UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549
 
FORM 10-Q

(Mark One)
 
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended September 30, 2011
 
OR
 
¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from ____ to ____
 
Commission file number 001-32954
 
CLEVELAND BIOLABS, INC.
(Exact name of registrant as specified in its charter)
 
 
DELAWARE
 
20-0077155
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Employer Identification No.)
 
 
 
73 High Street, Buffalo, New York
 
14203
(Address of principal executive offices)
 
(Zip Code)
 
(Registrant’s telephone number, including area code)   (716) 849-6810
 
_______________________________________________
(Former name, former address and former fiscal year,
if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   x   No   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes   x   No   ¨
 
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
 
Large accelerated filer ¨
 
Accelerated filer x
 
Non-accelerated filer ¨
 
Smaller reporting company ¨
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
 
As of November 5, 2011, there were 35,511,651 shares outstanding of registrant's common stock, par value $0.005 per share.
 
 
 

 
 
CLEVELAND BIOLABS INC. AND SUBSIDIARY
10-Q
11/9/2011
 
 
TABLE OF CONTENTS
PAGE
     
PART I - FINANCIAL INFORMATION  
     
ITEM 1:
Consolidated Financial Statements
  1
     
 
Consolidated Balance Sheets as of September 30, 2011 and December 31, 2010
  1
     
 
Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2011 and 2010
  2
     
 
Consolidated Statement of Stockholders' Equity for the Nine Months Ended September 30, 2011
  3
     
 
Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2011 and 2010
  4
     
 
Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2011 and 2010
  5
     
 
Consolidated Notes to Financial Statements
  6
 
 
 
ITEM 2:
Management's Discussion and Analysis of Financial Condition and Results of Operations
  12
 
 
 
ITEM 3:
Quantitative and Qualitative Disclosures About Market Risk
  20
 
 
 
ITEM 4:
Controls and Procedures
  20
 
 
 
PART II - OTHER INFORMATION
 
 
 
 
ITEM 1:
Legal Proceedings
  21
 
 
 
ITEM 1A:
Risk Factors
  21
     
ITEM 2:
Unregistered Sales of Equity Securities and Use of Proceeds
  21
 
 
 
ITEM 3:
Defaults Upon Senior Securities
  21
 
 
 
ITEM 4:
Removed and Reserved
  21
 
 
 
ITEM 5:
Other Information
  21
 
 
 
ITEM 6:
Exhibits
  21
 
 
 
Signatures
  21

In this report, except as otherwise stated or the context otherwise requires, the terms “Cleveland BioLabs” and “CBLI” refer to Cleveland BioLabs, Inc., but not its consolidated subsidiary and the “Company,” “we,” “us” and “our” refer to Cleveland BioLabs, Inc. together with its consolidated subsidiary. Our common stock, par value $0.005 per share, is referred to as “common stock.”
 
 
 

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
 
CONSOLIDATED BALANCE SHEETS
 
             
   
September 30,
   
December 31,
 
   
2011
   
2010
 
   
(unaudited)
       
ASSETS
           
             
CURRENT ASSETS
           
Cash and equivalents
  $ 25,260,037     $ 10,918,537  
Short-term investments
    31,372       459,364  
Accounts receivable
    412,537       5,382,121  
Other current assets
    963,233       991,062  
Total current assets
    26,667,179       17,751,084  
                 
EQUIPMENT
               
Computer equipment
    557,223       400,892  
Lab equipment
    1,754,085       1,528,066  
Furniture
    522,696       397,013  
      2,834,004       2,325,971  
Less accumulated depreciation
    1,709,790       1,384,847  
      1,124,214       941,124  
                 
OTHER ASSETS
               
Intellectual property
    -       1,162,287  
Other long-term assets
    332,533       32,108  
      332,533       1,194,395  
                 
TOTAL ASSETS
  $ 28,123,926     $ 19,886,603  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
               
                 
CURRENT LIABILITIES
               
Accounts payable
  $ 1,329,026     $ 1,261,493  
Deferred revenue
    -       349,111  
Accrued expenses
    634,502       136,163  
Accrued bonuses
    -       3,321,131  
Accrued warrant liability
    6,013,294       25,350,733  
Total current liabilities
    7,976,822       30,418,631  
                 
LONG-TERM LIABILITIES
               
Deferred revenue
    -       1,968,107  
                 
Commitments and contingencies - See Note 1
    -       -  
                 
STOCKHOLDERS' EQUITY (DEFICIT)
               
Common stock, $.005 par value
               
Authorized - 80,000,000 shares, issued and outstanding
               
35,477,531 and 28,959,176 shares at September 30, 2011 and
               
December 31, 2010, respectively
    177,388       144,796  
Additional paid-in capital
    108,258,416       80,241,717  
Accumulated other comprehensive loss
    (81,857 )     (30,544 )
Accumulated deficit
    (92,876,154 )     (96,053,977 )
Total Cleveland BioLabs, Inc. stockholders' equity (deficit)
    15,477,793       (15,698,008 )
Noncontrolling interest in stockholders' equity
    4,669,311       3,197,873  
Total stockholders' equity (deficit)
    20,147,104       (12,500,135 )
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
  $ 28,123,926     $ 19,886,603  
 
See Notes to Consolidated Financial Statements
 
 
1

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
 
   
Three months ended
   
Nine months ended
 
   
September 30,
   
September 30,
   
September 30,
   
September 30,
 
   
2011
   
2010
   
2011
   
2010
 
REVENUES
                       
Grants and contracts
  $ 3,801,267     $ 3,189,488     $ 6,844,298     $ 11,570,599  
                                 
OPERATING EXPENSES
                               
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)
    4,082,770       (6,317,834     21,207,301       (8,133,268
                                 
NET INCOME/(LOSS)
    (2,878,554 )     (7,285,539 )     2,506,228       (13,178,458 )
                                 
                                 
LOSS ATTRIBUTABLE TO  NONCONTROLLING INTERESTS
    187,213       82,246       671,596       171,494  
                                 
NET INCOME/( LOSS) ATTRIBUTABLE TO CLEVELAND
                               
BIOLABS, INC.
  $ (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
  $ (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
    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  

See Notes to Consolidated Financial Statements

 
2

 
CLEVELAND BIOLABS, INC.  AND SUBSIDIARY
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
Nine months ended September 30, 2011
(unaudited)
 
               
Additional
   
Accumulated Other
             
         
Common
   
Paid-in
   
Comprehensive
   
Accumulated
   
Noncontrolling
 
   
Shares
   
Stock
   
Capital
   
Loss
   
Deficit
   
Interests
   
Total
 
Balance at January 1, 2011
    28,959,176     $ 144,796     $ 80,241,717     $ (30,544 )   $ (96,053,977 )   $ 3,197,873     $ (12,500,135 )
                                                         
Stock based compensation
    -       -       5,314,294       -       -       -       5,314,294  
Issuance of compensatory shares
    178,354       892       740,472       -       -       -       741,364  
Exercise of options
    186,090       930       526,204       -       -       -       527,134  
Exercise of warrants
    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
    -       -       (2,525,175 )     -       -       -       (2,525,175 )
Net income/(loss)
    -       -       -       -       3,177,824       (671,596 )     2,506,228  
Other comprehensive income
                                                 
Foreign currency translation
    -       -       -       (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  
 
See Notes to Consolidated Financial Statements

 
3

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(unaudited)
 
   
Three months ended
   
Nine months ended
 
   
September 30,
   
September 30,
   
September 30,
   
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
    (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.
  $ (2,933,909 )   $ (7,122,833 )   $ 3,126,511     $ (13,026,791 )
 
See Notes to Consolidated Financial Statements
 
 
4

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
(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
    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
    65,753       (882,961 )
Deferred revenue
    (2,317,218 )     (12,570 )
Accrued expenses
    499,006       (35,019 )
Accrued bonuses
    (328,951 )     -  
Net cash used in operating activities
    (10,609,458 )     (2,386,258 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES
               
Sale of short-term investments
    407,842       -  
Issuance of note to Panacela Labs, LLC
    (300,000 )     -  
Purchase of equipment
    (508,128 )     (384,424 )
Investment in patents
    (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
    21,946,801       4,508,673  
Noncontrolling interest capital contribution to Incuron, LLC
    2,340,374       3,509,402  
Exercise of options
    527,134       264,079  
Exercise of warrants
    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  
 
See Notes to Consolidated Financial Statements
 
 
5

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARY
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

1. Summary of significant accounting policies

Basis of presentation and consolidation
 
Cleveland BioLabs, Inc. (“CBLI”) is a clinical-stage biotechnology company focused on developing biodefense, tissue protection and cancer treatment drugs based on modulation of cell death for therapeutic benefit.  The accompanying unaudited consolidated financial statements include the accounts of CBLI and its majority-owned subsidiary, Incuron, LLC (“Incuron”) (collectively, the “Company”).   All significant intercompany balances and transactions have been eliminated in consolidation.

The unaudited consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010, as filed with the Securities and Exchange Commission.
 
In the opinion of the Company’s management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature, and are necessary to present fairly the financial position of the Company as of September 30, 2011, results of operations for the three and nine month periods ended September 30, 2011 and 2010, and cash flows for the nine month periods ended September 30, 2011 and 2010. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.

Intellectual property
 
During the quarter ended September 30, 2011, the Company performed its periodic review of capitalized patent costs and incorporated a more restrictive standard of capitalization widely utilized in the biotechnology industry, which includes a prerequisite of the U.S. Food and Drug Administration (“FDA”) marketability approval as one of several factors needed to justify the continued capitalization of costs associated with securing patents.  Given that the Company is currently developing requisite data towards submission to the FDA of new drug applications on its existing drug candidates, capitalized patent costs of approximately $1.5 million were expensed as general and administrative expenses during the three months ended September 30, 2011.  This item has been treated as a change in estimate in the accompanying financial statements.
 
Revenue recognition

Our revenue sources consist of government grants and government contracts.  Under cost reimbursement grants, revenue is recognized during the period that the costs are incurred.  Under fixed-cost grants, revenue is recognized using a percentage-of-completion method. The assumptions and estimates used in determination of the percentage-of-completion are developed in coordination with the principal investigator performing the work.

We recognize revenue related to the funds received under a sponsored research agreement with the Roswell Park Cancer Institute as allowable costs are incurred.  As of September 30, 2011, all grant revenue available to us under this sponsored research agreement was recognized.

Contingencies

From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business.  The Company accrues for liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.  For all periods presented, the Company is not a party to any pending material litigation or other material legal proceedings.

Earnings per share
 
Basic net income (loss) per share of common stock excludes dilution for potential common stock issuances and is computed by dividing net income (loss) by the weighted average number of shares outstanding for the period. Diluted net income per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock.  Diluted net loss per share is identical to basic net loss per share as potentially dilutive securities have been excluded from the calculation of the diluted net loss per common share because the inclusion of such securities would be anti-dilutive.
 
 
6

 
 
The following table presents the calculation of basic and diluted earnings (loss) per share for the three and nine months ended September 30, 2011 and 2010:
 
   
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 )
 
The dilutive securities above represent only those stock options and warrants whose exercise prices were less than the average market price of the Company’s common stock during the nine months ended September 30, 2011and therefore were dilutive.  Stock options to purchase 1,086,199 shares of common stock and warrants to purchase 225,000 shares of common stock are not included in the diluted calculation during the nine months ended September 30, 2011 because their exercise prices exceeded the average market price of the stock during the respective periods and, hence, the inclusion of such options and warrants would be anti-dilutive.

   Accounting for stock-based compensation
 
As of September 30, 2011, the Company has a stock-based compensation plan, the 2006 Equity Incentive Plan, as amended (the “Plan”), under which the Company is authorized to grant options to purchase common stock and restricted stock units.  The Company determines the fair value of restricted stock units using the closing market price of the Company’s common stock on the day prior to the date of grant.  The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted.  The fair value of each option is estimated on the date of grant.  Set forth below are the assumptions used in valuing the stock options granted and a discussion of the Company’s methodology for developing each of the assumptions used:
 
   
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.
 
 
7

 
 
Comprehensive income (loss)
 
Comprehensive income (loss) is comprised of net income (loss) attributable to the Company and other changes in equity that are excluded from net income (loss) attributable to the Company. The Company includes gains and losses incurred when converting its subsidiary’s financial statements from their functional currency to the U.S. dollar in accumulated other comprehensive income (loss).
 
Reclassifications
 
Certain amounts presented in the prior year financial statements have been reclassified to conform with the current year presentation.
 
2.  Fair value of financial instruments

The Company measures and records cash equivalents and warrant liabilities at fair value in the accompanying financial statements.  Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.  Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value include: 
 
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.
 
The Company used Level 3 inputs for valuation of the outstanding warrants.  Fair value was determined using the Black-Scholes valuation model based on the following assumptions as of September 30, 2011:
 
   
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 %
 
As of September 30, 2011, approximately $6.0 million of accrued warrant liability was measured using Level 3 inputs.
 
The following table sets forth a summary of changes in the fair value measurements using significant unobservable inputs (Level 3):
 
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
 
 
8

 

Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis, as documented above, from those measured at fair value on a nonrecurring basis.  As of September 30, 2011 and December 31, 2010, the Company had no assets or liabilities that were measured at fair value on a nonrecurring basis.
 
The carrying amounts of the Company’s short-term financial instruments, which include cash, accounts receivable and accounts payable, approximate their fair values due to their short maturities.

3. Noncontrolling Interests

On January 20, 2011 and March 14, 2011, Bioprocess Capital Ventures, the noncontrolling interest in Incuron, contributed 68.0 million Russian Rubles (approximately $2.3 million) and 1.73 million Russian Rubles (approximately $0.1 million), respectively, to Incuron, which increased their ownership percentage from 16.1% to 24.2% and decreased CBLI’s ownership percentage from 83.9% to 75.8%.

4. Stockholders’ Equity

During June 2011, CBLI issued 5,872,500 shares of its common stock and warrants to purchase a total of 2,936,250 shares of its common stock to certain accredited investors for gross proceeds of $23.5 million (the “June 2011 Common Stock Equity Offering”).  The common stock and warrants were sold in units, at a price of $4.00 per unit, with each unit consisting of: (i) one share of common stock; (ii) a Series E Warrant to purchase 0.25 of a share of common stock, with an exercise price of $4.50 per share; and (iii) a Series F Warrant to purchase 0.25 of a share of common stock, with an exercise price of $5.00 per share.  The Series E Warrants will be exercisable beginning six months following issuance and will expire on the twelve month anniversary of issuance.  The Series F Warrants will be exercisable beginning six months following issuance and will expire on the five year anniversary of issuance.  The number of shares issuable upon exercise of the warrants and the exercise price of the warrants are adjustable in the event of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.  In total, there were 5,872,500 shares of common stock, 1,468,125 Series E Warrants and 1,468,125 Series F Warrants issued to investors in this offering.

In addition, the placement agent received warrants to purchase up to 176,175 shares of common stock, equal to 3% of the aggregate number of shares of common stock sold in the offering.  The placement agent’s warrants have an exercise price of $5.00 per share, an initial exercise date on the six month anniversary of issuance and an expiration date of June 17, 2015. The number of shares issuable upon exercise of the placement agent’s warrants and the exercise price of such warrants are adjustable in the event of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.

In addition, the Series F warrants contain provisions that could require the Company to settle the warrants in cash, and  accordingly, have been classified as a liability.  The fair value of the Series F warrants at issuance amounted to $2,525,175 and was determined based on the following assumptions using the Black-Scholes valuation model.
 
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 %

Immediately after the completion of the June 2011 Common Stock Equity Offering, pursuant to weighted-average anti-dilution provisions of the Series B Warrants, the Series C Warrants and the warrants issued in March 2010, the following adjustments were made:

 
·  
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.

The Company has granted options to purchase shares of common stock and has granted restricted stock units under the Plan.   As of September 30, 2011, an aggregate of 7.0 million shares of common stock are authorized for issuance under the Plan, of which a total of approximately 1.2 million   shares of common stock remain available for future awards to be made to plan participants. The maximum number of shares subject to awards that may be granted per year under the 2006 Plan to a single participant is 400,000. The exercise price of each option must not be less than 100% of the fair market value of the shares underlying such option on the date of grant.  Awards granted under the Plan have a contractual life of no more than 10 years.  The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Plan are determined by the Company’s compensation committee, which administers the Plan.  Each equity award granted under the Plan vests as specified in the relevant agreement.
 
 
9

 
 
The following is a summary of option award activity under the Plan during the nine months ended September 30, 2011 :
 
         
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  
 
During the three months ended September 30, 2011 and 2010, the Company granted 396,524 and 175,499 stock options under the Plan, respectively.  The Company recognized a total of $675,784 and $387,490 in net expense related to stock options for the three months ended September 30, 2011 and 2010, respectively.  The Company granted 102,437 and 40,054 shares of stock under the Plan  and recognized a total of $280,054 and $169,224 in expense during the three months ended September 30, 2011 and 2010, respectively.

During the nine months ended September 30, 2011 and 2010, the Company granted 1,410,159 and 1,021,932 stock options under the Plan, respectively.  The Company recognized a total of $2,304,162 and $1,292,974 in net expense related to stock options for the nine months ended September 30, 2011 and 2010, respectively.  The Company granted 161,407 and 306,919 shares of stock under the Plan  and recognized a total of $664,194 and $1,097,808 in expense during the nine months ended September 30, 2011 and 2010, respectively.  In addition, the Company granted 11,947 and 34,000 shares of stock and recognized a total of $77,058 and $112,540 in expense related to shares issued during the nine months ended September 30, 2011 and 2010 that were outside of the Plan, respectively.

5. Warrants
 
The Company has issued warrants to strategic partners, consultants and investors with exercise prices ranging from $1.60 to $9.19.  The warrants expire between one and seven years from the date of grant, subject to the terms applicable in the agreement.  The following is a summary of warrant activity for the nine months ended September 30, 2011:

 
 
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  
 
 
10

 
 
6. Subsequent Events

On October 4, 2011, the Company consummated the transactions contemplated by the Investment Agreement, dated as of September 19, 2011 (the “Investment Agreement”),  with Panacela Labs, Inc., a Delaware corporation (“Panacela”), and an open joint stock company organized under the laws of the Russian Federation (“Rusnano”), to provide funding to Panacela for the Project (as defined below).  Panacela was incorporated on March 18, 2011 in anticipation of the transactions contemplated by the Investment Agreement and, in particular, to carry out a complete cycle of development, research, performance of clinical trials, production and sales of a line of pharmaceutical drugs for the treatment of oncological, infectious or other diseases (collectively, the “Project”).
 
Pursuant to the Investment Agreement, (i) the Company invested $3.0 million and, together with certain third-party owners, assigned and/or provided exclusive licenses, as applicable, to Panacela in respect of certain intellectual property necessary for the Project and (ii) Rusnano provided $9.0 million to Panacela with additional amounts of up to $17.0 million to be provided by Rusnano upon the achievement of certain development milestones as set forth in the Investment Agreement. The Company and Rusnano also received warrants in Panacela that will provide them with an option to increase their respective investments at two and four years following the initial investment.
 
Following the  closing, the Company has an initial ownership stake of approximately 55% in Panacela. It is anticipated that the Company will retain an ownership stake of approximately 51% in Panacela after giving effect to all subsequent investments by Rusnano, the exercise of all the warrants and the completion of the third party investment.  As a result, subsequent to the closing, Panacela became a consolidated subsidiary of the Company .
 
As of September 30, 2011, the Company had advanced $300,000 to Panacela, which was classified as Other Long-Term Assets on the Balance Sheet.  On October 4, 2011, an additional $2.7 million investment was made by the Company in satisfaction of its obligation to invest $3.0 million as referenced above.

 
11

 

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations

This management's discussion and analysis of financial condition and results of operations and other portions of this filing contain forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated by the forward-looking information. Factors that may cause such differences include, but are not limited to, availability and cost of financial resources, results of our research and development efforts and clinical trials, product demand, market acceptance and other factors discussed below and in our other SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2010. See also the Risk Factors discussed under Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2010 and our Quarterly Report on Form 10-Q for the period ended June 30, 2011. This management 's discussion and analysis of financial condition and results of operations should be read in conjunction with our financial statements and the related notes included elsewhere in this filing and in our Annual Report on Form 10-K for the year ended December 31, 2010.

GENERAL OVERVIEW

Cleveland BioLabs, Inc. (“CBLI”) is a clinical-stage biotechnology company focused on developing biodefense, tissue protection and cancer treatment drugs based on the concept of modulation of cell death for therapeutic benefit. CBLI was incorporated in Delaware and commenced business operations in June 2003. We have devoted substantially all of our resources to the identification, development and commercialization of new types of drugs for protection of normal tissues from exposure to radiation and other stresses, such as toxic chemicals and cancer treatments. Our pipeline includes products from two primary families of compounds: protectans and curaxins. We are developing protectans as drug candidates that protect healthy tissues from acute stresses such as radiation, chemotherapy and ischemia (a circulatory obstruction). Curaxins are being developed by Incuron, LLC, our majority-owned Russian subsidiary (“Incuron”), as anticancer agents that could act as monotherapy drugs or in combination with other existing anticancer therapies. Our common stock is listed on the NASDAQ Capital Market under the symbol “CBLI.”
 
Technology

Our development efforts are primarily based on discoveries made in connection with the investigation of the cell-level process known as apoptosis. Apoptosis is a highly specific and tightly regulated form of cell death that can occur in response to external events such as exposure to radiation, toxic chemicals or internal stresses. Apoptosis is a major determinant of tissue damage caused by a variety of medical conditions including cerebral stroke, heart attack and acute renal failure. Conversely, apoptosis is also an important protective mechanism that allows the body to shed itself of defective cells, which otherwise can cause cancerous growth.

Research has demonstrated that apoptosis is sometimes suppressed naturally. For example, most cancer cells develop resistance to apoptotic death caused by drugs or natural defenses of the human body. Our research is geared towards identifying the means by which apoptosis can be affected and manipulated depending on the need.

Severe toxicities of anticancer drugs and radiation and the resulting collateral damage to healthy tissues often limit their use and/or dosage in cancer patients.  A drug, which can ameliorate such toxicities, may enable a more aggressive treatment regimen using anticancer drugs and radiation and thereby increase their effectiveness.  Our preclinical studies demonstrated that that our drug candidates could temporarily and reversibly suppress apoptosis, which thereby increased resistance of normal tissues to cancer treatment without a decrease of its effect to cancer cells.  We also have accumulated animal data suggesting that the same mechanisms utilized by our drug candidates to suppress apoptosis may trigger an innate immune system response to cancers and, thus, have a direct anticancer effect .

Given that our drug candidates appear to suppress apoptotic death of normal cells under stress from radiation and chemotherapy, along with the stimulation of an autoimmune response leading to direct anti-cancer activity, we believe that our drug candidates could have broad clinical potential for cancer patients.

Through our research and development ("R&D"), and our strategic partnerships, we have established a technological foundation for the development of new pharmaceuticals and their rapid preclinical evaluation.

We have acquired rights to develop and commercialize the following prospective drugs:
 
 
·
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.
 
 
12

 
 
In the area of radiation protection, we have achieved high levels of protection in animal models. With respect to cancer treatment, the biology of cancer is such that there is no single drug that can be successfully used to treat a significant proportion of the large number of different cancers and there is wide variability in individual responses to most therapeutic agents. This means there is a continuing need for additional anticancer drugs for most cancers.

Our drug candidates demonstrate the value of our scientific foundation. Our most advanced drug candidate,  Protectan CBLB502, is under development for acute radiation syndrome targeting approval under the animal rule of the U.S. Food and Drug Administration (“FDA”) and has qualified for “Fast Track” status. Curaxin CBLC102 demonstrated activity and safety in a Phase IIa clinical trial concluded in late 2008. A multi-center clinical trial of Curaxin CBLC102 in patients with gastrointestinal and liver tumors in the Russian Federation continues to enroll patients and is expected to report data in 2012.

RESEARCH AND DEVELOPMENT

We are highly dependent on the success of our R&D efforts and, ultimately, upon regulatory approval and market acceptance of our products under development.

There are significant risks and uncertainties inherent in the preclinical and clinical studies associated with our R&D projects. As a result, the costs to complete such projects, as well as the period in which net cash outflows from such programs are expected to be incurred, may not be reasonably estimated. From our inception to September 30, 2011, we recognized $91,170,466 in R&D expenses. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Financial Overview” for a more detailed discussion of our R&D spending.
 
Our ability to complete our R&D on schedule is, however, subject to a number of risks and uncertainties.  In addition, we have sustained losses from operations in each fiscal year since our inception in June 2003, and we may exhaust our financial resources and be unable to complete the development of our products due to the substantial investment in R&D that will be required. We expect to spend substantial additional sums on the continued R&D of proprietary products and technologies with no certainty that we will ever become profitable as a result of our efforts.

The testing, marketing and manufacturing of any product for use in the U.S. will require approval from the FDA. We cannot predict with any certainty the amount of time necessary to obtain such FDA approval and whether any such approval will ultimately be granted. Preclinical studies and clinical trials may reveal that one or more products are ineffective or unsafe, in which event further development of such products could be seriously delayed or terminated. Delays in obtaining necessary regulatory approvals for any of our proposed products would have an adverse effect on the product’s potential commercial success and on our business, prospects, financial condition and results of operations. In addition, it is possible that a product may be found to be ineffective or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this event, we may be required to withdraw such product from the market. To the extent that our success will depend on any regulatory approvals from government authorities outside of the U.S. that perform roles similar to that of the FDA, uncertainties similar to those stated above will also exist.

PRODUCTS IN DEVELOPMENT

Protectans

We are exploring a new natural source of factors that temporarily suppress the programmed cell death (apoptosis) response in human cells, which can be developed into therapeutic products. These inhibitors, known as protectans, are anti-apoptotic factors developed by microorganisms of human microflora throughout millions of years of co-evolution with mammalian hosts.  We have established a technological process for screening these factors that provides for rapid preclinical evaluation. We believe these inhibitors may be used as protection from cancer treatment toxicities and antidotes against injuries induced by radiation and other stresses associated with ischemic injury (i.e., heart attack or stroke) or other pathologies.

Our lead protectan drug candidate, Protectan  CBLB502, is a rationally designed bio-engineered derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of apoptosis, reduction of oxidative damage, and induction of regeneration-promoting cytokines.  Protectan CBLB502 is being developed under the FDA's Animal Efficacy Rule for reducing the risk of or preventing death following total body irradiation during or after a radiation disaster and was granted Fast Track and Orphan Drug designations from the FDA for this indication. We are currently in discussions with the FDA to determine the scope and design of remaining development steps required to complete a Biologic License Application. In addition, we have recently opened an Investigational New Drug application (“IND”) for clinical testing of Protectan CBLB502 in a variety of oncologic patients.
 
 
13

 
 
We have accumulated preclinical data in numerous mouse and rat transplanted cancer models suggesting that the same mechanisms that suppress apoptosis may trigger an innate immune system response to cancers and, thus, have a direct anticancer effect. In one of the animal models using transplanted colon cancer, treatment with Protectan  CBLB502 resulted in the complete tumor regression with no recurrence of the disease in a large percentage of animals. Experimental results suggest that Protectan  CBLB502's anticancer effect involves tissue-specific activation of an innate immune system response mediated by Protectan  CBLB502's interaction with its receptor, TLR5. In addition, experimental results suggest that antitumor effects of Protectan  CBLB502 largely depend on the expression of TLR5 by the tumor. However, in the case of tumors residing in the liver, the organ  that we have identified as the natural primary target site for Protectan  CBLB502 activity, experimental results suggest that tumors become effectively suppressed as a result of host immune system attack regardless of their TLR5 status. This characteristic may make liver metastasis a favorable target for potential anticancer applications of Protectan  CBLB502, and is the focus of our recently announced clinical trial in patients with advanced cancers.
 
We recently announced the pre-publication of a study in the International Journal of Radiation Oncology, Biology and Physics  demonstrating Protectan  CBLB502's ability to provide protection against local radiation toxicity in mice and to inhibit tumor growth in mouse tumor models. This work provides the first demonstration of CBLB502's potential radioprotective efficacy in a model of localized irradiation of cancer and shows that it potentially has direct anticancer properties as well.

We also recently announced the publication of a study in The Journal of Immunology demonstrating that   CBLB502 may inhibit acute renal ischemic failure. Ischemia-reperfusion injury continues to be a major clinical problem causing significant morbidity and mortality in transplantation as well as in other surgeries. This study and previously collected data on Protectan CBLB502's efficacy against tourniquet-induced injury in animal models further reinforces our belief that Protectan CBLB502 may be efficacious in protecting against ischemic injury.
 
Curaxins

Curaxins are small molecules that are intended to destroy tumor cells by simultaneously targeting two regulators of apoptosis. A multi-center, Phase I single-dose ascending trial of Curaxin CBLC102 in patients with gastrointestinal and liver tumors in the Russian Federation is expected to be concluded in 2012. A Phase I clinical trial of the oral formulation of next generation Curaxin CBLC137 in solid tumors is planned to start in 2012 in the Russian Federation. An intravenous formulation of the compound is currently being developed to further optimize the bioavailability of CBLC137, with plans to initiate a Phase I trial in the United States as soon as formal preclinical toxicology and other preparations supporting an IND filing are completed.

In August, we announced the publication of findings regarding the mechanisms of action of curaxins in Science Translational Medicine. The findings highlighted by this publication introduce the possibility of both a novel anticancer target and a new class of DNA intercalators that may exert their function without genotoxic effects.
 
Recent Developments

On October 4, 2011, the Company consummated the transactions contemplated by the Investment Agreement, dated as of September 19, 2011 (the “Investment Agreement”), with Panacela Labs, Inc., a Delaware corporation (“Panacela”), and an open joint stock company organized under the laws of the Russian Federation (“Rusnano”), to provide funding to Panacela for the Project (as defined below).  Panacela was incorporated on March 18, 2011 in anticipation of the transactions contemplated by the Investment Agreement and, in particular, to carry out a complete cycle of development, research, performance of clinical trials, production and sales of a line of pharmaceutical drugs for the treatment of oncological, infectious or other diseases (collectively, the “Project”).
 
 
14

 
 
Pursuant to the Investment Agreement, (i) the Company invested $3.0 million and, together with certain third-party owners, assigned and/or provided exclusive licenses, as applicable, to Panacela in respect of certain intellectual property necessary for the Project and (ii) Rusnano provided $9.0 million to Panacela with additional amounts of up to $17.0 million to be provided by Rusnano upon the achievement of certain development milestones as set forth in the Investment Agreement. The Company and Rusnano also received warrants in Panacela that will provide them with an option to increase their respective investments at two and four years following the initial investment.

Following the closing, the Company has an initial ownership stake of approximately 55% in Panacela. It is anticipated that the Company will retain an ownership stake of approximately 51% in Panacela after giving effect to all subsequent investments by Rusnano, the exercise of all the warrants and the completion of the third party investment. As a result, subsequent to the closing, Panacela is a consolidated subsidiary of the Company.

FINANCIAL OVERVIEW

The following table sets forth our statement of operations data for the three and nine months ended September 30, 2011 and 2010 and should be read in conjunction with our financial statements and the related notes appearing elsewhere in this filing.
 
   
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 )
 
Critical Accounting Policies

We prepare our financial statements in conformity with accounting principles generally accepted in the United States. Such accounting principles require that our management make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. Our actual results could differ materially from those estimates. The items in our financial statements that have required us to make significant estimates and judgments are as follows:

Revenue recognition
 
Our primary  revenue sources consist of government grants and government contracts.  Under cost reimbursement grants, revenue is recognized during the period that the costs are incurred.  Under fixed-cost grants, revenue is recognized using a percentage-of-completion method. The assumptions and estimates used in determination of the percentage-of-completion are developed in coordination with the principal investigator performing the work.

Costs of pre-clinical studies and clinical trials
 
We accrue estimated costs for pre-clinical studies and clinical trials conducted by contract research organizations and participating hospitals. These costs are a significant component of R&D expenses. We accrue costs for pre-clinical studies and clinical trials performed by contract research organizations based on estimates of work performed under the contracts. Costs of setting up hospital sites for participation in trials are accrued immediately. Hospital costs related to patient enrollment are accrued as patients are entered in the trial.

Share-based payment
 
We account for share-based compensation based on the estimated grant date fair value of the award using the Black-Scholes option-pricing model. The estimated grant date fair value is recognized over the requisite service period.  Determining the appropriate fair value model and calculating the fair value of share-based payment awards require the input of highly subjective assumptions, including the expected life of the share-based payment awards and stock price volatility. Since our historical data is limited, the expected life was determined in accordance with SEC Staff Accounting Bulletin No. 107 guidance for "plain vanilla" options. We estimated the expected volatility based on closing prices of our common stock for a period consistent with the expected life of the option.   In those cases where the expected life of the option exceeds the trading history of the Company then the volatility of the common stock of comparable companies is layered in with that of the Company.   The assumptions used in calculating the fair value of share-based payment awards represent management's best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our stock-based compensation expense could be materially different in the future. See Note 1 to the consolidated financial statements for a further discussion on stock-based compensation and the relative ranges of our historical, underlying assumptions.

 
15

 
 
Research and development
 
We expense R&D costs as they are incurred. Our R&D expenses consist primarily of:
 
 
·
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.
 
