Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2009
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 001-32157
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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84-1318182 |
(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.) |
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6725 Mesa Ridge Road, Suite 100, San Diego, CA
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92121 |
(Address of principal executive offices)
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(Zip Code) |
(858) 552-0866
(Registrants telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or shorter period that the registrant was required to submit and post such files). Yes o 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.
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
The number of shares outstanding of the registrants common stock, $0.001 par value, as of April
21, 2009 was 90,252,572.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
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March 31, |
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December 31, |
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2009 |
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2008 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,306,646 |
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$ |
9,849,904 |
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Interest and other receivables |
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304,594 |
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121,736 |
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Prepaid expenses |
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353,340 |
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477,902 |
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Total current assets |
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5,964,580 |
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10,449,542 |
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Property and equipment, net |
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166,527 |
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199,052 |
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Other assets |
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60,247 |
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60,664 |
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Total assets |
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$ |
6,191,354 |
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$ |
10,709,258 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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1,054,680 |
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1,721,376 |
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Accrued liabilities |
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1,342,945 |
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2,077,188 |
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Accrued compensation and payroll taxes |
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781,546 |
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915,459 |
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Total current liabilities |
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3,179,171 |
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4,714,023 |
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Stockholders equity: |
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Common stock, $0.001 par value; 200,000,000 shares
authorized; 90,252,572 shares issued and outstanding at
March 31, 2009 and December 31, 2008 |
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90,254 |
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90,254 |
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Additional paid-in capital |
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131,925,397 |
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131,751,439 |
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Deficit accumulated during the development stage |
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( 129,003,468 |
) |
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(125,846,458 |
) |
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Total stockholders equity |
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3,012,183 |
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5,995,235 |
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Total liabilities and stockholders equity |
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$ |
6,191,354 |
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$ |
10,709,258 |
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Note: |
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The balance sheet at December 31, 2008 has been derived from audited financial statements at
that date. It does not include, however, all of the information and notes required by accounting
principles generally accepted in the United States of America for complete financial statements. |
See accompanying notes to unaudited condensed consolidated financial statements.
3
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(Unaudited)
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Inception |
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(June 12, 1996) |
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through |
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Three months ended March 31, |
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March 31, |
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2009 |
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2008 |
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2009 |
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Revenues: |
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Net sales |
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$ |
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$ |
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$ |
174,830 |
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Grant revenue |
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129,733 |
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Licensing revenue |
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300,000 |
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1,300,000 |
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Total net revenues |
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300,000 |
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1,604,563 |
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Cost of goods sold |
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51,094 |
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Gross margin |
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300,000 |
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1,553,469 |
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Operating expenses: |
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Research and development |
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1,647,300 |
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3,820,307 |
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63,661,856 |
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Selling, general and administrative |
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1,779,240 |
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2,365,194 |
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44,748,442 |
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Depreciation and amortization |
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32,246 |
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46,779 |
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10,830,317 |
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In-process research and development |
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10,422,130 |
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Impairment loss write off of goodwill |
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5,702,130 |
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Equity in loss of investee |
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178,936 |
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Total operating expenses |
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3,458,786 |
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6,232,280 |
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135,543,811 |
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Loss from operations |
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(3,158,786 |
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(6,232,280 |
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(133,990,342 |
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Loss on fair value of warrants |
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(12,239,688 |
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Interest income |
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4,582,028 |
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Other income |
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1,776 |
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299,208 |
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114,154 |
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Interest expense |
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(179,090 |
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Loss before cumulative effect of change in accounting principle |
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(3,157,010 |
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(5,933,072 |
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(141,712,938 |
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Cumulative effect of change in accounting principle |
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(25,821 |
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Net loss |
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(3,157,010 |
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(5,933,072 |
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(141,738,759 |
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Preferred stock dividends |
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(621,240 |
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Net loss applicable to common stock |
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$ |
(3,157,010 |
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$ |
(5,933,072 |
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$ |
(142,359,999 |
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Net loss per common share basic and diluted |
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$ |
(0.03 |
) |
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$ |
(0.07 |
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Weighted average shares basic and diluted |
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90,252,572 |
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90,252,572 |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Inception |
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(June 12, 1996) |
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through |
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Three months ended March 31, |
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March 31, |
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2009 |
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2008 |
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2009 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(3,157,010 |
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$ |
(5,933,072 |
) |
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$ |
(141,738,759 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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32,246 |
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46,779 |
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10,380,317 |
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Loss (gain) on disposal of fixed assets |
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279 |
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188 |
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(3,319 |
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Fair value of warrant liability |
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12,239,688 |
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Expenses related to employee stock options |
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173,958 |
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638,416 |
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8,026,520 |
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Expense related to stock options issued to non-employees |
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5,680 |
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204,664 |
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Expenses paid by issuance of common stock |
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1,341,372 |
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Expenses paid by warrants |
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573,357 |
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Expenses paid by preferred stock |
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142,501 |
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Expenses related to stock warrants issued |
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612,000 |
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Accretion of discount |
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(131,929 |
) |
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(1,249,853 |
) |
Amortization of debt discount |
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450,000 |
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Gain /loss on disposals of property and equipment |
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Accretion of discount on investments in securities |
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(354,640 |
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Forgiveness of employee receivable |
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30,036 |
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Impairment loss write-off of goodwill |
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5,702,130 |
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Equity in loss of investee |
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178,936 |
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In-process research and development |
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10,422,130 |
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Write-off of license agreement |
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152,866 |
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Write-off of assets available-for-sale |
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108,000 |
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Cumulative effect of change in accounting principle |
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25,821 |
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Changes in assets and liabilities, net of effect of acquisitions: |
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Increase (decrease) in prepaid expenses and other assets |
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(57,879 |
) |
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17,648 |
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(965,550 |
) |
Increase (decrease) in accounts payable and accrued liabilities |
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(1,534,852 |
) |
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588,129 |
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3,355,878 |
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Decrease in other long-term liabilities |
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(5,352 |
) |
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Net cash used in operating activities |
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(4,543,258 |
) |
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(4,773,513 |
) |
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(90,365,905 |
) |
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Cash flows from investing activities: |
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Purchases of short-term investments |
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(6,437,340 |
) |
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(111,183,884 |
) |
Proceeds from sales and maturities of short-term investments |
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16,750,000 |
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112,788,378 |
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Purchases of property and equipment |
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(20,522 |
) |
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(1,030,354 |
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Proceeds from sale of property and equipment |
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33,906 |
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Purchase of certificate of deposit |
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(1,016,330 |
) |
Maturity of certificate of deposit |
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1,016,330 |
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Payment on obligation under license agreement |
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(106,250 |
) |
Cash acquired from acquisitions, net of cash paid |
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32,395 |
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Issuance of note receivable related party |
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(35,000 |
) |
Payments on note receivable |
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405,993 |
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Advance to investee |
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(90,475 |
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Cash transferred in rescission of acquisition |
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(19,475 |
) |
Cash received in rescission of acquisition |
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230,000 |
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Net cash provided by (used in) investing activities |
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10,292,138 |
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1,025,234 |
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Cash flows from financing activities: |
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Proceeds from sale of preferred stock |
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4,200,993 |
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Proceeds from sale of common stock |
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84,151,342 |
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Proceeds from exercise of stock options |
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712,367 |
|
Proceeds from sale or exercise of warrants |
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11,382,894 |
|
Repurchase of warrants |
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(55,279 |
) |
Payment of financing and offering costs |
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(6,483,809 |
) |
Payments of notes payable and long-term debt |
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|
|
|
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|
(605,909 |
) |
Proceeds from issuance of notes payable and detachable warrants |
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|
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|
1,344,718 |
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Net cash provided by financing activities |
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94,647,317 |
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Net increase (decrease) in cash and cash equivalents |
|
|
(4,543,258 |
) |
|
|
5,518,625 |
|
|
|
5,306,646 |
|
Cash and cash equivalents at beginning of period |
|
|
9,849,904 |
|
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|
14,780,739 |
|
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Cash and cash equivalents at end of period |
|
$ |
5,306,646 |
|
|
$ |
20,299,364 |
|
|
$ |
5,306,646 |
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|
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|
See accompanying notes to unaudited condensed consolidated financial statements.
5
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. |
|
Basis of Presentation |
|
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|
ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (ADVENTRX, we or the Company),
prepared the unaudited interim condensed consolidated financial statements in accordance with
accounting principles generally accepted in the United States of America (U.S. GAAP) for
interim financial information and with the instructions of the Securities and Exchange Commission
(SEC). Accordingly, they do not include all of the information and disclosures required by U.S.
GAAP for annual audited financial statements and should be read in conjunction with our audited
consolidated financial statements and related notes for the year ended December 31, 2008 included
in our Annual Report on Form 10-K filed with the SEC on March 27, 2009 (2008 Annual Report).
The condensed consolidated balance sheet as of December 31, 2008 has been derived from the
audited consolidated financial statements included in the 2008 Annual Report. In the opinion of
management, these interim condensed consolidated financial statements include all adjustments
(consisting of normal recurring adjustments) necessary for a fair presentation of the financial
position, results of operations, and cash flows for the periods presented. The results of
operations for the interim periods shown in this report are not necessarily indicative of results
expected for the full year. |
|
|
|
Since our inception, we have an accumulated net loss of approximately $141.7 million and
recurring negative cash flows from operations. Currently, we are focused primarily on evaluating
strategic options, including the sale or exclusive license of one or more of our product
candidate programs, a strategic business merger and other similar transactions. We implemented
restructuring and cost-cutting measures in October 2008, January 2009 and March 2009 and
eliminated all but a select, small number of full-time employees and discontinued substantially
all of our development activities and fundamental business operations to provide additional time
to consummate a strategic transaction or otherwise obtain financing. |
|
|
|
The condensed consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries, SD Pharmaceuticals, Inc. and ADVENTRX (Europe) Ltd. All intercompany
accounts and transactions have been eliminated in consolidation. |
|
2. |
|
Going Concern |
|
|
|
The accompanying unaudited interim condensed consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. Going concern contemplates the
realization of assets and the satisfaction of liabilities in the normal course of business over a
reasonable length of time. However, as a result of the Companys continued losses and current
cash and financing position, such realization of assets or satisfaction of liabilities, without
substantial adjustments, is uncertain. The future of the Company is dependent upon its ability to
obtain additional funding. |
|
|
|
In December 2008, the Company announced that it was evaluating various strategic options, including
the sale or exclusive license of one or more of the Companys product candidate programs, a
strategic business merger and other similar transactions, certain of which would result in a change
of control of the Company. However, progress with potential strategic transaction partners has not
been as rapid or on terms as attractive as the Company would have desired. The Company previously
has taken steps designed to provide additional time to consummate a strategic transaction or
otherwise obtain financing, including eliminating all but a select, small number of full-time
employees and discontinuing substantially all of its development activities and fundamental
business operations. As a result, its ability to further curtail expenses to provide further time
is limited, and the restructuring and cost-cutting measures it has taken may not provide it with
sufficient additional time to consummate a strategic transaction or otherwise obtain financing.
Further, in May 2009, the Company announced that the primary endpoint in its bioequivalence study
of ANX-514 was not met, that the resulting uncertainty around the cost and timeline to approval by
the U.S. Food and Drug Administration, or FDA, of ANX-514 may adversely impact the Companys
on-going strategic transaction discussions, and that, in light of its working capital, the Company
is evaluating both its strategic and non-strategic options. Accordingly, in May 2009, the Company
began to evaluate the process of winding-down its operations, including engaging a third-party firm
to assist it with its evaluation. There can be no assurances that we will continue to pursue our
strategic transaction alternatives or, if we do, that we will be able to consummate a strategic
transaction on a timely basis, or at all. The Company likely will not be
able to continue as a going concern, unless, as part of a strategic transaction or otherwise, it
raises adequate capital. Given this uncertainty, there is significant doubt as to the Companys
ability to continue as a going concern. |
|
|
|
The accompanying financial statements for the quarter ended March 31, 2009 do not include any
adjustments related to the recovery and classification of recorded assets, or the amounts and
classification of liabilities, that might be necessary in the event the Company cannot continue
as a going concern. |
6
3. |
|
Use of Estimates |
|
|
|
The preparation of financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ from those estimates. |
|
4. |
|
Fair Value Measurements |
|
|
|
Effective January 1, 2008, we adopted Statement of Financial Accounting Standards (FAS) No.
157, Fair Value Measurements (FAS 157). In February 2008, the Financial Accounting Standards
Board (FASB) issued FASB Staff Position (FSP) No. FAS 157-2, Effective Date of FASB
Statement No. 157, which provides a one year deferral of the effective date of FAS 157 for
non-financial assets and non-financial liabilities, except those that are recognized or disclosed
in the financial statements at fair value at least annually. As a result, we only partially
adopted FAS 157 as it relates to our financial assets and liabilities until we are required to
apply this pronouncement to our non-financial assets and liabilities beginning with fiscal year
2009. The adoption of FAS 157 did not have a material impact on our consolidated results of
operations or financial condition. |
|
|
|
In October 2008, the FASB issued FSP No. FAS 157-3 Determining the Fair Value of a Financial
Asset When the Market for That Asset Is Not Active (FSP FAS 157-3). FSP FAS 157-3 clarifies
the application of FAS No. 157, in a market that is not active and provides an example to
illustrate key considerations in determining the fair value of a financial asset when the market
for that financial asset is not active. FSP FAS 157-3 is effective upon issuance, including prior
periods for which financial statements have not been issued. The adoption of FSP FAS 157-3 had
no impact on our consolidated results of operations, financial position or cash flows. |
|
|
|
FAS 157 defines fair value, establishes a framework for measuring fair value under U.S. GAAP and
enhances disclosures about fair value measurements. Fair value is defined under FAS 157 as the
exchange price that would be received for an asset or paid to transfer a liability (an exit
price) in the principal or most advantageous market for the asset or liability in an orderly
transaction between market participants on the measurement date. Valuation techniques used to
measure fair value under FAS 157 must maximize the use of observable inputs and minimize the use
of unobservable inputs. FAS 157 describes a fair value hierarchy based on three levels of inputs,
of which the first two are considered observable and the last unobservable, that may be used to
measure fair value which are the following: |
|
|
|
|
|
|
|
|
|
|
|
Level 1
|
|
Quoted prices
in active markets for identical assets or liabilities. |
|
|
|
|
|
|
|
|
|
|
|
Level 2
|
|
Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or
liabilities; quoted prices in markets that are not active; or other
inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or
liabilities. |
|
|
|
|
|
|
|
|
|
|
|
Level 3
|
|
Unobservable inputs that are supported by little or no market
activity and that are significant to the fair value of the assets
or liabilities. |
The following table represents our fair value hierarchy for our financial assets (which consisted
solely of cash equivalents) measured at fair value on a recurring basis as of March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
Money Market funds |
|
$ |
5,306,646 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,306,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,306,646 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,306,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective January 1, 2008, we adopted FAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities (FAS 159). FAS 159 allows an entity the irrevocable option to elect
to measure specified financial assets and liabilities in their entirety at fair value on a
contract-by-contract basis. If an entity elects the fair value option for an eligible item,
changes in the items fair value must be reported as unrealized gains and losses in earnings at
each subsequent reporting date. In adopting FAS 159, we did not elect the fair value option for
any of our financial assets or financial liabilities.
7
5. |
|
Share-Based Payments |
|
|
|
Estimated share-based compensation expense related to equity awards granted to employees for the
three months ended March 31, 2009 and 2008 was as follows: |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2009 |
|
|
2008 |
|
Selling, general and administrative expense |
|
$ |
199,334 |
|
|
$ |
332,720 |
|
Research and development expense |
|
|
(25,376 |
) |
|
|
305,696 |
|
|
|
|
|
|
|
|
Share-based compensation expense before taxes |
|
|
173,958 |
|
|
|
638,416 |
|
Related income tax benefits |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
$ |
173,958 |
|
|
$ |
638,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net share-based compensation expense per common share basic and diluted |
|
$ |
0.002 |
|
|
$ |
0.001 |
|
|
|
|
|
|
|
|
|
|
In January 2009, we granted under our 2008 Omnibus Incentive Plan restricted stock units to seven
employees that represented the right to receive in the aggregate 3,700,000 shares of our common
stock. These units will vest immediately prior to a strategic transaction (as defined in the
documentation evidencing the grant of the units). We will record share-based compensation
expense in connection with these restricted stock units, if at all, only if a strategic
transaction is consummated. |
|
|
|
Since we have a net operating loss carryforward as of March 31, 2009, no excess tax benefits for
the tax deductions related to share-based awards were recognized in the condensed consolidated
statement of operations. There were no employee stock options exercised in the three months ended
March 31, 2009 and 2008. |
|
|
|
At March 31, 2009, total employee stock compensation expense
included forfeitures for terminated employees resulting in a credit to research and development stock
compensation expense for the three month period ended March 31, 2009. |
|
|
|
At March 31, 2009, total unrecognized estimated compensation cost related to non-vested employee
and non-employee director share-based awards granted prior to that date was $1.7 million, which
is expected to be recognized over a weighted-average period of 3.0 years. During the three months
ended March 31, 2009 and 2008, we granted 0 and 1,802,500 stock options, respectively, to our
employees and non-employee directors with an estimated weighted-average grant-date fair value of
$0 and $0.51. |
|
|
|
Estimated share-based compensation expense related to equity awards granted to non-employee
consultants was $0 and $6,000 for the three months ended March 31, 2009 and 2008, respectively. |
|
6. |
|
Net Loss Per Common Share |
|
|
|
We calculate basic and diluted net loss per common share in accordance with the FAS No. 128,
Earnings Per Share. Basic net loss per common share was calculated by dividing the net loss for
the period by the weighted-average number of common shares outstanding during the period, without
consideration for common stock equivalents. Options, warrants and restricted stock units are
considered to be common stock equivalents and are only included in the calculation of diluted
earnings per common share when their effect is dilutive. Because of the net loss, all of the
options, warrants and restricted stock units were excluded from the calculation. |
|
|
|
We have excluded the following options, warrants and restricted stock units from the calculation
of diluted net loss per common share for the three months ended March 31, 2009 and 2008 because
they are anti-dilutive, due to the net loss: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Warrants |
|
|
13,373,549 |
|
|
|
13,373,549 |
|
Options |
|
|
3,509,897 |
|
|
|
5,589,483 |
|
Restricted Stock Units |
|
|
3,700,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,583,446 |
|
|
|
18,963,032 |
|
|
|
|
|
|
|
|
8
7. |
|
Comprehensive Loss |
|
|
|
Comprehensive loss is defined as the change in equity of a business enterprise during a
period from transactions and other events and circumstances from non-owner sources, including
foreign currency translation adjustments and unrealized gains and losses on short-term
investments. Our components of comprehensive loss consist of net loss and unrealized gains or
losses on short-term investments in securities. For the three months ended March 31, 2009 and
2008, comprehensive loss was $3.2 million and $5.9 million, respectively. For the three months
ended March 31, 2008 and 2007 and the period from inception (June 12, 1996) through March 31,
2009, comprehensive loss was $5.9 million, $5.1 million and $141.7 million, respectively. |
|
8. |
|
Recent Accounting Pronouncements |
|
|
|
In April 2009, the FASB issued three new FASB Staff Positions (FSP) relating to fair value
accounting; FSP FAS 157-4, Determining Fair Value When the Volume and Level of Activity of the
Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not
Orderly, FSP FAS 115-2 and FSP FAS 124-2, Recognition and Presentation of Other-Than-Temporary
Impairments and FSP FAS 107-1/APB 28-1, Interim Disclosures about Fair Value of Financial
Instruments. These FSPs impact certain aspects of fair value measurements, impairments of
securities and related disclosures. The provisions of these FSPs are effective for interim and
annual periods ending after June 15, 2009. The Company does not expect the impact of adopting
these FSPs to have a material effect on its consolidated results of operations or financial
position. |
|
|
|
In April 2009, the FASB issued FSP FAS 141(R) -1, Accounting for Assets Acquired and Liabilities
Assumed in a Business Combination That Arises from Contingencies. The FSP amends and clarifies
FASB Statement No. 141 (revised 2007), Business Combinations to address application issues on
initial recognition and measurement, subsequent measurement and accounting, and disclosure of
assets and liabilities arising from contingencies in a business combination. This FSP is
effective for assets or liabilities arising from contingencies in business combinations for which
the acquisition date is on or after the beginning of the first annual reporting beginning on or
after December 15, 2008. |
|
9. |
|
Licensing Revenue |
|
|
|
In March 2009, we announced that we and our wholly-owned subsidiary, SD Pharmaceuticals, Inc.,
had entered into a license agreement with respect to our product candidate ANX-514 (docetaxel
emulsion) (the License Agreement) with Shin Poong Pharmaceutical Co., Ltd., a company organized
under the laws of the Republic of Korea (Shin Poong), pursuant to which we granted to Shin
Poong an exclusive license, including the right to sublicense, to research, develop, make, have
made, use, offer for sale, sell and import licensed products, in each case solely for the
treatment of cancer by intravenous administration of formulations of docetaxel as emulsified
products and solely in South Korea. Under the terms of the License Agreement, we will receive an
upfront licensing fee of $0.3 million, a regulatory milestone payment of either $0.2 million or
$0.4 million (depending on whether Shin Poong is required by the Korea Food and Drug
Administration to conduct a bioequivalence or clinical study in human subjects prior to receipt
of regulatory approval) upon receipt of regulatory approval for marketing a licensed product in
South Korea, one-time commercial milestone payments tied to annual net sales of licensed products
in an aggregate amount of up to $1.5 million and royalty payments on net sales of licensed
products. Shin Poong is responsible for all development and commercial activities related to
ANX-514 in South Korea. If Shin Poong is required by the Korea Food and Drug Administration to
conduct a bioequivalence or clinical trial in human subjects prior to receipt of regulatory
approval and we elect not to supply product to conduct such trial, which supply obligation is
subject to limitations, we will pay Shin Poong $0.1 million. |
|
|
|
We received the $0.3 million upfront licensing fee in April 2009. We recognized $0.3 million in
licensing revenue in the three-month period ended March 31, 2009 because we met the criteria
under our revenue recognition policy in that period. |
9
10. |
|
Supplementary Cash Flow Information |
|
|
|
Noncash investing and financing transactions not presented on the condensed consolidated
statements of cash flows for the three months ended March 31, 2009 and 2008 and for the period
from inception (June 12, 1996) through March 31, 2009 are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inception |
|
|
|
|
|
|
|
|
|
|
|
(June 12, 1996) |
|
|
|
|
|
|
|
|
|
|
|
through |
|
|
|
Three months ended March 31, |
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
|
|
|
$ |
179,090 |
|
Income taxes paid |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants, common stock and preferred stock for: |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of notes payable and accrued interest |
|
$ |
|
|
|
$ |
|
|
|
|
1,213,988 |
|
Prepaid services to consultants |
|
|
|
|
|
|
|
|
|
|
1,482,781 |
|
Conversion of preferred stock |
|
|
|
|
|
|
|
|
|
|
2,705 |
|
Acquisitions |
|
|
|
|
|
|
|
|
|
|
24,781,555 |
|
Payment of dividends |
|
|
|
|
|
|
|
|
|
|
213,000 |
|
Financial advisor services in connection with private placement |
|
|
|
|
|
|
|
|
|
|
1,137,456 |
|
Acquisition of treasury stock in settlement of a claim |
|
|
|
|
|
|
|
|
|
|
34,747 |
|
Cancellation of treasury stock |
|
|
|
|
|
|
|
|
|
|
(34,737 |
) |
Assumptions of liabilities in acquisitions |
|
|
|
|
|
|
|
|
|
|
1,235,907 |
|
Acquisition of license agreement for long-term debt |
|
|
|
|
|
|
|
|
|
|
161,180 |
|
Cashless exercise of warrants |
|
|
|
|
|
|
|
|
|
|
4,312 |
|
Dividends accrued |
|
|
|
|
|
|
|
|
|
|
621,040 |
|
Trade asset converted to available-for-sale asset |
|
|
|
|
|
|
|
|
|
|
108,000 |
|
Dividends extinguished |
|
|
|
|
|
|
|
|
|
|
408,240 |
|
Trade payable converted to note payable |
|
|
|
|
|
|
|
|
|
|
83,948 |
|
Issuance of warrants for return of common stock |
|
|
|
|
|
|
|
|
|
|
50,852 |
|
Detachable warrants issued with notes payable |
|
|
|
|
|
|
|
|
|
|
450,000 |
|
Purchases of equipment, which are included in accounts payable |
|
|
|
|
|
|
12,382 |
|
|
|
3,825 |
|
Unrealized (gain) loss on short-term investments |
|
|
|
|
|
|
(6,101 |
) |
|
|
|
|
11. |
|
Severance Related Expenses |
|
|
|
In January 2009, as part of a restructuring to reduce operating costs, we completed a work force
reduction of six employees. As a result of the work force reduction, in accordance with SFAS No.
146, Accounting for Costs Associated with Exit or Disposal Activities, we recorded
severance-related charges of $174,000, of which $86,000 was recorded in research and development
and the remainder in selling, general, and administrative expenses. Severance-related charges
of $144,000 were recorded in the first quarter of 2009 and the remainder will be recorded in the
second quarter of 2009. |
|
|
|
On April 3, 2009, we effected the reduction in our full-time workforce to small, select number of
full-time employees that we announced on March 20, 2009. In addition, we have discontinued
substantially all of our development activities and fundamental business operations. Our
remaining employees will focus their efforts primarily on continuing to evaluate and execute
strategic options. As a result of this reduction in force, we recorded severance-related charges
of $163,000, of which $114,000 was recorded in the first quarter of 2009 and $49,000 is expected
to be recorded in the second quarter of 2009. The severance-related charges that we expect to
incur in the second quarter of 2009 are subject to a number of assumptions, and actual results
may differ. We may also incur other charges not currently contemplated due to events that may
occur as a result of, or associated with, this and other reductions in our workforce. |
|
12. |
|
Subsequent Event |
|
|
|
In May 2009, we announced that we did not meet the primary endpoint in our bioequivalence study
of ANX-514, that the resulting uncertainty around the cost and timeline to FDA approval of
ANX-514 may adversely impact our on-going strategic transaction discussions, and that, in light
of our working capital, we are evaluating both our strategic and
non-strategic options. Accordingly, in May 2009, the Company began to evaluate the process of winding-down its operations,
including engaging a third-party firm to assist it with its evaluation. |
10
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should
be read in conjunction with the condensed consolidated financial statements and related notes
appearing elsewhere in this report. In addition to historical information, this discussion and
analysis contains forward-looking statements that involve risks, uncertainties, and assumptions.
Our actual results may differ materially from those anticipated in these forward-looking
statements.
Overview
We are a development-stage biopharmaceutical company whose fundamental business is focused on
in-licensing, developing and commercializing proprietary product candidates for the treatment of
cancer. We seek to improve the performance and commercial potential of existing treatments by
addressing limitations associated principally with their safety and use. We have devoted
substantially all of our resources to R&D or to acquisition of our product candidates. We have not
yet marketed or sold any products or generated any significant revenue.
We have an immediate need to raise additional capital to support our operations. We have
incurred annual net losses since inception. We had a net loss of $3.2 million in the first quarter
of 2009, which included charges associated with our October 2008 and January and March 2009
reductions in force, and cash and cash equivalents of approximately $5.3 million and working
capital of $2.8 million at March 31, 2009. These factors raise substantial doubt about our ability
to continue as a going concern. Our interim condensed consolidated financial statements for the
period ended and at March 31, 2009 have been prepared assuming we will continue as a going concern.
This basis of accounting contemplates the recovery of our assets and the satisfaction of
liabilities in the normal course of business and does not include any adjustments to reflect the
possible future effects on the recoverability and classification of assets or the amounts and
classification of liabilities that might be necessary should we be unable to continue as a going
concern.
In December 2008, we announced that we were evaluating strategic options, including the sale or
exclusive license of one or more of our product candidate programs, a strategic business merger and
other similar transactions. However, progress with potential strategic transaction partners has not
been as rapid or on terms as attractive as we would have desired. We previously have taken steps
designed to provide additional time to consummate a strategic transaction or otherwise obtain
financing, including eliminating all but a small, select number of full-time employees and
discontinuing substantially all of our development activities and fundamental business operations.
