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CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A

COMPLETE VERSION OF THIS EXHIBIT
HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE

SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING
CONFIDENTIAL

TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS AMENDED.

 

CONFIDENTIAL

 

CLINICAL TRIAL SERVICES
AGREEMENT

 

Sponsor: Vascular Biogenics
Ltd.

Protocol: VB-111-701/GOG-3018

Protocol Title: The
OVAL study: A Randomized, Controlled, Double-Arm, Open-Label, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with
Paclitaxel vs. Paclitaxel Monotherapy for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

 

This Clinical Trial Services
Agreement (“Agreement”) is between Vascular Biogenics Ltd. (“Sponsor”), and the GOG Foundation,
Inc. (“GOG”), a not-for-profit corporation organized under the laws of the District of Columbia, to conduct the Clinical
Trial according to the protocol attached as Exhibit A (“Protocol”) and incorporated by reference into this Agreement.

 

	1.	Definitions. The following terms, when capitalized, shall have the following meanings as used in this Agreement:

 

	 	A.	“Applicable Law” means all international and United States federal, state and local laws, rules, regulations, requirements, guidelines and policies that govern or apply to the conduct of the Clinical Trial (as defined below), including without limitation the Federal Food Drug and Cosmetic Act and related regulations, including 21 CFR Parts 11, 50, 54, 56 and 312; Guideline for Good Clinical Practice (“GCP”) adopted by the International Conference on Harmonization (ICH GCP”) of Technical Requirements for Registration of Pharmaceuticals for Human Use, as ratified by the FDA to the extent applicable for this type of project and to the extent ICH GCP guidelines conform to the FDA GCP, and state and federal privacy laws, including the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the regulations promulgated thereunder; the False Claims Act (31 U.S.C. §§3729- 3733) (“FCA”); the Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)); and the Physician Self-Referral Law (a.k.a. Stark Law, 42 U.S.C. §1395nn), as any of the foregoing may be amended from time to time.
	 	 	 
	 	B.	“Case Report Form” (“CRF”) means the case history and/or individual research record created and maintained for each Enrolled Participant in the Clinical Trial, as required by FDA regulations.
	 	 	 
	 	C.	“Clinical Investigators” means the physicians at the Participating Institutions participating in the conduct of the Clinical Trial, each of which is an ‘investigator’ (as described in 21 CFR §312.3(b)) for the conduct of the Clinical Trial at such physician’s Participating Institution.
	 	 	 
	 	D.	“Clinical Trial” means that certain clinical trial of the Study Drug to be performed by GOG through one or more Participating Institutions, as described in the Protocol.
	 	 	 
	 	E.	“Clinical Trial Agreement” (“CTA”) means the agreement between the GOG and each Participating Institution and Clinical Investigator, as applicable, for performance of the Clinical Trial, the template for which is attached hereto as Exhibit C and incorporated herein by this reference.
	 	 	 
	 	F.	“Eligible Patient” means a patient who meets the enrollment criteria set forth in the Protocol.
	 	 	 
	 	G.	“Enrolled Participant” means an Eligible Patient who has consented to participate and has been enrolled in the Clinical Trial.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

	 	H.	“FDA” means the United States Food and Drug Administration or any successor agency thereto.
	 	 	 
	 	I.	“Intentionally Omitted.”
	 	 	 
	 	J.	“IND” means an investigational new drug application submitted to the FDA.
	 	 	 
	 	K.	“IRB” means an Institutional Review Board constituted and operating in accordance with FDA regulations.
	 	 	 
	 	L.	“Participating Institutions” means the locations within the GOG system at which the Clinical Trial will be conducted, including the Clinical Investigators and the employees engaged by the Participating Institutions in the Clinical Trial.
	 	 	 
	 	M.	“Patient Informed Consent” means a form of document describing the Clinical Trial and its reasonable risks, which addresses all matters customarily addressed in patient informed consents appropriate to clinical trials of this type, includes an authorization by the patient to share with Sponsor all patient data required for performance of the Clinical Trial and the preparation of all regulatory submissions, and complies, at a minimum, with the requirements set forth in FDA regulations, including without limitation 21 CFR §§50.20, 50.25, 50.27, and any successor provisions.
	 	 	 
	 	N.	“Study Drug” means Ofranergene Obadenovec (VB-111), produced by Sponsor or on its behalf in compliance with all applicable laws and regulations, including FDA regulations, to be supplied by Sponsor to the Participating Institutions for the sole purpose of conducting the Clinical Trial, as provided in the Protocol.

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	2.	Engagement to Perform Clinical Trial Services; Responsibility for Participating Institutions.

 

	 	A.	Sponsor hereby engages GOG to provide, and GOG hereby agrees to provide, the Clinical Trial management and other services described herein, in accordance with the Task and Responsibilities Table attached hereto as Exhibit B, and in accordance with the attached Protocol (collectively, the “Services”), in accordance with the terms and conditions set forth in this Agreement, with respect to the Clinical Trial, the Applicable Law and the instructions of Sponsor, from time to time.
	 	 	 
	 	B.	GOG hereby represents and warrants that it has the lawful authority to contractually bind the Participating Institutions and Clinical Investigators, to the material terms and conditions of this Agreement in connection with their respective performance of the Clinical Trial on behalf of GOG and Sponsor. In addition, and notwithstanding anything to the contrary in this Agreement, GOG shall contractually require that the Participating Institutions and Clinical Investigators assisting with the Clinical Trial comply, inter alia, with Section 4 hereof and all other relevant provisions of this Agreement. In the event any material terms and conditions of an agreement between GOG and a Participating Institution for performance of the Clinical Trial, or other material obligations according to the Agreement (including, without limitation, Confidentiality, Publication, Patent and Invention, Insurance and Indemnification) conflict with the terms of the CTA, Sponsor shall be consulted and if written consent is not obtained from Sponsor, the terms of this Agreement shall prevail. GOG shall cause Sponsor to be a third-party beneficiary of each CTA entered into with a Participating Institution.
	 	 	 
	 	C.	In the event that GOG subcontracts part of the Services to a third party, GOG shall be responsible and retain primary liability for the performance of all obligations of third party selected, managed and contracted by GOG. 

 

	4.	Duties of Participating Institutions and Clinical Investigators.
	 	 
	 	As part of GOG’s performance of the Services, GOG shall contractually require that:
	 	 	 
	 	A.	Participating Institutions conduct the Clinical Trial in accordance with the Protocol and all applicable laws, regulations, and good clinical and research practices and according the Sponsor approved CTA;
	 	 	 
	 	B.	Unless Sponsor approves in writing a deviation from the Exhibit C template, Participating Institutions shall, as required, perform the responsibilities associated with the conduct and management of the Clinical Trial contained in the Exhibit “C” CTA template.
	 	 	 
	 	C.	Participating Institutions submit completed CRFs according to Protocol requirements;

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

	5.	Period of Performance.
	 	 
	 	This Agreement shall become effective on the date last signed below (“Effective Date”) and (unless terminated earlier pursuant to Section 13 below) shall continue in force until Sponsor receives all Data, including completed case histories and CRFs for all Enrolled Participants in the Clinical Trial, questions about data submitted have been resolved, the database has been locked, and the final study report provided to and accepted by Sponsor.

 

 

 

	6.	Duties of Sponsor; Compensation of GOG; Changes to Services.

 

	 	A.	Sponsor shall (i) be the regulatory sponsor of the Clinical Trial in accordance with FDA regulations, and meet the obligations of a sponsor under such regulations or applicable law, except to the extent expressly delegated to GOG hereunder, (ii) provide Participating Institutions without charge, properly formulated i n a c c o r d a n c e w i t h G MP and acceptably labeled Study Drug in a timely manner and in sufficient quantity to complete the Protocol, and (iii) provide GOG with the Investigator’s Brochure, and any amendments and/or updates to the Investigator’s Brochure for the Study Drug. With prior written notice to GOG, Sponsor may entrust third party vendors in performing some of its tasks according to the Agreement. 

 

	 	B.	In consideration of and as payment in full for the Services rendered under this Agreement by GOG and performance of the Clinical Trial by the Participating Institutions, Sponsor shall pay GOG in accordance with the Exhibit D Budget which is incorporated herein by reference.
	 	 	 
	 	C.	Changes to Services. The timelines, fees and expenses specified in this CTSA with respect to Services are subject to the assumptions outlined therein. In addition, the timelines, fees and expenses estimates assume that: (i) the scope of Services remains constant; (ii.) the parties reasonably execute all of their obligations under this CTSA; and (iii.) third parties timely and reasonably perform all relevant tasks to this CTSA. In the event of a material change to the above assumptions, the parties shall confer in good faith to negotiate and sign a formal Change Order to this CTSA. A formal Change Order shall be prepared by the parties and shall provide a written description of the changes to the Services and an estimate, if any, of the cost consequences, higher or lower, arising from the change. GOG shall continue to provide Services as called for in the executed CTSA pending approval of the formal Change Order by Sponsor. If the parties cannot agree on such changes, GOG shall not be obligated to implement the changes in the proposed Change Order.

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	7.	Confidential Information.
	 	 	 
	 	A.	“Confidential Information” means all p r o p r i e t a r y , t r a d e s e c r e t a n d / o r c o n f i d e n t i a l information, including the Study Drug, that Sponsor or a third party on its behalf, provides to GOG or the Participating Institutions and information that GOG provides to the Participating Institutions, including Clinical Investigators, on behalf of Sponsor, whether disclosed prior to or during the Term of this Agreement or developed and/or discovered by GOG or the Participating Institutions, as a result of the performance of the Clinical Trial or required during this Agreement and the CTA and any deliverables under this Agreement or the CTA including un-published Data and Study results, any analysis which are not a part of the Protocol, or using Sponsor- disclosed Confidential Information, which is (i) in writing or other tangible or electronic medium and designated “confidential” or otherwise marked with indicia of its confidential nature; (ii) orally disclosed and not previously reduced to a tangible medium, provided that Sponsor shall use reasonable efforts to identify such information as “confidential” at the time of disclosure and thereafter summarize such information in writing or reduce it to a tangible medium within thirty (30) days of disclosure; or (iii) the foregoing notwithstanding, disclosed by Sponsor or on behalf of Sponsor and which a reasonable person would understand to be confidential or proprietary in nature, including, without limitation, the Protocol, Investigator’s Brochure and any regulatory documents. GOG acknowledges and understands that Sponsor is a public company traded on the NASDAQ, and accordingly, the Confidential Information may be considered as “inside information” pursuant to securities laws and regulations.
	 	 	 
	 	B.	Notwithstanding any designation by Sponsor, “Confidential Information” shall not include information which the receiving party can demonstrate that:
	 	 	 
	 	 	
        (i) is or becomes publicly known or available
        through no fault of GOG, or Participating Institutions;

         

        (ii) Sponsor has made available to third-parties
        without a confidentiality obligation;

         

        (iii) is already independently known to GOG,
        or Participating Institutions, as shown by their prior written records except for information concerning the Clinical Trial that
        was created in collaboration with the Sponsor or in view of this Agreement or prior thereto; and/or

         

        (iv) is publicly- available that relates to
        potential hazards or warnings associated with the production, handling, or use of the Study Drug.

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	 	GOG shall not, and shall require that the Participating Institutions: (i) not disclose, and cause their respective employees and agents not to disclose, the Confidential Information to any third party without the prior written permission of Sponsor except as permitted by this Agreement; (ii) not use the Confidential Information for any purpose other than the conduct of the Clinical Trial; (iii) restrict the dissemination of the Confidential Information with its organization to only those persons who have a need to know, shall ensure that all of its directors, officers, employees, agents, representatives and advisors (collectively, “Associates”) are aware of this Agreement and bound by terms of confidentiality no less stringent than those stated herein and shall remain liable at all time for the compliance of the confidentiality obligations of such Associates.
	 	 	 
	 	C.	In the event that GOG or a Participating Institution or their employees and agents reasonably find it necessary to disclose any Confidential Information to a governmental authority to defend the research against an allegation of fraud or other misconduct, or to defend themselves in any other legal proceeding, or are required by applicable law or medical duty to disclose Confidential Information, the party may make the necessary disclosure after providing reasonable prior notice to Sponsor, and attempting in good faith to agree upon a mutually satisfactory way to disclose only such portions of the Confidential Information as is necessary to achieve this limited purpose. In the event disclosure is required under this section, after reasonable notice has been provided to the Sponsor, the GOG and/or Participating Institution with whom the request for Confidential Information has been made agrees to fully cooperate at Sponsor’s sole cost and expense with Sponsor should Sponsor seek a protective order, or other legal remedy to limit the disclosure of such Confidential Information.
	 	 	 

 

	 	D.	GOG or a Participating Institutions may publishing or otherwise publicly disclose data generated from the Clinical Trial as provided in Sections 8 and 9, below.
	 	 	 
	 	E.	The obligations of this Section 7 shall survive the expiration or termination of this Agreement.

 

	8.	Recordkeeping and Access to Data.

 

	 	A. 	As part of the Services, GOG shall contractually require that:
	 	 	 
	 	 	(i) Participating Institutions complete and maintain customary accurate and authentic records and clinical trial documentation, including without limitation signed consent forms, clinical data, CRFs, case histories, notes, accounts, and adverse event and Serious Adverse Event reports of the work performed under this Agreement (“Data”);
	 	 	 
	 	 	(ii) Sponsor and authorized agents of FDA, United States Department of Health and Human Services (“HHS”), and other federal agencies shall have the right to inspect and review such Data at the Participating Institutions to the extent permitted by law and during regular business hours and upon reasonable notice;

 

 

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

	 	 	Participating Institutions maintain confidentiality of personally identifiable information concerning Enrolled Participants, andshall disclose such information to third parties only as permitted by applicable state and Federal privacy laws, including (but not limited to) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”). All Data provided by GOG to Sponsor with respect to Enrolled Participants shall be furnished without patient names. In the event either GOG or Sponsor is exposed to a patients’ personally identifiable information (including medical records and other health information), GOG and Sponsor shall comply with Applicable Law regarding access to, confidentiality of, and security of such information and shall act in accordance with the Informed Consent and HIPAA authorization signed by the Enrolled Participant.
	 	 	 
	 	B.	The Study Drug and all Data generated or required by the Clinical Trial are and shall remain the property of Sponsor.

 

	 	C.	The Statistical and Data Management Center (SDMC) of GOG will provide data management and statistical services for this Study. Subject to any third party licensing requirements, GOG shall provide Sponsor’s data management group sufficient information regarding the data management system used for the Protocol, including without limitation Data Management Plan, database structure, annotated case report forms, data dictionaries, and data mapping, such that the Protocol data can be transferred and merged with other Sponsor data for the Study Drug. At mutually agreed upon specified time points during the conduct of the Study, and at other time points which may be necessary based on Study requirements, GOG SDMC shall provide, interim datasets to support the independent Data Safety Committee and other agreed upon Sponsor requirements, including but not limited to safety and efficacy data, to the Sponsor.

 

	9.	Publication and Other Public Presentation of Results.

 

	 	A.	The Institution and Participating Institutions agree that the Sponsor shall have the right to the first publication of the results of the Study in accordance with the terms of this Agreement. The Sponsor recognizes that, consistent with the principles of academic freedom, GOG requires that Participating Institutions be free to publish the results of their research activities after provision by GOG of the final study report to the Sponsor or and as otherwise agreed to in writing by the Sponsor. The Sponsor agrees that GOG and Participating Institutions engaged in this Clinical Trial shall be permitted to publish reports in journals and other professional publications, and to present the methods and results of this Clinical Trial at symposia and professional meetings (each, a “Publication”), in accordance with the requirements of this Section 9. Such publication by GOG and Participating Institution may be no earlier than after a cooperative multi-center publication has been published by Sponsor. However, if a multi-center publication is not submitted after one (1) year from the date of completion or termination of the Study, or if Sponsor confirms there will be no multi-center Study publication, GOG the Participating Institution may publish the Study results after providing Sponsor an opportunity to review and comment in accordance with the terms herein.

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	B.	Sponsor shall be furnished a copy of any proposed Publication for advisory review at least sixty (60) days in advance of the submission of such proposed Publication for journals and other professional publications and thirty (30) days for any other Publication, such as a poster presentation, abstract, or other written or oral material which describes the results of the Clinical Trial. Expedited review or additional review time may be arranged by mutual written agreement. Sponsor may remove from the proposed publication any information that is Confidential Information.
	 	 	 
	 	C.	If within such review period, Sponsor determines and notifies GOG in writing that the proposed Publication contains disclosures of the intellectual property of Sponsor, GOG shall require that the proposed Publication be delayed for up to an additional ninety (90) days in order to allow Sponsor sufficient time to take appropriate steps to preserve U.S. or foreign patent or other intellectual property rights. GOG shall require that Participating Institutions shall provide, at Sponsor’s sole cost and expense, any additional information in their possession which Sponsor deems necessary to file such patent application(s) or otherwise protect such intellectual property rights. Sponsor shall have three (3) months from its receipt of such additional information to file such patent application(s). GOG shall not and shall require that the Participating Institutions shall not submit the proposed Publication to anyone who is not employed by GOG or the Participating Institutions and under an obligation of non-disclosure and non-use at least substantially similar to that imposed on the Participating Institutions until each such patent application has been filed by Sponsor or the conclusion of the three (3) month period of this Paragraph, whichever occurs first, or until the information on the potentially patentable invention(s) is excised from the manuscript.
	 	 	 
	 	D.	GOG shall have no ownership rights or copyright in any publications or presentations prepared by Sponsor in the performance of this Agreement.

 

	10.	Use of Names.
	 	 
	 	Neither GOG nor Sponsor shall use the name, symbols and/or marks of the other in connection with the Clinical Trial without prior written permission from the other party. Such permission is not required for disclosure of the existence of the Agreement in reports generated in the normal course of business by GOG or Sponsor, or where acknowledgment of sponsorship is required by the guidelines of a scientific publication or organization, or the fact that GOG is conducting the Clinical Trial in disclosures made by Sponsor in the normal course of business, or where required by regulatory authority, law or stock exchange rule. Neither party shall use, nor authorize others to use, the name, symbols, or marks of the other or any affiliate thereof in any advertising or publicity material or make any form of representation or statement in relation to the Clinical Trial that would constitute an express or implied endorsement by the other party of any commercial product or service, without prior written approval from the other party. None of the foregoing in this Section 10 shall restrict Sponsor from disclosing factual information regarding Sponsor’s relationship with GOG or the Clinical Trial or the terms of this Agreement to prospective investors or sublicensees in the normal course of its business relating to the Study Drug.

 

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	11.	Patents and Inventions.

 

	 	A.	Sponsor Inventions. Any New Inventions (whether patentable or not), innovations, suggestions, ideas and reports arising out of or in connection with the Study Drug or Sponsor’s Confidential Information by GOG and/or any Participating Institution or the contractors of any of the foregoing, shall be promptly disclosed to Sponsor, and shall be the exclusive property of Sponsor (“Sponsor Inventions”). Upon Sponsor’s request, and at Sponsor’s sole expense, Participating Institutions and GOG shall take all reasonable actions necessary or appropriate to obtain patent or other proprietary protection in Sponsor’s name with respect to any of the Sponsor Inventions. Subject to the terms and conditions of this Agreement, Sponsor hereby grants GOG a non-exclusive, non-transferable license to use the Sponsor’s Study Drug for the sole and limited purpose of granting sublicenses to Participating Institutions pursuant to the CTA, as attached hereto, to the extent required for Participating Institutions to carry out the Clinical Trial in compliance with the Protocol. Sponsor hereby grants to GOG a non-exclusive, royalty free limited license to all Sponsor Inventions for all non-commercial academic research, subject to Sponsor’s confidentiality and publications rights.
	 	 	 
	 	B.	“New Invention(s)” shall mean any invention or discovery conceived reduced to practice, or otherwise discovered or developed, in whole or in part, by Sponsor, GOG, any Participating Institution or the contractors of any of the foregoing, based on or resulting from performance of the Clinical Trial. As used in this Section 11, the term “conceived” shall have the same definition of “conception” as set forth in section 2138.04 of the United States Patent and Trademark Office’s Manual of Patent Examining Procedure, Eighth Edition, Latest Revision July 2010.
	 	 	 
	 	C.	The right of publication by GOG and Participating Institutions, as described in Section 9, shall not be affected by a license to use any New Invention. Sponsor has no obligation or commitment to enter into any patent license or other agreement with GOG relating to the subject matter hereof.

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	D.	Background IP. Existing inventions, ideas, discoveries, technologies, methodologies and other intellectual property of each party that were conceived, reduced to practice, or otherwise discovered or developed before the Effective Date (“Background IP”) are their separate property, whether protected by patent or other intellectual property rights, and except as expressly provided in Section 11(A), are not affected by this Agreement. Neither party shall have any claims to or rights in any such inventions, ideas, discoveries or methodologies of the other party.

 

	12.	Insurance and Indemnification.

 

	 	A.	Each party states that it maintains a policy or program of insurance or self-insurance in accordance with industry standards or otherwise as required by law. Upon request, each party shall provide the other with evidence of its insurance or self-insurance coverage, and unless self- insured, will notify the other party within three (3) business days of notice of any reduction, non-renewal or cancellation of its coverage. GOG shall contractually require Participating Institutions a n d C l i n i c a l I n v e s t i g a t o r s to maintain a policy or program of insurance of self-insurance in full force and effect, throughout the performance of the Clinical Trial that covers: (a) employer’s liability; (b) general liability; (c) contractual liability; (d) premises liability; (e) professional medical and nursing indemnity in amounts adequate to cover its obligations hereunder and in accordance with industry standards or as otherwise required by law.
	 	 	 
	 	B.	Sponsor shall defend, indemnify and hold harmless the GOG, the Participating Institutions and their respective directors, officers, employees and agents (each, a “Sponsor Indemnitee”, and collectively, the “Sponsor lndemnitees”) against any liability, damage, loss or expense (“Losses”) incurred by, imposed on or alleged against any Sponsor Indemnitee in connection with any third party claims, suits, actions, demands or judgments t o t h e e x t e n t arising out of (a) any side effect, adverse reaction, illness of injury occurring to any Enrolled Participant as a result of his or her involvement in the Clinical Trial’s non-standard of care activities or (b) any breach or alleged breach of this Agreement by Sponsor; (c) negligence or intentional misconduct by Sponsor; provided that the amount of such Losses shall be reduced by an amount in proportion to the percentage of responsibility of GOG or any third party for such Losses.
	 	 	 
	 	 	Sponsor’s indemnification hereunder shall not apply to any liability, damage, loss or expense incurred by any Sponsor Indemnitee to the extent directly attributable to: (v) the willful, reckless or negligent acts or omissions, or professional malpractice of such Sponsor Indemnitee, (w) failure of such Sponsor Indemnitee to adhere strictly to the terms of the Protocol good clinical practices, FDA or other government requirements or law (as applicable) or any other written instructions received from Sponsor and/or GOG, provided, however, that emergency medical care reasonably necessary to protect the safety, rights or welfare of an Enrolled Participant shall not be deemed a violation of the Protocol, (x) failure of any Sponsor Indemnitee to materially comply with applicable laws, rules, regulations or guidance,

 

 

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    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	 	(y) failure to comply with Sponsor’s written recommendations or instructions relative to use of the Study Drug, or (z) any other material breach of this Agreement by the GOG or material breach of the CTA by the Participating Institution.
	 	 	 
	 	 	 
	 	 	GOG shall indemnify, defend and hold harmless Sponsor and its Associates (“GOG Indemnitee”) from and against any and all damages, liabilities, losses, fines, penalties, settlement amounts, cost and expenses of any kind or nature whatsoever, including, without limitation, reasonable attorney’s fees, expert witnesses and court costs, incurred in connection with any claim, but only to the extent arising from the negligence, intentional misconduct, or material breach of Agreement of GOG or its Associates; provided however, that GOG shall have no obligation of indemnity hereunder with respect to any claim which arose from the negligence act error or omission, intentional misconduct or material breach of Agreement on the part of Sponsor or its Associates.
	 	 	 
	 	 	
        Each party’s obligation to indemnify
        the lndemnitees hereunder (“Indemnifying Party”) shall apply only if such Indemnitee provides prompt notification
        upon receipt of any claim or suit, permits Indemnifying Party and its attorneys and personnel to handle and control the defense
        of such claims or suits, including but not limited to a l l d e c i s i o n s r e l a t i v e t o pretrial, trial, appeal or settlement,
        and the Indemnitee fully cooperates and assists in such defense (including access to pertinent records and documents and provision
        of relevant testimony). In no event shall any Indemnitee seeking to be indemnified under this Agreement settle any claim or action
        without the prior express written approval of Indemnifying Party, which shall not be unreasonably withheld. Subject to the foregoing,
        each Indemnitee may participate in any such claims at its, his, or her own cost and expense.

         

	 	 	 
	 	C.	Sponsor’s agreement to indemnify, defend and hold an Indemnitees harmless pursuant to this Section is condition upon Indemnitees obtaining: (i) informed consent from each of the subjects participating in the Clinical Trial, in compliance with 21 CFR, Part 50; and (ii) IRB review and approval for the Clinical Trial in compliance with 21 CFR, Part 56.

 

	 	D.	Except for the parties above Article 12 Indemnification obligations, neither party shall be liable to the other party for any incidental, indirect, special or consequential losses or damages (including loss of profits), whether in contract or tort. 

 

    	11

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	13.	Termination.

 

	 	A.	This Agreement will terminate automatically if any of the following occur:

 

	 	 	(i) if FDA imposes a permanent hold on the Study Drug;
	 	 	 
	 	 	(ii) if the Clinical Trial is terminated by Sponsor for reasons of patient safety; or
	 	 	 
	 	 	(iii) if a formal investigation by an authorized governmental agency finally determines that the Data have been falsified or irreparably compromised by research misconduct.

 

	 	B.	This Agreement may be terminated by either party, upon thirty (30) days prior written notice, if either party fails to materially comply with the terms of this Agreement after receipt of written notice, with reasonable opportunity to cure, from the other party.
	 	 	 
	 	C.	This Agreement may be terminated by Sponsor upon thirty (30) days prior written notice to GOG if it reasonably determines that patient safety requires termination. This Agreement may be terminated by Sponsor for any reason upon thirty (30) days prior written notice to GOG. Provided, however, Sponsor may suspend the Clinical Trial at any time for any reason. The suspension of the Clinical Trial by Sponsor for any reason shall not be deemed a material breach of this Agreement and shall be supported by a written statement explaining the reason for suspension.
	 	 	 
	 	D.	Upon the effective date of termination, there shall begin an accounting conducted by GOG. Within sixty (60) days after receipt of adequate documentation describing in reasonable detail (including reasonable itemization) the services rendered and moneys expended by GOG, Sponsor shall make payment to GOG, on a pro rata basis, for all undisputed amounts representing:

 

	 	(i)	all services properly rendered and monies properly expended by GOG or a Participating Institution under this Agreement prior to the date of termination, and not yet reimbursed;and

 

    	12

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	(ii)	all reasonable non- cancelable obligations properly incurred for the Clinical Trial by GOG prior to the effective date of termination; unless the Sponsor objects to any charge, in which case, the parties shall use best efforts to resolve expeditiously any disagreement. In the event of disagreement, Sponsor shall not withhold any amounts not in dispute and shall make payment thereof as required in this Section 13.

 

	 	E.	GOG shall return to the Sponsor any portion of the Sponsor funds not properly expended or obligated by GOG or Participating Institutions in connection with the Clinical Trial, in each case prior to the effective termination date indicated in the notice of termination or the date of automatic termination, if applicable. Further, GOG, Principal Investigator or the Participating Institutions, including the Clinical Investigators shall, within thirty (30) days of the effective date of such termination or expiration, return any Confidential Information, provided, however, that one (1) archival copy of Sponsor’s Confidential Information may be retained solely for purposes of monitoring compliance with this Agreement.
	 	 	 
	 	F.	Upon the effective date of any termination or expiration of this Agreement, Sponsor shall, in collaboration with GOG and Sponsor’s designee, (i) notify the Participating Institutions that the Clinical Trial has been terminated, (ii) cease (and cause the Participating Institutions and Clinical Investigators to cease) enrolling further patients in the Clinical Trial, (iii) cease (and cause the Participating Institutions and Clinical Investigators to cease) treating Enrolled Participants according to the Protocol as directed by Sponsor to the extent medically permissible and appropriate, and (iv) terminate (and cause the Participating Institutions and Clinical Investigators to terminate) as soon as practicable, but in no event more than thirty (30) days after the effective date of termination, all other applicable Clinical Trial activities; provided however, that upon Sponsor’s request, GOG and Participating Institutions shall continue to collect Data and prepare and complete CRFs for Enrolled Participants treated in the terminated Clinical Trial prior to termination or expiration. Within one hundred twenty (120) days from the effective date of any termination, GOG shall provide to Sponsor all Data.

 

	 	G.	Expiration or termination of this Agreement for any reason shall not affect the rights and obligations of the parties accrued prior to the effective date of such expiration or termination. The rights and duties as specified under Sections 2.8., 4 (C, D, F, G, I, J and K), 6 (B, C, D, and E, in each case solely with respect to amounts accrued before expiration or termination), 7, 8, 9, 10, 11, 12, 13 (D, E, F, G, H) and 14 and any other provision that by its terms is intended to survive termination or expiration, shall survive the termination or expiration of this Agreement.

 

    	13

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	H.	The parties shall cooperate with each other and with Federal agencies in winding down the Clinical Trial and, when appropriate, in transferring the care of Enrolled Participants to suitably trained practitioners of their choice.

 

	14.	Miscellaneous.

 

	 	A.	Independent Contractor. GOG, Participating Institutions and other research staff are independent contractors and are neither employees nor agents of Sponsor. Neither GOG nor Sponsor intends to create any partnership, joint venture, employment or agency relationship pursuant to this Agreement. Neither party to this Agreement shall have the right to bind the other party by contract or otherwise to transact business in the other party’s name or on its behalf, unless with the specific written consent of the other party.

 

	 	B.	Correspondence. For purposes of medical/scientific communications email communication is expressly permitted. Sponsor shall address all medical/scientific communications to the Study Chair at the address listed in the Protocol, and to GOG as follows:

 

	 	GOG Foundation, Inc.
	 	Four Penn Center, Suite 1020
	 	1600 John F. Kennedy Boulevard
	 	Philadelphia, Pennsylvania 19103-2800
	 	
         

        [***]

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

 

[***]

 

	 	C.	Notices. Legal claim notices given to the respective parties hereunder shall be in writing and sent by facsimile or by registered or certified mail to the following:

 

    	14

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

	 	If to Sponsor:
	 	 	 
	 	If to GOG:	GOG Foundation, Inc.
	 	 	Four Penn Center, Suite 1020
	 	 	1600 John F. Kennedy Boulevard
	 	 	Philadelphia, Pennsylvania 19103-2800
	 	 	[***]
	 	 	[***]
	 	 	[***]
	 	 	[***]
	 	 	 
	 	With a copy, which shall not constitute notice, to:
	 	 	[***]
	 	 	General Counsel
	 	 	GOG Foundation, Inc.
	 	 	1600 John F. Kennedy Boulevard 
	 	 	Philadelphia, PA 19103
	 	 	 
	 	Notices shall be deemed given when facsimile transmission or mail receipt is confirmed.

 

	 	D.	Assignment. Due to the specialized nature of the services provided under this Agreement, neither party shall assign, transfer or convey this Agreement without the other party’s prior written consent. Notwithstanding the foregoing, Sponsor may assign its rights under this Agreement (in whole or in part, and to multiple assignees) without the prior written consent of GOG to any affiliate or other entity that controls, is controlled by or is under common control with Sponsor, or to a successor-in-interest in connection with a merger, acquisition, or sale of all or substantially all of its assets, a licensee, or sublicensee of any of the assets of Sponsor to which this Agreement relates. This Agreement shall inure to the benefit of each party and its permitted successors and assigns. This Section 14.0 shall not be deemed to preclude GOG from contracting with Clinical Investigators and Participating Institutions to perform the Clinical Trial hereunder, or to require Sponsor to consent to such contracts, except as otherwise specifically set forth above.

 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	E.	Amendment. Any amendment(s) to this Agreement must be in writing and signed by both parties.
	 	 	 
	 	F.	Governing Law. This Agreement shall be construed, governed and interpreted in accordance with the laws of the State of Delaware exclusive of any conflict of law provisions.
	 	 	 
	 	G.	Alternative Dispute Resolution. The parties agree to submit any dispute arising hereunder to binding arbitration pursuant to the Rules of Arbitration of the International Chamber of Commerce. The arbitration shall be conducted in New-York City, New York USA. The decision of the arbitrator shall be final and binding upon the parties hereto and shall be enforceable by any court of competent jurisdiction.
	 	 	 
	 	H.	Entirety of Agreement. This Agreement constitutes the entire agreement between the parties concerning the subject matter herein, and supersedes all prior terms or understandings, written or oral. In the event of a conflict between the terms of this Agreement and the Protocol, this Agreement shall govern all legal and financial matters and the Protocol shall govern all clinical matters.
	 	 	 
	 	I.	Waiver. Neither the waiver by any of the parties hereto of a breach of or a default under any of the provisions of this Agreement, nor the failure of any of the parties, on one or more occasions, to enforce any of the provisions of this Agreement or to exercise any right or privilege hereunder shall thereafter be construed as a waiver of any subsequent breach or default of a similar nature, or as a waiver of any of such provisions, rights or privileges hereunder. No waiver by a party hereto of, or consent by a party hereto to, a variation from any provision of this Agreement shall be effective unless made in a written instrument duly executed on behalf of such party.
	 	 	 
	 	J.	Severability. The invalidity or unenforceability of any term or provision of this Agreement shall not affect the validity or enforceability of any other term of this Agreement.
	 	 	 
	 	K.	No Debarment. GOG represents and warrants that neither GOG nor Participating Institutions or Clinical Investigator or any of their employees or agents, rendering activities pursuant to this Agreement is presently debarred pursuant to the Generic Drug Enforcement Act of 1992, 21  U.S.C. § 335a, or any other FDA authority. GOG shall notify Sponsor immediately upon the commencement of any such proceeding concerning GOG or any such person or entity.
	 	 	 
	 	L.	Inspections. If any governmental or regulatory authority conducts or gives notice to GOG of its intent with respect to any activities under this Agreement to conduct an inspection, audit, or monitoring visit at GOG or any Participating Institution or take any other regulatory action, or if GOG becomes aware of any such governmental inspection or other regulatory activity at GOG or one of the Participating Institutions, GOG shall promptly give Sponsor and Sponsor’s designee notice thereof by telephone with follow-up notice provided in writing within forty-eight (48) hours of the telephonic notification, including all information pertaining to any such inspections or actions, and GOG shall allow or cause the applicable Participating Institution to allow Sponsor or its representatives or designee to be present at any such inspection or actions. GOG shall contractually require that any required response or action by any Participating Institution shall be made within two (2) weeks of issuance of any citations or within any earlier deadline set by the issuing regulatory authority and shall make a good faith consideration any comments provided by Sponsor and/or Sponsor’s designee on any proposed written response and provide Sponsor a n d Sponsor’s d e s i g n e e with a copy of any such written response. In the event the FDA or other regulatory authority requests or requires any action to be taken to address any citations, GOG shall provide Sponsor with written notice thereof and shall require that the Participating Institution, after consultation with GOG and Sponsor, take such action as necessary to address and correct such citations, and cooperate with Sponsor with respect to any such citation and/or action taken with respect thereto.

 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	M.	Sponsor audit at GOG facilities. GOG hereby give Sponsor and Sponsor’s designee permission to perform audits at GOG facilities. Sponsor will provide at least four (4) weeks notice in writing, including scope of audit. 
	 	 	 
	 	N.	No Sanctions. GOG hereby represents and warrants that neither GOG nor any of its personnel, nor to the knowledge of GOG any Participating Institution or the research staff of any have been or shall be involved in an investigation or in research that was terminated, as the term “termination” is used in 21 CFR 812.3(q), nor have they been subjected to any sanctions related to allegations of research or professional misconduct.
	 	 	 
	 	O.	Additional Actions and Documents. Each of the parties hereto hereby agrees to take or cause to be taken such further actions, to execute, deliver and file or cause to be executed, delivered and filed such further documents and instruments, and to obtain such consents, as may be necessary or as may be reasonably requested in order to fully effectuate the purposes, terms and conditions of this Agreement.
	 	 	 
	 	0. 	Authority of the Parties. The Parties hereby represent and warrant that they have the legal authority to enter into this Agreement and that the terms of this Agreement are not inconsistent with their other contractual arrangements.
	 	 	 
	 	P.	“Intentionally Omitted.”
	 	 	 
	 	Q.	Counterparts. To facilitate execution, this Agreement may be executed in as many counterparts as may be required. It shall not be necessary that the signature of or on behalf of each party appears on each counterpart, but it shall be sufficient that the signature of or on behalf of each party appears on one or more of the counterparts. All counterparts shall collectively constitute a single agreement. It shall not be necessary in any proof of this Agreement to produce or account for more than a number of counterparts containing the respective signatures of or on behalf of all of the parties. Any signature provided by facsimile or electronic image transmission shall be binding to the same extent as an original signature page.

 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	R.	Headings. The headings of this Agreement are for ease of reference only and shall not limit or otherwise affect the meaning of the terms and conditions of this Agreement.

 

The Parties hereby accept
and agree to the terms and conditions of this Agreement.

 

	Vascular Biogenics Ltd.:	 	GOG FOUNDATION INC.:
	 	 	 	 	 
	By:  	 	 	By: 	 
	 	 	 	 	 
	Name: 	 	 	Name:	 
	 	 	 	 	 
	Title: 	 	 	Title:	 
	 	 	 	 	 
	Date: 	 	 	Date:	 

 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

EXHIBIT A

 

[Protocol insert]

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

  

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

EXHIBIT C

 

CLINICAL TRIAL AGREEMENT

 

This Clinical Trial Agreement
(“Agreement”) is between the GOG Foundation, Inc. (“GOG”), a not-for-profit corporation
organized under the laws of the District of Columbia, located at Four Penn Center, Suite 1020, 1600 John F. Kennedy Boulevard,
Philadelphia, Pennsylvania 19103 and __ (“Institution”) whose principal place of business is ____________________.
This Agreement is effective as of the last date of signature below (the “Effective Date”).

 

	I.	Definitions. The following terms, when capitalized, shall have the following meanings as used in this Agreement:

 

	 	A.	“Applicable Law” means all United States federal, state and local laws, rules, regulations, requirements, guidelines and policies that govern or apply to the conduct of the Clinical Trial (as defined below), including without limitation the Federal Food Drug and Cosmetic Act and related regulations, including 21 CFR Parts 11, 50, 54, 56 and 312; Guideline for Good Clinical Practice (“GCP”) adopted by the International Conference on Harmonization (ICH GCP”) of Technical Requirements for Registration of Pharmaceuticals for Human Use, as ratified by the FDA to the extent applicable for this type of project and to the extent ICH GCP guidelines conform to the FDA GCP, and state and federal privacy laws, including the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”) and the regulations promulgated thereunder; the False Claims Act (31 U.S.C. §§3729-3733) (“FCA”); the Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)); and the Physician Self- Referral Law (a.k.a. Stark Law, 42 U.S.C. §1395nn), as any of the foregoing may be amended from time to time.
	 	 	 
	 	B.	“Case Report Form” (“CRF”) means the case history and/or individual research record created and maintained for each Enrolled Participant in the Clinical Trial, as required by FDA regulations.
	 	 	 
	 	C.	“Clinical Trial” means the performance of the clinical trial conducted in accordance with the Protocol (defined below).
	 	 	 
	 	D.	“Data” means customary accurate and authentic records and clinical trial documentation, including without limitation signed consent forms, clinical data, CRFs, case histories, notes, accounts, and adverse event reports created for the Clinical Trial excluding original source medical records.
	 	 	 
	 	E.	“Eligible Patient” means a patient who meets the enrollment criteria set forth in the Protocol.

 

    	 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	F.	“Enrolled Participant” means an Eligible Patient who has consented to participate and has been enrolled in the Clinical Trial. 
	 	 	 
	 	G.	“FDA” means the United States Food and Drug Administration or any successor agency thereto.
	 	 	 
	 	H.	 “Intentionally Omitted.”
	 	 	 
	 	I.	“IND” means an investigational new drug application submitted to the FDA.
	 	 	 
	 	J.	“Investigator” means the properly licensed medical doctor employed or contracted by or affiliated with the Institution who is responsible for performance of the Clinical Trial at the Institution.
	 	 	 
	 	K.	“IRB” means the Institution’s Institutional Review Board constituted and operating in accordance with 21 CFR Part 56 and any other applicable FDA/HHS regulations.
	 	 	 
	 	L.	“Patient Informed Consent” means a form of document describing the Clinical Trial and its reasonable risks, which addresses all matters customarily addressed in patient informed consents appropriate to clinical trials of this type, includes an authorization by the patient to share with GOG, Sponsor and/or sponsor’s designee all patient data required for performance of the Clinical Trial and the preparation of all regulatory submissions, and complies, at a minimum, with the requirements set forth in FDA regulations, including without limitation 21 CFR §§50.20, 50.25, 50.27, and any successor provisions.
	 	 	 
	 	M.	“Protocol” means the protocol titled, “The OVAL Study: A Randomized, Controlled, Double-Arm, Open-Label, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Monotherpay for the Treatment of Recurrent Plantinum-Resistant Ovarian Cancer,” attached as Exhibit A, including any amendments thereto.
	 	 	 
	 	N.	“Sponsor” means Vascular Biogenics Ltd. and is an intended third-party beneficiary of this Agreement.
	 	 	 
	 	O.	“Study Drug” means Ofranergene Obadenovec (VB-111).

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	II.	Performance of Clinical Trial.

 

	 	A.	Investigator. The Institution, Sponsor, Sponsor’s designee and GOG have agreed that _  ___ is the Investigator at Institution. Institution represents that Investigator holds the necessary professional license and has the necessary expertise, time and resources to perform the Clinical Trial and will ensure that Investigator is made aware of and acknowledges the obligations applicable to the Investigator set forth in this Agreement. