Document:

Exhibit
10.27(iii)

      

       

      THIRD
AMENDMENT TO STANDSTILL AND OPTION AGREEMENT

       

      This
THIRD AMENDMENT TO STANDSTILL AND OPTION AGREEMENT (this “Third Amendment”) effective
this 20th day of October, 2010 (the “Effective Date”), is
made and entered into by and among Baxter Healthcare Corporation, a Delaware
Corporation with a place of business at One Baxter Parkway, Deerfield, IL 60015
(“BHC”), Baxter Healthcare S.A.,
a corporation organized under the laws of Switzerland with a place of business
at Thurgauerstrasse 130, 8152 Glattpark (Opfikon) Switzerland (“BHSA”), Baxter
Innovations GmbH, a corporation organized under the laws of Austria with a place
of business at Industriestrasse 67, 1221 Vienna, Austria (“Innovations” and, together with BHC
and BHSA, “Baxter”) and Medgenics, Inc., a Delaware corporation with a place of
business at Teradion Business Park, P.O. Box 14, Misgav 20179 Israel (“Medgenics”). Baxter
and Medgenics are each sometimes referred to herein as a “Party” and,
collectively, as the “Parties”.

       

      BACKGROUND

       

      WHEREAS,
Baxter and Medgenics entered into that certain Standstill and Option Agreement
dated October 22, 2009 as amended by that certain First Amendment to Standstill
and Option Agreement dated October 22, 2009, and further amended by that certain
Second Amendment to Standstill and Option Agreement dated December 29, 2009 (as
amended, the “Agreement”) pursuant
to which inter alia
Baxter agreed to fund certain research and development activities to be
conducted by Medgenics relating to the application of Medgenics' Biopump
Technology to produce human Factor VIII (hFVIII) protein; and

       

      WHEREAS,
the Parties wish to extend the Standstill Period for an additional six (6)
months pursuant to Section 2.b. of the Agreement without any further Development
Funding (as such term is defined in the Agreement) to be paid by Baxter to
Medgenics during such extension.

       

      NOW,
THEREFORE, in consideration of the foregoing and such other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:

       

      AGREEMENT

       

      1.      Incorporation of the
Agreement. All capitalized terms which are not defined herein shall have
the same meanings as set forth in the Agreement, and the Agreement, to the
extent not inconsistent with this Third Amendment, is incorporated herein by
this reference as though the same was set forth in its entirety. To the extent
any terms and provisions of the Agreement are inconsistent with the amendments
set forth in Paragraph 2 below, such terms and provisions shall be deemed
superseded hereby. Except as specifically set forth herein, the Agreement shall
remain in full force and effect and its provisions shall be binding on the
Parties hereto.

       

      2.      Amendment of the
Agreement. The Agreement is hereby amended as follows:

       

      
        	
                 
      

              	
                a.

              	
                Baxter
      and Medgenics hereby agree to extend the Standstill Period for an
      additional six (6) months, as set forth in Section 2.b. of the Agreement,
      from October 22, 2010 through April 21, 2011 (the “Extended Standstill
      Period”). The Parties further agree that Baxter (a) has no liability to
      Medgenics and does not owe Medgenics for any amount of Development Funding
      prior to the Extended Standstill Period, and (b) will not be responsible
      for any Development Funding or any other amounts under the Agreement
      during the Extended Standstill
Period.

              

      

       

      
        	
                 
      

              	
                b.

              	
                Section 3.a. is
      hereby amended by deleting the last sentence of such Section 3.a. in
      its entirety and replacing it with the following
  sentence:

              

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      “Baxter
shall not be responsible for any additional payments (including but not limited
to Development Funding).”

       

      
        	
                 
      

              	
                c.

              	
                Section 3.d. is
      hereby amended by deleting the section in its entirety and replacing it
      with the following language:

              

      

       

      
        
          	
                	
                  “d.

                	
                  If
      and when Medgenics achieves the target in vitro performance milestone as
      set forth in the Development Plan (the “In Vitro
      Milestone”), Medgenics shall deliver written notice to Baxter of
      such achievement. If and when Medgenics achieves the target animal
      performance milestone as set forth in the Development Plan (the “Animal
      Milestone”), Medgenics shall deliver written notice to Baxter of
      such achievement.”

                

        

      

       

      
        	
                3.

