e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
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For the quarter ended:
June 30, 2005
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Commission File
Number: 0-19871 |
STEMCELLS,
INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
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94-3078125 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
identification No) |
3155 PORTER DRIVE
PALO ALTO, CA 94304
(Address of principal executive offices including zip code)
(650) 475-3100
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding twelve months (or
for such shorter periods 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 is an accelerated filer as defined in Exchange Act
Rule 12b-2.
Yes þ No o
At July 25, 2005, there were 63,912,716 shares of Common Stock, $.01 par value, issued and
outstanding.
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, 2005 |
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December 31, 2004 |
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(unaudited) |
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Assets |
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Current assets: |
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|
|
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|
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Cash and cash equivalents |
|
$ |
36,395,545 |
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|
$ |
41,059,532 |
|
Receivables |
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|
146,153 |
|
|
|
180,963 |
|
Other current assets |
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|
546,659 |
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|
209,074 |
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|
|
|
|
|
|
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|
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Total current assets |
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37,088,357 |
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41,449,569 |
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Property, plant and equipment, net |
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3,175,176 |
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3,424,294 |
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Other assets, net |
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2,682,633 |
|
|
|
2,753,419 |
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Total assets |
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$ |
42,946,166 |
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$ |
47,627,282 |
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Liabilities and stockholders equity
Current liabilities: |
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Accounts payable |
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$ |
424,433 |
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$ |
524,917 |
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Accrued expenses |
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|
935,500 |
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|
|
1,547,370 |
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Accrued wind-down expenses, current portion |
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|
1,095,448 |
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|
1,013,460 |
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Capital lease obligations, current portion |
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|
55,001 |
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|
52,843 |
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Bonds payable, current portion |
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|
249,083 |
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|
|
244,167 |
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|
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Total current liabilities |
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2,759,465 |
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|
|
3,382,757 |
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Capital lease obligations less current maturities |
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13,017 |
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|
41,065 |
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Bonds payable, less current maturities |
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1,480,752 |
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1,605,417 |
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Deposits & other long-term liabilities |
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533,185 |
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610,126 |
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Accrued wind-down expenses, non-current portion |
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|
5,578,922 |
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4,514,569 |
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Deferred rent |
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|
566,640 |
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|
523,801 |
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|
|
|
|
|
|
|
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Total liabilities |
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10,931,981 |
|
|
|
10,677,735 |
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Stockholders equity: |
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Common stock, $.01 par value; 125,000,000
shares authorized; 63,545,160 and 62,129,407
shares issued and outstanding at June 30, 2005
and December 31, 2004, respectively |
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635,451 |
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621,293 |
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Additional paid in capital |
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213,600,451 |
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211,419,300 |
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Accumulated deficit |
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(181,522,333 |
) |
|
|
(174,205,214 |
) |
Deferred compensation |
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|
(699,384 |
) |
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|
(885,832 |
) |
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|
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Total stockholders equity |
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32,014,185 |
|
|
|
36,949,547 |
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Total liabilities and stockholders equity |
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$ |
42,946,166 |
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$ |
47,627,282 |
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See accompanying notes to condensed consolidated financial statements .
3
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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2005 |
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2004 |
|
2005 |
|
2004 |
Revenue: |
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Revenue from grants |
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$ |
26,092 |
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|
|
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$ |
52,184 |
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$ |
92,593 |
|
Revenue from licensing agreements |
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|
10,677 |
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$ |
5,837 |
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19,906 |
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6,336 |
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|
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Total revenue |
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36,769 |
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|
5,837 |
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72,090 |
|
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|
98,929 |
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Operating expenses: |
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Research and development |
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2,102,362 |
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1,939,415 |
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3,927,293 |
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3,807,341 |
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General and administrative |
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821,276 |
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877,158 |
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2,120,480 |
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1,740,988 |
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Wind-down expenses |
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|
1,197,226 |
|
|
|
467,574 |
|
|
|
1,718,200 |
|
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|
598,143 |
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Total operating expenses |
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4,120,864 |
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|
3,284,147 |
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|
7,765,973 |
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|
6,146,472 |
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Loss from operations |
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|
(4,084,095 |
) |
|
|
(3,278,310 |
) |
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|
(7,693,883 |
) |
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|
(6,047,543 |
) |
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Other income (expense): |
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Interest income |
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|
261,389 |
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|
|
27,283 |
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|
489,152 |
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|
76,410 |
|
Interest expense |
|
|
(45,345 |
) |
|
|
(49,436 |
) |
|
|
(91,756 |
) |
|
|
(98,931 |
) |
Other income (expense) |
|
|
(235 |
) |
|
|
(2,184 |
) |
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|
(20,632 |
) |
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(3,195 |
) |
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Total other income (expense) |
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215,809 |
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(24,337 |
) |
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376,764 |
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(25,716 |
) |
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Net loss applicable to common stockholders |
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|
(3,868,286 |
) |
|
($ |
3,302,647 |
) |
|
|
(7,317,119 |
) |
|
($ |
6,073,259 |
) |
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Net loss per share applicable to common
stockholders; basic and diluted |
|
($ |
0.06 |
) |
|
($ |
0.08 |
) |
|
($ |
0.12 |
) |
|
($ |
0.14 |
) |
|
|
|
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|
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|
|
|
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|
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|
Weighted average shares used to compute
net loss per share applicable to common
stockholders; basic and diluted |
|
|
63,072,873 |
|
|
|
43,066,807 |
|
|
|
62,741,639 |
|
|
|
42,038,437 |
|
See accompanying notes to condensed consolidated financial statements.
4
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Six months ended |
|
|
June 30, |
|
|
2005 |
|
2004 |
Cash flows from operating activities: |
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
($ |
7,317,119 |
) |
|
($ |
6,073,259 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
552,237 |
|
|
|
508,098 |
|
Amortization of deferred compensation |
|
|
69,501 |
|
|
|
10,442 |
|
Stock-based compensation expense |
|
|
65,280 |
|
|
|
134,966 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accrued interest receivable |
|
|
(4,481 |
) |
|
|
(4,327 |
) |
Receivables |
|
|
39,289 |
|
|
|
81,107 |
|
Other current assets |
|
|
(337,584 |
) |
|
|
33,822 |
|
Other assets, net |
|
|
52,947 |
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
(712,355 |
) |
|
|
(109,988 |
) |
Accrued wind-down expenses |
|
|
1,146,341 |
|
|
|
18,919 |
|
Deposits received (refunded) |
|
|
(76,941 |
) |
|
|
|
|
Deferred rent |
|
|
42,839 |
|
|
|
(186,200 |
) |
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(6,480,046 |
) |
|
|
(5,586,420 |
) |
|
|
|
|
|
|
|
|
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|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
Purchase of property, plant and equipment |
|
|
(235,280 |
) |
|
|
(63,380 |
) |
Acquisition of other assets |
|
|
(50,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(285,280 |
) |
|
|
(63,380 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Cash flows from financing activities: |
|
|
|
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|
|
|
|
|
Proceeds from the exercise of stock options |
|
|
309,026 |
|
|
|
|
|
Proceeds from the exercise of warrants |
|
|
1,937,952 |
|
|
|
|
|
Proceeds from issuance of common stock, net |
|
|
|
|
|
|
18,707,730 |
|
Repayments of capital lease obligations |
|
|
(25,890 |
) |
|
|
|
|
Repayment of debt obligations |
|
|
(119,749 |
) |
|
|
(117,500 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
2,101,339 |
|
|
|
18,590,230 |
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents |
|
|
(4,663,987 |
) |
|
|
12,940,430 |
|
Cash and cash equivalents, beginning of period |
|
|
41,059,532 |
|
|
|
13,081,703 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
36,395,545 |
|
|
$ |
26,022,133 |
|
|
|
|
|
|
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Supplemental disclosure of cash flow information: |
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
91,756 |
|
|
$ |
98,931 |
|
See accompanying notes to condensed consolidated financial statements
5
PART I ITEM 1. FINANCIAL STATEMENTS
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
June 30, 2005 and 2004
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The terms StemCells, the Company, our, we and us as used in this report refer to
StemCells Inc. The accompanying unaudited, condensed consolidated financial statements have been
prepared by the Company in accordance with generally accepted accounting principles for interim
financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not include all of the information and footnotes required by generally
accepted accounting principles for complete financial statements. In the opinion of management,
the accompanying financial statements include all adjustments, consisting of normal recurring
accruals, considered necessary for a fair presentation of the financial position, results of
operations and cash flows for the periods presented. Results of operations for the six months
ended June 30, 2005, are not necessarily indicative of the results that may be expected for the
entire fiscal year ending December 31, 2005.
The balance sheet at December 31, 2004 has been derived from the audited financial statements
at that date but does not include all of the information and footnotes required for complete
financial statements in accordance with accounting principles generally accepted in the United
States of America. For the complete financial statements, refer to the audited financial
statements and footnotes thereto as of December 31, 2004, included on Form 10-K.
The Company has incurred significant operating losses and negative cash flows since inception.
It has not achieved profitability and may not be able to realize sufficient revenues to achieve or
sustain profitability in the future. The Company has limited capital resources and it will need to
raise additional capital from time to time to sustain its product development efforts, acquisition
of technologies and intellectual property rights, preclinical and clinical testing of anticipated
products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office
facilities, establishment of production capabilities, general and administrative expenses and other
working capital requirements. To fund its operations, the Company relies on cash balances,
proceeds from equity and debt offerings, proceeds from the transfer or sale of intellectual
property rights, equipment, facilities or investments, and on government grants and collaborative
arrangements. The Company cannot be certain that such funding will be available when needed. The
financial statements do 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
may result from the outcome of this uncertainty.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial statements. Actual
results could differ from these estimates. Significant estimates include the accrued wind-down
expenses.
Net Loss Per Share
The Company has computed net loss per common share according to the Financial Accounting
Standards Board Statement (SFAS) No. 128, Earnings Per Share, which requires disclosure of
basic and diluted earnings per share. Basic earnings per share excludes any dilutive effects of
options, warrants and convertible securities, and is computed using the weighted average number of
common shares outstanding during the period. Diluted earnings
per share includes the impact of potentially dilutive securities and is computed using the weighted
average of common and diluted equivalent stock options, warrants and convertible securities
outstanding during the period. Stock options, warrants and convertible securities that are
antidilutive are excluded from the calculation of diluted loss per common share.
6
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|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net loss applicable to common stockholders |
|
$ |
(3,868,286 |
) |
|
$ |
(3,302,647 |
) |
|
|
(7,317,119 |
) |
|
$ |
(6,073,259 |
) |
Weighted average shares used in computing
net loss per share applicable to common
stockholders, basic and diluted |
|
|
63,072,873 |
|
|
|
43,066,807 |
|
|
|
62,741,639 |
|
|
|
42,038,437 |
|
Net loss per share applicable to common
stockholders, basic and diluted |
|
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.14 |
) |
The Company has excluded outstanding stock options, warrants and convertible securities from the
calculation of diluted loss per common share because all such securities are anti-dilutive for all
applicable periods presented. These outstanding securities consist of the following potential
common shares:
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, |
|
|
2005 |
|
2004 |
Outstanding options |
|
|
6,741,787 |
|
|
|
5,095,389 |
|
Outstanding warrants |
|
|
4,187,439 |
|
|
|
6,038,430 |
|
Total |
|
|
10,929,226 |
|
|
|
11,133,819 |
|
Stock-Based Compensation
The Companys employee stock option plan is accounted for under Accounting Principles Board
Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees. The Company grants
qualified stock options for a fixed number of shares to employees with an exercise price equal to
the fair market value of the shares at the date of grant. In these circumstances in accordance
with APB 25, the Company recognizes no compensation expense for qualified stock option grants. The
Company also issues non-qualified stock options for a fixed number of shares to employees with an
exercise price less than the fair market value of the shares at the date of grant. When such
options vest, the Company recognizes the difference between the exercise price and fair market
value as compensation expense in accordance with APB 25.
For purposes of disclosures pursuant to Statement of Financial Accounting Standards No. 123,
Accounting for Stock-Based Compensation, (SFAS 123) as amended by Statement of Financial
Accounting Standards No. 148, Accounting for Stock-Based Compensation Transition and
Disclosure, (SFAS 148), the estimated fair value of options is amortized to expense over the
options vesting period. The following table illustrates the effect on net loss and net loss per
share if the Company had applied the fair value recognition provisions of SFAS 123 to stock-based
employee compensation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net loss applicable
to common
stockholders as
reported |
|
$ |
(3,868,286 |
) |
|
$ |
(3,302,647 |
) |
|
$ |
(7,317,119 |
) |
|
$ |
(6,073,259 |
) |
Add: Stock-based
employee/director
compensation
expense included in
reported net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,728 |
|
Deduct: Total
stock-based
employee/director
compensation
expense under the
fair value based
method for all
awards |
|
|
(101,231 |
) |
|
|
(178,828 |
) |
|
|
(238,693 |
) |
|
|
(420,489 |
) |
Net loss applicable
to common
stockholders pro
forma |
|
$ |
(3,969,517 |
) |
|
$ |
(3,481,475 |
) |
|
$ |
(7,555,812 |
) |
|
$ |
(6,455,020 |
) |
Basic and diluted
net loss per share
applicable to
common stockholders
as reported |
|
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.14 |
) |
Basic and diluted
net loss per share
applicable to
common stockholders
pro forma |
|
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.15 |
) |
Shares used in
basic and diluted
loss per share
applicable to
common stockholder
amounts |
|
|
63,072,873 |
|
|
|
43,066,807 |
|
|
|
62,741,639 |
|
|
|
42,038,437 |
|
7
The effects on pro forma net loss and net loss per share of expensing the estimated fair value
of stock options are not necessarily representative of the effects on reporting the results of
operations for future years. As required by SFAS 123, the Company has used the Black-Scholes model
for option valuation, which method may not accurately value the options described.
The Company accounts for stock options granted to non-employees in accordance with SFAS 123
and Emerging Issues Task Force (EITF) 96-18 Accounting For Equity Instruments That Are Issued To
Other Than Employees For Acquiring, Or In Conjunction With Selling, Goods Or Services, and
accordingly, recognizes as expense the estimated fair value of such options as calculated using the
Black-Scholes valuation model. The fair value is remeasured during the service period and is
amortized over the vesting period of each option or the recipients contractual arrangement, if
shorter.
In December 2004, FASB issued SFAS No. 123R (revised 2004), Share-Based Payment (SFAS
123R). This Statement is a revision of SFAS 123 and amends SFAS No. 95, Statement of Cash Flows.
This Statement supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and its
related implementation guidance. SFAS 123R covers a wide range of share-based compensation
arrangements including stock options, restricted share plans, performance-based awards, share
appreciation rights, and employee share purchase plans. The new standard is effective as of the
beginning of the first interim or annual reporting period that begins after December 15, 2005.
Based on the aforementioned effective date, the Company will begin expensing stock options granted
to its employees in its Statement of Operations using a fair-value based method effective the
period beginning January 1, 2006. Adoption of the expensing requirements will increase the
Companys operating expenses.
Revenue Recognition
Revenues from collaborative agreements and grants are recognized as earned upon either the
incurring of reimbursable expenses directly related to the particular research plan or the
completion of certain development milestones as defined within the terms of the collaborative
agreement. Payments received in advance of research performed are designated as deferred revenue.
Fees associated with substantive at risk, performance-based milestones are recognized as revenue
upon their completion, as defined in the respective agreements. Incidental assignment of
technology rights is recognized as revenue at the time of receipt.
