EX-10.7 13 d693633dex107.htm EX-10.7 EX-10.7

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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

 

LOGO

 

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


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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

CONTENTS

 

1. Scope of agreement
2. Parties to agreement
3. Products
4. Quality standards
  4.1 Manufacturer’s Licence
  4.2 Compliance with GMP
  4.3 Product specifications
  4.5 Starting materials
  4.6 Batch Manufacture
  4.7 Storage and shipping
  4.8 Third party laboratory

 

5. Responsibilities
  5.1 General and regulatory responsibilities
  5.2 Product-related responsibilities
  5.3 Validation, deviations, changes, complaints and recalls
  5.4 Audit

 

6. Signatories

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

 

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


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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

 

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


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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 [***]

 

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      

 

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


Page 5 of 13

 

 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

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


Page 6 of 13

 

 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

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


Page 7 of 13

 

 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

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


Page 8 of 13

 

 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

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


Page 9 of 13

 

 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

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


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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: CEO     Title: (QP)
May 19, 2008     May 2, 2008
Date:     Date:

 

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


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Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

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


Page 12 of 13

 

 

Technical Agreement between Encap Drug Delivery and Vascular Biogenics

 

 

[***]

 

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


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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 Manager     Title: QA Manager
Production    
/s/ Naamit Sher     /s/ J. Savage
Name: Naamit Sher     Name: J Savage
Title: Drug Development VP     Title: Production Director

 

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