EX-10.7



 Exhibit 10.7 

TECHNICAL AGREEMENT ON THE 

MANUFACTURE OF CAPSULES 

CI-201 
 for 

VASCULAR BIOGENICS 
 Prepared by: W
Bowtle 
 ENCAP DRUG DELIVERY 
 Encap Ref: EN 0906
;Vascular Biogenics Tech Agreement 
 Revision : 03 
 Print
date: 29 April 2008 
  
 



 

  
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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
	  	 	5	  
	 5.2    Product-related responsibilities
	  	 	6	  
	 5.3    Validation, deviations, changes, complaints and recalls
	  	 	8	  
	 5.4    Audit
	  	 	9	  
		
	 6.      Signatories
	  	 	10	  
		
	 Attachments:
	  			
	 Attachment 1: Product manufacturing and technical release specifications
	  			
	 Attachment 2: Starting materials provided by Encap
	  			
	 Attachment 3: Manufacturing document references
	  			
	 Attachment 4: Contact Personnel
	  			


  
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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 CI-201
between Encap Drug Delivery and Vascular Biogenics Ltd (VBL) 
 Vascular Biogenics is investigating formulations of CI-201 for use in humans
and requires manufacture of bulk capsules for use in clinical trails. The new formulations for these products has 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. 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
 by
Vascular
 Biogenics
	  	 Country

	Capsules CI 201	  	(application in process)	  	Europe and / or USA/ and South America


  
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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, 2003) 
  

	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	Storage and shipping 

  

							
	4.6.1	  	Storage:	  	[***]
			
	4.6.2	  	Shipping:	  	[***]

  

	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: General and regulatory responsibilities 

 

					
	 ITEM
	  	 Responsibilities

	  	 Encap
	  	 Vascular Biogenics

	Organisation & Personnel	  	 •   Ensure personnel have appropriate training, skills, knowledge & experience to manufacture and test
Product
	  	 •   Confirm by audit

			
	Premises & equipment	  	 •   Provide properly designed, qualified & maintained premises, utilities & equipment
	  	 •   Confirm by audit

			
	Regulatory notifications	  	 •   Provide technical recommendations and information in support of Vascular Biogenics’s regulatory Variation
(s) (eg, formulation, process outline, test methods, specification limits)
	  	 •   Prepare and submit all product-specific documentation to regulatory
authorities
  
 •   Notify
Encap of intended country (ies) of use (Europe, USA, South America)
  

•   Provide copy of regulatory approval documents to Encap to support product release

 
 •   Provide Encap with
updated IMPD submissions and approvals, according to ongoing project progress
  

•   

			
	Marketing Authorisations (MA)	  	 n/a
	  	 •   Notify Encap of IMPD references and requirements arising from Variations

			
	Regulatory controls	  	 •   Meet Vascular Biogenics’s requirements on product regulatory controls
	  	 •   Notify Encap on regulatory controls in the specific market

			
	Use of Contract Analytical Laboratories (CAL)	  	 •   Approve Contract Analytical Laboratories (CAL)

 
 •   Notify Vascular Biogenics
of CALs prior to their use
	  	 •   Consent to the proposed use of CAL’s



  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 5.2 : Product-related responsibilities 

 

					
	 ITEM
	  	 Responsibilities

	  	 Encap
	  	 Vascular Biogenics

	Raw materials for process & packaging of Product	  	 •   Generate and approve internal specifications, according to initial advice
from Vascular Biogenics
  

•   Source, test & release starting materials of appropriate quality for processing of
Product, primary and second packaging components
  

•   Qualification of vendors

 
 •   Retain representative
samples
	  	 •   Notify Encap of the properties (chemistry, clinical, safety and handling) of
the active material
  

•   Provide initial specifications for Starting materials, packaging components & Product

 
 •   Confirmation of
compliance of materials supplied by Vascular Biogenics with TSE requirements.
  

•   Approve the API supplier and notify Encap of the approval

			
	Product specification	  	 •   Generate specifications for bulk products (includes test methods) according to Vascular Biogenics
requirements
	  	 •   Define Vascular Biogenics requirements on initial specification

 
 •   Definition of product
expiry date
  
 •   Agree
final specifications

			
	Production & process control	  	 •   Manufacture of Product to cGMP standards

 
 •   Designate lot numbers for
raw materials and Product
  

•   Establish in-process controls

 
 •   Generate and approve
Master Batch Instructions and Records for manufacture
	  	 •   Confirm by audit

 
 •   Agree in-process control
testing strategy
  

•   Regulatory pharmaceutics sections to be made available to Encap

			
	Laboratory controls	  	 •   Starting materials and bulk product release testing against
specification
  
 •   Operate
to cGMP standards
  

•   Retain representative samples of starting materials, packaging components and products,
according to the relevant specification
	  	 •   Confirm by audit

 
 •   Agree retention time of
samples

			
	Product storage, labelling and packaging prior to shipment	  	 •   Store, label and pack the bulk Product as defined in the Product Specification, for full testing and assembly
by third party nominated by the client
	  	 •   Confirm by audit

 
 •   Assembly of IMP by
Vascular Biogenics or third-party nominated by Vascular Biogenics



  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 2 (ctd) 
  

					
	 ITEM
	  	 Responsibilities

	  	 Encap
	  	 Vascular Biogenics

	Bulk Product Release (Investigative Medicinal product, IMP)	  	 •   Bulk product, for release to Vascular Biogenics, according to agreed specifications
	  	 •   Forward required batch-related documentation to VBL’s third-party
packaging contractor
  

•   Final technical release of bulk and assembled product, in compliance with the relevant
regulatory trial authorisation
  