              	
                Effectuation. The amendment to
      the Agreement contemplated by this Third Amendment shall be deemed
      effective as of the date first written above upon the full execution of
      this Third Amendment and without any further action required by the
      Parties hereto. There are no conditions precedent or subsequent to the
      effectiveness of this Third
Amendment.

              

      

       

      
        	
                4.

              	
                Counterparts.
      This Third Amendment may be executed in two or more counterparts, each of
      which shall be deemed to be an original, but all of which together shall
      constitute one and the same instrument. One or more counterparts of this
      Third Amendment may be delivered by facsimile, with the intention that
      delivery by such means shall have the same effect as delivery of an
      original counterpart thereof.

              

      

       

      [Signature
Page Follows]

      
        
           

        

        
           

          
            

          

        

        
           

        

      

       

      [Signature Page to Third
Amendment]

       

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

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                
                                                  
                                                    
                                                      
                                                        
                                                          
                                                            
                                                              
                                                                
                                                                  
                                                                    
                                                                      
                                                                        
                                                                          	
                                                                                  BAXTER
      HEALTHCARE CORPORATION

                                                                                	 
      	
                                                                                  MEDGENICS,
      INC.

                                                                                
	 
      	 
      	 
      	 
      	 
      
	By:	
                                                                                  /s/ L.
      Handon

                                                                                	 
      	
                                                                                  By:

                                                                                	
                                                                                  
                                                                                    /s/ Andrew L.
      Pearlman

                                                                                  

                                                                                
	Name:	
                                                                                  L.
      Handon

                                                                                	 
      	
                                                                                  Name:

                                                                                	
                                                                                  Andrew L.
      Pearlman

                                                                                
	Title:	
                                                                                  CVP,
      President Bioscience

                                                                                	 
      	
                                                                                  Title:

                                                                                	
                                                                                  CEO

                                                                                
	 
      	 
      	 
      	 
      	 
      
	
                                                                                  BAXTER
      HEALTHCARE S.A.

                                                                                	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                                                                  By:

                                                                                	
                                                                                  /s/ Ignacio Martinez de
      Lecea

                                                                                	 
      	 
      	 
      
	
                                                                                  Name:

                                                                                	
                                                                                  Ignacio Martinez de
      Lecea

                                                                                	 
      	 
      	 
      
	
                                                                                  Title:

                                                                                	
                                                                                  Sr. Counsel
      ECEMEA

                                                                                	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	By:	/s/
      Sarah Byrne-Quinn	 	 	 
	Name:	Sarah
      Byrne-Quinn	 	 	 
	Title:	VP
      Business Development & Strategy	 	 	 
	 	 	 	 	 
	
                                                                                  BAXTER
      INNOVATIONS GmbH

                                                                                	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                                                                  By:

                                                                                	
                                                                                  
                                                                                    /s/ Hartmut J. Ehrlich,
      M.D.

                                                                                  

                                                                                	 
      	 
      	 
      
	
                                                                                  Name:

                                                                                	
                                                                                  
                                                                                    Hartmut J. Ehrlich,
      M.D.

                                                                                  

                                                                                	 
      	 
      	 
      
	
                                                                                  Title:

                                                                                	
                                                                                  
                                                                                    VP, Global R&D, Baxter
      BioScience

                                                                                    Managing Director, Baxter
      Innovations GmbH

                                                                                    Member of the Board of
      Directors, Baxter AG 

                                                                                    15/11/10

                                                                                  

                                                                                	 
      	 
      	 
      
	 	 	 	 	 
	
                                                                                  By:

                                                                                	
                                                                                  
                                                                                    /s/
      Friedrich Schelflinger, Ph.D.

                                                                                  

                                                                                	 	 	 
	
                                                                                  Name:

                                                                                	
                                                                                  
                                                                                    Friedrich
      Schelflinger, Ph.D.