As a result, our ability to further curtail expenses to provide further time is limited, and the
restructuring and cost-cutting measures we have taken may not provide us with sufficient additional
time to consummate a strategic transaction or otherwise obtain financing. Further, in May 2009, we
announced that we did not meet the primary endpoint in our bioequivalence study of ANX-514, that
the resulting uncertainty around the cost and timeline to approval by the FDA of ANX-514 may
adversely impact our on-going strategic transaction discussions, and that, in light of our working
capital, we are evaluating both our strategic and non-strategic options. Accordingly, in May 2009,
the Company began to evaluate the process of winding-down its operations, including engaging a
third-party firm to assist it with its evaluation. There can be no assurances that we will
continue to pursue our strategic transaction alternatives or, if we do, that we will be able to
consummate a strategic transaction on a timely basis, or at all. If we are unable to consummate a
strategic transaction or otherwise obtain financing on a timeline that we believe is acceptable, we will
begin the process of divesting our assets on best-available terms, entirely winding-down our
operations and distributing any remaining cash to our stockholders. However, based on our current
working capital and the estimated costs associated with seeking approval for and implementing a
liquidation plan, we expect our remaining cash, if any, to be insignificant.
Our business was incorporated in Delaware in December 1995. In October 2000, we merged our
wholly-owned subsidiary, Biokeys Acquisition Corp., with and into Biokeys, Inc. and changed our
name to Biokeys Pharmaceuticals, Inc. In May 2003, we merged Biokeys, Inc., our wholly-owned
subsidiary, with and into us and changed our name to ADVENTRX Pharmaceuticals, Inc. In July 2004,
we formed a wholly-owned subsidiary, ADVENTRX (Europe) Ltd., in the United Kingdom primarily to
facilitate conducting clinical trials in the European Union and to obtain favorable pricing for
discussions with the European Medicines Agency. In April 2006, we acquired SD Pharmaceuticals, Inc.
as a wholly-owned subsidiary. Our executive offices are located at 6725 Mesa Ridge Road, Suite 100,
San Diego, California 92121, and our telephone number is (858) 552-0866. Our corporate website is
located at www.adventrx.com.
Our trademark CoFactor® is registered in the United States Patent and Trademark
Office (in the Supplemental Register) under Registration No. 2,946,934, for use in connection with
chemotherapy modulators derived from folic acid. We are developing commercial names for our other
product candidates. All other trademarks, service marks or trade names appearing in this report,
including but not limited to Navelbine® and Taxotere®, are the property of
their respective owners. Use or display by us of other
parties trademarks, service marks, trade names, trade dress or products is not intended to
and does not imply a relationship with, or endorsements or sponsorship of, us by the trademark,
service mark, trade name, trade dress or product owners.
11
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon
consolidated financial statements that we have prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation of these consolidated financial
statements requires management to make a number of assumptions and estimates that affect the
reported amounts of assets, liabilities, revenues and expenses in our consolidated financial
statements and accompanying notes. On an on-going basis, we evaluate these estimates and
assumptions, including those related to recognition of expenses in service contracts, license
agreements, share-based compensation and registration payment arrangements. Management bases its
estimates on historical information and assumptions believed to be reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities not readily apparent from other sources. Actual results may differ from
these estimates under different assumptions or conditions.
Revenue Recognition. We recognize revenue in accordance with the SECs Staff Accounting
Bulletin Topic 13, Revenue Recognition, or Topic 13, and Emerging Issues Task Force Issue, or
EITF, No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21. Revenue is
recognized when all of the following criteria are met: (1) persuasive evidence of an arrangement
exists; (2) delivery has occurred or services have been rendered; (3) the sellers price to the
buyer is fixed and determinable; and (4) collectibility is reasonably assured.
Revenue from licensing agreements is recognized based on the performance requirements of the
agreement. Revenue is deferred for fees received before earned. Nonrefundable upfront fees that are
not contingent on any future performance by us are recognized as revenue when revenue recognition
criteria under Topic 13 and EITF 00-21 are met and the license term commences. Nonrefundable
upfront fees, where we have ongoing involvement or performance obligations, are recorded as
deferred revenue and recognized as revenue over the life of the contract, the period of the
performance obligation or the development period, whichever is appropriate in light of the
circumstances.
Payments related to substantive, performance-based milestones in an agreement are recognized
as revenue upon the achievement of the milestones as specified in the underlying agreement when
they represent the culmination of the earnings process. Royalty revenue from licensed products will
be recognized when earned in accordance with the terms of the applicable license agreements.
R&D Expenses. R&D expenses consist of expenses incurred in performing R&D activities,
including salaries and benefits, facilities and other overhead expenses, bioequivalence and
clinical trials, research-related manufacturing services, contract services and other outside
expenses. R&D expenses are charged to operations as they are incurred. Advance payments, including
nonrefundable amounts, for goods or services that will be used or rendered for future R&D
activities are deferred and capitalized. Such amounts will be recognized as an expense as the
related goods are delivered or the related services are performed. If the goods will not be
delivered, or services will not be rendered, then the capitalized advance payment is charged to
expense.
Milestone payments that we make in connection with in-licensed technology or product
candidates are expensed as incurred when there is uncertainty in receiving future economic benefits
from the licensed technology or product candidates. We consider the future economic benefits from
the licensed technology or product candidates to be uncertain until such licensed technology or
product candidates are approved for marketing by the FDA or when other significant risk factors are
abated. For accounting purposes, management has viewed future economic benefits for all of our
licensed technology or product candidates to be uncertain.
Payments in connection with our bioequivalence and clinical trials are often made under
contracts with multiple contract research organizations that conduct and manage these trials on our
behalf. The financial terms of these agreements are subject to negotiation and vary from contract
to contract and may result in uneven payment flows. Generally, these agreements set forth the scope
of work to be performed at a fixed fee or unit price or on a time-and-material basis. Payments
under these contracts depend on factors such as the successful enrollment or treatment of patients
or the completion of other milestones. Expenses related to bioequivalence and clinical trials are
accrued based on our estimates and/or representations from service providers regarding work
performed, including actual level of patient enrollment, completion of patient studies, and trials
progress. Other incidental costs related to patient enrollment or treatment are accrued when
reasonably certain. If the contracted amounts are modified (for instance, as a result of changes in
the bioequivalence or clinical trial protocol or scope of work to be performed), we modify our
accruals accordingly on a prospective basis. Revisions in scope of contract are charged to expense
in the period in which the facts that give rise to the revision become reasonably certain. Because
of the uncertainty of possible future changes to the scope of work in bioequivalence and clinical
trials contracts, we are unable to quantify an estimate of the reasonably likely effect of any such
changes on our consolidated results of operations or
financial position. Historically, we have had no material changes in our bioequivalence and
clinical trial expense accruals that would have had a material impact on our consolidated results
of operations or financial position.
12
Purchased In-Process Research and Development. In accordance with SFAS No. 141, Business
Combinations, we accounted for the costs associated with any purchased in-process research and
development, or IPR&D, to the statement of operations upon acquisition through December 31, 2008.
These amounts represent an estimate of the fair value of purchased IPR&D for projects that, as of
the acquisition date, had not yet reached technological feasibility, had no alternative future use,
and had uncertainty in generating future economic benefits. We determine the future economic
benefits from the purchased IPR&D to be uncertain until such technology is incorporated into
products approved for marketing by the FDA or when other significant risk factors are abated.
We adopted SFAS No. 141(R)-1, Business Combinations, effective for fiscal years beginning on
or after December 15, 2008. The adoption of SFAS 141(R) did not have a material effect on our
consolidated results of operations and financial condition.
Stock-based Compensation Expenses. Effective January 1, 2006, we accounted for stock-based
compensation awards granted to employees, including members of our board of directors, in
accordance with the revised SFAS No. 123, Share-Based Payment, or SFAS 123R, including the
provisions of Staff Accounting Bulletins No. 107 and No. 110. Share-based compensation cost is
measured at the grant date, based on the estimated fair value of the award, and is recognized as
expense over the employees requisite service period. As of March 31, 2009, we had no awards with
market or performance conditions other than the restricted stock units that we granted in January
2009, which will vest, if at all, immediately prior to a strategic transaction (as defined in the
documentation evidencing the grant of the units). As stock-based compensation expense is based on
awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS 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. Forfeitures were estimated based on
historical experience. Although estimates of stock-based compensation expenses are significant to
our consolidated financial statements, they are not related to the payment of any cash by us. Prior
to January 1, 2006, we accounted for stock-based compensation under the recognition and measurement
principles of SFAS 123, Accounting for Stock-Based Compensation.
We estimate the fair value of stock option awards on the date of grant using the Black-Scholes
option-pricing model, or Black-Scholes model. The determination of the fair value of stock-based
payment awards on the date of grant using an option-pricing model is affected by our stock price as
well as assumptions regarding a number of complex and subjective variables. These variables
include, but are not limited to, our expected stock price volatility over the term of the awards,
actual and projected employee stock option exercise behaviors, a risk-free interest rate and
expected dividends. We may elect to use different assumptions under the Black-Scholes model in the
future, which could materially affect our net income or loss and net income or loss per share.
We account for stock-based compensation awards granted to non-employees in accordance with
EITF No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services, or EITF 96-18. Under EITF 96-18, we
determine the fair value of the stock-based compensation awards granted as either the fair value of
the consideration received or the fair value of the equity instruments issued, whichever is more
reliably measurable. If the fair value of the equity instruments issued is used, it is measured
using the stock price and other measurement assumptions as of the earlier of either of (1) the date
at which a commitment for performance by the counterparty to earn the equity instruments is reached
or (2) the date at which the counterpartys performance is complete.
Income Taxes. In June 2006, FASB issued Financial Interpretation No., or FIN, 48, Accounting
for Uncertainty in Income Taxes-an Interpretation of FASB Statement 109, which clarifies the
accounting for uncertainty in tax positions. FIN 48 provides that the tax effects from an uncertain
tax position can be recognized in our consolidated financial statements only if the position is
more likely than not of being sustained upon an examination by tax authorities. An uncertain income
tax position will not be recognized if it has less than a 50% likelihood of being sustained.
Additionally, FIN 48 provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition. The provisions of FIN 48 were effective
for us as of January 1, 2007, with the cumulative effect of the change in accounting principle
recorded as an adjustment to opening retained earnings in the year of adoption. We adopted FIN 48
on January 1, 2007, which did not have a material impact on our consolidated results of operations
or financial position.
Costs Associated with Exit or Disposal Activities. In accordance with SFAS No. 146,
Accounting for Costs Associated with Exit or Disposal Activities, as part of a restructuring to
reduce operating costs, in January 2009, we completed a work force reduction of six employees. As
a result of the reduction in force, we recorded severance-related charges of $174,000, of which
$86,000 was recorded in research and development and the remainder in selling, general, and
administrative expenses. Severance-related charges of $144,000 were recorded in the first quarter
of 2009 and the remainder will be recorded in the second quarter of 2009.
13
In accordance with SFAS No. 146, Accounting for Costs Associated with Exit or Disposal
Activities, as part of a restructuring to reduce operating costs, in March 2009, we announced that
we would reduce to a small, select number of full-time employees. The severance costs and employer
taxes associated with the reduction in force of nine employees was $163,000. Severance-related
charges of $114,000 were recorded in the first quarter of 2009 and the remainder will be recorded
in the second quarter of 2009. We may also incur other charges not currently contemplated due to
events that may occur as a result of, or associated with, the restructuring.
The foregoing is not intended to be a comprehensive list of all of our accounting policies. In
most cases, the accounting treatment of a particular transaction is specifically dictated by
accounting principles generally accepted in the United States of America.
Results of Operations
A general understanding of the drug development process is critical to understanding our
results of operations. Drug development in the U.S. and most countries throughout the world is a
process that includes several steps defined by the FDA and similar regulatory authorities in
foreign countries. The FDA approval processes relating to new drugs differ, depending on the nature
of the particular drug for which approval is sought. With respect to any drug product with active
ingredients not previously approved by the FDA, a prospective drug manufacturer is required to
submit a new drug application, or NDA, which includes complete reports of pre-clinical, clinical
and laboratory studies and extensive manufacturing information to prove such products safety and
effectiveness. The NDA process generally requires, before the submission of the NDA, filing of an
investigational new drug application, or IND, pursuant to which permission is sought to begin
clinical testing of the new drug product. An NDA based on published safety and effectiveness
studies conducted by others, or previous findings of safety and effectiveness by the FDA, may be
submitted under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FDCA. Development
of new formulations of pharmaceutical products under Section 505(b)(2) of the FDCA may have shorter
timelines than those associated with developing new chemical entities.
Generally, with respect to any drug product with active ingredients not previously approved by
the FDA, an NDA must be supported by data from at least phase 1, phase 2 and phase 3 clinical
trials. Phase 1 clinical trials can be expected to last from 6 to 18 months, phase 2 clinical
trials can be expected to last from 12 to 24 months and phase 3 clinical trials can be expected to
last from 18 to 36 months. However, clinical development timelines vary widely, as do the total
costs of clinical trials and the likelihood of success. We anticipate that we will make
determinations as to which R&D programs to pursue and how much funding to direct to each program on
an ongoing basis in response to the scientific and clinical success of each product candidate, our
ongoing assessment of its market potential and our available resources. In March 2009, we announced
that we would discontinue substantially all of our development activities and fundamental business
operations to provide additional time to consummate a strategic transaction or otherwise obtain
financing.
If we are successful in consummating a strategic transaction, future expenditures on R&D
programs are subject to many uncertainties, including whether our product candidates will be
further developed with a partner or independently. At this time, due to such uncertainties and the
risks inherent in drug development and the associated regulatory process, we cannot estimate with
reasonable certainty the duration of or costs to complete our R&D programs or whether or when or to
what extent revenues will be generated from the commercialization and sale of any of our product
candidates. The duration and costs of our R&D programs, in particular those associated with
bioequivalence trials and research-related manufacturing, can vary significantly among programs as
a result of a variety of factors, including:
|
|
|
the number and location of sites included in trials and the rate of site approval for
the trial; |
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|
|
the rates of patient recruitment and enrollment; |
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|
the ratio of randomized to evaluable patients; |
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the availability and cost of reference product in the jurisdiction of each site; |
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|
the time and cost of process development activities related to our product
candidates; |
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|
the costs of manufacturing our product candidates; and |
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|
|
the costs, requirements, timing of and the ability to secure regulatory approvals. |
14
The difficult process of seeking regulatory approvals for our product candidates, in particular
those containing new chemical entities, and compliance with applicable regulations, requires the
expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining,
regulatory approvals could cause our R&D expenditures to increase and, in turn, have a material and
unfavorable effect on our results of operations. We cannot be certain when, if ever, we will
generate revenues from sales of any of our products.
While substantially all of our R&D expenses are transacted in U.S. dollars, certain of our expenses
are required to be paid in foreign currencies and expose us to transaction gains and losses that
could result from changes in foreign currency exchange rates. We include realized gains and losses
from foreign currency transactions in operations as incurred.
Comparison of Three Months Ended March 31, 2009 and 2008
Revenue. Revenue recognized for the three months ended March 31, 2009 represents a $0.3 million
nonrefundable license fee under our license agreement with Shin Poong Pharmaceutical Co., Ltd.
Consistent with our revenue recognition policy, we recognized the license fee as revenue in the
three-month period ended March 31, 2009 because, in that period, persuasive evidence of an
arrangement existed, services had been rendered, the amount of the payment was fixed and
determinable and collectability was reasonably assured. No revenue was recognized for the three
months ended March 31, 2008.
R&D Expenses. We maintain and evaluate our R&D expenses by the type of cost incurred rather than by
project. We maintain and evaluate R&D expenses by type primarily because of the uncertainties
described above, as well as because we out-source a substantial portion of our work and our R&D
personnel work across multiple programs rather than dedicating their time to one particular
program. We began maintaining such expenses by type on January 1, 2005. The following table
summarizes our consolidated R&D expenses by type for the three months ended March 31, 2009 compared
to the same period in 2008:
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|
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|
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|
|
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|
|
|
|
|
|
|
|
January 1, 2005 |
|
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|
Three months ended March 31, |
|
|
through |
|
|
|
2009 |
|
|
2008 |
|
|
$ Variance |
|
|
% Variance |
|
|
March 31, 2009 |
|
External clinical study fees
and expenses |
|
$ |
578,992 |
|
|
$ |
1,021,920 |
|
|
$ |
(442,928 |
) |
|
|
(43 |
%) |
|
$ |
23,778,472 |
|
External non-clinical study
fees and expenses (1) |
|
|
470,248 |
|
|
|
1,418,985 |
|
|
|
(948,737 |
) |
|
|
(67 |
%) |
|
|
19,415,722 |
|
Personnel costs |
|
|
623,436 |
|
|
|
1,073,706 |
|
|
|
(450,270 |
) |
|
|
(42 |
%) |
|
|
10,134,624 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
(25,376 |
) |
|
|
305,696 |
|
|
|
(331,072 |
) |
|
|
(108 |
%) |
|
|
2,858,784 |
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,647,300 |
|
|
$ |
3,820,307 |
|
|
$ |
(2,173,007 |
) |
|
|
(57 |
%) |
|
$ |
56,187,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
External non-clinical study fees and expenses include preclinical,
research-related manufacturing, quality assurance and regulatory expenses. |
R&D expenses decreased by $2.2 million, or 57%, to $1.6 million for the three months ended March
31, 2009, compared to $3.8 million for the comparable period in 2008. The decrease in R&D expenses
was primarily due to a $0.6 million decrease in external clinical trial expenses related to
CoFactor, a $1.0 million decrease
in non-clinical expenses related to ANX-514 and ANX-530, a $0.5 million decrease in personnel costs related to
the reductions in staff and a $0.3 million decrease in
share-based compensation expense, offset by a $0.2 million
increase in clinical trial expenses related to ANX-514. We expect
R&D expenses to continue to decline given our recent reductions in full-time employees and that we
have discontinued substantially all of our development activities and fundamental business
operations until we complete a strategic transaction or otherwise obtain financing.
Selling, General and Administrative Expenses. SG&A expenses decreased by $0.6 million, or 25%, to
$1.8 million for the three months ended March 31, 2009, compared to $2.4 million for the comparable
period in 2008. The decrease was primarily due to a $0.3 million
decrease in personnel costs
related to reductions in staff, a $0.2 million decrease in legal
and professional services and a $0.1 million decrease in business insurance. We expect SG&A expenses to continue to decline given our
recent reductions in full-time employees and that we have discontinued substantially all of our
development activities and fundamental business operations until we complete a strategic
transaction or otherwise obtain financing.
Interest and Other Income. Interest and other income decreased by $0.3 million, or 99%, to $1,776
for the three months ended March 31, 2009, compared to $0.3 million for the comparable period in
2008. The decrease was primarily attributable to lower interest
income based on lower cash balances. We expect that interest income will continue to decline as
forecasted interest rates decline along with lower cash balances.
15
Net Loss. Net loss was $3.2 million, or $0.03 per share, for the three months ended March 31,
2009, compared to a net loss of $5.9 million, or $0.07 per share, for the comparable period in
2008. Included in the net loss for the three months ended March 31, 2009 were charges associated
with our October 2008 and January and March 2009 reductions in force.
Liquidity and Capital Resources
We have a history of recurring losses from operations and we have funded our operations
primarily through sales of our equity securities. We had a net loss of $3.2 million in the first
quarter of 2009, which included charges associated with our October 2008 and January and March 2009
reductions in force, and cash and cash equivalents of approximately $5.3 million and working
capital of $2.8 million at March 31, 2009. We have an immediate need to raise additional capital to
support our operations, though in the current financial and economic environment it is uncertain
that we can obtain funding through our traditional sources of capital. These factors raise
substantial doubt about our ability to continue as a going concern.
We are evaluating strategic options, including the sale or exclusive license of one or more of our
product candidate programs, a strategic business merger and other similar transactions, as well as
non-strategic options, including financing transactions and orderly winding-down our operations.
Certain strategic options may improve our liquidity and provide us with working capital to fund
continuing business operations or may result in the divestiture of future development and
commercialization activities and related expenses. However, there can be no assurances that we will
continue to pursue our strategic alternatives or, if we do, that we will be successful in
consummating a strategic transaction on a timely basis, or at all. We likely will not be able to
continue as a going concern, unless, as part of a strategic transaction or otherwise, we raise
adequate capital. We have eliminated all but a select, small number of full-time employees and
discontinued substantially all of our development activities and fundamental business operations
and our ability to further curtail expenses to provide additional time to consummate a strategic
transaction or otherwise obtain financing is limited.
Operating Activities. Net cash used in operating activities was $4.5 million for the three
months ended March 31, 2009, compared to $4.8 million for the comparable period in 2008. The
decrease in net cash used in operating activities was primarily due to reductions in development
activities and fundamental business operations, offset by a $0.3 million increase in licensing
revenue. Included in net cash used in operating activities for the three months ended March 31,
2009 were charges associated with our October 2008 and January and March 2009 reductions in force.
Accordingly, the decreased expenses we otherwise would have realized in the first quarter of 2009
were offset by charges associated with our October 2008 and January and March 2009 reductions in
force.
Investing Activities. Net cash provided by investing activities was $0 for the three months
ended March 31, 2009, compared to net cash used in investing activities of $10.3 million for the
comparable period in 2008.
Financing Activities. There were no financing activities in the three months ended March 31,
2009 and 2008.
Accrued Compensation and Payroll Taxes. Accrued compensation and payroll taxes were $0.8
million at March 31, 2009, compared to $0.9 million at December 31, 2008, a decrease of $0.1
million, or 15%. The decrease was primarily due to the paying-down of severance-related expenses
associated with our October 2008 reduction in staff, offset by severance-related expenses
associated with our January and March 2009 reductions in staff.
Management Outlook
We have an immediate need to raise additional capital to support our operations. Our ability
to raise capital has been materially and adversely affected by current credit conditions and the
downturn in the financial markets and overall economy. In addition, our ability to timely raise
capital on commercially reasonable terms may be limited by requirements, rules and regulations of
the Securities and Exchange Commission and the NYSE Amex (formerly, the American Stock Exchange).
In December 2008, we announced that we were evaluating strategic options, including the sale or
exclusive license of one or more of our product candidate programs, a strategic business merger and
other similar transactions. However, progress with potential strategic transaction partners has not
been as rapid or on terms as attractive as we would have desired. We previously have taken steps
designed to provide additional time to consummate a strategic transaction or otherwise obtain
financing, including eliminating all but a small, select number of full-time employees and
discontinuing substantially all of our development activities and fundamental business operations.
As a result, our ability to further curtail expenses to provide further time is limited, and the
restructuring and cost-cutting measures we have taken may not provide us with sufficient additional
time to consummate a strategic transaction or otherwise obtain financing. Further, in May 2009, we
announced that we did not meet the primary endpoint in our bioequivalence study of ANX-514, that
the resulting uncertainty around the cost and timeline to approval by the FDA of ANX-514 may
adversely impact our on-going strategic transaction discussions, and that, in light of our working
capital, we are evaluating both our strategic and non-strategic options. Accordingly, in May 2009,
the Company began to evaluate the process of winding-down its operations, including engaging a
third-party firm to assist it with its evaluation. There can be no assurances that we will
continue to pursue our strategic transaction alternatives or, if we do, that we will be able to
consummate a strategic transaction on a timely basis, or at all. If we are unable to consummate a
strategic transaction or otherwise obtain financing on a timeline that we believe is acceptable, we
will begin the process of divesting our assets on best-available terms, entirely winding-down our
operations and distributing any remaining cash to our stockholders. However, based on our current
working capital and the estimated costs associated with seeking approval for and implementing a
liquidation plan, we expect our remaining cash, if any, to be insignificant.
16
We are unable to predict when, if ever, we will consummate a strategic transaction or the
form, structure or terms of any potential strategic transaction, including whether we will continue
as a going concern, or whether we will entirely wind-down our operations. As a result, the duration
that our existing cash and cash equivalents will sustain our current operations is uncertain.
Recent Accounting Pronouncements
See Note 8, Recent Accounting Pronouncements, of the Notes to the Condensed Consolidated
Financial Statements (unaudited) in this report for a discussion of recent accounting announcements
and their effect, if any, on us.
Forward Looking Statements
This Quarterly Report on Form 10-Q, particularly in Item 2 Managements Discussion and
Analysis of Financial Condition and Results of Operations, includes 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. All statements, other than statements of historical
fact, are statements that could be deemed forward-looking statements, including, but not limited
to, statements regarding business strategy, expectations and plans, our objectives for future
operations, including product development, and our future financial position. When used in this
report, the words believe, may, could, will, estimate, continue, anticipate,
intend, expect, indicate and similar expressions are intended to identify forward-looking
statements.
We have based these forward-looking statements on our current expectations and projections
about future events and trends that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business operations and objectives, and
financial needs, including our ability to consummate a strategic transaction or otherwise satisfy
our immediate need for additional capital. These forward-looking statements are subject to risks
and uncertainties that could cause our actual results to differ materially from those reflected in
these forward-looking statements. Factors that could cause or contribute to such differences
include, but are not limited to: the risk that we will liquidate our
assets, entirely wind-down our operations and dissolve; the risk that, based on our current working capital,
and the estimated costs associated with seeking approval for and implementing a plan of
liquidation, our remaining capital available for distribution to our stockholders, if any, will be
insignificant; the risk that we will be unable to consummate a strategic or partnering transaction
or otherwise raise sufficient capital on a timely basis, or at all, to continue as a going concern,
including as a result of negative perceptions of the data from our bioequivalence study of ANX-514;
the risk that our recent cost-containment measures, including the discontinuation of substantially
all of our development activities and fundamental business operations and reduction in force to a
small, select number of full-time employees, will negatively impact our ability to consummate a
strategic transaction; the potential for regulatory authorities to require additional preclinical
work and/or clinical activities to support regulatory filings, including prior to the submission or
the approval of a New Drug Application for ANX-530 and ANX-514, and the impact of increased
uncertainty regarding the need for such activities on strategic, partnering and capital-raising
transactions; the risk that the departure of our former Chief Executive Officer and President, our
former Executive Vice President and Chief Financial Officer and/or our reduced workforce and
leadership by officers who do not have substantial previous experience in executive leadership
roles will negatively impact our ability to attract a strategic or other partner, raise capital or
maintain effective disclosure controls and procedures or internal control over financial reporting;
the risk the FDA will determine that ANX-530 and Navelbine and/or ANX-514 and Taxotere are not
bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based on a
patient population other than the population on which we based our analysis or determining that
increased docetaxel blood-levels during and immediately following infusion are clinically relevant;
the risk of investigator bias in reporting adverse events as a result of the open-label nature of
the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events
associated with Navelbine and/or that decreased the reporting of adverse events associated with
ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing
ANX-530 and ANX-514, including validating commercial manufacturers and suppliers and the potential
for automatic injunctions regarding FDA approval of ANX-514; the risk that the performance of third
parties on whom we rely to conduct our studies or evaluate the data, including clinical
investigators, expert data monitoring
17
committees, contract laboratories and contract research
organizations, may be substandard, or they may fail to perform as expected; the risk that our common stock will be delisted by the NYSE Amex
(formerly, the American Stock Exchange), including as a result of failing to maintain sufficient
stockholders equity or a sufficient stock price; the risk that we are unable to file timely
required reports with the Securities and Exchange Commission; the risk that we will trigger a
maintenance failure under that certain Rights Agreement, dated July 27, 2005, as amended, and be
required to pay liquidated damages, including as a result of losing our eligibility to use Form S-3
if our common stock is delisted from the NYSE Amex or we are not timely in our filings with the
Securities and Exchange Commission; and other risks and uncertainties discussed in other reports
and documents we file with the Securities and Exchange Commission. Except as required by law, we do
not intend to update these forward-looking statements publicly or to update the reasons actual
results could differ materially from those anticipated in these forward-looking statements, even if
new information becomes available in the future.
In light of these risks and uncertainties and our assumptions, the forward-looking events and
circumstances discussed in this report and in the documents incorporated in this report may not
occur and actual results could differ materially and adversely from those anticipated or implied in
such forward-looking statements. Accordingly, you are cautioned not to place undue reliance on such
forward-looking statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not required.
Item 4T. Controls and Procedures
Evaluation of disclosure controls and procedures
As of the end of the period covered by this report, we conducted an evaluation, under the
supervision and with the participation of our principal executive officer and principal financial
officer, of the effectiveness of our 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).
