DELAWARE
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20-0077155
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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73 High Street, Buffalo, New York
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14203
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(Address of principal executive offices)
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(Zip Code)
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(Registrant’s telephone number, including area code)
(716) 849-6810
_______________________________________________
(Former name, former address and former fiscal year,
if changed since last report)
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Large accelerated filer
¨
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Accelerated filer
x
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Non-accelerated filer
¨
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Smaller reporting company
¨
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TABLE OF CONTENTS
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PAGE
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PART I - FINANCIAL INFORMATION | ||
ITEM 1:
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Consolidated Financial Statements
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1 |
Consolidated Balance Sheets as of September 30, 2011 and December 31, 2010
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1 | |
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Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2011 and 2010
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2 |
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Consolidated Statement of Stockholders' Equity for the Nine Months Ended September 30, 2011
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3 |
Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2011 and 2010
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4 | |
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Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2011 and 2010
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5 |
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Consolidated Notes to Financial Statements
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6 |
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ITEM 2:
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Management's Discussion and Analysis of Financial Condition and Results of Operations
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12 |
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ITEM 3:
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Quantitative and Qualitative Disclosures About Market Risk
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20 |
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ITEM 4:
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Controls and Procedures
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20 |
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PART II - OTHER INFORMATION
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||
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ITEM 1:
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Legal Proceedings
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21 |
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ITEM 1A:
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Risk Factors
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21 |
ITEM 2:
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Unregistered Sales of Equity Securities and Use of Proceeds
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21 |
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ITEM 3:
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Defaults Upon Senior Securities
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21 |
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ITEM 4:
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Removed and Reserved
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21 |
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ITEM 5:
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Other Information
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21 |
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ITEM 6:
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Exhibits
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21 |
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Signatures
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21 |
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(unaudited)
|
Three months ended
|
Nine months ended
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|||||||||||||||
September 30,
|
September 30,
|
September 30,
|
September 30,
|
|||||||||||||
2011
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2010
|
2011
|
2010
|
|||||||||||||
REVENUES
|
||||||||||||||||
Grants and contracts
|
$ | 3,801,267 | $ | 3,189,488 | $ | 6,844,298 | $ | 11,570,599 | ||||||||
OPERATING EXPENSES
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||||||||||||||||
Research and development
|
6,522,904 | 3,083,665 | 17,441,031 | 10,951,560 | ||||||||||||
General and administrative
|
4,239,687 | 1,073,528 | 8,104,340 | 5,664,229 | ||||||||||||
Total operating expenses
|
10,762,591 | 4,157,193 | 25,545,371 | 16,615,789 | ||||||||||||
LOSS FROM OPERATIONS
|
(6,961,324 | ) | (967,705 | ) | (18,701,073 | ) | (5,045,190 | ) | ||||||||
OTHER (INCOME)/EXPENSE
|
||||||||||||||||
Interest income
|
52,776 | 49,448 | 158,106 | 62,860 | ||||||||||||
Other income/(expense)
|
36,555 | 40,966 | (45,257 | ) | (90,584 | ) | ||||||||||
Change in value of warrant liability
|
3,993,439 | (6,408,248 | ) | 21,094,452 | (8,105,544 | ) | ||||||||||
Total other income/(expense)
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4,082,770 | (6,317,834 | ) | 21,207,301 | (8,133,268 | ) | ||||||||||
NET INCOME/(LOSS)
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(2,878,554 | ) | (7,285,539 | ) | 2,506,228 | (13,178,458 | ) | |||||||||
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS
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187,213 | 82,246 | 671,596 | 171,494 | ||||||||||||
NET INCOME/( LOSS) ATTRIBUTABLE TO CLEVELAND
|
||||||||||||||||
BIOLABS, INC.
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$ | (2,691,341 | ) | $ | (7,203,293 | ) | $ | 3,177,824 | $ | (13,006,964 | ) | |||||
NET INCOME/(LOSS) AVAILABLE TO COMMON
|
||||||||||||||||
SHAREHOLDERS PER SHARE OF COMMON STOCK
|
||||||||||||||||
BASIC
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$ | (0.08 | ) | $ | (0.27 | ) | $ | 0.10 | $ | (0.51 | ) | |||||
DILUTED
|
$ | (0.08 | ) | $ | (0.27 | ) | $ | 0.09 | $ | (0.51 | ) | |||||
WEIGHTED AVERAGE NUMBER OF SHARES USED
|
||||||||||||||||
IN CALCULATING NET INCOME/(LOSS) PER SHARE
|
||||||||||||||||
BASIC
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35,447,032 | 26,984,059 | 31,553,562 | 25,756,300 | ||||||||||||
DILUTED
|
35,447,032 | 26,984,059 | 36,802,952 | 25,756,300 |
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
|
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
|
Nine months ended September 30, 2011
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(unaudited)
|
Additional
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Accumulated Other
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|||||||||||||||||||||||||||
Common
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Paid-in
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Comprehensive
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Accumulated
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Noncontrolling
|
||||||||||||||||||||||||
Shares
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Stock
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Capital
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Loss
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Deficit
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Interests
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Total
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||||||||||||||||||||||
Balance at January 1, 2011
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28,959,176 | $ | 144,796 | $ | 80,241,717 | $ | (30,544 | ) | $ | (96,053,977 | ) | $ | 3,197,873 | $ | (12,500,135 | ) | ||||||||||||
Stock based compensation
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- | - | 5,314,294 | - | - | - | 5,314,294 | |||||||||||||||||||||
Issuance of compensatory shares
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178,354 | 892 | 740,472 | - | - | - | 741,364 | |||||||||||||||||||||
Exercise of options
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186,090 | 930 | 526,204 | - | - | - | 527,134 | |||||||||||||||||||||
Exercise of warrants
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281,411 | 1,407 | 1,943,813 | - | - | - | 1,945,220 | |||||||||||||||||||||
Noncontrolling interest capital contribution to Incuron, LLC
|
- | - | 176,092 | - | - | 2,164,282 | 2,340,374 | |||||||||||||||||||||
Issuance of common stock net of offering costs of $1,619,638
|
5,872,500 | 29,363 | 21,840,999 | - | - | - | 21,870,362 | |||||||||||||||||||||
Allocation of financing proceeds to fair value of warrants
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- | - | (2,525,175 | ) | - | - | - | (2,525,175 | ) | |||||||||||||||||||
Net income/(loss)
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- | - | - | - | 3,177,824 | (671,596 | ) | 2,506,228 | ||||||||||||||||||||
Other comprehensive income
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||||||||||||||||||||||||||||
Foreign currency translation
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- | - | - | (51,313 | ) | - | (21,249 | ) | (72,562 | ) | ||||||||||||||||||
Balance at September 30, 2011
|
35,477,531 | $ | 177,388 | $ | 108,258,416 | $ | (81,857 | ) | $ | (92,876,154 | ) | $ | 4,669,311 | $ | 20,147,104 |
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
|
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
|
(unaudited)
|
Three months ended
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Nine months ended
|
|||||||||||||||
September 30,
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September 30,
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September 30,
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September 30,
|
|||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Net income/(loss) including noncontrolling interests
|
$ | (2,878,554 | ) | $ | (7,285,539 | ) | $ | 2,506,228 | $ | (13,178,458 | ) | |||||
Other comprehensive income (loss)
|
||||||||||||||||
Foreign currency translation adjustment
|
(320,005 | ) | 95,947 | (72,562 | ) | (23,643 | ) | |||||||||
Comprehensive income/(loss) including noncontrolling interests
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(3,198,559 | ) | (7,189,592 | ) | 2,433,666 | (13,202,101 | ) | |||||||||
Comprehensive loss attributable to noncontrolling interests
|
264,650 | 66,759 | 692,845 | 175,310 | ||||||||||||
Comprehensive income/(loss) attributable to Cleveland BioLabs, Inc.
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$ | (2,933,909 | ) | $ | (7,122,833 | ) | $ | 3,126,511 | $ | (13,026,791 | ) |
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
|
CONSOLIDATED STATEMENTS OF CASH FLOWS
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(unaudited)
|
Nine months ended September 30,
|
||||||||
2011
|
2010
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net income/(loss)
|
$ | 2,506,228 | $ | (13,178,458 | ) | |||
Adjustments to reconcile net income/(loss) to net cash
|
||||||||
used in operating activities:
|
||||||||
Depreciation
|
324,950 | 290,426 | ||||||
Amortization
|
13,147 | 10,801 | ||||||
Noncash compensation
|
3,063,477 | 2,782,951 | ||||||
Warrant issuance costs
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150,827 | 231,980 | ||||||
Change in value of warrant liability
|
(21,094,452 | ) | 8,105,544 | |||||
Patent costs
|
1,481,318 | - | ||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
4,969,584 | 436,109 | ||||||
Other current assets
|
57,763 | (126,372 | ) | |||||
Other long-term assets
|
(890 | ) | (8,689 | ) | ||||
Accounts payable
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65,753 | (882,961 | ) | |||||
Deferred revenue
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(2,317,218 | ) | (12,570 | ) | ||||
Accrued expenses
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499,006 | (35,019 | ) | |||||
Accrued bonuses
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(328,951 | ) | - | |||||
Net cash used in operating activities
|
(10,609,458 | ) | (2,386,258 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Sale of short-term investments
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407,842 | - | ||||||
Issuance of note to Panacela Labs, LLC
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(300,000 | ) | - | |||||
Purchase of equipment
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(508,128 | ) | (384,424 | ) | ||||
Investment in patents
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(322,544 | ) | (127,074 | ) | ||||
Net cash used in investing activities
|
(722,830 | ) | (511,498 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Net proceeds from issuance of common stock
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21,946,801 | 4,508,673 | ||||||
Noncontrolling interest capital contribution to Incuron, LLC
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2,340,374 | 3,509,402 | ||||||
Exercise of options
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527,134 | 264,079 | ||||||
Exercise of warrants
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949,793 | 86,743 | ||||||
Net cash provided by financing activities
|
25,764,102 | 8,368,897 | ||||||
Effect of exchange rate change on cash and equivalents
|
(90,314 | ) | (22,435 | ) | ||||
INCREASE IN CASH AND EQUIVALENTS
|
14,341,500 | 5,448,705 | ||||||
CASH AND EQUIVALENTS AT BEGINNING OF
|
10,918,537 | 963,100 | ||||||
PERIOD
|
||||||||
CASH AND EQUIVALENTS AT END OF PERIOD
|
$ | 25,260,037 | $ | 6,411,805 | ||||
Supplemental schedule of noncash financing activities:
|
||||||||
Conversion of warrant liability to equity upon warrant exercise
|
$ | 995,428 | $ | 626,775 | ||||
Noncash financing costs on common stock offering
|
$ | 207,905 | $ | 227,486 | ||||
Noncash warrant issuance costs
|
$ | 19,361 | $ | 91,283 |
Three months
ended
September
30,
2011
|
Three months
ended
September
30,
2010
|
Nine months
ended
September
30,
2011
|
Nine months
ended
September
30,
2010
|
|||||||||||||
Income Available to Common Shareholders
|
$ | (2,691,341 | ) | $ | (7,203,293 | ) | $ | 3,177,824 | $ | (13,006,964 | ) | |||||
Weighted Average Number of Common Shares Outstanding
|
35,447,032 | 26,984,059 | 31,553,562 | 25,756,300 | ||||||||||||
Adjustments for Dilutive Securities:
|
||||||||||||||||
- Stock Options
|
- | - | 684,765 | - | ||||||||||||
- Warrants
|
- | - | 4,564,625 | - | ||||||||||||
Adjusted Weighted Average Number of Common Shares Outstanding
|
35,447,032 | 26,984,059 | 36,802,952 | 25,756,300 | ||||||||||||
Basic Earnings Per Share
|
$ | (0.08 | ) | $ | (0.27 | ) | $ | 0.10 | $ | (0.51 | ) | |||||
Diluted Earnings per Share
|
$ | (0.08 | ) | $ | (0.27 | ) | $ | 0.09 | $ | (0.51 | ) |
Nine months ended
|
Nine months ended
|
|||||||
|
September 30, 2011
|
September 30, 2010
|
||||||
Risk-free interest rate
|
0.96-2.61 | % | 1.46-2.75 | % | ||||
Expected dividend yield
|
0 | % | 0 | % | ||||
Expected life
|
5-6 years
|
5-6 Years
|
||||||
Expected volatility
|
84.28-90.14 | % | 84.23-89.55 | % |
Expected dividend yield — the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.
|
Expected volatility — a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. Expected volatility is based on the Company’s historical volatility and incorporates the volatility of the common stock of comparable companies when the expected life of the option exceeds the Company’s trading history.
|
Risk-free interest rate — the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date on which the option is granted.
|
Expected average life of options — the period of time that options granted are expected to remain outstanding, based primarily on the use of the Simplified (Safe Harbor) Method.
|
Level 1 — |
Observable inputs for identical assets or liabilities such as quoted prices in active markets;
|
Level 2 — |
Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
|
Level 3 — |
Unobservable inputs in which little or no market data exists, which are therefore developed by the Company
using estimates and assumptions that reflect those that a market participant would use.
|
Accrued Warrant Liability
|
||||
Value at
|
||||
September 30, 2011
|
||||
Stock price
|
$ | 2.53 | ||
Exercise price
|
$ | 2.89 | ||
Term in years
|
2.18 | |||
Volatility
|
67.59 | % | ||
Annual rate of quarterly dividends
|
- | |||
Discount rate- bond equivalent yield
|
0.28 | % |
Accrued Warrant Liability
|
Three months ended
September 30, 2011
|
Nine months ended
September 30, 2011
|
||||||
Beginning balance
|
$ | 10,006,733 | $ | 25,350,733 | ||||
Total gains or losses (realized/unrealized) i
ncluding in earnings as change in value of warrant liability
|
(3,993,439 | ) | (21,060,938 | ) | ||||
Total amount of realized gains/(losses)
|
- | (33,514 | ) | |||||
Issuances
|
- | 2,752,441 | ||||||
Settlements
|
- | (995,428 | ) | |||||
Ending balance
|
$ | 6,013,294 | $ | 6,013,294 | ||||
The amount of total gains or losses for the period included in earnings as change in value of
warrant liability attributable to the change in unrealized gains or losses relating to liabilities
still held at the reporting date
|
$ | (3,993,439 | ) | $ | (21,060,938 | ) |
Stock price
|
$ | 4.45 | ||
Exercise price
|
$ | 5.00 | ||
Term in years
|
2.50 | |||
Volatility
|
69.36 | % | ||
Annual rate of quarterly dividends
|
- | |||
Discount rate- bond equivalent yield
|
0.53 | % |
·
|
the exercise price of CBLI’s Series B Warrants was reduced from $5.99 to $5.28 and the aggregate number of shares of common stock issuable upon exercise of the Series B Warrants was increased from 3,918,376 to 4,445,276 shares;
|
·
|
the exercise price of the CBLI’s Series C Warrants was reduced from $6.32 to $5.54 and the aggregate number of shares of common stock issuable upon exercise of the Series C Warrants was increased from 464,852 to 530,297 shares; and
|
·
|
the exercise price of CBLI’s warrants issued in March 2010 was decreased from $4.50 to $4.00 per share.
|
Weighted
|
Weighted
|
|||||||||||
average
|
average
|
|||||||||||
exercise
|
remaining
|
|||||||||||
Stock
|
price per
|
contractual
|
||||||||||
options
|
share
|
term (in Years)
|
||||||||||
Outstanding, December 31, 2010
|
3,264,440 | $ | 5.10 | |||||||||
Granted
|
1,410,159 | $ | 5.91 | |||||||||
Exercised
|
(186,090 | ) | $ | 2.83 | ||||||||
Forfeited, Canceled
|
(55,314 | ) | $ | 3.61 | ||||||||
Outstanding, September 30, 2011
|
4,433,195 | $ | 5.46 | 7.87 | ||||||||
Exercisable, September 30, 2011
|
3,999,795 | $ | 5.34 | 7.79 |
|
Number of
|
Weighted average
|
Number of common
|
|||||||||
warrants
|
exercise price
|
shares exerciseable into
|
||||||||||
Outstanding at December 31, 2010
|
7,530,689 | $ | 3.79 | 9,450,633 | ||||||||
Granted
|
3,112,425 | 4.76 | 3,112,425 | |||||||||
Exercise Price Adjustment
|
- | (0.70 | ) | 592,341 | ||||||||
Exercised
|
(301,895 | ) | 3.96 | (371,206 | ) | |||||||
Forfeited, Canceled
|
(170,000 | ) | 8.70 | (170,000 | ) | |||||||
Outstanding at September 30, 2011
|
10,171,219 | $ | 3.77 | 12,614,193 |
·
|
Protectans - modified factors of microbes that protect cells from apoptosis, and which therefore have a broad spectrum of potential applications. The potential applications include both defense applications such as protection from exposure to radiation, whether as a result of military or terrorist action or as a result of a nuclear accident, as well as medical applications such as reducing cancer treatment toxicities. And as mentioned above, preliminary results suggest that some protectans may also have direct anticancer properties. |
·
|
Curaxins - small molecules designed to kill tumor cells by simultaneously targeting two regulators of apoptosis. Initial test results indicate that curaxins may be effective against a number of malignancies, including hormone-refractory prostate cancer, renal cell carcinoma ("RCC") (a highly fatal form of kidney cancer), and soft-tissue sarcoma.
|
Three months
ended
September
30,
2011
|
Three months
ended
September
30,
2010
|
Nine months
ended
September
30,
2011
|
Nine months
ended
September
30,
2010
|
|||||||||||||
Revenues
|
$ | 3,801,267 | $ | 3,189,488 | $ | 6,844,298 | $ | 11,570,599 | ||||||||
Operating expenses
|
10,762,591 | 4,157,193 | 25,545,371 | 16,615,789 | ||||||||||||
Other expense (income)
|
(4,029,994 | ) | 6,367,282 | (21,049,195 | ) | 8,196,128 | ||||||||||
Net interest expense (income) | (52,776 | ) | (49,448 | ) | (158,106 | ) | (62,860 | ) | ||||||||
Net loss
|
$ | (2,878,554 | ) | $ | (7,285,539 | ) | $ | 2,506,228 | $ | (13,178,458 | ) |
·
|
personnel-related expenses;
|
|
·
|
fees to professional service providers for, among other things, preclinical and analytical testing, independently monitoring our clinical trials and acquiring and evaluating data from our clinical trials and non-clinical studies;
|
|
·
|
costs of contract manufacturing services for clinical trial material;
|
|
·
|
costs of materials used in clinical trials and R&D;
|
|
·
|
depreciation of capital assets used to develop our products; and
|
|
·
|
facility operational costs.
