Exhibit 10.53

 

FOURTH AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT

 

THIS FOURTH AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT (this “Fourth Amendment”) is made and entered into as of February 16, 2018 (“Fourth Amendment Date”), by and among CEDARS-SINAI MEDICAL CENTER, a California nonprofit public benefit corporation (“CSMC”), SYNTHETIC BIOLOGICS, INC., a Nevada corporation (“Synthetic” or “SYN”) and SYNTHETIC BIOMICS, INC., a Nevada corporation (“Licensee”), under the following circumstances:

 

A.CSMC, Synthetic and Licensee entered into an Exclusive License Agreement dated December 5, 2013, as amended (the “Agreement”), whereby CSMC granted to Licensee an exclusive license to use the Patent Rights and the Technical Information (as such terms are defined in the Agreement) pursuant to the terms and conditions of the Agreement.

 

B.The parties desire to amend the Agreement to add certain patent applications solely owned by CSMC and certain patent applications co-owned by CSMC and Synthetic to the Patent Rights (as such term is defined in the Agreement) licensed under the Agreement, as further described herein.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein and in the Agreement and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

  

1.          Recitals; Defined Terms. The parties hereby acknowledge and agree that Recital A is true and accurate. Terms not otherwise defined herein shall have the meaning ascribed to them in the Agreement.

 

2.          Amendments to Schedule A to the Agreement. The patents and patent applications of Appendix A below are hereby added to Schedule A of the Agreement (in the case of entries which are co-owned, CSMC’s undivided interest is added to Schedule A).

 

3.          Co-Owned Patent Rights. With respect to the Patent Rights that are co-owned by the parties (including the patents and patent applications listed in Appendix A below), Licensee shall be obligated to pay CSMC a Royalty (as such term is defined in the Agreement) for the duration of the term of the Agreement (as outlined in Section 6.1), regardless of co-ownership of the Patent Rights between the parties and any early termination of the Agreement in accordance with Section 6.2(f) of the Agreement.

 

4.          Other Provisions. This Fourth Amendment is a revision to the Agreement only; it is not a novation thereof. Except as otherwise provided herein, the terms and conditions of the Agreement shall remain in full force and effect.

 

5.          Further Assurances. Each of the parties hereto shall execute such further documents and instruments, and do all such further acts, as may be necessary or required in order to effectuate the intent and accomplish the purposes of this Fourth Amendment.

 

6.          Counterparts. This Fourth Amendment may be executed in any number of counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument.

 

[Remainder of Page Intentionally Left Blank]

 

   

 

 

WITNESS WHEREOF, the parties have executed this Fourth Amendment to Exclusive License Agreement as of the Fourth Amendment Date.

 

Dated: February 16, 2018 SYNTHETIC BIOMICS, INC.
     
  By: /s/ Steven Shallcross
    Steven Shallcross
    Interim CEO and CFO
     
Dated: February 16, 2018 SYNTHETIC BIOLOGICS, INC.
     
  By: /s/ Steven Shallcross
    Steven Shallcross
    Interim CEO and CFO
     
Dated: February 16, 2018 CEDARS-SINAI MEDICAL CENTER
     
  By: /s/ Edward M. Prunchunas
    Edward M. Prunchunas
    Executive Vice President for Finance & CFO
     
  By: /s/ James D. Laur
    James D. Laur, JD
    Vice President for
    Technology & Business Affairs

 

   

 

 

Appendix A

 

Title   Country   Patent Appn. No.   Filing Date   CSMC
Reference ID:
  Status
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   US   61/912,297   12/5/2013   416PR20   Converted
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   US   61/931,498   1/24/2014   416PR30   Converted
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   PCT   PCT/US2014/27697   03/14/2014   416WO00   Converted
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   Australia   2014239164   03/14/2014   416AU00   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   Brazil   1120150228259   03/14/2014   416BR00   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   Canada   2,903,493   03/14/2014   416CA00   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   China   2014800276522   03/14/2014   416CN00   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   Europe   14770590.9   03/14/2014   416EP00   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   Hong Kong   16102623.3   03/14/2014   416HK00   Pending

 

   

 

 

Title   Country   Patent Appn. No.   Filing Date   CSMC
Reference ID:
  Status
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   Japan   2016-502522   03/14/2014   416JP00   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   Mexico   MX/a/2015/012444   03/14/2014   416MX00   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   USA   14/211,197 (9,289,418)   03/14/2014   416US00   Patented
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   USA  

14/776,465

(9,744,208)

  09/14/2015   416US10   Patented
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   USA  

15/043,223

(9,845,511)

  02/12/2016   416US20   Patented
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   USA   15/656,758   07/21/2017   416US30   Pending
METHODS OF DIAGNOSIS, SELECTION, AND TREATMENT OF DISEASES AND CONDITIONS CAUSED BY OR ASSOCIATED WITH METHANOGENS   USA   15/810,891   11/13/2017   416US40   Pending
ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Australia   2015301596   8/13/2015   455AU00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Brazil   1120170027615   8/13/2015   455BR00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Canada   2,955,666   8/13/2015   455CA00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   China   2015800502316   8/13/2015   455CN00  

Pending

 

Co-Owned CSMC/SYN

 

   

 

 

Title   Country   Patent Appn. No.   Filing Date   CSMC
Reference ID:
  Status
ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Europe   15831885.7   8/13/2015   455EP00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Japan   2017-528760   8/13/2015   455JP00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Israel   250568   8/13/2015   455IL00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   India   201727005511   8/13/2015   455IN00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Korea   10-2017-7005268   8/13/2015   455KR00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Mexico   MX/a/2017/001971   8/13/2015   455MX00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   Russia   2017106896   8/13/2015   455RU00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC COMPOSITIONS AND USES THEREOF   South Africa   2017/00566   8/13/2015   455ZA00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC STATINS AND THEIR DERIVATIVES   PCT   PCT/US2016/025214   3/31/2016   542WO00  

Nat’l Filed

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC STATINS AND THEIR DERIVATIVES   USA   15/560,145   09/20/2017   542US00  

Pending

 

Co-Owned CSMC/SYN

ANTI-METHANOGENIC STATINS AND THEIR DERIVATIVES   Europe   16774176.8   3/31/2016   542EP00  

Pending

 

Co-Owned CSMC/SYN

CLINICALLY EFFICACIOUS ANTI-METHANOGENIC COMPOSITIONS AND USES   USA   62/352,952   6/21/2016   632PR00  

Expired

 

Co-Owned CSMC/SYN

CLINICALLY EFFICACIOUS ANTI-METHANOGENIC COMPOSITIONS AND USES   USA   62/413,847   10/27/2016   632PR10  

Expired

 

Co-Owned CSMC/SYN

CLINICALLY EFFICACIOUS ANTI-METHANOGENIC COMPOSITIONS AND USES   PCT   PCT/US2017/038499   6/21/2017   632WO00  

Pending

 

Co-Owned CSMC/SYN