We believe that significant investment in product development is a competitive necessity and plan to continue these investments in order to be in a position to realize the potential of our product candidates. We expect that spending for our product pipeline will increase as our product development activities continue based on ongoing advancement of our product candidates, and as we prepare for regulatory submissions and other regulatory activities. We expect that the magnitude of any increase in our R&D spending will be dependent upon such factors as the results from our ongoing preclinical studies and clinical trials, the size, structure and duration of any follow-on clinical programs that we may initiate, and costs associated with manufacturing our product candidates on a large-scale basis.
 
General and administrative
 
General and administrative expenses consist primarily of salaries and other related costs for personnel serving the executive, sales and marketing, business development, finance, accounting, information technology, legal and human resource functions. Other costs include facility costs not otherwise included in R&D expense and professional fees for accounting and legal services, including the legal costs in support of our intellectual property applications.

Three Months Ended September 30, 2011 Compared to Three Months Ended September 30, 2010
 
Revenue
 
Revenue increased from $3,189,488 for the three months ended September 30, 2010 to $3,801,267 for the three months ended September 30 2011, representing an increase of $611,779 or 19.2%.   This increase was due to an increase in research sponsored by the U.S. Department of Defense (“DoD”) of $655,726, and an increase in research sponsored by the Roswell Park Cancer Institute (“RPCI”) of $2,304,579, partially  offset by a decrease in research sponsored by the U.S. Biomedical Advanced Research Development Authority (“BARDA”) of $2,348,526.
 
Operating Expenses
 
Operating expenses increased from $4,157,193 for the three months ended September 30, 2010 to $10,762,591 for the three months ended September 30, 2011, representing an increase of $6,605,398 or 158.9%. We recognized a total of $933,589 of non-cash, stock-based compensation for the three months ended September 30, 2011 compared to $560,049 for the three months ended September 30, 2010. We recognized a total of $114,939 in depreciation and amortization charges for the three months ended September 30, 2011 compared to $101,550 for the three months ended September 30, 2010.  We recognized $ 1,481,318 in expense in connection with our change in estimates on capitalized patents for the three months ended September 30, 2011 compared to $0 for the three months ended September 30, 2010, as more fully described in Note 1 to the consolidated financial statements.  If these non-cash expenses were excluded, operating expenses would have increased from $3,495,594 for the three months ended September 30, 2010 to $ 8,232,745 for the three months ended September 30, 2011. This would have represented an increase in operating expenses of $ 4,737,206 or 135.5% as explained below.
 
 
16

 
 
R&D costs increased from $3,083,665 for the three months ended September 30, 2010 to $6,522,904 for the three months ended September 30, 2011. This represents an increase of $3,439,239 or 111.5%. We recognized a total of $250,792 of R&D non-cash, stock based compensation for the three months ended September 30, 2011 compared to $291,879 for the three months ended September 30, 2010. We recognized a total of $94,217 in R&D depreciation and amortization charges for the three months ended September 30, 2011 compared to $80,205 for the three months ended September 30, 2010.  Without the non-cash expenses, the R&D expenses would have increased from $2,711,582 for the three months ended September 30, 2010 to $6,177,895 for the three months ended September 30, 2011, representing an increase of $3,466,313 or 127.8%. The higher R&D expenses primarily resulted from increased R&D efforts by Incuron for a multi-center clinical trial with Curaxin CBLC102  that commenced patient enrollment towards the end of 2010, increases in expenditures to support preclinical animal studies for Protectan CBLB502 for defense applications and for Protectan CBLB612, increases in expenditures relating to manufacturing of Protectan CBLB502, and increases in expenditures relating to preparation for initiation of clinical studies for medical applications of Protectan CBLB502 .
 
   
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  
 
General and administrative costs increased from $1,073,528 for the three months ended September 30, 2010 to $4,239,687 for the three months ended September 30, 2011. This represents an increase of $3,166,159 or 294.9%. We recognized a total of $682,797 of non-cash, stock-based compensation under general and administrative costs for the three months ended September 30, 2011 compared to $268,170 for the three months ended September 30, 2010. We recognized a total of $20,722 in depreciation and amortization charges under general and administrative costs for the three months ended September 30, 2011 compared to $17,225 for the three months ended September 30, 2010.  We recognized $1,481,318 in expense for the change in estimates on patents for the three months ended September 30, 2011 compared to $0 for the three months ended September 30, 2010.  Without the non-cash expenses, the general and administrative expenses would have increased from $784,012 for the three months ended September 30, 2010 to $2,054,850 for the three months ended September 30, 2011, representing an increase of $ 1,270,838 or 162.1 %. This increase is due to expenses arising from an increase and change in the timing of our investor relations activities resulting from the challenging financial market environment of approximately $250,000; a tax credit recognized in 2010 of approximately $240,000; costs associated with the prosecution of patents, which the Company no longer capitalizes as referenced above and costs associated with the consummation of the Panacela transaction, referenced above, both totaling approximately $221,000; an increase in personnel related expenses, including personnel for Incuron, of approximately $165,000; expenses relating to severance and outside consulting services in connection with our chief financial officer transition of approximately $135,000; and other cost increases of approximately $260,000.
 
Other Income

Other income increased from an expense of $6,317,834 to income of $4,082,770 for the three months ended September 30, 2011, representing an increase of $10,400,604 or 164.6%.  This increase was primarily attributable to the periodic fair vauluation of the Company's warrant liability which was a non-cash expense of $6,408,248 for the three months ended Septmeber 30, 2010 as compared to  a non-cash gain of $3,993,439 for the three months ended September 30, 2011.

Nine Months Ended September 30, 2011 Compared to Nine Months Ended September 30, 2010
 
Revenue
 
Revenue decreased from $11,570,599 for the nine months ended September 30, 2010 to $6,844,298 for the nine months ended September 30 2011, representing a decrease of $4,726,301 or 40.8%. This resulted from a decrease in research sponsored by BARDA of $8,552,002 , which was partially offset by an increase in research sponsored by DoD of $1,521,053, and an increase in research sponsored by RPCI of $2,304,648.
 
Operating Expenses
 
Operating expenses increased from $16,615,789 for the nine months ended September 30, 2010 to $25,545,371 for the nine months ended September 30, 2011, representing an increase of $8,929,582 or 53.7%. We recognized a total of $3,063,477 of non-cash, stock-based compensation for the nine months ended September 30, 2011 compared to $3,753,152 for the nine months ended September 30, 2010. We recognized a total of $338,097 in depreciation and amortization charges for the nine months ended September 30, 2011 compared to $301,227 for the nine months ended September 30, 2010.  We recognized $ 1,481,318 in expense for the change in estimates on patents for the three months ended September 30, 2011 compared to $0 for the three months ended September 30, 2010, as more fully described in Note 1 to the consolidated financial statements.  If these non-cash expenses were excluded, operating expenses would have increased from $12,561,410 for the nine months ended September 30, 2010 to $20,662,479 for the nine months ended September 30, 2011. This would have represented an increase in operating expenses of $8 ,101,069 or 64.5% as explained below.
 
 
17

 
 
R&D costs increased from $10,951,560 for the nine months ended September 30, 2010 to $17,441,031 for the nine months ended September 30, 2011. This represents an increase of $6,489,471 or 59.3%. We recognized a total of $1,412,248 of R&D non-cash, stock based compensation for the nine months ended September 30, 2011 compared to $648,735 for the nine months ended September 30, 2010. We recognized a total of $265,070 in R&D depreciation and amortization charges for the nine months ended September 30, 2011 compared to $238,320 for the nine months ended September 30, 2010.  Without the non-cash expenses, the R&D expenses would have increased from $10,064,505 for the nine months ended September 30, 2010 to $15,763,713 for the nine months ended September 30, 2011, representing an increase of $5,669,208 or 56.6%. The higher R&D expenses primarily resulted from increased R&D efforts by Incuron for a multi-center clinical trial with Curaxin CBLC102 that commenced patient enrollment towards the end of 2010, increases in expenditures to support preclinical animal studies for Protectan CBLB502 for defense applications and for Protectan CBLB612, increases in expenditures relating to manufacturing of Protectan CBLB502, and increases in expenditures relating to preparation for initiation of clinical studies for medical applications of Protectan CBLB502 .
 
 
   
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  
 
General and administrative costs increased from $5,664,229 for the nine months ended September 30, 2010 to $8,104,340 for the nine months ended September 30, 2011. This represents an increase of $2,440,111 or 43.1%. We recognized a total of $1,651,229 of non-cash, stock-based compensation under general and administrative costs for the nine months ended September 30, 2011 compared to $2,134,216 for the nine months ended September 30, 2010. We recognized a total of $73,027 in depreciation and amortization charges under general and administrative costs for the nine months ended September 30, 2011 compared to $62,907 for the nine months ended September 30, 2010.  We recognized $1, 481,318 in expense for the change in estimates on patents for the nine months ended September 30, 2011 compared to $0 for the three months ended September 30, 2010.  Without the non-cash expenses, the general and administrative expenses would have increased from $3,467,106 for the nine months ended September 30, 2010 to $4,898,766 for the nine months ended September 30, 2011, representing an increase of $1, 431,661 or 41.3%.  This increase is due to an increase in personnel related expenses of approximately $269,000 for Incuron which commenced operations in May 2010 and approximately $402,000 for CBLI; costs associated with the prosecution of patents, which the Company no longer capitalizes as referenced above and costs associated with the creation of Panacela and the consummation of the Panacela transaction, as described above, both totaling approximately $270,000; a tax credit recognized in 2010 of approximately $240,000; expenses related to severance and outside consulting services in connection with our chief financial officer transition of approximately $135,000; expenses related to an increase in our year-to-date investor relations activities resulting from the challenging financial market environment of approximately $90,000; and other cost increases of approximately $26,000.
 
Other Income/Expense

Other income increased from an expense of $8,133,268 to income of $21,207,301 for the nine months ended September 30, 2011, representing an increase of $29,340,569 or 360.7%.  This increase in other income was primarily attributable to the periodic fair valuation of the Company's warrant liability which was a non-cash expense of $8,105,544 for the nine months ended September 30, 2010 as compared to a non-cash gain of $21,094,452 for the nine months ended September 30, 2011.
 
Liquidity and Capital Resources

Our total cash and equivalents, short-term investments and accounts receivable increased from $16,760,022 at December 31, 2010 to $25,703,946 at September 30, 2011.  This increase of $8,943,924 or 53.4% was primarily due to the proceeds from the June 2011 financing, capital contributions to Incuron from our joint venture partner, Bioprocess Capital Ventures, and cash proceeds from the exercise of warrants and options, partially offset by our operating losses.

We have incurred annual operating losses since our inception, and, as of September 30, 2011, we had an accumulated deficit of $92,876,154.  Our principal sources of liquidity have been cash provided by sales of our securities, government grants and contracts and licensing agreements. Our principal uses of cash have been R&D and working capital. We expect our future sources of liquidity to be primarily government contracts and grants, equity financing, licensing fees and milestone payments in the event we enter into licensing agreements with third parties, and research collaboration fees in the event we enter into research collaborations with third parties .
 
 
18

 
 
Net cash used in operating activities totaled $10,609,438 for the nine months ended September 30, 2011, compared to $2,386,259 used in operating activities for the nine months ended September 30, 2010. This increase in cash used in operating activities resulted from increased activities on the part of our consolidated subsidiary, Incuron for a milti-center clinical trial with Curaxin CBLC102 that commenced patient enrollment towards the end of 2010, pre-clinical  animal studies for Protectan  CBLB502 for defense applications and Protectan CBLB612, increases in expenditures relating to manufacturing of Protectan CBLB502, and increases in expenditures relating to preparation for initiation of clinical studies for medical applications of Protectan CBLB502 , combined with a reduction in sponsored research funding by BARDA.

Net cash used in investing activities was $722,830 for the nine months ended September 30, 2011, compared to net cash used in investing activities of $511,499 for the nine months ended September 30, 2010. The increase in cash used in investing activities resulted from increased investment in equipment and intellectual property in the first nine months of 2010 as compared to the first nine months of 2010, a loan to Panacela's as more fully described in Note 6 to the consolidated financial statements, partially offset by a reduction in our short-term investments. .

Net cash provided by financing activities totaled $25,764,102 for the nine months ended September 30, 2011, compared to net cash provided by financing activities of $8,368,897 for the nine months ended September 30, 2010.  This increase in cash provided by financial activities was primarily attributed to the larger June 2011 equity offering that took place in the first nine months of 2011 as compared to the March 2010 equity offering that took place in the first nine months of 2010.
 
We believe that although existing cash resources will be sufficient to finance our currently planned operations beyond the next twelve months, these amounts will not be sufficient to meet our longer-term cash requirements, including our cash requirements for the commercialization of certain of our drug candidates currently in development. We may be required to issue equity or debt securities or enter into other financial arrangements, including relationships with corporate and other partners, in order to raise additional capital. Depending upon market conditions, we may not be successful in raising sufficient additional capital for our long-term requirements. In such event, our business, prospects, financial condition and results of operations could be materially adversely affected.

Impact of Inflation

We believe that our results of operations are not dependent upon moderate changes in inflation rates.

Impact of Exchange Rate Fluctuations

From time-to-time our operations are somewhat dependent upon changes in foreign currency exchange rates, however at September 30, 2011, we were not obligated to make payments in foreign currencies.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements.
 
 
19

 
 
Item 3: Quantitative and Qualitative Disclosures About Market Risk

There has been no significant change in our exposure to market risk during the first nine months of 2011. For a discussion of our exposure to market risk, refer to Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” contained in our Annual Report on Form 10-K for the year ended December 31, 2010 and Part II, Item 1.A. of our Quarterly Report on Form 10-Q for the period ended June 30, 2011 .

Item 4: Controls and Procedures

Effectiveness of Disclosure

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act as of September 30, 2011. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2011, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective to assure that information required to be declared by us in reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act) during the fiscal quarter ended September 30, 2011, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 
20

 

PART II - Other Information

Item 1. Legal Proceedings

As of September 30, 2011, we were not a party to any litigation or other legal proceeding.

Item 1A. Risk Factors

There have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the period ended December 31, 2010 and our previously filed Quarterly Reports on Form 10-Q. For a further discussion of our Risk Factors, refer to the “Risk Factors” discussion contained in our Annual Report on Form 10-K for the period ended December 31, 2010 and Part II, Item 1.A. of our Quarterly Report on Form 10-Q for the period ended June 30, 2011 .
 
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Removed and Reserved

Item 5. Other Information

None.

Item 6. Exhibits
 
(a) The following exhibits are included as part of this report:

 
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.*

*             Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections .

           Confidential treatment has been requested from the Securities and Exchange Commission as to certain portions of this document.
 
 
21

 
 
Signatures

In accordance with the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 
CLEVELAND BIOLABS, INC.
 
       
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)
 
 
 
22

 

 

Exhibit 10.1

INVESTMENT AGREEMENT
 
THIS INVESTMENT AGREEMENT (together with all Exhibits and Schedules attached hereto, which are incorporated herein and constitute part hereof, this “ Agreement ”) is dated as of the Effective Date (as defined below), by and among PANACELA LABS, INC., a Delaware corporation (the “ Company ”), CLEVELAND BIOLABS, INC., a Delaware corporation (“ CBLI ”), and Open Joint Stock Company “RUSNANO”, a company organized under the laws of the Russian Federation (“ Rusnano ” and, together with CBLI, the “ Investors ” and the Investors, together with the Company, the “ Parties ” and, each, a “ Party ”).
 
RECITALS
 
A.           CBLI caused the incorporation of the Company in Delaware on March 18, 2011 and the formation of Limited Liability Company “Panacela Labs”, a limited liability company formed under the laws of the Russian Federation (the “ Russian Entity ”) on July 14, 2011 in anticipation of the transactions contemplated hereby. The Company is the sole participant of the Russian Entity.
 
B.           The Parties shall exercise their best efforts to carry out a complete cycle of development, research, performance of clinical trials, production and sales of innovative pharmaceutical Portfolio Drugs (as defined below) to be used for treatment of oncological, infectious or other diseases in the Russian Federation and leading global markets to be selected by the Investors, to be implemented through the Company and the Russian Entity.
 
C.           In furtherance of the foregoing, the Investors wish to participate in the ownership and operation of the Company and through it, of the Russian Entity, in accordance with the terms and conditions of this Agreement and other Transaction Agreements as defined and referred to herein.
 
D.           The Parties desire to confirm their agreement to consummate the transactions contemplated by, and on the terms and subject to the conditions set forth in, this Agreement and the other Transaction Agreements on the Closing Date (as defined below), and to set forth the various agreements and actions to be taken by the Parties in order to do so.
 
NOW, THEREFORE, in consideration of the foregoing premises, agreements and the mutual covenants herein contained and upon the terms and conditions hereinafter set forth, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be mutually bound, hereby agree as follows:
 
ARTICLE I
 
DEFINITIONS
 
As used in this Agreement, in addition to the various terms defined elsewhere in this Agreement, the following terms shall have the following meanings:
 
(a)                 “ Affiliate ” means, with respect to any Person, any other Person that directly or indirectly Controls or is Controlled by or is under common Control with such Person.

 
 

 
 
(b)                 “ Business Day ” means a day (other than a Saturday or Sunday) on which banks are generally open for business in Moscow, the Russian Federation, and New York, New York, the United States of America.
 
(c)                 “ Business of the Company ” has the meaning set forth in Section 2.1 .
 
(d)                 “ Business Plan ” means a document prepared by the Chief Executive Officer of the Company and approved by the board of directors of the Company in accordance with Section 2.2, which consists of a detailed investment plan and an action plan for fulfillment of the Project’s goals. Business Plan shall be adopted for a seven-year term   and shall consist of the following main parts: the Milestones, an action plan in respect of fulfillment of the Milestones, including a plan for scientific and research works and technological developments, and a financial plan that includes but is not limited to (i) profit and loss forecast, (ii) cash flow forecast and (iii) balance sheet forecast.
 
(e)                 “ Bylaws ” has the meaning set forth in Section 3.1(c) .
 
(f)                 “ CBLI Subscription Agreement ” means that certain Subscription Agreement, dated as of the Closing Date, between CBLI and the Company.
 
(g)                 “ CCF ” means Cleveland Clinic Foundation, a non-profit Ohio corporation.
 
(h)                 “ CCIA ” means Children’s Cancer Institute Australia for Medical Research, an Australian not for profit medical research institute with registration number ACN 072 279 559.
 
(i)                 “ Charter ” has the meaning set forth in Section 3.1(c) .
 
(j)                 “ Closing ” includes the Initial Closing, the Second Closing, the Third Closing and the Fourth Closing, and the term “ Closings ” means all of the foregoing, collectively.
 
(k)                 “ Closing Date ” means, unless the context otherwise requires and unless otherwise expressly stated herein, the date on which the Initial Closing occurs under this Agreement.
 
(l)                 “ Common Stock ” means the shares of common stock, par value $0.001 per share, of the Company.
 
(m)                 “ Company Escrow Account ” means the operating bank account established by the Company with a commercial bank of its choice in the U.S., which shall at all times comply with the requirements of Section 6.6(c)-(d).
 
(n)           “ Company Escrow Agreement ” means that certain Company Escrow Agreement or similar agreement, dated as of the Closing Date, among the Company, JPMorgan Chase Bank, National Association, and Rusnano.
 
(o)           “ Company Indemnitees ” has the meaning set forth in Section 10.1(b) .

 
2

 

           (p)           “ Control ” means possession, directly or indirectly, of power to direct or cause the direction of management, business, decisions or policies (whether through ownership of securities or partnership or other ownership interests, by contract or otherwise) of any other Person, provided that, in any event, any Person which owns, directly or indirectly, a majority of the securities having ordinary voting power or otherwise the majority of votes for the election of directors or other governing body of a corporation or a majority of the partnership or other ownership interests of any other Person (other than as a limited partner of such other Person) will be deemed to control such corporation or other Person (whereby their correlative meanings, “ Controlled by ” and “ under Control ” shall be construed accordingly).
 
(q)           “ Co-Investor ” has the meaning set forth in Section 5.4 .
 
(r)           “ Effective Date ” means the date on which all Parties will have executed and delivered this Agreement.
 
(s)           “ Fiscal Year ” means the period starting on January 1 and ending on the following December 31 (both dates inclusive).
 
(t)           “ Fourth Closing ” has the meaning set forth on Schedule 5.1(c)(ii) hereto .
 
(u)           “ Governmental Body ” means any federal, state, municipal, local or foreign governmental authority, department, commission, board, bureau, regulatory or administrative agency or official, court, tribunal, instrumentality, political subdivision or taxing authority.
 
(v)           “ Initial Closing ” has the meaning set forth in Section 5.1 .
 
(w)           “ Intellectual Property Agreements ” means all of the license and/or sublicense agreements, assignment agreements, letter agreements, acknowledgements and amendments listed on Exhibit A.
 
(x)           “ Knowledge of CBLI ” or words of similar import means the knowledge of CBLI after reasonable investigation.
 
(y)           “ Knowledge of the Company ” or words of similar import means the knowledge of the Company after reasonable investigation.
 
(z)           “ Law ” means any federal, state, local, municipal, foreign, international, multinational, or other constitution, law, statute, treaty, rule, regulation, ordinance, code, binding case law or principle of common law.
 
(aa)         “ Litigation ” means any action, suit, investigations proceeding or litigation.
 
(bb)        “ Liens ” means all claims, liens, charges, encumbrances and security interests of any kind or nature whatsoever.
 
(cc)         “ Losses ” means any and all damages, fines, fees, taxes, penalties, deficiencies, losses and expenses, including interest, reasonable expenses of investigation, court costs, reasonable fees and expenses of attorneys, accountants and other experts or other expenses of Litigation or other proceedings or of any claim, default or assessment (including reasonable fees and expenses of attorneys incurred in connection with the investigation or defense of any claim, default or assessment or asserting or disputing any rights under this Agreement.

 
3

 
 
(dd)        “ Milestones ” means key events (indicators) of the Project which are essential for fulfilment of interim and ultimate objectives of the Project specified in Schedule 1(dd) hereto.
 
(ee)         “ Monitoring Regulation ” means the Regulations on Monitoring and Control of the OJSC “RUSNANO” Investment Assets Used by the Company and the Russian Entity attached as Schedule III to the Stockholders Agreement, as the same may be updated or supplemented by Rusnano from time to time.
 
(ff)           “ New Board ” has the meaning set forth in Section 7.1(vi)(C).
 
(gg)        “ Note ” means that certain Convertible Promissory Note made by the Company for the benefit of CBLI in the principal amount of $300,000 on July 8, 2011, as amended and restated by the date of the Initial Closing.
 
(hh)        “ Order ” means any order, injunction, judgment, decree, ruling, writ, assessment or arbitration award.
 
(ii)           “ Other Indemnitees ” has the meaning set forth in Section 10.1(c).
 
(jj)           “ Person ” means any individual, corporation, company, limited liability company, partnership, joint venture, trust, association, unincorporated organization, or other entity or group, including any Governmental Body.
 
(kk)         “ Plan ” means the Company Stock Plan adopted effective July 21, 2011, together with ancillary agreements, instruments and documents annexed thereto and part thereof, as the same may be modified or amended from time to time.
 
(ll)           “ Portfolio Drugs ” means the pharmaceutical drug candidates set forth on Schedule 1(ll) hereto.
 
(mm)       “ Pre-Closing Escrow Agreement ” means that certain Escrow Agreement, dated as of the date of this Agreement, among the Company, Rusnano and JPMorgan Chase Bank, National Association, in its capacity as the escrow agent thereunder with respect to the funds to be released upon the Initial Closing consummated under this Agreement.
 
(nn)        “ Preferred Stock ” means the shares of Series A Preferred Stock, par value $0.001 per share, of the Company.
 
(oo)        “ Project ” has the meaning set forth in Section 2.1 .
 
(pp)        “ Proprietary Information ” has the meaning set forth in Section 9.2.
 
(qq)        “ Released Parties ” has the meaning set forth in Section 8.2.
 
(rr)          “ Releasing Parties ” has the meaning set forth in Section 8.2 .

 
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(ss)         “ RPCI ” means Roswell Park Cancer Institute, a New York Public Benefit Corporation.
 
(tt)          “ Russian Entity ” has the meaning set forth in the recitals hereto.
 
(uu)        “ Russian Entity Special Account ” means the bank account of the Russian Entity established pursuant to the Special Account Agreement, which shall at all times comply with the requirements of Section 6.6(a)-(b).
 
(vv)        “ Rusnano Subscription Agreement ” means that certain Subscription Agreement, dated as of the Closing Date, between Rusnano and the Company.
 
(ww)       “ Russian Entity Charter ” has the meaning set forth in Section 3.2(b).
 
(xx)          “ Second Closing ” has the meaning set forth on Schedule 5.1(c)(ii) hereto.
 
(yy)        “ Service Agreement ” means that certain Service Agreement between the Company and the Russian Entity, relating to the provisions of certain services in respect of the Project by the Company to the Russian Entity.
 
(zz)          “ Shares ” has the meaning set forth in Section 5.1(b)(iii) .
 
(aaa)       “ Special Account Agreement ” means that certain Special Account Agreement, dated as of the Closing Date, among the Russian Entity and Open Joint Stock Company “Alfa Bank” or any other bank agreed by the Parties.
 
(bbb)      “ Stockholders Agreement ” means that certain Stockholders and Investor Rights Agreement, dated as of the Closing Date, among the Company, CBLI, Rusnano and the other stockholders of the Company party thereto.
 
(ccc)       “ Subsidiary ” means, with respect to a specified Person, any other Person of which securities or other interests having the power to elect a majority of that other Person’s board of directors or similar governing body, or otherwise having the power to direct the business and policies of that corporation or other Person (other than securities or other interests having such power only upon the happening of a contingency that has not occurred) are held by the specified Person or one or more of its Subsidiaries.
 
(ddd)      “ Third Closing ” has the meaning set forth on Schedule 5.1(c)(ii) hereto.
 
(eee)       “ Transaction Agreements ” means, collectively, this Agreement, the Pre-Closing Escrow Agreement, the Intellectual Property Agreements, the Stockholders Agreement, the CBLI Subscription Agreement, the Rusnano Subscription Agreement, the Special Account Agreement, the Company Escrow Agreement and the Warrants.
 
(fff)       “ Transferred IP ” has the meaning set forth in Section 2.1 .

 
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(ggg)      “ US GAAP ” means U.S. generally accepted accounting principles and practices for financial reporting as in effect from time to time and applied consistently throughout the periods involved.
 
(hhh)      “ Warrants ” means, collectively, the First CBLI Warrant, the Second CBLI Warrant, the First Rusnano Warrant and the Second Rusnano Warrant (each such term as defined in Section 6.5 herein), each dated as of the Closing Date, to be issued by the Company to each Investor on the terms set forth therein and in this Agreement, and the term “ Warrant ” means any thereof.
 
(iii)          “ Withdrawing Party ” has the meaning set forth in Section 8.2 .
 
ARTICLE II
 
BUSINESS OF THE CORPORATION
 
2.1            Scope of Business.   The Parties shall exercise their best efforts to carry out a complete cycle of development, research, performance of clinical trials, production and sales of innovative Portfolio Drugs to be used for treatment of oncological, infectious or other diseases in the Russian Federation and leading global markets to be selected by the Investors (the “ Business of the Company ”).  The Business of the Company will be carried out through the Company and its wholly-owned subsidiary, the Russian Entity, the activities of which shall comply with this Agreement, including without limitation, Section 6.6 .  The activities of the Company and the Russian Entity will utilize the intellectual property listed on Schedule 2.1(i) hereto as specifically provided for in the Intellectual Property Agreements (the “ Transferred IP ”) and the intellectual property resulting from research and development activities of the Company and the Russian Entity as provided for in Section 6.3 and as expected by the Parties to occur in development stages listed on Schedule 2.1(ii) hereto (the foregoing activities as applicable from time to time, the “ Project ”).
 
2.2            Business Plan.   The New Board shall approve a Business Plan of the Company no later than 30 days after the date on which the Initial Closing occurs.  At least 60 days prior to the completion of each Fiscal Year of the Company, the New Board or each subsequent board of directors of the Company will, subject to compliance with the terms of this Agreement and the other Transaction Agreements, adopt a revised Business Plan for each subsequent Fiscal Year.
 
ARTICLE III
 
FORMATION OF THE COMPANY AND THE RUSSIAN ENTITY
 
3.1            Formation, Charter and Capitalization of the Company.
 
(a)           CBLI caused the Company to be incorporated on March 18, 2011 under the laws of the State of Delaware, U.S., in the form of a corporation, under the name of “BioTar, Inc.” and thereafter on May 11, 2011 to change the name of the Company to its current name, “Panacela Labs, Inc.”

 
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(b)           Copies of the certificate of incorporation, as amended, and the bylaws of the Company have been delivered by CBLI to Rusnano.
 
(c)           The current capitalization of the Company on the date of this Agreement is set forth in Schedule 3.1 (Table 1) hereto.  Company shall take or cause to be taken any and all necessary actions in order that, at the Closing Date (i) the Company shall have the share capital in accordance with this Agreement, as listed on Schedule 3.1 (Table 3) hereto; (ii) the Company shall have the amended and restated certificate of incorporation (the “ Charter ”) substantially in the form attached hereto as Exhibit B-1 ; and (iii) the Company shall have the amended and restated bylaws (the “ Bylaws ”) substantially in the form attached hereto as Exhibit B-2.   The actions contemplated to be taken by this Section 3.1 shall include, without limitation, the adoption of the stockholders resolution to approve and adopt the Charter and to approve the issuance of the Company’s capital stock consistent herewith and therewith.
 
3.2            Formation, Charter and Capitalization of the Russian Entity .
 
(a)           As of the date of this Agreement, the Company is the sole participant in the Russian Entity, formed in accordance with the Law of the Russian Federation.
 
(b)           Copies of the formation documents of the Russian Entity have been delivered previously by CBLI to Rusnano.  The charter of the Russian Entity in its current form on the date of this Agreement is attached as Exhibit C hereto (the “ Russian Entity Charter ”).
 
(c)           At the Closing Date, the charter capital of the Russian Entity will be as listed on Schedule 3.2 hereto.
 
ARTICLE IV
 
REPRESENTATIONS AND WARRANTIES
 
4.1            Representations and Warranties of the Company and CBLI to Rusnano .  As an inducement for Rusnano to participate in the Project, CBLI and the Company, jointly and severally hereby represent and warrant to Rusnano as of the date of this Agreement (unless otherwise expressly stated in the Schedules hereto) and as of the Closing Date as follows:
 
(a)            Representations and Warranties Regarding the Company:
 
(i)           The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware.  The Company has all requisite power and authority to own, lease and operate its properties and assets and to carry on the Business of the Company as it is now being conducted.
 
(ii)          The Company is maintaining and has always maintained true and complete copies of (A) the certificate of incorporation; (B) the bylaws; (C) minutes of meetings, or written consents in lieu of meetings, of the stockholders and the board of directors; (D) stock certificates and stock transfer ledgers; and (E) other organizational documents. The Company is not in default under or in violation of any provision of its organizational documents. The Company has not had any proceedings of the board of directors or its stockholders, other than those for which true, correct and complete copies have been delivered by the Company and CBLI to Rusnano.

 
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(iii)         The Company has all requisite corporate power and authority to execute and deliver this Agreement, the other Transaction Agreements to which it is a party and other agreements and documents to be delivered by the Company in connection with this Agreement or the Project contemplated hereby, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby.  The execution, delivery and performance by the Company of this Agreement, the other Transaction Agreements to which it is a party and other agreements to be executed and performed by the Company in connection with this Agreement or the Project contemplated hereby have been duly and validly authorized by all requisite corporate action, and no other corporate proceeding or action on the part of the Company, the board of directors of the Company, or the Company stockholders is necessary to authorize execution, delivery and performance of this Agreement, the other Transaction Agreements and other agreements to be executed and performed by the Company in connection herewith and therewith.  This Agreement and the other Transaction Agreements do not violate the provisions of the Company’s certificate of incorporation or bylaws and constitute the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with their terms, except that enforceability thereof may be limited by (A) applicable bankruptcy, insolvency, reorganization, moratorium and similar laws affecting creditors’ rights generally and (B) equitable principles which may limit the availability of certain equitable remedies (such as specific performance).
 
(iv)        Except as set forth on Schedule 4.1(a)(iv) , neither the execution and delivery of this Agreement and the other Transaction Agreements nor the consummation of the transactions contemplated hereby and thereby will (i) violate, result in a breach of any of the terms or provisions of, constitute a default (or any event which, with the giving of notice or the passage of time or both, would constitute a default under, result in the acceleration of any indebtedness under or performance required by, result in any right of termination of, increase any amounts payable under, decrease any amounts receivable under, change any other rights pursuant to, or conflict with, any material agreement, trust, indenture, mortgage, loan agreement or other instrument to which the Company is a party or by which any of its properties is bound, the organizational documents of the Company, or any Law, rule, regulation or Order of any court, Governmental Body or arbitrator applicable to the Company; or (ii) affirmatively require any consent, approval, authorization or permit of or from, or filing with or notification to, any Governmental Body, except for such consents, approvals, authorizations, permits or filings which will have been obtained by the Initial Closing and those referenced in the certificate to be delivered pursuant to Section 7.4(iv) .
 
(v)         With the exception of the Russian Entity, the Company has never had, and currently does not have, any other Subsidiaries.
 
(vi)        Upon filing of the Charter with the Secretary of State of the State of Delaware the authorized capital stock of the Company will consist of 137,420 shares of Common Stock of the Company par value $0.001 per share and 102,580 shares of Preferred Stock of the Company par value $0.001 per share. Tables 2 and 3 of Schedule 3.1 accurately set forth the total number of issued and outstanding shares (in each case, on a fully diluted basis) of the Company Common Stock and Preferred Stock immediately prior to and immediately after the Closing Date, respectively, and the name of each holder of such shares.