|
Three months ended
September 30, 2011
|
Three months ended
September 30, 2010
|
Increase (Decrease)
|
||||||||||
General R&D
|
$ | 332,144 | $ | 64,356 | $ | 267,788 | ||||||
Protectan CBLB502 - Defense applications
|
5,549,454 | 2,689,779 | 2,859,675 | |||||||||
Protectan CBLB502 - medical applications
|
111,086 | - | 111,086 | |||||||||
Protectan CBLB612
|
243,168 | 5,103 | 238,065 | |||||||||
Curaxin CBLC102
|
146,144 | 86,131 | 60,013 | |||||||||
Other Curaxins
|
140,908 | 238,296 | (97,388 | ) | ||||||||
Total R&D | $ | 6,522,904 | $ | 3,083,665 | $ | 3,439,239 |
Nine months ended
September 30, 2011
|
Nine months ended
September 30, 2010
|
Increase (Decrease)
|
||||||||||
General R&D
|
$ | 657,467 | $ | 201,477 | $ | 455,990 | ||||||
Protectan CBLB502 - Defense applications
|
14,463,477 | 10,016,092 | 4,447,385 | |||||||||
Protectan CBLB502 - medical applications
|
133,857 | - | 133,857 | |||||||||
Protectan CBLB612
|
253,684 | 5,103 | 248,581 | |||||||||
Curaxin CBLC102
|
1,229,275 | 288,061 | 941,214 | |||||||||
Other Curaxins
|
703,271 | 440,827 | 262,444 | |||||||||
Total R&D | $ | 17,441,031 | $ | 10,951,560 | $ | 6,489,471 |
Exhibit
Number
|
Description of Document
|
|
10.1
|
Investment Agreement, dated September 19, 2011, by and among Panacela Labs, Inc., the Registrant and Open Joint Stock Company Rusnano.
|
|
10.2
|
Exclusive License and Option Agreement, dated September 23, 2011, by and between Children’s Cancer Institute Australia for Medical Research and Panacela Labs, Inc.†
|
|
10.3
|
Second Amendment to Exclusive License Agreement, dated September 22, 2011, by and between The Cleveland Clinic Foundation and the registrant.†
|
|
10.4
|
Exclusive License and Option Agreement, dated September 23, 2011, by and between Health Research, Inc., Roswell Park Institute Division, Roswell Park Cancer Institute Corporation, and Panacela Labs, Inc.†
|
|
10.5
|
Amended and Restated Exclusive Sublicense Agreement, dated September 23, 2011, by and between the registrant and Panacela Labs, Inc.
|
|
10.6
|
Exclusive Sublicense Agreement, dated September 23, 2011, by and between the registrant and Panacela Labs, Inc.
|
|
10.7
|
Assignment Agreement, dated September 23, 2011, by and between Panacela Labs, Inc. and the registrant.
|
|
31.1
|
Certification of Michael Fonstein, Chief Executive Officer, pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
|
|
31.2
|
Certification of C. Neil Lyons, Chief Financial Officer, pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
|
|
32.1
|
Certification Pursuant To 18 U.S.C. Section 1350
|
|
101.1
|
The following information from CBLI’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 formatted in XBRL: (i) Unaudited Consolidated Statements of Operations for the three and nine months ended September 30, 2011 and 2010; (ii) Consolidated Balance Sheets as of September 30, 2011 (Unaudited) and December 31, 2010; (iii) Unaudited Consolidated Statements of Stockholders’ Equity as of September 30, 2011; (iv) Unaudited Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2011; (v) Unaudited Consolidated Statements of Cash Flows for the nine months ended September 30, 2011 and 2010; and (v) Notes to Unaudited Consolidated Financial Statements tagged as blocks of text.*
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CLEVELAND BIOLABS, INC.
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Dated: November 9, 2011
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By:
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/s/ MICHAEL FONSTEIN
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Michael Fonstein
Chief Executive Officer
(Principal Executive Officer)
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Dated: November 9, 2011
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By:
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/s/ C. NEIL LYONS
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C. Neil Lyons
Chief Financial Officer
(Principal Financial Officer)
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PANACELA LABS, INC.
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By
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/s/ Dmitry Tyomkin
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Name: Dmitry Tyomkin
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Title: Chief Executive Officer
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CLEVELAND BIOLABS, INC.
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By
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/s/ Michael Fonstein, Ph.D.
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Name: Michael Fonstein, Ph.D.
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Title: Chief Executive Officer
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OPEN JOINT STOCK COMPANY “RUSNANO”
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By
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/s/ Andrey Borisovich Malyshev
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Name: Andrey Borisovich Malyshev
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Title: Deputy Chairman of the Management Board
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1.
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DEFINITIONS
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1.1.
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“
Affiliate
” shall mean any individual or entity directly or indirectly controlling, controlled by or under common control with, a party to this Agreement and in the case of Panacela, includes OOO Panacela Labs, a limited liability company formed under the laws of the Russian Federation. For purposes of this Agreement, (i) the direct or indirect ownership of fifty-one percent (51%) or more of the outstanding voting securities of an entity, (ii) the right to receive fifty-one percent (51%) or more of the profits or earnings of an entity, or (iii) the power to direct or cause the direction of the management or policies of an entity shall be deemed to constitute control. Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control.
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1.2.
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“
Application
” shall mean the intended use or Indication for a Licensed Product.
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1.3.
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“
CCIA Invention
” shall mean an Innovation created or conceived solely by employees or agents of CCIA.
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1.4.
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“
Employee
” shall mean employees, contractors, leased employees and agents of CCIA or Panacela.
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1.5.
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“
Improvement Invention
” shall mean any CCIA Invention and CCIA’s rights as a joint owner in a Joint Invention that is sufficiently different from the scope of a Licensed Patent to be separately patentable, and covered by the claims of Licensed Patents.
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1.6.
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“
INDA
” shall mean an investigational new drug application also known as a “Notice of Claimed Investigational Exemption for a New Drug” filed with the FDA, as defined in 21 CFR Part 312 or any and all foreign equivalents.
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1.7.
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“
Indication
” shall mean the disease or other condition in a man or other animal that a Licensed Product is being developed, tested or approved by a regulatory agency to diagnose, cure, mitigate, treat, or prevent.
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1.8.
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“
Innovation
” shall mean all inventions, discoveries and enhancements and all data relating to Option Products.
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1.9.
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“
Joint Invention
” shall mean an Innovation created or conceived jointly by (a) employees or agents of CCIA, and (b) employees or agents of Panacela or Affiliates thereof.
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1.10.
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“
Know-How
” shall mean (i) all unpatented or unpatentable subject matter disclosed within the Licensed Patents described in
Exhibit B
and all patents anywhere in the world issued thereon; and (ii) unpatented or unpatentable Technology created and owned by CCIA during the five (5) years after the Effective Date.
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1.11.
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“
Licensed Field
” shall mean all fields of use.
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1.12.
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“
Licensed Patent
” shall mean any and all rights in and to: (i) the patent applications described in
Exhibit B
and all patents anywhere in the world issued thereon; and (ii) all continuations, continuations in part to the extent the claims are directed to subject matter specifically described in such corresponding parent application, divisionals, reexaminations, extensions, and reissue applications thereof, and all foreign applications and patents corresponding thereto, with respect to any of the foregoing applications.
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1.13.
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“
Licensed Product
” shall mean any and all products that employ or are in any way contains or is made or produced using, or by the practice of the Licensed Patents, licensed Improvement Inventions, the Technology, or the Know-How, including the drug candidates set forth on
Exhibit A
.
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1.14.
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“
NDA
” shall mean a new drug application submitted to the FDA or an equivalent foreign regulatory agency which contains complete details of the manufacture and testing of a new drug for purposes of obtaining regulatory approval to market such new drug in the United States or any foreign country, for a particular indication, including any product license application.
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1.15.
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“
Net Sales
” shall mean the gross amount collected from sales of Licensed Products to a Third Party, less (i) trade, cash and quantity discounts actually allowed or paid; (ii) credits, allowances and adjustments actually granted to customers; (iii) charge back payments and rebates granted to managed care organizations or to federal, state, local or foreign governments, their agencies, and purchasers and reimbursers or to trade customers, including, but not limited to, wholesalers and buying groups; (iv) separately itemized or allocated (in direct proportion to the amount of sales of such Products bears to the total amount of sales of all Panacela products) shipping costs, insurance or other transportation costs, to the extent not paid or absorbed by non-Affiliate purchasers of such Products; and (v) sales, use and/or other excise taxes or duties actually paid. All costs shall be determined in accordance with generally accepted accounting principles.
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1.16.
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“
Non-Improvement Invention
” shall mean any CCIA Invention and CCIA’s rights as a joint owner in a Joint Invention that is not an Improvement Invention.
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1.17.
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“
Option Products
” shall mean Licensed Products and any and all products that employ or are in any way contained or made or produced using, or by the practice of the Projects set forth on
Exhibit B
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1.18.
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“
Panacela Invention
” shall mean an Innovation created or conceived solely by employees or agents of Panacela or Affiliates thereof.
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1.19.
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“
Patent Rights
” shall mean all patent applications and issued and subsisting patents, including all provisionals, converted provisionals, requests for continued examination, substitutions, divisionals, continuations, continuations-in-part, reissues, reexaminations, extensions, supplementary protection certificates, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing.
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1.20.
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“
Phase II clinical trial
” shall mean that portion of the clinical development program which provides for the initial trials of a product on a limited number of patients for the primary purpose of evaluating safety, dose ranging and efficacy in the proposed therapeutic indication, as more precisely defined by the rules and regulations of the FDA and corresponding rules and regulations in other countries.
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1.21.
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“
Phase III clinical trial
” shall mean that portion of the clinical development program which provides for the continued trials of a product on sufficient numbers of patients to establish the safety and efficacy of a product for the desired claims and indications, as more precisely defined by the rules and regulations of the FDA and corresponding rules and regulations in other countries. Any trial designed to support a NDA without further clinical studies will be considered a Phase III trial for purposes of this Agreement.
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1.22.
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“
Target
” shall mean the tissue, cellular or molecular structure that a Licensed Product acts on to diagnose, cure, mitigate, treat, or prevent a disease or other condition in a man or other animal.
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1.23.
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“
Technology
” shall mean (1) all inventions, data, results, know how, trade secrets, techniques, methods, developments, ideas, creations, concepts, materials, compositions of matter of any type or kind, expertise, formulas, technology, process, or discoveries, whether patentable or not, relating to or involving the use and development, or either, of the drug candidates further described on
Exhibit A
, and (2) to the extent not covered by the foregoing subpart (1), all inventions, data, results, trade secrets, methods, developments, materials, compositions of matter of any type or kind, expertise, formulas, technology and processes, whether patentable or not, arising during and in the course of carrying out those projects described in
Exhibit B
.
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1.24.
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“
Territory
” shall mean worldwide.
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1.25.
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“
Third Party
” shall mean a party other than Panacela and Affiliates thereof.
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2.
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LICENSE GRANT
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2.1.
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Exclusive License
. Subject to the terms and conditions of this Agreement, CCIA hereby grants to Panacela an exclusive license under the Licensed Patents and the Know-How in the Territory and within the Licensed Field to (a) make, have made, develop, use, practice, import, export, distribute, market, promote, offer for sale, and sell the Licensed Products, (b) use and practice any method, process, or procedure within the Licensed Patents, and (c) otherwise use and exploit the Licensed Patents, (collectively, the “
License
”).
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2.2.
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Retained Rights
. Notwithstanding the foregoing or anything else herein to the contrary, CCIA shall retain the non-exclusive right to use and practice the Licensed Patents, Improvement Inventions, Non-Improvement Inventions, Sponsored Inventions, Technology, and Know-How for non-profit research, education, and teaching purposes.
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2.3.
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Affiliates
.
Panacela may extend the right and license granted to Panacela under
Sections 2.1
and
2.2
, or part thereof, to any Panacela Affiliate provided that such Affiliate consents to be bound by the terms of this Agreement to the same extent as Panacela.
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2.4.
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Sublicenses
. Panacela may grant sublicenses (including through multiple tiers) consistent with the scope of the rights and licenses granted under this Agreement upon written consent of CCIA, which shall not be unreasonably delayed, conditioned or withheld. Upon termination of this Agreement, all such sublicenses shall survive; provided that such sublicensees promptly agree in writing to be bound by the terms of this Agreement.
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3.
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OWNERSHIP AND OPTION
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3.1.
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Ownership of Innovations
.
Innovations shall be either jointly owned or solely owned as follows: (a) CCIA Inventions shall be owned solely by CCIA, (b) Panacela Inventions shall be owned solely by Panacela, and (c) Joint Inventions shall be jointly owned by CCIA and Panacela.
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3.2.
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Grant of Option
. CCIA hereby grants to Panacela an exclusive option to exclusively license any and all Improvement Inventions and Non-Improvement Inventions (the “
Option
”). CCIA will provide Panacela written notice (each, an “
Option Notice
”) of any Improvement Invention or Non-Improvement Invention within thirty (30) days of CCIA’s actual knowledge of the existence of such Improvement Invention or Non-Improvement Invention, which Option Notice shall include sufficient detail for Panacela to assess the patentability of the applicable Improvement Invention or Non-Improvement Invention.
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3.3.
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Exercise
. Panacela may exercise the Option with regard to the applicable Improvement Invention or Non-Improvement Invention by providing written notice thereof to CCIA the earlier of (1) one hundred and eighty (180) days following receipt of the Option Notice, and (2) one hundred and eighty (180) days after Panacela becomes aware of an Improvement Invention or Non-Improvement Invention in sufficient detail to assess its patentability pertaining to such Improvement Invention or Non-Improvement Invention, as evidenced by written or electronic documentation, including a patent application filing.
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3.4.
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Improvement Invention.
Upon exercise by Panacela of an Option to an Improvement Invention pursuant to
Section 3.2
, the Patent Rights disclosing such Improvement Invention shall immediately be deemed to be Licensed Patents and shall be governed by the terms and conditions of this Agreement.
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3.5.
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Non-Improvement Invention
. Upon exercise by Panacela of an Option to a Non-Improvement Invention pursuant to
Section 3.2
, the Parties will negotiate in good faith for up to one hundred and eighty (180) days (“
NII Option Negotiation Period
”) an exclusive license agreement to such Non-Improvement Invention (“
Optioned NII
”) which exclusive license agreement shall include the non-financial terms of this Agreement with financial terms to be agreed upon by the Parties during the NII Option Negotiation Period. After the expiration of the NII Option Negotiation Period, CCIA may license the Optioned NII to any third party.
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3.6.
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Additional Rights
. CCIA agrees that it shall not assert any ownership rights in and to any Panacela Invention or Panacela’s rights as a joint owner of any Joint Invention.
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4.
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CONSIDERATION.
In consideration of rights granted by CCIA to Panacela under this Agreement, Panacela will pay CCIA as follows:
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4.1.
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[***]
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4.2.
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Royalties
.
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4.2.1.
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Royalty Rate
. Panacela shall pay CCIA the following royalties for each Licensed Product sold by Panacela and Affiliates thereof:
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a)
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Where the Licensed Patent covering such Licensed Product is solely owned by CCIA, a running royalty of [***] percent ([***]%) of the applicable seller’s Net Sales; and
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b)
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Where the Licensed Patent or Improvement Invention covering such Licensed Product is jointly owned by CCIA and Panacela and/or a third party, a running royalty of [***] percent ([***]%) of the applicable seller’s Net Sales;
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4.2.2.
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Royalty Term
. Panacela shall pay royalties for a period of twenty (20) years following the Effective Date on a country-by-country basis at the rate specified above in
Section 4.2.1
; provided, that said rate shall be reduced by one half on a country-by-country basis in the event that there is not a valid or pending claim of the Licensed Patents covering the Licensed Product in a given country. At the end of the royalty term in any country, Panacela shall have a fully paid-up license for the Licensed Products in such country.
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4.2.3.
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To the extent that statutes, laws, codes, or government regulations (including currency exchange regulations) of any foreign country in which Licensed Products are sold prevent royalty payments under
Section 4.2
, the Parties shall negotiate a mutually acceptable arrangement that preserves the benefit of this Agreement for each of the Parties.
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4.2.4.
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Sublicense Fees
. Panacela will pay the following sublicense fees in connection with sublicensing rights regarding Licensed Products:
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a)
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Where a sublicense has been granted by Panacela prior to the filing of an INDA for a Licensed Product, Panacela shall pay to CCIA the following percentage of any and all sublicense fees and all royalties received from the sublicensee of a Licensed Patent: (1) for the sublicense of Licensed Patents related to a Licensed Product that are solely owned by CCIA, [***]%; or (2) for the sublicense of Licensed Patents related to a Licensed Product that are jointly owned by CCIA and Panacela and/or a third party, [***]%;
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b)
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Where a sublicense has been granted after filing of an INDA for a Licensed Product, Panacela shall pay to CCIA the following percentage of any and all sublicense fees and all royalties received from the sublicensee of a Licensed Patent: (1) for the sublicense of Licensed Patents related to a Licensed Product that are solely owned by CCIA, [***]%; or (2) for the sublicense of Licensed Patents related to a Licensed Product that are jointly owned by CCIA and Panacela and/or a third party, [***]%; and
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c)
|
Where a sublicense has been granted after final approval of the relevant NDA for a Licensed Product, Panacela shall pay to CCIA the following percentage of any and all sublicense fees and all royalties received from the sublicensee of a Licensed Patent: (1) for the sublicense of Licensed Patents related to a Licensed Product that are solely owned by CCIA, [***]%; or (2) for the sublicense of Licensed Patents related to a Licensed Product that are jointly owned by CCIA and Panacela and/or a third party, [***]%.
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4.2.5.
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Milestone Payments
.
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a)
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As each Licensed Product progresses through major developmental milestones in the United States, Panacela shall pay to CCIA milestone payments, creditable against royalties and sublicense fees, as follows:
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1)
|
For any INDA filing for a Licensed Product, (1) for a Licensed Product related to Licensed Patents that are solely owned by CCIA, $[***]; or (2) for a Licensed Product related to Licensed Patents that are jointly owned by CCIA and Panacela and/or a third party, $[***];
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2)
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Upon commencement of a Phase II clinical trial, (1) for a Licensed Product related to Licensed Patents that are solely owned by CCIA, $[***]; or (2) for a Licensed Product related to Licensed Patents that are jointly owned by CCIA and Panacela and/or a third party, $[***];
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3)
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Upon commencement of a Phase III clinical trial, (1) for a Licensed Product related to Licensed Patents that are solely owned by CCIA, $[***]; or (2) for a Licensed Product related to Licensed Patents that are jointly owned by CCIA and Panacela and/or a third party, $[***];
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4)
|
Any NDA filing for a Licensed Product, (1) for a Licensed Product related to Licensed Patents that are solely owned by CCIA, $[***]; or (2) for a Licensed Product related to Licensed Patents that are jointly owned by CCIA and Panacela and/or a third party, $[***]; and
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5)
|
Upon regulatory approval of Licensed Product permitting it to be marketed either singly or in combination with another product, (1) for a Licensed Product related to Licensed Patents that are solely owned by CCIA, $[***]; or (2) for a Licensed Product related to Licensed Patents that are jointly owned by CCIA and Panacela and/or a third party, $[***];
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b)
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To the extent a similar milestone is reached in any other country(ies) in the world (“
Other Country
”) the milestone payment due shall be calculated applying the formula defined below:
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4.2.6.
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In the event that more than one patent within the Licensed Patents is applicable to any Product subject to payment obligations under
Section 4.2.1
,
Section 4.2.4
or
Section 4.2.5
, then only one royalty shall be paid to CCIA as follows: (a) for more than one Licensed Patent, each of which is solely owned by CCIA, the payment shall be at the rate of a Licensed Patent solely owned by CCIA, (b) for more than one Licensed Patent, one of which is jointly owned by CCIA and Panacela and/or a third party, the payment shall be at the rate of a Licensed Patent jointly owned by CCIA and Panacela and/or a third party.