Based on this evaluation, our principal executive officer and principal financial officer concluded
that our disclosure controls and procedures were effective as of March 31, 2009.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with
the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during
the period covered by this report that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting. However, as a result of recent reductions in our workforce and other departures, we have
experienced substantial turn-over in our personnel responsible for performing activities related to
our internal control over financing reporting. We have used third-party contractors to ensure our
internal control over financial reporting remains effective during this turn-over. We intend to
continue to use these contractors as long as our working capital permits.
18
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In the normal course of business, we may become subject to lawsuits and other claims and
proceedings. Such matters are subject to uncertainty and outcomes are often not predictable with
assurance.
Item 1A. Risk Factors
Not required.
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.
Item 5. Other Information
None.
Item 6. Exhibits
An Exhibit Index has been attached as part of this report and is incorporated herein by reference.
19
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ADVENTRX Pharmaceuticals, Inc.
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Date: May 15, 2009 |
By: |
/s/ Brian M. Culley
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Brian M. Culley |
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Chief Business Officer and Senior Vice President
(Duly Authorized Officer) |
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By: |
/s/ Mark N.K. Bagnall
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Mark N.K. Bagnall |
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Director
(Principal Financial and Principal Accounting Officer) |
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20
Exhibit Index
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Exhibit |
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Description |
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10.1 |
# |
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Confidential Separation Agreement and General Release of All Claims, effective January 8, 2009, between
the registrant and Mark N.K. Bagnall |
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10.2 |
#(1) |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Brian M. Culley |
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10.3 |
# |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Patrick L. Keran |
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10.4 |
# |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Mark E. Erwin |
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10.5 |
# |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Michele L. Yelmene |
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10.6 |
#(1) |
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Form of Notice of Grant of Restricted Stock Units under the 2008 Omnibus Incentive Plan (for grants to
employees in January 2009) |
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10.7 |
#(1) |
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Form of Restricted Stock Units Agreement under the 2008 Omnibus Incentive Plan |
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10.8 |
* |
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License Agreement, dated March 25, 2009, between the registrant, SD Pharmaceuticals, Inc. and Shin
Poong Pharmaceutical Co., Ltd. |
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31.1 |
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Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) |
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31.2 |
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Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) |
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32.1 |
± |
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Certification of principal executive officer and principal financial officer pursuant to 18 U.S.C.
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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* |
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Indicates that confidential treatment has been requested or granted to certain
portions, which portions have been omitted and filed separately with the SEC |
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# |
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Indicates management contract or compensatory plan |
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± |
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These certifications are being furnished solely to accompany this report pursuant to 18
U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange
Act of 1934 and are not to be incorporated by reference into any filing of the registrant,
whether made before or after the date hereof, regardless of any general incorporation
language in such filing. |
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(1) |
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Filed with the registrants Current Report on Form 8-K on February 2, 2009 (SEC file
number 001-32157- 09561715) |
21
Exhibit 10.1
Exhibit 10.1
CONFIDENTIAL SEPARATION AGREEMENT
AND GENERAL RELEASE OF ALL CLAIMS
This Confidential Separation Agreement and General Release of All Claims (Separation
Agreement) is made by and between ADVENTRX Pharmaceuticals, Inc. (ADVENTRX) and Mark N. K.
Bagnall (Employee) with respect to the following facts:
A. Employee is currently employed by ADVENTRX.
B. ADVENTRX is reducing its costs and is terminating Employees employment. As a result,
Employees employment with ADVENTRX will terminate effective December 26, 2008 (Separation Date).
ADVENTRX wishes to reach an amicable separation with Employee and assist Employees transition to
other opportunities. As part of this transition, ADVENTRX wishes to engage Employee as an
independent contractor consultant in accordance with that certain Consulting Agreement, in
substantially the form attached hereto as Exhibit A (the Consulting Agreement).
C. The parties desire to settle all claims and issues that have, or could have, been raised in
relation to Employees employment with ADVENTRX and arising out of or in any way related to the
acts, transactions or occurrences between Employee and ADVENTRX to date, including, but not limited
to, Employees employment with ADVENTRX and the termination of that employment, on the terms set
forth below.
THEREFORE, in consideration of the promises and mutual agreements hereinafter set forth, it is
agreed by and between the undersigned as follows:
1. Severance Package. ADVENTRX agrees to provide Employee with the following payments
and benefits (Severance Package) to which Employee is not otherwise entitled. Employee
acknowledges and agrees that this Severance Package constitutes adequate legal consideration for
the promises and representations made by Employee in this Separation Agreement.
1.1 Severance Payment. ADVENTRX agrees to provide Employee with a severance payment
of $165,500, less all applicable taxes and withholdings (Severance Payment). Assuming this
Separation Agreement is timely signed and delivered and not revoked, the Severance Payment will be
made in a lump sum payment on the first payday following the Effective Date as described below in
paragraph 10 but in no event later than March 15, 2009.
1.2 Health Benefit Allowance. ADVENTRX agrees to provide Employee with a health
benefit allowance of $18,351.55, which the Employee may use, at Employees discretion, to pay the
premiums required to continue Employees group health care coverage under the applicable provisions
of the Consolidated Omnibus Budget Reconciliation act of 1985 (COBRA) or any other health
care-related expenses. This health benefit allowance will be paid in the same manner as the
Severance Payment and will be subject to all applicable taxes and withholdings.
1.3 Consultant Engagement. ADVENTRX agrees to engage Employee, and Employee agrees to
provide services, as an independent contractor consultant for the period set forth in the
Consulting Agreement (Consulting Period). During the Consulting Period, Employee will provide
services in accordance with the Consulting Agreement.
2. General Release. Employee unconditionally, irrevocably and absolutely releases and
discharges ADVENTRX, and any parent and subsidiary corporations, divisions and affiliated
corporations, partnerships or other affiliated entities of ADVENTRX, past and present, as well as
ADVENTRXs employees, officers, directors, agents, successors and assigns (collectively, Released
Parties), from all claims related in any way to the transactions or occurrences between them to
date, to the fullest extent permitted by law, including, but not limited to, Employees employment
with ADVENTRX, the termination of Employees employment, and all other losses, liabilities, claims,
charges, demands and causes of action, known or unknown, suspected or unsuspected, arising directly
or indirectly out of or in any way connected with Employees employment with ADVENTRX. This
release is intended to have the broadest possible application and includes, but is not limited to,
any tort, contract, common law, constitutional or other statutory claims, including, but not
limited to alleged violations of the California Labor Code or the federal Fair Labor Standards Act,
Title VII of the Civil Rights Act of 1964 and the California Fair Employment and Housing Act, the
Americans with Disabilities Act, the Age Discrimination in Employment Act of 1967, as amended, and
all claims for attorneys fees, costs and expenses. Employee expressly waives Employees right to
recovery of any type, including damages or reinstatement, in any administrative or court action,
whether state or federal, and whether brought by Employee or on Employees behalf, related in any
way to the matters released herein. However, this general release is not intended to bar any
claims that, by statute, may not be waived, such as claims for workers compensation benefits,
unemployment insurance benefits, statutory indemnity and any challenge to the validity of
Employees release of claims under the Age Discrimination in Employment Act of 1967, as amended, as
set forth in this Separation Agreement.
3. California Civil Code Section 1542 Waiver. Employee expressly acknowledges and
agrees that all rights under Section 1542 of the California Civil Code are expressly waived. That
section provides:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES
NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF
EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM OR HER MUST HAVE
MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.
4. Reaffirmation. At the end of the Consulting Period, Employee agrees to sign the
Reaffirmation Clause set forth at the end of this Separation Agreement in order to extend and
reaffirm the promises made by Employee in this Separation Agreement, including, but not limited to,
the general release of all claims. Employee agrees that if he fails to sign the Reaffirmation
Clause on or about the end of the Consulting Period, he will not be entitled to receive the
Severance Package or any part thereof and must repay ADVENTRX for any portion of the Severance
Package he has already received.
5. Representation Concerning Filing of Legal Actions. Employee represents that, as of
the date of this Separation Agreement, Employee has not filed any lawsuits, charges, complaints,
petitions, claims or other accusatory pleadings against ADVENTRX or any of the other Released
Parties in any court or with any governmental agency.
6. Nondisparagement. Employee agrees that Employee will not make any voluntary
statements, written or oral, or cause or encourage others to make any such
statements that defame, disparage or in any way criticize the personal and/or business
reputations, practices or conduct of ADVENTRX or any of the other Released Parties.
2
7. Confidentiality and Return of ADVENTRX Property; Surviving Obligations. Employee
understands and agrees that as a condition of receiving the Severance Package described in
paragraph 1, all ADVENTRX property must be returned to ADVENTRX, except such property that is
reasonably required by Employee to perform services as a member of the Companys Board of Directors
or that is reasonably related to such services and such property that is needed by Employee to
provide services pursuant to the Consulting Agreement. However, any such property retained for use
during the Consulting Period must be returned to ADVENTRX immediately upon the conclusion of the
Consulting Period, unless such property is reasonably required by Employee to perform services as a
member of the Companys Board of Directors or that is reasonably related to such services. By
signing this Separation Agreement, Employee represents and warrants that Employee has returned to
ADVENTRX all ADVENTRX property, data and information belonging to ADVENTRX as required herein and
agrees that Employee will not use or disclose to others any confidential or proprietary information
of ADVENTRX or any of the other Released Parties, except, as applicable, in connection with the
Consulting Agreement or Employees position as a member of the Companys Board of Directors, which
use and disclosure will be governed by such documents, agreements and duties as apply to such
position. Employee further agrees to comply with the continuing obligations set forth in the
surviving provisions of ADVENTRXs Confidential Information, Non-Solicitation and Invention
Assignment Agreement for Employees, the Code of Business Conduct and Ethics, the Policies and
Procedure Manual, as updated from time to time, and the Insider Trading and Disclosure Policy, each
as previously executed by Employee (collectively, Employment Documents). In addition, Employee
agrees to keep the terms of this Separation Agreement confidential between Employee and ADVENTRX,
except that Employee may tell, in confidence, Employees immediate family and attorney or
accountant, if any, as needed, but in no event should Employee discuss this Separation Agreement or
its terms with any current or prospective employee of ADVENTRX.
8. Section 16 Reporting. Employee understands that ADVENTRX is required to disclose
in its annual proxy statement information regarding Section 16 reporting delinquencies by its
directors and officers that occurred during the prior fiscal year. To assist ADVENTRX in meeting
such disclosure requirements, Employee hereby (a) certifies that all reportable transactions in
ADVENTRX securities through the Separation Date have been reported on a Form 4, and (b) agrees to
execute and deliver to ADVENTRX promptly after December 31, 2008, but no later than January 30,
2009, the no filing due certification in the form attached hereto as Appendix A.
9. No Admissions. By entering into this Separation Agreement, the Released Parties
make no admission that they have engaged, or are now engaging, in any unlawful conduct. The
parties understand and acknowledge that this Separation Agreement is not an admission of liability
and shall not be used or construed as such in any legal or administrative proceeding.
3
10. Older Workers Benefit Protection Act. This Separation Agreement is intended to
satisfy the requirements of the Older Workers Benefit Protection Act, 29 U.S.C. sec. 626(f).
Employee is advised to consult with an attorney before executing this Separation Agreement.
10.1 Acknowledgments/Time to Consider. Employee acknowledges and agrees that
(a) Employee has read and understands the terms of this Separation Agreement;
(b) Employee has been advised in writing to consult with an attorney before executing this
Separation Agreement; (c) Employee has obtained and considered such legal counsel as Employee deems
necessary; (d) Employee has been given twenty-one (21) days to consider whether or not to enter
into this Separation Agreement (although Employee may elect not to use the full 21-day period at
Employees option); and (e) by signing this Separation Agreement, Employee acknowledges that
Employee does so freely, knowingly, and voluntarily. If a signed copy of this Separation Agreement
is not received by the Companys corporate secretary by 5:00 p.m. Pacific Time on January 21, 2008,
ADVENTRX will assume Employee is not interested in the Severance Package, and the offer will be
automatically withdrawn.
10.2 Revocation/Effective Date. This Separation Agreement shall not become effective
or enforceable until the eighth day after Employee signs and delivers to ADVENTRX this Separation
Agreement. In other words, Employee may revoke Employees acceptance of this Separation Agreement
within seven (7) days after the date Employee signs and delivers it to ADVENTRX. Employees
revocation must be in writing and received by Pamela Lopez, Human Resources, by 5:00 p.m. Pacific
Time on the seventh day in order to be effective. If Employee does not revoke acceptance within
the seven (7) day period, Employees acceptance of this Separation Agreement shall become binding
and enforceable on the eighth day (Effective Date). The Severance Package will become due and
payable in accordance with paragraph 1 above and its subparts after the Effective Date, provided
Employee does not revoke.
10.3 Preserved Rights of Employee. This Separation Agreement does not waive or
release any rights or claims that Employee may have under the Age Discrimination in Employment Act
of 1967, as amended, that arise after the execution of this Separation Agreement. In addition,
this Separation Agreement does not prohibit Employee from challenging the validity of this
Separation Agreements waiver and release of claims under the Age Discrimination in Employment Act
of 1967, as amended.
11. Severability. In the event any provision of this Separation Agreement shall be
found unenforceable, the unenforceable provision shall be deemed deleted and the validity and
enforceability of the remaining provisions shall not be affected thereby.
12. Full Defense. This Separation Agreement may be pled as a full and complete
defense to, and may be used as a basis for an injunction against, any action, suit or other
proceeding that may be prosecuted, instituted or attempted by Employee in breach hereof.
13. Applicable Law. The validity, interpretation and performance of this Separation
Agreement shall be construed and interpreted according to the laws of the United States of America
and the State of California.
14. Entire Agreement; Modification. This Separation Agreement, including the
surviving provisions of the Employment Documents, all of which are herein incorporated by
reference, is intended to be the entire agreement between the parties and supersedes and cancels
any and all other and prior agreements, written or oral, between the parties regarding this subject
matter. For clarity, the terms and conditions of this Separation Agreement supersede and replace
any conflicting terms and conditions set forth in that certain letter, dated April 1, 2008,
pursuant to which the Company offered employment to Employee (the Offer Letter). In particular,
the Company and Employee agree that (a) Section 1.1 of this Separation Agreement supersedes and
replaces Section 3(a) of the Offer Letter, (b) Section 1.2 of this Separation Agreement supersedes
and replaces Section 3(b) of the Offer Letter and (c)
assuming this Separation Agreement is timely signed and delivered and not revoked (as
described in this Separation Agreement and as contemplated by Section 3(x) of the Offer Letter),
Employee is entitled to the benefits described in this Separation Agreement without the need to
submit Employees resignation as a member of the Companys Board of Directors (as contemplated by
Section 3(y) of the Offer Letter). This Separation Agreement may be amended only by a written
instrument executed by all parties hereto.
4
THE PARTIES TO THIS SEPARATION AGREEMENT HAVE READ THE FOREGOING SEPARATION AGREEMENT AND FULLY
UNDERSTAND EACH AND EVERY PROVISION CONTAINED HEREIN. WHEREFORE, THE PARTIES HAVE EXECUTED THIS
SEPARATION AGREEMENT ON THE DATES SHOWN BELOW.
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Dated: December 31, 2008 |
By: |
/s/ Mark Bagnall
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Mark N. K. Bagnall |
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Adventrx Pharmaceuticals, Inc.
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Dated: December 31, 2008 |
By: |
/s/ Patrick Keran
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Patrick L. Keran |
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Vice President and General Counsel |
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REAFFIRMATION
By re-signing this Separation Agreement below on or about the end of the Consulting Period, I
hereby reaffirm and extend the release of all known and unknown claims set forth in paragraphs 2
and 3 above, to include all such claims arising through and including the date on which I re-sign
this Separation Agreement below, including any claims relating to or arising from my independent
contractor relationship with ADVENTRX pursuant to the Consulting Agreement.
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Dated:
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By: |
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Mark N. K. Bagnall
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5
APPENDIX A
CERTIFICATE
I am aware that, as a Section 16 officer of ADVENTRX Pharmaceuticals, Inc. during the fiscal
year ended December 31, 2008, I must file a Form 5 with the Securities and Exchange Commission
within 45 days after the end of the fiscal year, unless I have previously reported all transactions
and holdings otherwise reportable on such Form 5.
After reviewing my records, I hereby certify to ADVENTRX that I am not required to file a
Form 5 for the fiscal year ended December 31, 2008.
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Date: December 31, 2008 |
By: |
/s/ Mark Bagnall
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Name: |
Mark Bagnall |
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6
Exhibit A
CONSULTING AGREEMENT
7
CONSULTING AGREEMENT
This Consulting Agreement (this Agreement) is dated December 31, 2008, but will
become effective (the Effective Date) one business day after the date that Mark N. K.
Bagnall signs and delivers to ADVENTRX Pharmaceuticals, Inc. the Confidential Separation Agreement
and General Release of All Claims to which this Consulting Agreement is an exhibit. This Agreement
is entered into between Mark N. K. Bagnall, an individual resident of the State of California
(Consultant), and ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (the
Company).
1. Consulting Relationship. During the term of this Agreement, Consultant will
provide consulting services (the Services) to the Company as described on
Exhibit A attached to this Agreement. Consultant shall provide Services only as requested
by the Company.
2. Fees. As consideration for the Services to be provided by Consultant and other
obligations, the Company shall pay to Consultant the amounts specified in Exhibit B
attached to this Agreement at the times specified therein.
3. Expenses. Consultant shall not be authorized to incur on behalf of the Company any
expenses without the prior consent of the Companys Chief Business Officer, which consent shall be
evidenced in writing for any expenses in excess of $5,000 per month. As a condition to receipt of
reimbursement, Consultant shall be required to submit to the Company reasonable evidence that the
amount involved was expended and related to Services provided under this Agreement.
4. Term and Termination. Consultant shall serve as a consultant to the Company for a
period commencing on the Effective Date and terminating on December 31, 2009, unless sooner
terminated upon written notice of termination from the Company to Consultant or from Consultant to
the Company.
5. Independent Contractor. Consultants relationship with the Company will be that of
an independent contractor and not that of an employee.
(a) Method of Provision of Services. Consultant shall be solely responsible for
determining the method, details and means of performing the Services. Consultant may not employ or
engage the service of any third parties to perform the Services required by this Agreement.
(b) No Authority to Bind Company. Consultant has no authority to enter into contracts
that bind the Company or create obligations on the part of the Company without the prior written
authorization of the Company.
(c) No Benefits. Consultant acknowledges and agrees that Consultant (or Consultants
employees, if Consultant is an entity) will not be eligible for any Company employee benefits and,
to the extent Consultant (or Consultants employees, if Consultant is an entity) otherwise would be
eligible for any Company employee benefits but for the express terms of this Agreement, Consultant
(on behalf of itself and its employees) hereby expressly declines to participate in such Company
employee benefits.
(d) Withholding; Indemnification. Consultant shall have full responsibility for
applicable withholding taxes for all compensation paid to Consultant, its partners, agents or
its employees under this Agreement, and for compliance with all applicable labor and
employment requirements with respect to Consultants self-employment, sole proprietorship or other
form of business organization, and Consultants partners, agents and employees, including state
workers compensation insurance coverage requirements and any US immigration visa requirements.
6. Supervision of Consultants Services. All of the services to be performed by
Consultant, including but not limited to the Services, will be as agreed between Consultant and the
Companys Chief Business Officer. Consultant will be required to report to the Companys Chief
Business Officer concerning the Services performed under this Agreement. The nature and frequency
of these reports will be mutually determined by Consultant and the Companys Chief Business
Officer.
7. Confidentiality. During the performance of the Services, the Company may disclose
to Consultant, and Consultant may generate or develop, data and other information that the Company
regards as confidential and/or proprietary (including the terms of this Agreement) (collectively,
Confidential Information). Consultant will maintain all Confidential Information in confidence
and will employ reasonable procedures to prevent its unauthorized disclosure. Consultant will not
disclose any Confidential Information to anyone, or use any Confidential Information for any
purpose, other than as is necessary to perform the Services.
8. Inventions. Any inventions or discoveries (whether or not patentable or
copyrightable), innovations, suggestions and ideas (Inventions), and intellectual property rights
therein related to the Services or any Confidential Information, made, discovered or developed by
Consultant, jointly or with others, as a result of performing Services shall be promptly disclosed
to the Company and shall be the sole and exclusive property of the Company. Consultant hereby
assigns and agrees to assign to the Company any rights Consultant may have or acquire in any such
Inventions and agrees to assist the Company in every proper way to obtain and from time to time
enforce the Companys intellectual property rights, whether registrable or not, including, but not
limited to, patents, copyrights and trademarks on Inventions in any and all jurisdictions, and to
that end Consultant will execute all documents for use in applying for and obtaining intellectual
property rights covering and enforcing Inventions as the Company may desire, together with any
assignments of Inventions to the Company or persons designated by it.
9. Conflicts with this Agreement. Consultant represents and warrants that neither
Consultant nor any of Consultants partners, employees or agents is under any pre-existing
obligation in conflict or in any way inconsistent with the provisions of this Agreement. Consultant
represents and warrants that Consultants performance of all the terms of this Agreement will not
breach any agreement to keep in confidence proprietary information acquired by Consultant in
confidence or in trust prior to commencement of this Agreement. Consultant warrants that Consultant
has the right to disclose and/or or use all ideas, processes, techniques and other information, if
any, which Consultant has gained from third parties, and which Consultant discloses to the Company
or uses in the course of performance of this Agreement, without liability to such third parties.
Notwithstanding the foregoing, Consultant agrees that Consultant shall not bundle with or
incorporate into any deliveries provided to the Company herewith any third party products, ideas,
processes, or other techniques, without the express, written prior approval of the Company.
Consultant represents and warrants that Consultant has not granted and will not grant any rights or
licenses to any intellectual property or technology that would conflict with Consultants
obligations under this Agreement. Consultant will not knowingly infringe upon any copyright,
patent, trade secret or other property
right of any former client, employer or third party in the performance of the Services
required by this Agreement.
-2-
10. Miscellaneous.
(a) Amendments and Waivers. Any term of this Agreement may be amended or waived only
with the written consent of the parties.
(b) Sole Agreement. This Agreement, including the Exhibits hereto, constitutes the
sole agreement of the parties and supersedes all oral negotiations and prior writings with respect
to the subject matter hereof. The foregoing notwithstanding, the Company and Consultant
acknowledge that this Agreement is entered into in connection with that certain Confidential
Separation Agreement and General Release of All Claims (the Separation Agreement), and that this
Agreement has no effect on the Separation Agreement or any of the documents or other agreements
referenced therein or executed in connection therewith.
(c) Notices. Any notice required or permitted by this Agreement shall be in writing
and shall be deemed sufficient upon receipt, when delivered personally or by courier, overnight
delivery service or confirmed facsimile, 48 hours after being deposited in the regular mail as
certified or registered mail (airmail if sent internationally) with postage prepaid, if such notice
is addressed to the party to be notified at such partys address or facsimile number as set forth
below, or as subsequently modified by written notice.
(d) Choice of Law. The validity, interpretation, construction and performance of this
Agreement shall be governed by the laws of the State of California as applied to agreements among
California residents entered into and to be performed entirely within California.
(e) Severability. If one or more provisions of this Agreement are held to be
unenforceable under applicable law, the parties agree to renegotiate such provision in good faith.
In the event that the parties cannot reach a mutually agreeable and enforceable replacement for
such provision, then (i) such provision shall be excluded from this Agreement, (ii) the balance of
the Agreement shall be interpreted as if such provision were so excluded and (iii) the balance of
the Agreement shall be enforceable in accordance with its terms.
(f) Counterparts. This Agreement may be executed in counterparts, each of which shall
be deemed an original, but all of which together will constitute one and the same instrument.
(g) Arbitration. Any dispute or claim arising out of or in connection with any
provision of this Agreement will be finally settled by binding arbitration in San Diego County,
California, in accordance with the rules of the American Arbitration Association by one arbitrator
appointed in accordance with said rules. The arbitrator shall apply California law, as applied to
agreements among California residents entered into and to be performed entirely within California,
to the resolution of any dispute. Judgment on the award rendered by the arbitrator may be entered
in any court having jurisdiction thereof. Notwithstanding the foregoing, the parties may apply to
any court of competent jurisdiction for preliminary or interim equitable relief, or to compel
arbitration in accordance with this paragraph, without breach of this arbitration provision. This
Section 10(g) shall not apply to Section 7 hereof.
(h) Advice of Counsel. EACH PARTY ACKNOWLEDGES THAT, IN EXECUTING THIS AGREEMENT,
SUCH PARTY HAS HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND HAS READ
AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE
CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION HEREOF.
-3-
The parties have executed this Agreement on the respective dates set forth below.
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ADVENTRX PHARMACEUTICALS, INC. |
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By: |
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Name: Patrick Keran |
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Title: Vice President, Legal |
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Date: December 31, 2008 |
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Address:
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6725 Mesa Ridge Road,
Suite 100
San Diego, CA 92121 |
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MARK N. K. BAGNALL |
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Signature |
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Date: |
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Address:
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5341 Golden Gate Ave.
Oakland, CA 94618 |
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-4-
EXHIBIT A
DESCRIPTION OF CONSULTING SERVICES
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Description of Services |
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Schedule/Deadline |
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Consultant will: |
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Not applicable |
Make himself reasonably available to
assist the Company in identifying and
evaluating strategic options, including
particular strategic transaction candidates,
as requested by the Company. |
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Respond to inquiries of the
Companys personnel regarding finance
matters, and such other matters related to
the Company regarding which Consultant has
knowledge. |
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EXHIBIT B
COMPENSATION
For Services rendered by Consultant under this Agreement, the Company shall pay Consultant at
the rate of $100 per hour.
Consultant will invoice the Company within 10 days of the end of each calendar month for
services provided during the preceding month. Invoices will be due within 30 days of receipt of
an invoice reasonably acceptable to the Company.
Exhibit 10.3
Exhibit 10.3
RETENTION AND INCENTIVE AGREEMENT
This Retenion and Incentive Agreement (this Agreement) is made as of January 28, 2009 (the
Effective Date) by and between Adventrx Pharmaceuticals, Inc., a Delaware corporation (the
Company), and Patrick L. Keran, an individual resident of the State of California (Employee).
Certain capitalized terms used in this Agreement are defined in Section 12 below.
1. At-Will Employment. Employees employment is and shall continue to be at-will, as
defined under applicable law. If Employees employment terminates for any reason, Employee shall
not be entitled to any payments, benefits, damages, awards or compensation other than as provided
by this Agreement or required by applicable law, or as may otherwise be established under the
Companys then existing employee benefit plans or policies at the time of termination.
2. Severance Benefits. If Employees employment with the Company terminates as a
result of an Involuntary Termination at any time, and Employee delivers (and does not revoke) the
Release (as defined in Section 8 below), then Employee shall be entitled to an amount payable by
the Company to Employee equal to the Severance Payment, less applicable withholdings, which amount
shall be payable in a lump-sum on the date determined pursuant to Section 8.
3. Issuance of Restricted Stock Units. The Company shall execute a Notice of Grant of
Restricted Stock Units in substantially the form of Exhibit A attached hereto pursuant to which
Employee shall be granted an award of Restricted Stock Units pursuant to the Companys 2008 Omnibus
Incentive Plan (the Award); provided, however, that the Company has received a written waiver
under that certain Rights Agreement, dated July 25, 2005, as amended (the Rights Agreement), that
allows the Company to grant the Award without complying with the participation rights (and any
related rights, including rights to notice) set forth in the Rights Agreement.
4. Other Terminations. If Employees employment with the Company is terminated, other
than as a result of an Involuntary Termination, then Employee shall not be entitled to the benefits
of Section 2 of this Agreement.
5. Accrued Wages and Vacation, Expenses. Without regard to the reason for, or the
timing of, Employees termination of employment: (i) the Company shall pay Employee any unpaid base
salary due for periods prior to and including the Termination Date; (ii) the Company shall pay
Employee all of Employees accrued and unused vacation through the Termination Date; and (iii)
following submission of proper expense reports by Employee, the Company shall reimburse Employee
for all expenses reasonably and necessarily incurred by Employee in connection with the business of
the Company prior to the Termination Date. These payments shall be made promptly upon termination
and within the period of time mandated by law (including but limited to Section 409A of the
Internal Revenue Code of 1986, as amended (the Code)).