 
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(vii)       The information relating to the Company set forth on Schedule 3.1 hereto is complete, true and accurate in all material respects.
 
(viii)      Except for the Note, there are no (A) outstanding obligations of the Company to repurchase, redeem or otherwise acquire any securities of the Company, to provide funds to, or to make an investment (in the form of a loan, capital contribution or otherwise) in any Person. Except as set forth in Schedules 3.1 and 3.2 , there are no other outstanding shares of Company capital stock, voting securities, options, warrants, calls, commitments, securities, agreements or other rights of any kind to acquire, or any securities that, upon conversion, exchange or exercise would require or give any Person the right to require the issuance, sale or transfer of, shares of capital stock of any class of, or other debt obligations of or equity interests in, the Company or the Russian Entity that have been issued, granted or entered into by the Company or the Russian Entity.  The Company has not declared or paid any dividends on or made any other distribution in respect of any of its securities at any time during the year of 2011.
 
(ix)         Except for the Company Plan, the Company has not adopted, sponsored or maintained any equity plan or any other plan or agreement providing for equity compensation to any person.
 
(x)          Except as set forth in Schedule 4.1(a)(x) , the Company currently has no business operations and has not transacted any material business since its formation, except for the activities and transactions relating to the Project as have been disclosed by CBLI and the Company to Rusnano.
 
(xi)         Except as set forth in Schedule 4.1(a)(xi) , the Company has no liabilities or obligations of any kind other than those liabilities or obligations as are imposed upon the Company solely by virtue of its formation, performance of this Agreement and the other Transaction Agreements and the consummation of the transactions contemplated hereby and thereby. Schedule 4.1(a)(xi) sets forth a true, complete and correct list of all indebtedness of the Company, including, without limitations, all (A) indebtedness for borrowed money; (B) obligations evidenced by notes, bonds, debentures or similar instruments, or pursuant to any guaranty or arrangements having the economic effect of a guarantee; (C) obligations under capital leases; and (D) obligations issued or assumed as the deferred purchase price of property (including the Transferred IP) or services.
 
(xii)        Except as set forth in Schedule 4.1(a)(xii) , the Company has never had, and currently does not have, any employees.
 
(xiii)       True and complete copies of (A) the balance sheet and (B) the statement of income and cash flows for the three-month period ended on August 30, 2011 have been delivered by the Company to Rusnano and are attached hereto in Schedule 4.1(xiii) . The balance sheet and the statement of income and cash flows were prepared in accordance with the books of account and other financial records of the Company and present fairly in all material respects the financial condition and results of operations of the Company as of August 30, 2011.

 
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(xiv)       To the Knowledge of each of CBLI and the Company, there is no Litigation, charge, finding of deficiency or non-compliance, notice of violation, notice of alleged liability, penalty, fine, or sanction pending or threatened against the Company.
 
(xv)        To the Knowledge of each of CBLI and the Company, the Company is not in violation of any Law that is material to its operations as currently conducted, the Business or the Project.
 
(xvi)       Except as otherwise provided in Schedule 4.1(xvi) , the Company is not a party to any other material contracts that involve the aggregate payments by or to the Company or that relate to or evidence Company indebtedness, of more than $10,000.
 
(xvii)      To the Knowledge of CBLI and the Company, there is no judgment by any Governmental Body against CBLI or the Company, which has or may, in the reasonable judgment of CBLI, have the effect of invalidating or terminating the Project, this Agreement or any other Transaction Agreements or transactions contemplated hereby and thereby.
 
(xviii)     The Warrants and certificates evidencing the Shares, when issued and delivered in accordance with the terms of this Agreement and the other Transaction Agreements, will be duly and validly issued and free of restrictions on transfer other than restrictions set forth herein or therein or under applicable U.S. federal and state securities laws and the provisions of the Stockholders Agreement.
 
(b)           Representations and Warranties Regarding the Russian Entity:
 
(i)           To the Knowledge of each of CBLI and the Company, the Russian Entity is a limited liability company duly incorporated, validly existing and in good standing under the laws of the Russian Federation.
 
(ii)          The Russian Entity has charter capital in the amount of 250,000 Russian Rubles, free from any Liens.  The Company owns 100% participation interest in the charter capital of the Russian Entity.
 
(iii)         The Russian Entity has all requisite corporate power and authority to execute and deliver the Transaction Agreements to which it is a party, to perform its obligations thereunder and to consummate the transactions contemplated thereby. The Transaction Agreements do not violate the provisions of the Russian Entity Charter and constitute the legal, valid and binding obligation of the Russian Entity, enforceable against the Russian Entity in accordance with their terms.
 
(iv)        To the Knowledge of CBLI and the Company, there is no Litigation, charge, finding of deficiency or non-compliance, notice of violation, notice of alleged liability, penalty, fine, or sanction pending or threatened against the Russian Entity. To the Knowledge of each of CBLI and the Company, there is no action, suit, claim, proceeding or investigation by any Person or by or before any Governmental Body disputing this Agreement or the other Transaction Agreements, any transactions or documents entered into by the Russian Entity in connection with its formation and/or in anticipation of the transactions contemplated hereby, or the payment by CBLI of the charter capital of the Russian Entity.

 
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(v)         To the Knowledge of CBLI and the Company, there is no judgment by any Governmental Body against the Russian Entity, which has or may, in the reasonable judgment of CBLI, have the effect of invalidating or terminating the Project, this Agreement or the other Transaction Agreements or transactions contemplated hereby and thereby.
 
(vi)        As of the Closing Date, the Monitoring Regulation will have been duly adopted by the Russian Entity.
 
(vii)       As of the Closing Date, the Russian Entity Charter in the form attached as Exhibit C hereto will have been duly adopted by the Russian Entity and will be in full force and effect.
 
(viii)      As of the Closing Date, the Company will be the sole participant in the charter capital of the Russian Entity, as evidenced by extract of the register of its participants certified by the Russian Entity and delivered to Rusnano.
 
(ix)         As of the Closing Date, the Russian Entity will have no indebtedness or other obligations, except for those incurred in connection with its formation, the Transaction Agreements and the transactions contemplated thereby.
 
(x)          The Russian Entity has not had any proceedings of the board of directors or its participants, other than those for which true and complete copies have been delivered to Rusnano.
 
(xi)         Except as set forth on Schedule 4.1(b)(xi) , the Russian Entity has never had, and currently does not have, any employees.
 
(xii)        To the Knowledge of CBLI and the Company, the Russian Entity is not in violation of any Law material to its operations, the Business or the Project.
 
(xiii)       Except as set forth on Schedule 4.1(b)(xiii) , the Russian Entity is not a party to any material contracts that involve the aggregate payments by or to the Russian Entity or that relate to or evidence the Russian Entity indebtedness, of more than $10,000.   Schedule 4.1(b)(xiii) sets forth a true, complete and correct list of all indebtedness of the Russian Entity, including, without limitation, all (A) indebtedness for borrowed money; (B) obligations evidenced by notes, bonds, debentures or similar instruments, or pursuant to any guaranty or arrangements having the economic effect of a guarantee; (C) obligations under capital leases; and (D) obligations issued or assumed as the deferred purchase price of property (including the Transferred IP) or services.
 
(xiv)       There are no (A) outstanding obligations of the Russian Entity to repurchase, redeem or otherwise acquire any participation interest in the charter capital of the Russian Entity, to provide funds to, or to make an investment (in the form of a loan, capital contribution or otherwise) in any Person.  There are no other outstanding participation interests in the charter capital of the Russian Entity, voting ownership interests therein, options, warrants, calls, commitments, agreements or other rights of any kind to acquire, or any ownership interests that, upon conversion, exchange or exercise would require or give any Person the right to require the issuance, sale or transfer of, any ownership interests in, or debt obligations of, the Russian Entity that have been issued, granted or entered into by the Russian Entity.  The Russian Entity has not declared or paid any dividends on or made any other distribution in respect of any of its participation interests at any time since formation of the Russian Entity.

 
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(xv)        The Russian Entity has not adopted, sponsored or maintained any equity plan or any other plan or agreement providing for equity compensation to any Person.
 
(xvi)       To the Knowledge of CBLI and the Company, there is no judgment by any Governmental Body against the Russian Entity, which has or may, in the reasonable judgment of CBLI, have the effect of invalidating or terminating the Project, this Agreement or any other Transaction Agreements or transactions contemplated hereby and thereby.
 
(c)           Representations and Warranties Regarding Intellectual Property by CBLI:
 
(i)           Except as set forth on Schedule 4.1(c)(i) , CBLI owns or has the lawful unencumbered right to the Transferred IP without limitation.  To the Knowledge of CBLI, the Transferred IP will be sufficient for the implementation of the Project as currently contemplated by the Parties and will be assigned and licensed by CBLI to the Company and the Russian Entity pursuant to the terms of the Intellectual Property Agreements.  All such Transferred IP is listed in Schedule 2.1(i) hereto. The Intellectual Property Agreements, when entered into by CBLI, will not violate the terms of any agreement or arrangements of CBLI with any third party.
 
(ii)          To the Knowledge of CBLI, other than the licensed patents and patent applications listed on Schedule 2.1(i) hereto, there are no patent rights that are necessary for the development, research, performance of clinical trials, manufacture, use, offer for sale, sale, import or export of Portfolio Drugs as currently contemplated by the Project.
 
(iii)         (A) No other Person presently has any effective option or license from CBLI to use the Transferred IP to discover, develop, research, make, have made, use, offer for sale, sell, import or export any Portfolio Drugs, within the scope of the rights to be granted to the Company or the Russian Entity; and (B) CBLI is not currently, and will not in the future, violate or be in breach of any provisions of any license agreement with a third party relating to the Transferred IP.
 
(iv)        To the Knowledge of CBLI, it is not in violation of any patent, trade secret or other intellectual property rights related to the Transferred IP of any third parties. To the Knowledge of CBLI, no third party is currently infringing, misappropriating or violating rights in and to the Transferred IP.
 
(d)          Representations and Warranties of CBLI .  As an inducement for Rusnano to participate in the Project, CBLI hereby represents and warrants to Rusnano as of the date of this Agreement and as of the Closing Date as follows:
 
(i)           CBLI is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware.

 
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(ii)          CBLI has all requisite corporate power and authority to execute and deliver the Agreement and the other Transaction Agreements to which it is a party and to consummate the transactions contemplated hereby and thereby.  The execution and delivery by CBLI of the Agreement and the other Transaction Agreements to which it is a party and the consummation of all transactions contemplated hereby and thereby have been duly and validly authorized by all corporate actions necessary to authorize or to consummate the transaction contemplated hereby. This Agreement and the other Transaction Agreements to which CBLI is a party have been duly and validly executed and delivered by CBLI, and this Agreement and the other Transaction Agreements to which CBLI is a party constitute valid and binding agreements of CBLI, enforceable against it in accordance with their respective terms, except that enforceability thereof may be limited by (A) applicable bankruptcy, insolvency, reorganization, moratorium and similar laws affecting creditors’ rights generally and (B) equitable principles which may limit the availability of certain equitable remedies (such as specific performance).
 
(iii)         Neither the execution and delivery of this Agreement and the other Transaction Agreements nor the consummation of the transactions contemplated hereby and thereby will (i) violate, result in a breach of any of the terms or provisions of, constitute a default (or any event which, with the giving of notice or the passage of time or both, would constitute a default under, result in the acceleration of any indebtedness under or performance required by, result in any right of termination of, increase any amounts payable under, decrease any amounts receivable under, change any other rights pursuant to, or conflict with, any material agreement, trust, indenture, mortgage, loan agreement or other instrument to which CBLI is a party or by which any its properties is bound, the organizational documents of CBLI, or any Law, rule, regulation or Order of any court, Governmental Body or arbitrator applicable to CBLI; or (ii) affirmatively require any consent, approval, authorization or permit of or from, or filing with or notification to, any Governmental Body, except for such consents, approvals, authorizations, permits or filings which will have been obtained by the Initial Closing and those referenced in the certificate to be delivered pursuant to Section 7.4(iv) .
 
(iv)        To the Knowledge of CBLI, there is no judgment by any Governmental Body against CBLI which has or may, in the reasonable judgment of CBLI, have the effect of invalidating or terminating the Project, this Agreement or any other Transaction Agreement or transactions contemplated hereby and thereby.
 
4.2          Representations and Warranties of Rusnano .  As an inducement for CBLI and the Company to participate in the Project, Rusnano hereby represents and warrants to each of CBLI and the Company as of the date of this Agreement and as of the Closing Date as follows:

 
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(i)           Rusnano has all requisite corporate power and authority to execute and deliver the Agreement and the other Transaction Agreements and to consummate the transactions contemplated hereby and thereby.  The execution and delivery by Rusnano of this Agreement and the other Transaction Agreements and the consummation of all transactions contemplated hereby and thereby have been duly and validly authorized by all corporate actions necessary to authorize or to consummate the transaction contemplated hereby. This Agreement has been duly and validly executed and delivered by Rusnano and constitutes a valid and binding agreement of Rusnano, enforceable against it in accordance with its terms.
 
(ii)          Neither the execution and delivery of this Agreement and the other Transaction Agreements to which Rusnano is a party nor the performance of its financing obligations hereunder and thereunder will (i) violate, result in a breach of any of the terms or provisions of, constitute a default (or any event which, with the giving of notice or the passage of time or both, would constitute a default under, result in the acceleration of any indebtedness under or performance required by, result in any right of termination of, increase any amounts payable under, decrease any amounts receivable under, change any other rights pursuant to, or conflict with, any material agreement, trust, indenture, mortgage, loan agreement or other instrument to which Rusnano is a party or by which any of its properties is bound, the organizational documents of Rusnano, or any Law, rule, regulation or Order of any court or Governmental Body applicable to Rusnano; or (ii) affirmatively require any consent, approval, authorization or permit of or from, or filing with or notification to, any Governmental Body prior to the Initial Closing and those referenced in the certificate to be delivered pursuant to Section 7.4(iv) .
 
ARTICLE V
 
FINANCING OF THE COMPANY AND THE RUSSIAN ENTITY
 
5.1            Subscriptions by Rusnano and CBLI for Capital Stock of the Company .  Upon the terms and subject to the applicable conditions of this Agreement set forth in Article VII and on Schedule 5.1(c)(ii) hereto (in each case, share numbers are stated on a fully diluted basis), the Investors shall consummate the initial Closing (the “ Initial Closing ”) as follows:
 
(a)           Prior to the Initial Closing, the Company shall have issued in favor of CBLI the Note, the proceeds of which were used by the Company to fund its formation and organizational expenses.  The Note shall be converted into 284 shares of Preferred Stock by the date of the Initial Closing.
 
(b)           At the Initial Closing:
 
(i)           the Company will issue and sell to Rusnano in consideration for the aggregate purchase price of $9,000,000, and Rusnano will subscribe to and purchase from the Company, 8,515 shares of Preferred Stock;
 
(ii)          the Company will issue and sell to CBLI in consideration for the aggregate purchase price of $2,700,000, and CBLI will subscribe to and purchase from the Company, 2,554 shares of Preferred Stock; and

 
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(iii)           the Company will issue and sell to CBLI in consideration for the Transferred IP, and CBLI will subscribe to and purchase from the Company, 18,652 shares of Common Stock (all the shares of Common Stock and Preferred Stock to be issued by the Company to Rusnano and CBLI, collectively, the “ Shares ”).
 
(c)           Subsequent Closings:
 
Upon the achievement by the Company of the respective Milestones set forth in Schedule 1(dd) hereto and the fulfillment or waiver of the conditions to the Second Closing, Third Closing and Fourth Closing set forth in Schedule 5.1(c)(ii) to Rusnano satisfaction, which satisfaction shall not be unreasonably withheld or denied, Rusnano will acquire additional shares of Preferred Stock of the Company for the consideration listed on Schedule 5.1(c)(iii) hereto within 30 days (subject to additional extension of time deemed necessary by the Parties) of each respective Second Closing, Third Closing and Fourth Closing; provided that if Rusnano exercises any of its Warrants (as set forth in Section 5.1(d)), its commitment under this Section 5.1(c) shall be reduced by the amount exercised pursuant to such Warrant.
 
(d)           In the event that CBLI or Rusnano elects to exercise any of its respective Warrants on the terms and conditions stated herein and therein, then at each subsequent closing of a Warrant exercise following the Closing Date, the Company will issue and sell to each of CBLI and/or Rusnano, as applicable, and each of them will subscribe to and purchase from the Company, the Shares of Preferred Stock as set forth on Schedule 5.1(d) hereto with respect to each such Warrant exercise closing.
 
(e)           The investment commitment of Rusnano to contribute the funds to the Company or the Russian Entity during the Project shall not exceed 780,000,000 RUR or $26,000,000 as Rusnano may unilaterally decide; provided , however , that the foregoing shall not affect in any way Rusnano’s commitment under Section 5.1(b)(i) above on the terms and subject to the conditions set forth in this Agreement.  Rusnano hereby represents and warrants to the Company and CBLI that Rusnano has, and will continue to have, these funds available for investment in the Project on the terms and subject to the conditions set forth in the Transaction Agreements.
 
(f)           The use of all funds to be received by the Company and the Russian Entity at the Closings contemplated by this Agreement will comply at all times with Section 6.6 .
 
5.2            Financing of the Russian Entity.
 
(a)            Capital Contribution.   In accordance with the intention of CBLI and Rusnano to carry out the Project through the Company and the Russian Entity, it is contemplated that:
 
(i)           on the Closing Date for the Initial Closing, the Company shall transfer or caused to be transferred $7,200,000 to the Russian Entity in the form of capital or assets contribution by the Company to the charter capital of the Russian Entity; and
 
(ii)           the Company shall support the Project activities of the Russian Entity through contributions of portions of the funds received by the Company from the Investors, in accordance with the Business Plan then in effect and in accordance with this Agreement and the other Transaction Agreements as may be amended and supplemented by the Parties hereto and thereto;

 
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provided that , it is understood and acknowledged by the Investors that all such funds to be received by the Russian Entity will be deposited in the Russian Entity Special Account pursuant to the Special Account Agreement, which shall comply at all times with Section 6.6 .
 
(b)            Rusnano Monitoring Regulation and Information.   As a condition of Rusnano’s participation in the Project, the Russian Entity will adopt the Monitoring Regulation by the Closing Date and will use all reasonable efforts to ensure compliance therewith and with Section 6.6 during the course of the Project.  The Company also shall comply with Section 6.7 of this Agreement.
 
5.3            Additional Voluntary Financing by Investors.   Subject to the requirements and terms of the Transaction Agreements and the then effective Business Plan, CBLI and Rusnano may contribute additional funds voluntarily to the Company by way of additional share purchases, loans, guaranties or otherwise as allowed under applicable Law.
 
5.4            Additional Financing by CBLI or Third Parties . During the period commencing on the date of the Initial Closing and throughout Segment I of the Project, as described in more detail in Schedule 2.1(ii) hereto, but no later than fifteen (15) months after the Initial Closing, CBLI shall use its best efforts to involve a third party to contribute in the Project (the “ Co-Investor ”) in the minimum amount of $6,000,000 in the form of additional contribution to the Company’s equity capital in exchange for shares of Company stock, provided that the subscription price for such shares shall be determined on the basis of the Company’s valuation being equal to or higher than the total investment amount (including the value of the Transferred IP) contributed by both Investors by the date of such Co-Investor’s contribution.  For the avoidance of doubt and subject to its compliance with this Section 5.4 , CBLI may, but shall not be required to, be a Co-Investor.

5.5            Accounting; Tax Elections .  The Company will keep books of account in accordance with US GAAP.  The Company will adopt and maintain a calendar fiscal year. CBLI and Rusnano may request at any time that certain tax elections allowed under U.S. federal income tax laws be made with respect to CBLI and Rusnano (or with respect to their ownership of any securities of the Company).  CBLI and Rusnano hereby agree to direct the Company to cooperate, and vote all of their capital stock in the Company, in making (or complying with) any such tax elections, subject to compliance with the applicable Laws.
 
5.6            Financial Statements.   The Company will cause to be prepared and distributed to CBLI and Rusnano as promptly as possible after the end of each Fiscal Year annual audited financial statements and such other financial statements and information as required by the Stockholders Agreement.

 
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ARTICLE VI
 
AGREEMENTS AND ACTIONS OF THE PARTIES
 
6.1            Overall Intention of the Parties.   Each of the Parties hereto hereby (i) acknowledges and confirms that it has reviewed and understood this Agreement, the other Transaction Agreements to which it is a party and other documents and agreements to be delivered in connection with the Project (including in Russian language) and (ii) agrees to enter into this Agreement and the Transaction Agreements to which it is a party and to consummate the transactions contemplated hereby and thereby on the terms and subject to the conditions set forth herein and therein and in other documents and agreements to be delivered in connection with the Project, and, in furtherance hereof and thereof, to take the actions and enter into the agreements as more specifically set forth herein and therein.
 
6.2            Stockholder and Governance Matters.
 
(a)            The Company .   The Parties hereby agree to provide for certain corporate governance and stockholder matters, including, without limitation, those relating to composition and powers of the board of directors and the stockholders of the Company, board meetings and decisions, stockholder consent rights, drag along and tag along rights for specified stockholders of the Company and other rights and obligations of the stockholders of the Company specified in the Charter and the Stockholders Agreement, in substantially the form attached hereto as Exhibit D .
 
(b)            The Russian Entity .   The Parties hereby agree to provide for certain corporate governance and participant matters relating to the Russian Entity, including, without limitation, those relating to composition and powers of the board of directors and the participant(s) of the Russian Entity, meetings and decisions of the board of directors and participant(s) of the Russian Entity, all other matters contemplated by the Russian Entity Charter and Section 6.6 of this Agreement, all in compliance with the Monitoring Regulation.
 
(c)            Rusnano Subscription.   Rusnano hereby agrees to subscribe for Shares of the Company as contemplated herein, pursuant to the Rusnano Subscription Agreement, which will be substantially in the form attached hereto as Exhibit E .
 
(d)            CBLI Subscription.   CBLI hereby agrees to subscribe for Shares of the Company as contemplated herein, pursuant to the CBLI Subscription Agreement, which will be substantially in the form attached hereto as Exhibit F .
 
6.3            Intellectual Property Matters.   CBLI, Rusnano and the Company hereby agree that:
 
(a)           the Company shall be the sole and exclusive owner of all intellectual property, including inventions, discoveries, developments and improvements, created or developed by employees of the Company or the Russian Entity, or by consultants (in the course of their provision of services to the Company or the Russian Entity), in each case in connection with the Project;
 
(b)           CBLI shall license or assign, as applicable, the Transferred IP to the Company pursuant to the Intellectual Property Agreements to which it is a party;

 
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(c)           the Company shall enter into the Intellectual Property Agreements listed on Exhibit A hereto with CCIA, RPCI, CCF and CBLI to license or assign, as applicable, the Transferred IP to the Company; and
 
(d)           the Company and the Russian Entity will enter into the Intellectual Property Agreements to which they are parties, for the Company to license, assign or extend to the Russian Entity, as applicable, (A) the Transferred IP and (B) the intellectual property developed and owned by the Company as described in subsection (a) of this Section 6.3, within the territory of the Commonwealth of Independent States (CIS), in each case as necessary for the Company and the Russian Entity to engage in the Business of the Company and to carry out the Project.
 
6.4            Amendment and Restatement of the Company’s Certificate of Incorporation and Bylaws.
 
(a)           Prior to the Closing Date, CBLI and the Company shall have procured to amend and restate the current certificate of incorporation of the Company such that, upon filing and acceptance of the Charter with the Secretary of State of the State of Delaware, the Charter shall reflect the capitalization of the Company and the terms of its capital stock in substantially the form attached hereto as Exhibit B-1 .
 
(b)           Prior to the Closing Date, CBLI and the Company shall have procured to amend and restate the current bylaws of the Company such that, on the Closing Date, the Bylaws will be substantially in the form attached hereto as Exhibit B-2 .
 
6.5            Issuance of Warrants to the Investors .  Subject to the terms and conditions of this Agreement, at the Closing Date the Company will issue (a) to CBLI a Warrant to acquire shares of Preferred Stock of the Company, which will be substantially in the form attached hereto as Exhibit G-1 (the “ First CBLI Warrant ”) and a Warrant to acquire shares of Preferred Stock of the Company, which will be substantially in the form attached hereto as Exhibit G-2 (the “ Second CBLI Warrant ”); and (ii) issue to Rusnano a Warrant to acquire shares of Preferred Stock of the Company, which will be substantially in the form attached hereto as Exhibit G-3 (the “ First Rusnano Warrant ”) and a Warrant to acquire shares of Preferred Stock of the Company, which will be substantially in the form attached hereto as Exhibit G-4 (the “ Second Rusnano Warrant ”).
 
6.6            Control Over Rusnano Funds Contribution : In accordance with Section 5.2 , the Parties agree that any and all funds to be received pursuant to this Agreement and the other Transaction Agreements at Closings (i) by the Company will be deposited in the Company Escrow Account, and (ii) such funds to be received by the Russian Entity will be deposited in the Russian Entity Special Account, in each case to be held and expended in compliance with the Monitoring Regulation and this Section 6.6 .  To ensure compliance with this Agreement and the other Transaction Agreements and in furtherance of the Parties’ intent, the Parties hereto hereby agree that:
 
(a)           not less than 80% of all funds invested by Rusnano during and in furtherance of the Project shall always be placed in the Russian Entity Special Account under the terms of this Agreement and the Special Account Agreement to support activities of the Russian Entity;

 
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(b)           the Russian Entity shall use all funds received hereunder in compliance with the Monitoring Regulation;
 
(c)           the remaining 20% of all funds invested by Rusnano during and in furtherance of the Project shall be placed in the Company Escrow Account under the terms of this Agreement and the Company Escrow Agreement to support activities of the Company; and
 
(d)           any single or successive withdrawal of funds from the Company Escrow Account (i) of $15,000 or more in one transaction or in a series of related transactions; or (ii) in furtherance of any transaction with an Affiliate of CBLI or the Company shall require approval in writing of Rusnano, to enable Rusnano to comply with its internal requirement for monitoring expenditures on a quarterly basis,  and to ensure compliance with the then current Business Plan and the budget of the Company.  CBLI and the Company shall deliver a complete and accurate list of their respective Affiliates to JPMorgan Chase, National Bank, in its capacity as escrow agent under the Company Escrow Agreement (or a successor escrow agent) and shall ensure that such list is timely and accurately updated.
 
6.7            Monitoring Over the Use of Funds by the Company .  Without limiting any other provision in this Agreement:
 
(a)           Monitoring and financial oversight shall be established over all funds contributed by Rusnano to the Company with respect to all purchases of the Company’s capital stock by Rusnano and to any loan or any other similar instrument provided by Rusnano to the Company;
 
(b)           The Company shall establish financial and management accounting procedures to ensure provision of timely and accurate information in respect of financial and operations performance of the Company as well as control over the use of investment funds, as applicable;
 
(c)           The Company shall adopt annual and quarterly budgets in accordance with the Business Plan and research and development plan of the Company; and
 
(d)           The Company shall prepare and deliver to Rusnano and CBLI the reports and materials listed on Schedule 5.2(b) hereto.
 
6.8            Russian Entity Documents .  On or prior to the Closing Date, the Company will cause the Russian Entity to have (i) the Russian Entity Charter (substantially in the form attached as Exhibit C hereto) duly adopted and in full force and effect; (ii) entered into the Intellectual Property Agreements to which it is a party; (iii) duly adopted the Monitoring Regulation; and (iv) executed and delivered the Special Account Agreement, the material terms of which are attached hereto as Exhibit H .
 
6.9            Transaction Agreements .  To effectuate the transactions contemplated by this Agreement and the other Transaction Agreements, each of the Parties hereby agrees to enter into each Transaction Agreement to which it is a party.

 
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           6.10            Pre-Closing Escrow Agreement.   Rusnano will deposit the funds to be invested hereby upon the Initial Closing with JPMorgan Chase Bank, National Association, acting in its capacity as the escrow agent under the Pre-Closing Escrow Agreement, which will be substantially in the form attached hereto as Exhibit I , within 7 Business Days upon satisfaction of all of the following conditions: (i) approval of the Project by the governing body of Rusnano; (ii) execution of this Agreement and the Stockholders Agreement; (iii) execution of Intellectual Property Agreements; (iv) execution of each of the Pre-Closing Escrow Agreement, the Company Escrow Agreement and the Special Account Agreement; and (v) satisfaction of other conditions, if any, approved by the Parties.  
 
ARTICLE VII
 
CONDITIONS AND OBLIGATIONS OF EACH PARTY TO CLOSE
 
The respective obligations of the Company, CBLI and Rusnano to consummate the transactions contemplated hereby at the Initial Closing shall be subject to the satisfaction or waiver (to the extent permitted under applicable Law), on or prior to the Closing Date, of the following conditions:
 
7.1            Conditions of Rusnano’s Obligation to Close .  Rusnano’s obligation to consummate the transactions contemplated herby shall be subject to the satisfaction, on or prior to the Closing Date, of the following conditions, any of which may be waived, in writing, by Rusnano:
 
(i)           The transactions contemplated hereby will have received the requisite approval of the governing board of Rusnano;
 
(ii)           CBLI and the Company shall have complied with all of their respective covenants, obligations and conditions hereunder required to be performed and complied with by CBLI or the Company prior to the Closing Date;
 
(iii)           The representations and warranties of CBLI and the Company contained in this Agreement, including the representations and warranties contained in Section 4.1(c) of this Agreement, shall have been true and correct as of the date of this Agreement and shall be true and correct as of the Closing Date with the same force and effect as if made on the Closing Date;
 
(iv)           The Company and the Russian Entity shall have been operated in the ordinary course of business and shall not have incurred any liabilities or Losses, except for the customary startup or organizational liabilities and those activities necessary to support continued research and development activities relating to the Project during the time period between the date of this Agreement and the Closing Date, which will have been disclosed to the Investors;
 
(v)           The Parties shall have executed and signed the other Transaction Agreements (including without limitation, the Intellectual Property Agreements) and other agreements and documents to be executed by the Parties in connection with this Agreement or the Project, which are contemplated hereby;
 
(vi)           The Company and/or CBLI shall have taken or caused to be taken the following actions to the satisfaction of Rusnano:

 
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(A)           the Charter of the Company shall have been duly and properly approved by the Company and filed with the Secretary of State of the State of Delaware;
 
(B)           the Bylaws of the Company shall have been duly and properly adopted by the Company; and
 
(C)           the board of directors of the Company, the composition of which shall comply with the Stockholders Agreement, shall have been duly and properly elected and shall have as its members the individuals listed in the Stockholders Agreement (the “ New Board ”);
 
(D)           the board of directors of the Company shall duly and properly adopt the following resolutions: (aa) to elect new members of the board of directors of the Russian Entity with Leysan Shaydullina, Dmitry Tyomkin and Yakov Kogan as its members; and (bb) to transfer certain funds to the Russian Entity in the form of capital contribution to its charter capital or asset contribution in the aggregate amount of $7,200,000, all in accordance with the provisions of this Agreement and the Special Account Agreement to be dated as of the Closing Date.
 
(vii)           the Russian Entity shall have taken or caused to be taken the following actions: (aa) duly and properly procured the registration of the amendments to its charter; (bb) duly and properly adopted the Monitoring Regulation; (cc) duly and properly adopted the Russian Entity Charter; and (dd) approved and executed the Special Account Agreement;
 
(viii)           Rusnano shall have procured all consents and approvals that may be required or necessary in connection with any law of the Russian Federation or contractual obligation of Rusnano;
 
(ix)           The Company shall have issued and sold to CBLI in consideration for cash, Transferred IP and the Note, and CBLI shall have subscribed to and purchased from the Company,  2,838 shares of Preferred Stock and 18,652 shares of Common Stock all in accordance with Sections 5.1(a) , 5.1(b)(ii) and 5.1(b)(iii) of this Agreement;
 
(x)           the Company and CBLI shall have delivered to Rusnano the closing deliveries as set forth in Section 7.3 and Section 7.4 of this Agreement, respectively.
 
7.2            Conditions of CBLI’s and the Company’s Obligation to Close .  CBLI’s and the Company’s obligation to consummate the transaction contemplated hereby shall be subject to the satisfaction, on or prior to the Closing Date, of the following conditions, any of which may be waived, in writing by CBLI or the Company:
 
(i)           This Agreement, the other Transaction Agreements and the transactions contemplated hereby will have been approved by the board of directors or other governing bodies of CBLI and the Company;
 
(ii)           CBLI and the Company shall have procured all consents and approvals that may be required or necessary in connection with any Law or contractual obligation of CBLI or the Company;

 
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(iii)           The representations and warranties of Rusnano contained in this Agreement, including the representations and warranties contained in Section 4.2 of this Agreement, shall have been true and correct as of the date of this Agreement and shall be true and correct as of the Closing Date with the same force and effect as if made on the Closing Date;
 
(iv)                      Rusnano shall have delivered to CBLI and the Company the closing deliveries as set forth in Section 7.5 of this Agreement.
 
