Vascular Biogenics Ltd. (Form: F-1/A, Received: 07/18/2014 15:48:09)

As filed with the Securities and Exchange Commission on July 18, 2014

Registration no. 333-196584

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Amendment No. 3

Form F-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

VASCULAR BIOGENICS LTD.

(Exact Name of Registrant as Specified in Its Charter)

N/A

(Translation of Registrant’s Name into English)

Israel

2834

Not applicable

(State or Other Jurisdiction of

Incorporation or Organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer

Identification Number)

Vascular Biogenics Ltd.

6 Jonathan Netanyahu St.

Or Yehuda

Israel 60376

972-3-634-6450

(Address, Including ZIP Code, and Telephone Number,

Including Area Code, of Registrant’s Principal Executive Offices)

CT Corporation System

111 8 ^th Avenue

New York, New York 10011

(212) 894-8800

(Name, Address, Including ZIP Code, and Telephone Number,

Including Area Code, of Agent for Service)

Copies to:

Mitchell S. Bloom, Esq.

Lawrence S. Wittenberg, Esq.

Goodwin Procter LLP

Exchange Place

53 State Street

Boston, MA 02109

(617) 570-1000

Yuval Horn, Adv.

Keren Kanir, Adv.

Horn & Co, Law Offices

Amot Investments Tower

2 Weizmann St., 24 ^th Floor

Tel Aviv, Israel 6423902

972-3-637-8200

Brent B. Siler

Darren K. DeStefano

Cooley LLP

11951 Freedom Drive

Reston, VA 20190

(703) 456-8000

Chaim Friedland, Adv.

Ari Fried, Adv.

Gornitzky & Co.

Zion House, 45 Rothschild Blvd.

Tel Aviv, Israel 6578403

972-3-710-9191

Approximate date of commencement of proposed offering to the public: As soon as practicable after this Registration Statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

Explanatory Note

The sole purpose of this Amendment No. 3 to the Registration Statement on Form F-1 is to amend the exhibit index and to submit exhibits 10.3, 10.4, 10.5, 10.7, 10.8, 10.9, 10.10, 10.11, 10.12, 10.13 and 10.15. Accordingly, this Amendment No. 3 consists only of this explanatory note and Part II, including the signature page and the exhibit index. This Amendment No. 3 does not contain a copy of the prospectus that was included in Amendment No. 2 to the Draft Registration Statement on Form F-1 and is not intended to amend or delete any part of the prospectus.

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 6. Indemnification of Officer Holders (Including Directors).

Under the Israeli Companies Law 1999, or the Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty. An Israeli company may exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care, but only if a provision authorizing such exculpation is included in the company’s articles of association. Our articles of association to be effective immediately prior to the closing of this offering include such a provision. The company may not exculpate in advance a director from liability arising out of a prohibited dividend or distribution to shareholders.

Under the Companies Law, a company may indemnify an office holder for the following liabilities, payments and expenses incurred for acts performed by him or her as an office holder, either pursuant to an undertaking given by the company in advance of the act or following the act, provided its articles of association authorize such indemnification:

•

a monetary liability imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator’s award approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount, or according to criteria, determined by the board of directors as reasonable under the circumstances. Such undertaking shall detail the foreseen events and amount or criteria mentioned above;

•

reasonable litigation expenses, including reasonable attorneys’ fees, incurred by the office holder (1) as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding; and (ii) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent (mens rea); and (2) in connection with a monetary sanction; and

•

reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf, or by a third party, or in connection with criminal proceedings in which the office holder was acquitted, or as a result of a conviction for an offense that does not require proof of criminal intent (mens rea).

In addition, under the Companies Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder, if and to the extent provided in the company’s articles of association:

•

a breach of a duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;

•

a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; and

•

a monetary liability imposed on the office holder in favor of a third party.

II-1

Under the Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:

•

a breach of the duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;

•

a breach of the duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;

•

an act or omission committed with intent to derive illegal personal benefit; or

•

a fine or penalty levied against the office holder.

Under the Companies Law, for the approval of exculpation, indemnification and insurance of office holders who are executive officers, directors and controlling shareholders, see the section of the prospectus that forms a part of this Registration Statement entitled “Management—Approval of Related Party Transactions Under Israeli Law.”

Our amended and restated articles of association to be effective immediately prior the closing of this offering permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted under the Companies Law (other than indemnification for litigation expenses in connection with a monetary sanction).

We have entered into indemnification and exculpation agreements with each of our current office holders exculpating them from a breach of their duty of care to us to the fullest extent permitted by the Companies Law and undertaking to indemnify them to the fullest extent permitted by the Companies Law.

We are not aware of any pending or threatened litigation or proceeding involving any of our office holders as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any office holder.

The proposed form of Underwriting Agreement filed as Exhibit 1.1 to this Registration Statement provides for indemnification of our office holders by the underwriters against certain liabilities.

Item 7. Recent Sales of Unregistered Securities.

Since January 1, 2011, after giving effect to the 1-to-4.5 forward share split of our shares to be effected prior to the completion of this offering:

•

We have granted options to purchase an aggregate of 531,166 ordinary shares to our directors, officers, employees and service providers, in each case having an exercise price of $3.32 per share.

•

We have issued and sold 154,634 ordinary shares pursuant to the exercise of options held by our directors, officers and employees, having a weighted average exercise price per share of $1.72.

•

In January 2011, we issued 343,080 Series D preferred shares at $11.21 per share to 11 investors.

•

On April 30, 2013, we issued a convertible loan in the aggregate principal amount of approximately $10.0 million to 10 investors.

•

In May 2014, we issued an aggregate of 1,495,331 Series E preferred shares to 21 investors, consisting of 413,096 Series E preferred shares at a purchase price of $11.95 per share and 1,082,235 Series E preferred shares issued upon conversion of our convertible loan that we received on July 1, 2013.

II-2

The sales and issuances of the above securities were deemed to be exempt from registration under the Securities Act in reliance upon (i) Section 4(2) of the Securities Act, including Regulation S promulgated thereunder, as transactions by an issuer not involving any public offering or involving offers and sales of securities outside the United States (ii) Section 3(a)(9) of the Securities Act, as exchanges of our securities with our existing security holders and no commission or remuneration was paid or given directly or indirectly for soliciting such exchanges, or (iii) Rule 701, as issuances under our equity incentive plans.

Item 8. Exhibits and Financial Statement Schedules.

•

The Exhibit Index is hereby incorporated herein by reference.

•

Financial Statement Schedules.

All schedules have been omitted because they are not required, are not applicable or the information is otherwise set forth in the Financial Statements and related notes thereto.

Item 9. Undertakings.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the provisions described in Item 6 hereof, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned Registrant hereby undertakes:

•

To provide the underwriters specified in the Underwriting Agreement, at the closing, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

•

That for purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4), or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

•

That for the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-3

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing this Amendment No. 3 to its Registration Statement on Form F-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, on July 18, 2014.


VASCULAR BIOGENICS LTD.

By:		/s/ Dror Harats
Name: Dror Harats Title: Chief Executive Officer

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.


Signatures	Title	Date

/s/ Dror Harats Dror Harats	Chief Executive Officer and Director (Principal Executive Officer)	July 18, 2014

* Bennett M. Shapiro	Non-Executive Director	July 18, 2014

* Ruth Arnon	Non-Executive Director	July 18, 2014

* Jide J. Zeitlin	Non-Executive Director	July 18, 2014

* Jecheskiel Gonczarowski	Non-Executive Director	July 18, 2014

* Dan J. Gelvan	Non-Executive Director	July 18, 2014

II-4


* Ruth Alon	Non-Executive Director	July 18, 2014

/s/ Amos Ron Amos Ron	Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)	July 18, 2014


		Authorized Representative in the United States

/s/ Donald J. Puglisi		July 18, 2014

Name: Donald J. Puglisi

Title: Authorized Representative in the United States



*By:		/s/ Amos Ron
		Amos Ron
		Attorney-in-fact

II-5

EXHIBIT INDEX


Exhibit No.		Description

1.1*		Form of Underwriting Agreement.

3.1**		Articles of Association of the Registrant as amended and in effect prior to this offering.

3.2**		Amended and Restated Articles of Association of the Registrant to be effective immediately prior to the closing of this offering.

3.3**		Memorandum of Association of the Registrant as amended and in effect prior to this offering.

3.4**		Amendment to Memorandum of Association of the Registrant to be effective immediately prior to the closing of this offering.

4.1**		Amended and Restated Investors’ Rights Agreement, dated as of March 13, 2008, by and among the Registrant and the other parties thereto, as amended.

4.2*		Specimen share certificate.

4.3**		Warrant to purchase ordinary shares, dated May 8, 2014, issued to S.R. Horn Assets Ltd.

4.4**		Warrant to purchase ordinary shares, dated April 1, 2001, issued to Dror Harats, as amended.

4.5**		Warrant to purchase ordinary shares, dated May 14, 2001, issued to Dror Harats, as amended.

4.6**		Warrant to purchase ordinary shares, dated December 28, 2001, issued to Dror Harats, as amended.

5.1*		Opinion of Horn & Co, Law Offices, Israeli legal counsel of the Registrant.

10.1!**		Employee Ownership and Share Option Plan (2011) of the Registrant, and form of agreement thereunder.

10.2!**		Form of Release and Indemnification Agreement to be entered into between the Registrant and its officers and directors.

10.3+		Commercial Gene Therapy License Agreement, dated April 15, 2011, between the Registrant and Crucell Holland B.V.

10.4+		Agreement, dated February 3, 2013, between the Registrant and Tel Hashomer—Medical Research, Infrastructure and Services Ltd.

10.5+		Manufacturing Services Agreement, dated January 5, 2012, between the Registrant and Lonza Houston, Inc.

10.6**		Master Services Agreement, dated May 14, 2008, between the Registrant and Genzyme Pharmaceuticals.

10.7+		Technical Agreement on the Manufacture of Capsules, dated April 29, 2008, between the Registrant and Encap Drug Delivery and standard terms and conditions of purchase order.

10.8+		Technical Agreement on the Manufacture of Capsules, dated August 3, 2012, between the Registrant and Encap Drug Delivery and standard terms and conditions of purchase order.

10.9+		Material Transfer and Confidentiality Agreement, effective as of September 19, 2005, among the Registrant, Crucell Holland B.V. and BioReliance Ltd.


Exhibit No.		Description

10.10+		General Services Agreement, dated September 24, 2012, between the Registrant and BioClinica, Inc., and Addendum dated November 19, 2012 and August 29, 2013.

10.11+		Clinical Trial Agreement, dated September 9, 2012, between the Registrant and SCIderm GmbH.

10.12+		Service Agreement, dated November 8, 2012, between the Registrant and KCR S.A.

10.13+		Service Agreement, dated December 16, 2013, between the Registrant and KCR S.A.

10.14#**		Lease Agreement, dated January 2013, between the Registrant and Matzlawi Building Company Ltd.

10.15+		Material Transfer and Confidentiality Agreement, effective February 6, 2012 between the Registrant, Crucell Holland B.V. and Lonza Houston, Inc.

10.16**		Agreement between the Registrant and Prof. Jacob George, dated January 24, 2010, as amended on August 1, 2012.

10.17!**		Employee Share Ownership and Option Plan (2014) of the Registrant, and form of Capital Gains Option Agreement thereunder.

21.1**		Subsidiaries of the Registrant.

23.1**		Consent of Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Limited, Independent Registered Public Accounting Firm.

23.2*		Consent of Horn & Co, Law Offices (included in Exhibit 5.1).

24.1**		Powers of Attorney (included on signature page to the original filing of this Registration Statement on Form F-1).

*	To be filed by amendment.

**	Previously filed.

!	Management contract or plan.

+	Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request.

#	English summary of original Hebrew document.

Exhibit 10.3

CRUCELL HOLLAND B.V. – VASCULAR BIOGENICS LTD.

COMMERCIAL GENE THERAPY LICENSE AGREEMENT

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

COMMERCIAL GENE THERAPY LICENSE AGREEMENT

This Commercial Gene Therapy License Agreement (“Agreement”) is made and entered into on April 15, 2011 (“EFFECTIVE DATE”) by and between:

CRUCELL HOLLAND B.V. , a corporation organized under the laws of the Netherlands, having offices located at Archimedesweg 4, 2333 CN, Leiden, the Netherlands “CRUCELL”)

and

VASCULAR BIOGENICS Ltd. , with offices located at 6 Jonathan Netanyahu Street, 60376, Or-Yehuda, Israel (hereinafter referred to as “VBL” or “LICENSEE”),

the parties hereinafter individually referred to as “Party” and collectively as “Parties”.

PREAMBLE

•

WHEREAS, CRUCELL is the owner of a PER.C6 ^® cell line and of the associated information, know-how, and patents rights (as defined below);

•

WHEREAS, LICENSEE is engaged in the business of biomedical research, and the manufacturing, testing and commercializing of pharmaceutical products and services;

•

WHEREAS, LICENSEE and CRUCELL are parties to a Research License and Option Agreement dated March 24, 2005, granting LICENSEE the rights to conduct research under the PER.C6 ^® PATENTS and to utilize PER.C6 ^® KNOW HOW (as such terms are defined below) to prepare and evaluate gene therapeutics based on adenoviral vectors, and an option for a commercial license;

•

WHEREAS, LICENSEE has exercised its option to a commercial license and the Parties have negotiated an agreement for commercial rights under the terms and conditions as set forth hereinafter;

NOW, THEREFORE , in consideration of the mutual covenants and promises set forth herein, the Parties, intending to be legally bound, agree as follows:

1.	DEFINITIONS

Plural used in this Agreement shall mean singular and vice versa.

1.1.

AFFILIATE means any person, corporation, organization or other legal entity which, directly or indirectly, controls, or is controlled by, or is under common control with, a Party. CONTROL shall mean the ability, directly or indirectly, to direct the activities of the relevant entity, including the ownership or holding (directly or indirectly) of fifty percent (50%) or more of (i) the securities or other ownership interests representing the equity, the voting stock or general partnership interest, or (ii) the rights to elect or appoint directors (or other governing body).

1.2.

APPROVED COUNTRIES means the countries mentioned in Exhibit 1.2

1.3.

BMF means the PER.C6 ^® Biologics Master File as filed with the United States Food and Drug Administration

1.4.

EFFECTIVE DATE has the meaning set forth in the first paragraph of this Agreement.

1.5.

FIELD means the treatment of cancer in human by administering to a subject an adenoviral vector including, but not limited to, therapeutic gene sequence(s), the therapeutic effect of which is principally caused by the expression product of said gene sequence(s) and will not serve as a vaccine.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

1.6.

FIRST COMMERCIAL SALE means the first sale of a PRODUCT in a country by LICENSEE or any of its SUBLICENSEES OR REGISTERED AFFILIATES.

1.7.

FUNCTIONAL GENOMICS means the identification and/or validation of the biological function(s) of human and animal genes, and/or gene fragments and/or proteins and/or fragments of proteins transcribed from such genes, by means of the construction and use of arrayed collections of said genes and/or gene fragments, in non-phage viral vectors, to enable the identification and validation of drug targets, nutriceuticals and/or protein therapeutics, for the treatment or prevention of human or animal disease(s) and/or the maintenance of nutritional health.

1.8.

GOVERMENTAL AUTHORITIES means the FDA and other foreign governmental equivalents.

1.9.

IMPROVEMENT KNOW HOW RIGHTS means know how rights owned or licensable by LICENSEE or its REGISTERED AFFILIATES, which are developed during the Term using the technology claimed by the IMPROVEMENT PATENT RIGHTS, and which (i) come into the possession of LICENSEE or its REGISTERED AFFILIATES during the course of PROGRAMS and during the TERM of this Agreement, (ii) are not generally known, (iii) are related to the subject matter(s) of the IMPROVEMENT PATENT RIGHTS and are necessary for CRUCELL’s practice of the IMPROVEMENT PATENT RIGHTS as permitted under Section 2.5, and (iv) are not subject to a good faith reasonable third party confidentiality obligation that prevents the disclosure of the same.

1.10.

IMPROVEMENT PATENT RIGHTS means any patent issued after the EFFECTIVE DATE only to the extent that it claims (i) a new use of the PACKAGING CELLS including a generic product by process using said cells, (ii) an improved cell line derived from the PACKAGING CELLS, (iii) culturing or processing of PACKAGING CELLS, or (iv) a new use of an improved cell line described in clause (ii) of this sentence, in each case that is developed during the course of PROGRAMS under this Agreement.

1.11.

MODIFIED CELLS means PER.C6 ^® CELLS modified by incorporating therein VBL TECHNOLOGY, but excluding the integration thereof into the genome of the PER.C6 ^® CELL.

1.12.

NET Sales means the gross amount invoiced on sales of the PRODUCTS by LICENSEE, SUBLICENSEES, REGISTERED AFFILIATES and/or their respective sub-licensees to customers, less the following deductions related to the sale and delivery of PRODUCTS: (i) any commercially reasonable credits and allowances, repayments or adjustments granted or made to customers; (ii) any commercially reasonable trade or cash discounts, rebates, charge-backs or administrative fees or other price reductions granted to customers; and (iii) any sales, transportation, import, export or other like taxes, duties and government charges (but specifically excluding any taxes based on net income imposed upon the sale of the PRODUCTS) to the extent included in the gross sales price, wherein rebates, charge-backs, administrative fees and sales or other like taxes are actually paid or incurred by LICENSEE, SUBLCENSEES, REGISTERED AFFILIATES and/or their respective sub-licensees. A sale of the Product to third party customers shall also include a transfer or other disposition for consideration other than case, in which case such consideration shall be valued at the fair market value thereof.

1.13.

NON-APPROVED COUNTRIES means any countries other than APPROVED COUNTRIES.

1.14.

PACKAGING CELLS means PER.C6 ^® CELLS and MODIFIED CELLS.

1.15.

PACKAGING CELL-EXPRESSION SEQUENCE means (i) any recombinant DNA sequence used by LICENSEE, or expression product or any alteration or modification

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

thereof, derived from or obtained by, or produced using PACKAGING CELLS; or (ii) a fragment of any recombinant DNA sequence or expression product derived from obtained by, or produced using PACKAGING CELLS, and (iii) provided that (i) and (ii) are based upon and/or are derived from VBL TECHNOLOGY in combination with the genome of a serotype 5 human adenovirus.

1.16.

PACKAGING CELL KNOW HOW means PER.C6 ^® KNOW HOW, MODIFIED CELLS and all materials, information, experience and data, formulae, procedures, results and specifications, regulatory filings and clinical and pre-clinical data, in written or electronic form, which are specifically related to MODIFIED CELLS, which (i) are in the possession of the Parties at the EFFECTIVE DATE or come into the possession of the Parties during the TERM of this Agreement, (ii) are not generally known (iii) are necessary for the research use of the MODIFIED CELLS, and (iv) are not subject to a third party confidentiality obligation that prevents either Party from disclosing the same.

1.17.

PATENT means granted patents, including utility models and certificates of I vention, and reissues, reexaminations, supplementary protection certificates, extensions, and term restorations thereof, and patent applications therefor, including any continuations, continuations-in-parts, and/or divisionals applications thereof, and any and all patents issuing from any of the above.

1.18.

PER.C6 ^® CELL LINE or PER.C6 ^® CELL means the cells deposited under ECACC No. 96022940, as described in Exhibit 1.15, as updated by CRUCELL from time to time in accordance with Section 3 below to include additional CELLS deposited following the EFFECTIVE DATE.

1.19.

PER.C6 ^® KNOW HOW means PER.C6 ^® CELLS and all materials, information, experience and data, formulae, procedures, processes and techniques, results and specifications, know-how, regulatory filings and clinical and pre-clinical data, which are specifically related to PER.C6 ^® CELLS, and which are described in the PER.C6 ^® KNOW HOW FILE, as updated by CRUCELL from time to time in accordance with Section 3 below.

1.20.

PER.C6 ^® KNOW HOW FILE means the written compilation of PER.C6 ^® KNOW HOW and PACKAGING CELL KNOW HOW, which is provided to all PER.C6 ^® licensees, and which includes but it not limited to processing and manufacturing information and data limited to using PER.C6 ^® CELLS and/or MODIFIED CELLS for the production of replication defective adenoviral vectors therewith.

1.21.

PER.C6 ^® PATENTS mean PATENTS that CRUCELL owns, or controls by license or otherwise, wherein said license has a sublicense right, or which CRUCELL has a right to assignment, and that claim PER.C6 ^® CELLS or the use thereof for the manufacture of replication defective adenoviral vectors, identified on Exhibit 1.21.

1.22.

PRODUCT means a pharmaceutical product, intended for administration to human subjects, comprising of PACKAGING CELL-EXPRESSION SEQUENCE, in final finished form.

1.23.

PROGRAMS means research and development programs of LICENSEE or its SUBLICENSEES in the FIELD to develop PRODUCT in the FIELD, including but not limited to any and all pre-market-registration activities and post-market-approval studies.

1.24.

REGISTERED AFFILIATE means an AFFILIATE operating in APPROVED COUNTRIES to the extent identified in Exhibit 1.24 from time to time in accordance with the provisions of Section 2.1.5 below, providing full details of the name, offices and branches of such AFFILIATE or STRATEGIC PARTNER.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

1.25.

STRATEGIC PARTNER means a reputable company with whom VBL has entered into a collaboration agreement for the co-development and / or co-marketing of pharmaceutical products, substantially discovered, researched or developed by VBL in the FIELD which either (i) enters into a material transfer agreement with CRUCELL substantially in the form of Exhibit 1.25 hereto , or (ii) does not obtain access to the PACKAGING CELLS.

1.26.

SUBLICENSEE means a REGISTERED AFFILIATE to which LICENSEE grants a sublicense under and in accordance with this Agreement.

1.27.

TERM starts on the EFFECTIVE DATE and continues as described in Section 7.1.

1.28.

THIRD PARTIES means any person or entity other than VBL, CRUCELL, SUBLICENSEES, AFFILIATES or STRATEGIC PARTNER.

1.29.

VALID PATENT CLAIM shall mean a claim in any issued and unexpired PER.C6 ^® PATENT, which claim has not been held invalid by a non-appealed or unappealable decision by a court or other appropriate body of competent jurisdiction, provided , however , that there exists no outstanding order, injunction or other action (including any temporary relief) that impairs the rights granted under such CLAIM by LICENSEE, its SUBLICENSEES or REGISTERED AFFILIATES, as contemplated under this Agreement. For the purpose of royalty determination and payment, any claim being prosecuted in a pending patent application in a particular country shall be deemed to be a VALID PATENT CLAIM provided such claim is not pending for more than ten (10) years from the earliest filing date to which the patent application is entitled to claim in such country (such as the first filed application based on a PCT application and claiming the PCT filing date, or the first national patent application from which subsequent patent applications claim filing date benefit) and in which case it shall cease to be considered a VALID PATENT CLAIM until a patent in the pertinent country based on such application is granted.

1.30.

VTS™ TECHNOLOGY means LICENSEE’s proprietary VTS™ (Vascular Targeting System) platform technology that enables control of gene expression to areas in which angiogenesis is taking place to either promote or destroy newly formed blood vessels.

1.31.

VBL PROPRIETARY RIGHTS shall mean, as between the Parties, all right and title in and to VBL TECHNOLOGY, LICENSEE’S INFORMATION, PACKAGING CELL-EXPRESSION SEQUENCE and PRODUCTS, including without limitation (i) all data, results, inventions, know-how, improvements, developments or other information arising from or in connection with the PROGRAM; and (ii) any applications, improvements, modifications and derivatives of any of the above and any know-how, proprietary rights and PATENTS relating thereto or arising therefrom.

1.32

VBL TECHNOLOGY shall mean, as between the Parties, replication-deficient E1-and E3-deleted adenoviral 5 vector or adenovirus 3 vector and conditionally replicative adenovirus (CRAD) 3 and 5 Vector, containing either the FAS-Chimera transgene or Tyrosine Kinase and VTS™ TECHNOLOGY, and any know how related thereto and to the use thereof. At any time during the TERM, LICENSEE may provide CRUCELL with written notice of its wish for the transgene to be changed. Such change shall be deemed effective unless CRUCELL responds to LICENSEE’s notice within thirty (30) days of its receipt that is withholding consent, provided such consent may only be withheld if such change would result in a technology which is either (i) directly competitive with another technolofy under a then existing exclusive out-license by CRUCELL, or (ii) infringes any CRUCELL’s patent which are not otherwise covered in this Agreement. For the avoidance of doubt VBL technology will contain only one (1) Transgene in combination with aforementioned either Adenovirus 3 or 5 or (CRAD) and VTS™ TECHNOLOGY.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

2.	LICENSES; SUBLICENSING; OWNERSHIP OF CERTAIN RIGHTS; GRANT BACK LICENSE

2.1.

CRUCELL Grant to LICENSEE .

2.1.1.

CRUCELL hereby grants to LICENSEE, a non-exclusive, worldwide license, under the PER.C6 ^® PATENTS and PER.C6 ^® KNOW HOW, without the right to grant sublicenses except to SUBLICENSEES in accordance with the provisions of Section 2.1.4 below, (1) to use and import PER.C6 ^® CELLS and PER.C6 ^® KNOW HOW for the sole purpose of making MODIFIED CELLS during the course and performance of PROGRAMS; and (2) to use and import MODIFIED CELLS and PACKAGING CELL KNOW HOW during the course and performance of PROGRAMS; and (3) to use and import PACKAGING CELLS and PACKAGING CELL KNOW HOW to manufacture and to have made, in facilities of LICENSEE or its SUBLICENSEES subject to Section 2.4 below, PRODUCTS for use in the FIELD. For the avoidance of doubt, and subject to such third party entering first into a Material Transfer Agreement with CRUCELL prior to the transfer of any PACKAGING CELLS or PACKAGING CELL KNOW HOW, LICENSEE is also granted hereunder the right to provide PACKAGING CELLS, PACKAGING CELL KNOW-HOW and PRODUCTS to third parties for bona fide contract service purposes in the course and performance of PROGRAMS and for the manufacture and making of PRODUCTS solely on LICENSEES’ behalf.

2.1.2.

CRUCELL hereby grants to LICENSEE, a non-exclusive, worldwide license, under the PER.C6 ^® PATENTS and PER.C6 ^® KNOW HOW, with the right to grant sublicenses, to develop, use, import, offer to sell, and sell PRODUCTS for use in the FIELD.

2.1.3.

Sublicense Requirements in General . Any agreement in which LICENSEE purports to sublicense the rights granted herein under the PER.C6 ^® PATENTS and PER.C6 ^® KNOW HOW, (i) shall not grant any further right to sublicense under the PER.C6 ^® PATENTS and PER.C6 ^® KNOW HOW nor grant any right to transfer the PER.C6 ^® KNOW HOW or the sublicensed rights; and (ii) shall include terms at least as restrictive as those contained in this Agreement with respect to the use and exploitation of the rights granted under the PER.C6 ^® PATENTS and PER.C6 ^® KNOW HOW.

2.1.4.

Certain Sublicense Requirements – REGISTERED AFFILIATES . LICENSEE shall be permitted to sublicense its rights and obligations pursuant to Section 2.1.1 to REGISTERED AFFILIATES (without the right to further sublicense), provided each such REGISTERED AFFILIATE acknowledges and assumes all of the rights, restrictions and obligations of this Agreement applicable to such SUBLICENSEE hereunder, except, as between the Parties, for those rights and obligations for which LICENSEE shall be solely responsible as provided for herein (e.g. indicated by wording such as “on its own behalf and on behalf of its SUBLICENSEES”), in a writing signed by a duly authorized representative of such REGISTERED AFFILIATE. LICENSEE shall be responsible for assuring that each REGISTERED AFFILIATE has become fully aware of, and complies with, its rights, restrictions and obligations under this Agreement as a SUBLICENSEE prior to such REGISTERED AFFILIATE exercising any right that LICENSEE may sublicense to such REGISTERED AFFILIATE hereunder. Irrespective of any written sublicense to a REGISTERED AFFILIATE, the exercise of any sublicenseable right hereunder by a REGISTERED

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

AFFILIATE shall be deemed to bind such REGISTERED AFFILIATE to comply with the applicable restrictions, obligations and duties hereunder, except for those obligations and duties for which LICENSEE is solely responsible as provided herein. Irrespective of the number of SUBLICENSEES, CRUCELL shall only be required to communicate with, and provide technical assistance to, LICENSEE, or one designated SUBLICENSEE, unless the Parties agree otherwise in a written and duly executed amendment hereto. LICENSEE and its REGISTERED AFFILIATES shall be jointly and severally liable towards CRUCELL for their compliance with the restrictions, obligations and duties hereunder.

2.1.5.

At any time during the TERM, LICENSEE may provide CRUCELL with written notice of its wish for a new AFFILIATE to become a REGISTERED AFFILIATE. If Parties agree in writing that such AFFILIATE shall become a REGISTERED AFFILIATE, such AFFILIATE shall be included in Exhibit 1.20, by way of a duly executed written amendment, after CRUCELL has received the document duly executed by the respective AFFILIATE as referred to in Section 2.1.4. CRUCELL shall respond to LICENSEE’s notice within fourteen (14) days of its receipt, and shall not unreasonably withhold its consent to the addition of an Affiliate as aforesaid.

2.1.6.

The license grant in this Section 2 shall be effective from the date that CRUCELL receives the License Fee specified in Section 4 herein until expiration of the TERM.

2.2.

Restricted Access to PACKAGING CELLS

The licenses grant herein is restricted such that LICENSEE and its SUBLICENSEES shall not be permitted under the terms of this Agreement to engage in the following activities:

2.2.1.

to use PACKAGING CELLS (i) in or for FUNCTIONAL GENOMICS studies, (ii) for the manufacture of RECOMBINANT PROTEIN, (iii) in or for the manufacture of vaccines against communicable infectious agents, or (iv) in or for the development of products to prevent or treat diseases caused by chicken anemia virus, or to produce vectors, or expression products thereof, containing all or a part of a chicken anemia virus gene;

2.2.2.

to use, store, hold or otherwise deliver PACKAGING CELLS or PACKAGING CELL KNOW HOW in or to NON-APPROVED COUNTRIES;

2.2.3.

to offer, provide, give access to or to otherwise make available to third parties or to AFFILIATES that are not SUBLICENSEES, PACKAGING CELLS and/or PACKAGING CELLS KNOW HOW, except as provided for in Section 2.3 and 2.4 below;

2.2.4.

to offer or provide services to third parties, or to AFFILIATES that are not SUBLICENSEES, relating to or using PACKAGING CELLS and/or PACKAGING CELLS KNOW HOW.

2.3.

Permitted Access to PACKAGING CELLS . Sections 2.2.3 and 2.2.4 shall not apply to the extent that LICENSEE or its REGISTERED AFFILIATES will be required to provide, give access to or otherwise make available, by order or regulation of a governmental agency or court of competent jurisdiction, the results, materials, or know how obtained in the course of PROGRAMS, or

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

incorporating PACKAGING CELLS or PACKAGING CELL KNOW HOW, or the sale and/or distribution of PRODUCTS. Under such circumstances, LICENSEE shall promptly notify CRUCELL of such order or regulation requiring disclosure and shall make its best efforts to cooperate with CRUCELL to preserve the confidentiality of, and CRUCELL’s proprietary interest in, the PACKAGING CELL KNOW HOW.

2.4.

Supply of PACKAGING CELLS to Contractors .

2.4.1.

Subject to the conditions stated in this Section, LICENSEE shall have the right to deliver to a fee-for-service contractor (“Contractor”), PACKAGING CELLS and PACKAGING CELL KNOW HOW (1) to conduct authorized studies of and other tasks relating to PACKAGING CELLS, solely for use by LICENSEE in PROGRAMS, and/or (2) to use PACKAGING CELLS and PACKAGING CELL KNOW HOW to develop processes and perform other tasks for the manufacture and making of, and to manufacture and make, PACKAGING CELLS and PRODUCTS. LICENSEE shall not provide PACKAGING CELLS or PACKAGING CELL KNOW HOW to a fee-for-service Contractor except pursuant to a completely executed, written PER.C6 ^® Material Transfer Agreement (“MTA”) with CRUCELL. The Contractor shall enter into a material transfer agreement substantially in the form of Exhibit 2.4.1 hereto.

2.4.2.

CRUCELL shall have the right to disapprove the choice of any fee-for-service third party that is not reputable and/or reliable or operates in a NON-APPROVED COUNTRY, which disapproval shall only be asserted reasonably and upon prompt notice to LICENSEE of no later than fourteen (14) days following receipt of such Contractor’s details with reference specifically to this section, setting forth the reasons for CRUCELL’S disapproval. For purposes of this Section 2.4.2, “not reputable and/or reliable” shall mean, by way of example, that such fee-for-service third party is located in a country or jurisdiction where CRUCELL has reason to believe in good faith (a) does not provide adequate protection for intellectual property and proprietary information or (b) does not provide adequate judicial recourse in case of misappropriation or misuse of intellectual property or proprietary information. Countries or jurisdictions that are on the U.S. Trade Representative’s annual “Special 301” Watch List shall be deemed to qualify as countries or jurisdictions that do not provide adequate protection or recourse as referred to under (i)(a) and (i)(b) above. CRUCELL has pre-approved on Exhibit 2.4.2 the third party contractors listed therein.

2.5.

Ownership of Certain Rights; Grant Back License

2.5.1.

Except where expressly stated otherwise in this Agreement to the contrary, CRUCELL shall have no right, title and interest in and to any VBL PROPRIETARY RIGHTS (including any right to be notified thereof), provided that LICENSEE may notify CRUCELL of such information from time to time, at its sole discretion.

2.5.2.

LICENSEE and its REGISTERED AFFILIATES hereby agree to grant to CRUCELL a perpetual, royalty-free, non-exclusive worldwide license, with the right to sublicense, under the IMPROVEMENT PATENT RIGHTS and IMPROVEMENT KNOW HOW RIGHTS, provided that the license right under this Section shall not extend to the manufacture, use or sale of the particular PACKAGING

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

CELLEXPRESSION SEQUENCE(S) and/or PRODUCT(S) or the VBL Technology that are developed by LICENSEE or its SUBLICENSEES and that are the subject of this Agreement or the VBL PROPRIETARY RIGHTS.

3.	SUPPLY OF CELLS AND KNOW-HOW; CERTAIN UPDATES; TECHNICAL ASSISTANCE; REPORTING

3.1.

Supply of Cells and Know-How . Within thirty (30) days after receipt of the License Issuance Fee payment under Section 4.1.1, CRUCELL shall disclose and transfer to LICENSEE PER.C6 ^® CELLS and the PER.C6 ^® KNOW HOW that is incorporated into the most recent version of the PER.C6 ^® KNOW HOW FILE.

3.2.

Updates . During the TERM, CRUCELL shall promptly provide updates (i) of the PER.C6 ^® KNOW HOW FILE to LICENSEE as it is revised and made available to all or substantially all PER.C6 ^® licensees or to PER.C6 ^® licensees conducting activities or granted rights similar to those contained in this Agreement, including without limitation new uses in the Field of PER.C6 ^® CELLS and KNOW HOW, improved and updated techniques and know-how for the use of PER.C6 ^® CELLS and PER.C6 ^® LOW HOW, and any known problems relating to the use of PER.C6 ^® CELLS and PER.C6 ^® KNOW HOW or deviations from previously provided information, all as may be applicable to the license granted to LICENSEE hereunder and (ii) of any safety or regulatory concerns that come to CRUCELL’s attention relating to the PACKAGING CELL and PACKAGING CELL KNOW HOW.

3.3.

Technical Assistance . During the TERM, CRUCELL shall provide reasonable technical assistance (including guidance on know how related to the work with the PER.C6 ^® CELLS) to LICENSEE, as may be necessary to use PACKAGING CELLS and PACKAGING CELL KNOW HOW in PROGRAMS, upon reasonable request and free of any additional cost to LICENSEE. To support the KNOW HOW transfer, LICENSEE shall be entitled, upon reasonable notice to CRUCELL, to visit CRUCELL’s facilities from time to time, but no more than five (5) days, once a year and view the production of the PER.C6 ^® CELLS and other relevant processes and techniques relating to the making of MODIFIED CELLS, as well as to receive answers from CRUCELL’s employees regarding the use of such cells and of the PACKAGING CELL KNOW HOW, to the extent necessary for the purposes of a PROGRAM. LICENSEE shall compensate CRUCELL for technical assistance in excess of two (2) man-day visits by CRUCELL technical personnel to LICENSEE’s facilities, on an annual basis, for the first two (2) years of the TERM, on reasonable terms to be agreed in advance. A third man-day visit (or more) shall be at no additional cost if LICENSEE reports a material deviation from established PER.C6 KNOW HOW performance parameters, which deviation report requires such third man-day of technical assistance.

3.4.

Access and Reference to BMF; Conduct of Registration and Testing .

3.4.1.

LICENSEE and its REGISTERED AFFILIATES acknowledge that the BMF is owned by CRUCELL, may be filed by CRUCELL with other foreign governmental equivalent to the FDA and is confidential and of crucial importance to the Parties as well as to all other licensees of PER.C6 ^® CELL technology. LICENSEE and its REGISTERED AFFILIATES shall have the right to review CRUCELL’s copy of the BMF filed with the FDA and other Governmental Authorities after providing CRUCELL with thirty (30) days prior notice. LICENSEE has the right to cross-reference the BMF as may be required for any regulatory submissions to Governmental Authorities, and upon

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

LICENSEE’ request CRUCELL shall (i) notify the FDA (with a copy to LICENSEE) that LICENSEE is authorized to reference the data within the BMF; and (ii) provide LICENSEE with any and all existing BMF documentation in the possession of CRUCELL (provided that CRUCELL is legally able to do so) in so far required to support any regulatory submission LICENSEE makes to a Governmental Authority in a country where a BMF or its foreign equivalent has not been submitted or is not in effect or may not be referenced to. CRUCELL shall notify LICENSEE of any significant update to the BMF from time to time and shall provide LICENSEE with a copy thereof upon its request as set forth above.

3.4.2.

LICENSEE and its REGISTERED AFFILIATES shall not be entitled to, and agree that they will not, characterize, or issue releases or certificates of analysis for, or analyze the genome of, any PACKAGING CELLS, or engage in any research of PACKAGING CELLS that concern any safety, toxicity or tumorgenicity of PACKAGING CELLS without obtaining the prior written agreement of CRUCELL, provided that, if any Governmental Authority requests additional data or characterization of PACKAGING CELLS that CRUCELL chooses not to provide LICENSEE shall have the right to perform its own studies solely as required by the Governmental Authority, and to provide the results to the requesting Governmental Authority. Failure by CRUCELL to provide LICENSEE with such information or data for delivery to the applicable Governmental Authority within a reasonable period shall be deemed as CRUCELL choosing not to provide same. The aforementioned restrictions shall only apply with respect to PACKAGING CELLS, and not PACKAGING CELL-EXPRESSION SEQUENCE or PRODUCT, the analysis of which shall be at the sole discretion of LICENSEE and not subject to any approval of CRUCELL.

3.4.3.

LICENSEE further agrees to use its reasonable efforts to promptly notify CRUCELL of any and all communications to and from Governmental Authorities directly relating to the safety of PACKAGING CELLS and agrees to consult promptly with CRUCELL to resolve any such concerns with the FDA or such other Governmental Authorities, Noncompliance by LICENSEE with the obligation to use its reasonable efforts to obtain prior agreement of CRUCELL prior to any characterization, release or certificate issuances of PACKAGING CELLS as set forth in Section 3.4.2 above, or to promptly notify and consult with CRUCELL in its efforts to resolve any such issues with the FDA or other Governmental Authorities as set forth in this Section 3.4.3 shall be considered to constitute a failure to comply with a material condition or covenant of this Agreement to which Section 6.5 herein applies.

3.5.

Reporting .

3.5.1.

LICENSEE, on its own behalf and on behalf of its SUBLICENSEES, shall keep CRUCELL informed on a bi-yearly (six(6)-month) basis about (1) any communication with Regulatory Authorities about PACKAGING CELLS, and (2) results of any testing performed on the PACKAGING CELLS. A template for use in complying with the quarterly reporting obligation is attached as Exhibit 3.5.1.

3.5.2.

LICENSEE, on its own behalf and on behalf of its SUBLICENSEES, shall keep CRUCELL informed on an annual basis, on or before the anniversary of the EFFECTIVE DATE, with a detailed report of the

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

data relating specifically to PACKAGING CELL performance, PACKAGING CELL KNOW HOW, as well as the operating, culturing and manufacturing parameters and data resulting from its use of the PACKAGING CELL during the course of the PROGRAM. To facilitate the mutually beneficial resolution of any PACKAGING CELL technical performance issue, if any, LICENSEE hereby agrees to discuss with CRUCELL technical personnel relevant technical data to assist in resolving such issues. A template for use in complying with the annual reporting obligation is attached as Exhibit 3.5.2.

3.5.3.

It is agreed and understood that LICENSEE shall not be obligated to disclose any information, data or know-how relating to VBL PROPRIETARY RIGHTS unless and to the extent it is related to PACKAGING CELLS and/or their use hereunder. In such event, any and all disclosed information, data or know-how shall not be used or disclosed without LICENSEE’s prior written consent, which consent may be withheld at its sole discretion.

3.5.4.

LICENSEE, on its own behalf and on behalf of its SUBLICENSEES, shall promptly notify CRUCELL in writing of any substantial deviations from established PER.C6 ^® CELL characteristics and/or performance parameters included in PER.C6 ^® KNOW HOW, prior to any notification by LICENSEE or its SUBLICENSEES to any other entity other than to the appropriate Regulatory Authorities such as the FDA.

3.5.5.

Subject to the provisions of Section 3.5.3, information reported to CRUCELL pursuant to Sections 3.5.1 through 3.5.4 may be used by CRUCELL to assist LICENSEE in the successful implementation of PACKAGING CELL KNOW HOW, resolving technical and regulatory issues respecting PACKAGING CELL and the BMF, to amend and/or annotate the collection of PER.C6 ^® KNOW HOW for delivery to PER.C6 ^® licensees and/or to update the BMF, which PER.C6 ^® KNOW HOW and BMF shall only be disclosed under conditions of confidentiality. Except as expressly in Sections 2.5.2, 2.5.3 and 2.5.4 above, CRUCELL shall not use any information or know-how relating to PRODUCT(S) or PACKAGING CELL EXPRESSION SEQUENCE(S) that are developed by LICENSEE or its SUBLICENSEES, or relating to any VBL PROPRIETARY RIGHTS, nor disclose any of the above to any licensee or other third party (including any Regulatory Authority) without the prior written consent of LICENSEE, which consent may be withheld at its sole discretion.

4.	LICENSE FEES

4.1.

License Fees . In consideration of the licenses granted and the PER.C6 ^® KNOW HOW supplied hereunder, LICENSEE shall pay the following amounts to CRUCELL during the TERM:

4.1.1.

Within ten (10) days from the EFFECTIVE DATE, a License Issuance Fee of € 75,000 (seventy-five thousand Euros), exclusive of V.A.T.; and

4.1.2.

Starting on the first anniversary date of the EFFECTIVE DATE (TBD when the first anniversary date should start, since we are already paying an annual fee with a different anniversary date), an Annual License Maintenance Fee of € 100,000 (one hundred thousand Euros), exclusive of V.A.T., to be paid in arrears.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

4.2.

Development Milestone Payments : LICENSEE shall pay CRUCELL non-creditable and non-refundable payments of € 400,000 (four hundred thousand Euros), exclusive of V.A.T., with respect to each PRODUCT for which a governmental health regulatory authority grants marketing approval, within thirty (30) days of the issuance of the first regulatory marketing approval letter from such governmental health regulatory authority for the first indication for each such PRODUCT. Payment under this Section 4.2 shall be made once for each unique PRODUCT.

4.3.

Running Royalty . LICENSEE shall pay to CRUCELL a running royalty (the “Running Royalty”) as follows:

4.3.1.

If PACKAGING CELLS and/or PACKAGING CELL KNOW-HOW are, or were, used in the development, use, manufacture, importation or sale of the PRODUCT, a Running Royalty of one and half a percent (1.5%) of the NET SALES for the longer of (i) ten (10) years from the FIRST COMMERCIAL SALE of the PRODUCT;

4.3.2.

If the use, manufacture, importation or sale of the PRODUCT comes under the scope of at least one VALID PATENT CLAIM, on a country by country basis, a Running Royalty of half a percent (0.5%) of NET SALES.

4.3.3.

Only one Running Royalty, that may be either a Know-How Royalty (Section 4.3.1), or a Patent Royalty (Section 4.3.2) or a combination of the Know-How and Patent Royalties (1.5 + 0.5 = 2.0%), shall be due with respect to the same unit of PRODUCT.

5.	PAYMENTS; BOOKS AND RECORDS

5.1.

Royalty Reports and Payments . After the FIRST COMMERCIAL SALE of the PRODUCT on which Running Royalties are required, LICENSEE shall submit quarterly written reports to CRUCELL within ninety (90) days after the end of each calendar quarter, stating in each such report the number, description, and aggregate NET SALES of the PRODUCT sold during the calendar quarter upon which a Running Royalty is payable under Section 4 above. Concurrently with the submission of such reports, LICENSEE shall pay to CRUCELL Running Royalties at the rate specified in Section 4.

5.2.

LICENSEE Obligations . LICENSEE shall be solely responsible for the payment to CRUCELL of any royalties, license fees and milestone or other payments due from its AFFILIATES and/or SUBLICENSEES, and for any payments to third parties under licenses or similar agreements between LICENSEE and such third parties necessary to allow the manufacture, use or sale of the PRODUCT by LICENSEE, or SUBLICENSEES;

5.3.

Method of Payment .

5.3.1.

All payments due hereunder to CRUCELL shall be paid in Euros in immediately available funds, for CRUCELL’s account, to a bank designated in writing by CRUCELL . CRUCELL shall provide LICENSEE with an invoice prior to the due dates specified in Section 4.1.2 and 4.2, and LICENSEE shall pay such invoices within the later of the applicable due date or thirty (30) days of receipt by LICENSEE. If the invoice is received later than the due date, then LICENSEE shall have thirty (30) days from the receipt of the invoice to pay the invoiced amount.

5.3.2.

CRUCELL shall submit an invoice to LICENSEE for all transportation, packing or other documented and reasonable costs incurred on LICENSEE’S benefit and at LICENSEE’S request pursuant to this

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Agreement in connection with providing PACKAGING CELL KNOW HOW to LICENSEE. LICENSEE shall pay invoices specifying these reasonable costs within thirty (30) days of receipt.

5.3.3.

Inflation Index Adjustment: Commencing from the first (1st) anniversary date of the EFFECTIVE DATE, license fees due under Setion 4.1 shall be increased by two and one half percent (2.5%) upon each anniversary of the EFFFECTIVE DATE until and including the eighth anniversary of the EFFECTIVE DATE.

5.4.

Interest . If LICENSEE fails to make any payment under this Agreement within ninety (90) days of the date on which the same becomes due and payable, LICENSEE shall owe CRUCELL interest at the rate of twelve and a half percent (12.5%) per annum (as determined on the date the payment first become due) on any outstanding amount until payment is made in full. If parties are in dispute on the amount of the royalties payable pursuant to Clause 5.1. the penalty becomes due only after Parties have agreed on the exact royalty amount due.

5.5.

No Refunds . Payments referred to in this Section 5 shall not be refundable under any circumstances, including but not limited to the termination of this Agreement for whatever reason.

5.6.

Currency Conversion . If any currency conversion shall be required in connection with the calculation of royalties hereunder, such conversion shall be made using the following procedures. Sales recorded during a month will be translated to Euro values at the rate on the 1st working day of that month based on the exchange rates published on the OANDA website. Any changes to procedures for currency conversion shall only apply after such notice has been delivered and provided that such changes are consistently applied across LICENSEE’s operating units and continue to maintain a set methodology for currency conversion.

5.7.

Withholding Taxes . If LICENSEE is required by any applicable law, rule or regulation to make any deduction or withholding for or on account of any Tax (as defined below) from any payment to be made to CRUCELL under this Agreement, then LICENSEE shall (i) promptly notify CRUCELL of such requirement, (ii) pay to the relevant authorities the full amount required to be deducted or withheld promptly upon determining that such deduction or withholding is required or receiving notice that such amount has been assessed against CRUCELL, and (iii) promptly forward to CRUCELL an official receipt, or certified copy or other documentation reasonably acceptable to CRUCELL, evidencing such payment to such authorities.

5.7.1.

If CRUCELL is entitled to an exemption from or reduction of withholding tax under any applicable law or treaty with respect to any payments made hereunder, CRUCELL shall deliver to LICENSEE at the time or times prescribed by applicable law or reasonably requested by LICENSEE, such properly completed and executed documentation prescribed by applicable law as will permit such payments to be made without withholding or at a reduced rate.

5.7.2.

For purposes of this Section, the term “Tax” shall mean any present or future tax, levy, impost, duty, charge, assessment or fee of any nature (including interest, penalties and additions thereto) that is imposed by any government or other taxing authority in respect of a payment under this Commercialization Agreement.

5.8.

Records; Inspection . LICENSEE shall and shall cause its REGISTERED AFFILIATES and its SUBLICENSEES shall keep complete, true and accurate

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

books of account and records for the purpose of determining the Running Royalty amounts payable under this Agreement. Such books and records shall be kept at the principal place of business of LICENSEE, and SUBLICENSEES, as the case may be, for at least three (3) years following the end of the calendar quarter to which they pertain. Such records will be open for inspection during such three (3) year period by an independent public accounting firm of national prominence retained by CRUCELL and acceptable to LICENSEE for the purpose of verifying the Running Royalty statements. Such inspections may be made no more than once each calendar year, at reasonable times mutually agreed to by LICENSEE and CRUCELL. CRUCELL’s representative or agent will be obliged to execute a reasonable confidentiality agreement prior to commencing any such inspection. Inspections conducted under this Section shall be at CRUCELL’s expense, unless a variation or error producing an increase exceeding ten percent (10%) of the Running Royalty amount stated for any period covered by the inspection is established in the course of any such inspection, whereupon all reasonable and customary costs relating to the inspection for such period will be paid by LICENSEE.

6.	TERM AND TERMINATION

6.1.

Agreement Term . This Agreement shall become effective as of the EFFECTIVE DATE and, unless earlier terminated pursuant to the other provisions of this Section, shall continue in full force and effect on a country-by-country basis, until LICENSEE has no remaining obligation to pay to CRUCELL the Running Royalty in accordance with Section 4.3. Thereafter, LICENSEE shall have a fully paid up, world wide, royalty free, perpetual license right under the PER.C6 ^® PATENTS and PER.C6 ^® KNOW HOW to continue to make, have made, import, use, offer for sale and sell the PRODUCT(S) in such countries.

6.2.

Termination by LICENSEE . LICENSEE may terminate this Agreement by giving CRUCELL three (3) months prior written notice, and payment of all outstanding monies owed to CRUCELL until the date of termination, such as partial payment of arrears obligations pursuant to Section 4.1.2, which payment is due prior to actual termination of the Agreement.

6.3.

Termination by Mutual Agreement . This Agreement may be terminated upon mutual written agreement between the Parties.

6.4.

Termination Upon Insolvency or Bankruptcy . Either Party may terminate this Agreement, by notice to the other Party with immediate effect, if (a) the other Party (i) pledges substantially all of its assets for the benefit of creditors, and the conditions for the creditors to enforce their rights to control those assets have been satisfied (such as the expiration of a cure period for an uncured default), institutes, consents to or fails to diligently oppose any proceeding seeking to adjudicate it a bankrupt or insolvent or (b) any proceeding is instituted against or in respect of the other Party by third parties seeking bankruptcy relief and such proceeding continues undismissed, or unstayed and in effect for a period of 60 days after the institution thereof.

6.5.

Termination by Default . If either Party defaults in the performance of, or fails to be in compliance with, any material condition or covenant of this Agreement and any such default or noncompliance shall not have been remedied, or steps initiated to remedy the same, to the other Party’s reasonable satisfaction within three (3) months for payment defaults, and within six (6) months for other defaults or non-compliance, after receipt by the defaulting Party of a written notice thereof from the other Party, the Party not in default may, without further notice, forthwith terminate this Agreement at its option, provided however that in the event of breach by CRUCELL, accrual and

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

payment of any amounts due to it hereunder shall be suspended during the cure period; and provided, further, that in the event of a dispute as to default, non-compliance or right to terminate this Agreement, this Agreement shall continue until such dispute is finally resolved pursuant to Section 10.3 hereof.

6.6.

Rights and Obligations on Term, Termination, or Suspension .

6.6.1.

Unless expressly provided to the contrary, the following provisions shall survive the termination of this Agreement: Sections 1, 2.3, 2.5, 3.5.4, 3.5.5, 6.6, 6.7, 7, 8, 9 and 10 hereof.

6.6.2.

Return of PACKAGING CELL KNOW HOW . Except in the case of termination by LICENSEE for default pursuant to Section 6.5, upon early termination of this Agreement by either Party, at CRUCELL’S written request, LICENSEE and its AFFILIATES shall destroy all supplies of PACKAGING CELL KNOW HOW, and shall promptly thereafter confirm such destruction in writing to CRUCELL, except for one copy of such written information to be retained in confidential files and to be used solely to establish rights and obligations under this Agreement, and for no other use or purpose.

6.7.

Termination by either Party pursuant to this Article shall not prejudice any other remedy that a Party might have at law or equity.

7.	CONFIDENTIALITY

7.1.

Confidentiality Obligations . Each Party shall maintain in confidence all information disclosed or otherwise made available by the other which is identified as confidential and which is confirmed in writing and marked “confidential” or otherwise properly labeled as confidential within thirty (30) days of such original disclosure, including without limitations, information relating to PACKAGING CELL KNOW HOW and PROGRAMS or results of PROGRAMS (all such information hereafter referred to as “INFORMATION”), and shall not use such INFORMATION or disclose the same to anyone, except (i) that LICENSEE may disclose CRUCELL’S INFORMATION to its REGISTERED AFFILIATES and SUBLICENSEES, those of its agents, direct employees, consultants and investigators for the execution of PROGRAMS and manufacturing and sale of PRODUCTS, as set out in this Agreement; (ii) that LICENSEE may disclose CRUCELL’S INFORMATION as required to governmental health regulatory authorities; (iii) that CRUCELL may disclose LICENSEE’S INFORMATION to its agents, direct employees, consultants and investigators who have a need-to-know for the performance of this Agreement; the foregoing as permitted by this Agreement and subject to the responsibilities and obligations as set forth in this Agreement. Either Party may disclose the other Party’s INFORMATION to potential investors and/or strategic partners within the course of a good faith due diligence inquiry to the extent relevant for the purpose of the inquiry. The foregoing is subject to the below:

7.1.1.

Prior to such permitted disclosure to such LICENSEE REGISTERED AFFILIATES and SUBLICENSEES, Contractors, agents, direct employees, consultants, investigators, potential investors and other financing sources, investment bankers, advisors, attorneys, accountants and strategic investors, disclosure must be subject to the provisions of a confidentiality agreement containing restrictions no less stringent than the obligations in this Section 7.1 as such restrictions apply to LICENSEE, provided that attorneys and accountants shall not be required to execute such agreement if so informed of the confidential obligations hereunder and provided their professional code of conduct requires that such confidentiality obligations be so observed.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

7.1.2.

Each Party shall use a similar effort to that which it uses to protect its own trade secrets or proprietary information (but that in any event be no less than customary industry standards) to protect the other Party’s INFORMATION and to ensure that its applicable AFFILIATES and SUBLICENSEES and Contractors (if any), agents, direct employees, consultants, investigators, potential investors and strategic investors do not disclose or make any unauthorized use of such INFORMATION. Each Party shall notify the other promptly of its knowledge of any unauthorized use or disclosure of the other’s INFORMATION and enable it to enforce rights against such use or disclosure.

7.2.

Exceptions . The confidentiality and non-use obligations under this Agreement shall not apply to the extent that:

7.2.1.

the Party who has received the INFORMATION (“RECIPIENT”) is required to disclose information by order or regulation of a governmental agency or court of competent jurisdiction subject to the provisions of Section 7.3.3 below; or

7.2.2.

the RECIPIENT can demonstrate that

7.2.2.1.

the party who has received the INFORMATION (“RECIPIENT”) is requited to disclose information by order or regulation of a governmental agency to court of competent jurisdiction subject to the provisions of Section 7.3.3 below or;

7.2.2.2.

the disclosed INFORMATION is independently developed without use or regard to the INFORMATION (as shown by RECIPIENT’s written records); or

7.2.2.3.

the disclosed INFORMATION was lawfully known by RECIPIENT (as shown by its written records) prior to the date of disclosure to RECIPIENT without an obligation of secrecy, from sources legally entitled to disclose the same without an obligation of secrecy or received by RECIPIENT (as shown by its written records) on an unrestricted basis from a source unrelated to any Party to this Agreement and not, to its knowledge, under a duty of confidentiality.

7.3.

Publications and Public Announcements :

7.3.1.

Each party shall have the right to publish the existence of this Agreement, but not the terms thereof, with the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed.

7.3.2.

Any disclosure which is required by law may be made without the prior consent of the other Party, although the other Party shall be given prompt notice of any such legally required disclosure and an opportunity to comment on, and attempt to challenge or limit the proposed disclosure reasonably in advance to the extent feasible.

7.3.3.

Furthermore, the disclosing Party shall make diligent efforts to limit the nature and scope of any disclosure to the extent reasonably possible and to otherwise prevent the disclosure of the non-disclosing Party’s INFORMATION.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

8.	PATENTS

8.1.

CRUCELL shall be responsible and use commercially reasonable efforts for the prosecution, protection and maintenance of PER.C6 ^® PATENTS throughout the TERM, and shall bear all costs, fees and expenses in connection thereto.

8.2.

If either Party after the EFFECTIVE DATE is warned or sued by a third party alleging or charging infringement of any patents or published patent applications or any other rights, due to or in connection with the use of PACKAGING CELLS, by either Party, the Party which is warned or sued, shall notify promptly the other Party.

8.3.

CRUCELL shall be responsible, at its expense, for settling and/or defending any warning or litigation for patent infringement in which the alleged infringing process or product giving rise to liability for damages involves or arises from use by CRUCELL of PACKAGING CELLS or the practice of any of the PACKAGING CELLS, PER.C6 ^® PATENTS or PACKAGING CELL KNOW-HOW.

In so far as any such infringement action, or the settlement or defense thereof, might have an effect on LICENSEE activities, CRUCELL shall promptly inform LICENSEE of such claim and (i) CRUCELL and LICENSEE shall confer as to any modification of any right granted to LICENSEE hereunder, provided, that such modification shall not substantially alter LICENSEE’s rights hereunder; (ii) LICENSEE shall be entitiled, but shall not be obligated, to attempt to obtain a license from such third party for the right to use such third party’s patent or other applicable right and (iii) in the event that LICENSEE is named thereunder, it shall have the right to participate in the defense of such claim. In any event, if such infringement action might have an effect on LICENSEE activities (i) upon CRUCELL’s written request, LICENSEE agrees to reasonably assist CRUCELL in any such defense; and (ii) LICENSEE shall be entitled to immediately terminate this Agreement.

If LICENSEE should suffer any out of pocket costs and other expenses, including reasonable attorney’s fees, as a result of the assistance in such dispute, CRUCELL shall reimburse LICENSEE such out of pocket costs and expenses incurred by LICENSEE.

LICENSEE shall be responsible, at its expense, for settling and/or defending any warning or litigation for patent infringement made against CRUCELL, in which the alleged infringing process or product giving rise to liability for damages involves use by LICENSEE of PACKAGING CELLS, other than as set forth in Section 8.3 above. If CRUCELL should suffer any damages, losses, out of pocket costs and other expenses and liabilities as a result of such dispute, including reasonable attorney’s fees and payments of royalties to third parties, LICENSEE shall indemnify CRUCELL and it AFFILIATES and hold them harmless against any such expenses and liabilities.

8.4.

No Party shall enter into any settlement which admits or concedes that any aspect of the PATENT or know how of the other Party is invalid or unenforceable in any way, without the prior written consent of such other Party.

9.	REPRESENTATIONS; WARRANTY, INDEMNIFICATION

9.1.

CRUCELL Representations and Warranties . CRUCELL represents and warrants that (a) CRUCELL has the full legal right to enter in this Agreement and to perform its obligations thereunder; (b) CRUCELL will not be violating any law, regulation, order or contractual or other obligations of or applicable to CRUCELL or to the PER.C6 ^® CELLS, PER.C6 ^® PATENTS or PER.C6 ^® KNOW-HOW by executing, delivering or performing this Agreement, and neither the execution or delivery of this Agreement shall not conflict with or violate any

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

such law, regulation, order or contractual or other obligation; (c) CRUCELL has duly executed and delivered this Agreement, which constitutes a legal valid and binding obligation of CRUCELL, enforceable against CRUCELL in accordance with its terms; (d) CRUCELL is the legal owner of all rights and title in and to the PER.C6 ^® CELLS, PER.C6 ^® PATENTS and PER.C6 ^® KNOW HOW licensed hereunder, free and clear of any encumbrance, charge or restriction, and has the right to grant LICENSEE the licenses granted under this Agreement without conflicting with any third party rights and without creating any encumbrance, charge or restriction in connection therewith; (e) the PER.C6 ^® CELLS provided to LICENSEE or to a designated contractor under 2.1.4 (i) comply with the certificates of analysis that accompany the cells, (ii) comply with the specifications as set forth in the Exhibits hereto, and (iii) have been manufactured, tested and maintained according to the current ICH, FDA and EMEA guidelines; (f) the terms of this Agreement do not create a conflict with or result in the breach of any right, obligation or agreement that CRUCELL has with any third party; (g) it has not received any communication alleging that the PER.C6 ^® CELLS infringes the intellectual property rights of any third party; and (h) CRUCELL will prosecute, maintain and take other actions necessary, in the course of its exercise of good business judgment, to support the continued validity and enforceability of the PER.C6 ^® PATENTS during the term. UNLESS OTHERWISE EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, CRUCELL DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, FITNESS FOR ANY PARTICULAR PURPOSE, RESPECTING ANY MATERIALS PROVIDED TO LICENSEE PURSUANT TO, OR IN ASSOCIATION WITH THE PERFORMANCE OF THIS AGREEMENT, INCLUDING ANY WARRANTIES CONCERNING THE INHERENT PROPERTIES OF PACKAGING CELLS SUPPLIED UNDER THIS AGREEMENT. CRUCELL MAKES NO WARRANTY AS TO THE MERCHANTABILITY OF THE PRODUCTS, PER.C6 ^® KNOW HOW OR PER.C6 ^® PATENTS.

9.2.

LICENSEE Warranties . LICENSEE (a) is entitled to enter in this Agreement and to perform its obligations thereunder; (b) LICENSEE does not violate any law, regulation, order or its existing contractual obligations by executing, delivering and performing this Agreement; and (c) LICENSEE has duly executed this Agreement, which constitutes a legal valid and binding obligation of LICENSEE, enforceable against LICENSEE in accordance with its terms.

9.3.

Product Liability and Indemnification. CRUCELL shall not be liable for and LICENSEE shall indemnify CRUCELL and hold CRUCELL harmless against any and all liabilities (including product liability), damages, losses or injury, death, costs and expenses, including reasonable attorney’s fees, arising in any manner from the use by LICENSEE or its AFFILIATES of PACKAGING CELLS and/or the PACKAGING CELL KNOW HOW, or the use of any PRODUCT by any human being, regardless of whether such use was contemplated by the Parties, except to the extent such liabilities result from (i) the willful misconduct, gross negligence or written instructions of CRUCELL; and/or pursuant to Section 8.3 above; and/or (iii) any breach of this Agreement by CRUCELL. CRUCELL shall hold harmless LICENSEE and its AFFILIATES against losses arising from the events set forth in clauses (i) and (ii) immediately above.

10.

MISCELLANEOUS/ RULES OF CONSTRUCTION

10.1.

Amendment. This Agreement may not be changed, modified, amended, or supplemented except by a written instrument signed by authorized representatives of both Parties hereto.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

10.2.

Assignability . LICENSEE’s rights and obligations in this Agreement may not be assigned without the prior written consent of CRUCELL, except to an AFFILIATE, or in the event of a merger or sale of all, or substantially all, of LICENSEE’s assets relating to the subject matter of this Agreement to an assignee, provided that LICENSEE shall remain joint and severally liable with any such assignee for the performance of its assigned obligations hereunder if LICENSEE continues to conduct business following such merger or sale. Such assignment shall then be binding upon, inure to the benefit of the Parties, and be enforceable. Any attempted assignment contrary to the terms of this provision shall be void.

10.3.

Choice of Law and Dispute Resolution . This Agreement shall be governed by and construed under the laws of the Netherlands. If any dispute arises out of this Agreement, the Parties will themselves endeavor to settle such dispute amicably. If the Parties fail to arbitration before a single arbitrator, such arbitration to be held in accordance with the rules of arbitration of the International Chamber of Commerce and to be held in The Hague, Netherlands. The Parties shall use good faith efforts to expedite the arbitration. The parties agree that any judgment of the foregoing arbitrator shall be final and binding and shall be enforceable in any competent court having jurisdiction over the adjudged party. Nothing herein shall prevent either party from seeking injunctive relief or other equitable remedies in or out of law.

10.4.

Expenses . Each Party shall bear its own expenses, if not expressly agreed otherwise in this Agreement.

10.5.

Force Majeure . Neither LICENSEE nor CRUCELL shall be liable for any failure or delay in performance under this Agreement which is due in whole or in part directly or indirectly to any cause of any nature beyond the reasonable control of such Party.

10.6.

Further Assurances . Each Party hereto agrees to execute, acknowledge and/or deliver such further instruments, and to do all other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

10.7.

Notice and Reports . All notices required by this Agreement shall be in writing. All notices and reports shall be sent by fax followed by registered airmail to the Parties at the following addresses or such other addresses as may be designated in writing by the respective Parties:

To CRUCELL:

CRUCELL HOLLAND B.V.

Archimedesweg 4

P.O. Box 2048

2301 CA Leiden

THE NETHERLANDS

Attn. Business Development

FAX: +31-71-5248702

To LICENSEE:

VASCULAR BIOGENICS Ltd.

6 Jonathan Netanyahu Street,

60376, Or-Yehuda,

ISRAEL

Attn. Emmanuel Elalouf

VP Business Development

FAX: 972-3-6346449

Any notices shall be deemed given when received by the other Party.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

10.8.

Relationships of the Parties . Both Parties are independent contractors under this Agreement. Nothing contained in this Agreement is intended nor is to be construed so as to constitute CRUCELL and LICENSEE as agents, partners or joint ventures with respect to this Agreement. Neither Party hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any other contract, agreement, or undertaking with any third party.

10.9.

Rules Of Construction .

10.9.1.

Captions . Paragraph captions are inserted for convenience only and in no way are to be construed to define, limit or affect the construction or interpretation hereof.

10.9.2.

Entire Agreement. This Agreement contains the entire agreement of the Parties regarding the subject matter hereof, and supersedes all prior agreements, understandings, and negotiations between the Parties regarding the same.

10.9.3.

“Including” . The words “include”, “including” or “included” are used to indicate that the matters listed are not a complete enumeration of all matters covered and should be read such as “including but not limited to”.

10.9.4.

Singular, Plural, Gender . Words denoting the singular, shall include the plural and vice versa. Words denoting one gender shall include all others.

10.9.5.

Severability . If any part of this Agreement shall be held invalid and/or unenforceable, the remaining provisions of this Agreement shall nevertheless remain in full force and effect provided that such provisions will permit the transaction contemplated herein to take place in substantially the same manner as originally contemplated by the Parties.

10.9.6.

Translations . This Agreement has been written and executed in the English language. Any translation into any other language shall not be an official version of this Agreement. In the event of any conflict in interpretation between the English version and such translation of this Agreement, the English version shall prevail.

10.9.7.

Waiver . The waiver by either Party of a breach of any provisions contained herein shall be in writing and shall in no way be construed as a waiver of any prior or succeeding breach of such provision or the waiver of the provision itself.

10.9.8.

Trademarks. PER.C6 ^® is a registered trademark of CRUCELL. All right title and interest therein shall remain with CRUCELL. CRUCELL is solely entitled to all goodwill accruing in the trademark PER.C6 ^® as a consequence of the use thereof by LICENSEE or otherwise. LICENSEE may only use CRUCELL’s PER.C6 ^® trademark upon the execution of a separate trademark license agreement with CRUCELL. Not withstanding the aforementioned, for the avoidance of doubt LICENSEE can use the PER.C6 ^® trademark for reference purposes in connection with research publications as well as regulatory filings.

10.9.9.

Use of Party’s Name . No right, express or implied, is granted by tHIS AGREement to LICENSEE to use in any manner other than for regulatory submission purposes the name “CRUCELL” or “INTROGENE”, or to CRUCELL to use in any manner the name of LICENSEE or its Affiliates, or any other trade name, logo or

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

trademark of the other party in connection with the performance of this Agreement without prior permission from such other party except as elsewhere permitted under this Agreement.

IN WITNESS WHEREOF , the Parties hereto have executed this Agreement to be effective as of the date the last Party signs below.


VASCULAR BIOGENICS LTD.		CRUCELL HOLLAND B.V.

		For and on behalf of Crucell N.V.

By:	/s/ Dror Harats	By:	/s/ [Illegible]
			Crucell NV, represented by
Or Yehuda, April 14, 2011			Leiden April 13, 2011

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

Exhibit 1.18 — Cell Line Designation: PER.C6 ^®

Origin of the Cell Line

PER.C6 ^® cells are [***] transformed with [***] of [***] The estimated copy number is [***] The [***] in the construct is driven by the [***] The [***] are derived from [***]

Cell Line Passage History

Research Master Cell Bank [***] was stored at passage number [***] on 17 January 1996. Research Working Cell Bank [***] was generated from [***] and stored at passage number [***] on 7 February 1996. The cell banks are stored in the [***] of [***] at [***] in [***]

Components Used For Culture of the Cells

[***] with [***] and, optionally, [***]. [***] was used for [***]

Quality Control

All work on the development of PER.C6 ^® cells carried out at Crucell Holland has been carried out under controlled conditions. The data have been reviewed by QA Crucell Holland. The research Master Cell Bank and research Working Cell Bank have been tested by GLP-inspected contract testing companies. All recorded data mentioned have been reviewed by Quality Assurance, Crucell Holland BV, Leiden. All final reports have been reviewed for compliance to the specifications and pertinent relevant regulatory requirements from the US and EEC.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Safety Tests on the PER.C6 ^® Human Adenoviral Packaging cell Line

Research Master Cell Bank


Test		Result

[***]		[***]

Research Working Cell Bank


Test		Result

[***]		[***]

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Exhibit 1.2 – APPROVED COUNTRIES

United States of America

Canada

The member states of the European Union on the EFFECTIVE DATE

Israel

Japan

Australia

New Zealand

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Exhibit 1.21 – PER.C6 ^® Patents

National patents corresponding to [***] ([***]; [***], [***]). The currently filed members of patent family [***] claim priorities based on European priority documents [***] ([***]) and [***] ([***]). Members of this patent (application) family further include:


Applications	Filing Date	Published	Publication
[***]	[***]	[***]	[***]


Patents		Issue date
[***]		[***]

2. Claims covering the PACKAGING CELLS and the use thereof, excluding claims specifically directed to [***], [***] complementing cells and vectors, in all PATENTS entitled to claim rights from [***] ([***]; [***]: [***]) of the patent family [***] of [***] that claim priority from French priority document [***] ([***]). PATENTS that include the aforesaid claims and that are granted as of the EFFECTIVE DATE are listed below:

[***]

3. PATENTS entitled to claim rights from [***] to [***], which application claims priority from [***]. PATENTS that are granted as of the EFFECTIVE DATE include [***]

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Exhibit 1.24 – REGISTERED AFFILIATES

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

EXHIBIT 1.25 – FORM OF MATERIAL TRANSFER AGREEMENT FOR STRATEGIC PARTNER

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

EXHIBIT 1.25 – FORM OF MATERIAL TRANSFER AGREEMENT FOR A CONTRACTOR

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Attachment I: Statement of Work to which the use of the MATERIAL is to be limited

Contractor may only use MATERIAL and INFORMATION for

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

EXHIBIT 2.4.2 – PRE-APPROVED THIRD PARTY CONTRACTORS

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Exhibit 3.5.1– Quarterly reporting form

To:

CRUCELL HOLLAND B.V.

Archimedesweg 4

P.O. Box 2048

2301 CA Leiden

THE NETHERLANDS

Attn. Business Development

FAX: +31-71-5248702

From: ( Please fill in COMPANY name and address )

Date:

Subject: QUARTERLY REPORT LICENSE AGREEMENT

Period covered by the report

General culturing

•

A short description on general cell culture activities.

•

Have you encountered problems culturing the PER.C6 ^® cell line?

•

Have you seen substantial deviations from the culture protocols described in the PER.C6 ^® KNOW HOW FILE?

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

VECTOR production

•

Number and types of Protein/MAB produced in the PER.C6 ^® cell line.

•

Have you encountered problems or observed remarkable results when transfecting the PER.C6 ^® cell line, or when creating MODIFIED CELLS?

•

Any substantial deviations from and/or additions to the protocols provided in the PER.C6 ^® KNOW HOW FILE?

•

Code(s) for tracking the individual Protein/MAB in future reports.

Interactions with regulatory authorities

•

In the past three months, were there any communications with regulatory authorities that were NOT subject to Section 3.4.3 of the License Agreement? If YES, please provide a summary of the reason, the nature and the outcome of these discussions. Please provide copies of the communication.

•

What safety, tumorgenicity and/or other tests have been performed on the PACKAGING CELLS for regulatory purposes? Please provide reason, nature and outcome of the tests.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Exhibit 3.5.2. – Annual reporting form

To:

CRUCELL HOLLAND B.V.

Archimedesweg 4

P.O. Box 2048

2301 CA Leiden

THE NETHERLANDS

Attn. Business Development

FAX: +31-71-5248702

From: ( Please fill in COMPANY name and address )

Date:

Subject: ANNUAL REPORT LICENSE AGREEMENT

Period covered by the report

General culturing

•

A short description on general cell culture activities.

•

Media used.

•

Cell banks prepared.

•

General performance; cell growth, viabilities, doubling times.

•

Scale and scale-up data.

•

Systems used (Shake-flasks, Roller bottles, Bioreactors, Wave bags).

•

Have you encountered problems culturing the PER.C6 ^® cell line?

•

Have you seen substantial deviations from the culture protocols described in the PER.C6 ^® KNOW HOW files?

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

VECTOR production

•

Number and type of vectors produced in the PER.C6 ^® cell line.

•

Yields reached per produced VECTOR.

•

Have you encountered problems or observed remarkable results when transfecting the PER.C6 ^® cell line, or when creating MODIFIED CELLS?

•

Any substantial deviations from and/or additions to the protocols provided in the PER.C6 ^® KNOW HOW FILE?

•

Code(s) for tracking the individual new PRODUCT in future reports.

Third party activities

•

Have you performed CMO activities for third parties using the PER.C6 ^® cell line or worked with the PER.C6 ^® cell line in collaborations programs with third parties? If yes, please state the name of the company/companies and a short description of the project(s).

•

Has a CMO performed any activities with the PER.C6 ^® cell line? If yes, please state the name of the company/companies and a short description of the project(s).

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Interactions with regulatory authorities / Clinical activities

•

What pre-IND meetings and IND filings have taken place for products produced on PER.C6 ^® ? For which products? What was the outcome (related to PER.C6 ^® ) of those meetings?

•

Were there any communications with regulatory authorities that were NOT subject to Section 3.4.3 of the License Agreement? If YES, please provide a summary of the reason, the nature and the outcome of these discussions. Please provide copies of the communication.

•

What safety, tumorgenicity and/or other tests have been performed on the PACKAGING CELLS for regulatory purposes. Please provide reason, nature and outcome of the tests.

•

Was clinical material produced using the PER.C6 ^® cell line?

