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
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 [***].
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics |
CONTENTS
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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 | |
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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 | |
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6. Signatories | | | 10 | |
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| 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 [***].
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Technical Agreement between Encap Drug Delivery and Vascular Biogenics |
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.
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| Contract Giver: | | Vascular Biogenics Ltd.,6 Jonathan Nethanyahu St. Or Yehuda, 60376 (Israel) |
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| Contract receiver | | Encap Drug Delivery, Oakbank Park, Livingston, UK EH53 0TH |
| 3. | PRODUCT REGULATORY REFERENCES |
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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 |
| 4.1 | 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).
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
Batch manufacturing documents are defined in Attachment 3
| 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).
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| 5.1 General and regulatory responsibilities | | see Table 5.1 |
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| 5.2 Product-related responsibilities | | see Table 5.2 |
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| 5.3 Validation, deviations, changes, complaints and recalls | | see Table 5.3 |
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| 5.4 Audit | | see Table 5.4 |
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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 |
Table 5.1: [***]
Page 5 of 14
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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 |
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| Vascular Biogenics | | | | Encap Drug Delivery |
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[Illegible] | | | | /s/ J Darling |
| Name: | | | | | | Name: | | J Darling |
| Title | | (Quality) | | | | Title: | | QA Manager / QP |
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| | | | 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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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
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| Vascular Biogenics | | | | Encap Drug Delivery |
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| Quality | | | | |
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/s/ Genya Mor | | | | /s/ J Darling |
| Name: | | Genya Mor | | | | Name: | | J Darling |
| Title | | Head of QA | | | | Title: | | QA Manager |
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| Production | | | | | | |
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/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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