Document:

EX-10.11

 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. 

  

			
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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”. 

  

			
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 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. 

  

			
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 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: 

  

	 	a.	Appendix 1: Time Schedule 

  

	 	b.	Appendix 2: Financial Provisions 

  

	 	c.	Appendix 3: Distribution of Investigational Product 

  

	 	d.	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. 

  

			
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 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: 

  

			
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	 	i.	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° 3a; 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. 

 

	 	v.	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. 

  

  

			
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	 	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: 

  

	 	i.	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 

  

	 	v.	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 

  

			
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(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 

  

			
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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.

  

			
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	 	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 

  

			
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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. 

  

			
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 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 

  

			
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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: 

  

	 	i.	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. 

  

	 	v.	 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 14th, 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
 ofdocs/
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. 

  

	 	2.	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 

 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 (see Art. 6.4.4). 

  

			
	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 Summary1 

 

															
	 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 Summary1 

 

															
	 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 
  

	 	1 	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 
 to

 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 27th of 2008 SCIderm is certified according to DIN ISO-Norm 9001:2000 and since 5th 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 [***].EX-10.12

 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: 
  

	a)	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. 

  

	2.	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 

 

	1.	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. 

  

	2.	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 
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Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by
[***]. 

 CONFIDENTIAL 
  

	4.	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. 

 

	5.	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. 

 

	6.	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 1st August 2012. 

 

	8.	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.

  

	9.	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 
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Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by
[***]. 

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

 CONFIDENTIAL 
  

	2.	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. 

  

	3.	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. 

  

	2.	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 
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Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by
[***]. 

 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: 

  

	 	a)	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. 

  

	 	b)	for any costs related to use of CRO company cars for business travels to and from study sites indicated by the Sponsor, 

  

	 	c)	for any other costs necessary for the proper conduct of the Study provided that such expenses have been pre-approved by the Sponsor. 

 

	6.	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. 

  

	7.	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 
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Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by
[***]. 

 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 
  

	1.	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. 

  

	2.	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. 

 

	3.	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: 

  

	 	a)	is known to the receiving Party at the moment of its disclosure, 

  

	 	b)	is publicly accessible at the time of its disclosure to the receiving Party or it becomes later publicly accessible without the Party’s fault, 

 

	 	c)	may be disclosed upon the other Party’s consent expressed in writing otherwise being void, 

  
 Service Agreement 

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

 CONFIDENTIAL 
  

	 	d)	was disclosed to the receiving Party by a third party that was not obliged to keep it confidential or 

  

	 	e)	is disclosed by virtue of laws in force. 

  

	5.	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 
  

	1.	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. 

  

	3.	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 
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Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by
[***]. 

 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. 

  

	7.	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: 

 

	 	a)	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; 

  

	 	b)	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; 

 

	 	c)	the data processor undertakes to preserve the confidentiality of the personal data entrusted to it under this Agreement; 

  

	 	d)	only persons who were authorized by the data processor shall be allowed to carry out the processing of personal data; 

  

	 	e)	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;

  
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for a Clinical Study Conduct 
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Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by
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 CONFIDENTIAL 
  

	 	f)	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;

  

	 	g)	the data processor shall grant the data controller, at its request, any necessary information concerning all personal data processed by the data processor; 

 

	 	h)	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; 

 

	 	i)	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; 

 

	 	j)	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; 

  

	 	k)	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; 

 

	 	l)	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.

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

 CONFIDENTIAL 
  

 § 8. Intellectual property 

 

	1.	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. 

  

	2.	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. 

  

	3.	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. 

 

	2.	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 

  
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 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.

  

	5.	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. 

  

	2.	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. 

 

	2.	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. 

  

	3.	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, 

  
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 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. 

  

	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 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. 

 

	5.	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. 

 

	6.	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. 

  

	9.	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 

  
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 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

  
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 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	  	  				  				  			

  
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 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 InformationSheet. Approval process
according to KCR
SOP.

				
	Monitoring Plan development	  	X	  		  	Draft of Monitoring
Plan to be provided to
VBL by 5th November
2012.
				
	Monitoring Plan approval	  		  	X	  	Final version of Monitoring
Plan to be approved by
VBL by 15th November
2012
				
	Recruitment Plan development	  	X	  		  	Recruitment Plan to be
provided to VBL by 5th
November 2012.
				
	Trial Master File Set-up	  	X	  		  	
				
	Distribution of Site Documents	  	X	  		  	
				
	Randomization schedule preparation	  	X	  		  	Task will be subcontracted
to ALMAC.

  
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 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

  
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 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	  	
				
		  		  		  	

  
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 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	  	

  
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 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	  	

  
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[***]. 