                                                                                  

                                                                                	 	 	 
	
                                                                                  Title:

                                                                                	
                                                                                  
                                                                                    Vice
      President

                                                                                    TA
      Hemophilia/Hematology

                                                                                    Baxter
      Innovations GmbH 

                                                                                    15/11/10Exhibit
10.51

    

     

    EXCHANGE
OF SCIENTIFIC MATERIALS AND DATA

    AGREEMENT

    (Materials
Are
Not
for Use in Human Subjects)

     

    Whereas,
Baylor College of Medicine (“BCM”) located at One Baylor Plaza, Houston, Texas
77030 and Medgenics,
Inc. (“Medgenics”),
located at Teradion Business Park, P.O. Box 14, Misgav 20179, Israel,
enter into this Agreement for the conduct of the research project entitled
“Helper Dependent Adenoviral Vectors (HDAd) for use in Biopump”
(“ResearchProject”). BCM and Medgenics shall together be referred to as the
“Parties” throughoutthis Agreement. The Parties agree as
follows:

     

    The
capitalized terms as used herein are defined as follows: 

    “Research Materials” means all
materials used in the carrying out of the Research Project including those
provided by Medgenics, i.e., the plasmid constructs, expression cassettes
including the Factor VIIII gene, and shall not include biopumps or other
Medgenics technology not provided to BCM by Medgenics in connection with the
Research Project. Likewise, Research Materials shall comprise those used by BCM
including the BCM HDAd vector (“BCM Materials”). Research Materials shall also
mean “Combined Materials” which are HDAd Factor VIII, and any sample fluids
derived therefrom by BCM during preparation of the Combined Materials and
transferred to Medgenics.

     

    “Invention”
means any invention or discovery patentable or not arising out of the
Research Project. Notwithstanding, the Combined Materials are not an
Invention.

     

    The
Parties shall exercise reasonable efforts to carry out the activities described
in the work scope provided for in Exhibit 1, which is hereby incorporated into
this Agreement by reference. The Principal Investigator for BCM shall be Philip
Ng, PhD (“BCM Principal Investigator”). The Principal Investigator for Medgenics
shall be Baruch Stern, PhD (“Medgenics Principal
Investigator”).

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    BCM shall
provide specifications for the preparation of research grade plasmids containing
the expression constructs for Factor VIII to Medgenics. Medgenics shall prepare
(or have prepared) the plasmids according to the specifications and transfer the
plasmids to BCM. BCM shall insert Factor VIII expression constructs from the
plasmids into appropriate BCM HDAd vectors and verify the identity and titer of
the HDAd–Factor VIII (the “Combined Materials”). BCM shall transfer the Combined
Material and verification information to Medgenics as provided for in the work
scope.

     

    All
Research Materials, including the Combined Material, and unmodified derivatives
thereof will be used only for internal research purposes involved in the
Research Project. Any and all other studies or uses by the Party that does not
own such Research Material are expressly prohibited, including isolating
contaminating helper virus or any other materials from the Combined Material and
the making of any Derivatives, other than as reasonably necessary to perform the
work described in Exhibit 1. “Derivatives” is defined as any
material derived from the Research Materials, including any progeny, any mutant
or other variant thereof (including any genetically engineered variant), any
portion of any such biological, sample, progeny, mutant or variant (such as an
expression product, protein or nucleic acid). It further means any material
derived therefrom (including by chemical modification or physical alteration or
combination), any copy of such nucleic acid or composition, any cell containing
such material, derivative or copy, and any portion of any such cell, as well as
any material derived from any of these. The Research Materials and the Combined
Materials are only to be used in animals and are not to be used, implanted in
humans or used to treat humans. For sake of clarity, Medgenics’s use of the
Research Materials it is providing, or its biopump or other technology, is not
limited by this Agreement.

     

    The
Research Materials will only be used under suitable containment conditions. The
Parties agree to comply with all local, state, and federal laws, rules, and
regulations applicable to the Research Project and the handling of the Research
Material, including, but not
limited to, laws governing the use of hazardous or radioactive materials,
protecting the environment, and the care of laboratory animals.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    Medgenics
shall obtain an executed informed consent form for each patient from whom tissue
is obtained for use in the Research Project in a form that complies with all
applicable local and national governmental laws, rules and regulations, and
guidelines.

     

    Medgenics
shall obtain written approval of the protocol establishing the procedure for
obtaining the tissue samples for use in the Research Project from a properly
constituted Institutional Review Board / Ethics Committee prior to the
commencement of the Research Project.

     

    Medgenics
shall perform the Research Project, and all related work, in conformance with
generally accepted standards of good clinical practice, the related protocol and
all applicable local and national governmental laws, regulations, and guidelines
governing the performance of clinical investigations.

     

    The
Parties agree to treat in confidence for a period of three (3) years from the
date of its disclosure by the other party any and all information about the
Research Project and the Research Materials, except for information that was
previously known to the Parties, or is publicly available, or is disclosed after
the date of this Agreement to either party by a third party without breach of an
obligation of confidentiality, or is required to be disclosed due a government
or court request.

