Improving their safety and reducing the incidence and severity of adverse effects; and

EX-10.15 3 a38505exv10w15.htm EXHIBIT 10.15 exv10w15
 

Exhibit 10.15
LICENSE AGREEMENT
     This Agreement is entered into as of December 10, 2005 (the “Effective Date”) by and between (i) SD Pharmaceuticals, Inc., a Delaware corporation (“SDP”), and (ii) Latitude Pharmaceuticals, Inc., a Delaware corporation (“LPI”), and (iii) Andrew X. Chen (“Dr. Chen”), with respect to the following facts:
A. Dr. Chen is the sole owner of LPI and is a co-founder and a principal owner in SDP.
B. In connection with the formation of SDP, Dr. Chen assigned to SDP certain inventions and related patent rights, and LPI granted to SDP (pursuant to that certain Inventions First Negotiation and Refusal Agreement, dated as of June 16, 2004, the “Inventions Agreement”) a first negotiation right for SDP to acquire additional future inventions and related patent rights conceived and developed by LPI.
C. From June 2004 through December 2005, various additional inventions and related patent rights have been conceived and developed by Dr. Chen, as an employee of LPI, which inventions and related patent rights are useful for the business plan of SDP; and SDP has funded some of the development costs and patent application costs for said additional inventions (collectively called the “Additional Inventions”).
     WHEREFORE, the parties hereto and each agree as follows:
1. Assignment. In consideration of the license grant-back set forth in Section 2 of this Agreement, LPI and Dr. Chen hereby assign to SDP all rights and interests of Dr. Chen and LPI in the Additional Inventions and the related patent rights for all areas worldwide except for China, Taiwan, Hong Kong and Macao (collectively called the “Retained Asian Territories”). Additionally, Dr. Chen and LPI agree to execute and deliver such additional assignment documents as may be necessary or appropriate to further evidence such assignment. Attached hereto as Exhibit A is a combined listing of the Additional Inventions and the previously assigned inventions and related patent rights (collectively called the ‘Subject Patent Rights”). LPI and Dr. Chen hereby ratify and confirm their assignment to SDP of all of their rights and interests in the Subject Patent Rights except for rights and interests in the Retained Asian Territories.
2. License Grant-Back. In consideration for the forgoing assignment of the Additional Inventions, and subject to the terms of this Agreement, SDP hereby grants to LPI the worldwide, exclusive, royalty-free, paid-up, and irrevocable license right to use the Subject Patent Rights for LPI to use to develop, make, have made, use, sell and import products and to practice methods and processes, only within the Permitted Fields (as defined below).
     (a) “Permitted Fields” means all fields of use other than the “Excluded Fields” as defined in Exhibit B attached hereto.
     (b) For avoidance of doubt, SDP retains the sole and exclusive right to utilize and practice the Subject Patent Rights in the Excluded Fields for all areas worldwide except for the

 


 

Retained Asian Territories; and LPI has no rights to utilize or practice the Subject Patent Rights in the Excluded Fields, other than in the areas of the Retained Asian Territories.
     (c) LPI shall be entitled to grant sublicenses (and sub-tier-sublicenses), and to assign its license rights under this Agreement; and upon any such sublicense or assignment, LPI shall give prompt written notice thereof to SDP.
3. Patent Prosecution and Maintenance. SDP shall have the responsibility and authority to manage the patent prosecution for the Subject Patent Rights, worldwide except for the Retained Asian Territories, and to monitor and maintain the Subject Patent Rights, all at the expense of SDP. SDP shall instruct the patent attorney handling these patent matters to keep LPI fully informed as to all material matters concerning the patent prosecution and patent maintenance for the Subject Patent Rights, including furnishing copies of correspondence with the governmental patent offices, and furnishing copies of relevant documents related to the Subject Patent Rights.
4. Patent Infringement. If there is any third party infringing the Subject Patent Rights, LPI and SDI shall confer and endeavor to reach a consensus as to how best to deal with the infringer. If the infringement primarily affects the Excluded Fields in the SDP territories, then SDP shall have the final and ultimate authority to decide how to proceed against the infringer; and alternatively, if the infringement primarily affects the Permitted Fields or the Retained Asian Territories, then LPI shall have the final and ultimate authority to decide how to proceed against the infringer.
5. Inventions Agreement. As additional consideration for the assignment set forth in Section 1 above, SDP shall also amend the Inventions Agreement (described in Recital B), so as to allow LPI to have an early termination of the Inventions Agreement in the event that SDP is later sold or there is a change in control of SDP.
6. Development Costs. As additional consideration for the assignment set forth in Section 1 above, if SDP is later sold, funded, or there is a change in control of SDP (the “Triggering Event”), then SDP shall reimburse LPI for its actual costs incurred after June 2004 through the date of the Triggering Event to further develop the Subject Patent Rights (the “Development Costs”). Said Development Costs shall be for the actual materials, labor, and overhead for such development work, but shall not include any time and efforts contributed by Dr. Chen.
7. Confidentiality. To the extent that either party discloses its confidential information to the other party, such other party shall maintain the confidentiality of that confidential information and shall not use that confidential information without the prior written consent of the disclosing party. This obligation of non-disclosure and non-use shall not extend to any information which: (a) can be demonstrated by the recipient to have been within its legitimate possession prior to the time of disclosure by the disclosing party; or (b) was in the public domain prior to disclosure by the disclosing party; or (c) comes into the public domain through no fault of the recipient party; or (d) is disclosed to the recipient by third party having legitimate possession thereof and the unrestricted right to make such disclosure; or (e) is required by law or legal proceedings to be disclosed, but then only to the limited extent the such disclosure is legally required.

