such that the amount of such Product successfully
manufactured by Borrower in accordance with all specifications thereof and the
required payments related thereto in any month shall decrease significantly with
respect to the quantities of such Product produced in the prior
month.
6
AFFIRMATIVE
COVENANTS
Until all
Obligations have been satisfied in full and Lenders are under no further
obligation to make Credit Extensions hereunder, Borrower shall do all of the
following:
6.1 Government
Compliance.
(a) Maintain
its and all its Subsidiaries’ legal existence and good standing in their
respective jurisdictions of formation and maintain qualification in each
jurisdiction in which the failure to so qualify would reasonably be expected to
have a material adverse effect on Borrower’s business or
operations. Borrower shall comply, and have each Subsidiary comply,
with all Laws, ordinances and regulations to which it is subject, the
noncompliance with which could have a material adverse effect on Borrower’s
business.
(b) Use
commercially reasonable efforts to obtain all of the Governmental Approvals
necessary for the performance by Borrower of its obligations under the Loan
Documents to which it is a party and the grant of a security interest to Agent
for the ratable benefit of the Lenders, in all of its
property. Borrower shall promptly provide copies of any such obtained
Governmental Approvals to Agent.
(c) In
connection with the development, testing, manufacture, marketing or sale of each
and any Product by Borrower, Borrower shall comply fully and completely in all
respects with all Required Permits at all times issued by any Governmental
Authority the noncompliance with which could have a material adverse effect on
Borrower’s business, specifically including the FDA, with respect to such
development, testing, manufacture, marketing or sales of such Product by
Borrower as such activities are at any such time being conducted by
Borrower.
6.2 Financial Statements, Reports,
Certificates.
(a) Deliver
to Agent: (i) as soon as available, but no later than five (5) days
after filing with the Securities Exchange Commission, Peregrine’s 10K, 10Q, and
8K reports; (ii) a Compliance Certificate together with delivery of the 10K and
10Q reports; (iii) within 60 days after the end of each fiscal year, annual
financial projections for the following fiscal year (on a quarterly basis) as
approved by Peregrine’s board of directors, together with any related business
forecasts used in the preparation of such annual financial projections;
(iv) a prompt report of any litigation or governmental proceedings pending
or threatened against Borrower or any Subsidiary that could result in damages or
costs to Borrower or any Subsidiary of $100,000 or more or could result in a
Material Adverse Change; (v) prompt notice of an event that materially and
adversely affects the value of the Borrower’s Intellectual Property; and (vi)
budgets, sales projections, operating plans or other financial information Agent
reasonably requests. Peregrine’s 10K, 10Q, and 8K reports required to
be delivered pursuant to Section 6.2(a)(i) shall be deemed to have been
delivered on the date on which Peregrine posts such report or provides a link
thereto on Borrower’s or another website on the Internet; provided, that
Borrower shall provide paper copies to Agent of the Compliance Certificates
required by Section 6.2(a)(ii).
(b) Borrower
will keep proper books of record and account in accordance with GAAP in which
full, true and correct entries shall be made of all dealings and transactions in
relation to its business and activities. Borrower shall allow, at the
sole cost of Borrower, Agent, and Lenders to visit and inspect any of its
properties, to examine and make abstracts or copies from any of their respective
books and records, to conduct a collateral audit and analysis of its operations
and the Collateral, to verify the amount and age of the accounts, the identity
and credit of the respective account debtors, to review the billing practices of
Borrower and to discuss its respective affairs, finances and accounts with their
respective officers, employees and independent public accountants as often as
may reasonably be desired. Notwithstanding the foregoing, such audits
shall be conducted at Borrower's expense no more often than once every twelve
(12) months unless an Event of Default has occurred and is
continuing.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(c) Borrower
shall deliver to Agent an updated Schedule 5.2 promptly upon Borrower’s
acquisition or development of any Material Intellectual Property not already
listed on Schedule 5.2 and upon any other material change in Borrower’s Material
Intellectual Property from that listed on Schedule 5.2.
(d) If
after the Effective Date, Borrower wishes to manufacture, sell, develop, test or
market any new Product, Borrower shall give prior written notice to Agent of
such intention (which shall include a brief description of such Product, plus a
list of all Required Permits relating to such new Product (and a copy of such
Required Permits if requested by Agent) and/or Borrower’s manufacture, sale,
development, testing or marketing thereof issued or outstanding as of the date
of such notice) along with a copy of an amended and restated Schedule 5.11; and
further, provided,
that, if
Borrower shall at any time obtain any new or additional Required Permits from
the FDA, DEA, or parallel state or local authorities, or foreign counterparts of
the FDA, DEA, or parallel state or local authorities, with respect to any
Product which has previously been disclosed to Agent, Borrower shall promptly
give written notice to Agent of such new or additional Required Permits (along
with a copy thereof if requested by Agent).
6.3 Inventory;
Returns. Keep all Inventory in good and marketable condition,
free from material defects. Returns and allowances between Borrower
and its Account Debtors shall follow Borrower’s customary practices as they
exist at the Effective Date. Borrower must promptly notify Agent of
all returns, recoveries, disputes and claims that involve more than One Hundred
Thousand Dollars ($100,000).
6.4 Taxes;
Pensions. Make, and cause each of its Subsidiaries to make,
timely payment of all foreign, federal, state, and local taxes or assessments
(other than taxes and assessments which Borrower is contesting pursuant to the
terms of Section 5.8 hereof) and shall deliver to Agent, within a reasonable
period of time (not to exceed five (5) Business Days) following demand,
appropriate certificates attesting to such payments, and pay all amounts
necessary to fund all present pension, profit sharing and deferred compensation
plans in accordance with their terms.
6.5 Insurance. Keep its
business and the Collateral insured for risks and in amounts standard for
companies in Borrower’s industry and location and as Agent may reasonably
request. Insurance policies shall be in a form, with companies, and
in amounts that are satisfactory to Agent. All property policies
shall have a lender’s loss payable endorsement showing Agent as lender loss
payee and waive subrogation against Agent, and all liability policies shall
show, or have endorsements showing, the Agent, as an additional
insured. All policies (or the loss payable and additional insured
endorsements) shall provide that the insurer must give Agent at least twenty
(20) days notice before canceling, amending, or declining to renew its
policy. At Agent’s request, Borrower shall deliver certified copies
of policies and evidence of all premium payments. Proceeds payable
under any policy with respect to any casualty event involving the Collateral
shall, at Lenders’ option, be payable to Lenders on account of the
Obligations. Notwithstanding the foregoing, (a) so long as no Event
of Default has occurred and is continuing, Borrower shall have the option of
applying the proceeds of any casualty policy up to $50,000 with respect to any
loss, but not exceeding $100,000, in the aggregate, for all losses under all
casualty policies in any one year, toward the replacement or repair of destroyed
or damaged Collateral; provided that any such replaced or repaired Collateral
(i) shall be of equal or like value as the replaced or repaired Collateral and
(ii) shall be deemed Collateral in which Agent and Lenders have been
granted a first priority security interest, and (b) after the occurrence and
during the continuance of an Event of Default, all proceeds payable under such
casualty policy with respect to any casualty event involving the Collateral
shall, at the option of Lenders, be payable to Lenders on account of the
Obligations. If Borrower fails to obtain insurance as required under
this Section 6.5 or to pay any amount or furnish any required proof of
payment to third persons and Agent, Agent may make all or part of such payment
or obtain such insurance policies required in this Section 6.5, and take any
action under the policies Agent deems prudent.
6.6 Operating
Accounts. For each Collateral Account that Borrower at any
time maintains with institutions other than Agent, provided the Borrower
received prior consent from the Agent, Borrower shall cause the applicable bank
or financial institution (other than Agent) at or with which any Collateral
Account is maintained to execute and deliver a Control Agreement or other
appropriate instrument with respect to such Collateral Account to perfect
Agent's Lien in such Collateral Account in accordance with the terms
hereunder. The provisions of the previous sentence shall not apply to
deposit accounts exclusively used for payroll, payroll taxes and other employee
wage and benefit payments to or for the benefit of Borrower’s employees and
identified to Agent by Borrower as such.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
6.7 Intellectual Property
Rights. Borrower shall own, or be licensed to use or otherwise
have the right to use, all Material Intellectual Property. Except as
indicated on Schedule 5.2, Borrower is and all times shall be the sole and
exclusive owner or licensee of the entire and unencumbered right, title and
interest in and to each such Material Intellectual Property, free and clear of
any Liens and/or licenses in favor of third parties or agreements or covenants
not to sue such third parties for infringement. All Material
Intellectual Property is and shall be fully protected and/or duly and properly
registered, filed or issued in the appropriate office and jurisdictions for such
registrations, filings or issuances, except where the failure to do so would not
reasonably be expected to result in a Material Adverse
Change. Borrower shall not become a party to, nor become bound by,
any material license or other agreement with respect to which Borrower is the
licensee that prohibits or otherwise restricts Borrower from granting a security
interest in Borrower’s interest in such license or agreement or other
property. Borrower shall, to the extent it determines, in the
exercise of its reasonable business judgment, that it is prudent to do the
following: (a) protect, defend and maintain the validity and enforceability of
its Intellectual Property; (b) promptly advise Agent in writing of material
infringements of its Intellectual Property; and (c) not allow any Material
Intellectual Property to be abandoned, forfeited or dedicated to the public
without Agent’s prior written consent. Within ten (10) days after the
end of each calendar quarter, Borrower shall provide written notice to Agent of
(i) any patent, registered trademark or servicemark, registered mask work, or
any pending application for any of the foregoing, obtained by Borrower, whether
as owner, licensee or otherwise, and (ii) any patent or the registration of any
trademark or servicemark applied for by Borrower, and Borrower shall execute
such intellectual property security agreements and other documents and take such
other actions as Agent shall request in its good faith business judgment to
perfect and maintain a first priority security interest in favor of Agent, for
the ratable benefit of Lenders, in such property. If Borrower obtains
any registered copyright or any pending application for any copyright, then
Borrower shall immediately provide written notice thereof to Agent and shall
execute such intellectual property security agreements and other documents and
take such other actions as Agent shall request in its good faith business
judgment to perfect and maintain a first priority security interest in favor of
Agent, for the ratable benefit of Lenders, in such property. If
Borrower decides to register any copyrights or mask works in the United States
Copyright Office, Borrower shall: (x) provide Agent with at least fifteen (15)
days prior written notice of Borrower’s intent to register such copyrights or
mask works together with a copy of the application it intends to file with the
United States Copyright Office (excluding exhibits thereto); (y) execute an
intellectual property security agreement and such other documents and take such
other actions as Agent may request in its good faith business judgment to
perfect and maintain a first priority perfected security interest in favor of
Agent, for the ratable benefit of the Lenders, in the copyrights or mask works
intended to be registered with the United States Copyright Office; and (z)
record such intellectual property security agreement with the Untied States
Copyright Office contemporaneously with filing the copyright or mask work
application(s) with the United States Copyright Office. Concurrently
with the delivery of the notices required under this Section 6.7 for the
applications described above, Borrower shall provide Agent with evidence of the
recording of the intellectual property security agreement necessary for Agent,
for the ratable benefit of the Lenders, to perfect and maintain a first priority
perfected security interest in such property.
6.8 Litigation
Cooperation. From the date hereof and continuing through the
termination of this Agreement, make available to Agent, without expense to
Agent, Borrower and its officers, employees and agents and Borrower's books and
records, to the extent that Agent may deem them reasonably necessary to
prosecute or defend any third-party suit or proceeding instituted by or against
Agent with respect to any Collateral or relating to Borrower.
6.9 Further
Assurances. Execute any further instruments and take further
action as Agent reasonably requests to perfect or continue Agent’s Lien in the
Collateral or to effect the purposes of this Agreement. Deliver to
Agent, within five (5) days after the same are sent or received, copies of all
correspondence, reports, documents and other filings with any Governmental
Authority regarding compliance with or maintenance of Governmental Approvals or
Requirements of Law or that could reasonably be expected to have a material
effect on any of the Governmental Approvals or otherwise on the operations of
Borrower or any of its Subsidiaries. For the avoidance of doubt, the
foregoing requirement to deliver copies of correspondence shall not apply to
filings and communications with the FDA respecting protocols for clinical trials
that have yet to commence.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
6.10 Notices of Defaults and Events of
Default. Without limiting or contradicting any other more
specific provision of this Agreement, promptly (and in any event within three
(3) Business Days) upon Borrower becoming aware of the existence of any Default
or Event of Default, Borrower shall give written notice to Agent of such
occurrence, which such notice shall include a reasonably detailed description of
such Default or Event of Default.
6.11 Cash and Cash
Equivalents. In the event of the termination of or other
material adverse change to Borrower’s current contract with the U.S. Department
of Defense for the study of bavituximab in treating viral hemorrhagic fever,
Borrower shall be required at all times thereafter to maintain cash and Cash
Equivalents of at least eighty percent (80%) of the then outstanding principal
balance under the Growth Capital Advances in a restricted account over which
Borrower shall not be permitted to make withdrawals or otherwise exercise
control, and with respect to which Borrower has complied with the requirements
of Section 6.6.
6.12 Evidence of
Insurance. Within ten (10) days after the Effective Date,
Borrower shall deliver to Agent evidence that the insurance policies required by
Section 6.5 hereof are in full force and effect, together with appropriate
evidence showing lender loss payable and/or additional insured clauses or
endorsements in favor of Agent, for the ratable benefit of the
Lenders.
6.13 Landlord
Waiver. Within forty-five (45) days after the Effective Date,
Peregrine shall deliver to Agent a landlord’s consent acceptable to Agent and
executed in favor of Agent, for the ratable benefit of the Lenders, for
Peregrine’s leased premises at 14282 Franklin Avenue, Tustin, California
92780 and 5353 W. Alabama, Suite 306, Houston, Texas 77056.
7
NEGATIVE
COVENANTS
Until all
Obligations have been satisfied in full and Agent and Lenders are under no
further obligation to make Credit Extensions hereunder, Borrower shall not do
any of the following without Agent’s prior written consent:
7.1 Dispositions. Convey,
sell, lease, transfer, assign, or otherwise dispose of (collectively, “Transfer”), or permit any of
its Subsidiaries to Transfer, all or any part of its business or property,
except for Transfers (a) of Inventory in the ordinary course of business;
(b) of worn-out or obsolete Equipment; (c) in connection with Permitted Liens
and Permitted Investments; and (d) comprised of the sale of the capital
stock of Avid by Peregrine or the sale of all or substantially all of Avid’s
assets so long as in either case Peregrine receives at least *********** in
upfront net cash proceeds from such sale (the “Permitted Avid
Transaction”). Agent and Lenders hereby agree to release the
Avid Liens, at Borrower’s expense, upon the closing of the Permitted Avid
Transaction.
7.2 Changes in Business, Management,
Ownership, or Business Locations. (a) Engage in or permit
any of its Subsidiaries to engage in any business other than the businesses
currently engaged in by Borrower and such Subsidiary, as applicable, or
reasonably related thereto; (b) liquidate or dissolve; or (c) permit or
suffer any Change in Control (except a change in ownership of Avid in connection
with the Permitted Avid Transaction). Borrower shall not, without at
least thirty (30) days prior written notice to Agent: (1) add any new
offices or business locations, including warehouses (unless such new offices or
business locations contain less than Twenty Five Thousand Dollars ($25,000) in
Borrower’s assets or property), (2) change its jurisdiction of organization,
(3) change its organizational type, (4) change its legal name, or
(5) change any organizational number (if any) assigned by its jurisdiction
of organization. Borrower shall deliver a landlord's waiver, bailee
agreement or similar agreement, in form and substance acceptable to Agent in its
reasonable discretion, for any location that contains greater than Twenty Five
Thousand Dollars ($25,000) in assets (other than in regard to 8858 Rochester
Avenue, Rancho Cucamonga, California).
7.3 Mergers or
Acquisitions. Merge or consolidate, or permit any of its
Subsidiaries to merge or consolidate, with any other Person, or acquire, or
permit any of its Subsidiaries to acquire, all or substantially all of the
capital stock or property of another Person, except for the Permitted Avid
Transaction. A Subsidiary may merge or consolidate into another
Subsidiary or into Borrower.
7.4 Indebtedness. Create,
incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do
so, other than Permitted Indebtedness.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
7.5 Encumbrance. Create,
incur, allow, or suffer any Lien on any of its property, or assign or convey any
right to receive income, including the sale of any Accounts, or permit any of
its Subsidiaries to do so, except for Permitted Liens, or permit any Collateral
not to be subject to the first priority security interest granted herein, or
enter into any agreement, document, instrument or other arrangement (except with
or in favor of Agent) with any Person which directly or indirectly prohibits or
has the effect of prohibiting Borrower or any Subsidiary from assigning,
mortgaging, pledging, granting a security interest in or upon, or encumbering
any of Borrower’s or any Subsidiary’s Intellectual Property, except as is
otherwise permitted in Section 7.1 hereof and the definition of “Permitted
Liens” herein. For the avoidance of doubt, the foregoing provision
shall not prohibit the Borrower from in-licensing Intellectual
Property.
7.6 Maintenance of Collateral
Accounts. Maintain any Collateral Account except pursuant to
the terms of Section 6.6 hereof.
7.7 Distributions;
Investments. (a) Pay any dividends or make any distribution or
payment or redeem, retire or purchase any capital stock provided that (i)
Borrower may pay dividends solely in common stock or preferred stock to the
extent permitted under clause (g) of the definition of “Permitted Indebtedness”
in Section 13.1 below, and (ii) Borrower may repurchase the stock of former
employees or consultants pursuant to stock repurchase agreements so long as no
Default or Event of Default exists at the time of such repurchase and would
exist after giving effect to such repurchase, provided such repurchases do not
exceed in the aggregate Fifty Thousand Dollars ($50,0000) in any twelve-month
period, or (b) directly or indirectly make any Investment other than Permitted
Investments, or permit any of its Subsidiaries to do so.
7.8 Transactions with
Affiliates. Directly or indirectly enter into or permit to
exist any material transaction with any Affiliate of Borrower, except for
transactions that are in the ordinary course of Borrower’s business upon fair
and reasonable terms that are no less favorable to Borrower than would be
obtained in an arm’s length transaction with a non-affiliated
Person.
7.9 Subordinated
Debt. (a) Make or permit any payment on any Subordinated Debt,
except under the terms of the subordination, intercreditor, or other similar
agreement to which such Subordinated Debt is subject, or (b) amend any
provision in any document relating to the Subordinated Debt which would increase
the amount thereof or adversely affect the subordination thereof to Obligations
owed to the Lenders.
7.10 Compliance. Become
an “investment company” or a company controlled by an “investment company”,
under the Investment Company Act of 1940 or undertake as one of its important
activities extending credit to purchase or carry margin stock (as defined in
Regulation U of the Board of Governors of the Federal Reserve System), or use
the proceeds of any Credit Extension for that purpose; fail to meet the minimum
funding requirements of ERISA, permit a Reportable Event or Prohibited
Transaction, as defined in ERISA, to occur; fail to comply with the Federal Fair
Labor Standards Act or violate any other Law or regulation, if the violation
could reasonably be expected to have a material adverse effect on Borrower’s
business, or permit any of its Subsidiaries to do so; withdraw or permit any
Subsidiary to withdraw from participation in, permit partial or complete
termination of, or permit the occurrence of any other event with respect to, any
present pension, profit sharing and deferred compensation plan which could
reasonably be expected to result in any liability of Borrower, including any
liability to the Pension Benefit Guaranty Corporation or its successors or any
other governmental agency.
7.11 Compliance with Anti-Terrorism
Laws. Agent hereby notifies Borrower that pursuant to the
requirements of Anti-Terrorism Laws, and Agent's policies and practices, Agent
is required to obtain, verify and record certain information and documentation
that identifies Borrower and its principals, which information includes the name
and address of Borrower and its principals and such other information that will
allow Agent to identify such party in accordance with Anti-Terrorism
Laws. Borrower will not, nor will Borrower permit any Subsidiary or
Affiliate to, directly or indirectly, knowingly enter into any documents,
instruments, agreements or contracts with any Person listed on the OFAC
Lists. Borrower shall immediately notify Agent if Borrower has
knowledge that Borrower or any Subsidiary or Affiliate is listed on the OFAC
Lists or (a) is convicted on, (b) pleads nolo contendere to, (c) is
indicted on, or (d) is arraigned and held over on charges involving money
laundering or predicate crimes to money laundering. Borrower will
not, nor will Borrower permit any Subsidiary or Affiliate to, directly or
indirectly, (i) conduct any business or engage in any transaction or dealing
with any Blocked Person, including, without limitation, the making or receiving
of any contribution of funds, goods or services to or for the benefit of any
Blocked Person, (ii) deal in, or otherwise engage in any transaction relating
to, any property or interests in property blocked pursuant to Executive Order
No. 13224, any similar executive order or other Anti-Terrorism Law, or (iii)
engage in or conspire to engage in any transaction that evades or avoids, or has
the purpose of evading or avoiding, or attempts to violate, any of the
prohibitions set forth in Executive Order No. 13224 or other Anti-Terrorism
Law.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
7.12 Third Party Possession of
Assets. Maintain assets with a value in excess of $750,000 at
8858 Rochester Avenue, Rancho Cucamonga, California.
8
EVENTS OF
DEFAULT
Any one
of the following shall constitute an event of default (an “Event of Default”) under this
Agreement:
8.1 Payment
Default. Borrower fails to (a) make any payment of
principal or interest on any Credit Extension on its due date (provided,
however, that if such failure results from a failure of an auto-debit to occur
through no fault of Borrower, then no “Event of Default” shall be deemed to have
occurred unless Borrower fails to make the applicable payment within two (2)
Business Days after Borrower’s receipt of notice from Agent of the failure of
such auto-debit), or (b) pay any other Obligations within three (3)
Business Days after such Obligations are due and payable (which three (3)
Business Day grace period shall not apply to payments due on the Growth Capital
Line Maturity Date). During the cure period, the failure to cure the
payment default is not an Event of Default (but no Credit Extension will be made
during the cure period);
8.2 Covenant Default.
(a)
Borrower fails or neglects to perform any obligation in Sections 6.1(c), 6.5,
6.6, 6.12, 6.13 or violates any covenant in Section 7;
(b)
Borrower fails or neglects to perform any obligation in Sections 6.2 or 6.4 and
fails to cure the default within five (5) days after the occurrence thereof;
or
(c)
Borrower fails or neglects to perform, keep, or observe any other term,
provision, condition, covenant or agreement contained in this Agreement, or any
Loan Documents, and as to any default (other than those specified in this
Section 8) under such other term, provision, condition, covenant or agreement
that can be cured, has failed to cure the default within ten (10) days after the
occurrence thereof; provided, however, that if the default cannot by its nature
be cured within the ten (10) day period or cannot after diligent attempts by
Borrower be cured within such ten (10) day period, and such default is likely to
be cured within a reasonable time, then Borrower shall have an additional period
(which shall not in any case exceed thirty (30) days) to attempt to cure such
default, and within such reasonable time period the failure to cure the default
shall not be deemed an Event of Default (but no Credit Extensions shall be made
during such cure period).