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

Exhibit 10.4

AGREEMENT

This Agreement (“ Agreement ”) is made and entered into as of the 3 day of February 2013 (“ Effective Date ”), by and between:

Tel Hashomer - Medical Research, Infrastructure and Services Ltd. , a private company duly incorporated under the laws of the State of Israel having its registered office at Tel Hashomer, Israel, 52621, represented by its authorized representatives ( “ THM ”); and

Prof. Dror Harats, ID no. 054496641 of Ramat Gan, Israel (“ Prof. Harats ”); and

Vascular Biogenics Ltd. , Company no. 51-289976-6, a private company duly incorporated under the laws of the State of Israel having its registered office at 6 Yoni Netanyahu Street, Or Yehuda, Israel, 60376, represented by its authorized representatives (“ VBL ” or the “ Company ”).

WHEREAS :

THM declares that it is a private company, whose purpose is to promote the welfare of the Sheba Medical Center (the “ Hospital ”); and

WHEREAS:

THM declares that at the request of the Hospital and the Fund, as defined below, THM undertook to act as the operational body of the Hospital and Fund, with respect to promotion, development and commercialization of intellectual property deriving from inventions of Hospital’s and/or Fund’s employees; and

WHEREAS:

Prof. Harats has been an employee of the Hospital and/or the Fund since 1995; and

WHEREAS :

VBL was established in 1999; and

WHEREAS :

The Hospital and the Fund have claims regarding the ownership of certain inventions and patent rights of the Company, developed in part by Prof. Harats, and certain other inventors defined herein as Inventors and VBL disagrees, denies and refutes all such claims in their entirety; and

WHEREAS :

THM, on behalf of the Hospital, and the Fund reached an agreement resolving the above dispute as stipulated and set forth hereunder;

NOW, THEREFORE , in consideration of the mutual covenants and undertakings herein contained, the parties hereby agree and stipulate as follows:

1.	PREAMBLE AND DEFINITIONS

1.1

The Preamble to this Agreement as well as all the Agreement’s appendices constitutes an integral part thereof.

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

1.2

The descriptive headings of this Agreement are inserted for convenience only and shall not be considered a part or affect the interpretation of this Agreement.

1.3

In addition to terms defined elsewhere in this Agreement or its appendices, the following terms shall have the meaning ascribed to them hereinafter:

1.3.1

“ Affiliate ” shall mean, with respect to a Party , any person, organization or entity controlling, controlled by or under common control with, such party. For purposes of this definition only, “control” of another person, organization or entity shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the activities, management or policies of such person, organization or entity, whether through the ownership of voting securities, by contract or otherwise. Without limiting the foregoing, “control” shall be presumed to exist when a person, organization or entity (i) owns or directly controls fifty percent (50%) or more of the outstanding share capital or other ownership interest of the other organization or entity, or (ii) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity.

1.3.2

The “ Fund ” shall mean Medical Research Infrastructure Development and Health Services Fund by the Sheba Medical Center (RA).

1.3.3

“ Intellectual Property ” shall mean any or all intellectual property and similar proprietary rights in any jurisdiction throughout the world, including without limitation: (i) all United States, Israeli, international and foreign patents and applications therefor (including PCT), including any and all reissues, divisionals, patent of division applications, renewals, extensions, continuations, and continuity applications thereof, whether or not related to such divisionals, patent of division application, renewals, extensions, continuations or continuity applications through one or more intervening applications, and any patent or application acquired as a result of prevailing in any interference proceeding (the “ Patent Rights ”); (ii) all inventions (whether patentable or not), invention disclosures, trade secrets, proprietary information, know-how, technology, technical data and customer lists, and all documentation in any form or media relating to any of the foregoing; (iii) all copyrights, copyrights registrations and applications therefor, and all other rights corresponding thereto throughout the world; (iv) all databases and data collections and all rights therein throughout the world; (v) all trade names, logos, common law trademarks and service marks, trademark and service mark registrations and applications therefore throughout the world; and (vi) all domain names, uniform resource locators, and other names and locators associated with the internet.

1.3.4

The “ Inventors ” – As specifically detailed in Appendix A attached hereto and constituting an integral part thereof. Such Inventors are inventors who have been employed by Sheba.

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

1.3.5

The “Company’s IP”: shall mean (i) the Intellectual Property owned, registered or controlled by the Company which is specified in Appendix B attached hereto ; (ii) any continuations in part of the Company’s IP listed in Appendix B ; and (iii) any Intellectual Property to the extent that it is dated prior to the date hereof and incorporates and /or based upon the patents specified in Appendix B and/or any Intellectual Property to the extent that it is dated prior to the date hereof and that the patents listed in Appendix B are based thereon.

1.3.6

The “ Products ” shall mean any product, agent, process, or service device which is covered by or is produced or manufactured or rendered (as the case may be) using a process or method covered by the Company’s IP.

1.3.7

“ Net Sales ” shall mean the total amount invoiced by or on behalf of VBL or any of its Affiliates or Licensees, in connection with the sale of a Product after deduction of: (i) value added taxes, excise and sales taxes, or other similar taxes imposed on such sales (excluding income or franchise taxes of any kind) (ii) amounts credited by a credit note; and (iii) reasonable quantities for promotional purposes, and compassionate uses; provided however that the Company doesn’t receive any consideration relating thereto;

For the purpose hereof: (a) with respect to sales which are not at arm’s length and/or are not according to the current market conditions for such a sale, the term “Net Sales” shall mean the total amount that would have been paid in an arm’s length sale made according to the current market conditions for such sale or according to market conditions for sale of products similar to the Products; (b) with respect to sales by VBL and/or a Licensee, as applicable, to any Affiliate, the term, “Net Sales” shall mean the higher of: (i) “Net Sales”, as defined above in paragraph (a) and (ii) the total amount invoiced by such affiliated entity on resale to an independent third party purchaser and (c) with respect to sales for non-monetary consideration for any Products, “Net Sales” shall be calculated based on the higher of: (i) “Net Sales”, as defined in paragraph (a) above; and (ii) the total amount invoiced by the party acquiring the Products in such transaction in each case, after deducting the amounts permitted above, to the extent applicable.

1.3.8

“ License ” shall mean the grant of any right or license and any agreement executed, by VBL to or with any entity, permitting any use of Company’s IP (or any part thereof) including for the development and/or manufacture and/or marketing and/or distribution and/or sale of Company’s IP, and/or the Products and the term “ Licensee ” shall be construed accordingly.

1.3.9

“ License Fee ” shall mean the consideration of any type or nature, received (for the removal of doubt, whether received before or after the First Commercial Sale in any country) by the Company in return for or in connection with the grant of Licences or the grant of an

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

option for a Licence, and excluding amounts received by the Company which are included under the definition of “Net Sales” based on sales of the Products by Licensees, in respect of which the Company has paid royalties to THM according to this Agreement or otherwise constitute payment upon Exit Event according to this Agreement; License Fee shall include any lump sums, revenues from License Fees, milestone payments, etc. but shall specifically exclude reimbursement for research and development and patent related expenses/reimbursement for payments specifically committed to cover costs reasonably and actually incurred by Company under, and in accordance with detailed budgets and workplans included in, license agreements with Licensees. Any consideration other than cash payment shall be calculated based on the fair market value of such consideration assuming an arm’s length transaction made in the ordinary course of business. Upon request, the Company shall provide THM with all documents and figures reasonably necessary in order to verify Company’s compliance with this clause.

1.3.10

“ First Commercial Sale ” shall mean with respect to any Product in any country, the first commercial sale of the Product in such country after FDA Approval for marketing or equivalent approval in such country has been obtained if such approval is required.

2.	PARTIES’ DECLARATIONS AND UNDERTAKINGS

2.1

THM undertakes and covenants as follows:

2.1.1

Subject to the performance of the Company’s obligations hereunder, THM hereby irrevocably confirms on behalf of the Hospital and the Fund that such entities, or anyone on their behalf do not have any further right to receive any payment, compensation, funds or securities from Prof. Dror Harats and/or from the Company (including its officers, directors, shareholders, employees, affiliates, successors and assigns, whether current, past or in the future) and/or the Inventors (the “ Released Parties ”) deriving from any claim of ownership in the Company’s IP, and hereby irrevocably waives and releases acquits and forever discharges each of the Released Parties from any and all rights, claims, demands, commitments, actions, charges, complaints, promises, agreements, controversies, debts, counterclaims, suits, causes of action, damages, liabilities, obligations, costs and expenses of every kind and nature whatsoever, known or unknown, past, present or future, at law or in equity, contingent or otherwise (collectively, a “ Claim ”), such parties, including their successors and/or assigns, may have, as a result of a claim of ownership in the Company’s IP now or in the future, (“ Released Matters ”).

2.1.2

Notwithstanding anything to the contrary in this Agreement, it is hereby clarified that the above waiver specified in this clause 2.1.1, applies and relates only to any part of the Company’s IP which is created, conceived and/or developed by the Inventors and not to Company’s IP or any part thereof or any other Intellectual Property

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

owned by the Company which is created, conceived and/or developed by any other inventors, employees, agents and/or contractors on behalf of the Company to the extent they are not listed in Appendix A .

2.1.3

Prof Harats shall be entitled to serve as Chief Executive Officer and member of the Board of Directors of the Company to develop intellectual property that constitutes continuations in part of the Company IP and subject to duly filing the required reports to THM and to the Ministry of Health, to receive compensation in shares and in cash, without any further claim by the Releasing Parties.

2.2

Each party hereby represents and warrants that: (a) it has the power and authority to execute and deliver this Agreement, and to perform its obligations hereunder, and that the execution, delivery and performance by it of this Agreement and its compliance with the terms and provisions hereof do not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) any loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) any other right or obligation provided under any other agreement or obligation that it has with any third party; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; (b) the Agreement is a binding enforceable obligation of such Party; and (c) no consent, approval, authorization order, filing, registration, or qualification of or with any court, governmental authority, or third person is required to be made or obtained by a party in connection with the execution and delivery of this Agreement or the consummation by a party of the transactions contemplated hereby, which has not been received.

3.	LICENSE BY THE COMPANY

VBL undertakes that any License granted by it shall be subject to the following terms:

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

3.1

The License is granted according to a written appropriate and binding agreement. The material terms of each License will be disclosed orally by the legal counsel of VBL to the head of THM prior to the execution of any License agreement. Following execution of any such agreement, the Company will either (i) provide a copy of such agreement to THM; or (ii) if the provision of a copy of such agreement is not allowed under the terms thereof, disclose to THM’s attorney and its accounting firm the material terms of such agreement, including without limitation, any terms that have bearing upon the consideration payable to THM hereunder. Such disclosure to THM’s attorney or CPA shall be subject to their execution of a non disclosure agreement. The Company shall verify that the License includes terms that will allow the disclosure of the material terms thereof to THM or to a third party to be designated by THM, and shall comply with such terms.

3.2

The License is being granted in a bona fide arms-length commercial transaction.

3.3

Non monetary consideration, if any, shall be valued as set forth in this Agreement.

4.	CONSIDERATION TO THM

4.1

VBL undertakes to pay THM the following amounts on a Product-by-Product and country-by-country basis until the later to occur of: (i) the last to expire or terminate of any of the Patent Rights covering such Product in such country; or (ii) fifteen (15) years from the date of the First Commercial Sale of such Product in such country:

4.1.1

Royalties. VBL shall pay THM 1% (one percent) of Net Sales by or on behalf of VBL or any Affiliate or any Licensee (the “ Royalties ”).

4.1.2

Licensing Consideration. VBL shall pay THM 2% (two percent) of any License Fee received by VBL (the “Licensing Consideration ”).

4.2

The amounts payable to THM under clause 4.1 shall be paid as follows:

4.2.1

Royalties, as specified in sub-clause 4.1.1 in connection with Net Sales by VBL and its Affiliate, shall be paid on a quarterly basis, within 60 (sixty) days after the end of each quarter in which the respective sale took place, commencing on the first quarter where the First Commercial Sale took place. Royalties in connection with Net Sales by a Licensee shall be paid on a quarterly basis, within 60 (sixty) days after the end of each quarter in which VBL receives payment on account of Net Sales.

4.2.2

Licensing Consideration, as specified in sub-clause 4.1.2 shall be paid within 30 (thirty) business days from receipt of any License Fee by the VBL.

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

4.3

Consideration from Exit . Upon the closing of each Exit Event, as defined bellow, THM shall be entitled to receive from the Company 1% (one percent) of any and all consideration received by the Company and/or its shareholders as a result of or in connection with such Exit Event (“ Consideration From Exit” ).

Consideration from Exit Event under clause 4.3 shall be paid in cash within 15 (fifteen) days from the closing of the Exit Events defined above. To the extent that the applicable Exit Event is an IPO or the consideration is in kind and not cash payment then the Company may pay the Consideration From Exit within 12 months following the closing of the respective Exit Event.

“ Exit Event ” means any of the following events: (i) the closing of the merger or consolidation of VBL into or with other corporation or the acquisition of the Company thereby, excluding a transaction following which VBL is the surviving corporation and the shareholders of VBL prior to the transaction constitute the majority of the shareholders following such transaction; or (ii) the closing of the sale of all or substantially all of the assets of VBL or all or substantially all of its issued and outstanding share capital or (iii) the closing of an Initial Public Offering (“ IPO ”). Notwithstanding the above, in all cases, a transaction with a wholly owned subsidiary or a transaction effected for the purpose of changing the domicile or structure of VBL shall not be deemed an Exit Event.

4.4.

Payment obligations under clause 4 shall expire if the payment to THM upon or prior to such Exit Event (but not by way of payment of Royalties under clause 4.1.1) is or exceeds NIS100 million. In addition, at any time following the execution hereof the Company, its assignees or successors shall be entitled to terminate the payment obligations under clause 4 by payment to THM of the amount of NIS100 million after deduction of any amount previously received by THM, provided that such amounts were not received by THM as Royalties under clause 4.1.1.

4.5

All amounts set forth herein are inclusive of any and all taxes. The Company (or the escrow agent, if applicable) shall be entitled to deduct at source or withhold from any amount payable hereunder any tax amount applicable to THM in connection with each payment.

4.6

The Company shall report in writing to THM immediately upon execution of an agreement relating to the First Commercial Sale and upon the occurrence of such first Commercial Sale. The Company shall specify in such report the date of execution of such agreement and the date of the First Commercial Sale according to the agreement.

4.7

In calculating Net Sales and License Fee, all amounts shall be expressed in US Dollars and any amount received or invoiced in a currency other than US Dollars shall be translated into US Dollars, for the purposes of calculation, in accordance with the exchange rate between the US Dollar and such currency on the date of such receipt or invoice, as the case may be.

4.8

The Company shall provide THM with the following written reports: (a) a detailed quarterly report, commencing with the first calendar quarter in which any Net Sales are made, or License Fee received, in a form reasonably acceptable to THM, signed by the chief financial officer of VBL,

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

specifying all amounts payable to THM under this clause 4 in respect of the previous quarter to which the report refers. Such report shall include: (i) the sales made by the Company, Affiliates and Licensees with a breakdown of Net Sales according to country, identity of seller, currency of sales, dates of invoices, number and type of Products sold and; (ii) License Fee with a breakdown according to identity of Licensees, countries, the currency of the payment and date of receipt thereof; and (iii) deductions applicable, as provided in the definition of “Net Sales”; (b) a detailed report within twenty one (21) days of an Exit Event specifying the nature of the Exit Event, the consideration to be received by the Company or its shareholders in connection with such Exit Event and all other substantial terms and details of such Exit Event and enclose to the report any agreement executed in connection with such Exit Event immediately following the execution thereof; and (iv) any other matter, data and documents reasonably required by THM and existing with VBL in order to calculate and/or verify the amounts payable hereunder; and (c) Within four months after the end of each fiscal year, the Company will provide THM with a detailed report, certified by VBL’s Chairman of the Board and by its independent auditor, stating all amounts due to THM pursuant to this clause 4 in the reported year including relevant invoices issued and all invoices and all payments received by the Company with respect to details specified in the above reports; 21 days prior to an Exit Event he material terms of such Exit will be disclosed orally by the legal counsel of VBL to the head of THM.

4.9

The Company shall keep and shall cause Licensees to keep complete, accurate and correct books of account and records consistent with sound business and accounting principles and practices.

4.10

Following the First Commercial Sale, THM shall be entitled to appoint an independent auditor selected by it to inspect, after coordination with VBL and during VBL’s regular business hours, all records, and documents of VBL as may contain information bearing upon the amounts payable to THM under this clause 4. The Company shall take all steps necessary so that all such books of account, records and other documentation of VBL and its Licensees and Affiliates are available for inspection as aforesaid for each of the Company and its Licensees and Affiliates. The cost of such auditing shall be borne by VBL if the audit uncovers an underreporting of the corresponding amounts owed to THM by more than ten percent (10%). Otherwise, such costs and expenses shall be borne by THM. VBL shall remedy such discrepancy and pay (i) the shortfall within thirty (30) days of the date of discovery; and (ii) interest thereon at the rate of 4% above the London Interbank Offered Rate (LIBOR) applicable to a 12 month USD deposit, as such rate shall be in effect on each Disbursement Date. The Interest shall be compounded annually and computed on the basis of a 360 day year.

4.11

Upon THM’s request but not more than once every six months, the Company shall provide THM with a progress report specifying the following details, as updated from the last report: (i) the activities the

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

Company conducted for the development of Products; and (ii) sales and marketing efforts.

5.	INDEMNITY

5.1

VBL undertakes to indemnify and hold harmless THM, the Fund, the Hospital, the State of Israel, and their employees, representatives, agents and contractors (the “ THM Beneficiaries ”) against and from any loss, liability, claims, damages or expenses of whatever kind or nature incurred by or imposed upon the THM Beneficiaries, to the extent arising out of or resulting from (i) the use and/or exploitation of the Company’s IP or any use of any products incorporating the Company’s IP or any part thereof and/or manufactured or developed based upon the Company’s IP; and (ii) to the extent that it is based on a claim that the Company’s IP, the Products or other material produced or developed or marketed by or on behalf of VBL or any of its Affiliates or Licensee infringes any third party’s intellectual property rights including copyright, trade secret, patent, trademark (a “THM Claim” ).

5.2

5.3

The following mechanism shall apply to any THM Claim pursuant to clause 5.1. If any THM Beneficiary receives notice of any THM Claim, such THM Beneficiary shall, as promptly as is reasonably possible, give VBL notice of such THM Claim. The failure to give such notice promptly shall relieve VBL of any indemnification obligation it may have hereunder to the extent such failure diminishes its ability to respond to or to defend the Beneficiary against such THM Claim. VBL shall exclusively assume the defence or represent the interests of the THM Beneficiary in respect of such THM Claim, that shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the THM Beneficiary and to propose, accept or reject offers of settlement, all at its sole cost and discretion.

5.4

VBL, at its own expense, shall maintain insurance in an amount consistent with industry standards which provides VBL adequate coverage for (i) performing clinical studies of the Product in humans, (ii) product liability and (iii) commercial sales of applicable and relevant Products.

6.	PATENT RIGHTS

In the event that the Company decides to abandon its patents in all applicable jurisdictions in connection with its intent to stop its entire business activities of either of its two business units, then with respect to such Patent Rights that are included in the Company’s IP, the Company will inform THM (“ VBL Notice ”) of its intention prior to the abandonment of any such Patent Rights.

THM shall have the right to continue to support and maintain any such Patent Rights provided that it notifies VBL of its intention within 30 days following the receipt of VBL Notice, and provided further that within 60 days following the notice by THM, the parties reach an agreement for the assignment or license of such Patent Rights to THM. The parties shall negotiate such agreement in good faith. The parties further agree that such agreement shall provide VBL with payments similar to those set forth in clause 4

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

and that any such agreement shall be subject to any limitations and restrictions imposed by applicable third parties, including without limitation, the Office of the Chief Scientist and shall be subject to the assumption by THM of any repayment obligations thereto. THM right hereunder shall lapse and be of no further force and effect, in the event that THM fails to timely respond to VBL Notice, indicates that it is not interested in the Patent Rights or otherwise the parties fail to reach an agreement as aforesaid during the 90 day period.

7.	MISCELLANEOUS

7.1

Law and Venue . All disputes arising in connection with this Agreement shall be settled amicably in the first instance. If amicable settlement cannot be reached by the Parties within 15 (fifteen) days from the day either Party approached the other Parties specifying the essence of the dispute, the dispute shall be settled by 1 (one) arbitrator. If the Parties fail to reach an agreement on the nomination of the arbitrator within 30 (thirty) days of the date when the claimant’s request for arbitration was communicated by the other Parties, the appointment shall be made by the Head of the Israel Bar. The arbitration will be conducted in Tel Aviv, Israel. The Parties shall be entitled to seek interim measures of protection in the form of pre-award attachment of assets or injunctive relief. The tribunal shall issue a reasoned award. Such award may grant any relief appropriate under applicable law including without limitation declaratory relief and/or specific performance. As part of its award the tribunal may award attorneys fees and costs to the prevailing party. The award of the arbitrator shall be final and binding upon the Parties, but subject to appeal, with respect to the disputes so submitted and the costs of such arbitration. The law that shall apply shall be the statutes and laws of the State of Israel.

7.2

Use of Names . The Company shall not use the names of the State Of Israel, Hospital, the Fund and/or THM and/or their employees, representatives, agents and contractors in any manner or in any publication including commercial publicity, without the prior written consent of THM.

7.3

Assignment . This Agreement shall be personal to the parties and therefore the Parties may not assign any of their rights or obligations hereunder without the prior written consent of the other party. Notwithstanding the aforementioned, THM shall be entitled to assign the right to receive payments under this Agreement to any association and/or organization and or company that was established in connection with or for the benefit of the Hospital. In addition, VBL may, without the consent of THM, assign this Agreement and the rights, obligations and interests of VBL, in whole, to any purchaser of all or substantially all of its assets, or to any successor corporation resulting from any merger or consolidation of VBL with or into such corporation, provided that any such assignee agrees in writing to be bound by all the terms of this Agreement.

7.4

Notices . Except as otherwise provided in this Agreement, all notices permitted or required by this Agreement shall be in writing and shall be deemed to have been duly served (i) upon personal delivery (ii) upon facsimile transmission (receipt of which has been orally confirmed by the recipient) or (iii) Seven (7) business days after deposit, postage prepaid,

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

return receipt requested, if sent by Registered Mail and addressed to the address of the parties first above stated or in accordance with such other address information as the party to receive notice may provide in writing to the other party in accordance with the above notice provisions. Any notice given by any other method will be deemed to have been duly served upon receipt thereof.

7.5

Waivers . No course of dealing in respect of, nor any omission or delay in the exercise of, any right, power, or privilege by either Party shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any further or other exercise thereof or of any other, as each such right, power, or privilege may be exercised either independently or concurrently with others and as often and in such order as each party may deem expedient.

7.6

Entire Agreement; Amendments . This Agreement, including, without limitation, its schedules, contains the entire agreement of the parties with respect to its subject matter. No oral or prior written statements or representations not incorporated herein shall have any force or effect, nor shall any part of this Agreement be amended, supplemented, waived or otherwise modified except in a writing signed by both parties.

7.7

Confidentiality . Each party undertakes to the other party that all confidential information disclosed by a party to the other party hereunder or as a result of this Agreement, including the terms and conditions set forth herein, will be kept in the strictest confidence and will not, without the prior written consent of the disclosing party, be used by the receiving party or be disclosed to, or discussed with, any third party whatsoever. The above undertaking of confidentiality will not apply to information which: (i) is in the public domain at the time of disclosure; or (ii) subsequently becomes part of the public domain, except by breach by the receiving party of its obligations, or (iii) is received from a third party who is not under an obligation of confidentiality to the disclosing party. VBL may disclose, on a confidential basis, the terms of this Agreement to its Board of Directors, shareholders, potential investors, acquirers or licensees in the process of due diligence reviews of its contracted obligations, assets and undertakings.

7.8

THM hereby declares that Sheba’s management reached an understanding with the management of Tel Aviv University (“ TAU ”), that as between the Hospital and TAU, inventions of TAU professors who work as medical doctors for Sheba such as Prof. Dror Charats, Prof. Shoenfeld and Prof. Gerge Jacob, shall belong to Sheba.

[Remainder of the Page was left intentionally blank]

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

IN WITNESS WHEREOF , the parties hereto have caused this Agreement to be duly executed and each of the undersigned hereby warrants and represents that it has been and is, on the date of this Agreement, duly authorized by all necessary and appropriate action to execute this Agreement.


Tel Hashomer - Medical Research,		Vascular Biogenics Ltd.
Infrastructure and Services Ltd.

By:	/s/ [Illegible]	By:	/s/ Dror Harats

/s/ Dror Harats Prof. Dror Harats

Approved and Acknowledged

/s/ [Illegible] The Government of Israel By the Ministry of Health

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

Appendix A

INVENTORS

1. Prof. Dror Harats

2. Shoenfeld Yehuda

3. George Jacob

4. Halperin Gideon – up to 2003

5. Bloom Nira

6. Greenberger Shoshana

7. Tal Reshef

8. Peled Michael

*	detailed list of inventions is provided under Appendix B .

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

Appendix B’ up to 3 Feb 2013

METHODS AND COMPOSITIONS FOR ENHANCING TARGETING OF VIRAL VECTORS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

ISOLATED POLYNUCLEOTIDES AND NUCLEIC ACID CONSTRUCTS FOR DIRECTING EXPRESSION OF A GENE-OF-INTEREST IN CELLS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

52423

PCT

19-Oct-2010

12/10/2011

3182.041PC01

Pending

TREATMENT WITH VB-201

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

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

[***]

50378

PCT

05-Jan-2010

61/292,226

05-Jan-2011

IL2011/000012

Publ. Date: 14-Jul-2011

Publ. #: WO2011/083469

3182.018PC05

Expired

YACOV Niva; BREITBART
Eyal; MENDEL Itzhak; FEIGE
Erez; COHEN Yael

PAF-LIKE HOMOLOGS AND USES THEREOF

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

44504

PCT

16-Oct-2007

60/960,846

05-Oct-2008

IL2008/001315

Publ. Date: 23-Apr-2009

Publ. #: WO2009/050692

Expired

YACOV Niva; BREITBART
Eyal; MENDEL Itzhak

48215

Israel

16-Oct-2007

60/960,846

15-Apr-2010

05-Oct-2008

205144

3182.019IL01

Aban

YACOV Niva; BREITBART
Eyal; MENDEL Itzhak

48216

USA

16-Oct-2007

60/960,846

15-Apr-2010

05-Oct-2008

12/738,097

3182.0190001

Aban

YACOV Niva; BREITBART
Eyal; MENDEL Itzhak

48217

Europe

16-Oct-2007

60/960,846

14-May-2010

05-Oct-2008

08808113.8

3182.019EP01

Aban

YACOV Niva; BREITBART
Eyal; MENDEL Itzhak

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

IMPROVED SYNTHESIS OF OXIDIZED PHOSPHOLIPIDS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

IMPROVED PROCESS FOR THE PREPARATION OF OXIDIZED PHOSPHOLIPIDS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

28367

PCT

09-Jul-2004

60/586,219

10-Jul-2005

IL2005/000735

Publ. Date: 19-Jan-2006

Publ. #: WO2006/006161

Expired

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33799

Israel

09-Jul-2004

60/586,219

09-Jan-2007

10-Jul-2005

1-Mar-2012

180628

3182.020IL00

GRANTED

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

50430

Israel

DIV

09-Jul-2004

60/586,219

17-Mar-2011

10-Jul-2005

211795

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

50431

Israel

DIV

09-Jul-2004

60/586,219

17-Mar-2011

10-Jul-2005

211796

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33793

Europe

09-Jul-2004

60/586,219

09-Feb-2007

10-Jul-2005

05758938.4

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33793 Div

Europe

Div

09-Jul-2004

60/586,219

Oct 2012

10-Jul-2005

3182.020EP10

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

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

33793 Div

Europe

Div

09-Jul-2004

60/586,219

Oct 2012

10-Jul-2005

12179533.0

3182.020EP20

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

39643

Hong Kong

09-Jul-2004

60/586,219

31-May-2007

10-Jul-2005

07105789.7

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33795

Canada

09-Jul-2004

60/586,219

09-Jan-2007

10-Jul-2005

2,573,396

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33796

Japan

09-Jul-2004

60/586,219

09-Jan-2007

10-Jul-2005

2007-519983

24-Jun-2011

4,767,948

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

48896

Japan

DIV

09-Jul-2004

60/586,219

21-May-2010

10-Jul-2005

2010-116964

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33797

Republic of Korea

09-Jul-2004

60/586,219

09-Feb-2007

10-Jul-2005

2007-7003288

9-Nov-2012

10-1201935

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33798

China

09-Jul-2004

60/586,219

28-Feb-2007

10-Jul-2005

200580029218.9

3-Aug-2011

200580029218.9

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

48018

China

DIV

09-Jul-2004

60/586,219

11-Feb-2010

10-Jul-2005

201010128184.1

Pending

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

[***]

33801

Russian Federation

09-Jul-2004

60/586,219

09-Feb-2007

10-Jul-2005

2007105097

20-Sep-2010

2399626

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

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

33802

Mexico

09-Jul-2004

60/586,219

08-Jan-2007

10-Jul-2005

MX/a/
2007/000361

17-Mar-2011

284830

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33803

Australia

DIV

09-Jul-2004

60/586,219

09-Jan-2007

10-Jul-2005

2007200090

5 Jan 2012

3182.020AU00

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

50536

Mexico

DIV

09-Jul-2004

60/586,219

14-Jan-2011

10-Jul-2005

MX/a/
2011/000630

3 Sep 2012

303011

Granetd

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33804

New Zealand

09-Jul-2004

60/586,219

09-Feb-2007

10-Jul-2005

553147

06-Nov-2010

553147

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

48999

New Zealand

DIV

09-Jul-2004

60/586,219

29-Jun-2010

10-Jul-2005

586503

10 Oct 2011

586503

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

33805

South Africa

09-Jul-2004

60/586,219

10-Jul-2005

2007/01178

25-Sep-2008

2007/01178

Granted

HALPERIN Gideon;
KOVALEVSKI-ISHAI Eti

PROMOTERS EXHIBITING ENDOTHELIAL CELL SPECIFICITY AND METHODS OF USING SAME

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

02/23345

USA

CIP

17-Nov-2000

60/248,582

01-May-2002

10/135,447

27-Jun-2006

7,067,649

Granted

HARATS Dror; BREITBART
Eyal; BLOOM Nira

28786

USA

DIV

17-Nov-2000

60/248,582

29-Oct-2004

01-May-2002

10/975,619

25-Aug-2009

7,579,327

Granted

HARATS Dror; BREITBART
Eyal; BLOOM Nira

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

45023

USA

DIV

17-Nov-2000

60/248,582

03-Jun-2009

01-May-2002

12/457,200

Pending

HARATS Dror; BREITBART

Eyal; BLOOM Nira

50926

USA

DIV

17-Nov-2000

60/248,582

27-Apr-2011

01-May-2002

13/094,900

Pending

HARATS Dror; BREITBART

Eyal; BLOOM Nira

53777

USA

DIV

17-Nov-2000

60/248,582

24-April 2012

01-May-2002

13/454,171

3182.0350004

Pending

HARATS Dror; BREITBART

Eyal; BLOOM Nira

25974

PCT

01-May-2002

10/135,447

30-Apr-2003

IL03/00347

Publ. Date: 13-
Nov-2003

Publ. #: WO03/093409

Expired

HARATS Dror

28650

Singapore

01-May-2002

10/135,447

01-Nov-2004

30-Apr-2003

200406381-4

30-May-2008

107841 [WO 03/093409]

Granted

HARATS Dror; BREITBART

Eyal; BLOOM Nira

28655

South Africa

01-May-2002

10/135,447

05-Nov-2004

30-Apr-2003

2004/8989

26-Jul-2006

2004/8989

Granted

HARATS Dror; BREITBART

Eyal; BLOOM Nira

[***]

28646

Japan

01-May-2002

10/135,447

01-Nov-2004

30-Apr-2003

2004-501545

Abandoned

HARATS Dror

[***]

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

[***]

28651

Canada

01-May-2002

10/135,447

01-Nov-2004

30-Apr-2003

2,483,996

Abandoned

HARATS Dror; BREITBART
Eyal; BLOOM Nira

28652

Mexico

01-May-2002

10/135,447

28-Oct-2004

30-Apr-2003

PA/a/2004/010711

Abandoned

HARATS Dror; BREITBART
Eyal; BLOOM Nira

[***]

COMBINED TREATMENT UTILIZING VB-201

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

50379

PCT

05-Jan-2010

61/292,226

05-Jan-2011

IL2011/000010

Publ. Date: 14-Jul-2011

Publ. #: WO2011/083467

Expired

YACOV Niva; BREITBART
Eyal; COHEN Yael

US NP

05-Jan-2010

61/292,226

5-July 2012

05-Jan-2011

13/520,713

3182.0160005

Pending

YACOV Niva; BREITBART
Eyal; COHEN Yael

EP NP

05-Jan-2010

61/292,226

1-Aug 2012

3182.016EP05

Pending

YACOV Niva; BREITBART
Eyal; COHEN Yael

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

JP NP

05-Jan-2010

61/292,226

4-July 2012

3182.016JP05

Pending

YACOV Niva; BREITBART
Eyal; COHEN Yael

POLYPEPTIDES AND POLYNUCLEOTIDES ENCODING SAME AND USE THEREOF IN THE TREATMENT OF MEDICAL CONDITIONS ASSOCIATED WITH ISCHEMIA

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

41795

PCT

31-Jul-2006

60/834,157

31-Jul-2007

IL2007/000959

Publ. Date: 07-Feb-2008

Publ. #: WO/2008/015675

Expired

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

45501

China

31-Jul-2006

60/834,157

26-Mar-2009

31-Jul-2007

200780035863.0

8-Aug 2012

ZL20078003 5863.0

3182.040CN01

Granted

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

54283

China

Div

31-Jul-2006

60/834,157

26-June-2012

31-Jul-2007

201210210646.3

3182.040CN11

Pending

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

45495

USA

31-Jul-2006

60/834,157

02-Feb-2009

31-Jul-2007

12/309,856

Abandoned

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

51521

USA

DIV

31-Jul-2006

60/834,157

20-Jun-2011

31-Jul-2007

13/163,776

Pending

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

45496

Israel

31-Jul-2006

60/834,157

29-Jan-2009

31-Jul-2007

196792

Pending

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

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

[***]

45499

Australia

31-Jul-2006

60/834,157

02-Feb-2009

31-Jul-2007

2007280017

26-July 2012

2007280017

3182.040AU01

Granted

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

54370

Australia

Div

31-Jul-2006

60/834,157

12-July 2012

31-Jul-2007

2012204128

3182.040AU11

Pending

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

45500

Japan

31-Jul-2006

60/834,157

02-Feb-2009

31-Jul-2007

2009-522416

Pending

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

45502

Republic of Korea

31-Jul-2006

60/834,157

27-Feb-2009

31-Jul-2007

2009-7004288

Abandoned

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

45503

Mexico

31-Jul-2006

60/834,157

29-Jan-2009

31-Jul-2007

MX/a/
2009/001157

Pending

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

45504

New Zealand

31-Jul-2006

60/834,157

26-Jan-2009

31-Jul-2007

574410

9 July 2012

574410

3182.040NZ01

Granted

TAL Reshef; BREITBART
Eyal; BANGIO Livnat

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

45505

South Africa

31-Jul-2006

60/834,157

26-Jan-2009

31-Jul-2007

2009/00581

31-Mar-2010

2009/00581

Granted

TAL Reshef; BREITBART

Eyal; BANGIO Livnat

45506

Singapore

31-Jul-2006

60/834,157

30-Jan-2009

31-Jul-2007

200900642-0

30-Jun-2011

149616[WO2008/015675]

Granted

TAL Reshef; BREITBART

Eyal; BANGIO Livnat

TREATMENT WITH VB-201

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

50377

PCT

05-Jan-2010

61/292,226

05-Jan-2011

IL2011/000008

Publ. Date: 14-Jul-2011

Publ. #: WO2011/083465

Expired

YACOV Niva; BREITBART
Eyal; MENDEL Itzhak;
SHER Naamit; COHEN Yael

US NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.0170005

Pending

AU NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017AU05

Pending

[***]

CANADA NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017CA05

Pending

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

China NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017CN05

Pending

HK NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017HK05

Pending

EP NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017EP05

Pending

[***]

Japan NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017JP05

Pending

South Korea NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017KR05

Pending

MX NP

05-Jan-2010

61/292,226

June 2012

05-Jan-2011

3182.017MX05

Pending

[***]

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

ANTI-ANGIOGENIC ADENOVIRUS VECTOR SUITABLE FOR CLINICAL APPLICATIONS AND METHODS FOR PRODUCTION THEREOF

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

METHODS OF PRODUCING ADENOVIRUS VECTORS AND VIRAL PREPARATIONS GENERATED THEREBY

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

49684

PCT

12-Jan-2010

61/294,158

12-Jan-2011

IB2011/050137

Publ. Date: 21-Jul-2011

Publ. #: WO2011/086509

Expired

BREITBART Eyal; BANGIO
Livnat; SHER Naamit

US NP

12-Jan-2010

61/294,158

June 2012

12-Jan-2011

3182.0330001

Pending

BREITBART Eyal; BANGIO
Livnat; SHER Naamit

EP NP

12-Jan-2010

61/294,158

June 2012

12-Jan-2011

3182.033EP01

Pending

BREITBART Eyal; BANGIO
Livnat; SHER Naamit

[***]

JP NP

12-Jan-2010

61/294,158

June 2012

12-Jan-2011

3182.033JP01

Pending

BREITBART Eyal; BANGIO
Livnat; SHER Naamit

[***]

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

IMMUNOMODULATION (IMMUNIZATION AND TOLERANCE) OF APO-E DEFICIENT MICE WITH 1 HEXADECINYL 2-5’ OXOPENTYL PHOSPHATIDYCHLOLINE (2-5 ALLE-ALDEHYDE LECITIN ETHER) SUPPRESSES EARLY ATHEROGENESIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

METHODS EMPLOYING AND COMPOSITIONS CONTAINING DEFINED OXIDIZED PHOSPHOLIPIDS FOR PREVENTION AND TREATMENT OF ATHEROSCLEROSIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

01/22753

PCT

24-Nov-2000

60/252,574

22-Nov-2001

IL01/01080

Publ. Date: 30-May-2002

Publ. #: WO02/41827

Expired

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26035

Europe

22-Nov-2000

60/252,574

15-May-2003

22-Nov-2001

01997274.4

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

52529

EP Div

22-Nov-2000

60/252,574

17-Nov 2011

22-Nov-2001

11189562.9

3182.021EP11

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

27265

Hong Kong

24-Nov-2000

60/252,574

12-Dec-2003

22-Nov-2001

03109096.1

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26036

Israel

22-Nov-2000

60/252,574

20-May-2003

22-Nov-2001

156015

10-May-2008

156015

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

32434

Israel

DIV

24-Nov-2000

60/252,574

20-Jul-2006

22-Nov-2001

176976

1-Dec 2012

176976

3182.021IL11

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

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

26037

India

22-Nov-2000

60/252,574

22-May-2003

22-Nov-2001

796/CHENP/2003

19-Sep-2008

223638

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26039

Canada

22-Nov-2000

60/252,574

22-May-2003

22-Nov-2001

2,429,817

3182.021CA01

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26040

Australia

22-Nov-2000

60/252,574

23-May-2003

22-Nov-2001

2002218461

21-Dec-2006

2002218461

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26041

Japan

22-Nov-2000

60/252,574

23-May-2003

22-Nov-2001

2002-544008

01-Aug-2008

4,162,486

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

44299

Japan

DIV

24-Nov-2000

60/252,574

10-Jun-2008

22-Nov-2001

2008-151301

25 May 2012

5001906

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26042

China

22-Nov-2000

60/252,574

22-Jul-2003

22-Nov-2001

01822215.3

06-Jan-2010

ZL01822215.3

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26043

Republic of Korea

22-Nov-2000

60/252,574

24-May-2003

22-Nov-2001

2003-7006991

17-Oct-2008

865142

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

26044

Mexico

22-Nov-2000

60/252,574

22-May-2003

22-Nov-2001

PA/a/2003/004517

02-Sep-2009

269738

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

46494

Mexico

DIV

24-Nov-2000

60/252,574

12-Jun-2009

22-Nov-2001

MX/a/2009/006365

2 December 2011

293020

3182.021MX11

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

PROMOTERS EXHIBITING ENDOTHELIAL CELL SPECIFICITY AND METHODS OF USING SAME FOR REGULATION OF ANGIOGENESIS

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

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

36194

USA

CIP

17-Nov-2000

60/248,582

30-Apr-2007

11/790,992

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

43177

PCT

30-Apr-2007

11/790,992

27-Apr-2008

IL2008/000543

Publ. Date: 06-Nov-2008

Publ. #: WO2008/132729

Expired

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47030

Europe

30-Apr-2007

11/790,992

27-Nov-2009

27-Apr-2008

08738245.3

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

48882

Hong Kong

30-Apr-2007

11/790,992

11-Jun-2010

27-Apr-2008

10105838.3

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47031

Japan

30-Apr-2007

11/790,992

30-Oct-2009

27-Apr-2008

2010-505002

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47032

Canada

30-Apr-2007

11/790,992

27-Oct-2009

27-Apr-2008

2,685,394

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47033

China

30-Apr-2007

11/790,992

30-Dec-2009

27-Apr-2008

200880022935.2

3182.039CN01

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

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

47034

Australia

30-Apr-2007

11/790,992

27-Nov-2009

27-Apr-2008

2008243817

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47035

Republic of Korea

30-Apr-2007

11/790,992

18-Nov-2009

27-Apr-2008

2009-7024041

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

[***]

47037

Israel

30-Apr-2007

11/790,992

26-Oct-2009

27-Apr-2008

201760

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47038

Mexico

30-Apr-2007

11/790,992

29-Oct-2009

27-Apr-2008

MX/a/2009/011750

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47039

New Zealand

30-Apr-2007

11/790,992

27-Nov-2009

27-Apr-2008

581511

5 June 2012

581511

3182.039NZ01

Granetd

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47040

South Africa

30-Apr-2007

11/790,992

25-Nov-2009

27-Apr-2008

2009/08331

29-Dec-2010

2009/08331

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47041

Singapore

30-Apr-2007

11/790,992

30-Oct-2009

27-Apr-2008

200907209-1

15 May 2012

156740

3182.039SG01

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

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

THE EFFECT OF MUCOSAL TOLERANCE WITH LIPID IPOPROTEIN AND PROTEIN ANTIGENS ON ATHEROSCLEROSIS IN LDL-RECEPTOR DEFICIENT MICE

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

METHODS EMPLOYING AND COMPOSITIONS CONTAINING PLAQUE ASSOCIATED MOLECULES FOR PREVENTION AND TREATMENT OF ATHEROSCLEROSIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

01/23033

PCT

04-Jan-2001

60/259,512

03-Jan-2002

IL02/00005

Publ. Date: 11-Jul-2002

Publ. #: WO02/053092

Expired

HARATS Dror; GEORGE Jacob

26046

Israel

04-Jan-2001

60/259,512

03-Jul-2003

03-Jan-2002

156770

Allowed

HARATS Dror; GEORGE Jacob

26047

India

04-Jan-2001

60/259,512

04-Jul-2003

03-Jan-2002

1044/CHENP/
2003

19-Sep-2008

223640

Granted

HARATS Dror; GEORGE Jacob

26048

USA

04-Jan-2001

60/259,512

02-Jul-2003

03-Jan-2002

10/451,370

09-Oct-2007

7,279,459

Granted

HARATS Dror; GEORGE Jacob

26050

Australia

04-Jan-2001

60/259,512

11-Jul-2003

03-Jan-2002

2002225301

03-Mar-2006

2002225301

Granted

HARATS Dror; GEORGE Jacob

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

26051

Japan

04-Jan-2001

60/259,512

03-Jul-2003

03-Jan-2002

2002-554043

26-Sep-2008

4,191,997

Granted

HARATS Dror; GEORGE Jacob

26052

China

04-Jan-2001

60/259,512

04-Sep-2003

03-Jan-2002

02805950.6

Pending

HARATS Dror; GEORGE Jacob

26054

Mexico

04-Jan-2001

60/259,512

01-Jun-2003

03-Jan-2002

PA/a/2003/006043

17-Mar-2009

265173

Granted

HARATS Dror; GEORGE Jacob

26045

Europe

04-Jan-2001

60/259,512

18-Jul-2003

03-Jan-2002

02715682.7

Abandoned

HARATS Dror; GEORGE Jacob

27463

Hong Kong

04-Jan-2001

60/259,512

28-Jan-2004

03-Jan-2002

04100565.1

Abandoned

HARATS Dror; GEORGE Jacob

26049

Canada

04-Jan-2001

60/259,512

03-Jul-2003

03-Jan-2002

2,433,781

Abandoned

HARATS Dror; GEORGE Jacob

[***]

FORMULATIONS AND DOSAGE FORMS OF CI-201 AND RELATED COMPOUNDS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

[***]

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

PCT

Sept. 1, 2011

61/529,989

Aug. 31, 2012

PCT/US2012/053533

3182.013PC01

Pending

SHER Naamit; YOUNG Victor M.; McNAUGHTON Alyn; WILDING Ian; BAKHSHAEE Massoud

PROMOTERS EXHIBITING ENDOTHELIAL CELL SPECIFICITY AND METHODS OF USING SAME FOR REGULATION OF ANGIOGENESIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

Status

Inventor

31577

USA

CIP

17-Nov-2000

60/248,582

23-Feb-2006

11/359,513

18 October 2011

8,039,261

3182.0380000

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

37180

PCT

23-Feb-2006

11/359,513

22-Feb-2007

IL2007/000242

Publ. Date: 30-Aug-2007

Publ. #: WO2007/096882

Expired

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

44720

USA

17-Nov-2000

60/248,582

20-Aug-2008

22-Feb-2007

12/224,178

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

44708

Europe

23-Feb-2006

11/359,513

28-Aug-2008

22-Feb-2007

07713267.8

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

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

[***]

44709

Israel

23-Feb-2006

11/359,513

19-Aug-2008

22-Feb-2007

193554

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

[***]

44711

Canada

23-Feb-2006

11/359,513

20-Aug-2008

22-Feb-2007

2,638,829

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

44712

Australia

23-Feb-2006

11/359,513

23-Sep-2008

22-Feb-2007

2007219088

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

44713

Japan

23-Feb-2006

11/359,513

25-Aug-2008

22-Feb-2007

2008-555946

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

44714

China

23-Feb-2006

11/359,513

21-Oct-2008

22-Feb-2007

200780014285.2

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

44715

Republic of Korea

23-Feb-2006

11/359,513

22-Sep-2008

22-Feb-2007

2008-7023144

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

44716

Mexico

23-Feb-2006

11/359,513

22-Aug-2008

22-Feb-2007

MX/a/2008/010859

Abandoned

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; PELED Michael; BANGIO Livnat

[***]

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

PROCESS FOR THE PREPARATION OF OXIDIZED PHOSPHOLIPIDS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

33794

USA

CIP

09-Jul-2004

60/586,219

09-Jan-2007

11/650,973

05-Oct-2010

7,807,847

3182.0200001

Granted

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

49396

USA

DIV

09-Jul-2004

60/586,219

24-Aug-2010

09-Jan-2007

12/861,921

28- Feb 2012

8,124,800

3182.0200002

Granted

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

52800

USA DIV

09-Jul-2004

60/586,219

May 24, 2012

January 26, 2012

13/358,573

3182.0200003

Pending

HALPERIN Gideon; KOVALEVSKI

USA CIP

09-Jul-2004

60/586,219

Nov. 9, 2012

13/672,811

3182.0200004

Pending

HALPERIN Gideon; KOVALEVSKI

US CON

09-Jul-2004

60/586,219

Dec. 10, 2012

13/709,198

3182.0200005

Pending

HALPERIN Gideon; KOVALEVSKI

IMPROVED PROCESS FOR THE PREPARATION OF OXIDIZED PHOSPHOLIPIDS

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

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

43029

PCT

09-Jan-2007

11/650,973

02-Jan-2008

IL2008/000013

Publ. Date: 17-Jul-2008

Publ. #: WO2008/084472

Expired

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

46756

South Africa

09-Jan-2007

11/650,973

02-Jan-2008

2009/05601

26-May-2010

2009/05601

Granted

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

46755

New Zealand

09-Jan-2007

11/650,973

07-Aug-2009

02-Jan-2008

578947

4-Dec 2011

578947

3182.020NZ01

Granted

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

51026

New Zealand

DIV

09-Jan-2007

11/650,973

15-Jun-2011

02-Jan-2008

593529

3182.020NZ11

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

[***]

46754

Australia

09-Jan-2007

11/650,973

07-Aug-2009

02-Jan-2008

2008204238

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

46753

Mexico

09-Jan-2007

11/650,973

09-Jul-2009

02-Jan-2008

MX/a/2009/007422

9-Jan 2012

294470

Granted

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

[***]

46751

Israel

09-Jan-2007

11/650,973

09-Jul-2009

02-Jan-2008

199792

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

46750

China

09-Jan-2007

11/650,973

31-Aug-2009

02-Jan-2008

200880006707.6

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

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

46749

Republic of Korea

09-Jan-2007

11/650,973

27-Jul-2009

02-Jan-2008

2009-7015780

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

46748

Japan

09-Jan-2007

11/650,973

09-Jul-2009

02-Jan-2008

2009-545295

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

46747

Canada

09-Jan-2007

11/650,973

06-Jul-2009

02-Jan-2008

2,674,902

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

46746

Europe

09-Jan-2007

11/650,973

07-Aug-2009

02-Jan-2008

08700247.3

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

Europe

Div

09-Jan-2007

11/650,973

July 27, 2012

02-Jan-2008

EP 12178298.1

3182.020EP11

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

48328

Hong Kong

16-Mar-2010

02-Jan-2008

10102729.2

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti

COMPOSITIONS AND METHODS FOR TREATING GLIOBLASTOMA GBM

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

METHODS FOR USE OF A SPECIFIC ANTI-ANGIOGENIC ADENOVIRAL AGENT

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

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

50375

PCT

05-Jan-2010

61/282,228

05-Jan-2011

IL2011/000007

Publ. Date: 14-Jul-2011

Publ. #: WO2011/083464

Expired

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

US NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.0310002

Pending

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.031EP02

Pending

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.031IL02

Pending

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

[***]

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.031JP02

Pending

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

[***]

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.031MX02

Pending

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

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

[***]

Canada

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.031CA02

Pending

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.031AU02

Pending

BREITBART Eyal; BANGIO Livnat; SHER Naamit; FEIGE Erez; COHEN Yael

COMPOSITIONS AND METHODS FOR TREATING GLIOBLASTOMA GBM

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

50376

PCT

05-Jan-2010

61/282,228

05-Jan-2011

IL2011/000009

Publ. Date: 14-Jul-2011

Publ. #: WO2011/083466

3182.032PC02

Expired

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

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

US NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.0320002

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

EU NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.032EP02

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

IL NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.032IL02

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

[***]

JP NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.032JP02

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

KR NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.032KR02

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

MX NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.032MX02

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

[***]

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

CA NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.032CA02

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

AU NP

05-Jan-2010

61/282,228

June 2012

05-Jan-2011

3182.032AU02

Pending

BREITBART Eyal; BANGIO Livnat; COHEN Yael; BRENNER Andrew J.

OXIDIZED LIPIDS AND USES THEREOF IN THE TREATMENT OF INFLAMMATORY DISEASES AND DISORDERS

Our Ref

Country

Earliest Priority

Entry
Date

Filing Date

Application No.

Issue Date

Patent No.

Status

Inventor

32516

USA

CIP

27-May-2003

10/445,347

28-Sep-2006

11/528,657

01-Dec-2009

7,625,882

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; MENDEL Itzhak

46643

USA

DIV

27-May-2003

10/445,347

14-Oct-2009

28-Sep-2006

12/588,371

05-Jul-2011

7,973,023

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; MENDEL Itzhak

50968

USA

CON

27-May-2003

10/445,347

13-Apr-2011

28-Sep-2006

13/085,542

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; MENDEL Itzhak

AN IMMUNOLOGICAL AND ORAL TOLERANCE-INDUCING COMPOSITION AND USE THEREOF FOR THE PREVENTION AND/OR FOR THE TREATMENT OF ATHEROSCLEROSIS

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

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

00/21414

Israel

Basic

04-Oct-1998

126447

30-Dec-2004

126447

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

A COMPOSITION FOR THE PREVENTION AND/OR TREATMENT OF ATHEROSCLEROSIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

01/21558

PCT

04-Oct-1998

126447

01-Apr-2001

30-Sep-1999

IL99/00519

Publ. Date: 13-Apr-2000

Publ. #: WO00/20019

Expired

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/21884

Europe

04-Oct-1998

126447

30-Sep-1999

99970026.3

14-May-2003

1126867

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/21886

Canada

04-Oct-1998

126447

30-Sep-1999

2,345,445

24-Aug-2010

2,345,445

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/21887

Australia

04-Oct-1998

126447

30-Sep-1999

59966/99

28-Aug-2003

760582

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/21888

China

04-Oct-1998

126447

04-Apr-2001

30-Sep-1999

99814030.9

24-Nov-2004

ZL99814030.9

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

02/23904

Hong Kong

04-Oct-1998

126447

19-Jul-2002

30-Sep-1999

02105365.4

18-Nov-2005

HK1043743

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

28590

China

DIV

04-Oct-1998

126447

23-Sep-2004

30-Sep-1999

200410011940.7

05-Nov-2008

ZL200410011940.7

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

30562

Hong Kong

DIV

04-Oct-1998

126447

28-Sep-2005

30-Sep-1999

05108561.7

21-Aug-2009

HK1076600

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

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

01/21889

Singapore

04-Oct-1998

126447

30-Sep-1999

200101998-3

30-Apr-2003

80182

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/21890

Japan

04-Oct-1998

126447

30-Sep-1999

2000-573378

Pending

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/21891

Hungary

04-Oct-1998

126447

30-Sep-1999

P0104410

Pending

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

[***]

01/21893

Republic of Korea

04-Oct-1998

126447

30-Sep-1999

2001-7004285

02-Feb-2007

680707

Granted

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/21885

USA

04-Oct-1998

126447

30-Mar-2001

30-Sep-1999

09/806,400

Abandoned

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

01/22498

USA

CON

04-Oct-1998

126447

04-Sep-2001

30-Sep-1999

09/944,592

Abandoned

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob

COMPOSITIONS CONTAINING BETA 2-GLYCOPROTEIN I FOR THE PREVENTION AND/OR TREATMENT OF VASCULAR DISEASE

Our Ref

Country

Earliest Priority

Entry Date

Filing Date
Application No.

Issue Date
Patent No.

SKGF Ref

Status

Inventor

28919

USA

CIP

04-Oct-1998

126447

15-Apr-2005

11/106,665

Abandoned

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob; YACOV Niva

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

METHODS EMPLOYING AND COMPOSITIONS CONTAINING DEFINED OXIDIZED PHOSPHOLIPIDS FOR PREVENTION AND TREATMENT OF ATHEROSCLEROSIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

26038

USA

CIP

22-Nov-2000

60/252,574

27-May-2003

10/445,347

04-Jan-2005

6,838,452

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

27041

USA

DIV

24-Nov-2000

60/252,574

24-Nov-2003

27-May-2003

10/718,596

06-Mar-2007

7,186,704

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

29890

USA

DIV

24-Nov-2000

60/252,574

19-Jul-2005

27-May-2003

11/183,884

17-Mar-2009

7,504,388

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

45347

USA

DIV

24-Nov-2000

60/252,574

17-Feb-2009

27-May-2003

12/371,930

22-Feb-2011

7,893,291

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

50439

USA

CON

24-Nov-2000

60/252,574

06-Jan-2011

27-May-2003

12/985,365

17 April 2012

8,158,611

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

53355

USA

CON

24-Nov-2000

60/252,574

March 27, 2012

27-May-2003

13/431,262

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

OXIDIZED LIPIDS AND USES THEREOF IN THE TREATMENT OF INFLAMMATORY DISEASES AND DISORDERS

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

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

27909

PCT

27-May-2003

10/445,347

27-May-2004

IL2004/000453

Publ. Date: 09-Dec-2004

Publ. #: WO2004/106486

Expired

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

31532

USA

27-May-2003

10/445,347

25-Apr-2008

27-May-2004

10/567,543

08-Mar-2011

7,902,176

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

30958

Mexico

27-May-2003

10/445,347

25-Nov-2005

27-May-2004

pa/A/2005/012784

14-Oct-2008

261341

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon

[***]

30947

Europe

27-May-2003

10/445,347

07-Dec-2005

27-May-2004

04735088.9

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

32340

Hong Kong

27-May-2003

10/445,347

03-Aug-2006

27-May-2004

06108608.1

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

30948

Japan

27-May-2003

10/445,347

30-Nov-2005

27-May-2004

2006-531006

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

[***]

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

30949

Canada

27-May-2003

10/445,347

28-Nov-2005

27-May-2004

2,527,483

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

30950

China

27-May-2003

10/445,347

01-Nov-2005

27-May-2004

200480021217.5

22-Dec-2010

ZL200480021217.5

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

49865

China

DIV

27-May-2003

10/445,347

25-Oct-2010

27-May-2004

201010537971.1

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

30951

Australia

27-May-2003

10/445,347

13-Dec-2005

27-May-2004

2004243695

17-Mar-2011

2004243695

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

30952

Republic of Korea

27-May-2003

10/445,347

28-Nov-2005

27-May-2004

2005-7022741

3-Nov 2011

1081977

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

50809

Republic of Korea

DIV

27-May-2003

10/445,347

18-Feb-2011

27-May-2004

2011-7003840

23 Feb 2012

10-1122160

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

30953

New Zealand

27-May-2003

10/445,347

01-Dec-2005

27-May-2004

544285

12-Mar-2009

544285

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

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

30954

South Africa

27-May-2003

10/445,347

01-Dec-2005

27-May-2004

2005/09929

27-Dec-2006

2005/9929

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

30955

India

27-May-2003

10/445,347

27-Dec-2005

27-May-2004

3555/CHENP/2005

26-Mar-2009

232654

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

[***]

30957

Russian Federation

27-May-2003

10/445,347

01-Dec-2005

27-May-2004

2005140666

27-Jul-2009

2362567

Granted

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

46052

Russian Federation

DIV

27-May-2003

10/445,347

06-Apr-2009

27-May-2004

2009112686

Pending

HARATS Dror; GEORGE Jacob; HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva

OXIDIZED THIOPHOSPHOLIPID COMPOUNDS AND USES THEREOF

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

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

46530

PCT

08-Oct-2008

61/103,571

01-Oct-2009

IL2009/000949

Publ. Date: 15-Apr-2010

Publ. #: WO2010/041242

Expired

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50053

USA

08-Oct-2008

61/103,571

06-Apr-2011

01-Oct-2009

13/122,766

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50054

Europe

08-Oct-2008

61/103,571

20-Apr-2011

01-Oct-2009

09818874.1

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50055

Israel

08-Oct-2008

61/103,571

05-Apr-2011

01-Oct-2009

212153

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

COMPOSITIONS CONTAINING BETA 2-GLYCOPROTEIN I-DERIVED PEPTIDES FOR THE PREVENTION AND/OR TREATMENT OF VASCULAR DISEASE

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

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

31865

PCT

15-Apr-2005

60/671,500

11-Apr-2006

IL2006/000467

Publ. Date: 19-Oct-2006

Publ. #: WO2006/109312

Expired

YACOV Niva; BREITBART Eyal

41853

Europe

15-Apr-2005

60/671,500

24-Oct-2007

11-Apr-2006

06728268.1

Abandoned

YACOV Niva; BREITBART Eyal

41854

USA

15-Apr-2005

60/671,500

10-Oct-2007

11-Apr-2006

11/918,141

Abandoned

YACOV Niva; BREITBART Eyal

[***]

NOVEL DERIVATIVES OF OXIDIZED PHOSPHOLIPIDS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

OXIDIZED LIPID COMPOUNDS AND USES THEREOF

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

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

45018

PCT

06-Nov-2008

61/193,220

05-Nov-2009

IL2009/001049

Publ. Date: 14-May-2010

Publ. #: WO2010/052718

Expired

HALPERIN Gideon;

KOVALEVSKI-ISHAI Eti;

YACOV Niva; BREITBART Eyal;

MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50603

USA

06-Nov-2008

61/193,220

05-May-2011

05-Nov-2009

13/127,717

Pending

HALPERIN Gideon;

KOVALEVSKI-ISHAI Eti;

YACOV Niva; BREITBART Eyal;

MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

[***]

50605

Europe

06-Nov-2008

61/193,220

16-May-2011

05-Nov-2009

09824498.1

Pending

HALPERIN Gideon;

KOVALEVSKI-ISHAI Eti;

YACOV Niva; BREITBART Eyal;

MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

51983

Hong Kong

05-Nov-2009

Pending

HALPERIN Gideon;

KOVALEVSKI-ISHAI Eti;

YACOV Niva; BREITBART Eyal;

MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50606

Canada

06-Nov-2008

61/193,220

13-Apr-2011

05-Nov-2009

2,740,726

Pending

HALPERIN Gideon;

KOVALEVSKI-ISHAI Eti;

YACOV Niva; BREITBART Eyal;

MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

[***]

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

50608

Australia

06-Nov-2008

61/193,220

15-Apr-2011

05-Nov-2009

2009312355

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50609

New Zealand

06-Nov-2008

61/193,220

19-Apr-2011

05-Nov-2009

592357

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

[***]

50611

Japan

06-Nov-2008

61/193,220

06-May-2011

05-Nov-2009

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50612

Republic of Korea

06-Nov-2008

61/193,220

02-Jun-2011

05-Nov-2009

2011-7012700

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50613

Mexico

06-Nov-2008

61/193,220

04-May-2011

05-Nov-2009

MX/a/2011/004773

Pending

HALPERIN Gideon; KOVALEVSKI-ISHAI Eti; YACOV Niva; BREITBART Eyal; MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

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

50614

Russian Federation

06-Nov-2008

61/193,220

06-Jun-2011

05-Nov-2009

2011122729

Pending

HALPERIN Gideon;

KOVALEVSKI-ISHAI Eti;

YACOV Niva; BREITBART Eyal;

MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

50615

China

06-Nov-2008

61/193,220

30-Jun-2011

05-Nov-2009

200980153378.2

Pending

HALPERIN Gideon;

KOVALEVSKI-ISHAI Eti;

YACOV Niva; BREITBART Eyal;

MENDEL Itzhak; ZINIUK Zeev; FEIGE Erez

ENDOTHELIAL-SPECIFIC APOPTOSIS INDUCED BY AN ADENOVIRAL VECTOR CONTAINING A CHIMERIC RECEPTOR DRIVEN BY A TISSUE SPECIFIC PROMOTER

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

POLYNUCLEOTIDE CONSTRUCTS, PHARMACEUTICAL COMPOSITIONS AND METHODS FOR TARGETED DOWNREGULATION OF ANGIOGENESIS AND ANTICANCER THERAPY

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

02/23346

PCT

19-Oct-2001

60/330,118

01-May-2002

IL02/00339

Publ. Date: 24-Apr-2003

Publ. #: WO03/033514

Expired

HARATS Dror; GREENBERGER Shoshana

27526

USA

19-Oct-2001

60/330,118

12-Apr-2004

01-May-2002

10/490,746

08-Sep-2009

7,585,666

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

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

44506

USA

DIV

19-Oct-2001

60/330,118

08-Aug-2008

01-May-2002

12/222,439

02-Aug-2011

7,989,427

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

51506

USA

DIV

19-Oct-2001

60/330,118

20-Jun-2011

01-May-2002

13/163,767

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27527

Europe

19-Oct-2001

60/330,118

21-Apr-2004

01-May-2002

02801473.6

22-Sep-2010

1436313

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

29028

Hong Kong

19-Oct-2001

60/330,118

06-Jan-2005

01-May-2002

05100081.5

01-Apr-2011

HK1067641

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

49785

Europe

DIV

19-Oct-2001

60/330,118

17-Sep-2010

01-May-2002

EP10177257.2

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

47553

Europe

DIV

19-Oct-2001

60/330,118

18-Nov-2009

01-May-2002

09176343.3

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

49931

Hong Kong

DIV

19-Oct-2001

60/330,118

10-Dec-2010

01-May-2002

10111522.2

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

51004

Hong Kong

DIV

19-Oct-2001

60/330,118

27-Apr-2011

01-May-2002

11104228.3

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27528

Japan

19-Oct-2001

60/330,118

16-Apr-2004

01-May-2002

2003-536253

22-Aug-2008

4,173,446

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27529

Republic of Korea

19-Oct-2001

60/330,118

17-Apr-2004

01-May-2002

2004-7005720

24-Oct-2008

866117

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

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

27530

India

19-Oct-2001

60/330,118

19-Apr-2004

01-May-2002

801/CHENP/2004

26-Dec-2008

226357

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27531

China

19-Oct-2001

60/330,118

09-Jun-2004

01-May-2002

02824547.4

01-Jul-2009

ZL02824547.4

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

46077

China

DIV

19-Oct-2001

60/330,118

27-Apr-2009

01-May-2002

200910137707.6

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27532

Singapore

19-Oct-2001

60/330,118

16-Apr-2004

01-May-2002

200402237-2

31-May-2006

103725

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27533

Canada

19-Oct-2001

60/330,118

16-Apr-2004

01-May-2002

2,463,816

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27534

Mexico

19-Oct-2001

60/330,118

19-Apr-2004

01-May-2002

PA/a/2004/003514

12-Nov-2010

280956

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

[***]

27535

Australia

19-Oct-2001

60/330,118

20-Apr-2004

01-May-2002

2002307793

17-May-2007

2002307793

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

27536

New Zealand

19-Oct-2001

60/330,118

16-Apr-2004

01-May-2002

532348

12-Oct-2006

532348

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

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

27537

South Africa

19-Oct-2001

60/330,118

08-Apr-2004

01-May-2002

2004/2756

31-May-2006

2004/02756

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal

USING A MINI-GENE CONSTRUCT (3X-PPR-1) FOR ENDOTHELIAL CELLS SPECIFIC GENE THERAPY. IMPLICATIONS IN CARDIOVASCULAR, CANCER AND WOUND HEALING

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

01/22752

PCT

17-Nov-2000

60/248,582

15-Nov-2001

IL01/01059

Publ. Date: 23-May-2002

Publ. #: WO02/40629

Expired

HARATS Dror

26025

Europe

17-Nov-2000

60/248,582

15-May-2003

15-Nov-2001

01996590.4

20-Jan-2010

1443970

Granted

HARATS Dror; BLOOM Nira

29027

Hong Kong

17-Nov-2000

60/248,582

12-Jan-2005

15-Nov-2001

05100240.3

20-Aug-2010

HK1068057

Granted

HARATS Dror; BLOOM Nira

47088

Europe

DIV

17-Nov-2000

60/248,582

04-Nov-2009

15-Nov-2001

09174998.6

Pending

HARATS Dror; BLOOM Nira

49806

Europe

DIV

17-Nov-2000

60/248,582

01-Oct-2010

15-Nov-2001

EP10185193.9

Pending

HARATS Dror; BLOOM Nira

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

49498

Hong Kong

DIV

17-Nov-2000

60/248,582

13-Oct-2010

15-Nov-2001

10109698.4

Pending

HARATS Dror; BLOOM Nira

52630

Hong Kong

DIV

17-Nov-2000

60/248,582

2-Dec-2011

15-Nov-2001

11113094.5

3182.034HK21

Pending

HARATS Dror; BLOOM Nira

26026

Israel

17-Nov-2000

60/248,582

15-May-2003

15-Nov-2001

155940

30-Mar-2009

155940

Granted

HARATS Dror; BLOOM Nira

26027

India

17-Nov-2000

60/248,582

14-May-2003

15-Nov-2001

743/CHENP/2003

20-Nov-2007

211599

Granted

HARATS Dror; BLOOM Nira

26028

USA

17-Nov-2000

60/248,582

16-May-2003

15-Nov-2001

10/416,917

Abandoned

HARATS Dror

26029

Canada

17-Nov-2000

60/248,582

15-May-2003

15-Nov-2001

2,429,342

Pending

HARATS Dror; BLOOM Nira

26030

Australia

17-Nov-2000

60/248,582

15-May-2003

15-Nov-2001

2002224002

26-Jul-2007

2002224002

Abandoned

HARATS Dror

28653

Australia

DIV

17-Nov-2000

60/248,582

01-Dec-2004

15-Nov-2001

2003222427

09-Sep-2010

2003222427

Granted

HARATS Dror; BREITBART Eyal; BLOOM Nira

49098

Australia

DIV

15-Nov-2001

2002224002

25-Jun-2010

15-Nov-2001

2010202660

1-Dec 2011

2010202660

Granted

HARATS Dror; BREITBART Eyal; BLOOM Nira

26031

Japan

17-Nov-2000

60/248,582

16-May-2003

15-Nov-2001

2002-543626

16-Jan-2009

4,243,653

Granted

HARATS Dror; BLOOM Nira

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

26032

China

17-Nov-2000

60/248,582

16-Jul-2003

15-Nov-2001

01822075.4

04-Feb-2009

ZL0182275.4

Granted

HARATS Dror; BLOOM Nira

26033

Republic of Korea

17-Nov-2000

60/248,582

17-May-2003

15-Nov-2001

2003-7006728

14-Nov-2008

869814

Granted

HARATS Dror

44105

Republic of Korea

DIV

17-Nov-2000

60/248,582

28-Jul-2008

15-Nov-2001

2008-7018598

10-Sep-2009

917854

Granted

HARATS Dror; BLOOM Nira

26034

Mexico

17-Nov-2000

60/248,582

16-May-2003

15-Nov-2001

PA/a/2003/004325

15-Aug-2008

259670

Granted

HARATS Dror

COMPOSITIONS CONTAINING BETA 2-GLYCOPROTEIN I FOR THE PREVENTION AND/OR TREATMENT OF ATHEROSCLEROSIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

28918

USA

CIP

04-Oct-1998

126447

17-Nov-2004

10/989,724

Abandoned

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob; YACOV Niva

COMPOSITIONS CONTAINING BETA 2-GLYCOPROTEIN I FOR THE PREVENTION AND/OR TREATMENT OF VASCULAR DISEASE

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

30236

PCT

17-Nov-2004

10/989,724

25-Sep-2005

IL2005/001022

Publ. Date: 26-May-2006

Publ. #: |WO2006/054281

Expired

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob; YACOV Niva

39233

Europe

17-Nov-2004

10/989,724

13-Jun-2007

25-Sep-2005

05788473.6

Abandoned

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob; YACOV Niva

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

42004

Hong Kong

17-Nov-2004

10/989,724

12-Sep-2007

07109873.6

Abandoned

HARATS Dror; SHOENFELD Yehuda; GEORGE Jacob; YACOV Niva

PROMOTERS EXHIBITING ENDOTHELIAL CELL SPECIFICITY AND METHODS OF USING SAME FOR REGULATION OF ANGIOGENESIS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

28376

USA

CIP

17-Nov-2000

60/248,582

14-Nov-2004

10/988,487

6-Dec 2011

8,071,740

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

50225

USA

DIV

17-Nov-2000

60/248,582

01-Feb-2011

14-Nov-2004

13/018,447

26-June 2012

8,206,743

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

50927

USA

DIV

17-Nov-2000

60/248,582

02-May-2011

14-Nov-2004

13/098,512

Aban

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47407

USA

DIV

17-Nov-2000

60/248,582

13-Nov-2009

14-Nov-2004

12/591,252

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

60001

USA

Con

17-Nov-2000

60/248,582

13-July 2012

14-Nov-2004

13/549,355

3182.0370004

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

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

30269

PCT

14-Nov-2004

10/988,487

14-Nov-2005

IL2005/001195

Publ. Date: 18-May-2006

Publ. #: WO2006/051545

Expired

HARATS Dror; GREENBERGER Shoshana

[***]

47087

Europe

DIV

14-Nov-2004

10/988,487

28-Aug-2009

14-Nov-2005

09168899.4

2 Nov 2011

2174668

Grnated

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

49224

Hong Kong

DIV

12-Oct-2010

14-Nov-2005

10109638.7

15 June 2012

HK1143078

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

49804

Europe

DIV

14-Nov-2004

10/988,487

01-Oct-2010

14-Nov-2005

EP10185195.4

26 Sep 2012

2301586

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

49805

Europe

DIV

14-Nov-2004

10/988,487

30-Sep-2010

14-Nov-2005

EP10184033.8

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

39318

Australia

14-Nov-2004

10/988,487

08-Jun-2007

14-Nov-2005

2005303385

Allowed

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

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

51825

Australia

DIV

14-Nov-2004

10/988,487

14-Nov-2005

28 June 2012

2011205076

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

53691

Australia

DIV

14-Nov-2004

10/988,487

15 June 2012

14-Nov-2005

2012203578

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

39323

New Zealand

14-Nov-2004

10/988,487

05-Jun-2007

14-Nov-2005

555612

08-Apr-2010

555612

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

47297

New Zealand

DIV

14-Nov-2004

10/988,487

09-Oct-2009

14-Nov-2005

580289

05-Apr-2011

580289

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

39324

South Africa

14-Nov-2004

10/988,487

05-Jun-2007

14-Nov-2005

2007/04687

31-Dec-2008

2007/04687

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat

[***]

50629

Singapore

DIV

14-Nov-2004

10/988,487

11-Apr-2011

14-Nov-2005

201102612-7

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat

39315

Israel

14-Nov-2004

10/988,487

14-May-2007

14-Nov-2005

183187

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

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

50104

Israel

DIV

14-Nov-2004

10/988,487

31-Oct-2010

14-Nov-2005

209034

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat

[***]

39317

Canada

14-Nov-2004

10/988,487

17-May-2007

14-Nov-2005

2,587,469

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

39319

Japan

14-Nov-2004

10/988,487

14-May-2007

14-Nov-2005

2007-540833

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

52137

Japan

Div

14-Nov-2004

10/988,487

Sep 2011

14-Nov-2005

2011-191492

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

39320

China

14-Nov-2004

10/988,487

13-Aug-2007

14-Nov-2005

200580046412.8

Aban

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

39321

Republic of Korea

14-Nov-2004

10/988,487

14-Jun-2007

14-Nov-2005

2007-7013464

Pending

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat; PELED Michael

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

39322

Mexico

14-Nov-2004

10/988,487

11-May-2007

14-Nov-2005

MX/a/2007/005783

8 May 2012

299008

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat

52598

Mexico

Div

14-Nov-2004

10/988,487

14-Nov-2005

4 Sep 2012

303042

3182.037MX11

Granted

HARATS Dror; GREENBERGER Shoshana; BREITBART Eyal; BANGIO Livnat

[***]

Method for treating vascular inflammation and psoriasis

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

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

Treatment Of Inflammation

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

53305

PCT

12 Dec 2011

61/569,545 and

12 Dec 2011

61/569,481

11 Dec 2012

PCT/US2012/068995

3182.014PC01

Pending

MENDEL, Itzhak;

FEIGE, Erez;

YACOV, Niva;

PROPHETE-MEIRAN, Oshrat; BREITBART, Eyal;

SALEM, Yaniv

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

Treatment Methods Using Adenovirus

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

[***]

TARGETED GENE EXPRESSION USING PREPROENDOTHELIN-1 PROMOTERS

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

N/A

USA CIP

03-Mar-1994

08/254,015

28-Feb-1995

08395742

05-May-1998

5747340

Originally assinged to Syntex USA. Licensed to VBL

Granted

HARATS Dror;

KURIHARA Hiroki;

NANETTE BELLONI Paula; SIGAL Charles Elliott

METHOD AND COMPOSITION TO INCREASE RADIATION-INDUCED TUMOR THERAPEUTIC EFFECTS

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

Our Ref

Country

Earliest Priority

Entry Date

Filing Date

Application No.

Issue Date

Patent No.

SKGF Ref

Status

Inventor

N/A

PCT

08-Dec-2009

61/283,696

07-Dec-2010

US2010/059204

Publ. Date: 16-Jun-2011

Publ. #: WO/2011/071859

As of June 2012, the applicant is also VBL

Pending

KOLESNICK, Richard, N.

STANCEVIC, Branka;

SADELAIN, Michel;

FUKS, Zvi;

VARDA-BLOOM, Nira;

HARATS, Dror;

Trademark: VBL therapeutics & logo

Our Ref

Client Ref

Country

Class

Earliest

Priority

Filing Date

Application No.

Registration Date

Registration No.

SKGF Ref

Status

47638

Europe

5, 42 & 44

03-Dec-2009

008730541

02-Jun-2010

008730541

Registered

Trademark: VASCULAR BIOGENICS

Our Ref

Client Ref

Country

Class

Earliest Priority

Filing Date

Application No.

Registration Date

Registration No.

SKGF Ref

Status

42092

Israel

23-Aug-2007

203346

06-May-2009

203346

Registered

43074

USA

(Paris)

23-Aug-2007

203346

14-Feb-2008

77/397,305

22-Jun-2010

3,805,239

Registered

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

43075

Europe

(Paris)

5, 42 & 44

23-Aug-2007

203346

18-Feb-2008

006675599

20-Feb-2009

006675599

Registered

Trademark: VBL VASCULAR BIOGENICS LTD. & Device

Our Ref

Client Ref

Country

Class

Earliest

Priority

Filing Date

Application No.

Registration Date

Registration No.

SKGF Ref

Status

42199

Israel

09-Sep-2007

203748

10-May-2009

203748

Registered

43602

USA

(Paris)

09-Sep-2007

203748

03-Mar-2008

77/411,204

22-Jun-2010

3,805,245

Registered

43603

Europe

(Paris)

09-Sep-2007

203748

04-Mar-2008

006721823

04-Sep-2009

006721823

Registered

Trademark: VTS

Our Ref

Client Ref

Country

Class

Earliest

Priority

Filing Date

Application No.

Registration Date

Registration No.

SKGF Ref

Status

42198

Israel

09-Sep-2007

203747

06-May-2009

203747

Registered

43600

USA

(Paris)

09-Sep-2007

203747

03-Mar-2008

77/411,151

20-Oct-2009

3,697,519

Registered

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

43601

Europe

(Paris)

09-Sep-2007

203747

04-Mar-2008

006721484

20-Feb-2009

006721484

Registered

Trademark: VASCULAR TARGETING SYSTEM VTS

Our Ref

Client Ref

Country

Class

Earliest Priority

Filing Date

Application No.

Registration Date

Registration No.

SKGF Ref

Status

41864

Israel

23-Aug-2007

203345

08-Sep-2009

203345

Registered

43072

USA

(Paris)

23-Aug-2007

203345

14-Feb-2008

77/397,328

18-May-2010

3,789,108

Registered

43073

Europe

(Paris)

5, 42 & 44

23-Aug-2007

203345

18-Feb-2008

006675896

29-Jan-2009

006675896

Registered

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

Trademark: VBL

Our Ref

Client Ref

Country

Class

Earliest

Priority

Filing Date

Application No.

Registration Date

Registration No.

SKGF Ref

Status

42093

Israel

23-Aug-2007

203347

22-Jan-2009

203347

Registered

43076

USA

(Paris)

23-Aug-2007

203347

14-Feb-2008

77/397,293

14-Jul-2009

3,653,176

Registered

43077

Europe

(Paris)

5, 42 & 44

23-Aug-2007

203347

18-Feb-2008

006673263

22-Jan-2009

006673263

Registered

Trademark: VBL therapeutics & logo

Our Ref

Client Ref

Country

Class

Earliest Priority

Filing Date

Application No.

Registration Date

Registration No.

SKGF Ref

Status

47612

Israel

30-Nov-2009

225329

07-Feb-2011

225329

Registered

47639

USA

(Paris)

30-Nov-2009

225329

26-Apr-2010

85/023,397

24-May-2011

3,964,829

Registered

Domains: VBL

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

vascularbiogenics.com

vascularbiogenicsltd.com

vbl-therapeutics.com

vbltherapeutics.com

vbltx.com

vascularbiogenics.net

vbl.co.il

vblrx.com

vascular-biogenics.com

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

Exhibit 10.5

EXECUTION COPY

MANUFACTURING SERVICES AGREEMENT

This Manufacturing Services Agreement (the “ Agreement ”) is made as of January 5, 2012, (the “ Effective Date ”) between Lonza Houston, Inc., a Delaware corporation having its principal place of business at 8066 El Rio St., Houston, TX 77054 (“ LHI ”), and Vascular Biologics, Ltd., an Israeli corporation , having an office at 6 Jonathan Netanyahu St., Or Yehuda, Israel 60376 (“ CLIENT ”) (each of LHI and CLIENT, a “ Party ” and, collectively, the “ Parties ”).

RECITALS

A. LHI operates multi-client research, testing and production facilities located at 8030, 8032 and 8066 El Rio, Houston, Texas 77054 (the “ Facility ”).

B. CLIENT desires to have LHI produce a product containing human cells and/or viruses intended for therapeutic use in humans, and LHI desires to produce such product.

C. CLIENT desires to have LHI conduct work according to individual Statement of Work, as further defined in Section 1.30 below.

NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, LHI and CLIENT, intending to be legally bound, hereby agree as follows:

AGREEMENT

1.	D EFINITIONS

When used in this Agreement, capitalized terms will have the meanings as defined below and throughout the Agreement. Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular.

1.1. “ Acceptance Period ” shall have the meaning set forth in Section 5.2.2.

1.2. “ Affiliate ” means, with respect to either Party, any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, the term “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means direct or indirect ownership of more than fifty percent (50%) of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, or otherwise.

1.3. “ Batch ” means a quantity of Product derived from a process which is the subject of an SOW that is intended to have uniform character and quality, within specified

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

EXECUTION COPY

limits, and is produced according to a single manufacturing order during the same cycle of manufacture

1.4.

“ Batch Record ” means the production record pertaining to a Batch.

1.5.

“ cGMP ” means the regulatory requirements for current good manufacturing practices promulgated by the FDA under 21 CFR Parts 210 and 211, as amended from time to time.

1.6.

“ Change Order ” has the meaning set forth in Section 2.2.

1.7.

“ CLIENT Development Materials ” has the meaning set forth in Section 2.3.

1.8.

“ CLIENT Inventions ” means any know-how or inventions, whether or not patentable, conceived, developed or reduced to practice by CLIENT on or before the Effective Date.

1.9.

“ CLIENT Materials ” means the CLIENT Development Materials and the CLIENT Production Materials.

1.10.

“ CLIENT Personnel ” has the meaning set forth in Section 4.7.1.

1.11.

“ CLIENT Production Materials ” has the meaning set forth in Section 4.1.

1.12.

“ Commencement Date ” means the date set forth in the Statement of Work for the commencement of the production of the Product.

1.13.

“ Confidential Information ” has the meaning set forth in Section 10.1.

1.14.

“ Disapproval Notice ” shall have the meaning set forth in Section 5.2.2.

1.15.

“ FDA ” means the U.S. Food and Drug Administration, and any successor agency thereof.

1.16.

“ First Statement of Work ” has the meaning set forth in the definition of Statement of Work.

1.17.

“ Intellectual Property ” means all worldwide patents, copyrights, trade secrets, know-how and all other intellectual property rights, including all applications and registrations with respect thereto, but excluding all trademarks, trade names, service marks, logos and other corporate identifiers.

1.18.

“ LHI Inventions ” means any know-how, media, assays, methods or other inventions, whether or not patentable, conceived, developed or reduced to practice by LHI on or before the Effective Date.

1.19.

“ LHI Operating Documents ” means the standard operating procedures, standard manufacturing procedures, raw material specifications, protocols, validation documentation, and supporting documentation used by LHI, such as environmental

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

EXECUTION COPY

monitoring, for operation and maintenance of the Facility and LHI equipment used in the process of producing the Product, excluding any of the foregoing that are unique to the manufacture of Product.

1.20.

“ LHI Parties ” has the meaning set forth in Section 15.2.

1.21.

“ Materials ” means all raw materials and supplies to be used in the production of a Product.

1.22.

“ Process ” means the manufacturing process for a Product provided to LHI by CLIENT and further developed by LHI pursuant to the terms of this Agreement.

1.23.

“ Product ” has the meaning set forth in a Statement of Work.

1.24.

“ Product Warranties ” means those warranties as specifically stated in Section 5.2.2.

1.25.

“ Production Term ” shall have the meaning set forth in Section 4.3.

1.26.

“ Regulatory Approval ” means the approval by the FDA to market and sell the Product in the United States.

1.27.

“ SOP ” means a standard operating procedure.

1.28.

“SOW Documentation” means the compilation of documentation generated by LHI in preparation of and during the performance of a given SOW, including, without limitation, executed batch records, component records, test records and test record forms, certificates of analysis, study protocols, study summary reports, deviation reports, laboratory investigations, environment excursions, formulation records, and other related documents.

1.29.

“ Specifications ” means the Product specifications set forth in the Statement of Work or as modified by the Parties in connection with the production of a particular Batch of Product hereunder.

1.30.

“ Statement of Work ” or “ SOW ” means a plan to develop a Process or Product that is attached hereto as Appendix A or later becomes attached through an amendment by the Parties. The first Statement of Work, which is attached hereto, is numbered Appendix A-1 and is hereby incorporated and made a part of this Agreement (the “ First Statement of Work ”). It is contemplated that each separate project shall have its own Statement of Work. As each subsequent Statement of Work is agreed to by the Parties, each shall state that it is to be incorporated and made a part of this Agreement and shall be consecutively numbered as A-2, A-3, etc.

1.31.

“ Technology Transfer ” means the transfer of documentation, specifications, and production process by CLIENT to LHI for the development of the SOW Documentation for the manufacture of the Product specifically for the CLIENT.

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

EXECUTION COPY

1.32.

“ Third Party ” means any party other than LHI, CLIENT or their respective Affiliates.

2.	S TATEMENTS OF W ORK - P ROCESS AND P RODUCT D EVELOPMENT ; T ECHNOLOGY T RANSFER ; P ROCESS OR P RODUCT M ANUFACTURE

2.1 Statement of Work . Prior to performing any Process or Product development, Technology Transfer, or Process or Product manufacture, the Parties will collaborate to develop a Statement of Work, describing the activities to be performed by the Parties, or to be subcontracted by LHI to Third Parties. Once agreed to by the Parties, the Statement of Work shall be executed by each of the Parties and appended hereto as part of Appendix A . In the event of a conflict between the terms and conditions of this Agreement and any Statement of Work, the terms and conditions of this Agreement shall control.

2.2 Modification of Statement of Work . Should CLIENT want to change a Statement of Work, to reduce services not yet performed or to include additional services to be provided by LHI, CLIENT may propose to LHI an amendment to the Statement of Work with the desired changes or additional services (“ Change Order ”). If LHI determines that it has the resources and capabilities to accommodate such Change Order, LHI will prepare a modified version of the Statement of Work reflecting such Change Order (including, without limitation, any changes to the estimated timing, estimated charges or scope of a project) and will submit such modified version of the Statement of Work to CLIENT for review and comment. The modified Statement of Work shall be binding on the Parties only if it refers to this Agreement, states that it is to be made a part thereof, and is signed by both Parties. Thereafter such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of Work. Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to by both Parties, the existing Statement of Work shall remain in effect.

2.3 CLIENT Deliverables . Within the time period specified in a Statement of Work, CLIENT will provide LHI with (a) the materials listed in the Statement of Work for which CLIENT is responsible for delivering to LHI, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Statement of Work, and (b) any protocols, SOPs and other information and documentation in possession or control of CLIENT and necessary for the performance of the Statement of Work, and for the preparation of the SOW Documentation in conformance with cGMP, including, without limitation, process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packing and shipping instructions, and product specific cleaning and decontamination information, (collectively, the “ CLIENT Development Materials ”). It is hereby agreed that CLIENT Development Materials are the proprietary and confidential information of the CLIENT and shall be used by LHI solely for the purpose of this Agreement.

2.4 Performance by LHI . Subject to the provision by CLIENT of the CLIENT Development Materials pursuant to Section 2.3, LHI will use commercially reasonable efforts to perform, directly or, subject to the terms of the Statement of Work or approval by CLIENT (such approval not to be unreasonably withheld), through a Third Party contractor, the work described

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

EXECUTION COPY

in a Statement of Work in a professional and workmanlike manner in accordance with the terms of this Agreement. LHI shall ensure, and at all times remain responsible and liable for the compliance of such Third Party contractor with the terms of this Agreement. LHI will use commercially reasonable efforts promptly to notify CLIENT of any material delays that arise during the performance of the Statement of Work. Subject to the exceptions in Section 17.2, delay of commencement of the Statement of Work due to delay by a Third Party contractor by more than 45 days shall be considered a breach of the Agreement.

3.	T ECHNOLOGY T RANSFER

3.1 Based on the information provided by CLIENT and including process changes developed by LHI pursuant to any applicable Statement of Work, LHI will prepare the SOW Documentation for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LHI of any specific requirements CLIENT may have relating to the SOW Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LHI intends to include in the SOW Documentation the use of any assay, medium, or other technology that is not commercially available, LHI will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The SOW Documentation shall be completed and delivered by LHI at completion of a Batch.

3.2 CLIENT will cooperate with LHI to assist LHI to develop the SOW Documentation and Process, including, without limitation, by providing LHI with additional information and procedures as may be required to create the SOW Documentation, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.

3.3 LHI will deliver a draft version of the SOW Documentation to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LHI in writing of any objections it has to the draft Master Production Record, and upon such notification, representatives of LHI and CLIENT will meet promptly to resolve such objections. Upon CLIENT’s written acceptance of the draft SOW Documentation, or in the event that CLIENT does not submit a written notice setting forth CLIENT’s objections to the draft SOW Documentation within fifteen (15) working days following receipt of such draft by CLIENT, such draft will be deemed approved by CLIENT.

3.4 The Process, SOW Documentation, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LHI Operating Documents, LHI Inventions or LHI Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 10. Without derogating from Section 11.2.2, CLIENT shall be permitted to use the Process and/or the SOW Documentation for any research or commercial purpose solely related to the Product or Process and to manufacture and sell Product, either alone or by a Third Party on its behalf; provided, however, that if the Process and/or the SOW Documentation

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

EXECUTION COPY

incorporates or contains any LHI Intellectual Property or LHI Confidential Information that does not solely relate to Product or Process, then prior to any disclosure of such LHI Intellectual Property or LHI Confidential Information to, or use by, a Third Party manufacturer, Client shall obtain LHI prior approval, which shall not be unreasonably withheld.

4.	M ANUFACTURE O F P RODUCT ; O RDER P ROCESS ; D ELIVERIES

4.1 CLIENT Deliverables. Within any time period agreed to in any applicable Statement of Work, CLIENT will provide LHI with the materials listed in the Statement of Work required to be supplied by CLIENT for the production of the Product, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Statement of Work (collectively, the “ CLIENT Production Materials ”).

4.2 Commencement Date . The Statement of Work will include a Commencement Date agreed upon by the Parties.

4.3 Manufacture by LHI . During the time period specified in any Statement of Work during which Product will be manufactured (the “ Production Term ”), LHI will use commercially reasonable efforts to manufacture, package, ship, handle quality assurance and quality control for the Product, all as set forth in the Statement of Work, and to deliver to CLIENT the quantities of Product requested by CLIENT in the Statement of Work, all in accordance with the terms set forth in Section 4.4 below. Notwithstanding the foregoing, LHI shall have the right to revise the production schedule with respect to a Statement of Work provided that such schedule does not advance or delay commencement of the production of Batches under a Statement of Work by more than forty five (45) days.

4.4 Packaging and Shipping . LHI will package and label the Product for shipment in accordance with the SOW Documentation and LHI’s standard practices in effect at the time of performance by LHI. LHI will ship the Product FOB Shipping Point delivered at the Facility to a common carrier designated by CLIENT to LHI in writing not less than ten days prior to the applicable delivery date unless otherwise agreed to in a Statement of Work. CLIENT will provide to LHI its account number with the selected carrier and will pay for all shipping costs in connection with each shipment of Product. Each shipment will be accompanied by the documentation listed in the Statement of Work. LHI will use commercially reasonable efforts to deliver each shipment of Product to CLIENT or to any CLIENT-designated Third Party on its behalf on the requested delivery date for such shipment. CLIENT may ask to ship Batches in different shipments and to different locations. LHI will promptly notify CLIENT if LHI reasonably believes that it will be unable to meet a delivery date. CLIENT shall be required to take delivery of a Batch of Product within thirty (30) days after acceptance of such Batch in accordance with Section 5.2 (the “Delivery Period”), unless CLIENT requests in writing, and LHI consents in writing, to store the material on CLIENT’s behalf and at CLIENT’s expense.

4.5 Genetic Alterations . LHI is not responsible for any genetic alterations that occur during production of any product, except for those genetic alterations that result from a grossly negligent or intentionally wrongful act or omission of LHI and not as a result of the predisposition of any material provided by CLIENT. Unless they arise from a grossly negligent

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

EXECUTION COPY

or intentionally wrongful act or omission of LHI, genetic alterations shall not be the basis for a breach of warranty claim by CLIENT. If LHI fails to deliver materials in accordance with the terms of this Agreement or a Statement of Work, or if materials produced pursuant to the Statement of Work fail to meet any technical specification required by the Statement of Work, and such failure is due to genetic alterations which do not arise from a grossly negligent or intentionally wrongful act or omission of LHI, LHI will re-perform the specific project at issue at the earliest practicable time, for an additional fee equal to the original fee for that part of the project.

4.6 Records . LHI will maintain accurate records for the production of the Product, as required by applicable laws and regulations. LHI will retain possession of the SOW Documentation, all Batch Records and LHI Operating Documents, and will make copies thereof available to CLIENT upon CLIENT’s request and at CLIENT’s expense. LHI Operating Documents will remain LHI Confidential Information provided that it shall not limit in any way the CLIENT rights to use the Product. CLIENT will have the right to use and reference any of the foregoing in connection with a filing for Regulatory Approval of the Product or as otherwise authorized by the Agreement.

4.7 CLIENT Access .

4.7.1 CLIENT’s employees and agents (including its independent contractors) (collectively, “ CLIENT Personnel ”) shall be entitled to participate in the production of the Product only in order to review the production process in such capacities as shall be agreed in writing in advance by the Parties, subject to mutually agreed scheduling. CLIENT Personnel working at the Facility are required to comply with LHI’s Operating Documents and any other applicable LHI facility and/or safety policies. For the avoidance of doubt, CLIENT Personnel may not physically participate in the production or manufacture of any Product that may be used in or on humans.

4.7.2 CLIENT Personnel working at the Facility will be and remain employees of CLIENT, and CLIENT will be solely responsible for the payment of compensation for such CLIENT Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensation insurance, health insurance, and other similar statutory and fringe benefits). CLIENT covenants and agrees to maintain workers’ compensation benefits and employers’ liability insurance as required by applicable laws with respect to all CLIENT Personnel working at the Facility.

4.7.3 CLIENT will pay for the actual cost of repairing or replacing to its previous status (to the extent that LHI determines, in its reasonable judgment, that repairs cannot be adequately effected) any property of LHI damaged or destroyed by CLIENT Personnel, provided CLIENT shall not be liable for repair or replacement costs resulting from ordinary wear and tear.

4.7.4 CLIENT Personnel visiting or having access to the Facility will abide by LHI standard policies, operating procedures and the security procedures established by LHI. CLIENT will be liable for any breaches of security by CLIENT Personnel. In addition, CLIENT will reimburse LHI for the cost of any lost security cards issued to CLIENT Personnel, at the rate

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

EXECUTION COPY

of $50 per security card. All CLIENT Personnel will agree to abide by LHI policies and SOPs established by LHI, and will sign an appropriate confidentiality agreement.

4.7.5 CLIENT will indemnify and hold harmless LHI from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) arising out of any injuries suffered by CLIENT Personnel while at the Facility or elsewhere, except to the extent caused by the gross negligence or willful misconduct on the part of any LHI Party.

4.8 Disclaimers . CLIENT acknowledges and agrees that LHI Parties will not engage in any Product refinement or development of the Product, other than as expressly set forth in this Agreement and the Statement of Work. CLIENT acknowledges and agrees that LHI Parties have not participated in the invention or testing of any Product, and have not evaluated its safety or suitability for use in humans or otherwise.

5.	P RODUCT W ARRANTIES ; A CCEPTANCE A ND R EJECTION O F P RODUCTS

5.1 Product Warranties . LHI warrants that any Product manufactured by LHI pursuant to this Agreement, at the time of delivery pursuant to Section 4.4: (a) conforms to the Specifications; (b) was manufactured in accordance with the SOW Documentation; and (c) where applicable was manufactured in accordance with cGMP.

5.2 Approval of Completed Product .

5.2.1 When a Statement of Work has been completed, LHI will notify CLIENT and supply CLIENT with the required documentation set forth in the Statement of Work.

5.2.2 Within twenty one (21) calendar days after CLIENT’s receipt of substantially complete documentation and Batch Records regarding such Product (the “ Acceptance Period ”), Client shall determine by review of such documentation whether or not the given Batch conforms to the product warranties set forth in Section 5.1 above (“ Product Warranties ”). If CLIENT asserts that the Product does not comply with the Product Warranties set forth in Section 5.1 above, CLIENT will deliver to LHI, in accordance with the notice provisions set forth in Section 17.4 hereof, written notice of disapproval (the “ Disapproval Notice ”) of such Product, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LHI during the Acceptance Period, then LHI and CLIENT will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to both the production of the Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Acceptance Period, the Product will be deemed accepted and ready for shipment to CLIENT, or storage for CLIENT, as applicable. If Product is to be shipped to CLIENT, then upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within 10-days after such acceptance. Title and risk of loss to such Product shall pass to CLIENT at the time of delivery to the common carrier pursuant to Section 4.4. If the Product is to be stored by LHI for CLIENT, LHI shall do so in accordance with agreed upon terms of a Statement of Work which covers all relevant details of a Product storage engagement.

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

EXECUTION COPY

5.3 Dispute Resolution . LHI and CLIENT will attempt to resolve any dispute regarding the conformity of a Batch of Product with the Product Warranties. If such dispute cannot be settled within 30 days of the submission by each Party of such related paperwork and records to the other Party, and if the Product is alleged not to conform with the Product Warranties set forth in Section 5.1(a), then CLIENT will submit a sample of the Batch of the disputed Product to an independent testing laboratory of recognized repute selected by CLIENT and approved by LHI (such approval not to be unreasonably withheld) for analysis, under quality assurance approved procedures, of the conformity of such Batch of Product with the Specifications. The costs associated with such analysis by such independent testing laboratory will be paid by the Party whose assessment of the conformity of the Batch of Product with the Specifications was mistaken.

5.4 Remedies for Non-Conforming, Damaged, or Destroyed Product .

5.4.1 In the event that the Parties agree, or an independent testing laboratory determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties, or Product and/or Materials are destroyed or damaged by LHI Personnel, due to the failure of: (a) LHI personnel properly to execute the SOW Documentation, (b) LHI personnel to comply with cGMP, or (c) the Facility utilities, then, at CLIENT’s written request, LHI will commence, as soon as it is commercially practicable to do so and not later than 30 days after such written request, unless the Facility is not available due to prior obligations which cannot be postponed, produce one time for CLIENT sufficient quantities of Product to replace the non-conforming, damaged or destroyed portion of such Batch of Product (the “ Production Rerun ”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT.

5.4.2 In the event that the Parties agree, or an independent testing laboratory determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties, or Product and/or Materials are destroyed or damaged by LHI Personnel, for any reason other than as set forth in Section 5.4.1, then LHI shall have no liability to CLIENT with respect to such Batch, Product or Material and LHI will, at CLIENT’s request, produce for CLIENT a Production Rerun at CLIENT’s expense. Notwithstanding anything to the contrary set forth in Section 5.4, if during the manufacture of Product pursuant to this Agreement, Product or Materials are destroyed or damaged by LHI Personnel while LHI Personnel were acting at the written direction of CLIENT Personnel, then LHI will have no liability to CLIENT as the result of such destruction or damage.

5.4.3 CLIENT acknowledges and agrees that its sole remedy with respect to (i) the failure of Product to conform with any of the Product Warranties and (ii) damaged or destroyed Materials and/or Product, is as set forth in this Section 5.4, and in furtherance thereof, Client hereby waives all other remedies at law or in equity regarding the foregoing claims.

6.	RESERVED

7.	S TORAGE O F M ATERIALS

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

EXECUTION COPY

7.1 Pre-Production . LHI will store at the expense of CLIENT any CLIENT Materials, equipment or other property delivered pursuant to the Statement of Work to the Facility by CLIENT more than 30 days prior to the Commencement Date. The storage rates will be set forth in the Statement of Work and may be amended from time to time by LHI. No storage fees will be charged during the period starting 30 days prior to the Commencement Date and ending upon the expiration or termination of the Production Term.

7.2 Post-Production . LHI will store at the Facility free of charge any in–process materials, CLIENT Materials, equipment and other CLIENT property (other than Product manufactured hereunder) that remains at the Facility on the date of expiration or termination of the Production Term (collectively “ Remaining CLIENT Property ”), for up to 30 calendar days. If CLIENT has not provided any instructions as to the shipment or other disposition of Remaining CLIENT Property prior to the expiration of such thirty (30)-day period, LHI may, continue to store such Remaining CLIENT Property at the Facility or elsewhere. In the event that LHI continues to store such Remaining CLIENT Property, CLIENT will enter into a storage agreement with LHI and agree to pay to LHI a storage charge at LHI’s then-standard monthly storage rates for the period beginning on the thirty-first (31st) day after the expiration or termination of the Production Term through the date that the storage terminates.

7.3 Product . Notwithstanding the foregoing, if CLIENT fails to take delivery of a Product within the applicable Delivery Period as required by Section 4.4 and fail to enter into a storage agreement with LHI, CLIENT will pay to LHI a storage charge at one and a half times LHI’s then-standard monthly storage rate, which shall begin accruing on the first day following the expiration of the applicable Delivery Period.

8.	R EGULATORY M ATTERS

8.1 Permits and Approvals . Upon the Commencement Date and during the Production Term, LHI will maintain any licenses, permits and approvals necessary for the manufacture of the Product in the Facility. LHI will promptly notify CLIENT if LHI receives notice that any such license, permit, or approval is or may be revoked or suspended.

8.2 Inspections/Quality Audit by CLIENT . Up to two times during the Production Term and upon not less than 15 days’ prior written notice, LHI will permit CLIENT to inspect and audit the parts of the Facility where the manufacture of the Product is carried out in order to assess LHI’s compliance with cGMP, and to discuss any related issues with LHI’s management personnel. CLIENT Personnel engaged in such inspection will abide by the terms and conditions set forth in Sections 4.7.4 and 10.

8.3 Inspections by Regulatory Agencies . LHI will allow representatives of any regulatory agency to inspect the relevant parts of the Facility where the manufacture of the Product is carried out and to inspect the SOW Documentation and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify CLIENT of the scheduling of any such inspection relating to the manufacture of Product. LHI will promptly send to CLIENT a copy of any reports, citations, or warning letters received by CLIENT in connection with an inspection of a regulatory agency to the extent such documents relate to or affect the manufacture of the Product.

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

EXECUTION COPY

9.	F INANCIAL T ERMS

9.1 Payments . CLIENT will make payments to LHI in the amounts and on the dates set forth in the Statement of Work. In the event that CLIENT has not paid an invoice within thirty (30) business days of the applicable due date (as established by Section 9.2), CLIENT’s failure shall be considered a material breach under Section 14.2, subject to the cure provisions set forth therein. Further, in addition to all other remedies available to LHI, in the event that CLIENT has not paid an invoice within sixty (60) business days of the applicable due date (as established by Section 9.2), LHI may elect to suspend the provision of all or a portion of the services under this Agreement, provided that CLIENT shall remain liable for all fees owed pursuant to the Statement of Work during any such suspension. LHI will submit to the CLIENT a valid certificate of Tax Residency (Form 6166) at least 45 days prior to first payment under this Agreement, and thereafter shall provide such certificate annually upon the CLIENT’s written request.

9.2 Invoices . LHI will charge for the services in accordance with the price schedule in each individual Statement of Work. LHI will invoice CLIENT according to the schedule set forth in a Statement of Work. LHI will deliver invoices electronically by email, which shall be considered to be an original invoice. Invoices should be e-mailed to Dr. Eyal Breitbart (eyal@vblrx.com), and/or to such other e-mail address(es) as CLIENT may stipulate from time to time. LHI will not deliver a paper invoice. Payment of invoices is due as provided in the Statement of Work. .

9.3 Taxes . CLIENT agrees that it is responsible for and will pay any sales, use or other taxes (the “ Taxes ”) resulting from LHI’s production of Product under this Agreement (except for income or personal property taxes payable by LHI). To the extent not paid by CLIENT, CLIENT will indemnify and hold harmless the LHI Parties from and against any and all penalties, fees, expenses and costs whatsoever in connection with the failure by CLIENT to pay the Taxes. LHI will not collect any sales and use taxes from CLIENT in connection with the production of any Product hereunder if CLIENT provides to LHI the appropriate valid exemption certificates .

9.4 Interest . Any fee, charge or other payment due to LHI by CLIENT under this Agreement that is not paid within 30 days after it is due will accrue interest on a daily basis at a rate of 1.0% per month (or the maximum legal interest rate allowed by applicable law, if less) from and after such date.

9.5 Method of Payment . All payments to LHI hereunder by CLIENT will be in United States currency and will be by check, wire transfer, money order, or other method of payment approved by LHI. Bank information for wire transfers is as follows:

Mailing address for wire transfer payments:

To:

Branch:

[***]

Wire ABA Routing:

Check-ACH ABA:

[***]

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

EXECUTION COPY

Account:

Remarks:

[***]

9.6 Cost Adjustments . After the first anniversary of the Effective Date, LHI may annually adjust the various costs and rates set forth in the Statement of Work attached hereto to reflect changes in the cost of materials and/or labor rate paid by LHI in connection with the production of Product under this Agreement; provided, however, that any increase in labor rates shall not exceed any percentage increase in the US Consumer Price Index for the most recently published percentage change for the 12-month period preceding the applicable contract anniversary date. LHI agrees to provide CLIENT with written notice of any such cost adjustment.

10.

C ONFIDENTIAL I NFORMATION

10.1 Definition . “ Confidential Information ” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, specifications, data, results and other material, pre-clinical and clinical trial results, manufacturing procedures, test procedures and purification and isolation techniques, and any tangible embodiments of any of the foregoing, and any scientific, manufacturing, marketing and business plans, any financial and personnel matters relating to a Party or its present or future products, sales, suppliers, customers, employees, investors or business, that has been disclosed by or on behalf of such Party to the other Party either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing this Agreement. Without limiting the foregoing, the terms of this Agreement will be deemed “Confidential Information” and will be subject to the terms and conditions set forth in this Article 10.

10.2 Exclusions . Notwithstanding the foregoing Section 10.1, any information disclosed by a Party to the other Party will not be deemed “Confidential Information” to the extent that such information:

(a) at the time of disclosure is in the public domain;

(b) becomes part of the public domain, by publication or otherwise, through no fault of the Party receiving such information;

(c) at the time of disclosure is already in possession of the Party who received such information, as established by contemporaneous written records;

(d) is lawfully provided to a Party, without restriction as to confidentiality or use, by a Third Party lawfully entitled to possession of such Confidential Information; or

(e) is independently developed by a Party without use of or reference to the other Party’s Confidential Information, as established by contemporaneous written records.

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

EXECUTION COPY

10.3 Disclosure and Use Restriction . Except as expressly provided herein, the Parties agree that for the term of the Agreement and the five-year period following any termination of the Agreement, each Party and its Affiliates will keep completely confidential and will not publish or otherwise disclose any Confidential Information of the other Party, its Affiliates or sublicensees, except in accordance with Section 10.4. Neither Party will use Confidential Information of the other Party except as necessary to perform its obligations or to exercise its rights under this Agreement.

10.4 Permitted Disclosures . Each receiving Party agrees to (i) institute and maintain security procedures to identify and account for all copies of Confidential Information of the disclosing Party and (ii) limit disclosure of the disclosing Party’s Confidential Information to its U.S. and European Affiliates and each of its and their respective officers, directors, employees, agents, consultants and independent contractors having a need to know such Confidential Information for purposes of this Agreement; provided that such U.S. and European Affiliates and each of its and their respective officers, directors, employees, agents, consultants and independent contractors are informed of the terms of this Agreement and are subject to obligations of confidentiality, non-disclosure and non-use similar to those set forth herein. Each Party may disclose this Agreement during a due diligence process in connection with the proposed transfer of its assets or capital stock, whether through purchase, merger, consolidation or otherwise. Such disclosure will be subject to obligations of confidentiality, non-disclosure and non-use similar to those set forth herein.

10.5 Government-Required Disclosure . If a duly constituted government authority, court or regulatory agency orders that a Party hereto disclose information subject to an obligation of confidentiality under this Agreement, such Party shall comply with the order, but shall notify the other Party as soon as possible, so as to provide the said Party an opportunity to apply to a court of record for relief from the order.

10.6 Publicity . Neither Party will refer to, display or use the other’s name, trademarks or trade names confusingly similar thereto, alone or in conjunction with any other words or names, in any manner or connection whatsoever, including any publication, article, or any form of advertising or publicity, except with the prior written consent of the other Party or as otherwise set forth in Section 10.7.

10.7 Publications . The confidentiality provisions of this Section 10 are applicable to all publications, abstracts, and papers authored by either Party , or its respective employees, consultants or contractors (the “Submitting Party”) relating to services performed by LHI hereunder or to data created pursuant to or related to the Statement of Work. Manuscripts of all such publications shall be submitted to the other Party (the “Reviewing Party”) at least sixty (60) days prior to submission in final form to any publisher. The Reviewing Party shall promptly inform the Submitting Party of any alterations or deletions necessary to protect its rights under Section 10 and the Submitting Party shall be obligated to make such changes prior to submitting any manuscripts in final form. The Reviewing Party may further withhold its approval for such publication if necessary to protect its rights under Section 10. For general business development purposes, each Party may announce on its website or in press releases the general nature of work performed for CLIENT under any given Statement of Work upon receiving permission from the other Party, such permission not being unreasonably withheld or delayed.

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

EXECUTION COPY

11.

I NTELLECTUAL P ROPERTY

11.1 Ownership .

11.1.1 Neither party will acquire any right, title, or interest in any Intellectual Property that the other party owns or controls as of the Effective Date of this Agreement, or that the other party obtains separate and apart from this Agreement.

11.1.2 As between the Parties, CLIENT shall own any and all inventions or discoveries that are (i) made, conceived or reduced to practice in the course of or resulting from this Agreement by either Party alone or the Parties jointly and (ii) applicable to the Product or the Process (“ CLIENT New IP ”). LHI hereby assigns to CLIENT all of LHI’s right, title and interest in and to such CLIENT New IP.

11.1.3 As between the Parties, LHI shall own any and all inventions or discoveries that are (i) made, conceived or reduced to practice in the course of or resulting from this Agreement by LHI and (ii) capable of being applied to products or processes other than the Product or the Process, and (iii) relates generally to LHI’s business of producing biological materials and (iv) are not a part of CLIENT New IP and (v) do not make use of or any reference of CLIENT’s Confidential Information (“ LHI New IP ”). CLIENT hereby assigns to LHI all of CLIENT’s right, title and interest in and to such LHI New IP.

11.1.4 LHI shall own any know-how, media, assays, methods or other inventions, whether or not patentable that are conceived, acquired from a third party, developed or reduced to practice by LHI after the Effective Date that is not LHI New IP (“LHI Independent IP”). LHI may offer to CLIENT to include said LHI Independent IP into the Product or Process. If CLIENT elects to include such LHI Independent IP in the Product or Process, such use of LHI Independent IP shall be subject to a license to be negotiated in good faith by the Parties. For the avoidance of doubt, LHI Independent IP is Intellectual Property developed by or for LHI independently and outside the scope of this Agreement by persons (i) without using actual knowledge of or not having access to CLIENT Confidential Information, but excluding LHI New IP, or (ii) not performing Process or Product development activities under a Statement of Work pursuant to this Agreement.

11.2 License Grants .

11.2.1 During the term of this Agreement, CLIENT hereby grants to LHI a fully paid, non-exclusive license under any and all CLIENT Intellectual Property that is necessary for LHI to perform its obligations under this Agreement for the sole and limited purpose of LHI’s performance of its obligations under this Agreement, including, without limitation, the development of the Process and the manufacture of Product for CLIENT.

11.2.2 LHI hereby grants to CLIENT an irrevocable, fully paid, non-exclusive license, with the right to grant and authorize sublicenses, under any and all (i) LHI Intellectual Property (including LHI Inventions and LHI New IP but excluding LHI Independent IP) that LHI incorporates into the Process, to make, have made, use, sell, offer for sale, have sold and import the Product, or for any other commercial or research purpose related solely to the Product or Process, either by the CLIENT or a Third Party on its behalf and (ii) know-how included in

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

EXECUTION COPY

the LHI New IP and not claimed in a patent or patent application, to use for any purpose related solely to the Product or Process.

11.3 Further Assurances . Each Party agrees to take all necessary and proper acts, and will cause its employees, Affiliates, contractors, and consultants to take such necessary and proper acts, to effectuate the ownership provisions set forth in this Article 11.

11.4 Prosecution of Patents .

11.4.1 LHI will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming LHI Inventions at LHI’s expense. CLIENT will cooperate with LHI to file, prosecute and maintain patent applications and patents claiming LHI Inventions, and will have the right to review and provide comments to LHI relating to such patent applications and patents.

11.4.2 CLIENT will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming CLIENT Inventions at CLIENT’s expense. LHI will cooperate with CLIENT to file, prosecute and maintain patent applications and patents claiming CLIENT Inventions, and will have the right to review and provide comments to CLIENT relating to such patent applications and patents.

12.

R EPRESENTATIONS AND W ARRANTIES

12.1 By CLIENT . CLIENT hereby represents and warrants to LHI that, to the best of its knowledge, (i) it has the requisite intellectual property and legal rights related to the CLIENT Deliverables and the Product to authorize the performance of LHI’s obligations under this Agreement, and (ii) the performance of the Statement of Work and the production by LHI of the Product as contemplated in this Agreement will not give rise to a potential cause of action by a Third Party against LHI for infringement or another violation of intellectual property rights. Such representation and warranty will not apply to any production equipment supplied by LHI, method used by LHI or any other material or data used by LHI in the provision of the Services and which were not received from the CLIENT or agreed by CLIENT to be used in the provision of the Services.

12.2 By LHI . LHI hereby represents and warrants to CLIENT that, to the best of its knowledge, (i) it has the requisite intellectual property rights to be able to perform its obligations under this Agreement, and (ii) that LHI Intellectual Property, including LHI Inventions and LHI New IP as contemplated in this Agreement will not give rise to a potential cause of action by a Third Party against CLIENT for infringement or another violation of intellectual property rights.

13.

D ISCLAIMER ; L IMITATION OF L IABILITY

13.1 DISCLAIMER. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, INCLUDING WITHOUT LIMITATION THE EXPRESS PRODUCT WARRANTIES SET FORTH IN SECTION 5.1, LHI MAKES NO REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, WITH RESPECT TO THE PRODUCTS, MATERIALS, AND SERVICES PROVIDED

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

EXECUTION COPY

UNDER THIS AGREEMENT, AND LHI SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE WITH RESPECT TO SUCH PRODUCTS, MATERIALS, OR SERVICES.

13.2 Disclaimer of Consequential Damages. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

13.3 Limitation of Liability. BOTH PARTIES HEREBY AGREE THAT TO THE FULLEST EXTENT PERMITTED BY LAW, LHI’S LIABILITY TO CLIENT, FOR ANY AND ALL INJURIES, CLAIMS, LOSSES, EXPENSES, OR DAMAGES, WHATSOEVER, ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT FROM ANY CAUSE OR CAUSES, INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE, ERRORS, OMISSIONS OR STRICT LIABILITY, SHALL BE LIMITED SOLELY TO LHI REPEATING ONE TIME, AT LHI’S EXPENSE, SERVICES WHICH WERE MUTUALLY DEEMED TO BE NON-CONFORMING. HOWEVER THIS SECTION SHALL NOT APPLY IN THE EVENT BUT ONLY TO THE EXTENT OF GROSS NEGLIGENCE OR WILLFULL MISCONDUCT UNDER THIS AGREEMENT. TO THE EXTENT THAT THIS CLAUSE CONFLICTS WITH ANY OTHER CLAUSE, THIS CLAUSE SHALL TAKE PRECEDENCE OVER SUCH CONFLICTING CLAUSE. IF APPLICABLE LAW PREVENTS ENFORCEMENT OF THIS CLAUSE, THEN THIS CLAUSE SHALL BE DEEMED MODIFIED TO PROVIDE THE MAXIMUM PROTECTION FOR LHI AS IS ALLOWABLE UNDER APPLICABLE LAW.

14.

T ERM AND T ERMINATION

14.1 Term . The term of this Agreement will commence on the Effective Date and will continue until the fifth anniversary of the Effective Date unless terminated prior to that time or extended by the Parties.

14.2 Termination for Material Breach . Either Party may terminate this Agreement, by written notice to the other Party, for any material breach of this Agreement by the other Party, if such breach is not cured within thirty (30) days after the breaching Party receives written notice of such breach from the non-breaching Party; provided, however, that if such breach is not capable of being cured within such thirty-day period and the breaching Party has commenced and diligently continued actions to cure such breach within such thirty-day period, except in the case of a payment default, the cure period shall be extended to 60 days, so long as the breaching Party is making diligent efforts to do so. Such termination shall be effective upon expiration of such cure period.

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

EXECUTION COPY

14.3

Termination by Notice .

14.4 14.3.1 Without Cause . During the term of the Agreement, the CLIENT may terminate the Agreement upon 60 days notice. After the first anniversary of the Effective Date, either Party may terminate this Agreement by providing written notice of termination no less than two months in advance of the date of termination. For the avoidance of doubt, in the event of termination by CLIENT under this Section 14.3.1, CLIENT shall, at minimum, remain liable for all charges for materials that have already been purchased, all fees owed pursuant to actual services rendered, including all work in process, and un-cancellable costs, including un-cancellable labor commitments, related to any outstanding Statement of Work. In addition to the foregoing, in connection with any termination under this Section 14.3.1, CLIENT shall also pay to LHI a suite fee of Fifty Thousand Dollars ($50,000.00) per month for each of the three months prior to termination. Notwithstanding the foregoing, LHI will use commercially reasonable efforts to secure new projects (but excluding any project then under contract with LHI) for the suite space reserved for all cancelled CLIENT SOWs, for the same dates and duration that would have been occupied by CLIENT. If such new projects are secured by LHI, the suite fee due from CLIENT upon cancellation shall be reduced by an amount equal to one hundred percent (100%) of the production fees associated with such new projects; provided, however, in no event shall any such reduction result in a refund or credit to CLIENT.

14.3.2 Termination of Clinical Trials . Either Party may terminate this Agreement if such Party receives notice that the production of Product hereunder or the clinical trials for which Product is being produced hereunder have been or will be suspended or terminated by the FDA (or other regulatory authority) by providing written notice of termination not less than 2 months in advance of the date of termination. For the avoidance of doubt, in the event of termination by CLIENT under this Section 14.3.2, CLIENT shall, at minimum, remain liable for all charges for materials that have already been purchased, all fees owed pursuant to actual services rendered, including all work in process, and un cancellable costs, including un-cancellable labor commitments, related to any outstanding Statement of Work during such two-month period.

14.5 Termination by Insolvency . Either Party may terminate this Agreement upon notice to the other Party, upon (a) the dissolution, termination of existence, liquidation or business failure of the other Party; (b) the appointment of a custodian or receiver for the other Party who has not been terminated or dismissed within ninety (90) days of such appointment; (c) the institution by the other Party of any proceeding under national, federal or state bankruptcy, reorganization, receivership or other similar laws affecting the rights of creditors generally or the making by such Party of a composition or any assignment for the benefit of creditors under any national, federal or state bankruptcy, reorganization, receivership or other similar law affecting the rights of creditors generally, which proceeding is not dismissed within ninety (90) days of filing. All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code, licenses of rights of “intellectual property” as defined therein.

14.6 Effects of Termination .

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

EXECUTION COPY

14.6.1 Accrued Rights . Termination of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to such termination. Such termination will not relieve a Party of obligations that are expressly indicated to survive the termination of this Agreement.

14.6.2 Disposition of Remaining CLIENT Property and Confidential Information . Upon termination or expiration of this Agreement, LHI will store any Remaining CLIENT Property as set forth in Section 7.2 and, at CLIENT’s option, return or destroy any CLIENT Confidential Information in the possession or control of LHI. Likewise, CLIENT will, at LHI’s option, return or destroy any LHI Confidential Information in the possession or control of CLIENT. Notwithstanding the foregoing provisions: (i) LHI may retain and preserve, at its sole cost and expense, samples and standards of each Product following termination or expiration of this Agreement solely for use in determining LHI’s rights and obligations hereunder; and (ii) each Party may retain a single copy of the other Party’s Confidential Information for documentation purposes only and which shall remain subject to the obligations of nonuse and confidentiality set forth in this Agreement.

14.6.3 Survival . Sections 1, 3.4, 4.8, 7.2, 10, 11, 13, 14.4, 15, 16 and 17 of this Agreement, together with any appendices referenced therein, will survive any expiration or termination of this Agreement.

15.

I NDEMNIFICATION

15.1 Indemnification of Client . LHI will indemnify CLIENT, its Affiliates, and their respective directors, officers, employees and agents, and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) in connection with any and all liability suits, investigations, claims or demands (collectively, “ Losses ”) to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: (a) any material breach by LHI of this Agreement, or (b) the gross negligence or willful misconduct on the part of one or more of the LHI Parties in performing any activity contemplated by this Agreement, except for those Losses for which CLIENT has an obligation to indemnify the LHI Parties pursuant to Section 15.2, as to which Losses each Party will indemnify the other to the extent of their respective liability for the Losses.

15.2 Indemnification of LHI . CLIENT will indemnify LHI and its Affiliates, and their respective directors, officers, employees and agents (the “ LHI Parties ”), and defend and hold each of them harmless, from and against any and all Losses to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: (a) any material breach by CLIENT of this Agreement, (b) the use or sale of Products, except to the extent such Losses arise out of or result from a breach by LHI of the Product Warranties, (c) the gross negligence or willful misconduct on the part of CLIENT or its Affiliates in performing any activity contemplated by this Agreement, or (d) the use or practice by LHI of any process, invention or other intellectual property supplied by CLIENT to LHI under this Agreement, except for those Losses for which LHI has an obligation to indemnify CLIENT pursuant to Section 15.1, as to which Losses each Party will indemnify the other to the extent of their respective liability for the Losses.

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

EXECUTION COPY

15.3 Indemnification Procedure .

15.3.1 An “ Indemnitor ” means the indemnifying Party. An “ Indemnitee ” means the indemnified Party, its Affiliates, and their respective directors, officers, employees and agents.

15.3.2 An Indemnitee which intends to claim indemnification under Section 15.1 or Section 15.2 hereof shall promptly notify the Indemnitor in writing of any claim, lawsuit or other action in respect of which the Indemnitee, its Affiliates, or any of their respective directors, officers, employees and agents intend to claim such indemnification. The Indemnitee shall permit, and shall cause its Affiliates and their respective directors, officers, employees and agents to permit, the Indemnitor, at its discretion, to settle any such claim, lawsuit or other action and agrees to the complete control of such defense or settlement by the Indemnitor; provided, however, that in order for the Indemnitor to exercise such rights, such settlement shall not adversely affect the Indemnitee’s rights under this Agreement or impose any obligations on the Indemnitee in addition to those set forth herein. No such claim, lawsuit or other action shall be settled without the prior written consent of the Indemnitor and the Indemnitor shall not be responsible for any legal fees or other costs incurred other than as provided herein. The Indemnitee, its Affiliates and their respective directors, officers, employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any claim, lawsuit or other action covered by this indemnification, all at the reasonable expense of the Indemnitor. The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and expense.

15.4 Insurance . LHI will maintain, at all times during the term of this Agreement and for five years thereafter, a sufficient insurance policy, including a products liability policy, to assure its obligations under this Agreement (the “ Insurance Policy ”), with a per occurrence limit of at least five million dollars ($5,000,000) and an aggregate limit of at least five million dollars ($5,000,000), and will provide a Certificate of Insurance to the CLIENT that the Insurance Policy has been endorsed to designate the CLIENT as an additional insured. LHI shall maintain the Insurance Policy with an insurance company having a minimum AM Best rating of A. CLIENT will maintain, during the term of its clinical trials and to the extent required by law thereafter, a Clinical trials insurance policy, with a per occurrence limit of at five million dollars ($5,000,000) and an aggregate limit of five million dollars ($5,000,000), and will provide a Certificate of Insurance evidencing that the CLIENTS Insurance Policy has been endorsed to include LHI as an additional insured. Should any of the above described policies be cancelled before the expiration date thereof, notice will be delivered in accordance with the policy provisions.

16.

A DDITIONAL C OVENANTS

16.1 Non-Solicitation . During the term of this Agreement and for two (2) years thereafter, each of the Parties agrees not to seek to induce or solicit any employee of the other Party or its Affiliates to discontinue his or her employment with the other Party or its Affiliate in order to become an employee or an independent contractor of the soliciting Party or its Affiliate; provided, however, that neither Party shall be in violation of this Section 16.1 as a result of

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

EXECUTION COPY

making a general solicitation for employees or independent contractors. For the avoidance of doubt, the publication of an advertisement shall not constitute solicitation or inducement.

16.2 Commercial Scale Manufacture . In the event that CLIENT desires to commence commercial scale manufacture of Product, and following manufacture of the Product in accordance with the Process, the Parties agree to negotiate for the provision of such manufacturing services to CLIENT by LHI.

17.

M ISCELLANEOUS

17.1 Independent Contractors . Each of the Parties is an independent contractor and nothing herein contained shall be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between the Parties. Neither Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever.

17.2 Force Majeure . Neither Party shall be in breach of this Agreement if there is any failure of performance under this Agreement (except for payment of any amounts due under this Agreement) occasioned by any reason beyond the control and without the fault or negligence of the Party affected thereby, including, without limitation, an act of God, fire, flood, act of government or state, war, civil commotion, insurrection, acts of terrorism, embargo, sabotage, a viral, bacterial or mycoplasmal contamination which causes a shutdown of the Facility, prevention from or hindrance in obtaining energy or other utilities, a shortage of raw materials or other necessary components, labor disputes of whatever nature, or any other reason beyond the control and without the fault or negligence of the Party affected thereby (a “ Force Majeure Event ”). Such excuse shall continue as long as the Force Majeure Event continues. Upon cessation of such Force Majeure Event, the affected Party shall promptly resume performance under this Agreement as soon as it is commercially reasonable for the Party to do so. Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof, and the extent to which the affected Party will be unable to fully perform its obligations under this Agreement. Each Party further agrees to use commercially reasonable efforts to correct the Force Majeure Event as quickly as practicable (provided that in no event shall a Party be required to settle any labor dispute) and to give the other Party prompt written notice when it is again fully able to perform such obligations.

17.3 Condemnation . If the Facility is condemned or taken as a result of the exercise of the power of eminent domain or will be conveyed to a governmental agency having power of eminent domain under the threat of the exercise of such power (any of the foregoing, a “ Condemnation ”), then this Agreement will terminate as of the date on which title to the Facility vests in the authority so exercising or threatening to exercise such power and CLIENT will not have any right to the Condemnation proceeds.

17.4 Notices . Any notice required or permitted to be given under this Agreement by any Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a nationally-recognized courier service guaranteeing next-day or second day delivery, charges prepaid, or (d) delivered by facsimile (with documented evidence of transmission), to the addresses or facsimile numbers of the other

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

EXECUTION COPY

Party set forth below, or at such other addresses as may from time to time be furnished by similar notice by any Party. The effective date of any notice under this Agreement shall be the date of receipt by the receiving Party.

If to LHI :

Lonza Houston, Inc.

Attn: Business Head

8066 El Rio St. Houston, TX 77056

With a copy to:

Assistant General Counsel

Lonza America, Inc.

90 Boroline Road

Allendale, NJ 07401

Fax: (201) 378-5630

If to Client :

Vascular Biogenics Ltd. Attn: Eyal Breitbart

6 Yonni Netanyahu St.

Or –Yehuda Israel

Fax: +972-3-6346449

Either Party may change its address for notice by giving notice thereof in the manner set forth in this Section 17.4.

17.5 Entire Agreement; Amendments . This Agreement, including the Appendices attached hereto and referenced herein, constitutes the full understanding of the Parties and a complete and exclusive statement of the terms of their agreement with respect to the specific subject matter hereof and supersedes all prior agreements and understandings, oral and written, among the Parties with respect to the subject matter hereof. No terms, conditions, understandings or agreements purporting to amend, modify or vary the terms of this Agreement (including any Appendix hereto) shall be binding unless hereafter made in a written instrument referencing this Agreement and signed by each of the Parties.

17.6 . Governing Law . This Agreement will be governed by and construed in accordance with the internal laws of the Kingdom of England and Wales, without giving effect to its conflicts of laws provisions. Any dispute under this Agreement which cannot be resolved amicably shall be settled by the, shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (“ICC”) by one arbitrator appointed in accordance with the said rules. The award shall be final and binding and enforceable in any court of competent jurisdiction. The arbitration shall be held in London, United Kingdom, in English language.

17.7 Counterparts . This Agreement and any amendment hereto may be executed in any number of counterparts, each of which shall for all purposes be deemed an original and all of which shall constitute the same instrument. This Agreement shall be effective upon full

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

EXECUTION COPY

execution by facsimile or original, and a facsimile signature shall be deemed to be and shall be as effective as an original signature.

17.8 Severability . If any part of this Agreement shall be found to be invalid or unenforceable under applicable law in any jurisdiction, such part shall be ineffective only to the extent of such invalidity or unenforceability in such jurisdiction, without in any way affecting the remaining parts of this Agreement in that jurisdiction or the validity or enforceability of the Agreement as a whole in any other jurisdiction. In addition, the part that is ineffective shall be reformed in a mutually agreeable manner so as to as nearly approximate the intent of the Parties as possible.

17.9 Titles and Subtitles . All headings, titles and subtitles used in this Agreement (including any Appendix hereto) are for convenience only and are not to be considered in construing or interpreting any term or provision of this Agreement (or any Appendix hereto).

17.10 Exhibits . All “RECITALS”, “DEFINITIONS”, exhibits and appendices referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference.

17.11 Pronouns . Where the context requires, (i) all pronouns used herein will be deemed to refer to the masculine, feminine or neuter gender as the context requires, and (ii) the singular context will include the plural and vice versa.

17.12 Assignment . This Agreement shall be binding upon the successors and assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of its successors and assigns. Neither Party may assign its interest under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld. Any permitted assignment of this Agreement by either Party will be conditioned upon that Party’s permitted assignee agreeing in writing to comply with all the terms and conditions contained in this Agreement. Any purported assignment without a required consent shall be void. No assignment shall relieve any Party of responsibility for the performance of any obligation that accrued prior to the effective date of such assignment.

17.13 Waiver . The failure of any Party at any time or times to require performance of any provision of this Agreement (including any Appendix hereto) will in no manner affect its rights at a later time to enforce the same. No waiver by any Party of any term, provision or condition contained in this Agreement (including any Appendix hereto), whether by conduct or otherwise, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement (including any Appendix hereto).

17.14 Dispute Resolution . If the Parties are unable to resolve a dispute, despite its good faith efforts, either Party may refer the dispute to the President of each Party’s respective business unit (or other designee). In the event that no agreement is reached by the Presidents (or other designees) with respect to such dispute within thirty (30) days after its referral to them, either Party may pursue any and all remedies available at law or in equity according to section 17.6 above.

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

EXECUTION COPY

17.15 No Presumption Against Drafter . For purposes of this Agreement, CLIENT hereby waives any rule of construction that requires that ambiguities in this Agreement (including any Appendix hereto) be construed against the drafter.

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

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

EXECUTION COPY

IN WITNESS WHEREOF , the parties have executed this Agreement as of the date last signed by the parties hereto.


	VASCULAR BIOLOGICS, LTD.

1/05/2012	By:	/s/ Dror Harats
Date		Name: Dror Harats
		Title: CEO

	LONZA HOUSTON, INC.

1/05/2012	By:	/s/ J. David Enloe Jr.
Date		Name: J. David Enloe Jr.
		Title: Head of Viral-based Therapeutics

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

LOGO

APPENDIX A-1

Statement of Work VBLT-001

Formulation Buffer Evaluations for VB-111 Final Product

January 31, 2012

I.	Introduction and Background

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biogenics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

This SOW outlines the performance of a [***] designed to evaluate [***] as potential alternatives to the [***] currently utilized for VBL Therapeutics’ (“VBL”) VB-111 [***] final product. The study will be performed by Lonza Process Development and/or Quality Control personnel, except for the execution of the [***] assays performed by VBL; assays will be performed under GLP conditions and documented in laboratory notebooks. In addition, a study to evaluate the [***] at [***] will be performed by VBL using samples generated by Lonza and transferred to VBL.

The [***] consist of the following components:

[***]

Samples of VB-111 formulated in VBL’s standard final product buffer consisting of [***] and [***] at [***] will be analyzed alongside [***], for comparison and as a control.

II. Project Assumptions

In the development of this SOW, the following assumptions were made:

The two batches of research and development-grade VB-111 provided by VBL will have been documented to be Mycoplasma-free and bioburden-free and/or sterile, prior to their arrival at Lonza;

The VB-111 material provided for the study will be purified and formulated in [***] at a [***] and be of a [***] of approximately [***]; and

For each instance of physical virus particle titer determination, Lonza’s standard [***] method will be utilized. In addition, it is assumed that Lonza’s standard [***] standard curve generation procedure will be followed and will utilize VB-111 Reference Standard in the performance of this activity.

III. Scope of Work

The scope of the project includes the following tasks:

Sample Preparation

Lonza Job Code VBLT-001

Page 1 of 3

CONFIDENTIAL

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

Using [***] of [***] of VB-111 [***] formulated with [***] in [***] provided by VBL, [***] will be stored at [***] upon sample arrival to be used as controls for the [***] and [***], described below. The remaining [***] of [***] will be [***] and the material from both batches will be [***] Of the [***] will be [***] into each of [***] as described above [***]. Following [***], the material will be [***] at [***] into approximately [***] for each [***] before [***]

[***]

One VB-111 [***] will be subjected to [***] and tested after the final cycle. Testing that is to be performed both before and after [***] includes [***], total, are required to perform this study; the total number of samples to be analyzed during this study is [***] of approximately [***] will be made from each [***] on the date of testing and used for analysis. [***] will be stored at [***] for future analysis usage.

Temperature Storage Condition Stability Study

Following preparation, samples will be transferred to storage at [***] at Lonza and provided to VBL for transfer to proper storage temperature and analysis at each time point by VBL as desired by VBL, according to the following analysis plan:


Testing Time point (month)	Storage Condition
Testing Time point (month)	4 ^o C	-20 ^o C	-80 ^o C
[***]	[***]	[***]	[***]

Deliverables

In addition to sample preparation and study performance, Lonza will compose a Process Development Protocol (PDP) in standard Lonza format prior to study commencement, and upon completion of the [***], a summary report for the [***] in standard Lonza format which will describe the materials and procedures used in, and the results of, the study. Lonza will provide the report to VBL via electronic mail for review prior to report finalization. VBL will be provided with a signed copy of the report for its records.

IV.

Fees and Terms

The fees and payment terms for the activities described above total [***], payable as follows:

[***]

Lonza Job Code VBLT-001

Page 2 of 3

CONFIDENTIAL

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

[***]

Shipments from Lonza to VBL will be made via World Courier and utilize VBL’s World Courier account. In the event that shipments from Lonza to VBL utilize Lonza’s World Courier courier account, such shipment(s) will be invoiced for as pass-through costs and supporting documentation of associated fees will be provided along with the invoice.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

In the event of a termination of this SOW or the Agreement for any reason, VBL shall pay reasonable costs incurred by Lonza up to the effective date of termination (including out-of-pocket losses to Lonza for purchase of unmarketable materials which have become unusable by reason of termination), all uncancellable labor commitments and all work in process (including all professional services rendered) through the effective date of termination.

V.	Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-001

Page 3 of 3

CONFIDENTIAL

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

LOGO

APPENDIX A-2

Statement of Work VBLT-002

Small-scale [***] Process Development &

Downstream Process Technology Transfer for VB-111

February 14, 2012

I.	Introduction

II.

Scope of Work

Lonza will provide the following services surrounding the process development activities for the VB-111 product:

Phase 1, [***]

At the [***] Lonza will perform two studies simultaneously to determine parameters for [***] as well as [***] The cell densities to be evaluated are [***] will be used for VB-111 infection. [***] An extra sample per time point will be taken and stored for possible future analysis by VBL.

Phase 2, [***]

Lonza Process Development personnel will evaluate the feasibility of a [***] as an alternative to [***] in the manufacture of the VB-111 product at volumes of [***] Three studies will be performed during Phase 1, as listed below:

[***]

Study 1, above, will be performed in parallel with the [***]. The goal for Study 1, above, is to evaluate the [***] and to demonstrate that [***] Observations from and data generated during this activity

Lonza Job Code VBLT-002

Page 1 of 3

CONFIDENTIAL

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

will be drawn upon during the performance of Studies 2 and 3 to achieve [***]

Studies 2 and 3 may be overlapped as reasonably possible to shorten overall project timeline. Transferred standard operating parameter set-points from VBL’s existing VB-111 manufacturing procedure ([***]) will be used [***]

Cells from [***] provided by VBL, and standard [***] added by Lonza at [***] provided by VBL, will be used throughout the studies.

[***] using previously determined and transferred [***] for the product [***] will be determined by analyzing the [***] will be compared to historical VB-111 [***] to determine whether [***] In addition, samples will be provided to VBL [***].

Phase 3, [***]

Using technical documentation and SOPs provided by VBL as basis for experiment planning and [***], Lonza will perform a technology transfer of the existing VB-111 downstream production process at the appropriate scale. Two executions of VBL’s downstream production process will be performed. The first execution will utilize [***]; the second execution will utilize [***] will be processed first, followed by [***] The major processing steps for each [***] are as follows: [***] The [***] will be analyzed for [***] Samples will be taken throughout the downstream process for each [***] as follows: [***] These samples will be analyzed for [***] by both Lonza and VBL and the data from both parties compared for consistency.

[***]

Deliverable

Lonza Job Code VBLT-002

Page 2 of 3

CONFIDENTIAL

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

electronic mail for review prior to report finalization. VBL will be provided with a signed copy of the report for its records.

III.

Fees and Terms

The fees for the activities described above total [***], payable as follows:

Phase 1, [***], due upon Statement of Work acceptance;

Phase 2, [***]

[***], due upon Statement of Work acceptance;

[***], due upon Phase 1 completion.

Phase 3, [***]

[***], due upon Phase 2 activity commencement;

[***], due upon issuance of the Summary Report.

Courier fees for shipments from Lonza to VBL which utilize Lonza’s courier account will be invoiced for as pass-through costs and supporting documentation of associated fees will be provided along with the invoice.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

IV. Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-002

Page 3 of 3

CONFIDENTIAL

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

LOGO

APPENDIX A-2

Change Order 1 to Statement of Work VBLT-002

Resin Capacity Study for IEX Chromatography Resin

June 12, 2012

I.	Introduction and Background

This Change Order (CO) to Statement of Work (SOW) VBLT-002 between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this CO, the Agreement shall control.

VBL has requested that Lonza perform analysis on samples taken during the performance of the activities as described in SOW VBLT-002, Section II., “Phase 2, [***]” which are incremental to the analyses included in the SOW. The analyses to be performed per this Change Order are listed in Section II.A., below.

In addition, VBL has requested that Lonza evaluate the capacity of the ion exchange (IEX) chromatography resin that is used for the purification of VBL’s VB-111 product, in consideration of the potential need for increasing the size of the column and/or the quantity of resin utilized to purify VB-111 when produced at larger (i.e., 500L) working volumes. VB-111 material produced by Lonza in the performance of the work described in SOW VBLT-002, Section II., “Phase 2, Small Scale Stirred-tank Bioreactor (STB) Process Development,” will be used as test article for the activities described in Section II.B., below.

II.

Scope of Work

A., Incremental Analysis on VB-111 Material

Lonza will perform or coordinate the performance of the following assays, which are incremental to the work scope described in SOW VBLT-002, on two samples of VB-111 material [***] generated in the performance of the work scope described in SOW VBLT-002:

[***]

B., [***]

[***]

Following verification of the [***], the maximum quantity [***] per milliliter of [***] will be determined. This activity will be performed utilizing approximately [***] in each of [***]. VB-111 column load material produced as per [***], will be added to each of the [***] and [***], followed by [***] from each tube will be collected and stored for future titer analysis, which, if necessary, will be performed under a separate CO. The [***] will be [***] with [***] and the [***]. Following this, the material will be [***] with [***]; each of the [***] will be tested for [***] by [***] Should either [***] than what was analyzed be detected, this study may be repeated one time.

Lonza Job Code VBLT-002

Page 1 of 2

CONFIDENTIAL

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

Operational Capacity

Based on the outcome of the [***] the operational capacity of an [***] will be determined. VB-111 will be [***] using [***] of the maximum column load capacity as determined in the [***] will be tested for [***] by [***] and for purity, [***] using [***] Based on the assay results when compared to the historical [***] recoveries and product purity using this process [***] will be tested and analyzed, if appropriate. This process may be repeated up to three times at [***] until the [***] s reached which delivers comparable data to the [***]

Column Height Evaluation

Based on the outcome of the [***] the height of the [***] will be increased from [***] to match the [***] The [***] will be used to perform [***] and the [***] will be analyzed for [***] and [***]

Deliverable

Upon completion of the above activities, Lonza will compose a Technology Transfer Report in standard Lonza format, which will describe the materials and procedures used in, and the results of, the activities described above, as well as the activities described in SOW VBLT-002. Lonza will provide the report to VBL via electronic mail for review prior to report finalization. VBL will be provided with a signed copy of the report for its records.

III.

Fees and Terms

The fees for the activities described above total [***], payable as follows:

[***];

[***].

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

In the event of a termination of this CO or the Agreement for any reason, VBL shall pay reasonable costs incurred by Lonza up to the effective date of termination (including out-of-pocket losses to Lonza for purchase of unmarketable materials which have become unusable by reason of termination), all uncancellable labor commitments and all work in process (including all professional services rendered) through the effective date of termination.

IV. Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-002

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-3

Statement of Work VBLT-003

[***] Demonstration Run in

Process Development Laboratory Environment

May 7, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. (“Client”) and Lonza Houston, Inc. (“Lonza”) is subject to the Manufacturing Services Agreement dated January 5, 2012 (2012-01-05 VBL-Lonza MSA_fully executed.pdf), between Client, and Lonza (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

II.

Scope of Work

Lonza will provide the following services surrounding the process development activities for the VB-111 product:

Upon successful completion of the deliverables described in SOW-002, Lonza will perform [***] using a [***] provided by Client and [***] will be used throughout the production process; the batch will be [***] will be used in the performance of this batch.

It is assumed that the [***] of the upstream process used in the [***] will be identical to that of the [***] In addition, it is assumed that [***] is not necessary for [***]

The existing VB-111 downstream process that has been transferred to Lonza under SOW-002 will be used in the performance of the [***] as reasonably requested by Client; [***] as reasonably requested by Client. [***] will be analyzed for the presence of [***]

Deliverable

Upon completion of the above activities, Lonza will compose a Report in standard Lonza format, which will describe the materials and procedures used in, and the results of, the activities associated with this Project Component. Lonza will provide the report to Client via electronic mail for review prior to report finalization. Client will be provided with a signed copy of the report for its records.

III.

Fees and Terms

Lonza Job Code VBLT-003

Page 1 of 2

CONFIDENTIAL

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

The fees for the activities described above total [***], payable as follows:

[***] due upon execution of this Statement of Work;

[***] due upon Lonza’s completion of the upstream work

[***] due upon Lonza’s issuance of the initial draft Summary Report

Courier fees for shipments from Lonza to Client which utilize Lonza’s courier account will be invoiced for as pass-through costs and supporting documentation of associated fees will be provided along with the invoice.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

In the event of a termination of this SOW or the Agreement for any reason, Client shall pay reasonable costs incurred by Lonza up to the effective date of termination (including out-of-pocket losses to Lonza for purchase of unmarketable materials which have become unusable by reason of termination), all uncancellable labor commitments and all work in process (including all professional services rendered) through the effective date of termination.

IV. Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-003

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A4 -Statement of Work VBLT-004 Purchase of Cell Culture

Medium for VB-111 Production at the [***] Scale

June 12, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologies, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologies, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

Lonza and VBL are currently planning for Lonza to perform a [***] scale production batch of VBL’s VB-111 product during Quarter 4 2012. To provide a sufficient quantity of medium to produce the [***] and to have [***] VBL has requested that Lonza order a total of [***] The standard approximate lead time from the time the [***] In consideration of the duration of the lead time and shelf life, VBL has requested that Lonza order [***] to be produced as soon as possible and [***] to be produced two to three months later.

II.

Scope of Work

Lonza will order [***]. The [***] is to be produced as soon as possible; the second [***] is to be produced two to three months after the first batch.

III.

Fees and Terms

The cost of each [***], supplied in [***], is [***] USD.

The Lonza fee for medium procurement and receiving is [***], in addition to the batch cost.

The total fee for the activities described above is [***], payable as follows:

[***], due upon SOW execution;

[***], due upon notification of VBL by Lonza that the [***] has been fully received.

Any shipping and handling fees and sales tax charged by [***] and/or FedEx to Lonza will be passed through to VBL at no mark-up.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

Lonza Job Code VBLT-004

Page 1 of 2

CONFIDENTIAL

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

IV. Acceptance


Lonza Houston, Inc.		Vascular Biologies, Ltd.

By	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-004

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-4 Statement of

Work VBLT-005 VB-111

Sample Analysis July 5, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologies, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologies, Ltd. (“VBL”), and Lonza Houston, Inc. (‘Lonza’) (the “Agreement”) and is incorporated therein and made a part of such Agreement, in the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

VBL has requested that Lonza analyze five samples of its VB-111 Drug Product using Lonza’s [***] The samples and documentation of each sample’s Mycoplasma-free and sterile or bioburden-free status will be provided to Lonza by VBL, at VBL’s sole expense. The VB-111 samples to be analyzed are one sample from each of the following lots:

•

[***]

•

[***]

•

[***]

•

[***]

•

[***]

II.

Scope of Work

Lonza Quality Control (QC) personnel will perform two executions of assay [***], analyzing three of the VB-111 samples on one assay and the other two VB-111 samples on one separate assay. Upon assay completion, the assay documentation will be audited by Lonza QC and Quality Assurance personnel.

VBL will be provided with QA-reviewed and -approved assay documentation for its records.

III.

Pees and Terms

The fee for each [***] assay is [***] USD for the first sample [***] for each additional sample submitted and analyzed simultaneously on the same Test Record Form, up to three total samples per assay. To analyze [***] samples, [***] separate assays are required. Thus, the total fee for the activities as described above is [***] USD, 100% payable upon Lonza’s issuance of the assay documentation to VBL.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

In the event of a termination of this SOW or the Agreement for any reason, VBL shall pay reasonable costs incurred by Lonza up to the effective date of term !nation (including out-of-pocket losses to Lonza for purchase of unmarketable materials which have become unusable by reason of termination), all uncancellable labor commitments and aN work in process (including all professional services rendered) through the effective date of termination.

IV.

Acceptance


Lonza Houston, Inc		Vascular Biologies, Ltd.

B y [Illegible]		By: /s/ Amos Ron
Name: [Illegible]		Name: Amos Ron
Title:		Title: Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-005

Page 1 of 1

CONFIDENTIAL

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

LOGO

APPENDIX A-6

Statement of Work VBLT-006

50L GMP Production & Analysis of VB-111

September 6, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

VBL has requested that Lonza produce VBL’s VB-111 product under cGMP conditions at the [***] in a [***], as well as perform in-process and release testing on the VB-111 material as outlined in Section III., below.

II.

Project Assumptions

In the development of this SOW, the following assumptions were made:

United States Pharmacopoeia (USP) and FDA, as well as European Pharmacopoeia (EP) and European Medicines Agency (EMA), guidelines will be followed in the manufacture and analysis of VB-111;

PER.C6 cell and VB-111 materials provided by VBL will have been certified to be bioburden-free and/or sterile and Mycoplasma-free, prior to their arrival at Lonza;

[***] is not required for the [***] of the [***] at the [***];

For [***] a [***] and [***] is required. Note: [***] no longer requires [***] ;

For [***] a [***] and [***] is required;

A concentration of [***] is required for the [***] and the [***] for this [***] is [***];

The [***] for the [***] and [***] consists of [***] In addition, it is assumed that it is necessary to verify the identity of each component of the [***];

[***] and [***] will be utilized throughout the project;

Lonza Job Code VBLT-006

Page 1 of 8

CONFIDENTIAL

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

VB-111 Drug Product will be filled using a [***] in accordance with EMA guidelines into [***];

10.

Based on previous discussions with VBL, it is estimated that [***] thus, it is assumed that approximately [***] could be produced at the [***] it is estimated that approximately [***] could be achieved at the [***] It is therefore assumed that the quantity of [***] under this SOW is [***];

11.

Product release testing will be performed and/or coordinated by Lonza, with the exception of the assays designated in Section III., below, to be performed by VBL. Lonza will, at the written direction of VBL, sample the VB-111 material as needed for these assays and provide the samples to VBL for analysis by VBL or a VBL-designated third-party testing laboratory;

12.

[***] will have previously been performed, and a report for this activity is available to Lonza for reference.

13.

As the product is a [***] Lonza has assumed that its [***] which have been shown to [***].

14.

The quality agreement signed between Lonza and VBL will be an addendum to this agreement.

III.

Scope of Work


Project Component	Description	Detailed Description	Estimated Duration	Fee (USD)
a.	Materials Transfer from VBL to Lonza	[***]	[***]	N/A
b.	Manufacturing Preparation: Project-Specific GMP Documentation	Lonza will create documents specific to the project, including but not limited to: Specifications and Part Numbers for VB-111 product intermediates, raw materials such as resins, filters, columns, buffers, etc.; Master Label for DP; Certificates of Analysis for BDS and DP; Sample Transfer Forms for BDS and DP; In-process Testing and Yield Form; Product-specific Master Flow Record; Formulation Records for the Final Formulation Buffer and various buffers for downstream processing; product-specific Manufacturing Batch Records, Component Assembly Records. Information presented within summary reports developed by Lonza Process Development personnel, as well as information contained within the technical documentation provided by VBL, will be utilized and referenced in the development of the VB-111 project GMP documentation. Draft Manufacturing Batch Records and other draft GMP documentation, as appropriate and reasonably desired by VBL, will be provided to VBL for review and approval prior to implementation and use by Lonza.	[***]	[***]

Lonza Job Code VBLT-006

Page 2 of 8

CONFIDENTIAL

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


Project Component	Description	Detailed Description	Estimated Duration	Fee (USD)
c.	Manufacturing Preparation: Product-Dedicated Equipment Procurement	Lonza will purchase, install, and qualify (as appropriate) product-dedicated equipment, including but not limited to: [*] [] [] [] [**] Product-dedicated equipment will be designated property of VBL and may be used for future GMP batches of VB-111. Lonza shall have the right of possession and control of the equipment. Title to the equipment shall at all times remain with Client and the equipment shall be owned by Client. All costs for maintenance, service, repairs and replacements shall be borne by Client. Client shall bear all risk of loss of equipment in Lonza’s possession, except for losses due to the gross negligence or willful misconduct of Lonza.	[***]	[***]

d.	cGMP Manufacturing of VB-111 Clinical Lot [***]	Upon successful completion of the [*] Process Development run currently underway at Lonza per SOW VBLT-005, and utilizing official GMP documentation and VB-111-dedicated equipment obtained and qualified during Project Components b. and c., Lonza Manufacturing personnel will produce VB-111 clinical trial material in one GMP production run at the [] scale utilizing []. Cells from the [] provided by VBL will be utilized in the production of the batch. VB-111 infection and harvest parameters as previously identified by VBL and by Lonza Process Development personnel in the performance of SOWs A-2 and A-3 will be utilized throughout the production process. Standard Lonza SOP’s will be used where possible, except those project-specific documents created during Project Component b. As stated in Section II., Project Assumptions, above, it is estimated that approximately [] could be produced at the [] it is estimated that approximately [] could be achieved at the [] It is therefore assumed that the []; however, [*] Production will occur in Lonza’s multi-product GMP manufacturing facility at 8076 El Rio Street in Houston, Texas USA. Copies of all controlled documents executed during batch preparation will be uploaded to the VBL Projects site on the Lonza Extranet following Lonza Quality Assurance review for compliance.	[***]	[***]

Lonza Job Code VBLT-006

Page 3 of 8

CONFIDENTIAL

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

Project
Component

Description

Detailed Description

Estimated
Duration

Fee
(USD)

Cleaning Verification

Study

Post-production, Lonza will perform [***] testing [***].

[***]

Lonza Job Code VBLT-006

Page 4 of 8

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)
f.	In-Process and Release Testing, VB-111 Bulk Drug Substance	Lonza will coordinate the performance of required contract and in-house testing as required by the agreed-upon Bulk Certificate of Analysis. A list of recommended analyses is below; the price estimate assumes that the BDS will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly. Assay quantities are considered to be “1,” unless otherwise noted. In addition and as desired by VBL, Lonza will take VB-111 samples throughout the production process in addition to those listed herein, to be analyzed under separate SOW(s), as appropriate and as desired by VBL.		[***]	[***]
		Assay	Vendor / Protocol
		HARVEST
		[***]	[***]
		IN-PROCESS
		[***]	[***]
		FINAL FORMULATED BULK
		[***]	[***]

*	Assay will be performed/coordinated by VBL and will not be reported on the Lonza-issued Certificate of Analysis.

y	Assay will be performed/coordinated by Lonza and the results reported to VBL for information only. Results will not be included on the Lonza-issued Certificate of Analysis.

Lonza Job Code VBLT-006

Page 5 of 8

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)
g.	Release Testing, VB-111 Drug Product	Lonza will coordinate the performance of required contract and in-house testing as required by the agreed-upon DP Certificate of Analysis. A list of recommended analyses is below; the price estimate assumes that the DP will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly.		[***]	[***]
		Assay	Vendor / Protocol
		[***] (Continued below)	[***]

Lonza Job Code VBLT-006

Page 6 of 8

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)
g. (Cont’d)	Release Testing, VB-111 Drug Product (Cont’d)	Assay	Vendor / Protocol
		[***]	[***]	See above	See above
		Assay will be performed/coordinated by VBL and will not be reported on the Lonza-issued Certificate of Analysis. *Assay will be performed by both Lonza and VBL and the results compared. Only the Lonza result will be reported on the Lonza-issued Certificate of Analysis.

Deliverable for Project Components f. and g.		Lonza Quality Assurance representatives will review all testing records/reports and will issue Certificates of Analysis for VB-111 DS and DP for review by VBL or a VBL-designated Qualified Person (QP). VBL personnel or a delegate will be responsible for release of the DS and DP for use.		2 weeks	Included
TOTAL, VB-111: PROCESS DEVELOPMENT, GMP MANUFACTURE, AND ANALYSIS				[***]	[***]
OTHER SERVICES
Regulatory Support		Lonza Viral has extensive Regulatory experience both with FDA and EMA, and if desired, will perform consulting services on VBL’s behalf. Examples of such activities include the assembly of documents or data-mining of information for inclusion in a Product Master File; writing, reviewing, or editing of Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings; participation in teleconferences with regulatory agencies, etc.		As needed	[***]
Product Storage		Lonza will store vialed product in fully monitored, GMP conditions free of charge for a period of up to thirty (30) days after issuance of the product’s Certificate of Analysis. [*] [] [] [*]		Monthly	To be Determined

Lonza Job Code VBLT-006

Page 7 of 8

CONFIDENTIAL

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

IV.

Fees and Terms

The total fee for the activities described above, not inclusive of Regulatory Support and Product Storage services, is [***] , payable as follows:

[***]

[***], due upon SOW execution

[***], due upon [***]

[***]

[***], due upon SOW execution

[***], due upon [***]

[***]

[***], due upon [***]

c. [***], due upon completion of testing

Fees for Regulatory Support services will be invoiced for on a monthly basis, as applicable. Fees for Product Storage, if applicable, will be invoiced for on a semi-annual basis, in advance.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

In the event of a termination of this SOW or the Agreement for any reason, VBL shall be responsible for any charges for all labor, testing and materials, including raw materials, that have already been purchased to perform the services detailed in this SOW and VBL shall pay all other reasonable costs incurred by Lonza up to the effective date of termination, including completed but unbilled services, all uncancellable labor commitments and all work in process (including all professional services rendered) through the effective date of termination.

V.	Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-006

Page 8 of 8

CONFIDENTIAL

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

LOGO

APPENDIX A-7 Statement of Work VBLT-007 Stability

Study [***] November 5, 2012

I.	Introduction

VBL has requested that Lonza, via [***], perform a stability study on the [***], which is used in the manufacture of VBL’s VB-111 product. The lot of [***] to be analyzed is currently being produced by [***] for Lonza on behalf of VBL under SOW VBLT-004, “Purchase of [***] for VB-111 Production at the [***],” dated June 12, 2012.

II.

Scope of Work

Lonza will coordinate the performance of a stability study on one lot of [***] as described in the attached study protocol, “Product Chemical Stability Study” on GMP product number [***] to evaluate product stability over one year when stored at [***]. Client hereby agrees to the terms of such attached study protocol.

Lonza Quality Control and Quality Assurance personnel will review each report provided to Lonza by [***], and will provide an electronic copy of each report to VBL for its records upon completion of Lonza’s review of each report. The reports will be issued by [***] according to the following time schedule:

An Interim Report will be provided within four weeks of completion of the tests at each of the 3-6-, , and 10-month time points;

A Final Report will be provided within four weeks of completion of the tests at the 13-month time point.

Lonza shall not be responsible for any act or omission of [***], including any delay by [***] in releasing any report.

III.

Fees and Terms

The fee for the activities described herein is [***], payable as follows:

[***], payable upon SOW execution;

[***], payable upon Lonza providing VBL with an electronic copy of the final study report issued by [***].

Lonza Job Code VBLT-007

Page 1 of 2

CONFIDENTIAL

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

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

In the event of a termination of this SOW or the Agreement for any reason, VBL shall pay reasonable costs incurred by Lonza up to the effective date of termination (including out-of-pocket losses to Lonza for purchase of (i) unmarketable materials which have become unusable by reason of termination and (ii) services from a third party), all uncancellable labor commitments and all work in process (including all professional services rendered) through the effective date of termination.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologies, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-007

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-8

Statement of Work VBLT-008

Procurement of Dedicated Equipment for Large-Scale VB-111 GMP Production

September 21, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

Production of VBL’s VB-111 product at the [***] at Lonza is planned to occur in the late 2012 to early 2013 timeframe under a separate SOW. The [***] are known to exist in limited quantities and to have relatively long lead times from order placement to material receipt, which could possibly jeopardize the timing of the planned [***]. To address the availability of the [***] VBL has requested that Lonza order these items on VBL’s behalf under this SOW.

II.

Scope of Work

The following items will be purchased by Lonza from [***] on VBL’s behalf, in support of VB-111 production:


Item / Description	Qty	GEHC Catalog No.	Cost, ea (USD)	Total Cost (USD)
[***]	[***]	[***]	[***]	[***]
TOTAL				[***]

III.

Fees and Terms

Should shipping and handling fees for the items listed above be assessed by [***], Lonza will invoice VBL for the charges as a pass-through cost.

The total fee for the items listed above, not inclusive of any shipping and handling charges, is [***], payable as follows:

[***], payable upon SOW execution;

[***], payable upon Lonza’s receipt of all the items listed above from [***].

These items will be designated property of VBL and may be used for future GMP batches of VB-111.

Lonza Job Code VBLT-008

Page 1 of 2

CONFIDENTIAL

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

Lonza shall have the right of possession and control of the equipment. Title to the equipment shall at all times remain with Client and the equipment shall be owned by Client. All costs for maintenance, service, repairs and replacements shall be borne by Client. Client shall bear all risk of loss of equipment in Lonza’s possession, except for losses due to the gross negligence or willful misconduct of Lonza.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

In the event of a termination of this SOW or the Agreement for any reason, VBL shall be responsible for any charges for all labor, testing and materials, including raw materials and equipment, that have already been purchased to perform the services detailed in this SOW and VBL shall pay all other reasonable costs incurred by Lonza up to the effective date of termination, including completed but unbilled services, all uncancellable labor commitments and all work in process (including all professional services rendered) through the effective date of termination.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-008

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-9

Statement of Work VBLT-009

Evaluation of [***]

December 22, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

VBL has requested that Lonza evaluate the use of a [***] for performance of [***] in the formulation of VBL’s VB-111 product instead of performing [***] in an effort to increase product recovery at the [***] in the VB-111 production process. Lonza has drafted and VBL has reviewed and approved the plan for this study, entitled, “[***] (attached).

II.

Scope of Work

Lonza Process Development (PD) personnel will perform the study as described in the attached study plan. The study includes the [***] followed by up to [***]. The below table outlines the samples to be taken and the analyses to be performed on the sampled material:


Sample Material	Quantity Samples	Assay
[***]	[***]	[***]

*	[***] will be performed by PD; R&D-grade

**	Retained samples will be stored at [***] in Lonza PD in anticipation of future analysis if VBL so requests in writing, in which case a Change Order to this SOW will be drafted to document the incremental work scope and associated fees.

Upon the completion of the study, Lonza will draft a brief Summary Report in standard Lonza format which will describe the materials, equipment, and procedures which were utilized throughout the study, as well as the study results and conclusions. An electronic copy of the report will be provided to VBL for review and approval prior to finalization. Upon its finalization VBL will be provided with a signed electronic copy of the report for its records.

III.

Fees and Terms

The fee for the activities described herein is [***], payable as follows:

Lonza Job Code VBLT-009

Page 1 of 2

CONFIDENTIAL

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

[***], payable upon SOW execution;

[***], payable upon Lonza providing VBL with an electronic copy of the draft study report for its records.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-009

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-10

Statement of Work VBLT-010

VB-111 Drug Product Room Temperature Stability Study and Sample Analysis

November 9, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

II.

Scope of Work

The work scope includes the execution of two activities, as described below:

A. Drug Product Stability Study at Room Temperature

During [***] filling [***] at Lonza [***] are routinely maintained at [***] throughout [***] before being transferred to [***] The purpose of this study is to evaluate the [***]

Lonza Process Development (PD) and Quality Control (QC) personnel will execute the study outlined in the attached file, [***] In addition to study planning, set-up, sampling, and documentation, four samples will be tested using [***]. The assays will be performed on official Quality Assurance-issued Test Record Forms. Upon assay completion, the assay documentation will be audited by Lonza QC and Quality Assurance personnel.

Upon study completion, a Summary Report will be created by Lonza in standard Lonza format, which will be provided to VBL for review prior to finalization.

Should additional testing be desired by VBL, this testing would be captured under a separate SOW or via a Change Order to this SOW.

B. Analysis of VB-111 for [***]

Lonza QC will analyze five samples of the VB-111 Drug Product using [***] The VB-111 samples to be analyzed are one sample from each of the following lots:

[***]

[***] Upon assay completion, the assay documentation will be audited by Lonza QC and Quality Assurance personnel.

Lonza Job Code VBLT-010

Page 1 of 2

CONFIDENTIAL

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

VBL will be provided with QA-reviewed and –approved assay documentation for its records.

III.

Fees and Terms

The fee for the activities described above is as follows:

[***]

The total fee, [***], is payable as follows:

[***], due upon SOW execution;

[***], due upon Lonza providing the [***] and [***]

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-010

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-11

Statement of Work VBLT-011

Evaluation of [***]

December 5, 2012

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

In consideration of the high cost of the [***] that are required for [***] produced at the [***] that is planned to be performed at Lonza under a separate SOW, VBL has requested that Lonza perform a study to evaluate the [***] rather than [***], which is VBL’s current practice. Lonza has drafted and VBL has approved the plan for this study, entitled, [***]; attached).

II.

Scope of Work

[***] personnel will perform the study as described in [***] The study includes the performance of up to [***] and up to [***] Following completion of the [***] will be analyzed by analytical [***] For both [***] will be performed to [***]

Upon the completion of the study as described in [***], Lonza will draft a Summary Report in standard Lonza format which will describe the materials, equipment, and procedures which were utilized throughout the study, as well as the study results and conclusions. An electronic copy of the report will be provided to VBL for review and approval prior to finalization. Upon its finalization VBL will be provided with a signed electronic copy of the report for its records.

III.

Fees and Terms

The fee for the activities described herein is [***], payable as follows:

[***], payable upon SOW execution;

[***], payable upon Lonza providing VBL with an electronic copy of the draft study report for its records.

Lonza Job Code VBLT-011

Page 1 of 2

CONFIDENTIAL

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

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

IV. Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-011

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-12

Statement of Work VBLT-012

[***]

February 26, 2013

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

The volume of [***] that will be generated during the performance of the [***] by Lonza on behalf of VBL is estimated to be approximately [***] This material is planned to be [***] and is to be [***] VBL has requested that Lonza perform a study to determine [***] Lonza has drafted and VBL has reviewed and approved the plan for this study, entitled, [***]; attached).

II.

Scope of Work

Lonza Validation personnel will perform the study as described in the attached study plan.

III.

Fees and Terms

The fee for the activities described herein is [***], payable as follows:

[***], payable upon SOW execution;

[***], payable upon Lonza providing VBL with an electronic copy of the draft study report for its records.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

Lonza Job Code VBLT-012

Page 1 of 2

CONFIDENTIAL

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

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-012

Page 2 of 2

CONFIDENTIAL

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

LOGO

Amended and Restated APPENDIX A-13

Statement of Work VBLT-013

[***] GMP Production & Analysis of VB-111

May 23, 2013

I.	Introduction

This Amended and Restated Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

VBL has requested that Lonza produce VBL’s VB-111 product under cGMP conditions at the [***], as well as perform in-process and release testing on the VB-111 material as outlined in Section II., below.

This Amended and Restated Appendix A-13, Statement of Work VBLT-013, [***] replaces in its entirety the original Appendix A-13, Statement of Work VBLT-013, [***] entered by the parties, dated December 20, 2012 (the “Original SOW”).

II.

Scope of Work

Project
Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

Manufacturing Preparation:

Project-Specific GMP

Documentation

Lonza will create documents specific to the project, including but not limited to: Specifications and Part Numbers for VB-111 product intermediates, raw materials such [***]; In-process Testing and Yield Form; Product-specific Master Flow Record; Formulation Records for the Final Formulation Buffer and various buffers for downstream processing; product-specific Manufacturing Batch Records, Component Assembly Records.

Information presented within summary reports developed by Lonza Process Development personnel, as well as information contained within the technical documentation provided by VBL, will be utilized and referenced in the development of the VB-111 project GMP documentation. Draft Manufacturing Batch Records and other draft GMP documentation, as appropriate and reasonably requested by VBL, will be provided to VBL for prompt review and approval prior to implementation and use by Lonza.

[***]

Lonza Job Code VBLT-0013

Page 1 of 11

CONFIDENTIAL

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


Project Component	Description	Detailed Description	Estimated Duration	Fee (USD)
b.	Manufacturing Preparation: Product-dedicated Equipment Installation & Qualification	The following items which were purchased by VBL for this project per SOW A-8 will be utilized in the production of VB-111 at the [*] [] This product-dedicated equipment will be designated property of VBL and may be used for future GMP batches of VB-111. Lonza shall have the right of possession and control of the equipment. Title to the equipment shall at all times remain with Client and the equipment shall be owned by Client. All costs for maintenance, service, repairs and replacements shall be borne by Client. Client shall bear all risk of loss of equipment in Lonza’s possession, except for losses due to the gross negligence or willful misconduct of Lonza. The fee at right represents the fee for installing and qualifying the [**]	[***]	[***]

c.	Refrigerated Storage Container Preparation & Rental	As the large quantity of refrigerated buffers and cell culture media that will be used throughout this project exceeds the quantity that Lonza’s cold room can accommodate at one time, a portable refrigerated storage container will be leased by Lonza from an equipment supply vendor for use throughout the duration of this project to supplement the cold room storage space. The container (20’ long x 8’ wide x 8.5’ high) is designed to maintain temperatures [*] and will be transported and delivered to Lonza, where it will remain on-site until the project is complete. The fee at right represents the fee for container transport to Lonza; the monthly rental fee for up to 4 months; and for supplying electricity to the container. If the project extends beyond 4 months, VBL shall be charged an additional [*] per month. Temperature data will be electronically monitored regularly.	[***]	[***]

Lonza Job Code VBLT-013

Page 2 of 11

CONFIDENTIAL

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

Project
Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

cGMP Manufacturing of VB-111

Clinical Lot

[***]

Utilizing official GMP documentation created under Project Component a. and VB-111-dedicated equipment obtained and qualified during in the performance of SOW A-8 and Project Component b., Lonza Manufacturing personnel will produce VB-111 clinical trial material in one GMP production run at the [***] as the production reactor. [***] to be used in the performance of the [***] include [***]

[***] as previously identified by VBL and by Lonza Process Development and Manufacturing personnel in the performance of SOWs A-2, A-3, and A-6 will be utilized throughout the production process. Standard Lonza SOP’s will be used where possible, except those project-specific documents created during Project Component a.

It is understood that the [***] will be operated at the [***] and that the entire [***] material produced will be [***] A portion of this [***] will be [***] Following this, a [***] will be [***] to produce a [***]

It is assumed that two full [***] However [***] be necessary or desired by [***], a Change Order to this SOW will be drafted to accommodate the incremental work scope.

Production will occur in Lonza’s multi-product GMP2 manufacturing facility at 8076 El Rio Street in Houston, Texas USA. Copies of all controlled documents executed during batch preparation will be uploaded to the VBL Projects site on the Lonza Extranet following Lonza Quality Assurance review for compliance.

[***]

Lonza Job Code VBLT-013

Page 3 of 11

CONFIDENTIAL

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

Project

Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

Changes in quantities and types of some production raw materials from those originally contemplated have resulted in the need for Lonza to purchase additional materials in support of this [***] These items are as follows:

Item

Purpose

Manufacturer
/Vendor

Qty

[***]

Additional

[***]

Harvest and

Downstream Processing

Materials

*	[*] are required for the performance of the [] However, should any of them require replacement [**]

**	A total of five filters are planned to be required for the [*] However, should any of them require replacement due to [] or for other reasons as deemed necessary, VBL will be charged [**] used over these five.

Lonza Job Code VBLT-013

Page 4 of 11

CONFIDENTIAL

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


Project Component	Description	Detailed Description	Estimated Duration	Fee (USD)
f.	Satellite Cultures in Process Development	At the time the GMP culture is transferred from the [*] In parallel with the [] The process and monitoring described above will be repeated when the culture is transferred from the [**]. This satellite culture will be discontinued after four days post-infection and will not be harvested or purified. Results of tests performed throughout the culture will be provided to VBL in summary table format.	[***]	[***]

g.	Cleaning Verification Study	Post-production, Lonza will perform [***].	3 weeks	[***]

Lonza Job Code VBLT-013

Page 5 of 11

CONFIDENTIAL

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

Project
Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

Lonza will coordinate the performance of required contract and in-house testing on the VB-111 Harvest material as required by the agreed-upon Bulk Drug Substance Certificate of Analysis. A list of recommended analyses is below; the price estimate assumes that the Harvest will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly. Assay quantities are considered to be “1,” unless otherwise noted. In addition and as reasonably requested in writing by VBL, Lonza will take VB-111 samples throughout the production process in addition to those listed herein, to be analyzed under separate SOW(s), as appropriate and as reasonably requested in writing by VBL.

Assay

Vendor /
Protocol

HARVEST

[***]

In-Process and

Release Testing,

VB-111 Harvest

IN-PROCESS

[***]

*	Assay will be performed/coordinated by VBL, at VBL’s sole expense and responsibility, and will not be reported on the Lonza-issued Certificate of Analysis.

y	Assay will be performed/coordinated by Lonza and the results reported to VBL for information only. Results will not be included on the Lonza-issued Certificate of Analysis.

Lonza Job Code VBLT-013

Page 6 of 11

CONFIDENTIAL

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

Project
Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

Lonza will coordinate the performance of required contract and in-house testing as required by the agreed-upon Bulk Certificates of Analysis. A list of recommended analyses is below; the price estimate assumes that the BDS will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly. Assay quantities are considered to be “1,” unless otherwise noted. In addition and as reasonably requested in writing by VBL, Lonza will take VB-111 samples throughout the production process in addition to those listed herein, to be analyzed under separate SOW(s), as appropriate and as reasonably requested in writing by VBL. Results of assays performed on the VB-111 material as described below will be included in the Certificate of Analysis for each Bulk Drug Substance.

Assay

Vendor /
Protocol

IN-PROCESS

[***]

In-Process and

Release Testing,

VB-111 Bulk

[***]

Drug Substance

FINAL FORMULATED BULK

[***]

*	Assay will be performed/coordinated by VBL, at VBL’s sole expense and responsibility, and will not be reported on the Lonza-issued Certificate of Analysis.

y	Assay will be performed/coordinated by Lonza and the results reported to VBL for information only. Results will not be included on the Lonza-issued Certificate of Analysis.

Lonza Job Code VBLT-013

Page 7 of 11

CONFIDENTIAL

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

Project
Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

Lonza will coordinate the performance of required contract and in-house testing as required by the agreed-upon DP Certificate of Analysis. A list of recommended analyses is below; the price estimate assumes that the DP will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly.

Assay

Vendor /
Protocol

[***]

Release Testing,

VB-111

Drug Product

(Continued below)

Lonza Job Code VBLT-013

Page 8 of 11

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)

		Assay	Vendor / Protocol
		[***]	[***]
	Release Testing,
j.	VB-111			See above	See above
(Cont’d)	Drug Product (Cont’d)	* Assay will be performed/coordinated by VBL, at VBL’s sole expense and responsibility, and will not be reported on the Lonza-issued Certificate of Analysis.
		** Assay will be performed by both Lonza and VBL and the results compared. Only the Lonza result will be reported on the Lonza-issued Certificate of Analysis.

Deliverable for Project Components h., i., and j.		Lonza Quality Assurance representatives will review testing records/reports and will issue Certificates of Analysis for VB-111 Harvest, DS and DP for review by VBL or a VBL-designated Qualified Person (QP). VBL personnel or a delegate will be responsible for release of the Harvest, DS and DP for use.		[***]	[***]

		The following analyses will be performed by Lonza Process Development personnel on VB-111 samples taken throughout the GMP production process:

		Assay	Quantity
	R&D-grade	[***]	[***]
k.	VB-111 In-
	Process			[***]	[***]
	Testing

		Analysis activities will be documented in laboratory notebooks and the results reported to VBL in an electronic Excel file.

TOTAL, VB-111 GMP MANUFACTURE AND ANALYSIS				[***]	[***]

OTHER SERVICES

Regulatory Support		Lonza Viral has extensive Regulatory experience both with FDA and EMA, and if desired, will perform consulting services on VBL’s behalf. Examples of such activities include the assembly of documents or data-mining of information for inclusion in a Product Master File; writing, reviewing, or editing of Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings; participation in teleconferences with regulatory agencies, etc.		As needed	[***]

Lonza Job Code VBLT-013

Page 9 of 11

CONFIDENTIAL

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

Project
Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

Product Storage

Lonza will store vialed product in fully monitored, GMP conditions free of charge for a period of up to thirty (30) days after issuance of the product’s Certificate of Analysis.

After the 30-day complimentary storage period, Lonza will provide ongoing GMP product storage at < -60ºC, as follows:

1. [***]—Waived if Lonza-produced material

2. [***]

3. [***]

Monthly

To be

Determined

III.

Fees and Terms

The total fee for the activities described above, not inclusive of Regulatory Support and Product Storage services, is [***], payable as follows:

[***]

[***], due upon SOW execution

[***], due upon [***]

[***]

[***], due upon SOW execution

[***], due upon [***]

[***]

[***], due upon [***]

[***]

Fees for Regulatory Support services will be invoiced for on a monthly basis, as applicable. Fees for Product Storage, if applicable, will be invoiced for on a semi-annual basis, in advance.

For each shipment of final product or other VB-111 materials samples to VBL, BioReliance or other parties at VBL’s written request, Lonza will charge a fee of [***] for handling and shipment preparation. Courier fees will be charged in addition to the shipping and handling fee should Lonza’s World Courier account be used instead of VBL’s World Courier account. Courier fees will not be charged should VBL’s World Courier account be used instead of Lonza’s. Fees for shipping services will be invoiced for on a monthly basis, as applicable.

Fees for additional materials as outlined in Project Component e., “Additional Harvest and Downstream Processing Materials,” if applicable, will be invoiced for after completion of the downstream processing activities.

Lonza Job Code VBLT-013

Page 10 of 11

CONFIDENTIAL

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

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer
Date:		Date:

Lonza Job Code VBLT-013

Page 11 of 11

CONFIDENTIAL

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

LOGO

APPENDIX A-14

Statement of Work VBLT-014

VB-111 Sample Analysis

January 31, 2013

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

VBL has requested that Lonza coordinate the performance of integrity testing on the container/closure that will be used for vialing VBL’s VB-111 Drug Product. The container/closure unit consists of a [***]

II.

Scope of Work

Lonza Quality Control (QC) personnel will coordinate the performance of [***] on VBL’s behalf, using [***] were previously filled by Lonza with [***]. Lonza QC and Quality Assurance personnel will review and audit the [***] upon its receipt by Lonza.

VBL will be provided with a scanned electronic copy of the Lonza QA-reviewed and –approved assay final report documentation from [***] for its records.

III.

Fees and Terms

The fee for this activity is [***], 100% payable upon Lonza’s issuance of the [***] to VBL.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-014

Page 1 of 1

CONFIDENTIAL

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

LOGO

APPENDIX A-15

Statement of Work VBLT-015

[***]

February 26, 2013

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

The volume of [***] that will be generated during the performance of the [***] by Lonza on behalf of VBL is estimated to be approximately [***]. VBL has requested that Lonza evaluate [***] held in [***]) for up to [***], as a potential alternative to [***] Lonza has drafted and VBL has reviewed and approved the plan for this study, entitled, [***] (attached).

II.

Scope of Work

Lonza Process Development and Quality Control personnel will perform the study as described in the attached study plan. Sample analysis will be performed by Lonza QC personnel; testing documentation will be audited by Lonza QC and Quality Assurance personnel. The following analyses will be performed on the samples collected during the study:

•

Lonza method [***] (one assay execution to analyze 4 samples)

•

Lonza method [***] (one assay execution to analyze 4 samples)

III.

Fees and Terms

The fee for the activities described herein is [***], payable as follows:

[***], payable upon SOW execution;

[***], payable upon Lonza providing VBL with an electronic copy of the draft study report for its records.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

Lonza Job Code VBLT-015

Page 1 of 2

CONFIDENTIAL

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

of termination), all uncancellable labor commitments and all work in process (including all professional services rendered) through the effective date of termination.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-015

Page 2 of 2

CONFIDENTIAL

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

LOGO

Amended and Restated APPENDIX A-16

Statement of Work VBLT-016

Analysis of VB-111

May 23, 2013

I.	Introduction and Background

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

VBL has requested that VB-111 [***] not be filled as [***] and subsequently tested, as planned per SOW [***] However, [***] stage has been performed by Lonza as outlined in SOW [***] The purpose of this Amended and Restated Appendix A-16, Statement of Work VBLT-016, is to remove the cGMP Production of VB-111 Drug Product and GMP-grade Release Testing for VB-111 Drug Product from the Scope of Work of SOW VBLT-016. This Amended and Restated Appendix A-16, Statement of Work VBLT-016, “Analysis of VB-111,” replaces in its entirety the original Appendix A-16, Statement of Work VBLT-016, “GMP Filling & Analysis of VB-111,” entered by the parties, dated March 14, 2013 (the “Original SOW”).

II.

Scope of Work

Project

Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

GMP-grade In-Process and Release Testing, VB-111 Bulk Drug Substance

Lonza will coordinate the performance of required contract and in-house testing as required by the agreed-upon Bulk Certificate of Analysis. A list of recommended analyses is below; the price estimate assumes that the BDS will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly. Assay quantities are considered to be “1,” unless otherwise noted. In addition and as requested by VBL, Lonza will take VB-111 samples throughout the production process in addition to those listed herein, to be analyzed under separate SOW(s), as appropriate and as desired by VBL.

Assay

Vendor / Protocol

[***]

HARVEST

[***]

(Continued below)

Lonza Job Code VBLT-006b

Page 1 of 3

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)
		Assay	Vendor / Protocol

		IN-PROCESS

		[***]	[***]
a., Cont’d	GMP-grade In-Process and Release Testing, VB-111 Bulk Drug Substance, Cont’d	FINAL FORMULATED BULK		See above	See above
		[***]	[***]
		* Assay will be performed/coordinated by VBL and will not be reported on the Lonza-issued Certificate of Analysis. Cost is not included in fee at right.
		y Assay will be performed/coordinated by Lonza and the results reported to VBL for information only. Results will not be included on the Lonza-issued Certificate of Analysis.
Deliverable for Project Component a.		Lonza Quality Assurance representatives will review all Lonza-performed or –coordinated testing records/reports and will issue a Certificate of Analysis for VB-111 BDS for review by VBL or a VBL-designated Qualified Person (QP).		[***]	Included

		The following analyses will be performed by Lonza Process Development personnel on VB-111 samples taken throughout the GMP production process:
	R&D-grade VB-111 In- Process Testing	Assay	Quantity
b.		[***]	[***]	[***]	[***]
		Analysis activities will be documented in laboratory notebooks and the results reported to VBL in an electronic Excel file comparing the process step-yields for the production of lots S820002 and S820001.
		TOTAL, VB-111 ANALYSIS		[***]	[***]

Lonza Job Code VBLT-006b

Page 2 of 3

CONFIDENTIAL

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

III.

Fees and Terms

The total fee for the activities described above is [***], payable as follows:

[***], due upon SOW execution

[***], due upon Lonza’s issuance of [***]

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

For each shipment of final product or other VB-111 materials samples to VBL, BioReliance or other parties at VBL’s written request, as of the date of this Amended and Restated SOW VBLT-016, Lonza will charge a fee of [***] USD for handling and shipment preparation. Courier fees will be charged in addition to the shipping and handling fee should Lonza’s World Courier account be used instead of VBL’s World Courier account. Courier fees will not be charged should VBL’s World Courier account be used instead of Lonza’s. Fees for shipping services will be invoiced for on a monthly basis, as applicable.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-006b

Page 3 of 3

CONFIDENTIAL

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

LOGO

APPENDIX A-17

Statement of Work VBLT-017

GMP Filling & Analysis of VB-111

May 23, 2013

I.	Introduction and Background

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

II.

Scope of Work

Project
Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

cGMP Production of VB-111 Drug Product

VB-111 will be [***] It is assumed that:

[***]

[***]; however, this number may vary;

[***]

GMP documentation such as the DP Quality Control Sample Transfer Form, Master Label for DP, and BDS and DP Certificates of Analysis for VB-111, which were created during the performance of SOW 6, will be used throughout the performance of this SOW. Draft GMP documentation, as appropriate and reasonably requested by VBL, will be provided to VBL for review and approval prior to implementation and use by Lonza.

Production of DP will occur in Lonza’s multi-product GMP manufacturing facility at 8066 El Rio Street in Houston, Texas USA. Copies of all controlled documents executed during batch preparation will be sent by air mail to VBL at VBL’s expense following Lonza Quality Assurance review for compliance.

[***]

Lonza Job Code VBLT-006c

Page 1 of 5

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)
		Lonza will coordinate the performance of required contract and in-house testing as required by the agreed-upon Bulk Certificate of Analysis. A list of recommended analyses is below; the price estimate assumes that the BDS will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly. Assay quantities are considered to be “1,” unless otherwise noted. In addition and as requested by VBL, Lonza will take VB-111 samples throughout the production process in addition to those listed herein, to be analyzed under separate SOW(s), as appropriate and as desired by VBL.

		Assay	Vendor / Protocol
		HARVEST
		[***]	[***]
	GMP-grade
	In-Process and
	Release	IN-PROCESS		[***]	[***]
b.	Testing, VB-111
	Bulk Drug
	Substance	[***]	[***]

		FINAL FORMULATED BULK
		[***]	[***]

		* [*] will be performed/coordinated by VBL and will not be reported on the Lonza-issued Certificate of Analysis. Cost is not included in fee at right. y [*] will be performed/coordinated by Lonza and the results reported to VBL for information only. Results will not be included on the Lonza-issued Certificate of Analysis.

Lonza Job Code VBLT-006c

Page 2 of 5

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)
		Lonza will coordinate the performance of required contract and in-house testing as required by the agreed-upon DP Certificate of Analysis. A list of recommended analyses is below; the price estimate assumes that the DP will be analyzed using the methods listed. Should VBL desire to add to or remove tests from the list, or to use a version of a test that is different than the method listed, the price will be adjusted accordingly.

		Assay	Vendor / Protocol
c.	GMP-grade Release Testing, VB-111 Drug Product	[***]	[***]	[***]	[***]

		(Continued below)

Lonza Job Code VBLT-006c

Page 3 of 5

CONFIDENTIAL

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


Project Component	Description	Detailed Description		Estimated Duration	Fee (USD)

		Assay	Vendor / Protocol
		[***]	[***]
c. (Cont’d)	Release Testing, VB-111 Drug Product (Cont’d)
		* Assay will be performed/coordinated by VBL and will not be reported on the Lonza-issued Certificate of Analysis.		See above	See above

		** Assay will be performed by both Lonza and VBL and the results compared. Only the Lonzaresult will be reported on the Lonza-issued Certificate of Analysis.

Deliverable for Project Components b. and c.		Lonza Quality Assurance representatives will review all Lonza-performed or –coordinated testing records/reports and will issue Certificates of Analysis for VB-111 DS and DP for review by VBL or a VBL-designated Qualified Person (QP). VBL personnel or a delegate will be responsible for release of the DP for use in the clinic.		2 weeks	Included

		The following analyses will be performed by Lonza Process Development personnel on VB-111samples taken throughout the GMP production process:

		Assay	Quantity
	R&D-grade VB-	[***]	[***]	[***]	[***]
d.	111 In-Process
	Testing

		Analysis activities will be documented in laboratory notebooks and the results reported to VBL in an electronic Excel file comparing the process step-yields for the production of [***]


		TOTAL, VB-111: DRUG PRODUCT GMP MANUFACTURE AND ANALYSIS		[]*	[]*

		OTHER SERVICES

Regulatory Support		Lonza Viral has extensive Regulatory experience both with FDA and EMA, and if desired, will perform consulting services on VBL’s behalf. Examples of such activities include the assembly of documents or data-mining of information for inclusion in a Product Master File; writing, reviewing, or editing of Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings; participation in teleconferences with regulatory agencies, etc.		As needed	[***]

Lonza Job Code VBLT-006c

Page 4 of 5

CONFIDENTIAL

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

Project

Component

Description

Detailed Description

Estimated
Duration

Fee (USD)

Product Storage

[***]

3. [***]

Monthly

To be

Determined

III.

Fees and Terms

The total fee for the activities described above, not inclusive of Regulatory Support and Product Storage services, is [***], payable as follows:

[***], due upon SOW execution

[***], due upon Lonza’s issuance of [***]

Fees for Regulatory Support services will be invoiced for on a monthly basis, as applicable. Fees for Product Storage, if applicable, will be invoiced for on a semi-annual basis, in advance.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Amos Ron
J. David Enloe, Jr.		Name:	Amos Ron
Head, Viral-based Therapeutics		Title:	Chief Financial Officer

Date:		Date:

Lonza Job Code VBLT-006c

Page 5 of 5

CONFIDENTIAL

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

LOGO

APPENDIX A-18

Statement of Work VBLT-018

VB-111 Sample Analysis for [***]

August 22, 2013

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

VBL has requested that Lonza coordinate the performance of VB-111 in-process sample analysis for determination of [***]

II.

Scope of Work

Lonza Quality Control (QC) personnel will coordinate the performance of “for information only” [***] for determination of [***] Lonza will provide the following samples of VB-111 material to [***] for analysis:


Lonza Part No.	Description	Qty
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]

The samples will be analyzed by [***].

Deliverable: Lonza will provide VBL with an electronic copy of the report provided to Lonza by Dow, which will consist of a summary of results including a general description of test method, [***]. Follow-up consultation of up to 0.5 hours to clarify report content with [***]s included in the testing fee; consultation beyond [***] and any changes to the result reporting format and/or report will be charged at a rate of [***].

III.

Fees and Terms

The fee for this activity, exclusive of any additional fees for consultation or report or result reporting format revision, is [***] 100% payable upon Lonza providing a copy of the analysis report to VBL. Should consultation with [***] hours or should Lonza be charged by [***] for report or result reporting format revisions, a separate invoice will be issued by Lonza to VBL for the applicable charges at [***] USD/hour.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

Lonza Job Code VBLT-018

Page 1 of 2

CONFIDENTIAL

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

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ J. David Enloe, Jr.	By:	/s/ Eyal Breitbart
J. David Enloe, Jr.		Name:	Eyal Breitbart
Head, Viral-based Therapeutics		Title:	Vice President, Research and Operations

Date:		Date:

Lonza Job Code VBLT-005

Page 2 of 2

CONFIDENTIAL

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

LOGO

APPENDIX A-19

Statement of Work VBLT-019

Regulatory Support Services

January 15, 2014 (“SOW Date”)

I.	Introduction

This Statement of Work (SOW) between Vascular Biologies, Ltd. (“VBL”) and Lonza Houston, Inc. (“Lonza”) is subject to the Manufacturing Services Agreement dated January 5, 2012, between VBL., and Lonza (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

II.

Scope of Work

Lonza personnel will act as consultant(s) to VBL with respect to developing [***]. Lonza will perform these activities as directed by the Client in writing. It is estimated that these activities will take approximately 50 hours. Other activities can be performed under this SOW as mutually agreed by the parties in writing.

III.

Fees and Terms

Fees will be charged on a monthly or less frequent basis. Lonza will charge a labor fee [***]. All invoices are due upon receipt. Labor fees may be adjusted by Lonza upon written notice in accordance with Section 9.6 of the Agreement.

Either party may terminate this SOW upon sixty (60) days’ written notice to the other party. If this SOW is terminated for any reason, Client shall be responsible for any labor charges that have already been performed as detailed in this SOW, including completed but unbilled labor charges through the effective date of termination.

The pricing and terms offered in this SOW shall be valid until April 15, 2014. If this SOW is not accepted by both parties by this date, a revision of the SOW may be necessary prior to execution.

IV.

Acceptance

IN WITNESS WHEREOF, the parties have caused their duly-authorized representatives to execute this SOW as of the dates below, effective as of the SOW Date.


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ Ryan Scanlon	By:	/s/ Eyal Breitbart
Ryan Scanlon		Name:	Eyal Breitbart
Global Head of Business Development Viral Therapeutics, Custom Manufacturing Lonza Pharma & Biotech		Title:	Vice President, Research and Operations

Date:		Date:

Lonza SOW VLBT-019

Page 1 of 1

CONFIDENTIAL

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

LOGO

APPENDIX A-21

Statement of Work VBLT-021

Final Product Container/Closure Procurement & Media Fills

February 04, 2014 (“SOW Date”)

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. (“VBL”) and Lonza Houston, Inc. (“Lonza”) is subject to the Manufacturing Services Agreement dated January 5, 2012, between VBL, and Lonza (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

II.

Scope of Work

Lonza personnel will procure the final product container/closures and perform media fills as described below:

Item

Detailed Description

Fee (USD)

Lonza will purchase, release for GMP use on arrival, and store, on VBL’s behalf, the following materials:

Item

Lonza Part
Number

Qty

Unit

[***]

Procurement of Final Product Vials

The quantity of [***] as listed above is assumed to be [***], in consideration and assuming the following:

• [***]

These materials will be designated property of VBL and used by Lonza in the performance of projects for VBL as directed by VBL. Lonza shall have the right of possession and control of the materials. VBL shall bear all risk of loss of materials in Lonza’s possession, except for losses due to the gross negligence or willful misconduct of Lonza. All costs for maintenance, service, repairs and replacements shall be borne by VBL. VBL shall bear any expenses associated with transferring this equipment from Lonza to VBL or to a third party.

Fees for these items, until this stock is depleted, will not be included in fees for activities such as final product filling operations or fill line qualifications that are performed by Lonza related to VBL projects, as VBL will have already purchased these items under a separate Statement of Work (SOW).

[***]

Lonza SOW VLBT-021

Page 1 of 3

CONFIDENTIAL

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

Item

Detailed Description

Fee (USD)

Fill Line Qualification using [***]

Lonza has previously performed [***] [***] to qualify the product filling process for VB-111. [***]

Accordingly, Lonza will execute [***] The following assumptions are made:

• [***] vial[***]

• [***]

[***]

Shipment of caps to VBL

VBL has requested Lonza to ship 1000 [***] to their site. The fee includes the materials and shipment but excludes courier costs. Courier costs will be applied as a pass thru cost or applied to the clients designated courier account.

[***]

Total

[***]

III.

Fees and Terms

The total fee for the activities described above is [***], payable as follows:

[***], due upon SOW execution

[***], due upon initiation of [***]

[***], due upon completion of [***]

Any additional media fills beyond the [***] identified above in early 2014, will be billed once initiated.

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

Lonza SOW VLBT-021

Page 2 of 3

CONFIDENTIAL

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

The pricing and terms offered in this SOW shall be valid until May 04, 2014. If this SOW is not accepted by both parties by this date, a revision of the SOW may be necessary prior to execution.

IV.

Acceptance

IN WITNESS WHEREOF, the parties have caused their duly-authorized representatives to execute this SOW as of the dates below, effective as of the SOW Date.


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ Ryan Scanlon	By:	/s/ Dror Harats
Ryan Scanlon		Name:	Dror Harats
Global Head of Business Development Viral Therapeutics, Custom Manufacturing Lonza Pharma & Biotech		Title:	Chief Executive Officer

Date:		Date:

Lonza SOW VLBT-021

Page 3 of 3

CONFIDENTIAL

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

LOGO

APPENDIX A-23

Statement of Work VBLT-023

Purchase of Cell Culture Medium for VB-111 Production at the [***]

April 14, 2014

I.	Introduction

This Statement of Work (SOW) between Vascular Biologics, Ltd. and Lonza Houston, Inc. is subject to the Manufacturing Services Agreement dated January 5, 2012, between Vascular Biologics, Ltd. (“VBL”), and Lonza Houston, Inc. (“Lonza”) (the “Agreement”) and is incorporated therein and made a part of such Agreement. In the event of an inconsistency between the Agreement and this SOW, the Agreement shall control.

Lonza and VBL are currently planning for Lonza to perform [***] production batches of VBL’s VB-111 product [***]. To provide a sufficient quantity of [***] to produce each batch and maintain a back-up supply for each batch, Lonza will order a total of [***]. The standard approximate lead time from the time the [***] order is placed with the vendor is [***]. In consideration of the duration of the lead time, Lonza will order [***] to be produced as soon as possible, with [***] to ship as soon as possible to Lonza and the other [***] to be held in storage at the vendor for two to three months and then shipped to Lonza, and another [***] to be produced four to six months later in anticipation of the [***] VB-111 batch being performed Q1 2015.

II.

Scope of Work

Lonza will order [***] and [***] to be supplied in [***] Lonza will order the [***]o be produced as soon as possible with half of it shipped to Lonza as soon as possible and the other half to be held in storage at the vendor for two to three months and then shipped to Lonza, and a [***] to be produced four to six months after the [***]

III.

Fees and Terms

The fee for the activities described herein is [***], payable as follows:

[***], due upon SOW execution;

[***], due upon notification of VBL by Lonza that the [***] has been fully received;

[***], due upon notification of VBL by Lonza that the [***] has been fully received.

Any shipping and handling fees, storage fees, and/or sales tax charged by [***] and/or courier to Lonza will be billed to VBL as pass-through costs.

Lonza Job Code VBLT-023

Page 1 of 2

CONFIDENTIAL

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

Invoices will be provided via e-mail and associated payments are due upon invoice receipt. Payments are to be made via wire transfer using the Lonza account information set forth in the Agreement.

The pricing and terms offered in this SOW shall be valid until July 4, 2014. If this SOW is not accepted by both parties by this date, a revision of the SOW may be necessary prior to execution.

IV.

Acceptance


Lonza Houston, Inc.		Vascular Biologics, Ltd.

By:	/s/ Ryan Scanlon	By:	/s/ Dror Harats
Ryan Scanlon		Name:	Dror Harats
Global Head of Business Development Viral Therapeutics, Custom Manufacturing Lonza Pharma & Biotech		Title:	Chief Executive Officer

Date:		Date:

Lonza Job Code VBLT-023

Page 2 of 2

CONFIDENTIAL

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

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

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 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

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

Production

/s/ Naamit Sher		/s/ J. Savage
Name: Naamit Sher		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 [***].

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	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 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.

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

Storage and shipping


4.6.1	API Storage:	[***]

4.6.2	Product Storage:	[***]

4.6.3	Product 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 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: 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 or USA) • 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 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: 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 & sign 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 • Approve manufacturing documentation

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 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 (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 (15) 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 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 : 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	• 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 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: 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 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

/s/ [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

ATTACHMENT 1

Listing of agreed capsule specifications


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

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

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*


Product reference	Raw material reference	Raw material title	Function	Compliance
[***]	[***]	[***]	[***]	[***]

[***]

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

ATTACHMENT 3

MANUFACTURING PARAMETERS

Manufacturing Process

The process is defined in specific batch processing instructions

Processing controls

Process controls are defined in specific batch processing instructions

(Fill weight)

Processing Instructions and Records

Product

Reference

Document

Preparation and filling

[***]

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 [***].

Exhibit 10.9

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 1 of 6

MATERIAL TRANSFER AND CONFIDENTIALITY AGREEMENT

This Material and Confidentiality Agreement (“Agreement”) is by and between:

Crucell Holland B.V. , a dutch Company with offices located at Archimedesweg 4, 2333 CN, Leiden, the Netherlands, hereinafter referred to as “CRUCELL”; and

Vascular Biogenics Ltd. , with offices located at 6 Jonathan Netanyahu Street, 60376, Or-Yehuda, Israel (hereinafter referred to as “Vascular Biogenics”; and

BioReliance Ltd. , a company with offices located at Innovation Park, Hillfoots Road, Stirling FK9 4NF, hereinafter referred to as “Contractor”.

(hereinafter individually referred to as “Party” and collectively as “Parties”)

WHEREAS CRUCELL is the owner of a proprietary PER.C6 ^® cell line (hereinafter referred to as “MATERIAL”), and of related proprietary and confidential information and patent rights;

WHEREAS CRUCELL and Vascular Biogenics have signed a research license and option agreement for the conduct of research & development programs that employ PER.C6 ^® cells to manufacture, use and develop a pharmaceutical products in the gene therapy field, effective as of March 24 2000 (“License”);

WHEREAS under Vascular Biogenics’ rights under Section 2.1.4 of the License, Vascular Biogenics wishes Contractor to perform certain scientific work within the field described in Attachment I, hereinafter referred to as the “Statement of Work”, using the MATERIAL and related proprietary and confidential information (“INFORMATION”) (MATERIAL and INFORMATION hereinafter collectively referred to as “Know How”) on the condition that Contractor enter Into this Agreement with Vascular Biogenics and Crucell;

WHEREAS Crucell is willing to make available the Know How to Contractor for the performance of the Statement of Work on behalf of Vascular Biogenics;

WHEREAS the Parties wish to make arrangements with respect to the use by Contractor of the MATERIAL, and of the results of the Statement of Work Performed thereon.

NOW, THEREFORE , the Parties hereto, intending to be legally bound, agree as follows:

Supply of Know How : Crucell agrees to provide and consents to Vascular Biogencs’s providing, the MATERIAL and the INFORMATION to Contractor upon the execution of this Agreement; solely for scientific use under the Statement of Work, If Crucell is requested to deliver MATERIAL and INFORMATION to Contractor, Crucell shall ship the MATERIAL and the INFORMATION to Contractor at Vascular Biogenics expense.

Permitted and Restricted Uses: Contractor shall only use the MATERIAL:

2.1.

for scientific research solely in the performance of the statement of Work and solely in its own laboratories.

2.2.

solely for the purpose of the Statement of Work;

and not use the MATERIAL:

2.3.

for administering MATERIAL, or any materials produced therefrom, to humans;

2.4.

for purposes of commercial production or sale;

2.5.

with any other entity or organization other than 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 [***].

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 2 of 6

2.6.

to chemically or biologically modify MATERIAL, except as contemplated by this Agreement in accordance with the explicit purpose of the Statement of Work, unless otherwise agreed to in writing by Crucell.

2.7.

to modify, alter, change and/or reconstruct the MATERIAL, other than as further described in the Statement of Work in Attachment I.

Ownership of results and materials : Subject to the terms and conditions agreed between Vascular Biogenics and Crucell in the License, all rights to any materials, data and any physical, chemical, or biological results (hereinafter referred to collectively as “RESULTS”) generated under the Statement of Work will vest in Vascular Biogenics. If during the course and performance of the Statement of Work, one or more employees of Contractor conceive or reduce to practice one or more inventions directly resulting from the Statement of Work, Contractor agrees that all right, title and interest in and to all such inventions, shall vest in Vascular Biogenics. For the avoidance of doubt, any RESULTS, including inventions and patent applications and patents emanating therefrom shall constitute IMPROVEMENT KNOW HOW RIGHTS and/or IMPROVEMENT PATENT RIGHTS as defined in the license and consequently shall be subject to the grant-back provision clause 2.3 of the License. Contractor shall promptly disclose such inventions to Vascular Biogenics, and at Vascular Biogenics’s cost and expense, including without limitation compensation for time expended by Contractor, shall diligently cooperate with Vascular Biogenics in the preparation of patent applications covering such Inventions, prosecution of such applications and any other acts necessary for the protection of rights to such inventions, Including but no limited to the execution of documents such as declarations and assignments to perfect Vascular Biogencis’s rights in and to such inventions, Contractor will refrain from any and all acts that may jeopardize the patentability of the invention in any jurisdiction.

Notwithstanding the foregoing the Parties agree and acknowledge that all methodological innovations solely related to Contractor’s assays, methods and technology and all know-how developed by Contractor solely related to Contractor’s assays, methods and technology arising as a result of work performed for Vascular Biogenics whether using the Materials or otherwise shall remain the property of Contractor and no rights to same shall pass to Vascular Biogenics or Crucell in terms of this Agreement or otherwise.

Contractor Control and Legal Obligations : Contractor shall at all times maintain control over the MATERIAL and comply with all applicable laws, regulations and guidelines related to the MATERIAL (hereinafter collectively referred to as “the Rules”). Contractor will not, unless Crucell will have given prior written approval on conditions it deems fit, release, transfer or distribute the MATERIAL to any party other than Vascular Biogenics and its authorized employees.

Reporting: All RESULTS obtained from the screening, testing or use of MATERIAL by Contractor will be reported, under the confidentiality terms of Section 7, to Vascular Biogenics without delay.

Termination : After the termination or expiration of this Agreement, Contractor shall transfer to Vascular Biogenics all remaining MATERIAL, derivates and any substances obtained from the Statement of Work and confirm such in writing to the other Parties, or shall –at the request of Vascular Biogenics – diligently destroy the MATERIAL, derivatives and any substances derived there from in accordance with the Rules referred to in Section 4, and confirm such in writing to the other Parties. Upon completion of review of Crucell’s

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 3 of 6

INFORMATION by Contractor, upon the request of Crucell or in the absence of further agreement between Vascular Biogenics all the provided INFORMATION, and any copies thereof in Its possession, promptly by registered mail, certified mail, or courier service, for example. Federal Express, which retains record of the mailing, except that Contractor may retain one copy of such INFORMATION for the sole purpose of determining any continuing legal obligations to Crucell and Vascular Biogenics.

Confidentiality Obligations :

7.1.

Contractor shall treat all RESULTS and INFORMATION as confidential and shall not itself use, except for the purposes of this Agreement, or disclose to any fourth party any of such RESULTS and INFORMATION, except as to any of such RESULTS and INFORMATION which Contractor can establish:

(a)

at the time of disclosure is in the public domain;

(b)

after disclosure becomes part of the public domain by publication or, except by breach of this Agreement by Contractor or breach by any other party under an agreement of confidentiality to Crucell or Vascular Biogenics;

(c)

by written records was in its possessions at the time of disclosure by Crucell or Vascular Biogenics and was not acquired directly or indirectly from Crucell, Vascular Biogenics or from any other party under an agreement of confidentiality to Crucell or Vascular Biogenics;

(d)

Contractor receives from a fourth party legally in a position to provide Contractor with the INFORMATION or RESULTS, provided, however, that such was not obtained by said fourth party directly or indirectly from Crucell or Vascular Biogenics under an obligation of secrecy;

(e)

is excepted by prior written approval of Crucell in the case of INFORMATION or RESULTS in the case of Vascular Biogenics;

(f)

is required by law to be disclosed; or

(g)

is Independently developed by Contractor without reference to the INFORMATION or RESULTS as evidence by records, however maintained.

7.2.

Contractor shall have the right to disclose RESULTS and INFORMATION to those directors, officers, employees and consultants of Contractor to whom such disclosure is necessary for the aforesaid purposes; provided that those persons to whom such RESULTS and INFORMATION may be disclosed under this paragraph have undertaken in writing confidentiality obligations with respect to such RESULTS and INFORMATION substantially similar to those undertaken by Contractor under this Agreement.

7.3.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 4 of 6

from violating this Agreement. Contractor shall notify Crucell and Vascular Biogenics promptly of its knowledge of any unauthorized use or unauthorized disclosure of RESULTS or INFORMATION.

Title and all rights to all Crucell’s Know How disclosed under this Agreement remain vested in Crucell.

Nothing in this Agreement is to be construed as a license to Contractor to utilize Crucell’s Know How, Trademarks, or trade names, except as provided in this Agreement, in any way whatsoever or under any patent or patent application owned by Crucell, unless a separate written license agreement is executed. Any modification to this Agreement shall be in writing.

10.

Use of Names : None of the parties will use the name of another party hereto in relation to this Agreement in any advertising or other form of publicity, without the prior written approval of such party.

11.

Limited Warranty :

11.1.

Vascular Biodenics and Crucell warrant that they own, possess, have access to, or are licensed under all patents, patent applications, inventions, improvements, trademarks, trade names, copyrights, licenses, information, proprietary rights, processes, know-how necessary to permit BioRellance’s use of the Materials and Information for the purpose of the Statement of Work.

11.2.

Contractor acknowledges that the MATERIAL is experimental in nature and is being made available by Crucell and Vascular Biogenics for research purposes. Except as otherwise provided herein, Crucell and Vascular Biogenics make no representation with regard to purity or biological activity of MATERIAL provided, MATERIAL is supplied “as is” with no warranties, express or implied, including any warranty of merchantability or fitness for a particular purpose.

12.

Indemnification : Crucell shall not be liable for any claim or damage arising from or in connection with Contractor’s use, handling or storage of MATERIAL and Contractor and Vascular Biogenics shall hold harmless and Indemnify Crucell for any such claim or damage, unless such claim or damage arises for any claim or damage arising from Vascular Biogenics’ use of RESULTS, and Vascular Biogenics shall hold harmless and indemnify Contractor for any such claim or damage, unless such claim or damage arises from the negligence or wrong doing of Vascular Biogenics.

13.

Each party warrants that it is permitted to enter into this Agreement and that the terms of this Agreement are not inconsistent with other contractual obligations it may have.

14.

Notwithstanding the terms of this Agreement, no party to this Agreement shall be obligated to enter into any further agreement with the other.

15.

This Agreement is binding upon the parties hereto and their successors in business, but is not otherwise assignable, other than in connection with a merger, consolidation or sale of all or substantially all assets related to the subject matter of this agreement.

16.

Effective Date, Termination Date and Survival : This Agreement will be effective on 19 ^th September 2005 and will terminate after the earlier of (i) the completion of the Statement of Work described in Attachment I, or (ii) twelve (12) months after the effective date. Section 3, 5, 6, 7, 11, 12, 14, 16, 18, 19 and 20 will survive any termination of this Agreement.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 5 of 6

17.

Except as otherwise set forth herein, this Agreement may not be modified, assigned or transferred in whole or in part by Contractor, unless Crucell will have given prior written approval on conditions it reasonably deems fit.

18.

Contractor agrees that its obligations set forth in Sections 2, 4 and 7 are necessary and reasonable to protect Crucell and expressly agrees that monetary damages may be inadequate to compensate Crucell for any breach of any covenant or agreement set forth in Sections 2, 4 or 7. Contractor agrees and acknowledges that any such violation or threatened violation may cause irreparable injury to Crucell and that in addition to any other remedies to seek injunctive relief against any threatened breach of this Agreement or the continuation of any such breach, without the necessity of proving actual damages.

19.

This Agreement shall be exclusively governed by and construed in accordance with the laws of the Netherlands. All disputes arising out of or in relation to this agreement shall, to the exclusion of all others, be referred exclusively to the competent Dutch Courts, and the Parties agree that judgments of the Parties. In the event of a dispute between the parties regarding this agreement, the parties shall first attempt to resolve their dispute through amicable discussion.

20.

In case of conflict between the License and this Agreement, the provisions of the License shall prevail, except with respect to Contractor in which case this Agreement shall prevail.

IN WITNESS WHEREOF , Contractor, Vascular Biogenics and Crucell have executed this Agreement by their respective, duly authorized, representatives of the date hereinafter written:


CRUCELL HOLLAND B.V. For and on behalf of Crucell N.V.		Vascular Biogenics Ltd.

By:	/s/ Ronald H.P. Brus	By:	/s/ Elalouf Emmanuel
Name:	Ronald H.P. Brus	Name:	Elalouf Emmanuel

Function:

President & CEO

Leiden, October 3, 2005

Function:

VP Business Development

Gaithersburg, September 20, 2005


BioReliance Ltd.

By:		/s/ Diana Morgan
Name:		Diana Morgan

Function:

Global Leader Manufacturing

Glasgow, September 19, 2005

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 6 of 6

ATTACHMENT 1 STATEMENT OF WORK

Quotations:

[***]

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

Exhibit 10.10

GENERAL SERVICES AGREEMENT

BioClinica Agreement #40801

This General Services Agreement (this “Agreement”) effective as of the last date of signature hereof (the “Effective Date”), by and between BioClinica, Inc., a Delaware Corporation, with its principal place of business at 826 Newtown-Yardley Road, Newtown, Pennsylvania, 18940-1721 (“BIOCLINICA”) and Vascular Biogenics Ltd. with its principal place of business at 6 Jonathan Netanyahu Street, Or Yehuda, Israel 60376 (“VASCULAR BIOGENICS”). BIOCLINICA and VASCULAR BIOGENICS are individually referred to as a “Party” and collectively as the “Parties”.

PURPOSE

WHEREAS, BIOCLINICA has certain experience, knowledge and abilities that VASCULAR BIOGENICS wishes to utilize in developing and expanding various business and organizational considerations, policy formations and overall strategic planning.

WHEREAS, VASCULAR BIOGENICS is in the trade or business of the manufacture and sale of pharmaceutical, diagnostic and other scientific materials.

WHEREAS, BIOCLINICA is willing to provide consulting services to VASCULAR BIOGENICS and desires to accept the arrangement upon the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, the Parties agree as follows:

1.	SCOPE OF SERVICES

1.1

BIOCLINICA will provide medical imaging core laboratory services to VASCULAR BIOGENICS as more fully set forth in the attached Exhibit A, which is hereby made part of this Agreement as if fully included herein (the “Services”). Any special or related service which the Parties agree are outside the scope of the Services to be provided hereunder shall be covered under a separate agreement.

1.2

In providing Services under this Agreement, BIOCLINICA shall report to the VASCULAR BIOGENICS employee designated by VASCULAR BIOGENICS.

1.3

BIOCLINICA shall use commercially reasonable efforts and such working time as may be required for the satisfactory performance of the Services in accordance with this Agreement and shall comply with all applicable laws and regulations in the performance of the Services.

1.4

BIOCLINICA shall perform the Services at BIOCLINICA facilities, such locations set forth on Exhibit A, or other such locations as are mutually agreed by the Parties.

1.5

BIOCLINICA represent and warrants that the execution and delivery of this Agreement and the fulfillment of the terms hereof will constitute the valid, binding and enforceable obligations of BIOCLINICA and will not constitute a default under or breach of any agreement and/or undertaking and/or other instrument to which BIOCLINICA is a party or by which it is bound, or any provision of law, rule or regulation applicable to BIOCLINICA, including without limitation, any confidentiality agreement; and in the performance of its obligations hereunder, BIOCLINICA will not make use of (i) any confidential or proprietary information belonging to any third party, or (ii) any information to which BIOCLINICA is restricted from disclosing or using due to contractual undertakings (or by law).

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

2.	COMPENSATION

2.1

VASCULAR BIOGENICS agrees to pay as a fee to BIOCLINICA, for the Services rendered during the project, the amount and at such times as indicated in Exhibit A.

2.2

In addition to the fee specified in Exhibit A, VASCULAR BIOGENICS will reimburse BIOCLINICA for reasonable travel and out-of-pocket expenses related to the provision of the Services, provided that such expenses have been pre-approved by VASCULAR BIOGENICS. Invoices for the Services and out-of-pocket expenses will be detailed according to tasks completed and will include all relevant backup documentation. A 0.5% per month carrying charge will be billed for any undisputed fees and expenses not paid within thirty (30) days of invoice receipt.

2.3

In order to allow payments, BIOCLINICA will provide to VASCULAR BIOGENICS upon the execution of this Agreement a Certificate of Residency from its Tax Authorities (form 6166).

3.	INTELLECTUAL PROPERTY

BIOCLINICA agrees that any data, reports, materials, work product or other deliverables generated as a result of the performance of the services, or that are derived from the use or possession of VASCULAR BIOGENICS’ confidential information (collectively, the “Data”) shall be the sole and exclusive property of VASCULAR BIOGENICS. BIOCLINICA hereby assigns to VASCULAR BIOGENICS all right, title and interest to such Data, and all worldwide intellectual property rights therein, including without limitation, patents, copyrights, and trade secrets ("VASCULAR BIOGENICS' Intellectual Property Rights"). It is recognized and understood that certain pre-existing inventions and technologies are the separate property of VASCULAR BIOGENICS or BIOCLINICA and are not affected by this Agreement, and neither Party shall have any claims to or rights in such separate pre-existing inventions or technologies of the other. It is also recognized and understood that in the event that any improvements or developments related to BIOCLINICA’s own technology are created by BIOCLINICA during the performance of the Services under this Agreement, including but not limited to BIOCLINICA’s source code, or other unique methodology, and are not part of VASCULAR BIOGENICS' Intellectual Property Rights such improvements or developments shall be owned by BIOCLINICA.

4.	CONFIDENTIALITY

With respect to any and all information indicated as being or which reasonably appears to be, of a confidential nature, including but not limited to protocols, data forms, material, study results and any proprietary information relating to a Party’s business, clinical trials activity, operations or products acquired by a Party from the other Party as a result of this Agreement or from performance of the Services to be rendered hereunder, each Party agrees that it and its respective employees (i) will use the confidential information solely for the purpose of this Agreement, (ii) will not use that information or disclose same to persons other than as may be necessary to carry out such Party's duties hereunder and provided that such persons have been advised about the confidential nature of the information and agreed to be bound by confidentiality; and (iii) will maintain the confidential information in secure location . VASCULAR BIOGENICS' Intellectual Property Rights shall be considered VASCULAR BIOGENICS' confidential information. The foregoing obligation shall not apply to information which the receiving Party can demonstrate that:

Which is known to the receiving Party prior to its receipt thereof from the disclosing Party;

Which is or lawfully becomes generally available to the public;

Which is lawfully acquired from third parties who have a right to disclose such information; or

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

Which by mutual agreement in writing of the Parties hereto is released from a confidential status.

All employees of a Party who will have access to any of the foregoing information supplied by the disclosing Party have executed or shall have executed prior to undertaking performance under this Agreement, agreements with the receiving Party requiring them to maintain in confidence all such information which they receive.

5.	RELATIONSHIP OF PARTIES

The relationship of BIOCLINICA to VASCULAR BIOGENICS is that of an independent contractor and nothing in this Agreement shall be construed as creating any other relationship.

6.	AGREEMENT TERM/TERMINATION

The term of this Agreement is for the period of time mutually agreed upon by VASCULAR BIOGENICS and BIOCLINICA and set forth in Exhibit A to complete the Services.

Termination of this Agreement may be effected upon the giving of thirty (30) days written notice by VASCULAR BIOGENICS without any specified cause or reason. In the event that either Party commits a breach or default in any terms of this Agreement and such Party fails to remedy the breach or default within thirty (30) days after notification of the breach or default from the other Party, the Party giving notice may, at its option and in addition to any other remedies it may have in law or in equity, terminate this Agreement by sending written notice of immediate termination to the other Party.

In the event of a termination of this Agreement, VASCULAR BIOGENICS will be responsible for payments for all work completed at that time of termination. In the event of such close down, BIOCLINICA shall furnish to VASCULAR BIOGENICS a written estimate of close-down costs.

Upon the termination of the Agreement, BIOCLINICA shall return to VASCULAR BIOGENICS all VASCULAR BIOGENICS' Data and confidential information. For the sole purpose of determining the scope of obligations incurred under this Agreement, BIOCLINICA may retain, in a secure location and, to the extent possible, segregated from unrelated materials, a single archival copy of Confidential Information returned to VASCULAR BIOGENICS.

7.	ARBITRATION

Any controversy or claim arising out of or relating to this Agreement, or the breach thereof, which is not settled within a reasonable time, shall be settled by arbitration in accordance with the arbitration rules of the International Chamber Of Commerce (the “ICC Rules”) by one arbitrator appointed in accordance with the ICC Rules. Any arbitration proceedings shall take place in London, England unless otherwise agreed. The award of the arbitrator shall be by majority vote (if more than one arbitrator was appointed in accordance with the ICC Rules), shall be in writing and shall set forth the facts found by the arbitrator to exist. The arbitrator is authorized to grant pre-award and post-award interest at commercial rates. Notwithstanding other provisions of this agreement which may be interpreted to the contrary, the arbitrator appointed herein shall not have the authority to grant damages to either party that are disclaimed or limited under this agreement. Aside from the arbitrator’ fees and costs, which shall be shared equally by the parties unless the arbitrator for good cause determine otherwise, each party will be responsible for paying its own fees and costs (including attorney’s fees) incurred in connection with such arbitration. Each party shall cooperate in providing fully to each other all requested information and documents relating to the arbitration proceedings, except for information and documents subject to any privilege or to governmental export restrictions. The arbitration proceedings shall be conducted in the English language. The arbitral award must be consistent with the provisions of this Agreement and shall be exclusive, final, and binding upon both Parties, and enforcement of the award may be carried out in any court or other body of competent jurisdiction. The award of any such arbitral tribunal shall be final and binding upon the parties. Each Party acknowledges and agrees that any decision resulting from the arbitration proceedings contemplated hereunder would be enforceable in their respective countries and as specified by article 17.

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

8.	INDEMNIFICATION

8.1

VASCULAR BIOGENICS Indemnification of BIOCLINICA

Except for any item for which BIOCLINICA is responsible to indemnify VASCULAR BIOGENICS under Section 8.2, VASCULAR BIOGENICS agrees to defend, indemnify and hold harmless BIOCLINICA and its employees, agents, contractors and subcontractors against and from any claims arising out of or in reference to the Services or for any claim arising out of bad faith, willful misconduct or negligent acts of VASCULAR BIOGENICS or its employees, agents, contractors and subcontractors or acts which are not in accordance with the terms of this Agreement or with ethical practices of the consultations specified herein. VASCULAR BIOGENICS agrees to bear all costs and expenses, including reasonable attorney's fees, incurred in connection with the defense of any such claim.

VASCULAR BIOGENICS shall be promptly notified of any claim being made against BIOCLINICA and BIOCLINICA shall cooperate at the request of VASCULAR BIOGENICS in the defense of such claim. VASCULAR BIOGENICS will not enter into any settlement agreement without the written consent of BIOCLINICA.

8.2

BIOCLINICA Indemnification of VASCULAR BIOGENICS

BIOCLINICA agrees to defend, indemnify and hold harmless VASCULAR BIOGENICS and its employees and agents against and from any third party claims arising out of or in reference to the bad faith, willful misconduct or grossly negligent acts of BIOCLINICA and its employees, agents, contractors and subcontractors or acts which are not in accordance with the terms of this Agreement or with ethical practices of the consultations specified herein. BIOCLINICA agrees to bear all costs and expenses, including reasonable attorney's fees, incurred in connection with the defense of any such third party claim.

BIOCLINICA shall be promptly notified of any claim being made against VASCULAR BIOGENICS and VASCULAR BIOGENICS shall cooperate at the request of BIOCLINICA in the defense of such claim. BIOCLINICA will not enter into any settlement agreement without the written consent of VASCULAR BIOGENICS.

9.	COMMUNICATIONS AND PAYMENTS

Any notice or other communication required or permitted under this Agreement shall be in writing and shall be delivered by hand, first class mail, a nationally recognized overnight courier service, or facsimile transmission, to the Party at the address listed below or to any other address subsequently specified by such Party in writing:

To BIOCLINICA :

Mark L. Weinstein

President and CEO

BIOCLINICA, INC.

826 Newtown-Yardley Road

Newtown, PA 18940

Tel: (267) 757-3000

FAX: (267) 757-3007

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

To VASCULAR BIOGENICS:

Dr. Yael Cohen

VASCULAR BIOGENICS LTD.

6 Jonathan Netanyahu Street,

Or Yehuda, 60376

Israel

Tel: +972-3-6346450

FAX: +972-3-6346449

Payments – [***]

[***]


EUR Wire Instruction
Bank Name		[***]
Bank Address		[***]
Swift / BIC		[***]
IBAN		[***]
Account #		[***]
Beneficiary Name		[***]
Further Credit To		[***]
Reference		[***]

Any such notice shall be effective (i) in the case of hand delivery, when received; (ii) in the case of an overnight delivery service, on the next business day after being placed in the possession of such delivery service, with delivery charges prepaid; (iii) in the case of the mail, three days after deposit in the postal system, first class postage prepaid; and (iv) in the case of facsimile transmission, when electronic indication of receipt is received.

10.

ASSIGNMENT

Neither Party shall have the right to assign this agreement or any of the rights or obligations hereunder without the prior written consent of the other, such consent not to be unreasonably withheld; provided, however, either Party may make an assignment to an affiliate or to an assignee of that part of its business to which this Agreement relates without the consent of the other Party, provided however that such party shall remain liable at all times for its obligations under this Agreement, including without limitation to the Confidentiality and intellectual property rights obligations. In no event will such an assignment relieve VASCULAR BIOGENICS of its financial obligation under this Agreement, in the event that such affiliate or assignment fails to make payment as promised for herein.

11.

LIMITATION OF LIABILITY

In no event neither Party shall be liable to the other Party for any special, exemplary, indirect, incidental, consequential or punitive damages of any kind or nature whatsoever.

12.

HEADINGS

All section headings and sub-headings are for convenience only and do not in themselves define a scope of work or specific terms or conditions of this Agreement.

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

13.

ENTIRE AGREEMENT

This Agreement, including Exhibit A, constitutes the entire Agreement between the Parties and, except as specified herein, supersedes all prior contracts, agreements and understandings relating to the same subject matter between the Parties. The Parties intend this Agreement to be a complete statement of the terms of their Agreement and no change or modification of any of the provisions of this Agreement shall be effective unless it is in writing and signed by a duly authorized officer of BIOCLINICA and VASCULAR BIOGENICS.

14.

WAIVER

The failure of a Party in any instance to insist on the strict performance of the terms of this Agreement shall not be construed to be a waiver or relinquishment of any terms of this Agreement, either at the time of the Party’s failure to insist upon strict performance or at any subsequent time, and such terms shall continue in full force and effect.

15.

SEVERANCE

Each clause of this Agreement is a distinct and severable clause and if any clause is deemed illegal, void, or unenforceable, the validity, legality, or enforceability of any other clause or portion of this Agreement shall not be affected thereby.

16.

GOVERNING LAW

The construction and performance of this Agreement shall be governed by the laws of England.

17.

SURVIVAL

Sections 2, 3, 4, and 6 through 16 will survive termination or expiration of this Agreement.

In WITNESS WHEREOF, the undersigned Parties have executed this Agreement on the dates set forth below.


BioClinica, Inc.		Vascular Biogenics Ltd.

By:	/s/ Maria T. Kraus	By:	/s/ Amos Ron
Print:	Maria T. Kraus	Print:	Amos Ron
Title:	VP & Corporate Controller	Title:	CFO
Date:	24-Sep-2012	Date:	September 24, 2012

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

LOGO

Vascular Biogenics Ltd.

Medical Imaging Core Laboratory Services in Support of

a Study Entitled: “A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed

by a 12-Week Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in

Patients with Mild to Moderate Ulcerative Colitis.”

Prepared for:

Vascular Biogenics Ltd.

6 Jonathan Netanyahu Street

Or Yehuda, Israel 60376

BioClinica Addendum #40801_1

November 19, 2012

BioClinica, Inc., 826 Newtown Yardley Road, Newtown, PA 18940, www.bioclinica.com

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

TABLE OF CONTENTS


1. SCOPE OF WORK			3
1.1. ADDENDUM ASSUMPTIONS			3
2. ADDENDUM PROJECT FEES AND EXPENSES			4
2.1. ADDENDUM PROJECT FEES			4
2.2. ADDENDUM EXPENSES			5
2.3. BILLING POLICY			6
3. TERMS AND CONDITIONS			7

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

1.	SCOPE OF WORK

Vascular Biogenics Ltd. (hereinafter referred to as “VASCULAR BIOGENICS”) has requested that BioClinica, Inc. and subsidiaries (hereinafter referred to as “BIOCLINICA”) provide additional medical imaging core laboratory services in support of an Ulcerative Colitis study.

This Addendum serves to document the additional services requested for this study beyond those contained within the following:

•

Agreement #40801 between BIOCLINICA and VASCULAR BIOGENICS, executed 24 September 2012

This Addendum also serves to document the fees for the additional services.

1.1.

ADDENDUM ASSUMPTIONS

Presented below is an outline of the additional and modified services requested by VASCULAR BIOGENICS for an Ulcerative Colitis study that are not included within the original agreement.

•

Additional two (2) sites, one (1) in Poland and one (1) in Hungary.

•

Added one (1) web-based Image Interpretation Training session for eligibility.

•

One hundred fifty-eight (158) fewer timepoints prepared for review.

•

One hundred ten (110) fewer screening timepoints as screening will be prepared for review only once.

•

Sixty-six (66) fewer timepoints re-read by a second reader if there is a discrepancy between the local and central review.

•

Addition of 10% of screening timepoints (12 timepoints) reviewed by a second reader for eligibility plus 5% of screening timepoints (6 timepoints) reviewed for the primary review if read by the third reader.

•

One hundred ten (110) fewer fax/e-mail notifications to site and VASCULAR BIOGENICS of rolling read results as screening will be read only once.

•

Forty-eight (48) fewer fax/e-mail notifications to site and VASCULAR BIOGENICS of secondary read results.

•

Removal of 20% or sixty-six (66) timepoints re-read by a second reader if there is a discrepancy between the local and central review.

•

Applicable pass-through and reader fees. Reader fees are updated to reflect US Dollars.

Eligibility Review:

•

One (1) additional reader for a total pool of three (3) readers, sharing the workload, for the eligibility review.

•

Screening timepoints will be re-read by a second reader for screening timepoints with a score of

< 2, assuming 10% of timepoints will be re-read.

Primary Review:

•

One (1) reader from a pool of two (2) readers for the primary review.

•

Each screening timepoint will only be read once for eligibility review and then count as baseline in the primary review assuming the same two (2) readers that are reading for eligibility are the same as the primary review. Timepoints read by the third reader for eligibility will be re-read by reader one (1) or two (2) in the primary review, assuming 5% of timepoints will be re-read.

•

Removal of 20% of timepoints re-read due to a discrepancy between the local and central assessment.

*All	other assumptions from Original Agreement #40801 will remain the same.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

2.	ADDENDUM PROJECT FEES AND EXPENSES

2.1.

ADDENDUM PROJECT FEES

The fees for services detailed within this Addendum are summarized below. BIOCLINICA will only charge pro-rata for work performed at the rates quoted.

As per the original agreement, BIOCLINICA fees will increase annually beginning with month 25 of the project as defined by the actual (original) project start date. This increase will be equivalent to the percent increase in the Euro Harmonized Index of Consumer Prices (HICP).

2.1.1.

Addendum Fees

TABLE 2.1.1.

Addendum Services

Unit Cost

Units

Cost Total

Study Preparation Services

Site Technical Evaluation and Coordination

[***

]

[***

]

[***

]

Study kit preparation and provision to sites

[***

]

[***

]

[***

]

Image Interpretation Services

Performance of Image Interpretation Sessions and Management of Independent Reviewers

[***

]

[***

]

[***

]

Fax/E-mail notification to site and VASCULAR BIOGENICS of Rolling Read Results

[***

]

[***

]

[***

]

Fax/E-mail notification to site and VASCULAR BIOGENICS of Secondary Read Results

[***

]

[***

]

[***

]

ADDENDUM TOTAL

[***

]

2.1.2.

Overall Project Budget Summary

TABLE 2.1.2.


	Cost Total
Project Fees – [***]		[***	]
Project Fees – [***]		[***	]
Revised Study Budget (Service Fees)		[***	]

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

2.2.

ADDENDUM EXPENSES

2.2.1.

Miscellaneous Expenses

The estimated project expenses, in this document, unless otherwise specified, do not include [***] Please see the table below for an estimate of miscellaneous expenses:

TABLE 2.2.1.


Addendum Pass Through Item(s)	Estimated Total
Media:
Archival media sent to sites for image transmittal – [***]		[***	]
Study Kit Supplies: Labels, Binders, Tabs, etc. [***]		[***	]
Courier:
Study Kits – estimated priority [***]		[***	]
Sub-total		[***	]
% Administrative Fee		[***	]
Estimated Expenses Total including administrative fee		[***	]

2.2.2.

Overall Project Expense Summary

TABLE 2.2.2.


	Estimated Total
Expenses including administrative fee – [***]		[***	]
Expenses including administrative fee – [***]		[***	]
Revised Expenses Budget		[***	]

2.2.3.

Reader Professional Fees and Expenses

BIOCLINICA will prepare all reader agreements and manage all reader fees for this study. [***]

Table 2.2.3. reflects the assumptions and fees as defined in original agreement [***]. These assumptions have been modified and are reflected in table 2.2.4.

TABLE 2.2.3.


Assumption	Total Cost
Eligibility: [***]		[***	]
Primary: [***]		[***	]
Image Interpretation Training Session: [***]		[***	]
Sub-total		[***	]
[***]		[***	]
Estimated Reader Professional Fees and Expenses		[***	]

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

[***]

TABLE 2.2.4.


Assumption	Estimated Total
Eligibility: [***]		[***	]
Primary: [***]		[***	]
Eligibility Web-based Image Interpretation Training Session: [***]		[***	]
Primary Image Interpretation Training Session: [***]		[***	]
Sub-Total		[***	]
[***]		[***	]
Estimated Reader Professional Fees and Expenses		[***	]

2.2.5.

Overall Reader Professional Fee Summary

TABLE 2.2.5.


	Estimated Total
[***]		[***	]
[***]		[***	]
Revised Estimated Reader Professional Fees Total		[***	]

2.3.

BILLING POLICY

The above mentioned fees will continue to be billed to VASCULAR BIOGENICS on a monthly basis and will include relevant back-up documentation.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

3.	TERMS AND CONDITIONS

All services will be performed by BIOCLINICA as an Addendum to BIOCLINICA Agreement #40801, and all terms and conditions of Agreement #40801 shall apply.


AGREED AND ACCEPTED:

VASCULAR BIOGENICS			BIOCLINICA

By:	/s/ Amos Ron	By:	/s/ Ted Kaminer
Print:	Amos Ron	Print:	Ted Kaminer
Title:	CFO	Title:	Executive VP & CFO
Date:	December 31, 2012	Date:	02-Jan-2013

LOGO

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

LOGO

Vascular Biogenics Ltd.

Additional Medical Imaging Core Laboratory Services in Support of a Study Entitled: “A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Mild to Moderate Ulcerative Colitis.”

BioClinica Addendum #40801_2

July 26, 2013 version one

August 29, 2013 version two

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

TABLE OF CONTENTS


1. SCOPE OF WORK			2
1.1. ADDENDUM ASSUMPTIONS			2
2. ADDENDUM PROJECT FEES AND EXPENSES			3
2.1. ADDENDUM PROJECT FEES			3
2.2. ADDENDUM EXPENSES			4
2.3. BILLING POLICY			5
3. TERMS AND CONDITIONS			5

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

1.	SCOPE OF WORK

This Addendum serves to document the additional services requested for this study beyond those contained within the following:

•

Agreement #40801 between BIOCLINICA and VASCULAR BIOGENICS, executed 24 September 2012

•

Addendum #40801_1 between BIOCLINICA and VASCULAR BIOGENICS, executed 02 January 2013

This Addendum also serves to document the fees for the additional services.

1.1.

ADDENDUM ASSUMPTIONS

Presented below is an outline of the additional and modified services requested by VASCULAR BIOGENICS for an Ulcerative Colitis study that are not included within the original agreement.

•

Timeline extension due to recruitment period being extended through December 2013

•

Additional forty (40) Screening timepoints to be received. BIOCLINICA assumes that a total of 160 Patients will be screened in order to achieve 110 Patients enrolled on the study. 160 Total Screening timepoints to include the 120 Screening timepoints in the original contract plus 40 additional Screening timepoints.

Eligibility Review:

•

Forty (40) additional Screening timepoints to be received

•

Screening timepoints will be re-read by a second reader for screening timepoints with a score of < 2, assuming 20% or eight (8) of the 40 additional timepoints and an additional 10% or 12 of the 120 screening timepoints in the current contract will be re-read.

Primary Review:

•

Each screening timepoint will only be read once for eligibility review and then count as baseline in the primary review assuming the same pool of two (2) readers that are reading for eligibility are the same as the primary review. Timepoints read by the third reader for eligibility will be re-read by reader one (1) or two (2) in the primary review, assuming 5% of timepoints (two (2) timepoints) will be re-read.

TABLE 1.2.


Project Timeline Assumptions	Agreement #40801 and Addendum #40801_1	Addendum #40801_2
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]
[***]	[***]	[***]
[]*	[]*	[]*
[]*	[]*	[]*

[***]

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

2.	ADDENDUM PROJECT FEES AND EXPENSES

2.1.

ADDENDUM PROJECT FEES

The fees for services detailed within this Addendum are summarized below. BIOCLINICA will only charge pro-rata for work performed at the rates quoted.

2.1.1.

Addendum Fees

TABLE 2.1.1 [***]

Addendum Services

Unit Cost

Units

Cost Total

Centralized Image Data Tracking & Quality Control

[***]

Electronic image transfer via sFTP – 50% of data

Endoscopy Image data log-in and Image Data Quality Control

[***]

Image Interpretation Services

[***]

Performance of Image Interpretation Sessions and Management of Independent Reviewers

40 Additional Screening Timepoints

[***]

20% or 8 of the Additional 40 Screening Timepoints re-read by a second reader for eligibility

[***]

10% or 12 of the 120 Screening Timepoints in the original contract to achieve 20% re-read by a second reader for eligibility

[***]

5% or 2 of the Additional 40 Screening Timepoints re-read during the primary review if read by a third reader for eligibility

[***]

Fax/E-mail notification to site and VASCULAR BIOGENICS of Eligibility Results

[***]

Project Management Services

July 2014 – September 2014

[***]

Site Management & Image Archival Services

June 2014 – August 2014

[***]

ADDENDUM TOTAL

[***]

2.1.2.

Overall Project Budget Summary

TABLE 2.1.2.


	Cost Total
Project Fees – [***]		[***]
Project Fees – [***]		[***]
Project Fees – [***]		[***]
Revised Study Budget (Service Fees)		[]*

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

2.2.

ADDENDUM EXPENSES

2.2.1.

Miscellaneous Expenses

The estimated project expenses, in this document, unless otherwise specified, do not include [***] Please see the table below for an estimate of miscellaneous expenses:

TABLE 2.2.1.


Addendum Pass Through Item(s)	Estimated Total
Media:
[***]		[***	]
[]*
[***]		[***	]
Sub-total		[***	]
[***]		[***	]
Estimated Expenses Total including administrative fee		[***	]

2.2.2.

Overall Project Expense Summary

TABLE 2.2.2.


	Estimated Total
Expenses including administrative fee – [***]		[***	]
Expenses including administrative fee – [***]		[***	]
Expenses including administrative fee – [***]		[***	]
Revised Expenses Budget		[***	]

2.2.3.

Reader Professional Fees and Expenses

BIOCLINICA will prepare all reader agreements and manage all reader fees for this study. All such expenses will be passed through to VASCULAR BIOGENICS on a monthly basis. VASCULAR BIOGENICS will be responsible for any other read related expenses, including any applicable travel, food and lodging required for the performance of their duties, as described in this document.

TABLE 2.2.3.


Assumption	Estimated Total
Eligibility: [***]		[***	]
Primary: [***]		[***	]
Sub-Total		[***	]
[***]		[***	]
Estimated Reader Professional Fees and Expenses		[***	]

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

2.2.4.

Overall Reader Professional Fee Summary

TABLE 2.2.4.


	[]*
Reader Professional Fee – [***]		[***	]
Reader Professional Fee – [***]		[***	]
Reader Professional Fee – [***]		[***	]
Revised Estimated Reader Professional Fees Total		[***	]

2.3.

BILLING POLICY

The above mentioned fees will continue to be billed to VASCULAR BIOGENICS on a monthly basis and will include relevant back-up documentation.

3.	TERMS AND CONDITIONS

All services will be performed by BIOCLINICA as an Addendum to BIOCLINICA Agreement #40801, and all terms and conditions of Agreement #40801 shall apply.

AGREED AND ACCEPTED:


VASCULAR BIOGENICS			BIOCLINICA

By:	/s/ Amos Ron	By:	/s/ Ted Kaminer
Print:	Amos Ron	Print:	Ted Kaminer
Title:	CFO	Title:	Executive VP & CFO
Date:	November 4, 2013	Date:	17 Oct 2013

LOGO

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

LOGO

Exhibit A

Vascular Biogenics Ltd.

Medical Imaging Core Laboratory Services in Support of

a Study Entitled: “A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed

by a 12-Week Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in

Patients with Mild to Moderate Ulcerative Colitis.”

BioClinica Agreement #40801

Prepared for:

Vascular Biogenics Ltd.

6 Jonathan Netanyahu Street

Or Yehuda, Israel 60376

July 13, 2012 / Version 1

August 24, 2012 / Version 2

September 20, 2012 / Version 3

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

TABLE OF CONTENTS


EXECUTIVE SUMMARY		3

1. PROJECT SCOPE OF WORK		4
1.1.	SCOPE OF WORK	4
1.2.	PROJECT TIMELINE ASSUMPTIONS	5

2. CORE LABORATORY SERVICES		5

2.1.	STUDY PREPARATION, SITE SET-UP AND STANDARDIZATION	5
2.2.	CENTRALIZED IMAGE DATA TRACKING AND QUALITY CONTROL	7
2.3.	IMAGE INTERPRETATION SERVICES	7
2.4.	DATA MANAGEMENT SERVICES	10
2.5.	PROJECT ADMINISTRATION	11
2.6.	PROJECT CLOSE-OUT SERVICES	13
2.7.	REGULATORY COMPLIANCE	13

3. PROJECT FEES AND EXPENSES		14

3.1.	PROJECT FEES	14
3.2.	EXPENSES	16
3.3.	OVERALL TOTAL PROJECT BUDGET	17

4. PAYMENT SCHEDULE AND BILLING		17

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

EXECUTIVE SUMMARY

C OMPANY O VERVIEW

BioClinica, established in 1990, is an independent, financially stable, global clinical trials service organization, specializing in medical image management and eClinical services. The services include, site standardization, medical image collection and quality control, independent review, electronic data capture, IVR/IWR and clinical data management solutions for pharmaceutical, medical device companies and other organizations, including contract research organizations. BioClinica is a publicly traded corporation listed on the NASDAQ Global Market under the symbol BIOC. BioClinica has over 20 years of experience in providing comprehensive design and management of the medical imaging portion of clinical trials worldwide.

Please refer to Appendix A to learn more about our eClinical service offerings

M AIN O FFICE L OCATIONS

BioClinica’s HQ is located at 826 Newtown-Yardley Road, Newtown, PA 18940, USA.

Additional BioClinica offices involved in Image Management are located in:

•

Leiden, The Netherlands (European Headquarters & imaging core laboratory)

•

Lyon, France (software development for image analysis)

•

Tianjin, China (Medical Image Management)

K EY D IFFERENTIATORS

The key differentiators that separate BioClinica from our competitors are:

•

Publicly traded company audited by PricewaterhouseCoopers – this offers our clients financial transparency and reassurance on our company’s reliability for their long-term clinical trial projects.

•

Full service imaging core lab locations in Europe and the USA which is critical for managing global studies due to language barriers and various time zones. Our 24/7 multilingual contact center offers around the clock support.

•

We support ALL imaging modalities and therapeutic areas with certified technologists and highly experienced, trained Readers.

•

BioClinica has a network of approximately 106 expert readers across all therapeutic areas. This network of readers has active confidentiality agreements and executed contracts.

•

Project Managers are highly skilled, focusing on setting expectations via strong communication skills and pro-activeness via risk management. The Project Management teams are aligned by therapeutic areas which allow the project managers to utilize their prior experiences in developing risk management plans.

•

Led by an extremely stable Management team - the President of BioClinica has been with the company since 1997 and the average tenure of the Bio-Imaging division senior manager is 10+ years.

S TUDY E XPERIENCE

BioClinica has extensive experience in supporting international multi-center clinical trials in the therapeutic areas of oncology, neurology, cardiology, endocrinology, gastrointestinal, women’s health, inflammation and orthopedics.

Inflammatory Bowel Diseases; Crohn’s and Ulcerative Colitis study Experience:

BIOCLINICA is presently performing an endoscopy trial with 60 global sites and over 100 patients.

In the past we have performed trials in Crohn’s disease and Ulcerative Colitis with different imaging modalities such as Ultrasound, MRI and Endoscopy, with patients ranging form 20-150 and sites ranging from 4 to 100.

O VERALL B UDGET

The overall budget is presented below:

•

[***]

•

[***]

•

[***]

P OINTS FOR C ONSIDERATION

BioClinica would welcome the opportunity to discuss the set-up in a meeting with Vascular Biogenics Ltd to design the imaging part of the project in the best possible way. There are several options for the set-up and the decision depends on the value and the associated costs and is best discussed in a meeting.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

1.	PROJECT SCOPE OF WORK

Vascular Biogenics Ltd. (hereinafter referred to as “VASCULAR BIOGENICS”) has requested that BioClinica, Inc. and subsidiaries (hereinafter referred to as “BIOCLINICA”) provide medical imaging core laboratory services in support of an Ulcerative Colitis Study.

1.1.

SCOPE OF WORK

TABLE 1.1.

General Study Assumptions


# of Patients		[***]

# of Sites		[***]

# of Investigator’s Meetings including location, # of BIOCLINICA representatives attending meeting and # of days assumed for meeting, including travel time		[***]

Type of Imaging Performed		[***]

Method of Data Transfer to BIOCLINICA		[***]

Endoscopy Test Data Assumptions

Type of Test Data		[***]

Overall Number of Test Scans		[***]

Endoscopy Data Assumptions

Total # of Patients with Endoscopy		[***]

Total # of Endoscopy Timepoints		[***]

Independent Read Plan Assumptions

Assessment Criteria		[*] [*]

Independent Read Plan		[***]

Eligibility Review

# of Timepoints Prepared for Eligibility		[***]

BIOCLINICA Turnaround Time for Eligibility Results		[*] [*]

# of Fax/E-mail Notifications to site and VASCULAR BIOGENICS of Eligibility Results		[***]

# of Independent Reader(s)		[*] [*]

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

TABLE 1.1. CONTINUED

Rolling Read


# of Timepoints Prepared for Rolling Read		[***]
BIOCLINICA Turnaround Time for Rolling Read Results		[***]
# of Timepoints Prepared for Secondary Read		[***]
BIOCLINICA Turnaround Time for Secondary Read		[***]
# of Fax/E-mail Notifications to site and VASCULAR BIOGENICS of Rolling Read Results		[***]
# of Independent Reader(s)		[***]

Read Data Summary
Overall Total # of Timepoints Prepared for Review		[***]
# of Data Transfers and Frequency		[***]

[***]

1.2.

PROJECT TIMELINE ASSUMPTIONS

BIOCLINICA assumes the following timelines:

TABLE 1.2.

Project Timeline Assumptions


BIOCLINICA Project Start		[***]
First Patient Enrolled		[***]
Last Patient Enrolled		[***]
Last Patient Out		[***]
BIOCLINICA Project Complete		[***]
Total Duration of Data Collection		[]*
Total Study Duration		[]*

2.	CORE LABORATORY SERVICES

2.1.

STUDY PREPARATION, SITE SET-UP AND STANDARDIZATION

2.1.1.

Study Set-Up

If available, VASCULAR BIOGENICS will provide BIOCLINICA with the final study protocol and subsequent amendments at the start of the study.

BIOCLINICA will perform the following services upon commencement of the study:

•

Preparation and set-up of internal clinical trial and regulatory files

•

Preparation and set-up of required folders on the BIOCLINICA network

•

Preparation and set-up of project specific BioPACS™ database

BioPACS™ is a custom designed enterprise system that provides image management and workflow, query capabilities, inventory and image archival, site and project management tools to automate and accelerate the process of evaluating images generated during a clinical trial. The BioPACS™ Image Core Laboratory technology system complies with FDA 21 CFR Part 11 requirements and adheres to the industry DICOM standard for compatibility with image viewers and other analysis software.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

BIOCLINICA will provide VASCULAR BIOGENICS with access to the BioPACS™ web portal which will allow VASCULAR BIOGENICS to view study documents, access real time project reports and follow the course of study progression within BIOCLINICA. The Web Portal will be password protected and VASCULAR BIOGENICS will have twenty-four (24) hour access to the site.

BIOCLINICA will establish a password protected FTP account for each site. The sites will submit 50% of the data to BIOCLINICA via FTP server.

2.1.2.

Site Technical Evaluation and Coordination

BIOCLINICA will create a study specific site technical survey in an effort to capture all necessary contact and equipment information. BIOCLINICA will contact each of the sites to:

•

Identify the technologist(s) who will be responsible for protocol implementation at each site

•

Review the site’s imaging equipment at the site

•

Review the site’s data transfer capabilities and archival procedures

Upon receipt of the completed site survey, a BIOCLINICA technologist will review the technical information and verify overall completeness. All site interaction will be logged, indicating the date the site was contacted, the method of contact and the number of communication attempts. In the event that any follow up or action items are required as a result of the site survey, BIOCLINICA will capture all related information in the tracking database.

If site equipment (hardware or software) is upgraded or changed during the course of the study, it will be the site’s responsibility to inform BIOCLINICA of the upgrade.

2.1.3.

Development of Imaging Manual

BIOCLINICA will develop an imaging manual including image acquisition guidelines, site procedures for image transfer (courier or electronic) and image data transmittal forms (paper or electronic). These forms are required to establish an image data audit trail and are utilized by BIOCLINICA during the data collection and quality control process.

2.1.4.

Study Kit Preparation and Provision to Sites

BIOCLINICA will prepare a study kit for delivery to the participating sites. The study kit will contain the imaging manual, supply re-order forms, sample data transmittal forms, a BIOCLINICA contact list, and for sites submitting data via courier, pre-addressed courier waybills, archival media, padded mailers and/or courier mailers. In addition to containing the imaging binder, the study kit may contain other client approved study specific materials that are needed per the protocol.

2.1.5.

Investigator’s Meeting Preparation and Presentation

A BIOCLINICA Project Manager will attend and present at the Investigator’s Meeting(s) organized by VASCULAR BIOGENICS.

BIOCLINICA will prepare a PowerPoint presentation to be presented during the meeting which will include the study requirements, imaging guidelines and the process for submission of data to BIOCLINICA. BIOCLINICA will provide the presentation to VASCULAR BIOGENICS prior to the meeting for review and approval. BIOCLINICA will also prepare any supporting materials that are required for the meeting. (e.g. handouts, sample binders).

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

During the meeting, BIOCLINICA will review the presentation and field any questions. Reasonable travel costs and expenses for the meeting will be billed separately. BIOCLINICA has assumed a project manager will be the designated representative at the Investigator’s Meeting.

2.2.

CENTRALIZED IMAGE DATA TRACKING AND QUALITY CONTROL

BIOCLINICA has assumed that all image data for a given timepoint will be sent to BIOCLINICA from the sites as the timepoints are completed. Timely quality assurance of the data is not possible if data are not received in a timely manner. BIOCLINICA will notify VASCULAR BIOGENICS of data transmittal delays and of the potential impact on BIOCLINICA timelines if the delays are not corrected.

2.2.1a. Image

Data Log-In

Upon receipt of the data, BIOCLINICA will review the demographic data (e.g. patient number, site number, scan date, timepoint description, imaging modality etc.) provided by the site and will perform a verification check that the correct image data has been received. The data will be uploaded into BioPACS™. Any discrepancies between the data received and the information provided by the site will be resolved directly with the site.

2.2.1b. Image

Data Quality Control

Image data quality control will be performed by certified radiologic technologists. All image data will be saved into a standard file format (typically DICOM), so that the images may be read and archived digitally. This process may include the following tasks:

•

Anonymization of imaging data (e.g. removal of site, subject, timepoint identifiers etc.)

•

Conversion of digital image data into a standard file format

•

Quality Control of the image data for protocol compliance

•

Process endoscopy image data including selection of clips and streaming video to match read / analysis criteria

•

Generate labels for the masked videotapes and prepare for use in the independent review

•

Notification to VASCULAR BIOGENICS and participating sites of technical imaging adequacy issues and recommendation of appropriate action(s) to resolve the issues

•

Fax/E-mail notification to site and VASCULAR BIOGENICS of Test Data

BIOCLINICA will generate a query in the event that data discrepancies are noted during the QC of the image data, which is performed by a certified radiologic technologist. The query is generated to document the following issues, but is not limited to, data quality, protocol compliance issues and missing data.

The query process includes the following:

•

Preparation of a query including documentation of the issue

•

Preparation and shipment of letter or email to site and VASCULAR BIOGENICS documenting the query

•

Resolution and filing of query documentation

2.3.

IMAGE INTERPRETATION SERVICES

2.3.1.

Image Review Application Development and Validation

BIOCLINICA will develop a custom application, BioREAD™, to execute the independent image review session. The development of this application will include the following:

•

Creation of a client business requirements specification document

•

Creation of a technical design specification document

•

Programing of the BioREAD ™ application

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

•

Full unit testing

•

Test script development and execution of test plan

•

Validation report

•

User acceptance testing

BIOCLINICA will work in collaboration with VASCULAR BIOGENICS to design this application. The timeline for the delivery of the application and the milestones for key deliverables (e.g. business requirements document) will be agreed upon by VASCULAR BIOGENICS and BIOCLINICA.

2.3.2.

Image Interpretation Training Session

BIOCLINICA will conduct a training session prior to the first image interpretation session. Representatives from BIOCLINICA’s Project Management, Clinical Operations and Technical Services departments will attend and participate in this session. The training session is conducted in part for the purpose of familiarizing both VASCULAR BIOGENICS personnel and the reader(s) with the image review application as well as the independent image review design. During this meeting, VASCULAR BIOGENICS personnel and the independent reader(s) will review the operation of the BioREAD™ application, including the interrelationship between questions, sessions, and image display utilizing non-study subjects with relevant image sets. The BioREAD™ application is a custom-designed system that provides full automatic image display capabilities for independent reads and captures the reader’s interpretation and image evaluation all in one solution.

BIOCLINICA will develop a Read Rules Document. This document will include an overview of the clinical protocol, imaging requirements, and image review application questions/answers. It will also include rules for each reader to follow when completing the read electronic case report form (eCRF). This document will be developed by BIOCLINICA’s Clinical Operations personnel and reviewed by both reader(s) and VASCULAR BIOGENICS.

2.3.3.

Conduct and Monitoring of the Image Interpretation Session

2.3.3a. Performance

of Image Review Sessions and Management of Independent Readers

The review of the image data will be performed by independent readers not affiliated with the study either at the location of the independent reader or at a BIOCLINICA site. All reader image assessments will be captured electronically within the BioREAD™ application.

The following services will be performed in conjunction with the image review session:

•

Testing of BioREAD™ System (hardware and software)

•

Loading of the timepoints for the given image review session to the BioREAD™ application

•

Independent reader training, including review of reader rules prior to the first read session

•

Image review application back-up and export of reader image interpretations

All costs related to this service include BIOCLINICA licensing fees for the use of the BioREAD™ application during the image interpretation sessions. BIOCLINICA will procure the equipment that will be utilized during the image review sessions and will deploy the equipment and the image review application to the off-site read locations, if necessary. BIOCLINICA will provide technical support to the readers during the off-site read sessions.

Leasing fees are included for the use of the equipment as well as any related costs for dedicated communications lines that are required for remote reading sessions, in order to retrieve the data assessed by the readers from their remote location.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

BIOCLINICA will notify the site and VASCULAR BIOGENICS via fax or e-mail of patient eligibility results as well as the rolling read results within 3 – 5 business days of data receipt at BIOCLINICA (excluding public holidays and weekends). BIOCLINICA will notify the site and VASCULAR BIOGENICS via fax or e-mail of the results from the secondary read within 5 – 8 business days of data receipt at BIOCLINICA (excluding public holidays and weekends).

2.3.3b.

Image Review Monitoring Plan

BIOCLINICA will perform an evaluation of the image review results to monitor read quality. Monitoring is also performed to ensure adherence to the response criteria as defined in the Imaging Charter, the Read Rules Document and the VASCULAR BIOGENICS clinical protocol. This evaluation will be conducted on an agreed upon basis as deemed appropriate by BIOCLINICA and as per the monitoring plan.

If necessary, BIOCLINICA and VASCULAR BIOGENICS will make a joint decision to determine if retraining of the reader is deemed appropriate. If so, BIOCLINICA will conduct a training session to review specific cases.

Further discussion is required between BIOCLINICA and VASCULAR BIOGENICS in order to finalize the image read plan.

2.3.4.

Final Study Report

BIOCLINICA will prepare a study report, which will include:

•

Protocol Overview

•

Project Summary

•

Summary of Subject Assessments

•

Receipt and Preparation of Image Data for Image Review

•

Description of the image review application

•

Image Interpretation Training Session and Reader Training/Qualification

•

Image Interpretation Sessions

•

Transfer of Data to VASCULAR BIOGENICS

Appendices may include the following documents:

•

Imaging Charter

•

Listing of Image Data Received

•

Business Requirements Specification Document

•

Applicable Note to File(s)

•

Curriculum Vitae of Radiologists and Designated Experts

•

Read Rules Document

•

Image Review Monitoring Plan

•

Listing of Subjects Read

•

Data Export Specifications Document

*Please note the Final Study Report does not include a statistical analysis of the data.

BIOCLINICA shall deliver the study report to VASCULAR BIOGENICS within thirty (30) business days following completion of the final data transfer. VASCULAR BIOGENICS will have a review period of thirty (30) business days, following delivery of the report. Within this period, VASCULAR BIOGENICS may request within-scope revisions to the report and BIOCLINICA will make requested within-scope revisions at no additional cost to VASCULAR BIOGENICS.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

2.4.

DATA MANAGEMENT SERVICES

2.4.1.

Development & Validation of Export Program

The results obtained from the independent image review session will be provided to VASCULAR BIOGENICS in BIOCLINICA’s standard export format, SAS datasets. BIOCLINICA will provide a detailed export specification document describing the data sets to be provided. Upon written approval of this specification document by VASCULAR BIOGENICS, BIOCLINICA will begin the programming and validation of the export program.

In the event VASCULAR BIOGENICS requests a custom export format, the export specification will be developed by BIOCLINICA in collaboration with VASCULAR BIOGENICS. The additional time and costs associated with a custom export are not reflected in this agreement. VASCULAR BIOGENICS will be notified of such increases in writing for approval.

2.4.2.

Data Cleaning and Maintenance

BIOCLINICA will work in collaboration with VASCULAR BIOGENICS at the start of the study to define protocol-specific fields to be checked at regularly scheduled intervals. This includes but is not limited to the following:

•

Comparison of demographic information (Site, Subject, Initials, Exam Date(s), etc.) collected by BIOCLINICA against those provided by the client enrollment log

•

Chronological date progression (e.g., ensure that the date of Visit 2 is later than Visit 1, no images acquired after a Date of Death if applicable.)

•

Data derived by the independent image review application

Standard Edit Checks

Standard edit checks are composed of checks for technical quality such as identifying duplicate records within a table and table-to-table comparisons by key parameters (e.g. site number, subject number) to assure subjects appear in all applicable tables. These checks also compare and reconcile key parameters of the data housed in BioREAD™ compared to BioPACS™.

Study Specific Checks

Study-specific edit checks are developed for each study based on the response criteria that is utilized as well as other study related requirements that are defined in the Read Management Plan.

Edit Check Management

Edit Checks are performed regularly on the image read data to allow identification of any data discrepancies. Any data discrepancies noted in the output are investigated by a BIOCLINICA Clinical Data Manager to identify the reason for the output. The Clinical Data Manager works with the internal project team (Medical Affairs, Clinical Operations, Applications Development, Clinical Application Technical Services, and Project Management) to resolve data discrepancies appropriately. If any database updates are performed in resolving the discrepancies, the edit checks are re-run to insure no new issues arise. This is an iterative process and continues until all edit checks are resolved.

2.4.3.

Data Export

BIOCLINICA will export data as SAS datasets unless otherwise specified. BIOCLINICA will perform a final QC of the data prior to submission to VASCULAR BIOGENICS.

BIOCLINICA will perform a transfer of test data to ensure that VASCULAR BIOGENICS can successfully receive data and the data meets the provisions of the specification document. The final data will be sent to VASCULAR BIOGENICS within ten (10) business days after all the data for a given export has been acquired.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

If required, BIOCLINICA will follow up with VASCULAR BIOGENICS on issues related to each given export up until ninety (90) days post project completion as defined in Table 1.2. In the event export questions are received after this period, VASCULAR BIOGENICS will be billed on an ad-hoc basis as deemed appropriate by BIOCLINICA. BIOCLINICA will not perform any research or follow up on these inquiries without written authorization from VASCULAR BIOGENICS to proceed.

2.5.

PROJECT ADMINISTRATION

2.5.1.

Project Management Services

BIOCLINICA will provide in-house project management and administration for this project. A project manager and project team will be assigned to the study. This team may include the representatives from the following departments:

•

Project Management

•

Medical Affairs

•

Clinical Operations

•

Core Laboratory

•

Product Development

•

Regulatory

•

Data Management

•

Administrative support staff, as necessary

The assigned project manager serves as the primary contact for the project. The project manager oversees the day to day operations for projects in-house at BIOCLINICA. Regular internal project meetings are organized by the project manager to monitor resource planning and project progress. Administrative personnel provide support to the project managers and are included in the project management fee.

Additional responsibilities include:

Communication Plan

The project manager will develop a project communication plan that will describe the processes that will be followed during the course of the study including the levels of communication between BIOCLINICA, VASCULAR BIOGENICS, and other project related vendors. In addition, this document will outline details of the process to be followed for project issue resolution.

Teleconferences

The BIOCLINICA project manager will participate in teleconferences as needed with VASCULAR BIOGENICS to discuss the overall project progress, issues, timelines etc. The frequency and duration of the teleconferences may vary during the course of the study.

Work Instruction Development

The project manager will be responsible for the development of an internal project specific work instruction manual. The purpose of this manual is to provide BIOCLINICA employees a detailed description of the procedures to be utilized during the course of the study.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

2.5.2.

Project Reporting Services

Web portal Reporting

BIOCLINICA will provide real time access to the web portal in order for VASCULAR BIOGENICS to have appropriate status updates. Presented below are standard summary reports:

•

Project Start up Report – study startup details including the status of the site surveys and study kits

•

Collection of Site Data Report – a detail listing of the responses, by the site, on the site surveys

•

Image Status Report – details regarding data received, individual modalities received per timepoint, missing image data and query status, study sequence listings

•

Query Status Report – report displaying all outstanding queries as well as resolved queries

•

Read Summary Report – detailed information related to the project read status, including patient/timepoint/modality reviewed

•

Project Metrics Report – a multifunctional report providing predefined metrics and projections including averages and study targets

•

Program Metrics Report – predefined metrics including averages and study targets defined with metrics presented as collected on a monthly basis

Metrics Champion Consortium (MCC)

BIOCLINICA is an active member of the MCC, which is an organization that develops performance metrics within the Biotechnology and Pharmaceutical industry with the intent to jointly encourage performance improvement, effectiveness, efficiency, and appropriate levels of controls for both VASCULAR BIOGENICS and Service Providers in support of the drug development process.

BIOCLINICA participates in the continuous collaborative development of standardized performance metrics including process improvement tools. As a result, BIOCLINICA can provide the Imaging Metrics Report to VASCULAR BIOGENICS throughout the duration of the study.

2.5.3.

Site Management and Image Archival Services

Site Management

BIOCLINICA will provide support services to manage, monitor and coordinate the imaging acquisition, collection and query resolution portion of the study. BIOCLINICA will interact directly with the site on image data tracking, follow-up on issues as necessary and maintain the image audit trail. Communication with the sites will be documented appropriately.

VASCULAR BIOGENICS will be responsible for providing BIOCLINICA with patient enrollment updates as well as participating site lists on an ongoing basis. These updates should visibly indicate new information since the last send. Incremental updates are preferred or if cumulative updates are sent all incremental changes from the prior report should be identified.

Based on enrollment logs sent from VASCULAR BIOGENICS, BIOCLINICA will follow up with each participating site on an ongoing basis regarding site surveys, outstanding image data and image data related queries. In the event that a site becomes unresponsive, BIOCLINICA will inform and seek assistance from VASCULAR BIOGENICS.

Data Back-up and Archive

Throughout the study an image data back-up will be performed on data storage systems. Off-site image data back-up will also be performed at two (2) geographically distant sites. Other electronic data (electronic CRFs, audit trails, database contents, electronic documents, etc.) will be stored on a dedicated database server and saved daily throughout the study, via a secure network connection at two (2) different geographical sites.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

All study data will be digitally archived in compliance with ICH Guidelines for at least 15 years at study end. Additional costs will apply for this long term archive and a separate cost estimate will be provided at the end of the study, based on the actual total size of the data to be archived (digital and paper data).

Audit Trails

BIOCLINICA will consistently maintain an audit trail for each step of image data collection, quality control, processing, image interpretation assessment, central and off-site archiving procedures and all site communication in compliance with the applicable regulatory requirements including GCP and FDA’s 21 CFR part 11.

2.6.

PROJECT CLOSE-OUT SERVICES

2.6.1.

Project Close-Out

Upon completion of the study, BIOCLINICA will perform independent departmental study close-out procedures. Project close-out procedures may include the following services:

•

Archive the study materials and destroy any excess supplies

•

Collate all study files which may include; correspondence, Notes to Files, DTFs etc… and forward to BIOCLINICA’s Records Management department

•

Archive all study data from BIOCLINICA network to digital media; one (1) copy will be sent to long-term off-site storage. The storage facility is a secure environmental controlled facility.

•

Perform official close-out of study-specific administrative accounts including generation of final invoice

BIOCLINICA’s Records Management department will facilitate the close-out process by organizing and cataloging project related documents, including any regulatory or internal BIOCLINICA filings. These materials will be stored off-site in long-term storage for fifteen (15) years. After the fifteen (15) year retention period, BIOCLINICA will have the materials destroyed in accordance with the appropriate Standard Operating Procedures and Work Instructions.

BIOCLINICA assumes that all original image data sent to BIOCLINICA will be returned to VASCULAR BIOGENICS upon completion of the project or sooner if no longer required by BIOCLINICA. Original image data is defined as the source data, acquired at the sites, that is forwarded to BIOCLINICA after the patient has been imaged for a specific timepoint. BIOCLINICA will need ample notice to comply with the request, should VASCULAR BIOGENICS require the image data to be blinded prior to shipping. In the event VASCULAR BIOGENICS requires all original image data to be sent back to the sites, additional courier fees will apply.

2.7.

REGULATORY COMPLIANCE

BIOCLINICA’s custom designed enterprise system, BioPACS™, provides Image Core Laboratory technology of image, workflow, query, inventory, site and project management tools to automate and accelerate the process of evaluating images generated during a clinical trial. This system complies with FDA 21 CFR Part 11 requirements.

An audit trail will be consistently maintained for each step of the BIOCLINICA process in compliance with the applicable regulatory requirements including Good Clinical Practice (GCP) and FDA 21 CFR part 11.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

3.	PROJECT FEES AND EXPENSES

3.1.

PROJECT FEES

The estimated fees provided below are based upon the specific assumptions found within this document. Material alterations to the assumptions, including, but not limited to, a change in the number of patients, amount of data, level of support services or timeline, will impact final pricing. BIOCLINICA will only charge pro-rata for work performed at the rates quoted. BIOCLINICA fees will increase annually beginning with month 25 of the project as defined by the actual project start date. This increase will be equivalent to the percent increase in the Euro Harmonized Index of Consumer Prices (HICP).

In the event the study is canceled, BIOCLINICA will not charge a cancellation fee.

All the fees presented below are based on preliminary assumptions. Once a final protocol has been established, BIOCLINICA will collaborate with VASCULAR BIOGENICS on the image review design and the analyses required. Based on the outcome of these discussions BIOCLINICA may submit a revised proposal to VASCULAR BIOGENICS in which fees may be modified.

3.1.1.

Service Fees

TABLE 3.1.1.

Section No.

Services

Unit Fee

# Units

Cost Total

Study Preparation Services

2.1.1.

Study Set-up services

[***

]

[***

]

[***

]

2.1.1.

Setup of sFTP server

[***

]

[***

]

[***

]

2.1.2.

Site Technical Evaluation and Coordination

[***

]

[***

]

[***

]

2.1.3.

Development of Imaging Manual

[***

]

[***

]

[***

]

2.1.4.

Study Kit preparation and provision to sites

[***

]

[***

]

[***

]

2.1.5.

Investigator’s Meeting Preparation

[***

]

[***

]

[***

]

2.1.5.

Investigator’s Meeting Presentation. One (1) BIOCLINICA representative, two (2) days including travel: Project Manager

[***

]

[***

]

[***

]

2.2.1.

Centralized Image Data Tracking & Quality Control

Electronic image transfer via sFTP – 50% of data (including test data)

[***

]

[***

]

[***

]

[***] log-in and Image Data Quality Control (including test data)

[***

]

[***

]

[***

]

Fax/E-mail notification to site and VASCULAR BIOGENICS of Test Data

[***

]

[***

]

[***

]

Image Interpretation Services

2.3.1.

Image Review System development and validation

[***

]

[***

]

[***

]

2.3.2.

Image Interpretation Training Session

[***

]

[***

]

[***

]

2.3.3.

Performance of Image Interpretation Sessions and Management of Independent Reviewers

[***

]

[***

]

[***

]

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

TABLE 3.1.1. CONTINUED

Section No.

Services

Unit Fee

# Units

Cost Total

Image Interpretation Services (continued)

2.3.3.

Fax/E-mail notification to site and VASCULAR BIOGENICS of Eligibility Results

[***

]

[***

]

[***

]

2.3.3.

Fax/E-mail notification to site and VASCULAR BIOGENICS of Rolling Read Results

[***

]

[***

]

[***

]

2.3.3.

Fax/E-mail notification to site and VASCULAR BIOGENICS of Secondary Read Results

[***

]

[***

]

[***

]

2.3.4.

Final Study Report

[***

]

[***

]

[***

]

Data Management Services

2.4.1.

Development & Validation of export program

[***

]

[***

]

[***

]

2.4.2.

Data Cleaning & Maintenance

[***

]

[***

]

[***

]

2.4.3.

Data Export

[***

]

[***

]

[***

]

2.5.1.-2.5.2.

Project Management Services

Start up period - First 6 study months

[***

]

[***

]

[***

]

Remaining study months

[***

]

[***

]

[***

]

2.5.3.

Site Management & Image Archival Services

Start up period - First 6 study months

[***

]

[***

]

[***

]

Remaining study months

[***

]

[***

]

[***

]

2.6.1.

Project Close-Out Services

[***

]

[***

]

[***

]

PROJECT TOTAL

[***

]

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

3.2.

EXPENSES

3.2.1.

Miscellaneous Expenses

Presented in Table 3.2.1. below are estimated expenses for this project. [***]

TABLE 3.2.1.


Pass Through Item(s)	Estimated Cost
Travel, Meals and Hotel:
Investigator’s Meeting: One (1) meeting / One (1) BIOCLINICA representative		[***	]
Printing:
Data transmittal forms, imaging guidelines, etc.		[***	]
Media and Supplies:
Archival media sent to sites for image transmittal – average [*]/ site (assuming [] sites – assuming [**] of sites submitting via courier)		[***	]
Study Kit Supplies: Labels, Binders, Tabs, etc. @ [*]/ site (assuming [*] sites)		[***	]
Padded Mailers: [*] mailers per box @ []/ box (assuming [**] boxes)		[***	]
Courier:
Study kits- estimated priority @ [*]/ International Site (assuming [*] sites)		[***	]
Site transmittal to BIOCLINICA @ [*]/ shipment (assuming [*] total shipments, including test data)		[***	]
Study report		[***	]
Sub-total		[***	]
% Administrative Fee		[***	]
Estimated Expenses Total including administrative fee		[***	]

3.2.2.

Reader Professional Fees and Expenses

[***]

The below assumption is an estimate, actual rates will be based on the negotiations between VASCULAR BIOGENICS and the given readers.

TABLE 3.2.2.


Assumption	Total Cost
Eligibility: Assuming [*]/reader for [] eligibility reader from a pool of [] readers [] Timepoints for Review - Assuming [] timepoints read per hour ([*] total hours)		[***	]
Primary: Assuming [*]/hour/reader for [] readers [] Timepoints for Review ([] timepoints plus an additional [] or [] timepoints will be re-read by a second reader) - Assuming [] timepoints read per hour ([*] total hours)		[***	]
Image Interpretation Training Session: Assuming [*] per day Assuming [] Image Interpretation Training Session ([] readers – [*] days)		[***	]
Sub-total		[***	]
Reader Management Fee (5%)		[***	]
Estimated Reader Professional Fees and Expenses		[***	]

If VASCULAR BIOGENICS chooses to use an independent reader not on BIOCLINICA’s preferred reader list or decides to add readers during the course of the study, additional fees may apply for image read system equipment and installation. BIOCLINICA will not order equipment or begin the installation process without the written authorization from VASCULAR BIOGENICS.

LOGO

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

Vascular Biogenics Ltd.

Ulcerative Colitis Study

3.3.

OVERALL TOTAL PROJECT BUDGET


		Total
Project Total / Direct Service Fees		[***]
Pass Through Expenses		[***]
Reader Professional Fees		[***]

OVERALL TOTAL PROJECT		[]*

4.	PAYMENT SCHEDULE AND BILLING

TABLE 4 [***]


Milestone	% Fee	€ Fee
Signature of Agreement	[***]	[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

LOGO

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

Exhibit 10.11

CLINICAL TRIAL AGREEMENT

“A Randomized, Double-Blind, 24-Week, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis” (the “Study”)

Protocol No. VB-201-079

EudraCT No. 2012-002763-10

BETWEEN

Vascular Biogenics Ltd.

6, Jonathan Netanyahu St.

Or-Yehuda

Israel

duly represented by its Chief Executive Officer

(hereinafter called “SPONSOR”)

AND

SCIderm GmbH

Drehbahn 1-3

D-20354 Hamburg

duly represented by its Managing Directors

(hereinafter called “SCIDERM” or “INSTITUTION”)

Preamble

SCIDERM is a contract research organization (CRO) principally engaged in the design, set-up and management of human clinical trials and other related services on behalf of a Sponsor of the clinical study.

The SPONSOR has selected the services of SCIDERM to perform clinical tests and to provide assistance in respect of a clinical trial and has delegated and authorized SCIDERM to act on its behalf relative to the implementation, set-up and management of the trial. The clinical trial hereof will be performed at different sites in different countries. It is estimated that the whole clinical trial will include approximately 180 patients and that there are two (2) different European Countries involved.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 1 of 29

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

THE PARTIES HAVE AGREED AS FOLLOWS:

Art. 1

Definitions

As used in this agreement, the following terms shall have the meanings set out below:

Adverse Event

This means any untoward medical occurrence in a patient or clinical trial subject administered with a medicinal product and which does not necessarily have a causal relationship with the Project.

Case Report Form (CRF)

A printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. An electronical version of this is called “ eCRF ”.

Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicentre trial in a defined country.

Effective Date

The Effective Date is the date on which this agreement comes into effect. The Effective Date is the date of the last signature hereunder.

Eligible Participant (or Study Participant)

Any potential participant who upon entrance into the treatment phases of the trial meets all of the inclusion criteria and none of the exclusion criteria set forth in the Protocol and has signed a valid IRB/EC (as hereinafter defined) approved Informed Consent Form (as hereinafter defined).

Informed Consent

A process by which a Study Participant voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated. This document is called “ Informed Consent Form ” (ICF).

IRB/EC (Institutional Review Board/ Ethics Committee)

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Investigator

A person with medical expertise in clinical trials who is responsible for the conduct of the trial at a site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the “ Principal Investigator ”.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 2 of 29

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

Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOP’s), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Protocol

Generally it is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referred documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

Here it details of the Study entitled “ A Randomized, Double-Blind, 24-Week, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis ”, together with any amendments (as agreed by the Parties) made thereto is incorporated herein by reference as part of this Agreement.

The details of the trial are contained in Protocol dated 17.06.2012.

Regulations

Any relevant legislation, codes or guidelines directly or indirectly related to the conduct of the Trial including but not limited to (as applicable) the Clinical Trials Directive 2001/20/EC and its transforming legislation in the relevant countries of the European Union, the ICH GCP Guideline (“ICH-GCP”), and/or any other relevant applicable legislation, codes or guidelines issued by any Regulatory Authority. For the avoidance of doubt such legislation, codes or guidance shall include those related to the protection and privacy of the personal data of individuals.

Regulatory Authorities

Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections. Theses bodies are sometimes referred to as competent authorities.

Serious Adverse Event (SAE)

Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity is a congenital anomaly / birth defect and/or constitutes an important medical event.

Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the physical health of the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Site

The locations where trial-related activities are actually conducted by an Investigator.

Study Synopsis

The details of the trial are contained in Synopsis dated 17.06.2012.

Trial

The clinical trial known as Protocol-No VB-201-079 will be conducted according to the Protocol.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 3 of 29

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

Trial Drug

An Investigational Medical Product (“Investigational Product”) as defined in Art. 2 lit. d) Directive 2001/20/EC and therefore including all products used in a clinical trial, no matter if it is just a placebo or a reference product.

All technical words not defined above shall match ICH-GCP standards and therefore be defined according to the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) from July 2002.

Art. 2

Scope of Agreement

2.1	The agreement consists of this Clinical Trial Agreement (“Agreement”) and the following Appendices:

Appendix 1: Time Schedule

Appendix 2: Financial Provisions

Appendix 3 : Distribution of Investigational Product

Appendix 4 : Cost Estimate of INSTITUTION from 31.07.2012 (incl. separate lab offer from 13.07.2012)

2.2

The Parties agree that the performances under this Agreement will be made according to all applicable laws, rules, and regulations. The terms of the Protocol and the ICH-GCP Guidelines which by definition are no laws, are expressly considered terms of this Agreement, and therefore will be obeyed by the Parties.

2.3

Each party in performing its obligations and duties hereunder shall be conclusively deemed to be an independent contractor and not under the control and supervision of the other party hereto and nothing in this Agreement shall be read to create any agency, partnership, joint venture, trust or other fiduciary relationship between the parties.

2.4	Should there be any inconsistency between the Protocol and the other terms of this Agreement, or any other document incorporated therein, the terms of this Agreement shall prevail.

2.5	In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator of each site and shall be implemented by the research staff as required by the INSTITUTION after trial authorization for the amendments.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 4 of 29

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

Art. 3

Obligations

3.1

No Party hereunder shall commit any acts that would cause another Party to be in violation of applicable legislation, especially but not limited to applicable anti-bribery / anti-corruption laws. The INSTITUTION certifies that it has not and will not use in any capacity in connection with this Agreement the services of any individual, corporation, partnership, or association which has been debarred, excluded, or disqualified from participation in clinical investigations under any applicable laws, regulations, or guidance. In the event that the INSTITUTION receives notice of the debarment or threatened debarment, exclusion or disqualification or threatened disqualification, of any individual, corporation, partnership or association providing services to the INSTITUTION, which relate to the Investigator’s activities under this Agreement, the INSTITUTION shall notify the SPONSOR immediately.

3.2

The INSTITUTION represents and warrants that it has obtained, and will maintain throughout the term of this Agreement, all governmental or regulatory approvals, licenses, registrations and insurances that may be required to complete the Trial, and that it has full right, power and authority to perform its obligations hereunder and to grant the rights set forth herein.

3.3	The INSTITUTION shall not during the term of this Agreement conduct any other trial which would adversely affect the ability of the INSTITUTION to perform their obligations under this Agreement.

3.4	The estimated schedule is written down in Appendix 1.

3.5	The specific trial performance by INSTITUTION is set out in the Cost Estimate under Appendix 4.

3.5.1

The INSTITUTION will organize the Trial on behalf of the SPONSOR in the following countries: Germany and Spain, or as other countries as shall mutually agreed between the Parties. There shall be approx. 180 patients enrolled for the entire Study, meaning planned twelve to fourteen (12-14) sites in Germany, four to six (4-6) sites in Spain, having approximately ten (10) patients each. According to the internal competitive aspect of the Trial recruitment in a country, the INSTITUTION will notify any Investigator in writing when the total enrolment number is reached and therefore the enrolment of new subjects shall be stopped. Any change to the numbers of subjects enrolled or the period of enrolment requires the prior written approval by SPONSOR.

3.5.2

Subcontracting :

3.5.2.1

The INSTITUTION will sub-contract on behalf of the SPONSOR:


CTA (engl.) ß10.6 (SCIderm/VBL)		page 5 of 29

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

other Investigators and/or Sites in Germany; these sub-contracts will be made in German and be bound by German Law as it is required by national law.

The Corresponding Investigator under German Law (Leiter Klinische Prüfung, “LKP ”) will be Professor Ulrich Mrowietz from the University of Kiel, Germany.

The SPONSOR will execute an agreement directly with Professor Mrowietz solely in his capacity as Coordinating Investigator. INSTITUTION has no right under this Agreement, to set-up a special service agreement with LKP covering all LKP-duties and costs, independent from Site contract.

The Corresponding Investigator under Spanish Law will be Lluis Puig, MD from Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

The SPONSOR will execute an agreement directly with Dr. Puig solely in his capacity as Coordinating Investigator. INSTITUTION has no right under this Agreement, to set-up a special service agreement with Dr. Puig covering all Corresponding Investigator-duties and costs, independent from Site contract.

ii.

a central lab in; these sub-contracts will be made in English and be bound by German Law as it is required by national law.

iii.

an entity managing pharmacovigilance; these sub-contracts will be made in English and be bound by German Law as it is required by national law.

iv.

if necessary, other CROs in Spain (namely SCIderm HISPANIA S.L., C/Bailén 20, 3° 3 ^a ; 08010 Barcelona,which will contract local iInvestigators and/or Sites; these sub-contracts will be made in English , and the CROs will sub-contract Sites and Investigators in English, if possible, otherwise in local language.

a provider for hosting of eCRF; these sub-contracts will be made in English , if possible.

vi.

In the event that an agreement shall not be executed in English, the INSTITUTION shall provide the SPONSOR with a translated copy on expense of SPONSOR of the draft agreement for the SPONSOR's review for negotiation purposes, and a translated copy of the executed agreement.

3.5.2.2

The INSTITUTION is responsible for selecting and contracting vendors, , Sites/Investigator, central lab and data host, provided that the INSTITUTION shall submit for the SPONSOR's prior review and approval any such sub-contractors and following the SPONSOR's approval, shall provide to the SPONSOR the draft agreement for review and comments.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 6 of 29

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

3.5.2.3

Subject to section 3.5.2.2 above, with signatures under this Agreement SPONSOR grants power of attorney to INSTITUITION to select and sub-contract CROs, sites and investigators subject to the SPONSOR’s approval. With termination of this Agreement according to Art. 6, the power of attorney ceases.

3.5.2.4

Notwithstanding, the INSTITUTION has the right to sub-contract in its own name entities other then the above mentioned sub-contractors, to fulfill own duties hereunder, as long as these comply with all rules and legal obligations and subject to the SPONSOR's approval.

3.5.2.5

The INSTITUTION will ensure that sub-contractors are made aware of and acknowledge the obligations applicable to such sub-contractors according to this Agreement including without limitation confidentiality, Intellectual property rights and publications and the INSTITUTION shall remain liable for such sub-contractors compliance with such obligations.

3.5.3

Conduct of Sites and Investigators

3.5.3.1

The SPONSOR ensures that the Investigational Product will be supplied to the Sites/Investigators free of charge.

3.5.3.2

The INSTITUTION is responsible for the clearing process to start the supply. The INSTITUTION will clear a shipment only after:

approval of local Ethic Committees and Competent Authorities has been reached,

ii.

the Investigator has given a signed copy of the protocol to INSTITUTION,

iii.

the Investigator has given a recent, signed Curriculum Vitae (CV) to INSTITUTION

iv.

the Site/Investigator has signed a Clinical Study Contract (CSA) with INSTITUTION

the Site was successfully initiated (Initiation Visit)

3.5.3.3

The INSTITUTION ensures that the Investigational Product is properly recorded, handled, stored and dispensed to the trial subjects only and in accordance with the Protocol and applicable laws and regulations. The Investigational Product, medical equipment or supplies provided by or in the name of the SPONSOR shall not be used for any other purpose than the trial and shall remain the SPONSOR's property.

3.5.3.4

The INSTITUTION ensures that the Investigators at each Site hold the necessary registration and have the necessary expertise, time and resources to perform the clinical trial


CTA (engl.) ß10.6 (SCIderm/VBL)		page 7 of 29

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

(especially meaning the use of eCRF) and will ensure that the Investigators are made aware of and acknowledges the obligations applicable to the Investigator set out elsewhere in this Agreement.

3.5.3.5

The INSTITUTION respects the applicable legal obligations concerning the anonymity of the subjects, and warrants that the Sites and Investigators will do the same.

3.6

The INSTITUTION will keep SPONSOR informed upon request by SPONSOR. The INSTITUTION will keep SPONSOR regularly informed every one to two (1-2) weeks in writing and via teleconference about the status of the Trial, especially with regard to the recruitment of subjects. In order to do that the INSTITUTION will obligate the Sites and Investigators to regularly inform the INSTITUTION about the status of the Trial, especially with regard to the recruitment of subjects.

3.7

In the event an Investigator becomes either unwilling or unable to perform the duties required, INSTITITION and Investigator will cooperate, in good faith and expeditiously, to find a replacement Investigator acceptable to the SPONSOR; however, Investigator shall continue to be bound by all obligations and conditions stipulated in section 6.4.7 of this Agreement.

3.8	Record keeping

3.8.1

After the last close-out visit in investigational Sites located in each country, the local TMF of the study is sent to SPONSOR where the TMF is closed and archived. INSTITUTION shall archive all records required to be maintained in accordance with the Study Protocol and under applicable laws, regulations, and guidance.

3.9	Audit and inspection

3.9.1

The INSTITUTION will permit Trial-related audits by auditors mandated by SPONSOR, and inspections by domestic or foreign regulatory authorities, after reasonable notice. The main purposes of an audit or inspection are to confirm that the rights and well-being of the enrolled subjects have been protected, and that all data relevant for the evaluation of the Investigational Product have been processed and reported in compliance with the present Agreement, the Trial Protocol, any amendments and any Trial-related instructions given by the SPONSOR, as well as all ICH GCP, EU, and applicable regulatory requirements. The INSTITUTION will provide direct access to all Trial documents and makes sure that this obligation is respected by Sites and Investigators.

3.9.2

The INSTITUTION shall notify SPONSOR immediately, but in no case more than twenty-four (24) hours after, if the EMA or any other regulatory authority inspects, requests an inspection, makes written, or oral inquiries regarding any


CTA (engl.) ß10.6 (SCIderm/VBL)		page 8 of 29

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

aspect of Institute’s activities pursuant to this Agreement, or requests the suspension, termination or material alteration of the Study Protocol. The INSTITUTION shall notify SPONSOR immediately, but in no case more than twenty-four (24) hours thereafter, upon learning of any violation or deficiency noted by EMA or any other regulatory agency.

3.9.3

The INSTITUTION shall immediately take appropriate action to address any violations or deficiencies identified by the EMA or other regulatory authority during such inspection and shall keep SPONSOR informed of its efforts to address any violations or deficiencies.

3.9.4

Where any regulatory authority has objective grounds for considering that the conditions in the request for authorization of the Study are no longer met or has information raising doubts about the safety or scientific validity of the Study Protocol (and can, accordingly, suspend or prohibit the Study), the INSTITUTION shall, if permitted by the regulatory authority, deliver its, or his or her, opinion in accordance with Article 12 (1) of Directive 2001/20/EC.

3.9.5

The INSTITUTION shall provide SPONSOR with a copy of all correspondence between them and the EMA or any regulatory authority pertaining to activities undertaken pursuant to this Agreement, purged only of confidential information that is unrelated to the activities under this Agreement.

3.10

Reporting

3.10.1

The INSTITUTION shall fully comply with adverse event provisions of the Protocol and make sure all participating Sites and Investigators do the same. In the event of any omission of or in such provisions or in the event of the conflict of such provisions with the local Regulations, then the local regulations shall apply in relation thereto.

3.10.2

The INSTITUTION ensures that the duties of reporting according to the protocol will be obeyed by the Investigators and Sites.

3.10.3

The INSTITUTION shall also inform any other investigators involved in the Study under INSTITUTION´s attendance of all SUSARs.

3.10.4

In the case that the INSTITUTION has been wrongly informed of a AE/SAE/SUSAR by the Investigators and/or Sites instead of the responsible person described in the Protocol, the INSTITUTION shall report the SAE to the entity responsible for reporting within a maximum of twenty-four (24) hours of first knowledge by itself, and shall report all Adverse Events and/or laboratory abnormalities identified as critical to safety evaluations to SPONSOR according to the reporting requirements. The INSTITUTION shall keep detailed records of all Adverse Events which are reported to it. These records shall be submitted by the INSTITUTION to SPONSOR or the relevant competent authority(ies), upon request.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 9 of 29

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

3.10.5

Following the ICH-GCP 4.11.1 (Safety Reporting), 5.16.2 (Safety Information) and 5.17 (ADR Reporting) and the relevant provisions of Directive 2001/20/EC, SPONSOR will inform INSTITUTION of any Suspected Unexpected Serious Adverse Reaction (SUSAR, as defined in Directive 2001/20/EC) occurring in any other trial involving VB-201 and INSTITUTION will forward it according to local laws and regulations to Competent Authorities, Sites, and Investigators.

3.11	SPONSOR Responsibilities

3.11.1

The INSTITUTION´s employees data and the Investigator’s personal data are processed by SPONSOR in accordance with the applicable data protection laws for the purpose of complying with clinical practice regulations and for answering requests from the authorities. These data can be transmitted and processed under the responsibility of SPONSOR for the same purpose.

3.11.2

The SPONSOR is responsible for holding in each of the performing countries separated insurance coverage, as required by applicable legislation. INSTITUTION will help the SPONSOR select and arrange insurance coverage for damages to Clinical Trial Subjects resulting from the Clinical Trial.

3.11.3

SCIDERM warrants and declares that it has sufficient professional liability coverage.

3.11.4

Notwithstanding the SPONSOR's obligation to maintain Clinical Trials Insurance as provided under the respectively applicable Law, the INSTITUTION is responsible that all Investigators and Sites maintain adequate medical practice and/or other insurance to cover its obligations hereunder.

3.11.5

SPONSOR is responsible for labeling and distribution of Investigational Product (incl. placebo).

3.11.6

SPONSOR is responsible to contract with the Coordinating Investigator (LKP) of the Study (see Art. 3.5.2.1)

Art. 4

Liability and Indemnification

4.1	INSTITUTION Liability & Indemnity

4.1.1

The INSTITUTE shall compensate SPONSOR for any and all losses and claims caused by breach of this Agreement by the INSTITUTE or the Sites/Investigators.

4.1.2

The liability of the INSTITUTION, its officers, employees and designees, Sites, and Investigators towards SPONSOR (i) with respect to the grounds of a claim shall be limited to damages caused by gross negligence or deliberate acts, and (ii) with respect to the scope of damages in case of gross negligence shall be


CTA (engl.) ß10.6 (SCIderm/VBL)		page 10 of 29

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

limited to the value of the agreement. The aforementioned limitations of liability shall not apply in cases of compulsory liability (strict product liability), and damages occurring through the infliction of bodily harm (injuries or death). These limitations shall also not apply in case of infringement of major duties (e.g. documentation and reporting duties).

4.1.3

The INSTITUTION agrees to indemnify and hold the SPONSOR and its officers, directors, employees and agents harmless from liability for any claim, demand or lawsuit arising out of any willful or negligent act or failure to act of Institution or any Investigator and/or any failure to comply with, (i) applicable law, rules and regulations, (ii) the terms of this Agreement, (iii) the Protocol or (iv) written instructions provided by SPONSOR including without limitation in instructions of the administration of the Investigational Product or (v) the use of reasonable medical judgment in the administration of the Investigational Product or (vi) the generally accepted standards of the medical community.

4.1.4

The INSTITUTION shall have no obligation of indemnification hereunder for any loss or damages arising out of the gross negligence or willful misconduct or failure to act of SPONSOR in connection with the conduct of the Study. This does not count for bodily damages.

4.1.5

The indemnification by the INSTITUTION is expressly conditioned upon adherence by the SPONSOR and its officers, directors, employees and agents in all respects to this Agreement and the respective Protocol as well as compliance with all applicable regulations and requirements of the EMA, local regulations which may apply and instructions provided by SPONSOR.

4.2	The Parties acknowledge that the liability for the Investigational Product lies with the SPONSOR and/or the Marketing Authorization Holder (MAH).

4.3	INSTITUTION holds adequate comprehensive general liability and property insurance for CRO activities and medical activities.

4.4	If any third party should make a claim against the SPONSOR, the INSTITUTION, a Site or an Investigator, arising - whether directly or indirectly - as a result of this Clinical Trial, then the Parties agree to notify each other immediately after becoming aware of such a claim.

4.5	The Parties shall provide each other with such assistance as it may reasonably require conducting and handling such a claim.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 11 of 29

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

Art. 5

Financial Provisions

5.1	In consideration of the services rendered hereunder and named in Appendix 4 , SPONSOR shall pay a budget described in Appendix 2 . The INSTITUTION will be responsible to pay the Sites and Investigators.

5.2	All payments will be made by SPONSOR according to Appendix 2 . Invoices shall include the Reverse Charge Method, according to tax law, if possible, otherwise plus (VAT). The Sponsor shall make payments only upon receipt of a valid Tax Residency Certificate from the INSTITUTION's Tax Authority.

5.3

[***]


Bank account Holder:		[***]
Address:		[***]
Complete account number:		[***]
Bank key:		[***]
Bank name		[***]
SWIFT		[***]
IBAN		[***]
Payment reference		[***]

5.4	In the event that agreed amendments to the Protocol require changes to the Clinical Trial financing arrangements, an amended financial schedule will be signed by the Parties.

Art. 6

Term and Termination

6.1

This Agreement commences on the Effective Date and shall continue in force until completion of the clinical trial (close-out of the sites and completion of the obligations of the Parties under this Agreement), until termination of the Study or until early termination in accordance with this article.

6.2	The Parties acknowledge the sole right of the SPONSOR to terminate the Study without the requirements of any special reason.

6.3	Either Party (the “ Terminating Party ”) may terminate this Agreement with immediate effect if justified by a legitimate reason. Such a legitimate reason is given, but not limited to, if the other Party (the “ Defaulting Party ”):

6.3.1

is in breach of any of the Defaulting Party’s obligations hereunder (including a failure without just cause to meet a Timeline) and fails to remedy such


CTA (engl.) ß10.6 (SCIderm/VBL)		page 12 of 29

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

breach where it is capable of remedy within thirty (30) days of a written notice from the Terminating Party specifying the breach and requiring its remedy.

6.3.2

becomes or is declared insolvent or a petition in bankruptcy has been filed against it.

Or, in the event that;

6.3.3

the authorization and approval to conduct the trial is withdrawn by the relevant health authorities or EC.

6.4	Effect of Termination

6.4.1

Immediately upon receipt of a notice of termination according to Art. 6.2 or 6.3, the INSTITUTION shall stop all associated Sites and Investigators from entering potential participants into the Study and shall cease conducting procedures, to the extent legally, medically, and ethically permissible, on participants already entered into the Study.

6.4.2

In cases of termination by the SPONSOR following Art. 6.2 or in cases of early termination by SPONSOR following Art. 6.3 and subject to an obligation on the INSTITUTION to mitigate any loss, SPONSOR shall pay all costs incurred and falling due for payment up to the date of termination.

6.4.3

If the early termination according to Art. 6.3. is justly declared by SPONSOR because of a willful breach of contract by INSTITUTION, the INSTITUTION only gets payment for the Services rendered until the termination date, which were conducted according to this Agreement, and which are from interest to the SPONSOR.

6.4.4

If the Study is discontinued for any reason it is agreed that the amounts paid or payable under this Appendix 2 shall be prorated based on actual work duly performed pursuant to the Protocol in accordance with the explanations made hereunder. Any funds not due under this calculation, but already paid, shall be returned to SPONSOR, within thirty (30) days of the date of termination of the Study.

6.4.5

In cases of termination according to Art. 6.1, 6.2, or 6.3, the INSTITUTION shall immediately deliver to SPONSOR on SPONSORS expense all Confidential Information, all records for the Study produced and any other unused materials and Investigational Product provided to the INSTITUTION, Site, and/or the Investigator pursuant to this Agreement and ensures that the Sites and Investigator comply with this clause.

6.4.6

Within ninety (90) days of the end of the Study the INSTITUTION shall notify the relevant competent authority(ies) and IRB/EC that the Study has ended. If the clinical trial is terminated early, this period shall be reduced to 15 days


CTA (engl.) ß10.6 (SCIderm/VBL)		page 13 of 29

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

and the INSTITUTION shall provide clear explanations for the early termination to the relevant competent authority(ies) and IRB/EC.

6.4.7

Sections 4, 6, 7, 8, 9, 11.1, 11.3, and 11.6 shall survive the termination or expiration of this Agreement.

Art. 7

Confidentiality

7.1

The INSTITUTION shall keep confidential any and all information and data concerning SPONSOR`s business or its activities (including reports and information as well as all clinical data about the Study or its progress produced by the INSTITUTION within the framework of this Agreement), or information obtained that may come to the knowledge of the INSTITUTION, its personnel or appointed representatives prior, during or in connection with the execution of this Agreement ("Sponsor's Confidential Information"). The INSTITUTION shall use SPONSOR's Confidential Information solely for the purpose of this Agreement. For the avoidance of any doubt, the Protocol, the Investigational Product, the Study results, and the Inventions (as defined below) shall be considered the Sponsor's Confidential Information.

7.2

SPONSOR shall keep confidential any and all information and data concerning the INSTITUTION`s business or its activities (including information produced by SPONSOR within the framework of this Agreement) or information obtained that may come to the knowledge of SPONSOR, its personnel or appointed representatives prior, during or in connection with the execution of this Agreement, and is not considered Sponsor's Confidential Information.

7.3	Neither Party shall divulge or reproduce such data and information obtained under Art. 7.1 and 7.2 or make the same available to Third Parties in any other way without the other Parties prior written consent.

7.4	The obligations referred to in Art. 7.1., 7.2., and 7.3 shall not apply insofar as the data and information:

Were demonstrably already in the Party`s possession at the time that the other Party provided the data and information to the first one.

ii.

Were known in the public domain or subsequently enter into the public domain through no fault of the other Party or any of its sub-contractors, Sites or Investigators, which obtains the data and the information.

iii.

Were disclosed to the obtaining Party by a third Party, who was entitled to provide the data and information, without an obligation to secrecy.

iv.

Were developed by or for the Party independent of disclosure hereunder as evidenced by that Party`s written records.

Were required by law pursuant to an appropriate legal order by a court or government agency having the authority to compel such disclosure. Provided , however , that recipient shall provide discloser with prompt prior written notice thereof and


CTA (engl.) ß10.6 (SCIderm/VBL)		page 14 of 29

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

any commercially reasonable assistance to enable the discloser to seek a protective order or otherwise prevent or contest such disclosure.

7.5	The Non–Disclosure Agreement executed between the parties on February 14 ^th , 2012 is void, and replaced by this Section 7.

Art. 8

(Intellectual) Property Rights

8.1	Investigational Product

The

Investigational Product is owned by the SPONSOR.

8.2	Property Rights & Inventions

8.2.1

Inventions or discoveries whether or not patentable, processes, trade secrets, data, improvements, and/or patents relating to the Investigational Product or otherwise arising from the Study, conceived, generated, developed or first reduced to practice, as the case may be, during the term of this Agreement (hereinafter called “ Inventions ”), either by the INSTITUTION, Sites, Investigator or any other Sub-Contractor shall be the property of the SPONSOR.

8.2.2

All materials submitted to INSTITUTION from SPONSOR (formulas, etc.) are owned by SPONSOR.

8.3	Claims to Employee’s Inventions

8.3.1

The SPONSOR acknowledges that INSTITUTION and any sub-contractor in Germany may be bound by the German Employee Inventions Act (Arbeitnehmererfindungsgesetz – ArbNErfG) for any inventions made by an employee.

8.3.2

In case of an employee’s invention under the ArbNErfG, INSTITUTION assigns all of its rights under §§ 5 ff. ArbNErfG to the SPONSOR. INSTITUTION is responsible that the notification of such an employee´s invention will be made to SPONSOR properly. If the SPONSOR claims the Invention according to § 6 ArbNErfG, it shall indemnify the employee-inventor according to § 9 ArbNErfG.

8.3.3

INSTITUTION will make sure, that such an article as Art. 8.3.2 will be included in every Clinical Study Agreement (CSA) with a Site in Germany in order to protect the right of the SPONSOR.

8.4	Intellectual Property Rights

8.4.1

All intellectual property rights and know how owned by or licensed to any of the Parties prior to the date of this Agreement are and shall remain the property of that Party.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 15 of 29

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

8.4.2

The SPONSOR shall own the intellectual property rights and know how arising directly or indirectly from the clinical trial relating to the Investigational Product (including but not limited to its formulation and use alone or in combination with other drugs) or the Protocol to which INSTITUTION, Sites and/or Investigators are able to dispose of according to the applicable laws and regulations of each country, but excluding any clinical procedure and improvements thereto that are clinical procedures established at a Site which are not related to the Investigational Product.

8.4.3

The INSTITUTION will promptly inform SPONSOR of any Invention or discovery arising directly from the Clinical Trial, and assign its rights in relation to all intellectual property rights and know how, and provide reasonable assistance to the SPONSOR in filing or prosecuting intellectual property rights, at the expense of the SPONSOR. The INSTITUTION shall disclose all own Study relating Inventions to the SPONSOR.

Art. 9

Publication

(a)

The parties understand and agree that participation in the Study will involve a commitment to publish the data from the Study in a cooperative publication with other Investigators participating in the Study prior to publication or oral presentations on an individual basis. Each Site conducting the Study may publish the results of the Study at the Site (without raw data, detailed patient CRFs, or patient identification) in any scientific journals, manuscripts or at scientific meetings after such cooperative publication, or latest twenty-four (24) months after SPONSOR`s final evaluation of all the Study data from all Sites, whichever occurs first, subject to compliance with the provisions of this Article below. It is further agreed by the Parties that SPONSOR is entitled to request the Site of a delay of such publication due to SPONSOR`s business or operational reasons.

(b)

The release or publication by the Site of any publication or presentation as aforesaid, shall be subject to the prior written consent of Sponsor. INSTITUTION and SPONSOR expressly acknowledge the fundamental interest of the Sites and the Investigators in a potential scientific publication and warrant not to restrict any such publication inequitably, but only on good grounds, including without limitation to protect its Confidential Information, to enable it to seek patent protection or to protect patient's rights.

(c)

Each publication or presentation will adequately acknowledge and appropriately reflect the contribution of the Investigators, Researchers and/or Employees of each SPONSOR and INSTITUTION and/or the source of the information included therein, in accordance with customary scientific practice.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 16 of 29

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

(d)

Consent granted by SPONSOR in respect of any particular publication or presentation shall not be deemed to be consent to any other publication or presentation.

(e)

At least ninety (90) days prior to submitting a manuscript to a publisher or other outside persons (i.e., reviewer(s)) or prior to any public presentation, a copy of the abstract, manuscript, or presentation will be provided to SPONSOR by the Site for review and comment. SPONSOR shall have said ninety (90) day period to respond to the site with comments. If requested to do so by SPONSO, the Site shall remove from the manuscript any Confidential Information prior to submitting the manuscript for publication.

§ 10

Data safety

10.1

With signing this Agreement the Parties agree that all the relevant personal and non-personal data will be saved on the internal database, and that this data will be used to perform the services rendered hereunder. This data can be submitted to third parties if necessary. This data shall be used only for the following purposes:

•

administration of study

•

submission to competent authorities, local authorities and/or ethics committees

•

internal data management

10.2

If personnel are required to submit personal data of employees, the submitting Party warrants that the employees who submit the data and/or work with the date know their duty to keep this data confidential. This is achieved by letting them sign a Confidential Agreement or by such a clause in the employment contracts.

Art. 11

Miscellaneous

11.1	The present Agreement is governed by laws of the plaintiff, like all other disputes that may arise out of the business connection between the Parties.

11.2	If any of the provisions of this Agreement are held to be rendered void or unenforceable, the Parties agree that the same shall not result in the nullity or unenforceability of the remaining provisions of this Agreement.

11.3

All disputes, controversies or claims arising out of or in connection with this Agreement and which cannot be settled amicably between the parties shall be settled according to the with the International Chamber of Commerce (“ICC”) Arbitration Rules as at present in force and shall be held at London England by an arbitrator. The appointing authority shall be the ICC acting in accordance with the Rules adopted by the ICC for this purpose. The award of such arbitration shall be final and binding on the parties hereto. The language of such an arbitration is English.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 17 of 29

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

11.4	All Changes to the present Agreement have to be in writing. This holds true also for this clause.

11.5	This Agreement is drawn up in the English language, which is exclusively authentic. Said language shall be the respective binding and controlling language for all matters pertaining to its meaning or interpretation.

11.6	The SPONSOR shall be a third-party beneficiary of this Agreement and may directly enforce the provisions of this Agreement relating to SPONSORS's rights and interests, including SPONSOR's rights and interests in the Inventions and its confidential and proprietary information.

IN WITNESS WHEREOF , the Parties have caused this Agreement to be executed by their duly authorized representatives.

Signature SPONSOR


9-9-12		/s/ Dror Harats
Date		CEO

Signature INSTITUTION

31-08-2012		/s/ Ina Zschocke
Date		Managing Director


CTA (engl.) ß10.6 (SCIderm/VBL)		page 18 of 29

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

APPENDIX 1

TIMELINES


[***]		[***]


CTA (engl.) ß10.6 (SCIderm/VBL)		page 19 of 29

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

APPENDIX 2

FINANCIAL PROVISIONS

The payments listed below represent all Study costs for services named in Appendix 4 .

