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. 

  

			
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 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”. 

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. 

  

			
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confidential treatment request and are indicated by [***]. 

  

 Trial 

The clinical trial known as Protocol-No VB-201-079 will be conducted according to the Protocol. 

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. 

  

			
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	 	3.5.2	Subcontracting: 

  

	 	3.5.2.1	The INSTITUTION will sub-contract on behalf of the SPONSOR: 

  

	 	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. 

  

			
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	 	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 (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. 

  

			
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	 	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 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) 

  

			
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 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 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	     

 [***] 
  

	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”): 

  

			
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	 	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 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. 

  

			
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	 	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 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. 

  

			
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	 	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 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. 

  

			
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	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. 

 

	 	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. 

  

			
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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. 

  

	11.4	All Changes to the present Agreement have to be in writing. This holds true also for this clause. 

  

			
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	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

  

			
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 [***] 

  

			
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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. 

  

			
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	[***]

  

			
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confidential treatment request and are indicated by [***]. 

  

			
	[***]

  

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

  

			
	[***]

 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) 

  

			
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	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. 

  

			
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	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	[***]  

 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	[***] 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. 

  

			
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 [***] 
  

	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). 

  

			
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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. 

  

			
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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

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confidential treatment request and are indicated by [***].EX-10.12

 CONFIDENTIAL 
  

 Exhibit 10.12 

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 
 1/38 

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 
 2/38 

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 

  
 Service Agreement 

for a Clinical Study Conduct 
 3/38 

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

 CONFIDENTIAL 
  

	 	
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 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. 

  
 Service Agreement 

for a Clinical Study Conduct 
 4/38 

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. 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. 

  

	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.

  
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	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 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. 

  
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	8.	Sponsor is obliged to reimburse CRO for the costs and expenses incurred by CRO in relation to the execution of the Agreement within 30 days from the receipt of relevant documentary evidence supporting such costs and
expenses from CRO. 

  

	9.	Payment of the remuneration and reimbursement of costs incurred by CRO shall be made by a transfer to CRO bank account indicated on the invoice. 

 

	10.	CRO rates included in the budget in Attachment 6 shall automatically increase each calendar year beginning from January 1, 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, 

  
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	 	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, 

  

	 	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. 

  
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	4.	Sponsor cannot use entrusted personal data for any other purpose or in any other manner than necessary to execute the Agreement. Sponsor is also obliged neither to disclose nor to pass on the personal data to any entity
without prior written CRO’s consent. 

  

	5.	Sponsor is liable for the damages caused to CRO or any third party in the result of personal data processing against the Agreement by Sponsor or under its responsibility. 

 

	6.	When the Agreement is finished/terminated/expired, Sponsor is obliged to finish personal data processing, return or destroy all received documents and their copies, and return all received electronic data mediums to
CRO. 

  

	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; 

  
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	 	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;

  

	 	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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 § 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 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.

  
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	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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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 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. 

  
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	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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 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 Information Sheet. 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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        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	  		  	

  
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        KCR        
	  	
VBL
        Ltd.        
	  	 Comments

	Final Site Selection	  	X	  	X	  	 KCR to provide VBL with pre-study visit reports and lists of recommended sites in all selected countries.

VBL to approve selected sites.

				
	Conduct Site Selection Visits	  	X	  		  	
				
	Negotiate Investigators/Sites Contracts	  	X	  		  	
				
	Final Approval for Investigators/Sites Contracts	  		  	X	  	
				
	Signature on Investigators/Sites Contracts	  	X	  		  	
				
	Regulatory Documents collection & review	  	X	  		  	
				
	Conduct Site Initiation Visits	  	X	  		  	
				
	INVESTIGATOR MEETING	  		  		  	
				
	Investigator’s Meeting Planning	  	X	  		  	
				
	Investigator ‘s Meeting Preparation	  	X	  	X	  	 VBL to present:
 -VB-201: Scientific
Background
 -Phase I/II Experience & Development Plan