 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	  	

  
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 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	  	

  
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 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	  	

  
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[***]. 

 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
	[***]	  	[***]

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

			
	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. 

  

			
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	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

  

  

			
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	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:
	  	  

  

			
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	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

  

			
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	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

  

			
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	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	  		  	

  

			
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	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:	  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

			
		
	Dosage Regimen and Treatment Groups	  	[***]
		
	Investigative Product Name and Description	  	[***]
		
	Number of Subjects:	  	[***]
		
	Duration of Participation:	  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

  

			
		
	Eligibility Criteria	  	
		
	Inclusion Criteria	  	[***]
		
	Exclusion Criteria	  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

  

							
		
		  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

  

			
		
		  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

  

			
		
		  	[***]
		
	Concomitant Medications:	  	[***]
		
	Safety Endpoints:	  	[***]
		
	Base Phase Primary Efficacy Endpoint:	  	[***]
		
	Extension Phase Primary Efficacy Endpoint:	  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

  

			
		
	Base Phase Secondary Endpoints:	  	[***]
		
	Extension Phase Secondary Efficacy Endpoints:	  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

  

			
		
		  	[***]
		
	 Base Phase Tertiary

Endpoints
	  	[***]
		
	 Extension Phase Tertiary

Endpoints
	  	[***]
		
	 Population

Pharmacokinetics
	  	[***]
		
	Compliance Measures	  	[***]
		
	Study Conduct	  	[***]
		
	Statistical Methods	  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

  

			
		
		  	[***]
		
	Rationale for Number of Subjects:	  	[***]

  

			
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	Protocol VB-201-064	 	VB-201

  

 Figure 1 VB-201-064 Study Flowchart 

 
 

 

  

			
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	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
	 	X	 		  		  		  		  	
	 Medical History & Demography2
	 	X	 		  		  		  		  	
	 Physical Exam
	 	X	 		  		  		  	X	  	
	 Inclusion/ Exclusion Criteria
	 	X	 	X	  		  		  		  	
	 Randomization
	 		 	X	  		  		  		  	
	 [***]
	 	X	 		  		  		  		  	
	 [***]
	 	X	 		  		  		  	X	  	
	 [***]
	 	X	 	X	  	X	  	X	  	X	  	X5
	 [***]
	 		 	[***]	  		  		  	[***]	  	
	[***]	 	X	 	X	  	X	  	X	  	X	  	X5
	[***]	 		 	X	  	X6	  	X7	  	X	  	
	[***]	 		 	X	  	X6	  	X7	  	X	  	
	[***]	 	X	 		  		  		  		  	
	[***]	 	X	 		  		  		  		  	
	[***]	 	X	 		  		  		  	X	  	
	[***]	 	X9	 	X9,10	  		  		  	X9,10	  	
	[***]	 	X11	 	X12	  	X	  	X	  	X	  	X
	[***]	 	X	 	X	  		  		  	X	  	
	[***]	 		 	X	  	X	  	X	  	X13	  	
	[***]	 		 		  	X	  	X	  	X	  	
	 [***]
	 	X	 	X	  	X	  	X	  	X	  	X
	 [***]
	 		 	X	  	X	  	X	  	X	  	X
	 [***]
	 		 		  	X	  	X	  	X	  	
	 [***]
	 	X16	 		  		  		  	X	  	
	 [***]
	 		 	X	  	X	  	X	  	X	  	
	 [***]
	 	X	 		  		  		  	X	  	
	 [***]
	 	X	 		  		  		  	X	  	
	 [***]
	 		 	X	  	X	  	X	  		  	
	 [***]
	 		 	X	  		  		  	X	  	

  

			
	[***]	  	[***]

  

			
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 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
	18FDG	  	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

  

			
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	 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

  

			
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	 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

  

			
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	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. 

  

			
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	4.2	Name and description of the investigational product 

 [***] 

 

	4.3	Summary of findings from nonclinical studies relevant to the trial 

 [***] 

 

	1.	[***] 

  

			
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	 	[***] 

 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. [***] 

  

			
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 [***] 

2. [***] 

  

			
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 [***] 
  

	4.5	[***] 

 [***] 

  

			
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	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 

 [***] 

  

			
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	[***]	

 1. 
  

	6.2	Number of Subjects 

 [***] 
  

	6.3	Subject Identification Number and Randomization Number 

 [***] 

 

	6.4	Subject Selection 

  

	6.4.1	Inclusion Criteria 

 [***] 

  

			
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	5.	[***] 

 [***] 

OR 
 [***] 

 

	6.4.2	Exclusion Criteria 

 Subjects who meet ANY of the following criteria will be excluded from participation
in this [***] 
 [***] 

  

			
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	7.	[***] 

 [***] 

  

			
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	13.	[***] 

 [***] 
  

	18.	[***] 

 [***] 

  

			
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	22.	[***] 

 [***] 
  

	6.6	Duration of Participation 

 [***] 
  

	6.7	Protocol Amendments 

 [***] 
  

	6.8	Withdrawal Criteria 

 [***] 

  

			
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	 	•	 	AEs (serious or non-serious). 

