Exhibit 10.19


  


RITTER PHARMACEUTICALS,
INC.


 


AMENDMENT NO. 2 TO


 


RESEARCH AND DEVELOPMENT
AGREEMENT & LICENSE


 


This Amendment No. 2 (the
“Amendment”) to the Research and Development Agreement & License, dated as of November 17, 2010, and first
amended on July 6, 2011 (as amended to date, the “Original Agreement”), is made and entered into as of September
30, 2011, pursuant to Section 13.4 of the Original Agreement, by and among KOLU POHAKU TECHNOLOGIES, LLC, a Delaware limited
liability company (together with its successors and assigns, “Kolu Pohaku”); KOLU POHAKU MANAGEMENT,
LLC, a Delaware limited liability company (together with its successors and assigns, “KPM”); and
RITTER PHARMACEUTICALS, INC., a Delaware corporation (together with its successors and assigns, the “Company”).
Capitalized terms used in this Amendment that are not otherwise defined herein shall have the respective meanings assigned to them
in the Original Agreement.


 


RECITALS


 


WHEREAS, the Company,
Kolu Pohaku and KPM are parties to the Original Agreement;


 


WHEREAS, the parties
wish to amend the Original Agreement in the manner set forth below in order to fund additional Qualified Research activities in
accordance with the terms of the Original Agreement; and


 


WHEREAS, the Original
Agreement may be amended by written agreement of the parties thereto.


 


NOW, THEREFORE,
the parties hereto hereby agree as follows:


 


AGREEMENT


 


1.          Section
2.19 of the Original Agreement shall be amended and restated in its entirety to read as set forth below:


 


“Royalty
Payments” means the 2010 Royalty Payments, the 2011 Royalty Payments and the 2012 Royalty Payments by Researcher to Kolu
Pohaku described in Section 9 herein.


 


2.          7
of the Original Agreement shall be amended and restated in its entirety to read as set forth below:


 


R&D Fee.


 


7.1           2010
R&D Fee. Kolu Pohaku shall pay to the Researcher Seven Hundred and Fifty Thousand Dollars ($750,000.00) as the research
and development fee (“2010 R&D Fee”) for performing the KP Research in 2010 through 2014. Two Hundred
Fifty Thousand Dollars ($250,000.00) of the R&D Fee shall be payable upon signing of the


 




    	 



    	 



    

  


Agreement (the
“2010 R&D Fee Installment”) and Five Hundred Thousand Dollars ($500,000.00) shall be paid no later
than January 10, 2011, provided that the conditions set forth in Section 8 have been satisfied (the “2011 R&D Fee
Installment”). Researcher agrees that the 2010 R&D Fee will be disbursed to Researcher in amounts corresponding
to, and within five (5) business days of the receipt of each request for a disbursement from Researcher unless Kolu Pohaku objects
in writing to such request in such time period (each such amount, a “2010 R&D Disbursement”). Notwithstanding
the foregoing sentence, the Parties agree that the 2010 R&D Fee Installment shall be disbursed upon execution of this Agreement
and shall be considered a 2010 R&D Disbursement for all purposes hereunder. Researcher agrees that a minimum amount of KP Research
will be performed in each year of the Agreement as provided in Exhibit B. Researcher further agrees that the payments set forth
in this Agreement shall be full and complete compensation for all obligations and deliverables by Researcher under this Agreement
and for all inventions, developments and improvements assigned under this Agreement, if any. Researcher specifically agrees that
Kolu Pohaku shall not be responsible for any costs of overhead, salaries, materials or other expenses, except as set forth herein.
Not later than March 15 of each year, Researcher shall deliver to Kolu Pohaku a certificate of the Chief Financial Officer of Researcher
(i) setting forth in reasonable detail the application of the 2010 R&D Fee performed to date pursuant to the funding of the
KP Research, (ii) demonstrating that no less than 100% of such funding was applied toward the KP Research, and (iii) certifying
that the KP Research has not been funded from the proceeds of any other third party agreement such that the third party has ownership
of any of the results of the KP Research.


 


7.2           2011
R&D Fee. Kolu Pohaku shall pay to the Researcher Three hundred Thousand Dollars ($300,000.00) as the research and development
fee (“2011 R&D Fee”) for performing certain KP Research in 2011. Researcher agrees that the 2011
R&D Fee will be disbursed to Researcher in amounts corresponding to, and within five (5) business days of the receipt of, each
request for a disbursement from Researcher unless Kolu Pohaku objects in writing to such request in such time period (each such
amount, a “2011 R&D Disbursement”). Researcher further agrees that the payments set forth in this
Agreement shall be full and complete compensation for all obligations and deliverables by Researcher under this Agreement and for
all inventions, developments and improvements assigned under this Agreement, if any. Researcher specifically agrees that Kolu Pohaku
shall not be responsible for any costs of overhead, salaries, materials or other expenses, except as set forth herein. Not later
than March 15 of each year, Researcher shall deliver to Kolu Pohaku a certificate of the Chief Financial Officer of Researcher
(i) setting forth in reasonable detail the application of the 2011 R&D Fee performed to date pursuant to the funding of the
KP Research, (ii) demonstrating that no less than 100% of such funding was applied toward the KP Research, and (iii) certifying
that the KP Research has not been funded from the proceeds of any other third party agreement such that the third party has ownership
of any of the results of the KP Research.


