Document:

Exhibit 10.35

  
 

  
ADDENDUM

  
TO

  
NON-EXCLUSIVE LICENSE AGREEMENT

  
 

  
THIS ADDENDUM TO NON-EXCLUSIVE LICENSE AGREEMENT (this "Addendum") is made and entered into as of the 16th day of March, 2009, by and between Baylor College of Medicine, a Texas nonprofit corporation, residing at One Baylor Plaza, Houston, Texas 77030 ("Baylor") and Medgenics, Inc., a corporation organized under the laws of the State of Delaware, having its principal place of business at Hanapach 12, Karmiel 20101, Israel, and its Affiliates (as defined in the 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 that certain 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 thereto (the "Agreement"); and

  
 

  
WHEREAS, pursuant to Section 3.4 of the Agreement, Medgenics agreed to provide Baylor certain materials and documentation generated by Medgenics or its contractors (the "Transferred Materials"), all subject to the consent and approval of third parties whose intellectual property or other rights may be involved in such Material; and

  
 

  
WHEREAS, Baylor now wishes to receive to its possession the Transferred Materials from Medgenics; and

  
 

  
WHEREAS, Medgenics and Baylor wish to supplement certain provisions of the Agreement for the purpose of clarifying that Medgenics has no and will have no liability of any kind to any person or entity in connection with supplying the Transferred Materials to Baylor, which will be in effect as of the date hereof;

  
 

  
NOW THEREFORE, the Parties hereby agree as follows:

  
 

  	
	
1.	
     Any capitalized term not specifically defined herein shall have the meaning ascribed to it in the Agreement.

  
 

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

  
 

  	
	
3.	
    The following paragraphs will be added to Section 13 of the Agreement:

  
"Medgenics has no and will have no liability of any kind to Baylor and to any third party in respect to the Transferred Materials and any other materials and documentation supplied to Baylor at its requests, including their use by Baylor or by third party. Medgenics makes no warranties or representations, express or implied, including, but not limited to, warranties of fitness or merchantability, regarding or with respect to the materials and documentations provided by it to Baylor under this Agreement (including pursuant to Section 3.4 above) and Medgenics makes no warranties or representations, express or implied, of the patentability of these materials and documentations or of the enforceability of any patents issuing thereupon, if any, or that they are or shall be free from infringement of any patent or other rights of third parties. Nothing in this Agreement shall be construed as conferring by implication, estoppel or otherwise any license or rights under any patents of Medgenics. Medgenics shall not be liable for any losses incurred as the result of an action for infringement brought against Baylor, its faculty members, scientists, researchers, employees, students, officers, trustees and agents as the result of their exercise of any right granted under this Agreement or use of the materials and documentations supplied by Medgenics. The decision to defend or not defend shall be in the Baylor's sole discretion.

  
 

  
Baylor agrees that it will defend, indemnify and hold Medgenics and its officers, directors, employees, agents and shareholders harmless (the "Medgenics Indemnified Parties"), from and against any and all claims, causes of action, lawsuits or other proceedings filed or otherwise instituted against any of the Medgenics Indemnified Parties related directly or indirectly to or arising out of the manufacture or use by Baylor of Transferred Materials and documentations or any person or entity accessing them through Baylor even though such claims and the costs (including, but not limited to, the payment of all reasonable attorneys' fees and costs of litigation or other defense) are based upon doctrines of strict liability or product liability; provided, however, that such indemnity shall not apply to any claims arising from the gross negligence or intentional misconduct of any Medgenics Indemnified Party. Baylor will also assume responsibility for all costs and expenses related to such claims for which it is obligated to indemnify the Medgenics Indemnified Parties pursuant to this Paragraph, including, but not limited to, the payment of all reasonable attorneys' fees and costs of litigation or other defense."

  
 

  
 

  

  
 

  	
	
4.	
Baylor further agrees and undertakes: (i) that the Transferred Materials are experimental in nature and have unknown characteristics; (ii) not to use the Transferred Materials in humans; and (iii) that the Transferred Materials are provided "as is" without any warranty or liability of any type.

  
 

  	
	
5.	
Except for the additions stated herein, all the terms of the Agreement shall remain valid and bind the parties without any change. In any case of a contradiction between the provisions of this Addendum and the provisions of the Agreement, the provisions of this Addendum shall prevail. Without limiting the generality of the foregoing, the term "Agreement" as used in the Agreement shall be deemed to be the Agreement as supplemented by this Addendum.

  
 

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

  
 

  	
  
Medgenics, Inc.

	
  
Baylor College of Medicine

	
  
 

	
  
 

	
  
/s/ Andrew Pearlman

	
  
/s/ Cyndi M. Baily

	
  
 

	
  
 

	
  
Name:  Andrew Pearlman

	
  
By:  Cyndi M. Baily

	
  
 

	
  
 

	
  
Title:  CEO

	
  
Title: Senior Vice President & General Counsel 

	
  
 

	
  
 

	
  
Date:  March 16, 2009

	
  
Date:  3/12/09Exhibit 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

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