8.3 Material Adverse
Change. A Material Adverse Change occurs;
8.4 Attachment. (a) Any
material portion of Borrower’s assets is attached, seized, levied on, or comes
into possession of a trustee or receiver and the attachment, seizure or levy is
not removed in ten (10) days; (b) the service of process seeking to attach,
by trustee or similar process, any funds of Borrower, or of any entity under
control of Borrower (including a Subsidiary), on deposit with the Lenders and/or
Agent or an Affiliate; (c) Borrower is enjoined, restrained, or prevented by
court order from conducting a material part of its business; (d) a judgment or
other claim in excess of One Hundred Thousand Dollars ($100,000.00) becomes a
Lien on any of Borrower’s assets; or (e) a notice of lien, levy, or assessment
is filed against any of Borrower’s assets by any government agency and not paid
within ten (10) days after Borrower receives notice. These are not
Events of Default if stayed or if a bond is posted pending contest by Borrower
(but no Credit Extensions shall be made during the cure period);
8.5 Insolvency. (a) Borrower is
unable to pay its debts (including trade debts) as they become due or otherwise
becomes insolvent; (b) Borrower begins an Insolvency Proceeding; or (c) an
Insolvency Proceeding is begun against Borrower and not dismissed or stayed
within forty five (45) days (but no Credit Extensions shall be made while of any
of the conditions described in clause (a) exist and/or until any Insolvency
Proceeding is dismissed);
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
8.6 Other
Agreements. (a) There is a default under the UTSW Agreement or
any other agreement to which Borrower is a party with a third party or parties
resulting in a right by such third party or parties, whether or not exercised,
to accelerate the maturity of any Indebtedness in an amount in excess of Fifty
Thousand Dollars ($50,000) or that could have a material adverse effect on
Borrower’s business, (b) delivery of written notice by UT Southwestern to
Borrower of an intended termination under Section 7.2 of the UTSW Agreement, or
(c) the termination of the UTSW Agreement.
8.7 Judgments. One or
more judgments, orders, or decrees for the payment of money in an amount,
individually or in the aggregate, of at least One Hundred Thousand Dollars
($100,000) (not covered by independent third-party insurance as to which
liability has been accepted by such insurance carrier) shall be rendered against
Borrower and shall remain unsatisfied, unvacated or unstayed for a period of ten
(10) days after the entry thereof (provided that no Credit Extensions will be
made prior to the satisfaction, vacation, or stay of such judgment, order, or
decree);
8.8 Misrepresentations. Borrower
or any Person acting for Borrower makes any representation, warranty, or other
statement now or later in this Agreement, any Loan Document or in any writing
delivered to Agent and/or Lenders or to induce Agent and/or Lenders to enter
this Agreement or any Loan Document, and such representation, warranty, or other
statement is incorrect in any material respect when made; or
8.9 Subordinated
Debt. A default or breach occurs under any agreement between
Borrower and any creditor of Borrower that signed a subordination,
intercreditor, or other similar agreement with Agent or Lenders, or any creditor
that has signed such an agreement with Agent or Lenders breaches any terms of
such agreement.
8.10 Governmental
Approvals. Any Governmental Approval shall have been (a)
revoked, rescinded, suspended, modified in an adverse manner or not renewed in
the ordinary course for a full term or (b) subject to any decision by a
Governmental Authority that designates a hearing with respect to any
applications for renewal of any of such Governmental Approval or that could
result in the Governmental Authority taking any of the actions described in
clause (a) above, and such decision or such revocation, rescission, suspension,
modification or non-renewal (i) has, or could reasonably be expected to have, a
Material Adverse Change, or (ii) adversely affects the legal qualifications of
Borrower or any of its Subsidiaries to hold such Governmental Approval in any
applicable jurisdiction and such revocation, rescission, suspension,
modification or non-renewal could reasonably be expected to affect the status of
or legal qualifications of Borrower or any of its Subsidiaries to hold any
Governmental Approval in any other jurisdiction. For the avoidance of
doubt, the foregoing covenant shall not apply to filings or communications with
the FDA with respect to protocols for clinical trials that have yet to
commence.
8.11 Withdrawals, Recalls, Adverse Test
Results and Other Matters. (a) The institution of any
proceeding by FDA or similar Governmental Authority to order the withdrawal of
any Product or Product category from the market or to enjoin Borrower or any
representative of Borrower from manufacturing, marketing, selling or
distributing any Product or Product category, (b) the institution of any action
or proceeding by any DEA, FDA, or any other Governmental Authority to revoke,
suspend, reject, withdraw, limit, or restrict any Required Permit held by
Borrower or any representative of Borrower, which, in each case, could cause a
Material Adverse Change, (c) the commencement of any enforcement
action against Borrower by DEA, FDA, or any other Governmental Authority, (d)
the recall of any Products from the market, the voluntary withdrawal of any
Products from the market, or actions to discontinue the sale of any Products, or
(e) the occurrence of adverse test results in connection with a Product which
could cause a Material Adverse Change.
8.12 Criminal
Proceeding. The institution by any Governmental Authority of
criminal proceedings against Borrower.
8.13 Lien
Priority. Except as permitted by Agent, any Lien created
hereunder or by any other Loan Document shall at any time fail to constitute a
valid and perfected Lien on all of the Collateral purported to be secured
thereby, subject to no prior or equal Lien.
9
RIGHTS AND
REMEDIES
9.1 Rights and
Remedies. While an Event of Default occurs and continues Agent
may, without notice or demand, do any or all of the following:
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(a) declare
all Obligations immediately due and payable (but if an Event of Default
described in Section 8.5 occurs all Obligations are immediately due and payable
without any action by Agent or Lenders);
(b) stop
advancing money or extending credit for Borrower’s benefit under this Agreement
or under any other agreement between Borrower and Agent and/or
Lenders;
(c) settle
or adjust disputes and claims directly with Account Debtors for amounts on terms
and in any order that Agent considers advisable, notify any Person owing
Borrower money of Agent’s and Lenders' security interest in such funds, and
verify the amount of such account;
(d) make
any payments and do any acts it considers necessary or reasonable to protect the
Collateral and/or its security interest in the Collateral. Borrower
shall assemble the Collateral if Agent requests and make it available as Agent
designates. Agent may enter premises where the Collateral is located,
take and maintain possession of any part of the Collateral, and pay, purchase,
contest, or compromise any Lien which appears to be prior or superior to its
security interest and pay all expenses incurred. Borrower grants Agent a license
to enter and occupy any of its premises, without charge, to exercise any of
Agent’s rights or remedies;
(e) apply
to the Obligations any (i) balances and deposits of Borrower it holds, or (ii)
any amount held by Agent or Lenders owing to or for the credit or the account of
Borrower;
(f) ship,
reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise
for sale, and sell the Collateral. Agent is hereby granted a
non-exclusive, royalty-free license or other right to use, without charge,
Borrower’s labels, patents, copyrights, mask works, rights of use of any name,
trade secrets, trade names, trademarks, service marks, and advertising matter,
or any similar property as it pertains to the Collateral, in completing
production of, advertising for sale, and selling any Collateral and, in
connection with Agent’s exercise of its rights under this Section, Borrower’s
rights under all licenses and all franchise agreements inure to Agent for
the benefit of the Lenders;
(g) place
a “hold” on any account maintained with Agent or Lenders and/or deliver a notice
of exclusive control, any entitlement order, or other directions or instructions
pursuant to any Control Agreement or similar agreements providing control of any
Collateral;
(h) demand
and receive possession of Borrower’s Books; and
(i) exercise
all rights and remedies available to Agent under the Loan Documents or at law or
equity, including all remedies provided under the Code (including disposal of
the Collateral pursuant to the terms thereof).
9.2 Power of
Attorney. Borrower hereby irrevocably appoints Agent as its
lawful attorney-in-fact, exercisable only upon the occurrence and during the
continuance of an Event of Default, to: (a) endorse Borrower’s name
on any checks or other forms of payment or security; (b) sign Borrower’s name on
any invoice or bill of lading for any Account or drafts against Account Debtors;
(c) settle and adjust disputes and claims about the Accounts directly with
Account Debtors, for amounts and on terms Agent determines reasonable; (d) make,
settle, and adjust all claims under Borrower’s insurance policies; (e) pay,
contest or settle any Lien, charge, encumbrance, security interest, and adverse
claim in or to the Collateral, or any judgment based thereon, or otherwise take
any action to terminate or discharge the same; and (f) transfer the Collateral
into the name of Agent or a third party as the Code permits. Borrower
hereby appoints Agent as its lawful attorney-in-fact to sign Borrower’s name on
any documents necessary to perfect or continue the perfection of Agent’s and
Lenders' security interest in the Collateral regardless of whether an Event of
Default has occurred until all Obligations have been satisfied in full and Agent
and Lenders are under no further obligation to make Credit Extensions
hereunder. Agent’s foregoing appointment as Borrower’s attorney in
fact, and all of Agent’s rights and powers, coupled with an interest, are
irrevocable until all Obligations have been fully repaid and performed and
Agent’s and Lenders' obligation to provide Credit Extensions
terminates.
9.3 Protective
Payments. If Borrower fails to obtain the insurance called for
by Section 6.5 or fails to pay any premium thereon or fails to pay any other
amount which Borrower is obligated to pay under this Agreement or any other Loan
Document, Agent may obtain such insurance or make such payment, and all amounts
so paid by Agent are Lenders' Expenses and immediately due and payable, bearing
interest at the Default Rate, and secured by the Collateral. Agent
will make reasonable efforts to provide Borrower with notice of Agent obtaining
such insurance at the time it is obtained or within a reasonable time
thereafter. No payments by Agent are deemed an agreement to make
similar payments in the future or Agent’s waiver of any Event of
Default.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
9.4 Application of Payments and
Proceeds. Notwithstanding anything to the contrary contained
in this Agreement, upon the occurrence and during the continuance of an Event of
Default, (a) Borrower irrevocably waives the right to direct the application of
any and all payments at any time or times thereafter received by Agent from or
on behalf of Borrower of all or any part of the Obligations, and, as between
Borrower on the one hand and Agent and Lenders on the other, Agent shall have
the continuing and exclusive right to apply and to reapply any and all payments
received against the Obligations in such manner as Agent may deem advisable
notwithstanding any previous application by Agent, and (b) the proceeds of any
sale of, or other realization upon all or any part of the Collateral shall be
applied: first, to the Lenders Expenses; second, to accrued and unpaid interest
on the Obligations (including any interest which, but for the provisions of the
United States Bankruptcy Code, would have accrued on such amounts); third, to
the principal amount of the Obligations outstanding; and fourth, to any other
indebtedness or obligations of Borrower owing to Agent or any Lender under the
Loan Documents. Any balance remaining shall be delivered to Borrower
or to whoever may be lawfully entitled to receive such balance or as a court of
competent jurisdiction may direct. In carrying out the foregoing, (x)
amounts received shall be applied in the numerical order provided until
exhausted prior to the application to the next succeeding category, and (y) each
of the Persons entitled to receive a payment in any particular category shall
receive an amount equal to its pro rata share of amounts available to be applied
pursuant thereto for such category.
9.5 Liability for
Collateral. So long as the Agent and Lenders comply with
reasonable banking practices regarding the safekeeping of the Collateral in the
possession or under the control of the Agent and Lenders, the Agent and Lenders
shall not be liable or responsible for: (a) the safekeeping of the Collateral;
(b) any loss or damage to the Collateral; (c) any diminution in the value of the
Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or
other Person. Borrower bears all risk of loss, damage or destruction
of the Collateral.
9.6 No Waiver; Remedies
Cumulative. Agent’s failure, at any time or times, to require
strict performance by Borrower of any provision of this Agreement or any other
Loan Document shall not waive, affect, or diminish any right of Agent thereafter
to demand strict performance and compliance herewith or therewith. No
waiver hereunder shall be effective unless signed by Agent and then is only
effective for the specific instance and purpose for which it is
given. Agent’s rights and remedies under this Agreement and the other
Loan Documents are cumulative. Agent has all rights and remedies
provided under the Code, by law, or in equity. Agent’s exercise of
one right or remedy is not an election, and Agent’s waiver of any Event of
Default is not a continuing waiver. Agent’s delay in exercising any
remedy is not a waiver, election, or acquiescence.
9.7 Demand
Waiver. Borrower waives demand, notice of default or dishonor,
notice of payment and nonpayment, notice of any default, nonpayment at maturity,
release, compromise, settlement, extension, or renewal of accounts, documents,
instruments, chattel paper, and guarantees held by Agent on which Borrower is
liable.
10 NOTICES
All
notices, consents, requests, approvals, demands, or other communication
(collectively, “Communication”) by any party
to this Agreement or any other Loan Document must be in writing and shall be
deemed to have been validly served, given, or delivered: (a) upon the earlier of
actual receipt and three (3) Business Days after deposit in the U.S. mail, first
class, registered or certified mail return receipt requested, with proper
postage prepaid; (b) upon transmission, when sent by electronic mail or
facsimile transmission; (c) one (1) Business Day after deposit with a reputable
overnight courier with all charges prepaid; or (d) when delivered, if
hand-delivered by messenger, all of which shall be addressed to the party to be
notified and sent to the address, facsimile number, or email address indicated
below. Agent, any Lender or Borrower may change its address or
facsimile number by giving the other party written notice thereof in accordance
with the terms of this Section 10.
|
If
to Borrower:
|
Peregrine
Pharmaceuticals, Inc.
14282
Franklin Avenue
Tustin,
California 92780
Attention:
Paul Lytle
|
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
|
with
a copy to (which shall not constitute notice):
|
Snell & Wilmer L.L.P.
600
Anton Boulevard, Suite 1400
Costa
Mesa, California 92626-7689
Attention :
Mark R. Ziebell
|
|
If
to Agent or Lenders:
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BlueCrest
Capital Finance, L.P.
225
West Washington, Suite 200
Chicago,
Illinois 60606
Attention:
Mark King
Phone:
(312) 368-4978
Facsimile:
(312) 443-0126
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with
a copy to (which shall not constitute notice):
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Troutman
Sanders LLP
1660
International Drive, 6th
floor
McLean,
Virginia 22102
Attention:
David J. Lawson
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11
CHOICE OF
LAW, VENUE AND JURY TRIAL WAIVER
Maryland
Law governs the Loan Documents (other than the Warrant) without regard to
principles of conflicts of law. Borrower, Lenders and Agent each
submit to the exclusive jurisdiction of the State and Federal courts in
Maryland. Notwithstanding the foregoing, nothing in this Agreement
shall be deemed to operate to preclude Agent from bringing suit or taking other
legal action in any other jurisdiction to realize on the Collateral or any other
security for the Obligations, or to enforce a judgment or other court order in
favor of Agent and Lenders. Borrower expressly submits and consents
in advance to such jurisdiction in any action or suit commenced in any such
court, and Borrower hereby waives any objection that it may have based upon lack
of personal jurisdiction, improper venue, or forum non conveniens and hereby
consents to the granting of such legal or equitable relief as is deemed
appropriate by such court. Borrower hereby waives personal service of
the summons, complaints, and other process issued in such action or suit and
agrees that service of such summons, complaints, and other process may be made
by registered or certified mail addressed to Borrower at the address set forth
in Section 10 of this Agreement and that service so made shall be deemed
completed upon the earlier to occur of Borrower's actual receipt thereof or
three (3) days after deposit in the U.S. mails, proper postage
prepaid.
TO THE EXTENT PERMITTED BY APPLICABLE
LAW, BORROWER, LENDERS AND AGENT EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY
CLAIM OR CAUSE OF ACTION ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN
DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF
DUTY AND ALL OTHER CLAIMS. THIS WAIVER IS A MATERIAL INDUCEMENT FOR BOTH PARTIES
TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED THIS WAIVER
WITH ITS COUNSEL.
12 GENERAL
PROVISIONS
12.1 Joint
Liability. Each Person included in the term “Borrower” hereby
covenants and agrees with Agent and Lenders as follows:
(a) The
Obligations include all present and future indebtedness, duties, obligations,
and liabilities under the Loan Documents, whether now existing or contemplated
or hereafter arising, of any one or more of the Persons included in the term
“Borrower”.
(b) Reference
in this Agreement and the other Loan Documents to the “Borrower” or otherwise
with respect to any one or more of the Persons now or hereafter included in the
definition of “Borrower” shall mean each and every such Person and any one or
more of such Persons, jointly and severally, unless the context requires
otherwise.
(c) Each
Person included in the term “Borrower” in the discretion of its respective
management is to agree among themselves as to the allocation of the benefits of
the proceeds of the Credit Extensions, provided, however, that each such Person
shall be deemed to have represented and warranted to Agent and Lenders at the
time of allocation that each benefit and use of proceeds is permitted under this
Agreement.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(d) Neither
Agent nor any Lender assumes any responsibility or liability for any errors,
mistakes, and/or discrepancies in the oral, telephonic, written or other
transmissions of any instructions, orders, requests and confirmations by any one
or more of the Persons included in the term “Borrower” in connection with any
Credit Extension or any other transaction in connection with the provisions of
this Agreement.
12.1.2 Inter-Company Debt,
Contribution. Without implying any limitation on the joint and
several nature of the Obligations, Agent and Lenders agree that, notwithstanding
any other provision of this Agreement, the Persons included in the term
“Borrower” may create reasonable inter-company indebtedness between or among the
Persons included in the term “Borrower” with respect to the allocation of the
benefits and proceeds of the Credit Extensions under this
Agreement. The Persons included in the term “Borrower” agree among
themselves, and Agent and Lenders consent to that agreement, that each such
Person shall have rights of contribution from all of such Persons to the extent
such Person incurs Obligations in excess of the proceeds of the Credit
Extensions received by, or allocated to such Person. All such
indebtedness and rights shall be, and are hereby agreed by the Persons included
in the term “Borrower” to be, subordinate in priority and payment to the
indefeasible repayment in full in cash of the Obligations, and, unless Agent
agrees in writing otherwise, shall not be exercised or repaid in whole or in
part until all of the Obligations have been indefeasibly paid in full in
cash. Each Person included in the term “Borrower” agrees that all of
such inter-company indebtedness and rights of contribution are part of the
Collateral and secure the Obligations. Each Person included in the
term “Borrower” hereby waives all rights of counter claim, recoupment and offset
between or among themselves arising on account of that indebtedness and
otherwise. No Person included in the term “Borrower” shall evidence
the inter-company indebtedness or rights of contribution by note or other
instrument, and shall not secure such indebtedness or rights of contribution
with any Lien or security.
12.1.3 Borrowers are Integrated
Group.
Each
Person included in the term “Borrower” hereby represents and warrants to Agent
and Lenders that each of them will derive benefits, directly and indirectly,
from each Credit Extension, both in their separate capacity and as a member of
the integrated group to which each such Person belongs and because the
successful operation of the integrated group is dependent upon the continued
successful performance of the functions of the integrated group as a whole,
because (i) the terms of the Credit Extensions provided under this Agreement are
more favorable than would otherwise would be obtainable by such Persons
individually, and (ii) the additional administrative and other costs and reduced
flexibility associated with individual loan arrangements which would otherwise
be required if obtainable would substantially reduce the value to such Persons
of the Credit Extensions.
12.1.4 Primary
Obligations.
The obligations and liabilities of each
Person included in the term “Borrower” shall be primary, direct and immediate,
shall not be subject to any counterclaim, recoupment, set off, reduction or
defense based upon any claim that such Person may have against any one or more
of the other Persons included in the term “Borrower”, Agent, any Lender and/or
any other guarantor and shall not be conditional or contingent upon pursuit or
enforcement by Agent and Lenders of any remedies they may have against Persons
included in the term “Borrower” with respect to this Agreement, or any of the
other Loan Documents, whether pursuant to the terms thereof or by operation of
law. Without limiting the generality of the foregoing, neither Agent
nor any Lender shall be required to make any demand upon any of the Persons
included in the term “Borrower”, or to sell the Collateral or otherwise pursue,
enforce or exhaust its or their remedies against the Persons included in the
term “Borrower” or the Collateral either before, concurrently with or after
pursuing or enforcing its rights and remedies hereunder. Any one or
more successive or concurrent actions or proceedings may be brought against each
Person included in the term “Borrower”, either in the same action, if any,
brought against any one or more of the Persons included in the term “Borrower”
or in separate actions or proceedings, as often as Agent or Lenders may deem
expedient or advisable. Without limiting the foregoing, it is
specifically understood that any modification, limitation or discharge of any of
the liabilities or obligations of any one or more of the Persons included in the
term “Borrower”, any other guarantor or any obligor under any of the Loan
Documents, arising out of, or by virtue of, any bankruptcy, arrangement,
reorganization or similar proceeding for relief of debtors under federal or
state Law initiated by or against any one or more of the Persons included in the
term “Borrower”, in their respective capacities as borrowers and guarantors
under this Agreement, or under any of the Loan Documents shall not modify,
limit, lessen, reduce, impair, discharge, or otherwise affect the liability of
any other Borrower under this Agreement in any manner whatsoever, and this
Agreement shall remain and continue in full force and effect. It is
the intent and purpose of this Agreement that each Person included in the term
“Borrower” shall and does hereby waive all rights and benefits which might
accrue to any other guarantor by reason of any such proceeding, and the Persons
included in the term “Borrower” agree that they shall be liable for the full
amount of the obligations and liabilities under this Agreement regardless of,
and irrespective to, any modification, limitation or discharge of the liability
of any one or more of the Persons included in the term “Borrower”, any other
guarantor or any other obligor under any of the Loan Documents, that may result
from any such proceedings.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
12.2 Successors and
Assigns. This Agreement binds and is for the benefit of the
successors and permitted assigns of each party. Borrower may not
assign this Agreement or any rights or obligations under it without Agent’s
prior written consent (which may be granted or withheld in Agent’s
discretion). Lenders and Agent have the right, without the consent of
or notice to Borrower, to sell, transfer, assign, negotiate, or grant
participation in all or any part of, or any interest in, Lenders’ obligations,
rights, and benefits under this Agreement and the other Loan Documents,
including without limitation, an assignment to any Affiliate or any related
party. Borrower shall establish and maintain a record of ownership
(the “Register”) in
which it agrees to register by book entry each Lender’s and each initial and
subsequent assignee’s interest in each Credit Extension, and in the right to
receive any payments hereunder and any assignment of any such
interest. Notwithstanding anything to the contrary contained in this
Agreement, the Credit Extensions (including the notes in respect hereof) are
registered obligations and the right, title, and interest of each Lender and its
assignees therein shall be transferable upon notation of such transfer in the
Register, pursuant to Borrower’s obligation above. In no event is any
note to be considered a bearer instrument or bearer obligation. This
Section shall be construed so that the Credit Extensions are at all times
maintained in “registered form” within the meaning of Sections 163(f), 871(h)(2)
and 881(c)(2) of the Internal Revenue Code and any related regulations (or any
successor provisions of the Code or such regulations).