 


7.3           2012
R&D Fee. Kolu Pohaku shall pay to the Researcher Two Hundred Fifty Thousand Dollars ($250,000.00) as the research and development
fee (“2012 R&D Fee”) for performing certain KP Research in 2012. Researcher agrees that the 2012


 




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R&D Fee will
be disbursed to Researcher upon the effectiveness of this Amendment (such amount, a “2012 R&D Disbursement”
and, along with the 2010 R&D Disbursement and 2011 R&D Disbursement, the “R&D Disbursements”). Researcher
further agrees that the payments set forth in this Agreement shall be full and complete compensation for all obligations and deliverables
by Researcher under this Agreement and for all inventions, developments and improvements assigned under this Agreement, if any.
Researcher specifically agrees that Kolu Pohaku shall not be responsible for any costs of overhead, salaries, materials or other
expenses, except as set forth herein. Not later than March 15 of each year, Researcher shall deliver to Kolu Pohaku a certificate
of the Chief Financial Officer of Researcher (i) setting forth in reasonable detail the application of the 2012 R&D Fee performed
to date pursuant to the funding of the KP Research, (ii) demonstrating that no less than 100% of such funding was applied toward
the KP Research, and (iii) certifying that the KP Research has not been funded from the proceeds of any other third party agreement
such that the third party has ownership of any of the results of the KP Research.


 


3.          Section
9 of the Original Agreement shall be amended by the addition of a new Section 9.4 but shall otherwise remain unchanged:


 


9.4           2012
Quarterly Royalty Payment. Commencing with an initial payment on March 31, 2015, and continuing through December 31, 2035,
at the expiration of each calendar quarter (i.e., March 31, June 30, September 30, December 31, etc.), Researcher shall pay to
Kolu Pohaku a royalty payment of Seven Thousand Dollars ($7,000.00) (each a “2012 Royalty Payment”) for
the license and use of the results of the KP Research. In the event any Royalty Payment is not paid on or before its due date,
interest shall accrue on such amount at the rate of 12% per annum compounded annually.


 


4.          Exhibit
A of the Original Agreement shall be amended and restated in its entirety to read as attached to this Amendment.


 


5.          Exhibit
B of the Original Agreement shall be amended and restated in its entirety to read as attached to this Amendment.


 


6.          Except
as expressly set forth in this Amendment, the Original Agreement shall continue in full force and effect in accordance with its
terms.


 


7.          This
Amendment may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.


 


8.          All
corporate action on the part of the Company and its directors, officers, and stockholders necessary for the authorization, execution,
and delivery of this Amendment by the Company has been taken as of the date hereof.


 


9.          This
Amendment shall be governed by and construed and enforced in accordance with the laws of the State of Hawaii, without reference
to the conflict of laws provisions thereof.


 


(Signature pages follow)


 




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IN WITNESS WHEREOF, the
parties hereto have duly executed this Amendment as of the date first above written.


 


	 	KOLU POHAKU TECHNOLOGIES, LLC
	 	 
	 	By	/s/ Thomas Adamek
	 	 	Thomas Adamek, President
	 	 
	 	KOLU POHAKU MANAGEMENT, LLC
	 	 
	 	By	/s/ Thomas Adamek
	 	 	Thomas Adamek, President
	 	 
	 	RITTER PHARMACEUTICALS, INC.
	 	 
	 	By	/s/ Andrew J. Ritter
	 	 	Andrew Ritter, President and CEO


 


Signature Page to Amendment
No. 2 to

First Amendment to Research and Development Agreement & License


 




    	 



    	 



    

 





Exhibit A


 


Description of KP Research
to be performed on behalf of and for the benefit of Kolu Pohaku


 


[Description of Annual R&D
Activities (2010-2014) and Budgets attached hereto]


 


The KP Research that the
Researcher will perform pursuant to the Agreement will be based on and add to or supplement the Research Project described above.
The KP Research will be maintained and conducted separately. The details and scope of the research that will constitute KP Research
will be provided to Kolu Pohaku in Researcher’s regular reporting and the scope will be directed and further defined based
on the results that are achieved.