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5.
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COMMERCIALIZATION; REGULATORY APPROVALS.
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5.1.
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Commercialization
. Panacela shall, at its expense, use its commercially diligent efforts, which in any event shall not be less than the efforts Panacela uses with respect to its own proprietary products not derived from the Licensed Patents, to bring Licensed Products to market as timely and efficiently as possible consistent with sound and reasonable business practices and judgments. Such program shall likely include the preclinical and clinical development of Licensed Products at Panacela’s expense, including research and development, laboratory and clinical testing, and marketing and sales. This Agreement shall not provide to CCIA any ownership rights to any developments of Panacela not otherwise provided by separate agreements between the Parties, if any. Notwithstanding the foregoing, all business decisions shall be within the sole discretion of Panacela. CCIA acknowledges that Panacela is in the business of developing, manufacturing, marketing and selling biopharmaceutical products. Nothing in this Agreement shall be construed as restricting Panacela's conduct of such business or imposing on Panacela the duty to market and/or sell Licensed Products for which royalties are payable hereunder to the exclusion of, or in preference to, any other Panacela product, or in any way other than in accordance with its normal commercial practices.
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5.2.
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Regulatory Approval
. Panacela shall be solely responsible for securing any federal, including U.S. Food and Drug Administration ("
FDA
"), state, local or foreign Regulatory Approval necessary for commercial sale of Licensed Products. Each Regulatory Approval shall be made in Panacela's name or in the name of an Affiliate or lawful designee of Panacela unless applicable law requires otherwise, or CCIA and Panacela otherwise agree that a particular approval be made in the name of CCIA or an Affiliate or lawful designee of CCIA. CCIA agrees that, any such Regulatory Approval made in its name will not affect the rights granted to Panacela in this Agreement. CCIA will lend assistance, as necessary, on a reasonable basis to facilitate Panacela’s acquisition of necessary Regulatory Approvals. Such assistance will include the provision to Panacela as promptly as reasonably practicable of scientific and clinical data obtained by CCIA relating to the Licensed Patents and the Licensed Products. Panacela shall be responsible for reimbursing CCIA for any reasonable direct costs associated with such activity.
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6.
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REPRESENTATIONS AND WARRANTIES.
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6.1.
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Representations and Warranties of CCIA and Panacela.
Each Party represents and warrants to the other that it has the full right and authority to enter into this Agreement, and that it is not aware of any impediment that would inhibit its ability to perform the terms and conditions imposed on it by this Agreement. Each Party warrants and represents to the other that it has the legal right and power to extend the rights and licenses granted to the other in this Agreement, and to fully perform its obligations hereunder, and that it has not made nor will it make any commitments to others in conflict with or in derogation of such rights or this Agreement.
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6.2.
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Further Representations and Warranties of CCIA
. CCIA represents and warrants that:
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a)
|
CCIA has sufficient legal and beneficial title under its intellectual property rights, including the Licensed Patents, necessary for the purposes contemplated under this Agreement and to grant the licenses and rights contained in this Agreement without violating the terms of any agreement or other arrangements with any third party;
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b)
|
Other than the Licensed Patents, there are no Patent Rights owned or licensed by CCIA that are necessary for the manufacture, use, offer for sale, sale, import or export of Products in the Licensed Field;
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c)
|
No other person or organization presently has any effective option or license from CCIA to use the Licensed Patents, Licensed Products, or Technology to discover, develop, make, have made, use, offer for sale, sell, import or export any Licensed Product;
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d)
|
CCIA is not in breach or default of any agreements granting it rights in or to any intellectual property included in or protected by the Licensed Patents, Licensed Products, or Technology being licensed to Panacela under this Agreement;
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e)
|
There are no litigation proceedings, oppositions, interferences or other challenges against rights of CCIA pursuant to the Licensed Patents or enforcement actions brought by CCIA against any third party in connection with the Licensed Patents;
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f)
|
CCIA has not received any notice or other communication from any third party of infringement of third party patent rights that may affect the discovery, development, making, using or selling of Licensed Products; and
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g)
|
CCIA is unaware of any pending or threatened claim or cause of action, or restriction on exportation, by any third party, whether a private or governmental entity, regarding any Licensed Patent, Licensed Product, Technology, or Know-How, including without limitation regarding this license, and performance of this Agreement.
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6.3.
|
EXCEPT AS PROVIDED IN SECTION 6.1 AND 6.2, AND TO THE EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY MAKES ANY REPRESENTATIONS, OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. CCIA ASSUMES NO RESPONSIBILITIES WHATSOEVER WITH RESPECT TO USE, SALE, OR OTHER DISPOSITION BY PANACELA OR ITS VENDEES OR OTHER TRANSFEREES OF PRODUCTS INCORPORATING OR MADE BY, OR USE OF, INVENTIONS LICENSED UNDER THIS AGREEMENT. IN ADDITION, PANACELA MAKES NO WARRANTY OF ANY KIND THAT ANY LICENSED PATENT OR KNOW-HOW WILL LEAD TO THE DEVELOPMENT OF A LICNESED PRODUCT.
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7.
|
INDEMNIFICATION
|
|
7.1.
|
Panacela Indemnification Obligations
. Panacela shall at all times during the term of this Agreement and thereafter, indemnify, defend and hold harmless CCIA and its Affiliates, successors, and permitted assigns, and the officers, directors, employees, and agents of any of them (collectively, “
CCIA Indemnitees
”) from and against any claim, suit, loss, damage, liability, injury, cost or expense, including without limitation expenses of litigation and reasonable attorneys' fees (collectively, “
Claims
”): (i) arising from the negligence, willful misconduct, or material breach of this Agreement by Panacela, its officers, employees, agents, licensees, sublicencees or Affiliates; or (ii) arising out of the death of or injury to any person or persons or out of any damage to property and resulting from any activity of Panacela or its licensees or Affiliates under this Agreement; or (iii) arising out of or resulting from, any and all Claims brought by third parties alleging personal injury or property damage in connection with, or arising out of the research, development, design, manufacture, distribution, sale or use of the Licensed Products by Panacela, its Affiliates, and its licensees; provided, however, that Panacela shall not be obligated to provide indemnification hereunder to the extent that any such Claim results from the negligence, willful misconduct, or material breach of this Agreement by an CCIA Indemnitee.
|
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7.2.
|
CCIA Indemnification Obligations
. CCIA shall at all times during the term of this Agreement and thereafter, indemnify, defend and hold harmless Panacela, its Affiliates, successors, and permitted assigns, and the officers, directors, employees, and agents of any of them (collectively, “
Panacela Indemnitees
”) from and against any Claim: (i) arising from the negligence, willful misconduct, or material breach of this Agreement by CCIA, its officers, employees, agents, or Affiliates; or (ii) arising out of the death of or injury to any person or persons or out of any damage to property and resulting from any activity of CCIA, or Affiliates under this Agreement; or (iii) arising out of or resulting from, any and all Claims brought by third parties alleging personal injury or property damage in conjunction with, or arising out of the research, development, design, manufacture, distribution, sale or use of Licensed Products by CCIA and its Affiliates; provided, however, that CCIA shall not be obligated to provide indemnification hereunder to the extent that any such Claim results from the negligence, willful misconduct or material breach of this Agreement by a Panacela Indemnitee.
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7.3.
|
Notice
. With respect to all third party claims, each Party shall promptly give notice of each such claim to the other and shall cooperate fully with the other Party in the defense of such claim.
|
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7.4.
|
Procedure
. Should a Panacela Indemnitee or an CCIA Indemnitee (the “
Indemnitee
”) intend to claim indemnification under this Article, such Indemnitee shall promptly notify the other party (the “
Indemnitor
”) in writing of any loss, claim, damage, liability or action in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall be entitled to assume the defense thereof with counsel selected by the Indemnitor and approved by the Indemnitee, such approval not to be unreasonably withheld; provided, however, that if representation of Indemnitee by such counsel first selected by the Indemnitor would be inappropriate due to a conflict of interest between such Indemnitee and any other party represented by such counsel, then Indemnitor shall select other counsel for the defense of Indemnitee, with the fees and expenses to be paid by the Indemnitor, such other counsel to be approved by Indemnitee and such approval not to be unreasonably withheld. The indemnity agreements in any part of this Article shall not apply to amounts paid in settlement of any loss, claim, damage, liability or action if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld unreasonably. The failure to deliver notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under this Article, but the omission so to deliver notice to the Indemnitor will not relieve it of any liability that it may have to any Indemnitee otherwise than under this Article. The Indemnitee under this Article, its employees and agents, shall cooperate fully with the Indemnitor and its legal representatives in the investigation of any action, claim or liability covered by this indemnification.
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8.
|
PATENT PROSECUTION AND MAINTENANCE; COSTS
|
|
8.1.
|
Prosecution by Panacela
.
|
|
8.1.1.
|
Licensed Patents
. Panacela shall, at its full expense, diligently prosecute and maintain the Licensed Patents, in any jurisdiction, and any continuations, continuations-in-part, divisions, reissues, reexamined patents, and extensions of any patents that issue as a result of such applications, which Panacela determines in good faith may be required to advance the purposes of this Agreement or otherwise to protect the rights and licenses granted hereunder. All costs and expenses of all such patent work, including preparation fees, filing fees, taxes, annuities, working fees, issuance fees, maintenance fees, and/or renewal and extension charges shall be paid by Panacela. Panacela shall keep CCIA informed with respect to the status and progress of all such applications, prosecutions, and maintenance activities and will consult in good faith with CCIA and take into account CCIA’s comments and requests with respect thereto. Both parties shall reasonably cooperate with each other to facilitate the application and prosecution of patent applications pursuant to this Agreement.
|
|
8.1.2.
|
Improvement Inventions
. Panacela shall, in its full expense, responsibility, and control, diligently prepare and file Patent Rights covering the Improvement Invention, which shall be included within the Licensed Patents pursuant to
Section 3.3
.
|
|
8.1.3.
|
Notice and CCIA Right
. In the event that Panacela elects not to file any patent application within the Licensed Patents, or thereafter elects not to continue prosecution of any such patent application, or elects not to maintain any patent that may issue therefrom (together, the “
Abandoned Rights
”), Panacela shall provide CCIA with reasonable notice thereof, and CCIA shall have the right, at CCIA’s option and expense, in its own name, to file for and prosecute such patent application and maintain such patent using patent counsel selected by CCIA.
|
|
8.1.4.
|
Panacela shall cooperate therewith, and all rights of Panacela under the Abandoned Rights shall be terminated.
|
9.
|
PROTECTION OF LICENSED RIGHTS
|
|
9.1.
|
Notification and Procedure
. Panacela and CCIA shall notify each other in writing of any infringements by others of any intellectual property rights in the Licensed Rights. Following receipt of such notification, the Parties shall engage in meaningful consultation between themselves as to the means of preventing such infringements and shall cooperate in any preliminary steps, short of filing a lawsuit, including, but not limited to, preliminary investigations, engagement of counsel and/or sending cease-and desist letters, that the Parties may mutually determine are required prior to the filing of any lawsuit. Unless otherwise agreed in writing between the Parties, Panacela shall have the right, but not the obligation, at Panacela’s expense, to: (i) defend the any of Licensed Patents against infringement by other parties in any country, including by bringing any legal action for infringement, or defending any counterclaim of invalidity or action of a third party for declaratory judgment of non-infringement, and (ii) join CCIA as a party thereto at Panacela’s expense. Panacela acknowledges and agrees that should Panacela decline or fail to commence or prosecute such claims or suits, CCIA may institute such claims or suits in its own name and join Panacela as a party thereto at CCIA’s expense. Panacela shall cooperate and assist fully in any claims, suits or other actions commenced, prosecuted and/or defended by CCIA pursuant to this Section.
|
10.
|
TERMINATION.
|
|
10.1.
|
Termination
. This Agreement may be terminated by Panacela, in whole or in part, for any or no reason, upon 60 days written notice; or
by CCIA, upon the occurrence of any of the following:
|
|
a)
|
Failure by Panacela to pay any material amount due (cumulative USD$15,000) hereunder, which amount is not the subject of a bona fide dispute, within ninety (90) days of receipt of written notice that such amount is overdue;
|
|
b)
|
Material breach by Panacela of this Agreement, including material breach of the diligence obligations set forth in Section 5, other than as set forth above under clause 10(a), and has failed to cure such breach within ninety (90) days of receipt of written notice of the breach;
however
, if Panacela disputes such breach in good faith in writing within such ninety (90) day period, CCIA shall not have the right to terminate this Agreement unless and until a tribunal of competent jurisdiction has determined that this Agreement was materially breached, or
|
|
c)
|
Panacela (i) has instituted or has instituted against it any insolvency, receivership, bankruptcy or other proceeding and such proceeding has not been dismissed for ninety (90) days, (ii) makes an assignment for the benefit of creditors, or (iii) dissolves or ceases to do business.
|
|
10.2.
|
Upon termination of this Agreement pursuant to Section 10(c) above, the license granted to Panacela for use of the CCIA Intellectual Property, is and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “Code”), a license of rights to “intellectual property” as defined under Section 101(35A) of the Code. Panacela, as the licensee of such rights under this Agreement, shall retain and fully exercise all of its rights and elections under the Code. The foregoing provisions of this Section 10.2 are without prejudice to any rights Panacela may have arising under the Code or other applicable law.
|
|
10.3.
|
The express provisions regarding termination in this Agreement are in addition to, and do not limit, any other rights and remedies a party may have or exercise under this Agreement, in law or in equity
|
|
10.4.
|
Survival.
The following Sections shall survive any termination or expiration of this Agreement: 2.4, 6, 7, 11, 13.2.
|
11.
|
CONFIDENTIALITY
|
11.1.
|
Disclosure of Confidential Information
. The Parties acknowledge that a Party (the “
Disclosing Party
”) may disclose Confidential Information (as defined below) to the other Party (the “
Receiving Party
”) pursuant to the terms of this Agreement. Accordingly, the Receiving Party agrees to keep the Disclosing Party’s Confidential Information in confidence and not to use or disclose the Disclosing Party’s Confidential Information except in pursuance of the terms of this Agreement.
|
11.2.
|
Confidentiality Obligations
. The Receiving Party agrees to keep any information identified as confidential by the Disclosing Party, confidential using methods at least as stringent as the Receiving Party uses to protect its own Confidential Information. “Confidential Information” of CCIA shall include all Licensed Products, Technology, and Know-How, and all information concerning them and any other information disclosed by CCIA to Panacela that is marked confidential or is accompanied by correspondence indicating such information is confidential or that the Receiving Party should reasonably know is confidential. “Confidential Information” of Panacela shall include all information disclosed by Panacela to CCIA that is marked confidential or is accompanied by correspondence indicating such information is confidential. Except as may be authorized in advance in writing by the Disclosing Party, the Receiving Party shall grant access to the Disclosing Party’s Confidential Information only to its own employees involved in research relating to the Licensed Rights and/or manufacture or marketing of the Licensed Products, and each party shall require such employees to be bound by confidentiality obligations at least as stringent as those set forth in this Agreement as well. The Receiving Party agrees not to use any Confidential Information of the other party to its advantage and the Disclosing Party’s detriment, including, but not limited to, in the case of Panacela, claiming priority to any application serial numbers of any Licensed Patents in any patent prosecution by CCIA. The confidentiality and use obligations set forth above apply to all or any part of the Confidential Information disclosed hereunder except to the extent that:
|
|
a)
|
The Receiving Party can show by written record that it possessed the information prior to its receipt from the Disclosing Party;
|
|
b)
|
The information was already available to the public or became so through no fault of the Receiving Party;
|
|
c)
|
The information is subsequently disclosed to the Receiving Party by a third party that has the right to disclose it free of any obligations of the Disclosing Party; or
|
|
d)
|
The information is required by law or regulation to be disclosed; provided, however, that the Receiving Party has provided written notice to the Disclosing Party promptly to enable the Disclosing Party to seek a protective order or otherwise prevent disclosure of such Confidential Information.
|
11.3.
|
Publication
. To avoid loss of patent rights as a result of premature public disclosure of patentable information, CCIA agrees to submit to Panacela, at least forty-five (45) days prior to submission for publication or disclosure materials intended for publication or disclosure relating to inventions, discoveries or information within the Licensed Rights, or that may include an Option Invention. Panacela shall notify CCIA within thirty-five (35) days of receipt of such materials whether Panacela desires to file a patent application on any invention disclosed in such materials. In the event that Panacela desires to file such a patent application, CCIA shall withhold publication and disclosure of patentable information for a period not to exceed ninety (90) days from the date of receipt of such materials by Panacela. Further, if such material contains Confidential Information that Panacela has provided to CCIA, CCIA agrees to remove such Confidential Information from the proposed publication or disclosure. The parties understand and agree that the foregoing time periods may be modified by written agreement of the parties.
|
12.
|
ASSIGNABILITY.