Recent Accounting Pronouncements
In June 2005, the FASB issued Statement of Financial Accounting Standards No. 154, Accounting
Changes and Error Corrections (SFAS 154). SFAS 154 replaces APB Opinion No. 20, Accounting
Changes and SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements. SFAS 154
requires that a voluntary change in accounting principle be applied retrospectively with all prior
period financial statements presented on the new accounting principle. SFAS 154 also requires that
a change in method of depreciating or amortizing a long-lived nonfinancial asset be accounted for
prospectively as a change in estimate, and correction of errors in previously issued financial
statements should be termed a restatement. SFAS 154 is effective for accounting changes and
correction of errors made in fiscal years beginning after December 15, 2005. The implementation of
FAS 154 is not expected to have a material impact on the Companys consolidated financial
statements.
In March 2005, Staff Accounting Bulletin No. 107 (SAB 107) was issued which expressed views
of the Securities and Exchange Commission (SEC) regarding the interaction between SFAS 123R, and
certain SEC rules and regulations and provides the staffs views regarding the valuation of
share-based payment arrangements for public companies. FASB issued SFAS No. 123R in December 2004.
This Statement is a revision of SFAS No. 123,
8
Accounting for Stock-Based Compensation and amends SFAS No. 95, Statement of Cash Flows.
This Statement supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and its
related implementation guidance. SFAS 123R covers a wide range of share-based compensation
arrangements including stock options, restricted share plans, performance-based awards, share
appreciation rights, and employee share purchase plans. The new standard is effective as of the
beginning of the first interim or annual reporting period that begins after December 15, 2005.
Based on the aforementioned effective date, the Company will begin expensing stock options granted
to its employees in its Statement of Operations using a fair-value based method effective the
period beginning January 1, 2006. Adoption of the expensing requirements will reduce the Companys
reported earnings. See Stock-based Compensation above in this Note 1 for disclosures regarding
the effect on net earnings and earnings per share if we had applied the fair value recognition
provisions of the exposure draft and SFAS 123. Depending on the model used to calculate
stock-based compensation expense in the future, that disclosure may not prove indicative of the
stock-based compensation expense to be recognized in future financial statements.
NOTE 2. LEASES
The Company, which was originally resident in Rhode Island, had undertaken direct
financing transactions with the State of Rhode Island and received proceeds from the issuance of
industrial revenue bonds totaling $5,000,000 to finance the construction of a pilot manufacturing
facility related to its former encapsulated cell technology. The related leases are structured
such that lease payments will fully fund all semiannual interest payments and annual principal
payments through maturity in August 2014. Interest rates vary with the respective bonds
maturities, ranging currently from 8.1% to 9.5%. The outstanding principal at June 30, 2005 was
approximately $1,730,000. The bonds contain certain restrictive covenants, which limit among other
things, the payment of cash dividends and the sale of the related assets.
The Company entered into a fifteen-year lease for a laboratory facility in connection with a
sale and leaseback arrangement in 1997. The lease has escalating rent payments and accordingly,
the Company is recognizing rent expense on a straight-line basis. At December 31, 2004 and June
30, 2005, the Company had deferred rent liability for this facility of $1,177,000 and $1,192,000
respectively; the deferred rent liability is presented as part of the wind-down accrual.
Although the Company previously discontinued activities relating to encapsulated cell
technology, the Company remains obligated under the leases for the pilot manufacturing facility and
the laboratory facility. The Company has succeeded in subleasing the pilot manufacturing facility
and part of the laboratory facility. The aggregate income received by the Company is significantly
less than the Companys aggregate obligations under the leases, and the Companys continued receipt
of rental income is dependent on the financial ability of the occupants to comply with their
obligations under the subleases. The Company continues to seek to sublet the vacant portions of
the Rhode Island facilities, to assign or sell its interests in all of these properties, or to
otherwise arrange for the termination of its obligations under the lease obligations on these
facilities. There can be no assurance, however, that the Company will be able to dispose of these
properties in a reasonable time, if at all, or to terminate its lease obligations without the
payment of substantial consideration
As of February 1, 2001, the Company entered into a 5-year lease for a 40,000 square foot
facility located in the Stanford Research Park in Palo Alto, CA. The facility includes space for
animals, laboratories, offices, and a GMP (Good Manufacturing Practices) suite. GMP facilities can
be used to manufacture materials for clinical trials. On December 19, 2002 the Company negotiated
an amendment to the lease, which resulted in reducing the average annual rent over the remaining
term of the lease from approximately $3.7 million to $2.0 million. As part of the amendment the
Company issued a letter of credit on January 2, 2003 for $503,079, which was an addition to the
letter of credit in the amount of $275,000 issued at commencement of the lease, to serve as a
deposit for the duration of the lease. The Company negotiated an amendment to the lease effective
April 1, 2005, which extends the term of the lease through March 31, 2010, includes an immediate
reduction in the rent per square foot, and provides for an expansion of the leased premises by
approximately 28,000 additional square feet effective July 1, 2006. In addition, the Company has
sublet some of the additional space for the period from April 1, 2005 through June 30, 2006. The
average annual rent for the period commencing April 1, 2005 to March 31, 2010 will be approximately
$2 million before subtenant income. As the lease involves escalating rent payments, the Company is
recognizing rent expense on a straight-line basis. At December 31, 2004 and June 30, 2005, the
Company had deferred rent liability for this facility of $524,000 and $567,000 respectively. At
June 30, 2005 the Company has space-sharing agreements covering in total approximately 13,000
square feet of the 40,000 square foot facility. The Company receives the
amount of base rent plus the proportionate share of the operating expenses that it pays for
such space over the term of these agreements.
9
NOTE 3. RELOCATION TO CALIFORNIA FROM RHODE ISLAND
In October 1999 the Company relocated to California from Rhode Island and established a wind
down reserve for the estimated lease payments and operating costs of the Rhode Island facilities
through an expected disposal date of June 30, 2000. The Company did not fully sublet the Rhode
Island facilities in 2000. Even though it is the intent of the Company to dispose the facility at
the earliest possible time, it cannot determine with certainty a fixed date by which such disposal
will occur. In light of this uncertainty, based on estimates, the Company periodically
re-evaluates and adjusts the reserve. The Company considers various factors such as the Companys
lease payments through to the end of the lease, operating expenses, the current real estate market
in Rhode Island, and estimated subtenant income based on occupancy both actual and projected. At
December 31, 2004 the reserve was $4,350,000. The Company incurred $586,000 in operating expenses
for the six month period ending June 30, 2005, which was recorded against the reserve. After
evaluating the afore-mentioned factors the Company re-evaluated its estimate to $4,568,000 and
$5,482,000 at March 31, 2005 and June 30, 2005 respectively, by booking an additional $521,000 and
$1,197,000 respectively as wind-down expenses.
Wind-down reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January to March |
|
April to June 30, |
|
January to June 30, |
|
|
31, 2005 |
|
2005 |
|
2005 |
|
|
|
Accrued wind-down reserve at beginning
of period |
|
$ |
4,350,000 |
|
|
$ |
4,568,000 |
|
|
$ |
4,350,000 |
|
Less actual expenses recorded against
estimated reserve during the period |
|
|
(303,000 |
) |
|
|
(283,000 |
) |
|
|
(586,000 |
) |
Additional expense recorded to revise
estimated reserve at period-end |
|
|
521,000 |
|
|
|
1,197,000 |
|
|
|
1,718,000 |
|
|
|
|
Revised reserve at period-end |
|
|
4,568,000 |
|
|
|
5,482,000 |
|
|
|
5,482,000 |
|
Add deferred rent at period end (Note 2) |
|
|
1,185,000 |
|
|
|
1,192,000 |
|
|
|
1,192,000 |
|
|
|
|
Total accrued wind-down expenses at
period-end (current and non current
portion) |
|
$ |
5,753,000 |
|
|
$ |
6,674,000 |
|
|
$ |
6,674,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued wind-down expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion |
|
$ |
1,034,000 |
|
|
$ |
1,095,000 |
|
|
$ |
1,095,000 |
|
|
|
|
Non current portion |
|
|
4,719,000 |
|
|
|
5,579,000 |
|
|
|
5,579,000 |
|
|
|
|
Total accrued wind-down expenses |
|
$ |
5,753,000 |
|
|
$ |
6,674,000 |
|
|
$ |
6,674,000 |
|
|
|
|
NOTE 4. GRANTS
In September 2003 the Company was awarded a one year, $342,000, Small Business Innovation
Research grant from the National Institute of Neurological Disease and Stroke (NINDS), to further
its work in the treatment of spinal cord injuries. For this award, the Company has recognized
revenue of $143,000 in 2003, and $93,000 in 2004. No revenue from this grant was recognized in
2005 as the remaining $107,000 was paid to a subcontractor. In September 2004, the National
Institutes of Health (NIH) awarded the Company a Small Business Technology Transfer grant of
$464,000 for studies in Alzheimers disease, consisting of $308,000 for the first year and $156,000
for the remainder of the grant term, September 2005 through March 2006. The studies will be
conducted by Dr. George A. Carlson of the McLaughlin Research Institute (MRI) in Great Falls,
Montana, which will receive approximately $222,000 of the total award. The balance will be
recognized by the Company as grant revenue as and when resources are expended for this study. The
Company recognized $26,000 in the last quarter of 2004 and $52,000 for the six month period ended
June 30, 2005.
10
NOTE 5. STOCKHOLDERS EQUITY
During the six-month period ended June 30, 2005, warrants issued as part of the June 16,
2004 financing arrangement were exercised to purchase an aggregate of 258,342 shares of the
Companys common stock at $1.90 per share. The Company issued 258,342 shares of its common stock
and received proceeds of $490,850. In May 2005, warrants issued as part of a Stock Purchase
Agreement dated May 7, 2003, were exercised to purchase an aggregate of 800,000 shares of the
Companys common stock at $1.50 per share. The Company issued 800,000 shares of its common stock
and received proceeds of $1,200,000. Also in January 2005, 79,899 shares of unregistered stock
(which the Company has no obligation to register) were issued upon the cashless exercise by the
holder of a warrant acquired as partial compensation for services to the Company.
On April 13, 2000 the Company issued 1,500 shares of 6% cumulative convertible preferred stock
plus adjustable warrants to two members of its Board of Directors. The preferred shares were
converted into common shares in 2002. In March 2005, one of the members exercised his adjustable
warrant in full for 72,252 shares at $3.42 per share. The Company issued 72,252 shares and
received proceeds of $247,000. In May 2005 the other member through a cashless exercise, exercised
in full, his adjustable warrant for 72,252 shares for which, the Company issued 10,784 shares.
For the six month period ended June 30, 2005, the Company issued 194,475 shares from activity
related to its stock option plans. The following table presents the activity of the Companys
stock option plans for the six month period ended June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average Exercise |
|
|
Options |
|
Price |
Outstanding at January 1 |
|
|
6,682,201 |
|
|
$ |
2.67 |
|
Granted |
|
|
384,895 |
|
|
$ |
4.08 |
|
Exercised |
|
|
(194,475 |
) |
|
$ |
1.62 |
|
Canceled |
|
|
(130,834 |
) |
|
$ |
2.27 |
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30 |
|
|
6,741,787 |
|
|
$ |
2.79 |
|
|
|
|
|
|
|
|
|
|
Options exercisable at June 30 |
|
|
3,687,643 |
|
|
$ |
2.97 |
|
|
|
|
|
|
|
|
|
|
NOTE 6. SUBSEQUENT EVENTS
On July 1, 2005, the Company entered a license agreement with ReNeuron Limited, a
privately-owned UK biotech corporation, permitting ReNeuron to use the Companys neural stem cell
technology only in connection with ReNeurons c-mycER conditionally immortalized adult human
neural stem cell technology. In return for the license, StemCells received an equity interest in
ReNeuron and a cross-license to the exclusive use of ReNeuronsc-mycER technology for certain
diseases and conditions, including lysosomal storage diseases, spinal cord injury, cerebral palsy
and multiple sclerosis. ReNeuron will supply cells for StemCells use under the cross-license. The
agreement also provides for royalties and milestone payments by each party on the achievement of
various goals under the license and cross-license. The agreement is attached as an exhibit to this
Report.
In July 2005, warrants issued as part of the June 16, 2004 financing arrangement, were
exercised to purchase an aggregate of 351,710 of the Companys common stock at $1.90 per share.
The Company issued 351,710 shares of its common stock and received proceeds of $668,249.
11
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following discussion of our financial condition and the results of our operations for
the three and six month periods ended June 30, 2005 and 2004 should be read in conjunction with the
accompanying unaudited condensed consolidated financial statements and the related footnotes
thereto.
This report contains forward looking statements within the meaning of Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act that involve substantial risks and
uncertainties. Such statements include, without limitation, all statements as to expectation or
belief and statements as to our future results of operations, the progress of our research, product
development and clinical programs, the need for, and timing of, additional capital and capital
expenditures, partnering prospects, costs of manufacture of products, the protection of and the
need for additional intellectual property rights, effects of regulations, the need for additional
facilities and potential market opportunities, expectations regarding ReNeurons technology, the
Companys ability to develop products using the ReNeuron technology, the likelihood of obtaining
milestone or royalty payments from ReNeuron under the license agreement, the likelihood of any
future collaborations with ReNeuron, and the value of the Companys equity interest in ReNeuron.
Our actual results may vary materially from those contained in such forward-looking statements
because of risks to which we are subject, including uncertainty as to whether the U.S. Food and
Drug Administration will remove the clinical hold on our proposed initial clinical trial and permit
us to proceed to clinical testing despite the novel and unproven nature of the Companys
technology; the risk that, even if approved, our initial clinical trial could be substantially
delayed beyond its expected dates or cause us to incur substantial unanticipated costs;
uncertainties regarding the our ability to obtain the capital resources needed to continue our
current research and development operations and to conduct the research, preclinical development
and clinical trials necessary for regulatory approvals; the risk of failure to obtain a corporate
partner or partners to support the development of our stem cell programs, the uncertainty regarding
the outcome of the Phase I clinical trial and any other trials the Company may conduct in the
future; the uncertainty regarding the validity and enforceability of issued patents; the
uncertainty whether any products that may be generated in the Companys stem cell programs will
prove clinically effective and not cause tumors or other side effects; the uncertainty whether the
Company will achieve revenues from product sales or become profitable; uncertainties regarding the
Companys obligations in regard to its former facilities in Rhode Island; obsolescence of our
technology; competition from third parties; intellectual property rights of third parties;
litigation and other risks to which we are subject. Before you invest in our common stock, you
should be aware that the occurrence of the events described in the Cautionary Factors Relevant to
Forward Looking Information and Business sections included in our Form 10-K report as of
December 31, 2004 could harm our business, operating results and financial condition. All
forward-looking statements attributable to us or to persons acting on our behalf are expressly
qualified in their entirety by the cautionary statements and risk factors contained or referred to
herein.
OVERVIEW
Since our inception in 1988, we have been primarily engaged in research and development
of human therapeutic products. Since the second half of 1999, our sole focus has been on our stem
cell technology. In the last quarter of 2004 we filed the first in a planned series of INDs
(Investigational New Drug Applications) for CNS (Central Nervous System) diseases or conditions
with the FDA (U.S. Food and Drug Administration). This IND, which is for a Phase I clinical trial
of our human neural stem cells in Batten disease, is currently on clinical hold until questions and
issues raised by the FDA have been resolved. Batten disease is included among the neuronal ceroid
lipofuscinoses (NCLs), a set of several closely related genetic lysosomal storage disorders caused
by a deficiency of specific enzymes required for normal cell metabolism. The deficiency results in
storage of toxic waste materials and the death of certain neurons. The NCLs primarily affect
infants and young children, and are always fatal. There can be no assurance that the FDA will lift
the clinical hold and permit the trial to go forward.