-Study Design & Objectives
 -Protocol Overview

-Eligibility Criteria
 -Study Specific Procedures

-Study Assessment Scales
 -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)

unacceptable)
	  		  	X	  	
				
	 Ensure materials provided are suitable for use in GMP

facilities/operations and of sufficient quality for human clinical trials
	  		  	X	  	

  
 Service Agreement 

for a Clinical Study Conduct 
 18/38 

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

 CONFIDENTIAL 
  

							
	 	  	
        KCR        
	  	
VBL
        Ltd.        
	  	 Comments

	Notification to KCR and Almac, prior to receipt of the material and present on the delivery documentation regarding materials requiring any special handling requirements such as, Genetically Modified Organism (GMO), cytotoxic,
antibiotics	  		  	X	  	
				
	Provide specific testing specifications prior to arrival at ALMAC	  		  	X	  	
				
	Provide source documentation (eg Certificates of Analysis) confirming the expiry date for each input material supplied	  		  	X	  	
				
	Provide Transmissible Spongiform Encephalopathy (TSE) certification for manufacturing and primary packaging components prior to use	  		  	X	  	
				
	Provide Material Safety Data Sheet(s) (MSDS) sufficiently describing potency, solubility, potential hazards and transportation information prior to arrival of material at Almac	  		  	X	  	
				
	Arrangement of any relevant importation procedures	  		  	X	  	
				
	Ensure materials are stored and shipped under appropriate conditions with temperature monitors (where applicable).	  		  	X	  	
				
	Provide information on the cumulative time the product (refrigerated or frozen) can be out of its specified conditions for processing	  		  	X	  	
				
	Tablets, shells, capsules and/or powdered substances will be provided in sealed, tamper evident drums	  		  	X	  	
				
	Notification to Almac if the last day of the month is not the appropriate expiry date where format of month/year is used	  		  	X	  	
				
	 Each container of materials delivered to Almac will be labeled with the following information (at a minimum): Description (in English),
including
 Strength Batch/Lot Number
 KCR name and address

Shipped from name and address Expiry/Retest/Valid until Date Quantity/Weight

Unit Weight
 Container Number

Storage Conditions, e.g. 2 to 8°C Applicable protocol (if possible)

Special Handling Conditions, e.g. cytotoxic
 If the information
above cannot be included on the labels, it will be included with the shipping documents
	  		  	X	  	

  
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for a Clinical Study Conduct 
 19/38 

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

 CONFIDENTIAL 
  

							
	 	  	
        KCR        
	  	
VBL
        Ltd.        
	  	 Comments

	Shipments to Almac must include a delivery note or packing list which clearly state the contents and the storage conditions	  		  	X	  	
				
	Deliveries of materials which require special handling per 1.3 must be clearly marked on documents and the container	  		  	X	  	
				
	 All materials classified as dangerous goods must be

delivered per International Air Transport Association
 (IATA)
regulations
	  		  	X	  	
				
	Monitoring of recalls and notification to Almac within one working day should a recall occur (including comparator)	  		  	X	  	
				
	Where the Sponsor is responsible for the supply of a Non-Investigational Medicinal Product which is manufactured outside the EU and will be handled by Almac Craigavon, the sponsor is responsible for ensuring that the product is
manufactured in accordance with the principles and guidelines of Good Manufacturing Practice (GMP) and is of appropriate quality for the purposes of the trial	  		  	X	  	
				
	 Determination of the acceptability of drug products or

clinical kits after a temperature excursion during transit or storage based on data provided
	  		  	X	  	
				
	Determination of appropriate kit design based on the clinical protocol	  		  	X	  	
				
	Determination of expiry date associated with packaged materials (on label if applicable)	  		  	X	  	
				
	Determination of quantity of clinical kits to manufacture within each operation, depending on drug product information (eg expiry date) and protocol information	  		  	X	  	
				