Neither Party may assign this Agreement without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed, except that either Party may assign this Agreement without the prior written consent of the other Party to an Affiliate of the assigning Party or in connection with the acquisition (whether by merger, consolidation, sale or otherwise) of all or substantially all of such Party’s issued shareholding or the whole or part of such Party’s business to which this Agreement relates, provided that the assigning Party provides written notice within thirty (30) days to the non-assigning Party of such assignment and the assignee thereof agrees in writing to be bound as such assigning party by the terms of this Agreement.
|
13.
|
MISCELLANEOUS PROVISIONS
|
13.1.
|
Notice
. Any notice or other communication pursuant to this Agreement shall be sufficiently made or given on the date of mailing if sent to such Party by facsimile on such date, with a paper copy being sent by certified first class mail, postage prepaid, or by next day express delivery service, addressed to it at its address below (or such address as it shall designate by written notice given to the other Party).
|
13.2.
|
Choice of Law
. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without regard to its conflict of laws principles or those of any other jurisdiction that would require the application of the law of another jurisdiction. Any claim or law suit, other than a proceeding brought in the U.S. Patent & Trademark Office, must be brought in the Federal District Court for the Western District of New York. The Parties shall not challenge, and hereby irrevocably consent to, the exclusive personal jurisdiction and venue of such court, and further so consent to the transfer to that court of any claim or law suit brought elsewhere.
|
13.3.
|
Headings; Interpretation
. The headings of Articles and Sections of this Agreement are for convenience of reference only and shall not affect the meaning or interpretation of this Agreement in any way.
|
13.4.
|
Waiver
. The failure of either Party in any instance to insist upon the strict performance of the terms of this Agreement will not be construed to be waiver or relinquishment of any of the terms of this Agreement, either at the time of the Party's failure to insist upon strict performance or at any time in the future, and such terms will continue in full force and effect.
|
13.5.
|
Counterparts
. The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
|
13.6.
|
Use of Names
. Neither Party will, without prior written consent of the other party, use the name or any trademark or trade name owned by the other Party, or owned by an affiliate or parent corporation of the other Party, in any publication, publicity, advertising, or otherwise.
|
13.7.
|
Independent Contractors
. Nothing contained in this Agreement shall be deemed to constitute a joint venture, partnership or employer-employee relationship between the Parties, or to constitute one as the agent of the other. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to make one Party an agent, employee or legal representative of the other Party for any purpose or to give either Party the power or authority to act for, bind, or commit the other Party.
|
13.8.
|
Severability
. If any provision of this Agreement is held to be invalid or unenforceable, all other provisions will continue in full force and effect, and the Parties will substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible to the original intent of the Parties.
|
13.9.
|
Entire Agreement
. This Agreement [***], constitute the entire agreement and understanding between the parties with respect to the subject matter hereof, and supersedes all proposals, oral or written, and all other communications between the Parties with respect to such subject matter.
|
13.10.
|
Modifications
. The terms and conditions of this Agreement may not be amended or modified, except in a writing signed by both parties.
|
13.11.
|
Location of Research
. CCIA hereby acknowledges that it has been informed by Panacela that the initial research to be conducted utilizing in connection with the projects listed on
Exhibit B
and utilizing the Technology and/or the Know-How will be conducted outside of Australia, in countries including, but not limited to, the United States and Russia. CCIA is not aware of any license that must be obtained prior to Panacela’s initiation of research activities.
|
PANACELA LABS, INC.
|
CHILDREN’S CANCER
|
|||
INSTITUTE AUSTRALIA
|
||||
FOR MEDICAL RESEARCH
|
||||
By:
|
/s/ Dmitry Tyomkin
|
By:
|
/s/ Christopher R. Thomson
|
|
Name:
|
Dmitry Tyomkin
|
Name:
|
Christopher R. Thomson
|
|
Title:
|
Chief Executive Officer
|
Title:
|
Managing Director
|
|
Date:
|
9/22/11
|
Date:
|
23/9/2011
|
·
|
Drug summary
: MYC inhibitor.
|
·
|
Indications
: Drugs for treatment of a broad range of solid tumors (breast, prostate, colon, non-small cell lung carcinoma, etc.) and hematological malignancies (various types of leukemia and lymphoma).
|
·
|
[***]
|
|
1.
|
Projects
|
Mobilan
|
Research, development and support of an immunotherapeutic drug candidate based on recombinant adenovirus vector, stimulating immune response in humans as a vaccine-like treatment for cancer or other indications.
|
Revercom
|
Research, development, formulation and support of a drug candidate based on proprietary Reversan compound as an adjuvant for chemotherapy.
|
Antimycon
|
Research, development, lead optimization, formulation and support of a drug candidate regulating cMyc transcription factor for cancer indications.
|
Arkil
|
Research, development, lead optimization, formulation and support of a drug candidate regulating androgen receptor for prostate cancer.
|
Xenomycin
|
Research, development, lead optimization, formulation and support of a drug candidates based on proprietary Curaxin family of compounds for anti-infective/anti-biotic/anti-fungal applications.
|
|
2.
|
Licensed Patents
|
Project
|
Patent
Application
Title
|
Inventors
|
Country
|
Application
No.
|
Assignee /
Ownership
|
|||||
Small Molecules Inhibiting Oncoprotein MYC
|
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
|
US Provisional
|
61/392,296
|
RPCI / CCIA / CBLI
|
||||||
ANTIMYCON
|
||||||||||
Small Molecules inhibiting Oncoprotein MYC
|
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
|
US Provisional
|
61/423,832
|
RPCI / CCIA / CBLI
|
|
1.
|
Preamble.
The first paragraph is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
2.
|
Section 2.A.
Section 2.A is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
3.
|
Section 2.G.
Section 2.G is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
4.
|
Section 2.I.
The following section is hereby added to Section 2 as Section 2.I.
|
|
5.
|
Section 4.B. – Milestone Payments.
|
|
5.1.
|
The first paragraph is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
5.2.
|
Subsection (1) is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
5.3.
|
Subsection (2) is hereby renumbered subsection (3).
|
|
5.4.
|
The following is hereby added to Section 4.B. as new subsection (2).
|
|
5.5.
|
The last paragraph of Section 4.B. is hereby deleted in its entirety and substituted with the following in lieu thereof
|
|
6.
|
Section 4.C. – Earned Royalties.
Parts (i) and (v) of Section 4.C. is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
7.
|
Section 4.D. – Sublicense Royalties.
Parts (a)-(c) of Section 4.D.(i) are hereby deleted in their entirety and substituted with the following in lieu thereof.
|
|
8.
|
Section 5.A. – Representation and Warranties.
Part (i) of Section 5.A. is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
9.
|
Section 6 – Records.
Section 6.A is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
10.
|
Section 13 – Product Liability and Conduct of Business.
Section 13 is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
11.
|
Section 14 – Use of Names.
Section 14 is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
12.
|
Appendix A – Definition for “CCF Technology”.
Paragraph B is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
13.
|
Appendix A – Definition for “Improvement”.
Paragraph F is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
14.
|
Appendix A – Definition for “Licensed Field”.
The following part (v) is hereby added to Paragraph H.
|
|
15.
|
Appendix A – Definition for “Licensed Patents”.
Part (ii) of the definition for “Licensed Patents” at paragraph I is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
16.
|
Appendix A – Definition for “Net Sales”.
Paragraph N is hereby deleted in its entirety and substituted with the following in lieu thereof.
|
|
17.
|
Appendix A – Definition for “Application”.
The following paragraph R is hereby added to Appendix A.
|
|
18.
|
Appendix A – Definition for “INDA”.
The following paragraph S is hereby added to Appendix A.
|
|
19.
|
Appendix A – Definition for “Indication”.
The following paragraph T is hereby added to Appendix A.
|
|
20.
|
Appendix A – Definition for “NDA”.
The following paragraph U is hereby added to Appendix A.
|
|
21.
|
Appendix A – Definition for “Other Institution”.
The following paragraph V is hereby added to Appendix A.
|
|
22.
|
Appendix A – Definition for “Panacela Product”.
The following paragraph W is hereby added to Appendix A.
|
|
(i)
|
Arkil: small-molecular polycyclic organic compound for systemic use to treat hormone-independent prostate tumors;
|
|
(ii)
|
Mobilan: recombinant adenovirus of CBLB501 series for localized intratumor injection, converts the injected tumor into an efficient vaccine in situ by intratumor expression of a bacterial immunogen and its receptor; and
|
|
(iii)
|
Revercom: nano-particle combinaing a chemotherapeutic drug with an inhibitor of the tumor drug resistance molecular mechanism of CBLC500 series for the treatment of tumors resistant to chemotherapy.
|
|
23.
|
Appendix A – Definition for “Phase II clinical trials”
. The following paragraph X is hereby added to Appendix A.
|
|
24.
|
Appendix A – Definition for “Phase III clinical trials”
. The following paragraph Y is hereby added to Appendix A.
|
|
25.
|
Appendix A – Definition for “Target”.
The following paragraph Z is hereby added to Appendix A.
|
|
26.
|
Appendix A – Definition for “Third Party”.
The following paragraph AA is hereby added to Appendix A.
|
By:
|
/s/ Joseph F. Hohn
|
Date:
9/22
, 2011
|
Name:
|
Joseph F. Hohn
|
|
Title
|
CLEVELAND BIOLABS, INC.
|
||
By:
|
Michael Fonstein, Ph.D.
|
Date:
9/22
, 2011
|
Name:
|
Michael Fonstein, Ph.D.
|
|
Title:
|
Chief Executive Officer
|
By:
|
/s/ Joseph F. Hohn
|
Date:
9/22
, 2011
|
Name:
|
Joseph F. Hohn
|
|
Title
|
By:
|
/s/ Christopher R. Thomson
|
Date:
23/9
, 2011
|
Name:
|
Christopher R. Thomson
|
|
Title
|
Managing Director
|
1.
|
DEFINITIONS
|
|
1.1.
|
“
Affiliate
” means any individual or entity directly or indirectly controlling, controlled by or under common control with, a Party. For purposes of this Agreement, (i) the direct or indirect ownership of fifty-one percent (51%) or more of the outstanding voting securities of an entity, (ii) the right to receive fifty-one percent (51%) or more of the profits or earnings of an entity, or (iii) the power to direct or cause the direction of the management or policies of an entity shall be deemed to constitute control. Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control.
|
|
1.2.
|
“
Application
” means the intended use for a Licensed Product, including the diagnosing, treating, curing, mitigating, and/or preventing a disease or other condition in a human or other animal, such as small cell lung cancer, large cell lung cancer, or other specific disease state, for which such Licensed Product is being developed, and/or tested by a Party hereto or any Affiliate or Sublicensee(s) of such Party or has been approved by the FDA or foreign body licensing equivalent for commercial sale.
|
|
1.3.
|
“
Employee
” means employees, contractors, leased employees and agents of RPCI or Panacela.
|
|
1.4.
|
“
Improvement Invention
” means RPCI’s rights in any improvement, enhancement, addition, or adaptation to any Licensed Patent, which is owned by RPCI, actually assigned to RPCI, or is subject to an obligation to assign such to RPCI pursuant to an agreement with RPCI, that is sufficiently different from the scope of a Licensed Patent to be separately patentable, and covered by the claims of Licensed Patents that is conceived and reduced to practice during the five (5) years after the Effective Date.
|
|
1.5.
|
“including”
,
“include”
, and variants of the foregoing mean including but not limited to.
|
|
1.6.
|
“
INDA
” means an investigational new drug application also known as a “Notice of Claimed Investigational Exemption for a New Drug” or a therapeutic biologic application (
“BLA”
) filed with the FDA, as defined, respectively, in 21 CFR Part 312 and 21 CFR Part 600-680, or any and all foreign equivalents.
|
|
1.7.
|
“
Indication
” means the United States Federal Drug Administration (“
FDA
”), or foreign licensing body equivalent, approved labeled usage for a Licensed Product. For purposes of this Agreement, Indication shall exclude Supplemental New Drug Application (“
SNDA
”) approvals that solely permit changes in dosage form or strength or administration method, e.g., pill to injection.
|
|
1.8.
|
“
Know-How
” means, to the extent owned by RPCI (i) all unpatented or unpatentable subject matter disclosed within the Licensed Patents described in
Exhibit B
and all patents anywhere in the world issued thereon; and (ii) unpatented or unpatentable Project Information created by or under the direction of a Scientist during the five (5) years after the Effective Date and made available to Panacela.
|
|
1.9.
|
“
Licensed Field
” means all fields of use.
|
1.10.
|
“
Licensed Patents
” means RPCI’s rights in and to: (i) the patent applications described in
Exhibit B
and all patents anywhere in the world issued thereon; and (ii) all continuations, continuations in part to the extent the claims are directed to subject matter specifically described in such corresponding parent application, divisionals, reexaminations, extensions, and reissue applications thereof, and all foreign applications and patents corresponding thereto, with respect to any of the foregoing applications.
|
1.11.
|
“
Licensed Products
” means any and all products and processes that contain, employ or are in any way made or produced using, or by the practice of the Licensed Patents, licensed Improvement Inventions, the Technology, or the Know-How.
|
1.12.
|
“Licensed Rights”
means the Licensed Patents and Know-How.
|
1.13.
|
“
NDA
” shall mean a new drug application, as defined by 21 CFR Part 314, or a BLA as defined by 21 CFR Part 600-680, submitted to the FDA or an equivalent foreign regulatory agency.
|
1.14.
|
“
Net Sales
” means the aggregate gross invoice prices of Licensed Products sold by Panacela, its Affiliates and its Sublicensee(s), to or on behalf of one or more independent third parties in bona fide, arm’s-length transactions, less the following actual, reasonable, and customary deductions where applicable: (i) trade and quantity discounts, (ii) returns and allowances, (iii) chargebacks and rebates mandated by law or contract, (iv) governmental surcharges on particular sales, such as custom duties, tariffs, and sales and excise taxes, and (v) separately stated and paid out-of-pocket transportation and insurance charges with reference to such sales.
|
1.15.
|
“
Non-Improvement Invention
” means RPCI’s rights in: (i) any invention comprising Technology, which is conceived or reduced to practice under the direction of a Scientist that is not an Improvement Invention, and which is owned by RPCI, actually assigned to RPCI, or is to be assigned to RPCI pursuant to an agreement with RPCI; or (ii) any invention comprising Technology conceived or reduced to practice jointly by Employees of both Panacela and RPCI that is not an Improvement Invention, and with respect to (i) and (ii), rights which are owned by RPCI, are actually assigned to RPCI, or are to be assigned to RPCI pursuant to an agreement with RPCI.
|
1.16.
|
“
Patents
” means any patent or patent application, whether domestic or foreign, and all divisions, provisional applications, continuations, continuations-in-part, reissues, reexaminations or extensions of any of the foregoing, and any letters patent that issue on any of the foregoing.
|
1.17.
|
“
Phase II clinical trial
” means that portion of the clinical development program which provides for the initial trials of a product on a limited number of patients for the primary purpose of evaluating safety, dose ranging and efficacy in the proposed therapeutic indication, as more precisely defined by 21 CFR Part 312.21(b) and corresponding rules and regulations in other countries.
|
1.18.
|
“
Project Information
” means RPCI’s rights in all inventions, data, results, trade secrets, methods, developments, materials, compositions of matter of any type or kind, expertise, formulas, technology and processes, whether patentable or not, arising during and in the course of carrying out those projects described in
Exhibit B
, which may be amended from time to time by mutual consent of the Parties.
|
1.19.
|
“
Project Information Licensed Field
” means for the purposes of (i) research and development; and (ii) regulatory, export control, and other government filing.
|
1.20.
|
“
RPCI Intellectual Property
” means the Licensed Patents, Technology, Know-How, and any Improvement Inventions licensed or optioned to Panacela pursuant to this Agreement.
|
1.21.
|
“Scientist”
means those Employees of RPCI listed in
Exhibit C
, which list may be updated from time to time by the mutual consent of the Parties.
|
1.22.
|
“
Technology
” means RPCI’s rights in all inventions, data, results, know-how, trade secrets, techniques, methods, developments, ideas, creations, concepts, materials, compositions of matter of any type or kind, expertise, formulas, technology, process, or discoveries, whether patentable or not, directly relating to or involving the use or development, of four lines of drug candidates, namely Revercom, Mobilan, Antimycon and Arkil (as further described on
Exhibit A
) during the five years after the Effective Date.
|
1.23.
|
“
Territory
” means worldwide.
|
1.24.
|
“
Valid Claim
” means
,
on a country-by-country basis, either an unexpired claim in a patent application or an issued unexpired patent within the Licensed Patents that has not been revoked, abandoned, disclaimed or withdrawn, or held unenforceable, unpatentable or invalid by a court of competent jurisdiction in a final judgment that has not been appealed within the time allowed by law or from which there is no further appeal.
|
2.
|
GRANT
|
|
2.1.
|
Exclusive License
. Subject to the terms and conditions of this Agreement, RPCI hereby grants to Panacela an exclusive license under the Licensed Patents in the Territory to: make, have made, develop, use, practice, import, export, distribute, market, promote, offer for sale, and sell Licensed Products in the Licensed Field.
|
|
2.2.
|
Non-Exclusive License
. Subject to the terms and conditions of this Agreement, RPCI hereby grants to Panacela a non-exclusive license in the Territory under RPCI’s rights in the Know-How to use and practice any method, process, or procedure within the Know-How and otherwise use and exploit the Know-How; all in the Licensed Field; provided however, that with respect to Project Information, such non-exclusive license shall be limited to the Project Information Licensed Field.
|
|
2.3.
|
Retained Rights
. Notwithstanding the foregoing or anything else herein to the contrary, RPCI shall retain a non-exclusive right to use and practice the RPCI Intellectual Property, Licensed Patents and Non-Improvement Inventions for research, education, and teaching purposes, including licensing to other non-profit research organizations..
|
|
2.4.
|
Affiliates
. Panacela may, subject to the terms and conditions of this Agreement and with the prior written approval of RPCI, which shall not be unreasonably withheld, conditioned or delayed, extend the right and license granted to Panacela under
Sections 2.1
and
2.2
, or part thereof, to any Panacela Affiliate by contract, provided that such Affiliate consents to be bound by the terms of this Agreement to the same extent as Panacela. Such approval shall not be unreasonably withheld, conditioned or delayed and RPCI shall provide such approval or denial to Panacela within fifteen (15) days of RPCI’s receiving any proposed extension documentation from Panacela after the Effective Date. Each such contract with a Panacela Affiliate shall include all the protections provided to RPCI under this Agreement and provisions designating RPCI as a third party beneficiary with full right and authority to enforce such contract against the Panacela Affiliate if Panacela fails or refuses to do so. Notwithstanding the foregoing, the Parties acknowledge that Panacela plans to extend this Agreement to Panacela’s wholly-owned subsidiary Panacela Labs, a limited liability company formed under the laws of the Russian Federation (“
PLLLC
”) by contract on or shortly after the Effective Date (the “
Extension
”). The Extension shall be subject to the prior written approval requirements of this
Section 2.4
or Section 2.5, depending on the nature of the relationship delineated in the Extension Agreement, and Panacela shall obtain RPCI’s prior written approval, which shall not be unreasonably withheld, conditioned or delayed, to the Extension in the ordinary course following the Effective Date. However, for a period of one year from the Effective Date or until the Extension is executed consistent with the terms of this Agreement, whichever is shorter, RPCI hereby consents to Panacela allowing PLLLC to act on Panacela’s behalf solely within the Commonwealth of Independent States, understanding that all of PLLLC’s efforts will be on Panacela’s behalf and under Panacela’s contractual rights under this Agreement and that all acts and omissions of PLLLC shall be the responsibility of Panacela as though carried out by Panacela itself. For the avoidance of doubt any contracts addressing the subject matter of this Agreement and PLLLC shall have Panacela as a party and all of PLLLC’s Affiliates shall be considered Panacela’s Affiliates for purposes of obligations under this Agreement. Further, Panacela agrees to bind PLLLC to all terms of this Agreement as though it were Panacela and such obligations were carried out by Panacela.
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|
2.5.
|
Sublicenses
. Panacela or an Affiliate may, subject to the terms and conditions of this Agreement, with the prior written approval of RPCI, grant sublicenses to third parties (
“Sublicensee(s)”
) under the License (
“Sublicenses”
). Such approval shall not be unreasonably withheld, conditioned or delayed and such approval or denial shall be provided to Panacela by RPCI within fifteen (15) days of RPCI’s receiving any proposed Sublicense from Panacela after the Effective Date. Each Sublicense shall include all the protections provided to RPCI under this Agreement and provisions designating RPCI as a third party beneficiary with full right and authority to enforce the Sublicense against the Sublicensee(s) if Panacela fails or refuses to do so. Subject to the terms and conditions of this Agreement, upon expiration or termination of this Agreement for any reason, any and all Sublicenses with Sublicensee(s) that are in substantial compliance with the terms of such Sublicenses shall survive such termination, provided, however, RPCI shall not incur any obligation to any Sublicensee(s) not already incurred to Panacela by RPCI under this Agreement.
|
3.
|
OPTION
|
|
3.1.
|
Grant of Option
. RPCI hereby grants to Panacela an exclusive option to exclusively license any and all Improvement Inventions and an option to negotiate an exclusive license to all Non-Improvement Inventions (the “
Option
”) that are conceived and reduced to practice up until the fifth anniversary of the Effective Date. RPCI will provide Panacela written notice (each, an “
Option Notice
”) of any Improvement Invention or Non-Improvement Invention within thirty (30) days of the actual knowledge of the Director of RPCI’s Technology Transfer Office’s of the existence of such Improvement Invention or Non-Improvement Invention, which Option Notice shall include information submitted to RPCI’s Technology Transfer Office for Panacela to assess the patentability of the applicable Improvement Invention or Non-Improvement Invention.
|
|
3.2.
|
Exercise
. Panacela may exercise the Option with regard to the applicable Improvement Invention or Non-Improvement Invention by providing written notice thereof to RPCI upon the earliest of: (i) sixty (60) days after receipt of the Option Notice, (ii) sixty (60) days after an executive officer or Board member of Panacela becomes aware that an Improvement Invention or Non-Improvement Invention exists; and (iii) one hundred eighty (180) days after Panacela becomes aware that an Improvement Invention or Non-Improvement Invention exists under all other circumstances.
|
|
3.3.
|
Improvement Invention.
