TECHNICAL AGREEMENT ON THE MANUFACTURE OF CAPSULES for VASCULAR BIOGENICS
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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
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
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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
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| 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., 0 Xxxxxxxx Xxxxxxxxxx Xx. Xx Xxxxxx, 00000 (Israel) | |||
| Contract receiver | Encap Drug Delivery, Xxxxxxx Xxxx, Xxxxxxxxxx, XX XX00 0XX |
| 3. | PRODUCT REGULATORY REFERENCES |
| Product |
Investigative Medicinal Product Authorisations |
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
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| 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 [***].
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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
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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
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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
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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
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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
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| 6. | SIGNATURES |
| Vascular Biogenics | Encap Drug Delivery | |||
| /s/ Xxxxxx Xxxx | /s/ X. Xxxxxxx | |||
| Name: Xxxxxx Xxxx | Name: J Darling | |||
| Title: (Quality) | Title: QA Manager | |||
| May 19, 2008 | May 5, 2008 | |||
| Date: | Date: | |||
| /s/ Xxxx Xxxxxx | /s/ W. Bowtle | |||
| Name: Xxxx Xxxxxx | 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
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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
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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
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ATTACHMENT 4
Contact Personnel
| Vascular Biogenics | Encap Drug Delivery | |||
| Quality | ||||
| /s/ Xxxxx Mor | /s/ X. Xxxxxxx | |||
| Name: Xxxxx Mor | Name: J Darling | |||
| Title: QA Manager | Title: QA Manager | |||
| Production | ||||
| /s/ Xxxxxx Xxxx | /s/ X. Xxxxxx | |||
| Name: Xxxxxx Xxxx | 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 [***].
