Exhibit 10.1
    

    

    

    

    

    
      First Amendment of
Option and License Agreement
    

    

    

    
      THIS FIRST AMENDMENT OF OPTION AND LICENSE AGREEMENT (the “Amendment”)
      is dated as of March 9, 2015 (the “Amendment Effective Date”)
      by and between Opexa Therapeutics, Inc., a corporation organized under
      the laws of Texas having a place of business at 2635 Technology Forest
      Boulevard, The Woodlands, TX 77381 (“Opexa”), and Ares
      Trading S.A., a corporation organized under the laws of Switzerland
      having a place of business at Zone Industrielle de l’Ouriettaz, 1170
      Aubonne, Switzerland (“Merck”).  Opexa and Merck may be
      referred to herein as a “Party” or, collectively, as “Parties.”
    

    
      RECITALS:
    

    
      WHEREAS, Opexa and Merck entered into an Option and License Agreement
      dated February 4, 2013 (“Option Agreement”) pursuant
      to which Opexa granted certain exclusive rights to Merck to develop and
      commercialize Opexa’s personalized T-cell immunotherapy (Tcelna®) in
      multiple sclerosis.
    

    
      WHEREAS, the Parties wish to amend the Option Agreement as provided in
      this Amendment;
    

    
      NOW, THEREFORE, it is mutually understood and agreed by and between the
      Parties as follows:
    

    
      Article 1
AMENDMENT OF THE OPTION AGREEMENT
    

    
      1.1      Effective upon the Amendment Effective Date, the Option
      Agreement is amended as provided in this Article 1.  Except as expressly
      modified in this Article 1, all provisions of the Option Agreement shall
      remain in full
           force and effect.
    

    
      1.2      Any capitalized term not otherwise defined herein shall
      have the same meaning as defined in the Option Agreement.
    

    
      1.3      Article 2 of the Option Agreement is amended by adding
      the following new Sections immediately following Section 2.3 thereof:
    

    
      2.4       Creation of Pre-Phase III Plan.  
      Commencing on March 15, 2015, Opexa will create a detailed plan,
      including a GANTT chart containing key tasks, decision points, timing,
      budget and milestones, documenting all of the activities necessary for
      laboratory facilities both in the U.S. and Europe to reach operational
      readiness by the end of December 2016 (such plan, the “Pre-Phase
      III Plan”).  The Pre-Phase III Plan will include, among other items,
      (i) review and identification of a preferred contract manufacturing
      organization in Europe, (ii) set-up, identification and qualification of
      third parties for raw materials, (iii) validation of laboratory
      facilities in the U.S. and Europe; and (iv) a hiring plan for the key
      personnel to complete the Pre-Phase III Plan. For Europe, the Pre-Phase
      III Plan will address the creation of a dedicated lab to support a Phase
      III trial.  For the US, the Pre-Phase III Plan will address the
      expansion of existing capabilities and infrastructure to handle a Phase
      III trial.
    

    
      
        

        

      

      
        

        

        
          


        

      

      
        

        

      

    

    
      2.5       Approval of Pre-Phase III Plan.  Opexa
      will present its proposed Pre-Phase III Plan to the JSC and the JSC
      shall review the proposed Pre-Phase III Plan.  The Pre-Phase III Plan
      shall be subject to the approval of the JSC, which approval shall not be
      unreasonably withheld or delayed.
    

    
      2.6       Pre-Phase III Plan and Extension of Option Period.  Notwithstanding
      anything to the contrary in Section 2.1, in the event that the JSC has
      not approved the Pre-Phase III Plan prior to end of the Option Period,
      the Option Period shall be extended, and Merck may exercise the Option,
      until sixty (60) days following the approval of the Pre-Phase III Plan
      by the JSC.
    