Upon exercise by Panacela of an Option to an Improvement Invention pursuant to
Section 3.2
, the Patents disclosing such Improvement Invention shall immediately be deemed to be Licensed Patents and shall be governed by the terms and conditions of this Agreement, but in no event shall any Improvement Invention, even when deemed within Licensed Patents, be the basis for characterizing subsequent technological advances of any sort as Improvement Inventions under this Agreement.
|
|
3.4.
|
Non-Improvement Invention
. Upon exercise by Panacela of an Option to a Non-Improvement Invention pursuant to
Section 3.2
, the Parties will negotiate in good faith for up to one hundred twenty (120) days (“
NII Option Negotiation Period
”) an exclusive license agreement to such Non-Improvement Invention (“
Optioned NII
”) which exclusive license agreement shall include the non-financial terms of this Agreement with financial terms to be agreed upon by the Parties during the NII Option Negotiation Period. After the expiration of the NII Option Negotiation Period, RPCI may license the Optioned NII to any third party.
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|
3.5.
|
Limitation
. The rights granted pursuant to this
Article 3
shall be subject to any obligations of RPCI existing prior to the Effective Date, subject to the limitations set forth in the Cleveland BioLabs, Inc. waiver, and to any obligations to the U.S. federal or New York state government associated with funding now or later in effect.
|
4.
|
CONSIDERATION.
In partial consideration of rights granted by RPCI to Panacela under this Agreement, Panacela will pay RPCI as follows:
|
|
4.1.
|
[***]
|
|
4.2.
|
Royalties
.
|
|
4.2.1.
|
Royalty Rate
. On a country-by-country basis, Panacela shall pay RPCI a running royalty rate, as follows:
|
|
4.2.1.1.
|
[***] percent ([***]%) of Net Sales for each of the first and second Licensed Products approved for commercial sale for use in humans or other animals by the FDA or foreign licensing body equivalent (
“Initial Products
”) covered by a Valid Claim, and with such percentage to be decreased by [***] percent ([***]%) for the first and second Initial Products not covered by a Valid Claim; and
|
|
4.2.1.2.
|
[***] percent ([***]%) of Net Sales for all Licensed Products sold before approval for commercial sale for use in humans or other animals by the FDA or foreign licensing body equivalent and/or the third and each subsequent Licensed Product (e.g., receiving FDA approval after the Initial Products) approved for commercial sale for use in humans or other animals by the FDA or foreign licensing body equivalent, covered by a Valid Claim and with such percentage to be decreased by [***] percent ([***]%) for any such Licensed Product not covered by a Valid Claim.
|
|
4.2.1.3.
|
For clarity, each additional Indication for a Licensed Product shall be considered a separate Licensed Product under
Section 4.2.1.1
or
Section 4.2.1.2
, as applicable.
|
|
4.2.2.
|
Royalty Term
. Panacela shall pay royalties on Net Sales for as long as a Valid Claim exists in the applicable country at the rate specified above in
Section 4.2.1
. Panacela shall also pay royalties on Net Sales for a period of twenty (20) years following the Effective Date where there is not a Valid Claim covering the Licensed Product in a given country. If the sale of a Licensed Product is covered by more than one Licensed Patent, multiple royalties shall not be due. At the end of the royalty term in any country, Panacela shall have a fully paid-up license for the Licensed Products in such country.
|
|
4.2.3.
|
The obligation to pay royalties shall be waived and excused to the extent that statutes, laws, codes, or government regulations (including currency exchange regulations) of any foreign country in which Licensed Products are sold prevent such royalty payments. In such event, the Parties shall negotiate a mutually acceptable arrangement that preserves the benefit of this Agreement for each of the Parties, e.g., by increased royalties in another country.
|
|
4.2.4.
|
The amount of royalties shall be reduced proportionately on a country-by-country basis by the amount of royalties paid to non-Affiliate third parties by Panacela, an Affiliate, or a Sublicensee(s) of either for a license to patent rights necessary for Panacela, its Affiliate, or a Sublicensee(s) or either to make, have made, use, offer to sell, sell, or import Licensed Products pursuant to arm’s length agreements entered into in good faith with such unaffiliated third parties owning or controlling patent rights which, but for such agreements, would bar the manufacture, use, sale, or import of a Licensed Product (
“Blocking Technology”
), provided, however, the minimum royalty due under this
Section 4.2
shall not be less than the royalty rates set forth in
Section 4.2.1.1
and
Section 4.2.1.2
, as applicable. Panacela shall promptly inform RPCI if Panacela becomes aware of any potential Blocking Technology. In addition, if any seller of Licensed Products enters into any agreement with the owner or controller of any such Blocking Technology, Panacela shall insure that RPCI is treated no worse than such owner or controller with respect to a deduction or other offset of royalties or other compensation in connection with any Blocking Technology.
|
4.2.5.
|
Furthermore, if a compulsory license is granted to a third party with respect to a Licensed Product, the royalty rate to be paid by Panacela to RPCI for sale of such Licensed Product in that country shall be reduced to the rate paid under the compulsory license. Panacela shall provide RPCI all reasonably requested evidence regarding any such compulsory license, as allowed under applicable law.
|
|
4.2.6.
|
Sublicense Fees
. Panacela will pay the following sublicense fees in connection with sublicensing rights regarding Licensed Products:
|
|
a)
|
Where a Sublicense has been granted prior to the filing of an INDA for a Licensed Product covered by such Sublicense, Panacela shall pay to RPCI: [***] percent ([***]%) of any and all fees received from such Sublicensee(s) by Panacela or any Affiliate;
|
|
b)
|
Where a Sublicense has been granted after filing of an INDA for a Licensed Product covered by such Sublicense, Panacela shall pay to RPCI: [***] percent ([***]%) of any and all Sublicense fees received by Panacela or any Affiliate from such Sublicensee(s); or
|
|
c)
|
Where a Sublicense has been granted after final approval of the relevant NDA for a Licensed Product covered by such Sublicense, Panacela shall pay to RPCI: [***] percent ([***]%) of any and all Sublicense fees received by Panacela or such Affiliate from such Sublicensee(s).
|
|
d)
|
For the avoidance of doubt, in no event shall such Sublicensee(s) fees be deemed to include any royalties payable by a Sublicensee(s) on sales of a Licensed Product.
|
|
4.2.7.
|
Milestone Payments
.
|
|
a)
|
As each Licensed Product progresses through developmental milestones in the United States, Panacela shall pay to RPCI milestone payments, as follows:
|
|
1)
|
For the first Licensed Product(s) related to the drug candidates described as Mobilan, Antimycon and Arkil in
Exhibit A
:
|
|
i.
|
For any INDA filing requesting approval for clinical trials: (1) in the United States, $[***]; or (2) when a similar milestone is reached in any other country(ies) in the world (
“Other Country”
), $[***];
|
|
ii.
|
Upon commencement of the first Phase II clinical trial under the INDA for which a milestone is reached to
Section 4.2.7(a)(1)(i)
; (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***];
|
|
iii.
|
Any NDA filing requesting approval for sales and marketing of Licensed Product to consumers, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***]; and
|
|
iv.
|
Upon regulatory approval of Licensed Product permitting it to be manufactured, marketed and sold either singly or in combination with another product, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***];
|
|
2)
|
For the second and subsequent Licensed Products for new or additional Indications of each of the drug candidates described as Mobilan, Antimycon and Arkil in Exhibit A:
|
|
i.
|
Any NDA filing requesting approval for sales and marketing to consumers of a Licensed Product, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***]; and
|
|
ii.
|
Upon regulatory approval of a Licensed Product permitting it to be manufactured, marketed and sold either singly or in combination with another product, 1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***];
|
|
3)
|
For the first Licensed Product related to the drug candidate described as Revercom in
Exhibit A
:
|
|
i.
|
For any INDA filing requesting approval for clinical trials, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***];
|
|
ii.
|
Upon commencement of the first Phase II clinical trial under the INDA for which a milestone is reached pursuant to
Section 4.2.7(a)(3)(i)
, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***];
|
|
iii.
|
Any NDA filing requesting approval for sales and marketing of a Licensed Product to consumers, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***]; and
|
|
iv.
|
Upon regulatory approval of Licensed Product permitting it to be manufactured, marketed and sold either singly or in combination with another product, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***];
|
|
4)
|
For the second and subsequent Licensed Products for new or additional Indications of each such Licensed Product related to the drug candidate described as Revercom in
Exhibit A
:
|
|
i.
|
Any NDA filing requesting approval for sales and marketing of a Licensed Product to consumers, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***]; and
|
|
ii.
|
Upon regulatory approval of a Licensed Product permitting it to be manufactured, marketed and sold either singly or in combination with another product, (1) in the United States, $[***]; or (2) when a similar milestone is reached in an Other Country, $[***]; and
|
|
5)
|
For FDA regulatory approval or foreign licensing body equivalent applications for all other Licensed Products (i.e., excluding Licensed Products related to the drug candidates described as Mobilan, Antimycon, Arkil and Revercom in Exhibit A):
|
|
i.
|
For any each INDA filing requesting approval for clinical trials, $[***];
|
|
ii.
|
Upon commencement of the first Phase II clinical trial under each INDA for which a milestone is reached pursuant to
Section 4.2.7(a)(5)(i)
, $[***];
|
|
iii.
|
For each NDA filing requesting approval for sales and marketing of Licensed Product to consumers, $[***]; and
|
|
iv.
|
Upon regulatory approval of Licensed Product permitting it to be marketed either singly or in combination with another product, $[***];
|
|
b)
|
If a milestone that was first reached in an Other Country is subsequently achieved or surpassed in the United States, such as by relying on foreign clinical trials to support an NDA filing, Panacela shall pay RPCI the difference between what was paid for the milestone in all Other Countries, if any, and what would have been due under the applicable section if the milestone had first occurred in the United States.
|
|
4.2.8.
|
Patent Costs
. Following the Effective Date, RPCI shall invoice Panacela for previously incurred patenting costs of $[***] actually paid by RPCI prior to the Effective Date, and shall provide supporting documentation thereof. Panacela shall pay such invoice within thirty (30) days following receipt of investment funds in connection with the investment into Panacela by Open Joint Stock Company “Rusnano”, provided, however, that in no event shall Panacela provide such reimbursement payment later than six (6) months following the invoice date.
|
5.
|
COMMERCIALIZATION.
At its expense and consistent with sound and reasonable business practices and judgment, Panacela shall use commercially reasonable efforts to bring Licensed Products to market as timely and efficiently as possible, which in any event shall not be less than the efforts Panacela uses with respect to its own proprietary products for the same Application. Such program must include the preclinical and clinical development of Licensed Products, including research and development, laboratory and clinical testing, applying for all applicable governmental approvals, and marketing and sales (“
Level of Effort
”). Provided such decisions are commercially reasonable and subject to the Level of Effort required, all business decisions shall be within the sole discretion of Panacela. Panacela shall have the exclusive right to prepare and present all regulatory filings necessary or appropriate in any country to obtain and maintain any regulatory approval required to market any Licensed Product in any such country. Panacela shall plan and implement appropriate research and development, testing and production efforts directed toward commercialization of Licensed Products at a commercially practicable date and shall provide RPCI a copy of such plan and any amendments thereto. Panacela will provide RPCI detailed written reports on a semi-annual basis detailing Panacela’s clinical, regulatory, and financial progress, except that if there is any material communication from the FDA or any other government agency related to this Agreement or the occurrence of any adverse event, Panacela shall promptly notify RPCI regardless of whether a semi-annual report is due. RPCI understands that these reports may contain material non-public information and that to such extent such reports will be considered Confidential Information pursuant to
Section 12
. If Panacela fails to adhere to its diligence obligation with respect to a Licensed Product, RPCI may, in its discretion with respect to said Licensed Product: (i) terminate the License Agreement, with regard to the Product that Panacela failed to fulfill its diligence obligations hereunder, pursuant to
Section 11
, or (ii) terminate the exclusivity of the rights granted for such Product hereunder, in either case, if Panacela has not cured such breach within ninety (90) days of the date Panacela receives notice from RPCI of such breach,
provided
,
however
, if such breach is not capable of being cured within such ninety (90) day period, Panacela may request a reasonable extension to such period, not to exceed one hundred and eighty (180) days, which request shall not be unreasonably denied by RPCI.
|
6.
|
REPORTS, PAYMENTS, AND RECORDS
|
|
6.1.
|
Records
. Panacela shall keep at its respective principal place of business full, true, and accurate books of account kept in accordance with generally accepted U.S. accounting principles consistently applied and the supporting data containing all particulars that may be necessary for the purpose of showing and confirming its diligence and the amounts payable to RPCI (
“Records”
). Panacela shall require its Affiliates and Sublicensee(s) to keep at their respective principal places of business full, true, and accurate books of account kept in accordance with generally accepted U.S. accounting principles or comparable international accounting principles (e.g., I.F.R.S., the International Financial Reporting Standards) consistently applied and the supporting data containing all particulars that may be necessary for the purpose of showing and confirming its diligence and the amounts payable to RPCI (such records of such Affiliates and Sublicensee(s) shall also be deemed "Records"). RPCI or a designated auditor selected by RPCI, except one to whom the applicable entity has reasonable objection, may inspect the Records not more than once per year upon reasonable notice for six (6) years following the end of the calendar year to which the Records pertain for the purpose of verifying payments or compliance in other respects with this Agreement. If an inspection shows an underreporting or underpayment, the applicable entity shall promptly pay such amount within thirty (30) days after the date the applicable entity receives from RPCI written notice of the payment due, together with a late charge equal to the amount set forth in
Section 6.5
accrued on the unpaid amount until paid in full. In addition to any other rights of RPCI, if the underpayment is greater than [***] percent ([***]%) of the amount actually owed or exceeds $[***] for any twelve (12) month period, Panacela or the applicable entity shall also reimburse RPCI for the reasonable cost of the inspection within thirty (30) days after receipt of the invoice for such cost, which shall contain appropriate supporting documentation evidencing such costs. Any Records provided or made available to RPCI hereunder shall be delivered accurately in English.
|
|
6.2.
|
Payment
. Royalties shall be paid in United States dollars by wire transfer at such place as RPCI may reasonably designate consistent with the law controlling in the United States and, if applicable, in any foreign country. If, despite RPCI’s tax-exempt status under U.S. law, Panacela or any applicable Sublicensee(s) or Affiliate is required by law to withhold and pay any taxes on payment of a royalty or any other amount due hereunder, such amount may be deducted from such payment. However, to the extent that such deducted taxes are capable of being recouped or refunded as a result of any administrative, tax, or other filing or submission, such recouped or refunded amount shall be paid to RPCI promptly upon such filing or submission by Panacela or the applicable Sublicensee(s) or Affiliate. Panacela shall (i) furnish RPCI with the original copies of all official receipts for such taxes; (ii) use commercially reasonable efforts to seek such recoupment or refund to the fullest extent reasonably possible; and (iii) cooperate to the fullest extent reasonably possible, including by causing Sublicensee(s) and Affiliates to cooperate with Panacela and RPCI, to allow Panacela and RPCI to contest such tax determination and otherwise for RPCI to receive a refund of such taxes. If any currency conversion shall be required in connection with the payment of any amount due hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York, on the last business day of the calendar quarterly reporting period to which such payment(s) relate. Panacela shall be responsible for, and shall not deduct from any payment made, any exchange, collection, wire transfer, or other charge of such nature.
|
|
6.3.
|
Further Assurances
. From time to time during the Term, each Party shall execute and deliver to the other such documents and take such other action as the other Party may reasonably request to consummate more effectively the transactions contemplated hereby. Panacela shall reimburse RPCI for its reasonable costs incurred in connection with such cooperation.
|
|
6.4.
|
Reports
. Within sixty (60) days from the end of each semi-annual period following June 30, 2012, Panacela shall deliver to RPCI complete and accurate reports (
“Reports”
); provided that after the first commercial sale of a Licensed Product the Reports shall be delivered within sixty (60) days from the end of each calendar quarter following the then current semi-annual period, giving such particulars of the business conducted during such quarter as shall be pertinent to Panacela’s diligence obligations and payment accounting hereunder and sufficient to compute and verify amounts due and compliance with diligence obligations hereunder. With each such quarterly Report, Panacela shall pay (or cause the payment of) the amounts due and payable to RPCI. Each Report due after a calendar year shall include relevant information for the most recent calendar quarter and an annual summary for each Licensed Product on a country-by-country basis. Reports from or about Panacela shall be deemed to be Confidential Information and shall include at least the following:
|
|
6.4.1.
|
progress in meeting diligence obligations and efforts to commercialize Licensed Products directly or indirectly, including the results of research and experimentation to date;
|
|
6.4.2.
|
the number of Licensed Products manufactured, the number of Licensed Products disposed of, by, or for Panacela, any Sublicensee(s), or Affiliate; and the first commercial sale of a Licensed Product in any country shall be reported within sixty (60) days thereof to RPCI;
|
|
6.4.3.
|
total amounts invoiced for Licensed Products disposed of, by, or for Panacela, any Sublicensee(s), or Affiliate;
|
|
6.4.4.
|
gross receipts and a calculation of Net Sales for the applicable reporting period(s), including a listing of deductions;
|
|
6.4.5.
|
total amounts due based on Net Sales, together with the exchange rates used for conversion, if any;
|
|
6.4.6.
|
names and addresses of all Sublicensee(s) and Affiliates;
|
|
6.4.7.
|
a progress report on Patent filings in each country, including the serial number, name of Patent application, name of inventors and status of each Patent application relating to the Licensed Field; and
|
|
6.4.8.
|
on an annual basis, year-end financial statements.
|
|
6.5.
|
Late Charge
. Any amount not paid when due to RPCI shall be subject to a late charge from the due date until paid at the annual rate of twelve percent (12%). If any such amount is disputed in good faith, Panacela shall pay all undisputed amounts when due and work diligently with RPCI to resolve the dispute. Any amount which is ultimately determined to be due from either Party to the other Party shall be subject to the late charge from: (i) the date such amount was due until it is paid; or (ii) in the event of an overpayment by, five (5) business days after the date Panacela properly informed RPCI of such overpayment.
|
|
6.6.
