Exhibit 10.36
 
SECOND AMENDMENT
TO
 
NON-EXCLUSIVE LICENSE AGREEMENT
 
THIS SECOND AMENDMENT TO NON-EXCLUSIVE LICENSE AGREEMENT (this "AMENDMENT") is
made and entered into as of the 19th day of December, 2013, by and between
Baylor College of Medicine, a Texas nonprofit corporation, residing at One
Baylor Plaza, Houston, Texas 77030 ("Baylor") and Medgenics Medical Israel LTD,
having its principal place of business at Misgav Business Park P.O. Box 14
Misgav 20179, Israel, and its Affiliates (as defined in the License Agreement)
(collectively, "Medgenics"). Baylor and Medgenics shall be collectively referred
to as "Parties" and separately as a "Party".
 
WITNESSETH:
 
WHEREAS, Medgenics and Baylor entered into and executed a Non-Exclusive License
Agreement dated January 25, 2007, under which Baylor granted Medgenics a
non-exclusive license to the Subject Technology (as defined therein), subject to
the terms and conditions set forth therein, as amended by the first Addendum
executed by the Parties on March 16, 2009 (collectively the "License
Agreement"); and
 
WHEREAS, Medgenics and Baylor entered into and executed the following Exchange
of Scientific Materials and Data Agreements (each, an "MTA" and collectively the
"MTA Agreements"):
 

1. MTA CAG-EPO and CMV-EPO, dated January 25th, 2006;

 

2. MTA CAG-codon optimized hINFalpha, dated April 6th, 2006;

 

3. MTA CAG-EPO, dated January 30th, 2007, as was amended under the Amendment to
the MTA dated May 2007;

 

4. MTA MAR-CAG-wt-hEPO, dated February 4th, 2007;

 

5. MTA Factor VIII gene, dated January 25th, 2010.

 

6. MTA dated October 27th, 2013.

 
WHEREAS, Medgenics and Baylor wish to amend certain provisions of the License
Agreement, to inter alia, extend the license rights, terms and conditions
granted under the License Agreement to also cover the Research Materials and
Combined Materials (as defined such terms are defined under the MTA Agreements)
provided by Baylor to Medgenics under the MTA Agreements without limitations on
research and commercial use thereof, all as set out herein;
 
NOW THEREFORE, the Parties hereby agree as follows:
 

I. Unless otherwise provided herein, any capitalized term not specifically
defined herein shall have the meaning ascribed to it in the License Agreement.

 

2. This Amendment is hereby made pursuant to Section 14.8 of the License
Agreement and will come into force and obligate all Parties hereto upon signing
of this Amendment by all of the Parties hereto.

 

3. Section 1.3 of the License Agreement shall be amended to read as follows:

 
"1.3 The term "Licensed Product" shall mean any product, process or service that
incorporates, utilizes or is made with the use of the Subject Technology or
Research Materials, including Combined Materials (as defined under the MTA
Agreements, Future MTA Agreements and License Agreements) provided by Baylor to
Medgenics under the MTA Agreements, Future MTA Agreements and License
Agreements.
 

4. The following new "Section 1.7" shall be added to the License Agreement:

 
The term "MTA Agreements" shall mean the following Exchange of Scientific
Materials and Data Agreements entered into between the parties: (a) MTA CAG-EPO
and CMV-EPO, dated January 25th, 2006; (b) MTA CAG-codon optimized hINFalpha,
dated April 6th, 2006; (c) MTA CAG-EPO, dated January 30th, 2007, as was amended
under the Amendment to the MTA dated May 2007; (d) MTA MAR-CAG-wt-hEPO, dated
February 4th, 2007; (e) MTA Factor VIII gene, dated January 25th, 2010"; and (f)
MTA Dated October 27th, 2013.
 
 

 

5. The following new "Section 1.8"shall be added to the License Agreement:

 
"1.8 The term "Future MTA Agreement" shall mean any future exchange of
scientific materials and data agreements between the parties which solely
specify the production of vectors or generation of Combined Materials using the
Subject Technology licensed hereunder, namely the Helper Dependent Adenovirus
pHDΔ28E4, Helper Virus AdNG163 and Producer Cell Line 116. For clarity,
improvements or alterations to these materials or in processes for using them
generated after the Agreement Date shall not be considered Subject Technology as
defined herein."
 

