University of Pennsylvania

EX-10.1 2 v186982_ex10-1.htm
EXECUTION COPY
 
University of Pennsylvania

Second Amendment to the Amended and Restated Patent License Agreement

This Second Amendment (the “Second Amendment”) is made and entered into as of May 10, 2010 (the “Effective Date”) by and between The Trustees of the University of Pennsylvania (hereinafter referred to as “Penn”) and Advaxis, Inc., a corporation organized and existing under the laws of Delaware (hereinafter referred to as “Company”) having a place of business at Technology Centre of New Jersey, 675 U.S. Route 1, North Brunswick, NJ 08902.

WHEREAS, Penn and Company entered into an Amended and Restated License Agreement dated February 13, 2007 (the “Agreement”); and

WHEREAS, Penn and Company entered into a First Amendment to the Agreement dated March 26, 2007 (the “First Amendment”); and

WHEREAS, Company desires to further amend the Agreement to add docket numbers L2134,  Q3610, Q3614, R3702, S4225, S4243, and U4810 (hereinafter referred to as “Additional Penn Dockets”) developed under the supervision of, or in collaboration with Drs. Yvonne Paterson and Fred Frankel;

WHEREAS, Company owes $249,481of unreimbursed patent expenses and Company desires to pay the patent expenses in full; and

WHEREAS, Company owes $129,598 under the sponsored research agreement and Company desires to pay the SRA balance in full.

All terms not specifically defined herein will have the meaning ascribed to them in the Agreement.
Now, therefore, in consideration of the foregoing premises, and intending to be legally bound hereby, the parties hereto agree as follows:

1) 
 Attachment 1- List of Intellectual Property is deleted in its entirety and replaced with Exhibit 1 to this Second Amendment, which includes the Additional Penn Dockets.

2) 
 On the Effective Date of this Second Amendment Company shall pay to Penn, solely at Penn’s option, i) a non-refundable, non-assessable option exercise fee of $10,000 per Additional Docket ($70,000 total) in cash or ii) $140,000 in stock, or iii) a mix of cash and stock of which the stock component will be no less than twenty-five percent (25%) of the total.  The number of shares of stock to be issue to Penn will be calculated as follows: the percentage of the option exercise fee to be paid in stock multiplied by $140,000. The product of that calculation is then divided by the price per share of the most recently completed financing round to determine the number of shares of stock to be issued to Penn. Penn will be entitled to receive the same class of shares as the most recent round of financing. The issuance to Penn will entitle Penn to the same rights, preferences, warrant and/or option coverage, conversion privileges, etc. as granted to the participants in the most recent round of financing.
 
 
1

 
 
EXECUTION COPY

For illustrative purposes, if the most recently completed financing round by Company priced shares at $0.20 and Penn opts to convert fifty percent (50%) of the option exercise fee to stock, then to determine the number of shares Penn will receive, take $70,000 (50% of the total amount Penn can convert to equity and double it to achieve the 2:1 ratio of stock to cash) and divide it by $0.20. The quotient yields 350,000 shares of stock. This calculation does not take into consideration any preferential or other benefits afforded the investors in the most recently completed round. Should Penn exercise its option to convert a portion of the option exercise fee to equity, Penn will be entitled to receive the same preferential or other benefits afforded the investors in the most recently completed round. In this example, the remaining balance of the option fee, $35,000 would be payable to Penn in cash.
 
3)  
Company agrees to reimburse Penn for all outstanding expenses, associated with the Agreement and the First Amendment and the Sponsored Research Agreement (“SRA”), by wire transfer of immediately available funds, as follows:
 
a) 
 Sixty-five thousand dollars ($65,000) on or before the first day of each month beginning May 1, 2010 and ending on September 1, 2010, inclusive. And fifty-four thousand seventy-nine dollars ($54,079) on or before September 30, 2010.
 
4)  
Company agrees to pay all historical patent expenses associated with this Second Amendment that adds Additional Dockets. These expenses include, but are not limited to, all historically accrued patent and licensing expenses, attorney’s fees, official fees and all other charges incident to the preparation, prosecution and maintenance of the Penn Patent Rights that were incurred and docketed by Penn relating to the Additional Penn Dockets on or before the Effective Date of this Second Amendment.  Company shall pay such expenses to Penn, in cash, in the following amounts:
 
a) 
 at least twenty percent (20%) of any amount of funding raised on or after April 1, 2010 (whether or not the funding has been drawn), regardless of the form. Such payments will be paid to Penn within ten (10) days after the completion of each tranche of funding regardless of the form of the funding or the type of security and regardless of whether Company has drawn down funds. Notwithstanding the foregoing, Company is not precluded from paying a higher percentage of funding raised towards these obligations or paying the obligations in full at any time.
 
Notwithstanding the previous paragraph, regardless of the amounts of funding raised, all outstanding patent expenses for all licensed dockets plus all SRA amounts must be paid in full by September 30, 2010.
 
 
2

 
 
EXECUTION COPY

Any amounts not paid by the applicable due date will incur interest at one and one half percent (1.5%) per month back to April 1, 2010.
 
5)  
This section reaffirms Company’s obligations to reimburse Penn for all documented attorneys fees, expenses, official fees and other charges incident to the preparation, prosecution, maintenance and licensing of Penn Patent Rights pursuant to the terms of the Agreement, as amended.
 
6)  
Except as specifically modified or amended hereby, the Agreement, as amended by the First Amendment, shall remain in full force and effect.
 
7)  
No provision of this Amendment may be modified or amended except expressly in a writing signed by all parties nor shall any term be waived except expressly in a writing signed by the party charged therewith.
 
8)  
This Second Amendment may be executed in two or more counterparts, each of which shall be deemed an original but all of which taken constitute one and the same instrument.
 
IN WITNESS WHEREOF, the parties, intending to be legally bound, have caused this Second Amendment to be executed by their duly authorized representatives.
 
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
By:
/s/ Michael J. Cleare, PhD  
Name:  Michael J. Cleare, PhD
Title:   Executive Director
Date:
5/11/2010  
     
     
ADVAXIS, INC.
By:
/s/ Thomas A. Moore  
Name:
Thomas A. Moore  
Title:
Chairman and CEO  
Date:
May 7, 2010  

 
3

 
EXECUTION COPY

 
Exhibit 1
 
List of Intellectual Property
 
D751
Live, Recombinant Listeria Monocytogenes Vaccines and Production of Cytotoxic T-Cell Response
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
07/606,546
 
United States
 
10/31/1990
Utility
Abandoned
08/192,857
 
United States
 
02/07/1994
CIP
Abandoned
08/038,356
 
United States
 
03/26/1993
CIP
Abandoned
08/366,477
5,830,702
United States
11/03/1998
12/30/1994
Continuation
Issued
 
H1219
Specific Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine Vector
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
2,204,666
 
Canada
 
11/03/1995
National Phase
Filed
PCT/US1995/014741
 
World Patent Org
 
11/03/1995
PCT
Expired
2007-125462
 
Japan
 
05/10/2007
National Phase
Filed
95939926.2
0790835
Switzerland
08/04/2004
11/03/1995
EPO
Issued
95939926.2
0790835
United Kingdom
08/04/2004
11/03/1995
EPO
Issued
95939926.2
0790835
Belgium
08/04/2004
11/03/1995
EPO
Issued
95939926.2
0790835
Ireland
08/04/2004
11/03/1995
EPO
Issued
95939926.2
0790835
Germany
08/04/2004
11/03/1995
EPO
Issued
95939926.2
0790835
France
08/04/2004
11/03/1995
EPO
Issued
95939926.2
0790835
Liechtenstein
08/04/2004
11/03/1995
EPO
Issued
95939926.2
0790835
European Patent Office
08/04/2004
11/03/1995
National Phase
Issued
515534/96
3995712
Japan
08/10/2007
11/03/1995
National Phase
Filed
08/336,372
6,051,237
United States
04/18/2000
11/08/1994
Utility
Issued
10/441,851
7,135,188
United States
11/14/2006
05/20/2003
Continuation
Filed
 