|
Sublicensee(s)/Affiliate Records
. Panacela shall require Sublicensee(s) and applicable Affiliates to keep comparable records and to submit comparable quarterly and annual reports, in English, and shall forward to RPCI a copy of all such reports, together with all other documents received from any Affiliate or Sublicensee(s), as RPCI may reasonably request.
|
7.
|
REPRESENTATIONS AND WARRANTIES.
|
|
7.1.
|
Representations and Warranties of RPCI
. RPCI represents and warrants to Panacela that:
|
|
a)
|
RPCI has the full right and authority to enter into this Agreement;
|
|
b)
|
Except for existing agreements with Cleveland BioLabs, Inc. or its Affiliates or licensees of either, to the knowledge of RPCI’s General Counsel and Director of Technology Transfer, it is not aware of any impediment that would inhibit its ability to perform the terms and conditions imposed on it by this Agreement;
|
|
c)
|
Except for obligations under existing agreements with Cleveland BioLabs, Inc. or its Affiliates or licensees of either and except for the agreement set forth on
Schedule 7.1.c
, RPCI has the legal right and power to extend the rights and licenses granted to Panacela in this Agreement, and to fully perform its obligations hereunder.;
|
|
d)
|
Except for existing agreements with Cleveland BioLabs, Inc. or its Affiliates or licensees of either, RPCI has not made nor will it knowingly make any third-party agreements to others in conflict with or in derogation of such rights or this Agreement.
|
|
e)
|
It is the policy of RPCI that all scientific and medical employees of RPCI are required, as a condition of employment, to assign patentable inventions to RPCI;
|
|
f)
|
To the knowledge of RPCI’s General Counsel, there are no litigation proceedings, oppositions, interferences or other challenges (other than proceedings in the U.S. Patent and Trademark Office or other national patent office) against rights of RPCI pursuant to the Licensed Patents or enforcement actions brought by RPCI against any third party in connection with the Licensed Patents;
|
|
g)
|
To the knowledge of RPCI’s General Counsel, RPCI has not received any notice or other communication from any third party of infringement of third party patent rights that may affect the discovery, development, making, using or selling of Licensed Products;
|
|
h)
|
Other than the Licensed Patents, to the knowledge of its Director of Technology Transfer, RPCI is not aware of any invention disclosure filed with RPCI’s Technology Transfer Office or patent application filed by or on behalf of RPCI that would block Panacela or its Sublicensee(s) from fully exercising its rights to make, use, sell, offer to sell or import the Licensed Products;
|
|
i)
|
The inventors of those Licensed Patents filed with the U.S. Patent and Trademark Office by RPCI (the “
Inventors
”) under the employment of RPCI have executed assignments transferring all rights in the Licensed Patents to RPCI and with the United States Patent and Trademark Office; and
|
|
j)
|
Except as set forth on
Schedule 7.1.j
, to the knowledge of RPCI’s Vice-President of Corporate Ethics and Research Subject Protection, the Scientists have not requested approval of a conflict of interest between RPCI and a third-party.
|
|
7.2.
|
Representations and Warranties of Panacela
. Panacela represents and warrants to RPCI that:
|
|
a)
|
Panacela has the full right and authority to enter into this Agreement;
|
|
b)
|
Panacela is not aware of any impediment that would inhibit its ability to perform the terms and conditions imposed on it by this Agreement;
|
|
c)
|
Panacela has the legal right and power to extend the rights and licenses granted to RPCI in this Agreement, and to fully perform its obligations hereunder;
|
|
d)
|
Panacela has not made nor will it knowingly make any commitments to others in conflict with or in derogation of such rights or this Agreement;
|
|
e)
|
Neither Panacela nor any Affiliate is aware of any potential, pending, or threatened impediment, claim, cause of action, or restriction that would inhibit RPCI’s ability to grant the rights granted hereunder or otherwise to perform its obligations hereunder;
|
|
f)
|
Panacela and its Affiliates are unaware of any pending or threatened claim or cause of action, or restriction on exportation, by any third party, whether a private or governmental entity, regarding any Licensed Patents, Licensed Product, Technology, or Know-How, including regarding this license, and performance of this Agreement;
|
|
g)
|
Panacela will ensure that all Know-How, Project Information, Improvement Inventions, Non-Improvement Inventions, Technology and any other data or technological information of any sort provided by RPCI under this Agreement (
“Data”
) will be received and reviewed by an employee of Panacela who is a U.S. citizen or U.S. permanent resident and that Panacela with perform all necessary and appropriate export control evaluations, and secure any necessary export control licenses, before providing any such Data to any non-U.S. national or non-U.S. entity; and
|
|
h)
|
Panacela will perform all necessary and appropriate export control evaluations, and secure any necessary export control licenses, before providing any Data or rights under this Agreement to any Affiliate or Sublicensee(s) or any employee or agent of either.
|
|
7.3.
|
EXCEPT AS PROVIDED IN SECTION 7.1, RPCI MAKES NO REPRESENTATION AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. FURTHERMORE, NOTWITHSTANDING THE FOREGOING, RPCI MAKES NO REPRESENTATIONS TO THE MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, VALIDITY AND ENFORCEABILITY OF ANY PATENT RIGHT AND ANY CLAIM THEREOF ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. IN NO EVENT SHALL RPCI, OR ITS AFFILIATES AND THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES BE LIABLE FOR INCIDENTAL, INDIRECT, PUNITIVE, CONSEQUENTIAL, OR OTHER DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGES AND INJURY TO PROPERTY AND LOST PROFITS. RPCI DOES NOT WARRANT THAT IT HAS PERFORMED OR HAD PERFORMED ANY “FREEDOM TO OPERATE” SEARCH REGARDING THE SUBJECT MATTER OF THIS AGREEMENT. ALL RPCI INTELLECTUAL PROPERTY, INFORMATION, AND DATA PROVIDED BY OR ON BEHALF OF RPCI UNDER THIS AGREEMENT IS PROVIDED “AS-IS”.
|
|
7.4.
|
EXCEPT AS PROVIDED HEREIN, PANACELA MAKES NO REPRESENTATION AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING A WARRANTY THAT ANY LICENSED PATENT WILL LEAD TO THE DEVELOPMENT OF A LICENSED PRODUCT.
|
|
7.5.
|
With the exception of
Sections 7.1(d), (c)
,
7.2 (c), (d), (g)
and
(h)
, no representations and warranties above shall survive the Effective Date.
|
8.
|
INDEMNIFICATION; INSURANCE
|
|
8.1.
|
Panacela Indemnification Obligations
. Panacela shall defend, indemnify, and hold each of RPCI, its Affiliates, and their respective officers, trustees, employees, agents, successors, and assigns (
“Indemnitees”
) harmless from and against all liabilities, demands, costs, claims, suits, expenses (including attorneys’ fees and expenses, whether incurred as a result of a third party claim or a claim to enforce this provision), and other damages (collectively,
“Losses”
) under any theory of liability to the extent arising out of or resulting from: (i) any use or exercise of the rights granted hereunder by Panacela or any Affiliate or Sublicensee(s); (ii) any material breach or failure by Panacela (or any Affiliate or Sublicensee(s)) in the performance or non-performance of the obligations or covenants under this Agreement or any Sublicense; (iii) any breach by Panacela of any representation or warranty hereunder; (iv) the testing, manufacture, marketing, possession, use, sale or other disposition by Panacela or any Affiliate or Sublicensee(s) of any Licensed Product or the failure of any of the foregoing (or any contract manufacturer of any of the foregoing) to manufacture Licensed Products in accordance with good manufacturing processes; (v) FDA enforcement actions, inspections, product recalls or market withdrawals relating to a Licensed Product or Licensed Process; (vi) any personal or bodily injury, including death, illness, or property damage caused directly or indirectly by Panacela (or any Affiliate or Sublicensee(s)); and (vii) failure to comply with any law or regulation. Panacela shall not be obligated to indemnify an Indemnitee under this
Section 8.1
after any unappealed or unappealable order of a court of competent jurisdiction holds that the claim was legally caused solely by the gross negligence or willful misconduct by such Indemnitee. Panacela shall insure that every Sublicense contains a covenant by the Sublicensee(s) providing for the indemnification of the Indemnitees as provided in this Article.
|
|
8.2.
|
Notice
. With respect to all third party claims, each Party shall promptly give notice of each such claim to the other and shall cooperate fully with the other Party in the defense of such claim.
|
|
8.3.
|
Procedure
. RPCI or the applicable Indemnitee will provide Panacela with prompt notice of any claim, suit, action, demand, or judgment for which indemnification is sought. At its expense, Panacela shall provide counsel reasonably acceptable to the affected Indemnitee to defend against any such claim. The Indemnitees shall reasonably cooperate with Panacela in such defense and will permit Panacela to conduct and control such defense and the disposition of such claim, suit, or action (including all decisions relative to litigation, appeal, and settlement); provided, however, that any Indemnitee shall have the right to retain its own counsel, at the reasonable expense of Panacela, if, under the standards of professional conduct applicable to Panacela’s counsel without a waiver, representation of such Indemnitee by the counsel retained by Panacela would be inappropriate (a
“Conflict”
), provided however, such counsel selected by such Indemnitee shall be reasonably acceptable to Panacela (such counsel the
“Conflict Counse
l
”
) and provided, further, however, that Conflict Counsel’s representation of the Indemnitee in any matter shall be restricted solely to those issues where there is a Conflict. Conflict Counsel and Panacela counsel shall communicate with each other in good faith to keep each other fully informed of the status of the proceeding at all stages thereof, and shall each use commercially reasonable efforts to avoid duplicative work in connection therewith, it being understood that expenses incurred by Conflict Counsel for duplicative work shall be deemed “unreasonable expense” under this
Section 8.3
, and the Indemnitee shall be responsible for such expenses. In no event shall Panacela be liable for the fees and expenses of more than one Conflict Counsel in connection with any one action or claim or in connection with separate but similar or related actions or claims in the same jurisdiction arising out of the same general allegations unless there are multiple Indemnitees and representation by Panacela counsel or the initially engaged Conflict Counsel would be inappropriate. The Indemnitees may not settle any action or claim affected pursuant to this
Section 8.3
without the written consent of Panacela, such consent not to be unreasonably conditioned, withheld, or delayed.
|
|
8.4.
|
Failure to Indemnify
. If Panacela fails to promptly and adequately defend and indemnify, as may be determined by a court of competent jurisdiction, any applicable Indemnitee pursuant to this Article, Panacela shall not thereafter deny or disclaim its liability hereunder to any Indemnitee for any consequent Loss.
|
|
8.5.
|
Insurance
. Beginning not less than one hundred and twenty (120) days after the Effective Date, Panacela and all Sublicensee(s) shall maintain in full force and effect with a commercial insurance carrier commercial general liability insurance, written on an occurrence basis, having individual and aggregate limits appropriate to the conduct of Panacela’s and the applicable Sublicensee(s)’s business; covering the testing, marketing, sale and distribution of Licensed Products; and reasonably satisfactory to RPCI. Such insurance: (i) shall be issued by an insurer licensed to practice in the State of New York or an insurer pre-approved by RPCI having an A.M. Best rating of at least A- (A minus), such approval not to be unreasonably withheld, conditioned or delayed; (ii) shall list RPCI and its Affiliates, as specified by RPCI, as additional named insureds, (iii) shall be endorsed to include product liability coverage; and (iv) shall require thirty (30) days’ written notice to be given to RPCI prior to any cancellation or material change thereof. Panacela shall, upon request, provide RPCI with Certificates of Insurance evidencing compliance with this Section. Panacela shall continue to maintain such insurance after the expiration or termination of this Agreement during any period in which Panacela or any Affiliate or Sublicensee(s) continues to make, use, perform, or sell a product that was a Licensed Product under this Agreement and for a period of five (5) years thereafter.
|
9.
|
PATENT PROSECUTION AND MAINTENANCE; COSTS
|
|
9.1.
|
Prosecution by Panacela
.
|
|
9.1.1.
|
Licensed Patents
. Panacela shall, at its full expense, diligently prosecute and maintain the Licensed Patents, in any jurisdiction, and any continuations, continuations-in-part, divisions, reissues, reexamined patents, and extensions of any patents that issue as a result of such applications, which Panacela determines in good faith may be required to advance the purposes of this Agreement or otherwise to protect the rights and licenses granted hereunder and otherwise to reasonably procure the broadest patent protection. All costs and expenses of all such patent work, including preparation fees, filing fees, taxes, annuities, working fees, issuance fees, maintenance fees, and/or renewal and extension charges shall be paid by Panacela. Panacela shall promptly provide RPCI with copies of all correspondence relating to the filing, prosecution and maintenance of patents and patent applications addressed within this Agreement, including patent applications and patents covering Improvement Inventions; and shall keep RPCI informed with respect to the status and progress of all such applications, prosecutions, and maintenance activities and will consult in good faith with RPCI and take into account RPCI’s comments and requests with respect thereto. Both Parties shall reasonably cooperate with each other to facilitate the application and prosecution of patent applications pursuant to this Agreement.
|
|
9.1.2.
|
Improvement Inventions
. Panacela shall, in its full expense, responsibility, and control, diligently prepare and file patent applications covering the Improvement Inventions, which shall be included within the Licensed Patents pursuant to
Section 3.3
.
|
|
9.1.3.
|
Notice and RPCI Right
. If Panacela elects not to file any patent application within the Licensed Patents, or thereafter elects not to continue prosecution of any such patent application, or elects not to maintain any patent that may issue therefrom (together, the
“Abandoned Rights”
), Panacela shall provide RPCI with reasonable notice thereof, and RPCI shall have the right, at RPCI’s option and expense, in its own name, to file for and prosecute such patent application and maintain such patent using patent counsel selected by RPCI. Panacela shall cooperate therewith, and all rights of Panacela under the Abandoned Rights shall be terminated.
|
10.
|
PROTECTION OF LICENSED RIGHTS
|
10.1.
|
Notification and Procedure
. Panacela and RPCI shall notify each other in writing of any infringements by others of any intellectual property rights in the Licensed Rights. Following receipt of such notice, the Parties shall engage in meaningful consultation between themselves as to the means of preventing such infringements and shall cooperate in any preliminary steps, short of filing a lawsuit, including preliminary investigations, engagement of counsel and/or sending cease-and desist letters, that the Parties may mutually determine are required prior to the filing of any lawsuit. Unless otherwise agreed in writing between the Parties, Panacela shall have the right, but not the obligation, at Panacela’s expense, to: (i) defend any of Licensed Patents against infringement by other parties in any country, including by bringing any legal action for infringement, or defending any counterclaim of invalidity or action of a third party for declaratory judgment of non-infringement, and (ii) join RPCI as a party thereto at Panacela’s expense. No such action may be settled without RPCI’s consent, which consent shall not be unreasonably withheld, conditioned or delayed. Panacela shall indemnify and hold the Indemnitees harmless against any Losses that may be found or assessed against RPCI or any of the foregoing in connection with any such action. Panacela acknowledges and agrees that should Panacela decline or fail to promptly commence or prosecute such claims or suits within six (6) months after notice thereof, RPCI may institute such claims or suits in its own name and join Panacela as a party thereto at RPCI’s expense. Panacela shall cooperate and assist fully in any claims, suits or other actions commenced, prosecuted and/or defended by RPCI pursuant to this Section, and RPCI shall keep any recovery or damages awarded or recovered in connection therewith.
|
10.2.
|
Any recovery of damages in any suit defended or prosecuted by Panacela shall be applied: (a) pro rata, in satisfaction of any unreimbursed expenses and legal fees of the Parties relating to the suit; (b) to ordinary damages, which shall be equal to: (i) Panacela’s lost profits, and (ii) royalties on the lost Net Sales, all of which shall be payable to Panacela, and Panacela shall pay to RPCI royalties due based upon lost Net Sales, and (c) the balance, including whatever other measure of damages the court shall have applied to compensate for damages (e.g., willful conduct) shall be divided evenly between Panacela and RPCI. However, notwithstanding the foregoing, if RPCI has defended or prosecuted a suit after Panacela has declined or been unsuccessful in a suit against the alleged infringer, then all damages and other recovery shall be retained by RPCI; provided that RPCI shall reimburse Panacela out of such damages and recovery for any expenses reasonably incurred by Panacela in connection with its participation in the suit.
|
10.3.
|
In any suit to enforce and/or defend the rights pursuant to this Agreement, the Party not in control of such suit shall, at the request and expense of the controlling Party, cooperate in all respects and, to the extent possible, have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like.
|
11.
|
TERM: TERMINATION.
|
11.1.
|
Unless terminated earlier pursuant to this
Article 11
and subject to the performance of any then outstanding obligations, the term of this Agreement shall continue for the longest period allowed pursuant to
Section 4.2.2
(
“Term”
).
|
11.2.
|
This Agreement may be terminated by Panacela, in whole or in part, for any or no reason, upon sixty (60) days’ written notice.
|
11.3.
|
This Agreement may be terminated by RPCI, upon the occurrence of any of the following:
|
|
a)
|
Failure by Panacela to pay any amount due hereunder more than $25,000, which amount is not the subject of a bona fide dispute, within thirty (30) days of receipt of written notice that such amount is overdue, in which case RPCI may terminate this Agreement immediately (without further notice) if Panacela has not paid the applicable amount (with any late charge accrued thereon) within such thirty-day period. It shall not be necessary for RPCI to specify an exact amount due if RPCI does not know it, e.g., Panacela has Net Sales but has not paid royalties due on time.
|
|
b)
|
Material breach by Panacela of this Agreement other than as set forth above, and failure to cure such breach within ninety (90) days of receipt of written notice of the breach; provided, however, (i) if such breach is not capable of being cured within such ninety (90) day period, Panacela may request a reasonable extension to such period, not to exceed one hundred and eighty (180) days, which request shall not be unreasonably denied by RPCI; or (ii) if Panacela disputes such breach in good faith within such cure period, RPCI, shall not have the right to terminate this Agreement unless and until a tribunal of competent jurisdiction has determined that this Agreement was materially breached.
|
|
c)
|
Panacela (i) has instituted or has instituted against it any insolvency, receivership, bankruptcy or other proceeding and such proceeding has not been dismissed for ninety (90) days, (ii) makes an assignment for the benefit of creditors, or (iii) has ceased to conduct business or dissolves. The licenses granted to Panacela for use of RPCI Intellectual Property are and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “
Code
”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code. Panacela, as the licensee of such rights under this Agreement, is entitled to retain and fully exercise all of its rights and elections under the Code. The foregoing provisions of this
Section 11.3(c)
are without prejudice to any rights Panacela may have arising under the Code or other applicable law.
|
|
d)
|
If Panacela fails to market, promote, and otherwise exploit the Licensed Rights so that RPCI has not received any royalty payment during any twelve (12) month period after the first commercial sale of a Licensed Product, in which case this Agreement shall automatically terminate with respect to such Licensed Product, without further notice from RPCI to Panacela. Notwithstanding the foregoing, if Panacela’s failure to generate royalty payments is directly related to a hold placed on the sale of the Licensed Product by a regulatory or other government authority and if Panacela is using commercially reasonable efforts to resolve such issue, this Agreement with respect to such Licensed Product shall not automatically terminate.