6. Limitation on Payments. In the event it shall be determined that any compensation
by or benefit from the Company to Employee or for Employees benefit, whether pursuant to the terms
of this Agreement or otherwise (collectively, the Payments), (i) constitute parachute payments
within the meaning of Section 280G of the Code, and (ii) would be subject to the excise tax imposed
by Section 4999 of the Code (the Excise Tax), then Employees benefits under this Agreement shall
be either:
(a) delivered in full, or
(b) delivered as to such lesser extent which would result in no portion of such benefits being
subject to the Excise Tax,
whichever of the foregoing amounts, taking into account the applicable federal, state and local
income taxes and the Excise Tax, results in the receipt by Employee on an after-tax basis of the
greatest amount of benefits, notwithstanding that all or some portion of such benefits may be
taxable under Section 4999 of the Code.
Unless the Company and Employee otherwise agree in writing, any determination required under
this Section 6 shall be made in writing by the Companys independent public accountants (the
Accountants), whose determination shall be conclusive and binding upon Employee and the Company
for all purposes. For purposes of making the calculations required by this Section 6, the
Accountants may make reasonable assumptions and approximations concerning applicable taxes and may
rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999
of the Code. The Company and Employee shall furnish to the Accountants such information and
documents as the Accountants may reasonably request in order to make a determination under this
Section 6. The Company shall bear all costs the Accountants may reasonably incur in connection
with any calculations contemplated by this Section 6.
In the event that Payments must be reduced, then the Payments will be reduced in accordance
with the following order of priority: (a) first, Full Credit Payments (as defined below) will be
reduced in reverse chronological order such that the payment owed on the latest date following the
occurrence of the event triggering the Excise Tax will be the first Payment to be reduced until
such Payment is reduced to zero, and then the Payment owed on the next latest date following
occurrence of the event triggering the Excise Tax will be the second Payment to be reduced until
such payment is equal to zero, and so forth, until all such Full Credit Payments have been reduced
to zero, and (b) second, Partial Credit Payments (as defined below) will be reduced in a manner
such as to obtain the best economic benefit for the employee so that after giving effect to such
reduction, the employee retains the greatest economic value of such Partial Credit Payments. Full
Credit Payment means a payment, distribution or benefit, whether paid or payable or distributed or
distributable pursuant to the terms of this Agreement or otherwise, that if reduced in value by one
dollar reduces the amount of the parachute payment by one dollar. Partial Credit Payment means a
payment, distribution or benefit, whether paid or payable or distributed or distributable pursuant
to the terms of this letter or otherwise, that if reduced in value by one dollar reduces the amount
of the parachute payment by an amount that is less than one dollar. For clarification purposes
only, a Partial Credit Payment would include a stock option as to which vesting is accelerated
upon an event that triggers the Excise Tax, where the in the money value of the option exceeds the
value of the option acceleration that is added to the parachute payment.
7. Companys Successors. Any successor to the Company (whether direct or indirect and
whether by purchase, license, lease, merger, consolidation, liquidation or otherwise) to all or
substantially all of the Companys business and/or assets shall not later than the closing or
consummation of such succession assume the Companys obligations under this Agreement and agree
expressly to perform the Companys obligations under this Agreement in the same manner and to the
same extent as the Company would be required to perform such obligations in the absence of a
succession. For all purposes under this Agreement, the term Company shall include any successor
to the Companys business and/or assets which executes and delivers the assumption agreement
described in this section or which becomes bound by the terms of this Agreement by operation of
law.
8. Execution of Release Agreement upon Termination. As a condition of receiving the
benefits under Section 2 of this Agreement, Employee shall execute and not revoke a general release
of claims, which will also confirm any post-termination obligations and/or restrictions applicable
to Employee (the Release), such that the Release becomes effective no later than 60 days
following the Termination Date (the Release Deadline). The benefits under Section 2 shall be
paid on the date the Release is effective; provided, however, that, in the event Employees
separation occurs at a time during the calendar year where it would be possible for the Release to
become effective in the calendar year following the calendar year in which Employees separation
occurs, any severance that would be considered deferred compensation (as defined in Section 409A of
the Code) will be paid on the first payroll date to occur immediately following the Release
Deadline.
9. Notices.
(a) General. Notices and all other communications contemplated by this Agreement
shall be in writing and shall be deemed to have been duly given when personally delivered or when
mailed by U.S. registered or certified mail, return receipt requested and postage prepaid. In the
case of Employee, mailed notices shall be addressed to him or her at the home address that he or
she most recently communicated to the Company in writing. In the case of the Company, mailed
notices shall be addressed to its corporate headquarters, and all notices shall be directed to the
attention of its Secretary.
(b) Notice of Termination. Any termination by the Company with or without Cause or by
Employee as a result of an Involuntary Termination other than an Involuntary Termination pursuant
to Section 12(b)(vi) shall be communicated by a notice of termination to the other party hereto
given in accordance with this Section 9. Any such notice provided by the Company under
circumstances constituting a for-Cause termination, or by Employee under circumstances constituting
such an Involuntary Termination, shall indicate the specific termination provision in this
Agreement relied upon, shall set forth in reasonable detail the facts and circumstances claimed to
provide a basis for termination under the provision so indicated, and shall specify the Termination
Date (which shall be not more than 30 days after the giving of such notice). The failure by either
party to include in the notice any fact or circumstance which contributes to a showing of a
for-Cause termination or an Involuntary Termination shall not waive any right of such party
hereunder or preclude such party from asserting such fact or circumstance in enforcing such partys
rights hereunder.
10. Arbitration.
(a) Any dispute or controversy arising out of, relating to, or in connection with this
Agreement, or the interpretation, validity, construction, performance, breach, or termination
thereof, shall be settled by binding arbitration to be held in the County of San Diego, State of
California in accordance with the National Rules for the Resolution of Employment Disputes then in
effect of the American Arbitration Association (the Rules). The arbitrator may grant injunctions
or other relief in such dispute or controversy. The decision of the arbitrator shall be final,
conclusive and binding on the parties to the arbitration. Judgment may be entered on the
arbitrators decision in any court having jurisdiction.
(b) The arbitrator(s) shall apply California law to the merits of any dispute or claim,
without reference to conflicts of law rules. The arbitration proceedings shall be governed by
federal arbitration law and by the Rules, without reference to state arbitration law. Employee and
the Company consent to the personal jurisdiction of the state and federal courts located in
California for any action or proceeding arising from or relating to this Agreement or relating to
any arbitration in which the parties are participants.
(c) Nothing in this Section 10 modifies Employees at-will employment status. Either Employee
or the Company can terminate the employment relationship at any time, with or without Cause.
(d) SUBMISSION OF ANY CLAIMS ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS
AGREEMENT, OR THE INTERPRETATION, VALIDITY, CONSTRUCTION, PERFORMANCE, BREACH OR TERMINATION
THEREOF TO BINDING ARBITRATION, CONSTITUTES A WAIVER OF THE PARTYS RIGHT TO A JURY TRIAL AND
RELATES TO THE RESOLUTION OF ALL DISPUTES RELATING TO ALL ASPECTS OF THE EMPLOYER/EMPLOYEE
RELATIONSHIP, INCLUDING BUT NOT LIMITED TO, THE FOLLOWING CLAIMS:
(i) ANY AND ALL CLAIMS FOR WRONGFUL DISCHARGE OF EMPLOYMENT; BREACH OF CONTRACT, BOTH EXPRESS
AND IMPLIED; BREACH OF THE COVENANT OF GOOD FAITH AND FAIR DEALING, BOTH EXPRESS AND IMPLIED;
NEGLIGENT OR INTENTIONAL INFLICTION OF EMOTIONAL DISTRESS; NEGLIGENT OR INTENTIONAL
MISREPRESENTATION; NEGLIGENT OR INTENTIONAL INTERFERENCE WITH CONTRACT OR PROSPECTIVE ECONOMIC
ADVANTAGE; AND DEFAMATION;
(ii) ANY AND ALL CLAIMS FOR VIOLATION OF ANY FEDERAL STATE OR MUNICIPAL STATUTE, INCLUDING,
BUT NOT LIMITED TO, TITLE VII OF THE CIVIL RIGHTS ACT OF 1964, THE CIVIL RIGHTS ACT OF 1991, THE
AGE DISCRIMINATION IN EMPLOYMENT ACT OF 1967, THE AMERICANS WITH DISABILITIES ACT OF 1990, THE FAIR
LABOR STANDARDS ACT, THE CALIFORNIA FAIR EMPLOYMENT AND HOUSING ACT, AND LABOR CODE SECTION 201, et
seq; and
(iii) ANY AND ALL CLAIMS ARISING OUT OF ANY OTHER LAWS AND REGULATIONS RELATING TO EMPLOYMENT
OR EMPLOYMENT DISCRIMINATION.
11. Accrued Obligation. The Companys obligations under this Agreement, including its
obligations pursuant to Section 2, shall accrue and be owing as of the Effective Date and the
rights of Employee hereunder shall vest immediately but remain contingent and conditioned on the
occurrence of an Involuntary Termination and Employee delivering (and not revoking) a release of
claims as required under Section 8. For clarity, the Company shall treat its obligations hereunder
as outstanding as of the date hereof, including for purposes of determining its insolvency, and the
Companys obligations hereunder shall be due and payable regardless of any subsequent insolvency of
the Company.
12. Definition of Terms. The following terms referred to in this Agreement shall have
the following meanings:
(a) Cause. Cause shall mean (i) any act of personal dishonesty taken by Employee in
connection with his or her responsibilities as an employee which is intended to result in
substantial personal enrichment of Employee, (ii) Employees conviction of a felony that the Board
reasonably believes has had or will have a material detrimental effect on the Companys reputation
or business, (iii) a willful act by Employee that constitutes misconduct and is injurious to the
Company, or (iv) continued willful violations by Employee of Employees obligations to the Company
after there has been delivered to Employee a written demand for performance from the Company that
describes the basis for the Companys belief that Employee has not substantially performed his or
her duties.
(b) Involuntary Termination. Involuntary Termination shall mean (i) without
Employees express written consent, a significant reduction of Employees duties, position or
responsibilities relative to Employees duties, position or responsibilities in effect immediately
prior to such reduction, or the removal of Employee from such position, duties and
responsibilities; (ii) without Employees express written consent, a material reduction by the
Company of Employees base salary as in effect immediately prior to such reduction; (iii) without
Employees express written consent, a material reduction by the Company in the kind or level of
employee benefits (including cash and stock bonus plans) to which Employee is entitled immediately
prior to such reduction which results in a material adverse change to Employees employment
relationship; (iv) without Employees express written consent, the relocation of Employee to a
facility or a location that results in an increase in Employees one-way commute from Employees
residence immediately prior to such relocation by more than fifty (50) miles; (v) any purported
termination of Employee by the Company which is not effected for Cause; or (vi) a material breach
of this Agreement by the Company, including, but not limited to the failure of the Company to
obtain the assumption of this Agreement by any successors contemplated in Section 7.
(c) Severance Payment. Severance Payment shall mean Employees then-current base
salary multiplied by a fraction, the numerator of which is the number of calendar days between the
Termination Date and September 30, 2009 (not including the Termination Date but including September
30, 2009) and the demonitator of which is 365.
(d) Termination Date. Termination Date shall mean the date specified in a notice of
termination as contemplated under Section 9(b).
13. Miscellaneous Provisions.
(a) Amendment or Termination. The Board may in its sole discretion amend or terminate
this Agreement at any time and in any manner; provided, however, that the Board may not
terminate or amend this Agreement in a way that is materially adverse to Employee without the
written consent of Employee; provided further that notwithstanding anything to the contrary
contained in this paragraph or in this Agreement, it is the parties intent that no payment made or
to be made hereunder shall be subject to the provisions of Section 409A(a)(1)(B) of the Internal
Revenue Code, as amended, and accordingly, the parties agree that this Agreement and Employees
rights under it shall be amended to conform to their intent as set forth in this proviso.
(b) Effect of Statutory Benefits. To the extent that any severance benefits are
required to be paid to Employee upon termination of employment with the Company as a result of any
requirement of law or any governmental entity in any applicable jurisdiction, the aggregate amount
of severance benefits payable pursuant to Section 2 shall be reduced by such amount.
(c) No Duty to Mitigate. Employee shall not be required to mitigate the amount of any
payment contemplated by this Agreement, nor shall any such payment be reduced by any earnings that
Employee may receive from any other source.
(d) Waiver. No provision of this Agreement may be waived or discharged unless the
waiver or discharge is agreed to in writing and signed by Employee and by an authorized officer of
the Company (other than Employee). No waiver by either party of any breach of, or of compliance
with, any condition or provision of this Agreement by the other party shall be considered a waiver
of any other condition or provision or of the same condition or provision at another time.
(e) Integration. This Agreement supersedes all prior or contemporaneous agreements,
whether written or oral, with respect to this Agreement; provided, however, that, for
clarification purposes, this Agreement shall not affect any agreements between the Company and
Employee regarding intellectual property matters, non-solicitation restrictions or confidential
information of the Company. In addition, except as set forth in Sections 3 and 6, nothing in this
Agreement shall be construed as impacting any equity award granted to an employee.
(f) Choice of Law. The validity, interpretation, construction and performance of this
Agreement shall be governed by the internal substantive laws, but not the conflicts of law rules,
of the State of California as applied to agreements among California residents entered into and to
be performed entirely within California.
(g) Severability. The invalidity or unenforceability of any provision or provisions
of this Agreement shall not affect the validity or enforceability of any other provision hereof,
which shall remain in full force and effect.
(h) Employment Taxes. Employee is responsible for any applicable taxes of any nature
(including any penalties or interest that may apply to such taxes) that the Company reasonably
determines apply to any payment made hereunder. Employees receipt of any benefit hereunder is
conditioned on his or her satisfaction of any applicable withholding or similar obligations that
apply to such benefit, and any cash payment owed hereunder will be reduced to satisfy any such
withholding or similar obligations that may apply.
(i) Section 409A of the Code.
(i) This Agreement is intended to comply with, or otherwise be exempt from, Section 409A of
the Code and any regulations and Treasury guidance promulgated thereunder. The Company shall
undertake to administer, interpret, and construe this Agreement in a manner that does not result in
the imposition on an employee of any additional tax, penalty, or interest under Section 409A of the
Code. If the Company determines in good faith that any provision of this Agreement would cause
employees to incur an additional tax, penalty, or interest under Section 409A of the Code, the
Board may, without the consent of any employee, amend this Agreement as may be necessary to ensure
compliance with the distribution provisions of Section 409A of the Code or as otherwise needed to
ensure that this Agreement complies with Section 409A of the Code. The preceding provisions,
however, shall not be construed as a guarantee by the Company of any particular tax effect to an
employee under this Agreement. The Company shall not be liable to any employee for any payment
made under this Agreement that is determined to result in an additional tax, penalty, or interest
under Section 409A of the Code, nor for reporting in good faith any payment made under this
Agreement as an amount includible in gross income under Section 409A of the Code.
(ii) Termination of employment, resignation, or words of similar import, as used in this
Agreement, mean, for purposes of any payments under this Agreement that are payments of deferred
compensation subject to Section 409A of the Code, the employees separation from service as
defined in Section 409A of the Code.
(iii) If a payment obligation under this Agreement arises on account of the employees
separation from service while the employee is a specified employee (as defined under Section 409A
of the Code and determined in good faith by the Company), any payment of deferred compensation
(as defined under Treasury Regulation Section 1.409A-1(b)(1), after giving effect to the exemptions
in Treasury Regulation Sections 1.409A-1(b)(3) through (b)(12)) that is scheduled to be paid within
six (6) months after such separation from service shall accrue without interest and shall be paid
within 15 days after the end of the six-month period beginning on the date of such separation from
service or, if earlier, within 15 days after his or her death.
The parties have executed this Retention and Incentive Agreement as of the Effective Date.
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COMPANY: |
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ADVENTRX PHARMACEUTICALS, INC. |
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By: |
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/s/ Brian M. Culley |
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Name:
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Brian M. Culley |
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Title:
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Chief Business Officer and Senior Vice President |
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EMPLOYEE: |
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/s/ Patrick L. Keran |
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Patrick L. Keran
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Exhibit A
NOTICE OF GRANT OF RESTRICTED STOCK UNITS
(including Restricted Stock Units Agreement)
ADVENTRX PHARMACEUTICALS, INC.
NOTICE OF GRANT OF RESTRICTED STOCK UNITS
The Participant has been granted an award of Restricted Stock Units (the Award) pursuant to
the ADVENTRX Pharmaceuticals, Inc. 2008 Omnibus Incentive Plan (the Plan), each of which
represents the right to receive on the Settlement Date (described below) one (1) share of common
stock of ADVENTRX Pharmaceuticals, Inc., par value $0.001 per share, as follows:
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Participant:
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Patrick L. Keran |
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Grant Date:
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January 30, 2009 |
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Number of Restricted Stock Units:
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850,000, subject to adjustment as
provided by the Restricted Stock
Units Agreement. |
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Settlement Date:
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For each Restricted Stock Unit,
except as otherwise provided by the
Restricted Stock Units Agreement,
the date on which the units become
Vested Units in accordance with the
vesting schedule set forth below. |
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Vested Units:
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Except as provided by the Restricted
Stock Units Agreement and provided
that the Participants Services have
not terminated prior to the
consummation of a Strategic
Transaction (as defined below), one
hundred percent (100%) of the
Restricted Stock Units shall vest
immediately prior to the
consummation of a Strategic
Transaction. |
A Strategic Transaction shall mean: (a) any transaction or series of related transactions or
any plan (including, without limitation, any reorganization, merger, consolidation, exchange or
sale of stock or other securities) in which the stockholders of the Company as constituted
immediately prior to the consummation of such transaction, transactions or plan will, immediately
after the consummation of such transaction, transactions or plan and as a result of securities
issued as consideration for such transaction, transactions or plan, fail to hold at least 50% of
the outstanding voting capital stock of the resulting or surviving entity (or its parent if the
surviving entity is wholly owned by such parent entity); (b) any transaction or series of related
transactions or any plan (including, without limitation, any reorganization, merger, consolidation,
exchange or sale of stock or other securities) in which the stockholders of a subsidiary of the
Company as constituted immediately prior to the consummation of such transaction, transactions or
plan (including a wholly-owned subsidiary) will, immediately after the consummation of such
transaction, transactions or plan and as a result of securities issued as consideration for such
transaction, transactions or plan, fail to hold at least 50% of the outstanding voting capital
stock of the resulting or surviving entity (or its parent if the surviving entity is wholly owned
by such parent entity); (c) a sale, transfer, lease or other disposition by means of any
transaction or series of related transactions or any plan of all or substantially all of the assets
of the Company; (d) the assignment, transfer, lease, sale or other disposition by means of any
transaction or series of related transactions or any plan of all or substantially all of the assets
of one or more subsidiaries of the Company, the assets of which constitute all or substantially all
of the assets of the Company and its subsidiaries taken as a whole; (e) the grant of, among other
things, an exclusive license under the Companys patents and patent applications related to ANX-514
to make, use or sell products covered by such patents and patent applications in the United States
for the treatment of cancer by intravenous administration of formulations consisting of emulsified
products; and (f) any transaction that the Board or the Committee determines constitutes a
Strategic Transaction.
By their signatures below or by electronic acceptance or authentication in a form authorized
by the Company, the Company and the Participant agree that the Award is governed by this Notice and
by the provisions of the Plan and the Restricted Stock Units Agreement, both of which are made a
part of this document. The Participant represents that the Participant has read and is familiar
with the provisions of the Plan and Restricted Stock Units Agreement, and hereby accepts the Award
subject to all of their respective terms and conditions.
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ADVENTRX PHARMACEUTICALS, INC. |
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PARTICIPANT |
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By: |
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Its: |
Chief Business Officer and SVP |
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Signature |
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Date
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Address: |
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6725 Mesa Ridge Rd., Suite 100 |
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San Diego, CA 92121
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ATTACHMENTS:
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2008 Omnibus Incentive Plan, as amended to the Grant Date
Restricted Stock Units Agreement
Plan Prospectus |
2
Exhibit 10.4
Exhibit 10.4
RETENTION AND INCENTIVE AGREEMENT
This Retenion and Incentive Agreement (this Agreement) is made as of January 28, 2009 (the
Effective Date) by and between Adventrx Pharmaceuticals, Inc., a Delaware corporation (the
Company), and Mark E. Erwin, an individual resident of the State of California (Employee).
Certain capitalized terms used in this Agreement are defined in Section 12 below.
1. At-Will Employment. Employees employment is and shall continue to be at-will, as
defined under applicable law. If Employees employment terminates for any reason, Employee shall
not be entitled to any payments, benefits, damages, awards or compensation other than as provided
by this Agreement or required by applicable law, or as may otherwise be established under the
Companys then existing employee benefit plans or policies at the time of termination.
2. Severance Benefits. If Employees employment with the Company terminates as a
result of an Involuntary Termination at any time, and Employee delivers (and does not revoke) the
Release (as defined in Section 8 below), then Employee shall be entitled to an amount payable by
the Company to Employee equal to the Severance Payment, less applicable withholdings, which amount
shall be payable in a lump-sum on the date determined pursuant to Section 8.
3. Issuance of Restricted Stock Units. The Company shall execute a Notice of Grant of
Restricted Stock Units in substantially the form of Exhibit A attached hereto pursuant to which
Employee shall be granted an award of Restricted Stock Units pursuant to the Companys 2008 Omnibus
Incentive Plan (the Award); provided, however, that the Company has received a written waiver
under that certain Rights Agreement, dated July 25, 2005, as amended (the Rights Agreement), that
allows the Company to grant the Award without complying with the participation rights (and any
related rights, including rights to notice) set forth in the Rights Agreement.
4. Other Terminations. If Employees employment with the Company is terminated, other
than as a result of an Involuntary Termination, then Employee shall not be entitled to the benefits
of Section 2 of this Agreement.
5. Accrued Wages and Vacation, Expenses. Without regard to the reason for, or the
timing of, Employees termination of employment: (i) the Company shall pay Employee any unpaid base
salary due for periods prior to and including the Termination Date; (ii) the Company shall pay
Employee all of Employees accrued and unused vacation through the Termination Date; and (iii)
following submission of proper expense reports by Employee, the Company shall reimburse Employee
for all expenses reasonably and necessarily incurred by Employee in connection with the business of
the Company prior to the Termination Date. These payments shall be made promptly upon termination
and within the period of time mandated by law (including but limited to Section 409A of the
Internal Revenue Code of 1986, as amended (the Code)).
6. Limitation on Payments. In the event it shall be determined that any compensation
by or benefit from the Company to Employee or for Employees benefit, whether pursuant to the terms
of this Agreement or otherwise (collectively, the Payments), (i) constitute parachute payments
within the meaning of Section 280G of the Code, and (ii) would be subject to the excise tax imposed
by Section 4999 of the Code (the Excise Tax), then Employees benefits under this Agreement shall
be either:
(a) delivered in full, or
(b) delivered as to such lesser extent which would result in no portion of such benefits being
subject to the Excise Tax,
whichever of the foregoing amounts, taking into account the applicable federal, state and local
income taxes and the Excise Tax, results in the receipt by Employee on an after-tax basis of the
greatest amount of benefits, notwithstanding that all or some portion of such benefits may be
taxable under Section 4999 of the Code.
Unless the Company and Employee otherwise agree in writing, any determination required under
this Section 6 shall be made in writing by the Companys independent public accountants (the
Accountants), whose determination shall be conclusive and binding upon Employee and the Company
for all purposes. For purposes of making the calculations required by this Section 6, the
Accountants may make reasonable assumptions and approximations concerning applicable taxes and may
rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999
of the Code. The Company and Employee shall furnish to the Accountants such information and
documents as the Accountants may reasonably request in order to make a determination under this
Section 6. The Company shall bear all costs the Accountants may reasonably incur in connection
with any calculations contemplated by this Section 6.
In the event that Payments must be reduced, then the Payments will be reduced in accordance
with the following order of priority: (a) first, Full Credit Payments (as defined below) will be
reduced in reverse chronological order such that the payment owed on the latest date following the
occurrence of the event triggering the Excise Tax will be the first Payment to be reduced until
such Payment is reduced to zero, and then the Payment owed on the next latest date following
occurrence of the event triggering the Excise Tax will be the second Payment to be reduced until
such payment is equal to zero, and so forth, until all such Full Credit Payments have been reduced
to zero, and (b) second, Partial Credit Payments (as defined below) will be reduced in a manner
such as to obtain the best economic benefit for the employee so that after giving effect to such
reduction, the employee retains the greatest economic value of such Partial Credit Payments. Full
Credit Payment means a payment, distribution or benefit, whether paid or payable or distributed or
distributable pursuant to the terms of this Agreement or otherwise, that if reduced in value by one
dollar reduces the amount of the parachute payment by one dollar. Partial Credit Payment means a
payment, distribution or benefit, whether paid or payable or distributed or distributable pursuant
to the terms of this letter or otherwise, that if reduced in value by one dollar reduces the amount
of the parachute payment by an amount that is less than one dollar. For clarification purposes
only, a Partial Credit Payment would include a stock
option as to which vesting is accelerated upon an event that triggers the Excise Tax, where
the in the money value of the option exceeds the value of the option acceleration that is added to
the parachute payment.
7. Companys Successors. Any successor to the Company (whether direct or indirect and
whether by purchase, license, lease, merger, consolidation, liquidation or otherwise) to all or
substantially all of the Companys business and/or assets shall not later than the closing or
consummation of such succession assume the Companys obligations under this Agreement and agree
expressly to perform the Companys obligations under this Agreement in the same manner and to the
same extent as the Company would be required to perform such obligations in the absence of a
succession. For all purposes under this Agreement, the term Company shall include any successor
to the Companys business and/or assets which executes and delivers the assumption agreement
described in this section or which becomes bound by the terms of this Agreement by operation of
law.
8. Execution of Release Agreement upon Termination. As a condition of receiving the
benefits under Section 2 of this Agreement, Employee shall execute and not revoke a general release
of claims, which will also confirm any post-termination obligations and/or restrictions applicable
to Employee (the Release), such that the Release becomes effective no later than 60 days
following the Termination Date (the Release Deadline). The benefits under Section 2 shall be
paid on the date the Release is effective; provided, however, that, in the event Employees
separation occurs at a time during the calendar year where it would be possible for the Release to
become effective in the calendar year following the calendar year in which Employees separation
occurs, any severance that would be considered deferred compensation (as defined in Section 409A of
the Code) will be paid on the first payroll date to occur immediately following the Release
Deadline.
9. Notices.
(a) General. Notices and all other communications contemplated by this Agreement
shall be in writing and shall be deemed to have been duly given when personally delivered or when
mailed by U.S. registered or certified mail, return receipt requested and postage prepaid. In the
case of Employee, mailed notices shall be addressed to him or her at the home address that he or
she most recently communicated to the Company in writing. In the case of the Company, mailed
notices shall be addressed to its corporate headquarters, and all notices shall be directed to the
attention of its Secretary.
(b) Notice of Termination. Any termination by the Company with or without Cause or by
Employee as a result of an Involuntary Termination other than an Involuntary Termination pursuant
to Section 12(b)(vi) shall be communicated by a notice of termination to the other party hereto
given in accordance with this Section 9. Any such notice provided by the Company under
circumstances constituting a for-Cause termination, or by Employee under circumstances constituting
such an Involuntary Termination, shall indicate the specific termination provision in this
Agreement relied upon, shall set forth in reasonable detail the facts and circumstances claimed to
provide a basis for termination under the provision so indicated, and shall specify the Termination
Date (which shall be not more than 30 days after the giving of such notice). The failure by either
party to include in the notice any fact or circumstance which contributes to a showing of a
for-Cause termination or an Involuntary Termination shall not waive any right of such party
hereunder or preclude such party from asserting such fact or circumstance in enforcing such partys
rights hereunder.
10. Arbitration.
(a) Any dispute or controversy arising out of, relating to, or in connection with this
Agreement, or the interpretation, validity, construction, performance, breach, or termination
thereof, shall be settled by binding arbitration to be held in the County of San Diego, State of
California in accordance with the National Rules for the Resolution of Employment Disputes then in
effect of the American Arbitration Association (the Rules). The arbitrator may grant injunctions
or other relief in such dispute or controversy. The decision of the arbitrator shall be final,
conclusive and binding on the parties to the arbitration. Judgment may be entered on the
arbitrators decision in any court having jurisdiction.
(b) The arbitrator(s) shall apply California law to the merits of any dispute or claim,
without reference to conflicts of law rules. The arbitration proceedings shall be governed by
federal arbitration law and by the Rules, without reference to state arbitration law. Employee and
the Company consent to the personal jurisdiction of the state and federal courts located in
California for any action or proceeding arising from or relating to this Agreement or relating to
any arbitration in which the parties are participants.