12.3 Indemnification/Expenses.
(a) Borrower
agrees to indemnify, defend and hold Agent and the Lenders and their respective
directors, officers, employees, agents, attorneys, or any other Person
affiliated with or representing Agent or the Lenders harmless
against: (a) all obligations, demands, claims, and liabilities
(collectively, “Claims”)
asserted by any other party in connection with the transactions contemplated by
the Loan Documents; and (b) all losses or Lenders' Expenses incurred, or paid by
Lenders and/or Agent from, following, or arising from transactions between
Agent, and/or Lenders and Borrower (including reasonable attorneys’ fees and
expenses), except for Claims and/or losses directly caused by Agent’s or
Lenders' gross negligence, willful misconduct or violation of the
Law.
(b) Borrower
hereby indemnifies, defends and holds Agent and the Lenders and their respective
officers, employees, and agents (collectively called the “Indemnitees”) harmless from
and against any and all liabilities, obligations, losses, damages, penalties,
actions, judgments, suits, claims, costs, expenses and disbursements of any kind
or nature whatsoever (including the fees and disbursements of counsel for such
Indemnitee) in connection with any investigative, response, remedial,
administrative or judicial matter or proceeding, whether or not such Indemnitee
shall be designated a party thereto and including any such proceeding initiated
by or on behalf of Borrower, and the reasonable expenses of investigation by
engineers, environmental consultants and similar technical personnel and any
commission, fee or compensation claimed by any broker (other than any broker
retained by Agent or Lenders) asserting any right to payment for the
transactions contemplated hereby which may be imposed on, incurred by or
asserted against such Indemnitee as a result of or in connection with the
transactions contemplated hereby and the use or intended use of the proceeds of
the Growth Capital Advances, except that Borrower shall not have any obligation
hereunder to an Indemnitee with respect to any liability resulting from the
gross negligence, willful misconduct or violation of the Law of such Indemnitee,
as determined by a final non-appealable judgment of a court of competent
jurisdiction. To the extent that the undertaking set forth in the
immediately preceding sentence may be unenforceable, Borrower shall contribute
the maximum portion which it is permitted to pay and satisfy under applicable
Law to the payment and satisfaction of all such indemnified liabilities incurred
by the Indemnitees or any of them.
12.4 Time of
Essence. Time is of the essence for the performance of all
Obligations in this Agreement.
12.5 Severability of
Provisions. Each provision of this Agreement is severable from
every other provision in determining the enforceability of any
provision.
12.6 Amendments in Writing;
Integration. All amendments to this Agreement must be in
writing and signed by Agent, Lenders and Borrower. This Agreement and
the Loan Documents represent the entire agreement about this subject matter and
supersede prior negotiations or agreements. All prior agreements,
understandings, representations, warranties, and negotiations between the
parties about the subject matter of this Agreement and the Loan Documents merge
into this Agreement and the Loan Documents.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
12.7 Counterparts. This
Agreement may be executed in any number of counterparts and by different parties
on separate counterparts, each of which, when executed and delivered, is an
original, and all taken together, constitute one Agreement.
12.8 Survival. All
covenants, representations and warranties made in this Agreement continue in
full force until this Agreement has terminated pursuant to its terms and all
Obligations (other than inchoate indemnity obligations and any other obligations
which, by their terms, are to survive the termination of this Agreement) have
been satisfied. The obligation of Borrower in Section 12.3 to
indemnify each Lender and Agent shall survive until the statute of limitations
with respect to such claim or cause of action shall have run.
12.9 Confidentiality. In
handling any confidential information, Lenders and Agent shall exercise the same
degree of care that it exercises for its own proprietary information, but
disclosure of information may be made: (a) to Lenders' and Agent’s Subsidiaries,
Affiliates; (b) to prospective transferees or purchasers of any interest in the
Credit Extensions (provided, however, Lenders and Agent shall obtain such
prospective transferee’s or purchaser’s agreement to the terms of this
provision); (c) as required by Law, regulation, subpoena, or other order;
(d) to regulators or as otherwise required in connection with an
examination or audit; and (e) as Agent considers appropriate in exercising
remedies under this Agreement. Confidential information does not
include information that either: (i) is in the public domain or in Lenders'
and/or Agent’s possession when disclosed to Lenders and/or Agent, or becomes
part of the public domain after disclosure to Lenders and/or Agent; or (ii) is
disclosed to Lenders and/or Agent by a third party, if Lenders and/or Agent does
not know that the third party is prohibited from disclosing the
information.
12.10 Right of Set
Off. Borrower hereby grants to Agent and to each Lender,
a lien, security interest and right of set off as security for all Obligations
to Agent and each Lender hereunder, whether now existing or hereafter arising
upon and against all deposits, credits, collateral and property, now or
hereafter in the possession, custody, safekeeping or control of Agent or Lenders
or any entity under the control of Agent or Lenders (including an Agent
affiliate) or in transit to any of them. At any time after the
occurrence and during the continuance of an Event of Default, without demand or
notice, Agent or Lenders may set off the same or any part thereof and apply the
same to any liability or obligation of Borrower even though unmatured and
regardless of the adequacy of any other collateral securing the
Obligations. ANY AND ALL RIGHTS TO REQUIRE AGENT TO EXERCISE ITS
RIGHTS OR REMEDIES WITH RESPECT TO ANY OTHER COLLATERAL WHICH SECURES THE
OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF SETOFF WITH RESPECT TO SUCH
DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER ARE HEREBY KNOWINGLY,
VOLUNTARILY AND IRREVOCABLY WAIVED.
12.11 Publicity.
Borrower
will not directly or indirectly publish, disclose or otherwise use in any public
disclosure, advertising material, promotional material, press release or
interview, any reference to the name, logo or any trademark of Agent or any
Lender or any of their Affiliates or any reference to this Agreement or the
financing evidenced hereby, in any case except as required by applicable Law
(including the rules and regulations of the Securities and Exchange Commission),
subpoena or judicial or similar order, in which case Borrower shall endeavor to
give Agent prior written notice of such publication or other
disclosure.
Each
Lender and Borrower hereby authorizes each Lender to publish the name of such
Lender and Borrower, the existence of the financing arrangements referenced
under this Agreement, the primary purpose and/or structure of those
arrangements, the amount of credit extended under each facility, the title and
role of each party to this Agreement, and the total amount of the financing
evidenced hereby in any “tombstone”, comparable advertisement or press release
which such Lender elects to submit for publication. In addition, each
Lender and Borrower agrees that each Lender may provide lending industry trade
organizations with information necessary and customary for inclusion in league
table measurements after the Closing Date. With respect to any of the
foregoing, such authorization shall be subject to such Lender providing Borrower
and the other Lenders with an opportunity to review and confer with such Lender
regarding, and approve, the contents of any such tombstone, advertisement or
information, as applicable, prior to its initial submission for publication, but
subsequent publications of the same tombstone, advertisement or information
shall not require Borrower's approval.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
12.11 No Strict Construction. The
parties hereto have participated jointly in the negotiation and drafting of this
Agreement. In the event an ambiguity or question of intent or
interpretation arises, this Agreement shall be construed as if drafted jointly
by the parties hereto and no presumption or burden of proof shall arise favoring
or disfavoring any party by virtue of the authorship of any provisions of this
Agreement.
13
DEFINITIONS
13.1 Definitions. As
used in this Agreement, the following terms have the following
meanings:
“Account” is any “account” as
defined in the Code with such additions to such term as may hereafter be made,
and includes, without limitation, all accounts receivable and other sums owing
to Borrower.
“Account Debtor” is any
“account debtor” as defined in the Code with such additions to such term as may
hereafter be made.
“Advance Request Form” is that
certain form attached hereto as Exhibit
B.
“Affiliate” of any Person is a
Person that owns or controls directly or indirectly the Person, any Person that
controls or is controlled by or is under common control with the Person, and
each of that Person’s senior executive officers, directors, partners and, for
any Person that is a limited liability company, that Person’s managers and
members. For purposes of Section 12.9, the term “Affiliates” in
regard to a Lender shall also include any entity that provides capital to such
Lender to facilitate such Lender’s business activities.
“Agent” means, BlueCrest, not
in its individual capacity, but solely in its capacity as agent on behalf of and
for the benefit of the Lenders.
“Agreement” is defined in the
preamble hereof.
“Anti-Terrorism Laws” means any
Laws relating to terrorism or money laundering, including Executive Order No.
13224 (effective September 24, 2001), the USA PATRIOT Act, the Laws comprising
or implementing the Bank Secrecy Act, and the Laws administered by
OFAC.
“Arrangers” is defined in the
preamble hereof.
“Assignee Lender” is defined in
Section 3.1(h).
“Avid” is defined in the
preamble hereof.
“Avid Liens” means the Liens
granted by Peregrine in favor of Agent, for the ratable benefit of Lenders, on
the capital stock of Avid and the Liens granted by Avid in favor of Agent, for
the ratable benefit of Lenders, on the assets of Avid.
“Base LIBOR Rate” means, for
any Interest Period, the rate per annum, determined by Agent in accordance with
its customary procedures, and utilizing such electronic or other quotation
sources as it considers appropriate (rounded upwards, if necessary, to the next
1/100%), to be the rate at which Dollar deposits (for delivery on the first day
of such Interest Period of, if such day is not a Business Day on the preceding
Business Day) in the amount of $1,000,000 are offered to major banks in the
London interbank market on or about 11:00 a.m. (New York time) two (2) Business
Days prior to the commencement of such Interest Period, for a term comparable to
such Interest Period, which determination shall be conclusive in the absence of
manifest error.
“Blocked Person” means any
Person: (a) listed in the annex to, or is otherwise subject to the
provisions of, Executive Order No. 13224, (b) a Person owned or controlled by,
or acting for or on behalf of, any Person that is listed in the annex to, or is
otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person
with which any Lender is prohibited from dealing or otherwise engaging in any
transaction by any Anti-Terrorism Law, (d) a Person that commits, threatens or
conspires to commit or supports “terrorism” as defined in Executive Order No.
13224, or (e) a Person that is named a “specially designated national” or
“blocked person” on the most current list published by OFAC or other similar
list.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
“BlueCrest” is defined in the
preamble hereof.
“Borrower” is defined in the
preamble hereof.
“Borrower’s Books” are all
Borrower’s books and records including ledgers, federal and state tax returns,
records regarding Borrower’s assets or liabilities, the Collateral, business
operations or financial condition, and all computer programs or storage or any
equipment containing such information.
“Borrowing Resolutions” are,
with respect to any Person, those resolutions adopted by such Person’s Board of
Directors and delivered by such Person to Agent approving the Loan Documents to
which such Person is a party and the transactions contemplated thereby, together
with a certificate executed by its secretary on behalf of such Person certifying
that (a) such Person has the authority to execute, deliver, and perform its
obligations under each of the Loan Documents to which it is a party,
(b) that attached as Exhibit A to such certificate is a true, correct, and
complete copy of the resolutions then in full force and effect authorizing and
ratifying the execution, delivery, and performance by such Person of the Loan
Documents to which it is a party, (c) the name(s) of the Person(s) authorized to
execute the Loan Documents on behalf of such Person, together with a sample of
the true signature(s) of such Person(s), and (d) that Agent may
conclusively rely on such certificate unless and until such Person shall have
delivered to Agent a further certificate canceling or amending such prior
certificate.
“Business Day” is any day that
is not a Saturday, Sunday or a day on which Agent is closed.
“Cash Equivalents” means
(a) marketable direct obligations issued or unconditionally guaranteed by
the United States or any agency or any State thereof having maturities of not
more than one (1) year from the date of
acquisition; (b) commercial paper maturing no more than one (1)
year after its creation and having the highest rating from either Standard &
Poor’s Ratings Group or Moody’s Investors Service, Inc.; (c) certificates of
deposit maturing no more than one (1) year after issue; and (d) money market
funds at least ninety-five percent (95%) of the assets of which constitute Cash
Equivalents of the kinds described in clauses (a) through (c) of this
definition.
“Change in Control” is a
transaction in which any “person” or “group” (within the meaning of
Section 13(d) and 14(d)(2) of the Securities Exchange Act of 1934, as amended)
becomes the “beneficial
owner” (as defined in Rule 13d-3 under the Securities Exchange Act of
1934, as amended), directly or indirectly, of greater than 35% of the shares of
all classes of stock then outstanding of Borrower ordinarily entitled to vote in
the election of directors.
“Claims” are defined in Section
12.2.
“Code” is the Uniform
Commercial Code, as the same may, from time to time, be enacted and in effect in
the State of Maryland; provided, that, to the extent that the Code is used to
define any term herein or in any Loan Document and such term is defined
differently in different Articles or Divisions of the Code, the definition of
such term contained in Article or Division 9 shall govern; provided further,
that in the event that, by reason of mandatory provisions of law, any or all of
the attachment, perfection, or priority of, or remedies with respect to, Agent's
Lien on any Collateral is governed by the Uniform Commercial Code in effect in a
jurisdiction other than the State of Maryland, the term “Code” shall mean the Uniform
Commercial Code as enacted and in effect in such other jurisdiction solely for
purposes on the provisions thereof relating to such attachment, perfection,
priority, or remedies and for purposes of definitions relating to such
provisions.
“Collateral” is any and all
properties, rights and assets of Borrower described on Exhibit
A.
“Collateral Account” is any
Deposit Account, Securities Account, or Commodity Account.
“Commitment Percentage” is set
forth in Schedule 1.1, as amended from time to time.
“Commodity Account” is any
“commodity account” as defined in the Code with such additions to such term as
may hereafter be made.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
“Communication” is defined in
Section 10.
“Compliance Certificate” is
that certain certificate in the form attached hereto as Exhibit
C.
“Contingent Obligation” is, for
any Person, any direct or indirect liability, contingent or not, of that Person
for (a) any indebtedness, lease, dividend, letter of credit or other obligation
of another such as an obligation directly or indirectly guaranteed, endorsed,
co-made, discounted or sold with recourse by that Person, or for which that
Person is directly or indirectly liable; (b) any obligations for undrawn letters
of credit for the account of that Person; and (c) all obligations from any
interest rate, currency or commodity swap agreement, interest rate cap or collar
agreement, or other agreement or arrangement designated to protect a Person
against fluctuation in interest rates, currency exchange rates or commodity
prices; but “Contingent Obligation” does not include endorsements in the
ordinary course of business. The amount of a Contingent Obligation is
the stated or determined amount of the primary obligation for which the
Contingent Obligation is made or, if not determinable, the maximum reasonably
anticipated liability for it determined by the Person in good faith; but the
amount may not exceed the maximum of the obligations under any guarantee or
other support arrangement.
“Control Agreement” is any
control agreement entered into among the depository institution at which
Borrower maintains a Deposit Account or the securities intermediary or commodity
intermediary at which Borrower maintains a Securities Account or a Commodity
Account, Borrower, and Agent pursuant to which Agent obtains control (within the
meaning of the Code) for the benefit of the Lenders over such Deposit Account,
Securities Account, or Commodity Account.
“Credit Extension” is any
Growth Capital Advance or any other extension of credit by Agent or Lenders
under this Agreement or the Loan Documents for Borrower’s benefit.
“DEA” means the Drug
Enforcement Administration of the United States of America and any successor
agency thereof.
“Default” is any event which
with notice or passage of time or both, would constitute an Event of
Default.
“Default Rate” is defined in
Section 2.2(b).
“Deposit Account” is any
“deposit account” as defined in the Code with such additions to such term as may
hereafter be made.
“Designated Deposit Account” is
collectively Borrower’s deposit account, account numbers ***********,*********,
and ***********, maintained with Union Bank of California and over which Agent
has been granted control for the ratable benefit of all Lenders.
“Dollars,” “dollars” and “$” each mean lawful money of
the United States.
“Drug Application” means a new
drug application, an abbreviated drug application, or a product license
application for any Product, as appropriate, as those terms are defined in the
FDCA.
“Effective Amount” means with
respect to any Growth Capital Advances on any date, the aggregate outstanding
principal amount thereof after giving effect to any borrowing and prepayments or
repayments thereof occurring on such date.
“Effective Date” is defined in
the preamble of this Agreement.
“Equipment” is all “equipment”
as defined in the Code with such additions to such term as may hereafter be
made, and includes without limitation all machinery, fixtures, goods, vehicles
(including motor vehicles and trailers), and any interest in any of the
foregoing.
“ERISA” is the Employee
Retirement Income Security Act of 1974, and its regulations.
“Event of Default” is defined
in Section 8.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
“FDA” means the Food and Drug
Administration of the United States of America or any successor entity
thereto.
“FDCA” means the Federal Food,
Drug and Cosmetic Act, as amended, 21 U.S.C. Section 301 et seq. and all
regulations promulgated thereunder.
“Final Payment” is a payment in
regard to each Growth Capital Advance (in addition to and not a substitution for
the regular monthly payments of principal plus accrued interest) equal to the
amount of such Growth Capital Advance multiplied by the Final Payment
Percentage, due on the earlier of (a) the Growth Capital Line Maturity Date,
(b) the acceleration of such Growth Capital Advance or (c) the prepayment
of the Growth Capital Advances in accordance with Section 2.1.1(e); provided,
however, that fifty percent (50%) of the portion of the Final Payment owed to
any Lender shall be waived by such Lender in the event of a prepayment using
proceeds of a credit facility provided in whole or in part by such Lender which
refinances the Obligations.
“Final Payment Percentage” is,
for each Growth Capital Advance, three percent (3.0%).
“Funding Date” is any date on
which a Credit Extension is made to or on account of Borrower which shall be a
Business Day.
“GAAP” is generally accepted
accounting principles set forth in the opinions and pronouncements of the
Accounting Principles Board of the American Institute of Certified Public
Accountants and statements and pronouncements of the Financial Accounting
Standards Board or in such other statements by such other Person as may be
approved by a significant segment of the accounting profession, which are
applicable to the circumstances as of the date of determination.
“General Intangibles” is all
“general intangibles” as defined in the Code in effect on the date hereof with
such additions to such term as may hereafter be made, and includes without
limitation, all copyright rights, copyright applications, copyright
registrations and like protections in each work of authorship and derivative
work, whether published or unpublished, any patents, trademarks, service marks
and, to the extent permitted under applicable Law, any applications therefor,
whether registered or not, any trade secret rights, including any rights to
unpatented inventions, payment intangibles, royalties, contract rights,
goodwill, franchise agreements, purchase orders, customer lists, route lists,
telephone numbers, domain names, claims, income and other tax refunds, security
and other deposits, options to purchase or sell real or personal property,
rights in all litigation presently or hereafter pending (whether in contract,
tort or otherwise), insurance policies (including without limitation key man,
property damage, and business interruption insurance), payments of insurance and
rights to payment of any kind.
“Growth Capital Advance” or
“Growth Capital
Advances” is defined in Section 2.1.1(a).
“Growth Capital Draw Period” is
the period of time commencing upon the Effective Date and continuing through the
earliest to occur of (i) the Growth Capital Commitment Termination Date, (ii) an
Event of Default, or (iii) the existence of any Default.
“Growth Capital Commitment Termination
Date” is June 30, 2009.
“Growth Capital Line” is a
Growth Capital Advance or Growth Capital Advances in an aggregate amount of up
to Ten Million Dollars ($10,000,000.00).
“Growth Capital Line Maturity
Date” is, for each Growth Capital Advance, December 9, 2011.
“Governmental Approval” is any
consent, authorization, approval, order, license, franchise, permit,
certificate, accreditation, registration, filing or notice, of, issued by, from
or to, or other act by or in respect of, any Governmental
Authority.
“Governmental Authority” is any
nation or government, any state or other political subdivision thereof, any
agency, authority, instrumentality, regulatory body, court, central bank or
other entity exercising executive, legislative, judicial, taxing, regulatory or
administrative functions of or pertaining to government, any securities exchange
and any self-regulatory organization
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
“Indebtedness” is (a)
indebtedness for borrowed money or the deferred price of property or services,
such as reimbursement and other obligations for surety bonds and letters of
credit, (b) obligations evidenced by notes, bonds, debentures or similar
instruments, (c) capital lease obligations, (d) Contingent Obligations and (e)
preferred stock issued by Borrower.
“Insolvency Proceeding” is any
proceeding by or against any Person under the United States Bankruptcy Code, or
any other bankruptcy or insolvency Law, including assignments for the benefit of
creditors, compositions, extensions generally with its creditors, or proceedings
seeking reorganization, arrangement, or other relief.
“Intellectual Property” means,
with respect to any Person, all patents, patent applications and like
protections, including improvements, divisions, continuation, renewals,
reissues, extensions and continuations in part of the same, trademarks, trade
names, trade styles, trade dress, service marks, logos and other business
identifiers and, to the extent permitted under applicable Law, any applications
therefore, whether registered or not, and the goodwill of the business of such
Person connected with and symbolized thereby, copyright rights, copyright
applications, copyright registrations and like protections in each work of
authorship and derivative works, whether published or unpublished, technology,
know-how and processes, operating manuals, trade secrets, computer hardware and
software, rights to unpatented inventions and all applications and licenses
therefor, used in or necessary for the conduct of business by such Person and
all claims for damages by way of any past, present or future infringement of any
of the foregoing.
“Interest Payment Date” means
the first day of each month.
“Interest Period” means the
one-month period starting on the first day of each month and ending on the last
day of such month; provided, however, that the first Interest Period for each
Growth Capital Advance shall commence on the date that the applicable Growth
Capital Advance is made and end on the last day of such month.