We have not derived any revenues from the sale of any products apart from license revenue for
the research use of our human neural stem cells and other patented cells and media, and we do not
expect to receive revenues from product sales for at least several years. We have not
commercialized any product and in order to do so we must, among other things, substantially
increase our research and development expenditures as research and product development efforts
accelerate and clinical trials are initiated. We had expenditures for toxicology and other studies
12
in preparation for submitting the Batten disease IND to the FDA, and will incur more such
expenditures for any future INDs. We have incurred annual operating losses since inception and
expect to incur substantial operating losses in the future. As a result, we are dependent upon
external financing from equity and debt offerings and revenues from collaborative research
arrangements with corporate sponsors to finance our operations. There are no such collaborative
research arrangements at this time and there can be no assurance that such financing or partnering
revenues will be available when needed or on terms acceptable to us.
Since 2001, we have entered into a number of financing arrangements including an equity line
(which has now expired) from which we drew $4.6 million; sale of 1 million shares of common stock
for $1.1 million; sale of 4 million shares of common stock for $6.5 million; issuance of
convertible preferred stock for $5 million (all of which has now been converted); sale of 5 million
shares of common stock for a total of $9.5 million, and in 2004, two financing arrangements for
gross proceeds of $20 million and $22.5 million in June and October respectively. (See Liquidity
and Capital Resources below for further detail on each of these transactions.
Our results of operations have varied significantly from year to year and quarter to quarter
and may vary significantly in the future due to the occurrence of material recurring and
nonrecurring events including, without limitation, the receipt and payment of licensing payments,
the initiation or termination of research collaborations, the changes in the sublease income and
rental and other expenses to lease and maintain our facilities in Rhode Island and changes in the
costs associated with our move to a larger facility in California. To expand and provide high
quality systems and support to our research and development programs, we would need to hire more
personnel, which would lead to higher operating expenses.
CRITICAL ACCOUNTING POLICIES
We believe the following critical accounting policies affect our more significant judgments
and estimates used in the preparation of our consolidated financial statements:
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial statements. Actual
results could differ from these estimates. The significant estimates include the accrued wind-down
expenses related to our Rhode Island facilities.
Stock-Based Compensation
As permitted by the provisions of Statement of Financial Accounting Standards (SFAS) No.
148, Accounting for Stock-Based Compensation Transition and Disclosure, and Statement of
Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation, our employee
stock option plan is accounted for under Accounting Principles Board Opinion No. 25 (APB 25),
Accounting for Stock Issued to Employees. We grant qualified stock options for a fixed number of
shares to employees with an exercise price equal to the fair market value of the shares at the date
of grant. In these circumstances in accordance with APB 25, we recognize no compensation expense
for qualified stock option grants. We also issue non-qualified stock options for a fixed number of
shares to employees with an exercise price less than the fair market value of the shares at the
date of grant. When such options vest, we recognize the difference between the exercise price and
fair market value as compensation expense in accordance with APB 25. Note 9 of the Notes to the
Consolidated Financial Statements, included in our 2004 Annual Report on Form 10-K, describes our
equity compensation plans, and Note 1 of the Notes to the Condensed Consolidated Financial
Statements elsewhere in this report contains a summary of the pro forma effects to reported net
loss and loss per share for the three and six months ended June 30, 2005 and 2004 as if we had
elected to recognize compensation cost based on the fair value of the options granted at grant
date, as prescribed by SFAS 123. We account for certain stock options granted to non-employees in
accordance with SFAS No. 123 and Emerging Issues Task Force (EITF) 96-18 accounting for equity
instruments that are issued to other than employees for acquiring, or in conjunction with selling,
goods or services, and accordingly, we recognize as expense the estimated fair value of such
options as calculated using the Black-Scholes valuation model, and as re-measured during the
service period. Fair value is determined using methodologies allowable by
SFAS No. 123. The cost is amortized over the vesting period of each option or the recipients
contractual arrangement, if shorter.
13
In December 2004, FASB issued SFAS 123R (revised 2004), Share-Based Payment. This Statement
is a revision of SFAS 123, Accounting for Stock-Based Compensation and amends SFAS No. 95,
Statement of Cash Flows. This Statement supersedes APB Opinion No. 25, Accounting for Stock
Issued to Employees, and its related implementation guidance. SFAS 123R covers a wide range of
share-based compensation arrangements including stock options, restricted share plans,
performance-based awards, share appreciation rights, and employee share purchase plans. The new
standard is effective as of the beginning of the first interim or annual reporting period that
begins after December 15, 2005. Based on the afore mentioned effective date, we will begin
expensing stock options granted to our employees in our Statement of Operations using a fair-value
based method effective the period beginning January 1, 2006. Adoption of the expensing
requirements will reduce the Companys reported earnings.
Research and Development Costs
We expense all research and development costs as incurred. Research and Development costs
include costs of personnel, external services, supplies, facilities and miscellaneous other costs.
Wind-down and Exit Costs
In connection with the wind-down of our operations in Lincoln, Rhode Island, and the
relocation of our activities and corporate headquarters to California, in October 1999, we provided
a reserve for our estimate of the exit cost obligation in accordance with EITF 94-3, Liability
Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity. As the
lease for our former research facility in Rhode Island terminates in 2013, we will adjust our
reserve on an ongoing basis by reevaluating our estimated costs to exit this facility. The
estimates are based on assumptions and experience relevant to the real estate market conditions for
the facility. Such re-evaluation will include lease payments over the lease term, occupancy and
sublease rental rates, and facility operating expenses. We are seeking to sublease, assign, sell
or otherwise divest itself of our interest in the facility at the earliest possible time, but we
cannot determine with certainty a fixed date by which such events
will occur, if at all.
RESULTS OF OPERATIONS
Three months ended June 30, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from grants |
|
$ |
26,092 |
|
|
|
|
|
|
$ |
26,092 |
|
|
|
|
|
Revenue from licensing agreements |
|
|
10,677 |
|
|
$ |
5,837 |
|
|
|
4,840 |
|
|
|
83 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
36,769 |
|
|
$ |
5,837 |
|
|
$ |
30,932 |
|
|
|
530 |
% |
For the three months ended June 30, 2005 revenue from grants and licensing agreements totaled
approximately $37,000 of which $26,000 was part of a $464,000 Small Business Technology Transfer
grant for studies in Alzheimers disease and approximately $11,000 in licensing revenue. For the
three months ended June 30, 2004, no revenue from grants was recognized and revenue from licensing
agreements totaled approximately $6,000.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,102,362 |
|
|
$ |
1,939,415 |
|
|
$ |
162,947 |
|
|
|
8 |
% |
General and administrative |
|
|
821,276 |
|
|
|
877,158 |
|
|
|
(55,882 |
) |
|
|
(6 |
)% |
Wind-down expenses |
|
|
1,197,226 |
|
|
|
467,574 |
|
|
|
729,652 |
|
|
|
156 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
4,120,864 |
|
|
$ |
3,284,147 |
|
|
$ |
836,717 |
|
|
|
25 |
% |
14
Research and development expenses totaled approximately $2,102,000 for the three months ended
June 30, 2005, compared with approximately $1,939,000 for the same period in 2004. The increase of
$163,000 or approximately 8% from 2004 to 2005 was primarily attributable to the costs associated
with a higher head count in the three-month period ended June 30, 2005 as compared to the same
period in 2004. At June 30, 2005, we had thirty full-time employees working in research and
development and laboratory support services as compared to twenty-four at June 30, 2004. The
increase in expenses was offset by a decrease in expenses for external services in 2005 as compared
to 2004. In 2004, our external services included required toxicology studies and other outside
services in preparing the submission of our first IND to the FDA, to evaluate the safety and
efficacy of our human neural stem cells as a treatment for Batten disease.
General and administrative expenses were approximately $821,000 for the three months ended
June 30, 2005, compared with approximately $877,000 for the same period in 2004. The decrease of
$56,000 or approximately 6%, from 2004 to 2005 was primarily attributable to a credit received in
the current quarter for the cost of external services incurred in the evaluation and testing of our
internal financial control systems, offset by higher costs attributable to an increase in head
count required in part, to meet the requirements of and be in compliance with the new Securities
and Exchange Commission rules issued under section 404 of the Sarbanes-Oxley Act.
In 1999, in connection with exiting our former research facility in Rhode Island, we created a
reserve for the estimated lease payments and operating expenses related to it. The reserve has
been re-evaluated and adjusted based on assumptions relevant to real estate market conditions and
the estimated time until we could either fully sublease, assign or sell our remaining interests in
the property. At March 31, 2005 the reserve was $4,568,000. For the three months ended June 30,
2005, expenses of $283,000 net of subtenant income was recorded against this reserve. At June 30,
2005 we re-evaluated the estimate and adjusted the reserve to $5,482,000 by recording an additional
$1,197,000 as wind-down expenses. Wind-down expenses for the same period in 2004 were $468,000.
Expenses for this facility will fluctuate based on changes in tenant occupancy rates and other
operating expenses related to the lease. Even though it is our intent to sublease, assign, sell or
otherwise divest ourselves of our interests in the facility at the earliest possible time, we
cannot determine with certainty a fixed date by which such events
will occur, if at all. In light of this
uncertainty, based on estimates, we will periodically re-evaluate and adjust the reserve, as
necessary.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
261,389 |
|
|
$ |
27,283 |
|
|
$ |
234,106 |
|
|
|
858 |
% |
Interest expense |
|
|
(45,345 |
) |
|
|
(49,436 |
) |
|
|
4,091 |
|
|
|
8 |
% |
Other income (expense) |
|
|
(235 |
) |
|
|
(2,184 |
) |
|
|
1,949 |
|
|
|
89 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
$ |
215,809 |
|
|
$ |
(24,337 |
) |
|
$ |
240,146 |
|
|
|
987 |
% |
Interest income for the three months ended June 30, 2005 and 2004 was approximately $261,000
and $27,000 respectively. The increase in interest income in 2005 was primarily attributable to a
higher average investment balance. Interest expense for the three months ended June 30, 2005 and
2004 was approximately $45,000 and $49,000 respectively. The decrease in interest expense in 2005
was attributable to lower outstanding debt and capital lease balances in 2005 compared to 2004.
Other expenses include state franchise taxes paid.
Six months ended June 30, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from grants |
|
$ |
52,184 |
|
|
$ |
92,593 |
|
|
$ |
(40,409 |
) |
|
|
(44 |
)% |
Revenue from licensing agreements |
|
|
19,906 |
|
|
|
6,336 |
|
|
|
13,570 |
|
|
|
214 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
72,090 |
|
|
$ |
98,929 |
|
|
$ |
(26,839 |
) |
|
|
(27 |
)% |
15
For the six months ended June 30, 2005 revenue from grants and licensing agreements totaled
approximately $72,000 of which $52,000 was part of a $464,000 Small Business Technology Transfer
grant for studies in Alzheimers disease and approximately $20,000 in licensing revenue. For the
six months ended June 30, 2004, revenue from grants and licensing agreements totaled approximately
$99,000 of which $93,000 was part of the $342,000 Small Business Innovation Research grant from the
National Institute of Neurological Disease and Stroke, and $6,000 in licensing revenue.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,927,293 |
|
|
$ |
3,807,341 |
|
|
$ |
119,952 |
|
|
|
3 |
% |
General and administrative |
|
|
2,120,480 |
|
|
|
1,740,988 |
|
|
|
379,492 |
|
|
|
22 |
% |
Wind-down expenses |
|
|
1,718,200 |
|
|
|
598,143 |
|
|
|
1,120,057 |
|
|
|
187 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
7,765,973 |
|
|
$ |
6,146,472 |
|
|
$ |
1,619,501 |
|
|
|
26 |
% |
Research and development expenses totaled approximately $3,927,000 for the six months ended
June 30, 2005, compared with approximately $3,807,000 for the same period in 2004. The increase of
$120,000 or approximately 3% from 2004 to 2005 was primarily attributable to the costs associated
with a higher head count in the six-month period ended June 30, 2005 as compared to the same period
in 2004. At June 30, 2005, we had thirty full-time employees working in research and development
and laboratory support services as compared to twenty-four at June 30, 2004. The increase in
expenses was offset by a decrease in expenses for external services in 2005 as compared to 2004.
In 2004, our external services included required toxicology studies and other outside services in
preparing the submission of our first IND to the FDA, to evaluate the safety and efficacy of our
human neural stem cells as a treatment for Batten disease.
General and administrative expenses were approximately $2,120,000 for the six months ended
June 30, 2005, compared with approximately $1,740,000 for the same period in 2004. The increase of
$379,000 or approximately 22%, from 2004 to 2005 was primarily attributable to the cost of external
services incurred in the evaluation and testing of our internal financial control systems so as to
meet the requirements of and be in compliance with the new Securities and Exchange Commission rules
issued under section 404 of the Sarbanes-Oxley Act. The increase in general and administrative
expenses was also attributable to costs related to an increase in head count and recruiting.
In 1999, in connection with exiting our former research facility in Rhode Island, we created a
reserve for the estimated lease payments and operating expenses related to it. The reserve has
been re-evaluated and adjusted based on assumptions relevant to real estate market conditions and
the estimated time until we could either fully sublease, assign or sell our remaining interests in
the property. At December 31, 2004 the reserve was $4,350,000. For the six month period ended
June 30, 2005, expenses of $586,000 net of subtenant income were recorded against this reserve. At
March 31, 2005 and June 30, 2005, we re-evaluated the estimate and adjusted the reserve to
$4,568,000 and $5,482,000, respectively, by recording an additional $521,000 at March 31, 2005 and
$ 1,197,000 at June 30, 2005 for an aggregate of $1,718,000 as wind-down expenses. Aggregate
wind-down expenses for the same six-month period ended June 30, 2004 were $598,000. Expenses for
this facility will fluctuate based on changes in tenant occupancy rates and other operating
expenses related to the lease. Even though it is our intent to sublease, assign, sell or otherwise
divest ourselves of our interests in the facility at the earliest possible time, we cannot
determine with certainty a fixed date by which such events will
occur, if at all. In light of this
uncertainty, based on estimates, we will periodically re-evaluate and adjust the reserve, as
necessary.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
489,152 |
|
|
$ |
76,410 |
|
|
$ |
412,742 |
|
|
|
540 |
% |
Interest expense |
|
|
(91,756 |
) |
|
|
(98,931 |
) |
|
|
7,175 |
|
|
|
7 |
% |
Other income (expense) |
|
|
(20,632 |
) |
|
|
(3,195 |
) |
|
|
(17,437 |
) |
|
|
(546 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
$ |
376,764 |
|
|
$ |
(25,716 |
) |
|
$ |
402,480 |
|
|
|
1,565 |
% |
16
Interest income for the six months ended June 30, 2005 and 2004 was approximately $489,000 and
$76,000 respectively. The increase in interest income in 2005 was primarily attributable to a
higher average investment balance. Interest expense for the six months ended June 30, 2005 and
2004 was approximately $92,000 and $99,000 respectively. The decrease in interest expense in 2005
was attributable to lower outstanding debt and capital lease balances in 2005 compared to 2004.
Increase in other expense from approximately $3,000 to $26,000 was primarily attributable to an
increase in franchise tax paid to the State of Delaware as a result of a higher total value of
assets in 2005 as compared to 2004.
Liquidity and Capital Resources
Since our inception, we have financed our operations through the sale of common and preferred
stock, the issuance of long-term debt and capitalized lease obligations, revenues from
collaborative agreements, research grants and interest income.