 
4

 
EXECUTION COPY
 
 
Methods and compositions for immunotherapy of cancer
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
09/535,212
6,565,852
United States
05/20/2003
03/27/2000
CIP
Issued
 
J1598
Immunogenic Compositions Comprising DAL/DAT Double Mutant, Auxotrophic Attenuated Strains of Listeria and Their Methods of Use
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
12/216,806
 
United States
 
07/10/2008
Continuation
Filed
98957980.0
 
Germany
 
11/13/1998
EPO
Issued
98957980.0
 
United Kingdom
 
11/13/1998
EPO
Issued
98957980.0
 
France
 
11/13/1998
EPO
Issued
2,309,790
05083948
Canada
07/06/2000
11/13/1998
National Phase
Filed
98957980.0
1032417
European Patent Office
6-Jan-10
11/13/1998
National Phase
Issued
08/972,902
6,099,848
United States
08/08/2000
11/18/1997
Utility
Issued
14108/99
730296
Australia
13-Nov-98
11/13/1998
National Phase
Issued
 
Bacterial Vaccines Comprising Auxotrophic, Attenuated Strains of $I(Listeria) Expressing Heterologous Antigens

Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
PCT/US1998/024357
 
World Patent Org
 
11/13/1998
PCT
Expired
 
A Bacterial Vaccine Vector and Methods of Use Thereof
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
10/660,194
7,488,487
United States
02/10/2009
09/11/2003
Continuation
Issued
 
Isolated nucleic acids comprising Listeria dal and dat genes
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
09/520,207
6,504,020
United States
01/07/2003
03/07/2000
Divisional
Issued
10/136,253
6,635,749
United States
10/21/2003
05/01/2002
Divisional
Issued
 
 
5

 
EXECUTION COPY

L2134
Compositions, Methods and Kits for Enhancing the Immunogenicity of a Bacterial Vaccine Vector
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
2006-500840
 
Japan
 
01/08/2008
National Phase
Abandoned
04700858.6
 
European Patent Office
 
01/08/2004
EPO
Abandoned
06104227 1
 
Hong Kong
   
National Phase
Abandoned
169553
 
Israel
   
Unknown
Abandoned
10/541,614
 
United States
 
04/27/2006
National Phase
Filed
PCT/US2004/000366
 
World Patent Org
 
01/08/2004
PCT
Expired
60/439,009
 
United States
 
01/09/2003
Provisional
Expired
2,512,812
 
Canada
   
National Phase
Abandoned
20044204751
 
Australia
   
National Phase
Abandoned
60/259,738
 
United States
 
01/04/2001
Provisional
Expired
 
Compositions and Methods for Enhancing Immunogenicity of Antigens
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
151942
151942
Israel
10/21/2009
03/26/2001
National Phase
Issued
2,404,164
 
Canada
   
National Phase
Abandoned
01928324.1
 
European Patent Office
 
03/26/2001
EPO
Filed
01928324.1
 
Germany
 
03/26/2001
EPO
In Preparation
01928324.1
 
France
 
03/26/2001
EPO
In Preparation
2001-570290
 
Japan
 
03/26/2001
National Phase
Filed
01928324.1
 
United Kingdom
 
03/26/2001
EPO
In Preparation
PCT/US2001/009736
 
World Patent Org
 
03/25/2001
PCT
Expired
09/735,450
6,767,542
United States
07/27/2004
12/13/2000
CIP
Issued

 
6

 
EXECUTION COPY


Fusion of Non-hemolytic, Truncated Form of Listeriolysin O to Antigens to Enhance Immunogenicity
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
10/239,703
7,635,479
United States
12/22/2009
03/26/2001
National Phase
Issued
11/376,572
 
United States
 
03/16/2006
Divisional
Filed
11/376,564
 
United States
 
03/16/2006
Divisional
Filed
09/537,642
6,855,320
United States
02/15/2005
03/29/2000
Utility
Issued
10/835,662
7,588,930
United States
09/15/2009
04/30/2004
CIP
Issued
 
O2876
Compositions and Methods for Enhancing the Immunogenicity of Antigens
 
Q3610
Antibiotic Resistance Free DNA Vaccines
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
60/601,493
 
United States
 
08/13/2004
Provisional
Expired
05810446.4
 
European Patent Office
 
08/15/2005
EPO
Filed
2,577,270
 
Canada
 
08/15/2005
National Phase
Filed
11/203,408
 
United States
 
08/15/2005
Utility
Filed
2005271247
 
Australia
 
08/15/2005
National Phase
Abandoned
PCT/US2005/028896
 
World Patent Org
 
08/15/2005
PCT
Expired
2007-525862
 
Japan
 
08/15/2005
National Phase
Filed
 

 
7

 
EXECUTION COPY
 
Q3614
Methods for Constructing Antibiotic Resistance Free Vaccines
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
11/203,415
 
United States
 
08/15/2005
Utility
Filed
11/785,249
 
United States
 
04/16/2007
CIP
Filed
11/818,965
 
United States
 
04/27/2007
CIP
Filed
2,577,306
 
Canada
 
08/15/2005
National Phase
Filed
05808671.1
 
European Patent Office
 
08/15/2005
EPO
Filed
PCT/US2005/028895
 
World Patent Org
 
08/15/2005
PCT
Expired
2007-525861
 
Japan
 
08/15/2005
National Phase
Filed
60/601,492
 
United States
 
08/13/2004
Provisional
Expired
2005271246
 
Australia
 
08/15/2005
National Phase
Abandoned
PCT/US08/04861
 
World Patent Org
 
04/15/2008
PCT
Expired
TBD
 
Japan
 
04/15/2008
National Phase
In Preparation
60/924,033
 
United States
 
04/27/2007
Provisional
Unknown
08742912.2
 
European Patent Office
 
04/15/2008
National Phase
Filed
 
 
8

 
EXECUTION COPY

 
R3702
Listeria-Based and Llo-Based Vaccines
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
05811815.9
 
European Patent Office
 
09/14/2005
EPO
Filed
2005289957
 
Australia
 
09/14/2005
National Phase
Abandoned
2007-533537
 
Japan
 
09/14/2005
National Phase
Filed
2,581,331
 
Canada
 
09/14/2005
National Phase
Filed
PCT/US2005/032682
 
World Patent Org
 
09/14/2005
PCT
Expired
10/949,667
 
United States
 
09/24/2004
CIP
Filed
PCT/US06/43987
 
World Patent Org
 
11/13/2006
PCT
Expired
60/735,184
 
United States
 
11/10/2005
Provisional
Expired
12/084,829
 
United States
 
11/13/2006
National Phase
Abandoned
11/223,945
 
United States
 
09/13/2005
CIP
Filed
 
S4225
Compositions and Methods for Enhancing the Immunogenicity of Antigens
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
08726578.1
 
European Patent Office
 
03/07/2008
EPO
Filed
PCT/US2008/03067
 
United States
 
03/07/2008
PCT
Expired
TBD
 
Japan
 
03/07/2008
National Phase
Filed
PCT/US2007/10635
 
World Patent Org
 
05/02/2007
PCT
Expired
11/715,497
 
United States
 
03/08/2007
CIP
Filed
11/415,271
 
United States
 
05/02/2006
CIP
Filed

 
9

 
EXECUTION COPY

S4243
Methods and Compositions for Treating IgE-Mediated Diseases
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
2009-523812
 
Japan
 
08/06/2007
National Phase
Filed
11/882,782
 
United States
 
08/06/2007
Utility
Abandoned
60/835,420
 
United States
 
08/04/2006
Provisional
Expired
PCT/US2007/017479
 
World Patent Org
 
08/06/2007
PCT
Expired
078111120.0
 
European Patent Office
 
08/06/2007
National Phase
Filed
 
U4810
A listeria monocytogenes-based bacterial vaccine vector expressing mouse VEGFR2/Flk-1 for cancer therapy
 
Serial No.
Patent No.
Country
Issue Date
File Date
App Type
Status
61/157,367
 
United States
 
3/4/2009
Provisional
Filed


 
10