EXHIBIT 10.21


 


AMENDMENT TO NOVEL SURGERY AGREEMENT


 


This Amendment to Novel
Surgery Agreement (“Amendment”) is made, as of the last date set forth on the signature page below, between Harvard
Apparatus Regenerative Technology, Inc., a Delaware corporation having an office located at 84 October Hill Road, Holliston, Massachusetts
01746 Telephone: (508) 893-8999; Facsimile: (508) 892-6135 (“Manufacturer”), OSF Healthcare System, an Illinois not-for-profit
corporation, owner and operator of Saint Francis Medical Center and Children’s Hospital of Illinois (“Hospital”),
located at 530 N.E. Glen Oak Ave, Peoria, Illinois, 61637, and Mark Holterman, M.D., an employee of Hospital assigned to provide
professional services at Hospital (“Principal Surgeon”). Capitalized terms used but not otherwise defined herein shall
have the meanings ascribed to them in the Agreement (defined below).


 


WHEREAS, the Manufacturer,
Hospital and Principal Surgeon have entered into that certain Novel Surgery Agreement dated as of May 24, 2012 (the “Agreement”)
relating to the Surgery,


 


WHEREAS, the Agreement
contemplated the Manufacturer providing an In Breath® 3D Organ Bioreactor (the “Original Device”) in connection
with the Surgery;


 


WHEREAS, since the
date of the Agreement, the Manufacturer has developed and owns the rights to and manufactures a scaffold (the “Scaffold”)
that the Hospital and Principal Surgeon desire to use in connection with the Surgery;


 


WHEREAS, the FDA has
approved the use of the Scaffold in the Surgery and the Manufacturer has agreed to provide the Scaffold to the Hospital and Principal
Surgeon to use in connection with the Surgery;


 


WHEREAS, the parties
hereto desire to enter into this Amendment to amend the Agreement for the purpose of ensuring that the definition of Device in
the Agreement includes both the Original Device and the Scaffold;


 


NOW, THEREFORE, in
consideration of the premises and mutual promises and covenants expressed herein the parties agree as follows:


 


Section 1.         Amendment.
The Agreement is hereby amended as of the date hereof as follows:


 


(a)           Preamble.
The second WHEREAS clause in the Agreement is hereby amended and restated as follows:


 


“WHEREAS, the Clinical
Protocol contemplates the use of an In Breath® 3D Organ Bioreactor and a synthetic bioengineered scaffold (each individually
a “Device” and collectively the “Devices”) in connection with the Surgery, and Manufacturer owns the rights
to and manufactures the Devices;


 


(b)         References.
The initial reference in Section 4, and the references in Sections 5, 6, 7.2, 7.3, 13.1, to “Device” shall each refer
to “Devices”.


 




    	 



    	 



    

 


Section 2.        Miscellaneous.


 


(a)         This Amendment
may be executed in one or more counterparts, each of which when so executed and delivered shall be deemed to be an original and
all of which taken together shall constitute but one and the same agreement. Delivery of an executed counterpart of a signature
page to this Amendment by email or telecopier shall be effective as delivery of a manually executed counterpart of this Amendment.


 


(b)         Except as expressly
provided in this Amendment, the execution and delivery of this Amendment does not and will not amend, modify or supplement any
provision of, or constitute a consent to or a waiver of any noncompliance with the provisions of the Agreement, and, except as
specifically provided in this Amendment, the Agreement shall remain in full force and effect in accordance with the terms thereof.


 


[signatures on following page]


 




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EXHIBIT 10.21


 


IN WITNESS WHEREOF, Manufacturer, Hospital
and Principal Surgeon have caused this Amendment to be executed as of the date set forth below.


 


	HOSPITAL:	 	MANUFACTURER:
	 	 	 
	OSF Healthcare System, Saint Francis Medical	 	Harvard Apparatus Regenerative
	Center and Children’s Hospital of Illinois	 	Technology, Inc.


 


	Signature:	/s/ Keith Steffen	 	Signature:	/s/ Thomas McNaughton


 


	Printed Name:	Keith Steffen	 	Printed Name:	Thomas McNaughton


 


	Title:	CEO, Saint Francis Medical Center	 	Title:	CFO


 


	Date Signed:	April 4, 2013	 	Date signed:	April 5, 2013


 


	PRINCIPAL SURGEON:	 	 
	 	 	 
	Signature:	/s/ Mark J. Holterman	 	 
	 	 	 	 


 


	Printed Name:	Mark J. Holterman	 	 


 


	Title:	M.D.	 	 


 


	Date signed:	April 5, 2013