“Interest Rate Determination
Date” means the second Business Day prior to the first day of the related
Interest Period.
“Inventory” is all “inventory”
as defined in the Code in effect on the date hereof with such additions to such
term as may hereafter be made, and includes without limitation all merchandise,
raw materials, parts, supplies, packing and shipping materials, work in process
and finished products, including without limitation such inventory as is
temporarily out of Borrower’s custody or possession or in transit and including
any returned goods and any documents of title representing any of the
above.
“Investment” is any beneficial
ownership interest in any Person (including stock, partnership interest or other
securities), and any loan, advance or capital contribution to any
Person.
“IP Agreement” is that certain
Intellectual Property Security Agreement executed and delivered by Borrower to
Agent dated of even date herewith.
“Laws” means any and all
federal, state, provincial, territorial, local and foreign statutes, laws,
judicial decisions, regulations, guidances, guidelines, ordinances, rules,
judgments, orders, decrees, codes, plans, injunctions, permits, concessions,
grants, franchises, governmental agreements and governmental restrictions,
whether now or hereafter in effect, which are applicable to any Borrower in any
particular circumstance.
“Lender” is any one of the
Lenders.
“Lenders” shall mean the
Persons identified on Schedule 1.1 hereto and each assignee that becomes a party
to this Agreement pursuant to Section 12.1.
“Lenders’ Expenses” are,
subject to specific limitations contained in the Loan Documents, all audit fees
and expenses, costs, and expenses (including reasonable attorneys’ fees and
expenses) of Lenders and Agent for preparing, amending, negotiating,
administering, defending and enforcing the Loan Documents (including, without
limitation, those incurred in connection with appeals or Insolvency Proceedings)
or otherwise incurred with respect to Borrower relating to this Agreement or to
the other Loan Documents, provided that, if requested by Borrower in writing,
all such fees, expenses, and costs are supported by written invoices or
statements.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
“LIBOR Rate” means for each
Interest Period, the rate per annum determined by Agent (rounded upwards, if
necessary, to the next 1/100th%) by dividing (a) the Base LIBOR Rate for such
Interest Period, by (b) 100% minus the Reserve
Percentage. The LIBOR Rate shall be adjusted on and as of the
effective day of any change in the Reserve Percentage.
“LIBOR Rate Margin” is nine
percentage points (9.0%) per annum.
“Lien” is a claim, mortgage,
deed of trust, levy, charge, pledge, security interest or other encumbrance of
any kind, whether voluntarily incurred or arising by operation of law or
otherwise against any property.
“Loan Documents” are,
collectively, this Agreement, the Warrants, the Perfection Certificate, the IP
Agreement, any note, or notes or guaranties executed by Borrower or any
Guarantor in connection with the indebtedness governed by this Agreement, and
any other present or future agreement made by Borrower or any Guarantor for the
benefit of Lenders and Agent in connection with this Agreement, all as amended,
restated, or otherwise modified.
“Material Adverse Change” is
(a) a material impairment in the priority of Lenders' Lien in the Collateral or
in the value of such Collateral; (b) a material adverse change in the business,
operations, or condition (financial or otherwise) of Borrower; or (c) a material
impairment of the prospect of repayment of any portion of the
Obligations.
“Material Intellectual
Property” is all of Borrower’s Intellectual Property that is material to
the condition (financial or other), business or operations of
Borrower.
“Obligations” are Borrower’s
obligation to pay when due any debts, principal, interest, Lenders' Expenses,
Prepayment Fees, Final Payments, and other amounts Borrower owes Lenders now or
later, whether under this Agreement, the Loan Documents, or otherwise,
including, without limitation, all obligations relating to letters of credit
(including reimbursement obligations for drawn and undrawn letters of credit),
cash management services, and foreign exchange contracts, if any, and including
interest accruing after Insolvency Proceedings begin (whether or not allowed)
and debts, liabilities, or obligations of Borrower assigned to Lenders and/or
Agent, and the performance of Borrower’s duties under the Loan
Documents.
“OFAC” is the U.S. Department
of Treasury Office of Foreign Assets Control.
“OFAC Lists” are, collectively,
the Specially Designated Nationals and Blocked Persons List maintained by OFAC
pursuant to Executive Order No. 13224, 66 Fed. Reg. 49079 (Sept. 25, 2001)
and/or any other list of terrorists or other restricted Persons maintained
pursuant to any of the rules and regulations of OFAC or pursuant to any other
applicable Executive Orders.
“Operating Documents” are, for
any Person, such Person’s formation documents, as certified with the Secretary
of State of such Person’s state of formation on a date that is no earlier than
30 days prior to the Effective Date, and (a) if such Person is a corporation,
its bylaws in current form, (b) if such Person is a limited liability company,
its limited liability company agreement (or similar agreement), and (c) if such
Person is a partnership, its partnership agreement (or similar agreement), each
of the foregoing with all current amendments or modifications
thereto.
“Peregrine” is defined in the
preamble hereof.
“Perfection Certificate” is
defined in Section 5.1.
“Permits” means licenses,
certificates, accreditations, product clearances or approvals, provider numbers
or provider authorizations, marketing authorizations, other authorizations,
registrations, permits, consents and approvals required in connection with the
conduct of Borrower’s or any Subsidiary’s business or to comply with any
applicable Laws, including, without limitation, drug listings and drug
establishment registrations under 21 U.S.C. Section 510, registrations issued by
DEA under 21 U.S.C. Section 823 (if applicable to any Product), and those issued
by State governments for the conduct of Borrower’s or any Subsidiary’s
business.
“Permitted Avid Transaction” is
defined in Section 7.1.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
“Permitted Indebtedness”
is:
(a) Borrower’s
Indebtedness to Lenders and Agent under this Agreement and the other Loan
Documents;
(b) Indebtedness
existing on the Effective Date and shown on the Perfection
Certificate;
(c) Subordinated
Debt;
(d) unsecured
Indebtedness to trade creditors incurred in the ordinary course of
business;
(e) Indebtedness
incurred as a result of endorsing negotiable instruments received in the
ordinary course of business; and
(f) Indebtedness
secured by Permitted Liens;
(g) preferred
stock issued by Borrower which is not subject to any redemption right or
obligation or any other right or obligation which, if exercised or otherwise
enforced, would violate Section 7.7 or any other provision of this Agreement;
and
(h) extensions,
refinancings, modifications, amendments and restatements of any items of
Permitted Indebtedness (a) through (f) above, provided that the principal amount
thereof is not increased or the terms thereof are not modified to impose more
burdensome terms upon Borrower or its Subsidiary, as the case may
be.
“Permitted Investments”
are:
(a) Investments
shown on the Perfection Certificate and existing on the Effective
Date;
(b) Investments
consisting of Cash Equivalents;
(c) Investments
consisting of the endorsement of negotiable instruments for deposit or
collection or similar transactions in the ordinary course of Borrower’s
business;
(d) Investments
consisting of deposit accounts in which Agent, for the ratable benefit of
Lenders, has a perfected security interest;
(e) Investments
accepted in connection with Transfers permitted by Section 7.1;
(f) Investments
by Subsidiaries in or to other Subsidiaries or Borrower and Investments by
Borrower in Subsidiaries not to exceed $100,000 in the aggregate in any fiscal
year;
(g) Investments
consisting of (i) travel advances and employee relocation loans and other
employee loans and advances in the ordinary course of business, and (ii) loans
to employees, officers or directors relating to the purchase of equity
securities of Borrower or its Subsidiaries pursuant to employee stock purchase
plans or agreements approved by Borrower’s Board of Directors;
(h) Investments
(including debt obligations) received in connection with the bankruptcy or
reorganization of customers or suppliers and in settlement of delinquent
obligations of, and other disputes with, customers or suppliers arising in the
ordinary course of business; and
(i)
Investments consisting of notes receivable of, or
prepaid royalties and other credit extensions, to customers and suppliers who
are not Affiliates, in the ordinary course of business; provided that this
paragraph (i) shall not apply to Investments of Borrower in any
Subsidiary.
“Permitted Liens”
are:
(a) Liens
existing on the Effective Date and shown on the Perfection Certificate or
arising under this Agreement and the other Loan Documents;
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
(b) Liens
for taxes, fees, assessments or other government charges or levies, either not
delinquent or being contested in good faith and for which Borrower maintains
adequate reserves on Borrower’s Books, if they have no
priority over any of Lenders’ Liens;
(c)
purchase money Liens (i) on Equipment acquired or held by
Borrower incurred for financing the acquisition of the Equipment securing no
more than One Hundred Thousand Dollars ($100,000.00) in the aggregate amount
outstanding, or (ii) existing on Equipment when acquired, if the Lien is
confined to the property and improvements and the proceeds of the
Equipment;
(d) Liens
of carriers, warehousemen, suppliers, or other Persons that are possessory in
nature arising in the ordinary course of business so long as such Liens attach
only to Inventory, securing liabilities in the aggregate amount not to exceed
$100,000 and which are not delinquent or remain payable without penalty or which
are being contested in good faith and by appropriate proceedings which
proceedings have the effect of preventing the forfeiture or sale of the property
subject thereto;
(e) Liens
to secure payment of workers’ compensation, employment insurance, old age
pensions, social security and other like obligations incurred in the ordinary
course of business (other than Liens imposed by ERISA);
(f) Liens
incurred in the extension, renewal or refinancing of the indebtedness secured by
Liens described in (a) through (c), but any extension,
renewal or replacement Lien must be limited to the property encumbered by the
existing Lien and the principal amount of the indebtedness may not
increase;
(g) leases
or subleases of real property granted in the ordinary course of business, and
leases, subleases, non-exclusive licenses or sublicenses of property (other than
real property or Intellectual Property) granted in the ordinary course of
Borrower’s business, if the leases,
subleases, licenses and sublicenses do not prohibit granting Agent a security
interest;
(h) non-exclusive
license of Intellectual Property granted to third parties in the ordinary course
of business;
(i) exclusive
licenses of Intellectual Property so long as (i) Borrower’s Board of Directors
has approved each such exclusive license and (ii) no such exclusive license
involves the products bavituximab or Cotara;
(j)
Liens arising from attachments or judgments, orders, or decrees in
circumstances not constituting an Event of Default under Sections 8.4 and
8.7;
(k) Liens
in favor of other financial institutions arising in connection with Borrower’s
deposit and/or securities accounts held at such institutions, provided that
Agent, for the ratable benefit of Lenders, has a perfected security interest in
the amounts held in such deposit and/or securities accounts and such Lien does
not secure borrowed money; and
(l) Liens
in favor of XMark Fund, L.P. and Xmark Fund Ltd on (i) Peregrine’s registered
trademark for “COTARA” registered on February 24, 2004 with registration number
2,817,648 and (ii) certain of Peregrine’s patents, including, without
limitation, DETECTION OF NECROTIC MALIGNANT TISSUE AND ASSOCIATED THERAPY
registered on May 28, 1991 with registration number 5,019,368; provided,
however, that the Liens described in this clause (l) must be terminated prior to
advance of the initial Credit Extension hereunder.
“Person” is any individual,
sole proprietorship, partnership, limited liability company, joint venture,
company, trust, unincorporated organization, association, corporation,
institution, public benefit corporation, firm, joint stock company, estate,
entity or government agency.
“Prepayment Fee” shall be an
amount equal to:
|
(i)
|
for
a prepayment accruing on or prior to December 9, 2009, the Yield
Maintenance Amount;
|
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
|
(ii)
|
for
a prepayment accruing after December 9, 2009 and on or prior to December
9, 2010, five percent (5.0%) of the principal amount of any Growth Capital
Advance prepaid; or
|
|
(iii)
|
for
a prepayment accruing after December 9, 2010, three percent (3.0%) of the
principal amount of any Growth Capital Advance
prepaid.
|
“Products” means any products
manufactured, sold, developed, tested or marketed by any Borrower or any of its
Subsidiaries, including without limitation, those products set forth on Schedule
5.11 (as updated from time to time in accordance with Section 6.2(d) above);
provided that, if Borrower shall fail to comply with the obligations under
Section 6.2(d) to give notice to Agent and update Schedule 5.11 prior to
manufacturing, selling, developing, testing or marketing any new Product, any
such improperly undisclosed Product shall be deemed to be included in this
definition; and provided, further, that products manufactured by Avid for
unaffiliated third parties shall not be deemed “Products”
hereunder.
“Registered Organization” is
any “registered organization” as defined in the Code with such additions to such
term as may hereafter be made.
“Regulatory Change” means, with respect to
Lenders, any change on or after the date of this Agreement in United States
federal, state, or foreign Laws or regulations, including Regulation D, or the
adoption or making on or after such date of any interpretations, directives, or
requests applying to a class of lenders including Lenders, of or under any
United States federal or state, or any foreign Laws or regulations (whether or
not having the force of law) by any court or governmental or monetary authority
charged with the interpretation or administration thereof.
“Required Permit” means a
Permit (a) issued or required under Laws applicable to the business of Borrower
or any of its Subsidiaries or necessary in the manufacturing, importing,
exporting, possession, ownership, warehousing, marketing, promoting, sale,
labeling, furnishing, distribution or delivery of goods or services under Laws
applicable to the business of Borrower or any of its Subsidiaries or any Drug
Application (including without limitation, at any point in time, all licenses,
approvals and permits issued by the FDA or any other applicable Governmental
Authority necessary for the testing, manufacture, marketing or sale of any
Product by any applicable Borrower(s) as such activities are being conducted by
such Borrower with respect to such Product at such time), and (b) issued by any
Person from which Borrower or any of their Subsidiaries have received an
accreditation.
“Requirement of Law” is as to
any Person, the organizational or governing documents of such Person, and any
Law (statutory or common), treaty, rule or regulation or determination of an
arbitrator or a court or other Governmental Authority, in each case applicable
to or binding upon such Person or any of its property or to which such Person or
any of its property is subject.
“Reserve Percentage” means, on
any day, for any Lender, the maximum percentage prescribed by the Board of
Governors of the Federal Reserve System (or any successor Governmental
Authority) for determining the reserve requirements (including any basic,
supplemental, marginal, or emergency reserves) that are in effect on such date
with respect to eurocurrency funding (currently referred to as “eurocurrency
liabilities”) of that Lender, but so long as such Lender is not required or
directed under applicable regulations to maintain such reserves, the Reserve
Percentage shall be zero.
“Responsible Officer” is any of
the Chief Executive Officer, President, Chief Financial Officer and Controller
of Borrower.
“Securities Account” is any
“securities account” as defined in the Code with such additions to such term as
may hereafter be made.
“Subordinated Debt” is
indebtedness incurred by Borrower subordinated to all of Borrower’s now or
hereafter indebtedness to Lenders (pursuant to a subordination, intercreditor,
or other similar agreement in form and substance satisfactory to Agent and
Lenders entered into between Agent, the Borrower and the other creditor), on
terms acceptable to Agent and Lenders.
“Subsidiary” means, with
respect to any Person, any Person of which more than 50.0% of the voting stock
or other equity interests (in the case of Persons other than corporations) is
owned or controlled, directly or indirectly, by such Person or one or more of
Affiliates of such Person.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
“Transfer” is defined in
Section 7.1.
“UT Southwestern” has the
meaning set forth in the UTSW Agreement.
“UTSW Agreement” means that
certain Exclusive Patent License Agreement between the University of Texas
Southwestern and Peregrine Pharmaceuticals, Inc. effective as of August 1,
2001.
“Warrants” are those certain
Warrants to Purchase Stock dated as of the Effective Date executed by Borrower
in favor of each Lender.
“Yield Maintenance Amount”
means the sum of the present values (but in any event, not less than zero) of
the “Term Margin
Component” (defined below) of the remaining payments of interest under
this Agreement that will not be made by reason of the early termination of the
Growth Capital Line or Lenders’ funding obligations in respect thereof, all as
estimated and determined by Agent in accordance with the formula set forth
below. The “Term
Margin Component” means the portion of the remaining payments of interest
under this Agreement calculated based on (i) an amortized principal sum
initially equal to the amount prepaid and the LIBOR Rate Margin and (ii) the sum
of the LIBOR Rate Margin plus the amount (if any) by which 3% exceeds the LIBOR
Rate. The present value of each such estimated monthly payment shall
be calculated by discounting such estimated payment to the date of prepayment by
the Discount Rate. The “Discount Rate” for each such
payment is the rate which, when compounded monthly, is equivalent to the
Treasury Rate (as hereinafter defined), when compounded
semi-annually. The “Treasury Rate” is the yield
calculated by the linear interpolation of the nominal yields, as reported in the
Federal Reserve Statistical Release H.15 Selected Interest Rates (the “Release”) under the heading
“U.S. government securities” and the subheading “Treasury Constant Maturities”
for the week ending prior to the date of prepayment, of U.S. Treasury Constant
Maturities with maturity dates (one longer and one shorter) most nearly
approximating what would have been the payment due date of each such estimated
payment amount but for the termination or default. In the event the
Release is no longer published, Administrative Agent shall select a comparable
publication to determine the Treasury Rate in its commercially reasonable
discretion. Borrower agrees that the foregoing calculations are a reasonable
approximation of Lenders’ lost profits in view of the difficulties and
impracticality of determining actual damages resulting from an early termination
of this Agreement or Lenders’ funding obligations hereunder.
[Signature
Page Follows]
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
IN WITNESS WHEREOF, the
parties hereto have caused this Agreement to be executed as a sealed instrument
under the Laws of the State of Maryland as of the Effective Date.
BORROWER:
PEREGRINE
PHARMACEUTICALS, INC.
By:/s/ Steven
King
Name:
Steven
King
Title:
President and
CEO
AVID
BIOSERVICES, INC.
By:/s/ Steven
King
Name:
Steven
King
Title:
President and
CEO
AGENT:
BLUECREST
CAPITAL FINANCE, L.P., as
Agent
By:
BlueCrest Capital Finance GP, LLC, its General Partner
By: /s/ Mark
King
Name:
Mark
King
Title:
Managing
Director
LENDERS:
BLUECREST
CAPITAL FINANCE, L.P., as a Lender
By:
BlueCrest Capital Finance GP, LLC, its General Partner
By: /s/ Mark
King
Name:
Mark
King
Title:
Managing
Director
[Signature
page to Loan and Security Agreement]
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
SCHEDULE
1.1
LENDERS AND
COMMITMENTS
Lender
|
Commitment
|
Commitment Percentage
|
BlueCrest
Capital Finance, L.P.
|
$10,000,000.00
|
100.00%
|
|
|
|
TOTAL
|
$10,000,000.00
|
100.00%
|
[Schedule
1.1 to Loan and Security Agreement]
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
SCHEDULE
5.2
MATERIAL INTELLECTUAL
PROPERTY
Peregrine
has exclusive rights to market and sell world-wide the bavituximab family of
antibodies for treatment of all solid tumors, non-small cell lung cancer, breast
cancer, Hepatitis C and HIV through the following list of patents and license
agreements:
Product
Covered
|
Licensor
Name
|
Licensor
Address
|
Lic.
Exp. Date
|
IP
Exp. Date
|
Exclusive?
|
Restriction
|
|
|
|
|
|
|
|
Naked
anti-PS antibodies
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2018
|
Yes
|
Transferable
to successor
|
VTA
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2014
|
Yes
|
Transferable
to successor
|
bavituximab
|
Avanir
Pharmaceuticals
|
101
Enterprise, Suite 300, Aliso Viejo, CA 92656
|
10
year from first commercial sale per country
|
N/A
|
Yes
|
Transferable
to successor
|
Anti-PS
antibodies
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2022
|
Yes
|
Transferable
to successor
|
Peregrine
has exclusive rights to market and sell world-wide (except China) the product
known as Cotara® (a chimeric antibody labeled with radioactive iodine-131 that
targets necrotic tumor cells) for treatment of brain, colon, liver, lung,
prostate and pancreatic cancers, through the following list of patents and
license agreements:
Description
|
|
Registration/
Application
Number
|
|
Registration/
Application
Date
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (US)
|
|
10/877,959
|
|
06/25/04
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (PCT)
|
|
PCT/US04/020492
|
|
11/25/05
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (PCT)
|
|
2004253924
|
|
11/24/05
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (PCT)
|
|
200480017742.X
|
|
12/23/05
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (EPO – Belgium, Switzerland,
Germany, Denmark, Finland, France, Great Britain, Ireland, Netherlands
& Sweden)
|
|
04785799.0
|
|
01/05/06
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (HK)
|
|
06109573.0
|
|
08/28/06
|
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (EPO DIV)
|
|
08010871.5
|
|
06/13/08
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (India)
|
|
419/DELNP/2006
|
|
01/23/06
|
CONTINUOUS
LARGE SCALE METHOD FOR PROTEIN LABELING (New Zealand)
|
|
543495
|
|
11/10/05
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (Australia)
|
|
766564
|
|
7/2/1999
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (Canada)
|
|
2336114
|
|
7/2/1999
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (EPO – Denmark, France, Great Britain,
Netherlands)
|
|
EP1092028B1
|
|
7/2/1999
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (Japan)
|
|
2000-558212
|
|
7/2/1999
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (US)
|
|
6827925
|
|
9/27/2001
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (US)
|
|
10/890,945
|
|
7/13/2004
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (EP DIV)
|
|
EP0510644.2
|
|
5/17/2005
|
Specific
binding proteins including antibodies which bind to the necrotic centre of
tumours, and uses thereof (Hong Kong)
|
|
06108478.8
|
|
7/2/1999
|
Detection
of necrotic malignant tissue and associated therapy (US)
|
|
5019368
|
|
2/23/1989
|
Detection
of necrotic malignant tissue and associated therapy (US)
|
|
5882626
|
|
3/13/1991
|
MODIFIED
ANTIBODIES (US)
|
|
5194594
|
|
9/7/1990
|
MODIFIED
ANTIBODIES (UPO – Denmark, France, Great Britain, Italy,
Switzerland)
|
|
550663
|
|
8/28/1991
|
MODIFIED
ANTIBODIES (Canada)
|
|
2090700
|
|
8/28/1991
|
MODIFIED
ANTIBODIES (Japan)
|
|
3549525
|
|
8/28/1991
|
MODIFIED
ANTIBODIES (Japan Div)
|
|
2004-13610
|
|
8/28/1991
|
MODIFIED
ANTIBODIES (Australia)
|
|
649079
|
|
8/28/1991
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE (US)
|
|
5990286
|
|
1/10/1997
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE (EPO – Austria, Switzerland, Denmark,
Spain, France , Great Britain, Italy, Russia)
|
|
0873139
|
|
1/6/1997
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE (Australia)
|
|
730388
|
|
1/6/1997
|
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE (Canada)
|
|
2242750
|
|
1/6/1997
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE (Japan)
|
|
525384/1997
|
|
1/6/1997
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE (Korea)
|
|
485240
|
|
1/6/1997
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE (Mexico)
|
|
985565
|
|
1/6/1997
|
Peregrine
has the right to develop, market and sell other technologies such as
vasopermeation agents, vascular targeting agents and other technologies
(excluding those covering bavituximab and Cotara) through the following list of
patents and license agreements:
Licensed
Product
|
Licensor
Name
|
Licensor
Address
|
Lic.