7.3            Closing Deliveries by the Company .  On the Closing Date, the Company shall deliver or cause to be delivered to CBLI and Rusnano:
 
(i)           executed counterparts of this Agreement and each other Transaction Agreement to which it is a party and to which the Russian Entity is a party;
 
(ii)           a true and complete copy, certified by the Secretary of the Company, of the resolutions duly and validly adopted by the board of directors and the stockholders of the Company evidencing their authorization of (i) the execution and delivery of this Agreement and each other Transaction Agreement to which it is a party and the consummation of the transactions contemplated hereby and thereby and (ii) the adoption of resolutions with regard to matters set forth in Section 7.1(vi)(A)-(D) of this Agreement;
 
(iii)           a true and complete copy, certified by an officer of the Russian Entity, of the resolutions duly and validly adopted by the board of directors and the stockholders of the Russian Entity evidencing the adoption by the Russian Entity of the Monitoring Regulation, the Russian Entity Charter and the Special Account Agreement; and a true and complete copy of the register of the Russian Entity participants certified by an officer of the Russian Entity to the fact that the Company is the sole participant in the charter capital of the Russian Entity;
 
(iv)           a certificate of the Secretary or an Assistant Secretary of the Company certifying the names and signatures of the officers of the Company authorized to sign this Agreement and the other Transaction Agreements to which it is a party and the other documents to be delivered hereunder and thereunder;
 
(v)           a copy of (aa) the Charter of the Company, certified by the Secretary of State of the State of Delaware, as of a date not earlier than five Business Days prior to the Closing Date and accompanied by a certificate of the Secretary of the Company, dated as of the Closing Date, stating that no amendments have been made to such Charter since such date, and (bb) the Bylaws of the Company, certified by the Secretary of the Company;
 
(vi)           good standing certificate for the Company from the Secretary of State of the State of Delaware;
 
(vii)           a copy of the Plan, setting aside for grants thereunder not more than the number of shares of Common Stock equal to 10% of the capital stock of the Company on a fully-diluted basis, as of the date of the Initial Closing;

 
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(viii)           the share certificates representing the Shares in accordance with Sections 5.1(a) and (b) of this Agreement;
 
(ix)           an acknowledgement of receipt of the initial funding from the Investors in the form of cash, convertible Note and the Transferred IP, all in accordance with Sections 5.1(a) and (b) of this Agreement; and
 
(x)           copies of the Intellectual Property Agreements, to which the Company is a party, executed by the Company.
 
7.4            Closing Deliveries by CBLI .  On the Closing Date, CBLI shall deliver or cause to be delivered to Rusnano and the Company:
 
(i)           executed counterparts of this Agreement and each other Transaction Agreement to which it is a party;
 
(ii)           copies of the Intellectual Property Agreements executed by CBLI, RPCI, CCIA and CCF;
 
(iii)           a true and complete copy, certified by the Secretary or an Assistant Secretary of CBLI, of the resolutions duly and validly adopted by the board of directors of CBLI evidencing their authorization of the execution and delivery of this Agreement and each other Transaction Agreement to which it is a party and the consummation of the transactions contemplated hereby and thereby;
 
(iv)           a certificate of the Secretary or an Assistant Secretary of CBLI (aa) certifying the names and signatures of the officers of CBLI authorized to sign this Agreement and the other Transaction Agreements to which it is a party and the other documents to be delivered hereunder and thereunder, and (bb) confirming, to the Knowledge of CBLI, and to the reasonable satisfaction of Rusnano, the absence of any filing, authorization, consent or approval required under federal Law of the United States for the consummation of the transactions contemplated by this Agreement and the other Transaction Agreements;
 
(v)           a copy of (aa) the certificate of incorporation, as amended, of CBLI, certified by the Secretary of State of the State of Delaware, as of a date not earlier than five Business Days prior to the Closing Date and accompanied by a certificate of the Secretary or Assistant Secretary of CBLI, dated as of the Closing Date, stating that no amendments have been made to the certificate of incorporation since such date, and (bb) the bylaws of CBLI, certified by the Secretary or Assistant Secretary of CBLI;
 
(vi)           good standing certificate for CBLI from the Secretary of State of the State of Delaware;
 
(vii)           the sum of $2,700,000 by wire transfer or in other immediately available funds using the bank details to be advised by the Company in writing; and
 
(viii)           evidence of the conversion of the Note pursuant to Section 5.1(a) in a form reasonably acceptable to Rusnano.

 
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7.5            Closing Deliveries by Rusnano .  On the Closing Date, Rusnano shall deliver or cause to be delivered to CBLI and the Company:
 
(i)           executed counterparts of this Agreement and each other Transaction Agreement to which it is a Party;
 
(ii)           (x) a true and complete extract of the resolutions of the executive body of Rusnano evidencing the approval of the Project as required by Rusnano bylaws, and (y) true and complete copies of the Powers of Attorney granted by Rusnano to one or more of its attorneys-in-fact  evidencing their authority to execute and deliver this Agreement and the other Transaction Agreements to which Rusnano is a party and the other documents to be delivered hereunder and thereunder, in each case certified by an authorized signatory on behalf of Rusnano;
 
(iii)           a copy of the constituent documents of Rusnano, certified as of a date not earlier than five Business Days prior to the Closing Date and accompanied by a certificate of an officer of Rusnano, dated as of the Closing Date, stating that no amendments have been made to the constituent documents of Rusnano since such date; and
 
(iv)           executed counterpart of the written instruction, addressed to the escrow agent under the Pre-Closing Escrow Agreement and instructing such escrow agent to release the funds held in escrow thereby, to the Company Escrow Account and the Russian Entity Special Account upon the Initial Closing.
 
7.6            Subsequent Closings.   Each Closing following the Initial Closing shall be subject to (i) the compliance with, or waiver of, the conditions set forth on Schedule 5.1(c)(ii) ; and (ii) establishment of one or more escrow accounts substantially similar to that provided for under the Pre-Closing Escrow Agreement, for the same purpose as it is contemplated herein in respect of the Initial Closing.
 
ARTICLE VIII
 
CLOSINGS
 
8.1            Initial Closing .  Upon the Closing Date, subject to the terms of this Agreement, Rusnano shall cause JPMorgan Chase, National Association, in its capacity as the escrow agent under the Pre-Closing Escrow Agreement and as provided therein, to (i) transfer $1,800,000 to the Company Escrow Account and (ii) transfer $7,200,000 to the Russian Entity Special Account.  In the event that any of closing conditions of Rusnano are not satisfied, and Rusnano does not waive their non-satisfaction, the escrow agent shall immediately wire all the funds as set forth in Section 5.1(b)(i) hereof back to Rusnano.

 
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          8.2.            Time and Place of the Closings .  Each Closing shall take place at the offices of Riker Danzig Scherer Hyland Perretti LLP, 500 Fifth Avenue, 49 th Floor, New York, New York 10110 at 11:00 a.m. (Eastern Time) on the respective Closing Date for such Closing, or at such other time and place as the Parties may agree otherwise, upon the satisfaction or waiver of the conditions to each Closing set forth in Article VII and Schedule 5.1(c)(ii) to this Agreement. For the avoidance of doubt, if any Party furnishes signature pages to any Transaction Agreement (or any document or instrument contemplated thereby) with written instructions that such signature pages be held “in escrow”, such Party shall not be deemed to have executed and delivered such Transaction Agreement until such Party or its representative delivers written instructions that such signature is released from escrow, and prior to delivering such written instructions, such Party (a “ Withdrawing Party ”) may withdraw its signature at any time and for any reason whatsoever, and each other Party, for itself and all of its Affiliates, successors and assigns and all persons and entities claiming by, through or under them (the “ Releasing Parties ”), hereby unconditionally, and completely waives, releases and discharges any Withdrawing Party and its respective Affiliates and their respective predecessors, successors, assigns, representatives and attorneys (together, the “ Released Parties ”), whether past, present or future, from any and all actions, causes of action, suits, liabilities, obligations, expenses, claims and demands of any kind or nature whatsoever, in law or equity, whether or not such actions, liabilities, suits or rights are then fixed or contingent, known or unknown, asserted or unasserted, foreseeable or unforeseeable, suspected or unsuspected, that any Releasing Party had, has or may claim to have at any time against any Released Party arising from, related to or in connection with a Withdrawing Party’s actions or election not to proceed to Closing under this Section 8.2 .  Each of the Releasing Parties agrees not to, and agrees to cause its Affiliates not to, file, or permit to be filed on its behalf, any claim, cause of action, suit, charge or complaint against any Released Party with any state, federal or foreign court or any administrative agency asserting either the invalidity of the foregoing release or any claim that has been released herein.
 
ARTICLE IX
 
CONFIDENTIALITY
 
9.1            Application .  The term “ Investor ”, as used in this Article IX , includes any Affiliate of an Investor. The term “ Disclosing Party ” means the Party that originates or first discloses any specific Proprietary Information.
 
9.2            Proprietary Information.   The term “ Proprietary Information ” includes all know-how, trade secrets and other proprietary information, whether or not patented or patentable or copyrighted or copyrightable, developed or acquired by a Party, including, without limitation technical expertise and related experience, drawings, blueprints, specifications, engineering, technical and cost data, engineering and design information, testing and quality control procedures, operating techniques, processes, and computer and information programs, trade secrets, research, operations, customers (including identities of customers and prospective customers, identities of individual contacts at customers, preferences, business or habits), business relationships, products (including prices, costs, sales or content and including realized or unrealized products), financial information, marketing or promotion information, business methods, future business plans, databases, computer programs, designs, models, operating procedures, knowledge of the organization, internal organization, finances and procedures, as well as the terms of any Transaction Agreement, provided that Proprietary Information shall not include knowledge, information, documents or materials which a Party can establish (i) have entered the public domain without such Party’s or a third party’s breach of any obligation of confidentiality owed with respect thereto; (ii) are permitted to be disclosed by the prior written consent of the Disclosing Party; or (iii) are independently developed by such Party without breach of this Agreement.

 
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9.3            Proprietary Information of the Investors.   The Investors acknowledge that, in connection with their investigation, negotiation and current or future ownership of Shares in the Company and/or their rendering of services to the Company, Proprietary Information will be disclosed by the Investors to the Company and to one another.  Notwithstanding such disclosure, Proprietary Information of the Disclosing Party will remain the Proprietary Information of such Party, and no other Party will use such Proprietary Information in any manner or disclose such information to any third parties except as contemplated by this Agreement or as agreed to in writing by the Disclosing Party.  In the event any such Proprietary Information is required to be disclosed to a contracting party of the Company, the Company may make such disclosure provided it will first enter into a confidentiality agreement with such third party in form and substance reasonably acceptable to the Disclosing Party.  Each Party shall ensure that neither it nor its employees, Affiliates or employees of any of its Affiliates shall copy or divulge, communicate or make accessible to any third party (except as may be necessary for such party hereto to perform its obligations hereunder or as may be required by law) nor use for its or their own purpose any Proprietary Information about the Company, any client or customer of the Company, any company or other entity in which a client or customer of the Company may invest, the other party hereto or any Affiliate of the other party hereto.
 
9.4            Company’s Proprietary Information.   To the extent that the Company develops or acquires its own Proprietary Information, it will remain the sole and exclusive property of the Company, but the Company hereby grants to the Russian Entity a royalty free license   to use (but not to sublicense, sell, assign or otherwise transfer) such Proprietary Information, subject to the provisions of Section 9.5 below. No Investor will disclose such Proprietary Information to third parties except as may be incidental to the utilization of such license, and each Investor shall use its best efforts to ensure that its employees and agents refrain from disclosing such Proprietary Information.  In the event an Investor wishes to disclose any such Proprietary Information to a customer (other than a government) of either Investor or to a subcontractor, such Investor will first enter into a confidentiality agreement with such third party in form and substance reasonably acceptable to the Company and as approved by the board of directors.
 
9.5            Permitted Disclosures.   Notwithstanding anything to the contrary contained herein, (A) CBLI may disclose this Agreement, the other Transaction Agreements, information about the Project and any related information, agreement or document required by applicable Law, upon advice of counsel, to be disclosed by CBLI as a publicly traded company in the United States; and (B) the Investors may transmit Proprietary Information to their attorneys, accountants, agents, directors, officers and employees who have a need to know the same for investment consideration or professional advice for reporting obligations of such Investor and its Affiliates, or for consideration or professional advice regarding the transactions contemplated by this Agreement, provided that (a) such Persons receiving such information are informed of the terms of this Agreement and (b) prior written notice is given by the disclosing Investor to the other Investor.  The Party so disclosing shall be responsible for any breach of this Article IX by any of such Persons.

 
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9.6            Required Disclosures .  In the event that a Party receives a request to disclose all or any part of the Proprietary Information under the terms of a valid and effective subpoena or Order issued by a court of competent jurisdiction or by a Governmental Body, such Party agrees to, as soon as possible, notify the Company and the Disclosing Party in writing of the existence, terms and circumstances surrounding such a request so that the Company or such Disclosing Party, as applicable, may seek an appropriate protective order and/or waive compliance by such Party with the appropriate provisions of this Agreement.  If such Party is compelled to disclose any of the Proprietary Information, it will disclose only that portion thereof which it is compelled to disclose and shall use its reasonable efforts to obtain an Order or other reliable assurance that confidential treatment will be accorded to the Proprietary Information so disclosed.
 
9.7            Return of Documents and Property.   Upon the sale by an Investor of the Shares held thereby, and at any other time upon the request of the Company, the Investor (a) shall deliver to the Company all memoranda, disks, files, notes, records or other documents which contain or are based upon Proprietary Information of the Company and shall not retain any copies thereof in any format or storage medium (including computer disk or memory) and (b) purge from any computer system in the possession thereof other than those owned by and returned to the Company, all computer files which contain or are based upon any Proprietary Information of the Company and confirm such purging in writing to the Company; provided , however , such Investor may destroy, instead of delivering to the Company, all such memoranda, disks, files, notes, records or other documents described in clause (a) if such Investor provides written certification by its chief executive officer of such destruction.
 
9.8            Injunctive Relief.   Each Party hereby agrees and confirms that, because of the valuable nature of the Proprietary Information, irreparable damage would occur to the Company and each Investor in the event of any breach of the obligations set forth in this Article.  It is hereby agreed and confirmed that the Parties do not have an adequate remedy at Law to protect the Business of the Company and the other Parties from any breach of the obligations set forth in this Article, and that each of the Parties shall be entitled to injunctive relief, in addition to such other remedies and relief that would, in such event, be available to it or them at Law or in equity (including without limitation, specific performance), without proof of special damages and without the obligation to post any bond or provide any indemnity, which requirement is hereby waived by each of the Parties.
 
9.9               Indemnification.   Without prejudice to the foregoing, each Party hereby agrees to indemnify the other Parties and hold such Parties harmless against all costs, Losses or expenses which the other Parties may incur as a result of any breach or non-performance by the indemnifying Party of any of its obligations set forth in this Agreement.
 
 
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ARTICLE X
 
ADDITIONAL AGREEMENTS
 
10.1            Indemnification.
 
           (a)           CBLI and the Company shall jointly and severally defend, indemnify and hold harmless Rusnano and its Affiliates and their respective employees, agents, officers and directors (collectively, “ Rusnano Indemnitees ”) from and against any and all Losses suffered, incurred or sustained by Rusnano Indemnitees resulting from, arising out of or relating to (i) any breach by CBLI or the Company of any of the representations, warranties and covenants contained in this Agreement; or (ii) any negligence or willful misconduct by CBLI or the Company in performing its obligations hereunder.  Notwithstanding anything herein to the contrary, CBLI will not have any liability to Rusnano Indemnitees under any provision of this Agreement or otherwise for any punitive, incidental, consequential, special or indirect damages, including loss of future revenue or income or loss of business reputation or opportunity.
 
(b)           CBLI shall defend, indemnify and hold harmless the Company and its Affiliates and their respective employees, agents, officers and directors (collectively, “ Company Indemnitees ”) from and against any and all Losses suffered, incurred or sustained by the Company Indemnitees resulting from, arising out of or relating to (i) any breach by CBLI of any of the representations, warranties and covenants contained in this Agreement; or (ii) any negligence or willful misconduct by CBLI in performing its obligations hereunder.  Notwithstanding anything herein to the contrary, CBLI will not have any liability to the Company Indemnitees under any provision of this Agreement or otherwise for any punitive, incidental, consequential, special or indirect damages, including loss of future revenue or income or loss of business reputation or opportunity.
 
(c)           Rusnano shall defend, indemnify and hold harmless the Company, CBLI and their respective Affiliates and their respective employees, agents, officers and directors (collectively, the “ Other Indemnitees ”) from and against any and all Losses suffered, incurred or sustained by the Other Indemnitees resulting from, arising out of or relating to (i) any breach by Rusnano of any of the representations, warranties and covenants contained in this Agreement; or (ii) any negligence or willful misconduct by Rusnano in performing its obligations hereunder.  Notwithstanding anything herein to the contrary, Rusnano will not have any liability to the Other Indemnitees under any provision of this Agreement or otherwise for any punitive, incidental, consequential, special or indirect damages, including loss of future revenue or income or loss of business reputation or opportunity.
 
10.2            Further Assurances.   At any time prior to, on or after the Closing Date, each Party hereto shall (a) execute and deliver any further assignments, conveyances and other assurances, documents and instruments of transfer reasonably requested by another Party to carry out the purposes of this Agreement and the other Transaction Agreements; and (b) cooperate with the other Parties, as such Parties may reasonably request, so that the Parties shall (i) except as set forth in Section 10.6(ix), in a timely manner make all necessary filings with, and conduct negotiations with, all Governmental Bodies and other Persons the consent or approval of which, or a license or permit from which, is required for the consummation of the transactions contemplated herein, and (ii) provide to each other Party such information as the other Parties may reasonably request in order to enable it to prepare such filings and to conduct such negotiations.  The Parties hereto also agree to use their best efforts to expedite the review process and to obtain all such necessary consents, approvals, licenses and permits as promptly as practicable.  To the extent permitted by applicable Law, the Parties shall request that each Governmental Body or other Person whose review, consent or approval is requested treat as confidential all information that is submitted to it.

 
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10.3            Expenses.   Except as otherwise expressly provided in this Agreement, each Party hereto will bear its respective direct and indirect expenses incurred in connection with due diligence and the preparation and negotiation of this Agreement, the other Transaction Agreements and the consummation of the transactions contemplated by this Agreement and the other Transaction Agreements, including all fees and expenses of his, her or its advisors and representatives.
 
10.4            Legality of the Transaction Agreements .  Each Party agrees not to challenge in any court or proceeding before any Governmental Body in any jurisdiction the legality of the transactions contemplated by the Transaction Agreements.
 
10.5            Stock Plan of the Company.   The Investors acknowledge and agree that the Company has adopted the Plan, a copy of which has been delivered to the Investors, and that the Company has set aside and reserved 4,122 of shares of Common Stock of the Company for issuance under the Plan as set forth therein.  The Parties further agree that, upon each of the Second Closing, Third Closing and Fourth Closing, the Company shall have the right to increase the number of shares of Common Stock covered by the Plan to the number calculated as follows: (i) 10% of the aggregate amount of funds invested in the Company at each such Closing, divided by the respective purchase price per share of capital stock of the Company paid upon each such Closing; plus (ii) that number of shares of Common Stock calculated under subsection (i), which remains unused and available for issuance under the Plan at the time of the respective Closing.
 
10.6            Good Faith Cooperation After the Closing Date . The Parties agree to work in good faith to:
 
(i)           notify the local patent authorities in compliance with requirements of applicable Law, in respect of the relevant Intellectual Property Agreements;
 
(ii)           approve contracts with senior officers and employees of the Company;
 
(iii)           register the relevant Intellectual Property Agreements with the appropriate Governmental Bodies, in the event required by applicable Law;
 
(iv)           adopt and implement a non-disclosure and confidentiality policy and an invention and intellectual property assignment policy for the Company and the Russian Entity, whereby every employee or consultant of the Company or the Russian Entity shall be subject to appropriate non-disclosure obligations regarding the Company or the Russian Entity confidential information and each such employee and consultant shall assign to the Company and the Russian Entity all intellectual property rights he or she shall own that are related to the Business of the Company or the Russian Entity;
 
(v)           execute and deliver the Service Agreement in the form to be approved by Rusnano, CBLI and the Company;
 
(vi)           consistent with Section 2.2 hereof, procure consideration and approval by the New Board of (x) the Business Plan and a research and development plan of the Company; and (y) a first quarterly budget of the Company; provided that the Company shall not be allowed to withdraw any funds from the Company’s Escrow Account until the New Board approves the matters set forth in  (x) through (y) of this Section 10.6(vi);

 
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(vii)           within 30 days of the Initial Closing, procure consideration and approval of (x) the business plan and a research and development plan of the Russian Entity; and (y) a first quarterly budget of the Russian Entity;
 
(viii)           appoint senior officers of the Russian Entity and to approve their employment agreements, subject to the prior receipt of employment permits or authorizations required by applicable Law for foreign workers to be employed in the Russian Federation;
 
(ix)           no later than 90 days after the Initial Closing, the Company will (x) cause a legal review of any additional post-closing approvals in the United States of the transactions contemplated hereby and (y) deliver a written summary of such review to Rusnano, whereupon Rusnano shall have the right, in its reasonable discretion, to request the Company to provide any additional information and/or to take further related actions, in each case to the satisfaction of Rusnano; and
 
(x)           no later than 60 days after the Initial Closing, the New Board shall review that certain Master Services Agreement (the “ MSA ”) dated as of July 19, 2011 between the Company and CBLI and recommend appropriate modifications to the MSA, which shall be effected promptly after the same are mutually agreed upon by CBLI and the Company.
 
ARTICLE XI
 
MISCELLANEOUS
 
11.1            Waivers, Delays or Omissions.   Except where time limitations are specifically provided, no delay or omission to exercise any right, power or remedy accruing to any Party hereto, upon any breach or default of any Party under this Agreement, shall impair any such right, power or remedy of such Party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring.  Any waiver, permit, consent or approval of any kind or character on the part of any Party hereto of any breach or default under this Agreement or any other Transaction Agreement, or any waiver on the part of any Party of any provisions or conditions of this Agreement and of any other Transaction Agreement must be made in writing and shall be effective only to the extent specifically set forth in such writing, and no waiver in any one or more instances shall be deemed to be a further or continuing waiver of any such condition or breach in other instances or a waiver of any other condition or breach of any other provision or condition of this Agreement or any other Transaction Agreement; nor will any single or partial exercise of any right preclude an additional or further exercise thereof or the exercise of any other right.  All remedies, either under this Agreement or by Law or otherwise afforded to any Party, shall be cumulative and not alternative.

 
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11.2            Relationship of Parties .  This Agreement does not constitute a partnership and nothing herein contained is intended to constitute, nor will it be construed to constitute, the Investors as partners of each other or of the Company.  Nothing contained herein will constitute any Investor or the Company an agent of the other Investor or the Company.  Except as may otherwise be explicitly agreed in writing, no Party will have the authority to act on behalf of any other Party, nor will the Company have the authority to act on behalf of either Investor. None of the Investors or the Company will incur or accept any liability or enter into commitments or contracts on behalf of any Party other than itself without the express prior written approval of the Party to be bound.  The employees of each Party will remain the employees solely of such Party, except to the extent that the Company may agree in writing with an Investor that a specified employee is seconded to the Company.
 
11.3               Publicity .  None of the Parties will make any public announcement or release any publicity naming an Investor or the Company without the prior written consent of the Party being named, except as may be required by Law.
 
11.4               Necessary Measures.   The Parties will, in a timely manner and as required from time to time, take all such actions as may be necessary or appropriate to implement or to cause their Affiliates to implement the transactions contemplated by this Agreement and to assure the taking  of all actions as may be necessary to give full effect to the provisions of this Agreement and abstention from taking any actions which would contravene the intent of the provisions of this Agreement.  Without limitation of the foregoing, the Parties will assist each other in obtaining all necessary regulatory and statutory approvals and to coordinate all communications with the investor community, the regulators, the stock exchanges and the press, and the Parties shall use their best efforts to obtain necessary approvals, licenses and certificates, and the Parties will cooperate in good faith with each other as may be necessary or appropriate, to fulfil any compliance procedures required under the applicable Law with respect to licensing and intellectual property protection.
 
11.5            Term of Agreement.
 
(a)           This Agreement will continue in full force and effect until the earlier of (i) termination by mutual consent, (ii) with respect to an Investor who transfers all of its Shares in the Company in accordance with the terms of this Agreement and the applicable Transaction Agreements, upon the transfer of all of such Shares and (iii) the date of the dissolution and liquidation of the Company.  Articles IX, Section 10.1 and Sections 11.9 and 11.10 shall survive any termination of this Agreement.
 
(b)           In the event that (i) the Company consummates its first underwritten offering of shares of capital stock of the Company under the U.S. Securities Act of 1933, as amended, or a similar public offering outside the United States, or (ii) capital stock of the Company otherwise becomes publicly traded in or outside the United States, then the Investors hereto hereby agree to review and negotiate in good faith any appropriate modifications to this Agreement and other Transaction Agreements, in consultation with their respective counsel. All Parties hereby acknowledge and agree with the provisions and limitations of Section 1.4 of the Stockholders Agreement, including without limitation, the last sentence thereof.
 
11.6            Entire Agreement.   This Agreement, the Transaction Agreements, the Exhibits and Schedules attached hereto, and the Exhibits and Schedules attached thereto constitute the entire agreement of the Parties, except as provided herein, and supersede all prior agreements and understandings, both written and oral, among the Parties with respect to the subject matter hereof.

 
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11.7            Headings .  Headings of the Articles and Sections of this Agreement are for convenience of the Parties only, and shall be given no substantive or interpretative effect whatsoever.
 
11.8            Binding Effect; Survival and Assignment .  This Agreement will be binding on the Parties and their Affiliates and the successors and assigns of each of them.  No Party may assign its rights, duties or interests hereunder in whole or in part without the prior express written permission of the other Parties hereto, except as specifically provided herein.
 
11.9            Governing Law and Severability.   This Agreement and its enforcement, and any and all claims or disputes arising out of, relating to, or in connection with this Agreement or the making, performance, or interpretation of this Agreement, shall be governed by and construed exclusively in accordance with the State of New York’s substantive law (including but not limited to its law governing the attorney-client privilege and work product doctrine), without regard to the conflicts of law or choice of law principles of the State of New York or any other jurisdiction (including but not limited to U.S. federal law) that would require the application of the law of any other jurisdiction.  The provisions hereof will, to the greatest extent possible, be interpreted in such a manner as to comply with applicable law, but if any provision hereof is, notwithstanding such interpretation, determined to be invalid, void or unenforceable, the remaining provisions of this Agreement will not be affected thereby but will remain in full force and effect and binding upon the Parties.  In particular, should the choice of law be held invalid because for a part of this Agreement the choice of the laws of the State of New York is not possible, the choice of the laws of the State of New York for all remaining provisions of this Agreement shall continue to be valid in all respects.
 
11.10            Dispute Resolution .
 
(a)           Any and all claims or disputes (including but not limited to the arbitrability of any such claim or dispute or the jurisdiction of the arbitral tribunal provided for herein) arising out of, relating to, or in connection with this Agreement or the Transaction Agreements or the making, performance, or interpretation of this Agreement or the Transaction Agreements shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (“ Rules ”), by one arbitrator appointed in accordance with the Rules.
 
(b)           The place of arbitration shall be in Stockholm.  The law exclusively applicable to the arbitration (including but not limited to the law governing the attorney-client privilege and work product doctrine) shall be the State of New York’s substantive law.  Pursuant to Article 15.1 of the Rules, in the event that the Rules are silent as to a given procedural matter, said matter shall be governed by the procedural rules of the State of New York.  The U.S. Federal Arbitration Act, 9 U.S.C. §1, et seq., shall not apply to the arbitration.
 
(c)           Pursuant to such schedule as the arbitral tribunal shall determine, (i) the Parties shall be permitted to serve, and shall be required to respond to, demands to produce hearing exhibits and witness statements, documents, and other evidence relevant to the claims or disputes in the arbitration, and the arbitral tribunal shall be authorized, on the application of any Party or of its own motion, but in either case only after giving the Parties a reasonable opportunity to state their views, to order production of said materials; and (ii) each Party shall give notice of the identity of each witness (including but not limited to expert witnesses) whom the Party intends to call at the hearing and the subject matter of the witness’ testimony.

 
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(d)           The English language shall be used throughout the arbitral proceedings. The Parties shall bear their own attorneys’ fees, costs, expenses, and taxes in connection with the arbitration.  The arbitrator’s fee shall be borne equally by the parties to the arbitration.  The Parties hereby confirm and agree that the award of the arbitrator shall be the sole and exclusive remedy of the Parties regarding any claims, counterclaims, disputes, issues, or accountings presented to the arbitrator; that any arbitration award shall be made and shall promptly be payable in U.S. dollars free of any deduction or offset; and that any attorneys’ fees, costs, expenses, or taxes incident to enforcing the arbitration award shall, to the maximum extent permitted by law, be charged against the party opposing such enforcement.  The award shall include interest from the date of the arbitrator’s decision until the award has been paid in full, at the statutory rate of the State of New York.
 
11.11            Waiver of Immunities.

(a)           Each Party expressly, unconditionally and irrevocably waives, to the fullest extent permitted by applicable Law, with respect to itself and its revenues, property and assets, which it now possesses or may hereafter acquire (irrespective of their use or intended use), all immunity on the grounds of sovereignty (whether characterized as state immunity, sovereign immunity, act of state or otherwise), from (1) jurisdiction of the arbitration as provided in this Agreement, (2) suit, and the jurisdiction of any court of competent jurisdiction, to enforce the arbitrator’s award, (3) relief by way of injunction, order for specific performance or for recovery of property, (4) attachment of its revenues, property or assets (whether before or after judgment, in aid of execution or otherwise) and (5) execution or enforcement of, or recovery on, any judgment to which it or its revenues, property or assets might otherwise be entitled in any proceedings in the courts of any competent jurisdiction.

Each Party expressly, unconditionally and irrevocably agrees, to the fullest extent permitted by applicable law, that it will not claim, invoke or permit to be invoked on its behalf or on behalf of its revenues, property or assets, any such immunity in any such proceedings.  Each Party represents that it possesses the authority to so waive as indicated herein.

(b)           Subject to any applicable appellate rights, each Party consents generally in respect of any proceedings to the giving of any relief or the issue of  any process in connection with the proceedings including, without limitation, the making, enforcement or execution against any revenues, property or assets whatsoever (irrespective of their use or intended use) of any Order which may be made or given in the proceedings.

(c)           Each Party irrevocably and unconditionally acknowledges that the execution, delivery and performance of this Agreement constitute private and commercial (and not public) acts of Rusnano.

 
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11.12            Notices.   All notices, consents and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when delivered by hand or by Federal Express or a similar overnight courier to, (b) five (5) days after being deposited in any United States Post Office enclosed in a postage prepaid and registered or certified envelope addressed to or (c) when successfully transmitted by fax or e-mail (with a confirming copy of such communication to be sent as provided in clauses (a) or (b) above) to, the Party for whom intended, at the address, fax number or e-mail address for such Party set forth below (or at such other address, fax number or e-mail address for a party as shall be specified by like notice, provided , however , that any notice of change of address, fax number or e-mail address shall be effective only upon receipt):
 
If to the Company, to it at:
 
73 High Street
Buffalo, New York USA 14203
Attention: Chief Executive Officer
Facsimile: +1-716-849-6820
Email: Dtyomkin@cbiolabs.com
 
With copy (which shall not constitute notice) to:
 
Riker Danzig Scherer Hyland Perretti LLP
500 Fifth Avenue, 49 th Floor
New York, New York 10110
Attention: Natasha Ziabkina, Esq.
Facsimile: +1-212-302-6628
Email: Nziabkina@riker.com
 
If to CBLI, to it at:
 
73 High Street
Buffalo, New York USA 14203
Attention: Chief Executive Officer
Facsimile: +1-716-849-6820
Email: Mfonstein@cbiolabs.com

With copy (which shall not constitute notice) to:
 
Riker Danzig Scherer Hyland Perretti LLP
500 Fifth Avenue, 49 th Floor
New York, New York 10110
Attention: Natasha Ziabkina, Esq.
Facsimile: +1-212-302-6628
Email: Nziabkina@riker.com

If to Rusnano, to it at:
 
OJSC “RUSNANO”
10A Prospect 60-Letiya Oktyabrya

 
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Moscow 117036
Attention: Leysan Shaydullina, Investment Manager
Facsimile: +7 495-988-5399
Email: Leysan.Shaydullina@rusnano.com

With copy (which shall not constitute notice) to:
 
Orrick, Herrington & Sutcliffe LLP
51 West 52 nd Street
New York, NY  10019-6142
Attention: Elena Sauber, Esq.
Facsimile: +1-212-506-5151
Email: Esauber@orrick.com
 
11.13            Finders' Fees, Brokerage Commissions.   Each of the Parties represents and warrants to the other Parties that it has not incurred any liability for finder's fees, brokerage commissions or the like, and each Party indemnifies the other against liability for any such fees or commissions attributable to any act or failure to act of the indemnifying Party.
 
11.14            Amendments.   This Agreement or any provision hereof may be amended, modified, supplemented or waived only by a written instrument executed by all Parties.
 
11.15            Language of the Agreement .  This Agreement shall be executed by the Parties in the English language, and the same shall be the official and governing version of this Agreement and shall control.
 
11.16            Counterparts.   This Agreement may be executed in any number of counterparts and by different parties to this Agreement in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same Agreement.  This Agreement is effective upon delivery of one executed counterpart from each Party to the other Parties.  The signatures of all Parties need not appear on the same counterpart.  The delivery of signed counterparts by facsimile or email transmission that includes a copy of the sending Party’s signature is as effective as signing and delivering the counterpart in person, for all purposes.
 