(c) Nothing in this Section 10 modifies Employees at-will employment status. Either Employee
or the Company can terminate the employment relationship at any time, with or without Cause.
(d) SUBMISSION OF ANY CLAIMS ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS
AGREEMENT, OR THE INTERPRETATION, VALIDITY, CONSTRUCTION, PERFORMANCE, BREACH OR TERMINATION
THEREOF TO BINDING ARBITRATION, CONSTITUTES A WAIVER OF THE PARTYS RIGHT TO A JURY TRIAL AND
RELATES TO THE RESOLUTION OF ALL DISPUTES RELATING TO ALL ASPECTS OF THE EMPLOYER/EMPLOYEE
RELATIONSHIP, INCLUDING BUT NOT LIMITED TO, THE FOLLOWING CLAIMS:
(i) ANY AND ALL CLAIMS FOR WRONGFUL DISCHARGE OF EMPLOYMENT; BREACH OF CONTRACT, BOTH EXPRESS
AND IMPLIED; BREACH OF THE COVENANT OF GOOD FAITH AND FAIR DEALING, BOTH EXPRESS AND IMPLIED;
NEGLIGENT OR INTENTIONAL INFLICTION OF EMOTIONAL DISTRESS; NEGLIGENT OR INTENTIONAL
MISREPRESENTATION; NEGLIGENT OR INTENTIONAL INTERFERENCE WITH CONTRACT OR PROSPECTIVE ECONOMIC
ADVANTAGE; AND DEFAMATION;
(ii) ANY AND ALL CLAIMS FOR VIOLATION OF ANY FEDERAL STATE OR MUNICIPAL STATUTE, INCLUDING,
BUT NOT LIMITED TO, TITLE VII OF THE CIVIL RIGHTS ACT OF 1964, THE CIVIL RIGHTS ACT OF 1991, THE
AGE DISCRIMINATION IN EMPLOYMENT ACT OF 1967, THE AMERICANS WITH DISABILITIES ACT OF 1990, THE FAIR
LABOR STANDARDS ACT, THE CALIFORNIA FAIR EMPLOYMENT AND HOUSING ACT, AND LABOR CODE SECTION 201, et
seq; and
(iii) ANY AND ALL CLAIMS ARISING OUT OF ANY OTHER LAWS AND REGULATIONS RELATING TO EMPLOYMENT
OR EMPLOYMENT DISCRIMINATION.
11. Accrued Obligation. The Companys obligations under this Agreement, including its
obligations pursuant to Section 2, shall accrue and be owing as of the Effective Date and the
rights of Employee hereunder shall vest immediately but remain contingent and conditioned on the
occurrence of an Involuntary Termination and Employee delivering (and not revoking) a release of
claims as required under Section 8. For clarity, the Company shall treat its obligations hereunder
as outstanding as of the date hereof, including for purposes of determining its insolvency, and the
Companys obligations hereunder shall be due and payable regardless of any subsequent insolvency of
the Company.
12. Definition of Terms. The following terms referred to in this Agreement shall have
the following meanings:
(a) Cause. Cause shall mean (i) any act of personal dishonesty taken by Employee in
connection with his or her responsibilities as an employee which is intended to result in
substantial personal enrichment of Employee, (ii) Employees conviction of a felony that the Board
reasonably believes has had or will have a material detrimental effect on the Companys reputation
or business, (iii) a willful act by Employee that constitutes misconduct and is injurious to the
Company, or (iv) continued willful violations by Employee of Employees obligations to the Company
after there has been delivered to Employee a written demand for performance from the Company that
describes the basis for the Companys belief that Employee has not substantially performed his or
her duties.
(b) Involuntary Termination. Involuntary Termination shall mean (i) without
Employees express written consent, a significant reduction of Employees duties, position or
responsibilities relative to Employees duties, position or responsibilities in effect immediately
prior to such reduction, or the removal of Employee from such position, duties and
responsibilities; (ii) without Employees express written consent, a material reduction by the
Company of Employees base salary as in effect immediately prior to such reduction; (iii) without
Employees express written consent, a material reduction by the Company in the kind or level of
employee benefits (including cash and stock bonus plans) to which Employee is entitled immediately
prior to such reduction which results in a material adverse change to Employees employment
relationship; (iv) without Employees express written consent, the relocation of Employee to a
facility or a location that results in an increase in Employees one-way commute from Employees
residence immediately prior to such relocation by more than fifty (50) miles; (v) any purported
termination of Employee by the Company which is not effected for Cause; or (vi) a material breach
of this Agreement by the Company, including, but not limited to the failure of the Company to
obtain the assumption of this Agreement by any successors contemplated in Section 7.
(c) Severance Payment. Severance Payment shall mean Employees then-current base
salary multiplied by a fraction, the numerator of which is the number of calendar days between the
Termination Date and June 30, 2009 (not including the Termination Date but including June 30, 2009)
and the demonitator of which is 365.
(d) Termination Date. Termination Date shall mean the date specified in a notice of
termination as contemplated under Section 9(b).
13. Miscellaneous Provisions.
(a) Amendment or Termination. The Board may in its sole discretion amend or terminate
this Agreement at any time and in any manner; provided, however, that the Board may not
terminate or amend this Agreement in a way that is materially adverse to Employee without the
written consent of Employee; provided further that notwithstanding anything to the contrary
contained in this paragraph or in this Agreement, it is the parties intent that no payment made or
to be made hereunder shall be subject to the provisions of Section 409A(a)(1)(B) of the Internal
Revenue Code, as amended, and accordingly, the parties agree that this Agreement and Employees
rights under it shall be amended to conform to their intent as set forth in this proviso.
(b) Effect of Statutory Benefits. To the extent that any severance benefits are
required to be paid to Employee upon termination of employment with the Company as a result of any
requirement of law or any governmental entity in any applicable jurisdiction, the aggregate amount
of severance benefits payable pursuant to Section 2 shall be reduced by such amount.
(c) No Duty to Mitigate. Employee shall not be required to mitigate the amount of any
payment contemplated by this Agreement, nor shall any such payment be reduced by any earnings that
Employee may receive from any other source.
(d) Waiver. No provision of this Agreement may be waived or discharged unless the
waiver or discharge is agreed to in writing and signed by Employee and by an authorized officer of
the Company (other than Employee). No waiver by either party of any breach of, or of compliance
with, any condition or provision of this Agreement by the other party shall be considered a waiver
of any other condition or provision or of the same condition or provision at another time.
(e) Integration. This Agreement supersedes all prior or contemporaneous agreements,
whether written or oral, with respect to this Agreement; provided, however, that, for
clarification purposes, this Agreement shall not affect any agreements between the Company and
Employee regarding intellectual property matters, non-solicitation restrictions or confidential
information of the Company. In addition, except as set forth in Sections 3 and 6, nothing in this
Agreement shall be construed as impacting any equity award granted to an employee.
(f) Choice of Law. The validity, interpretation, construction and performance of this
Agreement shall be governed by the internal substantive laws, but not the conflicts of law rules,
of the State of California as applied to agreements among California residents entered into and to
be performed entirely within California.
(g) Severability. The invalidity or unenforceability of any provision or provisions
of this Agreement shall not affect the validity or enforceability of any other provision hereof,
which shall remain in full force and effect.
(h) Employment Taxes. Employee is responsible for any applicable taxes of any nature
(including any penalties or interest that may apply to such taxes) that the Company reasonably
determines apply to any payment made hereunder. Employees receipt of any benefit hereunder is
conditioned on his or her satisfaction of any applicable withholding or similar obligations that
apply to such benefit, and any cash payment owed hereunder will be reduced to satisfy any such
withholding or similar obligations that may apply.
(i) Section 409A of the Code.
(i) This Agreement is intended to comply with, or otherwise be exempt from, Section 409A of
the Code and any regulations and Treasury guidance promulgated thereunder. The Company shall
undertake to administer, interpret, and construe this Agreement in a manner that does not result in
the imposition on an employee of any additional tax, penalty, or interest under Section 409A of the
Code. If the Company determines in good faith that any provision of this Agreement would cause
employees to incur an additional tax, penalty, or interest under Section 409A of the Code, the
Board may, without the consent of any employee, amend this Agreement as may be necessary to ensure
compliance with the distribution provisions of Section 409A of the Code or as otherwise needed to
ensure that this Agreement complies with Section 409A of the Code. The preceding provisions,
however, shall not be construed as a guarantee by the Company of any particular tax effect to an
employee under this Agreement. The Company shall not be liable to any employee for any payment
made under this Agreement that is determined to result in an additional tax, penalty, or interest
under Section 409A of the Code, nor for reporting in good faith any payment made under this
Agreement as an amount includible in gross income under Section 409A of the Code.
(ii) Termination of employment, resignation, or words of similar import, as used in this
Agreement, mean, for purposes of any payments under this Agreement that are payments of deferred
compensation subject to Section 409A of the Code, the employees separation from service as
defined in Section 409A of the Code.
(iii) If a payment obligation under this Agreement arises on account of the employees
separation from service while the employee is a specified employee (as defined under Section 409A
of the Code and determined in good faith by the Company), any payment of deferred compensation
(as defined under Treasury Regulation Section 1.409A-1(b)(1), after giving effect to the exemptions
in Treasury Regulation Sections 1.409A-1(b)(3) through (b)(12)) that is scheduled to be paid within
six (6) months after such separation from service shall accrue without interest and shall be paid
within 15 days after the end of the six-month period beginning on the date of such separation from
service or, if earlier, within 15 days after his or her death.
The parties have executed this Retention and Incentive Agreement as of the Effective Date.
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COMPANY: |
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ADVENTRX PHARMACEUTICALS, INC. |
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By:
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/s/ Patrick Keran
Name: Patrick Keran
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Title: Vice President, Legal |
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EMPLOYEE: |
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/s/ Mark E. Erwin |
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Mark E. Erwin |
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Exhibit A
NOTICE OF GRANT OF RESTRICTED STOCK UNITS
(including Restricted Stock Units Agreement)
ADVENTRX PHARMACEUTICALS, INC.
NOTICE OF GRANT OF RESTRICTED STOCK UNITS
The
Participant has been granted an award of Restricted Stock Units (the
Award) pursuant to
the ADVENTRX Pharmaceuticals, Inc. 2008 Omnibus Incentive Plan (the
Plan), each of which
represents the right to receive on the Settlement Date (described below) one (1) share of common
stock of ADVENTRX Pharmaceuticals, Inc., par value $0.001 per share, as follows:
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Participant:
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Mark E. Erwin |
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Grant Date:
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January 30, 2009 |
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Number of Restricted
Stock Units:
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650,000, subject to adjustment as
provided by the Restricted Stock
Units Agreement. |
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Settlement Date:
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For each Restricted Stock Unit,
except as otherwise provided by the
Restricted Stock Units Agreement, the
date on which the units become Vested
Units in accordance with the vesting
schedule set forth below. |
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Vested Units:
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Except as provided by the Restricted
Stock Units Agreement and provided
that the Participants Services have
not terminated prior to the
consummation of a Strategic
Transaction (as defined below), one
hundred percent (100%) of the
Restricted Stock Units shall vest
immediately prior to the consummation
of a Strategic Transaction. |
A Strategic Transaction shall mean: (a) any transaction or series of related transactions or
any plan (including, without limitation, any reorganization, merger, consolidation, exchange or
sale of stock or other securities) in which the stockholders of the Company as constituted
immediately prior to the consummation of such transaction, transactions or plan will, immediately
after the consummation of such transaction, transactions or plan and as a result of securities
issued as consideration for such transaction, transactions or plan, fail to hold at least 50% of
the outstanding voting capital stock of the resulting or surviving entity (or its parent if the
surviving entity is wholly owned by such parent entity); (b) any transaction or series of related
transactions or any plan (including, without limitation, any reorganization, merger, consolidation,
exchange or sale of stock or other securities) in which the stockholders of a subsidiary of the
Company as constituted immediately prior to the consummation of such transaction, transactions
or plan (including a wholly-owned subsidiary) will, immediately after the consummation of such
transaction, transactions or plan and as a result of securities issued as consideration for such
transaction, transactions or plan, fail to hold at least 50% of the outstanding voting capital
stock of the resulting or surviving entity (or its parent if the surviving entity is wholly owned
by such parent entity); (c) a sale, transfer, lease or other disposition by means of any
transaction or series of related transactions or any plan of all or substantially all of the assets
of the Company; (d) the assignment, transfer, lease, sale or other disposition by means of any
transaction or series of related transactions or any plan of all or substantially all of the assets
of one or more subsidiaries of the Company, the assets of which constitute all or substantially all
of the assets of the Company and its subsidiaries taken as a whole; (e) the grant of, among other
things, an exclusive license under the Companys patents and patent applications related to ANX-514
to make, use or sell products covered by such patents and patent applications in the United States
for the treatment of cancer by intravenous administration of formulations consisting of emulsified
products; and (f) any transaction that the Board or the Committee determines constitutes a
Strategic Transaction.
By their signatures below or by electronic acceptance or authentication in a form authorized
by the Company, the Company and the Participant agree that the Award is governed by this Notice and
by the provisions of the Plan and the Restricted Stock Units Agreement, both of which are made a
part of this document. The Participant represents that the Participant has read and is familiar
with the provisions of the Plan and Restricted Stock Units Agreement, and hereby accepts the Award
subject to all of their respective terms and conditions.
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ADVENTRX PHARMACEUTICALS, INC. |
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PARTICIPANT |
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By: |
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Its: |
Vice President, Legal |
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Signature |
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Date
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Address: |
6725 Mesa Ridge Rd., Suite 100 |
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San Diego, CA 92121
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ATTACHMENTS:
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2008 Omnibus Incentive Plan, as amended to the Grant Date
Restricted Stock Units Agreement
Plan Prospectus |
Exhibit 10.5
Exhibit 10.5
RETENTION AND INCENTIVE AGREEMENT
This Retenion and Incentive Agreement (this Agreement) is made as of January 28, 2009 (the
Effective Date) by and between Adventrx Pharmaceuticals, Inc., a Delaware corporation (the
Company), and Michele L. Yelmene, an individual resident of the State of California (Employee).
Certain capitalized terms used in this Agreement are defined in Section 12 below.
1. At-Will Employment. Employees employment is and shall continue to be at-will, as
defined under applicable law. If Employees employment terminates for any reason, Employee shall
not be entitled to any payments, benefits, damages, awards or compensation other than as provided
by this Agreement or required by applicable law, or as may otherwise be established under the
Companys then existing employee benefit plans or policies at the time of termination.
2. Severance Benefits. If Employees employment with the Company terminates as a
result of an Involuntary Termination at any time, and Employee delivers (and does not revoke) the
Release (as defined in Section 8 below), then Employee shall be entitled to an amount payable by
the Company to Employee equal to the Severance Payment, less applicable withholdings, which amount
shall be payable in a lump-sum on the date determined pursuant to Section 8.
3. Issuance of Restricted Stock Units. The Company shall execute a Notice of Grant of
Restricted Stock Units in substantially the form of Exhibit A attached hereto pursuant to which
Employee shall be granted an award of Restricted Stock Units pursuant to the Companys 2008 Omnibus
Incentive Plan (the Award); provided, however, that the Company has received a written waiver
under that certain Rights Agreement, dated July 25, 2005, as amended (the Rights Agreement), that
allows the Company to grant the Award without complying with the participation rights (and any
related rights, including rights to notice) set forth in the Rights Agreement.
4. Other Terminations. If Employees employment with the Company is terminated, other
than as a result of an Involuntary Termination, then Employee shall not be entitled to the benefits
of Section 2 of this Agreement.
5. Accrued Wages and Vacation, Expenses. Without regard to the reason for, or the
timing of, Employees termination of employment: (i) the Company shall pay Employee any unpaid base
salary due for periods prior to and including the Termination Date; (ii) the Company shall pay
Employee all of Employees accrued and unused vacation through the Termination Date; and (iii)
following submission of proper expense reports by Employee, the Company shall reimburse Employee
for all expenses reasonably and necessarily incurred by Employee in connection with the business of
the Company prior to the Termination Date. These payments shall be made promptly upon termination
and within the period of time mandated by law (including but limited to Section 409A of the
Internal Revenue Code of 1986, as amended (the Code)).
6. Limitation on Payments. In the event it shall be determined that any compensation
by or benefit from the Company to Employee or for Employees benefit, whether pursuant to the terms
of this Agreement or otherwise (collectively, the Payments), (i) constitute parachute payments
within the meaning of Section 280G of the Code, and (ii) would be subject to the excise tax imposed
by Section 4999 of the Code (the Excise Tax), then Employees benefits under this Agreement shall
be either:
(a) delivered in full, or
(b) delivered as to such lesser extent which would result in no portion of such benefits being
subject to the Excise Tax,
whichever of the foregoing amounts, taking into account the applicable federal, state and local
income taxes and the Excise Tax, results in the receipt by Employee on an after-tax basis of the
greatest amount of benefits, notwithstanding that all or some portion of such benefits may be
taxable under Section 4999 of the Code.
Unless the Company and Employee otherwise agree in writing, any determination required under
this Section 6 shall be made in writing by the Companys independent public accountants (the
Accountants), whose determination shall be conclusive and binding upon Employee and the Company
for all purposes. For purposes of making the calculations required by this Section 6, the
Accountants may make reasonable assumptions and approximations concerning applicable taxes and may
rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999
of the Code. The Company and Employee shall furnish to the Accountants such information and
documents as the Accountants may reasonably request in order to make a determination under this
Section 6. The Company shall bear all costs the Accountants may reasonably incur in connection
with any calculations contemplated by this Section 6.
In the event that Payments must be reduced, then the Payments will be reduced in accordance
with the following order of priority: (a) first, Full Credit Payments (as defined below) will be
reduced in reverse chronological order such that the payment owed on the latest date following the
occurrence of the event triggering the Excise Tax will be the first Payment to be reduced until
such Payment is reduced to zero, and then the Payment owed on the next latest date following
occurrence of the event triggering the Excise Tax will be the second Payment to be reduced until
such payment is equal to zero, and so forth, until all such Full Credit Payments have been reduced
to zero, and (b) second, Partial Credit Payments (as defined below) will be reduced in a manner
such as to obtain the best economic benefit for the employee so that after giving effect to such
reduction, the employee retains the greatest economic value of such Partial Credit Payments. Full
Credit Payment means a payment, distribution or benefit, whether paid or payable or distributed or
distributable pursuant to the terms of this Agreement or otherwise, that if reduced in value by one
dollar reduces the amount of the parachute payment by one dollar. Partial Credit Payment means a
payment, distribution or benefit, whether paid or payable or distributed or distributable pursuant
to the terms of this letter or otherwise, that if reduced in value by one dollar reduces the amount
of the parachute payment by an amount that is less than one dollar. For clarification purposes
only, a Partial Credit Payment would include a stock
option as to which vesting is accelerated upon an event that triggers the Excise Tax, where
the in the money value of the option exceeds the value of the option acceleration that is added to
the parachute payment.
7. Companys Successors. Any successor to the Company (whether direct or indirect and
whether by purchase, license, lease, merger, consolidation, liquidation or otherwise) to all or
substantially all of the Companys business and/or assets shall not later than the closing or
consummation of such succession assume the Companys obligations under this Agreement and agree
expressly to perform the Companys obligations under this Agreement in the same manner and to the
same extent as the Company would be required to perform such obligations in the absence of a
succession. For all purposes under this Agreement, the term Company shall include any successor
to the Companys business and/or assets which executes and delivers the assumption agreement
described in this section or which becomes bound by the terms of this Agreement by operation of
law.
8. Execution of Release Agreement upon Termination. As a condition of receiving the
benefits under Section 2 of this Agreement, Employee shall execute and not revoke a general release
of claims, which will also confirm any post-termination obligations and/or restrictions applicable
to Employee (the Release), such that the Release becomes effective no later than 60 days
following the Termination Date (the Release Deadline). The benefits under Section 2 shall be
paid on the date the Release is effective; provided, however, that, in the event Employees
separation occurs at a time during the calendar year where it would be possible for the Release to
become effective in the calendar year following the calendar year in which Employees separation
occurs, any severance that would be considered deferred compensation (as defined in Section 409A of
the Code) will be paid on the first payroll date to occur immediately following the Release
Deadline.
9. Notices.
(a) General. Notices and all other communications contemplated by this Agreement
shall be in writing and shall be deemed to have been duly given when personally delivered or when
mailed by U.S. registered or certified mail, return receipt requested and postage prepaid. In the
case of Employee, mailed notices shall be addressed to him or her at the home address that he or
she most recently communicated to the Company in writing. In the case of the Company, mailed
notices shall be addressed to its corporate headquarters, and all notices shall be directed to the
attention of its Secretary.
(b) Notice of Termination. Any termination by the Company with or without Cause or by
Employee as a result of an Involuntary Termination other than an Involuntary Termination pursuant
to Section 12(b)(vi) shall be communicated by a notice of termination to the other party hereto
given in accordance with this Section 9. Any such notice provided by the Company under
circumstances constituting a for-Cause termination, or by Employee under circumstances constituting
such an Involuntary Termination, shall indicate the specific termination provision in this
Agreement relied upon, shall set forth in reasonable detail the facts and circumstances claimed to
provide a basis for termination under the provision so indicated, and shall specify the Termination
Date (which shall be not more than 30 days after the giving of such
notice). The failure by either party to include in the notice any fact or circumstance which
contributes to a showing of a for-Cause termination or an Involuntary Termination shall not waive
any right of such party hereunder or preclude such party from asserting such fact or circumstance
in enforcing such partys rights hereunder.
10. Arbitration.
(a) Any dispute or controversy arising out of, relating to, or in connection with this
Agreement, or the interpretation, validity, construction, performance, breach, or termination
thereof, shall be settled by binding arbitration to be held in the County of San Diego, State of
California in accordance with the National Rules for the Resolution of Employment Disputes then in
effect of the American Arbitration Association (the Rules). The arbitrator may grant injunctions
or other relief in such dispute or controversy. The decision of the arbitrator shall be final,
conclusive and binding on the parties to the arbitration. Judgment may be entered on the
arbitrators decision in any court having jurisdiction.
(b) The arbitrator(s) shall apply California law to the merits of any dispute or claim,
without reference to conflicts of law rules. The arbitration proceedings shall be governed by
federal arbitration law and by the Rules, without reference to state arbitration law. Employee and
the Company consent to the personal jurisdiction of the state and federal courts located in
California for any action or proceeding arising from or relating to this Agreement or relating to
any arbitration in which the parties are participants.
(c) Nothing in this Section 10 modifies Employees at-will employment status. Either Employee
or the Company can terminate the employment relationship at any time, with or without Cause.
(d) SUBMISSION OF ANY CLAIMS ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS
AGREEMENT, OR THE INTERPRETATION, VALIDITY, CONSTRUCTION, PERFORMANCE, BREACH OR TERMINATION
THEREOF TO BINDING ARBITRATION, CONSTITUTES A WAIVER OF THE PARTYS RIGHT TO A JURY TRIAL AND
RELATES TO THE RESOLUTION OF ALL DISPUTES RELATING TO ALL ASPECTS OF THE EMPLOYER/EMPLOYEE
RELATIONSHIP, INCLUDING BUT NOT LIMITED TO, THE FOLLOWING CLAIMS:
(i) ANY AND ALL CLAIMS FOR WRONGFUL DISCHARGE OF EMPLOYMENT; BREACH OF CONTRACT, BOTH EXPRESS
AND IMPLIED; BREACH OF THE COVENANT OF GOOD FAITH AND FAIR DEALING, BOTH EXPRESS AND IMPLIED;
NEGLIGENT OR INTENTIONAL INFLICTION OF EMOTIONAL DISTRESS; NEGLIGENT OR INTENTIONAL
MISREPRESENTATION; NEGLIGENT OR INTENTIONAL INTERFERENCE WITH CONTRACT OR PROSPECTIVE ECONOMIC
ADVANTAGE; AND DEFAMATION;
(ii) ANY AND ALL CLAIMS FOR VIOLATION OF ANY FEDERAL STATE OR MUNICIPAL STATUTE, INCLUDING,
BUT NOT LIMITED TO, TITLE VII OF THE CIVIL RIGHTS ACT OF 1964, THE CIVIL RIGHTS ACT OF 1991, THE
AGE DISCRIMINATION IN EMPLOYMENT ACT OF 1967, THE AMERICANS WITH DISABILITIES ACT OF 1990, THE
FAIR LABOR STANDARDS ACT, THE CALIFORNIA FAIR EMPLOYMENT AND HOUSING ACT, AND LABOR CODE SECTION
201, et seq; and
(iii) ANY AND ALL CLAIMS ARISING OUT OF ANY OTHER LAWS AND REGULATIONS RELATING TO EMPLOYMENT
OR EMPLOYMENT DISCRIMINATION.
11. Accrued Obligation. The Companys obligations under this Agreement, including its
obligations pursuant to Section 2, shall accrue and be owing as of the Effective Date and the
rights of Employee hereunder shall vest immediately but remain contingent and conditioned on the
occurrence of an Involuntary Termination and Employee delivering (and not revoking) a release of
claims as required under Section 8. For clarity, the Company shall treat its obligations hereunder
as outstanding as of the date hereof, including for purposes of determining its insolvency, and the
Companys obligations hereunder shall be due and payable regardless of any subsequent insolvency of
the Company.
12. Definition of Terms. The following terms referred to in this Agreement shall have
the following meanings:
(a) Cause. Cause shall mean (i) any act of personal dishonesty taken by Employee in
connection with his or her responsibilities as an employee which is intended to result in
substantial personal enrichment of Employee, (ii) Employees conviction of a felony that the Board
reasonably believes has had or will have a material detrimental effect on the Companys reputation
or business, (iii) a willful act by Employee that constitutes misconduct and is injurious to the
Company, or (iv) continued willful violations by Employee of Employees obligations to the Company
after there has been delivered to Employee a written demand for performance from the Company that
describes the basis for the Companys belief that Employee has not substantially performed his or
her duties.
(b) Involuntary Termination. Involuntary Termination shall mean (i) without
Employees express written consent, a significant reduction of Employees duties, position or
responsibilities relative to Employees duties, position or responsibilities in effect immediately
prior to such reduction, or the removal of Employee from such position, duties and
responsibilities; (ii) without Employees express written consent, a material reduction by the
Company of Employees base salary as in effect immediately prior to such reduction; (iii) without
Employees express written consent, a material reduction by the Company in the kind or level of
employee benefits (including cash and stock bonus plans) to which Employee is entitled immediately
prior to such reduction which results in a material adverse change to Employees employment
relationship; (iv) without Employees express written consent, the relocation of Employee to a
facility or a location that results in an increase in Employees one-way commute from Employees
residence immediately prior to such relocation by more than fifty (50) miles; (v) any purported
termination of Employee by the Company which is not effected for Cause; or (vi) a material breach
of this Agreement by the Company, including, but not limited to the failure
of the Company to obtain the assumption of this Agreement by any successors contemplated in
Section 7.
(c) Severance Payment. Severance Payment shall mean Employees then-current base
salary multiplied by a fraction, the numerator of which is the number of calendar days between the
Termination Date and June 30, 2009 (not including the Termination Date but including June 30, 2009)
and the demonitator of which is 365.
(d) Termination Date. Termination Date shall mean the date specified in a notice of
termination as contemplated under Section 9(b).
13. Miscellaneous Provisions.
(a) Amendment or Termination. The Board may in its sole discretion amend or terminate
this Agreement at any time and in any manner; provided, however, that the Board may not
terminate or amend this Agreement in a way that is materially adverse to Employee without the
written consent of Employee; provided further that notwithstanding anything to the contrary
contained in this paragraph or in this Agreement, it is the parties intent that no payment made or
to be made hereunder shall be subject to the provisions of Section 409A(a)(1)(B) of the Internal
Revenue Code, as amended, and accordingly, the parties agree that this Agreement and Employees
rights under it shall be amended to conform to their intent as set forth in this proviso.
(b) Effect of Statutory Benefits. To the extent that any severance benefits are
required to be paid to Employee upon termination of employment with the Company as a result of any
requirement of law or any governmental entity in any applicable jurisdiction, the aggregate amount
of severance benefits payable pursuant to Section 2 shall be reduced by such amount.
(c) No Duty to Mitigate. Employee shall not be required to mitigate the amount of any
payment contemplated by this Agreement, nor shall any such payment be reduced by any earnings that
Employee may receive from any other source.