	Review and/or approval of Interactive Response Technology (IRT) specifications	  		  	X	  	
				
	Participation in IRT User Acceptance Testing (UAT)	  		  	X	  	
				
	ALMAC SUPPLIED MATERIALS	  		  		  	
				
	Review and Approval of specifications	  	X	  		  	
				
	MEDICATION NUMBER (MED) LISTS	  		  		  	
				
	Approval of the random schemes and Med Lists based on the clinical protocol requirements	  		  	X	  	
				
	Provide Med Lists in an appropriate electronic format (per Attachment 2) at least three weeks prior to operations or prior to the first shipment if distribution only	  		  	X	  	
				
	For multiple Med Lists supplied for a single project, provide Med Lists such that sequence numbers are not duplicated across lists	  		  	X	  	

  
 Service Agreement 

for a Clinical Study Conduct 
 20/38 

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

 CONFIDENTIAL 
  

							
	 	  	
        KCR        
	  	
VBL
        Ltd.        
	  	 Comments

	LABELS	  		  		  	
				
	Ensure all electronic files provided use Arial Unicode as the default font	  		  	X	  	
				
	Provide label text for each component and label type in electronic form AND as a fixed text (i.e. uneditable PDF). Name and version number should be included on all documents for ease of identification	  		  	X	  	
				
	Provide sample labels in advance to assess compatibility with Almac equipment and materials (if applicable)	  		  	X	  	
				
	Labels provided to Almac by the KCR for overstrike/overprinting or labeling operations will be considered approved (Quality and Regulatory) by KCR	  		  	X	  	
				
	Provide label translations including a back translation of the label text to English.	  	X	  		  	
				
	Provide country specific regulatory requirements, pertinent to labels, for each country within the protocol	  	X	  		  	
				
	Approval of label proofs for each component and country within the protocol and verify acceptability of translations (where applicable)	  		  	X	  	
				
	SAMPLES – GENERAL	  		  		  	
				
	Generation of documentation which defines the standard retain and reserve samples to be obtained by Almac	  		  	X	  	
				
	Determination of destruction or return of samples 10 years or older	  		  	X	  	
				
	SAMPLES - ANNEX 13 SAMPLES FOR EU	  		  		  	
				
	Provide Almac with information regarding the product origin and supply chain to enable Almac to determine sampling requirements on a study by study basis	  		  	X	  	
				
	Perform sampling of reference and retention samples of Investigational Medicinal Product (IMP) and modified/repackaged Comparators in Europe in accordance with Annex 13	  		  	X	  	
				
	 Provide details of the site in Europe (if not Almac),

responsible for the storage of such samples, if the Almac QP is responsible for Final Release
	  		  	X	  	
				
	PRODUCTION	  		  		  	
				
	 Pre-approval of primary and secondary master batch

documents (methods). Ensure batch documentation adequately describes a process to support the protocol. e.g. blindness and kit design
	  		  	X	  	
				
	 Pre-approval of batch-specific documents prior to any

labeling or production operations (Packaging Specifications)
	  		  	X	  	

  
 Service Agreement 

for a Clinical Study Conduct 
 21/38 

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

 CONFIDENTIAL 
  

							
	 	  	
        KCR        
	  	
VBL
        Ltd.        
	  	 Comments

	Pre-approval of any rework or reprocessing of finished materials prior to commencement	  		  	X	  	
				
	For products packaged in the antibiotic facility (Craigavon only), VBL will confirm the appropriate environmental conditions and ensure this information is detailed in the batch document	  		  	X	  	
				
	DISTRIBUTION AND DEPOT SERVICES	  		  		  	
				
	Confirm regulatory and ethics approvals are in place prior to requesting supplies be dispatched	  	X	  		  	
				
	Identify “do not ship after” date and ensure orders are not generated after such date	  		  	X	  	
				
	 Review and approve Distribution Instructions (Almac

generated) prior to the receipt of the first shipment order
	  		  	X	  	
				
	 Management of approval for each country or site

(Regulatory Release)
	  	X	  		  	
				
	 Responsible for the management of the in-country

distribution depots
	  	X	  		  	
				
	RETURNS	  		  		  	
				
	 Confirmation in writing that finished product returned from

clinical depots/sites back into Almac inventory for reprocessing have been stored under appropriate conditions and justification is available for
reuse
	  		  	X	  	
				
	Retention of documentation to record the reason for any drug returns and disposition of returned material	  		  	X	  	
				
	 Performance of drug accountability at the clinical site

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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for a Clinical Study Conduct 
 22/38 

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

 CONFIDENTIAL 
  

							
	 	  	
        KCR        
	  	
VBL
        Ltd.        
	  	 Comments

	Audit the manufacturing sites (including packaging and labeling) and testing sites (release and stability) in support of a QP Declaration where confirmation of GMP to the relevant standards cannot be provided	  		  	X	  	
				
	Determine the requirement for testing of the IMP on import and communicate accordingly	  		  	X	  	
				
	Provide sufficient samples to facilitate import testing	  		  	X	  	
				
	 Provide a QP Declaration in support of a request for

authorization of a clinical trial
	  		  	X	  	
				
	INTERMEDIATE QUALIFIED PERSON (QP) RELEASE	  		  		  	
				
	Verify all activities performed in the supply chain, up to receipt of the Drug Product at Almac, are in compliance with the relevant standards of GMP, the PSF and the submitted CTA	  		  	X	  	
				
	FINAL QUALIFIED PERSON (QP) RELEASE	  		  		  	
				
	 Provide accurate and reliable information for product

evaluation to support Final QP Release
	  		  	X	  	
				
	Supply all requested documentation necessary to facilitate Final QP Release in a timely manner	  		  	X	  	
				
	Provide details of all manufacturing (including packaging and labelling), storage, testing sites (release and stability) including contractors involved in the supply chain	  		  	X	  	
				
	Provide the Final Releasing QP with visibility of all factors that could potentially influence product quality and thus the decision to release the IMP. This includes information pertaining to the manufacture (including packaging
and labeling), storage and testing. For example, deviations and out of specification results.	  		  	X	  	
				
	 For biological products, provide documentation to confirm compliance with EU/EEA GMP (or equivalent) for the following :

Storage sites for Working Cell Banks
 Drug Substance and Drug
Product manufacturing sites
 (including packaging and labelling)

Drug Substance and Drug Product testing sites (release and stability)
	  		  	X	  	
				
	For chemical products, provide documentation to confirm compliance with national GMP standards for the drug substance	  		  	X	  	
				
	 For chemical products, provide documentation to confirm compliance with EU/EEA GMP (or equivalent) for the following :

Drug Product manufacturing sites (including packaging and labelling)

Drug Product testing sites (release and stability)
	  		  	X	  	

  
 Service Agreement 

for a Clinical Study Conduct 
 23/38 

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

 CONFIDENTIAL 
  

							
	 	  	
        KCR        
	  	
VBL
        Ltd.        
	  	 Comments

	Audit the manufacturing sites (including packaging and labelling) and testing sites (release and stability) to support Final QP Release where confirmation of GMP to the relevant standards cannot be provided	  		  	X	  	
				
	Ensure that Drug Substance and Drug Product processes and analytical methods are appropriately validated for the stage of development	  		  	X	  	
				
	Maintain the Product Specification File (PSF) such that traceability to previous versions is retained and provide to the QP as requested	  		  	X	  	
				
	 Ensure that the PSF is consistent with the current

Investigational Medicinal Product Dossier (IMPD)
	  		  	X	  	
				
	 Update the Final Releasing QP of any pertinent

amendments to the PSF
	  		  	X	  	
				
	Provide updates to the Final Releasing QP regarding the submission status of the Clinical Trial Application (CTA), including any withdrawals, refusals, issues, queries or remarks during assessment of the submitted CTA	  		  	X	  	
				
