Document:

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/SYNExhibit 10.54

 

Amendment 005

Sponsored Research Agreement (SRA) UTA12-000950
(the “Agreement”)

Dated December 19, 2012 Between

The University of Texas at Austin (the
“University”)

And

Synthetic Biologics, Inc. (the “Sponsor”)

 

The purpose of this Amendment to extend the Termination Date
under the Agreement until January 17, 2019 in order to allow the University to continue the research, at no additional cost to
Sponsor.

 

This Agreement is modified by mutual agreement of the Parties
as follows:

 

1.          Article
2.2 of the Agreement is hereby amended to read: “The Research Program shall be performed during the period from the Effective
Date through and including January 17, 2019 (the “Termination”). Sponsor shall have the option of extending the Research
Program under mutually agreeable support terms.”

 

All other terms and conditions of the Agreement shall remain
unchanged, it being acknowledged and agreed that no further or additional payments shall be made by Sponsor to the University as
a result of this Amendment to Section 2.2 of the Agreement. The terms used herein without definition shall have the meanings ascribed
to such terms in the Agreement.

 

	The University of Texas at Austin	 	Synthetic Biologics, Inc.
	 	 	 
	/s/ Ty Helpinstill	 	/s/ Jeff Riley
	Ty Helpinstill	 	Jeff Riley
	Associate Director	 	CEO
	Office of Industry Engagement	 	 
	 	 	 
	Date:  22 August 2017	 	Date: 8/22/2017 | 10:30 PM EDT

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00279-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00279-of-00352.parquet"}]]