 


 

8. Disclaimers. Neither Dr. Chen, LPI nor SDP makes any representation or warranty of any kind with respect to (i) the claims that will ultimately be included in the Subject Patent Rights once patents are issued, or (ii) the validity or scope of any of the Subject Patent Rights, or (iii) whether or not any viable products or services can be developed under the Subject Patent Rights, or (iv) the utility or commercial applicability of the Subject Patent Rights, or (v) the nature and scope of any other related third party patent rights.
     IN WITNESS WHEREOF, the parties have executed this Agreement as of the date set forth above
         
/s/ Andrew X. Chen    
     
Andrew X. Chen    
 
       
Latitude Pharmaceuticals, Inc.    
 
       
By:
  /s/ Andrew X. Chen    
 
       
 
  Andrew X. Chen, President    
 
       
SD Pharmaceuticals, Inc.    
 
       
By:
  /s/ Paul J. Marangos    
 
       
 
  Paul J. Marangos, President    

 


 

Exhibit A
Subject Patent Rights
                         
        Pat./Appl.                
Reference            No.       Priority       Comments/Due
Number   Title   Appl. Date   Inventors   Applications   Status   Dates
401
                       
 
                       
401P1
  Pharmaceutical Compositions for
Delivering Macrolide Drugs
  60/493,209
08/06/03
  Chen   N/A   Expired    
 
                       
401
  Pharmaceutical Compositions for
Delivering Macrolides
  10/895,018
07/20/04
  Chen   60/493,209 (401P1)   Pending  
   Published as
US-2005-0049209-A1
on 03-Mar-05
 
                       
401CA
  Pharmaceutical Compositions for
Delivering Macrolides
      Chen       Unfiled  
   06-Jun-2007
- -National Stage
Filing due
 
                       
401EP
  Pharmaceutical Compositions for
Delivering Macrolides
  08/05/04   Chen   60/493,209 (401P1)
& 10/895,018 (401)
  Pending  
   05-Aug-2006
- - Annuity due
 
                       
401JP
  Pharmaceutical Compositions for
Delivering Macrolides
  08/05/04   Chen   60/493,209 (401P1)
& 10/895,018 (401)
  Pending  
   05-Aug-2007
- - Deferred Exam
 
                       
401PC
  Macrolides Containing
Oil-in-Water
Emulsions
  US04/25284
08/05/04
  Chen   60/493,209 (401P1)
& 10/895,018 (401)
  Pending  
   Published

 


 

                         
        Pat./Appl.                
Reference            No.       Priority       Comments/Due
Number   Title   Appl. Date   Inventors   Applications   Status   Dates
403
                       
 
                       
403P1
  Anti-Viral Pharmaceutical
Compositions
  60/528,843
12/10/03
  Chen   N/A   Expired    
 
                       
403
  Anti-Viral Pharmaceutical
Compositions
  11/003,302
12/03/04
  Chen   60/528,843 (403P1)   Pending  
   Published
 
                       
403PC
  Anti-Viral Pharmaceutical
Compositions
  US04/41117
12/08/04
  Chen   60/528,843 (403P1)
& 11/003,302 (403)
  Pending  
   10-Jun-2006 - - Chapter I/II National Stage Filing due
 
                       
404
                       
 
                       
404P1
  Elemene Compositions Containing
Liquid Oil
  60/538,851
01/23/04
  Chen   N/A   Expired    
 
                       
404
  Elemene Compositions Containing
Liquid Oil
  11/040,079
01/21/05
  Chen   60/538,851 (404P1)   Pending  
   Published
 
                       
406
                       
 
                       
406
  Injectable Pharmaceutical
Compositions for Irritating Drugs
  10/889,226
07/12/04
  Chen   N/A   Pending  
   Published
 
                       
406PC
  Compositions for Delivering Highly
Water Soluble Drugs
  US2005/24594
7/12/05
  Chen   10/889,226 (406)   Pending  
   Published
   18-Mar-2006
- - Amend Claims
   12-May-2006
- - Demand Due
(Priority Date)
 
                     
   12-Jan-2007 - - Chapter I/II National Stage Filing due

 