    
      2.7       R&D Funding Payment.  As
      consideration in advance of Opexa’s creation and performance of the
      Pre-Phase III Plan as well as Opexa’s performance of Section 2.8, Merck
      will pay to Opexa the sum of U.S. Three Million Dollars ($3,000,000)
      (the “R&D Funding Payment”), which sum shall be payable
      within fourteen (14) days of Merck’s receipt of an invoice from Opexa
      for the R&D Funding Payment.  For clarity, Opexa may submit such invoice
      on or after March 9, 2015.
    

    
      2.8       Immune Monitoring Data.  Opexa
      will provide to Merck updates and analysis on a blinded basis, grouped
      in patient batches according to Opexa’s analysis timetable, on the
      progress of Opexa’s immune monitoring program (the “Program”)
      being conducted in conjunction with the Abili-T Trial, with such updates
      and analysis to be shared by Opexa with Merck within thirty (30) days of
      Opexa’s initial assessment of such information.  Opexa will inform Merck
      of any existing or future external bioinformatics vendor used by Opexa
      for the Program, and Merck will have the right, at its expense, to
      review current and future data storage and integrity measures for the
      Abili-T Trial.
    

    
      1.4      Section 3.1 of the Option Agreement is amended by adding the
      following sentence immediately following the last sentence thereof:
    

    
      In addition to the foregoing responsibilities, the JSC shall also have
      responsibility for approving, and overseeing the completion by Opexa, of
      the Pre-Phase III Plan.  The JSC will meet at least quarterly beginning
      in the second (2nd) quarter of 2015 to advise and make
      specific recommendations with respect to the Pre-Phase III Plan,
      although the foregoing responsibility of the JSC shall not modify
      decision-making under Section 3.4 hereof.
    

    
      Article 2
ELECTRONIC EXECUTION
    

    
      2.1       This Amendment may be executed by the Parties by
      electronic means, by exchanging signed PDF copies that are scanned and
      emailed, and shall come into effect immediately upon execution by the
      last Party.
    

    
      
        

        

      

      
        
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      Article 3
RELATIONSHIP OF THE AMENDMENT WITH THE OPTION AGREEMENT
    

    
      3.1       The terms and conditions of this Amendment shall
      constitute a part of the Option Agreement as amended hereby, and shall
      be construed in accordance with the terms and conditions of the Option
      Agreement as amended.
    

    
      3.2       Except as expressly modified by this Amendment, the
      Option Agreement shall continue in fall force and effect.
    

    
      3.3       If there is a conflict between the Option Agreement and
      this Amendment, this Amendment shall prevail.
    

    
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      IN WITNESS WHEREOF, the Parties have caused this Agreement to be
      executed and delivered by their respective duly authorized officers as
      of the Effective Date.
    


    	
          
            Opexa Therapeutics, Inc.
          

        	
           
        	
          
            Ares Trading S.A.
          

        
	

        	

        	

        	

        	
           
        
	

        	

        	

        	

        	
           
        
	

        	

        	

        	

        	
           
        
	
          
            By:
          

        	
          
            /s/ Neil K. Warma
          

        	

        	
          
            By:
          

        	
          
            /s/ Cedric Hyde
          

        
	
          
            Name:
          

        	
          
            Neil K. Warma
          

        	

        	
          
            Name:
          

        	
          
            Cedric Hyde
          

        
	
          
            Title:
          

        	
          
            CEO
          

        	

        	
          
            Title:
          

        	
          
            Authorized Representative
          

        
	

        	

        	

        	

        	
           
        
	
          
            By:
          

        	
          
            /s/ Karthik Radhakrishnan
          

        	
          
             
          

        	
          
            By:
          

        	
          
            /s/ James Singleton
          

        
	
          
            Name:
          

        	
          
            Karthik Radhakrishnan
          

        	

        	
          
            Name:
          

        	
          
            James Singleton
          

        
	
          
            Title:
          

        	
          
            CFO
          

        	

        	
          
            Title:
          

        	
          
            Authorized Representative
          

        


    

    
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