1.	Compensation of INSTITUTION

1.1

Compensation for the Professional Service Fees (with Study Performance, Additional Examinations, and Additional Expenses) of [***] (including PTC) equalling [***] without PTC will be paid by SPONSOR to INSTITUTION based on an Activity Based Costing (ABC) according to the following schedule upon receipt of an invoice by wire transfer within 30 days to the bank account stated under Art. 5.3:

[see table on page 21, 22, 23, and 24]

SPONSOR will pay an [***] as a so called “handling fee” to the amount of each invoice, covering all additionals not included under 1.2 and 1.3, such as printing, scanning, copying, and transport of study documents, phone calls with CA, EC, and Sites/Investigators, and accounting fees.

The INSTITUTION will inform SPONSOR up front, if the compensation described above will be exceeded. Then the Parties will negotiate a solution. But, without such notice, no extra costs to the budget will be paid.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 20 of 29

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

TOPIC

ACTIVITIES

Total in EUR

Qu 02/12

Qu 03/12

Qu 04/12

Qu 01/13

Qu 02/13

Qu 03/13

Qu 04/13

Qu 01/14

Qu 02/14

Qu 03/14

Qu 04/14

1. Study Preparation & submission to competent authorities (CA), Ethics committees

Informed Consent CRF Investigator Site File, Trial Master file, preparation of CTA, selection of site documents, submission

Etc.

[

***]

submission
EC CA,
VHP

Approval
FPI

50%

recruitment

LPI

50%
patient
out

LPO

DBL/
statistics/re
suits

study
report

transfer
of docs/
Archiving

Preparation

[***]

Submission

[***]


CTA (engl.) ß10.6 (SCIderm/VBL)		page 21 of 29

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

TOPIC

ACTIVITIES

Total in EUR

Qu
02/12

Qu
03/12

Qu
04/12

Qu
01/13

Qu
02/13

Qu
03/13

Qu
04/13

Qu
01/14

Qu 02/14

Qu 03/14

Qu 04/14

Webinar

[***]

Preparation

[***]

Performance

[***]

Study performance

Patient Visits & Expenses (per patient)

[***]

Monitoring

Study Monitoring

[***]

Safety Monitoring

[***]


CTA (engl.) ß10.6 (SCIderm/VBL)		page 22 of 29

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

TOPIC

ACTIVITIES

Total in EUR

Qu
02/12

Qu
03/12

Qu
04/12

Qu
01/13

Qu
02/13

Qu
03/13

Qu
04/13

Qu
01/14

Qu 02/14

Qu 03/14

Qu 04/14

Data Management

Data collection, entry & plausibility check

[***]

Statistical Analyses

Statistical analysis & summary

[***]

Study Report

Study documentation & final report

[***]

Study management

Study coordination

[***]


CTA (engl.) ß10.6 (SCIderm/VBL)		page 23 of 29

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

TOPIC

ACTIVITIES

Total in EUR

Qu 02/12

Qu 03/12

Qu 04/12

Qu 01/13

Qu 02/13

Qu 03/13

Qu 04/13

Qu 01/14

Qu 02/14

Qu 03/14

Qu 04/14

Additional

Examinations

e.g. laboratory, medical devices

[***]

Additional expenses

on a time &

material basis

[***]

[***]

[***]

Total In € (net)

[

***]

[***]

Qu 02/12

Qu 03/12

Qu 04/12

Qu 01/13

Qu 02/13

Qu 03/13

Qu 04/13

Qu 01/14

Qu 02/14

Qu 03/14

Qu 04/14

submission
EC, CA,
VMP

Approval,
FPI

50%
recruitmemt

LPI

50%
patient
out

LPO

DBL/
statistics/re
sults

study
report

transfer
of

docs/
Archiving

(1)

(2)

(3)

Commentary :

(1)	All remuneration is subject to actual services performed during each quarter ( pro rata temporis payment) until reaching maximum amount of each quarter stated hereunder.

(2)	This Deliverable means: Database Transfer, as receipt of Data (but latest 2 weeks after Database Lock)

(3)	This Deliverable means: Receipt of Final Study Report (but latest 6 weeks after receipt of Draft Study Report)


CTA (engl.) ß10.6 (SCIderm/VBL)		page 24 of 29

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

1.2	All additionals will be paid according to the following rates (see below):

1.2.1

Additional expenses crucial to the services rendered hereunder will be paid on a time and material basis, e.g. but not limited to

•

Fees at national Competent Authorities,

•

Fees at national Ethic Committees,

•

Fees at federal Local Authorities (Germany),

•

Fees at other Authorities,

•

Fees for Licenses (e.g. DLQI etc.)

1.2.2

Any additional services asked by SPONSOR via email, mail, or fax in addition to Art. 3, Appendix 2 and 4 will be paid according to the hourly rates listed for each expert under Appendix 4.

1.2.3

For necessary travel costs for CRAs, Monitors etc.:

[***]

1.3

All additional examinations (for laboratory) will be paid on a time and material basis according to separate offer from 31.07.2012.

1.4

Invoices shall be made at the end of a quarter and include the Reverse Charge Method, according to tax law, if possible, otherwise plus (VAT).

All sums are in EURO . If an exchange rate needs to be set up, the exchange rate shall equal the average to the exchange rates, listed in the Wall Street Journal, for five (5) preceding business days including the date of payment.

Compensation of Site/Investigator

2.1

The compensations of sites/investigators are PTC and will be invoiced and paid on a time and material basis according to the following provisions by SPONSOR.

2.2

The INSTITUTION compensates the Sites/Investigators in the countries in which it conducts the study by wire transfer within 30 days after receipt of invoice by them. SPONSOR compensates the INSTITUTION by wire transfer within 14 days after receipt of the invoice by the INSTITUTION.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 25 of 29

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

2.3

The amount of remuneration of a Site/Investigator for execution of this Agreement shall be based on the number of patients properly enrolled into the Study (meaning: being randomized) in relation to whom the full program of the Study, defined in the Protocol, was carried out. The payment is due, at the end of the last visit of a patient and depending on the proper documentation (eCRF), which has been controlled by the Monitor.

A Screen Failure Subject Participant is a potential participant who has signed an ICF but has failed to satisfy the inclusion and/or exclusion criteria or was not enrolled in the Study for other reasons. An Investigator will receive payment for a maximum of two (2) screen failures during the study at a rate of [***] per screen failure (plus the patient refund).

If a subject does not complete the Clinical Trial then partial payment will be made based on the number of visits completed according to the following schedule (prices without VAT):

2.3.1

Investigator Fee Germany & Spain


Visit		[***]
Visit 0 Screening		[***]
Visit 1 Baseline		[***]
Visit 2 (week 2)		[***]
Visit 3 (week 4)		[***]
Visit 4 (week 8)		[***]
Visit 5 (week 12)		[***]
Visit 6 (week 16)		[***]
Visit 7 (week 20)		[***]
Visit 8 (week 24)		[***]
Visit 9 (week 28)		[***]
Totals		[***]

Invoices shall include the Reverse Charge Method, according to tax law, if possible, otherwise plus (VAT). All sums are in EUR.

Unless otherwise agreed in writing by SPONSOR, the INSTITUTION shall make no payment for participants whom the Investigator entered into the Study in violation of the Protocol (i.e. the participant is not an Eligible Participant).

2.4	An [***] to each Investigator compensation under 2.3 will be paid, if a site insists on such a fee and after SPONSOR has given written approval of such a payment. The SPONSOR acknowledges that such fees are mostly obligatory for governmental sites, such as universities or federal hospitals.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 26 of 29

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

[***]

2.6	The Sites will get an advertising-fee up to []* due at conclusion of contract for becoming acquainted with protocol, attending necessary training, performing pre-study and initiation visits.

2.7.	All non mentioned costs are already included within the rates under this 2. Section.

3.	Patient Compensation / Patient Travel Expenses

3.1	The compensations of patients are PTC and will be invoiced and paid on a time and material basis according to the following provisions by SPONSOR.

3.2

The INSTITUTION compensates the national Sites/Investigators which compensate the patients first. The Sites/Investigators shall pay the patients at the end of the Study or by the time of drop-out. The INSTITUTION compensates the national Sites/Investigators within 30 days after receipt of invoice. SPONSOR compensates the INSTITUTION within 14 days after receipt of the invoice.

3.3	The patient receives a refund of max. []* per capita. The refund includes [*] If a subject does not complete the trial then the patient’s compensation will be all inclusive [*] for every performed visit. The payment of refund has to be documented and signed by the Site/Investigator.

4.	Return of Funds Upon Early Termination


CTA (engl.) ß10.6 (SCIderm/VBL)		page 27 of 29

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

APPENDIX 3

Distribution of Investigational Product

SPONSOR is responsible for producing, labeling, and distributing Investigational Product (incl. placebo).

It is planned, that SPONSOR will contract a third party which will take over the responsibilities of labeling and distributing the Investigational Product (incl. placebo) in Germany and Spain.

INSTITUTION will take no part in the agreement between SPONSOR and Distributor.

Selected distributor will be the GMP-Unite AMATSI , with business offices at 17, parc des Vautes, 34980 Saint Gély de Fesc, France.

SPONSOR, INSTITUTION, and Distributor will work together, to set-up a distribution plan, which will be part of the Protocol VB-201-079 and submitted to all participating CROs, Sites, and Investigators. The responsibility of setting up this distribution plan lies within the SPONSOR.


CTA (engl.) ß10.6 (SCIderm/VBL)		page 28 of 29

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

APPENDIX 4

Cost Estimate from 31.07.2012 (incl. separate lab offer from 13.07.2012)

( The cost estimate follows attachment with its original numeration – separate lab offer

follows behind CE with its original numeration )


CTA (engl.) ß10.6 (SCIderm/VBL)		page 29 of 29

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

CONFIDENTIAL

Quest

Diagnostics

Quest Diagnostics Clinical Trials

Central Laboratory Services Budget

SCIderm GmbH

177-001

Version 5

13. Jul 12


Prepared Anastasia Kremp for: Project Manager SCIderm GmbH Esplanade 6 20354 Hamburg		by: Wolfgang Pohl Strategic Account Executive Quest Diagnostics Clinical Trials Unit B1, Parkway West Cranford Lane Heston, Middlesex TW5 9QA

Tel: 40 554401-128 Fax: 40 554401-291 Email: Anastasia.Kremp@sciderm.com		Tel: 49 8031 231 81 31 Fax: 49 8031 231 81 32 Email: wolfgang.r.pohl@questdiagnostics.com

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

Quest

Diagnostics

13. Jul 12

Anastasla Kremp

Project Manager

SCIderm GmbH

Esplanade 6

20354 Hamburg

Regarding:

Centralized Clinical Laboratory and Related Support Services for Protocol 177-001

Dear Anastasia:

Thank you for the opportunity to submit a revised budget for your study. This budget includes the following changes.

•

Version 5: Two countries only, [***]- Germany [***] and Spain [***]

Quest Diagnostics Clinical Trials has a commitment to peak performance, superior value for our customers, teamwork, innovation and integrity. We look forward to the opportunity to work with you to demonstrate our dedication to these values.

The prices given in this quotation are valid for a period of three months.

If you have any questions or require further assistance, please feel free to call me.

Yours sincerely,

Wolfgang Pohl

Strategic Account Executive

Quest Diagnostics Clinical Trials

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

SCIderm GmbH

Quote for Services

Assumptions

Protocol: 177-001

Quest

Diagnostics

Assumptions:

[***] samples from [***] patients screened, [***] patients randomized and completed from [***] sites in Europe; samples are tested in Quest Diagnostics Clinical Trial Laboratory in Heston, UK (near Heathrow)

Testing: [***]

Supplies: Visit specific kits are provided for all visits.

Supplies: [***] - [***]

Ambient Shipments General: The ambient shipment frequency is based on an average 1,5 visits = one shipment (average seen at Quest). If a site collects samples from more than one subject on the same day these may be shipped together reducing costs.

Outbound shipments: The start and end dates are estimated - on the basis of a [***] months study this Proposal allows for one initial supply of materials and 2 resupply.

Data Transfer: Weekly Data Transfers are included

Investigator meeting: For one investigator meeting attendance of a Quest representative and presentation is included in the bid (excluding travel, meals and accommodation)

Sample management and storage Inflammatory Biomarkers: One tube per occasion assumed; Average period of storage assumed 6 months (first months of storage included in ‘storage in fee’); Samples to be shipped to Israel at the end of the study, per instruction of Anastasia Kremp (SCIderm GmbH) on June 11th. 2012 per email biomarker samples can be shipped ambient on the day of the visit from the sites to Quest and be frozen at Quest upon receipt.

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

SCIderm GmbH

Quote for Services

Assumptions

Protocol: 177-001

Quest

Diagnostics

Primary End points:

Safety End points

Safety will be assessed based on all subjects in the study who have received at least one dose of study drug (Safety Population):

•

[***];

•

[***];

•

[***];

•

[***] - [***];

•

[***].

Efficacy Endpoint

The proportion of subjects in the VS-201 80 mg q12hrs treatment group who achieve at least 50% improvement from the baseline PASI score at Week 16 (PASI 50) compared to the proportion of PASl 50 responded in the placebo group;

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

SCIderm GmbH

Quote for Services

Analytes

Protocol: 177-001

Quest

Diagnostics

Requested Safety Analytes:

[***]

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

SCIderm GmbH

Quote for Services

Budget Summary

Protocol: 177-001

Quest

Diagnostics


Study Duration:	13 Months	Total Investigators:	18
Quote Date:	13. Jul 12	Total Countries:	2
Quote Expiration Date:	13. Okt 12	Total Visits:	10
		Total Patient Visits:	1,845


Estimated Grant Total Amount:	€	189,123,56
Average Cost Per Patient-Visit	€	102,51
Average Cost Per Patient	€	1,027,85

Budget Summary ¹

Sub-Totals

Region

Billing Amount

Conversion Rate

Estimated Total Amount

Europe

[***]

Study Set-up Fees

[***]

Average cost Per Patient-Visit

Region

Estimated Total Amount

Patient Visits

Average Cost

[***]

Sub-Totals

Region

Billing Amount

Conversion Rate

Estimated Total Amount

[***]

Detailed Budget Summary ¹

Laboratory Testing

Region

Billing Amount

Conversion Rate

Estimated Total Amount

[***]

Laboratory Testing Total ^{1LT,2LT,3LT,4LT,5LT,6LT,7LT}

[***]

Supplies

Region

Estimated Total Amount

Patient Visits

Average Cost

[***]

Supplies Total ^TBL

[***]

Estimated Supplies Total ^TBL

[***]

Additional Pass-Through Services

Region

Billing Amount

Conversion Rate

Estimated Total Amount

Europe

[***]

Additional Pass-Through Services Total

[***]

Storage

Region

Billing Amount

Conversion Rate

Estimated Total Amount

Europe

[***]

Storage Total ^1LT,2LT,3LT

[***]

Study Management

Region

Estimated Total Amount

Patient Visits

Average Cost

Europe

Study Set-up Fees

[***]

Study Management Total ^{1SM,2SM,3SM,4SM,5SM,6SM,7SM}

[***]

Inbound Transportation

Region

Billing Amount

Conversion Rate

Estimated Total Amount

Europe

[***]

Inbound Transportation ^1LT,2LT,3LT,

[***]

Estimated Inbound Transportation Total ^1LT,2LT,3LT,

[***]

Outbound Transportation

Region

Billing Amount

Conversion Rate

Estimated Total Amount

Europe

[***]

Outbound Transportation Total ^{1OT,2OT,3OT,4OT,5OT,6OT,7OT}

[***]

Shipping Container Transportation

Region

Billing Amount

Conversion Rate

Estimated Total Amount

Europe

[***]

Shipping Container Transportation Total ^5OT,6OT,7OT

[***]

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

SCIderm GmbH

Quote for Services

Detail Summary

Protocol: 177-001

Quest

Diagnostics

Laboratory Testing

Region

Time
Points

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

[***]

Europe

[***]

Europe

[***]

Europe

[***]

Europe

[***]

Europe

[***]

Europe

[***]

Laboratory Testing Total

[***]

Supplies

Region

Unit

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

Shipping Container Ambient 5/Case

Europe

[***]

Gel Whip

Europe

[***]

Investigator Manual Color

Europe

[***]

Vis Specific Kit (1 )

Europe

[***]

Vis Specific Kit (11-20)

Europe

[***]

SMAS Shipping Container – Large

Europe

[***]

SMAS Specimen Box

Europe

[***]

Pregnancy Hcg Test Strip 25/Box

Europe

[***]

Supplies Total

[***]

Estimated Supplies Total

[***]

Additional Pass-Through Services

Region

Unit

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

Outbound shipment Diagnostic SMAS samples From Haston – Israel with World Courier, assume 3 boxes

Europe

[***]

Additional pass-Through Services Total

[***]

Storage

Region

Allquote

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

Storage “In” Fee – Inflammatory Biomarkers

[***]

Storage “Monthly Maintenance” fee – Inflammatory Biomarkers

[***]

Storage “Pull” Fee – Inflammatory Biomarkers

[***]

Storage total

[***]

Study Management

Region

Unit

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

Per Visit Project Management fee

Europe

[***]

Per Visit Data Management fee

Europe

[***]

Per Visit Logistics Management fee

Europe

[***]

Specimen Pull Fee (per request)

Europe

[***]

Set-up – Project Management

Study Set-Up Fees

[***]

Set-up – Database

Study Set-Up Fees

[***]

Set-up Logistics

Study Set-Up Fees

[***]

Web-based Result/View TM

Study Set-Up Fees

[***]

Study Management Total

[***]

Inbound Transportation

Region

Unit

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

Germany (Berlin) Ambient: DHL

Europe

[***]

Spain (Madrid) Ambient: DHL

Europe

[***]

Inbound Transportation Total

[***]

Estimated Inbound Transportation Total

[***]

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

SCIderm GmbH

Quote for Services

Detail Summary

Protocol: 177-001

Quest

Diagnostics

Outbound Transportation

Region

Unit

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

Starter Packs Germany (Berlin) DHL

Europe

[***]

Starter Packs Spain (Madrid) DHL

Europe

[***]

Resupplies Germany (Berlin) DHL

Europe

[***]

Resupplies Spain (Madrid) DHL

Europe

[***]

Outbound Transportation Total

[***]

Shipping Container Transportation

Region

Unit

Quantity

Billing
Currency
Unit Price

Billing
Amount

Conversion
Rate

Estimated
Total Amount

Ambient Germany (Berlin) DHL

Europe

[***]

Ambient Spain (Madrid) DHL

Europe

[***]

Shipping Container Transportation Total

[***]

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

SCIderm GmbH

Quote for Services

Test Visit Schedule

All Locations

Protocol: 177-001

Quest

Diagnostics

Category

Name

Screening/
Day -20 to -0

Baseline/
Day 1

Week 2/
Day 14

Week 4/
Day 28

Week 8/
Day 56

Week 12/
Day 84

Week 16/
Day 112

Week 20/
day 140

Week 24/ET
Day 168

Week 48/
Day 196

Ambient

Complete Blood Count

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Ambient

Chemzyme Plus

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Ambient

Urinalysis, Routine

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Ambient

Human Chorionic Gonadotropin, Qualitative (Serum)

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Ambient

Quantiferon TB

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Ambient

Cardio CRP

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Ambient

Storage “In” Fee – Inflammatory Biomarkers

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Storage “Monthly Maintenance” Fee – Inflammatory Biomarkers

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Storage “Pull” Fee – Inflammatory Biomarkers

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Page 1 of 1

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

SCIderm GmbH

Quote for Services

Patient Visit Schedule

All Locations

Protocol: 177-001

Quest

Diagnostics

Country

Sites

Screening/
Day -20 to -0

Baseline/
Day 1

Week 2/
Day 14

Week 4/
Day 28

Week 8/
Day 56

Week 12/
Day 84

Week 16/
Day 112

Week 20/
day 140

Week 24/ET
Day 168

Week 48/
Day 196

Calculated Totals:

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Germany (Berlin)

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Spain (Madrid)

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

[

***]

Page 1 of 1

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

SCIderm GmbH

Quote for Services

End Notes

Protocol: 177-001

Quest

Diagnostics

Global Summary

See Study Specific Assumptions and Pricing Model, herein. Budget excludes any “TBO” (To Be Determined) items.

Global Summary - Laboratory Testing (LT)

^1LT

Quoted fees reflect Quest Diagnostics Clinical Trials’ Year 2012 Fee Schedule.

^2LT

Fees quoted tor testing services performed are exclusive of any applicable added Taxes (including Value Added Tax (VAT)).

^3LT

The sample testing fees include the receipt of samples Into a Quest Diagnostics-owned, affiliate or alliance partner laboratory. the direct costs associated with the laboratory testing of the samples, retention of the unused samples for a maximum of fourteen (14) days, laboratory quality control and global standardisation of equipment, processes, controls and calibrators.

^4LT

The sample testing fees also include the distribution of interim result reports (per patient visit) and final result reports lo Investigator(s) and/or Clients/CROs as applicable and agreed in the Central Laboratory Worksheet. Any final result reports Issued in hard copy will be sent via standard postal service or (within the continental United States only) Quest Diagnostics-US proprietary courier.

^5LT

It is Quest Diagnostics Clinical Trials’ (Quest) experience that Investigator sites experience significant challenges producing a peripheral blood smear ( PBS ) of sufficient quality for an appropriate hematology laboratory PBS review. Therefore, it is standard Quest practice to not provide glass slides and to not require the sites to make PBS slides . The performance by Quest of a routine safety CBC analysis (hematology) does Involve the occasional review of PBS slides for the white blood cell morphology and differential, red blood cell morphology and platelet evaluation if the instrument or the SOP flags the specimen for a PBS slide review. The PBS slide can be appropriately created and reviewed in the majority of cases by the laboratory from the submitted CBC sample if a review is required.

^6LT

If the protocol requires a PBS slide review then glass microscope slides will be provided to the site(s) for each appropriate visit so that the site can create and provide a PBS to the central laboratory. Protocols where in our experience peripheral blood smears are recommended Include significant hematological/bone marrow abnormalities (white or red cell, platelet abnormalities), leukaemia’s, HIV clinical trials, sepsis, or other severe Illnesses that would be impacting the hematological system. Our scientific affairs and medical affairs teams are available to further discuss the needs of your protocol regarding any requirements for PBS creation by the site or by the laboratory and PBS slide review by the Quest laboratory. Please could you confirm if this protocol requires a peripheral blood smear review or if subjects in this study are expected to have hematological abnormalities where we would recommend the preparation of peripheral blood smears at the investigator site.

^7LT

CBC and Peripheral blood smear pricing are based on assumptions received at the point of preparing this quotation. Quest Diagnostics reserves the right to adjust these pertinent to further discussion with the customer.

Global Summary - Supplies (SL)

The Worst Case Supplies total is representative of individual ambient shipping containers for individual patient visit ambient shipments and reflects the Worst Case Scenario. The Estimated Total reflects the assumption that 1,5 patient visits are batched per ambient shipment.

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

Global Summary - Storage (ST)

^lST

The “In” fee includes receipt, preparation, storage and entry of specimens into Quest Diagnostics Clinical Trials storage facility and computer system.

^2ST

The “Monthly Maintenance” fee includes inventory, storage, temperature monitoring and continuous security coverage at Quest Diagnostics Clinical Trials storage facility.

^3ST

The “Pull” fee Includes the removal of requested specimens from storage, sorting of specimens prior to shipment (in a manner requested by client, e.g. -by patient, by visit) and the generation of a manifest.

Global Summary - Study Management (SM)

^lSM

The Study Management set-up fees quoted Include provision for our standard toxicity and exclusions flagging; and cumulative data transmissions sent weekly via email zip file or SFTP or portals in our standard data file formal. The fees do not include any set-up related to storage samples, new testing method set-up’s, algorithms, microbiology testing or referral lab data entry. If client requires Quest to add any of these elements or set up additional flagging options and use data files which differ to our standard format, we reserve the right to adjust our set-up fees accordingly.

^2SM

The Project Management Study Set-Up fee Includes an internal review of the protocol in conjunction with the client’s study team and formulation of an agreed Central Laboratory Worksheet signed off by Client and Quest, which lays out detailed specifications for the set-up and management of the study. Quest will design study documents, which include Investigator Manuals in the languages specified in the budget, a Lab Requirement Summary and pictogram. and study specific test Requisition forms in accordance with these specifications, as part of this fee. The design of visit specific specimen collection kits and set-up of Investigator site information is included as part of Project Management set-up.

^3SM

The fee Per Visit for Project Management covers ongoing Project Management support. 24/7 investigator assistance/support by Quest Diagnostics CRC Support Team, including the use of toll-free phone lines. Auto faxing of supply expiry details and Inclusion of alerts and delta flagging are also covered by this fee.

^4SM

The fee Per Visit for Data Management covers ongoing Data Management support, maintenance of the results database and the actioning and documentation of all necessary data revisions and data transfers up to once per week.

^5SM

The fee Per Visit for Logistics covers the expertise and management of the ongoing study logistics, shipment (racking, processing and auditing of courier invoices and the performance management of the courier companies.

^6SM

Quest Diagnostics proprietary software Result/ViewTM - web-based version shall be included for the two users per study at no additional charge, more than two users will be charged. This includes training and support by telephone.

^7SM

Quest Diagnostics Clinical Trials will charge a per work order fee associated with each pull order. The purpose of this is to maximize the batching of samples whenever they are pulled for regular or ad hoc shipments from sample storage in order to create operational efficiency.

Global Summary - Inbound Transportation (IT)

^**

The Worst Case Inbound Transportation total is representative of individual patient visit shipments and reflects a “worst case scenario”. The Estimated Total reflects me assumption that 1,5 patient visits are batched per shipment.

^1IT

The inbound specimen transportation fees are based on typical volumetric weight, and vary by city. Quest Diagnostics Clinical Trials will bill client actual transport costs, per the Invoice of the transport company. Any change to the fee imposed by the courier will be passed on to client. Additional charges for secondary cities, holidays and weekend service may apply.

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

^2IT

The Euro (€) Inbound Diagnostic Transportation fees Quoted are based on an estimated exchange rate of £1 GBP = € 1,1628. However, all Inbound Diagnostic Transportation will be billed at the actual £GBP to Euro (€) rate ruling in the applicable month as published by UK Customs and Excise. Thus the Inbound Transportation fees may vary from those quoted In this budget in any given month depending on what the actual exchange rate is.

^3IT

The Logistics estimates included represent our best recommendations based on recent experience. We welcome the opportunity to discuss carrier performance and recommendations since the decision on courier selection ultimately resides with the sponsor.

Global Summary - Outbound Transportation (OT)

^1OT

Initial Supply Shipments: initial shipments will be distributed within ten (10) working days from Client’s approval of the (a) requisition form, (b) Investigator Manual, and (c) receipt of Client’s final Investigator list. Quest Diagnostics’ must also receive Client’s approval of Quest Diagnostics’ verification report (without changes) at least 2 days prior to shipment.

^2OT

Please note that Quest Diagnostics Clinical Trials does charge an additional fee for expedited/priority starter pack shipments.

^3OT

Shipment of Re-supplies: Re-supply orders will be distributed within five (5) working days of Quest Diagnostics’ receipt of the Request for Supplies form from the Investigator or Client- Any re-supply orders containing special supplies shall be shipped upon supply availability and may require more than a five (5) working day turnaround.

^4OT

Quest Diagnostics will use commercially-reasonable efforts to provide re-supply orders with less than five (5) working-days prior notification from Client or the Investigator (“STAT re-orders”). However, Client will be responsible for all additional labor and transportation charges associated with STAT re-orders.

^5OT

The Outbound transportation fees are based on typical volumetric weight. Quest Diagnostics Clinical Trials will bill client actual transport costs per the invoice of the transport company. Any change to me fee imposed by the courier will be passed on to client. Priority shipments, e.g. next-day air are additional. Fees for outbound supply shipments do not include any imposed tariffs.

^6OT

The Euro (€) Outbound transportation fees quoted are based on an estimated exchange rate of £1 GBP = € 1,1628. However, all Outbound Transportation will be billed at the actual £GBP to Euro {€) rate ruling in the applicable month as published by UK Customs and Excise. Thus the actual Outbound Transportation fees may vary from those quoted in this budget in any given month depending on what the actual exchange rate is.

^70T

The Logistics estimates included represent our best recommendations based on recent experience, We welcome the opportunity to discuss carrier performance and recommendations since the decision on courier selection ultimately resides with the sponsor.

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


Cost estimate, 177-001, Vascular Biogenics Ltd

Cost estimate

Vascular Biogenics Ltd

Dr Dorit Bregman

Dr Andi Leubitz

Contact Managing Director:

SCIderm GmbH

Dr. Ina Zschocke

Esplanade 6

D-20354 Hamburg

Tel.: +49-(0)40 - 55 44 01 -111

Fax: +49-(0)40 - 55 44 01 -291

E-mail: ina.2sch0cke@sciderm.com


Court of Record:		Hamburg District Court
Registration No:		HRB 93824
Int. VAT-Reg. No:		DE 206 689 821

Confidential

May not be used, published, or otherwise disclosed without the consent of Vascular Biogenics Ltd and SCIderm GmbH


STRICTLY CONFIDENTIAL		2012-07-31		Page 1 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

1. Conditions

The present cost estimate is based on the information summarized below.


Trial No.	177-001

Phase	II(b)

Sponsor	Vascular Biogenics Ltd.

Study sites	[*] sites in 2 countries: [] sites in Germany, [**] sites Spain

Design	Prospective, multicentre, randomized, placebo-controlled, double-blind group design

Patients	[***] evaluable patients

Treatment	3 treatment arms:

	•	VB-201-80mg/day;

	•	VB-201-160 mg (80 mg BID)

	•	Placebo

Duration of treatment	24 weeks treatment with a follow-up after 4 weeks (week 28)

Countries	2 countries: Spain, Germany

Number of visits	[***] visits

	•	[***]

	•	[***]

	•	[***]

	•	[***]

	•	[***]

	•	[***]

	•	[***]

	•	[***]

	•	[***]

	•	[***]

Population	Adults with moderate to severe plaque psoriasis [***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 2 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd


Time	Preparation	[***]
schedule	Approval CA/EC	[***]
	Recruitment period (FPI-LPI)	[***]
	Last patient out:	[***]
	Database lock:	[***]
	Statistics/Draft Report:	[***]
	Overall timelines	[***]

Primary Efficacy Endpoint	The proportion of subjects in the VB-201 160 mg (80 mg BID) treatment group who achieve at least 50% improvement from the baseline PASI score at Week 16 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group

Ethical Considerations	This trial will be conducted in accordance with applicable laws and regulations including, but not limited to, the ICH-GCP guideline and the ethics principles that have their origins in the Declaration of Helsinki. The independent Ethics Committee and the competent authority must review and approve the study before any patients are enrolled. Consent must be obtained from the patient using the approved informed consent form before any procedures specified in the protocol are performed.


STRICTLY CONFIDENTIAL		2012-07-31		Page 3 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

2. Description of Services

Since February 27 ^th of 2008 SCIderm is certified according to DIN ISO-Norm 9001:2000 and since 5 ^th of March 2011 re-certified according to DIN ISO-Norm 9001:2008. SCIderm is dedicated to the performance of clinical trials according to ICH-GCP and has implemented a complete system of SOPs covering all CRO activities including monitoring as well as the conduct of clinical trials. According to these SOPs all SCIderm employees including monitors are educated at the best.

Based on the above mentioned assumptions, SCIderm will provide the following services:

Study Preparation

The following regulatory aspects will be taken into consideration: This project will be conducted in accordance with the ethics principles that have their origins in the Declaration of Helsinki. The study will be submitted to the Ethics Committee and to the appropriate Regulatory Authorities in order to comply with the Medicines Law in Germany and Spain.

•

Study set-up

•

CRF (review, release)

•

Set-up of study documents

•

EudraCT number (drug studies)

•

Review of study protocol

•

Writing of ICF (draft version)

•

Review and release of ICF

•

Additional documents (advertisement, leaflet, patient card)

•

Preparation and distribution of Service binder (label, general practitioner letter, file, informed consent, Diaries, for each patient)

•

IMPD/ Safety data / IB / smPC - print, distribution

•

Preparation of documents for submission {CTA / Module 2 / checklist / DIMDI form)

•

Preparation of ISF / logs, update, release and distribution

•

Set-up and release of TMF

•

Set-up of Laboratory / Samples

•

Administration of translation etc.

•

Prepackaging and distribution of materials / devices

•

Set-up of Photodocumentation

•

Selection of sites / feasibility

•

Determining of sites

•

Communication plan (number of sites, CRA’s, laboratory etc.)

•

Collection of site/sponsor specific documents

•

Training of PMs in ES

•

Project Acquaintance Spain

•

Preparation Spain

•

Investigational products - logistics


STRICTLY CONFIDENTIAL		2012-07-31		Page 4 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

Regulatory Activities

•

Submission according to VHP (Voluntary Harmonisation Procedure)

•

Submission to national CAs

•

Submission to leading / participating EC

•

Notification to LA

GoToWebinar Meeting (Web Conference)

[***] sites will participate in the study. From each site 1 investigator and 1 study nurse are planned to attend the web conference. Further participants are appr. 5 CRAs, 4 delegates from SCIderm (project management, data management), 3 invited speaker from drug supply, laboratory, pharmacovigilance.

•

Planning, preparation and coordination of the web conference

•

Conduct of test runs with each site (registration, access support service etc.)

•

Preparation of agenda

•

Preparation of three presentations

•

Communication with sites

•

SCIderm (meeting’s assistance, 4 persons)

•

Attendance of 5 CRAs/PMs at the web conference

•

Attendance of 3 invited speaker

Monitoring

Monitoring Manual

•

Writing of the Monitoring Manual

•

Training of the CRAs on the Monitoring Manual

Site Selection Visit

•

Feasibility of sites

•

Performance of Site Selection Visits ([***] visits to be performed in order to select [***] sites; excluding practices of SCIderm Network - in these cases no site selection visit required è resulting in [***] SSVs)

•

Report of Site Selection Visit

•

Monitoring Report review and release

Initiation Visit

The initiation visit will be performed by a qualified monitor. Subject of the meeting will be:

•

Explanation of study protocol, especially inclusion / exclusion criteria and patient informed consent

•

Instruction of CRF completion

•

Briefing of source data handling


STRICTLY CONFIDENTIAL		2012-07-31		Page 5 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

•

Explanation of patient enrolment plans

•

Explanation of study procedures (especially central laboratories at selected sites)

•

Explanation of drug accountability procedures

•

Training of Serious Adverse Event reporting procedures

•

Complete Good Clinical Practice review

•

Report of Initiation Visit

•

Monitoring Report review and release

Periodic Visits

The first periodic monitoring visit will be performed within the first two weeks after first-patient-in at the site. The present calculation is based on periodic visits performed at each site every [***] months ([***] visits each site). The following activities will be conducted during the on-site periodic visits:

•

Adjustment of patient enrolment plan and de facto patient enrolment

•

Notification to sponsor in case of patient enrolment being lower than expected

•

Control of the CRF with [***] source data verification (SDV)

•

Control of patient informed consent with [***] SDV

•

Control of in-/exclusion criteria with [***] SDV

•

Comparison of source data and CRF entries

•

Control of drug accountability

•

Assurance of investigator’s file completeness

•

Administration, communication, query resolution

•

Report of periodic visit

•

Monitoring Report review and release

Close-out Visit

•

Review of the remaining data, solution of queries

•

Acquisition of signed CRF copies

•

Assurance of investigator’s file completeness

•

Retraction of the study medication

•

Filing/Storage of study relevant documents

•

Report of COV

•

Monitoring Report review and release

Site communication

CRAs serve as contact person between the study site and the CRO. Site communication including follow-up of queries is estimated to take [***] per month and site over a [***] months period.


STRICTLY CONFIDENTIAL		2012-07-31		Page 6 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

Safety Monitoring

The costs calculated are based on the assumption of [***] SAEs and [***] SUSAR during the treatment period of [***] months, beginning with the EC approval, and are subject to change in case of a different number of events to be documented or a different time schedule.

•

Set-up of safety monitoring

•

SAE Reporting

•

SUSAR Reporting

•

Preparation and Distribution of Annual Safety Report

•

Preparation and Distribution of Safety Section Final Report

Data Management

All data will be assessed by eCRF in a FDA 21 CFR part 11 compliant database (Clincase).

•

Development of database in Clincase incl. design of eCRF

•

Development of Validation Plan

•

Data validation check programming

•

Development of Data Management Plan

•

Development of Data Entry Guideline

•

Training eCRF

•

Data check/ Clarification/ Cleaning

•

Medical Review

•

Medical Coding (MedDRA) 5 terms (3 AEs, 2 conMeds) per patient

•

Preparation of Blind Review Meeting

•

Final Database Review

•

SAE Reconciliation

•

DB-lock

•

Database transfer activities

•

Preparation of necessary procedural documents (DM)

•

EDC Helpdesk

•

EDC User Account Management

•

External Data

•

Finalizing DM-specific TMF for Archiving

Statistics

•

Randomisation

•

Emergency envelopes

•

Administration of Emergency Envelopes

•

SAP

•

Creation of Analysis Datasets

•

Blind Review Meeting (incl. preparation)


STRICTLY CONFIDENTIAL		2012-07-31		Page 7 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

•

Programming tables and figures

•

Programming listings

•

Biometrical report

•

Review study report

Study Report

•

Writing and Revision of an Integrated Clinical Study Report (E3)

•

Revision of the Integrated Clinical Study Report (E3), 2 cycles

Study Management

The study will be performed in two countries (Germany and Spain).

The duration of the study is assumed to be approx. [***] weeks (s. 1. Conditions) with an intensive period of central study management (preparation, FPI - DBL) and a less intensive period during Set-up and DBL - Study Report. During that time in each country an experienced project manager and a project management assistant render the following services:

•

Finalisation of financial agreements with sites and CRAs

•

Project management and study coordination (including Maintenance of timelines)

•

Maintaining and closing central and country Master FilesfTMF

•

Administer and instruct on investigator Payment

•

Clinical team communication

•

Monthly status report for the Sponsor

•

Archiving

Study performance

For [***] evaluable patients (at [***] sites in 2 countries) [***] visits are planned for study duration of 28 weeks per patient and a recruitment period of [***] months.

The calculation comprises the following services:

•

Patients sourcing (advert etc.)

•

Patients travel expenses -[***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]

•

Fees for visit [***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 8 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

In addition to the Investigator fees for each site an overhead is estimated. Overhead will be approx. [***] to [***] in Germany for universities, [***] in Spain.

Extra fees for the assessment of photographies (at [***] selected sites) to document [***] patients at [***] visits are included in the proposal.

Central Lab Services:

The quote is based on the assumption of [***] samples from [***]-patients screened, [***] patients (average [***] patients) randomized and completed from [***] sites in Europe and is given per patient. Following services are included:

•

Laboratory testing:

•

[***]

•

[***]

•

[***]

•

[***]

•

[***]

•

[***]

•

[***]

•

[***]

•

Supplies (Visit specific kits including [***] for each site - each box includes [***] tests)

•

Storage (Sample management and storage inflammatory biomarkers: [***] occasion assumed; Average period of storage assumed 6 months; Samples to be shipped to Israel at the end of the study)

•

Study management

•

Inbound transportation (The inbound transportation is representative of individual patient visit shipments and reflects a “worst case scenario”. If a site collects samples from more than one subject on the same day these may be shipped together reducing costs)

•

Outbound transportation (The start and end dates are estimated on the basis of a [***] months study with one initial supply of materials and [***] resupply.)

•

Data Transfer; [***] Data Transfers are included

Furthermore a start-up fee is included in this cost estimate.


STRICTLY CONFIDENTIAL		2012-07-31		Page 9 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

Additional expenses

In addition to the offered services further additional expenses are expected. The estimation is based on preliminary information and may be adapted and charged on a time and material basis.

•

EDC-License (preliminary costs)

•

EDC System Configuration

•

EDC System Archiving

•

Randomisation via eCRF

•

Travel costs for CRAs (monitoring)

•

Approval of EC’s (GER, ES)

•

Approval CAs (GER, ES)

•

Approval of corresponding ECs (GER, ES)

•

Submission new investigator EC,CA,LA

•

Amendment

•

Licence fees GoToWebinar

•

Telephone charges Webinar

•

Translation costs (excl translation of synopsis and ICF into Spanish which is already covered under the preparation expenses)

•

Participation of safety monitor in meetings, audits (If necessary to be agreed with the Sponsor)

3. Calculation of Costs (in €) and Reimbursement

The prices below are to be understood as a price offer, based on the information summarized under paragraph 1. Condition

The compensation to be paid to SCIderm for the proper performance of the above-described services will be based on the actual activity performed on the project on the basis of the costs reported in the table below. Costs for all sen/ices are subject to change according to adjustments in study design or scope, especially like number of study centres and / or number of patients.

Medical monitoring activities as well as medication supply are not included in the proposal. These services will either be provided by Vascular Biogenics or an external supplier subcontracted from VBL

Additional services required by the sponsor which are not included in this proposal (e.g. MedDRA Coding of medical history/AEs, ATC-Coding of concomitant medication, audits and additional sites visits or project meetings, preparation and submission of amendments) will be charged on a time and material basis. The unit price is calculated in “Additional expenses”.


STRICTLY CONFIDENTIAL		2012-07-31		Page 10 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

This applies also to reimbursement of translation and language check of study documents (e.g. ICF, study outline) required in native language’s performed by a native speaker and fees for use questionnaires.

Postal, print, material, copy and courier charges as well as costs for conference calls will be charged on a monthly basis with [***] of Total I sum.

The costs for the additional expenses mentioned under ‘Additional expenses’ like approval of the study by the Ethics Committee as well as costs for the Notification of the BfArM and so forth will be passed through to Vascular Biogenics Ltd on a [***] basis. They are included in the cost estimate (Total II).

We hope to have made you an interesting proposal and look forward to a mutually satisfactory cooperation with Vascular Biogenics Ltd.

Kind regards

Dr. Ina Zschocke

Managing Director

SCIderm GmbH


STRICTLY CONFIDENTIAL		2012-07-31		Page 11 of 12

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


Cost estimate, 177-001, Vascular Biogenics Ltd

Appendix I


STRICTLY CONFIDENTIAL		2012-07-31		Page 12 of 12

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

Cost Estimate, 165-001, Vascular Biogenics Ltd

1. Study Preparation & submission to competent authorities (CA), Ethics committees (EC) and local authorities (LA)

Informed Consent, CRF, Investigator, Site File, Trial Master file, preparation of CTA, selection of the site documents, submission etc.

Clinical Development, medical and data management experts

[***]

Preparation

[***]

Submission

[***]

Webinar

Clinical project management expert

[***]

Study performance

Patient visits & expenses (per patient)

Clinical study experts

[***]

Patient sourcing (advert etc.)

Study team

[***]

Patients travel expenses – [***]

Study team

[***]

Monitoring

Study Monitoring

Study team, CRA

[***]

Safety Monitoring

Pharmacovigilance

[***]

Data Management

Data collection, entry & plausibility check

Data Management experts

[***]

Statistical Analyses

Statistical analysis & summary

Statistical expert

[***]

Study Report

Study documentation & final report

Medical and data management experts

[***]

Study management

Study coordination

Clinical project management expert

[***]

Additional Examinations

e.g. laboratory, medical devices

Medical experts

[***]

Additional expenses

on a time & material basis

on a time

[***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 1 of 6

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

Cost Estimate, 165-001, Vascular Biogenics Ltd

1. Study Preparation & submission to competent authorities (CA), Ethics committees (EC) and local authorities (LA)

Informed Consent, CRF, Investigator, Site File, Trial Master file, preparation of CTA, selection of the site documents, submission etc.

Clinical Development, medical and data management experts

[***]

Preparation

[***]

[***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 2 of 6

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

Cost Estimate, 165-001, Vascular Biogenics Ltd

[***]

Submissions

[***]

[***]

Clinical Project Manager

[***]

Clinical Research Assistant

[***]

Study Coordinator

[***]

Study Coordinator

[***]

Clinical Project Manager

[***]

Clinical Research Assistant

[***]

Clinical Research Assistant

[***]

Webinar

Clinical Project management expert

[***]

Preparation

[***]

Clinical Project Manager

[***]

Performance

[***]

Clinical Research Assistant

[***]

Clinical Research Assistant

[***]

Clinical Project Manager

[***]

Clinical Project Manager

[***]

Study team

[***]

Study team

[***]

Clinical Project Manager

[***]

Study performance

Patient visits & expenses (per patient)

Clinical study experts

[***]

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 3 of 6

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

Cost Estimate, 165-001, Vascular Biogenics Ltd

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Study team

[***]

Monitoring

Study Monitoring

Study team, CRA

[***]

Writing of Monitoring Manual incl. Revision

CRA

[***]

Training of the CRAs on Monitoring Manual Incl. QA

CRA

[***]

Site selection visits

CRA

[***]

Initiation visit

CRA

[***]

Periodic visit (5 each site) 50% SDV

CRA

[***]

Close-out visit

CRA

[***]

Site communication (study phase – DBL) 15 months, 6h per month

CRA

[***]

Site communication(start-up and enrollment)

CRA

[***]

Monitoring Report Review/Release

Senior CRA

[***]

Safety Monitoring

Pharmacovigilance

[***]

Set-up of safety monitoring

CRA

[***]

Monthly basic fee

CRA

[***]

SAE reporting

CRA

[***]

SUSAR reporting

CRA

[***]

Annual safety report

CRA

[***]

Safety section final report

CRA

[***]

Data Management

Data collection, entry & plausibility check

Data Management experts

[***]

Development of database in clincase

Data Manager

[***]

Development of Validation Plan

Data Manager

[***]

Data validation check programming

Data Manager

[***]

Development of Data Management Plan

Data Manager

[***]

Development of Data entry Guideline

Data Manager

[***]

Training eCRF

Data Manager

[***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 4 of 6

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

Cost Estimate, 165-001, Vascular Biogenics Ltd

Data check/ Clarification/ Cleaning (min per patient)

Data Manager

[***]

Medical Review

Data Manager

[***]

MedDRA coding, 5 terms per pat (3Aes, 2 conMeds)

[***]

Preparation of Blind Review Meeting

Data Manager

[***]

Final Database Review

Data Manager

[***]

DB-lock

Data Manager

[***]

Database transfer activities

Data Manager

[***]

Preparation of necessary procedural documents (DM)

Data Manager

[***]

EDC Helpdesk (0.5h/month/site)

Data Manager

[***]

EDC User Account Management

Data Manager

[***]

External data

Data Manager

[***]

Finalizing DM-specific TMF for Archiving

Data Manager

[***]

Statistical Analyses

Statistical analysis & summary

Statistical expert

[***]

Randomisation (stat)

Data Manager

[***]

Emergency envelopes

Data Manager

[***]

Administration of Emergency Envelopes

Data Manager

[***]

SAP

Data Manager

[***]

Creation of Analysis Datasets

Data Manager

[***]

Blind review Meeting (incl. preparation)

Data Manager

[***]

Programming tables and figures

Data Manager

[***]

Programming listings

Data Manager

[***]

Review study report (inhouse)

Data Manager

[***]

Biometrical report (extem)

Data Manager

[***]

Study Report

Study documentation & final report

Medical and data management experts

[***]

Preparation & writing

Medical writer

[***]

Preparation & writing

Project manager

[***]

Preparation & writing

Medical expert

[***]

Study management

Study coordination

Clinical project management expert

[***]

Set-up phase, DBL-Report – GER

Clinical Project Manager

[***]

Study Phase (preparation, FPI-DBL) – GER

Clinical Project Manager

[***]

Set-up phase, DBL-Report – Spain

Clinical Research Assistant

[***]

Study phase (preparation, FPI-DBL) – Spain

Clinical Project Manager

[***]

International project management – GER

Clinical Research Assistant

[***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 5 of 6

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

Cost Estimate, 165-001, Vascular Biogenics Ltd

TMF maintenance - GER

Clinical Research Assistant

[***]

Additional Examinations

e.g. laboratory, medical devices

Medical experts

[***]

Set-up fees

Central lab

[***]

Central lab analytics

Central lab

[***]

Administration of central lab

Project Manager Assistant

[***]

Administration of central lab

Project Manager

[***]

Additional expenses

On a time & material basis

[***]

EDC-License (preliminary costs) and hosting

[***]

EDC System Configuration

[***]

EDC System Archiving

Data Manager

[***]

Randomization via eCRF

[***]

Travel costs for CRAs (monitoring)

[***]

Approval of EC’s (GER, ES)

[***]

Approval Cas (GER, ES)

[***]

Approval of corresponding Ecs (Ger, ES)

[***]

License fees Webinar

[***]

Telephone charges Webinar

[***]

Participation of safety monitor in meetings, audits (if necessary to be agreed with the Sponsor)

CRA

[***]


STRICTLY CONFIDENTIAL		2012-07-31		Page 6 of 6

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

Exhibit 10.12

CONFIDENTIAL

SERVICE AGREEMENT

FOR A CLINICAL STUDY CONDUCT

concluded on 8 November 2012 (“Effective Date”) in Warsaw by and between:

KCR S.A. (Polish joint-stock company) with its registered office in Warsaw at 6 Postępu Str., 02-676 Warsaw, Poland, entered in the register of entrepreneurs kept by the District Court for the Capital City of Warsaw in Warsaw, 13th Commercial Division of the National Court Register, under number 0000289542, tax identification number NIP: 521-31-69-665, share capital (covered in total): PLN 700,000.00, hereinafter referred to as “ CRO ”, represented by Mr. Adam Kruszewski – President of the Management Board,

and

Vascular Biogenics Ltd., its principal place of business at 6 Jonathan Netanyahu Street, Or Yehuda, Israel 60376 hereinafter referred to as “ Sponsor ”, represented by Prof. Dror Harats - Chief Executive Officer,

hereinafter jointly referred to as “the Parties” and individually as a “Party”.

Whereas:

Sponsor intends to conduct a clinical study of the investigational medicinal product VB-201 [“Investigational Medicinal Product”] entitled “A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis” [“Study”] according to the protocol number VB-201-064 [“Protocol”] on the territory of Poland, Bulgaria and Hungary,

b)	Legal Representative of the Sponsor is Gregory Fryer Associates Ltd with its seat at 30 St Thomas Place, Cambridgeshire Business Park, Ely, Cambs, CB7 4EX, United Kingdom,

c)	Sponsor wishes to engage CRO to provide services connected with the conduct of the Study as defined herein,

d)	fulfillment of CRO’s obligations resulting from this agreement is included in the scope of CRO’s business activity and CRO has an experience in providing services of similar nature as described herein, including the fact that CRO employs qualified employees in order to perform such obligations.

Service Agreement

for a Clinical Study Conduct

1/37

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

CONFIDENTIAL

Now then , the Parties agree to conclude the agreement as follows [“Agreement”]:

§ 1. Subject of the Agreement

1.	Sponsor hereby entrusts CRO with performance of activities connected with the conduct of the Study as defined in Attachment No. 1 hereto (Scope of Services), hereinafter referred to as “Services”, and CRO hereby accepts such entrusted responsibilities.

Services shall be performed within the timelines indicated in Attachment No. 2. Parties declare that these timelines shall be deemed as a forecast only and may be changed due to reasons which are not attributable to the CRO. In case of necessity to provide Services within different timelines than those anticipated in Attachment No. 2 for reasons not attributable to CRO, Sponsor waives its right to bring any claims against CRO for an untimely provision of Services.

§ 2. Manner of Providing Services

CRO shall perform its responsibilities, in the scope indicated in the Agreement, with due diligence and in compliance with laws and regulations in force applicable in the countries where the Services will be performed, guidelines of Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, ICH GCP in a version applicable during the term of the Study conduct, in compliance with the Agreement and a valid version of the Protocol, constituting Attachment No. 3 to the Agreement, CRO’s SOPs listed in Attachment No. 4 and any written instructions of the Sponsor.

The CRO represents and warrants that it has obtained, and will maintain throughout the term of this Agreement, all governmental or regulatory approvals, licenses, registrations and insurances that may be required to complete the Study, and that it has full right, power and authority to perform its obligations hereunder and to grant the rights set forth herein. During the term of this Agreement the CRO shall not conduct any other trial which, at the CRO’s discretion, would adversely affect the ability of the CRO to perform their obligations under this Agreement.

3.	In order to perform Services, CRO undertakes an obligation to appoint from among its employees only persons with appropriate knowledge, experience and qualifications necessary to perform Services, and who have bound by confidentiality undertakings according to this Agreement.

Service Agreement

for a Clinical Study Conduct

2/37

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

CONFIDENTIAL

The CRO certifies that it has not and will not use in any capacity in connection with this Agreement the services of any individual, corporation, partnership, or association which has been debarred, excluded, or disqualified from participation in clinical investigations under any applicable laws, regulations, or guidance. In the event that the CRO receives notice of the debarment or threatened debarment, exclusion or disqualification or threatened disqualification, of any individual, corporation, partnership or association providing services to the CRO, which relate to its activities under this Agreement, the CRO shall notify the Sponsor immediately.

If the Sponsor raises any objections regarding provision of Services by a particular CRO employee, the Sponsor shall notify CRO of that fact in writing and may request replacement of such employee solely due to material and reasonable objections against his/her work or behavior. CRO shall appoint a new employee with appropriate qualifications and experience in the shortest possible time.

Sponsor shall have the right to reject any Services that it deems in nonconformance with the Protocol or the Agreement. Sponsor shall provide CRO with written notification of the deficiency or non-conformance and, within thirty (30) days of receipt of such written notification, CRO shall correct the deficiency or non-conformance at CRO’s expense.

7.	CRO has commenced providing the Services on the basis of Letter of Intent dated 1 ^st August 2012.

During the term of the Agreement and subject to the prior approval of the Sponsor (e-mail form is acceptable), CRO may entrust a third party, such as sites, investigators, and other relevant sub-contractors (“Sub-contractors”) with performance of all or some of the Services while observing due diligence in this choice, provided that such Sub-contractors are made aware of and acknowledge the obligations applicable to such Sub-contractors according to this Agreement including without limitation confidentiality, Intellectual property rights and publications. The CRO shall ensure, and shall at all times remain jointly and severally responsible and liable, for the compliance of such Sub-contractors with the terms of this Agreement. For the avoidance of doubt, the Parties agree that this section shall not release the Sponsor or the investigators from liability for the Study conduct according to provisions of law in force.

CRO acknowledge that the Sponsor may entrust third parties with performance of services, which are related to the Study but are not included in the Services, which shall be provided by the CRO. A list of such third parties attached hereto as Attachment 5 or as shall be amended by the Sponsor from time to time. CRO warrants that (i) it will fully cooperate with such third parties according to the Sponsor’s written instructions as necessary to the conduct

Service Agreement

for a Clinical Study Conduct

3/37

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

CONFIDENTIAL

of the Study and (ii) it will be obligated by the relevant written instructions imposed by such third parties as shall be presented to the CRO by such third party or the Sponsor.

10.

CRO warrants that the assumptions underlying each Attachment and/or timeline have been arrived at in good faith by CRO, based upon its experience and professional judgment. In the event the CRO or Sponsor requests to amend the Services, timelines or budget for a Study, the Parties agree to negotiate in good faith a written change order signed by the duly authorized representatives of the Parties.

11.	Both Sponsor and CRO shall carry, at its sole expense, with financially sound and reputable insurers, an insurance coverage with respect to the conduct of its business.

§ 3. Sponsor’s responsibilities

Sponsor undertakes an obligation in particular to:

a)	provide CRO with all information in its possession about the Investigational Medicinal Product necessary for the conduct of the Study,

b)	keep CRO informed on an ongoing basis about any new findings concerning safety of the Investigational Medicinal Product,

c)	supply CRO with the Investigational Medicinal Product manufactured in compliance with Good Manufacturing Practice, adequately packed and labeled,

d)	supply CRO with documentation necessary for conduct of the Study, including the valid version of the Protocol, Investigator’s Brochure and the Case Report Forms (CRF),

e)	conclude insurance agreement on third party liability of the Sponsor and investigators for damages related to the conduct of the Study, in compliance with laws in force and provide CRO with a valid copy of the insurance policy confirming conclusion of such agreement,

f)	notify CRO immediately of any suspension of the Study or withdrawal of the approval for the conduct of the Study ,

g)	perform other responsibilities not assigned to the CRO and necessary for the conduct of the Study.

§ 4. Audits and inspections

1.	On Sponsor’s reasonable request, CRO shall, at any time, provide the Sponsor with information on the status of the Services performed. In particular, the Sponsor may request CRO to prepare an activity report on the Services performed by CRO.

Service Agreement

for a Clinical Study Conduct

4/37

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

CONFIDENTIAL

During the term of the Agreement, CRO undertakes an obligation to allow the Sponsor and any competent authorities and national, foreign and international bodies or organizations responsible for registration of medicinal products and supervision, audit or inspection of clinical studies to conduct an audit, control or inspection of the Study as well as to access the records related to the Study conduct, and to monitor and audit the activities of the investigators and members of the study teams during the Study (including inspection and audit of the facilities and procedures used in the Study by the investigators and the study teams, as well as the equipment, data registration method and storing the records), and to enable both Sponsor and any national, foreign and international bodies or organizations responsible for registration of medicinal products and supervision or inspection of clinical studies to obtain any and all information on the conduct of the Study.

CRO shall notify Sponsor if any competent authorities and national, foreign and international bodies or organizations responsible for registration of medicinal products and supervision, audit or inspection of clinical studies inform CRO about any scheduled, or begin an unscheduled inspection of any study site, CRO or bioethics committee. CRO shall immediately provide the Sponsor with any correspondence and/or communication related to a notification, conduct and results of an audit or inspection and shall inform the Sponsor of the measures to be taken following finding and recommendations of such inspection and audits and their results.

4.	Sponsor agrees to cover the costs of CRO’s employees involvement in an audit, control or inspection based on real time spent on such activities according to the rates described in Attachment No. 6.

§ 5. Remuneration

1.	For execution of all obligations resulting from the Agreement by CRO, Sponsor undertakes an obligation to pay remuneration as well as reimburse costs and expenses as defined in net amounts in Attachment No. 6. Due VAT shall be added to the above fee.

The Sponsor is obliged to make payments within 30 days from the receipt of a VAT invoice from CRO and provided that the CRO has provided upon the execution of this Agreement a Certificate of Residency from its Tax Authorities. If it is necessary to convert one currency into another, it shall be calculated by CRO on the basis of a current foreign exchange selling rate of the Polish National Bank announced on the date of the VAT invoice issuance.

3.	The remuneration shall be calculated and paid on a monthly basis for the time committed to or a type of Services provided in a given month within 30 days from the delivery of the invoice issued by CRO to the Sponsor. CRO shall be entitled to issue and deliver a VAT invoice

Service Agreement

for a Clinical Study Conduct

5/37

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

CONFIDENTIAL

beginning with the last day of a given month for the amount covering time or type of Services performed in such month.

4.	On Sponsor’s request, CRO shall submit a list of Services performed in a given month, including a timesheet of persons providing Services with a detailed description of activities performed.

5.	The Sponsor shall reimburse CRO:

for any costs incurred by CRO in connection with conclusion of the Agreement and providing the Services hereunder - so called “pass through costs”, including in particular costs of telephone connections, faxes, internet, courier and mail services, accommodation and travel expenses of persons appointed to perform Services, which will be incurred in connection with the execution of the Agreement. These expenses will be invoiced on a monthly basis and presented to the Sponsor with a detailed list.

for any costs related to use of CRO company cars for business travels to and from study sites indicated by the Sponsor,

for any other costs necessary for the proper conduct of the Study provided that such expenses have been pre-approved by the Sponsor.

Specification of expected costs and expenses (so called “pass through costs”) is included in Attachment No. 6 hereto. In case if costs, expenses or a scope of Services connected with the conduct of the Study appear to be higher than those anticipated on the Agreement date, the Sponsor undertakes an obligation to cover these costs and reimburse CRO for expenses incurred in relation to the execution of the Agreement provided that such expenses have been pre-approved by the Sponsor.

When CRO is in charge of investigators, sites, Study subject or IRB/EC fees or expenses payment or reimbursement, estimated or known amounts for such payments/reimbursements will be invoiced to the Sponsor, before paying such fees or expenses. The CRO has no obligation to advance funds and make these payments unless and until the funds are received from the Sponsor. If Sponsor does not provide funds in time to enable CRO to make timely payments, Sponsor agrees to be liable for and to reimburse CRO for any interest and other charges, costs, fees and expenses incurred by CRO because of such late payment. Any excess funds paid to CRO for such fees and expenses shall be refunded to Sponsor at the end of the Study or sooner, upon Sponsor’s request.

8.	Sponsor is obliged to reimburse CRO for the costs and expenses incurred by CRO in relation to the execution of the Agreement within 30 days from the receipt of relevant documentary evidence supporting such costs and expenses from CRO.

Service Agreement

for a Clinical Study Conduct

6/37

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

CONFIDENTIAL

9.	Payment of the remuneration and reimbursement of costs incurred by CRO shall be made by a transfer to CRO bank account indicated on the invoice.

10.

CRO rates included in the budget in Attachment 6 shall automatically increase each calendar year beginning from January 1, 2014 for the next 12 month period, according to year inflation rate published by Eurostat, the Statistical Office of the European Communities. The Parties agree that increase of rates shall be effective from the beginning of calendar year regardless of the date of publishing year inflation rate by Eurostat.

§ 6. Confidentiality

The CRO shall keep confidential any and all information and data concerning Sponsor`s business or its activities (including reports and information as well as all clinical data about the Study or its progress produced by the CRO or the sites within the framework of this Agreement), or information obtained that may come to the knowledge of the CRO, its personnel or appointed representatives during or in connection with the execution of this Agreement including without limitation third party confidential information received by the Sponsor (“Sponsor’s Confidential Information”). For the avoidance of any doubt, the Protocol, the Investigational Medicinal Product, the Study results, and the Inventions (as defined below) and Patient Questionnaire IBDQ shall be considered the Sponsor’s Confidential Information.

Sponsor shall keep confidential any and all information and data concerning the CRO`s business or its activities (including information produced by Sponsor within the framework of this Agreement) or information obtained that may come to the knowledge of Sponsor, its personnel or appointed representatives during or in connection with the execution of this Agreement, and is not considered Sponsor’s Confidential Information.

Parties undertake an obligation to keep strictly confidential any confidential information or data which came into possession of the other Party in any manner, were delivered or otherwise disclosed to the other Party in connection with the Agreement. Parties may use and make the above mentioned information available solely for the purpose of the execution of the Agreement.

4.	The above provision does not apply to information which the receiving Party can demonstrate that:

is known to the receiving Party at the moment of its disclosure,

is publicly accessible at the time of its disclosure to the receiving Party or it becomes later publicly accessible without the Party’s fault,

may be disclosed upon the other Party’s consent expressed in writing otherwise being void,

Service Agreement

for a Clinical Study Conduct

7/37

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

CONFIDENTIAL

was disclosed to the receiving Party by a third party that was not obliged to keep it confidential or

is disclosed by virtue of laws in force.

If confidential information needs to be disclosed to a third party for the purpose of performance hereof, the Sponsor or CRO, prior to making any such disclosure, will cause such third party to undertake the confidentiality and non-use obligations in writing at least to the extent applicable to themselves under the Agreement. Any publication of data from the Study or oral presentations on an individual basis with respect to the Study data shall be subject to the Sponsor’s prior review and approval. The Sponsor is entitled at its sole discretion to delay or reject of such publication due to Sponsor’s business or operational reasons.

§ 7. Personal data processing

Sponsor undertakes to observe the provisions of Personal Data Protection Act of 29th of August 1997 (uniform text: Journal of Laws from 2002, No. 101, position 926 with later changes) as well as secondary regulations, regarding personal data of CRO’s employees, contractors and other individuals ( such as employees of CRO’s contractors), provided by CRO to Sponsor, in the scope of performance the obligations under the Agreement. The personal data of the CRO’s employees, contractors and other individuals will be processed by Sponsor on grounds of their consent or justified purposes of a data controller. However, for the purposes of processing by Sponsor of the personal data of the CRO’s employees or contractors in relation to the execution of obligations of CRO as an employer, CRO entrusts Sponsor with the processing of such personal data in accordance with the Agreement.

2.	Sponsor appoints CRO as its representative within the meaning of article 31a of the Personal Data Protection Act.

The scope of the entrusted personal data includes the following categories: names, surnames, addresses, contact details, professional experience, current and past position, education, skills. Sponsor undertakes to process the personal data by collecting, recording, storing, deleting compiling, amending, transferring in paper form and by electronic means.

4.	Sponsor cannot use entrusted personal data for any other purpose or in any other manner than necessary to execute the Agreement. Sponsor is also obliged neither to disclose nor to pass on the personal data to any entity without prior written CRO’s consent.

5.	Sponsor is liable for the damages caused to CRO or any third party in the result of personal data processing against the Agreement by Sponsor or under its responsibility.

Service Agreement

for a Clinical Study Conduct

8/37

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

CONFIDENTIAL

6.	When the Agreement is finished/terminated/expired, Sponsor is obliged to finish personal data processing, return or destroy all received documents and their copies, and return all received electronic data mediums to CRO.

Sponsor entrusts CRO with the processing of personal data of the investigators and the members of study teams for the purposes of the performance of activities connected with the conduct of the Study. The scope of the entrusted personal data includes the following categories: names, surnames, addresses, place of work, telephone numbers, e-mail addresses, bank account numbers, PESEL numbers, tax identification numbers, professional experience, current and past position, education. CRO undertakes to process the personal data by collecting, recording, storing, deleting, compiling, amending, transferring in paper form and by electronic means. Sponsor hereby authorizes CRO to subcontract the processing of the personal data to a further data processor as shall be agreed in advance by the Sponsor.

8.	CRO undertakes to observe the provisions of the Personal Data Protection Act and the secondary regulations. CRO cannot use the entrusted personal data for any other purpose or in any other manner than necessary to execute the Agreement.

9.	In relations between CRO and Sponsor acting as data controllers / data processors towards each other, the following rules shall apply accordingly:

the data processor is hereby obliged, prior to commencing the processing of the personal data and afterwards, during the term of this Agreement, to apply any technical and organizational measures that will ensure the security of the personal data being processed, as set forth in the Personal Data Protection Act and the secondary regulations, and any legislation that will supplement and/or replace them in the future; in particular, it should secure the personal data against access by unauthorized persons, its removal by unauthorized persons, and against it being damaged or destroyed;

the data processor shall be obliged to ensure supervision of the following: when and by whom the personal data has been entered into the data filing system and to whom the data has been transferred;

the data processor undertakes to preserve the confidentiality of the personal data entrusted to it under this Agreement;

only persons who were authorized by the data processor shall be allowed to carry out the processing of personal data;

the data processor shall be obliged to take all necessary steps to ensure that the persons referred to in point (d) of this clause keep the personal data and the methods of their protection confidential;

Service Agreement

for a Clinical Study Conduct

9/37

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

CONFIDENTIAL

the data processor shall immediately inform the data controller of any instance of any breach, whatsoever, of the security of the personal data entrusted to the data processor and processed under this Agreement;

the data processor shall grant the data controller, at its request, any necessary information concerning all personal data processed by the data processor;

the data controller shall have the right to conduct inspections as to whether the data processor is observing the principles of processing the personal data specified in the Personal Data Protection Act, the secondary regulations and this Agreement, by accessing and inspecting any premises where the personal data is processed, as well as the documents, equipment and IT systems relating to the personal data processing;

the data controller shall be entitled to review whether the above principles of the processing of the personal data are being observed and as such the data controller’s representatives will be entitled to demand that the data processor’s representatives provide to the data controller the necessary information concerning the way in which the data processor processes the personal data contained in the data filing system;

any inspection of whether the above principles of the personal data processing are being observed may only take place after the data controller has notified the data processor of the intention of carrying out such an inspection at least two days in advance of the date of the commencement of the inspection, and has indicated in writing the persons designated to carry out the inspection; an inspection may be exercised by the data controller at the location where the personal data are being processed – between the hours of 9 a.m. and 4 p.m. on any business day;

following the inspection, the data controller may draw up recommendations concerning the improvement of the quality of the safeguarding of the personal data, as well as the means of its processing by the data processor and the means of remedying any identified irregularities, which the data processor is obliged to immediately remedy not later than 30 days after the data controller’s notification of its observations;

upon the expiry or termination of this Agreement the data processor shall be obliged to transfer the personal data to the data controller or delete all the personal data, within seven days of receiving the data controller’s instruction; the deletion of the personal data shall be understood as the erasing of the personal data, or their modification in such a way that the identity of the persons to whom the data refers cannot be established.

Service Agreement

for a Clinical Study Conduct

10/37

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

CONFIDENTIAL

§ 8. Intellectual property

The Parties acknowledge that all rights to materials, Investigational Medicinal Product, data bases, notes, analyses, lists, studies or any other documents, as well as names and graphic signs made available to CRO by the Sponsor in any manner whatsoever, shall remain the property of the Sponsor and CRO shall not acquire any rights thereto, except for the right of use thereof during execution of the Agreement for the purpose of conducting the Study in the manner permitted by the Sponsor.

Inventions or discoveries whether or not patentable, processes, trade secrets, data, improvements, and/or patents relating to the Investigational Medicinal Product or otherwise arising from the Study, conceived, generated, developed or first reduced to practice, as the case may be, during the term of this Agreement (hereinafter called “Inventions”), either by the CRO, its employees, sites, investigator or any other Sub-contractors related to this Agreement shall be the property of the Sponsor.

The CRO its employees, sites, investigator or any other Sub-contractors will promptly inform Sponsor of any Invention or discovery arising from the Study, and assign its rights in relation to all intellectual property rights and know how, and provide reasonable assistance to the Sponsor in filing or prosecuting intellectual property rights, at the expense of the Sponsor.

§ 9. Duration of the Agreement and its termination

1.	The Agreement is concluded for a specified period of time and shall be valid from the Effective Date until the termination of the Study unless any circumstances indicated below should occur.

Each Party has a right to terminate the Agreement with immediate effect in case of a material breach by the other Party of the obligations resulting from the Agreement if a default is not cured within 30 (thirty) days from the date of delivery of a written notice on the discovered breach to the other Party.

3.	The Sponsor has a right to terminate the Agreement upon 90 days’ written notice without giving cause and CRO has a right to terminate the Agreement upon 120 days’ written notice without giving cause.

4.	Upon receipt of the notice of termination of the Agreement from the Sponsor by CRO or dispatch of the same to the Sponsor by CRO, CRO shall make all possible efforts to terminate or transfer further conduct of any unfinished Services as soon as possible, according to the

Service Agreement

for a Clinical Study Conduct

11/37

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

CONFIDENTIAL

Sponsor’s instructions. In such a case, CRO shall cease to provide Services or undertake further obligations in connection with the Services unless Parties agreed otherwise in writing.

The Sponsor undertakes an obligation to reimburse CRO for all necessary and actual costs connected with the termination or expiration of the Agreement as well as to pay CRO due remuneration, in particular to reimburse CRO for any expenses incurred (so called “pass through costs”) or to be incurred in relation to provision of the Services from which CRO cannot withdraw. Promptly after the date of the Agreement termination or expiration, CRO shall issue an invoice for the above costs and expenses to the Sponsor.

§ 10. Non-Solicitation Clause

1.	The Sponsor undertakes an obligation that it shall not employ any employee of the CRO , in its own enterprise or in any company under its control, during the term of the Agreement and for the period of 2 years from the date of termination or expiry hereof.

In the event of employing the above mentioned persons, the Sponsor shall be obliged to pay a contractual fine in the amount of Euro 50 000 (say: fifty thousands) per each person employed within 7 days from the receipt of the call for payment. Payment of contractual fine shall not deprive CRO of its right to claim damages exceeding the amount of the contractual fine reserved.

§ 11. Final provisions

1.	Neither Party shall be liable to the other Party in connection with this Agreement for any indirect, consequential (including without limitation lost profits), incidental, special or punitive damages.

CRO shall not bear any liability connected with the Investigational Medicinal Product, including liability for administering the Investigational Medicinal Product. CRO’s liability due to negligence, non-adherence to professional standards or breach of the Agreement shall be limited to the double amount of the remuneration (CRO fee) received.

Service Agreement

for a Clinical Study Conduct

12/37

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

CONFIDENTIAL

compound, device, placebo or Investigational Medicinal Product, potential product or procedure performed or administered as a result of the Protocol and this Agreement or any litigation, investigation or other proceeding relating to any of the foregoing, unless as a result of CRO’s its affiliates and their respective directors, officers, employees, consultants, sub-contractors, independent contractors, and agents negligence, non-adherence to professional standards or breach of the Agreement.

CRO shall defend, indemnify, and hold harmless Sponsor, its affiliates and its and their respective directors, officers, employees, and agents from and against any and all losses, claims (including third party claims), actions, damages, liabilities, costs and expenses (including reasonable legal counsel fees and expenses) (“Sponsor Losses”) but only to the extent such Sponsor Losses are related to or arise from or in connection with CRO’s negligence, non-adherence to professional standards or breach of this Agreement, except to the extent that such Sponsor Losses arise from (i) the negligence or reckless or willful act or omission of Sponsor, its affiliates or its and their respective directors, officers, employees, contractors or agents; or (ii) any breach of this Agreement by Sponsor, its affiliates, or its and their respective directors, officers, employees, contractors or agents.

The Party seeking indemnity will give the indemnifying party prompt written notice (within 15 days knowledge) of any matter upon which such indemnified party intends to base a claim for indemnification (an “Indemnity Claim”). The indemnified party shall have the right to participate jointly with the indemnifying party, at its own expense, in the defense, settlement or other disposition of any Indemnity Claim.

In no event shall either Party be liable to the other in case of not being able to perform its obligations hereunder due to a natural disaster, general strike, war, riots, fire, order of the authorities or any other unforeseeable and unpreventable circumstances, provided that such Party unable to perform its obligation will do its best effort to fulfill its obligations. The Party affected by such circumstances shall immediately notify the other Party of this fact in writing, providing any relevant information regarding the matter.

7.	No Party may assign any rights or obligations resulting from the Agreement to any third party without prior written consent of the other Party.

8.	Any representations of the Parties as specified herein shall be made in writing, otherwise null and void.

Service Agreement

for a Clinical Study Conduct

13/37

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

CONFIDENTIAL

served by the Party after its receipt by the addressee. All and any notices and statements sent thus far in connection with this Agreement to the addresses given above shall be deemed as served effectively.

10.	Provisions of § 4, § 6, § 8 and § 10 of the Agreement shall remain in force despite its expiry or termination for any reason.

11.	For the avoidance of doubt, this Agreement and the Protocol may only be amended by the agreement in writing of duly authorized signatories of Sponsor and CRO, otherwise being null and void. Changes in the Protocol may imply changes in the total course of the Study (costs, time-lines etc.).

12.	If any one or more provisions of this Agreement shall be found to be illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

13.

The Agreement and any matters connected herewith shall be governed by the laws of England, excluding its rules for choice of law. Any dispute relating to or arising in connection with this Agreement, which is not settled within a reasonable time, shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (“ICC”) by one arbitrator appointed in accordance with the said rules. The award shall be final and binding and enforceable in any court of competent jurisdiction. The arbitration shall be held in London, United Kingdom, in English language.

14.	The Agreement has been drawn up in two identical counterparts, one counterpart for each of the Parties.


CRO: /s/ Anna Baran		Sponsor: /s/ Amos Ron
/s/ Mike Jagielski		Vascular Biogenics Ltd.
		Amos Ron, CFO
		January 1, 2014

Service Agreement

for a Clinical Study Conduct

14/37

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

CONFIDENTIAL

Attachment No. 1

Scope of Services:

Study Assumptions

Division of Responsibilities CRO - Sponsor


STUDY ASSUMPTIONS
Number of countries involved	3
COUNTRIES INVOLVED	[]*	[]*	[]*	[]*
CRA staff involved	4	2	1	1
STUDY SITES	12	6	4	2
PATIENTS ENROLLED (# of expected)	110	45	27	38
NUMBER OF PATIENT’s VISITs IN SITE DURING THE STUDY	11
PLANNED NUMBER OF PAYMENTS FOR PI AND SITES DURING THE STUDY	4

Service Agreement

for a Clinical Study Conduct

15/37

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

CONFIDENTIAL

Division of Responsibilities CRO - Sponsor


	KCR	VBL Ltd.	Comments
STUDY INIATIATION

Protocol development		X

Protocol review	X	X	KCR Medical Director to review the draft of study protocol and provide VBL with comments.