|
11.4.
|
Upon termination of this Agreement, other than by expiration in accordance with
Section 11.1
, all Sublicenses shall survive and shall be assigned to RPCI, but RPCI shall not be obligated to perform or incur any obligation to any Sublicensee(s) not already required to be performed or incurred to Panacela by RPCI in this Agreement. Notwithstanding the foregoing, RPCI shall not be obligated to perform or incur any obligation to any Sublicensee(s) under
Articles 3 and 8
or
Section 16.13
, regardless of whether RPCI was obligated to perform or incur such obligations to Panacela prior to termination of this Agreement.
|
11.5.
|
Upon termination or expiration of this Agreement for any reason, nothing herein shall be construed to release either Party from any obligation that matured prior to the effective date of such termination or expiration. Panacela and any Affiliate may, however, after such date and for a period not to exceed six (6) months thereafter, complete and dispose of any applicable Licensed Products in the process of manufacture at the time of such termination, provided that Panacela shall pay or cause to be paid to RPCI the amounts due thereon and shall submit the Reports required by
Article 6
on such dispositions. Furthermore, upon termination or expiration of this Agreement in whole or in part for any default of Panacela with respect to any Licensed Product(s), Panacela and its Affiliates and Sublicensee(s) perpetually and irrevocably covenant not to sue RPCI or any direct or indirect licensee thereof for infringement or misappropriation of any Patents or other intellectual property rights of any kind owned by assigned to, or under the control of Panacela or any of its Affiliates or Sublicensee(s) or any of their respective assigns or successors in interest with respect to such Licensed Product(s). This covenant and right of RPCI will survive any termination or expiration of this Agreement.
|
11.6.
|
The express provisions regarding termination in this Agreement are in addition to, and do not limit, any other rights and remedies a Party may have.
|
11.7.
|
Challenge
.
|
11.7.1.
|
If Panacela or any Affiliate or Sublicensee(s) challenges, directly or indirectly, or supports any unaffiliated party in any such challenge based on an assertion or claim that any claim of a Licensed Patent is invalid, unenforceable, or should be invalidated (collectively, “
Challenges
”), Panacela shall give RPCI not less than one hundred eighty (180) days’ prior written notice of any proposed Challenge.
|
11.7.2.
|
If a Challenge occurs by or on behalf of Panacela or any Affiliate (“
Panacela Challenge
”), RPCI shall have the option, at its sole discretion, to terminate this Agreement, make the license rights granted non-exclusive, and/or limit such rights in scope, Territory, and/or Licensed Field, as RPCI deems appropriate, and/or require Panacela to immediately pay RPCI an additional non-refundable lump sum payment in the amount of one million dollars ($1,000,000.00).
|
11.7.3.
|
In the case of a Panacela Challenge, upon presentation of applicable invoices and supporting documentation, Panacela shall reimburse RPCI for all reasonable attorney fees and expenses incurred in connection with defending the Challenge. Panacela shall continue to pay to RPCI any amounts owed pursuant to the terms of this Agreement.
|
11.7.4.
|
In the event of a final and unappealable decision on the Panacela Challenge in the favor of RPCI, all future royalties due under
Section 4.2
of this Agreement shall be increased by multiplying the applicable royalty rate by a factor of five (5) (but provided that such rate shall in no event exceed six percent (6%)). If any Sublicensee(s) initiates such a Challenge without the approval or cooperation of Panacela, Panacela shall fully cooperate with RPCI in any such defense and shall terminate the applicable Sublicense.
|
11.7.5.
|
Any Challenge, other than a proceeding brought in the U.S. Patent & Trademark Office, must be brought in the district court for the Western District of New York. Panacela shall not challenge, and hereby irrevocably consents to, the exclusive personal jurisdiction and venue of such court, and further so consents to the transfer to that court of any Challenge brought elsewhere. Further, if a Sublicensee(s) initiates a Challenge, the provisions of this
Section 11.7
applicable to Panacela shall be applicable to such Sublicensee(s) for the benefit of RPCI.
|
11.8.
|
In addition to any obligations existing upon termination or expiration of this Agreement, the following Sections shall survive any such termination or expiration: 2.5, 4, until the obligations set forth in the Section and matured prior to the effective date of termination or expiration are met, 8, 11.4, 11.5, 11.7.2, 11.7.3, 11.7.4, 11.7.5, 12, 15, and 16.2.
|
12.
|
CONFIDENTIALITY
|
12.1.
|
Disclosure of confidential information
. The Parties acknowledge that a Party (the “
Disclosing Party
”) may disclose Confidential Information (as defined below) to the other Party (the “
Receiving Party
”) pursuant to the terms of this Agreement. Accordingly, the Receiving Party agrees to keep the Disclosing Party’s Confidential Information in confidence and not to use or disclose the Disclosing Party’s Confidential Information except pursuant to the terms of this Agreement.
|
12.2.
|
Confidentiality Obligations
. The Receiving Party agrees to keep confidential for a period of five (5) years from the date of disclosure any information identified as confidential by the Disclosing Party using methods similar to those used by the Receiving Party to protect its own Confidential Information of a like nature. “Confidential Information” of RPCI shall include all Technology and any other information disclosed by RPCI to Panacela that is marked confidential or is accompanied by correspondence indicating such information is confidential. “Confidential Information” of Panacela shall include Licensed Products and other information disclosed by Panacela to RPCI that is marked confidential or is accompanied by correspondence indicating such information is confidential. Except as may be authorized in advance in writing by the Disclosing Party, the Receiving Party shall grant access to the Disclosing Party’s Confidential Information only to its own employees involved in research relating to the Licensed Rights and/or manufacture or marketing of the Licensed Products, and each Party shall require such employees to keep such information confidential. The Receiving Party agrees not to use any Confidential Information of the other party to its advantage and to the Disclosing Party’s detriment, including, in the case of Panacela, claiming priority to any application serial numbers of any Licensed Patents in any patent prosecution by RPCI. The confidentiality and use obligations set forth above apply to all or any part of the Confidential Information disclosed hereunder except to the extent that:
|
|
a)
|
The Receiving Party can show by written record that it possessed the information prior to its receipt from the Disclosing Party;
|
|
b)
|
The information was already available to the public or became so available through no fault of the Receiving Party;
|
|
c)
|
The information is subsequently disclosed to the Receiving Party by a third party that has the right to disclose it free of any obligations of the Disclosing Party; or
|
|
d)
|
The information is required by law or regulation to be disclosed; provided, however, that the Receiving Party has provided written notice to the Disclosing Party promptly to enable the Disclosing Party to seek a protective order or otherwise prevent disclosure of such Confidential Information.
|
12.3.
|
Notwithstanding the foregoing, RPCI shall have the right to disclose any information related to this Agreement to any body or entity to which RPCI is subject or to whom it owes a duty of disclosure, whether or not in the ordinary course, but if such disclosure is of Panacela’s Confidential Information, RPCI shall provide written notice of such disclosure requirement, including a copy of the information to be disclosed, to Panacela promptly after learning of the required disclosure and work with Panacela to minimize the amount of such information to actually be disclosed and take such steps, including filing of provisional patent applications, as may be necessary to protect such information prior to disclosure. In addition, RPCI shall have the right to disclose, pursuant to a written confidentiality agreement, information related to this Agreement to a third party principally in the business of buying royalties, investment banking, financial services, or any similar business in connection with any effort to monetize any amounts due hereunder, and Panacela shall reasonably cooperate with RPCI and any potential buyers in such efforts; provided, however, in the event the disclosure is to a Person whose principal business is not financial services, then RPCI shall obtain Panacela’s written consent, which shall not be unreasonably withheld, conditioned or delayed, to prior to such disclosure.
|
13.
|
SPONSORED RESEARCH AGREEMENT.
During the five (5) years after the Effective Date, Panacela and RPCI may enter into a commercial sponsored research pursuant to which RPCI may supply services to Panacela. At this time it is expected that this will initially include, but not be limited to services provided by RPCI’s core facilities, such as Department of Laboratory Animal Resource, Small Molecule Screening Core, PK-PD Core, Histopathology Core, Genomics and Gene Expression Analysis Core, and Proteomics Core, which shall provide services to Panacela at a price equal to the price that RPCI charges for such services to investigators employed by RPCI, but not more than a fifteen percent (15%) overhead reimbursement rate.
|
14.
|
ASSIGNABILITY.
Neither Party may assign this Agreement without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed, except that either Party may assign this Agreement without the prior written consent of the other Party in connection with the sale or other transfer of substantially all of that part of the assigning Party’s business to which this Agreement relates, provided that the assigning Party provides written notice within thirty (30) days to the non-assigning Party of such assignment and the assignee thereof agrees in writing to be bound as such assigning Party by the terms of this Agreement.
|
15.
|
DISPUTE RESOLUTION
|
15.1.
|
Initial Mediation
. Any dispute arising under or in connection with this Agreement shall initially be attempted to settled by negotiation between the Parties. The Party seeking relief shall promptly advise the other Party of such claim, dispute or controversy in a writing which describes in reasonable detail the nature of such dispute. Not later than five (5) business days after the Party received such notice, each Party shall select a representative(s)(“Representative”), who shall have the authority to bind such Party, and shall advise the other Party in writing of the name and title of such Representative. Not later than ten (10) business days after the date of such notice of dispute, Panacela shall select a mediation firm located within the State of New York, reasonably acceptable to RPCI, and the Representatives shall meet with such firm for a mediation hearing within thirty (30) days within one hundred (100) miles of Buffalo, New York and in the United States. The Parties shall participate in such mediation in good faith and shall share the costs of the mediation firm equally. If Panacela does not select a firm within such time, RPCI may do so.
|
15.2.
|
Resolution
. If the Representatives have not been able to resolve the dispute within thirty (30) days after such mediation hearing (or in any event within sixty (60) days after they should have appointed their Representatives pursuant to
Section 15.1
), either Party shall be free to bring an action as permitted under
Section 16.2
.
|
15.3.
|
Tolling; Language
. All applicable statutes of limitation and time-based defenses (such as estoppel and laches) shall be tolled while any mediation procedures are pending and during any mediation. The Parties shall cooperate in taking any actions necessary to achieve this result. The language to be used in any mediation or arbitration shall be English.
|
15.4.
|
No Party shall terminate this Agreement during the pendency of the resolution of a dispute pursuant to this
Article 15
and
Section 16.2
if the reason for termination is the subject of the pending dispute resolution.
|
16.
|
MISCELLANEOUS PROVISIONS
|
16.1.
|
Notice
. Any notice or other communication pursuant to this Agreement shall be sufficiently made or given on the date of mailing if sent to such Party by facsimile or electronic mail on such date, with a paper copy being sent by certified first class mail, postage prepaid, or by next day express delivery service, addressed to it at its address below (or such address as it shall designate by written notice given to the other Party).
|
16.2.
|
Choice of Law
. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without regard to its conflict of laws principles. Any claim or lawsuit hereunder, other than a proceeding brought in the U.S. Patent & Trademark Office, must, subject to
Article 15
, be brought in the Federal District Court for the Western District of New York. The Parties shall not challenge, and hereby irrevocably consent to, the exclusive personal jurisdiction and venue of such court, and further so consent to the transfer to that court of any claim or lawsuit brought elsewhere.
|
16.3.
|
Export Control Compliance
. Panacela will comply with all applicable export laws, regulations, and restrictions. In connection with the exercise of Panacela’s rights hereunder, RPCI does not represent that an export license will not be required nor that, if required, such a license will be issued. It is also understood that the transfer of certain technical data and commodities may require a license from the United States Government. RPCI will reasonably cooperate with and assist Panacela to obtain any required export licenses. However, and notwithstanding anything to the contrary herein, Panacela will be solely responsible for ensuring that all export control regulations, laws, and restrictions (
“Export Laws”
) are complied with in connection with this Agreement, including overseeing the activities of its Affiliates and Sublicensee(s) in connection with any right exercised under this Agreement. If any transfer under this Agreement to any person or entity, whether private or governmental, violates any U.S. export control regulation, law or restriction, such transfer shall be void at its inception, but any such violation shall be subject to Panacela’s indemnity obligation under
Article 7
. Upon request, and in any event with each Report due hereunder, an officer of Panacela shall certify that Panacela and each Sublicensee(s) and Affiliate are in compliance with and have not violated any Export Law.
|
16.4.
|
Headings; Interpretation
. The headings of Articles and Sections of this Agreement are for convenience of reference only and shall not affect the meaning or interpretation of this Agreement in any way.
|
16.5.
|
Waiver
. The failure of either Party in any instance to insist upon the strict performance of the terms of this Agreement will not be construed to be waiver or relinquishment of any of the terms of this Agreement, either at the time of the Party's failure to insist upon strict performance or at any time in the future, and such terms will continue in full force and effect.
|
16.6.
|
Counterparts
. The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
|
16.7.
|
Use of Names
. Neither Party will, without prior written consent of the other Party, use the name or any trademark or trade name owned by the other Party, or owned by an Affiliate of the other Party, in any publication, publicity, advertising, or otherwise.
|
16.8.
|
Independent Contractors
. Nothing contained in this Agreement shall be deemed to constitute a joint venture, partnership or employer-employee relationship between the Parties, or to constitute one as the agent of the other. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to make one Party an agent, employee or legal representative of the other Party for any purpose or to give either Party the power or authority to act for, bind, or commit the other Party.
|
16.9.
|
Severability
. If any provision of this Agreement is held to be invalid or unenforceable, all other provisions will continue in full force and effect, and the Parties will substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible to the original intent of the Parties.
|
16.10.
|
Entire Agreement
. This Agreement constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof, and supersedes all proposals, oral or written, and all other communications between the Parties with respect to such subject matter [***].
|
16.11.
|
Force Majeure
. Each Party shall be excused from any breach of this Agreement to the extent such breach is caused by governmental regulations, act of war, strike, act of God, or other similar circumstance normally deemed outside the control of such Party (“
Force Majeure
”), but the affected Party shall work continuously and diligently to remove the cause of such Force Majeure and shall keep the other Party reasonably advised of its efforts and progress.
|
16.12.
|
Modifications
. The terms and conditions of this Agreement may not be amended or modified, except in a writing signed by the Parties.
|
16.13.
|
Publication
. The rights granted to Panacela hereunder are subject to the reserved, irrevocable, exclusive right of RPCI to publish its scientific findings, but RPCI shall cooperate with Panacela so that it may file for protection of any intellectual property rights to any Improvement Invention or Non-Improvement Invention before such publications are published, provided patent applications and other filings are diligently pursued so as not to unduly delay timely publication of such findings. Therefore, RPCI shall submit to Panacela, at least thirty (30) days prior to submission for publication or disclosure materials intended for publication or disclosure relating to such an Improvement Invention or Non-Improvement Invention. Panacela shall notify RPCI within thirty (30) days of receipt of such materials whether Panacela desires to file a patent application on any invention disclosed in such materials. If Panacela desires to file such a patent application, RPCI shall withhold publication and disclosure of patentable information for a period not to exceed thirty (30) days from the date of receipt of such materials by Panacela. Further, if such material contains Confidential Information that Panacela has provided to RPCI, RPCI agrees to remove such Confidential Information from the proposed publication or disclosure. Notwithstanding the foregoing, RPCI shall have no obligation under this
Section 16.13
with respect to any publication of a Scientist or anyone under the direction or control of any Scientist.
|
PANACELA LABS, INC.
|
HEALTH RESEARCH INC., ROSWELL
|
|||
PARK CANCER INSTITUTE DIVISION
|
||||
By:
|
/s/ Dmitry Tyomkin
|
By:
|
/s/ John Blandino
|
|
Name: Dmitry Tyomkin
|
Name: John Blandino
|
|||
Title: Chief Executive Officer
|
Title: Director
|
|
1.
|
American Cancer Society grant to Dr. Nikiforov regarding research targeting C-MYC with small molecules as a novel anti-melanom.
|
RPCI Employee
|
Outside Employment
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
1.
|
REVERCOM
|
·
|
Drug summary:
Liposome-packaged combination of proprietary molecule, inhibitor of multidrug resistance transporter, and conventional chemotherapeutic agent.
|
·
|
Potential use:
adjuvant applied as part of chemotherapy of cancer patients.
|
·
|
[***]
|
2.
|
MOBILAN
|
·
|
Drug summary:
Adenovirus-based treatment inducing immune response. Ready for final stage of preclinical development.
|
·
|
Potential use:
Universal anti-cancer vaccine.
|
·
|
[***]
|
3.
|
ARKIL
|
·
|
Drug summary:
Androgen receptor inhibitor, prepared for Hit-2-Lead optimization studies.
|
·
|
Potential use:
Nanodrugs for treatment of prostate cancer (both hormone (androgen)-dependent and –independent/refractory forms).
|
·
|
[***]
|
4.
|
ANTIMYCON
|
·
|
Drug summary
: MYC inhibitor.
|
·
|
Potential use
: Drugs for treatment of a broad range of solid tumors (breast, prostate, colon, non-small cell lung carcinoma, etc.) and hematological malignancies.
|
·
|
[***]
|
|
1.
|
Projects
|
Drug
|
Definition
|
Mobilan
|
Research, development and support of an immunotherapeutic drug candidate based on recombinant adenovirus vector, stimulating immune response in humans as a vaccine-like treatment for cancer or other indications.
|
Revercom
|
Research, development, formulation and support of a drug candidate based on proprietary Reversan compound as an adjuvant for chemotherapy.
|
Antimycon
|
Research, development, lead optimization, formulation and support of a drug candidate regulating cMyc transcription factor for cancer indications.
|
Arkil
|
Research, development, lead optimization, formulation and support of a drug candidate regulating androgen receptor for prostate cancer.
|
Xenomycin
|
Research, development, lead optimization, formulation and support of a drug candidates based on proprietary Curaxin family of compounds for anti-infective/anti-biotic/anti-fungal applications.
|
|
2.
|
Licensed Patents
|
|
1.
|
the patents and patent applications described in
Appendix B
hereto and all patents anywhere in the world issuing thereon;
|
|
2.
|
any patent or patent application of any kind anywhere in the world that claims any of the Licensed Mobilan Rights; and
|
|
3.
|
all divisions, continuations, continuations-in-part, patents of addition, patents, substitutions, registrations, reissues, reexaminations or extensions of any kind with respect to any of the foregoing applications and patents.
|
|
1.
|
the patents and patent applications described in Appendix C hereto and all patents anywhere in the world issuing thereon;
|
|
2.
|
any patent or patent application of any kind anywhere in the world that claims any of the Licensed Inhibitor and Modulator Rights; and
|
|
3.
|
all divisions, continuations, continuations-in-part, patents of addition, patents, substitutions, registrations, reissues, reexaminations or extensions of any kind with respect to any of the foregoing applications and patents.
|
|
1.
|
the patents and patent applications described under the heading “Xenomycin” on
Appendix C
hereto and all patents anywhere in the world issuing thereon;
|
|
2.
|
any patent or patent application of any kind anywhere in the world that claims any of the Licensed Xenomycin Rights; and
|
|
3.
|
all divisionals, continuations, continuations-in-part, patents of addition, patents, substitutions, registrations, reissues, reexaminations or extensions of any kind with respect to any of the foregoing patent applications and patents.