Exp. Date
|
IP
Exp. Date
|
Exclusive?
|
Restrictions
|
|
|
|
|
|
|
|
VEA
|
University
of Southern California
|
3740
McClintock Ave, Hughes Center EEB 131, Los Angeles, CA
90089-2561
|
Upon
exp of Patents
|
2009
|
Yes
|
Transferable
to successor
|
PEP
|
University
of Southern California
|
3740
McClintock Ave, Hughes Center EEB 131, Los Angeles, CA
90089-2561
|
Upon
exp of Patents
|
2016
|
Yes
|
Transferable
to successor
|
Coaguligand
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2014
|
Yes
|
Transferable
to successor
|
Coaguligand
|
SCRIPPS
Research Inst.
|
10550
North Torrey Pines Road, La Jolla CA 92037
|
Upon
exp of Patents
|
2014
|
Yes
|
Transferable
to successor
|
VTA
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2014
|
Yes
|
Transferable
to successor
|
Tissue
Factor
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2017
|
Yes
|
Transferable
to successor
|
AntiPS-Conjugates
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2018
|
Yes
|
Transferable
to successor
|
VPF
|
Beth
Israel Deaconess Medical Center
|
330
Brookline Ave, FN 2, Boston, MA 02215
|
Upon
exp of Patents
|
2011
|
Yes
|
Transferable
to successor
|
Anti-VEGF
|
Univ.
of Texas System
|
201
W. 7th Street, Austin, TX 78701
|
Upon
exp of Patents
|
2019
|
Yes
|
Transferable
to successor
|
PS-peptide
conjugate
|
MD
Anderson Cancer Center
|
1515
Holcombe Blvd, Houston, TX 77030
|
Upon
exp of Patents
|
2017
|
Yes
|
Transferable
to successor
|
Nicked
Beta-2GP1
|
MD
Anderson Cancer Center
|
1515
Holcombe Blvd, Houston, TX 77030
|
Upon
exp of Patents
|
2022
|
Yes
|
Transferable
to successor
|
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
SCHEDULE
5.3
LITIGATION
On
January 12, 2007, Peregrine filed a complaint in the Superior Court of the State
of California for the County of Orange against Cancer Therapeutics Laboratories
(“CTL”). The original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai MediPharm and its
related entities, and Alan Epstein, MD. The lawsuit alleges claims
for breach of contract, interference with contractual relations, declaratory
relief, and injunctive relief against the defendants. Peregrine's
claims stem from a 1995 license agreement with CTL, and two amendments thereto
(collectively referred to as the "License Agreement"). Peregrine
claims that CTL breached the License Agreement by, among other things, (i) not
sharing with Peregrine all inventions, technology, know-how, patents and other
information, derived and/or developed in the People’s Republic of China and/or
at the CTL laboratory, as was required under the License Agreement; (ii) not
splitting revenue appropriately with Peregrine as required under the License
Agreement; (iii) utilizing Peregrine's licensed technologies outside of the
People’s Republic of China; and (iv) failing to enter a sublicense agreement
with a Chinese sponsor obligating the Chinese sponsor to comply with the terms
and obligations in the License Agreement. Peregrine further alleges
that Medibiotech and Shanghai Medipharm Biotech Co., Ltd. ("Medipharm Entities")
interfered with the License Agreement, leading to CTL's
breaches. This interference by the Medipharm Entities includes: 1)
posturing Shanghai Medipharm as the designated sublicensee under the License
Agreement, without binding any of the Medipharm Entities to the terms
and obligations of an appropriate sublicense agreement called for under the
License Agreement; 2) entering into a license agreement with defendant Epstein
("Epstein License Agreement") instead of CTL; 3) restricting the information CTL
was allowed to provide to Peregrine, thereby prohibiting CTL from providing to
Peregrine all information required under the License Agreement; and 4) providing
compensation to CTL, and its principals, so that CTL would enter agreements that
prohibited CTL from performing under the License Agreement. These
same monetary inducements also interfered with the 1999 Material Transfer
Agreement between Peregrine and Dr. Epstein ("MTA"), and caused Dr. Epstein to
breach the MTA. Dr. Epstein has attempted to have our claims against
him referred to binding arbitration. The Superior Court has declined
his request.
On March
28, 2007, CTL filed a cross-complaint, which it amended on May 30, 2007,
alleging that the Company breached the Agreement, improperly terminated the
Agreement, is interfering with CTL’s agreements with various MediPharm entities
and is double-licensing the technology licensed to CTL to another
party. CTL’s cross-complaint, which seeks $20 million in damages, is
in part predicated on the existence of a sublicense agreement between CTL and
MediPharm. Peregrine is challenging the cross-complaint on the basis
that not only did CTL fail to allege an agreement with which the Company
interfered, they have been unable to produce the alleged sublicense agreement
with MediPharm despite our repeated demands.
On
February 22, 2008, the MediPharm entities filed a cross-complaint alleging, as a
third party beneficiary, that that the Company breached the Agreement by
double-licensing the technology licensed to CTL to another party, intentionally
interfered with a prospective economic advantage, and unjust
enrichment. MediPharm’s cross-complaint, which seeks $30 million in
damages, is in part predicated on MediPharm being the “Chinese Sponsor” under
the Agreement. Peregrine intends to bring pre-trial motions to
dispose of the MediPharm Cross-Complaint.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
SCHEDULE
5.11
PRODUCTS
ANTI-PS
PLATFORM TECHNOLOGY:
Borrower has a number of Products in
discovery and pre-clinical research that are covered under the Borrower’s
Anti-PS platform technology. The following represents Products
that are in clinical trials or later stage pre-clinical
development: bavituximab, PGN635, and PGN632.
TNT
PLATFORM TECHNOLOGY:
Borrower has a number of Products in
discovery and pre-clinical research that are covered under the Borrower’s TNT
platform technology. The following represent Products that are in
clinical trials or later stage pre-clinical development: Cotara® and
NHS76.
PERMITS:
The
following represents a list of Required Permits:
Permit
|
Permit
Number
|
California
Drug Manufacturing License
|
63637
|
Designated
Representative License
|
EXC
14347
|
FDA
Labeler Code
|
67062
|
California
Device Manufacturing License
|
63637
|
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
EXHIBIT
A
The
Collateral consists of all of Borrower’s right, title and interest in and to the
following personal property:
All
goods, Accounts (including health-care receivables), Equipment, Inventory,
contract rights or rights to payment of money, goods, leases, license
agreements, franchise agreements, General Intangibles (including Intellectual
Property), commercial tort claims, including without limitation claims for
interference with contractual relations and other tort claims arising from Peregrine Pharmaceuticals, Inc. v.
Cancer Therapeutics Laboratories et al., filed on January 12, 2007 in the
Superior Court of the State of California for the County of Orange as Case No.
07CC00544, documents, instruments (including any promissory notes), chattel
paper (whether tangible or electronic), cash, Collateral Accounts, all
certificates of deposit, fixtures, letters of credit rights (whether or not the
letter of credit is evidenced by a writing), securities, and all other
investment property, supporting obligations, and financial assets, whether now
owned or hereafter acquired, wherever located; and
All
Borrower’s Books relating to the foregoing, and any and all claims, rights and
interests in any of the above and all substitutions for, additions, attachments,
accessories, accessions and improvements to and replacements, products, proceeds
and insurance proceeds of any or all of the foregoing.
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
EXHIBIT
B
Advance Request
Form
Deadline
for same day processing is Noon E.S.T.
Date:
______________
Re: Loan
and Security Agreement dated December 9, 2008 (“Loan Agreement”)
Borrower(s)
Name: PEREGRINE PHARMACEUTICALS, INC. and AVID BIOSERVICES,
INC.
LOAN ADVANCE
REQUEST
The
undersigned Borrower hereby requests an advance under the Loan Agreement in the
gross amount of $___________________. Borrower consents to the
application of the gross advance to the following expenses and acknowledges that
the net loan advance will be the amount shown below:
Gross
Advance:
|
$___________
|
|
|
Less:
|
|
Legal
fees, including search expenses:
|
$___________
|
Background
searches
|
$___________
|
Insurance
review
|
$___________
|
Diligence
fees
|
$___________
|
Document
preparation fee
|
$___________
|
Commitment
fee or installment thereof
|
$___________
|
Payoff
|
$___________
|
Other
|
$___________
|
|
|
Plus:
|
|
Good
faith deposit
|
$___________
|
|
|
Net
loan advance:
|
$___________
|
PLEASE FILL-OUT OUTGOING
WIRE INSTRUCTIONS (FORM ATTACHED) FOR THE FULL AMOUNT OF THE NET LOAN
ADVANCE.
All
Borrower’s representations and warranties in the Loan Agreement are true,
correct and complete in all material respects on the date of the request for an
advance; provided, however, that such materiality qualifier shall not be
applicable to any representations and warranties that already are qualified or
modified by materiality in the text thereof; and provided, further that those
representations and warranties expressly referring to a specific date shall be
true, accurate and complete in all material respects as of such
date. All conditions precedent to the credit extension herein
requested, as set forth in Section 3 of the Loan Agreement, have been
satisfied.
BORROWER:
PEREGRINE
PHARMACEUTICALS, INC.
By:________________________________________
Name:______________________________________
Title:_______________________________________
AVID
BIOSERVICES, INC.
By:_________________________________________
Name:______________________________________
Title:_______________________________________
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
EXHIBIT
B
Advance Request
Form
Deadline
for same day processing is Noon E.S.T.
OUTGOING WIRE
INSTRUCTIONS
Amount of
wire:
Beneficiary
Name:
Beneficiary
Bank:
City and
State:
Beneficiary
Bank Transit (ABA) #:
Contact:
Special
instructions:
Amount of
wire:
Beneficiary
Name:
Beneficiary
Bank:
City and
State:
Beneficiary
Bank Transit (ABA) #:
Contact:
Special
instructions:
Amount of
wire:
Beneficiary
Name:
Beneficiary
Bank:
City and
State:
Beneficiary
Bank Transit (ABA) #:
Contact:
Special
instructions:
Amount of
wire:
Beneficiary
Name:
Beneficiary
Bank:
City and
State:
Beneficiary
Bank Transit (ABA) #:
Contact:
Special
instructions:
Amount of
wire:
Beneficiary
Name:
Beneficiary
Bank:
City and
State:
Beneficiary
Bank Transit (ABA) #:
Contact:
Special
instructions:
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
EXHIBIT
C
COMPLIANCE
CERTIFICATE
TO:
|
BLUECREST
CAPITAL FINANCE, L.P., as Agent
|
Date: ________________________
|
FROM:
|
PEREGRINE
PHARMACEUTICALS, INC. and AVID BIOSERVICES, INC.
|
|
The
undersigned authorized officer on behalf of Peregrine Pharmaceuticals, Inc. and
Avid Bioservices, Inc. (individually and collectively, “Borrower”)
certifies that under the terms and conditions of the Loan and Security Agreement
among Borrower, Agent and the Lenders (the “Agreement”), (1) Borrower is in
complete compliance for the period ending _______________ with all required
covenants except as noted below, (2) there are no Events of Default,
(3) all representations and warranties in the Agreement are true and
correct in all material respects on this date except as noted below; provided,
however, that such materiality qualifier shall not be applicable to any
representations and warranties that already are qualified or modified by
materiality in the text thereof; and provided, further that those
representations and warranties expressly referring to a specific date shall be
true, accurate and complete in all material respects as of such date, (4)
Borrower, and each of its Subsidiaries, has timely filed all required tax
returns and reports, and Borrower has timely paid all foreign, federal, state
and local taxes, assessments, deposits and contributions owed by Borrower except
as otherwise permitted pursuant to the terms of Section 5.8 of the Agreement,
and (5) no Liens have been levied or claims made against Borrower or any of its
Subsidiaries relating to unpaid employee payroll or benefits of which Borrower
has not previously provided written notification to Agent. Attached
are the required documents supporting the certification. The
undersigned certifies that these are prepared in accordance with GAAP
consistently applied from one period to the next except as explained in an
accompanying letter or footnotes. The undersigned acknowledges that
no borrowings may be requested at any time or date of determination that
Borrower is not in compliance with any of the terms of the Agreement, and that
compliance is determined not just at the date this certificate is
delivered. Capitalized terms used but not otherwise defined herein
shall have the meanings given them in the Agreement.
Please
indicate compliance status by circling Yes/No under “Complies”
column.
|
Reporting
Covenant
|
Required
|
Complies
|
|
|
|
10-Q,
10-K and 8-K
|
Within
5 days after filing with SEC
|
Yes No
|
Compliance
Certificate
|
With
10-Q and 10-K
|
Yes No
|
Board
Approved Projections
|
FYE
within 60 days
|
Yes No
|
|
The
following Intellectual Property was registered after the Effective Date
(if not registrations, state
“None”)
|
The following are the exceptions with
respect to the certification above: (If no exceptions exist, state
“No exceptions to note.”)
PEREGRINE
PHARMACEUTICALS, INC. and AVID BIOSERVICES, INC.
By:
Name:
Title:
|
AGENT
USE ONLY
Received
by: _____________________
authorized
signer
Date: _________________________
Verified:
________________________
authorized
signer
Date: _________________________
Compliance
Status: Yes No
|
Portions identified
with an asterisk (*) have been omitted pursuant to a request of confidentiality
filed separately with the Commission.
1
peregrine_10q-ex10112.htm
Exhibit 10.112
SECURED
TERM PROMISSORY NOTE
$1,500,000 |
December 19,
2008
|
FOR VALUE
RECEIVED, PEREGRINE
PHARMACEUTICALS, INC., a Delaware corporation (“Peregrine”), and AVID BIOSERVICES, INC., a
Delaware corporation (“Avid,” and together with
Peregrine, jointly and severally, individually and collectively, referred to as
“Borrower”) hereby
jointly and severally promise to pay to the order of BLUECREST CAPITAL FINANCE,
L.P., a Delaware limited partnership, or the registered holder of this
Note (“Lender”), at such place of payment as the registered holder of this
Secured Term Promissory Note (this “Promissory Note”) may specify from time to
time in writing, in lawful money of the United States of America, the principal
amount of One Million Five Hundred Thousand Dollars ($1,500,000) or such other
principal amount as Lender has advanced to Borrower, together with interest in
accordance with the Loan Agreement (as hereinafter defined) (or if and when
applicable, at a rate equal to the “Default Rate” (as defined in the Loan
Agreement referenced below) based upon a year consisting of 360 days, with
interest computed daily based on the actual number of days in each month until
the principal balance is paid in full.
This
Promissory Note is executed and delivered in connection with that certain Loan
and Security Agreement of even date herewith by and among Borrower, MidCap
Funding I, LLC, as agent for Lenders, MidCap Funding I, LLC, as a Lender, and
BlueCrest Capital Finance, L.P., as a Lender (as the same may from time to time
be amended, modified, restated or supplemented in accordance with its terms, the
“Loan Agreement”), and is entitled to the benefit and security of the Loan
Agreement and the other Loan Documents (as defined in the Loan Agreement), to
which reference is made for a statement of all of the terms and conditions
thereof. All payments shall be made in accordance with the Loan
Agreement. All terms defined in the Loan Agreement shall have the
same definitions when used herein, unless otherwise defined
herein. An Event of Default under the Loan Agreement shall constitute
a default under this Promissory Note, and upon any such Event of Default and
default, all principal and interest and other obligations owing under this
Promissory Note may be accelerated and declared immediately due and payable as
provided for in the Loan Agreement. Reference to the Loan Agreement
shall not affect or impair the absolute and unconditional obligation of Borrower
to pay all principal and interest and premium, if any, under this Promissory
Note upon demand or as otherwise provided herein.
Borrower
waives presentment and demand for payment, notice of dishonor, protest and
notice of protest under the Uniform Commercial Code as in effect in the State of
Maryland or any applicable law. Borrower agrees to make all payments
under this Promissory Note without setoff, recoupment or deduction and
regardless of any counterclaim or defense. This Promissory Note has
been negotiated and delivered to Lender and is payable in the State of
Maryland. This Promissory Note shall be governed by and construed and
enforced in accordance with, the laws of the State of Maryland, excluding any
conflicts of law rules or principles that would cause the application of the
laws of any other jurisdiction. Without limiting the generality of
the preceding paragraph, the provisions of Section 11 of the Loan Agreement
regarding jurisdiction, venue and jury trial waiver are incorporated
herein.
[SIGNATURES
APPEAR ON THE FOLLOWING PAGE]
IN
WITNESS WHEREOF, Borrower, as of the day and year first above written, has
caused this Note to be executed under seal.
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
|
By: /s/ Steven
King |
(SEAL) |
|
Name:
Steven King
Title:
President and CEO
|
|
|
|
|
|
AVID BIOSERVICES,
INC. |
|
|
|
|
|
By: /s/ Steven
King |
(SEAL) |
|
Name:
Steven King
Title:
President and CEO
|
|
peregrine_10q-ex10113.htm
Exhibit 10.113
SECURED
TERM PROMISSORY NOTE
$3,500,000 |
December 19,
2008
|
FOR VALUE
RECEIVED, PEREGRINE
PHARMACEUTICALS, INC., a Delaware corporation (“Peregrine”), and AVID BIOSERVICES, INC., a
Delaware corporation (“Avid,” and together with
Peregrine, jointly and severally, individually and collectively, referred to as
“Borrower”) hereby
jointly and severally promise to pay to the order of MIDCAP FUNDING I, LLC, a
Delaware limited liability company, or the registered holder of this Note
(“Lender”), at such place of payment as the registered holder of this Secured
Term Promissory Note (this “Promissory Note”) may specify from time to time in
writing, in lawful money of the United States of America, the principal amount
of Three Million Five Hundred Thousand Dollars ($3,500,000) or such other
principal amount as Lender has advanced to Borrower, together with interest in
accordance with the Loan Agreement (as hereinafter defined) (or if and when
applicable, at a rate equal to the “Default Rate” (as defined in the Loan
Agreement referenced below) based upon a year consisting of 360 days, with
interest computed daily based on the actual number of days in each month until
the principal balance is paid in full.
This
Promissory Note is executed and delivered in connection with that certain Loan
and Security Agreement of even date herewith by and among Borrower, MidCap
Funding I, LLC, as agent for Lenders, MidCap Funding I, LLC, as a Lender, and
BlueCrest Capital Finance, L.P., as a Lender (as the same may from time to time
be amended, modified, restated or supplemented in accordance with its terms, the
“Loan Agreement”), and is entitled to the benefit and security of the Loan
Agreement and the other Loan Documents (as defined in the Loan Agreement), to
which reference is made for a statement of all of the terms and conditions
thereof. All payments shall be made in accordance with the Loan
Agreement. All terms defined in the Loan Agreement shall have the
same definitions when used herein, unless otherwise defined
herein. An Event of Default under the Loan Agreement shall constitute
a default under this Promissory Note, and upon any such Event of Default and
default, all principal and interest and other obligations owing under this
Promissory Note may be accelerated and declared immediately due and payable as
provided for in the Loan Agreement. Reference to the Loan Agreement
shall not affect or impair the absolute and unconditional obligation of Borrower
to pay all principal and interest and premium, if any, under this Promissory
Note upon demand or as otherwise provided herein.
Borrower
waives presentment and demand for payment, notice of dishonor, protest and
notice of protest under the Uniform Commercial Code as in effect in the State of
Maryland or any applicable law. Borrower agrees to make all payments
under this Promissory Note without setoff, recoupment or deduction and
regardless of any counterclaim or defense. This Promissory Note has
been negotiated and delivered to Lender and is payable in the State of
Maryland. This Promissory Note shall be governed by and construed and
enforced in accordance with, the laws of the State of Maryland, excluding any
conflicts of law rules or principles that would cause the application of the
laws of any other jurisdiction. Without limiting the generality of
the preceding paragraph, the provisions of Section 11 of the Loan Agreement
regarding jurisdiction, venue and jury trial waiver are incorporated
herein.
[SIGNATURES
APPEAR ON THE FOLLOWING PAGE]
IN
WITNESS WHEREOF, Borrower, as of the day and year first above written, has
caused this Note to be executed under seal.
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
|
By: /s/ Steven
King |
(SEAL) |
|
Name:
Steven King
Title:
President and CEO
|
|
|
|
|
|
AVID BIOSERVICES,
INC. |
|
|
|
|
|
By: /s/ Steven
King |
(SEAL) |
|
Name:
Steven King
Title:
President and CEO
|
|
peregrine_10q-ex10114.htm
Exhibit 10.114
INTELLECTUAL
PROPERTY SECURITY AGREEMENT
This Intellectual Property Security
Agreement is entered into as of December 19, 2008 by and between MIDCAP FUNDING
I, LLC ("Agent") and AVID BIOSERVICES, INC. ("Grantor").
RECITALS
A. The
Lenders have agreed to make certain advances of money and to extend certain
financial accommodation to Grantor (the "Loans") in the amounts and manner set
forth in that certain Loan and Security Agreement by and between Agent, the
Lenders, Peregrine Pharmaceuticals, Inc. and Grantor dated the Effective Date
(as the same may be amended, modified or supplemented from time to time, the
"Loan Agreement"; capitalized terms used herein are used as defined in the Loan
Agreement). The Lenders are willing to make the Loans to Grantor, but
only upon the condition, among others, that Grantor shall grant to Agent, for
the ratable benefit of the Lenders, a security interest in certain Copyrights,
Trademarks, Patents, and Mask Works (as each term is described below) to secure
the obligations of Grantor under the Loan Agreement.
B. Pursuant
to the terms of the Loan Agreement, Grantor has granted to Agent, for the
ratable benefit of the Lenders, a security interest in all of Grantor's right,
title and interest, whether presently existing or hereafter acquired, in, to and
under all of the Collateral.
NOW, THEREFORE, for good and valuable
consideration, receipt of which is hereby acknowledged, and intending to be
legally bound, as collateral security for the prompt and complete payment when
due of its obligations under the Loan Agreement, Grantor hereby represents,
warrants, covenants and agrees as follows:
AGREEMENT
To secure its obligations under the
Loan Agreement, Grantor grants and pledges to Agent, for the ratable benefit of
the Lenders, a security interest in all of Grantor's right, title and interest
in, to and under its intellectual property (all of which shall collectively be
called the "Intellectual Property Collateral"), including, without limitation,
the following:
(a) Any
and all copyright rights, copyright applications, copyright registrations and
like protections in each work or authorship and derivative work thereof, whether
published or unpublished and whether or not the same also constitutes a trade
secret, now or hereafter existing, created, acquired or held, including without
limitation those set forth on Exhibit A attached
hereto (collectively, the "Copyrights");
(b) Any
and all trade secrets, and any and all intellectual property rights in computer
software and computer software products now or hereafter existing, created,
acquired or held;
(c) Any
and all design rights that may be available to Grantor now or hereafter
existing, created, acquired or held;
(d) All
patents, patent applications and like protections including, without limitation,
improvements, divisions, continuations, renewals, reissues, extensions and
continuations-in-part of the same, including without limitation the patents and
patent applications set forth on Exhibit B attached
hereto (collectively, the "Patents");
(e) Any
trademark and servicemark rights, whether registered or not, applications to
register and registrations of the same and like protections, and the entire
goodwill of the business of Grantor connected with and symbolized by such
trademarks, including without limitation those set forth on Exhibit C attached
hereto (collectively, the "Trademarks");
(f) All
mask works or similar rights available for the protection of semiconductor
chips, now owned or hereafter acquired, including, without limitation those set
forth on Exhibit
D attached hereto (collectively, the “Mask
Works”);
(g) Any
and all claims for damages by way of past, present and future infringements of
any of the rights included above, with the right, but not the obligation, to sue
for and collect such damages for said use or infringement of the intellectual
property rights identified above;
(h) All
licenses or other rights to use any of the Copyrights, Patents, Trademarks, or
Mask Works and all license fees and royalties arising from such use to the
extent permitted by such license or rights;
(i) All
amendments, extensions, renewals and extensions of any of the Copyrights,
Trademarks, Patents, or Mask Works; and
(j) All
proceeds and products of the foregoing, including without limitation all
payments under insurance or any indemnity or warranty payable in respect of any
of the foregoing.
This security interest is granted in
conjunction with the security interest granted to Agent, for the ratable benefit
of the Lenders, under the Loan Agreement. The rights and remedies of
Agent with respect to the security interest granted hereby are in addition to
those set forth in the Loan Agreement and the other Loan Documents, and those
which are now or hereafter available to Agent as a matter of law or
equity. Each right, power and remedy of Agent provided for herein or
in the Loan Agreement or any of the Loan Documents, or now or hereafter existing
at law or in equity shall be cumulative and concurrent and shall be in addition
to every right, power or remedy provided for herein and the exercise by Agent of
any one or more of the rights, powers or remedies provided for in this
Intellectual Property Security Agreement, the Loan Agreement or any of the other
Loan Documents, or now or hereafter existing at law or in equity, shall not
preclude the simultaneous or later exercise by any person, including Agent, of
any or all other rights, powers or remedies.
[Signature
page follows.]
IN WITNESS WHEREOF, the parties have
caused this Intellectual Property Security Agreement to be duly executed by its
officers thereunto duly authorized as of the first date written
above.
|
|
GRANTOR:
|
Address of
Grantor: |
|
AVID BIOSERVICES,
INC. |
|
|
|
|
|
By:
/s/ Steven
King
|
Attn: |
|
Title:
President
|
|
|
|
|
|
AGENT:
|
Address
of Agent: |
|
MIDCAP
FUNDING I, LLC |
|
|
|
7735 Old Georgetown
Road, Suite 400 |
|
By: /s/ Joshua Groman |
Bethesda,
Maryland 20814
Attn:
Portfolio Management- Life Sciences
|
|
Title:
Managing
Director
|
EXHIBIT
A
Copyrights
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
None
|
|
|
EXHIBIT
B
Patents
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
None
|
|
|
EXHIBIT
C
Trademarks
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
None
|
|
|
EXHIBIT
D
Mask
Works
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
None
|
|
|
peregrine_10q-ex10115.htm
Exhibit 10.115
INTELLECTUAL
PROPERTY SECURITY AGREEMENT
This Intellectual Property Security
Agreement is entered into as of December 19, 2008 by and between MIDCAP FUNDING
I, LLC ("Agent") and PEREGRINE PHARMACEUTICALS, INC.
("Grantor").
RECITALS
A. The
Lenders have agreed to make certain advances of money and to extend certain
financial accommodation to Grantor (the "Loans") in the amounts and manner set
forth in that certain Loan and Security Agreement by and between Agent, the
Lenders, Avid BioServices, Inc. and Grantor dated the Effective Date (as the
same may be amended, modified or supplemented from time to time, the "Loan
Agreement"; capitalized terms used herein are used as defined in the Loan
Agreement). The Lenders are willing to make the Loans to Grantor, but
only upon the condition, among others, that Grantor shall grant to Agent, for
the ratable benefit of the Lenders, a security interest in certain Copyrights,
Trademarks, Patents, and Mask Works (as each term is described below) to secure
the obligations of Grantor under the Loan Agreement.
B. Pursuant
to the terms of the Loan Agreement, Grantor has granted to Agent, for the
ratable benefit of the Lenders, a security interest in all of Grantor's right,
title and interest, whether presently existing or hereafter acquired, in, to and
under all of the Collateral.
NOW, THEREFORE, for good and valuable
consideration, receipt of which is hereby acknowledged, and intending to be
legally bound, as collateral security for the prompt and complete payment when
due of its obligations under the Loan Agreement, Grantor hereby represents,
warrants, covenants and agrees as follows:
AGREEMENT
To secure its obligations under the
Loan Agreement, Grantor grants and pledges to Agent, for the ratable benefit of
the Lenders, a security interest in all of Grantor's right, title and interest
in, to and under its intellectual property (all of which shall collectively be
called the "Intellectual Property Collateral"), including, without limitation,
the following:
(a) Any
and all copyright rights, copyright applications, copyright registrations and
like protections in each work or authorship and derivative work thereof, whether
published or unpublished and whether or not the same also constitutes a trade
secret, now or hereafter existing, created, acquired or held, including without
limitation those set forth on Exhibit A attached
hereto (collectively, the "Copyrights");
(b) Any
and all trade secrets, and any and all intellectual property rights in computer
software and computer software products now or hereafter existing, created,
acquired or held;
(c) Any
and all design rights that may be available to Grantor now or hereafter
existing, created, acquired or held;
(d) All
patents, patent applications and like protections including, without limitation,
improvements, divisions, continuations, renewals, reissues, extensions and
continuations-in-part of the same, including without limitation the patents and
patent applications set forth on Exhibit B attached
hereto (collectively, the "Patents");
(e) Any
trademark and servicemark rights, whether registered or not, applications to
register and registrations of the same and like protections, and the entire
goodwill of the business of Grantor connected with and symbolized by such
trademarks, including without limitation those set forth on Exhibit C attached
hereto (collectively, the "Trademarks");
(f) All
mask works or similar rights available for the protection of semiconductor
chips, now owned or hereafter acquired, including, without limitation those set
forth on Exhibit
D attached hereto (collectively, the “Mask
Works”);
(g) Any
and all claims for damages by way of past, present and future infringements of
any of the rights included above, with the right, but not the obligation, to sue
for and collect such damages for said use or infringement of the intellectual
property rights identified above;
(h) All
licenses or other rights to use any of the Copyrights, Patents, Trademarks, or
Mask Works and all license fees and royalties arising from such use to the
extent permitted by such license or rights;
(i) All
amendments, extensions, renewals and extensions of any of the Copyrights,
Trademarks, Patents, or Mask Works; and
(j) All
proceeds and products of the foregoing, including without limitation all
payments under insurance or any indemnity or warranty payable in respect of any
of the foregoing.
This security interest is granted in
conjunction with the security interest granted to Agent, for the ratable benefit
of the Lenders, under the Loan Agreement. The rights and remedies of
Agent with respect to the security interest granted hereby are in addition to
those set forth in the Loan Agreement and the other Loan Documents, and those
which are now or hereafter available to Agent as a matter of law or
equity. Each right, power and remedy of Agent provided for herein or
in the Loan Agreement or any of the Loan Documents, or now or hereafter existing
at law or in equity shall be cumulative and concurrent and shall be in addition
to every right, power or remedy provided for herein and the exercise by Agent of
any one or more of the rights, powers or remedies provided for in this
Intellectual Property Security Agreement, the Loan Agreement or any of the other
Loan Documents, or now or hereafter existing at law or in equity, shall not
preclude the simultaneous or later exercise by any person, including Agent, of
any or all other rights, powers or remedies.
[Signature
page follows.]
IN WITNESS WHEREOF, the parties have
caused this Intellectual Property Security Agreement to be duly executed by its
officers thereunto duly authorized as of the first date written
above.
|
|
GRANTOR:
|
Address of
Grantor: |
|
PEREGRINE
PHARMACEUTICALS, INC. |
|
|
|
14282 Franklin
Avenue |
|
By: /s/ Steven King |
Tustin,
California 92780
Attn:
Paul Lytle
|
|
Title:
President and
CEO
|
|
|
|
|
|
AGENT:
|
Address
of Agent: |
|
MIDCAP
FUNDING I, LLC |
|
|
|
7735 Old Georgetown
Road, Suite 400 |
|
By: /s/ Joshua Groman |
Bethesda,
Maryland 20814
Attn:
Portfolio Management- Life Sciences
|
|
Title:
Managing
Director
|
EXHIBIT
A
Copyrights
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
|
|
|
NONE
|
N/A
|
N/A
|
EXHIBIT
B
Patents
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
6,827,925
|
12/07/2004
|
|
|
|
COMPOSITION
AND METHOD FOR TREATING CANCER AND IMMUNOLOGICAL DISORDERS RESULTING IN
CHRONIC CONDITIONS
|
6,255,291
|
07/03/2001
|
|
|
|
DETECTION
OF NECROTIC MALIGNANT TISSUE AND ASSOCIATED THERAPY
|
6,071,491
|
06/06/2000
|
|
|
|
DETECTION
OF NECROTIC MALIGNANT TISSUE AND ASSOCIATED THERAPY
|
6,017,514
|
01/25/2000
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
5,990,286
|
11/23/1999
|
|
|
|
DETECTION
OF NECROTIC MALIGNANT TISSUE AND ASSOCIATED THERAPY
|
5,882,626
|
03/16/1999
|
|
|
|
METHOD
OF DIAGNOSING BY DETERMINING FORMIC ACID TO NICOTINIC ACID
RATIO
|
5,879,880
|
04/25/1997
|
|
|
|
MODIFIED
ANTIBODIES
|
5,194,594
|
03/16/1993
|
|
|
|
DETECTION
OF NECROTIC MALIGNANT TISSUE AND ASSOCIATED THERAPY
|
5,019,368
|
05/28/1991
|
|
|
|
CONSTRUCTS
BINDING TO PHOSPHATIDYLSERINE AND THEIR USE IN DISEASE
TREATMENT
|
11/339,392
|
01/24/2006
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
10/890,945
|
07/13/2004
|
|
|
|
METHODS
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
10/877,959
|
06/25/2004
|
|
|
|
COMBINED
COMPOSITIONS FOR TUMOR VASCULATURE COAGULATION AND TREATMENT
(Abandoned)
|
10/259,244
|
09/27/2002
|
COMBINED
METHODS FOR TUMOR VASCULATURE COAGULATION AND TREATMENT
(Abandoned)
|
10/259,236
|
09/27/2002
|
|
|
|
COMBINED
METHODS FOR TUMOR VASCULATURE COAGULIGAND TREATMENT
(Abandoned)
|
10/259,227
|
09/27/2002
|
|
|
|
COMBINED
COMPOSITIONS FOR TUMOR VASCULATURE COAGULIGAND TREATMENT
(Abandoned)
|
10/259,223
|
09/27/2002
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
PCT/US06/002964
|
01/24/2006
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
AU
2006206187
|
08/01/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
CA
2,591,914
|
06/20/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
CN
200680007064.8
|
09/04/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
EP
06719706.1
|
08/22/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
IL
184406
|
07/04/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
IN
5739/DELNP/2007
|
07/24/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
JP
2007-552418
|
07/23/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
NZ
556065
|
06/22/2007
|
|
|
|
Fc
FUSION CONSTRUCTS BINDING TO PHOSPHATIDYLSERINE AND THEIR THERAPEUTIC
USE
|
SG
200704601-4
|
06/20/2007
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
PCT/US04/020492
|
06/25/2004
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
AU
2004253924
|
11/25/2005
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
BE
1 638 989
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
CA
2,527,054
|
11/24/2005
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
CH
1 638 989
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
CN
200480017742.X
|
12/23/2005
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
DE
60 2004 015 454
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
DN
1 638 989
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
EP
2004785799
|
01/09/2006
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
EP
08010871.5
|
06/13/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
FI
1 638 989
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
FR
1 638 989
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
GB
1 638 989
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
HK
06109573.0
|
08/28/2006
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
IE
1 638 989
|
07/30/2008
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
IN
419/DELNP/2006
|
01/23/2006
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
NL
1 638 989
|
07/30/2008
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
NZ
543495
|
11/10/2005
|
|
|
|
METHOD
AND APPARATUS FOR CONTINUOUS LARGE-SCALE RADIOLABELING OF
PROTEINS
|
SE
1 638 989
|
07/30/2008
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
PCT/EP02/010913
|
09/27/2002
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
AU
2002362487
|
03/03/2004
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
CA
2461905
|
03/26/2004
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
EP
02800138.6
|
04/23/2004
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
HK
02800138.6
|
10/05/2004
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
NZ
532539
|
04/26/2004
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
MC
0 627 940
|
05/07/2003
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
NL
0 627 940
|
05/07/2003
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
PT
0 627 940
|
05/07/2003
|
|
|
|
COMBINED
COMPOSITIONS AND METHODS FOR TUMOR VASCULATURE COAGULATION AND
TREATMENT
|
SE
0 627 940
|
05/07/2003
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
AU
766564
|
07/02/1999
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
CA
2,336,114
|
07/02/1999
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
EP
1 092 028
|
07/02/1999
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
DN
1 092 028
|
07/02/1999
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
FR
1 092 028
|
07/02/1999
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
GB
1 092 028
|
07/02/1999
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
NL
1 092 028
|
07/02/1999
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
JP
2000-558212
|
07/02/1999
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF
|
EP
0510644.2
|
05/17/2005
|
|
|
|
SPECIFIC
BINDING PROTEINS INCLUDING ANTIBODIES WHICH BIND TO THE NECROTIC CENTRE OF
TUMOURS, AND USES THEREOF (HONG KONG)
|
HK
06108478.8
|
7/2/1999
|
|
|
|
MODIFIED
ANTIBODIES
|
EP
0 550 663
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
DN
0 550 663
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
FR
0 550 663
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
GB
0 550 663
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
IT
0 550 663
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
CH
0 550 663
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
CA
2,090,700
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
JP
3549525
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
JP
2004-13610
|
08/28/1991
|
|
|
|
MODIFIED
ANTIBODIES
|
AU
649079
|
08/28/1991
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
EP
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
AU
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
CH
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
DN
0 873 139
|
01/06/1997
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
ES
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
FR
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
GB
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
IT
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
RU
0 873 139
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
AU
730388
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
CA
2242750
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
JP
525384/1997
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
KR
485240
|
01/06/1997
|
|
|
|
ANTIBODIES
WITH REDUCED NET POSITIVE CHARGE
|
MX
985565
|
01/06/1997
|
EXHIBIT
C
Trademarks
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
AVID
BIOSERVICES, INC. (Registered)
|
3,362,424
|
01/01/2008
|
AVID
BIOSERVICES (Registered)
|
3,348,388
|
12/04/2007
|
COTARA
(Registered)
|
2,817,648
|
02/24/2004
|
EXHIBIT
D
Mask
Works
Description
|
Registration/
Application
Number
|
Registration/
Application
Date
|
|
|
|
peregrine_10q-ex10116.htm
Exhibit 10.116
THIS
WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR THE SECURITIES LAWS OF ANY
STATE AND, EXCEPT AND PURSUANT TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE
OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL
REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR SUCH OFFER,
SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM
REGISTRATION.
WARRANT
TO PURCHASE STOCK
Company: |
PEREGRINE
PHARMACEUTICALS, INC., a Delaware
corporation |
|
|
Number
of Shares: |
507,614,
plus all Additional Shares which Holder is entitled to purchase pursuant
to Section 1.7 |
|
|
Class of
Stock: |
Common |
|
|
Warrant
Price: |
$0.2955 |
|
|
Issue
Date: |
December
19, 2008 |
|
|
Expiration
Date: |
The 5th
anniversary after the Issue Date or the earlier expiration of this
Warrant pursuant to Section 1.6.2(A)(ii) |
|
|
Credit
Facility: |
This
Warrant is issued in connection with the Credit Extensions referenced in
the Loan and Security Agreement among Company, Avid BioServices, Inc.,
BlueCrest Capital Finance, L.P., as Administrative Agent and as a lender,
and the other lenders named therein, dated of even date herewith (the
“Loan
Agreement”) |
THIS WARRANT CERTIFIES THAT, for good
and valuable consideration, BlueCrest Capital Finance, L.P. (“BlueCrest”, together
with any registered holder from time to time of this Warrant or any holder of
the shares issuable or issued upon exercise of this Warrant, “Holder”) is entitled
to purchase the number of fully paid and nonassessable shares of the class of
securities (the “Shares”) of the
Company at the Warrant Price, all as set forth above and as adjusted pursuant to
Article 2 of this Warrant, subject to the provisions and upon the terms and
conditions set forth in this Warrant.
ARTICLE
1. EXERCISE.
1.1 Method of
Exercise. Holder may exercise this Warrant by delivering a
duly executed Notice of Exercise in substantially the form attached as Appendix
1 to the principal office of the Company. Unless Holder is exercising
the conversion right set forth in Article 1.2, Holder shall also deliver to the
Company a check, wire transfer (to an account designated by the Company), or
other form of payment acceptable to the Company for the aggregate Warrant Price
for the Shares being purchased.
1.2 Conversion
Right. In lieu of exercising this Warrant as specified in
Article 1.1, Holder may from time to time convert this Warrant, in whole or in
part, into a number of Shares determined by dividing (a) the aggregate fair
market value of the Shares or other securities otherwise issuable upon exercise
of this Warrant being exercised minus the aggregate Warrant Price of such Shares
by (b) the fair market value of one Share. The fair market value of
the Shares shall be determined pursuant to Article 1.3.
1.3 Fair Market
Value.
1.3.1 If
the Company’s common stock is traded in a public market, the fair market value
of each Share shall be the closing price of a Share reported for the business
day immediately before Holder delivers its Notice of Exercise to the Company (or
in the instance where the Warrant is exercised immediately prior to the
effectiveness of the Company’s initial public offering, the “price to public”
per share price specified in the final prospectus relating to such
offering). If the Company’s common stock is not traded in a public
market, the Board of Directors of the Company shall determine fair market value
in its reasonable good faith judgment (the “Company
Determination”).
1.3.2 If
the Holder disagrees with the Company Determination and by notice to the Company
given within twenty (20) days after receipt of notice of the Company
Determination (an "Appraisal Notice")
elects to dispute the Company Determination, such dispute shall be resolved as
set forth in Section 1.3.3 below.
1.3.3 For
a period of ten (10) days after the Appraisal Notice, the Company and the Holder
shall negotiate in good faith to resolve their differences as to the
determination of fair market value. In the absence of a mutually
satisfactory resolution within such ten (10)-day period, the Company shall
within ten (10) days after the last day of such ten (10)-day period engage an
investment bank or other qualified appraisal firm reasonably acceptable to the
Holder (the "Appraiser") to make
an independent determination of fair market value (the "Appraiser
Determination"). The Appraiser Determination shall be made
within sixty (60) days of the engagement of such Appraiser, shall be evidenced
in a written report addressed to the Company and the Holder, and shall be final
and binding on the Company and the Holder. The costs of the Appraiser
Determination shall be borne (i) solely by the Company if the difference between
the Appraiser Determination and the Company Determination is greater than ten
percent (10%), (ii) solely by the Holder if the difference between the Appraiser
Determination and the Company Determination is less than ten percent (10%) and
(iii) equally by the Company and the Holder if the difference between the
Appraiser Determination and the Company Determination is equal to ten percent
(10%).
1.4 Delivery of Certificate and
New Warrant. Promptly after Holder exercises or converts this
Warrant and, if applicable, the Company receives payment of the aggregate
Warrant Price, the Company shall deliver to Holder certificates for the Shares
acquired and, if this Warrant has not been fully exercised or converted and has
not expired, a new Warrant representing the Shares not so acquired.
1.5 Replacement of
Warrants. On receipt of evidence reasonably satisfactory to
the Company of the loss, theft, destruction or mutilation of this Warrant and,
in the case of loss, theft or destruction, on delivery of an indemnity agreement
reasonably satisfactory in form and amount to the Company or, in the case of
mutilation on surrender and cancellation of this Warrant, the Company shall
execute and deliver, in lieu of this Warrant, a new warrant of like
tenor.
1.6 Treatment of Warrant Upon
Acquisition of Company.
1.6.1 "Acquisition". For
the purpose of this Warrant, "Acquisition" means any sale, license, or other
disposition of all or substantially all of the assets of the Company, or any
reorganization, consolidation, or merger of the Company where the holders of the
Company's securities before the transaction beneficially own less than fifty
percent (50%) of the outstanding voting securities of the surviving entity after
the transaction.
1.6.2
Treatment of Warrant at
Acquisition.
(A) Upon
the written request of the Company, Holder agrees that, in the event of an
Acquisition that is not an asset sale and in which the sole consideration is
cash, either (i) Holder shall exercise its conversion or purchase right under
this Warrant and such exercise will be deemed effective immediately prior to the
consummation of such Acquisition or (ii) if Holder elects not to exercise the
Warrant, this Warrant will expire upon the consummation of such Acquisition
(subject to the automatic conversion provisions of Section 5.8
below). The Company shall provide Holder with written notice of its
request relating to the foregoing (together with such reasonable information as
Holder may request in connection with such contemplated Acquisition giving rise
to such notice), which is to be delivered to Holder not less than ten (10) days
prior to the closing of the proposed Acquisition.