 [***] 
  

	6.9	Study/Study Site Termination 

 [***] 
  

	7	STUDY DRUG 

  

	7.1	Formulation, Packaging, and Labeling 

 [***] 

  

			
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 [***] 
  

	7.2	Storage and Handling 

 [***] 
  

	7.3	Accountability 

 [***] 
  

	7.4	Access to Blinded Treatment 

 [***] 

  

			
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 [***] 
  

	7.5	Administration of Study Drug 

  

	7.5.1	Dosage 

 [***] 

Table 2 VB-201 Drug Distribution 
  

					
			
	 Treatment
	  	 Carton AM
	  	 Carton PM

			
	[***]	  	[***]	  	[***]

  

			
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	[***]	  	[***]	  	[***]

 [***] 
  

	7.5.2	Assignment of Treatment Cartons 

 [***] 

 

	7.5.3	Compliance 

 [***] 
  

	8	PRIOR AND CONCOMITANT MEDICATION 

 [***] 

  

			
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 [***] 
  

	9	OUTCOME MEASURES 

  

	9.1	Efficacy Assessments 

 [***] 

Table 3 Clinical Assessments Relating to Efficacy 
  

					
	 Assessment
	  	 Study Visit
	  	 Description

			
	[***]	  	[***]	  	[***]

  

			
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	 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 

 [***] 

  

			
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 Table 5 Clinical Laboratory & Other Assessments Relating to Safety 

 

					
	 Assessment
	  	 Study Visit
	  	 Description

			
	[***]	  	[***]	  	[***]

 [***] 

  

			
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	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 

 [***] 

  

			
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 [***] 
  

	10.1	Screening Visit 

 [***] 

  

			
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 [***] 
  

	10.2	Baseline [***] 

 [***] 

  

			
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 [***] 
  

	10.3	[***] 

  

	10.4	[***] 

  

			
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 [***] 
  

	10.5	[***] 

 [***] 

  

			
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	 	•	 	[***] 

 [***] 

[***] 
  

	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 
 [***] 

  

			
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 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: 
  

	 	•	 	[***] 

 [***] 

  

			
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	 	•	 	[***] 

 [***] 
  

	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 

  

			
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	 	•	 	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 

 [***] 

  

			
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 [***] 
  

	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 

 [***] 

  

			
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 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. 

  

			
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 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 

 [***] 

  

			
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	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 

 [***] 

  

			
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 [***] 
  

	12.2.3.3	Tertiary Endpoints 

  

	12.2.3.3.1	 Base Phase Tertiary Endpoints 

 [***] 

  

			
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 [***] 
  

	12.2.3.3.2	 Extension Phase Tertiary Endpoints 

 In addition to the secondary efficacy analyses, comparisons will be
performed for the following [***] 
 4. [***] 
 [***] 

  

			
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	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 

 [***] 

  

			
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	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 

 [***] 

  

			
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	 	•	 	[***] 

 [***] 
  

	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; 

  

			
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	 	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. 

 

	14	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: 

  

			
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	 	•	 	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. 

  

			
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	Protocol VB-201-064	 	VB-201

  

	16	REFERENCES 

  

	 	1.	Truelove SC. Ulcerative colitis beginning in childhood. N Engl J Med 1971;285:50–2. 

  

	 	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. 

 

	 	3.	Podolsky DK. Inflammatory bowel disease. N Engl J Med 2002;347:417–429. 

  

	 	4.	Kirsner JB. Inflammatory bowel disease. Part II: Clinical and therapeutic aspects. Dis Mon 1991;37:669–746. 

  

	 	5.	Floccji C. Inflammatory bowel disease: etiology and pathogenesis. Gastroenterology 1998;115:182–205. 

  

	 	6.	MacDermott RP. Alterations in the mucosal immune system in ulcerative colitis and Crohn’s disease. Med Clin North Am 1994;78:1207–1231. 

 

	 	7.	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. 

  

			
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	17	APPENDICES 

  

	17.1	Appendix A: Modified Mayo Score 

 Modified Mayo Clinic SCORE 

1. [***] 

  

			
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 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

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

 CONFIDENTIAL 
  

 Attachment No. 5 

List of third parties engaged by the Sponsor for the conduct of the Study 

 

	a.	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. 