(d) Waiver. No provision of this Agreement may be waived or discharged unless the
waiver or discharge is agreed to in writing and signed by Employee and by an authorized officer of
the Company (other than Employee). No waiver by either party of any breach of, or of compliance
with, any condition or provision of this Agreement by the other party shall be considered a waiver
of any other condition or provision or of the same condition or provision at another time.
(e) Integration. This Agreement supersedes all prior or contemporaneous agreements,
whether written or oral, with respect to this Agreement; provided, however, that, for
clarification purposes, this Agreement shall not affect any agreements between the Company and
Employee regarding intellectual property matters, non-solicitation restrictions or confidential
information of the Company. In addition, except as set forth in Sections 3 and 6, nothing in this
Agreement shall be construed as impacting any equity award granted to an employee.
(f) Choice of Law. The validity, interpretation, construction and performance of this
Agreement shall be governed by the internal substantive laws, but not the conflicts of law rules,
of the State of California as applied to agreements among California residents entered into and to
be performed entirely within California.
(g) Severability. The invalidity or unenforceability of any provision or provisions
of this Agreement shall not affect the validity or enforceability of any other provision hereof,
which shall remain in full force and effect.
(h) Employment Taxes. Employee is responsible for any applicable taxes of any nature
(including any penalties or interest that may apply to such taxes) that the Company reasonably
determines apply to any payment made hereunder. Employees receipt of any benefit hereunder is
conditioned on his or her satisfaction of any applicable withholding or similar obligations that
apply to such benefit, and any cash payment owed hereunder will be reduced to satisfy any such
withholding or similar obligations that may apply.
(i) Section 409A of the Code.
(i) This Agreement is intended to comply with, or otherwise be exempt from, Section 409A of
the Code and any regulations and Treasury guidance promulgated thereunder. The Company shall
undertake to administer, interpret, and construe this Agreement in a manner that does not result in
the imposition on an employee of any additional tax, penalty, or interest under Section 409A of the
Code. If the Company determines in good faith that any provision of this Agreement would cause
employees to incur an additional tax, penalty, or interest under Section 409A of the Code, the
Board may, without the consent of any employee, amend this Agreement as may be necessary to ensure
compliance with the distribution provisions of Section 409A of the Code or as otherwise needed to
ensure that this Agreement complies with Section 409A of the Code. The preceding provisions,
however, shall not be construed as a guarantee by the Company of any particular tax effect to an
employee under this Agreement. The Company shall not be liable to any employee for any payment
made under this Agreement that is determined to result in an additional tax, penalty, or interest
under Section 409A of the Code, nor for reporting in good faith any payment made under this
Agreement as an amount includible in gross income under Section 409A of the Code.
(ii) Termination of employment, resignation, or words of similar import, as used in this
Agreement, mean, for purposes of any payments under this Agreement that are payments of deferred
compensation subject to Section 409A of the Code, the employees separation from service as
defined in Section 409A of the Code.
(iii) If a payment obligation under this Agreement arises on account of the employees
separation from service while the employee is a specified employee (as defined under Section 409A
of the Code and determined in good faith by the Company), any payment of deferred compensation
(as defined under Treasury Regulation Section 1.409A-1(b)(1), after giving effect to the exemptions
in Treasury Regulation Sections 1.409A-1(b)(3) through (b)(12)) that is scheduled to be paid within
six (6) months after such separation from service shall accrue
without interest and shall be paid within 15 days after the end of the six-month period
beginning on the date of such separation from service or, if earlier, within 15 days after his or
her death.
The parties have executed this Retention and Incentive Agreement as of the Effective Date.
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COMPANY: |
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ADVENTRX PHARMACEUTICALS, INC. |
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By:
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/s/ Patrick Keran
Name: Patrick Keran
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Title: Vice President, Legal |
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EMPLOYEE: |
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/s/ Michele L. Yelmene |
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Michele L. Yelmene |
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Exhibit A
NOTICE OF GRANT OF RESTRICTED STOCK UNITS
(including Restricted Stock Units Agreement)
ADVENTRX PHARMACEUTICALS, INC.
NOTICE OF GRANT OF RESTRICTED STOCK UNITS
The Participant has been granted an award of Restricted Stock Units (the
Award) pursuant to the ADVENTRX Pharmaceuticals, Inc. 2008 Omnibus Incentive Plan (the
Plan), each of which
represents the right to receive on the Settlement Date (described below) one (1) share of common
stock of ADVENTRX Pharmaceuticals, Inc., par value $0.001 per share, as follows:
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Participant:
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Michele L. Yelmene |
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Grant Date:
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January 30, 2009 |
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Number of Restricted
Stock Units:
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450,000, subject to adjustment as
provided by the Restricted Stock Units
Agreement. |
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Settlement Date:
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For each Restricted Stock Unit, except
as otherwise provided by the
Restricted Stock Units Agreement, the
date on which the units become Vested
Units in accordance with the vesting
schedule set forth below. |
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Vested Units:
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Except as provided by the Restricted
Stock Units Agreement and provided
that the Participants Services have
not terminated prior to the
consummation of a Strategic
Transaction (as defined below), one
hundred percent (100%) of the
Restricted Stock Units shall vest
immediately prior to the consummation
of a Strategic Transaction. |
A Strategic Transaction shall mean: (a) any transaction or series of related transactions or
any plan (including, without limitation, any reorganization, merger, consolidation, exchange or
sale of stock or other securities) in which the stockholders of the Company as constituted
immediately prior to the consummation of such transaction, transactions or plan will, immediately
after the consummation of such transaction, transactions or plan and as a result of securities
issued as consideration for such transaction, transactions or plan, fail to hold at least 50% of
the outstanding voting capital stock of the resulting or surviving entity (or its parent if the
surviving entity is wholly owned by such parent entity); (b) any transaction or series of related
transactions or any plan (including, without limitation, any reorganization, merger, consolidation,
exchange or sale of stock or other securities) in which the stockholders of a subsidiary of the
Company as constituted immediately prior to the consummation of such transaction, transactions
or plan (including a wholly-owned subsidiary) will, immediately after the consummation of such
transaction, transactions or plan and as a result of securities issued as consideration for such
transaction, transactions or plan, fail to hold at least 50% of the outstanding voting capital
stock of the resulting or surviving entity (or its parent if the surviving entity is wholly owned
by such parent entity); (c) a sale, transfer, lease or other disposition by means of any
transaction or series of related transactions or any plan of all or substantially all of the assets
of the Company; (d) the assignment, transfer, lease, sale or other disposition by means of any
transaction or series of related transactions or any plan of all or substantially all of the assets
of one or more subsidiaries of the Company, the assets of which constitute all or substantially all
of the assets of the Company and its subsidiaries taken as a whole; (e) the grant of, among other
things, an exclusive license under the Companys patents and patent applications related to ANX-514
to make, use or sell products covered by such patents and patent applications in the United States
for the treatment of cancer by intravenous administration of formulations consisting of emulsified
products; and (f) any transaction that the Board or the Committee determines constitutes a
Strategic Transaction.
By their signatures below or by electronic acceptance or authentication in a form authorized
by the Company, the Company and the Participant agree that the Award is governed by this Notice and
by the provisions of the Plan and the Restricted Stock Units Agreement, both of which are made a
part of this document. The Participant represents that the Participant has read and is familiar
with the provisions of the Plan and Restricted Stock Units Agreement, and hereby accepts the Award
subject to all of their respective terms and conditions.
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ADVENTRX PHARMACEUTICALS, INC. |
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PARTICIPANT |
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By: |
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Its: |
Vice President, Legal |
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Signature |
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Date
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Address: |
6725 Mesa Ridge Rd., Suite 100 |
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San Diego, CA 92121
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ATTACHMENTS:
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2008 Omnibus Incentive Plan, as amended to the Grant Date
Restricted Stock Units Agreement
Plan Prospectus |
2
Exhibit 10.8
EXHIBIT 10.8
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (Agreement) dated as of March 25, 2009 (Effective
Date), is entered into among ADVENTRX Pharmaceuticals, Inc., a Delaware corporation, having
its principal place of business at 6725 Mesa Ridge Road, Suite 100, San Diego, California, USA
92121 (ADVENTRX), SD Pharmaceuticals, Inc., a Delaware corporation and wholly-owned
subsidiary of ADVENTRX (SDP), and Shin Poong Pharmaceutical Co., Ltd., a company
organized under the laws of Republic of Korea, having its principal place of business at 748-31,
Yoksam-Dong, Kangnam-Ku, Seoul, Korea 135-925(Licensee).
BACKGROUND
A. SDP owns certain patent rights related to a pharmaceutical product candidate known as
ANX-514, which SDP acquired pursuant to a License Agreement, dated December 10, 2005, with Latitude
Pharmaceuticals, Inc. (LPI) and Andrew X. Chen (the LPI Agreement), a true and
complete copy of which has been delivered to Licensee, pursuant to which LPI has certain rights
with respect to patent prosecution and maintenance and patent enforcement.
B. Licensee desires to receive a license to such patent rights and certain related know-how
for the territory of South Korea upon the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein
contained, and for other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties (defined below) hereby agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the following terms when used with initial capital letters
shall have the respective meanings set forth below in this Article 1 or elsewhere herein.
1.1 Adverse Event means any untoward medical occurrence in a patient or subject who
is administered a Product, whether or not considered related to a Product, including, without
limitation, any undesirable sign (including abnormal laboratory findings of clinical concern),
symptom or disease temporally associated with the use of such Product.
1.2 Affiliate of a Party means any person, corporation, or other business entity
which, directly or indirectly through one or more intermediaries, controls, is controlled by, or is
under common control with such Party, as the case may be. As used in this paragraph,
control means: (a) to possess, directly or indirectly, the power to affirmatively direct
the management and policies of such person, corporation, or other business entity, whether through
ownership of voting securities or by contract relating to voting rights or corporate governance; or
(b) direct or indirect beneficial ownership of fifty percent (50%) or more of the voting share
capital in such person, corporation, or other business entity.
1.3 ADVENTRX KnowHow means the physical embodiment, to the extent available, of any
proprietary information or materials related to the manufacture, preparation, formulation, use or
development of Products owned by ADVENTRX or SDP that were used or generated in connection with the
development or manufacture of ANX-514.
1.4 ADVENTRX Patents means the patents and patent applications listed on Exhibit
A attached to this Agreement, together with any patents issuing therefrom and all additions,
divisionals, continuations, continuations-in-part (only to the extent of the claims therein that
are entitled to the priority date of the listed patent applications), substitutions, reissues,
re-examinations, extensions, registrations, patent term extensions, Supplemental Protection
Certificates, and renewals of any of the foregoing.
1.5 ADVENTRX Technology means the ADVENTRX Patents and/or the ADVENTRX Know-How.
1.6 Bioequivalence means the absence of a significant difference in the rate and
extent to which the active pharmaceutical ingredient (API) or active moiety in a pharmaceutical
drug compound becomes available at the site of drug action when administered at the same molar dose
under similar conditions.
1.7 FDA means the United States Food and Drug Administration, or any successor
entity thereto performing similar functions.
1.8 Field means the treatment of cancer by intravenous administration of
formulations of docetaxel as emulsified products.
1.9 First Commercial Sale means the first sale of Product in the Territory following
receipt of Regulatory Approval.
1.10 KFDA means the Korea Food and Drug Administration, or any successor entity
performing similar functions.
1.11 NDA means a new drug application filed with the FDA pursuant to 21 C.F.R.
Sec.314, seeking permission to market a product in interstate commerce in the United States.
1.12 Net Sales means the aggregate gross sales price invoiced or otherwise received
(whichever is greater) by Licensee, its Affiliates, or Sublicensees, from sales or other
dispositions of all Products to Third Party customers, less reasonable and customary deductions for
the following items incurred with respect to the sale to such customers: (a) credits, allowances,
discounts, rebates and charge backs to the customer (including those granted to managed-care
entities and government agencies as well as entities that manage patient drug benefits), to the
extent actually taken by the customer; (b) freight, postage and insurance costs on shipments to the
customer (to the extent included in the gross sales price); (c) trade, quantity or cash discounts
allowed to and actually taken by the customer on the sale; and (d) sales, value-added and other
direct taxes (including customs, duties and other similar governmental charges) incurred by the
seller on the sale, other than franchise or income tax of any kind whatsoever. If a sale or other
disposition with respect to Products is not at arms length, then the Net Sales from such sale or
other disposition shall be the arms length fair market value of the Product, which will mean
Licensees, its Affiliates, or Sublicensees, as applicable, average sales price in arms length
sales of such Product for the calendar year in the country in which the sale took place.
1.13 NHI Price means the national health insurance price for a unit of Product set
by the Health Insurance Review Agency (HIRA).
1.14 Party means any of ADVENTRX, SDP or Licensee individually and Parties
means ADVENTRX, SDP and Licensee collectively. Except as otherwise expressly set forth in this
Agreement, references to either Party, the other Party and the like, shall mean either (i)
Licensee or (ii) ADVENTRX and SDP, as the case may be.
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1.15 Product means any one or more of (i) the pharmaceutical product candidate known
as ANX-514 (docetaxel emulsion) or any improvement or derivative thereof, or (ii) any product for
which the manufacture, use, sale or importation is covered by a Valid Claim of the ADVENTRX
Patents.
1.16 Regulatory Approval means: (a) in the United States, written notice of
marketing approval by the FDA for a pharmaceutical or biological therapeutic product, and (b) in
any other country, written notice of all approvals by each Regulatory Authority (other than the
FDA).
1.17 Regulatory Authority means the FDA or any regulatory body with similar
regulatory authority (including the KFDA) in any other jurisdiction together with, as applicable,
any other regulatory body with authority in such other jurisdiction over advertising, promoting,
marketing, selling and other commercial activities related to a pharmaceutical or biological
therapeutic product (including any pricing, reimbursement and similar determinations and
post-approval monitoring and safety matters related to the foregoing).
1.18 Right of Reference means a Right of Reference, as that term is defined in
Title 21, Section 314.3(b) of the United States Code of Federal Regulations, and any comparable
right existing under the laws or regulations of any other country.
1.19 Serious Adverse Event means any event at any dose that results in any of the
following outcomes: death, a life-threatening Adverse Event, in patient hospitalization or
prolongation of existing hospitalization, a persistent or significant disability or incapacity, or
a congenital anomaly or birth defect. Important medical events that may not result in death, be
life threatening, or require hospitalization may be considered a Serious Adverse Event when, based
upon appropriate medical judgment, they may jeopardize the patient or subject, and may require
medical or surgical intervention to prevent one of the outcomes listed in this definition.
1.20 Sublicensee means a Third Party to whom Licensee or an Affiliate of Licensee
grants, in accordance with Section 2.4, a sublicense to one or more Products under the ADVENTRX
Technology, as well as any person, corporation or other entity to whom a sublicense is granted by
such a Third Party.
1.21 Sublicense Revenue means all cash payments, the fair market cash value of any
equity consideration (less any amounts paid for such equity consideration), and forgivable loans
(to the extent actually forgiven) received by Licensee, its Affiliates, or Sublicensees from a
Third Party in consideration for the grant of a sublicense under the ADVENTRX Technology, including
any upfront payments, license maintenance fees, milestone payments or the like. Sublicense Revenue
will not include: (a) in the event that Licensee collaborates on research and/or development with
such a Sublicensee after the effective date of the sublicense agreement, amounts paid by such
Sublicensee as bona fide reimbursement for research and development costs (not to exceed
fully-allocated costs plus thirty percent (30%)) incurred after the date of such agreement;
(b) bona fide, non-forgivable loans (and forgivable loans unless and until forgiven); and (c)
running royalties (including any amounts paid based upon sales of a Product).
1.22 Supplementary Protection Certificate means, with respect to Switzerland or any
jurisdiction within the European Union or European Free Trade Association, a certificate extending
exclusive rights (following the expiration of applicable patents) with respect to a medicinal
product, pursuant to Council Regulation (EEC) No. 1768/92 of 18th June 1992, and any equivalent
extension of exclusive rights in a medicinal product in any other jurisdiction in the world.
1.23 Territory means South Korea.
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1.24 Third Party means any person, corporation, or other entity, other than
Licensee, ADVENTRX, SDP and their respective Affiliates. In the event Licensee or an Affiliate of
Licensee has granted to a Third Party, in accordance with Section 2.4, a sublicense to one or more
Products under the ADVENTRX Technology, and such Third Party further grants a sublicense to one or
more Products under the ADVENTRX Technology to another person, corporation, or other entity, Third
Party includes any person, corporation, or other entity other than such Third Party and its
Affiliates.
1.25 Valid Claim means a pending or issued claim of a patent or patent application
within the ADVENTRX Patents which: (a) has not been held invalid by a court or other government
agency of competent jurisdiction in a decision from which no appeal can or has been taken; and
(b) has not expired or been cancelled, withdrawn or abandoned. With respect to a Valid Claim of a
pending patent application, the phrase to infringe a Valid Claim means to engage in an activity
that would infringe (i.e., by either directly infringing, contributorily infringing, or inducing
infringement of) such Valid Claim if it were contained in an issued patent. With respect to any
jurisdiction in which a Supplementary Protection Certificate is in existence that provides
exclusivity substantially similar in scope to a Valid Claim that has expired in such jurisdiction,
a Valid Claim shall be deemed to exist in such jurisdiction for the life of such Supplementary
Protection Certificate.
1.26 Additional Definitions. Each of the following terms shall have the meaning
described in the corresponding section of this Agreement indicated below:
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Section Defined |
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Agreement |
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Introduction |
ADVENTRX |
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Introduction |
ADVENTRX Indemnitees |
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14.1 |
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Contract Manufacturer |
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9.1 |
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Controlling Party |
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11.5(c) |
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Disclosing Party |
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10.1 |
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Effective Date |
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Introduction |
Infringement |
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11.5(a) |
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Infringement Action |
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11.5(c) |
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Liabilities |
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14.1 |
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Minimum Annual Royalty Payment |
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5.5 |
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Proprietary Information |
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10.1 |
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Recipient |
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10.1 |
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Requested Supply |
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9.3 |
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Licensee |
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Introduction |
Licensee Indemnitees |
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14.2 |
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LPI |
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Introduction |
LPI Agreement |
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Introduction |
4
ARTICLE 2
GRANT OF LICENSE
2.1 Exclusive License. Subject to Licensees compliance with the terms and conditions
of this Agreement, SDP hereby grants to Licensee an exclusive, non-transferable (except in
accordance with Section 15.2) license, under the ADVENTRX Patents, including the right to
sublicense in accordance with Sections 2.3 and 2.4, to research, develop, make, have made, use,
offer for sale, sell and import Products, in each case solely within the Field and within the
Territory.
2.2 Non-exclusive License. Subject to Licensees compliance with the terms and
conditions of this Agreement, ADVENTRX and SDP hereby grant to Licensee a non-exclusive,
non-transferable (except as provided in Section 15.2) license, under the ADVENTRX Know-How,
including the right to sublicense in accordance with Sections 2.3 and 2.4, to research, develop,
make, have made, use, offer for sale, sell and import Products, in each case solely within the
Field and within the Territory.
2.3 Extension of License to Affiliates. Licensee may extend its rights under the
licenses granted in Sections 2.1 and 2.2 to one or more of its Affiliates; provided that Licensee
shall remain responsible for such Affiliates compliance with all obligations under this Agreement
applicable to such Affiliate, and any action by an Affiliate that would, if conducted by Licensee,
be a breach of this Agreement by Licensee shall be deemed to be a breach of this Agreement by
Licensee.
2.4 Sublicenses.
(a) Right to Grant Sublicenses; Sublicense Revenue. Subject to the terms and
conditions of this Section 2.4, Licensee shall have the right to grant and authorize sublicenses
under the rights granted in Sections 2.1 and 2.2 above.
(b) Other Sublicense Requirements. Licensee may not sublicense any rights under the
ADVENTRX Technology without the prior written consent of ADVENTRX, which consent shall not be
unreasonably withheld. Any sublicense (i) shall not conflict with, and shall be subordinate to, the
terms and conditions of this Agreement, and (ii) shall contain provisions at least as protective of
ADVENTRX, SDP and their Affiliates as the provisions in this Agreement related to confidentiality,
intellectual property, auditing, product labeling, effect of termination, indemnification and
insurance. Licensee shall be responsible for all actions of Sublicensees and shall remain
responsible to ADVENTRX for any royalties and other payments under this Agreement. For the
avoidance of doubt, the foregoing shall apply to sublicenses granted to an alleged infringer as
contemplated by Section 11.5.
2.5 No Other Rights. No license, either express or implied, is granted hereunder with
respect to any patent, trade secret, know-how, other information or intellectual property rights of
ADVENTRX or SDP except as expressly stated above in this Agreement.
ARTICLE 3
TECHNOLOGY TRANSFER
ADVENTRX shall provide its reasonable assistance to provide to Licensee the ADVENTRX Know-How
listed on Exhibit B. For the avoidance of doubt, ADVENTRX will retain ownership and be
entitled to retain copies of all such items. ADVENTRX will use good faith efforts to provide
answers to specific questions during normal business hours to assist Licensee in understanding and
implementing such ADVENTRX Know-How from time to time. Neither ADVENTRX nor SDP shall have any
responsibility for any modification of, or additional support with respect to, any ADVENTRX or SDP
process, methods or materials of the ADVENTRX Know-How in order to enable or improve manufacturing
or other operations of Licensee or any Third Party. ADVENTRX and SDP may, from time to time,
supplement or revise the ADVENTRX Know-How but shall have no obligation to provide any such
supplements or revisions to Licensee. ADVENTRX shall make ADVENTRX Know-How specifically relevant
to the manufacture of Products that it develops and provides to the Contract Manufacturer,
available for use by Contract Manufacturer on Licensees behalf in accordance with Article 9.
5
ARTICLE 4
DILIGENCE
4.1 Diligence.
(a) Licensee shall use reasonable best efforts to (i) pursue and achieve all Regulatory
Approvals for Products in the Territory, and (ii) maximize Product sales in the Territory.
(b) Conduct all of the activities, and on the timelines, set forth in the Development Plan
attached hereto as Exhibit C that are applicable to Licensee.
(c) Anything to the contrary in this Agreement (including Section 8.7 or Exhibit C)
notwithstanding, Licensees obligations hereunder are separate and independent from ADVENTRXs
research, development and/or commercialization activities, which ADVENTRX is free to conduct (or
not to conduct) in its discretion and without any impact on Licensees obligations hereunder.
4.2 Reporting. Licensee agrees to keep ADVENTRX reasonably informed as to its
development and commercialization activities with respect to Products, including by providing
prompt notification of the completion of any activities set forth on Exhibit C. Without
limiting the foregoing, Licensee shall provide ADVENTRX with written reports no less frequently
than biannually summarizing Licensees efforts to develop and commercialize Products hereunder,
which reports shall include out-of-pocket and fully-burdened costs and expenses associated with
such activities.
4.3 Meetings. ADVENTRX and Licensee shall meet, by teleconference, video conference,
or in-person, to discuss the state of the development and commercialization activities. At
ADVENTRXs request, but no more frequently than annually, the ADVENTRX and Licensee shall meet
in-person at ADVENTRXs corporate headquarter.
4.4 Competitive Products. During the term of this Agreement Licensee and its
Affiliates shall not develop, take or receive a license or sublicense to, manufacture, register,
sell, promote or distribute in the Territory any docetaxel products in the Field.
ARTICLE 5
PAYMENTS AND ROYALTIES
5.1 Upfront License Fee. Within 30 days of receipt of invoice after the Effective
Date, Licensee shall pay to ADVENTRX an upfront license fee of Three Hundred Thousand US Dollars
(US $300,000). Such amount shall not be creditable or refundable.
5.2 Regulatory Milestones. Licensee shall pay to ADVENTRX the regulatory milestone
payments set out below following the first achievement by Licensee, or any of its Affiliates, or
Sublicensees, of the corresponding regulatory milestone set out below with respect to each Product
within 30 days from the date of such events:
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Regulatory Milestone |
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Milestone Payment |
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Receipt of Regulatory Approval
for marketing of a Product in the Territory |
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US $400,000 |
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In the event Licensee is required by the KFDA to conduct a Bioequivalence or clinical trial in
human subjects prior to receipt of Regulatory Approval for a Product in the Territory, the
regulatory milestone payment for such Product shall be US $200,000.
5.3 Commercial Milestones. Licensee shall pay ADVENTRX the one-time commercial
milestone payments set forth below following the end of the calendar year in which the
corresponding commercial milestone for all Products is first achieved. Commercial milestone
payments are not creditable or refundable.
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Annual Net Sales of Products |
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Milestone Payment |
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US $5,000,000 |
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US $150,000 |
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US $10,000,000 |
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US $300,000 |
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US $15,000,000 |
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US $450,000 |
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US $20,000,000 |
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US $600,000 |
For the avoidance of doubt, and by way of example only, if Licensee has Net Sales of Products
of $6,000,000 in year 1, $12,000,000 in year 2 and $22,000,000 in year 3, then Licensee shall pay
commercial milestone payments of $150,000 for year 1 ($150,000 for achieving $5,000,000 in Net
Sales), $300,000 for year 2 ($300,000 for achieving $10,000,000 in Net Sales, but with no milestone
obligation for achieving $5,000,000 in Net Sales (milestone previously paid)) and $1,050,000 for
year 3 ($450,000 for achieving $15,000,000 in Net Sales and $600,000 for achieving $20,000,000 in
Net Sales, but with no milestone obligation for achieving $5,000,000 in Net Sales (milestone
previously paid) or $10,000,000 in Net Sales (milestone previously paid)).
5.4 Royalty Payments.
(a) In the event that the NHI Price is KRW 200,000 or more per 20mg vial, Licensee shall pay
to ADVENTRX the royalty of *** percent (***%) of the Net Sales of the Product.
(b) In the event that the NHI Price of the Product in the Territory is KRW 180,000 or more but
less than KRW 200,000 per 20mg vial, Licensee shall pay to ADVENTRX the royalty of *** percent
(***%) of the Net Sales of the Product.
(c) In the event that the NHI price of the Product in the Territory is KRW160,000 or more but
less than KRW180,000 per 20mg vial, Licensee shall pay to ADVENTRX the royalty of *** percent
(***%) of the Net Sales of the Product.
(d) In the event that the NHI price of the Product in the Territory is less than 160,000 per
20mg vial or no NHI price is designated, Licensee shall pay to ADVENTRX the royalty of *** percent
(***%) of the Net Sales of the Product.
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(e) Royalty Terms.
(i) One Royalty. No more than one royalty payment shall be due under this Agreement
with respect to a sale of a particular Product (e.g., even if such Product is covered by multiple
Valid Claims).
(ii) Royalty Term. Licensees obligation to pay royalties under this Section 5.4
shall continue with respect to sales of a Product in a particular country until the date which is
the later of: (i) expiration of the last Valid Claim in such country that would be infringed by
the sale of such Product in the Territory; or (ii) ten (10) years after the First Commercial Sale.
Thereafter, no further royalties shall be due with respect to such Product in the Territory.
5.5 Minimum Annual Royalty Payments. Beginning with the first full calendar year
following the date that is the second anniversary of the First Commercial Sale and for each
calendar year thereafter for the duration of the royalty term set forth in Section 5.4(e)(ii), a
minimum annual royalty payment of US $100,000 (the Minimum Annual Royalty Payment) shall
apply. In the event the royalty payments under Section 5.4 for a calendar year is less than the
Minimum Annual Royalty Payment for such calendar year, Licensee shall, by the due date for royalty
payments for such calendar year, pay to ADVENTRX such difference. For example, if the First
Commercial Sale occurs on February 20, 2011, then the first Minimum Annual Royalty Payment shall
apply with respect to the calendar year ending December 31, 2014. Such payments shall not be
refundable or creditable.
5.6 Payments With Respect to Sublicense Revenue. In the event Licensee or its
Affiliate sublicenses under Section 2.4 (or a Third Party to whom a sublicense was previously
granted further sublicenses to another Third Party), Licensee shall pay ADVENTRX a portion of any
Sublicense Revenue resulting from corresponding agreements executed by Licensee, or an Affiliate of
Licensee or a Sublicensee within the first three (3) years after the Effective Date, as set forth
below;
(a) if such agreements are executed in the first twelve (12) months after the Effective Date,
Licensee shall pay ADVENTRX fifty percent (50%) of all Sublicense Revenue resulting from such
agreements (including any extensions, amendments and restatements thereof);
(b) if such agreements are executed in the second twelve (12) months after the Effective Date,
Licensee shall pay ADVENTRX thirty percent (30%) of all Sublicense Revenue resulting from such
agreements (including any extensions, amendments and restatements thereof), and
(c) if such agreements are executed in the third twelve (12) months after the Effective Date,
Licensee shall pay ADVENTRX ten percent (10%) of Sublicense Revenue resulting from such agreements
(including any extensions, amendments and restatements thereof).