11.17            No Third Party Rights.   Nothing in this Agreement, whether express or implied, is intended to confer any rights or remedies under or by reason of this Agreement on any Persons other than the Parties hereto and the respective successors and assigns of the foregoing, and the Company, nor is anything in this Agreement intended to relieve or discharge the obligation or liability of any third parties to any Party to this Agreement or the Company, nor shall any provision hereof give any third parties any right of subrogation or action over or against any Party to this Agreement or the Company.

 
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11.18            Construction.   The language in all parts of this Agreement shall in all cases be construed simply, according to its fair meaning, and not strictly for or against any of the Parties hereto.  Without limitation, there shall be no presumption against any Party on the ground that such Party was responsible for drafting this Agreement or any part thereof.
 
11.19            Remedies.   The Parties each acknowledge and agree that no failure or delay in exercising any right, power or privilege hereunder will operate as a waiver thereof, nor will any single or partial exercise thereof preclude any other or further exercise thereof or any right, power or privilege hereunder.  The Parties further acknowledge and agree that money damages would not be a sufficient remedy for any breach of this Agreement, and that the non-breaching Party will be entitled to specific performance as a remedy for any such breach.  Such remedy will not be deemed to be the exclusive remedy for a breach thereof, but will be in addition to all other remedies available at Law or equity to the non-breaching Party.
 
11.20            Successors and Assigns.   All covenants and agreements in this Agreement by or on behalf of the respective Parties hereto shall bind and inure to the benefit of their respective successors and assigns.
 
11.21            Severability . If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, (a) such provision will be fully severable, (b) the remaining provisions of the Agreement will remain in full force and effect and will not be affected by such provision or its severance herefrom and (c) in lieu of such provision, there will be added automatically as part of this Agreement a legal, valid and enforceable provision as similar in terms to such provision as possible.
 
11.22            Rules of Construction.
 
(a)           Singular words shall connote the plural as well as the singular, and plural words shall connote the singular as well as the plural, and the masculine shall include the feminine and the neuter, as the context may required.
 
(b)           All references in this Agreement to particular articles, sections, subsections or clauses (whether in upper or lower case) are references to articles, sections, subsections or clauses of this Agreement.  All references in this Agreement to particular exhibits or schedules (whether in upper or lower case) are references to the exhibits and schedules attached to this Agreement, unless otherwise expressly stated or clearly apparent from the context of such reference.
 
(c)           Each Party and its counsel have reviewed and revised (or requested revisions of) this Agreement and have participated in the preparation of this Agreement, and therefore any rules of construction requiring that ambiguities are to be resolved against the Party which drafted this Agreement or any exhibits hereto shall not be applicable in the construction and interpretation of this Agreement or any exhibits hereto.
 
(d)           The terms “dollars” and “$” shall refer to United States Dollars, the currency of the United States.
 
(e)           The terms “hereby”, “hereof”, “hereto”, “herein”, “hereunder” and any similar terms shall refer to this Agreement, and not solely to the provision in which such term is used.

 
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(f)           The terms “include”, “including” and similar terms shall be construed as if followed by the phrase “without limitation”.
 
11.23            Schedules.   Capitalized terms used in the schedules which are defined herein shall have the meanings assigned to such terms herein unless otherwise defined in the schedule.  The inclusion of any description or document in a schedule is not intended, nor shall it be deemed to imply necessarily, that the matters referred to or contained in such schedule are not in the ordinary course of business.  Nothing in the schedules constitutes an admission of any liability of any Party or an admission against interest.  The disclosure of a matter in any schedule shall be deemed a disclosure for all purposes and shall qualify each representation or warranty made herein to the extent applicable.  Where the terms of a contract or other disclosure item have been summarized or described in a schedule, such summary or description does not purport to be a complete statement of the material terms of the contract or other item.
 
[SIGNATURES FOLLOW]

 
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers as of the date first above written.
 
 
PANACELA LABS, INC.
     
 
By
/s/ Dmitry Tyomkin
   
Name: Dmitry Tyomkin
   
Title: Chief Executive Officer
     
 
CLEVELAND BIOLABS, INC.
     
 
By
/s/ Michael Fonstein, Ph.D.
   
Name: Michael Fonstein, Ph.D.
   
Title: Chief Executive Officer
     
 
OPEN JOINT STOCK COMPANY “RUSNANO”
     
 
By
/s/ Andrey Borisovich Malyshev
   
Name: Andrey Borisovich Malyshev
   
Title: Deputy Chairman of the Management Board

[Signature Page to Investment Agreement]

 
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Exhibit 10.2
 
EXCLUSIVE LICENSE AND OPTION AGREEMENT
 
This Exclusive License and Option Agreement (“ Agreement ”) is made effective as of September 23, 2011 (“ Effective Date ”) by and between Children’s Cancer Institute Australia for Medical Research, , a not for profit medical institute formed under the laws of Australia with registration number ACN 072 279 559 ( “CCIA” ), and Panacela Labs, Inc., a Delaware corporation (“ Panacela ”).  The parties hereto are additionally referred to individually as a “ Party ”, and collectively, the “ Parties ”.
 
WHEREAS, CCIA is an independent medical research institute in Australia, which sponsors and conducts basic research and clinical trials relating to the causes, treatments, and prevention of the various forms of cancer and related diseases;
 
WHEREAS, CCIA possesses certain rights in and to certain patents, products, technology, and know-how, including the Licensed Rights (as defined below);
 
WHEREAS, Panacela is focused on development of a new generation of pharmaceutical drugs, including an initial focus on innovative oncology therapies; and
 
WHEREAS, CCIA desires to grant, and Panacela desires, a license under the Licensed Rights.
 
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
 
1.
DEFINITIONS
 
 
1.1.
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.
 
 
1.2.
Application ” shall mean the intended use or Indication for a Licensed Product.
 
 
1.3.
CCIA Invention ” shall mean an Innovation created or conceived solely by employees or agents of CCIA.
 
 
1.4.
Employee ” shall mean employees, contractors, leased employees and agents of CCIA or Panacela.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 
 
 
1.5.
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.
 
 
1.6.
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.
 
 
1.7.
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.
 
 
1.8.
Innovation ” shall mean all inventions, discoveries and enhancements and all data relating to Option Products.
 
 
1.9.
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.
 
 
1.10.
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.
 
 
1.11.
Licensed Field ” shall mean all fields of use.
 
 
1.12.
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.
 
 
1.13.
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 .
 
 
1.14.
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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1.15.
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.
 
 
1.16.
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.
 
 
1.17.
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
 
 
1.18.
Panacela Invention ” shall mean an Innovation created or conceived solely by employees or agents of Panacela or Affiliates thereof.
 
 
1.19.
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.
 
 
1.20.
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.
 
 
1.21.
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.
 
 
1.22.
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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1.23.
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 .
 
 
1.24.
Territory ” shall mean worldwide.
 
 
1.25.
Third Party ” shall mean a party other than Panacela and Affiliates thereof.
 
2.
LICENSE GRANT
 
 
2.1.
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 ”).
 
 
2.2.
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.
 
 
2.3.
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.
 
 
2.4.
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.
 
3.
OWNERSHIP AND OPTION
 
 
3.1.
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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3.2.
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.
 
 
3.3.
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.
 
 
3.4.
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.
 
 
3.5.
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.
 
 
3.6.
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.
 
4.
CONSIDERATION.   In consideration of rights granted by CCIA to Panacela under this Agreement, Panacela will pay CCIA as follows:
 
 
4.1.
[***]
 
 
4.2.
Royalties .
 
 
4.2.1.
Royalty Rate .  Panacela shall pay CCIA the following royalties for each Licensed Product sold by Panacela and Affiliates thereof:
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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a)
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
 
 
b)
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;
 
in each case, provided that if the manufacturing, use, lease, or sale of such Licensed Product or the performance of such Licensed Product is covered by more than one Licensed Patents or Optioned NII, multiple royalties shall not be due; and
 
in each case, provided further, that 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 or its Affiliate for a license to patent rights necessary for Panacela or its Affiliate 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 or would result in Panacela not being the exclusive licensor of all of the patent rights for the Licensed Products (“Blocking Technology”). Additionally, 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 CCIA for sale of Licensed Products in that country shall be reduced to the rate paid by the compulsory license.
 
 
4.2.2.
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.
 
 
4.2.3.
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.
 
 
4.2.4.
Sublicense Fees .  Panacela will pay the following sublicense fees in connection with sublicensing rights regarding Licensed Products:
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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a)
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, [***]%;
 
 
b)
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
 
 
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, [***]%.
 
 
4.2.5.
Milestone Payments .
 
 
a)
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:
 
 
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, $[***];
 
 
2)
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, $[***];
 
 
3)
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, $[***];
 
 
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
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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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, $[***];
 
in each case provided that the applicable milestone due CCIA under this Section has not accrued on another Licensed Product that is for the same (i) Application, (ii) Indication; or (iii) Target.
 
 
b)
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:
 
P = (OC / US) * MS, where
 
P – milestone payment due to CCIA in connection with obtaining regulatory approval in any Other Country;
 
OC – the size of the pharmaceutical market of the Other Country in US dollars at the time;
 
US – the size of the pharmaceutical market of the United States in US dollars at the time;
 
MS – applicable milestone payment set forth in the Section 4.2.5(a) of the agreement; where
 
the size of the pharmaceutical market shall be determined using the most recent applicable annual DSM Group (located at 7/2, 5-th Yamskogo Polya St. Moscow 125040 Russia) report or other generally accepted annual market data report.  However, 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 United States Food and Drug Administration (“FDA”) approval, Panacela shall pay CCIA 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.  For purposes of clarity, the maximum amount of milestone payments Panacela shall be obligated to pay to CCIA pursuant to this Agreement shall be the aggregate of the amounts set forth in Section 4.2.5(a) .
 
 
4.2.6.
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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5.
COMMERCIALIZATION; REGULATORY APPROVALS.
 
 
5.1.
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.
 
 
5.2.
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.
 
6.
REPRESENTATIONS AND WARRANTIES.
 
 
6.1.
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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6.2.
Further Representations and Warranties of CCIA .  CCIA represents and warrants that:
 
 
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;
 
 
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;
 
 
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;
 
 
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;
 
 
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;
 
 
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
 
 
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.
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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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.
 
 
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.
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
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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.
 
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 .
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
12

 
 
 
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
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
13

 
 
 
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:
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
14

 
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
15

 
 
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).
 
If to CCIA, to:
 
Children’s Cancer Institute Australia
PO Box 81
Randwick NSW2031 Australia
Attention: Managing Director
Telephone: 0293853140

If to Panacela, to:
 
Panacela Labs, Inc.
73 High Street
Buffalo, NY 14203
Attention: Chief Executive Officer
Telephone: (716) 849-6810
Facsimile: (716) 849-6820
 
With a copy (which shall not constitute notice) to:

Polsinelli Shughart PC
161 N. Clark Ave., Suite 4200
Chicago, IL 60601
Attention: Teddy C. Scott, Jr., Ph.D.
Telephone: (312) 819-1900
Facsimile: (312) 873-2913
Email: tscott@polsinelli.com

 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
16

 
 
 
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.
 
 [ Signature page follows ]
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
17

 
 
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth above.
 
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
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

EXHIBIT A
 
Description of Drug Candidates
 
ANTIMYCON
·
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).
 
·
[***]
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

EXHIBIT B
 
Projects and Licensed Patents
 
 
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
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

EXHIBIT C
 
[***]
 
Exhibit C pg. 1 of 4
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

[***]
 
Exhibit C pg. 2 of 4

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

[***]

Exhibit C pg. 3 of 4

 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

[***]
 

Exhibit C pg. 4 of 4

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
 

 
 
 
Exhibit 10.3
 
SECOND AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
 
 This Second Amendment (“Second Amendment”) is made effective as of September 22, 2011 (“Effective Date”) by and between The Cleveland Clinic Foundation, a non-profit Ohio corporation (“CCF”), and Cleveland BioLabs, Inc., a corporation organized and existing under the laws of the State of Delaware (“CBL”).
 
WHEREAS, CCF and CBL are parties to that certain Exclusive License Agreement effective July 1, 2004, and as amended on March 22, 2010 (the “License Agreement”);
 
WHEREAS, CCF and Children’s Cancer Institute Australia for Medical Research, a not for profit medical institute formed under the laws of Australia with registration number ACN 072 279 559  (“CCIA”) are parties to that certain Inter-Institutional Agreement for MDR Inhibitors dated April 1, 2008 (the “Inter-Institutional Agreement”), which is attached as Exhibit A, which grants to CCF certain rights for the administration and commercialization of a certain Invention (as defined in the Inter-Institutional Agreement) and Patent Rights (as defined in the Inter-Institutional Agreement);
 
WHEREAS, CBL and others have formed Panacela Labs Inc., a corporation organized under the laws of the State of Delaware (“Panacela”), as a joint venture for the purpose of developing a new generation of pharmaceutical drugs;
 
WHEREAS, CCF desires to grant, and CBL desires to receive, a license under the Invention (as defined in the Inter-Institutional Agreement) and Patent Rights (as defined in the Inter-Institutional Agreement), along with other rights, for the development and commercialization of Panacela Products (as defined below) by Panacela under rights owned by CCF, CCIA and others; and
 
WHEREAS, CCIA has consented to the licensing of the Invention (as defined in the Inter-Institutional Agreement) and Patent Rights (as defined in the Inter-Institutional Agreement) under the License Agreement as amended by the terms set forth below, pursuant to the Letter Agreement attached as Exhibit B.
 
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, the parties covenant and agree as follows:
 
 
1.
Preamble.    The first paragraph is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
THIS EXCLUSIVE LICENSE AGREEMENT (“Agreement”) is made effective the 1st day of July, 2004 (“Effective Date”) by and between The Cleveland Clinic Foundation, a non-profit Ohio corporation (“CCF”), and Cleveland BioLabs, Inc., a corporation organized and existing under the laws of the State of Delaware (“CBL”).
 
 
2.
Section 2.A.   Section 2.A is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 

 

A.   Exclusive License to CBL .
 
Subject to the terms and conditions of this Agreement, CCF hereby grants to CBL an exclusive license under the Licensed Rights to: (a) make, have made, develop, use, import, export, distribute, market, promote, offer for sale and sell Products, (b) practice any method, process or procedure within the Licensed Patents or the CCF Technology, and (c) otherwise exploit the Licensed Rights within the Licensed Territory for use within the Licensed Field; and to have any of the foregoing performed on its behalf by a third party.  This grant shall be subject to the rights retained by CCF and by Other Institution set forth in Section 2.G.
 
 
3.
Section 2.G.   Section 2.G is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
G.   Research Use Right .
 
(i)  All licenses granted under Section 2 of this Agreement based on rights owned by CCF are subject to a reserved, irrevocable, exclusive, fully-paid up non-assignable license back to CCF to make and use, for academic or research purposes only, any applicable CCF Technology, the Licensed Patents and any Improvement or Innovation created by CBL or CCF.
 
(ii)  All licenses granted under Section 2 of this Agreement based on rights owned by Other Institution are subject to an express reservation of rights to Other Institution for educational and research purposes.
 
 
4.
Section 2.I.    The following section is hereby added to Section 2 as Section 2.I.
 
I.   Ownership of Innovations .
 
Innovations shall be either jointly owned or solely owned by the party for whom ownership can be established under the provisions of U.S. patent law and licensed as provided herein.
 
 
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.
 
For each Product developed by CBL, a CBL affiliate, or a joint venture in which CBL is involved, CBL shall pay to CCF Milestone Payments, creditable against Earned Royalties, and Sublicense Royalties related to said Product, as development of a Product first reaches major developmental milestones as follows:
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
-2-

 
 
 
5.2.
Subsection (1) is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
(1) For Products limited to biodefense uses:
 
(i)    For any INDA filing for a Product, $[***];
 
(ii)   For any Product (a) entering Phase II clinical trials, or (b) entering a registration enabling definitive pivotal animal efficacy study under the FDA's Animal Rule (21 CFR 314.600 for drugs and 21 CFR 601.90 for biological products) or a registration enabling, pivotal human safety study (whichever comes first) and corresponding rules and regulations in other countries, $[***];
 
(iii)  For any PLA (Product License Application), BLA (Biologic License Application) or NDA filing for a Product, $[***]; and
 
(iv)  Upon regulatory approval permitting any Product to be sold to the commercial market, $[***]; or
 
 
5.3.
Subsection (2) is hereby renumbered subsection (3).
 
 
5.4.
The following is hereby added to Section 4.B. as new subsection (2).
 
(2) For a Panacela Product:
 
(i)    For any INDA filing for a Product, (a) for a Product related to Licensed Patents that are solely owned by CCF or jointly owned by CCF and Other Institution, $[***]; or (b) for a Product related to Licensed Patents that are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, $[***];
 
(ii)   For any Product entering Phase II clinical trials, (a) for a Product related to Licensed Patents that are solely owned by CCF, or jointly owned by CCF and Other Institution, $[***]; or (b) for a Product related to Licensed Patents that are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, $[***];
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
-3-

 

(iii)  For any Product entering Phase III clinical trials, (a) for a Product related to Licensed Patents that are solely owned by CCF or jointly owned by CCF and Other Institution, $[***]; or (b) for a Product related to Licensed Patents that are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, $[***];
 
(iv)  For any PLA (Product License Application) or NDA filing for a Product, (a) for a Product related to Licensed Patents that are solely owned by CCF or jointly owned by CCF and Other Institution, $[***]; or (b) for a Product related to Licensed Patents that are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, $[***]; and
 
(v)   Upon regulatory approval permitting any Product to be sold to the commercial market, (a) for a Product related to Licensed Patents that are solely owned by CCF or jointly owned by CCF and Other Institution, $[***]; or (b) for a Product related to Licensed Patents that are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, $[***];
 
 
5.5.
The last paragraph of Section 4.B. is hereby deleted in its entirety and substituted with the following in lieu thereof
 
provided that the applicable milestone due CCF under this Section 4.B. has not accrued on another Product that is for the same (i) Application; (ii) Indication, or (iii) Target.  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:
 
P = (OC / US) * MS, where
 
P – milestone payment due to Licensor in connection with obtaining regulatory approval in any Other Country;
 
OC – the size of the pharmaceutical market of the Other Country in US dollars at the time;
 
US – the size of the pharmaceutical market of the United States in US dollars at the time;
 
MS – applicable milestone payment set forth in the Section 4.2.5(a) of the agreement; and
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
-4-

 
 
The size of the pharmaceutical market shall be determined using the most recent applicable annual DSM Group (located at 7/2, 5-th Yamskogo Polya St. Moscow 125040 Russia) report or other generally accepted annual market data report. However, 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 United States Food and Drug Administration (“FDA”) approval, CBL shall pay CCF 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.  For purposes of clarity, the maximum amount of milestone payments CBL shall be obligated to pay to CCF pursuant to this Agreement shall be the aggregate of the amounts set forth in the applicable subsection of Section 4.B.
 
 
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.
 
(i) In further consideration of the rights and licenses granted by CCF to CBL under this Agreement, CBL agrees to pay CCF for each Product Sold in the commercial market by CBL, a CBL affiliate, or a joint venture in which CBL is involved, CBL agrees to pay to CCF as “Earned Royalties” a royalty calculated as a percentage of the Net Sales of Products actually received by CBL or an Affiliate thereof in accordance with the terms and conditions of this Agreement.  The royalty is deemed earned as of earlier of the date CBL receives payment for the sale, lease or other disposition of the Product for consideration or the date the Product is Sold to a consumer.  Subject to the terms of this Agreement, the royalty shall remain fixed while this Agreement is in effect as follows:  (a) for any Licensed Patent which is solely owned by CCF or jointly owned by CCF and Other Institution, a rate of [***] percent ([***]%); (b) for any Licensed Patent which is jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, a rate of [***] percent ([***]%).
 
(v) In the event that more than one patent within the Licensed Patents is applicable to any Product subject to royalties under Section 4.C. or Section 4.D., then only one royalty shall be paid to CCF as follows: (a) for more than one Licensed Patent, each of which is solely owned by CCF, the royalty shall be at the rate of a Licensed Patent solely owned by CCF, (b) for more than one Licensed Patent, one of which is jointly owned by CCF and CBL or an Affiliate thereof, the royalty shall be at the rate of a Licensed Patent jointly owned by CCF and CBL or an Affiliate thereof.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
-5-

 
 
 
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.
 
(a)           Where sublicenses have been granted by CBL prior to the filing of an INDA for a Product, under the sponsorship of CBL, CBL shall pay to CCF the following royalty rates for Product Sales:  (1) for the sublicense of Licensed Patents solely owned by CCF or jointly owned by CCF and Other Institution, [***] percent ([***]%) of any and all upfront Sublicensing Fees, and [***] percent ([***]%) of all royalties received from the Sublicensee; provided that the amount owed to CCF for royalties received from all Sublicensees shall not be less than [***]% of Net Sales; or (2) for any sublicense of Licensed Patents which are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, [***] percent ([***] %) of any and all upfront Sublicensing Fees, and [***] percent ([***] %) of all royalties received from the Sublicensee; provided that the amount owed to CCF for royalties received from all Sublicensees shall not be less than [***]% of Net Sales.
 
(b)           Where sublicenses have been granted after filing of an INDA for a Product, under the sponsorship of CBL, but prior to final approval of the relevant PLA/NDA, CBL shall pay to CCF the following royalty rates for Product Sales:  (1) for the sublicense of Licensed Patents solely owned by CCF or jointly owned by CCF and Other Institution, [***] percent ([***]%) of any and all upfront Sublicensing Fees, and [***] percent ([***]%) of all royalties received from the Sublicensee; provided that the amount owed to CCF for royalties received from all Sublicensees shall not be less than [***]% of Net Sales; or (2) for any sublicense of Licensed Patents which are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, [***] percent ([***]%) of any and all upfront Sublicensing Fees, and [***] percent ([***]%) of all royalties received from the Sublicensee; provided that the amount owed to CCF for royalties from all Sublicensees received shall not be less than [***]% of Net Sales.
 
(c)           Where sublicenses have been granted after final approval of the relevant PLA/NDA for a Product, CBL shall pay to the following royalty rates for Product Sales:  (1) for the sublicense of Licensed Patents solely owned by CCF or jointly owned by CCF and Other Institution, [***] percent ([***]%) of any and all upfront Sublicensing Fees, and [***] percent ([***]%) of all royalties received from the Sublicensee; provided that the amount owed to CCF for royalties received from all Sublicensees shall not be less than [***]% of Net Sales; or (2) for any sublicense of Licensed Patents which are jointly owned by CCF and CBL or an Affiliate thereof, or jointly owned by CCF, Other Institution, and CBL or an Affiliate thereof, [***] percent ([***]%) of any and all upfront Sublicensing Fees, and [***] percent ([***]%) of all royalties received from the Sublicensee; provided that the amount owed to CCF for royalties received from all Sublicensees shall not be less than [***]% of Net Sales.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
(i) except to the extent otherwise provided under Section 15 of this Agreement with respect to U.S. Government interests, it is the owner or designee of an Other Institution of the Licensed Rights free and clear of any lien, encumbrance, royalty or other payment obligation, and, to the best of its actual knowledge, without any conflict with or infringement of the rights of any third party;
 
 
9.
Section 6 – Records.   Section 6.A is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
A.   CBL shall keep books and records sufficient to verify the accuracy and completeness of CBL’s accounting referred to above, including without limitation inventory, purchase and invoice records relating to the Products or their manufacture, and all correspondence and meeting minutes with the FDA.  In addition, CBL shall maintain documentation evidencing that CBL is in fact pursuing development of Products as required herein.  Such documentation may include, but is not limited to, invoices for studies advancing development of Products, laboratory notebooks, internal job cost records, and filings made to the Internal Revenue Service to obtain tax credit, if available, for research and development of Products.  Such books and records shall be preserved for a period not less than three (3) years after they are created during and after the term of this Agreement.
 
 
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.
 
A.   CBL shall, at all times during the term of this Agreement and thereafter, indemnify, defend and hold CCF and Other Institution and each of its respective trustees, officers, employees, students, and agents harmless against all claims and expenses, including legal expenses and reasonable attorneys fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense and liability of any kind whatsoever (other than infringement claims) resulting from the production, manufacture, sale, use, lease, consumption or advertisement of Products arising from any right or obligation of CBL hereunder with respect to CCF or Other Institution, as the case may be.  CCF and Other Institution at all times reserves the right to select and retain counsel of its own to represent CCF’s and Other Institution’s interests in any such action, subject to CBL’s sole control of the defense thereof and all related settlement negotiations.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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B.      Neither party shall be liable to the other party for any indirect, special, consequential, or other damages whatsoever, whether grounded in tort (including negligence), strict liability, contract or otherwise.  Except as provided in this Agreement, CCF and Other Institution shall not have any responsibilities or liabilities whatsoever with respect to Product(s).
 
 
11.
Section 14 – Use of Names.   Section 14 is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
Section 14.  Use of Names.
 
Other than as required by law or regulation, CBL shall not use the name, logo, likeness, trademarks, image or other intellectual property of CCF, Other Institution for any advertising, marketing, or endorsement or any other purposes without the specific prior written consent of an authorized representative of CCF as to each such use.  For purposes of the foregoing provision, an authorized representative of CCF means a representative of CCF’s Department of Media Relations and/or CCF’s Office of General Counsel.
 
 
12.
Appendix A – Definition for “CCF Technology”.   Paragraph B is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
B. “CCF Technology”  shall mean all CCF’s and Other Institution’s unpatented inventions, know-how, trade secrets, analysis, discoveries, techniques, methods, clinical and other data, and other intellectual property relating to the research of Doctor or arising out of or in direct connection with work of Doctor in the field of regulating cell death: (i) curing cancer treatment side effects by differential modulation cell death / survival mechanisms uniquely deregulated in cancer cells; (ii) selective sensitization of cancer cells to treatment by using the same approach; (iii) using anti-apoptotic proteins secreted by microbial parasites to cure tissue damage associated with cancer treatment, inflammation and other pathologies (stroke, heart attack).
 
 
13.
Appendix A – Definition for “Improvement”.   Paragraph F is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
F. “Improvement”  shall mean any modification of an invention described in the Licensed Patents that is owned by CCF and that, if unlicensed, would infringe one or more claims of any Licensed Patent.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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14.
Appendix A – Definition for “Licensed Field”.   The following part (v) is hereby added to Paragraph H.
 
(v) 0500 series: modulating the androgen receptor (AR) pathway, constant activity of which is essential for growth and viability of the majority of prostate cancers, including those that have lost their dependence on androgen.
 
 
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.
 
(ii)           In the event that CCF or Other Institution is a joint owner of an invention by reason of the fact that an employee or consultant of CBL is a joint inventor of such an invention, it is understood that the Licensed Patents include only CCF’s or Other Institution’s rights as a joint owner of the patents and patent applications that claim such joint invention.  From time to time during the term of this Agreement, upon request by either party, CBL and CCF shall update Appendix G hereto to include all patent applications and patents that are within the Licensed Patents.
 
 
16.
Appendix A – Definition for “Net Sales”.   Paragraph N is hereby deleted in its entirety and substituted with the following in lieu thereof.
 
N. “Net Sales” shall mean the gross amount collected from sales of Products to an end-user, 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 CBL products) shipping costs, insurance or other transportation costs, to the extent not paid or absorbed by non-Affiliate purchasers of such Products; (v) sales, use and/or other excise taxes or duties actually paid; and (vi) sales to Affiliates and/or Sublicensees for research and development purposes.  All costs shall be determined in accordance with generally accepted accounting principles.
 
 
17.
Appendix A – Definition for “Application”.   The following paragraph R is hereby added to Appendix A.
 
R. “Application” shall mean the intended use or Indication for a Licensed Product.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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18.
Appendix A – Definition for “INDA”.   The following paragraph S is hereby added to Appendix A.
 
S. “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 such as but not limited to a “clinical trials exemption” in the United Kingdom.
 
 
19.
Appendix A – Definition for “Indication”.   The following paragraph T is hereby added to Appendix A.
 
T. “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.
 
 
20.
Appendix A – Definition for “NDA”.   The following paragraph U is hereby added to Appendix A.
 
U. “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.
 
 
21.
Appendix A – Definition for “Other Institution”.   The following paragraph V is hereby added to Appendix A.
 
V. “Other Institution” shall mean any third party that CCF is a party to an inter-institutional agreement that provides CCF with the right on behalf of both parties to administer and commercialize rights jointly owned by both parties, including CCIA.
 
 
22.
Appendix A – Definition for “Panacela Product”.   The following paragraph W is hereby added to Appendix A.
 
W. “Panacela Product” shall mean the following Products developed and commercialized by Panacella:
 
 
(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
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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(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.
 
X. “Phase II clinical trials” 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.
 
 
24.
Appendix A – Definition for “Phase III clinical trials” .  The following paragraph Y is hereby added to Appendix A.
 
Y. “Phase III clinical trials” 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.
 
 
25.
Appendix A – Definition for “Target”.   The following paragraph Z is hereby added to Appendix A.
 
Z. “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.
 
 
26.
Appendix A – Definition for “Third Party”.   The following paragraph AA is hereby added to Appendix A.
 
AA. “Third Party” shall mean a party other than CCF, CBL, a CBL Affiliate, a joint venture is which CBL is involved, or a sublicensee of CBL.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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27.       Counterparts .  This Second Amendment may be executed in counterparts with the same effect as if both parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
 
[Signatures follow.]
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
-12-

 
 
IN WITNESS WHEREOF , the parties hereto have duly executed this Agreement on the dates indicated below.

THE CLEVELAND CLINIC FOUNDATION:

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
 
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
-13-

 

EXHIBIT A

INTER-INSTITUTIONAL AGREEMENT
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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-19-

 
 
 
 
-20-

 
 
 
 
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-22-

 
 
 
 
-23-

 
 
 
 
-24-

 
 
 
 
-25-

 
 
 
 
-26-

 
 
 
 
-27-

 
 
 
 
-28-

 
 
 
 
-29-

 
 
 
 
-30-

 
 
 
 
-31-

 
 
 
 
-32-

 
 
 
 
-33-

 
 
 
 
-34-

 
 
 
 
-35-

 
 
EXHIBIT B
 
SIDE LETTER BETWEEN CCF AND CCIA
 
LETTER AGREEMENT
 
This Letter Agreement (“ Letter ”) is made effective as of                                         , 2011 (“ Effective Date ”) by and between The Cleveland Clinic Foundation, a non-profit Ohio corporation (“ CCF ”), and Children’s Cancer Institute Australia for Medical Research, a not for profit medical institute formed under the laws of Australia with registration number CAN 072 279 559 ( “CCIA” ).
 
CCF and CCIA are parties to that certain Inter-Institutional Agreement for MDR Inhibitors dated April 1, 2008 (the “Inter-Institutional Agreement”), which grants to CCF certain rights for the administration and commercialization of a certain Invention and Patent Rights.  This Letter Agreement contains the terms and conditions that CCIA consents to the licensing of the Invention and Patent Rights to Cleveland BioLabs, Inc., a corporation organized and existing under the laws of the State of Ohio (“CBLI”).  Capitalized terms used and not otherwise defined in this Letter Agreement shall have the meanings ascribed to them in the Inter-Institutional Agreement.
 
In consideration of the mutual covenants and agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:
 
Consent to Grant of Exclusive License
 
CCF and CBLI are parties to that certain Exclusive License Agreement dated July 1, 2004, and amended on March 22, 2010 (the “CCF-CBL License Agreement”).   CCF shall amend the CCF-CBL License Agreement pursuant to the Second Amendment to the CCF-CBL License Agreement attached as Exhibit A , whereby the Licensed Rights  (as defined in the CCF-CBL Agreement) shall include the interests of CCF and CCIA in the Invention and Patent Rights and CCIA consents thereto.
 
Payments
 
Under Section 8 of the CCF-CBL License Agreement, CCF hereby irrevocably assigns to CCIA its right to receive 50% of any payments owed for Licensed Products (as defined in the CCF-CBL Agreement) based on the Invention and Patent Rights (as defined in the Inter-Institutional Agreement).  Furthermore, CCF shall irrevocably direct CBL under Section 4.F. subsection (ii) of the CCF-CBL License Agreement to pay any amounts owed for Licensed Products  (as defined in the CCF-CBL Agreement) based on the Invention and Patent Rights (as defined in the Inter-Institutional Agreement) to CCF and CCIA at a distribution of 50% and 50%, respectively.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
  
 
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Right to Publish
 
Under Section 2.H of the CCF-CBL License Agreement. CBL grants back to CCF a non-reserved, irrevocable, exclusive, fully-paid up non-assignable license to publish the general scientific findings from research related to Licensed Rights including the Patent Rights (the “Publication Rights”).  CCF hereby grants to CCIA a co-exclusive license in the Publication Rights.
 
 [Signatures follow.]
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
  
 
-37-

 

IN WITNESS WHEREOF , the parties hereto have duly executed this Agreement on the dates indicated below.
 