	Inform the Final Releasing QP of any updates to the CTA in relation to the IMPD, protocol and label text	  		  	X	  	
				
	 Provide the Final Releasing QP with any pertinent

information regarding product stability that could impact the assigned expiry date
	  		  	X	  	
				
	Provide stability data to the Final Releasing QP to support expiry updates that are managed via re-labeling or by Interactive Response Technology (IRT)	  		  	X	  	
				
	FINAL QUALIFIED PERSON (QP) RELEASE	  		  		  	
				
	Inform the Final Releasing QP of any major or critical issues regarding Drug Substance or Drug Product manufacturing (including packaging and labelling) or testing sites including issues highlighted by regulatory authorities	  		  	X	  	
				
	Notification of the QP when a recall is being considered	  		  	X	  	
				
	Involve the Almac QP in the decision to recall materials when the Almac QP is responsible for final release	  		  	X	  	
				
	JUST-IN-TIME RELEASE AT ALMAC CRAIGAVON	  		  		  	
				
	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	  	

  
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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 
  

							
	 	  	
        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	  	

  
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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 
  

							
	 	  	
        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	  	

  
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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 
  

							
	 	  	
        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	  		  	

  
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for a Clinical Study Conduct 
 27/38 

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

 CONFIDENTIAL 
  

 [***] 

  
 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 
  

 [***] 

  
 Service Agreement 

for a Clinical Study Conduct 
 29/38 

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

 CONFIDENTIAL 
  

 Attachment No. 4 

List of SOPs applicable for the Study conduct 
  

													
	 P/Z
	  	 Number
	  	 Range
	  	 #Z
	  	 FULL TITLE OF P / Z
	  	 Version

#
	  	 Date

Effective

	    P    	  	101.1	  	MED	  		  	Feasibility process	  	5	  	06.12.11
							
	P	  	102.1	  	MED	  		  	Regulatory Submission for Clinical Study Application	  	2	  	03.01.10
							