Protocol approval		X

Protocol printing	X

Protocol distribution to sites	X

Preparation of amendments		X

CRF design and development (e CRF)		X

CRF review & approval		X

Preparation of master Informed Consent (IC) and Patient Information Sheet (PIS)		X

Revision and translation of Informed Consent and Patient Information Sheet according to local Ethical Committee requirements	X

Final approval of country specific IC and PIS		X	Based on back translation of local of Informed Consent and Patient Information Sheet. Approval process according to KCR SOP.

Monitoring Plan development	X		Draft of Monitoring Plan to be provided to VBL by 5 ^th November 2012.

Monitoring Plan approval		X	Final version of Monitoring Plan to be approved by VBL by 15 ^th November 2012

Recruitment Plan development	X		Recruitment Plan to be provided to VBL by 5 ^th November 2012.

Trial Master File Set-up	X

Distribution of Site Documents	X

Randomization schedule preparation	X		Task will be subcontracted to ALMAC.

Service Agreement

for a Clinical Study Conduct

16/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments
REGULATORY / ETHICS COMMITTEE SUBMISSIONS
Preparation of the documentation for Ethics Committees	X	X	VBL to provide : • Investigator’s Brochure • IMPD • CRF • Insurance certificate • Patient rated scales/diaries • Certificate of analysis • Drug label • Manufacturing authorisation • GMP certificate KCR to provide VBL with country specific requirements regarding submission and to prepare submission package.

Submission of the documentation for Ethics Committees and follow up until authorisation	X

Preparation of the documentation for Regulatory Authorities	X	X	VBL to provide : • Investigator’s Brochure • IMPD • CRF • Insurance certificate • Patient rated scales/diaries - Certificate of analysis

	X	X	• Drug label • Manufacturing authorisation • GMP certificate KCR to provide VBL with country specific requirements regarding submission and to prepare submission package.

Submission of the documentation for Regulatory Authorities and follow up until authorisation	X

TRANSLATIONS

Translations	X		Relevant for patient-related documents, labels, Power of Attorney
SITE RECRUITMENT AND INITIATION

Investigator Pre-Qualification	X

Investigator’s Site Selection	X

Final Site Selection	X	X	KCR to provide VBL with

Service Agreement

for a Clinical Study Conduct

17/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments
			pre-study visit reports and lists of recommended sites in all selected countries. VBL to approve selected sites.

Conduct Site Selection Visits	X

Negotiate Investigators/Sites Contracts	X

Final Approval for Investigators/Sites Contracts		X

Signature on Investigators/Sites Contracts	X

Regulatory Documents collection & review	X

Conduct Site Initiation Visits	X

INVESTIGATOR MEETING

Investigator’s Meeting Planning	X

Investigator ‘s Meeting Preparation	X	X	VBL to present: • VB-201: Scientific Background • Phase I/II Experience & Development Plan • Study Design & Objectives • Protocol Overview • Eligibility Criteria • Study Specific Procedures • Study Assessment Scales • Sigmoidoscopy/ colonoscopy KCR to present: • Timelines & Recruitment Strategies • ICH GCP Refreshment

Investigator’s Meeting Attendance	X	X

CENTRAL LABORATORY MANAGEMENT

Central Laboratory Supplies and Logistic Set-up/Courier Management	X	X	Task to be subcontracted to SYNEVO managed by KCR. VBL to subcontract the laboratory in charge of biomarkers and trough levels assessment.

Central Laboratory Management	X

STUDY DRUG MANAGEMENT			Labeling, Packaging, Distribution and Data Services (including IXRS) tasks to be subcontracted to Almac managed by KCR.

Provide materials of sufficient quality for use in Almac’s processing facility (eg. dusty tablets are unacceptable)		X

Ensure materials provided are suitable for use in GMP facilities/operations and of sufficient quality for human clinical trials		X

Service Agreement

for a Clinical Study Conduct

18/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments

Notification to KCR and Almac, prior to receipt of the material and present on the delivery documentation regarding materials requiring any special handling requirements such as, Genetically Modified Organism (GMO), cytotoxic, antibiotics		X

Provide specific testing specifications prior to arrival at ALMAC		X

Provide source documentation (eg Certificates of Analysis) confirming the expiry date for each input material supplied		X

Provide Transmissible Spongiform Encephalopathy (TSE) certification for manufacturing and primary packaging components prior to use		X

Provide Material Safety Data Sheet(s) (MSDS) sufficiently describing potency, solubility, potential hazards and transportation information prior to arrival of material at Almac		X

Arrangement of any relevant importation procedures		X

Ensure materials are stored and shipped under appropriate conditions with temperature monitors (where applicable).		X

Provide information on the cumulative time the product (refrigerated or frozen) can be out of its specified conditions for processing		X

Tablets, shells, capsules and/or powdered substances will be provided in sealed, tamper evident drums		X

Notification to Almac if the last day of the month is not the appropriate expiry date where format of month/year is used		X

Each container of materials delivered to Almac will be labeled with the following information (at a minimum): Description (in English), including Strength Batch/Lot Number KCR name and address Shipped from name and address Expiry/Retest/Valid until Date Quantity/Weight Unit Weight Container Number Storage Conditions, e.g. 2 to 8°C Applicable protocol (if possible) Special Handling Conditions, e.g. cytotoxic If the information above cannot be included on the labels, it will be included with the shipping documents		X

Service Agreement

for a Clinical Study Conduct

19/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments
Shipments to Almac must include a delivery note or packing list which clearly state the contents and the storage conditions		X

Deliveries of materials which require special handling per 1.3 must be clearly marked on documents and the container		X

All materials classified as dangerous goods must be delivered per International Air Transport Association (IATA) regulations		X

Monitoring of recalls and notification to Almac within one working day should a recall occur (including comparator)		X

Where the Sponsor is responsible for the supply of a Non-Investigational Medicinal Product which is manufactured outside the EU and will be handled by Almac Craigavon, the sponsor is responsible for ensuring that the product is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice (GMP) and is of appropriate quality for the purposes of the trial		X

Determination of the acceptability of drug products or clinical kits after a temperature excursion during transit or storage based on data provided		X

Determination of appropriate kit design based on the clinical protocol		X

Determination of expiry date associated with packaged materials (on label if applicable)		X

Determination of quantity of clinical kits to manufacture within each operation, depending on drug product information (eg expiry date) and protocol information		X

Review and/or approval of Interactive Response Technology (IRT) specifications		X

Participation in IRT User Acceptance Testing (UAT)		X

ALMAC SUPPLIED MATERIALS

Review and Approval of specifications	X

MEDICATION NUMBER (MED) LISTS

Approval of the random schemes and Med Lists based on the clinical protocol requirements		X

Provide Med Lists in an appropriate electronic format (per Attachment 2) at least three weeks prior to operations or prior to the first shipment if distribution only		X

For multiple Med Lists supplied for a single project, provide Med Lists such that sequence numbers are not duplicated across lists		X

Service Agreement

for a Clinical Study Conduct

20/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments
LABELS

Ensure all electronic files provided use Arial Unicode as the default font		X

Provide label text for each component and label type in electronic form AND as a fixed text (i.e. uneditable PDF). Name and version number should be included on all documents for ease of identification		X

Provide sample labels in advance to assess compatibility with Almac equipment and materials (if applicable)		X

Labels provided to Almac by the KCR for overstrike/overprinting or labeling operations will be considered approved (Quality and Regulatory) by KCR		X

Provide label translations including a back translation of the label text to English.	X

Provide country specific regulatory requirements, pertinent to labels, for each country within the protocol	X

Approval of label proofs for each component and country within the protocol and verify acceptability of translations (where applicable)		X

SAMPLES – GENERAL

Generation of documentation which defines the standard retain and reserve samples to be obtained by Almac		X

Determination of destruction or return of samples 10 years or older		X

SAMPLES - ANNEX 13 SAMPLES FOR EU

Provide Almac with information regarding the product origin and supply chain to enable Almac to determine sampling requirements on a study by study basis		X

Perform sampling of reference and retention samples of Investigational Medicinal Product (IMP) and modified/repackaged Comparators in Europe in accordance with Annex 13		X

Provide details of the site in Europe (if not Almac), responsible for the storage of such samples, if the Almac QP is responsible for Final Release		X

PRODUCTION

Pre-approval of primary and secondary master batch documents (methods). Ensure batch documentation adequately describes a process to support the protocol. e.g. blindness and kit design		X

Pre-approval of batch-specific documents prior to any labeling or production operations (Packaging Specifications)		X

Service Agreement

for a Clinical Study Conduct

21/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments
Pre-approval of any rework or reprocessing of finished materials prior to commencement		X

For products packaged in the antibiotic facility (Craigavon only), VBL will confirm the appropriate environmental conditions and ensure this information is detailed in the batch document		X

DISTRIBUTION AND DEPOT SERVICES

Confirm regulatory and ethics approvals are in place prior to requesting supplies be dispatched	X

Identify “do not ship after” date and ensure orders are not generated after such date		X

Review and approve Distribution Instructions (Almac generated) prior to the receipt of the first shipment order		X

Management of approval for each country or site (Regulatory Release)	X

Responsible for the management of the in-country distribution depots	X

RETURNS

Confirmation in writing that finished product returned from clinical depots/sites back into Almac inventory for reprocessing have been stored under appropriate conditions and justification is available for reuse		X

Retention of documentation to record the reason for any drug returns and disposition of returned material		X

Performance of drug accountability at the clinical site	X

PRODUCT DISPOSITION

Review and approval of executed batch documentation		X

Assign final product batch disposition relating to manufacturing activities performed by Almac		X

IMPORTING QUALIFIED PERSON (QP) FOR DRUG PRODUCT MANUFACTURED OUTSIDE OF THE EEA

Provide documentation to confirm that the Drug Substance (in the case of biological products only) and the drug product manufacturing (including packaging and labeling) and testing sites operate to the standards of EU/EEA GMP or equivalent		X

Verify that the manufacturing (including packaging and labeling) and testing sites operate to the standards equivalent to EU GMP in support of a QP Declaration		X

Service Agreement

for a Clinical Study Conduct

22/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments

Audit the manufacturing sites (including packaging and labeling) and testing sites (release and stability) in support of a QP Declaration where confirmation of GMP to the relevant standards cannot be provided		X

Determine the requirement for testing of the IMP on import and communicate accordingly		X

Provide sufficient samples to facilitate import testing		X

Provide a QP Declaration in support of a request for authorization of a clinical trial		X

INTERMEDIATE QUALIFIED PERSON (QP) RELEASE

Verify all activities performed in the supply chain, up to receipt of the Drug Product at Almac, are in compliance with the relevant standards of GMP, the PSF and the submitted CTA		X

FINAL QUALIFIED PERSON (QP) RELEASE

Provide accurate and reliable information for product evaluation to support Final QP Release		X

Supply all requested documentation necessary to facilitate Final QP Release in a timely manner		X

Provide details of all manufacturing (including packaging and labelling), storage, testing sites (release and stability) including contractors involved in the supply chain		X

Provide the Final Releasing QP with visibility of all factors that could potentially influence product quality and thus the decision to release the IMP. This includes information pertaining to the manufacture (including packaging and labeling), storage and testing. For example, deviations and out of specification results.		X

For biological products, provide documentation to confirm compliance with EU/EEA GMP (or equivalent) for the following : Storage sites for Working Cell Banks Drug Substance and Drug Product manufacturing sites (including packaging and labelling) Drug Substance and Drug Product testing sites (release and stability)		X

For chemical products, provide documentation to confirm compliance with national GMP standards for the drug substance		X

For chemical products, provide documentation to confirm compliance with EU/EEA GMP (or equivalent) for the following : Drug Product manufacturing sites (including packaging and labelling) Drug Product testing sites (release and stability)		X

Service Agreement

for a Clinical Study Conduct

23/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments

Audit the manufacturing sites (including packaging and labelling) and testing sites (release and stability) to support Final QP Release where confirmation of GMP to the relevant standards cannot be provided		X

Ensure that Drug Substance and Drug Product processes and analytical methods are appropriately validated for the stage of development		X

Maintain the Product Specification File (PSF) such that traceability to previous versions is retained and provide to the QP as requested		X

Ensure that the PSF is consistent with the current Investigational Medicinal Product Dossier (IMPD)		X

Update the Final Releasing QP of any pertinent amendments to the PSF		X

Provide updates to the Final Releasing QP regarding the submission status of the Clinical Trial Application (CTA), including any withdrawals, refusals, issues, queries or remarks during assessment of the submitted CTA		X

Inform the Final Releasing QP of any updates to the CTA in relation to the IMPD, protocol and label text		X

Provide the Final Releasing QP with any pertinent information regarding product stability that could impact the assigned expiry date		X

Provide stability data to the Final Releasing QP to support expiry updates that are managed via re-labeling or by Interactive Response Technology (IRT)		X

FINAL QUALIFIED PERSON (QP) RELEASE

Inform the Final Releasing QP of any major or critical issues regarding Drug Substance or Drug Product manufacturing (including packaging and labelling) or testing sites including issues highlighted by regulatory authorities		X

Notification of the QP when a recall is being considered		X

Involve the Almac QP in the decision to recall materials when the Almac QP is responsible for final release		X

JUST-IN-TIME RELEASE AT ALMAC

Provision of documented evidence that any expiry update being applied via JIT processes has been accepted by the relevant countries involved in the protocol		X

Provide a document signed by the QP when JIT activities involve the application of a printed label for studies where an Almac QP has no prior responsibilities. This is to verify that the content of the label is acceptable from a regulatory perspective.		X

Service Agreement

for a Clinical Study Conduct

24/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments
STUDY MONITORING

Conduct Site Monitoring Visits	X

Communication with Sites	X

Monitoring visit reports preparation and review	X

Monitoring visit reports final approval		X

100 % SDV	X

Periodic Regulatory Document Collection / Updates (Investigator’s Master File management)	X

Data review/correction on all CRF’s	X

Resolution of Queries with Sites	X

SAE Reconciliation with Sites	X

Conduct Site Close-out / Termination Visits	X

Drug accountability during study and final drug record reconciliation	X

End of Study Notification to Regulatory Agencies/ECs	X

CLINICAL STUDY MANAGEMENT

Maintain Central Trial Master File	X

Fortnightly enrolment updates and Weekly Status Reports to Sponsor	X

Administered Investigator’s Payments	X

Prepare and Distribute Newsletter (if applicable)		X	Item will be agreed upon progress of recruitment in the study.

Central File Archiving		X

Clinical Team Communication	X		KCR to provide Communication Plan.

MEDICAL MONITORING

Development of Medical Monitoring Plan		X

Provide Medical Oversight to CRO Project Team		X

Medical Communication/Consultation with Sites		X

Patient Eligibility - Medical Review		X

Review Safety Data Listing		X

Review CRFs for safety/efficacy		X

Review Safety Laboratory Data		X

Review of Data Management Coding		X

Review of Data Management SAE reconciliation		X

SAFETY MONITORING

Safety Plan Preparation		X

SAE Reporting Procedure and Database Set-up		X

Service Agreement

for a Clinical Study Conduct

25/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments
Receipt & Review of Initial SAE Report from Site	X

Tracking /Analyzing SAE Report		X

Entering SAE into Database		X

Writing SAE Narrative		X

Expectedness Judgment for SAE & Regulatory Reporting Assessment		X

Final Medical and Regulatory Judgment		X

Preparing Annual Report for Competent Authority in EU (inc. safety update)		X

Submitting Annual Report to Competent Authority in EU (inc. safety update)	X

Reporting Expedited SAEs to Regulatory Authorities		X

Reporting Expedited SAEs to Investigators and EC		X

Ongoing SAE File Maintenance		X

DATA MANAGEMENT

Preparation of Data Management Documentation such as Data Management Plan, Data Review Plan, Data Handling Guiding		X

EDC collector development		X

Data Review, Query Generation		X

Query Resolution	X

Import of Electronic (Laboratory) Data	X	X	Task will be subcontracted to Synevo managed by KCR.

Reconciliation of SAEs		X

Provision of data extracts during study to support interim analyses		X

Documentation Maintenance		X

Archiving of EDC tool, Archiving of Data Management Material		X

STATISTICS AND REPORTING

Development of Statistical Analysis Plan		X

Final Approval for Statistical Analysis Plan		X

Creation of Analysis Dataset (Statistical analysis of the dataset)		X

Programming of Tables, Figures and Listings		X

PK parameters calculation		X

Development of interim and final Integrated Statistical/Clinical Report in conformity to ICH guideline and CTD		X

Review of final Integrated Statistical/Clinical Report in conformity to ICH guideline and CTD		X

Final Approval for clinical Study Report		X

Service Agreement

for a Clinical Study Conduct

26/37

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

CONFIDENTIAL


	KCR	VBL Ltd.	Comments

Writing of SAE and AE Discontinuation Narratives		X

AUDITS

Conduct of GCP Audits of Investigator’s Sites	X

Conduct of Quality Assurance Audit of Database		X

Conduct of Quality Assurance Audit of Central Laboratory	TBD

PROJECT MANAGEMENT

Management of the study team	X

Communication with study sponsor and vendors	X

Coordination of start-up activities, realization phase and closure	X

Oversees the regulatory document collection and submission process.	X

Control and track the budget monthly and cumulative realization	X

Preparation of Risk Management Plan and/or Contingency Plan, if required	X		KCR to provide Risk Management Plan till end of October 2012.

CONTRACTS AND PAYMENTS

Preparation of study contracts	X

Signature and payments	X	X

Payment of Ethics Committees’ fees	X

Service Agreement

for a Clinical Study Conduct

27/37

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

CONFIDENTIAL

Attachment No. 2

Timelines


STUDY TIMELINES
[***]		[***]

Service Agreement

for a Clinical Study Conduct

28/37

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


Protocol VB-201-064		VB-201

Attachment No. 3

Study Protocol

CLINICAL PROTOCOL


Title:		A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

Protocol No.		VB-201-064

Eudra CT No.:		2012-003974-18

Investigational		VB-201
Product:

Indication:		Ulcerative Colitis

Development Phase:		2

Sponsor:		Vascular Biogenics Ltd. 6 Jonathan Netanyahu St., Or Yehuda 60376 Israel Phone: 972-3-6346450 Fax: 972-3-6346449

Version:		1.1

Date:		21 Aug 2012

CONFIDENTIAL

This document contains proprietary and confidential information of Vascular Biogenics Limited (VBL). Acceptance of this document constitutes agreement by the recipient that no previously unpublished information contained herein will be published or disclosed without the prior written approval of VBL, with the exception that this document may be disclosed to study personnel under your supervision who need to know the contents for conducting the study and appropriate Institutional Review Boards (IRBs)/Ethics Committees (IEC) under the condition that the personnel have agreed to keep this information confidential. The foregoing shall not apply to disclosure required by governmental regulations or laws; however, VBL shall be promptly notified of any such disclosure.


VBL		Page 1 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

AUTHOR SIGNATURE PAGE

The undersigned have written, reviewed and approved the following protocol:


Yael Cohen, M.D
Vice President,
Clinical Development
Vascular Biogenics Ltd
	Signature	Date

Naamit Sher, PhD
Vice President
Drug Development & RA
Vascular Biogenics Ltd
	Signature	Date

Natanya Slomovitz
Project Statistician
Vascular Biogenics Ltd
	Signature	Date


VBL		Page 2 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

CONFIDENTIALITY AND INVESTIGATOR STATEMENT

Vascular Biogenics Limited

Clinical Research Protocol VB-201-064

Draft Protocol

The information contained in this document and all information provided to you related to VB-201 (“drug”) are the confidential and proprietary information of Vascular Biogenics Limited (Sponsor) and except as may be required by federal, state or local laws or regulations, may not be disclosed to others without prior written permission of Sponsor. The Principal Investigator may, however, disclose such information to supervised individuals working on the Drug, provided such individuals agree to be bound to maintain the confidentiality of such Drug information.

I agree to abide by the statement of confidentiality.

I agree to conduct the study according to this protocol and have read and agree to comply with the Investigator’s Responsibilities. Any changes in procedure will only be made if necessary to protect the safety, rights, or welfare of subjects.

I agree to comply with the current International Conference on Harmonisation (ICH) Guideline on Good Clinical Practice (GCP), applicable laws and regulations, and the Declaration of Helsinki.

I agree to conduct the Study in person or to supervise the Study.

I agree to ensure that all who assist me in the conduct of the Study have access to the Study protocol and any amendments and are aware of their obligations.

Principal Investigator

Date (dd/mmm/yyyy)


Printed Name:

Institution:

Address:


VBL		Page 3 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

Table of Contents


CLINICAL PROTOCOL				1

CONFIDENTIALITY AND INVESTIGATOR STATEMENT				3

1	STUDY SYNOPSIS			7

2	EVALUATION			17

3	LIST OF ABBREVIATIONS			18

4	INTRODUCTION			21

	4.1	Ulcerative Colitis: Pathophysiology and Unmet Medical Need		21

	4.2	Name and description of the investigational product		22

	4.3	Summary of findings from nonclinical studies relevant to the trial		22

	4.4	Summary of findings from clinical trials		23

		4.4.1	VB-201 Phase I Studies	23

		4.4.2	VB-201 Phase II studies	23

	4.5	Rationale for Route of Administration, Pharmaceutical Form, Dosage, Dosage Regimen and Treatment Period		25

	4.6	Rationale for the Modified Mayo Score		26

5	OBJECTIVES			26

	5.1	Safety Objective		26

	5.2	Efficacy Objective		26

6	INVESTIGATIONAL PLAN			26

	6.1	Study Design		26

	6.2	Number of Subjects		27

	6.3	Subject Identification Number and Randomization Number		27

	6.4	Subject Selection		27

		6.4.1	Inclusion Criteria	27

		6.4.2	Exclusion Criteria	28

	6.5	Subject Screening and Randomization		31

	6.6	Duration of Participation		31

	6.7	Protocol Amendments		31

	6.8	Withdrawal Criteria		31

	6.9	Study/Study Site Termination		32

7	STUDY DRUG			32

	7.1	Formulation, Packaging, and Labeling		32

	7.2	Storage and Handling		33


VBL		Page 4 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



	7.3	Accountability		33

	7.4	Access to Blinded Treatment		33

	7.5	Administration of Study Drug		34

		7.5.1	Dosage	34

		7.5.2	Assignment of Treatment Cartons	35

		7.5.3	Compliance	35

8	PRIOR AND CONCOMITANT MEDICATION			35

9	OUTCOME MEASURES			36

	9.1	Efficacy Assessments		36

	9.2	Safety Assessments		37

		9.2.1	Physical Examination Assessments	37

		9.2.2	Clinical Laboratory & Other Safety Assessments	37

		9.2.3	Population Pharmacokinetics	39

		9.2.4	Study Withdrawals	39

		9.2.5	Adverse Events and Serious Adverse Events	39

10	SCHEDULE OF STUDY ASSESSMENTS			39

	10.1	Screening Visit		40

	10.2	Baseline (Day 1)		41

	10.3	Week 2, 4, 8, 14, 16, 20		42

	10.4	Weeks 12 and 24/Early Termination		42

	10.5	Week 28		43

11	ADVERSE EVENTS			44

	11.1	Definition of Adverse Event		44

	11.2	Definition of Serious Adverse Event		45

	11.3	Reporting and Documentation		46

	11.4	Subject Stopping Rules		47

	11.5	Pregnancy		47

12	STATISTICAL CONSIDERATIONS			48

	12.1	Statistical Methods		48

		12.1.1	Comparisons of Interest	48

		12.1.2	Sample Size Determination	48

		12.1.3	Subject Population/Data Sets To Be Evaluated	48

		12.1.4	Randomization	49

	12.2	Statistical Analyses		49


VBL		Page 5 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



		12.2.1	Subject Disposition	49

		12.2.2	Demography	50

		12.2.3	Efficacy Analysis	50

		12.2.4	Safety Analysis	53

		12.2.5	Concomitant Medications	54

13	DATA RECORDING, MONITORING, AND RETENTION			55

	13.1	Source Documents		55

	13.2	Electronic Case Report Forms (eCRFs)		55

	13.3	Record Retention		55

	13.4	Monitoring Requirements		55

	13.5	Subject Confidentiality		56

14	ETHICS			57

	14.1	Ethical Conduct of the Study		57

	14.2	Local Regulatory Approval		57

	14.3	Ethics Committee Approval		57

	14.4	Subject Information and Informed Consent		58

15	PUBLICATION			58

16	REFERENCES			59

	APPENDICES			60

	17.1	Appendix A: Modified Mayo Score		60

Table of Tables


Table 1	Schedule of Procedures for VB-201-064 (UC)	17

Table 2	VB-201 Drug Distribution	34

Table 3	Clinical Assessments Relating to Efficacy	36

Table 4	Physical Examination Assessments Relating to Safety	37

Table 5	Clinical Laboratory & Other Assessments Relating to Safety	38

Table 6	Population Pharmacokinetics	39

Table of Figures


Figure 1	VB-201-064 Study Flowchart	16

1


VBL		Page 6 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

STUDY SYNOPSIS



Title of Study:		A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

Sponsor:		VBL

Phase:		Phase 2

Subject Population:		[***]

Safety Objective:		To examine the safety and tolerability of 12 weeks treatment with VB-201 taken at 80 mg/day for 2 weeks followed by 160 mg/day (80 mg twice daily [BID]) for 10 weeks or placebo for 12 weeks followed by 12 additional weeks of VB-201 (placebo subjects will cross over to VB-201) in subjects with UC

Efficacy Objective:		To examine the effect of 12 weeks’ treatment with VB-201 (taken as described above) or placebo followed by 12 additional weeks of VB-201 (placebo subjects switched to VB-201) on measures of disease activity in subjects with UC

Study Design:		[***]


VBL		Page 7 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



Dosage Regimen and Treatment Groups		[***]

Investigative Product Name and Description		[***]

Number of Subjects:		[***]

Duration of Participation:		[***]


VBL		Page 8 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



Eligibility Criteria

Inclusion Criteria		[***]

Exclusion Criteria		[***]


VBL		Page 9 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



		[***]


VBL		Page 10 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



		[***]


VBL		Page 11 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



		[***]

Concomitant Medications:		[***]

Safety Endpoints:		[***]

Base Phase Primary Efficacy Endpoint:		[***]

Extension Phase Primary Efficacy Endpoint:		[***]


VBL		Page 12 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



Base Phase Secondary Endpoints:		[***]

Extension Phase Secondary Efficacy Endpoints:		[***]


VBL		Page 13 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



		[***]

Base Phase Tertiary Endpoints		[***]

Extension Phase Tertiary Endpoints		[***]

Population Pharmacokinetics		[***]

Compliance Measures		[***]

Study Conduct		[***]

Statistical Methods		[***]


VBL		Page 14 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



		[***]

Rationale for Number of Subjects:		[***]


VBL		Page 15 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

Figure 1 VB-201-064 Study Flowchart

LOGO


VBL		Page 16 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

Table 1 Schedule of Procedures for VB-201-064 (UC)

2 Evaluation

[***]

Study Days

[***]

Assessment Window ( ± Days)

[***]

Informed Consent

Medical History & Demography ²

Physical Exam

Inclusion/ Exclusion Criteria

Randomization

[***]

X ⁵

[***]

X ⁵

[***]

X ⁶

X ⁷

[***]

X ⁶

X ⁷

[***]

X ⁹

X ^9,10

[***]

X ¹¹

X ¹²

[***]

X ¹³

[***]

X ¹⁶

[***]


[***]		[***]


VBL		Page 17 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

3 LIST OF ABBREVIATIONS


Abbreviation/ Acronym		Definition
AE		Adverse Event
ALT		Alanine transaminase
ANCOVA		Analysis of Covariance
ASA		Aminosalicylic Acid
AST		Aspartate transaminase
AUC		Area Under the Curve
BID		Twice Daily
BMI		Body Mass Index
CD		Crohn’s Disease
CPK		Creatinine Phosphokinase
CRA		Clinical Research Associate
CRO		Contract Research Organization
DAI		Disease Activity Index
dL		Deciliter(s)
DSM-LV-TR		Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision
DSS		Dextrane Sodium Sulfate
ECG		Electrocardiogram
eCRF		Electronic Case Report Form
EDC		Electronic Data Capture
ET		Early Termination
FDA		Food and Drug Administration
¹⁸ FDG		Fluorodeoxyglucose
g		Gram(s)
GCP		Good Clinical Practice
GGT		Gamma Glutamyl Transferase
GMP		Good Manufacturing Practice
HDL		High Density Lipoprotein
Hgb		Hemoglobin
HIV		Human Immunodeficiency Virus


VBL		Page 18 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201


Abbreviation/ Acronym		Definition
hsCRP		High Sensitivity C-Reactive Protein
IBD		Inflammatory Bowel Disease
IBDQ		Inflammatory Bowel Disease Questionnaire
IBS		Irritable Bowel Syndrome
ICH		International Conference on Harmonisation
IEC		Independent Ethics Committee
IL		Interleukin
IRB		Institutional Review Board
ITT		Intent-to-Treat
IUD		Intrauterine Device
IVRS / IWRS		Interactive Voice Response System/Interactive Web Response System
kg		Kilogram(s)
LDL		Low Density Lipoprotein
LOCF		Last Observation Carried Forward
MCHC		Mean Corpuscular Hemoglobin Concentration
MCV		Mean Corpuscular Volume
MedDRA		Medical Dictionary for Regulatory Activities
mg		Milligram(s)
MITT		Modified Intent-To-Treat
mm		Millimeter(s)
msec		Millisecond(s)
MTD		Maximum Tolerated Dose
NYHA		New York Heart Association
PASI		Psoriasis Area and Severity Index
PET-CT		Positron Emission Tomography – Computed Tomography
PGA		Physician Global Assessment
PIF		Pregnancy Information Form
QD		Once Daily
Q12H		Every 12 Hours
RBC		Red Blood Cell
SAE		Serious Adverse Event


VBL		Page 19 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201


Abbreviation/ Acronym		Definition
SAP		Statistical Analysis Plan
SCID		Severe Combined Immunodeficiency
SOC		System Organ Class
TEAE		Treatment-Emergent Adverse Event
TLR		Toll Like Receptor
TNBS		Trinitrobenzene Sulfonic Acid
TNF- a		Tumor Necrosis Factor- a
TBR		Target to Background Ratio
UC		Ulcerative Colitis
µL		Microliter(s)
ULN		Upper Limit of Normal
URI		Upper Respiratory Infection
UTI		Urinary Tract Infection
VBL		Vascular Biogenics Ltd.
W		Week(s)
WBC		White Blood Cell
WHO		World Health Organization


VBL		Page 20 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

4	INTRODUCTION

4.1	Ulcerative Colitis: Pathophysiology and Unmet Medical Need

Ulcerative colitis (UC) is a chronic, relapsing inflammatory disease of the colon and rectum characterized by alternating episodes of remission and spontaneous relapse.1,3 The extent and severity of colon involvement are variable. In its most limited form it may be restricted to the distal rectum (ulcerative proctitis), while in its most extended form the entire colon is involved (pancolitis).

Because Crohn’s disease (CD) can involve the colon and shares clinical manifestations with UC, these entities are each considered as an inflammatory bowel disease (IBD), although they are clearly distinct entities. UC is the most common form of IBD worldwide. In contrast to CD, UC is a disease of the mucosa that is less prone to complications and can be cured by means of total colectomy.

Bloody diarrhea with or without mucus is the hallmark of UC. Other clinical characteristics of UC include non-bloody diarrhea, abdominal pain, and extra-intestinal manifestations involving the skin, liver and other sites.4

Although the etiology of UC is unknown, a dysregulation or overstimulation of the mucosal immune system is suspected of playing a key role in the pathophysiology of intestinal inflammation and contributes to mucosal ulceration.5,7

Common treatments for UC include 5-aminosalicylic acids (5-ASAs), glucocorticoids, various oral immunosuppressants, and biological agents, including inhibitors of Tumor Necrosis Factor- a (TNF- a ). These treatments may provide clinical benefit, reduce the signs and symptoms of disease, and improve subjects’ quality of life; however, they usually do not significantly alter the long-term course of the disease or it’s underlying immunopathology. Unfortunately, adverse effects are common with these interventions and may be severe. Therefore, there is an unmet medical need for effective, safe and well-tolerated orally effective products for inducing and maintaining remission in UC subjects.

Vascular Biogenics Ltd (VBL) has developed a small molecule, VB-201 (formerly known as CI-201) a new class of compounds, oxidized phospholipid analogs (lecinoxoids). [***]

Given the putative TLR complicity in UC, VB-201 has the potential to be an orally active drug for treating UC.

The current study is designed to test the safety, efficacy, and tolerability of an oral preparation of VB-201 in subjects with active UC.


VBL		Page 21 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

4.2	Name and description of the investigational product

[***]

4.3	Summary of findings from nonclinical studies relevant to the trial

[***]


VBL		Page 22 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

For details on these pre-clinical studies, please see the VB-201 Investigator Brochure.

4.4	Summary of findings from clinical trials

4.4.1

VB-201 Phase I Studies

[***]

4.4.2

VB-201 Phase II studies

VB-201 was further used in two Phase II clinical trials:

1. [***]


VBL		Page 23 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

2. [***]


VBL		Page 24 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

4.5

[***]


VBL		Page 25 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

4.6	Rationale for the Modified Mayo Score

[***]

5	OBJECTIVES

5.1	Safety Objective

•

To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in subjects with UC.

5.2	Efficacy Objective

•

Base Phase: To examine the effect of treatment with VB-201 80 mg BID compared to placebo (initial 12 weeks) on measures of disease activity in subjects with UC.

•

Extension Phase: To examine the effect of longer-term treatment with VB-201 (24 weeks) on measures of disease activity in subjects with UC.

6	INVESTIGATIONAL PLAN

6.1	Study Design

[***]


VBL		Page 26 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

6.2	Number of Subjects

[***]

6.3	Subject Identification Number and Randomization Number

[***]

6.4	Subject Selection

6.4.1

Inclusion Criteria

[***]


VBL		Page 27 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

6.4.2

Exclusion Criteria

Subjects who meet ANY of the following criteria will be excluded from participation in this [***]

[***]


VBL		Page 28 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]


VBL		Page 29 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

13.

[***]

18.

[***]


VBL		Page 30 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

22.

[***]

6.6	Duration of Participation

[***]

6.7	Protocol Amendments

[***]

6.8	Withdrawal Criteria

[***]


VBL		Page 31 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

•

AEs (serious or non-serious).

[***]

6.9	Study/Study Site Termination

[***]

7	STUDY DRUG

7.1	Formulation, Packaging, and Labeling

[***]


VBL		Page 32 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

7.2	Storage and Handling

[***]

7.3	Accountability

[***]

7.4	Access to Blinded Treatment

[***]


VBL		Page 33 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

7.5	Administration of Study Drug

7.5.1

Dosage

[***]

Table 2 VB-201 Drug Distribution



Treatment	Carton AM	Carton PM

[***]	[***]	[***]


VBL		Page 34 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201



[***]	[***]	[***]

[***]

7.5.2

Assignment of Treatment Cartons

[***]

7.5.3

Compliance

[***]

8	PRIOR AND CONCOMITANT MEDICATION

[***]


VBL		Page 35 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

9	OUTCOME MEASURES

9.1	Efficacy Assessments

[***]

Table 3 Clinical Assessments Relating to Efficacy


Assessment	Study Visit	Description

[***]	[***]	[***]


VBL		Page 36 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201


Assessment	Study Visit	Description

[***]	[***]	[***]

[***]

9.2	Safety Assessments

9.2.1

Physical Examination Assessments

[***]

Table 4 Physical Examination Assessments Relating to Safety


Assessment	Study Visit	Description

[***]	[***]	[***]

W-week, ET-early termination

9.2.2

Clinical Laboratory & Other Safety Assessments

[***]


VBL		Page 37 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

Table 5 Clinical Laboratory & Other Assessments Relating to Safety


Assessment	Study Visit	Description

[***]	[***]	[***]

[***]


VBL		Page 38 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

9.2.3

Population Pharmacokinetics

Blood collected for trough levels of VB-201 during the study are described in Table 6:

Table 6 Population Pharmacokinetics


Assessment	Study Visit	Description

[***]	[***]	[***]

W-week, ET-early termination

9.2.3.1

Blood and Urine Samples

[***]

9.2.3.2

Risk Assessment

[***]

9.2.4

Study Withdrawals

[***]

9.2.5

Adverse Events and Serious Adverse Events

Adverse events and serious adverse events (SAEs) are discussed in detail in Section 11.

10	SCHEDULE OF STUDY ASSESSMENTS

[***]


VBL		Page 39 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

10.1	Screening Visit

[***]


VBL		Page 40 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

10.2	Baseline [***]

[***]


VBL		Page 41 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

10.3

[***]

10.4

[***]


VBL		Page 42 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

10.5

[***]


VBL		Page 43 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

•

[***]

11.1	Definition of Adverse Event

An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, whether or not the event has a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. This definition includes intercurrent illnesses, accidents or injuries, exacerbations or preexisting conditions, changes on physical examination or physiological testing, abuse of drugs, or withdrawal reactions.

[***]

Severity Assessment

[***]


VBL		Page 44 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

Causality Assessment

[***]

11.2	Definition of Serious Adverse Event

In addition to the severity rating, each AE is to be classified by the Investigator as “serious” or “not serious”. The seriousness of an event is defined according to the applicable regulations and generally refers to the outcome of an event. A SAE is defined as any untoward medical occurrence that at any dose:

•

[***]


VBL		Page 45 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

•

[***]

11.3	Reporting and Documentation

The Investigator must report all directly observed AEs and all spontaneously reported AEs. At each visit the Investigator will ask the subject a nonspecific question (e.g., “Have you noticed anything different since your last visit?”) to assess whether any AEs have been experienced since the last report or visit. AEs will be identified and documented on the AE page of the eCRF in appropriate medical terminology. Details of the event must include seriousness, severity, relationship to study drug, duration, action taken, and outcome.

The action(s) taken regarding the AE are classified as follows:

Treatment for event

•

None

•

Concomitant medication given or changed

•

Hospitalization

•

Other

•

Unknown (only applicable if subject has been lost to follow up).

Action taken with study medication

•

None

•

Temporary discontinuation

•

Permanent discontinuation

•

Unknown (only applicable if subject has been lost to follow up).

The outcome of the AE is classified as follows

•

Recovered

•

Recovered with sequelae

•

Not recovered


VBL		Page 46 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

•

Death

•

Unknown (only applicable if subject has been lost to follow up).

Furthermore it must be stated if the study was discontinued permanently for the subject (yes, no) due to the AE/ SAE.

The Principal Investigator is responsible for evaluating all AEs, obtaining supporting documents, and determining that documentation of the event is adequate. The Principal Investigator may delegate these duties to Sub-Investigators and must assure that these Sub-Investigators are qualified to perform these duties under the supervision of the Principal Investigator.

In the event that a subject is withdrawn from the study because of an AE, it must be recorded on the eCRF. The subject should be followed and treated by the Investigator until the AE has resolved or a new chronic baseline has been established.

Any SAE, whether or not considered related to the study drug, must be reported immediately (within 24 hours) upon learning of the event (See Study Manual). The Investigator or his designee should complete the study-specific SAE Report Form. Investigators should not wait to collect additional information that fully documents the event before notifying VBL or its designee of a SAE. Contact numbers for reporting SAEs and events of concern will be provided prior to the start of the study.

It is the responsibility of the Investigator to report SAEs to their IRB/IEC according to the standard operating procedures and policies of the IRB or IEC. At a minimum, events identified by the Sponsor to require expedited reporting as serious, unexpected, and possibly related to study drug must be brought to the attention of the responsible IRB/IEC. Adequate documentation must be provided to VBL or its designee that the IRB or IEC was properly notified.

11.4	Subject Stopping Rules

The following stopping rule will be utilized in this study:

•

[***]

Subjects who permanently discontinue study medication shall return for an Early Termination Visit and subsequently for a final safety visit 4 weeks from the last dose.

11.5

Pregnancy

[***]


VBL		Page 47 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

12	STATISTICAL CONSIDERATIONS

12.1	Statistical Methods

12.1.1

Comparisons of Interest

[***]

12.1.2

Sample Size Determination

[***]

12.1.3

Subject Population/Data Sets To Be Evaluated

12.1.3.1

Modified Intent-To-Treat (MITT) Population

[***]

12.1.3.2

Per-Protocol Population

[***]

12.1.3.3

Safety Population

[***]


VBL		Page 48 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

All safety analyses will include the safety population.

12.1.4

Randomization

[***]

Subjects will be randomized upon successful completion of screening activities in a double-blind [***]

[***]

12.2	Statistical Analyses

[***]

One of the secondary efficacy endpoints will be the change in the modified Baron score, an [***]

[***]

12.2.1

Subject Disposition

A flowchart will be produced detailing the number of subjects randomized, receiving study drug and withdrawing from the study.


VBL		Page 49 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

In addition, the number (%) of subjects who withdraw from the study and their reasons for withdrawal will be tabulated. The distribution of withdrawals will be displayed for each visit.

12.2.2

Demography

[***]

12.2.3

Efficacy Analysis

[***]

12.2.3.1

Primary Efficacy Endpoints

12.2.3.1.1

Base Phase Primary Efficacy Endpoint

[***]

The primary efficacy analysis will also be completed in a Per-Protocol population.

12.2.3.1.2

Extension Phase Primary Efficacy Endpoints

[***]


VBL		Page 50 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

12.2.3.2

Secondary Efficacy Endpoints

12.2.3.2.1

Base Phase Secondary Efficacy Endpoints

In addition to the primary efficacy analysis, comparisons will be performed for the [***]

[***]

2. [***]

[***] analyses will be carried out using two-sided tests at the 5% level of significance.

12.2.3.2.2

Extension Phase Secondary Efficacy Endpoints

[***]


VBL		Page 51 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

12.2.3.3

Tertiary Endpoints

12.2.3.3.1

Base Phase Tertiary Endpoints

[***]


VBL		Page 52 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

[***]

12.2.3.3.2

Extension Phase Tertiary Endpoints

In addition to the secondary efficacy analyses, comparisons will be performed for the following [***]

4. [***]

[***]


VBL		Page 53 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

12.2.4.1

Adverse Events

[***]

12.2.4.2

Laboratory Parameters

[***]

12.2.4.3

Vital Signs

[***]

12.2.4.4

Withdrawals

[***]

12.2.4.5

Deaths

All deaths will be listed.

12.2.4.6

Dropouts

[***]

12.2.5

Concomitant Medications

[***]


VBL		Page 54 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

13	DATA RECORDING, MONITORING, AND RETENTION

13.1	Source Documents

[***]

13.2	Electronic Case Report Forms (eCRFs)

[***]

13.3	Record Retention

[***]

13.4	Monitoring Requirements

[***]


VBL		Page 55 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

•

[***]

13.5	Subject Confidentiality

The Investigator must ensure that the subject’s anonymity is maintained. In the eCRFs or other documents submitted to the Sponsor and/or designated CRO, subjects should be identified by a subject identification number and/or randomization number.

Documents that are not for submission to the Sponsor and/or designated CRO (e.g., signed informed consent forms and subject information sheets) should be kept in strict confidence by the Investigator in compliance with local regulations/ICH GCP Guidelines. It is required that the Investigator and institution permit authorized representatives of the Sponsor, of the regulatory agency, and the IRB/IEC direct access to review the subject’s original medical records for verification of study-related procedures and data.

Direct access includes examining, analyzing, verifying, and reproducing any records and reports that are important to the evaluation of the study. The Investigator is obligated to inform the subject that his/her study-related records will be reviewed by the above named representatives, although the confidentiality of his/her records will be maintained as much as reasonably possible. For the purposes of the study, only the data set forth in this protocol (including the CRFs) will be obtained regarding participating subjects (whether screen failures or enrolled subjects). Such data shall:

•

be processed in accordance with this Protocol or as otherwise instructed by the Sponsor;

•

be processed solely for the purposes of the study and in the manner specified in this Protocol;

•

not be processed in any manner incompatible with the purposes of the study;

•

be accurate, up to date and corrected to address any inaccuracies or omissions;


VBL		Page 56 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

•

be maintained (as specified in this Protocol/using reasonable measures) to protect against accidental or unlawful destruction, accidental loss or damage, alteration, unauthorized disclosure or access and against other unauthorized or unlawful forms of processing;

•

not be disclosed to any third party without the Sponsor’s prior written consent; and

•

be maintained as detailed in Section 13.3 unless a longer period is required by applicable laws or regulations.

Any reasonably requested assistance shall be provided to assist the Sponsor to enable it to comply with any data-related notification obligations under applicable laws or regulations. The Sponsor shall be promptly informed of any communication received from a study subject regarding the data collected about him/her in connection with the study.

ETHICS

14.1	Ethical Conduct of the Study

The study will be conducted in accordance with applicable national and international laws and regulations, the ICH-GCP guideline and the ethics principles that have their origins in the Declaration of Helsinki. The protocol and the proposed informed consent form must be reviewed and approved by a properly constituted IEC/IRB before study start at a particular study site. Prior to study start, the Principal Investigator is required to sign the protocol signature page (page 3 of this study protocol) confirming his/her agreement to conduct the study in accordance with these documents and all of the instructions and procedures found in this protocol, and to give access to all relevant data and records to monitors, auditors, IRBs/IECs, and regulatory authorities as required.

14.2	Local Regulatory Approval

The Sponsor or the CRO will supply the Competent Authorities of each participating country with a dossier containing the required pharmacological, toxicological and pharmaceutical data on the compound, so as to obtain import and study approval. The study will not start in that country until this has been obtained where appropriate.

14.3	Ethics Committee Approval

The Principal Investigator at each site is responsible for obtaining IRB or IEC approval for the protocol, informed consent form/ information sheet, and any advertisements to recruit subjects before being implemented at the investigative site. Written approval of these documents must be obtained from the committee before any subject is enrolled at a center.

The Principal Investigator is also responsible for the following interactions with the IRB/IEC:


VBL		Page 57 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

•

Obtaining IRB/IEC approval for any protocol amendments and informed consent form revisions before implementing the changes;

•

Providing the IRB/IEC with any required information before or during the study;

•

Submitting progress reports to the IRB/IEC, as required, during the conduct of the study; requesting re-review and approval of the study, as needed; providing copies of all IRB/IEC re-approvals and relevant communication to the CRO or the Sponsor;

•

Notifying the IRB/IEC of all serious and unexpected AEs related to the study drug reported by the Sponsor or the CRO, as required. Documentation of this notification should be retained.

14.4	Subject Information and Informed Consent

No Investigator may involve a human being as a subject in research unless the Investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An Investigator shall seek such consent only under circumstances that provide the prospective subject or the subject’s legally authorized representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in a language understandable to the subject or representative.

The Sponsor or its designated representative will provide the Investigator with a sample consent form. Local and/or institutional requirements may require disclosure of additional information in the informed consent. Any changes to the consent form must be submitted to the Sponsor or its designated representative for approval prior to submission to the IRB/IEC. The IRB/IEC must review the consent form for approval/favorable opinion, and a copy of the approved consent form must be submitted to the Sponsor or its designated representative prior to initiation of the study.

Before implementing any study procedure, informed consent shall be documented by the use of an IRB/IEC approved written consent form signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy of the signed informed consent will be given to the subject or the subject’s legally authorized representative. The original signed consent must be maintained by the Investigator and available for inspection by the Sponsor, its designated representative, or regulatory authority at any time.

15	PUBLICATION

The Sponsor recognizes the importance of communicating clinical study data and therefore it is the intent of the Sponsor to publish the results of this trial, the details of which will be provided in the Clinical Study Agreement.


VBL		Page 58 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

16	REFERENCES

Truelove SC. Ulcerative colitis beginning in childhood. N Engl J Med 1971;285:50–2.

Langholz E, Munkholm P, Davidsen M, Binder V. Course of ulcerative colitis: analysis of changes in disease activity over years. Gastroenterology 1994;107:3–11.

Podolsky DK. Inflammatory bowel disease. N Engl J Med 2002;347:417–429.

Kirsner JB. Inflammatory bowel disease. Part II: Clinical and therapeutic aspects. Dis Mon 1991;37:669–746.

Floccji C. Inflammatory bowel disease: etiology and pathogenesis. Gastroenterology 1998;115:182–205.

MacDermott RP. Alterations in the mucosal immune system in ulcerative colitis and Crohn’s disease. Med Clin North Am 1994;78:1207–1231.

Schreiber S, Rosenstiel J, Albrecht M, Hampe J, Krawczak M. Genetics of Crohn’s disease, an archetypal inflammatory barrier disease. Nat Rev Genet 2005;6:376–388.


VBL		Page 59 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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


Protocol VB-201-064		VB-201

17	APPENDICES

17.1	Appendix A: Modified Mayo Score

Modified Mayo Clinic SCORE

1. [***]


VBL		Page 60 of 60
Confidential Information		Protocol version 1.1, 21 Aug 2012

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

CONFIDENTIAL

Attachment No. 4

List of SOPs applicable for the Study conduct


P/Z	Number	Range	#Z	FULL TITLE OF P / Z	Version #	Date Effective
P	101.1	MED		Feasibility process	5	06.12.11
P	102.1	MED		Regulatory Submission for Clinical Study Application	2	03.01.10
P	102.3	MED.		Updating Clinical Study Documentation	1	03.01.10
P	102.5	MED.		Management of Regulatory Process	1	03.01.10
P	103.1	MED.		Pre-Study Visit	2	21.02.11
P	104.1	MED.		Informed Consent Form	3	10.11.11
P	105.1	MED.		Initiation Visit	2	04.03.11
P	106.1	MED.		Monitoring Visit	2	18.04.11
P	106.2	MED.		Taking Over The Study	2	14.03.11
P	106.3	MED.		Co-Monitoring Visit	2	25.07.11
P	106.4	MED		Reporting Protocol Deviations	1	14.04.10
P	107.1	MED.		Close-out Visit	2	30.04.11
P	108.1	MED		Translation	3	19.09.11
P	109.1	MED.		Clinial Trial Documents	2	09.08.10
P	109.2	MED.		Trial Master File	2	13.06.11
P	109.3	MED.		Investigator’s File	2	13.06.11
P	110.1	MED.		Clinical Supplies	2	06.04.11
P	111.1	MED		Clinical Trial Materials	2	14.04.11
P	112.1	MED		Serious Adverse Event Reporting	2	05.11.10
P	112.2	MED		Distribution of SUSAR reports	2	15.09.11
P	113.1	MED.		Training Clinical Operation Staff	3	15.09.11
P	114.1	MED		Insurance	2	07.12.10
P	115.1	MED		Milestones in Project Management	1	03.09.10
P	116.1	MED		Clinical Study Report	2	17.05.11
P	117.1	MED		Archiving Study Files	2	13.12.10
P	118.1	MED		Organization of MED SOP in Clinical Operations Dept.	2	05.11.10
P	118.2	MED		Management of Sponsors’ SOP	1	24.01.11
P	119.1	MED		Disaster Management in Clinical Operations Department	2	21.04.11
P	120.1	MED		Clinical Operations Staff Curriculum Vitae	4	23.05.11
P	120.2	MED		Completing Outlook Calendar	2	25.07.11
P	120.3	MED		Organization of meetings in Clinical Operations departments	2	25.07.11

Service Agreement

for a Clinical Study Conduct

30/37

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

CONFIDENTIAL


P/Z	Number	Range	#Z	FULL TITLE OF P / Z	Version #	Date Effective
P	120.4	MED		Working at home	2	25.07.11
P	120.5	MED		Weekly reporting	2	25.07.11
P	120.6	MED		Returning from outsourcing	2	25.07.11
P	121.1	MED		Contracts with Investigators and Investigational Sites	4	01.02.10
P	122.1	MED.		Confidentiality Agreements and Confidentiality Obligation	3	14.03.11
P	123.1	MED.		Principles of drawing contracts and master service agreements	2	28.03.11
P	124.1	MED		Fraud and Misconduct	2	09.01.11
P	125.1	MED		Purchases Within a Project	1	25.07.11
P	127.1	MED		Legislation in Clinical Trials	1	04.05.11
P	128.1	MED		Communication with Subcontractor	1	01.09.11
P	129.1	MED		Annual Progress Report to Competent Authorities	1	19.08.11
P	130.1	MED		Preparing Monitoring Plan	1	25.11.11
P	131.1	MED		Communication Plan	1	30.04.12

Service Agreement

for a Clinical Study Conduct

31/37

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

CONFIDENTIAL

Attachment No. 5

List of third parties engaged by the Sponsor for the conduct of the Study

Legal representative (Gregory Fryer Associates Ltd): CRO shall undertake the following obligation, and shall indemnify the sponsor for any damage in case it will breach such obligation: notify immediately Gregory Fryer Associates Ltd and the Sponsor of any untoward occurrences, including serious breaches of the protocol, GCP or regulations, occurring in the clinical trial.

b.	Pharmacovigilence group: CRO shall act according to the safety plan, as shall be determined for this clinical trial.

Data Management: CRO shall act according to the procedures, as shall be determined for this clinical trial. Licensing of Patient Questionnaire (IBDQ): CRO shall undertake to use the Questionnaire by it and by any sites or investigator solely for the purpose of the Study and to maintain and enforce the confidentiality of the Questionnaire by such sites and investigators.

Service Agreement

for a Clinical Study Conduct

32/37

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

CONFIDENTIAL

Attachment No. 6

Study Budget

Specification of anticipated costs and expenses

Part A


	Budget Totals (CRO fee)
A	MEDICAL WRITING	[***]
B	STUDY FAMILIARIZATION & TRAINING	[***]
C	SITE MANAGEMENT IN HOUSE (including site payments)	[***]
D	STUDY ADMINISTRATION & DOCUMENT MANAGEMENT	[***]
E	STUDY AUTHORIZATION & CONTRACTS	[***]
F	SITE SELECTION ACTIVITIES	[***]
G	MONITORING	[***]
H	SAFETY REPORTING & MEDICAL MONITORING	[***]
I	DATA MANAGEMENT	[***]
J	STATISTICAL ANALYSIS and CSR	[***]
K	PROJECT MANAGEMENT	[***]
L	QUALITY ASSURANCE SERVICES	[***]
	TOTAL ESTIMATED CRO FIXED COSTS	[]*
	TOTAL ESTIMATED PASS-THROUGH COSTS	[]*
	TOTAL ESTIMATED VENDORS COSTS	[]*
	TOTAL ESTIMATED INVESTIGATORS FEES	[]*
	GRAND TOTAL	[***]

Service Agreement

for a Clinical Study Conduct

33/37

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

CONFIDENTIAL

Attachment No. 6

Study Budget

Specification of anticipated costs and expenses

FINAL BUDGET (in €)

Ref.
#

[***]

MEDICAL WRITING

[***]

Protocol review

[***]

STUDY FAMILIARIZATION & TRAINING

[***]

Kick-Off Meeting

[***]

Monitors training (therapeutic)

[***]

Monitors training (therapeutic)

[***]

Investigators meeting

[***]

Investigators meeting

[***]

Investigators meeting organization

[***]

SITE MANAGEMENT IN HOUSE
(including site payments)

[***]

Create Investigator Binders

[***]

Regular site management (site contacts over phone and written communication)

[***]

CRF off site management

[***]

Resolve Issues & Queries

[***]

Administer Investigators Grants

[***]

STUDY ADMINISTRATION &
DOCUMENT MANAGEMENT

[***]

Set up study trial master files

[***]

Maintain & update study trial master files and project specific files

[***]

Archive, retain or return Study Documentation

[***]

STUDY AUTHORIZATION & CONTRACTS

[***]

Develop local Informed Consent Form

[***]

Informed Consent Form adaptation to country specifics

[***]

Collect Pre-Study / Regulatory Documentation from sites and Sponsor

[***]

Service Agreement

for a Clinical Study Conduct

34/37

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

CONFIDENTIAL

Coordinate translation/preparation process (protocol synopsis, drug labels, back translation)

[***]

Negotiate Investigator Budget & CSA (+ 2nd for hospital authorities)

[***]

Negotiate Investigator Budget & CSA (+ 2nd for hospital authorities)

[***]

Initial submission to CA and EC

[***]

Initial submission to CA and EC

[***]

Regulatory activities post approval

[***]

Insurance arrangement

[***]

SITE SELECTION ACTIVITIES

[***]

Identify Investigative Sites

[***]

Site Selection Visits Visits

[***]

Site Selection Visits - travelling

[***]

MONITORING

[***]

Conduct On-Site Study Initiation Visits

[***]

Initiation visits - travelling

[***]

Conduct Interim Monitoring Visits

[***]

Interim monitoring - travelling

[***]

Conduct Study Closure Visits

[***]

Closure visit travelling

[***]

SAFETY REPORTING & MEDICAL MONITORING

[***]

DATA MANAGEMENT

[***]

STATISTICAL ANALYSIS and CSR

[***]

PROJECT MANAGEMENT

[***]

Project management

[***]

Project Teleconferences - CRM with Sponsor

[***]

Verification of monitoring reports

[***]

Service Agreement

for a Clinical Study Conduct

35/37

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

CONFIDENTIAL

Project Management - Central Lab

[***]

Project Management - Drug Supply

[***]

QUALITY ASSURANCE SERVICES

[***]

Quality assurance services - Clinical management

[***]

CRO Subtotal:

[***]

ESTIMATED PASS THROUGH COSTS (this is rough estimation of the majority costs which should be taken into account and not directly paid by Sponsor)

[***]

Regulatory costs

[***]

1.1

Ethics Committee fees + RA fee

[***]

1.2

Custom clearance for

[***]

1.3

Insurance

[***]

Travels

[***]

2.1

CRA Travel (hotels, tickets, allowances)

[***]

2.2

Investigator Meetings travel and hotel costs (per attendee)

[***]

2.3

Patients travel costs

[***]

Administration

[***]

3.1

Copies / duplication (binding and photocopies included)

[***]

3.2

Courier / shipment

[***]

3.3

Telephone / fax

[***]

Translation

[***]

4.1

Translation of study documents

[***]

Vendors

[***]

5.1

DM - License

[***]

5.2

DM - Hosting productive server

[***]

5.3

DM - Hosting test/design server

[***]

5.4

DM - Help desk

[***]

5.5

DM - Data Archive of Central Database

[***]

5.6

Central Lab - Laboratory tests

[***]

Service Agreement

for a Clinical Study Conduct

36/37

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

CONFIDENTIAL

5.7

Central Lab - Shipments

[***]

5.8

Central Lab - Project management (subcontractor’s)

[***]

5.9

Drug Supply - Project Management[***]

[***]

5.10

Drug Supply - Materials

[***]

5.11

Drug Supply - Label Printing

[***]

5.12

Drug Supply - Receipts

[***]

5.13

Drug Supply - Secondary Production

[***]

5.14

Drug Supply - Storage

[***]

5.15

Drug Supply - Data Services

[***]

5.16

Drug Supply - QP Services

[***]

5.17

Drug Supply - Distribution

[***]

5.18

Drug Supply - Accountability & Destruction

[***]

5.19

IVRS - aXcess Project Implementation Web only

[***]

5.20

IVRS - aXcess Monthly Maintenance Fee

[***]

5.21

IVRS - aXcess Phone Implementation Fee

[***]

5.22

IVRS - aXcess Phone Transaction Fee

[***]

5.23

IVRS - aXcess Data Transfer Fee[***]

[***]

5.24

IVRS - Project Management (subcontractor’s)

[***]

5.25

IVRS - aXcess Rand List Generation by Almac

[***]

Investigators Fees

[***]

7.1

Investigators fee

[***]

7.2

Investigators fee (screen failures)

[***]

TOTAL ESTIMATED CRO FIXED COSTS

[***]

TOTAL ESTIMATED PASS-THROUGH COSTS

[***]

TOTAL ESTIMATED VENDORS COSTS

[***]

TOTAL ESTIMATED INVESTIGATORS FEES

[***]

PROJECT GRAND TOTAL

[***]

Service Agreement

for a Clinical Study Conduct

37/37

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

Exhibit 10.13

LOGO

SERVICE AGREEMENT

FOR A CLINICAL STUDY CONDUCT

concluded on 16 December 2013 (“Effective Date”) in Warsaw by and between:

KCR S.A. (Polish joint-stock company) with its registered office in Warsaw at 6 Postępu Str., 02-676 Warsaw, Poland, entered in the register of entrepreneurs kept by the District Court for the Capital City of Warsaw in Warsaw, 13th Commercial Division of the National Court Register, under number 0000289542, tax identification number NIP: 521-31-69-665, share capital (covered in total): PLN 700,000.00, hereinafter referred to as “ CRO ”, represented by Mr. Mike Jagielski – President of the Management Board and Ms. Anna Baran – Vice President of the Management Board,

and

hereinafter jointly referred to as „the Parties” and individually as a “Party”.

Whereas:

Sponsor intends to conduct a clinical study of the investigational medicinal product VB-201 [„Investigational Medicinal Product”] entitled “A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis” [„Study”] according to the protocol number VB-201-079 [“Protocol”] on the territory of Poland,

Legal Representative of the Sponsor is SCIderm GmbH, a company organized and existing under the laws of Federal Republic of Germany, entered in the Trade Register maintained by the District Court in Hamburg, under the number HRB 93824 with its registered office at Drehbahn 1-3, 20354 Hamburg, Germany,

Sponsor wishes to engage CRO to provide services connected with the conduct of the Study as defined herein,


VBL Confidential Information		Page 1 of 101 Version 2.2 02 DEC 2013

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

LOGO

fulfillment of CRO’s obligations resulting from this agreement is included in the scope of CRO’s business activity and CRO has an experience in providing services of similar nature as described herein, including the fact that CRO employs qualified employees in order to perform such obligations.

Now then , the Parties agree to conclude the agreement as follows [„Agreement”]:

§ 1. Subject of the Agreement

1.	Sponsor hereby entrusts CRO with performance of activities connected with the conduct of the Study as defined in Attachment No. 1 hereto (Scope of Services), hereinafter referred to as „Services”, and CRO hereby accepts such entrusted responsibilities.

§ 2. Manner of Providing Services


VBL Confidential Information		Page 2 of 101 Version 2.2 02 DEC 2013

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

LOGO

discretion, would adversely affect the ability of the CRO to perform their obligations under this Agreement.

3.	In order to perform Services, CRO undertakes an obligation to appoint from among its employees only persons with appropriate knowledge, experience and qualifications necessary to perform Services, and who have bound by confidentiality undertakings according to this Agreement.


VBL Confidential Information		Page 3 of 101 Version 2.2 02 DEC 2013

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

LOGO

the Sponsor or the investigators from liability for the Study conduct according to provisions of law in force.

10.	Both Sponsor and CRO shall carry, at its sole expense, with financially sound and reputable insurers, an insurance coverage with respect to the conduct of its business.

§ 3. Sponsor’s responsibilities

Sponsor undertakes an obligation in particular to:

provide CRO with all information in its possession about the Investigational Medicinal Product necessary for the conduct of the Study,

keep CRO informed on an ongoing basis about any new findings concerning safety of the Investigational Medicinal Product,

supply CRO with the Investigational Medicinal Product manufactured in compliance with Good Manufacturing Practice, adequately packed and labeled,

supply CRO with documentation necessary for conduct of the Study, including the valid version of the Protocol, Investigator’s Brochure and the Case Report Forms (CRF),

conclude insurance agreement on third party liability of the Sponsor and investigators for damages related to the conduct of the Study, in compliance with laws in force and provide CRO with a valid copy of the insurance policy confirming conclusion of such agreement,

notify CRO immediately of any suspension of the Study or withdrawal of the approval for the conduct of the Study,


VBL Confidential Information		Page 4 of 101 Version 2.2 02 DEC 2013

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

LOGO

perform other responsibilities not assigned to the CRO and necessary for the conduct of the Study.

§ 4. Audits and inspections

1.	On Sponsor’s reasonable request, CRO shall, at any time, provide the Sponsor with information on the status of the Services performed. In particular, the Sponsor may request CRO to prepare an activity report on the Services performed by CRO.

4.	Sponsor agrees to cover the costs of CRO’s employees involvement in an audit, control or inspection based on real time spent on such activities according to the rates described in Attachment No. 6.


VBL Confidential Information		Page 5 of 101 Version 2.2 02 DEC 2013

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

LOGO

§ 5. Remuneration

1.	For execution of all obligations resulting from the Agreement by CRO, Sponsor undertakes an obligation to pay remuneration as well as reimburse costs and expenses as defined in net amounts in Attachment No. 6. Due VAT shall be added to the above fee.

The remuneration shall be calculated and paid on a monthly basis for the time committed to or a type of Services provided in a given month within 30 days from the delivery of the invoice issued by CRO to the Sponsor. CRO shall be entitled to issue and deliver a VAT invoice beginning with the last day of a given month for the amount covering time or type of Services performed in such month.

4.	On Sponsor’s request, CRO shall submit a list of Services performed in a given month, including a timesheet of persons providing Services with a detailed description of activities performed.

5.	The Sponsor shall reimburse CRO:

for any costs incurred by CRO in connection with conclusion of the Agreement and providing the Services hereunder—so called “pass through costs”, including in particular costs of telephone connections, faxes, internet, courier and mail services, accommodation and travel expenses of persons appointed to perform Services, which will be incurred in connection with the execution of the Agreement. These expenses will be invoiced on a monthly basis and presented to the Sponsor with a detailed list.

for any costs related to use of CRO company cars for business travels to and from study sites indicated by the Sponsor,

for any other costs necessary for the proper conduct of the Study provided that such expenses have been pre-approved by the Sponsor.

Specification of expected costs and expenses (so called „pass through costs”) is included in Attachment No. 6 hereto. In case if costs, expenses or a scope of Services connected with the conduct of the Study appear to be higher than those anticipated on the Agreement date, the Sponsor undertakes an obligation to cover these costs and reimburse CRO for expenses incurred


VBL Confidential Information		Page 6 of 101 Version 2.2 02 DEC 2013

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

LOGO

in relation to the execution of the Agreement provided that such expenses have been pre-approved by the Sponsor.

8.	Sponsor is obliged to reimburse CRO for the costs and expenses incurred by CRO in relation to the execution of the Agreement within 30 days from the receipt of relevant documentary evidence supporting such costs and expenses from CRO.

9.	Payment of the remuneration and reimbursement of costs incurred by CRO shall be made by a transfer to CRO bank account indicated on the invoice.

10.

CRO rates included in the budget in Attachment 6 shall automatically increase each calendar year beginning from January 1, 2015 for the next 12 month period, according to year inflation rate published by Eurostat, the Statistical Office of the European Communities. The Parties agree that increase of rates shall be effective from the beginning of calendar year regardless of the date of publishing year inflation rate by Eurostat.

§ 6. Confidentiality

The CRO shall keep confidential any and all information and data concerning Sponsor`s business or its activities (including reports and information as well as all clinical data about the Study or its progress produced by the CRO or the sites within the framework of this Agreement), or information obtained that may come to the knowledge of the CRO, its personnel or appointed representatives during or in connection with the execution of this Agreement including without limitation third party confidential information received by the Sponsor (“Sponsor’s Confidential Information”). For the avoidance of any doubt, the Protocol, the Investigational Medicinal Product, the Study results, and the Inventions (as defined below) shall be considered the Sponsor’s Confidential Information.


VBL Confidential Information		Page 7 of 101 Version 2.2 02 DEC 2013

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

LOGO

4.	The above provision does not apply to information which the receiving Party can demonstrate that:

is known to the receiving Party at the moment of its disclosure,

is publicly accessible at the time of its disclosure to the receiving Party or it becomes later publicly accessible without the Party’s fault,

may be disclosed upon the other Party’s consent expressed in writing otherwise being void,

was disclosed to the receiving Party by a third party that was not obliged to keep it confidential or

is disclosed by virtue of laws in force.

§ 7. Personal data processing


VBL Confidential Information		Page 8 of 101 Version 2.2 02 DEC 2013

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

LOGO

the scope of performance the obligations under the Agreement. The personal data of the CRO’s employees, contractors and other individuals will be processed by Sponsor on grounds of their consent or justified purposes of a data controller. However, for the purposes of processing by Sponsor of the personal data of the CRO’s employees or contractors in relation to the execution of obligations of CRO as an employer, CRO entrusts Sponsor with the processing of such personal data in accordance with the Agreement.

2.	Sponsor appoints CRO as its representative within the meaning of article 31a of the Personal Data Protection Act.

4.	Sponsor cannot use entrusted personal data for any other purpose or in any other manner than necessary to execute the Agreement. Sponsor is also obliged neither to disclose nor to pass on the personal data to any entity without prior written CRO’s consent.

5.	Sponsor is liable for the damages caused to CRO or any third party in the result of personal data processing against the Agreement by Sponsor or under its responsibility.

6.	When the Agreement is finished/terminated/expired, Sponsor is obliged to finish personal data processing, return or destroy all received documents and their copies, and return all received electronic data mediums to CRO.

8.	CRO undertakes to observe the provisions of the Personal Data Protection Act and the secondary regulations. CRO cannot use the entrusted personal data for any other purpose or in any other manner than necessary to execute the Agreement.


VBL Confidential Information		Page 9 of 101 Version 2.2 02 DEC 2013

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

LOGO

9.	In relations between CRO and Sponsor acting as data controllers / data processors towards each other, the following rules shall apply accordingly:

the data processor shall be obliged to ensure supervision of the following: when and by whom the personal data has been entered into the data filing system and to whom the data has been transferred;

the data processor undertakes to preserve the confidentiality of the personal data entrusted to it under this Agreement;

only persons who were authorized by the data processor shall be allowed to carry out the processing of personal data;

the data processor shall grant the data controller, at its request, any necessary information concerning all personal data processed by the data processor;


VBL Confidential Information		Page 10 of 101 Version 2.2 02 DEC 2013

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

LOGO

the necessary information concerning the way in which the data processor processes the personal data contained in the data filing system;

§ 8. Intellectual property


VBL Confidential Information		Page 11 of 101 Version 2.2 02 DEC 2013

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

LOGO

its employees, sites, investigator or any other Sub-contractors related to this Agreement shall be the property of the Sponsor.

§ 9. Duration of the Agreement and its termination

1.	The Agreement is concluded for a specified period of time and shall be valid from the Effective Date until the termination of the Study unless any circumstances indicated below should occur.

3.	The Sponsor has a right to terminate the Agreement upon 90 days’ written notice without giving cause and CRO has a right to terminate the Agreement upon 120 days’ written notice without giving cause.

Upon receipt of the notice of termination of the Agreement from the Sponsor by CRO or dispatch of the same to the Sponsor by CRO, CRO shall make all possible efforts to terminate or transfer further conduct of any unfinished Services as soon as possible, according to the Sponsor’s instructions. In such a case, CRO shall cease to provide Services or undertake further obligations in connection with the Services unless Parties agreed otherwise in writing.

The Sponsor undertakes an obligation to reimburse CRO for all necessary and actual costs connected with the termination or expiration of the Agreement as well as to pay CRO due remuneration, in particular to reimburse CRO for any expenses incurred (so called „pass through costs”) or to be incurred in relation to provision of the Services from which CRO cannot withdraw. Promptly after the date of the Agreement termination or expiration, CRO shall issue an invoice for the above costs and expenses to the Sponsor.


VBL Confidential Information		Page 12 of 101 Version 2.2 02 DEC 2013

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

LOGO

§ 10. Non-Solicitation Clause

1.	The Sponsor undertakes an obligation that it shall not employ any employee of the CRO, in its own enterprise or in any company under its control, during the term of the Agreement and for the period of 2 years from the date of termination or expiry hereof.

§ 11. Final provisions

1.	Neither Party shall be liable to the other Party in connection with this Agreement for any indirect, consequential (including without limitation lost profits), incidental, special or punitive damages.

Sponsor shall defend, indemnify, and hold harmless CRO, its affiliates and their respective directors, officers, employees, consultants, sub-contractors, independent contractors, and agents from and against any and all losses, claims (including third party claims), actions, damages, liabilities, awards, costs and expenses (including reasonable legal counsel fees and expenses), whether joint or several, relating to or arising from or in connection with this Agreement or the Services contemplated herein, including but not limited to, the Study, test, specifications, compound, device, placebo or Investigational Medicinal Product, potential product or procedure performed or administered as a result of the Protocol and this Agreement or any litigation, investigation or other proceeding relating to any of the foregoing, unless as a result of CRO’s its affiliates and their respective directors, officers, employees, consultants, sub-contractors, independent contractors, and agents negligence, non-adherence to professional standards or breach of the Agreement.

4.	CRO shall defend, indemnify, and hold harmless Sponsor, its affiliates and its and their respective directors, officers, employees, and agents from and against any and all losses, claims (including third party claims), actions, damages, liabilities, costs and expenses (including


VBL Confidential Information		Page 13 of 101 Version 2.2 02 DEC 2013

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

LOGO

reasonable legal counsel fees and expenses) (“Sponsor Losses”) but only to the extent such Sponsor Losses are related to or arise from or in connection with CRO’s negligence, non-adherence to professional standards or breach of this Agreement, except to the extent that such Sponsor Losses arise from (i) the negligence or reckless or willful act or omission of Sponsor, its affiliates or its and their respective directors, officers, employees, contractors or agents; or (ii) any breach of this Agreement by Sponsor, its affiliates, or its and their respective directors, officers, employees, contractors or agents.

7.	No Party may assign any rights or obligations resulting from the Agreement to any third party without prior written consent of the other Party.

8.	Any representations of the Parties as specified herein shall be made in writing, otherwise null and void.

Except for cases expressly indicated in the Agreement, all statements, notices, calls etc. connected with the Agreement must be delivered to the addresses of the Parties defined in the preamble hereof, otherwise void and ineffective. Either Party should notify the other of the change of its address in accordance with this paragraph. Such notice shall be deemed properly served by the Party after its receipt by the addressee. All and any notices and statements sent thus far in connection with this Agreement to the addresses given above shall be deemed as served effectively.

10.	Provisions of § 4, § 6, § 8 and § 10 of the Agreement shall remain in force despite its expiry or termination for any reason.

11.	For the avoidance of doubt, this Agreement and the Protocol may only be amended by the agreement in writing of duly authorized signatories of Sponsor and CRO, otherwise being null


VBL Confidential Information		Page 14 of 101 Version 2.2 02 DEC 2013

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

LOGO

and void. Changes in the Protocol may imply changes in the total course of the Study (costs, time-lines etc.).

12.	If any one or more provisions of this Agreement shall be found to be illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

13.

14.	The Agreement has been drawn up in two identical counterparts, one counterpart for each of the Parties.


CRO:		Sponsor:

Anna Baran /s/ Anna Baran		/s/ Amos Ron
Mike Jagielski /s/ Mike Jagielski		Vascular Biogenics Ltd.
		Amos Ron
		January 1, 2014


VBL Confidential Information		Page 15 of 101 Version 2.2 02 DEC 2013

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

LOGO

Attachment No. 1

Scope of Services:

Part A

Study Assumptions


STUDY ASSUMPTIONS
Number of countries involved		1
COUNTRIES INVOLVED		Poland
CRA staff involved		3
STUDY SITES		10
PATIENTS ENROLLED (# of expected)		50
NUMBER OF PATIENT’s VISITs IN SITE DURING THE STUDY		9
PLANNED NUMBER OF PAYMENTS FOR PI AND SITES DURING THE STUDY		3


VBL Confidential Information		Page 16 of 101 Version 2.2 02 DEC 2013

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

LOGO

Attachment No. 1

Scope of Services:

Part B

Division of Responsibilities CRO—Sponsor


	KCR	VBL Ltd.	Comments
STUDY INITIATION

Protocol development		X

Protocol review	X	X	KCR to review the draft of study protocol and provide VBL with comments.