6. Section 2,1 of the License Agreement shall be amended to read as follows:

 
"Subject only to the limitations in Section 2.2 below and notwithstanding any
limitation set out in the MTA Agreements, Baylor hereby grants to Medgenics a:
(i) non-exclusive, worldwide, sublicensable license under the Subject Technology
to make, have made, use, have used, develop, manufacture, market, sell, have
sold, offer to sell, lease, license and import Licensed Products for ex-vivo
and/or in-vivo gene therapy ;and (ii) non-exclusive, worldwide, sublicensable
license under the Research Materials, including Combined Materials to make and
have made clinical grade Research Materials and Combined Materials for human use
in clinical trials by Medgenics. The Research Materials and Combined Materials,
provided by Baylor under the MTA Agreements and Future MTA Agreements are listed
in Appendix D attached hereto, as shall be updated by the parties, from time to
time, to include additional Research Materials and Combined Materials as may be
provided under Future MTA Agreements."
 

7. The list of Research Materials and Combined Materials, provided to date by
Baylor to Medgenics under the MTA Agreements and Future MTA Agreements attached
to this Amendment as Schedule A, is hereby attached to the License Agreement as
a new Appendix D, such list shall be updated by the parties, from time to time,
to include additional Research Materials and Combined Materials provided under
Future MTA Agreements.

 

8. Section 2.2(iii) of the License Agreement will be replaced in its entirety
with the following:

 
(iii) "the grant does not include the right to file patent applications claiming
the Helper Dependent Adenovirus pHDΔ28E4, Helper Virus AdNG163 and Producer Cell
Line 116, or uses thereof as developed and supplied by Baylor under the License
Agreement or under the MTA Agreements or any Future MTA Agreements, without
Baylor's prior written approval, to be granted at Baylor's discretion."
 

9. Section 3.10 of the License Agreement will be replaced in its entirety with
the following:

 
"The parties agree that the amounts indicated in this Section 3 constitute the
total consideration and payment due by Medgenics to Baylor for all rights
granted and materials provided under this Agreement and under MTA Agreements and
Future MTA Agreements, as in effect as of the date hereof. For clarity, except
as provided herein, no additional payment, royalty or consideration, is required
in connection with the License granted or the exploitation or commercial use of
any Subject Technology or Licensed Product. However, if Medgenics requests in
the future further work of Baylor, in the form of production of vectors or
generation of Combined Materials, such work shall be conducted under a Future
MTA Agreement and Baylor shall charge Medgenics the agreed upon cost of such
work. The forgoing notwithstanding, any such additional production of vectors or
generation of Combined Materials using the Subject Technology under Future MTA
Agreements shall be deemed Subject Technology and shall be licensed to Medgenics
in accordance with the terms hereof”.
 

10. Miscellaneous

 
10.1. It is hereby clarified that all other terms and conditions of the License
Agreement shall remain in full force and effect and without change.
 
10.2. In the event of any conflict between the provisions of the License
Agreement and the provisions of this Amendment, the latter shall govern and
prevail.
 
 

 
10.3. Each of the Parties hereto shall perform such further acts and execute
such further documents as may reasonably be necessary to carry out and give full
effect to the provisions of this Amendment and the intentions of the parties as
reflected thereby.
 
10.4. This Amendment may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument. This Amendment may also be executed and delivered by
facsimile signature and in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
 
10.5. Any term of this Amendment may be amended and the observance of any term
hereof may be waived (either prospectively or retroactively and either generally
or in a particular instance) only with the written consent of the parties
hereto. Any amendment or waiver affected in accordance with this section shall
be binding upon all parties hereto.
 
IN WITNESS WHEREOF, the Parties hereto have duly executed this Amendment as of
the date first above written.
 
Medgenics Medical Israel LTD
 
Baylor College of Medicine
 
 
 
/s/ Stephen Bellomo
 
/s/ Adam Kuspa
 
 
 
 
 
 
 
 
Name:
Stephen Bellomo
 
By:
Adam Kuspa
 
 
 
 
 
Title:
VP IP, Quality, Project Management
 
Title:
Sr. VP Research
 
 
 
 
 
Date:
December 19, 2013
 
Date: 
12/20/13