	P	  	102.3	  	MED.	  		  	Updating Clinical Study Documentation	  	1	  	03.01.10
							
	P	  	102.5	  	MED.	  		  	Management of Regulatory Process	  	1	  	03.01.10
							
	P	  	103.1	  	MED.	  		  	Pre-Study Visit	  	2	  	21.02.11
							
	P	  	104.1	  	MED.	  		  	Informed Consent Form	  	3	  	10.11.11
							
	P	  	105.1	  	MED.	  		  	Initiation Visit	  	2	  	04.03.11
							
	P	  	106.1	  	MED.	  		  	Monitoring Visit	  	2	  	18.04.11
							
	P	  	106.2	  	MED.	  		  	Taking Over The Study	  	2	  	14.03.11
							
	P	  	106.3	  	MED.	  		  	Co-Monitoring Visit	  	2	  	25.07.11
							
	P	  	106.4	  	MED	  		  	Reporting Protocol Deviations	  	1	  	14.04.10
							
	P	  	107.1	  	MED.	  		  	Close-out Visit	  	2	  	30.04.11
							
	P	  	108.1	  	MED	  		  	Translation	  	3	  	19.09.11
							
	P	  	109.1	  	MED.	  		  	Clinial Trial Documents	  	2	  	09.08.10
							
	P	  	109.2	  	MED.	  		  	Trial Master File	  	2	  	13.06.11
							
	P	  	109.3	  	MED.	  		  	Investigator’s File	  	2	  	13.06.11
							
	P	  	110.1	  	MED.	  		  	Clinical Supplies	  	2	  	06.04.11
							
	P	  	111.1	  	MED	  		  	Clinical Trial Materials	  	2	  	14.04.11
							
	P	  	112.1	  	MED	  		  	Serious Adverse Event Reporting	  	2	  	05.11.10
							
	P	  	112.2	  	MED	  		  	Distribution of SUSAR reports	  	2	  	15.09.11
							
	P	  	113.1	  	MED.	  		  	Training Clinical Operation Staff	  	3	  	15.09.11
							
	P	  	114.1	  	MED	  		  	Insurance	  	2	  	07.12.10
							
	P	  	115.1	  	MED	  		  	Milestones in Project Management	  	1	  	03.09.10
							
	P	  	116.1	  	MED	  		  	Clinical Study Report	  	2	  	17.05.11
							
	P	  	117.1	  	MED	  		  	Archiving Study Files	  	2	  	13.12.10
							
	P	  	118.1	  	MED	  		  	Organization of MED SOP in Clinical Operations Dept.	  	2	  	05.11.10
							
	P	  	118.2	  	MED	  		  	Management of Sponsors’ SOP	  	1	  	24.01.11
							
	P	  	119.1	  	MED	  		  	Disaster Management in Clinical Operations Department	  	2	  	21.04.11
							
	P	  	120.1	  	MED	  		  	Clinical Operations Staff Curriculum Vitae	  	4	  	23.05.11
							
	P	  	120.2	  	MED	  		  	Completing Outlook Calendar	  	2	  	25.07.11
							
	P	  	120.3	  	MED	  		  	Organization of meetings in Clinical Operations departments	  	2	  	25.07.11

  
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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 
  

													
	 P/Z
	  	 Number
	  	 Range
	  	 #Z
	  	 FULL TITLE OF P / Z
	  	 Version

#
	  	 Date

Effective

	    P    	  	120.4	  	MED	  		  	Working at home	  	2	  	25.07.11
							
	P	  	120.5	  	MED	  		  	Weekly reporting	  	2	  	25.07.11
							
	P	  	120.6	  	MED	  		  	Returning from outsourcing	  	2	  	25.07.11
							
	P	  	121.1	  	MED	  		  	Contracts with Investigators and Investigational Sites	  	4	  	01.02.10
							
	P	  	122.1	  	MED.	  		  	Confidentiality Agreements and Confidentiality Obligation	  	3	  	14.03.11
							
	P	  	123.1	  	MED.	  		  	Principles of drawing contracts and master service agreements	  	2	  	28.03.11
							
	P	  	124.1	  	MED	  		  	Fraud and Misconduct	  	2	  	09.01.11
							
	P	  	125.1	  	MED	  		  	Purchases Within a Project	  	1	  	25.07.11
							
	P	  	127.1	  	MED	  		  	Legislation in Clinical Trials	  	1	  	04.05.11
							
	P	  	128.1	  	MED	  		  	Communication with Subcontractor	  	1	  	01.09.11
							
	P	  	129.1	  	MED	  		  	Annual Progress Report to Competent Authorities	  	1	  	19.08.11
							
	P	  	130.1	  	MED	  		  	Preparing Monitoring Plan	  	1	  	25.11.11
							
	P	  	131.1	  	MED	  		  	Communication Plan	  	1	  	30.04.12

  
 Service Agreement 

for a Clinical Study Conduct 
 31/38 

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 
 32/38 

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

 CONFIDENTIAL 
  

 [***] 

  
 Service Agreement 

for a Clinical Study Conduct 
 33/38 

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

 CONFIDENTIAL 
  

 [***] 

  
 Service Agreement 

for a Clinical Study Conduct 
 34/38 

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

 CONFIDENTIAL 
  

 [***] 

  
 Service Agreement 

for a Clinical Study Conduct 
 35/38 

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

 CONFIDENTIAL 
  

 [***] 

  
 Service Agreement 

for a Clinical Study Conduct 
 36/38 

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

 CONFIDENTIAL 
  

 [***] 

  
 Service Agreement 

for a Clinical Study Conduct 
 37/38 

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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