Protocol approval		X

Protocol printing	X

Protocol distribution to sites	X

Preparation of amendments		X

CRF design and development (e CRF)		X

CRF review & approval		X

Preparation of master Informed Consent (IC) and Patient Information Sheet (PIS)		X

Revision and translation of Informed Consent and Patient Information Sheet according to local Ethical Committee requirements	X

Final approval of country specific IC and PIS		X	Based on back translation of local of Informed Consent and Patient Information Sheet. Approval process according to KCR SOP.

Monitoring Plan development	X

Monitoring Plan approval		X

Recruitment Plan development	X

Trial Master File Set-up	X

Distribution of Site Documents	X

Randomization schedule preparation	X


VBL Confidential Information		Page 17 of 101 Version 2.2 02 DEC 2013

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

LOGO


	KCR	VBL Ltd.	Comments
REGULATORY / ETHICS COMMITTEE SUBMISSIONS

Preparation of the documentation for Ethics Committees	X	X	VBL to provide : - Investigator’s Brochure - IMPD - CRF - Insurance certificate - Patient related scales/diaries - Certificate of analysis - Drug label - Manufacturing authorisation - GMP certificate KCR to provide VBL with country specific requirements regarding submission and to prepare submission package.

Submission of the documentation for Ethics Committees and follow up until authorisation	X

Preparation of the documentation for Regulatory Authorities	X	X	VBL to provide : - Investigator’s Brochure - IMPD - CRF - Insurance certificate - Patient rated scales/diaries - Certificate of analysis

	X	X	- Drug label - Manufacturing authorisation - GMP certificate KCR to provide VBL with country specific requirements regarding submission and to prepare submission package.

Submission of the documentation for Regulatory Authorities and follow up until authorisation	X


VBL Confidential Information		Page 18 of 101 Version 2.2 02 DEC 2013

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

LOGO


	KCR	VBL Ltd.	Comments
TRANSLATIONS

Translations	X		Relevant for patient-related documents, labels, Power of Attorney

SITE RECRUITMENT AND INITIATION

Investigator’s Site Identification	X

Investigator’s Site Selection	X

Final Site Selection	X	X	KCR to provide VBL with pre-study visit reports and lists of recommended sites in all selected countries. VBL to approve selected sites.

Conduct Site Selection Visits	X

Negotiate Investigators/Sites Contracts	X

Final Approval for Investigators/Sites Contracts		X

Signature on Investigators/Sites Contracts	X

Regulatory Documents collection & review	X

Conduct Site Initiation Visits	X

INVESTIGATOR MEETING

Investigator’s Meeting Planning	X

Investigator’s Meeting Preparation	X	X	VBL to present: - VB-201: Scientific Background - Phase I/II Experience & Development Plan - Study Design & Objectives - Protocol Overview - Eligibility Criteria - Study Specific Procedures - Study Assessment Scales KCR to present: - Communication Plan - Timelines & Recruitment Strategies - ICH GCP Refreshment

Investigator’s Meeting Attendance	X	X


VBL Confidential Information		Page 19 of 101 Version 2.2 02 DEC 2013

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

LOGO


	KCR	VBL Ltd.	Comments

STUDY DRUG MANAGEMENT/ CENTRAL LABORATORY MANAGEMENT

Clinical Trial Supply Logistics Management		X

Packaging and labeling of study medication		X

Distribution of study medication to sites		X

Destruction of unused supplies		X

Randomization list management		X

Central Laboratory Supplies and Logistic Set-up/Courier Management		X	By VBL subcontractor.

Central Laboratory Management		X	VBL subcontractor to manage the central laboratory.

STUDY MONITORING

Conduct Site Monitoring Visits	X

Communication with Sites	X

Monitoring visit reports preparation and review	X

Monitoring visit reports final approval		X

S.D.V.: (100% of patients, 100% of key study parameters)	X

Periodic Regulatory Document Collection / Updates (Investigator’s Master File management)	X

Data review/correction on all CRF’s	X

Resolution of Queries with Sites	X

SAE Reconciliation with Sites	X

Conduct Site Close-out / Termination Visits	X

Drug accountability during study and final drug record reconciliation	X

End of Study Notification to Regulatory Agencies/ECs	X


VBL Confidential Information		Page 20 of 101 Version 2.2 02 DEC 2013

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

LOGO


	KCR	VBL Ltd.	Comments
CLINICAL STUDY MANAGEMENT

Maintain Central Trial Master File	X

Fortnightly enrolment updates and Weekly Status Reports to Sponsor	X

Administered Investigator’s Payments	X		KCR will be responsible for bank transfers.

Prepare and Distribute Newsletter (if applicable)		X

Central File Archiving		X

Clinical Team Communication	X		KCR to provide Communication Plan.

MEDICAL MONITORING

Development of Medical Monitoring Plan		X

Provide Medical Oversight to CRO Project Team		X

Medical Communication/Consultation with Sites		X

Patient Eligibility - Medical Review		X

Review Safety Data Listing		X

Review CRFs for safety/efficacy		X

Review Safety Laboratory Data		X

Review of Data Management Coding		X

Review of Data Management SAE reconciliation		X

Organization of Data Safety Monitoring Board Meeting		X

SAFETY MONITORING

Safety Plan Preparation		X

SAE Reporting Procedure and Database Set-up		X

Receipt & Review of Initial SAE Report from Site	X

Tracking /Analyzing SAE Report		X

Entering SAE into Database		X

Writing SAE Narrative		X

Expectedness Judgment for SAE & Regulatory Reporting Assessment		X

Final Medical and Regulatory Judgment		X

Preparing Annual Report for Competent Authority in EU (inc. safety update)		X

Reporting Expedited SAEs to Regulatory Authorities		X

Reporting Expedited SAEs to Investigators and EC	X

Ongoing SAE File Maintenance		X


VBL Confidential Information		Page 21 of 101 Version 2.2 02 DEC 2013

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

LOGO


	KCR	VBL Ltd.	Comments
DATA MANAGEMENT

Preparation of Data Management Documentation such as Data Management Plan, Data Review Plan, Data Handling Guiding		X

EDC collector development		X

Data Review, Query Generation		X

Query Resolution	X

Import of Electronic (Laboratory) Data		X	By VBL subcontractor

Reconciliation of SAEs		X

Provision of data extracts during study to support interim analyses		X

Documentation Maintenance		X

Archiving of EDC tool, Archiving of Data Management Material		X

STATISTICS AND REPORTING

Development of Statistical Analysis Plan		X

Final Approval for Statistical Analysis Plan		X

Creation of Analysis Dataset (Statistical analysis of the dataset)		X

Programming of Tables, Figures and Listings		X

PK parameters calculation		X

Development of interim and final Integrated Statistical/Clinical Report in conformity to ICH guideline and CTD		X

Review of final Integrated Statistical/Clinical Report in conformity to ICH guideline and CTD		X

Final Approval for clinical Study Report		X

Writing of SAE and AE Discontinuation Narratives		X

AUDITS

Conduct of GCP Audits of Investigator’s Sites	X

Conduct of Quality Assurance Audit of Database		X

PROJECT MANAGEMENT

Management of the study team	X

Communication with study sponsor and vendors	X

Coordination of start-up activities, realization phase and closure	X

Oversees the regulatory document collection and submission process.	X

Control and track the budget monthly and cumulative realization	X

Preparation of Risk Management Plan and/or Contingency Plan, if required	X

CONTRACTS AND PAYMENTS

Preparation of study contracts	X

Signature and payments	X	X

Payment of Ethics Committees’ fees	X


VBL Confidential Information		Page 22 of 101 Version 2.2 02 DEC 2013

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

LOGO

Attachment No. 2

Timelines

STUDY TIMELINES


[***]			[***]


VBL Confidential Information		Page 23 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Attachment No. 3

Study Protocol

CLINICAL PROTOCOL


Title:		A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis

Protocol No.		VB-201-079

Eudra CT No.:		2012-002763-10

Investigational		VB-201
Product:

Indication:		Plaque Psoriasis

Development		2
Phase:

Sponsor:		Vascular Biogenics Ltd.
		6 Jonathan Netanyahu St.
		Or Yehuda, Israel 60376
		Phone: 972-3-6346450
		Fax: 972-3-6346449

Version:		2.2 (Poland and Israel only)

Date:		December 2, 2013

CONFIDENTIAL

This document contains proprietary and confidential information of VBL. Acceptance of this document constitutes agreement by the recipient that no previously unpublished information contained herein will be published or disclosed without the prior written approval of Vascular Biogenics Limited with the exception that this document may be disclosed to study personnel under your supervision who need to know the contents for conducting the study and appropriate Institutional Review Boards (IRBs)/Ethics Committees (IEC) under the condition that the personnel have agreed to keep this information confidential. The foregoing shall not apply to disclosure required by governmental regulations or laws, however, VBL shall be promptly notified of any such disclosure.


VBL Confidential Information		Page 24 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

AUTHOR SIGNATURE PAGE

The undersigned have written, reviewed and approved the following protocol:


Ron Goldblum, MD	/s/ Ron Goldblum	02 DEC 2013
Medical Monitor	Signature	Date
Vascular Biogenics Ltd

Naamit Sher, PhD	/s/ Naamit Sher	3 Dec 2013
Vice President	Signature	Date
Drug Development & RA
Vascular Biogenics Ltd


VBL Confidential Information		Page 25 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

CONFIDENTIALITY AND INVESTIGATOR STATEMENT

Vascular Biogenics Limited

Clinical Research Protocol

VB-201-079

I agree to abide by the statement of confidentiality.

I agree to comply with the current International Conference on Harmonisation (ICH) Guideline on Good Clinical Practice (GCP), applicable laws and regulations, and the Declaration of Helsinki.

I agree to conduct the Study in person or to supervise the Study.

I agree to ensure that all who assist me in the conduct of the Study have access to the Study protocol and any amendments and are aware of their obligations.



Principal Investigator				Date (dd/mmm/yyyy)

Printed Name:

Institution:

Address:


VBL Confidential Information		Page 26 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

TABLE OF CONTENTS


1.0	STUDY SYNOPSIS		31

2.0	LIST OF ABBREVIATIONS		44

3.0	INTRODUCTION		46

	3.1	Psoriasis: Pathophysiology and Unmet Medical Need	46

	3.2	Name and description of the investigational product	46

	3.3	Summary of findings from nonclinical studies relevant to the trial	46

	3.4	Summary of findings from clinical studies	48

		3.4.1 VB-201 Phase I Studies	48

		3.4.2 VB-201 Phase II studies	48

	3.5	Rationale for Route of Administration, Pharmaceutical Form, Dosage, Dosage Regimen and Treatment Period	50

	3.6	Rationale for the PASI 50 Endpoint	50

	3.7	Rationale for the Use of Placebo	51

4.0	OBJECTIVES		52

	4.1	Safety Objective	52

	4.2	Efficacy Objective	52

	4.3	Exploratory Biomarker	52

5.0	INVESTIGATIONAL PLAN		52

	5.1	Study Design	52

	5.2	Number of Patients	52

	5.3	Subject Selection	54

		5.3.1 Inclusion Criteria	54

		5.3.2 Exclusion Criteria	54

	5.4	Subject Screening and Randomization	56

	5.5	Duration of Participation	56

	5.6	Protocol Amendments	56

	5.7	Withdrawal Criteria	56

	5.8	Study/Study Site Termination	57

6.0	STUDY DRUG		57

	6.1	Formulation, Packaging, and Labeling	57

	6.2	Storage and Handling	58

	6.3	Accountability	58


VBL Confidential Information		Page 27 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201



	6.4	Access to Blinded Treatment	58

	6.5	Administration of Study Drug	59

		6.5.1 Dosage	59

		6.5.2 Assignment of Treatment Cartons	60

		6.5.3 Compliance	60

7.0	PRIOR AND CONCOMITANT MEDICATION		60

8.0	OUTCOME MEASURES		61

	8.1	Efficacy Assessments	61

	8.2	Safety Assessments	64

		8.2.1 Physical Examination Assessments	64

		8.2.2 Clinical Laboratory & Other Safety Assessments	64

		8.2.3 Population Pharmacokinetics	65

		8.2.3.1 Blood and Urine Samples	66

		8.2.3.2 Risk Assessment	66

		8.2.4 Study Withdrawals	66

		8.2.5 Adverse Events and Serious Adverse Events	66

	8.3	Exploratory Assessments	66

		8.3.1 Inflammatory Related Biomarkers	67

9.0	SCHEDULE OF STUDY ASSESSMENTS		67

	9.1	Screening Visit	67

	9.2	Baseline	67

	9.3	Week 2	68

	9.4	Week 4, 8, 12	69

	9.5	Week 16	69

	9.6	Week 20	70

	9.7	Week 24/ Early Termination	70

	9.8	Week 28	71

10.0	ADVERSE EVENTS		71

	10.1	Definition of Adverse Event	71

	10.2	Definition of Serious Adverse Event	72

	10.3	Reporting and Documentation	73

	10.4	Patient Stopping Rules	74

	10.5	Pregnancy	75

11.0	STATISTICAL CONSIDERATIONS		75


VBL Confidential Information		Page 28 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201



	11.1	Statistical Methods		75

		11.1.1	Comparisons of Interest	75

		11.1.2	Sample Size Determination	75

		11.1.3	Subject Population/Data Sets To Be Evaluated	75

		11.1.3.1 Modified Intent-To-Treat (MITT) Population		75

		11.1.3.2 Per-Protocol Population		76

		11.1.3.3 Safety Population		76

		11.1.4	Randomization	76

	11.2	Statistical Analyses		76

		11.2.1	Subject Disposition	77

		11.2.2	Demography	77

		11.2.3	Efficacy Analysis	77

		11.2.3.1 Primary Efficacy Endpoints		77

		11.2.3.2 Secondary Efficacy Endpoints		78

		11.2.3.3 Tertiary Endpoints		79

		11.2.4	Safety Analysis	80

		11.2.4.1 Adverse Events		80

		11.2.4.2 Laboratory Parameters		80

		11.2.4.3 Vital Signs		81

		11.2.4.4 Withdrawals		81

		11.2.4.5 Deaths		81

		11.2.4.6 Dropouts		81

		11.2.5	Concomitant Medications	81

12.0	DATA RECORDING, MONITORING, AND RETENTION			81

	12.1	Source Documents		81

	12.2	Case Report Forms (CRFs)		81

	12.3	Record Retention		81

	12.4	Monitoring Requirements		82

	12.5	Subject Confidentiality		82

13.0	ETHICS			83

	13.1	Ethical Conduct of the Study		83

	13.2	Local Regulatory Approval		83

	13.3	Ethics Committee Approval		84

	13.4	Subject Information and Informed Consent		84


VBL Confidential Information		Page 29 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


14.0 PUBLICATION			85

15.0 LIST OF APPENDICES			85

16.0 REFERENCES			87

LIST OF TABLES

Table 1: Schedule of Procedures for VB-201-079 (Psoriasis)			42

Table 2. Composition of the patient identification number			53

Table 3. Composition of the randomization number			53

Table 4. VB-201 Drug Distribution			59

Table 5. Clinical Assessments Relating to Efficacy			62

Table 6. Physical Examination Assessments Relating to Safety			64

Table 7. Clinical Laboratory & Other Assessments Relating to Safety			65

Table 8. Population Pharmacokinetics			66

Table 9. Clinical Laboratory for Exploratory Assessments			66


VBL Confidential Information		Page 30 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

1.0 STUDY SYNOPSIS


Title of Study:		A Randomized, Double-Blind, Dose-Ranging, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis

Sponsor:		VBL

Phase:		Phase 2

Patient Population:		Male or female patients > 18 to < 75 of age with moderate to severe, stable, active plaque Psoriasis Vulgaris affecting between 10% to 30% of the body surface and with a Psoriasis Area and Severity Index (PASI) score of 10 to 20

Efficacy Objective:		To examine the effect of treatment with two different doses of VB-201 compared to placebo for 16 weeks and 24 weeks on measures of disease activity in patients with psoriasis.

Safety Objective:		To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 vs. placebo in patients with psoriasis.

Study Design:		[***]


VBL Confidential Information		Page 31 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


Dosage Regimen and Treatment Groups		[***]

Investigative Product Name and Description		[***]

Number of Subjects:		;[***]

Duration of Participation:		[***]


VBL Confidential Information		Page 32 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


Eligibility Criteria Inclusion Criteria		[***]

Exclusion Criteria		[***]


VBL Confidential Information		Page 33 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


		4. [***]


VBL Confidential Information		Page 34 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


		[***]

Concomitant		[***]


VBL Confidential Information		Page 35 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


Medications:		[***]

Safety Endpoints:		[***]

Stage 1 Primary Efficacy Endpoint:		[***]

Stage 1 Secondary Endpoints:	1.	[***]


VBL Confidential Information		Page 36 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


		[***]

Stage 1 Tertiary Endpoints:	1.	[***]


VBL Confidential Information		Page 37 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


Stage 2 Primary Efficacy Endpoint:				[***]


VBL Confidential Information		Page 38 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


Stage 2 Secondary Endpoints:	1.	[***]

Stage 2 Tertiary Endpoints:	1.	[***]


VBL Confidential Information		Page 39 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201



	4.	[***]

Compliance Measures		[***]

Study Conduct		[***]

Statistical Methods		[***]


VBL Confidential Information		Page 40 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201



Rationale for Number of Subjects:				[***]


VBL Confidential Information		Page 41 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Table 1: Schedule of Procedures for VB-201-079 (Psoriasis)

Evaluation

[***]

STAGE 1

STAGE 2

Study Day

[

***]

[***]

Assessment Window (±Days)

[***]

Informed Consent

Inclusion/ Exclusion Criteria

[***]

X ¹

[***]

(X) ³

[***]

X ⁴

[***]

X ⁵

X ⁶

[***]

X ⁷

[***]

[***] ⁸

[***]


VBL Confidential Information		Page 42 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Figure 1. STUDY DIAGRAM

LOGO


VBL Confidential Information		Page 43 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

2.0

LIST OF ABBREVIATIONS


Abbreviation/ Acronym		Definition

AE		Adverse Event

ALT		Alanine transaminase

ANCOVA		Analysis of Covariance

AST		Aspartate transaminase

BSA		Body Surface Area

BUN		Blood Urea Nitrogen

CFR		Code of Federal Regulations

CRA		Clinical Research Associate

CRF		Case Report Form

CRO		Contract Research Organization

DLQI		Dermatology Life Quality Index

DSM-LV-TR		Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition

ECG		Electrocardiogram

eCRF		Electronic Case Report Form

EDC		Electronic Data Capture

ET		Early Termination

FDA		Food and Drug Administration

GCP		Good Clinical Practice

GGT		Gamma Glutamyl Transferase

Hb		Hemoglobin

HIPAA		Health Insurance Portability and Accountability Act

HIV		Human Immunodeficiency Virus

ICH		International Conference on Harmonization

IEC		Independent Ethics Committee

IL		Interleukin

IRB		Institutional Review Board

IUD		Intrauterine Device

IVRS / IWRS		Interactive Voice Response System/Interactive Web Response

LOCF		Last Observation Carried Forward

MCH		Mean Corpuscular Hemoglobin

MCHC		Mean Corpuscular Hemoglobin Concentration

MCV		Mean Corpuscular Volume


VBL Confidential Information		Page 44 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


Abbreviation/ Acronym		Definition

MedDRA		Medical Dictionary for Regulatory Activities

MITT		Modified Intent-To-Treat

PASI		Psoriasis Area and Severity Index

PBMC		Peripheral Blood Mononuclear Cells

PGA		Physician Global Assessment

PIF		Pregnancy Information Form

PK		Pharmacokinetics

PO		By Mouth

QD		Once Daily

RBC		Red Blood Cell

SAE		Serious Adverse Event

SUSAR		Suspected Unexpected Serious Adverse Reaction

TNF- a		Tumor Necrosis Factor- a

ULN		Upper Limit of Normal

URI		Upper Respiratory Infection

UTI		Urinary Tract Infection

VAS		Visual Analogue Scale

VBL		Vascular Biogenics Ltd.

WBC		White Blood Cell

WHO		World Health Organization


VBL Confidential Information		Page 45 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

3.0

INTRODUCTION

3.1

Psoriasis: Pathophysiology and Unmet Medical Need

Psoriasis is a life-long, immune-mediated inflammatory skin disease of unknown etiology, affecting up to 3% of the general population, with rates varying among geographic areas and races. ¹ Over 80% of patients have chronic plaque psoriasis, characterized by recurrent exacerbations and remissions of thickened, erythematous, scaly patches of skin that can occur anywhere on the body.

Psoriatic symptoms can cause physical discomfort (pain and pruritus), and when combined with the psychological effects of the disease often interfere with everyday activities and negatively impact a patient’s quality of life. ^2,3 While there are many available treatments, these agents each have limited efficacy and/or significant side effects. Thus, there remains a significant unmet need for a therapy that will provide high continuous efficacy and improved safety profile.

It is currently believed that environmental factors, including microorganisms, instigate a cascade of events which lead to psoriasis initiation. ⁴ Once encountered by microbial components, toll-like receptors (TLR) expressed on keratinocytes and dermal dendritic cells mediate the secretion of pro-inflammatory cytokines such as IL-6, IL-1, IL-12 and IL-23. ^5,6 These cytokines induce the generation of Th1 and Th17 cells which promote psoriasis pathogenesis. ^7,8,9

Vascular Biogenics Ltd (VBL) has developed a small molecule, VB-201 (formerly known as CI-201 as seen in some of the figures) a new class of compounds, oxidized phospholipid analogs (lecinoxoids). VB-201 was found to inhibit TLR signaling restricted to TLR2 and TLR4, an effect attributed to its binding to TLR2 and CD14. Consequently, when activated using TLR4 and TLR2 agonists in the presence of VB-201, antigen presenting cells showed impaired production of the Th1 and Th17- polarizing cytokines IL-12(p40) and IL-6 respectively.

Given the putative TLR complicity in psoriasis, VB-201 has the potential to be an orally active drug for treating psoriasis.

The current study is designed to test safety, efficacy, and tolerability of an oral preparation of VB-201 in patients with chronic plaque psoriasis.

3.2

Name and description of the investigational product

[***]

3.3

Summary of findings from nonclinical studies relevant to the trial

[***]


VBL Confidential Information		Page 46 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

5) [***]

[***]


VBL Confidential Information		Page 47 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

3.4

Summary of findings from clinical studies

3.4.1

VB-201 Phase I Studies

[***]

3.4.2

VB-201 Phase II studies

VB-201 was further used in two Phase II clinical trials:

1. [***]


VBL Confidential Information		Page 48 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

2. VB-201-030: [***]


VBL Confidential Information		Page 49 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

3.5

Rationale for Route of Administration, Pharmaceutical Form, Dosage, Dosage Regimen and Treatment Period

[***]

3.6

Rationale for the PASI 50 Endpoint

[***]


VBL Confidential Information		Page 50 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

3.7

Rationale for the Use of Placebo

[***]


VBL Confidential Information		Page 51 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

4.0

OBJECTIVES

4.1

Safety Objective

•

To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in patients with psoriasis.

4.2

Efficacy Objective

•

Stage 1: To examine the effect of treatment with two different doses of VB-201 compared to placebo (initial 16 weeks) on measures of disease activity in patients with psoriasis.

•

Stage 2: To examine the effect of treatment with two different doses of VB-201 compared to placebo (24 weeks) on measures of disease activity in patients with psoriasis.

4.3

Exploratory Biomarker

•

[***]

5.0

INVESTIGATIONAL PLAN

5.1

Study Design

[***]

5.2

Number of Patients

[***]


VBL Confidential Information		Page 52 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

Table 2. Composition of the patient identification number


	Combined site number
Letter	Country number		Site number	Patient number
S	Germany	01	Site numbers will be assigned in an ascending order: 01, 02, 03, 04…	Patient numbers will be assigned in an ascending order: 01, 02, 03, 04,…
	Spain	02
	Israel	03
	Poland	04

The 7-digit randomization number is a combination of the letter R (1 digit), the combined site number (4 digits), consisting of the country number (2 digits) and the site number (2 digits) and the patient number (2 digits). The site number is identical to the site number of the patient identification number. Patient numbers of the randomization number will start with 51 to ensure clear distinction from patient identification numbers. Example: R010151 is the site number 0101 and the patient number 51. Refer to Table 3 below.

Table 3. Composition of the randomization number


	Combined site number
Letter	Country number		Site number	Patient number
R	Germany	01	Site numbers will be assigned in an ascending order: 01, 02, 03, 04…	Patient numbers will be assigned in an ascending order: 51, 52, 53, 54,…
	Spain	02
	Israel	03
	Poland	04


VBL Confidential Information		Page 53 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

5.3

Subject Selection

5.3.1

Inclusion Criteria

[***]

5.3.2

Exclusion Criteria

Patients who meet ANY of the following criteria will be excluded from participation in this study:

1. [***]


VBL Confidential Information		Page 54 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

•

[***]


VBL Confidential Information		Page 55 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

5.4

Subject Screening and Randomization

[***]

5.5

Duration of Participation

[***]

5.6

Protocol Amendments

[***]

5.7

Withdrawal Criteria

[***]


VBL Confidential Information		Page 56 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

5.8

Study/Study Site Termination

[***]

6.0

STUDY DRUG

6.1

Formulation, Packaging, and Labeling

[***]


VBL Confidential Information		Page 57 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

6.2

Storage and Handling

The study drug should be stored on site at room temperature, in a secured location with access limited to authorized personnel. All boxes of study drug, both used and unused, must be saved for a drug audit by the Sponsor clinical monitor or an assigned designee. Once dispensed to the study subjects the study drug should be stored at room temperature. Subjects should be instructed on the proper storage methods and conditions.

6.3

Accountability

Study drug (VB-201 and placebo) will be supplied by the Sponsor. It is the responsibility of the Principal Investigator to supervise accurate monitoring of the receipt, storage, dispensing, and accounting of all study drug according to accepted medical and pharmaceutical practice.

Copies of all invoices of study drug shipments must be retained. Accurate, original site records of study drug inventory and dispensing must be maintained using the forms provided. All shipment, accountability, and dispensing records must be made available for inspection by the Sponsor or the designated CRO upon request.

Each site must keep all used and unused cartons in their original kit packaging until the Study Monitor either arranges return to the distribution center or gives instruction on their disposal. If any unused cartons remain at the end of the study, they will be accounted for at the Site Close-Out Visit in the presence of the Study Monitor, who will provide instructions on their disposal. If the Study Monitor directs the site to dispose of study drug or empty blister packs, disposal should be according to the institution standard operating procedures and all applicable local and national regulations.

6.4

Access to Blinded Treatment

A subject’s treatment assignment should only be unblinded when knowledge of the treatment is essential for the further management of the subject. Unblinding for any other reason will be considered a protocol violation.


VBL Confidential Information		Page 58 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

The Principal Investigator should make every effort to contact either the CRO or the Sponsor before unblinding any subject’s treatment assignment, but must do so within one working day after the event and must document the unblinding in the subject’s source documentation.

The identity of the treatment group assigned to subjects can be provided, in an emergency only, by the centralized randomization system via the CRO. The Principal Investigator or his/her designee is responsible for ensuring that the instructions on how to perform a code break are stored safely, that their location is known, and that access is readily available to the relevant staff in case of an emergency. A separate Sponsor representative who is not involved with the study will also have access to unblinding information if required.

The CRO’s safety officer will report SUSARs on the Sponsor’s behalf and will break the blind for SUSAR reporting.

6.5

Administration of Study Drug

6.5.1

Dosage

[***]

Table 4. VB-201 Drug Distribution


VBL Confidential Information		Page 59 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201


Treatment Group	Carton AM	Carton PM
[***]	[***]	[***]

Subjects will be instructed to take 2 capsules from the morning blister (white) pack at breakfast time with food and 2 capsules from the evening blister (silver) pack at dinner time with food every day for up to 24 weeks.

Each carton will be labeled to meet regional regulatory requirements. All capsules will be identical in appearance. There is no provision under this protocol for dose adjustments by the Investigator.

6.5.2

Assignment of Treatment Cartons

At each visit, the Investigator or designee will first assess the subject to confirm eligibility to continue to receive study drug. After eligibility is confirmed, study medication with the appropriate subject number can be distributed to the subject [***]

6.5.3

Compliance

[***]

7.0

PRIOR AND CONCOMITANT MEDICATION

[***]


VBL Confidential Information		Page 60 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

8.0

OUTCOME MEASURES

8.1

Efficacy Assessments

[***]


VBL Confidential Information		Page 61 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Table 5. Clinical Assessments Relating to Efficacy


Assessment	Study Visit	Description
[***]	[***]	[***]


VBL Confidential Information		Page 62 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Table 5. Clinical Assessments Relating to Efficacy (cont.)


Assessment	Study Visit	Description
[***]	[***]	[***]

W-week, D-day, ET-early termination

[***]


VBL Confidential Information		Page 63 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Plaque Photography

[***]

8.2

Safety Assessments

8.2.1

Physical Examination Assessments

The physical exam assessments relating to safety to be performed during the study are described in Table 6.

Table 6. Physical Examination Assessments Relating to Safety


Assessment	Study Visit	Description
[***]	[***]	[***]

W-week, D-day, ET-early termination

8.2.2

Clinical Laboratory & Other Safety Assessments

The clinical laboratory and other tests relating to safety to be performed during the study are described in Table 7.


VBL Confidential Information		Page 64 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Table 7. Clinical Laboratory & Other Assessments Relating to Safety


Assessment	Study Visit	Description
[***]	[***]	[***]

W-week, D-day, ET-early termination

*	If values are abnormal at the Week 24/ET visit, they should be repeated at the Week 28 visit to ensure values have returned to within normal limits.

8.2.3

Population Pharmacokinetics

Blood collected for trough levels of VB-201 during the study are described in Table 8:


VBL Confidential Information		Page 65 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Table 8. Population Pharmacokinetics


Assessment	Study Visit	Description
[***]	[***]	[***]

8.2.3.1

Blood and Urine Samples

[***]

8.2.3.2

Risk Assessment

[***]

8.2.4

Study Withdrawals

[***]

8.2.5

Adverse Events and Serious Adverse Events

Adverse events and serious adverse events (SAEs) are discussed in detail in Section 9.

8.3

Exploratory Assessments

The clinical laboratory and other tests relating to exploratory assessments to be performed during the study are described in Table 9:

Table 9. Clinical Laboratory for Exploratory Assessments


Assessment	Study Visit	Description
[***]	[***]	[***]

D- day, W-week, ET-early termination


VBL Confidential Information		Page 66 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

8.3.1

Inflammatory Related Biomarkers

[***]

9.0

SCHEDULE OF STUDY ASSESSMENTS

[***]

9.1

Screening Visit

[***]

9.2

Baseline

[***]


VBL Confidential Information		Page 67 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

•

[***]

NOTE: [***]

9.3

Week [***]

Each subject will be contacted by telephone at Week [***] and the following will be performed:


VBL Confidential Information		Page 68 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

•

[***]

9.4

Week [***]

Each of the following assessments will be performed on Week, [***]

•

[***]

9.5

Week [***]

Each of the following assessments will be performed on Week [***]:

•

[***]


VBL Confidential Information		Page 69 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

•

[***]

9.6

Week [***]

Each of the following assessments will be performed on Week [***]

•

[***]

9.7

Week [***]

Each of the following assessments will be performed at Week [***] or, if a subject discontinues early from the study:

•

[***]


VBL Confidential Information		Page 70 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

•

[***]

9.8

Week [***]

Patients who complete the Week [***] and those who discontinue early from the study will return to the clinic on Week [***] after their last study medication dose if the subject discontinued early from the study, for a follow-up evaluation and the following assessments:

•

[***]

10.0

Adverse Events

10.1

Definition of Adverse Event

[***]


VBL Confidential Information		Page 71 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

Severity Assessment

[***]

Causality Assessment

[***]

10.2

Definition of Serious Adverse Event

[***]


VBL Confidential Information		Page 72 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

•

[***]

10.3

Reporting and Documentation

The Investigator must report all directly observed AEs and all spontaneously reported AEs. At each visit the Investigator will ask the subject a nonspecific question (e.g., “Have you noticed anything different since your last visit?”) to assess whether any AEs have been experienced since the last report or visit. AEs will be identified and documented on the AE page of the CRF in appropriate medical terminology. Details of the event must include severity, relationship to study drug, duration, action taken, and outcome.

The action(s) taken regarding the AE are classified as follows:

Treatment for event

•

None

•

Concomitant medication given or changed

•

Hospitalization

•

Others

•

Unknown (only applicable if patient has been lost to follow up).

Action taken with study medication

•

None


VBL Confidential Information		Page 73 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

•

Temporary discontinuation

•

Permanent discontinuation

•

Unknown (only applicable if patient has been lost to follow up).

The outcome of the AE is classified as follows

•

Recovered

•

Recovered with sequelae

•

Not recovered

•

Death

•

Unknown (only applicable if patient has been lost to follow up).

Furthermore it must be stated if the study was discontinued permanently for patient (yes, no) due to the AE/ SAE

The Principal Investigator is responsible for evaluating all AEs, obtaining supporting documents, and determining that documentation of the event is adequate. The Principal Investigator may delegate these duties to Sub-investigators and must assure that these Sub-investigators are qualified to perform these duties under the supervision of the Principal Investigator.

In the event that a subject is withdrawn from the study because of an AE, it must be recorded on the CRF. The subject should be followed and treated by the Investigator until the AE has resolved or a new chronic baseline has been established.

Any SAE, whether or not considered related to the study drug, must be reported immediately (within 24 hours) upon learning of the event (See Study Manual). The Investigator or his designee should complete the study-specific SAE Report Form. Investigators should not wait to collect additional information that fully documents the event before notifying VBL or its designee of an SAE. Contact numbers for reporting SAEs and events of concern will be provided prior to the start of the study.

It is the responsibility of the Investigator to report SAEs to their IRB/IEC according to the standard operating procedures and policies of the IRB or EC. At a minimum, events identified by the Sponsor to require expedited reporting as serious, unexpected, and possibly related to study drug must be brought to the attention of the responsible IRB/IEC. Adequate documentation must be provided to VBL or its designee that the IRB or EC was properly notified.

10.4

Patient Stopping Rules

The following stopping rules will be utilized in this study:

[***]


VBL Confidential Information		Page 74 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

Subjects who permanently discontinue study medication shall return for an Early Termination visit and subsequently for a final safety visit 4 weeks from the last dose.

10.5

Pregnancy

[***]

11.0

STATISTICAL CONSIDERATIONS

11.1

Statistical Methods

11.1.1

Comparisons of Interest

[***]

11.1.2

Sample Size Determination

[***]

11.1.3

Subject Population/Data Sets To Be Evaluated

11.1.3.1

Modified Intent-To-Treat (MITT) Population

[***]


VBL Confidential Information		Page 75 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

11.1.3.2

Per-Protocol Population

[***]

11.1.3.3

Safety Population

[***]

11.1.4

Randomization

[***]

11.2

Statistical Analyses

[***]


VBL Confidential Information		Page 76 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

11.2.1

Subject Disposition

[***]

11.2.2

Demography

[***]

11.2.3

Efficacy Analysis

[***]

11.2.3.1

Primary Efficacy Endpoints

11.2.3.1.1

Stage 1 Primary Efficacy Endpoints

[***]

11.2.3.1.2

Stage 2 Primary Efficacy Endpoints

[***]


VBL Confidential Information		Page 77 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

11.2.3.2

Secondary Efficacy Endpoints

11.2.3.2.1

Stage 1 Secondary Efficacy Endpoints

[***]

11.2.3.2.2

Stage 2 Secondary Efficacy Endpoints

[***]


VBL Confidential Information		Page 78 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

11.2.3.3

Tertiary Endpoints

11.2.3.3.1

Stage 1 Tertiary Endpoints

[***]

11.2.3.3.2

Stage 2 Tertiary Endpoints

[***]


VBL Confidential Information		Page 79 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

[***]

11.2.4

Safety Analysis

[***]

11.2.4.1

Adverse Events

[***]

11.2.4.2

Laboratory Parameters

[***]


VBL Confidential Information		Page 80 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

11.2.4.3

Vital Signs

[***]

11.2.4.4

Withdrawals

[***]

11.2.4.5 Deaths

All deaths will be listed.

11.2.4.6

Dropouts

Dropout rates due to rescue intervention in each of the VB-201 groups will be compared to the placebo group using Fisher’s exact test.

11.2.5

Concomitant Medications

[***]

12.0

DATA RECORDING, MONITORING, AND RETENTION

12.1

Source Documents

Source records are original documents, data, and records (e.g., medical records, raw data collection forms, pharmacy dispensing records, recorded data from automated instruments, laboratory data) that are relevant to the clinical trial. The Investigator will prepare and maintain adequate and accurate source documents. These documents are designed to record all observations and other pertinent data for each subject enrolled in this clinical trial. Source records must be adequate to reconstruct all data transcribed onto the Case Report Forms (CRFs).

12.2

Case Report Forms (CRFs)

All data will be recorded on electronic data capture (EDC) system CRFs provided by the Sponsor or its designee. All electronic case report forms (eCRFs) should be completed by designated study personnel in a timely fashion.

All missing data must be explained in the subject’s source record. All eCRFs must be reviewed and verified by the investigator for accuracy, completeness, legibility, and timeliness of reporting to the Sponsor.

12.3

Record Retention

Investigators are required to maintain all study documentation, informed consent forms and subject information sheets and adequate records for the receipt and disposition of all study drugs in a secure and safe facility.


VBL Confidential Information		Page 81 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Essential documents must be retained for at least 2 years following the FDA or other regulatory approval date of the drug, or until two years after the drug investigational program is discontinued unless a longer period is required by applicable law or regulation. Only the Sponsor can notify an Investigator when any records may be discarded. If the investigator wishes to assign responsibility for the study records to another party or have them moved to another location, the Sponsor must be notified in advance. When the study documents no longer need to be retained, it is the responsibility of the Sponsor to inform the investigator/institution. Subject identity information will be maintained for 15 years unless a longer period is required by applicable law or regulation.

12.4

Monitoring Requirements

Following pre-qualification and initiation of the study site, periodic monitoring visits will be made by the Sponsor or its designated representative. The investigator must provide sufficient space and allocate sufficient time for the monitor to inspect subject source records, case report forms, drug accountability records, and regulatory documents.

The study monitor is responsible for visiting the study site at regular intervals to verify the following:

•

The rights and well-being of human Patients are protected;

•

The reported data are accurate, complete, and verifiable from source documents;

•

The conduct of the trial is in compliance with the currently approved protocol, amendment(s), International Conference on Harmonisation (ICH) Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and any other applicable national and local regulatory requirements.

The study monitor should have access to subject medical records and other study-related records needed to verify the entries in the database.

The Investigator must make study data accessible to the study monitor, the Sponsor, authorized representatives of the Sponsor (e.g., CRO), and Regulatory Agencies/Competent Authorities upon request.

12.5

Subject Confidentiality

The Investigator must ensure that the subject’s anonymity is maintained. On the CRFs or other documents submitted to the Sponsor and/or designated CRO, Patients should be identified by a Subject Identification number and/or randomization number.

Documents that are not for submission to the Sponsor and/or designated CRO (e.g., signed informed consent forms and subject information sheets) should be kept in strict confidence by the Investigator in compliance with Federal regulations/ICH GCP Guidelines. It is required that the Investigator and institution permit authorized representatives of the company, of the regulatory agency, and the IRB/IEC direct access to review the subject’s original medical records for verification of study-related procedures and data.


VBL Confidential Information		Page 82 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

representatives, although the confidentiality of his/her records will be maintained as much as reasonably possible.

For the purposes of the study, only the data set forth in this protocol (including the CRFs) will be obtained regarding participating Patients (whether screen failures or enrolled Patients). Such data shall:

•

be processed in accordance with this Protocol or as otherwise instructed by the Sponsor;

•

be processed solely for the purposes of the study and in the manner specified in this Protocol;

•

not be processed in any manner incompatible with the purposes of the study;

•

be accurate, up to date and corrected to address any inaccuracies or omissions;

•

not be disclosed to any third party without the Sponsor’s prior written consent; and

•

be maintained as detailed in Section 12.3 unless a longer period is required by applicable laws or regulations.

Any reasonably requested assistance shall be provided to assist the Sponsor to enable it to comply with any data-related notification obligations under applicable laws or regulations. In the US, conduct of this study will comply with all provisions of HIPAA. The Sponsor shall be promptly informed of any communication received from a study subject regarding the data collected about him/her in connection with the study.

13.0

ETHICS

13.1

Ethical Conduct of the Study

The study will be conducted in accordance with applicable national and international laws and regulations, the ICH-GCP guideline and the ethics principles that have their origins in the Declaration of Helsinki. The protocol and the proposed informed consent form have to been reviewed and approved by a properly constituted Independent Ethics Committee (IEC/IRB) before study start at a particular study site. Prior to study start, the principal investigator is required to sign the protocol signature page (page 3 of this study protocol) confirming his agreement to conduct the study in accordance with these documents and all of the instructions and procedures found in this protocol and to give access to all relevant data and records to monitors, auditors, IRBs/IECs, and regulatory authorities as required.

13.2

Local Regulatory Approval


VBL Confidential Information		Page 83 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

13.3

Ethics Committee Approval

The Principal Investigator at each site is responsible for obtaining Institutional Review Board (IRB) or Independent Ethics Committee (IEC), approval for the protocol, informed consent form/ information sheet, and any advertisements to recruit Patients before being implemented at the investigative site. Written approval of these documents must be obtained from the committee before any subject is enrolled at a center.

The Principal Investigator is also responsible for the following interactions with the IRB/IEC:

•

Obtaining IRB/IEC approval for any protocol amendments and informed consent form revisions before implementing the changes;

•

Providing the IRB/IEC with any required information before or during the study;

•

Notifying the IRB/IEC of all serious and unexpected AEs related to the study drug reported by the Sponsor or the CRO, as required. Documentation of this notification should be retained.

13.4

Subject Information and Informed Consent

No investigator may involve a human being as a subject in research unless the Investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An Investigator shall seek such consent only under circumstances that provide the prospective subject or the subject’s legally authorized representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in a language understandable to the subject or representative.

The Sponsor or its designated representative will provide the Investigator with a sample consent form. Local and/or institutional requirements may require disclosure of additional information in the informed consent. Any changes to the consent form must be submitted to the sponsor or its designated representative for approval prior to submission to the IRB/IEC. The IRB/IEC must review the consent form for approval/favorable opinion, and a copy of the approved consent form must be submitted to the Sponsor or its designated representative prior to initiation of the study.


VBL Confidential Information		Page 84 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

14.0

PUBLICATION

15.0

LIST OF APPENDICES

Appendix A: ELEMENTS OF THE PSORIASIS AREA AND SEVERITY INDEX (PASI)


VBL Confidential Information		Page 85 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

Appendix A: ELEMENTS OF THE PSORIASIS AREA AND SEVERITY INDEX (PASI)


	Head	Upper Extremities	Trunk	Lower extremities
[]*

[]*

[]*

[]*

[]*

[]*

[]*	[]*	[]*	[]*	[]*

[]*

[***]


VBL Confidential Information		Page 86 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

16.0

REFERENCES

1.	Krueger GG, Duvic M. Epidemiology of psoriasis: clinical issues. J Invest Dermatol. 1994;102(6):14S-8S.

2.	Kimball AB, Jacobson C, Weiss S, et al. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6(6):383-92.

3.	Russo PA, Ilchef R, Cooper AJ. Psychiatric morbidity in psoriasis: a review. Australas J Dermatol. 2004;45(3):155-9.

4.	Nestle FO, Kaplan DH, Barker J. Mechanisms of Disease: Psoriasis. N Engl J Med 2009 Jul;361:496-509.

5.	Nestle FO, Di Meglio P, Qin JZ. Skin immune sentinels in health and disease. Nature Reviews Immunology 2009 Oct;9:679-690.

6.	Di Meglio P, Perera GK, Nestle FO. The Multitasking Organ: Recent Insights into Skin Immune Function. Immunity 2011 Dec;35: 857-869.

Austin LM, Ozawa M, Kikuchi T, et al. The majority of epidermal T cells in Psoriasis vulgaris lesions can produce type 1 cytokines, interferon-gamma, interleukin-2, and tumor necrosis factor-alpha, defining TC1 (cytotoxic T lymphocyte) and TH1 effector populations: a type 1 differentiation bias is also measured in circulating blood T cells in psoriatic patients. J Invest Dermatol. 1999 Nov;113(5):752-9.

8.	Schlaak JF, Buslau M, Jochum W, et al. T cells involved in psoriasis vulgaris belong to the Th1 subset. J Invest Dermatol. 1994 Feb;102(2):145-9.

9.	Fitch E, Harper E, Skorcheva I, et al. A. Pathophysiology of psoriasis: recent advances on IL-23 and Th17 cytokines. Curr Rheumatol Rep. 2007 Dec;9(6):461- 7.

10.	Vascular Biogenics Ltd. VB-201 Investigator’s Brochure Version 13. Internal archive; 2012.


VBL Confidential Information		Page 87 of 101 Version 2.2 02 DEC 2013

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




Protocol VB-201-079		VB-201

CLINICAL PROTOCOL


		Title:		A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis

		Protocol No.		VB-201-079

		Eudra CT No.:		2012-002763-10

		Investigational Product:		VB-201

		Indication:		Plaque Psoriasis

		Development Phase:		2

		Sponsor:		Vascular Biogenics Ltd.
				6 Jonathan Netanyahu St.
				Or Yehuda, Israel 60376
				Phone: 972-3-6346450
				Fax: 972-3-6346449

		Version:		2.2 (Poland and Israel only)

		Date:		December 2, 2013

CONFIDENTIAL

This document contains proprietary and confidential information of VBL. Acceptance of this document constitutes agreement by the recipient that no previously unpublished information contained herein will be published or disclosed without the prior written approval of Vascular Biogenics Limited with the exception that this document may be disclosed to study personnel under your supervision who need to know the contents for conducting the study and appropriate Institutional Review Boards (IRBs)ZEthics Committees (1EC) under the condition that the personnel have agreed to keep this information confidential. The foregoing shall not apply to disclosure required by governmental regulations or laws, however, VBL shall be promptly notified of any such disclosure.


VBL Confidential Information		Page 88 of 101 Version 2.2 02 DEC 2013

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

LOGO

Attachment No. 4

List of SOPs applicable for the Study conduct

KCR SOP AND ASSOCIATED FORMS AND TEMPLATES


	Version	Effective date
101.1 MED. Feasibility process	5		06 Dec 11

Associated Forms And Templates: 101.1 MED. 01 Short Feasibility Worksheet	2		08 Mar 10
101.1 MED. 02 Feasibility Questionnaire	3		06 Dec 11
101.1 MED. 03 Feasibility Results	2		08 Mar 10
101.1 MED. 04 Thank You Letter	1		06 Dec 11

102.1 MED. Regulatory Submission for Clinical Study Application	4		13 Dec 12

102.3 MED. Updating Clinical Study Documentation	2		13 Aug 12

102.5 MED. Management of Regulatory Process	2		13 Aug 12

103.1 MED. Pre-Study Visit	2		21 Feb 11

Associated Forms And Templates :
103.1 MED. 01 Confirmation Pre-study Letter	2		21 Feb 11
103.1 MED. 02 Pre-study Visit Checklist	2		21 Feb 11
103.1 MED. 03 Pre-study Visit Report	2		21 Feb 11
103.1 MED. 04 Follow-up Pre-study Visit Letter	2		21 Feb 11
103.1 MED. 05 Site Selection Summary	2		21 Feb 11
103.1 MED. 06 Site Selection letter	2		21 Feb 11
103.1 MED. 07 Site Exclusion Letter	2		21 Feb 11
103.1 MED. 08 Declaration on Facilities 103.1 MED. 09 Curriculum Vitae form 103.1 MED. 10 Contact Data Form 103.1 MED. 11 Pre-study Visit Agenda	2 3 2 1		21 Feb 11 21 Jun 11 21 Feb 11 21 Feb 11

104.1 MED. Informed Consent Form	3		10 Nov 11

Associated Forms And Templates :
104.1 MED. 01 Informed Consent Form Approval Process	2		10 Nov 11
104.1 MED. 02 Informed Consent Form Checklist	2		10 Nov 11
104.1 MED. 03 Patient Information and Informed Consent Form Version Log	2		10 Nov 11
104.1 MED. 04 Informed Consent Form local adjustment	3		10 Nov 11


VBL Confidential Information		Page 89 of 101 Version 2.2 02 DEC 2013

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

LOGO


105.1 MED. Initiation Visit	2	04 Mar 11

Associated Forms And Templates:
105.1 MED. 01 Confirmation Initiation Visit Letter	2	04 Mar 11
105.1 MED. 02 Site Initiation Visit Checklist	2	04 Mar 11
105.1 MED. 03 IMP Release Form	2	04 Mar 11
105.1 MED. 04 Site Green Light Approval	2	04 Mar 11
105.1 MED. 05 Site Initiation Visit Report	2	04 Mar 11
105.1 MED. 06 Delegation of Responsibilities Log	2	04 Mar 11
105.1 MED. 07 Site Visit Log	2	04 Mar 11
105.1 MED. 08 Subject Identification Log	3	04 Mar 11
105.1 MED. 09 Subject Screening and Randomization Log	3	04 Mar 11
105.1 MED. 10 Follow-up Site Initiation Visit Letter	2	04 Mar 11
105.1 MED. 11 Financial Disclosure Form	2	04 Mar 11
105.1 MED. 12 Subject pre-screening Log	2	04 Mar 11
105.1 MED. 13 Site Initiation Visit Agenda	2	22 Jan 13
105.1 MED. 14 List of Site Initiation Visit Activities	1	04 Mar 11
105.1 MED. 15 Consent to Processing Personal Data	1	02 Jun 11
105.1 MED. 16 Instruction on How to Manage Consent for Personal Data in Clinical Operation Department	1	27 Aug 12

106.1 MED. Monitoring Visit	2	18 Apr 11

Associated Forms And Templates :
106.1 MED. 01 Confirmation Monitoring Visit Letter	2	18 Apr 11
106.1 MED. 02 Monitoring Visit Report	3	18 Apr 11
106.1 MED. 03 Contact Report	2	18 Apr 11
106.1 MED. 04 Subject Visit Status	2	18 Apr 11
106.1 MED. 05 Note to File	3	18 Apr 11
106.1 MED. 06 Follow-up Monitoring Visit Letter	2	18 Apr 11
106.1 MED. 07 Monitoring Visit and Reporting Plan	2	18 Apr 11
106.1 MED. 08 Data Clarification Form 106.1 MED. 09 Site Personal Training Log 106.1 MED. 10 Confidentiality Violation Log	1 1 1	18 Jul 11 26 Jun 12 26 Jun 12

106.2 MED. Taking Over The Study	3	31 May 13

Associated Forms And Templates :
106.2 MED. 01 CRA Site Take-Over Checklist	5	31 May 13
106.2 MED. 02 CTA Take-Over Checklist	2	31 May 13

106.3 MED. Co-Monitoring Visit	2	25 Jul 11

106.3 MED. 02 Co-monitoring Visit Report: Quality Control Assessment	2	25 Jul 11

106.4 MED. Reporting Protocol Deviations	2	10 Aug 10

Associated Forms And Templates :
106.4 MED. 01 Protocol deviation report 106.4 MED. 02 Protocol Deviation Cumulative List	2 1	10 Aug 10 10 Aug 10

107.1 MED. Close-out Visit	3	29 Dec 11


VBL Confidential Information		Page 90 of 101 Version 2.2 02 DEC 2013

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

LOGO


Associated Forms And Templates:
107.1 MED. 01 Confirmation Close-out Visit Letter	2	30 Apr 11
107.1 MED. 02 Close out Visits Plan	2	30 Apr 11
107.1 MED. 03 Close out Visit Checklist	2	30 Apr 11
107.1 MED. 04 Close out Visit Report	2	30 Apr 11
107.1 MED. 05 Record Retention Form	2	30 Apr 11
107.1 MED. 06 Site Close out Assessment	2	30 Apr 11
107.1 MED. 07 Follow-up Close out Visit Letter	2	30 Apr 11

108.1 MED. Translation Associated Forms And Templates: 108.1 MED. 01 Translation Certificate	3 3	19 Sep 11 19 Sep 11

109.1 MED. Clinial Trial Documents	4	16 Sep 13

Associated Forms And Templates :
109.1 MED 01 Essential Documents	4	16 Sep 13

109.3 MED. Trial Master File	1	16 Sep 13

Associated Forms And Templates :
109.2 MED. 01 Trial Maser File Table of Content	1	16 Sep 13
109.2 MED. 02 Trial Maser File and Shadow File Review Form 109.2 MED. 03 TMF Transfer Form 109 3 MED 04 Study Documentation Management Form	1 1 1	16 Sep 13 16 Sep 13 16 Sep 13

109.5 MED. Investigator’s File	1	16 Sep 13

Associated Forms And Templates :
109.5 MED. 01 Investigator’s File Table of Content	1	16 Sep 13

109.5 MED. Electronic Study Folder and Shadow File 109.7 MED.01 Shadow File Coordinators Log 109.7 MED.02 Electronic Folder Names 109.7 MED.03 Example of Electronic Study Folder and Shadow File Structure	1 1 1 1	16 Sep 13 16 Sep 13 16 Sep 13 16 Sep 13

110.1 MED. Clinical Supplies	3	16 Sep 13

Associated Forms And Templates :
110.1 MED. 01 Temperature Log	3	16 Sep 13
110.1 MED. 02 Clinical Supply Shipment Management Log	3	16 Sep 13
110.1 MED. 03 Clinical Supply Accountability Form	3	16 Sep 13
110.1 MED. 04 Re-labelling Report	3	16 Sep 13
110.1 MED. 05 Investigational product RECALL form	3	16 Sep 13
110.1 MED. 06 Investigational product RETURN form	3	16 Sep 13
110.1 MED. 07 Clinical Supply Destruction Report 110.1 MED.08 Site Investigational Product Accountability Log	3 1	16 Sep 13 16 Sep 13

111.1 MED. Clinical Trial Materials	2	30 Sep 13

Associated Forms And Templates :
111.1 MED.01 Trial Supply Shipment Form	4	30 Sep 13
111.1 MED.02 Controlled Copy Distribution Log	3	30 Sep 13
111.1 MED.03 Frozen Samples storage log	3	30 Sep 13
111.1 MED.04 Investigator’s Brochure Acknowledgement of Receipt	2	30 Sep 13


VBL Confidential Information		Page 91 of 101 Version 2.2 02 DEC 2013

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

LOGO


112.1 MED. Serious Adverse Event Reporting	3	08 Mar 13

Associated Forms And Templates :
112.1 MED. 01 SAE Pregnancy Report Form	3	08 Mar 13

112.2 MED. Distribution of SUSAR reports	2	15 Sep 11

Associated Forms And Templates :
112.2 MED. 01 SUSAR Reports Tracking Log	2	15 Sep 11

112.5 MED. Safety Management Principles	1	16 Sep 2013

114.1 MED. Insurance in Clinical Trial Associated Forms And Templates : 114.1 MED. 01 Questionnaire for Insurance Purposes	3 3	15 Apr 13 15 Apr 13

116.1 MED. Clinical Study Report	3	28 Jun 13

Associated Forms And Templates :
116.1MED. 01 Clinical Study Report Tracking Log	3	28 Jun 13

117.1 MED. Archiving Study Files	3	09 Sep 13

Associated Forms And Templates :
117.1 MED. 01 Archiving Facility Log	3	09 Sep 13
117.1 MED. 02 Archiving Coordinator Log	2	09 Sep 13
117.1 MED. 03 Archiving Coordinator Backup Log	2	09 Sep 13
117.1 MED. 04 Archiving Coordinator Take Over	2	09 Sep 13
117.1 MED. 05 Post Study Checklist	3	09 Sep 13
117.1 MED. 06 Content of Archived Box	2	09 Sep 13
117.1 MED. 07 List of Archived Studies	2	09 Sep 13
117.1 MED. 08 Retrieve from Archives Request	2	09 Sep 13
117.1 MED. 09 Confirmation of Destruction	2	09 Sep 13
117.1 MED. 10 Inventory of Archiving Boxes	2	09 Sep 13
117.1 MED. 11 Inventory of Archiving Locking Seals	2	09 Sep 13
117.1 MED. 12 Content of Archiving File	2	09 Sep 13

117.3 MED Management of Electronic Correspondence	1	29 Mar 13

121.1 MED. Contracts with Investigators and Investigational Sites	4	01 Feb 10

Associated Forms And Templates : 121.1 MED. 01 Bilateral contract (investigator) 121.1 MED. 02 Bilateral contract (centre)	4 4	08 Aug 11 08 Aug 11
121.1 MED. 03 Tripartite contract (investigator & centre) 121.1 MED. 04 Bilateral contract (investigator-coordinator) 121.1 MED. 06 Lend agreement (investigator) 121.1 MED. 07 Lend agreement (centre) 121.1 MED. 08 Service agreement (contractor with team)	4 4 2 2 2	08 Aug 11 08 Aug 11 08 Aug 11 08 Aug 11 08 Aug 11
121.1 MED. 09 Service agreement (single contractor) 121.1 MED. 10 Bilateral contract (investigator) – MD 121.1 MED. 11 Bilateral contract (centre) – MD	2 2 2	08 Aug 11 08 Aug 11 08 Aug 11
121.1 MED. 12Tripartite contract (investigator & centre) – MD	2	08 Aug 11


VBL Confidential Information		Page 92 of 101 Version 2.2 02 DEC 2013

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

LOGO


121.1 MED. 13 Bilateral contract (investigator-coordinator) – MD	2	08 Aug 11

122.1 MED. Confidentiality Agreements and Confidentiality Obligation	3	14 Mar 11

Associated Forms And Templates: 122.1 MED. 01 CA general unilateral (investigator—centre) 122.1 MED. 02 CA study specific unilateral (investigator—centre) 122.1 MED. 03 CA general unilateral (sponsor—contractor—other) 122.1 MED. 04 CA study specific unilateral (sponsor—contractor—other) 122.1 MED. 05 CA general mutual (sponsor—contractor—other) 122.1 MED. 06 CO in feasibility only (investigator) 122.1 MED. 07 CA/CO explanatory notice	2 2 2 2 2 3 2	15 Feb 11 15 Feb 11 15 Feb 11 15 Feb 11 15 Feb 11 15 Feb 11 01 Mar 11

123.1 MED. Principles of drawing contracts and master service agreements	2	28 Mar 11

Associated Forms And Templates: 123.1 MED. 01 KCR Group Contract Template: Master Service Agreement 123.1 MED. 02 KCR Group Contract Template: Service Agreement for a clinical study conduct	2 1	28 Mar 11 20 Oct 08

124.1 MED. Fraud and Misconduct	3	11 Feb 13

125.1 MED. Purchases Within a Project	1	25 Jul 11

127.1 MED. Legislation in Clinical Trials	2	31 Jul 13

127.3 MED Regulatory Intelligence Associated Forms And Templates: 127.3 MED.01 Regulatory Intelligence Responsibilities	1 1	28 Dec 12 28 Dec 12

128.1 MED. Communication with Subcontractor Associated Forms And Templates: 128.1 MED. 01 Subcontractor Tracking Log	1 1	01 Sep 11 01 Sep 11

129.1 MED. Annual Progress Report to Competent Authorities	2	30 Sep 11

Associated Forms And Templates :
129.1 MED. 01 Annual Progress Report Template	2	30 Sep 11

130.1 MED. Preparing Monitoring Plan	1	25 Nov 11

Associated Forms And Templates :
130.1 MED. 01 Monitoring Plan	1	25 Nov 11

131.1 MED. Communication Plan Associated Forms And Templates :	1	30 Apr 12
131.1 MED. 01 Communication GLOBAL Contact List	1	30 Apr 12
131.1 MED. 02 Communication COUNTRY Contact List	1	30 Apr 12
131.1 MED. 03 Communication VENDOR Contact List	1	30 Apr 12
131.1 MED. 04 Study Team Delegation Log	1	30 Apr 12


VBL Confidential Information		Page 93 of 101 Version 2.2 02 DEC 2013

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

LOGO


131.1 MED 05 Communication Plan	1	30 Apr 12

132.1 MED. Unbliding	1	28 Aug 12

Associated Forms And Templates:
132.1 MED. 01 Unblinding Contact List	1	28 Aug 12
132.1 MED. 02 Unblinding Report	1	28 Aug 12
132.2 MED. 03 Unblinding Listing	1	28 Aug 12

134.1.MED Principal Investigator Change	1	04 Apr 13
Associated Forms And Templates:
134 1 MED 01 Principal Investigator Change Checklist 131.1. MED. 03 134 1 MED 02 Letter to Competent Authorities About Principal Investigator Change	1 1	04 Apr 13 04 Apr 13


VBL Confidential Information		Page 94 of 101 Version 2.2 02 DEC 2013

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

LOGO

Attachment No. 5

List of third parties engaged by the Sponsor for the conduct of the Study

Legal representative (SCIderm GmbH): CRO shall undertake the following obligation, and shall indemnify the sponsor for any damage in case it will breach such obligation: notify immediately SCIderm GmbH and the Sponsor of any untoward occurrences, including serious breaches of the protocol, GCP or regulations, occurring in the clinical trial.

Data Management: CRO shall act according to the procedures, as shall be determined for this clinical trial.


VBL Confidential Information		Page 95 of 101 Version 2.2 02 DEC 2013

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

LOGO

Attachment No. 6

Study Budget

Specification of anticipated costs and expenses

Ref.
#

Service

Job
position

Unit
Cost
(€)

Quantity
of hours
units

Total

KCR Notes / Comments

MEDICAL WRITING

[***]

STUDY FAMILIARIZATION & TRAINING

[***]

B.1

Kick-off Meeting—attendance

[***]

B.3

Monitors training (therapeutic)

[***]

B.4

Monitors training (therapeutic)

[***]

B.5

Investigator’s meeting—attendance and travel

[***]

B.6

Investigator’s meeting—attendance and travel

[***]

B.11

Investigator’s meeting—attendance and travel

[***]

B.12

Investigator’s meeting—prepare presentation

[***]

B.13

Investigator’s meeting organization

[***]

B.14

Familiarization with study documentation, SOPs and study specifics

[***]

SITE MANAGEMENT IN HOUSE (including site payments)

[***]

C.1

Site contacts over phone and written communication

[***]

C.2

CRF off site management

[***]

C.3

Resolve issues & queries

[***]

C.4

Administer investigators grants

[***]


VBL Confidential Information		Page 96 of 101 Version 2.2 02 DEC 2013

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

LOGO

[***]

C.5

Collect Pre-Study/Regulatory Documentation from sites and Sponsor

[***]

STUDY ADMINISTRATION & DOCUMENT MANAGEMENT

[***]

D.1

Set up study Trial Master Files

[***]

D.2

Create Investigator Binders

[***]

D.3

Maintain & update study Trial Master Files and project specific files

[***]

D.4

Archive, retain or return Study Documentation

[***]

STUDY AUTHORIZATION & CONTRACTS

[***]

E.1

Develop local Informed Consent Form

[***]

E.2

Develop local Informed Consent Form

[***]

E.3

Coordinate translation/preparation process (protocol synopsis, drug labels, back translation)

[***]

E.4

Translation and country adaptation of drug labels

[***]

E.5

Development of project specific contract template

[***]

E.6

Preparing countries specific contract templates from the project specific template

[***]

E.7

Negotiate Investigator Budget & CSA (+ 2nd for hospital authorities)

[***]

E.8

Negotiate Investigator Budget & CSA (+ 2nd for hospital authorities)

[***]

E.9

Development of Authorization Letters

[***]

E.10

Initial submission to CA and EC

[***]


VBL Confidential Information		Page 97 of 101 Version 2.2 02 DEC 2013

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

LOGO

E.11

Initial submission to CA and EC

[***]

E.12

Regulatory maintenance—administrative amendments

[***]

E.13

Regulatory maintenance—substantial amendments

[***]

E.14

Project Management—Regulatory Affairs

[***]

E.15

Regulatory Manager—Teleconferences

[***]

E.16

Insurance arrangement

[***]

SITE SELECTION ACTIVITIES

[***]

F.1

Identify Investigative Sites

[***]

F.2

Site Selection Visits—visits

[***]

F.3

Site Selection Visits—travelling

[***]

MONITORING

[***]

G.1

Site Initiation Visits—visits

[***]

G.2

Site Initiation Visits—travelling

[***]

G.3

Interim Monitoring Visits—visits

[***]

G.4

Interim Monitoring Visits—travelling

[***]

G.5

Site Close-out Visits—visits

[***]

G.6

Site Close-out Visits—travelling

[***]

MEDICAL MONITORING

[***]

SAFETY REPORTING

[***]

DATA MANAGEMENT

[***]

PROJECT MANAGEMENT

[***]

K.1

Project management

[***]


VBL Confidential Information		Page 98 of 101 Version 2.2 02 DEC 2013

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

LOGO

[***]

K.3

Internal team meetings—COPM participation

[***]

K.5

Internal team meetings—CRAs participation

[***]

K.6

Verification of monitoring reports

[***]

QUALITY ASSURANCE SERVICES

[***]

L.1

Quality assurance services—Clinical management

[***]

CRO TOTAL

[***]

ESTIMATED PASS THROUGH COSTS (this
is rough estimation of the majority costs which
should be taken into account and not directly
paid by Sponsor)

Unit
Cost
(€)

Quantity
of units

Total

Regulatory costs

[***]

1.1

Ethics Committee fees + RA fee

[***]

1.2

Custom clearance

[***]

1.3

Insurance

[***]

Travel costs

[***]


VBL Confidential Information		Page 99 of 101 Version 2.2 02 DEC 2013

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

LOGO

2.1

CRA Travel (hotels, tickets, allowances)

[***]

2.2

QAD Travel (hotels, tickets, allowances)

[***]

2.3

Investigator Meetings travel and hotel costs (per attendee)

[***]

2.4

Patients travel costs

[***]

Administration

[***]

3.1

Copies / duplication (binding and photocopies included)

[***]

3.2

Courier / shipment

[***]

3.3

Telephone / fax

[***]

Translation

[***]

4.1

Translation of study documents

[***]

Other costs

[***]

5.1

Overnight stay

[***]

PASS-THROUGH COSTS TOTAL

[***]

SERVICE PROVIDERS COSTS

Unit
Cost
(€)

Quantity
of units

Total

Central Laboratory

[***]

Data Management

[***]

Drug Supply

[***]

IVRS

[***]

Statistical Analysis and CSR

[***]

SERVICE PROVIDORS COSTS TOTAL

[***]


VBL Confidential Information		Page 100 of 101 Version 2.2 02 DEC 2013

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

LOGO

INVESTIGATORS FEES

Unit
Cost
(€)

Quantity
of units

Total

[***]

1.1

Investigators fee

[***]

1.2

Country study co-ordinator fees

[***]

1.3

Investigators fee (screen failures)

[***]

1.4

Start-up fees (Polish sites)

[***]

1.5

Archiving fees (Polish sites)

[***]

INVESTIGATORS FEES TOTAL

[***]

TOTAL CRO FEES

[***]

TOTAL PASS THROUGH COSTS

[***]

TOTAL VENDORS COSTS

[***]

TOTAL INVESTIGATORS FEES

[***]

PROJECT GRAND TOTAL

[***]


VBL Confidential Information		Page 101 of 101 Version 2.2 02 DEC 2013

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

Exhibit 10.15

MATERIAL TRANSFER AND CONFIDENTIALITY AGREEMENT

This Material Transfer and Confidentiality Agreement (“Agreement”) is by and between:

Crucell Holland B.V. , a Dutch company with offices located at Archimedesweg 4, 2333 CN, Leiden, the Netherlands, hereinafter referred to as “CRUCELL”; and

Vascular Biogenics Ltd. , with offices located at 6 Jonathan Netanyahu Street, 60376, Or-Yehuda, Israel (hereinafter referred to as “Vascular Biogenics”; and

Lonza Houston Inc. , a company with offices located at 8066 El Rio Street, Houston, Texas 77054 U.S.A., hereinafter referred to as “Contractor”.

(hereinafter individually referred to as “Party” and collectively as “Parties”)

WHEREAS Crucell is the owner of a proprietary PER.C6 ^® cell line (hereinafter referred to as “PER.C6 ^® CELLS”), and of related proprietary and confidential information and patent rights (“Per.C6 ^® CELL KNOW-HOW”);

WHEREAS Crucell and VBL have signed a commercial license agreement that employs PER.C6 ^® CELLS and PER.C6 ^® CELLS modified by incorporating technology of VBL (collectively with PER.C6 ^® cELLS, “PACKGING CELLS”), to manufacture, use and develop a pharmaceutical products in certain fields, effective as of April 15, 2011 (the “License”);

WHEREAS under VBL’ rights under Section 2.4 of the License, VBL wishes Contractor to perform certain scientific work within the field described in Attachment I, hereinafter referred to as the “Statement of Work”, using the PACKAGING CELLS and related proprietary and confidential information (“INFORMATION”), including, without limitation, related know-how (“PACKAGING CELL KNOW HOW”) on the condition that Contractor enter Into this Agreement with VBL;

WHEREAS Crucell is willing to make available the PER.C6 ^® CELL KNOW-HOW to Contractor for the performance of the Statement of Work;

WHEREAS the Parties wish to make arrangements with respect to the use by Contractor of the PACKAGING CELLS, and of the results of the Statement of Work Performed thereon.

NOW, THEREFORE , the Parties hereto, intending to be legally bound, agree as follows:

Supply of Know How : Crucell agrees to provide and consents to VBL’s providing, the PACKAGING CELLS and the INFORMATION to Contractor upon the execution of this Agreement; solely for scientific use under the Statement of Work. If Crucell is requested to deliver PER.C6 ^® and PER.C6 ^® KNOW-HOW to Contractor, Crucell shall ship the PER.C6 ^® and PER.C6 ^® KNOW-HOW to Contractor at VBL’s expense.

Permitted and Restricted Uses: Contractor shall only use the PACKAGING CELLS and PACKAGING CELLS KNOW HOW to (1) to conduct authorized studies of or other tasks relating to the PACKAGING CELLS solely for use by VBL and/or (2) to use this PACKAGING CELLS and PACKAGING CELL KNOW HOW to develop processes and perform other tasks for the manufacturing and making of, and to manufacture and make, PACKAGING CELLS and products of VBL. Contractor shall not modify, alter, change and/or reconstruct the PER.C6 ^® CELLS, other than as further described in the Statement of Work.

Ownership of results and materials : Subject to the terms and conditions agreed between VBL and Crucell in the License, all rights to any materials, data and any physical, chemical, or biological results (hereinafter referred to

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 2 of 6

collectively as “RESULTS”) generated under the Statement of Work will vest in VBL. If during the course and performance of the Statement of Work, one or more employees of Contractor conceive or reduce to practice one or more inventions directly resulting from the Statement of Work, Contractor agrees that all right, title and interest in and to all such inventions, shall vest VBL or its nominee. Without derogating from the foregoing, to the extent certain RESULTS, including inventions and patent applications and patents emanating therefrom are subject to a license grant-back to CRUCELL under the License, VBL will effect such grant-back. Contractor shall promptly disclose such inventions to VBL, and at VBL’s cost and expense, including without limitation compensation for time expended by Contractor, shall diligently cooperate with VBL in the preparation of patent applications covering such Inventions, prosecution of such applications and any other acts necessary for the protection of rights to such inventions, Including but not limited to the execution of documents such as declarations and assignments to perfect VBL’s rights in and to such inventions. Contractor will refrain from any and all acts that may jeopardize the patentability of the invention in any jurisdiction.

Contractor Control and Legal Obligations : Contractor shall at all times maintain control over the PACKAGING CELLS and comply with all applicable laws, regulations and guidelines related to PACKAGING CELLS (hereinafter collectively referred to as “the Rules”). Contractor will not, unless Crucell and VBL will have given prior written approval on conditions it deems fit, release, transfer or distribute the PACKAGING CELLS to any party other than VBL and its authorized employees.

Reporting: All RESULTS obtained from the screening, testing or use of PACKAGING CELLS by Contractor will be reported, under the confidentiality terms of Section 7, to VBL without delay.

Termination : After the termination or expiration of this Agreement, Contractor shall transfer to VBL all remaining PACKAGING CELLS, derivates and any substances obtained from the Statement of Work and confirm such in writing to the other Parties, or shall –at the request of VBL – diligently destroy the PACKAGING CELLS, derivatives and any substances derived there from in accordance with the Rules referred to in Section 4, and confirm such in writing to the other Parties. Upon completion of review of Crucell’s and VBL’s INFORMATION by Contractor, upon the request of Crucell or in the absence of further agreement between VBL and the Contractor, Contractor shall return to VBL all the provided INFORMATION, and any copies thereof in Its possession, promptly by registered mail, certified mail, or courier service, for example. Federal Express, which retains record of the mailing, except that Contractor may retain one copy of such INFORMATION for the sole purpose of determining any continuing legal obligations to Crucell and VBL.

Confidentiality Obligations :

7.1.

(a)

at the time of disclosure is in the public domain;

(b)

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 3 of 6

(c)

by written records was in its possessions at the time of disclosure by Crucell or VBL and was not acquired directly or indirectly from Crucell, VBL or from any other party under an agreement of confidentiality to Crucell or VBL;

(d)

(e)

is excepted by prior written approval of Crucell in the case of INFORMATION or RESULTS in the case of VBL;

(f)

is required by law to be disclosed; or

(g)

is Independently developed by Contractor without reference to the INFORMATION or RESULTS as evidence by records, however maintained.

7.2.

7.3.

Contractor will take all reasonable steps, including but not limited to those steps taken to protect information, data or other tangible or Intangible property of its own that it regards as proprietary or confidential, to ensure that the RESULTS and INFORMATION are not disclosed or duplicated for any unauthorized party’s use and to prevent the directors, officers, employees and consultants of Contractor from violating this Agreement. Contractor shall notify Crucell and VBL promptly of its knowledge of any unauthorized use or unauthorized disclosure of RESULTS or INFORMATION.

Title and all rights to all Crucell’s INFORMATION owned by Crucell (as determined under the License) disclosed under this Agreement remain vested in Crucell.

10.

11.

Limited Warranty : Except as otherwise provided herein, Crucell and VBL make no representation with regard to purity or biological activity of PACKAGING CELLS provided.

12.

Indemnification : Crucell shall not be liable for any claim or damage arising from or in connection with Contractor’s use, handling or storage of PACKAGING CELLS and Contractor and VBL shall hold harmless and Indemnify Crucell for any such claim or damage, unless such claim or damage arises from the negligence or wrong-doing of Crucell. VBL shall hold harmless and

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 4 of 6

indemnify Contractor for any such claim or damage, unless such claim or damage arises from the negligence or wrong-doing of Contractor.

13.

Each party warrants that it is permitted to enter into this Agreement and that the terms of this Agreement are not inconsistent with other contractual obligations it may have.

14.

Notwithstanding the terms of this Agreement, no party to this Agreement shall be obligated to enter into any further agreement with the other.

15.

16.

Effective Date, Termination Date and Survival : This Agreement will be effective on February 6, 2012 and will terminate after the earlier of (i) the completion of the Statement of Work described in Attachment I, (ii) 60 months after the effective date or (ii) upon termination of the License. Section 3, 5, 6, 7, 8, 10, 11, 12, 14, 16, 18, 19 and 20 will survive any termination of this Agreement.

17.

18.

19.

20.

In case of conflict between the License and this Agreement, the provisions of the License shall prevail, except with respect to Contractor in which case this Agreement shall prevail.

IN WITNESS WHEREOF , Contractor, VBL and Crucell have executed this Agreement by their respective, duly authorized,

representatives of the date hereinafter written:


CRUCELL HOLLAND B.V.						Vascular Biogenics Ltd.
For and on behalf of Crucell N.V.

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 5 of 6



By:	/s/ [Illegible]	By:	/s/ Eyal Breitbart
Name:		Name:	Eyal Breitbart
Function:		Function: VP Research

Lonza Houston Inc.

By:	/s/ J. David Enloe, Jr.	/s/ [Illegible]
Name:	J. David Enloe, Jr.	VP Strategy & Corporate Development
Function: Head, Viral-based Therapeutics

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

Commercial License Agreement PER.C6 ^®

Crucell Holland – Vascular Biogenics

Page 6 of 6

ATTACHMENT 1 STATEMENT OF WORK

Quotations:

[***]

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