|
|
1.
|
CBLI has all requisite authority to execute and deliver this Agreement and perform its obligations hereunder, including, without limitation, the right to grant the License;
|
|
2.
|
CBLI has not previously assigned, transferred, conveyed or otherwise encumbered any of its right and interest in the Licensed Rights;
|
|
3.
|
to the best of CBLI’s knowledge, each of the inventors of the Licensed Patents has signed a full and effective assignment of his or her rights to either CCF, Other Institution or CBLI as applicable, and such assignments have been duly recorded with the United States Patent and Trademark Office;
|
|
4.
|
to the best of CBLI’s actual knowledge, there are no assignments by inventors of the Licensed Patents other than those assignment recorded with the United States Patent and Trademark Office;
|
|
5.
|
to the best of CBLI’s actual knowledge, there are no third party pending patent applications which, if issued, cover the development, manufacture, use or sale of Products;
|
|
6.
|
to the best of CBLI’s actual knowledge, the government of the United States of America does not have any rights in or to the Licensed Patents, whether derived from the provision of research funding or otherwise;
|
|
7.
|
there are no claims, judgments or settlements against or owed by CBLI or pending or, to the best of its knowledge, threatened claims or litigation relating to the Licensed Rights;
|
|
8.
|
all application and renewal fees and other steps required for the maintenance or protection of the Licensed Rights have been paid on time or taken;
|
|
9.
|
there are no collaborative, licensing, transfer, supply, distributorship or marketing agreements or arrangements or other kinds of agreements to which CBLI or any of its Affiliates are party relating to any of the Licensed Rights or Products except those previously disclosed to Panacela in the Disclosure Schedules to the Investment Agreement;
|
|
10.
|
neither CBLI nor its Affiliates shall enter into any oral or written agreement or arrangement that would be inconsistent with CBLI’s obligations under this Agreement;
|
|
11.
|
to the best of CBLI’s knowledge after reasonable investigation, CCF does not own or hold any rights in any other patent or patent application, the claims of which would dominate the claims of a patent or patent application within the Licensed Patents as applied to the applicable Licensed Field; and
|
|
12.
|
to the best of CBLI’s knowledge after reasonable investigation, CBLI does not own or hold any rights in any other patent or patent application, the claims of which would dominate the claims of a patent or patent application within the Licensed Patents as applied to the applicable Licensed Field.
|
|
1.
|
except as set forth above in this Section V.A., CBLI makes no warranty or representation as to the validity or scope of any of the Licensed Patents;
|
|
2.
|
except as set forth above in this Section V.A, CBLI makes no warranty or representation that anything made, used, sold or otherwise disposed of under the license granted in this Agreement will or will not infringe patents of third parties; or
|
|
3.
|
nothing in this Agreement shall be construed as an obligation to furnish any know-how not provided in the Licensed Rights or any services, other than those specified in this Agreement.
|
|
1.
|
Panacela and its Affiliates are unaware of any pending or threatened claim or cause of action, or restriction on exportation, by any third party, whether a private or governmental entity, regarding any Licensed Patents, Products, CCF Technology, including regarding this license, and performance of this Agreement.
|
|
2.
|
Panacela will ensure that all CCF Technology and any other data or technological information of any sort provided by CBLI under this Agreement (“Data”) will be received and reviewed by an employee of Panacela who is a U.S. citizen or U.S. permanent resident and that Panacela with perform all necessary and appropriate export control evaluations, and secure any necessary export control licenses, before providing any such Data to any non-U.S. national or non-U.S. entity.
|
|
3.
|
Panacela will perform all necessary and appropriate export control evaluations, and secure any necessary export control licenses, before providing any Data or rights under this Agreement to any Affiliate or Sublicensee or any employee or agent of either.
|
|
4.
|
No Product will be developed by Panacela or its Affiliates for biodefense purposes.
|
|
5.
|
Products produced under the License granted herein shall be manufactured in accordance with all material respects with applicable international, foreign, federal, state and local laws, rules and regulations, including, without limitation, in accordance in all material respects with all applicable rules and regulations of the FDA and all applicable regulatory bodies.
|
|
(i)
|
If from Panacela to CBLI:
|
|
(ii)
|
If from Panacela to CCF:
|
|
(iii)
|
If from Panacela to CCIA:
|
|
(iv)
|
If from CBLI to Panacela:
|
|
1.
|
The recipient party can show by written record that it possessed the information prior to its receipt from the other Party;
|
|
2.
|
The information was already available to the public or became so through no fault of the recipient party;
|
|
3.
|
The information is subsequently disclosed to the recipient party by a third party that has the right to disclose it free of any obligations of the disclosing party; or
|
|
4.
|
The information is required by law or regulation to be disclosed; provided, however, that the Party subject to such disclosure requirement has provided written notice to the other Party promptly to enable such other Party to seek a protective order or otherwise prevent disclosure of such Confidential Information.
|
By:
|
/s/ Michael Fonstein, Ph.D.
|
Date: September 23, 2011
|
Name: Michael Fonstein, Ph.D.
|
||
Title: Chief Executive Officer
|
By:
|
/s/ Dmitry Tyomkin
|
Date: September 23, 2011
|
Name: Dmitry Tyomkin
|
||
Title: Chief Executive Officer
|
Country/Region
|
App. No.
|
Assignee/Owner
|
PCT
|
PCT/US04/040753
|
CCF
|
Australia
|
2004296828
|
CCF
|
Canada
|
2,547,869
|
CCF
|
China
|
200480041259.5
|
CCF
|
EAPO
|
200601079
|
CCF
|
EPO
|
04813124.7
|
CCF
|
Hong Kong
|
07108097.8
|
CCF
|
Israel
|
175974
|
CCF
|
India
|
3112/DELNP/2006
|
CCF
|
South Korea
|
10-2006-7010934
|
CCF
|
Singapore
|
200809013-6
|
CCF
|
Ukraine
|
a200607304
|
CCF
|
USA
|
12/617,653
|
CCF
|
USA
|
12/617,639
|
CCF
|
USA
|
11/421,918
|
CCF
|
Japan
|
2006-542849
|
CCF
|
Malaysia
|
PI 20062641
|
CCF
|
PCT
|
PCT/US05/046485
|
CCF/CBLI
|
US
|
11/722,682
|
CCF/CBLI
|
Europe
|
05855104.5
|
CCF/CBLI
|
Japan
|
2007-548451
|
CCF/CBLI
|
Israel
|
184140
|
CCF/CBLI
|
Pakistan
|
0680/2006
|
CCF/CBLI
|
Country/Region
|
App. No.
|
Assignee/Owner
|
PCT
|
PCT/US2005/016832
|
CCF/CCIA
|
US
|
11/579,779
|
CCF/CCIA
|
EPO
|
05748307.5
|
CCF/CCIA
|
Ireland
|
05748307.5
|
CCF/CCIA
|
Germany
|
05748307.5
|
CCF/CCIA
|
France
|
05748307.5
|
CCF/CCIA
|
Switzerland
|
05748307.5
|
CCF/CCIA
|
Great Britain
|
05748307.5
|
CCF/CCIA
|
New Zealand
|
551424
|
CCF/CCIA
|
Australia
|
2005244872
|
CCF/CCIA
|
Country/Region
|
App. No.
|
Assignee/Owner
|
PCT
|
PCT/US06/38440
|
CCF / CBLI
|
US
|
11/992,874
|
CCF / CBLI
|
Country/Region
|
App. No.
|
Assignee/Owner
|
US
|
61/102,913
|
Incuron
|
PCT
|
PCT/US2009/059558
|
Incuron
|
Georgia
|
12213/01
|
Incuron
|
Belarus
|
a20110597
|
Incuron
|
US
|
13/121,051
|
Incuron
|
Kazakhstan
|
2011/2005.1
|
Incuron
|
Japan
|
2011-530291
|
Incuron
|
Vietnam
|
1-2011-00846
|
Incuron
|
OAPI
|
1201100107
|
Incuron
|
Cuba
|
2011-0078
|
Incuron
|
Brazil
|
Not yet known
|
Incuron
|
Ukraine
|
a201105704
|
Incuron
|
Russia
|
2011108932
|
Incuron
|
ARIPO
|
AP/P/2011/005637
|
Incuron
|
Canada
|
2,736,097
|
Incuron
|
Mexico
|
MX/a/2011/003416
|
Incuron
|
New Zealand
|
591516
|
Incuron
|
Singapore
|
201102290-2
|
Incuron
|
China
|
200980140333.1
|
Incuron
|
EPO
|
09793304.8
|
Incuron
|
Australia
|
2009302546
|
Incuron
|
South Korea
|
10-2011-7009438
|
Incuron
|
South Africa
|
2011/01513
|
Incuron
|
Vietnam
|
1-2011-00846
|
Incuron
|
Israel
|
211430
|
Incuron
|
|
1.
|
the patents and patent applications described in Appendix B hereto and all patents anywhere in the world issuing thereon;
|
|
2.
|
any patent or patent application of any kind anywhere in the world that claims any of the Licensed Mobilan Rights; and
|
|
3.
|
all divisions, continuations, continuations-in-part, patents of addition, patents, substitutions, registrations, reissues, reexaminations or extensions of any kind with respect to any of the foregoing applications and patents.
|
|
1.
|
the patents and patent applications described in Appendix C hereto and all patents anywhere in the world issuing thereon;
|
|
2.
|
any patent or patent application of any kind anywhere in the world that claims any of the Licensed Inhibitor and Modulator Rights; and
|
|
3.
|
all divisions, continuations, continuations-in-part, patents of addition, patents, substitutions, registrations, reissues, reexaminations or extensions of any kind with respect to any of the foregoing applications and patents.
|
|
1.
|
CBLI has all requisite authority to execute and deliver this Agreement and perform its obligations hereunder, including, without limitation, the right to grant the License;
|
|
2.
|
CBLI has not previously assigned, transferred, conveyed or otherwise encumbered any of its right and interest in the Licensed Rights;
|
|
3.
|
to the best of CBLI’s knowledge, each of the inventors of the Licensed Patents has signed a full and effective assignment of his or her rights to either CCF, Other Institution or CBLI as applicable, and such assignments have been duly recorded with the United States Patent and Trademark Office;
|
|
4.
|
to the best of CBLI’s actual knowledge, there are no assignments by inventors of the Licensed Patents other than those assignment recorded with the United States Patent and Trademark Office;
|
|
5.
|
to the best of CBLI’s actual knowledge, there are no third party pending patent applications which, if issued, cover the development, manufacture, use or sale of Products;
|
|
6.
|
to the best of CBLI’s actual knowledge, the government of the United States of America does not have any rights in or to the Licensed Patents, whether derived from the provision of research funding or otherwise;
|
|
7.
|
there are no claims, judgments or settlements against or owed by CBLI or pending or, to the best of its knowledge, threatened claims or litigation relating to the Licensed Rights;
|
|
8.
|
all application and renewal fees and other steps required for the maintenance or protection of the Licensed Rights have been paid on time or taken;
|
|
9.
|
there are no collaborative, licensing, transfer, supply, distributorship or marketing agreements or arrangements or other kinds of agreements to which CBLI or any of its Affiliates are party relating to any of the Licensed Rights or Products except those previously disclosed to Panacela in the Disclosure Schedules to the Investment Agreement;
|
|
10.
|
neither CBLI nor its Affiliates shall enter into any oral or written agreement or arrangement that would be inconsistent with CBLI’s obligations under this Agreement;
|
|
11.
|
to the best of CBLI’s knowledge after reasonable investigation, CCF does not own or hold any rights in any other patent or patent application, the claims of which would dominate the claims of a patent or patent application within the Licensed Patents as applied to the applicable Licensed Field; and
|
|
12.
|
to the best of CBLI’s knowledge after reasonable investigation, CBLI does not own or hold any rights in any other patent or patent application, the claims of which would dominate the claims of a patent or patent application within the Licensed Patents as applied to the applicable Licensed Field.
|
|
1.
|
except as set forth above in this Section V.A., CBLI makes no warranty or representation as to the validity or scope of any of the Licensed Patents;
|
|
2.
|
except as set forth above in this Section V.A, CBLI makes no warranty or representation that anything made, used, sold or otherwise disposed of under the license granted in this Agreement will or will not infringe patents of third parties; or
|
|
3.
|
nothing in this Agreement shall be construed as an obligation to furnish any know-how not provided in the Licensed Rights or any services, other than those specified in this Agreement.
|
|
1.
|
Panacela and its Affiliates are unaware of any pending or threatened claim or cause of action, or restriction on exportation, by any third party, whether a private or governmental entity, regarding any Licensed Patents, Products, CCF Technology, including regarding this license, and performance of this Agreement.
|
|
2.
|
Panacela will ensure that all CCF Technology and any other data or technological information of any sort provided by CBLI under this Agreement (“Data”) will be received and reviewed by an employee of Panacela who is a U.S. citizen or U.S. permanent resident and that Panacela with perform all necessary and appropriate export control evaluations, and secure any necessary export control licenses, before providing any such Data to any non-U.S. national or non-U.S. entity.
|
|
3.
|
Panacela will perform all necessary and appropriate export control evaluations, and secure any necessary export control licenses, before providing any Data or rights under this Agreement to any Affiliate or Sublicensee or any employee or agent of either.
|
|
4.
|
No Product will be developed by Panacela or its Affiliates for biodefense purposes.
|
|
5.
|
Products produced under the License granted herein shall be manufactured in accordance with all material respects with applicable international, foreign, federal, state and local laws, rules and regulations, including, without limitation, in accordance in all material respects with all applicable rules and regulations of the FDA and all applicable regulatory bodies.
|
|
(i)
|
If from Panacela to CBLI:
|
|
(ii)
|
If from Panacela to CCF:
|
|
(iii)
|
If from Panacela to CCIA:
|
|
(iv)
|
If from CBLI to Panacela:
|
|
1.
|
The recipient party can show by written record that it possessed the information prior to its receipt from the other Party;
|
|
2.
|
The information was already available to the public or became so through no fault of the recipient party;
|
|
3.
|
The information is subsequently disclosed to the recipient party by a third party that has the right to disclose it free of any obligations of the disclosing party; or
|
|
4.
|
The information is required by law or regulation to be disclosed; provided, however, that the Party subject to such disclosure requirement has provided written notice to the other Party promptly to enable such other Party to seek a protective order or otherwise prevent disclosure of such Confidential Information.
|
By:
|
/s/ Michael Fonstein, Ph.D.
|
Date: September 23, 2011
|
Name: Michael Fonstein, Ph.D.
|
||
Title: Chief Executive Officer
|
By:
|
/s/ Dmitry Tyomkin
|
Date: September 23, 2011
|
Name: Dmitry Tyomkin
|
||
Title: Chief Executive Officer
|
Country/Region
|
App. No.
|
Assignee/Owner
|
PCT
|
PCT/US04/040753
|
CCF
|
Australia
|
2004296828
|
CCF
|
Canada
|
2,547,869
|
CCF
|
China
|
200480041259.5
|
CCF
|
EAPO
|
200601079
|
CCF
|
EPO
|
04813124.7
|
CCF
|
Hong Kong
|
07108097.8
|
CCF
|
Israel
|
175974
|
CCF
|
India
|
3112/DELNP/2006
|
CCF
|
South Korea
|
10-2006-7010934
|
CCF
|
Singapore
|
200809013-6
|
CCF
|
Ukraine
|
a200607304
|
CCF
|
USA
|
12/617,653
|
CCF
|
USA
|
12/617,639
|
CCF
|
USA
|
11/421,918
|
CCF
|
Japan
|
2006-542849
|
CCF
|
Malaysia
|
PI 20062641
|
CCF
|
PCT
|
PCT/US05/046485
|
CCF/CBLI
|
US
|
11/722,682
|
CCF/CBLI
|
Europe
|
05855104.5
|
CCF/CBLI
|
Japan
|
2007-548451
|
CCF/CBLI
|
Israel
|
184140
|
CCF/CBLI
|
Pakistan
|
0680/2006
|
CCF/CBLI
|
Country/Region
|
App. No.
|
Assignee/Owner
|
PCT
|
PCT/US2005/016832
|
CCF/CCIA
|
US
|
11/579,779
|
CCF/CCIA
|
EPO
|
05748307.5
|
CCF/CCIA
|
Ireland
|
05748307.5
|
CCF/CCIA
|
Germany
|
05748307.5
|
CCF/CCIA
|
France
|
05748307.5
|
CCF/CCIA
|
Switzerland
|
05748307.5
|
CCF/CCIA
|
Great Britain
|
05748307.5
|
CCF/CCIA
|
New Zealand
|
551424
|
CCF/CCIA
|
Australia
|
2005244872
|
CCF/CCIA
|
Country/Region
|
App. No.
|
Assignee/Owner
|
PCT
|
PCT/US06/38440
|
CCF / CBLI
|
US
|
11/992,874
|
CCF / CBLI
|
CLEVELAND BIOLABS, INC.
|
||
/s/ Michael Fonstein, Ph.D.
|
||
Name:
|
Michael Fonstein, Ph.D.
|
|
Title:
|
Chief Executive Officer
|
|
PANACELA LABS, INC.
|
||
/s/ Dmitry Tyomkin
|
||
Name:
|
Dmitry Tyomkin
|
|
Title:
|
Chief Executive Officer
|
Country
|
Application/Patent No.
|
Owner
|
US Provisional
|
61/423,842
|
RPCI/CBLI
|
US Provisional
|
61/423,825
|
RPCI/CBLI
|
US Provisional
|
61/249,596
|
RPCI/CBLI
|
PCT
|
PCT/US10/51646
|
RPCI/CBLI
|
Country
|
Application/Patent No.
|
Owner
|
US Provisional
|
61/423,838
|
RPCI/CBLI
|
Country
|
Application/Patent No.
|
Owner
|
US Provisional
|
61/392,296
|
RPCI/CBLI/CCIA
|
US Provisional
|
61/423,832
|
RPCI/CBLI/CCIA
|
Country
|
Application/Patent No.
|
Owner
|
PCT
|
PCT/US06/38440
|
CCF/CBLI
|
US
|
11/992,874
|
CCF/CBLI
|
PCT
|
PCT/US2010/053916
|
RPCI/CBLI
|
US
|
61/254,395
|
RPCI/CBLI
|
Date: November 9, 2011
|
By:
|
/s/ Michael Fonstein
|
||||||
Michael Fonstein
|
||||||||
President and Chief Executive Officer
|
||||||||
(Principal Executive Officer)
|
Date: November 9, 2011
|
By:
|
/s/ C. Neil Lyons
|
||||||
Chief Financial Officer
|
||||||||
(Principal Financial Officer)
|
Dated: November 9, 2011
|
By:
|
/s/ MICHAEL FONSTEIN
|
||||||
Michael Fonstein
|
||||||||
Chief Executive Officer
|
||||||||
(Principal Executive Officer)
|
||||||||
Dated: November 9, 2011
|
By:
|
/s/ C. NEIL LYONS
|
||||||
C. Neil Lyons
|
||||||||
Chief Financial Officer
|
||||||||
(Principal Financial Officer)
|
*
|
This certification accompanies the Periodic Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Cleveland BioLabs, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Periodic Report), irrespective of any general incorporation language contained in such filing.
|