EX-10.8



 Exhibit 10.8 

TECHNICAL AGREEMENT ON THE 

MANUFACTURE OF CAPSULES 

VB-201 
 for 

VASCULAR BIOGENICS 
 Prepared by: J
McLachlan 
 ENCAP DRUG DELIVERY 
 Encap Ref:
EN1378;Vascular Biogenics Technical Agreement 
 Revision : 03 

Print date: 03 Aug 2012 
  
 



 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 CONTENTS 
  

					
	 1.      Scope of agreement
	  	 	3	  
	 2.      Parties to agreement
	  	 	3	  
	 3.      Products
	  	 	3	  
	 4.      Quality standards
	  	 	4	  
	 4.1    Manufacturer’s Licence
	  	 	4	  
	 4.2    Compliance with GMP
	  	 	4	  
	 4.3    Product specifications
	  	 	4	  
	 4.5    Starting materials
	  	 	4	  
	 4.6    Batch Manufacture
	  	 	4	  
	 4.7    Storage and shipping
	  	 	4	  
	 4.8    Third party laboratory
	  	 	4	  
		
	 5.      Responsibilities
	  	 	4	  
	 5.1    General and regulatory responsibilities
	  	 	4	  
	 5.2    Product-related responsibilities
	  	 	4	  
	 5.3    Validation, deviations, changes, complaints and recalls
	  	 	4	  
	 5.4    Audit
	  	 	4	  
		
	 6.      Signatories
	  	 	10	  
		
	Attachments:	  			
	 Attachment 1: Product manufacturing and technical release specifications
	  	 	11	  
	 Attachment 2: Starting materials provided by Encap
	  	 	12	  
	 Attachment 3: Manufacturing document references
	  	 	13	  
	 Attachment 4: Contact Personnel
	  	 	14	  


  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  


	1.	SCOPE OF AGREEMENT 

 This Technical Agreement is made in support of Capsules VB-201 (also
known as CI-201) between Encap Drug Delivery and Vascular Biogenics Ltd (VBL) and is subject to the Proposals and Standard Terms and Conditions executed between the parties in advance of each project related manufacture. 

Vascular Biogenics is investigating formulations of VB-201 for use in humans and requires manufacture of bulk capsules for use in clinical
trials. The new formulations for these products have been identified from project work at Encap on behalf of VBL. 
 This agreement details
the technical terms under which the contract will operate. It defines the products, quality standards, identifies the responsibilities of each party and defines supporting documentation. It identifies contacts for quality issues The document is
drawn up in accordance with Encap’s Standard Operating Procedure 0063 on generating a technical agreement for standard manufacture of licensed products (SOP 0063). 

Encap and VBL may, from time to time, agree Addenda to this agreement in writing. The Addenda will apply for particular supplies (strengths and
numbers) and will apply the Quality Standards and responsibilities described in this Technical Agreement. Such Addenda may also provide for related new strengths, as may be agreed from time to time. 

 

	2.	PARTIES TO AGREEMENT 

  

			
	Contract Giver:	  	Vascular Biogenics Ltd.,6 Jonathan Nethanyahu St. Or Yehuda, 60376 (Israel)
		
	Contract receiver	  	Encap Drug Delivery, Oakbank Park, Livingston, UK EH53 0TH


  

	3.	PRODUCT REGULATORY REFERENCES 

  

					
	 Product
	  	 Investigative Medicinal Product Authorisations
held
byVascular Biogenics
	  	 Country

	Capsules VB-201	  	Individual references client responsibility.	  	Europe and/or USA



  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  


	4.	QUALITY STANDARDS 

  

	4.1	Manufacturer’s Licence 

 MW Encap Ltd, trading as Encap Drug Delivery, holds a
Manufacturer’s Licence from the MHRA (UK) for the manufacture of Investigative Medicinal Products (IMP’s ) (reference MAIMP/13485). 
  

	4.2	Compliance with GMP 

 Batches will be manufactured and assembled to comply with all
current European rules regarding Good Manufacturing Practices (EudraLex, Volume 4, 1997 and 21CFR parts 210 and 211). 
  

	4.3	Product specifications 

 Specifications for finished products are listed in (Attachment
1). Responsibilities for testing and release are defined in Table 5.2 
  

	4.4	Starting materials and packaging components 

 Specifications for starting materials are
listed in (Attachment 2). Responsibilities for sourcing and approval are defined in Table 5.2 
  

	4.5	Batch Manufacture 

 Batch manufacturing documents are defined in Attachment 3 

 

	4.6	[***] 

  

	4.7	Sampling and sample retention 

 Sampling and sample retention of starting materials and
product will be done according to standard Encap procedures 
  

	4.8	Third party laboratory 

 (not applicable). 

 

	5.	RESPONSIBILITIES  

  

			
	5.1 General and regulatory responsibilities	  	see Table 5.1
		
	5.2 Product-related responsibilities	  	see Table 5.2
		
	5.3 Validation, deviations, changes, complaints and recalls	  	see Table 5.3
		
	5.4 Audit	  	see Table 5.4


  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 5.1: [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 5.2 : [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 2 [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 5.3 : [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 5.4: [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  


	6.	SIGNATURES 

  

									
	Vascular Biogenics	 		 	Encap Drug Delivery
			
	 [Illegible]
	 		 	 /s/ J Darling

	Name:	 		 		 	Name:	 	J Darling
	Title	 	(Quality)	 		 	Title:	 	QA Manager / QP
			
	  
	 		 	 August 6, 2012

	Date:	 		 		 	Date:	 	


  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 [***] 

  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 ATTACHMENT 4 

Contact Personnel 
  

									
	Vascular Biogenics	 		 	Encap Drug Delivery
			
	Quality	 		 	
			
	 /s/ Genya Mor
	 		 	 /s/ J Darling

	Name:	 	Genya Mor	 		 	Name:	 	J Darling
	Title	 	Head of QA	 		 	Title:	 	QA Manager
				
	Production	 		 		 	
			
	 /s/ Naamit Sher
	 		 	 /s/ J Savage

	Name:	 	Dr. Naamit Sher	 		 	Name:	 	J Savage
	Title	 	VP RA & Drug Development	 		 	Title:	 	Production Director


  
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