We had cash and cash equivalents totaling $36,396,000 at June 30, 2005. Cash equivalents are
invested in US Treasuries with maturities of less than 90 days. The table below summarizes our
cash flows for the respective six month periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
$ |
(6,480,046 |
) |
|
$ |
(5,586,420 |
) |
|
$ |
(893,626 |
) |
|
|
(16 |
)% |
Net cash used in investing activities |
|
|
(285,280 |
) |
|
|
(63,380 |
) |
|
|
(221,900 |
) |
|
|
(350 |
)% |
Net cash provided (used) by financing activities |
|
|
2,101,339 |
|
|
|
18,590,230 |
|
|
|
(16,488,891 |
) |
|
|
(89 |
)% |
|
|
|
Increase (decrease) in cash and cash equivalents |
|
$ |
(4,663,987 |
) |
|
$ |
12,940,430 |
|
|
$ |
(17,604,417 |
) |
|
|
(136 |
)% |
We used $6,480,000 and $5,586,000 of cash in operating activities for the six months ended
June 30, 2005 and 2004 respectively. The increase in cash used in operating activities in 2005 in
comparison to the same period in 2004 was primarily attributable to the increase in operating
expenses attributable to the costs associated with a higher head count including recruiting fees,
the cost of external services incurred in the evaluation and testing of our internal financial
control systems so as to meet the requirements of and be in compliance with the new Securities and
Exchange Commission rules issued under section 404 of the Sarbanes-Oxley Act, prepayment of our
Directors and Officers Insurance Policy and the payout of higher bonus and external service
accruals in 2005 as compared to 2004. The increase in expenses was offset by a decrease in
expenses for our external services related to toxicology studies and other outside services
required in preparing the submission of our first IND to the FDA, to evaluate the safety and
efficacy of our human neural stem cells as a treatment for Batten disease.
We used $285,000 and $63,000 of cash in investing activities for the six months ended June 30,
2005 and 2004 respectively. The increase in cash used in investing activities in 2005 in
comparison to the same period in 2004 was primarily attributable to an increase in capital
expenditures primarily for lab and support equipment and a payment towards a licensing agreement.
For the six-month period ended June 30, 2005 cash provided by financing activities was
primarily attributable to the exercise of warrants. A total of 1,282,745 warrants were exercised
for gross proceeds of $1,938,000 (See Note 5 to the financial statements for further details on
these transactions). For the same period in 2004 cash provided by financing activities was
primarily attributable to the June 16, 2004 financing in which we issued 13,160,000 shares for a
net amount of approximately $19,000,000.
On October 26, 2004, the Company entered into an agreement with institutional investors with
respect to the registered direct placement of 7,500,000 shares of its common stock at a purchase
price of $3.00 per share, for gross proceeds of $22,500,000. C.E. Unterberg, Towbin LLC
(Unterberg) and Shoreline Pacific, LLC (Shoreline) served as placement agents for the transaction.
The Company sold these shares under a shelf registration statement
17
previously filed with and declared effective by the U.S. Securities and Exchange Commission.
For acting as our placement agent Unterberg and Shoreline received fees of approximately $1,350,000
and expense reimbursement of approximately $40,000. No warrants were issued as part of this
financing transaction.
On June 16, 2004, we entered into a definitive agreement with institutional and other
accredited investors with respect to the private placement of approximately 13,160,000 shares of
our common stock at a purchase price of $1.52 per share, for gross proceeds of approximately
$20,000,000. Investors also received warrants exercisable for five years to purchase approximately
3,290,000 shares of common stock at an exercise price of $1.90 per share. Unterberg served as
placement agent for the transaction. For acting as our placement agent Unterberg, received fees
totaling $1,200,192, expense reimbursement of approximately $25,000 and a five year warrant to
purchase 526,400 shares of our common stock at an exercise price of $1.89 per share.
On December 10, 2003 we completed a $9.5 million financing transaction with Riverview Group
L.L.C. (Riverview), through the sale of 5 million shares of common stock at a price of $1.90 per
share. The closing price of our common stock on that date was $2.00 per share.
Pursuant to a Stock Purchase Agreement dated May 7, 2003, we issued 4 million shares of our
common stock to Riverview for $6.5 million, or $1.625 per share. On the date of the agreement, the
price was above the trading price of our common stock, which closed at $1.43 per share on that
date. We also agreed to issue a 2-year warrant to Riverview to purchase 1,898,000 shares of common
stock at $1.50 per share. The exercise price is subject to adjustment for stock splits, dividends,
distributions, reclassifications and similar events. The exercise price may be below the trading
market price at the time of the exercise. In the event that certain conditions are met, including
the closing sale price of the Common Stock remaining at or above $2.50 per share for 10 consecutive
trading days, we may require Riverview to exercise the warrant with respect to any remaining
warrant shares or relinquish the right to do so. We registered the resale of the purchased shares
and the shares to be issued on exercise of the warrants. On November 7, 2003 and November 11, 2003
Riverview exercised a total of 1,098,000 of these warrants at $1.50 by which, we received gross
proceeds of $1,647,000.
On August 23, 2002, pursuant to an agreement with Triton West Group, Inc. (Triton), we sold
1,028,038 shares of common stock for aggregate proceeds of $1,100,000, or approximately $1.07 per
share.
On December 4, 2001, we issued 5,000 shares of 3% Cumulative Convertible Preferred Stock to
Riverview. We received total proceeds of $4,727,515 net of applicable fees and other associated
costs. Riverview converted 1,000 of the preferred shares on December 7, 2001, at a conversion
price of $2.00 per share of common stock, receiving 500,125 shares of common stock; 2,000 of the
preferred shares on April 9, 2003, at $0.80 per share, receiving 2,521,042 shares of common stock;
and the remaining 2,000 preferred shares on November 11, 2003, for 1,010,833 shares of the
Companys common stock, all inclusive of accrued dividends. As a result of the above transactions
all of the 3% cumulative convertible preferred stock was fully converted into our common stock
before the mandatory redemption date of December 4, 2003.
On May 10, 2001, we entered into a common stock purchase agreement with Sativum Investments
Limited for the potential future issuance and sale of up to $30,000,000 of our common stock, at our
discretion and subject to restrictions and other obligations. We drew down $4,000,000, $118,000
and $441,000 before applicable fees in 2001, 2002 and 2003 respectively. The equity line
terminated in January of 2004.
We continue to have outstanding obligations in regard to our former facilities in Lincoln,
Rhode Island, and expect to pay in 2005, based on past experience and current assumptions,
approximately $1,000,000 in lease payments and other operating expenses net of subtenant income.
We have subleased a portion of these facilities and are actively seeking to sublease, assign or
sell our remaining interests in these facilities. Failure to do so within a reasonable period of
time will have a material adverse effect on our liquidity and capital resources.
18
The following table summarizes our future contractual cash obligations (including both Rhode
Island and California leases, but excluding interest income and sub-lease income):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable in |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
remainder |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
of fiscal |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(July to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable in |
|
|
|
|
|
|
December) |
|
Payable in |
|
Payable in |
|
Payable in |
|
Payable in |
|
2010 and |
|
|
Total |
|
2005 |
|
2006 |
|
2007 |
|
2008 |
|
2009 |
|
beyond |
|
|
|
Capital lease
payments |
|
$ |
2,601,422 |
|
|
$ |
234,297 |
|
|
$ |
445,486 |
|
|
$ |
332,545 |
|
|
$ |
244,531 |
|
|
$ |
244,572 |
|
|
$ |
1,099,991 |
|
Operating lease
payments |
|
|
19,106,802 |
|
|
|
1,260,374 |
|
|
|
2,831,930 |
|
|
|
3,165,162 |
|
|
|
3,469,017 |
|
|
|
3,536,843 |
|
|
|
4,843,476 |
|
|
|
|
Total contractual
cash obligations |
|
$ |
21,708,224 |
|
|
$ |
1,494,671 |
|
|
$ |
3,277,416 |
|
|
$ |
3,497,707 |
|
|
$ |
3,713,548 |
|
|
$ |
3,781,415 |
|
|
$ |
5,943,467 |
|
|
|
|
We have incurred significant operating losses and negative cash flows since inception. We
have not achieved profitability and may not be able to realize sufficient revenues to achieve or
sustain profitability in the future. We have limited capital resources and we will need to raise
additional capital from to time to time to sustain our product development efforts, acquisition of
technologies and intellectual property rights, preclinical and clinical testing of anticipated
products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office
facilities, establishment of production capabilities, general and administrative expenses and other
working capital requirements. To fund our operations, we rely on cash balances, proceeds from
equity and debt offerings, proceeds from the transfer or sale of intellectual property rights,
equipment, facilities or investments, and on government grants and collaborative arrangements. We
cannot be certain that such funding will be available when needed. The financial statements do 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 may result from the
outcome of this uncertainty.
We intend to pursue opportunities to obtain additional financing in the future through equity
and debt financings, grants and collaborative research arrangements. The source, timing and
availability of any future financing will depend principally upon market conditions, interest rates
and, more specifically, on our progress in our exploratory, preclinical and future clinical
development programs. Lack of necessary funds may require us to delay, scale back or eliminate
some or all of our research and product development programs and/or our capital expenditures or to
license our potential products or technologies to third parties.
With the exception of operating leases for facilities, we have not entered into any
off-balance sheet financial arrangements and have not established any special purpose entities. We
have not guaranteed any debts or commitments of other entities or entered into any options on
non-financial assets.
19
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
No significant changes in our quantitative and qualitative disclosures from the Form
10-K.
ITEM 4. CONTROLS AND PROCEDURES
In response to the requirement of the Sarbanes-Oxley Act of 2002, as of the end of the
period covered by this report, our chief executive officer and chief financial officer, along with
other members of management, reviewed the effectiveness of the design and operation of our
disclosure controls and procedures. Such controls and procedures are designed to ensure that
information required to be disclosed in the Companys Exchange Act reports is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms, and that
such information is accumulated and communicated to management, including the chief executive
officer and the chief financial officer, as appropriate, to allow timely decisions regarding
required disclosure. Based on this evaluation, the chief executive officer and chief financial
officer have concluded that the Companys disclosure controls and procedures are effective.
During the most recent quarter, there were no changes in internal controls over financial
reporting that occurred during the period covered by this report that have materially affected, or
are reasonably likely to materially affect, these controls of the Company. As reported in the
Companys Annual Report on Form 10-K for the year ended December 31, 2004, management was unable to
conclude that the Companys internal controls over financial reporting were then effective, as a
result of a material weakness resulting from a lack of segregation of duties. We are continuing to
evaluate and test the operating effectiveness of our internal controls over financial reporting.
PART II ITEM 1
LEGAL PROCEEDINGS
One party has opposed two of our issued European patent cases. While we are confident
that we will overcome the opposition, there is no guarantee that we will prevail. If we are
unsuccessful in our defense of the opposed patents, all claimed rights in the opposed patents will
be lost in Europe .
PART II ITEM 2
CHANGES IN SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES
None
PART II ITEM 3
DEFAULTS UPON SENIOR SECURITIES
None
20
PART II ITEM 4
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On May 10, 2005, we held our Annual Meeting of Shareholders. Irving Weissman, M.D., and
Ricardo Levy, Ph.D., were re-elected to the Board as Class II directors, with terms expiring in
2008. The remaining members of the Board, whose terms continued after the Annual Meeting, are Eric
Bjerkholt, MBA, Roger Perlmutter, M.D., Ph.D., John Schwartz, Ph.D., and Martin McGlynn, President
and CEO of StemCells. The
shareholders also ratified the selection of Grant Thornton LLP as StemCells independent
public accountants for the fiscal year ending December 31, 2005.
The number of proxies finally tabulated represented 55,712,353 of the 62,498,244 eligible shares,
or 89.14 percent of eligible shares. The votes on each of the proposals were as follows:
|
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Authority |
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For |
|
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Withheld |
|
|
Against |
|
|
Abstain |
|
|
No |
|
Election of Irving
Weissman, M.D., as
director |
|
|
55,399,776 |
|
|
|
312,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Election of Ricardo
Levy, Ph.D., as
director |
|
|
55,363,833 |
|
|
|
348,520 |
|
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|
|
|
|
|
|
|
|
|
|
|
Ratification of
Grant Thornton LLP
as independent
accountants for
2005 |
|
|
55,362,812 |
|
|
|
|
|
|
|
208,811 |
|
|
|
140,729 |
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1 |
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PART II ITEM 5
OTHER INFORMATION
There were no matters required to be disclosed in a current report on Form 8-K during the
fiscal quarter covered by this report that were not so disclosed.
PART II ITEM 6
EXHIBITS
Exhibit 10.71 License Agreement between StemCells, Inc. and ReNeuron Limited
Exhibit 31.1 Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.2 Certification of Judi Lum under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 32.1 Certification of Martin McGlynn Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Judi Lum Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
21
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
|
|
|
|
|
STEMCELLS, INC.
|
|
|
(name of Registrant) |
|
|
|
July 28, 2005
|
|
/s/ Judi Lum |
|
|
Judi Lum
Chief Financial Officer |
22
EXHIBIT INDEX
Exhibit 10.71 License Agreement between StemCells, Inc. and ReNeuron Limited
Exhibit 31.1 Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.2 Certification of Judi Lum under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 32.1 Certification of Martin McGlynn Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Judi Lum Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
exv10w71
1
Exhibit 10.71
LICENSE AGREEMENT BETWEEN STEMCELLS, INC. AND RENEURON LIMITED
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the Agreement), effective as of the 1st day of July, 2005 (the Effective
Date), is between STEMCELLS, INC., a Delaware corporation having its principal place of business
at 3155 Porter Drive Palo Alto CA, USA 94304 (SCI) and RENEURON LIMITED (company no. 03375897) a
corporation organized under the laws of the United Kingdom and having its principal place of
business at 10 Nugent Road, Surrey Research Park, Guilford, Surrey GU27AF, UK (ReN). SCI and ReN
are each individually referred to herein as a Party and are collectively referred to herein as
the Parties.
WHEREAS:
A. |
|
SCI owns or controls (with the right to sub-license) the SCI Patent Rights and ReN owns or
controls (with the right to sub-license) the ReN Patent Rights, each as hereinafter defined; |
|
B. |
|
SCI wishes to grant to ReN, and ReN wishes to secure from SCI, certain rights under the SCI
Patent Rights within the ReN Field, as set forth herein; |
|
C. |
|
ReN wishes to grant to SCI, and SCI wishes to secure from ReN, certain rights under ReN
Patent Rights as well as certain rights with respect to the c-MycER Cells, as set forth
herein. |
|
D. |
|
Simultaneously with the execution of this Agreement the Parties, together with ReNeuron Group
PLC, ReNeuron (UK) Limited and certain Existing Shareholders (as defined therein) have entered
into the Subscription Agreement (as hereafter defined) in consideration of the entering into
of this Agreement pursuant to which SCI is granted certain rights to be issued shares in
ReNeuron Group PLC. |
NOW, THEREFORE, THE PARTIES AGREE AS FOLLOWS:
The following capitalized terms used in this Agreement shall have the meanings given below unless
the context clearly requires otherwise.
1.01 |
|
Affiliate shall mean any corporation, company, partnership, joint venture and/or firm that
controls, is controlled by, or is under common control with a party. For purposes of this
definition, control shall mean (a) in the case of a corporate entity, possession, directly
or indirectly, of the power to direct the management and policies of such corporate entity,
whether through ownership of securities, by contract or agency or otherwise; and (b) in the
case of non-corporate entities, direct or indirect ownership of |
2
|
|
more than 50% of the equity interest with the power to direct the management and policies of
such non-corporate entities. |
|
1.02 |
|
Cell Line shall mean c-MycER Cells of clonal origin, differentiated by the integration site
of the c-MycER Cell insert. |
|
1.03 |
|
Cells shall mean cultures of neural Stem Cells to the full extent described or claimed in
the SCI Patent Rights and shall include all progeny and derivatives of such stem cells
(including Progenitor Cells and their progeny and Stem Cells and their progeny) and Cell
shall mean one of such cells. |
|
1.04 |
|
c-MycER Cells shall mean human neural Stem Cells and Progenitor Cells conditionally
immortalized with the c-Myc oncogene with an estrogen response element under tamoxifen
control. c-MycER Cells shall not include human neural Stem Cells or Progenitor Cells or their
progeny or derivatives that are not conditionally immortalized with c-myc under the control of
the estrogen response element. |
|
1.05 |
|
A Change of Control of a Party (or an the Affiliate of a Party to which assignment has
occurred pursuant to Section 8.01, below), shall be deemed to have occurred at such time as
any person or group (as such terms are used for purposes of Sections 13(d) and 14(d) of
the Securities Exchange Act of 1934) that, on the Effective Date, is not the beneficial
owner (as such term is used in Rule 13d-3 under the Securities Exchange Act of 1934) directly
or indirectly, of more than fifty percent (50%) of the total securities of such Party
entitled to vote for directors of such Party, becomes (except as the result of a Qualified
Investment in such Party), directly or indirectly, in one or more transactions, the beneficial
owner (as so defined), directly or indirectly, of more than fifty percent (50%) of the total
securities of such Party entitled to vote for directors of such Party. For purposes of this
definition a Qualified Investment shall mean a bona fide cash investment in the applicable
Party by a financial institution, venture capitalist or similar entity (excluding a venture
capital affiliate or similar financing arm of a collaborator or commercial partner of such
Party). |
|
1.06 |
|
Confidential Information shall mean any and all information disclosed by a Party (the
Discloser) to the other Party (the Recipient) hereunder that is clearly marked or
identified as confidential including all information relating to any technology, product,
process, business information or other intellectual property of such Person (including, but
not limited to, owned or license intellectual property rights, data, know-how, samples,
technical and non-technical materials and specifications, as well as any business plan or
other confidential commercial information of or about such Person). Confidential
Information shall further include the terms and conditions of this Agreement not otherwise
made public by agreement of the Parties or as required by law as well as information arising
or disclosed pursuant to Section 2.03(c), 3.03 or 3.06 or Article 6 of this Agreement.
Notwithstanding the foregoing, information shall not be considered Confidential Information
to the extent that the Recipient can demonstrate by written record or other suitable physical
evidence that: |
|
(a) |
|
such specific information was lawfully in the Recipients possession or control
prior to the time such information was disclosed to the Recipient by the Discloser; |
3
|
(b) |
|
such specific information was independently developed by one or more employees
of the Recipient without the use of such Confidential Information; |
|
|
(c) |
|
such specific information was lawfully obtained by the Recipient from a third
party under no obligation of confidentiality to the Discloser; or |
|
|
(d) |
|
such specific information was at the time it was disclosed or obtained by the
Recipient, or thereafter became, publicly known otherwise than through a breach of the
Recipients obligations hereunder. |
1.07 |
|
Control shall mean the possession by a Party of a license and the right to grant a
sub-license thereunder to the other Party in accordance with this Agreement. |
|
1.08 |
|
Dollar(s) (including the symbol $) shall mean United States dollar(s). |
|
1.09 |
|
Field shall mean the ReN Field or the SCI Field, as applicable. |
|
1.10 |
|
First Commercial Sale shall mean, with respect to a Product and country, the first sale of
such Product in such country after receipt of all applicable marketing and pricing approvals
(if any) have been granted by the applicable governing health authority. |
|
1.11 |
|
Fully Diluted Share Capital shall have the meaning set forth for such term in the
Subscription Agreement. |
|
1.12 |
|
Gross Revenues shall mean the gross revenues received by a Party, any Affiliate of a Party
and any sub-licensee hereunder of a Party from the sale of any Product to, or the commercial
use of any Product by, any Person other than that Party, its Affiliate or sub-licensee
hereunder. Gross Revenues shall not include any revenues resulting from the use of Product by
a Party or its Affiliates or sub-licensee hereunder solely for research and development (not
done for third party compensation (which does not include expense reimbursement)), regulatory
clearance, non-commercial product testing or quality control purposes. |
|
1.13 |
|
IND shall mean an Investigational New Drug application filed with the United States Food
and Drug Administration or equivalent application to the applicable governmental authority of
another country, required to commence human clinical testing of a Product. |
|
1.14 |
|
Indication shall mean a manifestation of a recognized disease or condition, one or more
symptoms of a recognized disease or condition, or adjunctive therapy for a disease or
condition. |
|
1.15 |
|
License, in the case of a license hereunder from one Party to the other Party shall include
a sub-license to such of a Partys Patent Rights as have been in-licensed by from a third
party. A Party may be referred to as owner of its Patent Rights even though some of such
rights may have been in-licensed by from a third party. |
|
1.16 |
|
Net Sales shall mean, with respect to any Product and any Party (including such Partys
Affiliates and sub-licensees hereunder), the aggregate Dollar equivalent of such Partys Gross
Revenues (including Gross Revenues of such Partys Affiliates and sub-licensees hereunder)
with respect to such Product, less: |
(a) credits, allowances or charge-backs, if any, granted on account of price adjustments,
recalls, rejection, return or spoilage of such Product previously sold,
4
(b) excise, import and export taxes, sales, use, value added and other direct taxes incurred
on the sale of such Product, customs duties, surcharges or other taxes imposed upon or paid
with respect to any sale or use generating such Gross Revenues (excluding income or
franchise taxes of any kind),
(c) the cost of insurance, packing and shipping Product in connection with such sale or use;
and
(d) cash, quantity or other discounts, and credits, rebates or price reductions for such
Product, given under price reduction programs that are consistent with industry practices.
1.17 |
|
Ordinary Shares shall mean TopCo Shares as such term is defined in the Subscription
Agreement. |
|
1.18 |
|
Patent Rights shall mean the SCI Patent Rights and/or the ReN Patent Rights, as the case
may be. |
|
1.19 |
|
Person shall mean any individual, corporation, governmental body or other legal entity. |
|
1.20 |
|
Phase I Clinical Trial shall mean a human clinical trial in any country that is intended to
evaluate the safety and/or pharmacological effect of a product in subjects, or that would
otherwise satisfy the requirements of 21 CFR 312.21(a), or its foreign equivalent. |
|
1.21 |
|
Phase II Clinical Trial shall mean a human clinical trial in any country that is intended
to evaluate the safety and effectiveness of a product for a particular Indication or
Indications in patients with the disease or Indication under study, or that would otherwise
satisfy the requirements of 21 CFR 312.21(b), or its foreign equivalent. |
|
1.22 |
|
Product shall mean an SCI Product, an ReN Product, an ReN NCT or an Unregulated Cells, as
the case may be. |
|
1.23 |
|
Progenitor Cell shall mean an undifferentiated Cell capable of limited proliferation and
the production of differentiated functional progeny. |
|
1.24 |
|
ReN c-MycER Cell Technology shall mean all know-how, data, biological materials, inventions
and other proprietary information and technology owned or Controlled by ReN and relating to
the manufacture, sale, use or manipulation of c-MycER Cells. |
|
1.25 |
|
ReN Discovery Field shall mean use of c-MycER Cells for the research, discovery, screening
and development of new non-cellular therapeutics for use in the treatment of any disease state
or condition in humans. |
|
1.26 |
|
ReN Field shall mean the ReN Transplantation Field, the ReN Discovery Field, and the ReN
Reagents Field. |
|
1.27 |
|
ReN NCT shall mean a non-cellular therapeutic molecule, i.e., a new chemical or
biological molecule, identified or developed by ReN through the practice of inventions claimed
in or covered by one or more of the SCI Patents or molecules derived therefrom, which
identification or development occurred during the term of a Valid Claim of any such SCI
Patent. |
|
1.28 |
|
ReN Patent Rights shall mean: |
(a) the patents and patent applications listed on Schedule 1.28 attached hereto (the ReN
Patents),
5
(b) any and all United States or foreign patents and patent applications corresponding to
any of the foregoing patents and patent applications, whether now existing of hereafter
filed,
(c) any provisionals, substitutions, divisionals, reissues, renewals, continuations,
continuations-in-part (but only to the extent not directed to new matter), extensions
(including patent term extensions), substitute applications and inventors certificates
arising from, or based upon, any of the foregoing patents or patent applications, in respect
of the foregoing;
(d) any patents issuing from any of the foregoing patent applications, and
(e) any issued patents now or hereafter owned or Controlled by ReN or an Affiliate of ReN to
the extent necessary or useful for the manufacture, use or sale of any product or method
utilizing c-MycER Cells or ReN c-MycER Cell Technology in the SCI Field.
1.29 |
|
ReN Product shall mean a c-MycER Cell or a product utilizing a c-MycER Cell identified or
developed, in whole or in part, through the practice by ReN or a sub-licensee of ReN of
inventions claimed in or covered by one or more of the SCI Patents, which practice occurred
during the term of a Valid Claim of any such SCI Patent. |
|
1.30 |
|
ReN Reagents Field shall mean use of Unregulated Cells for research and other non-clinical
and non-therapeutic purposes (not including administration to humans). |
|
1.31 |
|
ReN Transplantation Field shall mean Transplantation of c-MycER Cells for the diagnosis,
prevention and treatment of human diseases other than those in the SCI Field. |
|
1.32 |
|
Royalty Term shall mean, with respect to an SCI Product or an Unregulated Cell, in each
country of sale, the period ***. The Royalty Term for each Product shall be determined on a
country-by-country basis. Royalty Term shall mean, with respect to an ReN Product or an ReN
NCT, a period ***. |
|
1.33 |
|
SCI Field shall mean the diagnosis, prevention and treatment of: (i) lysosomal storage
diseases, (ii) spinal cord injury, or (iii) myelin-affected disorders including, without
limitation, cerebral palsy and multiple sclerosis. |
|
1.34 |
|
SCI Patent Rights shall mean: |
(a) the patents and patent applications listed on Schedule 1.34 attached hereto (the SCI
Patents),
(b) any and all United States or foreign patents and patent applications corresponding to
any of the foregoing patents and patent applications, whether now existing of hereafter
filed,
(c) any provisionals, substitutions, divisionals, reissues, renewals, continuations,
continuations-in-part (but only to the extent not directed to new matter), extensions
(including patent term extensions), substitute applications and inventors certificates
arising from, or based upon, any of the foregoing patents or patent applications, in respect
of the foregoing;
(d) any patents issuing from any of the foregoing patent applications; and
6
(e) any issued patents now or hereafter owned or Controlled by SCI or an Affiliate of SCI to
the extent necessary or useful for the manufacture, use or sale of:
(i) a c-MycER Cell (including without limitation a product utilizing a c-Myc-ER
Cell) identified or developed, in whole or in part, through the practice by ReN or a
sub-licensee of ReN of inventions claimed in or covered by one or more of the SCI
Patents, or
(ii) a ReN NCT.
1.35 |
|
SCI Product shall mean any product or method utilizing c-MycER Cells, the manufacture, use,
or sale of which, but for the license granted to SCI hereunder, would infringe any Valid Claim
of the ReN Patent Rights. |
|
1.36 |
|
Stem Cell shall mean an undifferentiated Cell capable of proliferation, self maintenance
and the production of a large number of differentiated functional progeny. |
|
1.37 |
|
Sub-license Revenue shall mean *** |
|
1.38 |
|
Subscription Agreement shall mean an agreement entitled Subscription and Share Exchange
Agreement of even date herewith among ReN, SCI and others. |
|
1.39 |
|
Third Party shall mean any Person other than a Party or an Affiliate of a Party. |
|
1.40 |
|
Transplantation shall mean the implantation of Cells, into a patient.. |
|
1.41 |
|
Unregulated Cells shall mean the ReN cell lines known as ReNcell CX and ReNcell VM and more
particularly described on Schedule 1.41 hereto and, on notice from ReN to SCI, any alternative
ReN cell line identified by ReN and substituted for either ReNcell CX or ReNcell VM as
provided in Section 2.05, below. |
|
1.42 |
|
Valid Claim shall mean a claim of an issued and unexpired patent included within the
Patents Rights that has not been held permanently revoked, unenforceable or invalid by a
decision of a court or other government agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and that has not been admitted to be invalid or
unenforceable through release or disclaimer or otherwise. |
2. |
|
LICENSES AND SUPPLY OF MATERIALS |
2.01 |
|
Licenses from SCI to ReN |
|
(a) |
|
SCI hereby grants to ReN a sole and exclusive (even as to SCI),
royalty-bearing, worldwide license under the SCI Patent Rights to research, develop,
make, have made, use, have used, sell, have sold, offer for sale and import ReN
Products in the ReN Transplantation Field. |
|
|
(b) |
|
SCI hereby grants to ReN a sole and exclusive (even as to SCI),
royalty-bearing, worldwide license under the SCI Patent Rights to make and use c-MycER
Cells to research, develop, make, have made, use, have used, sell, have sold, offer for
sale and import ReN NCTs in the ReN Discovery Field. |
7
|
(c) |
|
SCI hereby grants to ReN a non-exclusive, royalty-bearing, worldwide license,
under the SCI Patent Rights to research, develop, make, have made, use, have used,
sell, have sold, offer for sale and import, Unregulated Cells in the ReN Reagent Field. |
Any sub-licenses included in any of the foregoing licenses under SCI Patent Rights are
granted subject to the applicable terms and conditions of the agreement, if any, by which
SCI is licensed under such SCI Patent Rights; provided, however, that SCI shall be
responsible for the payment of royalties and other economic obligations to Third Parties
under any such agreement that is in effect as of the Effective Date and ReN shall be
responsible for the reimbursement to SCI of royalties calculated and due to Third Parties as
the result of sale of a Product by ReN or an Affiliate or sub-licensee hereunder (but not
any other economic obligations) under any such agreement that first comes into effect
following the Effective Date. With respect to SCI Patent Rights derived as a result of a
license to SCI from a Third Party that first comes into effect following the Effective Date,
SCI shall first notify ReN as to the nature (including term and scope) of the Patent Rights
in question and the royalty burden associated with the exercise of such rights by ReN
pursuant to this Agreement. ReN shall have the right, at any time by notice to SCI, to
decline (or, having first accepted thereafter to relinquish) its rights hereunder with
respect to such Patent Rights, in whole or part, whereupon such Patent Rights, to the extent
of such decline or relinquishment, shall be deleted from the grant of rights to ReN
hereunder. The licenses granted in this Section 2.01 are subject to the terms and
conditions of this Agreement.
2.02 |
|
License from ReN to SCI |
ReN hereby grants to SCI a sole and exclusive (even as to ReN), royalty-bearing, worldwide
license under the ReN Patent Rights and ReN c-MycER Cell Technology, to research, develop,
make, have made, use, have used, sell, have sold, and offer for sale SCI Products in the SCI
Field and to use the c-MycER Cells in order to make, use or sell an SCI Product in the SCI
Field.
Any sub-licenses included in any of the foregoing licenses under ReN Patent Rights are
granted subject to the applicable terms and conditions of the agreement by which ReN is
licensed under such ReN Patent Rights; provided, however, that ReN shall be responsible for
the payment of royalties and other economic obligations to Third Parties under any such
agreement that is in effect as of the Effective Date and SCI shall be responsible for the
reimbursement to ReN of royalties calculated and due to Third Parties as the result of sale
of a Product by SCI or any Affiliate or sub-licensee hereunder (but not any other economic
obligations) under any such agreement that first comes into effect following the Effective
Date. With respect to ReN Patent Rights derived as a result of a license to ReN from a
Third Party that first comes into effect following the Effective Date, ReN shall first
notify SCI as to the nature (including term and scope) of the Patent Rights in question and
the royalty burden associated with the exercise of such rights by SCI within the SCI Field.