(d) Licensee shall have no obligation to share Sublicense Revenues with ADVENTRX resulting
from any sublicense agreement executed after thirty-six (36) months after the Effective Date.
8
ARTICLE 6
PAYMENTS
6.1 Royalty and Sublicense Revenue Payment Terms. Royalties and, if applicable,
Sublicense Revenue that have accrued during the period covered by each report provided pursuant to
Section 7.1 shall be due and payable on the date such report is due.
6.2 Payment Method. Unless otherwise expressly stated in this Agreement, all amounts
specified in, and all payments to be made under, this Agreement shall be in United States Dollars
by wire transfer in immediately available funds to a U.S. account designated by ADVENTRX, or by
other mutually acceptable means. If any currency conversion shall be required in connection with
determining sales levels or the payment of any royalties, milestone payments or Sublicense Revenue
under this Agreement, such conversion shall be made by using the average of the interbank exchange
rates for the purchase and sale of United States Dollars reported by The Wall Street
Journal (U.S., Western Edition) on the last business day of the calendar year to which such
royalty, milestone or Sublicense Revenue payments relate.
6.3 Overdue Payments. In the event any amount payable by Licensee to ADVENTRX under
this Agreement is not paid when due, such outstanding payment shall accrue interest (from the date
such payment is due through and including the date upon which full payment is made) at a rate of
one and a half percent (1.5%) per month from the due date until paid in full, provided that in no
event shall said rate exceed the maximum interest rate permitted by law in regard to such payments.
Such payment when made shall be accompanied by all interest so accrued. In the event such payment
does not include all accrued interest, the payment will be applied first to amounts originally
payable and then to outstanding interest, and interest will continue to accrue on any unpaid
amounts (whether originally due or interest thereon). Said interest and the payment and acceptance
thereof shall not negate or waive the right of ADVENTRX to any other remedy, legal or equitable, to
which it may be entitled because of the delinquency of a payment.
6.4 Tax Withholding. Any sum required under applicable laws to be withheld from any
and all payments made to ADVENTRX under this Agreement shall be withheld and promptly paid to the
relevant tax authorities by Licensee (or its Affiliates, or Sublicensees, as the case may be).
Licensee shall ensure that the official tax receipts or other evidence of such payments be provided
to ADVENTRX in a timely manner and shall provide ADVENTRX upon request with such written
documentation regarding any such payment as available to Licensee relating to an application by
ADVENTRX for a foreign tax credit for such payment with the United States Internal Revenue Service.
Notwithstanding the foregoing, with respect to the upfront license fee under Section 5.1, any sum
required under the applicable laws to be withheld by Licensee will be the sole responsibility of
Licensee and all amounts owing from Licensee to ADVENTRX under that Section shall be grossed up to
account for any withholding taxes, value added taxes or other taxes, duties, tariffs, levies or
similar charges.
ARTICLE 7
REPORTS, RECORDS AND ACCOUNTING
7.1 Reports. After the first receipt by Licensee or an Affiliate of Licensee of
Sublicense Revenue pursuant to Section 5.6 or the First Commercial Sale, whichever is earlier,
Licensee shall furnish to ADVENTRX a written report for each calendar year during the term of this
Agreement showing:
(a) the aggregate gross sales and other dispositions of all Products (broken-out by Product)
sold or other disposed of by Licensee, its Affiliates and any Sublicensees during such calendar
year and the calculation of Net Sales from such amount;
(b) the applicable royalty rates and the royalties, payable in United States Dollars, which
shall have accrued under this Agreement based upon such Net Sales;
(c) the amount of any Sublicense Revenue received by Licensee or an Affiliate of Licensee or a
Sublicensee during such calendar year, if relevant;
(d) the exchange rates used in determining the amount of sales, royalties or Sublicense
Revenue, as applicable, payable in United States Dollars, as more specifically provided in
Section 6.2; and
(e) any reductions to or deductions from payments taken by Licensee in accordance with this
Agreement.
9
Reports to be provided by Licensee to ADVENTRX under this Section 7.1 shall be due
forty-five (45) days following the end of each calendar year (unless Licensee has sublicensed
rights to commercialize Products, in which event such reports shall be due within sixty (60) days
following the end of each calendar year). If for any year following the first receipt by Licensee
or an Affiliate of Licensee or a Sublicensee of Sublicense Revenue pursuant to Section 5.6 or the
First Commercial Sale, whichever is earlier, there were no Net Sales, and no Sublicense Revenues
were received by Licensee or an Affiliate of Licensee or a Sublicensee in such year, a report
stating such facts shall be due within sixty (60) days following the end of such year. A
responsible financial officer of Licensee (or that officers responsible designee), Licensees
independent accounting firm, or the head of Licensees internal audit committee shall certify in
writing that each report provided under this Section 7.1 is correct and complete.
7.2 Milestone Reports and Payments. Licensee shall notify ADVENTRX in writing within
forty-five (45) days after the achievement of each milestone set out in Sections 5.2 and 5.3 by
Licensee, its Affiliate or Sublicensee, and each such notice shall be accompanied by the
appropriate milestone payment.
7.3 Records. Licensee shall keep, and shall require that its Affiliates and each
Sublicensee keep, complete and accurate books of account and records in sufficient detail to enable
the amounts payable under this Agreement to be determined. Such books and records shall be kept at
the principal place of business of Licensee, its Affiliate or such Sublicensee, as the case may be,
for at least sixty (60) months following the end of the calendar year to which such books and
records pertain; provided, however, that in the event ADVENTRX conducts an audit and a dispute
arises over the accuracy of reports or payments, Licensee, its Affiliates and each Sublicensee, as
the case may be, shall retain all applicable books of account and records and continue to permit
access to such books of account and records until the resolution of such dispute.
7.4 Audits.
(a) Audit Rights. Upon reasonable prior written notice from ADVENTRX and not more
than once in each calendar year, Licensee shall permit, and shall require its Affiliates and each
Sublicensee to permit, an independent certified public accounting firm of nationally recognized
standing in the United States or the Territory selected by ADVENTRX to have access during normal
business hours to such books of account and records of Licensee, and its Affiliates and each
Sublicensee, at such persons or entitys principal place of business, as may be reasonably
necessary to verify the accuracy of the reports and payments provided by Licensee for any calendar
year ending not more than sixty (60) months prior to the date of such request.
(b) Audit Results. If as a result of any such audit, it is established that
additional payments were owed to ADVENTRX during the period covered by such audit pursuant to
Section 7.3(a), Licensee shall, within thirty (30) days, remit to ADVENTRX the amount of such
additional payments, together with interest on such amount, which shall be calculated pursuant to
Section 6.3. In the event such audit establishes that amounts were overpaid by Licensee during
such period, the amount of such overpayment shall be credited against future royalties and other
payments due to ADVENTRX under this Agreement. The fees charged by such accounting firm in
connection with any audit pursuant to this Section 7.3 shall be paid by ADVENTRX; provided,
however, that if a discrepancy of more than five percent (5%) of the payments due hereunder for any
calendar year within the period being audited is established, then Licensee shall within thirty
(30) days of notice of such audit results from ADVENTRX pay the fees and expenses charged by such
accounting firm in connection with such audit and such audit shall not be deemed an audit under
Section 7.3(a) for purposes of the number of audits ADVENTRX may conduct each calendar year.
(c) Confidential Financial Information. ADVENTRX shall treat all financial
information subject to review under this Article 7 as confidential, and shall cause its accounting
firm to retain all such financial information in confidence, except with respect to the enforcement
of ADVENTRXs rights under this Agreement.
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ARTICLE 8
REGULATORY MATTERS
8.1 ADVENTRX Matters. As between the Parties, ADVENTRX shall control all matters
related to submissions for Regulatory Approval outside of the Territory, including the conduct and
control of any preclinical and clinical studies related to any NDA submission to the FDA. ADVENTRX
and its designees may conduct and control any post-approval studies with respect to any submissions
for Regulatory Approvals outside of the Territory. For the avoidance of doubt, ADVENTRX shall have
complete authority and discretion with respect to such submissions, including the timing and
content of any submissions or whether to make any submissions, and makes no warranties as to the
results of any such submissions.
8.2 Licensee Matters. Licensee is responsible, at its expense, for all activities
required for manufacture, import, development and other testing of Products in the Territory and
for obtaining Regulatory Approval for Products in the Territory, including without limitation for
filing, obtaining and maintaining approvals for the development and commercialization of Products
in the Territory, pricing or reimbursement approvals in the Territory, and for managing all
interactions with Regulatory Authorities in the Territory. Licensee shall be responsible for
ensuring compliance with all regulatory requirements relating to Products in the Territory or in
connection with studies conducted by or on behalf of Licensee, and shall serve as the designated
regulatory official for purposes of receiving communications from relevant Regulatory Authorities.
ADVENTRX shall have the right, but not the obligation, to review and comment upon any submissions
or responses to Regulatory Authorities. LICENSEE WILL NOT CONDUCT, OR HAVE CONDUCTED, ANY CLINICAL
TRIAL FOR A PRODUCT OUTSIDE OF THE TERRITORY, WITHOUT THE PRIOR WRITTEN CONSENT OF ADVENTRX ON A
CASE-BY-CASE BASIS.
8.3 Adverse Events. Licensee shall be responsible for the surveillance, receipt and
evaluation of product complaints for Product in the Territory or in connection with any studies
conducted by or on behalf of Licensee and reporting to Regulatory Authorities regarding Adverse
Events associated therewith, including any required literature reviews. Within one hundred eighty
(180) days of the Effective Date, ADVENTRX and Licensee shall discuss and develop an agreement
containing mutually acceptable guidelines and procedures for the receipt, recordation,
communication, exchange and reporting of Adverse Events for Products. Until such time such
agreement is executed, to the extent either Party has or receives any information regarding any
Adverse Event, the Parties shall promptly forward such information as follows:
(a) Prior to First Commercial Sale, Serious Adverse Events judged by either the investigator
or sponsor of a clinical trial (or reported to a Party and judged) to be reasonably related to a
Product shall be transmitted to the other Party within three (3) calendar days from the date
received by the receiving Party; and
(b) After First Commercial Sale, Serious Adverse Events reported to a Party and judged to be
reasonably related to a Product shall be transmitted to the other Party within five (5) calendar
days from the date received by the receiving Party.
11
If to Licensee:
Facsimile:
82-2- 553-2578
Attn: Director, Regulatory Affairs
or
Overnight courier:
Director, Regulatory Affairs
Shin Poong Pharmaceutical, Co., Ltd.
748-31 Yoksam-Dong, Kangnam-Ku
Seoul 135-925 Korea
If to ADVENTRX:
Facsimile:
(858) 552-0876
Attn: Vice President, Regulatory Affairs
or
Overnight courier:
Vice President, Regulatory Affairs
ADVENTRX Pharmaceuticals, Inc.
6725 Mesa Ridge Road, Suite 100
San Diego, CA 92121
8.4 Regulatory Materials.
(a) ADVENTRX will provide to Licensee a copy of (i) all data resulting from any analytical,
stability, toxicology or pharmacokinetic work performed prior to the Effective Date relating
exclusively to a Product, and (ii) other written data, information and finalized reports (excluding
draft reports) generated prior to the Effective Date that relate exclusively to a Product, to the
extent ADVENTRX reasonably determines such information, data and reports are necessary or useful to
the preparation and submission of regulatory filings for Products within the Territory and to the
extent that such information, data and reports are in ADVENTRXs possession and that ADVENTRX has
rights to provide such materials to Licensee. All such material will be provided in its original
format and language. ADVENTRX shall retain ownership of all of such materials. ADVENTRX hereby
grants Licensee, its Affiliates, and permitted Sublicensees a Right of Reference to the foregoing
for purposes of making regulatory filings in the Territory.
(b) Licensee shall permit ADVENTRX to access (and will ensure that its Affiliates and each
Sublicensee permit ADVENTRX to access) (i) any clinical protocol, study, clinical data or result
used in or resulting from any clinical trial of any Product, including any underlying raw data, and
(ii) any investigational new drug application (or comparable application in the Territory),
application(s) for Regulatory Approval, Regulatory Approval(s) and other regulatory filings
regarding any Product, and any regulatory communications associated with any of the foregoing.
Licensee hereby grants ADVENTRX and its Affiliates a Right of Reference to the foregoing for
purposes of making regulatory filings outside the Territory.
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8.5 Regulatory Interactions for Product.
(a) Subject to Section 8.3, each Party shall promptly, but in any event within five (5)
business days, (i) provide to the other Party copies of any material documents or correspondence
received from any Regulatory Authority related to development and commercial activities for a
Product and (ii) inform the other Party of any inspections, proposed regulatory actions,
investigations or requests for information or a meeting by any Regulatory Authority with respect to
a Product.
(b) Licensee shall have responsibility for any recall, market withdrawals or other corrective
actions related to Products in the Territory or in connection with studies conducted by or on
behalf of Licensee and costs associated therewith; provided, however, that Licensee shall
immediately notify ADVENTRX of any consideration for the recall or withdrawal of or other action
with respect to a Product in the Territory or such a study and shall consult with ADVENTRX prior to
taking any actions with respect thereto.
(c) Subject to Section 8.3, each Party shall provide the other Party with notice of
notification or other information it receives (directly or indirectly) from any Regulatory
Authority that (i) raises any material concerns regarding the safety or efficacy of a Product; (ii)
indicates or suggests a claim of a Third Party arising in connection with a Product, or (iii) is
reasonably likely to lead to a recall or market withdrawal of a Product; provided that neither
Party shall be obliged to disclose information in breach of any contractual restriction which it
could not reasonably have avoided or which disclosure would waive any legal privilege.
8.6 Ownership. All Regulatory Approvals relating to Products labeled for use in the
Field shall be the property of ADVENTRX or its designee and held in the name of ADVENTRX or its
designee, except that Regulatory Approvals in the Territory for Products labeled for use in the
Field shall be the property of Licensee and held in the name of Licensee or its designee. Upon the
request of ADVENTRX upon or following the termination of this Agreement, Licensee shall, at its own
expense, promptly take whatever steps are necessary to transition and assign any existing
Regulatory Approvals and related filings to ADVENTRX.
8.7 Initial Product. ANX-514 manufactured from anhydrous docetaxel will be the initial
Product for which a New Drug Application for Regulatory Approval in the United States is submitted.
ARTICLE 9
SUPPLY AND MANUFACTURE
9.1 Contract Manufacturer. ADVENTRX is or was (at least as recently as March 5, 2009)
a party to a contract with *** (Contract Manufacturer) for certain services
related to, among other things, the supply of unlabeled and/or labeled vials of finished drug
product consisting of ANX-514 to ADVENTRX or its designee. As of March 5, 2009, Contract
Manufacturer has communicated with ADVENTRX that it would be willing to use good faith efforts to
enter into a contract with Licensee for the manufacture and supply of Product, and has delivered to
ADVENTRX the letter attached hereto as Exhibit D. Licensee may enter into negotiations
with Contract Manufacturer for the manufacture and supply of Products. ADVENTRX may, but has no
obligation to, assist Licensee in such contract negotiations, and Licensee acknowledges that
ADVENTRX shall not be required to conduct any activities in violation of its current or any future
contract with Contract Manufacturer; provided, however, that ADVENTRX shall have no responsibility
for the outcome of any negotiations between Licensee and Contract Manufacturer. EXCEPT AS
EXPRESSLY SET FORTH BELOW IN SECTION 9.2, ADVENTRX SHALL HAVE NO OBLIGATIONS OR LIABILITY WITH
RESPECT TO THE SUPPLY, MANUFACTURE, TESTING, FINISHING, PACKAGING OR LABELING OF PRODUCTS FOR THE
TERRITORY. Licensee agrees that ADVENTRX may, at any time, elect to utilize entities other than
Contract Manufacturer to manufacture Products.
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9.2 Transfer to Contract Manufacturer. ADVENTRX has provided to Contract
Manufacturer, among other things, the following items as they relate to ANX-514:
a list components and composition, including drug substance and bulk product for
characterization purposes;
a description of the manufacturing process, including a redacted batch record and
reports regarding lyophilization;
product and component specifications, including release specifications; and
information regarding the container closure system (collectively, Manufacturing
Items)
During the term of this Agreement, ADVENTRX agrees that it shall permit Contract Manufacturer
to utilize the Manufacturing Items in connection with the manufacture of Product for Licensee. AS
BETWEEN ADVENTRX AND LICENSEE, THE MANUFACTURING ITEMS ARE PROVIDED AS IS AND WITHOUT ANY
WARRANTIES.
9.3 Clinical Supply. In the event Licensee is required by the KFDA to
conduct a Bioequivalence or clinical trial in human subjects prior to receipt of Regulatory
Approval for a Product consisting of ANX-514 in the Territory, Licensee shall notify ADVENTRX of
such requirement and specify the volume of such Product in finished form that Licensee requires for
such trial; provided, however, that such requested volume of Product may not exceed the lesser of
(i) Licensees actual requirements for such trial, or (ii) the volume reasonably necessary to
properly conduct a single-dose, 45-subject, pharmacokinetic Bioequivalence study in humans for such
Product (such lesser amount, the Requested Supply). Within fifteen (15) business days of
receipt of such notice, ADVENTRX shall respond in writing to Licensee that it will (i) supply such
quantity of such Product for Licensees trial, or (ii) provide a refund equal to US $100,000.
9.4 Specifications. In the event ADVENTRX elects to supply the Requested Supply under
Section 9.3, ADVENTRX will deliver to Licensee with the Requested Supply, or each batch thereof, a
true, accurate and complete copy of the certificate of analysis (CoA) that it receives from the
manufacturer of such Requested Supply, and will pass-through to Licensee warranties from the
manufacturer with respect to such Requested Supply that ADVENTRX is permitted to pass-through.
Such Requested Supply shall be delivered ex works (manufacturers facility, or if stored by or on
behalf of ADVENTRX, such storage facility). EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
SECTION 9.4, THE REQUESTED SUPPLY IS PROVIDED ON AN AS IS BASIS. Without limiting the foregoing,
Licensee shall be responsible for proper release testing of the Requested Supply and compliance
with all applicable laws and instructions of Regulatory Authorities with respect to Licensees (or
its Affiliates or contractors) receipt and use of the Requested Supply.
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ARTICLE 10
CONFIDENTIALITY
10.1 Proprietary Information. Except as otherwise provided in this Article 10, during
the term of this Agreement and for a period of seven (7) years thereafter, each Party (the
Recipient) shall maintain in confidence and use only for purposes of this Agreement any
confidential information, data and materials supplied to such Party by the other Party (the
Disclosing Party) under this Agreement; provided that, unless the confidentiality of any
information, data or materials is expressly provided for in this Agreement, if any such
information, data or materials are in tangible form, they are marked Confidential or
Proprietary, or if disclosed orally, they are identified as confidential or proprietary when
disclosed and are confirmed in writing as confidential or proprietary within thirty (30) days
following such disclosure (such information, data and materials so disclosed, collectively
Proprietary Information). The ADVENTRX Know-How and any unpublished patent application
within the ADVENTRX Patents shall be deemed to be the Proprietary Information of ADVENTRX without
regard to the foregoing marking requirements, and without limiting or in any way affecting the
licenses set forth in Article 2. The obligations of the Recipient under this Article 10 not to
disclose or use Proprietary Information received from the Disclosing Party shall not apply,
however, to the extent that any such information, data or materials:
(a) are or become generally available to the public, or otherwise part of the public domain,
other than by acts or omissions of the Recipient in breach of this Agreement;
(b) are disclosed to the Recipient, other than under an obligation of confidentiality, by a
Third Party who had no obligation to the Disclosing Party not to disclose such information to
others;
(c) were already rightfully in the possession of the Recipient, other than under an obligation
of confidentiality, prior to disclosure by the Disclosing Party, as shown by Recipients written
records existing prior to such disclosure; or
(d) are subsequently and independently developed by the Recipient without use of, or reference
to, the Proprietary Information of the Disclosing Party, as shown by written records prepared
contemporaneously with such disclosure.
10.2 Permitted Disclosures. To the extent it is reasonably necessary or appropriate
to fulfill its obligations or exercise its rights under this Agreement:
(a) Recipient may disclose Proprietary Information which it is otherwise obligated under this
Article 10 not to disclose, to its legal advisers who are subject to a duty of confidentiality to
the Recipient, to its Affiliates, and, in each case whether actual or potential, to: Sublicensees
or other collaboration partners, assignees, contractors (including without limitation manufacturers
and researchers), acquirers, investors, and medical, scientific, business and financial advisors,
on a need-to-know basis in accordance with such Recipients exercise of its rights or performance
of its obligations under this Agreement; provided that such persons agree to be bound by
obligations of confidentiality with respect to such Proprietary Information which are substantially
similar in scope as those set forth in this Article 10.
(b) Recipient may disclose Proprietary Information of the Disclosing Party to government or
other regulatory authorities to the extent that such disclosure is (i) required by applicable law
(including all applicable securities laws), regulation, agency or court order, or (ii) is
reasonably necessary in connection with the prosecution of any Patent, to obtain any authorization
to conduct clinical studies, or to obtain any Approval for a Product; provided that, in case of any
disclosures required as described in clause (i) above, the Recipient shall provide reasonable
advance notice to the Disclosing Party to allow such Party to oppose such disclosure or to request
confidential treatment of such Proprietary Information.
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10.3 Prior Agreements. This Agreement supersedes the Mutual Nondisclosure Agreement
between Licensee and ADVENTRX dated August 6, 2008 (the Mutual Confidentiality
Agreement). All information exchanged between the Parties under the Mutual Confidentiality
Agreement shall be deemed to have been disclosed under this Agreement on a going-forward basis and
shall be subject to the terms of this Article 10 as of the Effective Date.
10.4 Terms of Agreement. The terms of this Agreement shall not be disclosed by either
Party without the prior written consent of the other Party, which shall not be unreasonably
withheld; provided, however that either Party may make such a disclosure (a) to the extent
required by law or by the requirements of any nationally recognized securities exchange, quotation
system or over-the-counter market on which such Party has its securities listed or traded, or (b)
to any Affiliates, legal advisors, accountants, and, in each case whether actual or potential, to:
licensees, sublicensees or other collaboration partners with a reasonable need-to-know; acquirers,
investors; lenders and other potential financing sources, who are obligated to keep such
information confidential. In the event that such disclosure is required as described in clause (a)
of the preceding sentence, the disclosing Party shall make reasonable efforts to provide the other
Party with notice beforehand and to coordinate with the other Party with respect to the wording,
timing and any redactions of any such disclosure.
10.5 Press Release and Future Announcement. None of the Parties may issue a press
release with respect to this transaction, without the prior written consent of the other Party.
Once such press release or any other written statement is approved for disclosure by the Parties,
each Party may make subsequent public disclosure of the contents of such statement without the
further approval of the other Party. Notwithstanding the foregoing, Licensee acknowledges and
agrees that ADVENTRX may (i) publicly disclose (including by press release and through fillings
with the United States Securities and Exchange Commission) the occurrence/attainment of each
regulatory milestone set forth in Section 5.2 and commercial milestone set forth in Section 5.3 and
the amount and payment of associated payments, as well as notice and/or receipt of Sublicense
Revenue, and (ii) include in its public disclosures (including in pipeline charts summarizing
development and commercialization results and goals for ADVENTRXs products and product candidates)
a general description of the stage of development of all Products, including gross sales and Net
Sales thereof.
ARTICLE 11
INTELLECTUAL PROPERTY AND INFRINGEMENT
11.1 General. Unless otherwise agreed in writing by the Parties, as between the
Parties, title to all inventions and other intellectual property made solely by personnel of
Licensee in connection with this Agreement shall be owned by Licensee, and title to all inventions
and other intellectual property made solely by personnel of ADVENTRX in connection with this
Agreement shall be owned by ADVENTRX.
11.2 Licensee Improvements. In the event that Licensee or its Affiliates or a
Sublicensee (i) invents, discovers or develops any improvement to Products or the subject matter of
any of the ADVENTRX Patents (Product Improvement), including without limitation any
modification to a Product or its components or its or its components manufacture or formulation
that enhances its safety, effectiveness, stability, administration or otherwise, or reduces its or
their cost, or (ii) acquires the right to grant a license to a Product Improvement, Licensee hereby
does, and agrees that its Affiliates and all Sublicensees hereby do, grant to ADVENTRX a
nonexclusive, perpetual, irrevocable, non-transferable (except in accordance with Section 15.2),
fully paid-up, worldwide license, with the right to sublicense, to Product Improvements, to use,
make, have made, sell, offer for sell, import and otherwise exploit Products.
11.3 Third Party License. In the event that Licensee has determined to enter into
discussions with a Third Party for a license to such Third Partys intellectual property as it
relates to a Product, Licensee shall, as soon as is reasonably practicable, notify ADVENTRX and
provide ADVENTRX with all information, data and reports that Licensee has collected or developed
that relates to such Third Party intellectual property. In the event that ADVENTRX determines that
it desires to enter into discussions with such Third Party for such intellectual property, the
Parties shall cooperate in good faith to determine the best manner to initiate and continue
discussions with such Third Party for such Third Party intellectual property. For the avoidance of
doubt, the results of any discussions or negotiations with a Third Party shall not impact any of
the terms of this Agreement.
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11.4 Patent Prosecution and Maintenance.
(a) By ADVENTRX. ADVENTRX (or its designee) shall have the right, at its option, to
control the preparation, filing, prosecution and maintenance of the ADVENTRX Patents, and Licensee
agrees to reimburse ADVENTRX for all of its out-of-pocket expenses in connection with such
activities in or related to the Territory as they are incurred. As used in this Section 11.4,
prosecution shall include interferences, re-examinations, reissues, oppositions, obtaining
certificates of correction, patent term extensions, Supplementary Protection Certificates, and the
like. ADVENTRX (or its designee) shall have the right to apply for an extension of the term of any
ADVENTRX Patent if available under the Drug Price Competition and Patent Term Restoration Act of
1984 and/or European, Japanese and other foreign counterparts of this law, including any foreign
laws extending marketing exclusivity for a Product, such as a Supplementary Protection Certificate.
(b) By Licensee. If ADVENTRX determines not to prosecute any ADVENTRX Patent within
the Territory, then ADVENTRX shall provide Licensee with written notice of such decision at least
sixty (60) days prior to the deadline for filing any such prosecution action for the ADVENTRX
Patent or the date on which the abandonment of any such ADVENTRX Patent would become effective. In
such event, Licensee shall have the right, but not the obligation, at its option and expense, to
control the preparation, filing, prosecution and maintenance of such ADVENTRX Patent in ADVENTRXs
name in the Territory.
(c) Cooperation. Each Party shall cooperate with the other Party in connection with
activities relating to the preparation, filing, prosecution and maintenance of the ADVENTRX Patents
undertaken by the other Party pursuant to this Section 11.4, including: (i) making available to
such other Party in a timely manner any documents or information reasonably necessary or
appropriate to facilitate such other Partys preparation, filing, prosecution and maintenance of
any ADVENTRX Patent; and (ii) if and as appropriate, signing (or causing to have signed) all
documents relating to the preparation, filing, prosecution and maintenance of any ADVENTRX Patent
by such other Party. Each Party shall also promptly provide to the other Party all information
reasonably requested by such other Party with regard to such Partys activities pursuant to this
Section 11.4.
11.5 Enforcement.
(a) Notice. In the event either Party learns of any infringement of the ADVENTRX
Patents by the manufacture, use, sale, offer for sale or importation of any product in the
Territory (an Infringement), it shall promptly provide written notice to the other Party
of such Infringement and shall supply such other Party with all evidence it possesses pertaining to
such Infringement.