 

                         
        Pat./Appl.                
Reference            No.       Priority       Comments/Due
Number   Title   Appl. Date   Inventors   Applications   Status   Dates
407
                       
 
                       
407P1
  Stable Injectable Composition of Alpha Tocopheryl Succinate, Analogues and Salts Thereof   60/592,097
07/28/04
  Chen   N/A   Expired    
 
                       
407
  Stable Injectable Composition of Alpha Tocopheryl Succinate, Analogues and Salts Thereof   11/192,439
07/28/05
  Chen   60/592,097 (407P1)   Pending  
   Published
 
                       
407PC
  Stable Injectable Composition of Alpha Tocopheryl Succinate, Analogues and Salts Thereof   US2005/026783
7/28/05
  Chen   60/592,097 (407P1)   Pending  
   Published
   28-Jan-2007 - - Chapter I/II National Stage Filing due
 
                       
408
                       
 
                       
408
  Low Oil Emulsion Compositions for Delivering Taxoids and Other Insoluble Drugs   10/952,243
9/28/04
  Chen   N/A   Pending  
   30-Mar-2006
- - Projected
Publication
 
                       
408 PC
  Low Oil Emulsion Compositions for Delivering Taxoids and Other Insoluble Drugs   US2005/34971
9/28/05
  Chen   10/952,243 (408)   Pending  
   28-Mar-2007 - - Chapter I/II National Stage Filing due

 


 

                         
        Pat./Appl.                
Reference            No.       Priority       Comments/Due
Number   Title   Appl. Date   Inventors   Applications   Status   Dates
409
                       
 
                       
409P1
  Vitamin E Succinate Stabilized Pharmaceutical Compositions, Methods for the Preparation Thereof and Methods for the Use Thereof   To be filed                
 
                       
409P2
  Vitamin E Succinate Stabilized Pharmaceutical Compositions, Methods for the Preparation Thereof and Methods for the Use Thereof   To be filed                
 
                       
410
  Vancomycin formation Patent   To be filed                

 


 

Exhibit B
Excluded Fields
1. Clarithromycin intravenous emulsion formulation for infectious disease and any other disease indication.
2. Chitosan in combination with Zinc for topical anti-viral use.
3. B-Elemene intravenous emulsion formulation for Cancer treatment and any other disease indication.
4. Vinca Alkyloid intravenous emulsion formulation for cancer treatment and any other disease indication.
5. Alpha tocopheryl Succinate, Paclitaxel and Docetaxel intravenous emulsion formulations for Cancer and any other disease indication.
6. Paclitaxel and Docetaxel intravenous emulsion formulation for cancer treatment and any other disease indication.
7. Vancomycin intravenous emulsion formulation for infectious disease and any other disease indication.

 


 

November 20, 2007
Latitude Pharmaceuticals, Inc.
6364 Ferris Square
San Diego, CA 92121
Andrew X. Chen, as an individual
6364 Ferris Square
San Diego, CA 92121
Re: Clarification under License Agreement
To Whom It May Concern:
     Reference is made to that certain License Agreement, dated December 10, 2005, among SD Pharmaceuticals, Inc., a Delaware corporation (“SDP”), Latitude Pharmaceuticals, Inc., a Delaware corporation (“Latitude”), and Andrew X. Chen (the “License Agreement”).
     I am writing to confirm our mutual understanding of the License Agreement; in particular, the scope of the “Excluded Fields” (and, thereby, the scope of the “Permitted Fields”) with respect to (i) patent applications US 11/003,302 (published as US 2005/0232895) and International Application PCT/US2004/041117 (published as WO 2005/074947), (ii) all additions, divisions, continuations, continuations-in-part, registrations, renewals, registrations and substitutions thereof, (iii) all foreign patent applications and counterparts corresponding to any of the preceding and (iv) all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues, and reexaminations (the “Patents”).
     We agree that the scope of the Excluded Field with respect to the Patents includes the right to make, have made, use, offer for sale, sell and import, and to otherwise practice and exploit, the inventions disclosed or claimed in the Patents, including in combination with other substances and/or devices. Other than as clarified or otherwise set forth in this letter, the terms and conditions of the License Agreement remain in full force and effect.
[Signature page follows]

 


 

November 20, 2007
Page 2
     If you agree with the foregoing, please countersign this letter. Do not hesitate to contact me if you have any questions.
             
    Very truly yours,    
 
           
    ADVENTRX Pharmaceuticals, Inc.    
 
           
 
  By:   /s/ Evan M. Levine    
 
           
 
      Evan M. Levine, Chief Executive Officer    
         
ACKNOWLEDGED AND AGREED:    
 
       
Latitude Pharmaceuticals, Inc.    
 
       
By:
  /s/ Andrew X. Chen    
 
       
 
  Andrew X. Chen, President    
 
       
/s/ Andrew X. Chen    
     
Andrew
  X. Chen, as an individual