EX-10.8 14 d693633dex108.htm EX-10.8 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

 

LOGO

 

Page 1 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

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   

 

Page 2 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

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

 

Page 3 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

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

 

Page 4 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

Table 5.1: [***]

 

Page 5 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

Table 5.2 : [***]

 

Page 6 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

Table 2 [***]

 

Page 7 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

Table 5.3 : [***]

 

Page 8 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

Table 5.4: [***]

 

Page 9 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

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:  

 

Page 10 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

Page 11 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

Page 12 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

Page 13 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].


 

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

 

Page 14 of 14

Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].