     

    Both
Parties may publish/present the results of the Research Project, provided that
such publication/presentation does not violate the obligations of
confidentiality set forth herein, and the Parties agree to acknowledge the other
Party as the source of Research Material and attribute the contributions of each
Party as is scientifically appropriate. Further, Medgenics is to include the
following citations in any abstracts, publications or presentations: Palmer and
Ng, 2003 Mol Ther 8:846; Palmer and Ng, 2004 Mol Ther 10:792. Medgenics shall
also include the following in the acknowledgement section of all public
disclosures regarding the Research Project: “HDAd produced and provided by Dr.
Philip Ng of Baylor College of Medicine.” Further, BCM is to include in any
resulting publications that the Dermal Biopump is the property of
Medgenics.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    The
Research Materials are proprietary to the providing Party. The Parties agree to
retain control over the Research Materials and not to transfer it to third
parties. Third party requests shall be directed to the appropriate providing
Party.

     

    This
Agreement is not to be construed as an assignment or license of either of the
Parties’ interest in the Research Materials or other proprietary rights. BCM
retains the unrestricted right to distribute the BCM HDAd to other commercial or
noncommercial entities. This Agreement in no way alters any rights the U.S.
Government may have in the Research Materials. The Parties agree to promptly
disclose to the other parties all Inventions made through the use of the
Research Materials and each grants to the other a non-exclusive license to use
the same for non-commercial research, educational and patient care
purposes.

     

    The
Parties agree that all profit-making or commercial use of any Invention,
product, or process derived from the Research Materials shall be subject to that
certain Non-Exclusive License Agreement dated January 25, 2007 by and between
the Parties.

     

    All
Research Materials are provided as a service to the Research Community. THEY ARE BEING
SUPPLIED BY THE PARTIES WITH NO WARRANTIES, EXPRESSEDOR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY OR FITNESS.

    The
Parties make no representations that the use of the Research Materials will not
infringe any patent or proprietary rights of third parties. The Parties accept
the Research Material with the knowledge and understanding that the hazardous
and toxicological properties of the Research Materials have not been completely
investigated and are unknown and that the Research Material should be handled as
if it is hazardous until its properties are fully investigated.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    In return
for the performance of BCM’s activities hereunder, Medgenics will pay to Baylor
College of Medicine ten thousand dollars ($10,000 US) for each Combined
Material, and an additional fifty three point five percent (53.5%) in indirect
costs, for a total amount of fifteen thousand three hundred and fifty dollars
($15,350 US) for each Combined Material as described in Exhibit 1, as full
compensation for same under this Agreement. For each such Combined Material as
specified in Exhibit 1, fifty percent (50%) of the respective amount shall be
paid within 10 days from execution of this agreement; and fifty percent (50%)
shall be paid within 10 days from delivery of each Combined Materials. Checks
should be made payable to “Baylor College of Medicine BCM tax
ID number: ###-##-####” and directed to the shipping address provided in
this document for Dr. Philip Ng.

     

    Medgenics
is responsible for any and all costs associated with any shipping and handling
of the Research Materials and shall provide courier information directly to the
BCM Principal Investigator prior to any shipping. Medgenics agrees to provide,
in completed format, all related export or customs forms regarding shipping or
such information as required to complete them if by law or custom BCM is
required to complete them.

     

    To the
extent allowed by law, each party will indemnify and hold the other party, and
its trustees, officers, agents, employees, students, persons holding academic
appointments with the other party, and the Parties’ affiliated hospitals and
institutions (the “Indemnified Parties”) harmless from and against any and all
claims or lawsuits for personal injury (including death), property damage, and
any other losses of any nature, together with related expenses (including
reasonable attorneys’ fees) made against the Indemnified Parties resulting
directly or indirectly from the use or possession of the Research Materials by
the other party as required by this Research Project or any subsequent research,
clinical use, or application of the results of the Research Project, except for
gross negligence or willful misconduct.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    In no
event shall either party or such Parties’ trustees, officers, agents and
employees be liable for any use by the other party of any Invention, results of
the Research Project, or for any claim, liability, cost, expense, damage,
deficiency, loss or obligation, of any kind or nature (including, without
limitation, reasonable attorneys’ fees and other costs and expenses of defense),
that may arise from or in connection with this Agreement or the use, handling,
storage, or disposition of an Invention or the Research Materials by the other
party, or others who possess the Research Materials through a chain of
possession leading back, directly or indirectly, to the other party
(collectively, “Claims”). The Parties agree to indemnify, defend and hold
harmless the other Party and its respective trustees, officers, agents, and
employees from any and all Claims. The Parties shall have no obligation to
indemnify, defend or hold harmless a party identified in the foregoing sentence
if it is determined with finality by a court of competent jurisdiction that the
relevant Claim resulted solely from such party’s own negligence or willful
misconduct. This paragraph shall survive termination of the
Agreement.