  

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

 CONFIDENTIAL 
  

 Attachment No. 6 

Study Budget 

Specification of anticipated costs and expenses 
  

															
	FINAL BUDGET (in €)
	 Ref.
#
	  	 	  	 [***]
	  	 [***]
	  	 [***]
	  	[***]	 	  	 [***]

	 A
	  	MEDICAL WRITING	  		  		  		  	 	[***]	  	  	
	 1
	  	Protocol review	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 B
	  	STUDY FAMILIARIZATION & TRAINING	  		  		  		  	 	[***]	  	  	
	 1
	  	Kick-Off Meeting	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2
	  	Monitors training (therapeutic)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3
	  	Monitors training (therapeutic)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 4
	  	Investigators meeting	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 5
	  	Investigators meeting	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 6
	  	Investigators meeting organization	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 C
	  	SITE MANAGEMENT IN HOUSE
(including site payments)	  		  		  		  	 	[***]	  	  	
	 1
	  	Create Investigator Binders	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2
	  	Regular site management (site contacts over phone and written communication)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3
	  	CRF off site management	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 4
	  	Resolve Issues & Queries	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 5
	  	Administer Investigators Grants	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 D
	  	STUDY ADMINISTRATION &
DOCUMENT MANAGEMENT	  		  		  		  	 	[***]	  	  	
	 1.
	  	Set up study trial master files	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2.
	  	Maintain & update study trial master files and project specific files	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3.
	  	Archive, retain or return Study Documentation	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 E
	  	STUDY AUTHORIZATION & CONTRACTS	  		  		  		  	 	[***]	  	  	
	 1.
	  	Develop local Informed Consent Form	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2
	  	Informed Consent Form adaptation to country specifics	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3
	  	Collect Pre-Study / Regulatory Documentation from sites and Sponsor	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]

  
 Service Agreement 

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

 CONFIDENTIAL 
  

															
	 4
	  	Coordinate translation/preparation process (protocol synopsis, drug labels, back translation)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 5
	  	Negotiate Investigator Budget & CSA (+ 2nd for hospital authorities)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 6
	  	Negotiate Investigator Budget & CSA (+ 2nd for hospital authorities)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 7
	  	Initial submission to CA and EC	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 8
	  	Initial submission to CA and EC	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 9
	  	Regulatory activities post approval	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 10
	  	Insurance arrangement	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 F
	  	SITE SELECTION ACTIVITIES	  		  		  		  	 	[***]	  	  	
	 1.
	  	Identify Investigative Sites	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2.
	  	Site Selection Visits Visits	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3.
	  	Site Selection Visits - travelling	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 G
	  	MONITORING	  		  		  		  	 	[***]	  	  	
	 1
	  	Conduct On-Site Study Initiation Visits	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2
	  	Initiation visits - travelling	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3
	  	Conduct Interim Monitoring Visits	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 4
	  	Interim monitoring - travelling	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 5
	  	Conduct Study Closure Visits	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 6
	  	Closure visit travelling	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 H
	  	SAFETY REPORTING & MEDICAL MONITORING	  		  		  		  	 	[***]	  	  	
	 I
	  	DATA MANAGEMENT	  		  		  		  	 	[***]	  	  	
	 J
	  	STATISTICAL ANALYSIS and CSR	  		  		  		  	 	[***]	  	  	
	 K
	  	PROJECT MANAGEMENT	  		  		  		  	 	[***]	  	  	
	 1
	  	Project management	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2
	  	Project Teleconferences - CRM with Sponsor	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3
	  	Verification of monitoring reports	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]

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

 CONFIDENTIAL 
  

															
	 4
	  	Project Management - Central Lab	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 5
	  	Project Management - Drug Supply	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 L
	  	QUALITY ASSURANCE SERVICES	  		  		  		  	 	[***]	  	  	
	 1
	  	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)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	
	 1
	  	Regulatory costs	  		  		  		  	 	[***]	  	  	
	 1.1
	  	Ethics Committee fees + RA fee	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 1.2
	  	Custom clearance for	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 1.3
	  	Insurance	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2
	  	Travels	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2.1
	  	CRA Travel (hotels, tickets, allowances)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2.2
	  	Investigator Meetings travel and hotel costs (per attendee)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 2.3
	  	Patients travel costs	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3
	  	Administration	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3.1
	  	Copies / duplication (binding and photocopies included)	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3.2
	  	Courier / shipment	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 3.3
	  	Telephone / fax	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 4
	  	Translation	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 4.1
	  	Translation of study documents	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 5
	  	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	  	[***]	  	[***]	  	[***]	  	 	[***]	  	  	[***]
	 7
	  	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
[***].

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00233-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00233-of-00352.parquet"}]]