University of Pennsylvania Third Amendment to the Amended and RestatedPatent License Agreement

Contract Categories: Intellectual Property - License Agreements
EX-10.5 6 v314612_ex10-5.htm EXHIBIT 10.5

Exhibit 10.5

 

EXECUTION COPY

 

 

University of Pennsylvania

 

Third Amendment to the Amended and Restated Patent License Agreement

 

This Third Amendment (the “Third Amendment”) is made and entered into as of December 12, 2011 (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 305 College Road East, Princeton, NJ 08540.

 

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, Penn and Company entered into a Second Amendment to the Agreement dated May 10, 2010 (the “Second Amendment”); and

 

WHEREAS, Company desires to further amend the Agreement to add docket numbers W5279 and X5631 (hereinafter referred to as the “Additional Penn Dockets”) developed under the supervision of, or in collaboration with, Dr. Yvonne Paterson;

 

All terms not specifically defined herein will have the meaning ascribed to them in the Agreement, as amended.

 

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 Third Amendment, which includes the Additional Penn Dockets.

 

2)On the Effective Date of this Third Amendment Company shall pay to Penn a non-refundable, non-assessable option exercise fee of $20,000.

 

3)Within thirty (30) days of the execution of this Third Amendment, Company agrees to pay all historical patent expenses associated with this Third Amendment, if any, that adds the 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 Third Amendment.

 

4)This section reaffirms Company’s obligations to reimburse Penn for all documented attorney’s 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.

 

 
 

 

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5)Except as specifically modified or amended hereby, the Agreement, as amended by the First Amendment and the Second Amendment, shall remain in full force and effect.

 

6)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.

 

7)This Third 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 Third Amendment to be executed by their duly authorized representatives.

 

THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
By: /s/ Michael J. Cleare  
Name: Michael J. Cleare, PhD  
Title: Executive Director  
Date: 12/07/11  

 

ADVAXIS, INC.  
By: /s/ John Rothman  
Name: John Rothman  
Title: Executive VP: Science & Operations  
Date: December 2, 2011  

 

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Exhibit 1
List of Intellectual Property

 

D751 Live, Recombinant Listeria Monocytogenes Vaccines and Production of Cytotoxic T-Cell Response
File Date   Serial No.   Patent No.   App Type   Status   Country
02/07/1994   08/192,857       CIP   Abandoned   US
10/31/1990   07/606,546       Utility   Abandoned   US
03/26/1993   08/038,356       CIP   Abandoned   US
12/30/1994   08/366,477   5,830,702   Continuation   Issued   US

 

H1219 Specific Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine Vector
File Date   Serial No.   Patent No.   App Type   Status   Country
11/03/1995   PCT/U51995/014741   11/03/1995   PCT   Expired   WPO
11/03/1995   95939926.2   0790835   EPOValidated   Issued   Germany
11/03/1995   95939926.2   0790835   EPOValidated   Issued   Switzerland
11/03/1995   95939926.2   0790835   EPOValidated   Issued   Liechtenstein
11/03/1995   95939926.2   0790835   EPOValidated   Issued   Belgium
11/03/1995   95939926.2   0790835   EPOValidated   Issued   Ireland
11/03/1995   95939926.2   0790835   EPOValidated   Issued   France
11/03/1995   95939926.2   0790835   EPOValidated   Issued   UK
11/03/1995   515534/96   3995712   National Phase   Issued   Japan
11/08/1994   08/336,372   6,051,237   Utility   Issued   US
11/03/1995   95939926.2   0790835   National Phase   Issued   EPO
11/03/1995   2,204,666   2,204,666   National Phase   Issued   Canada
05/10/2007   2007-125462       Divisional   Filed   Japan

 

Methods and compositions for Immunotherapy of cancer 

03/27/2000   09/535,212   6,565,852   CIP   Issued   US
05/20/2003   10/441,851   7,135,188   Continuation   Filed   US

 

J1598 Bacterial Vaccines Comprising Auxotrophic, Attenuated Strains of $1(Listeria)Expressing Heterologous Antigens
File Date   Serial No.   Patent No.   App Type   Status   Country
11/13/1998   PCT/US1998/024357       PCT   Expired   WPO

 

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  Immunogenic Compositions Comprising DAL/DAT Double-Mutant, Auxotrophic, Attenuated Strains of Listeria and their Methods of Use
File Date   Serial No.   Patent No.   App Type   Status   Country
11/13/1998   2,309,790   05083948   National Phase   Issued   Canada
11/18/1997   08/972,902   6,099,848   Utility   Issued   US
11/13/1998   14108/99   730296   National Phase   Issued   Australia
10/07/2008   12/216,806       Continuation   Filed   US
11/13/1998   98957980.0   1032417   National Phase   Issued   EPO
11/13/1998   98957980.0       EPOValidated   Issued   France
11/13/1998   98957980.0   698 41 437.
3-08		   EPOValidated   Issued   Germany
11/13/1998   98957980.0       EPOValidated   Issued   UK

 

  Isolated nucleic adds comprising Listeria dal and dat genes
File Date   Serial No.   Patent No.   App Type   Status   Country
03/07/2000   09/520,207   6,504,020   Divisional   Issued   US
05/01/2002   10/136,253   6,635,749   Divisional   Issued   US

 

  A Bacterial Vaccine Vector and Methods of Use Thereof
File Date   Serial No.   Patent No.   App Type   Status   Country
09/11/2003   10/660,194   7,488,487   Continuation   Issued   US

 

L2134 Compositions, Methods, and Kits for Enhancing the Immunogenicity of a Bacterial Vaccine Vector
File Date   Serial No.   Patent No.   App, Type   Status   Country
01/09/2003   60/439,009       Provisional   Expired   US
01/04/2001   60/259,738       Provisional   Expired   US
    20044204751       National Phase   Abandoned   Australia
    06104227 1       National Phase   Abandoned   Hong Kong
01/08/2004   PCT/US2004/000366       PCT   Expired   WPO
01/08/2004   04700858.6       EPO   Abandoned   EPO
    2,512,812       National Phase   Abandoned   Canada
    169553       National Phase   Abandoned   Israel
01/08/2008   2006-500840       National Phase   Abandoned   Japan
04/27/2006   10/541,614       National Phase   Filed   US

 

02876 Compositions and Methods for Enhancing the Immunogenicity of Antigens
   
Q3610 Antibiotic Resistance Free DNA Vaccines
File Date   Serial No.   Patent No.   App Type   Status   Country
08/13/2004   60/601,493       Provisional   Expired   US
    05810446.4       EPO   Abandoned   EPO
    2007-525862       National Phase   Filed   Japan
08/15/2005   2,577,270       National Phase   Abandoned   Canada
08/15/2005   PCT/US2005/028896       PCT   Expired   WPO
08/15/2005   2005271247       National Phase   Abandoned   Australia
08/15/2005   11/203,408       Utility   Filed   US

 

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Q3614 Methods for Constructing Antibiotic Resistance Free Vaccines
File Date   Serial No.   Patent No.   App Type   Status   Country
08/15/2005   PCT/US2005/028895       PCT   Expired   WPO
08/13/2004   60/601,492       Provisional   Expired   US
08/15/2005   2005271246       National Phase   Abandoned   Australia
08/15/2005   2,577,306       National Phase   Abandoned   Canada
08/15/2005   2007-525861       National Phase   Filed   Japan
08/15/2005   05808671.1       EPO   Filed   EPO
08/15/2005   11/203,415       Utility   Filed   US

 

  Antibiotic Resistance Free Vaccines and Methods for Constructing and Using Same
File Date   Serial No.   Patent No.   App Type   Status   Country
04/16/2007   11/785,249       CIP   Filed   US
04/27/2007   11/818,965       CIP   Filed   US
04/15/2008   08742912.2       National Phase   Filed   EPO
04/15/2008   2010-504068       National Phase   Filed   Japan
04/15/2008   PCT/U508/04861       PCT   Expired   WPO

 

  A technique for constructing antibiotic resistant free vaccine strains of plasmid L monocytogenes that express antigen from a high copy number
File Date   Serial No.   Patent No.   App Type   Status   Country
4/27/2007   60/924,033       Provisional   Expired   US

 

R3702 Listeria-Based and Llo-Based Vaccines
File Date   Serial No.   Patent No.   App Type   Status   Country
    2,581,331       National Phase   Abandoned   Canada
09/14/2005   PCT/US2005/032682       PCT   Expired   WPO
    2007-533537       National Phase   Filed   Japan
    2005289957       National Phase   Abandoned   Australia
11/10/2005   60/735,184       Provisional   Expired   US
    05811815.9       National Phase   Filed   EPO
09/24/2004   10/949,667   7,794,729   CIP   Issued   US
09/13/2005   11/223,945   7,820,180   CIP   Issued   US

 

  LLO-encoding DNA/nucleic acid vaccines and methods comprising same
File Date   Serial No.   Patent No.   App Type   Status   Country
11/13/2006   12/084,829       National Phase   Abandoned   US
11/13/2006   PCT/U506/43987       PCT   Expired   WPO

 

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54225 Compositions and Methods for Treatment of Non-Hodgkins Lymphoma
File Date   Serial No.   Patent No.   App Type   Status   Country
05/02/2006   11/415,271       CIP   Filed   US
05/02/2007   PCT/US2007/10635       PCT   Expired   WPO

 

  Compositions and Methods for Enhancing the Immunogenicity of Antigens
File Date   Serial No.   Patent No.   App Type   Status   Country
03/07/2008   08726578.1       National Phase   Filed   EPO
03/07/2008   2009-552749       National Phase   Filed   Japan

 

  Compositions and Methods for Treatment of Cervical Cancer
File Date   Serial No.   Patent No.   App Type   Status   Country
03/08/2007   11/715,497       CIP   Filed   US
03/07/2008   PCT/US2008/03067       PCT   Expired   US

 

S4243 Methods and Compositions for Treating IgE-Mediated Diseases
File Date   Serial No.   Patent No.   App Type   Status   Country
08/06/2007   07811120.0       National Phase   Filed   EPO
08/06/2007   2009-523812       National Phase   Abandoned   Japan
08/04/2006   60/835,420       Provisional   Expired   US
08/06/2007   PCT/US2007/017479       PCT   Expired   WPO
08/06/2007   11/882,782       Utility   Abandoned   US

 

T4531 Detoxified Non-Hemolytic LLO (by Site-Direct Mutagenesis) as a Protein Carrier for Antigens to Enhance Immunogenicity
File Date   Serial No.   Patent No.   App Type   Status   Country
06/23/2008   12/213,696       CIP   Filed   US
06/22/2009   PCT/US09/413085       PCT   Flied   WPO

 

U4810 Compositions Comprising Angiogenic Factors and Methods of use Thereof
File Date   Serial No.   Patent No.   App Type   Status   Country
03/04/2009   61/157,367       Provisional   Filed   US
03/04/2010   PCT/US10/26257       PCT   Filed   WPO

 

W5279 ISG 15 is a novel tumor antigen that can be used as a target for immunotherapy
File Date   Serial No.   Patent No.   App Type   Status   Country
4/19/10   61/325473       Provisional   Filed   US
TBD   TBD       Utility   In Prep   US

 

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X5631 The use of Listeria vaccine vectors to reverse vaccine unresponsiveness in parasitically infected individuals
File Date   Serial No.   Patent No.   App Type   Status   Country
10/01/2010   61/388,822       Provisional   Filed   US
11/03/2010   61/409,730       Provisional   Filed   US

 

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