TECHNICAL AGREEMENT ON THE MANUFACTURE OF CAPSULES for VASCULAR BIOGENICS

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

Page 1 of 13

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			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

Page 2 of 13

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 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 ▇▇▇▇▇▇▇▇ Nethanyahu St.
		Or ▇▇▇▇▇▇, 60376 (Israel)

Contract receiver		Encap Drug Delivery, ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇ ▇▇▇

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

Page 3 of 13

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, 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

Page 4 of 13

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: General and regulatory responsibilities


ITEM	Responsibilities
ITEM	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

Page 5 of 13

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 : Product-related responsibilities


ITEM	Responsibilities
ITEM	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

Page 6 of 13

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 (ctd)


ITEM	Responsibilities
ITEM	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

Page 7 of 13

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 : Validation, deviations, changes, complaints and recalls responsibilities


ITEM	Responsibilities
ITEM	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

Page 8 of 13

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: Audit responsibilities


ITEM	Responsibilities
ITEM	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

Page 9 of 13

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

/s/ ▇▇▇▇▇▇ ▇▇▇▇		/s/ ▇. ▇▇▇▇▇▇▇
Name:	▇▇▇▇▇▇ ▇▇▇▇	Name:	J Darling
Title	(Quality)	Title:	QA Manager

May 19, 2008		May 5, 2008
Date:		Date:

/s/ ▇▇▇▇ ▇▇▇▇▇▇		/s/ W. Bowtle
Name:	▇▇▇▇ ▇▇▇▇▇▇	Name:	W Bowtle
Title:	Title	Title:	(QP)

May 19, 2008		May 2, 2008
Date:		Date:

Page 10 of 13

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 1

Listing of agreed capsule specifications


PRODUCT	STRENGTH (mg)	REFERENCE
[***]	[***]	[***]

Page 11 of 13

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 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

[***]

Page 12 of 13

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/ ▇▇▇▇▇ Mor		/s/ ▇. ▇▇▇▇▇▇▇
Name: ▇▇▇▇▇ Mor		Name: J Darling
Title: QA Manageer		Title: QA Manager

Production

/s/ ▇▇▇▇▇▇ ▇▇▇▇		/s/ ▇. ▇▇▇▇▇▇
Name: ▇▇▇▇▇▇ ▇▇▇▇		Name: J Savage
Title: Drug Development VP		Title: Production Director

Page 13 of 13

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 ON THE MANUFACTURE OF CAPSULES for VASCULAR BIOGENICS

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