(B) Upon
the written request of the Company, Holder agrees that, in the event of an
Acquisition that is an “arms length” sale of all or substantially all of the
Company’s assets (and only its assets) to a third party that is not an Affiliate
(as defined below) of the Company (a “True Asset Sale”), either (i) Holder shall
exercise its conversion or purchase right under this Warrant and such exercise
will be deemed effective immediately prior to the consummation of such
Acquisition or (ii) if Holder elects not to exercise the Warrant, this Warrant
will continue until the Expiration Date if the Company continues as a going
concern following the closing of any such True Asset Sale. The
Company shall provide Holder with written notice of its request relating to the
foregoing (together with such reasonable information as Holder may request in
connection with such contemplated Acquisition giving rise to such notice), which
is to be delivered to Holder not less than ten (10) days prior to the closing of
the proposed Acquisition.
(C) Upon
the closing of any Acquisition other than those particularly described in
subsections (A) and (B) above, the successor entity shall assume the obligations
of this Warrant, and this Warrant shall be exercisable for the same securities,
cash, and property as would be payable for the Shares issuable upon exercise of
the unexercised portion of this Warrant as if such Shares were outstanding on
the record date for the Acquisition and subsequent closing. The
Warrant Price and/or number of Shares shall be adjusted
accordingly.
As used
herein “Affiliate” shall mean
any person or entity that owns or controls directly or indirectly ten percent
(10%) or more of the stock of Company, any person or entity that controls or is
controlled by or is under common control with such persons or entities, and each
of such person’s or entity’s officers, directors, joint venturers or partners,
as applicable.
1.7 Additional
Shares. Upon the funding of Tranche Two (as defined in the
Loan Agreement), the Company shall be deemed to have automatically granted to
Holder, in addition to the number of Shares which this Warrant can otherwise be
exercised for by Holder, the right to purchase that number of additional Shares,
rounded upward to the nearest whole number, equal to 150,000 divided by the
Warrant Price (such additional shares being called the “Additional
Shares”).
ARTICLE
2. ADJUSTMENTS TO THE
SHARES.
2.1 Stock Dividends, Splits,
Etc. If, at any time following the Issue Date, the Company
declares or pays a dividend on the Shares payable in common stock, or other
securities, then upon exercise of this Warrant, for each Share acquired, Holder
shall receive, without cost to Holder, the total number and kind of securities
to which Holder would have been entitled had Holder owned the Shares of record
as of the date the dividend occurred. If the Company subdivides the
Shares by reclassification or otherwise into a greater number of shares, the
number of shares purchasable hereunder shall be proportionately increased and
the Warrant Price shall be proportionately decreased. If the
outstanding shares are combined or consolidated, by reclassification or
otherwise, into a lesser number of shares, the Warrant Price shall be
proportionately increased and the number of Shares shall be proportionately
decreased.
2.2 Reclassification, Exchange,
Combinations or Substitution. Upon any reclassification,
exchange, substitution, or other event that results in a change of the number
and/or class of the securities issuable upon exercise or conversion of this
Warrant, Holder shall be entitled to receive, upon exercise or conversion of
this Warrant, the number and kind of securities and property that Holder would
have received for the Shares if this Warrant had been exercised immediately
before such reclassification, exchange, substitution, or other
event. The Company or its successor shall promptly issue to Holder an
amendment to this Warrant setting forth the number and kind of such new
securities or other property issuable upon exercise or conversion of this
Warrant as a result of such reclassification, exchange, substitution or other
event that results in a change of the number and/or class of securities issuable
upon exercise or conversion of this Warrant. The amendment to this
Warrant shall provide for adjustments which shall be as nearly equivalent as may
be practicable to the adjustments provided for in this Article 2 including,
without limitation, adjustments to the Warrant Price and to the number of
securities or property issuable upon exercise of the new Warrant. The
provisions of this Article 2.2 shall similarly apply to successive
reclassifications, exchanges, substitutions, or other events.
2.3 No
Impairment. The Company shall not, by amendment of its
Articles or Certificate (as applicable) of Incorporation or through a
reorganization, transfer of assets, consolidation, merger, dissolution, issue,
or sale of securities or any other voluntary action, avoid or seek to avoid the
observance or performance of any of the terms to be observed or performed under
this Warrant by the Company, but shall at all times in good faith assist in
carrying out of all the provisions of this Article 2 and in taking all such
action as may be necessary or appropriate to protect Holder's rights under this
Article against impairment.
2.4 Fractional
Shares. No fractional Shares shall be issuable upon exercise
or conversion of this Warrant and the number of Shares to be issued shall be
rounded down to the nearest whole Share. If a fractional share
interest arises upon any exercise or conversion of the Warrant, the Company
shall eliminate such fractional share interest by paying Holder the amount
computed by multiplying the fractional interest by the fair market value of a
full Share.
2.5 Certificate as to
Adjustments. Upon each adjustment of the Warrant Price, the
Company shall promptly notify Holder in writing, and, at the Company’s expense,
promptly compute such adjustment, and furnish Holder with a certificate of its
Chief Financial Officer setting forth such adjustment and the facts upon which
such adjustment is based. The Company shall, upon written request,
furnish Holder a certificate setting forth the Warrant Price in effect upon the
date thereof and the series of adjustments leading to such Warrant
Price.
ARTICLE
3. REPRESENTATIONS AND
COVENANTS OF THE COMPANY.
3.1 Representations and
Warranties. The Company represents and warrants to Holder as
follows:
(a) All
Shares which may be issued upon the exercise of the purchase right represented
by this Warrant, and all securities, if any, issuable upon conversion of the
Shares, shall, upon issuance, be duly authorized, validly issued, fully paid and
nonassessable, and free of any liens and encumbrances except for restrictions on
transfer provided for herein or under applicable federal and state securities
laws.
(b) The
Company’s capitalization table attached hereto as Schedule 1 is true
and complete as of the Issue Date.
3.2 Notice of Certain
Events. If the Company proposes at any time (a) to declare any
dividend or distribution upon any of its stock, whether in cash, property,
stock, or other securities and whether or not a regular cash dividend; (b) to
effect any reclassification or recapitalization of any of its stock; (c) to
merge or consolidate with or into any other corporation, or sell, lease,
license, or convey all or substantially all of its assets, or to liquidate,
dissolve or wind up; or (d) offer holders of registration rights the opportunity
to participate in an underwritten public offering of the Company's securities
for cash, then, in connection with each such event, the Company shall give
Holder: (1) at least ten (10) days prior written notice of the date on which a
record will be taken for such dividend, distribution, or subscription rights
(and specifying the date on which the holders of common stock will be entitled
thereto) or for determining rights to vote, if any, in respect of the matters
referred to in (a) above; (2) in the case of the matters referred to in (b) and
(c) above at least ten (10) days prior written notice of the date when the same
will take place (and specifying the date on which the holders of common stock
will be entitled to exchange their common stock for securities or other property
deliverable upon the occurrence of such event); and (3) in the case of the
matter referred to in (d) above, the same notice as is given to the holders of
such registration rights. Company will also provide information
requested by Holder reasonably necessary to enable Holder to comply with
Holder’s accounting or reporting requirements.
3.3 Piggyback Registration
Rights. If at any time the Company proposes to register for
sale its common stock (other than a registration on Form S-4 or Form S-8,
registrations relating solely to dividend investment plans, or any successor or
similar forms), the Company shall give written notice (the “Piggyback Notice”)
at least twenty (20) days prior to such proposed registration to the Holder of
the Company’s intention to do so, of the registration form that has been
selected by the Company and of the Holder’s rights under this Article
3.3. Upon the written request of the Holder made within ten (10) days
after receipt of the Piggyback Notice (which request shall specify the number of
Shares the Holder wishes to include in such registration), the Company will use
its reasonable best efforts to include, and to cause the underwriter or
underwriters, if applicable, to include, in the proposed offering, on the same
terms and conditions as the securities of the Company included in such offering,
all shares of common stock that the Holder has validly requested be included
pursuant to such notice (each such registration pursuant to this Article 3.3, a
“Piggyback Registration”) and
the Company shall keep such registration statement in effect and maintain
compliance with each federal and state law or regulation for the period
necessary for such Holder to effect the proposed sale or other disposition (but
in no event for a period greater than ninety (90) days); provided that if at any
time after giving a Piggyback Notice and prior to the effective date of the
registration statement filed in connection with such registration, the Company
shall determine for any reason not to register such securities, the Company may,
at its election, give written notice of such determination to the Holder and,
thereupon, shall be relieved of its obligation to register any of the common
stock in connection with such abandoned registration, and in case of a
determination by the Company to delay registration of its equity securities, the
Company shall be permitted to delay the registration of the common stock for the
same period as the delay in registering such other equity
securities.
3.4 No Shareholder
Rights. Except as provided in this Warrant, Holder will not
have any rights as a shareholder of the Company until the exercise of this
Warrant.
3.5 Certain
Information. The Company agrees to provide Holder at any time
and from time to time with such information as Holder may reasonably request for
purposes of Holder’s compliance with regulatory, accounting and reporting
requirements applicable to Holder.
ARTICLE
4. REPRESENTATIONS,
WARRANTIES OF HOLDER. Holder represents and warrants to the
Company as follows:
4.1 Purchase for Own
Account. This Warrant and the securities to be acquired upon
exercise of this Warrant by Holder will be acquired for investment for Holder’s
account, not as a nominee or agent, and not with a view to the public resale or
distribution within the meaning of the Act. Holder also represents
that Holder has not been formed for the specific purpose of acquiring this
Warrant or the Shares.
4.2 Disclosure of
Information. Holder has received or has had full access to all
the information it considers necessary or appropriate to make an informed
investment decision with respect to the acquisition of this Warrant and its
underlying securities. Holder further has had an opportunity to ask
questions and receive answers from the Company regarding the terms and
conditions of the offering of this Warrant and its underlying securities and to
obtain additional information (to the extent the Company possessed such
information or could acquire it without unreasonable effort or expense)
necessary to verify any information furnished to Holder or to which Holder has
access.
4.3 Investment
Experience. Holder understands that the purchase of this
Warrant and its underlying securities involves substantial
risk. Holder has experience as an investor in securities of companies
in the development stage and acknowledges that Holder can bear the economic risk
of such Holder’s investment in this Warrant and its underlying securities and
has such knowledge and experience in financial or business matters that Holder
is capable of evaluating the merits and risks of its investment in this Warrant
and its underlying securities and/or has a preexisting personal or business
relationship with the Company and certain of its officers, directors or
controlling persons of a nature and duration that enables Holder to be aware of
the character, business acumen and financial circumstances of such
persons.
4.4 Accredited Investor
Status. Holder is an “accredited investor” within the meaning
of Regulation D promulgated under the Act.
4.5 The
Act. Holder understands that this Warrant and the Shares
issuable upon exercise or conversion hereof have not been registered under the
Act in reliance upon a specific exemption therefrom, which exemption depends
upon, among other things, the bona fide nature of Holder’s investment intent as
expressed herein. Holder understands that this Warrant and the Shares
issued upon any exercise or conversion hereof must be held indefinitely unless
subsequently registered under the Act and qualified under applicable state
securities laws, or unless exemption from such registration and qualification
are otherwise available.
ARTICLE
5. MISCELLANEOUS.
5.1 Term. This
Warrant is exercisable in whole or in part at any time and from time to time on
or before the Expiration Date.
5.2 Legends. This
Warrant and the Shares (and the securities issuable, directly or indirectly,
upon conversion of the Shares, if any) shall be imprinted with a legend in
substantially the following form:
THIS
WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR THE SECURITIES LAWS OF ANY
STATE AND, EXCEPT AND PURSUANT TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE
OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL
REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR SUCH OFFER,
SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM
REGISTRATION.
5.3 Compliance with Securities
Laws on Transfer. This Warrant and the Shares issuable upon
exercise of this Warrant (and the securities issuable, directly or indirectly,
upon conversion of the Shares, if any) may not be transferred or assigned in
whole or in part without compliance with applicable federal and state securities
laws by the transferor and the transferee (including, without limitation, the
delivery of investment representation letters and legal opinions reasonably
satisfactory to the Company, as reasonably requested by the
Company). The Company shall not require Holder to provide an opinion
of counsel if the transfer is to an affiliate of
Holder. Additionally, the Company shall also not require an opinion
of counsel if there is no material question as to the availability of current
information as referenced in Rule 144(c), Holder represents that it has complied
with Rule 144(d) and, if applicable, Rule 144(e) in reasonable detail, the
selling broker represents that it has complied with Rule 144(f), and the Company
is provided with a copy of Holder's notice of proposed sale filed in accordance
with 144(h).
5.4 Transfer
Procedure. Subject to the provisions of Article 5.3 and unless
the resale of the Shares issuable upon exercise of this Warrant are then
registered on an effective registration statement, upon providing the Company
with written notice, any Holder may transfer all or part of this Warrant or the
Shares issuable upon exercise of this Warrant (or the Shares issuable directly
or indirectly, upon conversion of the Shares, if any) to any transferee,
provided, however, in connection with any such transfer, any Holder will give
the Company notice of the portion of the Warrant being transferred with the
name, address and taxpayer identification number of the transferee and Holder
will surrender this Warrant to the Company for reissuance to the transferee(s)
(and Holder if applicable). The Company may refuse to transfer this
Warrant or the Shares to any person who directly competes with the Company,
unless, in either case, the stock of the Company is publicly
traded.
5.5 Notices. All
notices and other communications from the Company to Holder, or vice versa,
shall be deemed delivered and effective when given personally or mailed by
first-class registered or certified mail, postage prepaid, at such address as
may have been furnished to the Company or Holder, as the case may (or on the
first business day after transmission by facsimile) be, in writing by the
Company or such Holder from time to time. Effective upon receipt of
the fully executed Warrant and the initial transfer described in Article 5.4
above, all notices to Holder shall be addressed as follows until the Company
receives notice of a change of address in connection with a transfer or
otherwise:
BlueCrest
Capital Finance, L.P.
225 West
Washington, Suite 200
Chicago,
Illinois 60606
Attn: Mark
King
Facsimile:
(312) 443-0126
Notice to
the Company shall be addressed as follows until Holder receives notice of a
change in address:
Peregrine Pharmaceuticals,
Inc.
Attn: Paul Lytle
14282 Franklin Avenue
Tustin, California 92780
Facsimile:
(714) 838-5817
5.6 Waiver. This
Warrant and any term hereof may be changed, waived, discharged or terminated
only by an instrument in writing signed by the party against which enforcement
of such change, waiver, discharge or termination is sought.
5.7 Attorneys’
Fees. In the event of any dispute between the parties
concerning the terms and provisions of this Warrant, the party prevailing in
such dispute shall be entitled to collect from the other party all costs
incurred in such dispute, including reasonable attorneys’ fees.
5.8 Automatic Conversion upon
Expiration. In the event that, upon the Expiration Date, the
fair market value of one Share (or other security issuable upon the exercise
hereof) as determined in accordance with Section 1.3 above is greater than the
Warrant Price in effect on such date, then this Warrant shall automatically be
deemed on and as of such date to be converted pursuant to Section 1.2 above as
to all Shares (or such other securities) for which it shall not previously have
been exercised or converted, and the Company shall promptly deliver a
certificate representing the Shares (or such other securities) issued upon such
conversion to Holder.
5.9 Counterparts. This
Warrant may be executed in counterparts, all of which together shall constitute
one and the same agreement.
5.10 Governing
Law. This Warrant shall be governed by and construed in
accordance with the laws of the State of Delaware, without giving effect to its
principles regarding conflicts of law.
[Signature
page follows.]
“COMPANY”
|
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
By:/s/ Steven King |
|
Name: Steven
King
Title:
President and CEO
|
|
“HOLDER”
|
|
BLUECREST
CAPITAL FINANCE, L.P.
By:
BlueCrest Capital Finance GP, LLC, its General Partner,
|
|
By:/s/ Mark
King |
|
Name: Mark
King
Title:
Managing Director
|
|
SCHEDULE
1
CAPITALIZATION
TABLE
Authorized
Capital:
Common
Stock, 325,000,000
Preferred Stock
5,000,000(1)
|
|
|
|
Shares
of Common Stock Issued and Outstanding as of December 5,
2008
|
|
|
226,210,617 |
|
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
|
|
15,534,845 |
|
Common
shares reserved for issuance upon exercise of outstanding
warrants
|
|
|
- |
|
Shares
reserved for issuance under two effective shelf registration
statements
|
|
|
5,030,634 |
|
Total
Shares of Common Stock Issued and Reserved for Issuance
|
|
|
246,776,096 |
(2) |
(1) There
are no shares of Preferred Stock issued and outstanding as of December 5,
2008.
(2)
Excludes shares of Common Stock available for issuance under Registration
Statement No. 333-139975, under which Peregrine may issue, from time to time, in
one or more offerings, shares of Common Stock for remaining gross proceeds of up
to $7,500,000.
APPENDIX
1
NOTICE OF
EXERCISE
1. Holder
elects to purchase ___________ shares of the Common/Series ______ Preferred
[strike one] Stock of __________________ pursuant to the terms of the attached
Warrant, and tenders payment of the purchase price of the shares in
full.
[or]
1. Holder
elects to convert the attached Warrant into Shares/cash [strike one] in the
manner specified in the Warrant. This conversion is exercised for
_____________________ of the Shares covered by the Warrant.
[Strike paragraph that does not
apply.]
2. Please
issue a certificate or certificates representing the shares in the name
specified below:
___________________________________________
Holders Name
___________________________________________
___________________________________________
(Address)
3. By
its execution below and for the benefit of the Company, Holder hereby restates
each of the representations and warranties in Article 4 of the Warrant as the
date hereof.
|
HOLDER:
|
|
|
|
By: |
|
|
|
Name: |
|
|
|
Title: |
|
|
|
(Date): |
peregrine_10q-ex10117.htm
Exhibit 10.117
THIS
WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR THE SECURITIES LAWS OF ANY
STATE AND, EXCEPT AND PURSUANT TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE
OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL
REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR SUCH OFFER,
SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM
REGISTRATION.
WARRANT
TO PURCHASE STOCK
Company: |
PEREGRINE
PHARMACEUTICALS, INC., a Delaware
corporation |
|
|
Number
of Shares: |
1,184,433,
plus all Additional Shares which Holder is entitled to purchase pursuant
to Section 1.7 |
|
|
Class of
Stock: |
Common |
|
|
Warrant
Price: |
$0.2955 |
|
|
Issue
Date: |
December
19, 2008 |
|
|
Expiration
Date: |
The 5th
anniversary after the Issue Date or the earlier expiration of this
Warrant pursuant to Section 1.6.2(A)(ii) |
|
|
Credit
Facility: |
This
Warrant is issued in connection with the Credit Extensions referenced in
the Loan and Security Agreement among Company, Avid BioServices, Inc.,
BlueCrest Capital Finance, L.P., as Administrative Agent and as a lender,
and the other lenders named therein, dated of even date herewith (the
“Loan
Agreement”) |
THIS WARRANT CERTIFIES THAT, for good
and valuable consideration, MIDCAP FUNDING I, LLC (“MidCap”, together
with any registered holder from time to time of this Warrant or any holder of
the shares issuable or issued upon exercise of this Warrant, “Holder”) is entitled
to purchase the number of fully paid and nonassessable shares of the class of
securities (the “Shares”) of the
Company at the Warrant Price, all as set forth above and as adjusted pursuant to
Article 2 of this Warrant, subject to the provisions and upon the terms and
conditions set forth in this Warrant.
ARTICLE
1. EXERCISE.
1.1 Method of
Exercise. Holder may exercise this Warrant by delivering a
duly executed Notice of Exercise in substantially the form attached as Appendix
1 to the principal office of the Company. Unless Holder is exercising
the conversion right set forth in Article 1.2, Holder shall also deliver to the
Company a check, wire transfer (to an account designated by the Company), or
other form of payment acceptable to the Company for the aggregate Warrant Price
for the Shares being purchased.
1.2 Conversion
Right. In lieu of exercising this Warrant as specified in
Article 1.1, Holder may from time to time convert this Warrant, in whole or in
part, into a number of Shares determined by dividing (a) the aggregate fair
market value of the Shares or other securities otherwise issuable upon exercise
of this Warrant being exercised minus the aggregate Warrant Price of such Shares
by (b) the fair market value of one Share. The fair market value of
the Shares shall be determined pursuant to Article 1.3.
1.3 Fair Market
Value.
1.3.1 If
the Company’s common stock is traded in a public market, the fair market value
of each Share shall be the closing price of a Share reported for the business
day immediately before Holder delivers its Notice of Exercise to the Company (or
in the instance where the Warrant is exercised immediately prior to the
effectiveness of the Company’s initial public offering, the “price to public”
per share price specified in the final prospectus relating to such
offering). If the Company’s common stock is not traded in a public
market, the Board of Directors of the Company shall determine fair market value
in its reasonable good faith judgment (the “Company
Determination”).
1.3.2 If
the Holder disagrees with the Company Determination and by notice to the Company
given within twenty (20) days after receipt of notice of the Company
Determination (an "Appraisal Notice")
elects to dispute the Company Determination, such dispute shall be resolved as
set forth in Section 1.3.3 below.
1.3.3 For
a period of ten (10) days after the Appraisal Notice, the Company and the Holder
shall negotiate in good faith to resolve their differences as to the
determination of fair market value. In the absence of a mutually
satisfactory resolution within such ten (10)-day period, the Company shall
within ten (10) days after the last day of such ten (10)-day period engage an
investment bank or other qualified appraisal firm reasonably acceptable to the
Holder (the "Appraiser") to make
an independent determination of fair market value (the "Appraiser
Determination"). The Appraiser Determination shall be made
within sixty (60) days of the engagement of such Appraiser, shall be evidenced
in a written report addressed to the Company and the Holder, and shall be final
and binding on the Company and the Holder. The costs of the Appraiser
Determination shall be borne (i) solely by the Company if the difference between
the Appraiser Determination and the Company Determination is greater than ten
percent (10%), (ii) solely by the Holder if the difference between the Appraiser
Determination and the Company Determination is less than ten percent (10%) and
(iii) equally by the Company and the Holder if the difference between the
Appraiser Determination and the Company Determination is equal to ten percent
(10%).