(b) Infringement Action. The Parties will discuss in good faith whether to bring any
action with respect to the Infringement. Licensee understands and agrees that ADVENTRX may notify
LPI of such infringement, and the Parties (and LPI if it desires) shall confer and endeavor to
reach consensus as to how best to deal with the infringer. If the Parties mutually determine to
proceed with enforcement, Licensee (directly or through its nominee) shall have the first right,
but not the obligation, to seek to abate such Infringement, or to file suit against the infringing
party for the Infringement, at its own cost and expense. In the event that Licensee or its nominee
does not, within one hundred twenty (120) days from date of a request by ADVENTRX to do so, take
action to abate such Infringement or file suit against the infringing party for the Infringement,
ADVENTRX (directly or through its nominee) shall have the right, but not the obligation, to enforce
the ADVENTRX Patents in connection with such Infringement, and at its own cost and expense.
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(c) Cooperation. In any suit, action or other proceeding in connection with an
Infringement (an Infringement Action), the Party assuming the primary role in the
Infringement Action (Controlling Party) shall keep the non-Controlling Party reasonably
informed of the progress of such Infringement Action. The non-Controlling Party shall cooperate
fully with the Controlling Party, including by joining as a nominal party and executing such
documents as the Controlling Party may reasonably request, provided that neither ADVENTRX nor SDP
shall be required to transfer any right, title or interest in or to any of the ADVENTRX Patents to
Licensee, its Affiliates, Sublicensees or any other Third Party to confer standing to bring an
Infringement Action. In any case, the non-Controlling Party shall have the right, even if not
required to be joined, to participate in any Infringement Action with counsel of its own choice at
its own expense.
(d) Costs and Recoveries. The Controlling Party with respect to any Infringement
Action may not settle any such action, or otherwise consent to any adverse judgment in any such
action, that restricts the scope of, or admits the unenforceability or invalidity of, any ADVENTRX
Patent without the express written consent of the non-Controlling Party, which consent shall not be
unreasonably withheld. Any damages, monetary awards or other amounts recovered, whether by
judgment or settlement, pursuant to any suit, proceeding or other action taken under this
Section 11.5 shall applied as follows:
(i) First, to reimburse the Parties for their respective costs and expenses (including
reasonable attorneys and experts fees and costs) incurred in prosecuting such Infringement
Action;
(ii) Second, any amounts remaining shall be allocated seventy percent (70%) to the Controlling
Party and thirty percent (30%) to the non-Controlling Party.
For the avoidance of doubt, if any judgment or settlement results in the granting to the
alleged infringer of a sublicense of any of the ADVENTRX Technology with running royalties payable
on post-judgment/settlement sales by the alleged infringer, such alleged infringer shall be deemed
to be a Sublicensee and such royalties on post-settlement sales (x) shall be subject to all
applicable royalty obligations hereunder as if the product the subject of such judgment or
settlement were a Product, and (y) shall not be subject to this Section 11.5(d).
11.6 Defense of Infringement Claims. If any Product manufactured, used or sold by
Licensee, its Affiliates, or Sublicensees, becomes the subject of a Third Partys claim or
assertion of infringement of a patent relating to the manufacture, use, sale, offer for sale or
importation of such Product, the Party first having notice of the claim or assertion shall promptly
notify the other Party, and the Parties shall promptly confer to consider the claim or assertion
and the appropriate course of action. Any such claim naming ADVENTRX or SDP as a defendant shall
be subject to Section 14.1. In any event, each Party shall reasonably assist the other Party and
cooperate in connection with any litigation, arbitration or similar proceedings in which such Party
is not named as a defendant, at the defending Partys request and expense.
11.7 Labeling and Promotional Materials. Subject to applicable laws and regulations,
packaging for all Products sold by or on behalf of Licensee, its Affiliates, or Sublicensees
pursuant to this Agreement and on all package inserts and labeling will identify SDP (or its
successor assign) as licensor of the ADVENTRX Patents and will comply with all patent marking
requirements as specified in 35 USC Sec. 287 or other applicable patent marking requirements of
other jurisdictions to preserve and maximize the rights and remedies of SDP and ADVENTRX.
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ARTICLE 12
TERM AND TERMINATION
12.1 Term. This Agreement shall commence on the Effective Date and, unless terminated
earlier pursuant to Sections 12.2, 12.3 or 12.4 shall continue in full force and effect until no
further royalties would be due. Upon expiration (but not early termination of this Agreement) in
accordance with this Section 12.1, the licenses and rights granted by ADVENTRX or SDP to Licensee
under this Agreement will continue on a fully paid-up, royalty-free basis.
12.2 Termination for Material Breach. If either Party materially breaches this
Agreement at any time, the non-breaching Party shall have the right to terminate this Agreement by
written notice to the breaching Party, if such breach is not cured within ninety (90) days (thirty
(30) days in the case of a failure to pay) after written notice is given by the non-breaching Party
to the breaching Party specifying the breach.
12.3 Termination for Financial Insecurity. In the event that either Party files for
protection under bankruptcy laws, makes an assignment for the benefit of creditors, appoints or
suffers appointment of a receiver or trustee over its property, files a petition under any
bankruptcy or insolvency act or has any such petition filed against it which is not discharged
within sixty (60) days of the filing thereof, then the other Party may terminate this Agreement
effective immediately upon written notice to such Party.
12.4 Termination by Licensee. Subject to the requirements of this Section 12.4, this
Agreement may be terminated by Licensee, in its sole discretion, upon sixty (60) days written
notice to ADVENTRX; provided, however, that, prior to making a final determination to terminate
this Agreement (and prior to delivering any notice of termination) pursuant to this Section 12.4,
Licensee shall first notify ADVENTRX of facts and circumstances that Licensee is considering and
might cause Licensee to make a final determination to terminate this Agreement pursuant to this
Section 12.4 and Licensee shall discuss with ADVENTRX in good faith for at least thirty (30) days
following the date it notifies ADVENTRX that it is considering terminating this Agreement possible
means to address or otherwise resolve Licensees concerns. Following such 30-day good faith
discussion period, Licensee may terminate this Agreement pursuant to this Section 12.4 provided any
notice to terminate is received by ADVENTRX within 10 days after the end of such 30-day good faith
discussion period.
12.5 Effect of Expiration or Termination.
(a) Termination. Upon termination of this Agreement:
(i) The licenses and rights granted to Licensee under Article 2 will immediately terminate;
provided that, at ADVENTRXs option, any sublicenses granted in accordance with Section 2.4 and to
alleged infringers as contemplated by Section 11.5 prior to the date of the corresponding notice of
breach (in the case of Section 12.2) or termination (in the case of Section 12.3 or 12.4) issued by
ADVENTRX shall survive if the relevant Sublicensee agrees in writing to be bound by the terms of
this Agreement as such terms apply to such Sublicensee (in which event, such Sublicensee will be
deemed a direct licensee of SDP (or its assignee or successor, as the case may be).
(ii) Licensees royalty and milestone obligations (other than royalty payments under Section
5.5), and related reporting obligations and audit rights, under this Agreement shall survive for
the royalty term set forth in Section 5.4(e)(ii).
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(iii) Licensee shall, as promptly as is reasonably practicable and in any event within thirty
(30) days, return to ADVENTRX all ADVENTRX Know-How, and all copies and any other tangible and
electronic embodiments thereof in Licensees, its Affiliates, or any Sublicensees possession,
subject to the rights of any surviving Sublicensee.
(iv) Licensee shall, as promptly as is reasonably practicable and in any event within thirty
(30) days, provide to ADVENTRX all copies of any Regulatory Approvals, and related filings, and
copies of all materials in Licensees control or possession related to the manufacture,
preparation, formulation, use, development, marketing, promotion, use, handling, storage, sale and
commercialization of each Product.
(v) Licensee shall comply with Section 8.6.
(b) Survival of Certain Obligations. The expiration or termination of this Agreement
for any reason shall not relieve either Party of any obligation accruing on or prior to such
expiration or termination, or which is attributable to a period prior to such expiration or
termination, nor preclude either Party from pursuing any rights and remedies it may have under this
Agreement, or at law or in equity, which accrued or are based upon any event occurring prior to
such expiration or termination. The following provisions shall survive the expiration or
termination of this Agreement for any reason: Articles 6 (Payments), 7 (Reports, Records and
Accounting), 10 (Confidentiality), 14 (Indemnification and Insurance) and 15 (Miscellaneous) and
Sections 8.3 (Adverse Events, with respect to Products distributed in the Territory during the
Term), 8.6 (Ownership), and 12.5 (Effect of Expiration or Termination).
ARTICLE 13
REPRESENTATIONS AND WARRANTIES
13.1 General Representations and Warranties. Each Party represents and warrants to
the other Party that:
(a) it is a corporation duly organized and validly existing under the laws of the jurisdiction
in which it is incorporated;
(b) it has full corporate power and authority, and has obtained all approvals, permits and
consents necessary, to enter into this Agreement and to perform its obligations hereunder;
(c) this Agreement is legally binding upon it and enforceable in accordance with its terms;
and
(d) the execution, delivery and performance of this Agreement does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party or by which it may
be bound, nor violate any material law or regulation of any governmental or regulatory authority
having jurisdiction over it.
13.2 Additional Warranties of ADVENTRX/SDP. ADVENTRX and SDP hereby covenant,
represent and warrant to Licensee that:
(a) ADVENTRX or SDP, as the case may be, has the right to grant the licenses to Licensee that
are set forth in this Agreement; and
(b) Neither ADVENTRX nor SDP has granted any rights in the ADVENTRX Technology that are
inconsistent with or that limit the rights granted to Licensee under this Agreement;
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13.3 DISCLAIMER. Nothing in this Agreement is or shall be construed as a warranty or
representation by ADVENTRX or SDP as to the validity or scope of any patent application or patent
licensed or accuracy or usefulness of any know-how or materials hereunder or a warranty or
representation that anything made, used, sold or otherwise disposed of under any license granted
pursuant to this Agreement is or will be free from infringement of patents, copyrights, and other
rights of third parties. Except as expressly set forth in this Agreement, NEITHER PARTY MAKES ANY
REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR OF
NON-INFRINGEMENT OF ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES, OR ANY
OTHER EXPRESS OR IMPLIED WARRANTIES.
ARTICLE 14
INDEMNIFICATION AND INSURANCE
14.1 Indemnification by Licensee. Licensee shall defend, indemnify, and hold harmless
ADVENTRX, SDP, its and their Affiliates and their respective directors, officers, shareholders,
employees and agents, and their respective heirs, successors and assigns (ADVENTRX
Indemnitees), from and against any and all liabilities, claims, damages, losses, costs and
expenses (including reasonable attorneys and experts fees and other costs of defense) owing to
Third Parties (collectively, Liabilities) suffered or sustained by an ADVENTRX
Indemnitee, or to which an ADVENTRX Indemnitee becomes subject, (i) resulting directly or
indirectly from the advertising, promotion, marketing, manufacture, use, handling, storage, sale or
other disposition of or development or commercialization activities related to a Product by
Licensee, its Affiliates, or Sublicensees or their respective agents and distributors, but only to
the extent that such claims do not result from the negligence or intentional misconduct of ADVENTRX
or SDP, or (ii) resulting directly from a breach of this Agreement by Licensee.
14.2 Indemnification by ADVENTRX. ADVENTRX shall defend, indemnify, and hold harmless
Licensee, its Affiliates and their respective directors, officers, shareholders, employees and
agents, and their respective heirs, successors and assigns (Licensee Indemnitees), from
and against any and all Liabilities suffered or sustained by a Licensee Indemnitee, or to which a
Licensee Indemnitee becomes subject, (i) resulting from any negligence or intentional misconduct of
ADVENTRX or SDP, or (ii) resulting directly from a breach of this Agreement by ADVENTRX or SDP.
14.3 Indemnification Procedures. In the event that any Indemnitee (either a Licensee
Indemnitee or an ADVENTRX Indemnitee) intends to claim indemnification under this Article 14, such
Indemnitee shall promptly notify the other Party in writing of the alleged Liability. The
indemnifying Party (Indemnifying Party) shall have the right to control the defense
thereof, provided that counsel for the Indemnifying Party, who shall conduct the defense of such
claim or any litigation resulting therefrom, shall be approved by the Indemnitee (which approval
shall not be unreasonably withheld), and the Indemnitee may participate in such defense at such
Indemnitees expense (unless the Indemnitee shall have reasonably concluded, based upon a written
opinion from outside legal counsel, that there may be a conflict of interest between the
Indemnifying Party and the Indemnitee in the defense of such action, in each of which cases the
Indemnifying Party shall pay the fees and expenses of one law firm serving as counsel for the
Indemnitee). The failure of any Indemnitee to give notice as provided herein shall not relieve the
Indemnifying Party of its obligations under this Agreement to the extent that such failure to give
notice did not result in material prejudice to the Indemnifying Party or the Indemnifying Partys
insurer. The Indemnifying Party, in the defense of any such claim or litigation, shall not, except
with the approval of the Indemnitee (which approval shall not be unreasonably withheld), consent to
entry of any judgment or enter into any settlement which (i) would result in injunctive or other
relief being imposed against the Indemnitee; or (ii) does not include as an unconditional term
thereof the giving by the claimant or plaintiff to such Indemnitee of a release from all liability
in respect to such claim or litigation. The Indemnitee shall furnish such information regarding
itself or the claim in question as the Indemnifying Party may reasonably request in writing, and
shall be reasonably required in connection with the defense of such claim or litigation resulting
therefrom.
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14.4 Insurance. Prior to the initiation of the first clinical trial for a Product and
during the term of this Agreement, Licensee shall obtain and maintain appropriate comprehensive,
commercial general liability and product liability insurance with respect to Licensed Products and
any clinical trial for a Product, including coverage types and amounts that Licensee typically
obtains in connection with the conduct of clinical trial with human subjects in the Territory, and
in any event, of at least the scope of coverage and amounts standard in the industry for the
Territory. Such insurance shall name ADVENTRX, SDP, and their Affiliates as additional insureds
and shall be primary and shall not participate with nor be excess over any valid and collectable
insurance or program of self-insurance carried or maintained by ADVENTRX, SDP, and their
Affiliates. At ADVENTRXs request, Licensee shall provide ADVENTRX with a certificate of such
insurance and shall promptly notify ADVENTRX of any change in the terms of insurance from those set
forth in the most recent certificate of insurance provided to ADVENTRX pursuant to this Section.
Such insurance shall be in effect not later than the first administration of such a Licensed
Product in humans. Licensee shall require Sublicensees and Affiliates, if performing clinical
trials or offering for sale or selling any Product, to carry equivalent insurance and to comply
with all provisions of this Section.
ARTICLE 15
MISCELLANEOUS
15.1 Force Majeure. Neither Party shall be held liable or responsible to the other
Party, nor be deemed to have defaulted under or breached this Agreement, for failure or delay in
fulfilling or performing any term of this Agreement to the extent, and for so long as, such failure
or delay is caused by or results from causes beyond the reasonable control of the affected Party
(Force Majeure Event), including fire, floods, embargoes, power shortage or failure, acts
of war (whether war be declared or not), insurrections, riots, terrorism, civil commotions,
strikes, lockouts or other labor disturbances, acts of God or other deities (including lesser gods)
or any acts, omissions or delays in acting by any governmental authority or the other Party;
provided the affected Party uses reasonable best efforts to mitigate the impact of such Force
Majeure Event and resume performance under this Agreement. Notwithstanding the foregoing, in the
event that any default or breach continues for more than one hundred eighty (180) days due to a
Force Majeure Event or series of Force Majeure Events, the other Party may terminate this Agreement
upon thirty (30) days prior written notice. For the avoidance of doubt, a failure to pay shall
never be excused by a Force Majeure Event.
15.2 Assignment. Neither Party may assign or transfer (including through operation of
law, reverse triangular merger or otherwise) this Agreement without the prior written consent of
the other Party, except (i) to an entity who acquires all or substantially all of its assets or
business related to the subject matter of this Agreement, whether through merger, sale of stock,
sale of assets, exclusive transfer of technology, reorganization or otherwise, (ii) with respect to
ADVENTRX, to an entity who acquires (by any of the foregoing methods) ADVENTRXs ANX-514 program
and (iii) with respect to SDP, to ADVENTRX. Any permitted assignee shall assume all obligations of
its assignor under this Agreement. Any purported assignment by a Party of this Agreement in
violation of this Section 15.2 shall be void. For the avoidance of doubt, nothing in this Section
15.2 or elsewhere in this Agreement shall restrict ADVENTRX from transferring, assigning or selling
its right to receive payment hereunder.
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15.3 Severability. If one (1) or more provisions of this Agreement is held to be
invalid, illegal or unenforceable, the Parties shall substitute, by mutual consent, valid
provisions for such invalid, illegal or unenforceable provisions which valid provisions are, in
their economic effect, sufficiently similar to the invalid provisions that it can be reasonably
assumed that the Parties would have entered into this Agreement with such provisions. In the event
that such provisions cannot be agreed upon, the invalidity, illegality or unenforceability of
one (1) or more provisions of the Agreement shall not affect the validity of this Agreement as a
whole.
15.4 Notices. Any notice, consent or report required or permitted to be given or made
under this Agreement by one Party to the other Party shall be in English and in writing, delivered
personally or by facsimile (receipt verified and a copy promptly sent by personal delivery, U.S.
first class mail or express courier providing evidence of receipt, postage prepaid (where
applicable)), or by U.S. first class mail or express courier providing evidence of receipt, postage
prepaid (where applicable), at the following address for a Party (or such other address for a Party
as may be specified by like notice):
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To ADVENTRX: |
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To Licensee: |
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ADVENTRX Pharmaceuticals, Inc.
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Shin Poong Pharmaceutical Co., Ltd. |
6725 Mesa Ridge Road, Suite 100
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748-31 Yoksam-Dong, Kangnam-Ku |
San Diego, CA 92121
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Seoul 135-952 Korea |
Attention: Vice President, Legal
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Attention: Vice President |
Facsimile: (858) 552-0876
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Facsimile: 82-2-3452-2866 |
Phone: (858) 552-0866
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Phone: 82-2-2189-3470 |
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With a copy to:
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With a copy to: |
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ADVENTRX Pharmaceuticals, Inc.
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Shin Poong Pharmaceutical Co., Ltd. |
6725 Mesa Ridge Road, Suite 100
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748-31 Yoksam-Dong, Kangnam-Ku |
San Diego, CA 92121
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Seoul 135-952 Korea |
Attention: Vice President, Business Development
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Attention: Managing Director, Business Development |
Facsimile: (858) 552-0876
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Facsimile: 82-2-553-2578 |
Phone: (858) 552-0866
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Phone: 82-2-2189-3556 |
All such notices, consents or reports shall be effective upon receipt.
15.5 Applicable Law. This Agreement shall be governed by and construed in accordance
with the laws of the State of California and the United States, excluding the Convention on
Contracts for the International Sale of Goods and that body of law known as conflicts of laws.
15.6 Arbitration.
(a) Any dispute arising out of or related to this Agreement shall be finally settled in
accordance with the Rules of Arbitration of the International Chamber of Commerce by one arbitrator
appointed in accordance with such Rules. The arbitration shall take place in San Diego,
California, but the Parties hereby agree to exclude any right of application or appeal to the
courts in connection with any question of law arising in the course of the arbitration or out of
the award. The arbitration shall be conducted in the English language. Relevant documents in
other languages shall be translated into English if the arbitrator so directs. The applicable
procedural law shall be the law of the place of arbitration. The Parties agree that they will,
before the hearing of any dispute, make discovery and disclosure of all materials relevant to the
subject matter of such dispute. A written transcript in English of the hearing will be made and
furnished to the Parties. Examination of witnesses by the parties and by the arbitrators will be
permitted. The arbitrator will decide in accordance with the terms of this Agreement (i.e., the
terms hereof) and will take into account any appropriate international trade usages applicable to
the transaction. The arbitrator will state the reasons upon which the award is based. The award
of the arbitrator will be final and binding upon the Parties. Judgment upon the award may be
entered in any court having jurisdiction. An application may be made to any such court for
judicial acceptance of the award and an order of enforcement.
(b) Pending the selection of the arbitrator or pending the arbitrators determination of the
merits of any dispute, either Party may seek appropriate interim or provisional relief from any
court of competent jurisdiction as necessary to protect the rights or property of that Party.
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15.7 LIMITATION OF LIABILITY. EXCEPT FOR A BREACH OF ARTICLE 10 (CONFIDENTIALITY) OR
FOR INTENTIONAL BREACHES OF THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
PUNITIVE, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT,
HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY; PROVIDED HOWEVER THAT NOTHING IN THIS SECTION 15.7
SHALL BE DEEMED TO LIMIT THE INDEMNIFICATION OBLIGATIONS OF EITHER PARTY UNDER ARTICLE 14 TO THE
EXTENT A THIRD PARTY RECOVERS ANY PUNITIVE, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES
FROM AN INDEMNITEE.
15.8 Entire Agreement. This Agreement (including the Exhibits attached hereto)
contains the entire agreement by the Parties with respect to the subject matter hereof and
supersedes any prior express or implied agreements, understandings and representations, either oral
or written, which may have related to the subject matter hereof in any way.
15.9 English Language. This Agreement is written in the English language, which shall
be controlling for all purposes. No translation of this Agreement into any other language shall be
of any force or effect in the interpretation of this Agreement or in a determination of the intent
of the Parties.
15.10 Interpretation. The captions to the several Articles and Sections of this
Agreement are not a part of this Agreement, but are included for convenience of reference and shall
not affect its meaning or interpretation. In this Agreement: (a) the word including shall be
deemed to be followed by the phrase without limitation or like expression; (b) the singular shall
include the plural and vice versa; and (c) masculine, feminine and neuter pronouns and expressions
shall be interchangeable.
15.11 Independent Contractors. It is expressly agreed that ADVENTRX and Licensee
shall be independent contractors and that the relationship between the two Parties shall not
constitute a partnership, joint venture or agency or other fiduciary relationship. Neither
ADVENTRX nor Licensee shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the other Party, without
the prior written consent of the other Party to do so.
15.12 Waiver; Amendment. Except as otherwise expressly provided in this Agreement,
any term of this Agreement may be waived only by a written instrument executed by the Party waiving
compliance. The delay or failure of any Party at any time to require performance of any provision
of this Agreement shall in no manner affect such Partys rights at a later time to enforce the
same. This Agreement may be amended, and any term of this Agreement may be modified, only by a
written instrument executed by each Party.
15.13 Binding Effect. This Agreement shall be binding upon and inure to the benefit
of the Parties and their respective legal representatives, successors and permitted assigns.
15.14 Counterparts. This Agreement may be executed in two (2) or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and the
same instrument.
[Remainder of page intentionally left blank; signature page follows.]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth
above.
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ADVENTRX PHARMACEUTICALS, INC. |
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BY: |
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/s/ Brian M. Culley |
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NAME:
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Brian M. Culley |
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TITLE:
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Chief Business Officer |
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SHIN POONG PHARMACEUTICAL CO., LTD. |
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BY: |
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/s/ Kim Byung Hwa |
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NAME:
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Byung Hwa Kim |
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TITLE:
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CEO & President |
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SD PHARMACEUTICALS, INC. |
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BY: |
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Brian M. Culley |
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NAME:
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Brian M. Culley |
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TITLE:
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Vice President |
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EXHIBIT A
ADVENTRX PATENTS
WO/2007/0899311 VITAMIN E SUCCINATE STABILIZED PHARMACEUTICAL COMPOSITIONS, METHODS FOR THE
PREPARATION AND THE USE THEREOF
International Application No. PCT/US2007/002929
WO/2006/037089 LOW OIL EMULSION COMPOSITIONS FOR DELIVERING TAXOIDS AND OTHER INSOLUBLE DRUGS
International Application No. PCT/US2005/034971
EXHIBIT B
ADVENTRX KNOW-HOW
***
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*** |
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Portions of this page have been omitted pursuant to a
request for Confidential Treatment filed separately with the Commission. |
EXHIBIT C
DEVELOPMENT PLAN
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Licensee shall be responsible for any research and development, including non-clinical
and clinical studies of the Product, in the Territory. |
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Licensee will undertake necessary steps to obtain Regulatory Approval for marketing of
the Product in the Territory. The application for such Regulatory Approval
(Regulatory Application) will be
*** Licensee will provide ADVENTRX with all notices and other correspondence with
Regulatory Authorities relating to the Regulatory Application. |
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Unless *** Licensee will submit a Regulatory Application (that it has prepared with
good faith, diligent efforts) for the Product in the Territory *** and receiving ***. ***. |
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Licensee will use all commercially reasonable efforts to meet the demands of the
Regulatory Authority relating to any Regulatory Application, any maintenance of each
Regulatory Approval or any application to vary or renew each Regulatory Approval. |
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*** |
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Portions of this page have been omitted pursuant to a
request for Confidential Treatment filed separately with the Commission. |
-2-
EXHIBIT D
LETTER FROM CONTRACT MANUFACTURER
-3-
***
March 5, 2009
BY COURIER
ADVENTRX Pharmaceuticals, Inc.
Attn: Brian Culley
6725 Mesa Ridge Road, Suite 100
San Diego, CA 92121
To Whom It May Concern:
It is the understanding of *** (***) that certain companies are negotiating with ADVENTRX
Pharmaceuticals, Inc. (Company) regarding the terms of a definitive agreement pursuant to which
one of such companies (Licensee) would take a license under certain Company patents and/or patent
applications to sell Companys product candidate ANX-514 (docetaxel emulsion) (Product) in South
Korea (Territory).
As of the date of this letter, *** and Company are parties to an agreement for certain services
related to, among other things, ***. *** has communicated to Company its interest and desire to
supply Product to licensees of Company. Subject to any necessary consent from Company, this letter
confirms ***s intent and desire to negotiate with Licensee in good faith for *** to Licensee for
sale in the Territory. Any such supply will be pursuant to a definitive agreement to be mutually
negotiated and agreed upon by *** and Licensee.
It is understood that this letter constitutes a statement of our intention with respect to the
proposed transactions; a binding commitment with respect to the transactions will result only from
the execution and delivery of the definitive agreement expressed therein.
Sincerely,
***
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By:
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/s/ *** |
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***, Managing Director
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*** |
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Portions of this page have been omitted pursuant to a
request for Confidential Treatment filed separately with the Commission. |
Exhibit 31.1
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
SECURITIES EXCHANGE ACT RULES 13a-14(a) AND 15(d)-14(a)
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Brian M. Culley, certify that:
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I have reviewed this Quarterly Report on Form 10-Q of ADVENTRX Pharmaceuticals, Inc.; |
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2. |
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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; |
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3. |
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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; |
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4. |
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The registrants 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: |
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Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b. |
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Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
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c. |
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Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such
evaluation; and |
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d. |
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Disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control
over financial reporting; and |
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The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of registrants board of directors (or persons performing the equivalent
functions): |
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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 registrants ability to record, process, summarize and report financial information;
and |
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Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
Date:
May 15, 2009
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/s/ Brian M. Culley
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Brian M. Culley |
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Chief Business Officer and Senior Vice President
(Principal Executive Officer) |
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Exhibit 31.2
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
SECURITIES EXCHANGE ACT RULES 13a-14(a) AND 15(d)-14(a)
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Mark N.K. Bagnall, certify that:
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I have reviewed this Quarterly Report on Form 10-Q of ADVENTRX Pharmaceuticals, Inc.; |
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2. |
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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; |
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3. |
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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; |
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4. |
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The registrants 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: |
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a. |
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Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b. |
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Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
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c. |
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Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such
evaluation; and |
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d. |
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Disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control
over financial reporting; and |
5. |
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The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of registrants board of directors (or persons performing the equivalent
functions): |
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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 registrants ability to record, process, summarize and report financial information;
and |
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b. |
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Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
Date:
May 15, 2009
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/s/ Mark N.K. Bagnall
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Mark N.K. Bagnall |
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Director
(Principal Financial and Accounting Officer) |
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Exhibit 32.1
Exhibit 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER PURSUANT
TO 18 U.S.C.
SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of ADVENTRX Pharmaceuticals, Inc. (the Company) on Form
10-Q for the quarter ended March 31, 2009, as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, Brian M. Culley, principal executive officer of the Company,
certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that:
(i) the Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934, and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Date:
May 15, 2009
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/s/ Brian M. Culley
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Brian M. Culley |
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Chief Business Officer and Senior Vice President
(Principal Executive Officer) |
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In connection with the Quarterly Report of ADVENTRX Pharmaceuticals, Inc. (the Company) on Form
10-Q for the quarter ended March 31, 2009, as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, Mark N.K. Bagnall, principal financial and accounting officer of
the Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that:
(i) the Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934, and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Date:
May 15, 2009
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/s/ Mark N.K. Bagnall
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Mark N.K. Bagnall |
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Director
(Principal Financial and Accounting Officer) |
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