SCI shall have the right, at any time by notice to ReN, to decline (or, having first
accepted thereafter to relinquish) its rights hereunder with respect to such
8
Patent Rights, in whole or part, whereupon such Patent Rights, to the extent of such decline
or relinquishment, shall be deleted from the grant of rights to SCI hereunder. The license
granted in this Section 2.02 is subject to the terms and conditions of this Agreement.
(a) ReN shall have the right to sub-license its rights under Sections 2.01(a), (b) or (c),
above, to an Affiliate of ReN on prior notice to SCI. Any such sub-license shall remain in
effect only for so long as such Affiliate remains as Affiliate of ReN. ReN shall have the
right to sub-license its rights under Sections 2.01(a) and (b), above, to a Third Party only
with the prior consent of SCI, which consent shall not be unreasonably withheld or delayed.
ReN shall have no right to sub-license its rights under Section 2.01 (c), above, to a Third
Party; provided, however, that ReN shall have: (i) the right to contract with one or more
distributors (including catalog reagent companies) with respect to the manufacture and/or
sale of Unregulated Cells in the ReN Reagent Field, (ii) the right to contract with a Third
Party to manufacture Products for sale in the ReN Reagent Field, and (iii) the right to pass
through implied sub-licenses (without the right further to sub-license or assign) to end
users of Unregulated Cells.
(b) SCI shall have the right to sub-license its rights under Section 2.02, above, to an
Affiliate of SCI on prior notice to ReN. Any such sub-license shall remain in effect only
for so long as such Affiliate remains an Affiliate of SCI. SCI shall have the right to
sub-license its rights under Section 2.02, above, to a Third Party only with the prior
consent of ReN, which consent shall not be unreasonably withheld or delayed.
(c) At least thirty (30) business prior to the proposed grant by a Party to a sub-licensee
of any of its rights hereunder, the granting Party shall provide to the other Party a
summary of the material terms and conditions (including the identity of the prospective
sub-licensee) of such proposed sub-license. In the event that a Party (the Controlling
Party) objects to the proposed sub-licensing of its Patent Rights by the other Party (the
Licensing Party) to a Third Party, the Controlling Party shall so notify the Licensing
Party within ten (10) days following its receipt of the proposed sub-license terms and
conditions stating, with reasonable specificity, the reasons for such objection. If no such
notice of objection is provided within such ten (10) day period, a sub-license consistent
with such proposed terms and conditions to the prospective sub-licensee previously
identified shall be deemed to have been approved by the Controlling Party, provide that such
sub-license enters into effect during the following one hundred and eighty (180) days. If
notice of objection is provided, at the request of the Licensing Party, the Parties shall
promptly meet to discuss in good faith the objections raised by the Controlling Party. If
the Controlling Party does not give its approval to the proposed sub-license terms and
conditions within five (5) business days following the date of the Licensing Partys initial
receipt of the Controlling Partys objection to the proposed sublicense, the reasonableness
of such objection shall, at the request of the Licensing Party, be resolvable by binding
arbitration as provided in Section 2.03(d), below.
9
(d) ***
(a) From time to time during the period commencing on the Effective Date and ending upon the
expiration of the Royalty Term SCI shall have the right to nominate one or more Cell Lines
either from among Cell Lines already in ReNs possession as of the Effective Date or for
creation by ReN according to reasonable specifications provided by SCI. ***
Following the nomination of an Approved Cell Line, the Parties shall establish a time-line
on which ReN, using reasonable diligence, shall establish the capacity (or have a
sub-contractor establish such capacity) to supply SCI pursuant to this Section 2.04. In
accordance with the agreed-upon time table, SCI shall notify ReN in advance of its projected
requirements of such Approved Cell Line and shall place firm orders for such Approved Cell
Line sufficiently in advance of the date proposed for delivery (as determined in the agreed
time line). SCI shall reimburse ReN for the *** of Approved Cell Lines nominated and
ordered by SCI, determined in accordance with United Kingdom GAAP.
With respect to Approved Cell Lines isolated, produced and supplied by ReN pursuant to this
Section 2.04, SCI shall have the right, no more than once in any 12 month period, during
ordinary working hours and with no fewer that 10 days prior written notice to ReN, to
conduct reasonable quality assurance audits of ReNs production and testing facilities.
(b) During the ninety (90) day period following the Effective Date the Parties shall,
diligently and in good faith, endeavor to reach agreement on a Supply Agreement pursuant
to which ReN shall supply (directly and/or through sub-contractors) to SCI Approved Cell
Lines for which SCI has reached the Trigger Point prior to ReN pursuant to subsection (a),
above, in cGMP and GMP form, for clinical and commercial use by SCI within the SCI Field.
The Supply Agreement shall provide, inter alia, for:
(i) reasonable and customary representations and warranties with respect to the
specifications of the materials delivered, with commercially reasonable rights to inspect
and reject non-conforming goods (subject to reasonable and customary limitations on remedies
and liability with respect thereto);
(ii) the establishment of a Quality Agreement covering such Approved Cell Line, the
assurance that SCI and all responsible governmental bodies have the right to inspect and
conduct audits (including quality assurance audits) of the ReN facilities used in the
testing and production of such Approved Cell Line and ReN records related thereto including,
without limitation, batch records, stability reports, and the results of internal and
regulatory audits and inspections;
10
(iii) the right to audit such ReN facilities under special circumstances (e.g. in
response to a serious adverse event or in connection with a governmental inspection);
(iv) the right for SCI to reference ReNs drug master file and the acquisition of
appropriate manufacturing permits and licensure from regulatory authorities with respect to
such Approved Cell Line and the facilities used for the testing or manufacture of such
Approved Cell Line;
(v) procedures applicable in the event of complaints, adverse events or recalls with
respect to materials supplied by ReN;
(vi) the forecasting of supply of materials and the timing of firm orders to be placed
by SCI with respect to materials to be produced and supplied by ReN;
(vii) a purchase price for such materials equal to ***;
(viii) quality control and terms and conditions for changes in manufacturing or testing
specifications;
(ix) reasonable advance notice and lead time to be given prior to initial production of
any Cell Lines under the Supply Agreement to allow for ReN to establish the capacity,
process and scale-up to manufacture and supply thereunder; and
(x) such other terms and conditions as are typical and reasonable for an agreement
providing for the supply of FDA regulated pharmaceutical products and the use of such
products for human clinical trials and commercial sale.
To the extent that the Parties are unable to reach agreement on all of the terms and
conditions of the Supply Agreement within such ninety (90) day period, either Party shall
have the right submit any open questions to binding arbitration using the procedure
specified in Section 2.03(d), above.
2.05 |
|
Substitution of Unregulated Cells. |
At any time during the term of this Agreement ReN shall have the right, by notice to SCI, to
nominate an ReN cell line identified on Schedule 1.41 other than those identified as ReNcell
CX or ReNcell VM as a substitute for ReNcell CX or ReNcell VM such that ReN will, at all
times have rights to two Unregulated Cells. SCI shall not enter into any license or other
agreement with a Third Party inconsistent with the foregoing.
2.06 |
|
Rights Limited to Those Expressed |
The rights granted to SCI and ReN hereunder shall be limited to the rights expressly stated
to be granted hereunder and no additional rights or licenses are implied.
11
3.01 |
|
ReN shall make the following payments to SCI: |
Within 30 days following the achievement by ReN or by an Affiliate or sub-licensee
hereunder of ReN of each of the following events, on a Product by Product basis, ReN
shall give written notice thereof to SCI and shall pay to SCI the corresponding
payments described below.
|
*** |
|
upon initiation of the first human Phase I Clinical Trial of
each ReN Product *** in the ReN Transplantation Field; |
|
|
*** |
|
upon completion of the first human Phase II Clinical Trial of
each ReN Product *** in the ReN Transplantation Field; |
|
|
*** |
|
upon submission of the first BLA or its foreign counterpart for
each ReN Product *** in the ReN Transplantation Field; |
|
|
*** |
|
upon approval of a BLA or its foreign counterpart for each ReN
Product *** in the ReN Transplantation Field in the first of the United States,
the European Union or Japan; |
|
|
*** |
|
upon initiation of the first human Phase II Clinical Trial of a
ReN NCT; and |
|
|
*** |
|
upon the First Commercial Sale of a ReN NCT. |
For purposes of determining whether a milestone payment is due pursuant to this subsection
(a) with respect to a given label Indication, a Product (the Follow-on Product) shall not
be considered as distinct from a Product as to which a milestone payment was previously made
for the same label Indication (the Initial Product) if the clinical development of the
Follow-on Product was lawfully conducted without the requirement that a new (as
distinguished from an amended) IND be filed with respect to the clinical testing of such
Follow-on Product, i.e. that clinical development of the Follow-on Product occurred
pursuant to the same IND (whether or not amended) as that applicable to the Initial Product.
Accordingly, a Follow-on-Product developed pursuant to the same IND as the Initial Product
shall not trigger (or accrue a payment obligation for) the milestone payments already paid
for such Initial Product with respect to a given label Indication.
In addition, the Parties acknowledge that a single development program intended to yield a
single commercial Product for a specific Indication or set of Indications may involve the
simultaneous development of multiple Product for that Indication or set of Indications, each
based on a different Cell Line or combination of Cell Lines, and that the
12
Product as to which one milestone event occurs (e.g. that due on the completion of a Phase
II Clinical Trial) may subsequently be abandoned and replaced by a back-up Product developed
in the course of such development plan, for the same Indication or set of Indications, as to
which the same milestone event occurs. In such event, the Parties intend that each
milestone payment shall be paid only one time for each Indication regardless of whether such
milestone payment is achieved by more than one Product developed for such Indication or set
of Indications in the course of the same development program.
Subject to the clarifications in the preceding two paragraphs, the Parties intend that
achievement of each Milestone Event (defined as the initiation of a given Phase I Clinical
Trial, completion of a given Phase II Clinical Trial, submission of a given BLA or approval
of a BLA, to the extent triggering a milestone payment above) shall result in an obligation
to make the corresponding payment obligation every time such Milestone Event occurs unless
the subsequent occurrence of the Milestone Event involves both the same Product *** as a
previous Milestone Event for which milestones were already paid. *** Furthermore, it is
understood and agreed that no more than one milestone payment (in the applicable amount
specified above, and not multiples thereof) shall be made with respect to a given Milestone
Event, without limiting any milestones due for a subsequent occurrence of the same Milestone
Event for a different Indication or Product. Thus, for example completion of a given Phase
II Clinical Trial for a given Product within the applicable Field will trigger only one
payment of ***, regardless of whether the Product in such trial was a combination product
containing two biological compounds from two different Cell Lines and regardless of whether
the Indication targeted in such trial could potentially cover different patient populations
or be subdivided into subtypes or subgroups.
During the applicable Royalty Term for each ReN Product or ReN NCT Product, on a
country-by-country basis, ReN shall pay to SCI a *** royalty on any and all Net Sales of
each ReN Product in the ReN Transplantation Field in such country and a *** royalty on any
and all Net Sales of each ReN NCT in the ReN Discovery Field in such country, regardless of
the number of Valid Claims of the SCI Patent Rights that are applicable. During the
applicable Royalty Term for each Unregulated Cell, ReN shall also pay to SCI a *** royalty
on any and all Net Sales of Unregulated Cells by ReN or any Affiliate of ReN (but not for
sales by permitted sublicensees (as per Section 2.03(a)(i)) or distributors of ReN with
respect to such Unregulated Cells).
ReN shall pay to SCI *** of all ReN Sub-license Revenue with respect to ReN Products and ReN
NCTs. In addition, ReN shall pay to SCI ten (10) percent of all revenues ReN receives
(whether in the form of license fees, milestones payments or royalties calculated as a
function of the sale or use of Unregulated Cells) from its sub-licensees and distributors of
Unregulated Cells within the ReN Reagent Field for the sale of (and/or the
13
right to make, use, or sell) Unregulated Cells (excluding any such revenues that fall within
the categories of (a), (b) and/or (c) of the Sub-license Revenue definition in Section
1.37).
|
(d) |
|
In addition to the payments provided in subsections (a), (b) and (c), above, as
provided in the Subscription Agreement, ReN shall secure the delivery to SCI of
Ordinary Shares constituting seven and one-half percent (7.5%) of the Fully Diluted
Share Capital of ReNeuron Group PLC as of the date on which such shares are issued. As
provided in the Subscription Agreement, SCI shall also benefit from certain
anti-dilution protection in respect of such share holding. The further rights of SCI as
a result of its ownership of such Ordinary Share are as specified in the Subscription
Agreement and in the articles of association of ReNeuron Group PLC. |
3.02 |
|
SCI shall make the following payments to ReN: |
Within 30 days following the achievement by SCI or by an Affiliate or sub-licensee
of SCI of each of the following events, on a Product by Product basis, SCI shall
give written notice thereof to ReN and shall pay to ReN the corresponding payments
described below.
|
*** |
|
upon initiation of the first human Phase I Clinical Trial of
each SCI Product *** in the SCI Field. |
|
|
*** |
|
upon completion of the first human Phase II Clinical Trial of
each SCI Product *** in the SCI Field. |
|
|
*** |
|
upon submission of the first BLA or its foreign counterpart for
each SCI Product *** in the SCI Field. |
|
|
*** |
|
upon approval of a BLA or its foreign counterpart for each SCI
Product *** in the SCI Field in the first of the United States, the European
Union or Japan. |
For purposes of determining whether a milestone payment is due pursuant to this subsection
(a) with respect to a given label Indication, a Product (the Follow-on Product) shall not
be considered as distinct from a Product as to which a milestone payment was previously made
for the same label Indication (the Initial Product) if the clinical development of the
Follow-on Product was lawfully conducted with the requirement that a new (as distinguished
from an amended) IND be filed with respect to the clinical testing of such Follow-on
Product, i.e. that clinical development of the Follow-on Product occurred pursuant
to the same IND (whether or not amended) as that applicable to the Initial Product.
Accordingly, a Follow-on-Product developed pursuant to the same IND as the Initial Product
shall not trigger (or accrue a payment obligation
14
for) the milestone payments already paid for such Initial Product with respect to a given
label Indication.
In addition, the Parties acknowledge that a single development program intended to yield a
single commercial Product for a specific Indication or set of Indications may involve the
simultaneous development of multiple Product for that Indication or set of Indications, each
based on a different Cell Line or combination of Cell Lines, and that the Product as to
which one milestone event occurs (e.g. that due on the completion of a Phase II Clinical
Trial) may subsequently be abandoned and replaced by a back-up Product developed in the
course of such development plan, for the same Indication or set of Indications, as to which
the same milestone event occurs. In such event, the Parties intend that each milestone
payment shall be paid only one time for each Indication regardless of whether such milestone
payment is achieved by more than one Product developed for such Indication or set of
Indications in the course of the same development program.
Subject to the clarifications in the preceding two paragraphs, the Parties intend that
achievement of each Milestone Event (defined as the initiation of a given Phase I Clinical
Trial, completion of a given Phase II Clinical Trial, submission of a given BLA or approval
of a BLA, to the extent triggering a milestone payment above) shall result in an obligation
to make the corresponding payment obligation every time such Milestone Event occurs unless
the subsequent occurrence of the Milestone Event involves both the same Product *** as a
previous Milestone Event for which milestones were already paid. *** Furthermore, it is
understood and agreed that no more than one milestone payment (in the applicable amount
specified above, and not multiples thereof) shall be made with respect to a given Milestone
Event, without limiting any milestones due for a subsequent occurrence of the same Milestone
Event for a different Indication or Product. Thus, for example completion of a given Phase
II Clinical Trial for a given Product within the applicable Field will trigger only one
payment of ***, regardless of whether the Product in such trial was a combination product
containing two biological compounds from two different Cell Lines and regardless of whether
the Indication targeted in such trial could potentially cover different patient populations
or be subdivided into subtypes or subgroups.
