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