1.4 Delivery of Certificate and
New Warrant. Promptly after Holder exercises or converts this
Warrant and, if applicable, the Company receives payment of the aggregate
Warrant Price, the Company shall deliver to Holder certificates for the Shares
acquired and, if this Warrant has not been fully exercised or converted and has
not expired, a new Warrant representing the Shares not so acquired.
1.5 Replacement of
Warrants. On receipt of evidence reasonably satisfactory to
the Company of the loss, theft, destruction or mutilation of this Warrant and,
in the case of loss, theft or destruction, on delivery of an indemnity agreement
reasonably satisfactory in form and amount to the Company or, in the case of
mutilation on surrender and cancellation of this Warrant, the Company shall
execute and deliver, in lieu of this Warrant, a new warrant of like
tenor.
1.6 Treatment of Warrant Upon
Acquisition of Company.
1.6.1 "Acquisition". For
the purpose of this Warrant, "Acquisition" means any sale, license, or other
disposition of all or substantially all of the assets of the Company, or any
reorganization, consolidation, or merger of the Company where the holders of the
Company's securities before the transaction beneficially own less than fifty
percent (50%) of the outstanding voting securities of the surviving entity after
the transaction.
1.6.2
Treatment of Warrant at
Acquisition.
(A) Upon
the written request of the Company, Holder agrees that, in the event of an
Acquisition that is not an asset sale and in which the sole consideration is
cash, either (i) Holder shall exercise its conversion or purchase right under
this Warrant and such exercise will be deemed effective immediately prior to the
consummation of such Acquisition or (ii) if Holder elects not to exercise the
Warrant, this Warrant will expire upon the consummation of such Acquisition
(subject to the automatic conversion provisions of Section 5.8
below). The Company shall provide Holder with written notice of its
request relating to the foregoing (together with such reasonable information as
Holder may request in connection with such contemplated Acquisition giving rise
to such notice), which is to be delivered to Holder not less than ten (10) days
prior to the closing of the proposed Acquisition.
(B) Upon
the written request of the Company, Holder agrees that, in the event of an
Acquisition that is an “arms length” sale of all or substantially all of the
Company’s assets (and only its assets) to a third party that is not an Affiliate
(as defined below) of the Company (a “True Asset Sale”), either (i) Holder shall
exercise its conversion or purchase right under this Warrant and such exercise
will be deemed effective immediately prior to the consummation of such
Acquisition or (ii) if Holder elects not to exercise the Warrant, this Warrant
will continue until the Expiration Date if the Company continues as a going
concern following the closing of any such True Asset Sale. The
Company shall provide Holder with written notice of its request relating to the
foregoing (together with such reasonable information as Holder may request in
connection with such contemplated Acquisition giving rise to such notice), which
is to be delivered to Holder not less than ten (10) days prior to the closing of
the proposed Acquisition.
(C) Upon
the closing of any Acquisition other than those particularly described in
subsections (A) and (B) above, the successor entity shall assume the obligations
of this Warrant, and this Warrant shall be exercisable for the same securities,
cash, and property as would be payable for the Shares issuable upon exercise of
the unexercised portion of this Warrant as if such Shares were outstanding on
the record date for the Acquisition and subsequent closing. The
Warrant Price and/or number of Shares shall be adjusted
accordingly.
As used
herein “Affiliate” shall mean
any person or entity that owns or controls directly or indirectly ten percent
(10%) or more of the stock of Company, any person or entity that controls or is
controlled by or is under common control with such persons or entities, and each
of such person’s or entity’s officers, directors, joint venturers or partners,
as applicable.
1.7 Additional
Shares. Upon the funding of Tranche Two (as defined in the
Loan Agreement), the Company shall be deemed to have automatically granted to
Holder, in addition to the number of Shares which this Warrant can otherwise be
exercised for by Holder, the right to purchase that number of additional Shares,
rounded upward to the nearest whole number, equal to 350,000 divided by the
Warrant Price (such additional shares being called the “Additional
Shares”).
ARTICLE
2. ADJUSTMENTS TO THE
SHARES.
2.1 Stock Dividends, Splits,
Etc. If, at any time following the Issue Date, the Company
declares or pays a dividend on the Shares payable in common stock, or other
securities, then upon exercise of this Warrant, for each Share acquired, Holder
shall receive, without cost to Holder, the total number and kind of securities
to which Holder would have been entitled had Holder owned the Shares of record
as of the date the dividend occurred. If the Company subdivides the
Shares by reclassification or otherwise into a greater number of shares, the
number of shares purchasable hereunder shall be proportionately increased and
the Warrant Price shall be proportionately decreased. If the
outstanding shares are combined or consolidated, by reclassification or
otherwise, into a lesser number of shares, the Warrant Price shall be
proportionately increased and the number of Shares shall be proportionately
decreased.
2.2 Reclassification, Exchange,
Combinations or Substitution. Upon any reclassification,
exchange, substitution, or other event that results in a change of the number
and/or class of the securities issuable upon exercise or conversion of this
Warrant, Holder shall be entitled to receive, upon exercise or conversion of
this Warrant, the number and kind of securities and property that Holder would
have received for the Shares if this Warrant had been exercised immediately
before such reclassification, exchange, substitution, or other
event. The Company or its successor shall promptly issue to Holder an
amendment to this Warrant setting forth the number and kind of such new
securities or other property issuable upon exercise or conversion of this
Warrant as a result of such reclassification, exchange, substitution or other
event that results in a change of the number and/or class of securities issuable
upon exercise or conversion of this Warrant. The amendment to this
Warrant shall provide for adjustments which shall be as nearly equivalent as may
be practicable to the adjustments provided for in this Article 2 including,
without limitation, adjustments to the Warrant Price and to the number of
securities or property issuable upon exercise of the new Warrant. The
provisions of this Article 2.2 shall similarly apply to successive
reclassifications, exchanges, substitutions, or other events.
2.3 No
Impairment. The Company shall not, by amendment of its
Articles or Certificate (as applicable) of Incorporation or through a
reorganization, transfer of assets, consolidation, merger, dissolution, issue,
or sale of securities or any other voluntary action, avoid or seek to avoid the
observance or performance of any of the terms to be observed or performed under
this Warrant by the Company, but shall at all times in good faith assist in
carrying out of all the provisions of this Article 2 and in taking all such
action as may be necessary or appropriate to protect Holder's rights under this
Article against impairment.
2.4 Fractional
Shares. No fractional Shares shall be issuable upon exercise
or conversion of this Warrant and the number of Shares to be issued shall be
rounded down to the nearest whole Share. If a fractional share
interest arises upon any exercise or conversion of the Warrant, the Company
shall eliminate such fractional share interest by paying Holder the amount
computed by multiplying the fractional interest by the fair market value of a
full Share.
2.5 Certificate as to
Adjustments. Upon each adjustment of the Warrant Price, the
Company shall promptly notify Holder in writing, and, at the Company’s expense,
promptly compute such adjustment, and furnish Holder with a certificate of its
Chief Financial Officer setting forth such adjustment and the facts upon which
such adjustment is based. The Company shall, upon written request,
furnish Holder a certificate setting forth the Warrant Price in effect upon the
date thereof and the series of adjustments leading to such Warrant
Price.
ARTICLE
3. REPRESENTATIONS AND
COVENANTS OF THE COMPANY.
3.1 Representations and
Warranties. The Company represents and warrants to Holder as
follows:
(a) All
Shares which may be issued upon the exercise of the purchase right represented
by this Warrant, and all securities, if any, issuable upon conversion of the
Shares, shall, upon issuance, be duly authorized, validly issued, fully paid and
nonassessable, and free of any liens and encumbrances except for restrictions on
transfer provided for herein or under applicable federal and state securities
laws.
(b) The
Company’s capitalization table attached hereto as Schedule 1 is true
and complete as of the Issue Date.
3.2 Notice of Certain
Events. If the Company proposes at any time (a) to declare any
dividend or distribution upon any of its stock, whether in cash, property,
stock, or other securities and whether or not a regular cash dividend; (b) to
effect any reclassification or recapitalization of any of its stock; (c) to
merge or consolidate with or into any other corporation, or sell, lease,
license, or convey all or substantially all of its assets, or to liquidate,
dissolve or wind up; or (d) offer holders of registration rights the opportunity
to participate in an underwritten public offering of the Company's securities
for cash, then, in connection with each such event, the Company shall give
Holder: (1) at least ten (10) days prior written notice of the date on which a
record will be taken for such dividend, distribution, or subscription rights
(and specifying the date on which the holders of common stock will be entitled
thereto) or for determining rights to vote, if any, in respect of the matters
referred to in (a) above; (2) in the case of the matters referred to in (b) and
(c) above at least ten (10) days prior written notice of the date when the same
will take place (and specifying the date on which the holders of common stock
will be entitled to exchange their common stock for securities or other property
deliverable upon the occurrence of such event); and (3) in the case of the
matter referred to in (d) above, the same notice as is given to the holders of
such registration rights. Company will also provide information
requested by Holder reasonably necessary to enable Holder to comply with
Holder’s accounting or reporting requirements.
3.3 Piggyback Registration
Rights. If at any time the Company proposes to register for
sale its common stock (other than a registration on Form S-4 or Form S-8,
registrations relating solely to dividend investment plans, or any successor or
similar forms), the Company shall give written notice (the “Piggyback Notice”)
at least twenty (20) days prior to such proposed registration to the Holder of
the Company’s intention to do so, of the registration form that has been
selected by the Company and of the Holder’s rights under this Article
3.3. Upon the written request of the Holder made within ten (10) days
after receipt of the Piggyback Notice (which request shall specify the number of
Shares the Holder wishes to include in such registration), the Company will use
its reasonable best efforts to include, and to cause the underwriter or
underwriters, if applicable, to include, in the proposed offering, on the same
terms and conditions as the securities of the Company included in such offering,
all shares of common stock that the Holder has validly requested be included
pursuant to such notice (each such registration pursuant to this Article 3.3, a
“Piggyback Registration”) and
the Company shall keep such registration statement in effect and maintain
compliance with each federal and state law or regulation for the period
necessary for such Holder to effect the proposed sale or other disposition (but
in no event for a period greater than ninety (90) days); provided that if at any
time after giving a Piggyback Notice and prior to the effective date of the
registration statement filed in connection with such registration, the Company
shall determine for any reason not to register such securities, the Company may,
at its election, give written notice of such determination to the Holder and,
thereupon, shall be relieved of its obligation to register any of the common
stock in connection with such abandoned registration, and in case of a
determination by the Company to delay registration of its equity securities, the
Company shall be permitted to delay the registration of the common stock for the
same period as the delay in registering such other equity
securities.
3.4 No Shareholder
Rights. Except as provided in this Warrant, Holder will not
have any rights as a shareholder of the Company until the exercise of this
Warrant.
3.5 Certain
Information. The Company agrees to provide Holder at any time
and from time to time with such information as Holder may reasonably request for
purposes of Holder’s compliance with regulatory, accounting and reporting
requirements applicable to Holder.
ARTICLE
4. REPRESENTATIONS,
WARRANTIES OF HOLDER. Holder represents and warrants to the
Company as follows:
4.1 Purchase for Own
Account. This Warrant and the securities to be acquired upon
exercise of this Warrant by Holder will be acquired for investment for Holder’s
account, not as a nominee or agent, and not with a view to the public resale or
distribution within the meaning of the Act. Holder also represents
that Holder has not been formed for the specific purpose of acquiring this
Warrant or the Shares.
4.2 Disclosure of
Information. Holder has received or has had full access to all
the information it considers necessary or appropriate to make an informed
investment decision with respect to the acquisition of this Warrant and its
underlying securities. Holder further has had an opportunity to ask
questions and receive answers from the Company regarding the terms and
conditions of the offering of this Warrant and its underlying securities and to
obtain additional information (to the extent the Company possessed such
information or could acquire it without unreasonable effort or expense)
necessary to verify any information furnished to Holder or to which Holder has
access.
4.3 Investment
Experience. Holder understands that the purchase of this
Warrant and its underlying securities involves substantial
risk. Holder has experience as an investor in securities of companies
in the development stage and acknowledges that Holder can bear the economic risk
of such Holder’s investment in this Warrant and its underlying securities and
has such knowledge and experience in financial or business matters that Holder
is capable of evaluating the merits and risks of its investment in this Warrant
and its underlying securities and/or has a preexisting personal or business
relationship with the Company and certain of its officers, directors or
controlling persons of a nature and duration that enables Holder to be aware of
the character, business acumen and financial circumstances of such
persons.
4.4 Accredited Investor
Status. Holder is an “accredited investor” within the meaning
of Regulation D promulgated under the Act.
4.5 The
Act. Holder understands that this Warrant and the Shares
issuable upon exercise or conversion hereof have not been registered under the
Act in reliance upon a specific exemption therefrom, which exemption depends
upon, among other things, the bona fide nature of Holder’s investment intent as
expressed herein. Holder understands that this Warrant and the Shares
issued upon any exercise or conversion hereof must be held indefinitely unless
subsequently registered under the Act and qualified under applicable state
securities laws, or unless exemption from such registration and qualification
are otherwise available.
ARTICLE
5. MISCELLANEOUS.
5.1 Term. This
Warrant is exercisable in whole or in part at any time and from time to time on
or before the Expiration Date.
5.2 Legends. This
Warrant and the Shares (and the securities issuable, directly or indirectly,
upon conversion of the Shares, if any) shall be imprinted with a legend in
substantially the following form:
THIS
WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR THE SECURITIES LAWS OF ANY
STATE AND, EXCEPT AND PURSUANT TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE
OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL
REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR SUCH OFFER,
SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM
REGISTRATION.
5.3 Compliance with Securities
Laws on Transfer. This Warrant and the Shares issuable upon
exercise of this Warrant (and the securities issuable, directly or indirectly,
upon conversion of the Shares, if any) may not be transferred or assigned in
whole or in part without compliance with applicable federal and state securities
laws by the transferor and the transferee (including, without limitation, the
delivery of investment representation letters and legal opinions reasonably
satisfactory to the Company, as reasonably requested by the
Company). The Company shall not require Holder to provide an opinion
of counsel if the transfer is to an affiliate of
Holder. Additionally, the Company shall also not require an opinion
of counsel if there is no material question as to the availability of current
information as referenced in Rule 144(c), Holder represents that it has complied
with Rule 144(d) and, if applicable, Rule 144(e) in reasonable detail, the
selling broker represents that it has complied with Rule 144(f), and the Company
is provided with a copy of Holder's notice of proposed sale filed in accordance
with 144(h).
5.4 Transfer
Procedure. Subject to the provisions of Article 5.3 and unless
the resale of the Shares issuable upon exercise of this Warrant are then
registered on an effective registration statement, upon providing the Company
with written notice, any Holder may transfer all or part of this Warrant or the
Shares issuable upon exercise of this Warrant (or the Shares issuable directly
or indirectly, upon conversion of the Shares, if any) to any transferee,
provided, however, in connection with any such transfer, any Holder will give
the Company notice of the portion of the Warrant being transferred with the
name, address and taxpayer identification number of the transferee and Holder
will surrender this Warrant to the Company for reissuance to the transferee(s)
(and Holder if applicable). The Company may refuse to transfer this
Warrant or the Shares to any person who directly competes with the Company,
unless, in either case, the stock of the Company is publicly
traded.
5.5 Notices. All
notices and other communications from the Company to Holder, or vice versa,
shall be deemed delivered and effective when given personally or mailed by
first-class registered or certified mail, postage prepaid, at such address as
may have been furnished to the Company or Holder, as the case may (or on the
first business day after transmission by facsimile) be, in writing by the
Company or such Holder from time to time. Effective upon receipt of
the fully executed Warrant and the initial transfer described in Article 5.4
above, all notices to Holder shall be addressed as follows until the Company
receives notice of a change of address in connection with a transfer or
otherwise:
MidCap
Funding I, LLC
7735 Old
Georgetown Road, Suite 400
Bethesda,
Maryland 20814
Attn: Will
Gould
Facsimile:
(301) 941-1450
Notice to
the Company shall be addressed as follows until Holder receives notice of a
change in address:
Peregrine Pharmaceuticals,
Inc.
Attn: Paul Lytle
14282 Franklin Avenue
Tustin, California 92780
Facsimile:
(714) 838-5817
5.6 Waiver. This
Warrant and any term hereof may be changed, waived, discharged or terminated
only by an instrument in writing signed by the party against which enforcement
of such change, waiver, discharge or termination is sought.
5.7 Attorneys’
Fees. In the event of any dispute between the parties
concerning the terms and provisions of this Warrant, the party prevailing in
such dispute shall be entitled to collect from the other party all costs
incurred in such dispute, including reasonable attorneys’ fees.
5.8 Automatic Conversion upon
Expiration. In the event that, upon the Expiration Date, the
fair market value of one Share (or other security issuable upon the exercise
hereof) as determined in accordance with Section 1.3 above is greater than the
Warrant Price in effect on such date, then this Warrant shall automatically be
deemed on and as of such date to be converted pursuant to Section 1.2 above as
to all Shares (or such other securities) for which it shall not previously have
been exercised or converted, and the Company shall promptly deliver a
certificate representing the Shares (or such other securities) issued upon such
conversion to Holder.
5.9 Counterparts. This
Warrant may be executed in counterparts, all of which together shall constitute
one and the same agreement.
5.10 Governing
Law. This Warrant shall be governed by and construed in
accordance with the laws of the State of Delaware, without giving effect to its
principles regarding conflicts of law.
[Signature
page follows.]
“COMPANY”
|
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
By:/s/ Steven King |
|
Name: Steven
King
Title:
President and CEO
|
|
|
|
“HOLDER”
|
|
MIDCAP
FUNDING I, LLC
|
|
By:/s/ Joshua Groman |
|
Name: Joshua
Groman
Title:
Managing Director
|
|
SCHEDULE
1
CAPITALIZATION
TABLE
Authorized
Capital:
Common
Stock, 325,000,000
Preferred Stock
5,000,000(1)
|
|
|
|
Shares
of Common Stock Issued and Outstanding as of December 5,
2008
|
|
|
226,210,617 |
|
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
|
|
15,534,845 |
|
Common
shares reserved for issuance upon exercise of outstanding
warrants
|
|
|
- |
|
Shares
reserved for issuance under two effective shelf registration
statements
|
|
|
5,030,634 |
|
Total
Shares of Common Stock Issued and Reserved for Issuance
|
|
|
246,776,096 |
(2) |
(1) There
are no shares of Preferred Stock issued and outstanding as of December 5,
2008.
(2)
Excludes shares of Common Stock available for issuance under Registration
Statement No. 333-139975, under which Peregrine may issue, from time to time, in
one or more offerings, shares of Common Stock for remaining gross proceeds of up
to $7,500,000.
APPENDIX
1
NOTICE OF
EXERCISE
1. Holder
elects to purchase ___________ shares of the Common/Series ______ Preferred
[strike one] Stock of __________________ pursuant to the terms of the attached
Warrant, and tenders payment of the purchase price of the shares in
full.
[or]
1. Holder
elects to convert the attached Warrant into Shares/cash [strike one] in the
manner specified in the Warrant. This conversion is exercised for
_____________________ of the Shares covered by the Warrant.
[Strike paragraph that does not
apply.]
2. Please
issue a certificate or certificates representing the shares in the name
specified below:
___________________________________________
Holders Name
___________________________________________
___________________________________________
(Address)
3. By
its execution below and for the benefit of the Company, Holder hereby restates
each of the representations and warranties in Article 4 of the Warrant as the
date hereof.
|
HOLDER:
|
|
|
|
By: |
|
|
|
Name: |
|
|
|
Title: |
|
|
|
(Date): |
peregrine_10q-ex3101.htm
Certification
of Chief Executive Officer
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
I, Steven
W. King, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Peregrine Pharmaceuticals,
Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing
and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this report is being prepared;
b) Designed
such internal control over financial reporting, or caused such internal control
over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and
procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the periods covered
by this report based on such evaluation; and
d)
Disclosed in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of
directors (or persons performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant’s internal control over financial
reporting.
Dated: March
11, 2009
|
Signed:
|
/s/ STEVEN
W. KING |
|
|
Steven
W. King
President, Chief Executive Officer, and
Director
|
peregrine_10q-ex3102.htm
Exhibit
31.2
Certification
of Chief Financial Officer
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
I, Paul
J. Lytle, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Peregrine Pharmaceuticals,
Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing
and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this report is being prepared;
b) Designed
such internal control over financial reporting, or caused such internal control
over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
c) Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the periods covered by this
report based on such evaluation; and
d) Disclosed
in this report any change in the registrant’s internal control over financial
reporting that occurred during the registrant’s most recent fiscal quarter (the
registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of
directors (or persons performing the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant’s internal control over financial
reporting.
Dated: March
11, 2009
|
Signed:
|
/s/ PAUL J.
LYTLE |
|
|
Paul
J. Lytle
Chief Financial
Officer
|
peregrine_10q-ex32.htm
Exhibit
32
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT
OF 2002
I,
Steven W. King, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of
Peregrine Pharmaceuticals, Inc. on Form 10-Q for the quarter ended January 31,
2009 fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 and that information contained in such Quarterly
Report of Peregrine Pharmaceuticals, Inc. on Form 10-Q fairly presents in all
material respects the financial condition and results of operations of Peregrine
Pharmaceuticals, Inc.
|
By:
|
/s/
STEVEN W. KING
|
|
Name:
|
Steven
W. King
|
|
Title:
|
President,
Chief Executive Officer, and Director
|
|
Date:
|
March
11, 2009
|
I,
Paul J. Lytle, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of
Peregrine Pharmaceuticals, Inc. on Form 10-Q for the quarter ended January 31,
2009 fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 and that information contained in such Quarterly
Report of Peregrine Pharmaceuticals, Inc. on Form 10-Q fairly presents in all
material respects the financial condition and results of operations of Peregrine
Pharmaceuticals, Inc.
|
By:
|
/s/
PAUL J. LYTLE
|
|
Name:
|
Paul
J. Lytle
|
|
Title:
|
Chief
Financial Officer
|
|
Date:
|
March
11, 2009
|
A
signed original of this written statement required by Section 906 has been
provided to Peregrine Pharmaceuticals, Inc. and will be retained by Peregrine
Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or
its staff upon request.
This
Certification is being furnished pursuant to Rule 15(d) and shall not
be deemed “filed” for purposes of Section 18 of the Exchange Act (15 U.S.C.
78r), or otherwise subject to the liability of that section. This Certification
shall not be deemed to be incorporated by reference into any filing under the
Securities Act or the Exchange Act, except to the extent that the Company
specifically incorporates it by reference.