Exhibit 10.19


 


SECOND AMENDMENT TO SUB-LICENSE AGREEMENT


 


THIS SECOND AMENDMENT (“Second
Amendment”) is made to the Sub-License Agreement by and between Miromatrix Medical Inc., a Delaware corporation with .a principal
place of business at 10399 West 70th Street, Eden Prairie; MN 55334 USA (hereinafter “Miromatrix”), and Texas. Heart Institute,
a Texas non-profit corporation with a principal place of business 01.6770 Bertner, Suite C 550, Houston, Texas 77030 (hereinafter
 “THI”), which has an effective date of October 1, 2013 (“Agreement”). Miromatrix and THI may be referred to as
a “Party” or, collectively, as “Parties.”


 


RECITALS


 


WHEREAS, on or about April
1, 2014, the Parties executed a First Amendment to the Agreement (“First Amendment”); and


 


WHEREAS, the Parties desire
to execute this Second Amendment to the Agreement.


 


NOW, THEREFORE, in consideration
of the premises and mutual covenants contained herein, and intending to be legally bound thereby, the Parties agree as follows:


 


The attached Exhibit B (Milestones)
hereby supersedes and replaces original. Exhibit B to the Agreement in its entirety. The original Exhibit B to the Agreement shall no
longer have any force or effect. All other Sections, terms, and provisions of the Agreement remain unchanged by this Second Amendment.
All Sections, terms, and provisions of the First Amendment remain unchanged by this Second Amendment.


 


IN WITNESS WHEREOF, the Parties
hereto have duly executed this Second Amendment to the Agreement, effective as of the date of the last signature of a Party set forth
below.


 


	MIROMATRIX MEDICAL INC.	 	TEXAS HEART INSTITUTE
	 	 	 
	By:	/s/ Jeff Ross	 	By:	/s/ Fred Zeidman
	 	Jeff Ross	 	 	Fred Zeidman
	 	President
    & CEO	 	 	Chief Financial
    Officer
	 	 	 
	Date:	9/25/2018	 	Date:	9/25/2018



 



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EXHIBIT B


 


WHOLE HEART MAJOR MILESTONES


 


Milestone 1 - Cardiac Source and Characterization
(.75 years, complete 9/30/2014)


 


		·	Define cardiac decellularization process from porcine sources



 


		·	Characterize the cardiac matrix and identify key process



 


		·	Define cardiac decellularization production process



 


Milestone 2:- Human Sized Whole Heart Recellularization
(5 years, complete 9/30/2019)


 


Recellularization of the Whole Heart
(3.5 years)


 


		·	Evaluate vascular and parenchymal human cell sources including for example iPS cells for cardiac recellularization



 


		·	Identify human cell sources and define regulatory strategy in consultation with



 


		·	Miromatrix



 


Functional Characterization of Human
Sized Heart with Human Cells (1.5 years)


 


		·	Demonstrate functional whole heart recellularization in three separate hearts as defined by:



 


		o	Contractile function and drug responsiveness consistent with human physiology.



 


Milestone 3 - Preclinical Lame Animal Safety/Efficacy
Studies of Human Sized Hearts with Human Cells (3 years, complete 9/30/2021) 


 


		·	Complete acute large animal preclinical studies



 


		o	Whole heart transplantation that successfully demonstrates cardiac function and acute stability for 6
hours in three animals



 


		·	Complete chronic large animal preclinical studies



 


		o	Whole heart transplantation that successfully demonstrates sustained cardiac function for 45 days following
transplantation in three animals



 


Milestone 4 - Whole Human Sized Heart with
Human Cells Productions and GLP Preclinical Studies (2 year, complete 9/30/2022 or at end of follow-up period required by FDA)


 


		·	Complete GLP preclinical studies for follow up period required by FDA to demonstrate efficacy and to support
IND submission



 


		·	Define release criteria to demonstrate safety for IND application



 






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Milestone 5 - IND Submission (1.5 year.
complete 3/31/2023) 


 


		·	Validate product SOPs for GLP and make available all data and documentation to Miromatrix



 


		·	File FDA regulatory submission for Phase I safety trials



 


Milestone 6 - First in Human Clinical Trial
(THI will send data from 3 patient trials within 3 months following the end of the FDA specified follow-up period for 3 patients enrolled.).


 


		·	Complete first in human clinical study (3 patients)



 


Milestone 7 - Phase I/II Clinical Trials
(complete 2 years after end of FDA specified follow-up period for patients enrolled)


 


		·	Complete within 18 months or timeline designated by FDA for Phase II clinical trials (5-10 patients)



 


		·	Potential for Phase I/11 initial study and compassionate use



 


Milestone 8 - Phase III Pivotal Clinical
Trial (complete 3 years after end of FDA specified follow-up period for patients enrolled) 


 


		·	Complete pivotal trial to demonstrate efficacy of whole heart transplantation



 


		·	Shortened clinical trial period to reflect potential for orphan status



 


Milestone 9 - PMA Approval (1 Year after
Milestone 8)


 


		·	File PMA submission with FDA



 








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