During the Royalty Term for each SCI Product, on a country-by-country basis, SCI
shall pay to ReN a *** royalty on any and all Net Sales of such Products in such
country regardless of the number of Valid Claims within the ReN Patent Rights that
are applicable.
SCI shall pay to ReN *** of all SCI Sub-license Revenue.
15
3.03 |
|
Reports and Payments |
Within sixty (60) days after the end of each calendar quarter each Party shall deliver to
the other Party a written report showing all royalties and payments due on account of Net
Sales and Sublicense Revenues due under this Agreement, on a Product-by-Product and
country-by-country basis. With respect to sales made or Sub-license Revenues received in
currencies other than Dollars, conversion to Dollars shall be made using the closing buying
price quoted by Bank of America N.T.S.A. (in the case of SCI) and Barclays Bank (in the
case of ReN) for the last business day of the calendar quarter in which such sale was made
or Sub-license Revenue received. All amounts shown to have accrued by each such report
shall be payable on the date such report is due.
3.04 |
|
Payments Subject to Embargo |
Where royalties and payments are due hereunder on account of Net Sales completed in a
country where, by reason of currency regulations or taxes of any kind, it is illegal for the
paying Party to transfer such payments out of such country for Net Sales in that country,
such payments shall be deposited in the other Partys account in a bank or other depository
in such country in a currency that is permitted for the paying Party to make the transfer
for the benefit or credit of the other Party entitled to receive such payments.
If a Party is required to withhold tax on royalties or payments on account of sublicense
revenues payable to the other Party hereunder, such taxes shall be deducted, provided that
the receiving Party shall be furnished at the time of deduction with suitable documentation
for obtaining credits to which the receiving Party may be entitled as a result of such
withholding on the income taxes of the receiving Party.
Each Party shall keep, and shall require all Affiliates and its sub-licensee(s) to keep,
full, true and accurate books of accounts and other records containing all information and
data which may be necessary to ascertain and verify all royalties and payments on account of
sublicense revenues payable hereunder. During the term of this Agreement and for a period of
two years following its termination, the receiving Party shall have the right from time to
time (not to exceed once during each calendar year), to have an accounting firm of
nationally recognized standing in the relevant jurisdiction inspect, at the receiving
Partys expense, on a confidential basis, the books, records and supporting data of the
paying Party. If such inspection shall reveal that the Paying party has not accurately
reported and paid royalties and payments on account of Sub-license Revenues due to the
receiving Party, then the paying Party shall pay to the receiving Party any shortfall in
royalties payable plus interest thereon at a rate equal to the lesser of (a) eight percent
per annum and (b) the highest lawful rate of interest in the receiving Partys jurisdiction
at the time; or, if the paying Party has overpaid royalties, the receiving Party shall
promptly refund the excess. If a shortfall greater than 10 percent of the royalties and
payments on
16
account of sublicense revenues payable in any year should be found to be due, the Party that
has underpaid shall pay the reasonable costs of the audit or inspection. Unless challenged
within three years after a statement is rendered, royalties and payments on account of
sublicense revenues calculated for the calendar quarter covered by such statement shall be
conclusively presumed to be correct. Upon request by the receiving Party no more than once
each calendar year, the paying party shall cause to be performed an audit of the books,
records and supporting data of each Affiliate or its sub-licensee(s), unless the paying
Party shall have had an audit of such Affiliate or its sub-licensee(s) performed within the
preceding three month period, in which case the paying Party shall share the relevant
results of such audit with the receiving Party without charge to the receiving Party. The
reasonable costs of such requested audit shall be borne by the receiving Party unless such
audit reveals that the paying Party, its Affiliate or its sub-licensee(s) has under reported
Net Sales or Sub-License Revenues by more than 10 percent.
3.07 |
|
No Multiple Royalties |
No multiple Royalties shall be payable because any Product or its manufacture, use or sale
are or shall be covered by more than one patent or invention or otherwise licensed
hereunder.
4. |
|
CONFIDENTIAL INFORMATION |
4.01 |
|
Treatment of Confidential Information |
Each Party hereto shall maintain the Confidential Information of the other Party in
confidence, and shall not disclose, divulge or otherwise communicate such Confidential
Information to any third party, or use it for any purpose, except pursuant to, and in order
to carry out, the terms and objectives of this Agreement, and hereby agrees to exercise
every reasonable precaution to prevent and restrain the unauthorized disclosure of such
Confidential Information by any of its directors, officers, employees, consultants,
subcontractors, sub-licensees or agents. In the event either Party becomes aware of the
unauthorized disclosure (including publication) of the other Partys Confidential
Information, or a material threat thereof, it shall promptly notify such other Party
describing in reasonable detail the nature of the disclosure (or threat thereof) and the
Confidential Information involved.
4.02 |
|
Release from Restrictions |
The provisions of Section 4.01, above, shall not apply to any Confidential Information
disclosed hereunder that is: required to be disclosed by the receiving Party to comply with
applicable laws, court orders, or to comply with applicable governmental regulations
(including without limitation to drug testing, marketing regulations and rules of NASD), in
each case only to the extent required to carry out the work contemplated by this Agreement
provided that the receiving Party provides prior written notice of such
17
disclosure to the other Party and takes reasonable and lawful actions to avoid and/or
minimize the degree of such disclosure.
4.03 |
|
Confidential Agreements |
Each Party has employment agreements with its respective employees and representatives
having confidentiality and nonuse commitments consistent with their obligations hereunder
and will require all of their sub-licensees hereunder, consultants, agents or others who
have access to any of such information to execute similar confidentiality agreements
covering all Confidential Information subject to Article 4 and will exercise its reasonable
best efforts to obtain compliance therewith.
5. |
|
PRODUCT DEVELOPMENT EFFORTS |
5.01 |
|
Diligence Development and Commercialization. |
Each Party shall use reasonable efforts consistent with prudent business judgment in the
development and commercialization of Products in any of its exclusive Fields.
The Parties shall reasonably cooperate with each other with respect to safety reporting that
is required by law or by ICH guideline, regulation or policy. If reporting to a regulatory
or other governmental body is required, the Parties shall put in place a separate
pharmaco-vigilance agreement with appropriate provisions to assure timely compliance. Any
information shared between the Parties as a result of such safety reporting shall be used by
the Party receiving such information solely for safety reporting and not as data to support
a claim as to the efficacy or safety of any Product. Each Party shall share with the other
Party any creditable information as to off-label or out-of-Field use of the former Partys
Product and, upon the written request of either Party, the Parties shall meet and in good
faith endeavor to reach agreement on means of correcting or abating such off-label or
out-of-Field uses.
6. |
|
FILING OF PATENTS: PROSECUTION OF INFRINGERS |
6.01 |
|
Filing, Prosecution, and Maintenance of Patents. |
Each Party shall be solely responsible for filing, prosecution, maintenance and enforcement,
in its sole discretion, of all patents or patent applications which are part of its Patent
Rights, and shall be and remain the owner of all of its Patent Rights. Each Party shall
engage its own patent counsel and in all respects control the prosecution of its Patent
Rights, at its own cost.
18
6.02 |
|
Infringement of Patents by Third Parties. |
|
(a) |
|
Notice of Infringement. |
Each Party shall notify the other of any infringement of Patent Rights of either Party by
Third Parties of which it becomes aware.
|
(b) |
|
Prosecution of Infringers. |
Subject to subsection (c), below, each Party shall have the sole right, in its absolute
discretion, to pursue actions against infringers of its Patent Rights, or not to pursue such
actions, or to abandon or settle any such action (except to the extent that any settlement
would involve the grant of a license inconsistent with a grant of rights pursuant to this
Agreement). Should a Party (the Owning Party) pursue such an action in the Field of the
other Party (the Licensed Party), the Licensed Party will co-operate and allow the Owning
Party to use its name in any such suit, to sue in its name or join it as a party to such
suit if legally required provided that the Owning Party will indemnify and hold harmless the
Licensed Party from any costs, damage or expenses incurred by the latter in respect of any
such acts or co-operation. If the Owning Party recovers damages, by settlement or judgment
or otherwise, then the amount recovered shall be divided as follows: (i) the reasonable and
documented litigation expenses of the Owning Party shall be reimbursed, and (ii) the
remainder shall be ***.
Following notice pursuant to subsection (a), above, at the request of the Party in whose
Field the infringement is alleged to have occurred, the Parties shall promptly meet to
discuss in good faith appropriate action, if any, to abate the alleged infringement.
|
(d) |
|
Unlicensed Competition. |
The Parties acknowledge that the sale of a Product by or for a Party during the Royalty Term
may be affected by competition from Third Parties that, for whatever reason, have chosen to
compete in the Field of such Party with respect to a product incorporating a biologically
active component the manufacture, use or sale of which such Party has been advised by
competent counsel infringes one or more of the Patent Rights licensed to such Party
hereunder (a Competing Product). With respect to sales of a Competing Product, when such
Competing Product takes a Market Share in excess of *** for any calendar quarter in any
country, the royalty rate applicable to Net Sales made in such country in such quarter shall
be reduced by *** For purposes of this Section 6.02(c), Market Share shall be determined
by the formula A divided by A + B (expressed as a percentage) in which A is the amount
(determined by weight or otherwise) of that biologically active component of the Competing
Product which is asserted to be infringing sold in such country during such calendar quarter
and B is the amount (determined in the same manner) of Product with which such Competing
Product competes that was sold by such Party in the subject country in such calendar
quarter.
19
Unit sales of Competing Product shall be determined by the sales reported by IMS America
Ltd. of Plymouth Meeting, Pennsylvania (IMS) or its equivalent in other countries of the
world or, if such sources are not available, such other source as the Parties shall
mutually agree.
7. |
|
REPRESENTATIONS AND WARRANTIES |
7.01 |
|
Corporate Representations. |
Each Party represents and warrants to the other that:
|
(a) |
|
it has and has obtained all corporate authorizations and all other applicable
consents, licenses, waivers or exemptions required to empower it to enter into this
Agreement and to consummate the transactions contemplated hereby; and |
|
|
(b) |
|
the execution and delivery of, and the performance by such Party of its
obligations under, this Agreement will not: |
(i) result in a breach of any provision of the memorandum or articles of
incorporation or association of such Party;
(ii) result in a breach of any provision of, or constitute a default under, any
instrument to which it is a party or by which it is bound; or
(iii) result in a breach of any order, judgment or decree of any court or
governmental agency to which it is a party or by which it is bound.
|
(c) |
|
the obligations of such Party under this Agreement will constitute the legal,
valid and binding obligation of it; and |
|
|
(d) |
|
such Party is duly incorporated and validly existing under the laws of the
jurisdiction in which it is incorporated. |
7.02 |
|
Intellectual Property Representations. |
|
(a) |
|
ReN represents and warrants as follows: |
|
(i) |
|
to ReNs knowledge as of the Effective Date, the patents/patent
applications listed in Schedule 1.28 are subsisting and no challenge has been
taken to them by any Third Party; |
|
|
(ii) |
|
ReN owns or Controls the ReN Patents; |
|
|
(iii) |
|
Schedule 1.28 is, as of the Effective Date, a complete and
accurate list of all patents and patent applications that ReN owns or Controls
which |
20
|
|
|
cover or claim the right to manufacture, use or sell an SCI Product within
the SCI Field; |
|
|
(iv) |
|
to ReNs knowledge as of the Effective Date, there are no Third
Party patents or patent applications that present a freedom to operate barrier
to compositions of c-MycER Cells or nucleic acid components used to generate
compositions of c-MycER Cells, or to the use of C-MycER Cells in the SCI Field;
and |
|
|
(v) |
|
no in-license from a Third Party in existence as of the
Effective Date under which Patent Rights are sub-licensed by ReN to SCI
hereunder contains a restriction or limitation on SCIs ability to exercise the
full scope of the rights granted to it hereunder. |
|
(b) |
|
SCI represents and warrants as follows: |
|
(i) |
|
to SCIs knowledge as of the Effective Date, the patents/patent
applications listed in Schedule 1.34 are subsisting and no challenge has been
taken to them by a Third Party; |
|
|
(ii) |
|
SCI owns or Controls the SCI Patents; |
|
|
(iii) |
|
Schedule 1.34 is, as of the Effective Date, a complete and
accurate list of all patents and patent applications that SCI owns or Controls
which cover or claim the right to manufacture, use or sell a product or
compound of any sort within the ReN Transplantation Field or the ReN Discovery
Field; |
|
|
(iv) |
|
to SCIs knowledge as of the Effective Date, there are no Third
Party patents or patent applications that that present a freedom to operate
barrier to compositions of neural stem cells; and |
|
|
(v) |
|
no in-licenses from a Third Party in existence as of the
Effective Date under which Patent Rights are sub-licensed by SCI to ReN
hereunder contains a restriction or limitation on ReNs ability to exercise the
full scope of its rights hereunder. |
Except as otherwise expressly set forth in Sections 7.01 through 7.02, above, or as otherwise
stated in this Agreement, ReN and SCI make no representations and extend no warranties of any kind
in relation to the matters addressed under this Agreement. ReN and SCI expressly disclaim any
representations and extend no warranties of any kind in relation to whether or not the practice, as
licensed under this Agreement, of the ReN Licensed Technology, will violate the rights of any third
party. Neither ReN nor SCI has conducted any infringement analysis on potential Products that may
be developed under the Parties respective Patent Rights or the ReN c-MycER Cell Technology. THE
REPRESENTATIONS AND WARRANTIES IN SECTIONS 7.01 THROUGH 7.02 ARE IN LIEU OF ALL OTHER
REPRESENTATIONS, WARRANTIES AND CONDITIONS, EXPRESS OR IMPLIED OR ARISING UNDER ANY LEGAL
21
THEORY, CONCERNING THE ReN LICENSED TECHNOLOGY, PATENT RIGHTS OR CELL TECHNOLOGY, OR ANY OF IT,
INCLUDING BUT NOT LIMITED TO THOSE OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Neither Party shall have the right, whether in connection with a merger or consolidation or
with the sale of substantially all of its assets or otherwise, to assign this Agreement or
any of the rights and licenses herein granted without the consent of the other Party, which
consent may be granted or withheld in the latter Partys sole discretion. Notwithstanding
the foregoing, ***; provided, however, that the assigning Party shall remain primarily
liable to the other Party for the performance by the assigning Partys Affiliates of the
assigning Partys obligations hereunder.
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Performance by Subcontractors |
Either Party may perform its obligations hereunder through its Affiliates, consultants or
subcontractors, but shall be responsible to the other Party for the performance of any such
third party.
