Unassociated Document



 




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.




 




  





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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.




 




  





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(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.




 




  





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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.




 




  





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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.






  





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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.




 




  





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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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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.




  




  





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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.


 




  





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