•   Final release for use in clinic

			
	Shipment	  	 •   Notify Vascular Biogenics of proposed shipment date

 
 •   Ship Product to locations
designated by Vascular Biogenics under specified conditions
	  	 •   Acknowledge receipt

 
 •   Confirm by
audit

			
	Retention of records	  	 •   Retain all manufacturing and testing records including records associated
with the inspection and release of raw materials / starting materials and packaging components of the Product for (TBA) years
  

•   Notify Vascular Biogenics of intent to destroy records with option to return records to
Vascular Biogenics
	  	 •   Confirm by audit

 
 •   Vascular Biogenics to
approve destruction or return of records

			
	Stability testing	  	 •   (under separate agreement)
	  	 •   n/a

			
	Product Specification File (IMP)	  	 •   Generate and maintain internal file for product for trial in Europe
	  	 •   VBL to maintain main file



  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 5.3 : Validation, deviations, changes, complaints and recalls responsibilities 

 

					
	 ITEM
	  	 Responsibilities

	  	 Encap
	  	 Vascular Biogenics

	Validation	  	 •   Premises, utilities and equipment; cleaning procedures

 
 •   Process validation

 
 •   Analytical method
validation
	  	 •   Confirm by audit

			
	Significant deviations, out of specification reports	  	 •   Evaluate & define follow up actions & final approval of deviations,
non conforming material reports (NMCR’s) & failed manufacture reports
  

•   Notify Vascular Biogenics of all significant deviations and out of specification reports

 
 •   Provide VBL with formal
QA investigations reports.
	  	 •   Confirm by audit

			
	Change control procedures	  	 •   Proposed changes to be accompanied with rationale for change to Product
specific Process parameters, test methods, sampling plans, critical raw material specifications, process control Specifications, Product specifications, validation protocols, reports and key personnel

 
 •   Notify Vascular Biogenics
of significant changes to premises, equipment, utilities and senior technical staff
	  	 •   Confirm by audit

 
 •   Should Vascular Biogenics
propose changes, these will be subject discussion and agreement with Encap
  

•   Notify in writing if audit is required prior to start of next manufacturing run

			
	Complaints	  	 •   Provide support and responses to Vascular Biogenics
	  	 •   Receive complaint and co-ordinate relevant investigation and responses

 
 •   Notify Encap of
complaint

			
	Product recall	  	 •   Notify Vascular Biogenics of quality issues considered likely to require
recall
  
 •   Provide
support , implement relevant investigations and provide responses to Vascular Biogenics
	  	 •   Assess need for recall

 
 •   Co-ordinate recall

 
 •   Notification to Encap

 
 •   Notification to
regulatory authority



  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 Table 5.4: Audit responsibilities 

 

					
	 ITEM
	  	 Responsibilities

	  	 Encap
	  	 Vascular Biogenics

	Audit	  	 •   Accommodate up to one day annual audits and ‘for cause’ (to
address significant Product quality issues) audits by Vascular Biogenics at mutually agreed dates
  

•   Provide a timely response to observations reported by Vascular Biogenics

 
 •   Allow access to areas of
the manufacturing facility where the Product related activities are being performed
  

•   Allow Vascular Biogenics to observe operations related to Product manufacture and testing
provided other Vascular Biogenics confidentiality is respected
  

•   Allow Vascular Biogenics to review all documentation associated with manufacturing and testing
of Product
  
 •   Issue
corrective action follow-up report
  

•   Allow Vascular Biogenics to review all documentation associated with Process and analytical
validation
	  	 •   Provide reasonable notice of intention to audit

 
 •   Hold an exit meeting to
discuss observations
  

•   Provide an audit report

			
	Regulatory inspection	  	 •   Notify Vascular Biogenics of pending regulatory agency inspections affecting manufacture or testing of
Product
	  	 •   Comment on proposed regulatory responses to observations relevant to
Product
  
 •   Provide, on
Encap request, on-site representative and involvement in technical discussions



  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  


	6.	SIGNATURES 

  

									
	Vascular Biogenics	 		 	Encap Drug Delivery
			
	 /s/ Naamit Sher
	 		 	 /s/ J. Darling

	Name:	 	Naamit Sher	 		 	Name:	 	J Darling
	Title	 	(Quality)	 		 	Title:	 	QA Manager
			
	 May 19, 2008
	 		 	 May 5, 2008

	Date:	 		 		 	Date:
			
	 /s/ Dror Harats
	 		 	 /s/ W. Bowtle

	Name:	 	Dror Harats	 		 	Name:	 	W Bowtle
	Title:	 	Title	 		 	Title:	 	(QP)
			
	 May 19, 2008
	 		 	 May 2, 2008

	Date:	 		 		 	Date:


  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 ATTACHMENT 1 

Listing of agreed capsule specifications 
  

					
	 PRODUCT
	  	 STRENGTH (mg)
	  	 REFERENCE

	[***]	  	[***]	  	[***]


  
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 


  

 ATTACHMENT 2 

STARTING MATERIALS 
  

	1.	STARTING MATERIALS PROVIDED BY CLIENT* 

  

							
	 Encap raw
 material

reference
	  	 Raw material title
	  	 Function
	  	 Compliance

	[***]	  	[***]	  	[***]	  	[***]

 [***] 
  

	2.	STARTING MATERIALS PROVIDED BY ENCAP* 

  

							
	 Raw material

reference
	  	 Raw material title
	  	Function	  	Compliance
	[***]	  	[***]	  	[***]	  	[***]

 [***] 

  
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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: QA Manageer	  	Title: QA Manager
		
	Production	  	
		
	 /s/ Naamit Sher
	  	 /s/ J. Savage

	Name: Naamit Sher	  	Name: J Savage
	Title: Drug Development VP	  	Title: Production Director


  
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