Unless sooner terminated as provided herein, the licenses granted to ReN under Sections 2.01
(a), (b) and (c) shall expire on a country-by-country basis upon the later of (i) the
expiration of the last to expire of the SCI Patent Rights in such country, or (ii) the
expiration of the last to expire of the Royalty Terms for all ReN Products, ReN NCTs and
Unregulated Cells in such country. The license granted to SCI under Section 2.02 shall
expire on a country-by-country basis upon the later of (i) the expiration of the last to
expire of the ReN Patent Rights in such country, or (ii) the expiration of the last to
expire of the Royalty Terms for all SCI Products in such country. Upon the expiration of
the last remaining license as provided above, this Agreement shall terminate; provided,
however, that with respect to any ReN Products or ReN NCTs for which human clinical trials
have been initiated (or which are in a later stage of development or commercialization at
the time of such termination), the applicable terms of this Agreement (i.e., Sections 2.01,
2.03 and 9.01 and Articles 3 (other than 3.02), 5 and 8) shall remain in effect with respect
to such ReN Products and ReN NCTs (on a Product-by-Product basis) until the Royalty Term for
each such Product expires or, if earlier, when development of such Product ceases (provided,
further that, if no First Commercial Sale of a given Product has occurred prior to seven (7)
years after the date of Agreement termination, the aforementioned surviving terms shall also
terminate with respect to such Product). Notwithstanding the foregoing, if ReN has not
raised at least *** in the
22
aggregate through the issuance of equity securities within 15 months after the Effective
Date, this Agreement shall immediately terminate.
If either Party shall fail to perform any of its material obligations hereunder, the other
Party may notify the defaulting Party of such default, stating in such notice the obligation
which the defaulting Party shall have failed to perform, and, if the defaulting party shall
not have cured such default within 60 days after the giving of such notice (the Cure
Period) then the Party not in default may, at its option and in addition to its other
remedies under law, terminate this Agreement by giving the defaulting Party notice of such
termination within fifteen (15) days after the end of the Cure Period.
To the extent allowed under applicable law, either Party may terminate this Agreement if, at
any time, the other Party shall file in any court or agency pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a receiver or trustee of the
Party or of its assets, or if the other Party proposes a written agreement of composition or
extension of its debts, or if the other party shall be served with an involuntary petition
against it, filed in any insolvency proceeding, and such petition shall not be dismissed or
stayed within 60 days after the filing thereof, or if the other Party shall propose or be a
party to any dissolution or liquidation, or if the other Party shall make an assignment for
the benefit of creditors.
***
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Effect of Termination: Survival |
Termination of this Agreement for any reason shall not release either Party from any
liability or obligation to the other Party that matured prior to the effective date of such
termination. Either Party may, however, after the effective date of such termination, sell
Products then on hand or in the process of manufacture at the time of such termination,
provided that each Party shall pay to the other Party the royalties thereon as required of
this Agreement and shall submit the reports required by Article 3 hereof on the sales of
such Products. The provisions of Articles 1, 4, 10, 11, 12 (except for Section 12.04) and
13 and Sections 3.01(c), 3.02(c) and 9.05 of this Agreement shall survive termination or
expiration of this Agreement for any reason. Except as otherwise provided in this Section
9.05, all rights and obligations of the parties under this Agreement shall terminate upon
the expiration or termination of this Agreement.
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RESOLUTION OF DISPUTES |
All disputes arising between the Parties with respect to or as a result of this Agreement
shall be resolved by arbitration before a three member panel pursuant to the rules of the
International Chamber of Commerce. Such proceedings shall be brought and maintained in
London, England if initiated by SCI and in San Francisco, California, USA, if initiated by
ReN.
The arbitrators ruling shall be, in the absence of fraud or manifest error, binding and
conclusive upon both Parties and may be enforced in a court of competent jurisdiction. The
arbitrators may not award punitive or exemplary damages but may, in their discretion, award
costs and attorneys fees to the prevailing Party.
Notwithstanding the foregoing, either Party shall have the right, without waiving any right
or remedy available to such Party under this Agreement or otherwise, to seek and obtain from
any court of competent jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party, pending the selection of the
arbitrators hereunder or pending the arbitrators determination of any dispute hereunder.
11.01 No Admission of Liability. By entering into this Agreement, ReN admits to no
liability or wrong-doing with respect to infringement of the SCI Patent Rights.
11.02 Past Claims. In consideration of the covenants and agreements contained herein, SCI,
on behalf of itself and on behalf of its predecessors, successors, assigns, and Affiliates
(collectively, the Releasors), hereby releases and forever discharges ReN, its predecessors,
successors, assigns, Affiliates, employees, officers, and directors from any all claims, actions,
suits or demands (and any resulting liabilities, costs, expense and losses of any type), whether
known or unknown, fixed or contingent, that the Releasors had or now have: (a) for past
infringement of the SCI Patent Rights, or (b) which were asserted in the action brought by SCI
against ReN in the United States District Court for the District of Maryland prior to the Effective
Date. SCI represents and warrants that there has been no assignment, transfer or other disposition
of any interest in any of the subject matter released in the preceding sentence.
11.03 Waiver. All rights under Section 1542 of the Civil Code of the State of California,
and under any and all similar laws of any governmental entity, are hereby expressly waived. Each
party is aware that said Section 1542 of the Civil Code provides as follows:
A general release does not extend to claims which the creditor does not know or
suspect to exist in his favor at the time of executing the release, which if known by him
must have materially affected his settlement with the debtor.
11.04 Full Settlement. The Parties agree that this Agreement (together with the
Subscription Agreement) is in full and complete settlement of any rights that either Party (or any
of its successors, licensees or assigns) may have against the other Party in connection with
24
infringement of the Patent Rights of the other Party prior to the Effective Date. This Agreement
may be pleaded as full and complete defense to any action, suit or claim and may be used as an
injunction against any such action, suit, claim, or other proceeding of any type which may be
prosecuted, initiated or attempted in violation of the terms hereof. The prevailing Party shall be
entitled to receive from the other Party the Prevailing Partys reasonable attorneys fees and
other related legal expenses incurred in defending against any suit, action or claim brought to
enforce the terms and conditions of this Agreement.
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INDEMNIFICATION AND INSURANCE |
12.01 Indemnification by ReN. ReN hereby agrees to defend, hold harmless and indemnify
(collectively Indemnify) SCI and its Affiliates, and its and their agents, directors, officers
and employees (the SCI Indemnitees) from and against any and all liabilities, expenses, damages
and/or losses (including without limitation reasonable legal expenses and attorneys fees)
(collectively Losses) resulting from suits, claims, actions and demands, in each case brought by
a Third Party (each, a Third-Party Claim), arising directly or indirectly out of: (i) a breach of
any of ReNs representations and warranties pursuant to this Agreement; or (ii) the research,
development, manufacture, storage, handling, use, sale, offer for sale, distribution or importation
of Products by ReN and/or its Affiliates and/or its sublicensees hereunder. ReNs obligation to
Indemnify the SCI Indemnitees pursuant to this Section 12.01 shall not apply to the extent that any
such Losses (A) arise from the negligence or intentional misconduct of any SCI Indemnitee; (B)
arise from any breach by SCI of this Agreement; or (C) are Losses for which SCI is obligated to
Indemnify ReN Indemnitees pursuant to Section 12.02, below.
12.02 Indemnification by SCI. SCI hereby agrees to Indemnify ReN and its Affiliates, and
its and their agents, directors, officers and employees (the ReN Indemnitees) from and against
any and all Losses resulting from Third-Party Claims arising directly or indirectly out of:(i) a
breach of any of SCIs representations and warranties pursuant to this Agreement; or (ii) the
research, development, manufacture, storage, handling, use, sale, offer for sale, distribution or
importation of Products by SCI and/or its Affiliates and/or its sublicensees hereunder. SCIs
obligation to Indemnify ReN Indemnitees pursuant to the foregoing sentence shall not apply to the
extent that any such Losses (A) arise from the negligence or intentional misconduct of any ReN
Indemnitee; (B) arise from any breach by ReN of this Agreement; or (C) are Losses for which ReN is
obligated to Indemnify the ReN Indemnitees pursuant to Section 12.01, above.
12.03 Procedure. To be eligible to be indemnified hereunder, the indemnified Party shall
provide the indemnifying Party with prompt notice of the Third-Party Claim giving rise to the
indemnification obligation pursuant to this Article 12 and the exclusive ability to defend (with
the reasonable cooperation of the indemnified Party) or settle any such claim; provided, however,
that the indemnifying Party shall not enter into any acknowledgement of liability nor settlement
for damages other than monetary damages without the indemnified Partys written consent, such
consent not to be unreasonably withheld or delayed. The indemnified Party shall have the right to
participate, at its own expense and with counsel of its choice, in the defense of any claim or suit
that has been assumed by the indemnifying Party. If the Parties cannot agree as to the application
of Section 12.01 or 12.02 to any particular Third Party Claim, the Parties may conduct separate
defenses of such Third Party Claim. Each Party reserves the right to claim indemnity from the
other in accordance with Sections 12.01 and 12.02, above, upon resolution of
25
the underlying claim, notwithstanding the provisions of this Section 12.03 requiring the
indemnified Party to tender to the indemnifying Party the exclusive ability to defend such claim or
suit.
12.04 Insurance. Each Party shall procure and maintain levels of product liability and
general liability insurance which are consistent with normal business practices of prudent
companies similarly situated, at all times during which any Product is being clinically tested in
human subjects or commercially distributed or sold by or on behalf of such Party. It is understood
that such insurance or self-insurance shall not be construed to create a limit of either Partys
liability with respect to its indemnification obligations under this Article 12. Each Party shall
provide the other with written evidence of such insurance upon request.
12.05 Limitation of Liability. WITHOUT LIMITING EITHER PARTYS INDEMNIFICATION OBLIGATIONS
UNDER ARTICLE 12, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES AND LICENSEES SHALL BE LIABLE FOR
SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT
LIABILITY OR OTHERWISE.
13.01 Publicity.
Neither party will use the name of the other Party in any advertising or promotions,
communicate, comment or originate any publicity, news release or other public announcement,
written or oral, without the prior written approval of the other party except as otherwise
required by applicable law, regulation, court order or the rules of stock exchanges and any
other applicable regulatory authorities.
13.02 Governing Law.
This Agreement shall be governed by and interpreted in accordance with the laws of the State
of California, without regard to conflicts of laws principles.
13.03 Force Majeure.
In the event that either Party is prevented from performing or is unable to perform any of
its obligations under this Agreement due to any act of God; fire; casualty; flood; war; act
of terrorism; strike; lockout; failure of public utilities; injunction or any act, exercise,
assertion or requirement of governmental authority, including any governmental law, order or
regulation permanently or temporarily prohibiting or reducing the level of research
development or production work hereunder or the manufacture, use or sale of Products;
epidemic; destruction or production facilities; riots; insurrection; inability to procure or
use materials, labor, equipment, transportation or energy sufficient to meet experimentation
or manufacturing needs; or any other cause beyond the reasonable control of the Party
invoking this Section 13.03 if such Party shall have used its reasonable best efforts to
avoid such occurrence, such Party shall give notice to the other party in writing promptly,
and thereupon the affected Partys performance shall be
26
excused, and the time for performance shall be extended for the period of delay or inability
to perform due to such occurrence. At the end of such period, the Party whose performance
is excused shall give prompt notice to the other Party.
13.04 Waiver.
The waiver by either Party of a breach or a default of any provision of this Agreement by
the other Party shall not be construed as a waiver of any succeeding breach of the same or
any other provision, nor shall any delay or omission on the part of either Party to exercise
or avail itself of any right, power or privilege that it has or may have hereunder operate
as a waiver of any right, power or privilege by such Party.
13.05 Notices.
Any notice or other communication in connection with this Agreement must be in writing and
delivered either personally by facsimile or by certified mail, return receipt requested, and
shall be effective when delivered to the addressee at the address specified above or such
other address as the addressee shall have specified in a notice actually received by the
addressor.
13.06 No Agency.
Nothing herein shall be deemed to constitute either Party as the agent or representative of
the other Party, or both Parties as joint venturers or partners for any purpose. Each Party
shall be an independent contractor, not an employee or partner of the other. Neither Party
shall be responsible for the acts or omission authority to speak for, represent or obligate
the other Party in any way without prior written authority from the other Party.
13.07 Entire Agreement.
This Agreement contains the full understanding of the parties with respect to the subject
matter hereof. No waiver, alteration or modification of any of the provisions hereof shall
be binding unless made in writing and signed by the Parties by their respective officers
thereunto duly authorized.
13.08 Headings.
The headings contained in this Agreement are for convenience of reference only and shall not
be considered in construing this Agreement.
13.09 Severability.
In the event that any provision of this Agreement is to be unenforceable because it is
invalid or any relevant jurisdiction, the validity of the remaining provision obligations of
the Parties shall, in the jurisdictions to be unenforceable, be construed and enforced
particular provisions held to be unenforceable.
27
13.10 Patent Marking.
All packaging containing individual Products, and/or documentation therefor, and/or to the
extent possible any Products sold by or by authorization of any Party, shall be marked
permanently and legibly with the number of each applicable patent(s) licensed hereunder in
accordance with each countrys patent laws, including Title 35, United States Code.
13.11 Successors and Assigns.
This Agreement shall be binding upon and inure to the benefit of the Parties hereto and
their successors and permitted assigns.
13.12 Counterparts.
This Agreement may be executed in any number of counterparts (which shall include facsimile
counterparts), each of which shall be deemed an original but all of which taken together
shall constitute one and the same instrument.
13.13 Recordation.
Each Party shall have the right, at its cost, at any time, to record or register an
acknowledgement of the licenses granted under this Agreement in any applicable patent office
or other appropriate facility, and the other Party shall provide reasonable assistance in
effecting such recording.
13.14 Joint Drafting.
This Agreement was jointly drafted and prepared by both Parties hereto and no presumption in
favor of or against any Party hereto shall be made with respect to the interpretation of any
provision of this Agreement.
28
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in their names by
their properly and duly authorized officers or representatives as of the date first above written.
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RENEURON LIMITED |
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By:
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/s/ Michael Hunt |
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Title:
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Chief Executive Officer |
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STEMCELLS, INC. |
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By:
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/s/ Martin McGlynn |
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Title:
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President and Chief Executive Officer |
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exv31w1
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT
I, Martin McGlynn, certify that:
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I have reviewed this quarterly report on Form 10-Q of StemCells, 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 quarterly report; |
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(4) |
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The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
(c) Evaluated the effectiveness of the 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
( d) 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): |
(a) all significant deficiencies and material weaknesses in the design or operation
of internal controls over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize and report
financial information; and
(b) any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting.
Date: July 28, 2005
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/s/ Martin McGlynn
Martin McGlynn
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President and Chief Executive Officer |
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exv31w2
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT
I, Judi Lum, certify that:
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I have reviewed this quarterly report on Form 10-Q of StemCells, Inc.; |
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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 quarterly report; |
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(4) |
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The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
(c) Evaluated the effectiveness of the 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
( d) 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(s) 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): |
(a) all significant deficiencies and material weaknesses in the design or operation
of internal controls over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize and report
financial information; and
(b) any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting.
Date: July 28, 2005
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/s/ Judi Lum
Judi Lum
Chief Financial Officer
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exv32w1
Exhibit 32.1
Certification 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 StemCells, Inc. (the Company) Quarterly on Form 10-Q for the period
ending June 30, 2005 as filed with the Securities and Exchange Commission on the date hereof (the
Report), I, Martin McGlynn, President and Chief 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, to the best of my knowledge:
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(1). The Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended; and |
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(2). The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to StemCells,
Inc. and will be retained by StemCells, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
Date: July 28, 2005
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/s/ Martin McGlynn
Martin McGlynn
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President and Chief Executive Officer |
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exv32w2
Exhibit 32.2
Certification 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 StemCells, Inc. (the Company) Quarterly on Form 10-Q for the period
ending June 30, 2005 as filed with the Securities and Exchange Commission on the date hereof (the
Report), I, Judi Lum, Chief Financial 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, to the
best of my knowledge:
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(1). The Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended; and |
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(2). The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to StemCells,
Inc. and will be retained by StemCells, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
Date: July 28, 2005
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Judi Lum |
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Chief Financial Officer |
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