 




    	 



    	 



    

  


Exhibit A (continued)


 


Hawaii Clinical Expenses Pursuant
to the 2010 R&D Agreement


 


	 	 	2010	 	 	2011	 	 	Total	 
	 	 	$	 	 	$	 	 	$	 
	 	 	 	 	 	 	 	 	 	 
	Clinical Supply	 	$	60,000	 	 	$	15,000	 	 	$	75,000	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Clinic	 	$	37,555	 	 	$	365,200	 	 	$	402,755	 
	Subject Cost (Attachment A)	 	$	10,000	 	 	$	265,000	 	 	$	275,000	 
	Parking Hawaii	 	$	1,000	 	 	$	6,000	 	 	$	7,000	 
	Screen Failure	 	$	5,000	 	 	$	47,000	 	 	$	52,000	 
	IRB Fees	 	$	1,155	 	 	$	-	 	 	$	1,155	 
	Recruitment Allowance	 	$	10,000	 	 	$	23,000	 	 	$	33,000	 
	Start-up Fees	 	$	5,400	 	 	$	-	 	 	$	5,400	 
	HBT Machines	 	$	-	 	 	$	1,200	 	 	$	1,200	 
	Validation Study	 	$	5,000	 	 	$	20,000	 	 	$	25,000	 
	Archiving Fees	 	$	-	 	 	$	3,000	 	 	$	3,000	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Clinical Research Organization	 	$	14,500	 	 	$	229,000	 	 	$	243,500	 
	Project Management	 	$	5,000	 	 	$	60,000	 	 	$	65,000	 
	Trial Master File	 	$	-	 	 	$	-	 	 	$	-	 
	Data Management (Attachment B)	 	$	5,000	 	 	$	17,500	 	 	$	22,500	 
	Statistical Programming (Attachment B)	 	$	-	 	 	$	-	 	 	$	-	 
	Statistical Programming (Attachment B)	 	$	2,000	 	 	$	22,000	 	 	$	24,000	 
	Clin Study Report (Attachment B)	 	$	-	 	 	$	8,000	 	 	$	8,000	 
	Teleconferences/Team Meetings (Attachment B)	 	$	1,000	 	 	$	2,000	 	 	$	3,000	 
	Medical Monitor (Jon Ruckle)	 	$	-	 	 	$	25,000	 	 	$	25,000	 
	Clinical Monitoring	 	$	-	 	 	$	96,000	 	 	$	96,000	 
	Administrative Set-up/Site Management	 	$	1,500	 	 	$	10,100	 	 	$	11,600	 
	Initiation Visit	 	$	-	 	 	$	12,000	 	 	$	12,000	 
	Process Monitoring Visit	 	$	-	 	 	$	12,800	 	 	$	12,800	 
	Routine Monitoring Visit	 	$	-	 	 	$	30,400	 	 	$	30,400	 
	Close-Out Visit	 	$	-	 	 	$	11,200	 	 	$	11,200	 
	Pass-through Estimates	 	$	-	 	 	$	18,000	 	 	$	18,000	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	General Expenses	 	$	-	 	 	$	33,000	 	 	$	33,000	 
	Liability Insurance	 	$	-	 	 	$	18,000	 	 	$	18,000	 
	Travel	 	$	-	 	 	$	15,000	 	 	$	15,000	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Totals	 	$	112,055	 	 	$	642,200	 	 	$	754,255	 



 


*Expenses based on estimated
performed work


 




    	 



    	 



    

  


Exhibit A-1


 


Hawaii Clinical Expenses for
2011


Pursuant to Amendment No.
2 to the R&D Agreement


 


	Operations	 	KP Research to be performed	 
	 	 	 	 
	 	 	2011	 	 	2012	 	 	TOTAL	 
	 	 	 	 	 	 	 	 	 	 
	General Expenses	 	$	20,000	 	 	$	15,000	 	 	$	35,000	 
	Consultants	 	$	20,000	 	 	$	15,000	 	 	$	35,000	 
	Subtotal Operations	 	$	40,000	 	 	$	30,000	 	 	$	70,000	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Clinic	 	 	 	 	 	 	 	 	 	 	 	 
	Clinical Supply	 	$	55,000	 	 	$	-	 	 	$	55,000	 
	CRO/Clinic	 	$	280,000	 	 	$	130,000	 	 	$	410,000	 
	Clinic Staff	 	$	5,000	 	 	$	10,000	 	 	$	15,000	 
	Subtotal Clinic	 	$	340,000	 	 	$	140,000	 	 	$	480,000	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	TOTAL	 	$	380,000	 	 	$	170,000	 	 	$	550,000	 



 




    	 



    	 



    

  


Exhibit B


 


Minimum Annual KP Research


Pursuant to Amendment No.
2 to the R&D Agreement


 


	Calendar
    Year	 	Annual
    Minimum KP Research to be performed
	 	 	 
	2010	 	$50,000 
	2011	 	
        $400,000 - See Exhibit
        A

        $380,000 - See Exhibit
        A-1

	 	 	 
	2012	 	$170,000 – See Exhibit A-1
	 	 	 
	2013	 	$37,500
	 	 	 
	2014	 	$37,500