     

    The term
of this Agreement shall commence on the last day of the signing of this
Agreement
and shall continue for a period of 18 months.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    Approved:
Agreed to this 25 day of January, 2010.

    

    
      
        
          
            	
                    BAYLOR
      COLLEGE OF MEDICINE

                  	 
      	
                    MEDGENICS

                  
	 
      	 
      	 
      
	
                    AUTHORIZED
      SIGNATORY:

                  	 
      	
                    AUTHORIZED
      SIGNATORY:

                  
	 
      	 
      	 
      
	
                    /s/
      Helen Shepherd

                  	 
      	
                    /s/
      Stephen Bellomo

                  
	
                    Helen
      Shepherd

                  	 
      	
                    Signature
      of Recipient Official

                  
	      
                    Executive
      Director, Office of Research

                  	 
      	 
      
	
                          
                       

                    

                  	 
      	
                    Stephen
      Bellomo

                  
	 
      	 
      	
                    Typed
      Name

                  
	 	 	 
	 
      	 
      	
                    COO

                  
	 
      	 
      	
                    Title

                  
	 	 	 
	
                    1/25/10

                  	 
      	
                    January
      26, 2010

                  
	
                    Date

                  	 
      	
                    Date

                  
	 
      	 
      	 
      
	/s/
      Philip Ng	 
      	/s/
      Baruch Stern
	
                    BCM
      Laboratory Director

                  	 
      	
                    Medgenics
      Principal Investigator

                  
	
                    Philip
      Ng, Ph.D.

                  	 
      	
                    Baruch
      Stern, Ph.D.

                  

          

        

      

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	
              BCM
      Shipping Address

            	
              Medgenics
      Shipping Address

            
	 
      	 
      
	
              Philip
      Ng, Ph.D.

            	
              Baruch
      Stern, Ph.D.

            
	
              Assistant
      Professor

            	
              Medgenics,
      Inc.

            
	
              Department
      of Molecular and Human Genetics

            	
              Misgav
      Business Park

            
	
              Baylor
      College of Medicine

            	
              P.O.
      Box 14

            
	
              One
      Baylor Plaza, T619

            	
              Misgav
      20179 

            
	
              Houston,
      TX 77030

            	Israel

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    EXHIBIT
1

    BCM
Activities

    For each
of the Factor VIII constructs provided by Medgenics:

    1.  Dr.
Ng’s group will produce an HDAd bearing the Factor VIII expression cassette and
provide approximately 3x1012
viral particles in approximately 3 months. If it becomes possible to provide
them significantly sooner than 3 months BCM will endeavor to do so.

    2.  Dr.
Ng’s group will verify the identity of the HDAd bearing the Factor VIII
expression cassette by ethidum bromide staining following restriction enzyme
digestion and agarose gel electrophoresis.

    3.  Dr.
Ng’s group will determine physical titer (viral particles per milliliter) of the
HDAd bearing the Factor VIII expression cassette by absorbance at 260
nm.

     

    Methodolgy
employed by Dr. Ng’s group will follow that of “Palmer and Ng, 2003 Mol Ther
8:846” which typically yields a helper virus contamination of 0.02%. Medgenics
agrees that it will be responsible for any such testing beyond that undertaken
in 3. above to confirm such levels.

     

    Medgenics
Activities

    1.  Medgenics
will provide 3 constructs containing Factor VIII gene as listed
below:

     

    1.      HDAd-CAG-wtFVIII

    2.      HDAd-CAG-optFVIII

    3.      HDAd-CAG-MAR-optFVIII

     

    2.  Medgenics
will use HDAd with the Factor VIII constructs, to transduce human dermal micro
organs to test for sustained high level Factor VIII secretion from Biopumps both
in vitro and in mice models.

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