THE CLEVELAND CLINIC FOUNDATION:

By:
/s/ Joseph F. Hohn
Date:                  9/22                  , 2011
Name:
Joseph F. Hohn
 
Title
   
 
CHILDREN’S CANCER INSTITUTE AUSTRALIA FOR MEDICAL RESEARCH:

By:
/s/ Christopher R. Thomson
Date:             23/9                , 2011
Name:
Christopher R. Thomson
 
Title
Managing Director
 
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
-38-

 

Exhibit 10.4

EXCLUSIVE LICENSE AND OPTION AGREEMENT
 
This Exclusive License and Option Agreement (“ Agreement ”) is made effective as of September 23, 2011 (“ Effective Date ”) by and between Health Research, Inc., Roswell Park Institute Division, a domestic not-for-profit corporation ( “HRI” ), Roswell Park Cancer Institute Corporation, a New York corporation (“ RPCI ”) (HRI and RPCI are, collectively, “ RPCI ”), and Panacela Labs, Inc., a Delaware corporation (“ Panacela ”).  The parties hereto are additionally referred to individually as a “ Party ”, and collectively, the “ Parties ”.
 
WHEREAS, RPCI is a National Cancer Institute designated Comprehensive Cancer Center, which sponsors and conducts basic research and clinical trials relating to the causes, treatments, and prevention of the various forms of cancer and related diseases;
 
WHEREAS, RPCI possesses certain rights in and to certain patents, products, technology, and know-how, including the Licensed Rights (as defined below);
 
WHEREAS, Panacela is focused on development of a new generation of pharmaceutical drugs, including an initial focus on innovative oncology therapies; and
 
WHEREAS, RPCI desires to grant, and Panacela desires to accept, a license under the Licensed Rights.
 
NOW, THEREFORE, in consideration of the promises in this Agreement, the mutual covenants and agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
 
1.
DEFINITIONS
 
In addition to the other terms defined herein, this Agreement uses the following defined terms:
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
1

 
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
2

 
 
 
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.
 
If a Licensed Product is sold in the form of a combination product containing one or more products or technologies which are themselves not a Licensed Product (“ Combination Product ”), Net Sales for such Combination Product shall be calculated by multiplying the sales price of the Combination Product by the fraction A/(A+B) where A is the invoice price of the Licensed Product or the fair market value of the Licensed Product if sold to a non-Affiliate third party, and B is the total invoice price of the other products or technologies or the fair market value of the other products or technologies if purchased from a non-Affiliate third party.
 
If a Licensed Product is sold, used, or otherwise disposed of but not in an arm’s length transaction for fair market value, Net Sales shall mean Panacela’s open market price for such Licensed Product in the country and on the date of such disposition after taking into account the exclusions in Sections 1.12(i) – (v) . Alternatively, if there is no market price, Net Sales shall mean an imputed price determined on a commercially reasonable basis, which shall be no less than the price of commercially available products materially similar to Licensed Products.
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
3

 
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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;
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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:
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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, $[***];
 
in each case provided that the applicable milestone for such Licensed Product has not previously accrued for the same Indication.  Also, no new milestone payment shall be due where the submission or approval of any SNDA pertains to a variance in the drug product formulation or dosage form, strength or administration method, e.g., pill to injectable form.  For clarity, new milestone payments shall be due where a new Indication for the same Licensed Product is applied for or approved, e.g., previous approved Indication was small cell lung cancer and new applied for or approved Indication is for large cell lung cancer.
 
 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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:
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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;
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
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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).
 
If to RPCI, to:
 
Roswell Park Cancer Institute
Elm and Carlton Streets
Buffalo, NY 14263
Attention:  General Counsel
Telephone: (716) 845-8717
Facsimile:  (716) 845-8057
Email: Michael.Sexton@roswellpark.org
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
26

 
 
With a copy (which shall not constitute notice) to:

Nixon Peabody LLP
1100 Clinton Square
Rochester, New York  14603
Attention: Peter H. Durant
Telephone: (585) 263-1227
Facsimile: +1(866) 947-1223
Email: pdurant@nixonpeabody.com

 
If to Panacela, to:
 
Panacela Labs, Inc.
73 High Street
Buffalo, NY 14203
Attention: Chief Executive Officer
Telephone: (716) 849-6810
Facsimile: (716) 849-6820
DTyomkin@cbiolabs.com
 
With a copy (which shall not constitute notice) to:

Polsinelli Shughart PC
161 N. Clark Ave., Suite 4200
Chicago, IL 60601
Attention: Teddy C. Scott, Jr., Ph.D.
Telephone: (312) 819-1900
Facsimile: (312) 873-2913
Email: tscott@polsinelli.com

 
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.
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
27

 
 
 
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 [***].
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
28

 
 
 
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.
 
[ Signatures follow ]
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
29

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
 
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

 
ROSWELL PARK CANCER INSTITUTE
CORPORATION

By:   /s/ Michael B. Sexton                                                 
 
Name:   Michael B. Sexton, Esq.                                                                            
 
Title:   Chief Institute Operations Officer/Secretary                                                                                                                                           
 
Date   9/23/11                                                 
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
2

 

SCHEDULE 7.1.d
 
 
1.
American Cancer Society grant to Dr. Nikiforov regarding research targeting C-MYC with small molecules as a novel anti-melanom.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 
 
Schedule 7.1.j


RPCI Employee
Outside Employment
   
[***]
 
[***]
 
   
[***]
 
[***]
 
   
[***]
 
[***]
 
   
[***]
 
[***]
 
   
[***]
 
[***]
 
   
[***]
 
[***]
 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 
 
EXHIBIT A
 
Description of Drug Candidates
 
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.
 
·
[***]
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

EXHIBIT B
 
Projects and Licensed Patents
 
 
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
 
Product
Title
Inventors
Country
Application No.
Patent No.
MOBILAN
Use of Toll-Like Receptor and Agonist for Treating Cancer
Andrei Gudkov (RPCI, CBLI)
U.S.
61/249,596
n/a
MOBILAN
Toll-like receptor 5 agonist produced and secreted by mammalian cells
Andrei Gudkov (RPCI), Venkatesh Natarajan (RPCI)
U.S.
61/423,842
n/a
MOBILAN
Functional bacreriophage-based nanoparticles coated by Toll-like receptor 5 agonist
Andrei Gudkov (RPCI, CBLI), Venkatesh Natarajan (RPCI)
U.S.
61/423,825
n/a
ANTIMYCON
Small molecules inhibiting oncoprotein MYC
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
U.S.
61/392,296
n/a
ANTIMYCON
Small Molecules Inhibiting Oncoprotein MYC
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
U.S.
61/423,832
n/a
ARKIL
Method for treating androgen receptor positive cancers
Katerina Gurova (RPCI), Natalia Narizhneva (CBL)
U.S.
61/254,395
n/a
REVERCOM
Dual cargo nanoparticles combining MRP1 inhibitors with chemotherapeutic drugs
Andrei Gudkov (RPCI, CBLI), Aridam Sen (RPCI), Catherine Burkhart (CBLI), Padmaja Kunapuli (RPCI)
U.S.
61/423,838
n/a

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

EXHIBIT C
 
Scientists
 
Andrei Gudkov, Ph.D., D.Sci.
 
Mikhail Nikiforov, Ph.D.
 
Katerina Gurova, Ph.D.
 
Brahm Segal, Ph.D.
 
Arindam Sen, Ph.D.
 
Elena A. Komarova
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 
 

 

EXHIBIT D
 
[***]
 
Exhibit D pg. 1 of 6
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 
 

 

[***]
 
Exhibit D pg. 2 of 6
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
 

 
 
[***]

 
Exhibit D pg. 3 of 6
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

[***]
 
Exhibit D pg. 4 of 6
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

[***]
 
Exhibit D pg. 5 of 6
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.
 
 
 

 
 
[***]
 
Exhibit D pg. 6 of 6
 
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Exchange Act of 1934, as amended.

 
 

 

 
Exhibit 10.5
 
AMENDED AND RESTATED EXCLUSIVE SUBLICENSE AGREEMENT
 
This Exclusive Sublicense Agreement (“ Agreement ”) is made effective as of September 23, 2011 (“ Effective Date ”) by and between Cleveland BioLabs, Inc., a corporation organized and existing under the laws of the State of Delaware (“ CBLI ”), and Panacela, a corporation organized under the laws of the State of Delaware (“ Panacela ”).  The parties hereto are additionally referred to individually as a “ Party ”, and collectively, the “ Parties ”.
 
WHEREAS, CBLI, the Open Joint Stock Company “RusNano” (“ RusNano ”), and others have entered into that certain Investment Agreement dated as of September 19, 2011 (the “Investment Agreement”), pursuant to which, among other things, Panacela was formed as a joint venture for the purpose of developing a new generation of pharmaceutical drugs, including an initial focus on innovative oncology, immunology and anti-microbial therapies;
 
WHEREAS, CBLI has a license to the Licensed Rights (as defined below) from (i) The Cleveland Clinic Foundation, a non-profit Ohio corporation (“ CCF ”) pursuant to that certain Exclusive License Agreement between CBLI and CCF effective July 1, 2004, and as amended on March 22, 2010, and as amended on September 22, 2011, which second amendment includes rights from Children’s Cancer Institute Australia for Medical Research, a not for profit medical institute formed under the laws of Australia with registration number ACN 072 279 559  (“ CCIA ”), and attached hereto as Appendix A (“ Exclusive License Agreement ”) related to oncology and other areas, and (ii) Incuron, LLC, a limited liability company organized under the laws of the Russian Federation (“ Incuron ”) pursuant to Section 6 of that certain Assignment Agreement dated as of May 11, 2010, a copy of which is attached hereto as Appendix D ;
 
WHEREAS, CCF and CCIA entered into a Letter Agreement on September 23, 2011, pursuant to which CCF irrevocably assigned its rights to receive 50% of the payments related to the patents listed under the Revercom title on Appendix C to CCIA;
 
WHEREAS, CBLI desires to grant, and Panacela desires to accept, a sublicense to Panacela under the Licensed Rights under the terms of this Agreement, pursuant to the Exclusive License Agreement; and
 
WHEREAS, the execution and delivery of this Agreement is required by the Investment Agreement.
 
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
 
I.         DEFINITIONS
 
For the purpose of this Agreement, the following definitions shall apply.  Any capitalized terms not defined herein or therein, shall have the meaning contained in the Exclusive License Agreement.
 
A.            “ Licensed Fields ” means, collectively, the Licensed Mobilan Field and the Licensed Inhibitor and Modulator Field and the Licensed Xenomycin Field.
 
 
 

 
 
B.            “ Licensed Mobilan Field " means medical and nonmedical uses of a bifunctional expression system containing genetic elements encoding flagellin and toll-like receptor 5.
 
C.           “ Licensed Mobilan Patents ” means any and all rights in and to:
 
 
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.
 
D.           “ Licensed Mobilan Rights ” means, collectively, inventions, discoveries, and information covered by the Licensed Mobilan Patents.
 
E.           “ Licensed Inhibitor and Modulator Field ” means the discovery, development, and commercialization of methods, techniques, devices, systems, animals, and therapeutics in the field of oncology and immunotherapy.
 
F.           “ Licensed Inhibitor and Modulator Patents ” means any and all rights in and to:
 
 
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.
 
G.           “ Licensed Inhibitor and Modulator Rights ” means, collectively, inventions, discoveries, and information covered by the Licensed Inhibitor and Modulator Patents.
 
H.           “ Licensed Xenomycin Field ” means the Field of Use as defined in that certain Assignment Agreement, dated May 11, 2010, by and between Incuron, a limited liability company organized under the laws of the Russian Federation (“ Incuron ”) and CBLI, and attached hereto as Attachment B .
 
I.           “ Licensed Xenomycin Patents ” means any and all rights in and to:
 
 
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

 
 
 
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.
 
J.           “ Licensed Xenomycin Rights ” means, collectively, inventions, discoveries and information covered by the Licensed Xenomycin Patents.
 
K.           “ Licensed Xenomycin 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 Xenomycin Rights.
 
L.           “ Licensed Patents ” means, collectively, the Licensed Mobilan Patents, the Licensed Inhibitor and Modulator Patents and the Licensed Xenomycin Patents.
 
M.           " Licensed Rights " means, collectively, the Licensed Mobilan Rights, the Licensed Inhibitor and Modulator Rights and the Licensed Xenomycin Rights.
 
II.         GRANT
 
A.            Exclusive Sublicense .
 
1.            Licensed Mobilan Rights .  Subject to the terms and conditions of this Agreement, CBLI hereby grants to Panacela an exclusive sublicense under the Licensed Mobilan Rights to: (a) make, have made, develop, use, import, export, distribute, market, promote, offer for sale and sell Products, (b) practice any method, process or procedure within the Licensed Mobilan Patents, and (c) otherwise exploit the Licensed Mobilan Rights, each within the Licensed Territory for use within the Licensed Mobilan Field; and to have any of the foregoing performed on its behalf by a third party.
 
2.            Licensed Inhibitor and Modulator Rights .  Subject to the terms and conditions of this Agreement, CBLI hereby grants to Panacela an exclusive sublicense under the Licensed Inhibitor and Modulator Rights to (a) make, have made, develop, use, import, export, distribute, market, promote, offer for sale, and sell Products, (b) practice any method, process, or procedure within the Licensed Inhibitor and Modulator Patents, and (c) otherwise exploit the Licensed Inhibitor and Modulator Rights, each within the Licensed Territory for use within the Licensed Inhibitor
 
3.            Licensed Xenomycin Rights .   Subject to the terms and conditions of this Agreement, CBLI hereby grants to Panacela an exclusive sublicense under the Licensed Xenomycin Rights to (a) make, have made, develop, use, import, export, distribute, market, promote, offer for sale, and sell Products, (b) practice any method, process, or procedure within the Licensed Xenomycin Patents, and (c) otherwise exploit the Licensed Xenomycin Rights, each within the Licensed Territory for use within the Licensed Xenomycin Field; and to have any of the foregoing performed on its behalf by a third party (collectively, with the rights granted to Panacela under Section II.A.1 and II.A.2, the “ License ”).
 
 
3

 
 
4.           Panacela hereby consents to be bound by the terms of the Exclusive License Agreement.
 
5.           From time to time during the term of this Agreement, upon request by either Party, CBLI and Panacela shall update Appendix B and Appendix C hereto to include all patent applications and patents that are within the Licensed Patents.
 
B.            Affiliates .   Panacela may extend the License, or any 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.
 
C.            Right to Sublicense .  Panacela and its Affiliates may grant and authorize sublicenses to third parties (“ Sublicensees ”) within the scope of the License (“ Sublicenses ”).  Subject to the terms and considerations of this Agreement, upon expiration or termination of this Agreement for any reason, any and all existing sublicenses shall survive; provided that such Sublicensees promptly agree in writing to be bound by the terms of this Agreement.
 
D.            Option to Improvements .  Panacela will have an option to license additional inventions, which are not covered under Existing Patent Rights as follows:
 
1.           CBLI shall promptly provide Panacela with a written, enabling disclosure (“ Invention Disclosure Report ”) with respect to any improvement, enhancement, addition, or adaptation to any Licensed Patent in the applicable in the Licensed Field, which is owned by CBLI, actually assigned to CBLI, or is subject to an obligation to assign such to CBLI pursuant to an agreement with CBLI, that is sufficiently different from the scope of a Licensed Patent to be separately patentable, and covered by the claims of Licensed Patents (an “Option Invention”), during the term of this Agreement.
 
2.           Panacela shall have the option to include any Option Invention within the Licensed Rights for all purposes of this Agreement.  To exercise such option with respect to any particular Option Invention, Panacela shall notify CBLI within sixty (60) days after receiving an Invention Disclosure Report and a written request from CBLI as to whether Panacela wishes to acquire a license to such Option Invention.  If Panacela elects to acquire such a license, the Option Invention shall be included within the License Rights and all worldwide patents rights disclosing the Option Invention shall be included with the Licensed Patents, both under this Agreement.  Panacela and CBLI agree promptly to update Appendix C hereto upon request by either party from time to time, to reflect all patents and patent applications then within the Licensed Patents.
 
E.            Control of Patent Prosecution .
 
1.            Licensed Mobilan Patents .  CBLI shall retain all control of patent prosecution regarding the Licensed Mobilan Patents.
 
 
4

 
 
2.            Licensed Xenomycin Patents . Incuron shall retain all control of patent prosecution regarding the Licensed Xenomycin Patents.
 
3.            Licensed Inhibitor and Modulator Patents .
 
a.          Panacela shall have primary responsibility to (a) file and prosecute any domestic and/or foreign patent application within the Licensed Inhibitor and Modulator Patents, and (b) maintain any patent that may issue therefrom. 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.
 
b.          Panacela shall give CBLI, CCF and CCIA a reasonable opportunity to review (a) the text of all such applications before filing, and (b) the content of any proposed responses to official actions of the United States Patent and Trademark Office and foreign patent offices during prosecution of such patent applications; and shall consult with CBLI, CCF and CCIA with respect thereto.  For purposes of this Section II.D.2(b) "reasonable" shall mean sufficiently in advance of any decision by Panacela or any deadline imposed upon written response by Panacela so as to allow CBLI, CCF and CCIA to meaningfully review such decision or written response and also to provide comments to Panacela in advance of such decision or deadline to allow comments of CBLI, CCF and CCIA, or either, to be considered and incorporated into Panacela's decision or written response.
 
c.          In consultation with CCF, CBLI and CCIA, Panacela will file patent applications within the Licensed Inhibitor and Modulator Patents, prosecute patent applications within the Licensed Inhibitor and Modulator Patents, and maintain patents within the Licensed Inhibitor and Modulator Patents, in each case pursuant to Panacela’s rights under this Section II.D.2 in such countries as Panacela may desire from time to time by notice to CBLI , CCF and CCIA.  In the event Panacela does not file for or continue prosecution of any such patent application within the Licensed Inhibitor and Modulator Patents or maintain any such patent pursuant to Panacela's rights under this Section II.D, in any country, (a) Panacela shall notify CBLI in writing pursuant to Section II.D.2.d.below, and in such event CBLI may at its discretion pursue such filing, prosecution and/or maintenance, and (b) Panacela's license with respect to such patent application and/or such patent in such country shall terminate.
 
d.          Panacela agrees to keep CBLI, CCF and CCIA informed in a timely manner of the contents, status and progress of all patent applications within the Licensed Inhibitor and Modulator Patents filed and prosecuted by Panacela, and to provide copies of such patent applications and documents relating thereto to CBLI, CCF and CCIA; Panacela shall copy CBLI on all correspondence with CCF and/or CCIA related to the Licensed Inhibitor and Modulator Patents.  Panacela agrees to provide CBLI, CCF and CCIA with such information and documentation with respect to all Licensed Inhibitor and Modulator Patents, as CBLI , CCF or CCIA, respectively, shall reasonably request.  Panacela further agrees that Panacela will not allow any such patent application or any patent that may issue therefrom to become abandoned until CCF, CBLI and CCIA have each determined, and informed Panacela, that it does not desire to continue prosecution or appeal(s) or maintenance of such patent application or patent in accordance with such party’s rights pursuant to Section II.D.2.c.above; provided that Panacela’s obligations to continue prosecution or appeals(s) or maintenance of any such patent application or patent will not extend beyond the three (3) month anniversary of Panacela’s written notice of Panacela's election pursuant to Section II.D.2.c. above.
 
 
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e.          In the event that Panacela elects not to file any patent application within the Licensed Inhibitor and Modulator Patents, or thereafter elects not to continue prosecution of any such patent application, or elects not to maintain any patent that may issue therefrom pursuant to Section II.D.2.c. above, CBLI shall have the right, at CBLI's option and expense and on its own make, to file for and prosecute such patent application and maintain such patent using patent counsel selected by CBLI, and Panacela shall cooperate therewith.
 
F.            Research Use Right .  Pursuant to Section 2.G of the Exclusive License Agreement, this Agreement does not include the exclusive, fully-paid up non-assignable right of CCF and Other Institution to make and use, for academic or research purposes only, the Licensed Rights (the “Reserved Rights”) to the extent that the Reserved Rights are based on the rights granted by CCF or Other Institution, as the case may be.
 
G.            Right to Publish . The License is subject to a reserved, irrevocable, exclusive, fully-paid up non-assignable license back to CCF and Other Institution, as the case may be, to publish the general scientific findings from such parties’ research related to the Licensed Rights.
 
H.            Ownership of Innovations .  Innovations shall be either jointly owned or solely owned by the party for whom ownership can be established under the provisions of U.S. patent law and licensed as provided herein.  Unless otherwise agreed in writing between the Parties, and subject to CCF’s and Other Institution’s rights under Sections II.E and II.F of this Agreement, Panacela shall own absolutely and exclusively immediately upon their creation all rights, title and interest in and to any and all Innovations created solely by employees or agents of Panacela or Affiliates thereof (“ Panacela Innovations ”), including, but not limited to, all patents, trade marks, design rights (whether registrable or otherwise), copyright, database rights, trade secrets, know-how and all other intellectual property rights and equivalent rights or similar forms of protection existing anywhere in the world.  Panacela shall have the sole and exclusive discretion regarding whether to seek protection (including, without limitation, patent protection) for Panacela Innovations.
 
III.          COMMERCIALIZATION; REGULATORY APPROVALS
 
A.            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 Rights, to bring 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 Products at Panacela’s expense, including research and development, laboratory and clinical testing, and marketing and sales.  This Agreement shall not provide to CBLI 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.  CBLI acknowledges that Panacela is in the business of developing, manufacturing, marketing and selling biopharmaceutical products.  Panacela shall provide CBLI written reports necessary for CBLI to satisfy its reporting obligations under the Exclusive License Agreement, including written reports on at least on a semi-annual basis detailing Panacela’s clinical, regulatory, and financial progress.  CBLI 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 XVIII.  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 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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B.            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 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 CBLI and Panacela otherwise agree that a particular approval be made in the name of CBLI or an Affiliate or lawful designee of CBLI.  CBLI agrees that, any such Regulatory Approval made in its name will not affect the rights granted to Panacela in this Agreement.  CBLI will lend assistance, including involving CCF or Other Institution 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 CBLI (including from CCF or Other Institution) relating to the Licensed Rights and the Products. Panacela shall be responsible for reimbursing CBLI for any reasonable direct costs associated with such activity, including costs incurred by CBLI to CCF or Other Institution.
 
IV.         CONSIDERATION
 
A.           For any amounts owed to CCF under Section 4.B of the Exclusive License Agreement (the “CCF Milestones”) on account of activities under the Licensed Rights (the “Panacela Activities”), Panacela shall pay the CCF Milestones directly to CCF or its designee, as applicable,  in the name of CBLI.
 
B.            Earned Royalties .  For any amounts owed to CCF under Section 4.C of the Exclusive License Agreement (the “ CCF Royalties ”) on account of Panacela Activities, Panacela shall pay the CCF Royalties directly to CCF or its designee, as applicable, in the name of CBLI.
 
C.            Sublicense Royalties .  For any amounts owed to CCF under Section 4.D of the Exclusive License Agreement (the “ CCF Sublicense Royalties ”) on account of Panacela Activities, Panacela shall pay the CCF Sublicense Royalties directly to CCF or its designee, as applicable, in the name of CBLI.
 
D.            Xenomycin Consideration .  In consideration of the rights and licensed granted by CBLI to Panacela under this Agreement, Panacela agrees to pay $5,000,000 in cash or shares, as determined by Panacela’s board of directors, to CBLI upon the commencement of the first Phase III clinical trial for a Licensed Xenomycin Product. The share price, if shares are issued, shall be based on the post-money valuation of the immediately preceding equity investment transaction.
 
 
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E.            Accounting .  Panacela shall provide CCF, CCIA and/or CBLI, as applicable, a full accounting showing how any amounts owing under this Section IV have been calculated on the date of each such payment and paid.  Such accounting will be on a per-country and product line, model, or trade name basis and shall be summarized in a reporting format that contains substantially similar information to the information obligations of CBLI as set out in Section 4. to the Exclusive License Agreement.  Should failure by Panacela to make a required payment when due hereunder cause interest to accrue against CBLI under the Exclusive License Agreement, the corresponding balance due by Panacela hereunder shall accrue interest until paid at the same rate.
 
F.            Currency .  Except as otherwise directed, all amounts owing under this Agreement shall be paid in U.S. dollars by wire transfer to an account specified by the designated recipient.  If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made at the rate used by Panacela in calculating Panacela's own revenues for financial reporting purposes.
 
G.            Withholdings .  Any withholding or other tax that Panacela or an Affiliate thereof is required by law to withhold shall be deducted from said royalties and promptly paid to the taxing authority.  If royalties paid to Panacela or an Affiliate thereof by a Sublicensee on Net Sales of Products are reduced for withholding or similar taxes, the Sublicense Royalties due shall be correspondingly reduced, and Panacela shall furnish CCF, CCIA and/or CBLI, as applicable with proper evidence of the taxes paid.
 
V.          REPRESENTATIONS AND WARRANTIES.
 
A.           CBLI represents and warrants as of the Effective Date that:
 
 
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;
 
 
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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.
 
Provided that:
 
 
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.
 
B.           CBLI MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND 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 USE OF THE LICENSED RIGHTS.
 
C.           Panacela represents and warrants that:
 
 
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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.
 
VI.         RECORDKEEPING
 
A.           Panacela shall keep books and records sufficient to verify the accuracy and completeness of Panacela's accounting referred to above, including without limitation inventory, purchase and invoice records relating to the Products or their manufacture. In addition, Panacela shall maintain documentation evidencing that Panacela is in fact pursuing development of Products as required herein.  Such documentation may include, but is not limited to, invoices for studies advancing development of Products, laboratory notebooks, internal job cost records, and filings made to the Internal Revenue Service to obtain tax credit, if available, for research and development of Products. Such books and records shall be preserved for a period not less than three (3) years after they are created during and after the term of this Agreement.
 
B.           Panacela shall take all reasonable steps necessary so that the accounting firm representing Panacela, or any other registered CPA mutually agreeable to CBLI and Panacela, may within forty-five (45) days of request by CBLI review and copy all the books and records to allow CBLI to verify the accuracy of Panacela's royalty reports and Development Reports. Such review shall be performed at the expense of CBLI upon reasonable notice and during regular business hours at a single U.S. location of Panacela's choice.
 
 
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VII.         LICENSE TERM AND TERMINATION PROVISIONS
 
A.           The term (the " Term ") of this license shall begin on the date of this Agreement and continue until the earlier of the expiration of exclusive rights pursuant to the Licensed Patents, or twenty (20) years after the commencement of Sales of Products, unless this Agreement is earlier terminated as provided herein.
 
B.           The License is strictly subject to Panacela's diligent efforts to develop and commercialize Products. CBLI may, at its option, terminate this Agreement ninety (90) days after giving written notice of termination to Panacela during the continuation of any of the following events by Panacela:
 
1.           commission of any breach in any material respect of any other covenant herein contained, including without limitation (a) failure to satisfy its diligence obligations pursuant to Article III ; (b) failure to timely pay any monies due hereunder; (c) failure to timely submit to CBLI any Development Report; (d) offering any component of the Licensed Rights to its creditors or any other third party in violation of this Agreement; or (e) raising or allowing to be raised any challenge of or regarding the validity of any of the Licensed Patents; or
 
2.           committing any act of bankruptcy, becoming insolvent, or unable to pay its debts as they become due, filing a petition under any bankruptcy or insolvency act, or having any such petition filed against it which is not dismissed within sixty (60) days.  Should Panacela, or a new entity which is an Affiliate of Panacela subsequently emerge from bankruptcy, CBLI shall negotiate in good faith with such entity to enter into a new license agreement between CBLI and such party containing substantially the same material terms as this License;
 
provided that Panacela may avoid such termination if before the end of such sixty (60) day period Panacela cures such breach or default.  This paragraph shall not suspend any obligation of Panacela to compensate CBLI for any undisputed amount, as provided for under any term of this Agreement, during the pendency of any determination of breach.
 
C.           Panacela may terminate this Agreement in its entirety or as to any particular patent application or patent within the Licensed Patents at any time by giving at least ninety (90) days written notice of such termination to CBLI.  A brief statement of the reasons for termination shall accompany such a notice.  From and after the effective date of a termination under this Paragraph with respect to a particular patent application or patent, such patent application and patent in the particular country shall cease to be within the Licensed Patents for all purposes of this Agreement.  Upon a termination of this Agreement in its entirety under this Paragraph, all rights and obligations of CBLI and Panacela shall terminate, except as provided in Section VII.F.
 
D.           Notwithstanding the foregoing, the obligations of Panacela with respect to the commercialization of Products under this Agreement are expressly conditioned upon the continuing absence of a materially adverse condition which results in a delay in the commercialization of the Products, including, but not limited to, a substantially adverse condition or event relating to the safety or efficacy of a Product or unfavorable pricing, pricing reimbursement, labeling or lack of Regulatory Approval, and the obligation of Panacela to develop or market any such Product, and CBLI’s right to terminate this Agreement set forth in this Section VII.B, shall be delayed, tolled or suspended so long as such condition or event exists as mutually agreed by CBLI and Panacela.
 
 
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E.           Upon termination of this Agreement, Panacela’s rights to the Licensed Rights granted hereunder and all use thereof shall terminate and any and all rights in the Licensed Patents shall revert back to CBLI and, if requested by CBLI, Panacela shall destroy or return, at CBLI’s sole option, all copies of any media or materials which are the property of CBLI, CCF or Other Institution, including but not limited to all documentation, notes, plans, drawings, copies, samples and computer code.  Notwithstanding the termination of this Agreement, Panacela shall remain obligated to provide an accounting for and to pay royalties earned up to the date of the termination and post-termination (as permitted by Section VII.H), subject to Section IV.B.
 
F.           Expiration or termination of the Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination, and the provisions of Section VI, VII.E, XIV, XV.A, XVII and XVIII shall survive the expiration or termination of this Agreement and remain in full force and effect regardless of the cause of termination. Any expiration or early termination of this Agreement shall be without prejudice to the rights of either party against the other accrued or accruing under this Agreement prior to termination.
 
G.           Waiver by either Party of a single breach or default, or a succession of breaches or defaults, shall not deprive such Party of any right to terminate this Agreement in the event of any subsequent breach or default.
 
H.           In the event that this Agreement is terminated for any reason, Panacela and Affiliates thereof and customers of either may, after the effective date of such termination, sell or otherwise dispose of all Products and parts thereof that Panacela, Affiliates thereof, and customers of either may have on hand on the effective date of such termination, subject to Panacela’s payment to CBLI of royalties pursuant to Section IV of this Agreement.
 
VIII.        ASSIGNABILITY
 
This Agreement may not be assigned by Panacela without notification of CCF and the prior written consent of CBLI, which will not be unreasonably withheld provided that such assignee or transferee promptly agrees in writing to be bound by the terms and conditions of this Agreement.  Panacela may assign its right to receive payments hereunder.
 
IX.          CONTEST OF VALIDITY
 
In the event Panacela or a third party contests the validity of any Licensed Patent, Panacela shall continue to pay royalties with respect to that patent as if such contest were not underway to an escrow agent mutually agreed to by the parties, to be held in a separate interest bearing account in accordance with the terms of a mutually acceptable escrow agreement between the parties in form and substance as is customary for such purposes, until such time as a court of last resort adjudicates the validity or invalidity of such patent. If such court of last resort confirms the invalidity or unenforceability of such patent, then all royalties previously paid by Panacela into escrow pursuant to this paragraph, together with all interest accrued thereon and any other amounts earned in respect thereof (collectively, the “ Escrow Funds ”), shall be promptly paid to Panacela.  If such court of last resort confirms the validity or enforceability of such patent, then the Escrow Funds shall be promptly paid to CCF and/or CCF and CCIA, as applicable.
 
 
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X.          PROTECTION OF LICENSED RIGHTS
 
CBLI and Panacela agree to assist each other to the extent necessary to protect any of Panacela’s rights in the Licensed Rights.  CBLI and Panacela each shall notify the other in writing of any infringements by others of the Licensed Rights.  Following receipt of such notification, CBLI and Panacela shall engage in meaningful consultation 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 CBLI and Panacela shall mutually determine are required prior to the filing of any lawsuit.  Pursuant to Section XI below, Panacela may commence or prosecute any claims or suits in its own name or join CBLI as a party thereto.  However, should Panacela decline or fail to commence or prosecute such claims or suits, CBLI may itself institute such claims or suits in its own name and join Panacela as a party thereto, except that CBLI shall not institute such claims or suits without first obtaining the written consent of Panacela to do so, which consent shall not be unreasonably withheld, conditioned or delayed.  CBLI and Panacela shall cooperate fully in any claims or suits commenced and prosecuted by either Party pursuant to this Section X .
 
XI.           ENFORCEMENT OF LICENSED RIGHTS
 
A.           Panacela has the right, but not the obligation, to defend the Licensed Rights (the “ Enforced Rights ”) against infringement, interference or opposition by other parties in any country, including by bringing any legal action for infringement or opposition or defending any counterclaim of invalidity, notice of opposition or action of a third party for declaratory judgment of non- infringement or interference.  Panacela may bring or defend, or subject to CBL’s approval, which approval shall not be unreasonably withheld, conditioned or delayed, may settle any such actions solely at its own expense and through counsel of its selection; provided, however, that CBLI, CCF and the Other Institution, to the extent that the Enforced Rights are based on the rights granted by CCF or Other Institution, as the case may be, shall be entitled in each instance to participate through counsel of its selection and at its own expense. CBLI has no obligation or responsibility with respect to any such infringement action or interference except to provide reasonable assistance to Panacela as requested, and Panacela shall reimburse CBLI and Other Institution, as the case may be, for its reasonable out-of-pocket expenses in connection with any such assistance.  Panacela shall be entitled to credit against royalties payable to CBLI hereunder to the same extent that CBLI shall be entitled to credit against royalties payable to CCF or CCIA, as applicable.  Any amounts entitled to be so credited and not previously credited may be carried forward.  In the event of a favorable settlement or award of damages, any amounts owed to CCF under Section 11.A of the Exclusive License Agreement shall be paid directly to CCF or CCIA, as applicable, in the name of CBLI.  CCF’s or CCIA’s sole financial obligation, as applicable, with respect to such litigation will be limited to the right of Panacela to credit fifty percent (50%) of its costs and expenses against royalties as provided herein.
 
 
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B.           In the event Panacela is permanently enjoined from exercising any of the License Rights granted hereunder pursuant to an infringement action brought by a third party, or if Panacela elects not to undertake the defense or settlement of such a claim of alleged infringement for a period of six (6) months from notice of such claim or suit, then Panacela’s rights and obligations under this Agreement with respect to said License Rights will terminate upon written notice from CBLI, subject to Section VII of this Agreement.  If Panacela elects to defend any such action, then Panacela shall be entitled to credit against royalties payable to CBLI hereunder fifty percent (50%) of its out-of-pocket costs and expenses incurred in connection with such action at a rate not to exceed fifty percent (50%) of the royalties due CBLI in any Half Year. Any amounts entitled to be so credited and not previously credited may be carried forward.
 
XII.         PATENT MARKING
 
Panacela shall mark all Products or Products’ packaging with the appropriate patent number reference in compliance with the requirements of United States law (see 35 U.S.C. §287).
 
XIII.         PRODUCT LIABILITY AND CONDUCT OF BUSINESS
 
A.           Panacela shall, at all times during the term of this Agreement and thereafter, indemnify, defend and hold CBLI, CCF, and Other Institution and each of its respective trustees, officers, employees, consultants, and agents of each, as the case may be, harmless against all claims and expenses, including legal expenses and reasonable attorneys fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense and liability of any kind whatsoever (other than infringement claims) resulting from the production, manufacture, sale, use, lease, consumption or advertisement of Products arising from any right or obligation of Panacela hereunder with respect to CBLI, CCF or Other Institution, as the case may be , provided that Panacela shall not be obligated to indemnify CBLI, CCF or Other Institution under this Section XIII.A 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 of CBLI, CCF or Other Institution.  CBLI, CCF and Other Institution at all times reserve the right to select and retain counsel(s) of their own to represent CBL’s, CCF’s and Other Institution’s interests in any such action, subject to Panacela’s sole control of the defense thereof and all related settlement negotiations.
 
B.           CBLI hereby agrees to indemnify, defend, and hold harmless Panacela and its current, former, or future stockholders, non-Panacela investors, officers, employees, consultants, and agents (each, an “ Indemnified Person ”) for, from, and against any and all claims, expenses (including attorneys’ fees), damages, losses, judgments, fines, amounts paid in settlement, and any other amounts that any Indemnified Person suffers, sustains, incurs, or becomes subject to arising out of or in connection with any breach of this Agreement or any inaccuracy of the representations contained in Section V.A.4 and V.A.11 of this Agreement.
 
 
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C.           Neither Party shall be liable to the other Party for any indirect, special, consequential, or other damages whatsoever, whether grounded in tort (including negligence), strict liability, contract or otherwise.  Except as provided in this Agreement, CBLI shall not have any responsibilities or liabilities whatsoever with respect to Product(s).
 
D.           Panacela shall at all times comply in all material respects, through insurance or self-insurance, with all statutory workers’ compensation and employers’ liability requirements covering any and all employees with respect to activities performed under this Agreement.
 
XIV.       USE OF NAMES
 
Other than as required by law or regulation, Panacela shall not use the name, logo, likeness, trademarks, image or other intellectual property of CBLI, CCF, Other Institution, or employees thereof for any advertising, marketing, endorsement or any other purposes without the specific prior written consent of an authorized representative of CBLI, CCF or Other Institution, as the case may be, as to each such use.  For purposes of the foregoing provision, an authorized representative of CCF means a representative of CCF’s Department of Media Relations and/or CCF’s Office of General Counsel, or comparable personnel.
 
XV.        MISCELLANEOUS
 
A.            Choice of Law .  This Agreement shall be governed, construed, and interpreted in all respects in accordance with laws of the State of New York without regard to the conflict of laws provisions of such.
 
B.            Notices .  Any notice required to be given pursuant to the provisions of this Agreement shall be in writing and shall be deemed to have been given at the earlier of the time when actually received as a consequence of any effective method of delivery, including but not limited to hand delivery, transmission by telecopier, or delivery by a professional courier service or the time when sent by certified or registered mail addressed to the Party for whom intended at the address below or at such changed address as the Party shall have specified by written notice, provided that any notice of change of address shall be effective only upon actual receipt.
 
 
(i)
If from Panacela to CBLI:
 
Cleveland BioLabs, Inc.
Attn: General Counsel
73 High Street
Buffalo, NY 14203
Fax: (716) 849-6820
 
With a copy to:
 
Polsinelli Shugart PC
Attn: Teddy C. Scott, Jr., Ph.D.
161 N. Clark Ave., Suite 4200
Chicago, IL 60601
Fax: (312) 873-2913
 
 
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(ii)
If from Panacela to CCF:
 
Commercialization Counsel
CCF Innovations / ND20
9500 Euclid Avenue
Cleveland, OH  44195

With a copy to:
 
Legal Department
3050 Science Park Dr.
AC3-231
Beachwood, OH 44122

Payments to:

The Cleveland Clinic Foundation
Re: CCF-CBL License
P.O. Box 931532
Cleveland, OH  44193-5007
Attn: Barbara Honeey

The CCF Federal Tax ID Number is 34-0714585.
 
 
(iii)
If from Panacela to CCIA:
 
Children’s Cancer Institute Australia
PO Box 81
Randwick NSW2031 Australia
Attention: Managing Director
Telephone: 0293853140
 
 
(iv)
If from CBLI to Panacela:
 
Panacela Labs, Inc.
73 High Street
Buffalo, NY 14203
Fax: (716) 849-6820
Attention: Chief Executive Officer

With a copy to:
 
Polsinelli Shugart PC
Attn: Teddy C. Scott, Jr., Ph.D.
161 N. Clark Ave., Suite 4200
Chicago, IL 60601
Fax: (312) 873-2913
 
 
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C.            Counterparts .  This Amendment may be executed in counterparts with the same effect as if both parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
 
XVI.       INTEGRATION
 
This Agreement constitutes the full understanding between the parties with reference to the subject matter hereof, and no statements or agreements by or between the Parties, whether orally or in writing, except as provided for elsewhere in this Section XVII , made prior to or at the signing hereof, shall vary or modify the written terms of this Agreement. Neither Party shall claim any amendment, modification, or release from any provisions of this Agreement by mutual agreement, acknowledgment, or otherwise, unless such mutual agreement is in writing, signed by the other Party, and specifically states that it is an amendment to this Agreement.
 
XVII.       SEVERABILITY
 
If any provision of this Agreement is held to be invalid, the other provisions will not be affected to the greatest extent possible consistent with the parties’ intent.
 
XVIII.      CONFIDENTIALITY
 
A.           Panacela acknowledges that CBLI may disclose valuable confidential information of CCF, Other Institution or CBLI to Panacela pursuant to the terms of this Agreement.  CBLI acknowledges that Panacela may disclose valuable confidential information to CBLI pursuant to the terms of this Agreement. Accordingly, the Parties agree to keep any Confidential Information in confidence and not to use or disclose the same except in pursuance of the terms of this Agreement.
 
B.           Both Parties agree to keep any information identified as confidential by the disclosing Party, confidential using methods at least as stringent as each Party uses to protect its own confidential information. “ Confidential Information ” shall include plans and reports of Panacela, Panacela’s books and records maintained pursuant to Section VI , the Licensed Rights and all information concerning them and any other information marked confidential or accompanied by correspondence indicating such information is confidential exchanged between the parties hereto.  Except as may be authorized in advance in writing by the other Party, each Party shall grant access to the Confidential Information only to its own employees involved in research relating to the subject matter of the Licensed Patents and/or manufacture or marketing of the Products, and each Party shall require such employees to be bound by confidentiality obligations substantially similar to those set forth in this Article XVIII . Each Party agrees not to use any Confidential Information to its advantage and the other Party’s detriment, including, but not limited to, in the case of Panacela, claiming priority to any application serial numbers of any Licensed Mobilan Patents in any patent prosecution by Panacela.  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:
 
 
1.
The recipient party can show by written record that it possessed the information prior to its receipt from the other Party;
 
 
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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.
 
C.           The Parties agree to keep the nature, existence and terms of this Agreement confidential until first publicly announced by the Parties pursuant to a joint press release mutually approved by the Parties.  The content and timing of all press releases and similar public communications regarding this Agreement and the subject matter hereof will be mutually agreed to in writing by the Parties, and neither Party may make or issue any public announcement or press release that refers to the other Party or describes any aspect of this Agreement without having first received the prior written consent of the other Party.  Notwithstanding the foregoing, either Party may make any public announcement or disclosure that it reasonably believes is required by law, rule or regulation of any governmental authority or other regulatory body (including, without limitation, the SEC or the FDA).
 
D.           Notwithstanding the provisions of this Section XVIII , Panacela shall have the right to disclose Confidential Information to its sublicensees, agents, vendors consultants, Affiliates or other third parties (collectively, “ Agents ”) in accordance with this paragraph.  Such disclosure shall be limited only to the Agents involved in the research, development, commercialization, manufacturing, marketing or promotion of Products.  Any such Agents must agree in advance and in writing to be bound by confidentiality and non-use obligations substantially similar to those contained in this Agreement.  In addition, Panacela and its Agents may make disclosure of such Confidential Information of CBLI as may be necessary in order to obtain or maintain any Regulatory Approvals, including, in connection with clinical trials, regulatory applications and filings, and otherwise.
 
XIX.        ANTI-KICKBACK STATUTE AND STARK LAW COMPLIANCE
 
By entering into this Agreement, the parties specifically intend to comply with all applicable laws, rules and regulations, including (i) the federal anti-kickback statute (42 U.S.C. §1320a-7b) and the related safe harbor regulations; and (ii) the Limitation on Certain Physician Referrals, also referred to as the “Stark Law” (42 U.S.C. §1395nn).  Accordingly, no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business.  In the event that any part of this Agreement is determined to violate federal, state, or local laws, rules, or regulations, the parties agree to negotiate in good faith revisions to the provision or provisions that are in violation.
 
 
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XX.         ELIGIBILITY TO PARTICIPATE IN FEDERAL HEALTH CARE PROGRAMS
 
By signing this agreement, Panacela hereby represents and warrants the following: (a) that is has not been debarred, excluded, suspended or otherwise determined to be ineligible to participate in any federal health care programs (collectively, “ Debarment ” or “ Debarred ”, as applicable); and (b) that it shall not knowingly employ or contract with, with or without compensation, any individual or entity (singularly or collectively, “Program Agent”) listed by a federal agency as Debarred.  To comply with this provision, Panacela shall make reasonable inquiry into the status of any Program Agent contracted or arranged by Panacela to fulfill the terms of this Agreement.  In the event that Panacela and/or an Program Agent thereof either (i) becomes Debarred or (ii) receives notice of action or threat of action with respect to its Debarment during the term of this Agreement, Panacela agrees to notify CBLI immediately.  Panacela agrees to timely notify CBLI in the event that Panacela has identified or reasonably suspects potential violations associated with its performance under this Section, and the nature of such potential violation, to enable CBLI to take prompt corrective action.  Further, in the event that Panacela or a Program Agent thereof becomes Debarred as set forth above and such Debarment shall have become final and non-appealable, this Agreement relative to such entity or individual’s participation hereunder may be terminated upon written notice.
 
XXI.      AUTHORITY
 
The persons signing on behalf of each of CBLI and Panacela hereby warrant and represent that they have authority to execute this Agreement on behalf of the Party for whom they have signed.
 
XXII.        PUBLICATION
 
To avoid loss of patent rights as a result of premature public disclosure of patentable material, CBLI will extend to Panacela and allow Panacela to exercise all of CBLI’s benefit and rights regarding intended publication or disclosure pertaining to the Licensed Rights.
 
XXIII.        DISPUTE RESOLUTION
 
A.            Disputes .  The Parties recognize that disputes as to certain matters arising under or relating to this Agreement or either Party’s rights and/or obligations hereunder may arise from time to time.  It is the objective of the Parties to establish procedures to facilitate the resolution of such disputes in an expedient manner by mutual cooperation and without resort to litigation.  To accomplish this objective, the Parties agree to follow the procedures set forth in Section XXIII.B if and when such a dispute arises between the Parties.
 
B.            Procedures . The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation between executives who have the authority to settle the controversy.  Either Party may give the other Party written notice of a dispute not resolved in the normal course of business.  If the matter has not been resolved by such executives within sixty (60) days of a disputing Party’s notice, the Parties agree to submit the matter to mediation unless mediation is waived upon written consent of the Parties.  If the matter is submitted to mediation but is not resolved through negotiation or mediation, or if the Parties waive mediation, either Party may initiate binding arbitration as provided in Section XXIII.C .
 
 
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C.            Arbitration .  Arbitration of disputes or claims (each, a “ Claim ”) between the parties under this Section XXIII.C shall be administered by JAMS in accordance with its Comprehensive Arbitration Rules and Procedures.  The arbitration shall be held in New York, New York.  The arbitration shall be conducted by one arbitrator who is knowledgeable in the subject matter at issue in the dispute.  The arbitrator will be selected by written agreement of the Parties.  The arbitrator shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded.  The arbitrator shall be authorized to award compensatory damages, but shall NOT be authorized (a) to award non-economic damages, such as for emotional distress, pain and suffering or loss of consortium, (b) to award punitive or multiple damages, or (c) to reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided, however, that the damage limitations described in subsections (a) and (b) of this sentence will not apply if such damages are statutorily imposed.  The arbitrator also shall be authorized to grant any temporary, preliminary or permanent equitable remedy or relief the arbitrator deems just and equitable and within the scope of this Agreement, including, without limitation, an injunction or order for specific performance.  The decision of the arbitrator shall be final and binding upon the Parties.  The award of the arbitrator shall be the sole and exclusive remedy of the Parties.  Judgment on the award rendered by the arbitrator may be entered in any court having competent jurisdiction thereof.  This Section XXIII.C shall not apply to any dispute, controversy or claim that concerns (i) the validity or infringement of a patent, trademark or copyright; or (ii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.  Notwithstanding the foregoing, claims for injunctive relief shall not be subject to the requirements of arbitration. English shall be the language of any arbitration proceeding.
 
D.            Costs and Awards .  Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrator; provided, however, that the arbitrator shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, and travel expenses), and/or the fees and costs of the arbitrator.
 
E.            Waiver and Acknowledgement .  By agreeing to this binding arbitration provision, the Parties understand that they are waiving certain rights and protections which may otherwise be available if a Claim between the Parties were determined by litigation in court, including, without limitation, the right to seek or obtain certain types of damages precluded by this provision, the right to a jury trial, certain rights of appeal, and a right to invoke formal rules of procedure and evidence.
 
XXIV.      CONFLICT OF INTEREST
 
CCF maintains and adheres to a Conflict of Interest Policy.  In connection therewith, Panacela represents that no CCF employees, officers or directors are consultants, employees, officers or directors of Panacela or any of its Affiliates serve on any boards or committees of or in any advisory capacity with Licensee or any of its affiliates.
 
 
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XXV.       COMPLIANCE WITH LAWS
 
A.           Panacela agrees to comply with all applicable US and Foreign laws, rules, regulations and restrictions.  Without limiting the foregoing, by entering into this Agreement, Panacela will comply with all applicable laws, rules and regulations including, the Foreign Corrupt Practices Act, export/import laws, security laws and regulations, currency restrictions, and tax and other applicable treaties. In the event that any part of this Agreement is determined to violate any such U.S. or foreign, federal, state, or local laws, rules, or regulations, the Parties agree to negotiate in good faith revisions to the provision or provisions that are in violation.  In the event the Parties are unable to agree to new or modified terms as required to bring the entire Agreement into compliance, either Party may terminate this agreement upon sixty (60) days' written notice to the other Party.
 
F.            Export Control Compliance . Panacela will comply with all applicable export laws, regulations, and restrictions. In connection with the exercise of Panacela’s rights hereunder, CBLI 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. CBLI 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 Sublicensees 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 13. Upon request, and in any event with each Report due hereunder, an officer of Panacela shall certify that Panacela and each Sublicensee and Affiliate are in compliance with and have not violated any Export Law.
 
 [Signatures follow.]
 
 
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IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement on the dates indicated below.
 
CLEVELAND BIOLABS, INC.:
 
By:
/s/ Michael Fonstein, Ph.D.
Date: September 23, 2011
     
Name: Michael Fonstein, Ph.D.
 
   
Title: Chief Executive Officer
 
 
PANACELA LABS, INC.
 
By:
/s/ Dmitry Tyomkin
Date: September 23, 2011
     
Name: Dmitry Tyomkin
 
   
Title: Chief Executive Officer
 
 
Signature Page to Amended and Restated Exclusive Sublicense Agreement
 
 
 

 

Appendix B
 
Licensed Mobilan Patent Applications and Patents
 
Mobilan
 
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
 
Appendix A
 
 
 

 

Appendix C
 
Licensed Inhibitor and Modulator Patent Applications and Patents
 
Revercom
 
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
 
Akril
 
Country/Region
App. No.
Assignee/Owner
PCT
PCT/US06/38440
CCF / CBLI
US
11/992,874
CCF / CBLI
 
Licensed Xenomycin Patent Applications and Patents
 
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
 
 
 

 
Exhibit 10.6
EXCLUSIVE SUBLICENSE AGREEMENT
 
This Exclusive Sublicense Agreement (“Agreement”) is made effective as of September 23, 2011 (“Effective Date”) by and between Cleveland BioLabs, Inc., a corporation organized and existing under the laws of the State of Delaware (“CBLI”), and Panacela, a corporation organized under the laws of the State of Delaware (“Panacela”).  The parties hereto are additionally referred to individually as a “Party”, and collectively, the “Parties”.
 
WHEREAS, CBLI, the Open Joint Stock Company “RusNano” (“RusNano”), and others have entered into that certain Investment Agreement dated as of September 19, 2011 (the “Investment Agreement”), pursuant to which, among other things, Panacela was formed as a joint venture for the purpose of developing a new generation of pharmaceutical drugs, including an initial focus on innovative oncology, immunology and anti-microbial therapies;
 
WHEREAS, CBLI has a license to the Licensed Rights (as defined below) from The Cleveland Clinic Foundation, a non-profit Ohio corporation (“CCF”) pursuant to that certain Exclusive License Agreement between CBLI and CCF effective July 1, 2004, and as amended on March 22, 2010, and as amended on September 22, 2011, which second amendment includes rights from Children’s Cancer Institute Australia for Medical Research, a not for profit medical institute formed under the laws of Australia with registration number ACN 072 279 559  (“CCIA”), and attached hereto as Appendix A (“Exclusive License Agreement”) related to oncology and other areas;
 
WHEREAS, CCF and CCIA entered into a Letter Agreement on September 23, 2011, pursuant to which CCF irrevocably assigned its rights to receive 50% of the payments related to the patents listed under the Revercom title on Appendix C to CCIA;
 
WHEREAS, CBLI desires to grant, and Panacela desires to accept, a sublicense to Panacela under the Licensed Rights under the terms of this Agreement, pursuant to the Exclusive License Agreement; and
 
WHEREAS, the execution and delivery of this Agreement is required by the Investment Agreement.
 
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
 
I.         DEFINITIONS
 
For the purpose of this Agreement, the following definitions shall apply.  Any capitalized terms not defined herein or therein, shall have the meaning contained in the Exclusive License Agreement.
 
A.           “Licensed Fields” means, collectively, the Licensed Mobilan Field and the Licensed Inhibitor and Modulator Field.
 
 
 

 
 
B.           “Licensed Mobilan Field" means medical and nonmedical uses of a bifunctional expression system containing genetic elements encoding flagellin and toll-like receptor 5.
 
C.           “Licensed Mobilan Patents” means any and all rights in and to:
 
 
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.
 
D.           “Licensed Mobilan Rights” means, collectively, inventions, discoveries, and information covered by the Licensed Mobilan Patents.
 
E.           “Licensed Inhibitor and Modulator Field” means the discovery, development, and commercialization of methods, techniques, devices, systems, animals, and therapeutics in the field of oncology and immunotherapy.
 
F.           “Licensed Inhibitor and Modulator Patents” means any and all rights in and to:
 
 
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.
 
G.           “Licensed Inhibitor and Modulator Rights” means, collectively, inventions, discoveries, and information covered by the Licensed Inhibitor and Modulator Patents.
 
H.           “Licensed Patents” means, collectively, the Licensed Mobilan Patents and the Licensed Inhibitor and Modulator Patents.
 
I.           "Licensed Rights" means, collectively, the Licensed Mobilan Rights and the Licensed Inhibitor and Modulator Rights.
 
 
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II.         GRANT
 
A.            Exclusive Sublicense .
 
1.            Licensed Mobilan Rights .  Subject to the terms and conditions of this Agreement, CBLI hereby grants to Panacela an exclusive sublicense under the Licensed Mobilan Rights to: (a) make, have made, develop, use, import, export, distribute, market, promote, offer for sale and sell Products, (b) practice any method, process or procedure within the Licensed Mobilan Patents, and (c) otherwise exploit the Licensed Mobilan Rights, each within the Licensed Territory for use within the Licensed Mobilan Field; and to have any of the foregoing performed on its behalf by a third party.
 
2.            Licensed Inhibitor and Modulator Rights .  Subject to the terms and conditions of this Agreement, CBLI hereby grants to Panacela an exclusive sublicense under the Licensed Inhibitor and Modulator Rights to (a) make, have made, develop, use, import, export, distribute, market, promote, offer for sale, and sell Products, (b) practice any method, process, or procedure within the Licensed Inhibitor and Modulator Patents, and (c) otherwise exploit the Licensed Inhibitor and Modulator Rights, each within the Licensed Territory for use within the Licensed Inhibitor and Modulator Field; and to have any of the foregoing performed on its behalf by a third party (collectively, with the rights granted to Panacela under Section II.A.1 and II.A.2, the “License”).
 
3.           Panacela hereby consents to be bound by the terms of the Exclusive License Agreement.
 
4.           From time to time during the term of this Agreement, upon request by either Party, CBLI and Panacela shall update Appendix B and C hereto to include all patent applications and patents that are within the Licensed Patents.
 
B.            Affiliates .Panacela may extend the License, or any 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.
 
C.            Right to Sublicense . Panacela and its Affiliate may grant and authorize sublicenses to third parties (“Sublicensees”) within the scope of the License (“Sublicenses”).  Subject to the terms and considerations of this Agreement, upon expiration or termination of this Agreement for any reason, any and all existing sublicenses shall survive; provided that such Sublicensees promptly agree in writing to be bound by the terms of this Agreement.
 
D.            Control of Patent Prosecution .
 
1.            Licensed Mobilan Patents .  CBLI shall retain all control of patent prosecution regarding the Licensed Mobilan Patents.
 
2.            Licensed Inhibitor and Modulator Patents .
 
a.          Panacela shall have primary responsibility to (a) file and prosecute any domestic and/or foreign patent application within the Licensed Inhibitor and Modulator Patents, and (b) maintain any patent that may issue therefrom. 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.
 
 
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b.          Panacela shall give CBLI, CCF and CCIA a reasonable opportunity to review (a) the text of all such applications before filing, and (b) the content of any proposed responses to official actions of the United States Patent and Trademark Office and foreign patent offices during prosecution of such patent applications; and shall consult with CBLI , CCF and CCIA with respect thereto.  For purposes of this Section II.D.2(b) "reasonable" shall mean sufficiently in advance of any decision by Panacela or any deadline imposed upon written response by Panacela so as to allow CBLI , CCF and CCIA to meaningfully review such decision or written response and also to provide comments to Panacela in advance of such decision or deadline to allow comments of CBLI, CCF and CCIA, or either, to be considered and incorporated into Panacela's decision or written response.
 
c.          In consultation with CCF , CBLI and CCIA, Panacela will file patent applications within the Licensed Inhibitor and Modulator Patents, prosecute patent applications within the Licensed Inhibitor and Modulator Patents, and maintain patents within the Licensed Inhibitor and Modulator Patents, in each case pursuant to Panacela’s rights under this Section II.D.2 in such countries as Panacela may desire from time to time by notice to CBLI , CCF and CCIA.  In the event Panacela does not file for or continue prosecution of any such patent application within the Licensed Inhibitor and Modulator Patents or maintain any such patent pursuant to Panacela's rights under this Section II.D, in any country, (a) Panacela shall notify CBLI in writing pursuant to Section II.D.2.d.below, and in such event CBLI may at its discretion pursue such filing, prosecution and/or maintenance, and (b) Panacela's license with respect to such patent application and/or such patent in such country shall terminate.
 
d.          Panacela agrees to keep CBLI, CCF and CCIA informed in a timely manner of the contents, status and progress of all patent applications within the Licensed Inhibitor and Modulator Patents filed and prosecuted by Panacela, and to provide copies of such patent applications and documents relating thereto to CBLI , CCF and CCIA; Panacela shall copy CBLI on all correspondence with CCF and/or CCIA related to the Licensed Inhibitor and Modulator Patents.  Panacela agrees to provide CBLI , CCF and CCIA with such information and documentation with respect to all Licensed Inhibitor and Modulator Patents, as CBLI , CCF or CCIA, respectively, shall reasonably request.  Panacela further agrees that Panacela will not allow any such patent application or any patent that may issue therefrom to become abandoned until CCF , CBLI and CCIA have each determined, and informed Panacela, that it does not desire to continue prosecution or appeal(s) or maintenance of such patent application or patent in accordance with such party’s rights pursuant to Section II.D.2.c.above; provided that Panacela’s obligations to continue prosecution or appeals(s) or maintenance of any such patent application or patent will not extend beyond the three (3) month anniversary of Panacela’s written notice of Panacela's election pursuant to Section II.D.2.c.above.
 
e.          In the event that Panacela elects not to file any patent application within the Licensed Inhibitor and Modulator Patents, or thereafter elects not to continue prosecution of any such patent application, or elects not to maintain any patent that may issue therefrom pursuant to Section II.D.2.c.above, CBLI shall have the right, at CBLI's option and expense and on its own make, to file for and prosecute such patent application and maintain such patent using patent counsel selected by CBLI, and Panacela shall cooperate therewith.
 
E.             Research Use Right .  Pursuant to Section 2.G of the Exclusive License Agreement, this Agreement does not include the exclusive, fully-paid up non-assignable right of CCF and Other Institution to make and use, for academic or research purposes only, the Licensed Rights (the “Reserved Rights”) to the extent that the Reserved Rights are based on the rights granted by CCF or Other Institution, as the case may be.
 

 
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F.            Right to Publish .The License is subject to a reserved, irrevocable, exclusive, fully-paid up non-assignable license back to CCF and Other Institution, as the case may be, to publish the general scientific findings from such parties’ research related to the Licensed Rights.
 
G.            Ownership of Innovations .  Innovations shall be either jointly owned or solely owned by the party for whom ownership can be established under the provisions of U.S. patent law and licensed as provided herein.  Unless otherwise agreed in writing between the Parties, and subject to CCF’s and Other Institution’s rights under Sections II.E and II.F of this Agreement, Panacela shall own absolutely and exclusively immediately upon their creation all rights, title and interest in and to any and all Innovations created solely by employees or agents of Panacela or Affiliates thereof (“Panacela Innovations”), including, but not limited to, all patents, trade marks, design rights (whether registrable or otherwise), copyright, database rights, trade secrets, know-how and all other intellectual property rights and equivalent rights or similar forms of protection existing anywhere in the world.  Panacela shall have the sole and exclusive discretion regarding whether to seek protection (including, without limitation patent protection) for Panacela Innovations.
 
III.        COMMERCIALIZATION; REGULATORY APPROVALS
 
A.            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 Rights, to bring 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 Products at Panacela’s expense, including research and development, laboratory and clinical testing, and marketing and sales.  This Agreement shall not provide to CBLI 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.  CBLI acknowledges that Panacela is in the business of developing, manufacturing, marketing and selling biopharmaceutical products.  Panacela shall provide CBLI written reports necessary for CBLI to satisfy its reporting obligations under the Exclusive License Agreement, including written reports on at least on a semi-annual basis detailing Panacela’s clinical, regulatory, and financial progress.  CBLI 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 XVIII.  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 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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B.            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 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 CBLI and Panacela otherwise agree that a particular approval be made in the name of CBLI or an Affiliate or lawful designee of CBLI. CBLI agrees that, any such Regulatory Approval made in its name will not affect the rights granted to Panacela in this Agreement. CBLI will lend assistance, including involving CCF or Other Institution 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 CBLI (including from CCF or Other Institution) relating to the Licensed Rights and the Products. Panacela shall be responsible for reimbursing CBLI for any reasonable direct costs associated with such activity, including costs incurred by CBLI to CCF or Other Institution.
 
IV.       CONSIDERATION
 
A.           For any amounts owed to CCF under Section 4.B of the Exclusive License Agreement (the “CCF Milestones”) on account of activities under the Licensed Rights (the “Panacela Activities”), Panacela shall pay the CCF Milestones directly to CCF or its designee, as applicable,  in the name of CBLI.
 
B.            Earned Royalties .  For any amounts owed to CCF under Section 4.C of the Exclusive License Agreement (the “CCF Royalties”) on account of Panacela Activities, Panacela shall pay the CCF Royalties directly to CCF or its designee, as applicable, in the name of CBLI.
 
C.            Sublicense Royalties .  For any amounts owed to CCF under Section 4.D of the Exclusive License Agreement (the “CCF Sublicense Royalties”) on account of Panacela Activities, Panacela shall pay the CCF Sublicense Royalties directly to CCF or its designee, as applicable, in the name of CBLI.
 
D.            Accounting .  Panacela shall provide CCF , CCIA and/or CBLI, as applicable a full accounting showing how any amounts owing under this Section IV have been calculated on the date of each such payment and paid.  Such accounting will be on a per-country and product line, model, or trade name basis and shall be summarized in a reporting format that contains substantially similar information to the information obligations of CBLI as set out in Section 4 to the Exclusive License Agreement.  Should failure by Panacela to make a required payment when due hereunder cause interest to accrue against CBLI under the Exclusive License Agreement, the corresponding balance due by Panacela hereunder shall accrue interest until paid at the same rate.
 
E.            Currency .  Except as otherwise directed, all amounts owing under this Agreement shall be paid in U.S. dollars by wire transfer to an account specified by the designated recipient. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made at the rate used by Panacela in calculating Panacela's own revenues for financial reporting purposes.
 
F.            Withholdings .  Any withholding or other tax that Panacela or an Affiliate thereof is required by law to withhold shall be deducted from said royalties and promptly paid to the taxing authority. If royalties paid to Panacela or an Affiliate thereof by a Sublicensee on Net Sales of Products are reduced for withholding or similar taxes, the Sublicense Royalties due CCF shall be correspondingly reduced, and Panacela shall furnish CCF, CCIA and/or CBLI with proper evidence of the taxes paid.
 
 
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V.         REPRESENTATIONS AND WARRANTIES
 
A.           CBLI represents and warrants as of the Effective Date that:
 
 
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;
 
 
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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.
 
Provided that:
 
 
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.
 
B.           CBLI MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND 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 USE OF THE LICENSED RIGHTS.
 
C.           Panacela represents and warrants that:
 
 
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.
 
 
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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.
 
VI.       RECORDKEEPING
 
A.           Panacela shall keep books and records sufficient to verify the accuracy and completeness of Panacela's accounting referred to above, including without limitation inventory, purchase and invoice records relating to the Products or their manufacture. In addition, Panacela shall maintain documentation evidencing that Panacela is in fact pursuing development of Products as required herein. Such documentation may include, but is not limited to, invoices for studies advancing development of Products, laboratory notebooks, internal job cost records, and filings made to the Internal Revenue Service to obtain tax credit, if available, for research and development of Products. Such books and records shall be preserved for a period not less than three (3) years after they are created during and after the term of this Agreement.
 
B.           Panacela shall take all reasonable steps necessary so that the accounting firm representing Panacela, or any other registered CPA mutually agreeable to CBLI and Panacela, may within forty-five (45) days of request by CBLI review and copy all the books and records to allow CBLIto verify the accuracy of Panacela's royalty reports and Development Reports. Such review shall be performed at the expense of CBLI upon reasonable notice and during regular business hours at a single U.S. location of Panacela's choice.
 
VII.      LICENSE TERM AND TERMINATION PROVISIONS
 
A.           The term (the "Term") of this license shall begin on the date of this Agreement and continue until the earlier of the expiration of exclusive rights pursuant to the Licensed Patents, or twenty (20) years after the commencement of Sales of Products, unless this Agreement is earlier terminated as provided herein.
 
B.           The License is strictly subject to Panacela's diligent efforts to develop and commercialize Products. CBLI may, at its option terminate this Agreement ninety (90) days after giving written notice of termination to Panacela during the continuation of any of the following events by Panacela:
 
1.           commission of any breach in any material respect of any other covenant herein contained, including without limitation (a) failure to satisfy its diligence obligations pursuant to Article III; (b) failure to timely pay any monies due hereunder; (c) failure to timely submit to CBLI any Development Report; (d) offering any component of the Licensed Rights to its creditors or any other third party in violation of this Agreement; or (e) raising or allowing to be raised any challenge of or regarding the validity of any of the Licensed Patents; or
 
 
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2.           committing any act of bankruptcy, becoming insolvent, or unable to pay its debts as they become due, filing a petition under any bankruptcy or insolvency act, or having any such petition filed against it which is not dismissed within sixty– (60) days.  Should Panacela, or a new entity which is an Affiliate of Panacela subsequently emerge from bankruptcy, CBLI shall negotiate in good faith with such entity to enter into a new license agreement between CBLI and such party containing substantially the same material terms as this License;
 
provided that Panacela may avoid such termination if before the end of such sixty(60) day period Panacela cures such breach or default.  This paragraph shall not suspend any obligation of Panacela to compensate CBLI for any undisputed amount, as provided for under any term of this Agreement, during the pendency of any determination of breach.
 
C.           Panacela may terminate this Agreement in its entirety or as to any particular patent application or patent within the Licensed Patents at any time by giving at least ninety (90) days written notice of such termination to CBLI.  A brief statement of the reasons for termination shall accompany such a notice.  From and after the effective date of a termination under this Paragraph with respect to a particular patent application or patent, such patent application and patent in the particular country shall cease to be within the Licensed Patents for all purposes of this Agreement.  Upon a termination of this Agreement in its entirety under this Paragraph, all rights and obligations of CBLI and Panacela shall terminate, except as provided in Section VII.F.
 
D.           Notwithstanding the foregoing, the obligations of Panacela with respect to the commercialization of Products under this Agreement are expressly conditioned upon the continuing absence of a materially adverse condition which results in a delay in the commercialization of the Products, including, but not limited to, a substantially adverse condition or event relating to the safety or efficacy of a Product or unfavorable pricing, pricing reimbursement, labeling or lack of Regulatory Approval, and the obligation of Panacela to develop or market any such Product, and CBLI’s right to terminate this Agreement set forth in this Section VII.B, shall be delayed, tolled or suspended so long as such condition or event exists as mutually agreed by CBLI and Panacela.
 
E.           Upon termination of this Agreement, Panacela’s rights to the Licensed Rights granted hereunder and all use thereof shall terminate and any and all rights in the Licensed Patents shall revert back to CBLI and, if requested by CBLI, Panacela shall destroy or return, at CBLI’s sole option, all copies of any media or materials which are the property of CBLI, CCF or Other Institution, including but not limited to all documentation, notes, plans, drawings, copies, samples and computer code. Notwithstanding the termination of this Agreement, Panacela shall remain obligated to provide an accounting for and to pay royalties earned up to the date of the termination and post-termination (as permitted by Section VII.H), subject to Section IV.B.
 
F.           Expiration or termination of the Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination, and the provisions of Section VI, VII.E, XIV, XV.A, XVII and XVIII shall survive the expiration or termination of this Agreement and remain in full force and effect regardless of the cause of termination. Any expiration or early termination of this Agreement shall be without prejudice to the rights of either party against the other accrued or accruing under this Agreement prior to termination.
 
 
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G.           Waiver by either Party of a single breach or default, or a succession of breaches or defaults, shall not deprive such Party of any right to terminate this Agreement in the event of any subsequent breach or default.
 
H.           In the event that this Agreement is terminated for any reason, Panacela and Affiliates thereof and customers of either may, after the effective date of such termination, sell or otherwise dispose of all Products and parts thereof that Panacela, Affiliates thereof, and customers of either may have on hand on the effective date of such termination, subject to Panacela’s payment to CBLI of royalties pursuant to Section IV of this Agreement.
 
VIII.    ASSIGNABILITY
 
This Agreement may not be assigned by Panacela without notification of CCF and the prior written consent of CBLI, which will not be unreasonably withheld provided that such assignee or transferee promptly agrees in writing to be bound by the terms and conditions of this Agreement.  Panacela may assign its right to receive payments hereunder.
 
IX.      CONTEST OF VALIDITY
 
In the event Panacela or a third party contests the validity of any Licensed Patent, Panacela shall continue to pay royalties with respect to that patent as if such contest were not underway to an escrow agent mutually agreed to by the parties, to be held in a separate interest bearing account in accordance with the terms of a mutually acceptable escrow agreement between the parties in form and substance as is customary for such purposes, until such time as a court of last resort adjudicates the validity or invalidity of such patent. If such court of last resort confirms the invalidity or unenforceability of such patent, then all royalties previously paid by Panacela into escrow pursuant to this paragraph, together with all interest accrued thereon and any other amounts earned in respect thereof (collectively, the “Escrow Funds”), shall be promptly paid to Panacela.  If such court of last resort confirms the validity or enforceability of such patent, then the Escrow Funds shall be promptly paid to CCF and/or CCF and CCIA, as applicable.
 
X.       PROTECTION OF LICENSED RIGHTS
 
CBLI and Panacela agree to assist each other to the extent necessary to protect any of Panacela’s rights in the Licensed Rights. CBLI and Panacela each shall notify the other in writing of any infringements by others of the Licensed Rights. Following receipt of such notification, CBLI and Panacela shall engage in meaningful consultation 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 CBLI and Panacela shall mutually determine are required prior to the filing of any lawsuit. Pursuant to Section XI below, Panacela may commence or prosecute any claims or suits in its own name or join CBLI as a party thereto. However, should Panacela decline or fail to commence or prosecute such claims or suits, CBLI may itself institute such claims or suits in its own name and join Panacela as a party thereto, except that CBLI shall not institute such claims or suits without first obtaining the written consent of Panacela to do so, which consent shall not be unreasonably withheld, conditioned or delayed. CBLI and Panacela shall cooperate fully in any claims or suits commenced and prosecuted by either Party pursuant to this Section X.
 
 
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XI.       ENFORCEMENT OF LICENSED RIGHTS
 
A.           Panacela has the right, but not the obligation, to defend the Licensed Rights (the “Enforced Rights”) against infringement, interference or opposition by other parties in any country, including by bringing any legal action for infringement or opposition or defending any counterclaim of invalidity, notice of opposition or action of a third party for declaratory judgment of non- infringement or interference. Panacela may bring or defend, or subject to CBL’s approval, which approval shall not be unreasonably withheld, conditioned or delayed, may settle any such actions solely at its own expense and through counsel of its selection; provided, however, that CBLI, CCF and the Other Institution, to the extent that the Enforced Rights are based on the rights granted by CCF or Other Institution, as the case may be, shall be entitled in each instance to participate through counsel of its selection and at its own expense. CBLIhas no obligation or responsibility with respect to any such infringement action or interference except to provide reasonable assistance to Panacela as requested, and Panacela shall reimburse CBLI and Other Institution, as the case may be, for its reasonable out-of-pocket expenses in connection with any such assistance. Panacela shall be entitled to credit against royalties payable to CBLI hereunder to the same extent that CBLI shall be entitled to credit against royalties payable to CCF or CCIA, as applicable.  Any amounts entitled to be so credited and not previously credited may be carried forward.  In the event of a favorable settlement or award of damages, any amounts owed to CCF under Section 11.A of the Exclusive License Agreement shall be paid directly to CCF or CCIA, as applicable, in the name of CBLI.  CCF’s or CCIA’s sole financial obligation, as applicable, with respect to such litigation will be limited to the right of Panacela to credit fifty percent (50%) of its costs and expenses against royalties as provided herein.
 
B.           In the event Panacela is permanently enjoined from exercising any of the License Rights granted hereunder pursuant to an infringement action brought by a third party, or if Panacela elects not to undertake the defense or settlement of such a claim of alleged infringement for a period of six (6) months from notice of such claim or suit, then Panacela’s rights and obligations under this Agreement with respect to said License Rights will terminate upon written notice from CBLI, subject to Section VII of this Agreement. If Panacela elects to defend any such action, then Panacela shall be entitled to credit against royalties payable to CBLI hereunder fifty percent (50%) of its out-of-pocket costs and expenses incurred in connection with such action at a rate not to exceed fifty percent (50%) of the royalties due CBLI in any Half Year. Any amounts entitled to be so credited and not previously credited may be carried forward.
 
XII.       PATENT MARKING
 
Panacela shall mark all Products or Products’ packaging with the appropriate patent number reference in compliance with the requirements of United States law (see 35 U.S.C.§287).
 
 
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XIII.        PRODUCT LIABILITY AND CONDUCT OF BUSINESS
 
A.           Panacela shall, at all times during the term of this Agreement and thereafter, indemnify, defend and hold CBLI, CCF, and Other Institution and each of its respective trustees, officers, employees, consultants, and agents of each, as the case may be, harmless against all claims and expenses, including legal expenses and reasonable attorneys fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense and liability of any kind whatsoever (other than infringement claims) resulting from the production, manufacture, sale, use, lease, consumption or advertisement of Products arising from any right or obligation of Panacela hereunder with respect to CBLI, CCF or Other Institution, as the case may be , provided that Panacela shall not be obligated to indemnify CBLI, CCF or Other Institution under this Section XIII.A. 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 of CBLI, CCF or Other Institution.  CBLI, CCF and Other Institution at all times reserve the right to select and retain counsel(s) of their own to represent CBL’s, CCF’s and Other Institution’s interests in any such action, subject to Panacela’s sole control of the defense thereof and all related settlement negotiations.
 
B.           CBLI hereby agrees to indemnify, defend, and hold harmless Panacela and its current, former, or future stockholders, non-Panacela investors, officers, employees, consultants, and agents (each, an “Indemnified Person”) for, from, and against any and all claims, expenses (including attorneys’ fees), damages, losses, judgments, fines, amounts paid in settlement, and any other amounts that any Indemnified Person suffers, sustains, incurs, or becomes subject to arising out of or in connection with any breach of this Agreement or any inaccuracy of the representations contained in Section V.A.4 and V.A.11 of this Agreement.
 
C.           Neither Party shall be liable to the other party for any indirect, special, consequential, or other damages whatsoever, whether grounded in tort (including negligence), strict liability, contract or otherwise.  Except as provided in this Agreement, CBLI shall not have any responsibilities or liabilities whatsoever with respect to Product(s).
 
D.           Panacela shall at all times comply in all material respects, through insurance or self-insurance, with all statutory workers’ compensation and employers’ liability requirements covering any and all employees with respect to activities performed under this Agreement.
 
XIV.       USE OF NAMES.
 
Other than as required by law or regulation, Panacela shall not use the name, logo, likeness, trademarks, image or other intellectual property of CBLI, CCF, Other Institution, or employees thereof for any advertising, marketing, endorsement or any other purposes without the specific prior written consent of an authorized representative of CBLI, CCF or Other Institution, as the case may be, as to each such use. For purposes of the foregoing provision, an authorized representative of CCF means a representative of CCF’s Department of Media Relations and/or CCF’s Office of General Counsel, or comparable personnel.
 
 
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XV.         MISCELLANEOUS
 
A.            Choice of Law .  This Agreement shall be governed, construed, and interpreted in all respects in accordance with laws of the State of New York without regard to the conflict of laws provisions of such.
 
B.            Notices .  Any notice required to be given pursuant to the provisions of this Agreement shall be in writing and shall be deemed to have been given at the earlier of the time when actually received as a consequence of any effective method of delivery, including but not limited to hand delivery, transmission by telecopier, or delivery by a professional courier service or the time when sent by certified or registered mail addressed to the Party for whom intended at the address below or at such changed address as the Party shall have specified by written notice, provided that any notice of change of address shall be effective only upon actual receipt.
 
 
(i)
If from Panacela to CBLI:
 
Cleveland BioLabs, Inc.
Attn: General Counsel
73 High Street
Buffalo, NY 14203
Fax: (716) 849-6820
 
With a copy to:
 
Polsinelli Shugart PC
Attn: Teddy C. Scott, Jr., Ph.D.
161 N. Clark Ave., Suite 4200
Chicago, IL 60601
Fax: (312) 873-2913

 
(ii)
If from Panacela to CCF:
 
Executive Director
CCF Innovations / GCIC10
9500 Euclid Avenue
Cleveland, OH  44195
 
With a copy to:
 
Legal Department
3050 Science Park Dr.
AC3-231
Beachwood, OH 44122
 
 
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Payments to:
 
The Cleveland Clinic Foundation
Re: CCF-CBL License
P.O. Box 931532
Cleveland, OH  44193-5007
Attn: Barbara Honeey

The CCF Federal Tax ID Number is 34-0714585.
 
 
(iii)
If from Panacela to CCIA:
 
Children’s Cancer Institute Australia
PO Box 81
Randwick NSW2031 Australia
Attention: Managing Director
Telephone: 0293853140
 
 
(iv)
If from CBLI to Panacela:
 
Panacela Labs, Inc.73 High Street
Buffalo, NY 14203
Fax: (716) 849-6820
 
With a copy to:
 
Polsinelli Shugart PC
Attn: Teddy C. Scott, Jr., Ph.D.
161 N. Clark Ave., Suite 4200
Chicago, IL 60601
Fax: (312) 873-2913
 
C.            Counterparts .  This Amendment may be executed in counterparts with the same effect as if both parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
 
XVI.      INTEGRATION
 
This Agreement constitutes the full understanding between the parties with reference to the subject matter hereof, and no statements or agreements by or between the Parties, whether orally or in writing, except as provided for elsewhere in this Section XVII, made prior to or at the signing hereof, shall vary or modify the written terms of this Agreement. Neither Party shall claim any amendment, modification, or release from any provisions of this Agreement by mutual agreement, acknowledgment, or otherwise, unless such mutual agreement is in writing, signed by the other Party, and specifically states that it is an amendment to this Agreement.
 
 
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XVII.     SEVERABILITY
 
If any provision of this Agreement is held to be invalid, the other provisions will not be affected to the greatest extent possible consistent with the parties’ intent.
 
XVIII.       CONFIDENTIALITY
 
A.           Panacela acknowledges that CBLI may disclose valuable confidential information of CCF, Other Institution or CBLI to Panacela pursuant to the terms of this Agreement.  CBLI acknowledges that Panacela may disclose valuable confidential information to CBLI pursuant to the terms of this Agreement. Accordingly, the Parties agree to keep any Confidential Information in confidence and not to use or disclose the same except in pursuance of the terms of this Agreement.
 
B.           Both Parties agree to keep any information identified as confidential by the disclosing Party, confidential using methods at least as stringent as each party uses to protect its own confidential information. “Confidential Information” shall include plans and reports of Panacela, Panacela’s books and records maintained pursuant to Section VI, the Licensed Rights and all information concerning them and any other information marked confidential or accompanied by correspondence indicating such information is confidential exchanged between the parties hereto. Except as may be authorized in advance in writing by the other Party, each Party shall grant access to the Confidential Information only to its own employees involved in research relating to the subject matter of the Licensed Patents and/or manufacture or marketing of the Products, and each Party shall require such employees to be bound by confidentiality obligations substantially similar to those set forth in Article XVIII. Each Party agrees not to use any Confidential Information to its advantage and the other Party’s detriment, including, but not limited to, in the case of Panacela, claiming priority to any application serial numbers of any Licensed Mobilan Patents in any patent prosecution by Panacela. 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:
 
 
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.
 
 
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C.           The Parties agree to keep the nature, existence and terms of this Agreement confidential until first publicly announced by the Parties pursuant to a joint press release mutually approved by the Parties. The content and timing of all press releases and similar public communications regarding this Agreement and the subject matter hereof will be mutually agreed to in writing by the Parties, and neither Party may make or issue any public announcement or press release that refers to the other Party or describes any aspect of this Agreement without having first received the prior written consent of the other Party. Notwithstanding the foregoing, either Party may make any public announcement or disclosure that it reasonably believes is required by law, rule or regulation of any governmental authority or other regulatory body (including, without limitation, the SEC or the FDA).
 
D.           Notwithstanding the provisions of this Section XVIII, Panacela shall have the right to disclose Confidential Information to its sublicensees, agents, vendors, consultants, Affiliates or other third parties (collectively, “Agents”) in accordance with this paragraph. Such disclosure shall be limited only to the Agents involved in the research, development, commercialization, manufacturing, marketing or promotion of Products. Any such Agents must agree in advance and in writing to be bound by confidentiality and non-use obligations substantially similar to those contained in this Agreement. In addition, Panacela and its Agents may make disclosure of such Confidential Information of CBLI as may be necessary in order to obtain or maintain any Regulatory Approvals, including, in connection with clinical trials, regulatory applications and filings, and otherwise.
 
XIX.        ANTI-KICKBACK STATUTE AND STARK LAW COMPLIANCE
 
By entering into this Agreement, the parties specifically intend to comply with all applicable laws, rules and regulations, including (i) the federal anti-kickback statute (42 U.S.C. §1320a-7b) and the related safe harbor regulations; and (ii) the Limitation on Certain Physician Referrals, also referred to as the “Stark Law” (42 U.S.C. §1395nn). Accordingly, no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business. In the event that any part of this Agreement is determined to violate federal, state, or local laws, rules, or regulations, the parties agree to negotiate in good faith revisions to the provision or provisions that are in violation.
 
XX.         ELIGIBILITY TO PARTICIPATE IN FEDERAL HEALTH CARE PROGRAMS
 
By signing this agreement, Panacela hereby represents and warrants the following: (a) that is has not been debarred, excluded, suspended or otherwise determined to be ineligible to participate in any federal health care programs (collectively, “Debarment” or “Debarred”, as applicable); and (b) that it shall not knowingly employ or contract with, with or without compensation, any individual or entity (singularly or collectively, “Program Agent”) listed by a federal agency as Debarred. To comply with this provision, Panacela shall make reasonable inquiry into the status of any Program Agent contracted or arranged by Panacela to fulfill the terms of this Agreement. In the event that Panacela and/or an Program Agent thereof either (i) becomes Debarred or (ii) receives notice of action or threat of action with respect to its Debarment during the term of this Agreement, Panacela agrees to notify CBLI immediately. Panacela agrees to timely notify CBLI in the event that Panacela has identified or reasonably suspects potential violations associated with its performance under this Section, and the nature of such potential violation, to enable CBLI to take prompt corrective action. Further, in the event that Panacela or a Program Agent thereof becomes Debarred as set forth above and such Debarment shall have become final and non-appealable, this Agreement relative to such entity or individual’s participation hereunder may be terminated upon written notice.
 
 
17

 
 
XXI.      AUTHORITY
 
The persons signing on behalf of each of CBLI and Panacela hereby warrant and represent that they have authority to execute this Agreement on behalf of the Party for whom they have signed.
 
XXII.       PUBLICATION
 
To avoid loss of patent rights as a result of premature public disclosure of patentable material, CBLI will extend to Panacela and allow Panacela to exercise all of CBLI’s benefit and rights regarding intended publication or disclosure pertaining to the Licensed Rights.
 
XXIII.      DISPUTE RESOLUTION
 
A.            Disputes .  The Parties recognize that disputes as to certain matters arising under or relating to this Agreement or either Party’s rights and/or obligations hereunder may arise from time to time.  It is the objective of the Parties to establish procedures to facilitate the resolution of such disputes in an expedient manner by mutual cooperation and without resort to litigation.  To accomplish this objective, the Parties agree to follow the procedures set forth in Section XXIII.B if and when such a dispute arises between the Parties.
 
B.            Procedures . The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation between executives who have the authority to settle the controversy.  Either Party may give the other Party written notice of a dispute not resolved in the normal course of business.  If the matter has not been resolved by such executives within sixty (60) days of a disputing Party’s notice, the Parties agree to submit the matter to mediation unless mediation is waived upon written consent of the Parties.  If the matter is submitted to mediation but is not resolved through negotiation or mediation, or if the Parties waive mediation, either Party may initiate binding arbitration as provided in Section XXIII.C.
 
C.            Arbitration .  Arbitration of disputes or claims (each, a “Claim”) between the parties under this Section XXIII.C shall be administered by JAMS in accordance with its Comprehensive Arbitration Rules and Procedures.  The arbitration shall be held in New York, New York.  The arbitration shall be conducted by one arbitrator who is knowledgeable in the subject matter at issue in the dispute.  The arbitrator will be selected by written agreement of the Parties.  The arbitrator shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded.  The arbitrator shall be authorized to award compensatory damages, but shall NOT be authorized (a) to award non-economic damages, such as for emotional distress, pain and suffering or loss of consortium, (b) to award punitive or multiple damages, or (c) to reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided, however, that the damage limitations described in subsections (a) and (b) of this sentence will not apply if such damages are statutorily imposed.  The arbitrator also shall be authorized to grant any temporary, preliminary or permanent equitable remedy or relief the arbitrator deems just and equitable and within the scope of this Agreement, including, without limitation, an injunction or order for specific performance.  The decision of the arbitrator shall be final and binding upon the Parties.  The award of the arbitrator shall be the sole and exclusive remedy of the Parties.  Judgment on the award rendered by the arbitrator may be entered in any court having competent jurisdiction thereof.  This Section XXIII.C shall not apply to any dispute, controversy or claim that concerns (i) the validity or infringement of a patent, trademark or copyright; or (ii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.  Notwithstanding the foregoing, claims for injunctive relief shall not be subject to the requirements of arbitration. English shall be the language of any arbitration proceeding.
 
 
18

 
 
D.            Costs and Awards .  Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrator; provided, however, that the arbitrator shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, and travel expenses), and/or the fees and costs of the arbitrator.
 
E.            Waiver and Acknowledgement .  By agreeing to this binding arbitration provision, the Parties understand that they are waiving certain rights and protections which may otherwise be available if a Claim between the Parties were determined by litigation in court, including, without limitation, the right to seek or obtain certain types of damages precluded by this provision, the right to a jury trial, certain rights of appeal, and a right to invoke formal rules of procedure and evidence.
 
XXIV.        CONFLICT OF INTEREST
 
CCF maintains and adheres to a Conflict of Interest Policy.  In connection therewith, Panacela represents that no CCF employees, officers or directors are consultants, employees, officers or directors of Panacela or any of its Affiliates serve on any boards or committees of or in any advisory capacity with Licensee or any of its affiliates.
 
XXV.        COMPLIANCE WITH LAWS
 
A.           Panacela agrees to comply with all applicable US and Foreign laws, rules, regulations and restrictions.  Without limiting the foregoing, by entering into this Agreement, Panacela will comply with all applicable laws, rules and regulations including, the Foreign Corrupt Practices Act, export/import laws, security laws and regulations, currency restrictions, and tax and other applicable treaties. In the event that any part of this Agreement is determined to violate any such us or foreign, federal, state, or local laws, rules, or regulations, the Parties agree to negotiate in good faith revisions to the provision or provisions that are in violation.  In the event the Parties are unable to agree to new or modified terms as required to bring the entire Agreement into compliance, either Party may terminate this agreement upon sixty (60) days' written notice to the other Party.
 
 
19

 

B.            Export Control Compliance . Panacela will comply with all applicable export laws, regulations, and restrictions. In connection with the exercise of Panacela’s rights hereunder, CBLI 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. CBLI 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 Sublicensees 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 13. Upon request, and in any event with each Report due hereunder, an officer of Panacela shall certify that Panacela and each Sublicensee and Affiliate are in compliance with and have not violated any Export Law.
 
[Signatures follow.]
 
 
20

 

IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement on the dates indicated below.
 
CLEVELAND BIOLABS, INC.:
 
By:
/s/ Michael Fonstein, Ph.D.
Date: September 23, 2011
Name: Michael Fonstein, Ph.D.
 
Title: Chief Executive Officer
 
 
PANACELA LABS, INC.
 
By:
/s/ Dmitry Tyomkin
Date: September 23, 2011
Name: Dmitry Tyomkin
 
Title: Chief Executive Officer
 
Signature Page to Exclusive Sublicense Agreement
 
 
 

 

Appendix B
 
Licensed Mobilan Patent Applications and Patents
 
Mobilan
 
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

 
 

 

Appendix C
 
Licensed Inhibitor and Modulator Patent Applications and Patents
 
Revercom
 
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
 
Akril
 
Country/Region
App. No.
Assignee/Owner
PCT
PCT/US06/38440
CCF / CBLI
US
11/992,874
CCF / CBLI
 
 
 

 
 
Exhibit 10.7 .
 
ASSIGNMENT AGREEMENT
 
This Assignment Agreement (this “ Agreement ”), dated as of September 23, 2011 (the “Effective Date”), is made by and between Panacela, a corporation organized under the laws of the State of Delaware (“ Panacela ”), and Cleveland BioLabs, Inc., a Delaware corporation (“ CBLI ”).  The parties hereto are additionally referred to individually as a “Party”, and collectively, the “Parties”.
 
RECITALS
 
A.           CBLI has developed and owns certain intellectual property rights in and to the patent applications listed on Exhibit A .
 
B.           CBLI and Panacela are parties to that certain Investment Agreement, dated as of September 19, 2011 (the “ Investment Agreement ”), pursuant to among other things, CBLI has agreed to transfer to Panacela the rights of CBLI in and to the Intellectual Property (as defined below).
 
C.           CBLI’s and Panacela’s execution and delivery of this Agreement, and the grant of such rights and licenses to the Intellectual Property, is required by Section 7.4(ii) of the Investment Agreement.
 
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants hereinafter set forth, and for other good and valuable consideration had and received, the parties hereby agree as follows:
 
1.            Definitions .  In addition to any terms defined throughout this Agreement, when used in this Agreement, the following capitalized terms shall have the meanings indicated below:
 
1.1           “ Assigned Assets ” means the Intellectual Property, the Registrations and the Registration Applications.
 
1.2           “ Copyrights ” means all copyrights owned by CBLI comprising, concerning or related to subject matter covered by the Patents, including copyrights in and to works of authorship and all other rights corresponding thereto throughout the world, whether published or unpublished, including rights to prepare derivative works based on, reproduce, perform, display and distribute such works of authorship and copies, compilations and derivative works thereof.
 
1.3           “ Intellectual Property ” has the meaning set forth in Section 2.1.
 
1.4           “ Know-How ” means all technical information, know-how, unpatented inventions, processes, compositions, methods, techniques, trade secrets, drawings, designs, data and all other information covered by the Patents, which is owned by CBLI.
 
1.5           “ Patents ” means (i) the patents and patent applications set forth on Exhibit A ; (ii) all patents issuing upon such foregoing applications; and (iii) all continuations, continuations-in-part, additions, divisions, renewals, extensions, or reexaminations and reissues of any of the foregoing, and all United States or foreign counterparts of any of the foregoing.

 
 

 
 
1.6           “ Registration ” means, with respect to any country in the world, approval of the Registration Application for a Product filed in such country, including pricing or reimbursement, where applicable, by the Regulatory Authority in such country.
 
1.7           “ Registration Application ” means any filing made with the Regulatory Authority in any country in the world for regulatory approval of the manufacture, marketing and sale of a Product in such country.
 
1.8           “ Regulatory Authority ” means the governmental authority in any country in the world with responsibility for granting regulatory approval for the manufacturing, marketing and sale of the Products in each such country, including but not limited to the U.S. Food and Drug Administration, and any successor authority thereto.
 
2.            Assignment .
 
2.1            Intellectual Property .  CBLI hereby assigns to Panacela all of CBLI’s worldwide rights, title and interests, in and to the Patents, Know-How, Copyrights, and all rights to causes of action and remedies related to the foregoing (including the right to sue for past, present or future infringement, misappropriation or violation of rights related to the foregoing) (all of the foregoing are collectively referred to herein as the “ Intellectual Property ”).
 
3.            Further Assurances .  Upon Panacela’s request, CBLI will promptly take such actions as may be reasonably necessary to vest, secure, perfect, protect or enforce the ownership rights and interests of Panacela in and to the Assigned Assets, including the prompt execution, delivery and filing of confirmatory assignments and other reasonably requested documents.  If Panacela is unable for any reason whatsoever to secure CBLI’s signature to any document it is entitled to under this Section 3, CBLI hereby irrevocably designates and appoints Panacela and its duly authorized officers and agents, as CBLI’s agents and attorneys-in-fact and with full power of substitution to act for and on CBLI’s behalf and instead of CBLI, to execute and file any such document or documents and to do all other lawfully permitted acts to further the purposes of the foregoing with the same legal force and effect as if executed by CBLI.  The parties acknowledge and agree that the foregoing power of attorney is a power coupled with an interest.  The parties further agree that in the event any issues arise in any jurisdiction regarding the interpretation, effect or enforceability of the assignment in Section 2 under such jurisdiction’s laws, including but not limited to issues that would affect or that are related to the recordation of the assignment of rights hereunder, or the prosecution, issuance and/or maintenance of patents and copyright registrations, the parties shall discuss and negotiate in good faith the resolution of such issues until a reasonable resolution that is mutually agreeable to both parties is reached.
 
4.            Warranty .  CBLI represents and warrants to Panacela that CBLI:
 
(i) is the sole or joint owner of all rights, title and interest in the Assigned Assets, free and clear of any lien or encumbrance, and, to the best of its actual knowledge, without any conflict with or infringement of the rights of any third party;
 
(ii) has not, orally or in writing, (a) assigned, transferred, licensed, pledged or otherwise encumbered any of its rights in any of the Assigned Assets or (b) agreed to do so;

 
2

 
 
(iii) has full power and authority to enter into this Agreement, to make the assignment as provided in Section 2 and to perform its other obligations hereunder; and
 
(iv) has not entered into, and is not bound by, any collaborative, licensing, transfer, supply, distributorship or marketing agreements or arrangements or other similar agreements relating to any of the Assigned Assets;
 
5.            Confidentiality .
 
5.1            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.
 
5.2            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 ” shall include all information from either Party 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 Intellectual Property and/or manufacture or marketing of products or services using the Intellectual Property, 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.  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.

 
3

 

6.            Indemnification .  CBLI shall, at all times during the term of this Agreement and thereafter, indemnify, defend and hold Panacela, and its officers, employees, sublicensees, agents and contractors harmless against all claims and expenses, including legal expenses and reasonable attorneys fees, arising out of any breach of the warranties given by CBLI in Section 4 above. Panacela at all times reserves the right to select and retain counsel of its own, at its own expense, to represent Panacela’s interests in any such action, subject to CBLI’s sole control of the defense thereof and all related settlement negotiations.
 
7.            Miscellaneous .
 
7.1            Notices .  All notices and other communications required or permitted hereunder shall be effective upon receipt and shall be in writing and may be delivered in person, by telecopy, electronic mail or overnight delivery service, addressed to the party’s principal address.
 
7.2            Entire Agreement .  This Agreement, together with the other agreements referred to herein, embodies the entire agreement among the parties in relation to its subject matter, and supersedes in their entirety all prior contracts, agreements, arrangements, communications, discussions, representations and warranties, whether oral or written among the parties, relating to such subject matter.
 
7.3            Severability .  Each section, subsection and lesser section of this Agreement constitutes a separate and distinct undertaking, covenant and/or provision hereof.  In the event that any provision of this Agreement shall finally be determined to be unlawful, all such provisions shall be deemed severed from this Agreement, but every other provision of this Agreement shall remain in full force and effect, and in substitution for any such provision held unlawful, there shall be substituted a provision of similar import reflecting the original intent of the parties hereto to the extent permissible under law.
 
7.4            Waivers and Amendments .  This Agreement may be amended or modified in whole or in part only by a writing, which makes reference to this Agreement executed by the parties.  The obligations of any party hereunder may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the party claimed to have given the waiver; provided , however , that any waiver by any party of any violation of, breach of, or default under any provision of this Agreement or any other agreement provided for herein shall not be construed as, or constitute, a continuing waiver of such provision, or a waiver of any other violation of, breach of or default under any other provision of this Agreement or any other agreement provided for herein.
 
7.5            Governing Law .  This Agreement shall in all respects be governed by and construed in accordance with the laws of the State of New York and the United States of America, without regard to conflicts of law principles.
 
7.6            Counterparts .  This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which shall constitute one and the same instrument.

 
4

 
 
IN WITNESS WHEREOF, the parties hereto have executed this Assignment Agreement as of the date first above written.
 
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
 

 
 

 
 
Exhibit A
 
Assigned Patents
 
Mobilan
 
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
 
Revercom
 
Country
Application/Patent No.
Owner
US Provisional
61/423,838
RPCI/CBLI
 
Antimycon
 
Country
Application/Patent No.
Owner
US Provisional
61/392,296
RPCI/CBLI/CCIA
US Provisional
61/423,832
RPCI/CBLI/CCIA
 
Arkil
 
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
 
 
 

 

Exhibit 31.1
 
Certification
 
I, Michael Fonstein, certify that:
 
1. I have reviewed this quarterly report on Form 10-Q of Cleveland BioLabs, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c)  Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the issuer’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
 
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

                 
       
Date: November 9, 2011
     
By:
 
/s/ Michael Fonstein
               
 Michael Fonstein
               
 President and Chief Executive Officer
               
 (Principal Executive Officer)
 
 
 

 
 
 
 

Exhibit 31.2
 
Certification
 
I, C. Neil Lyons, certify that:
 
1. I have reviewed this quarterly report on Form 10-Q of Cleveland BioLabs, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c)  Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the issuer’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
 
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

                 
       
Date: November 9, 2011
     
By:
 
/s/ C. Neil Lyons
                 
               
 Chief Financial Officer
               
 (Principal Financial Officer)
 
 
 

 
 

Exhibit 32.1
 
Certification*
 
In connection with the Quarterly Report of Cleveland BioLabs, Inc., (the “Company”), on Form 10-Q for the quarter ending September 30, 2011 as filed with the Securities and Exchange Commission on the date hereof (the “Periodic Report”) pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C.§ 1350), Michael Fonstein, Chief Executive Officer and C. Neil Lyons, Chief Financial Officer of the Company, hereby certifies that, to the best of his knowledge:
 
1.   The Periodic Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
 
2.   The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the period covered by the Periodic Report.

                 
       
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.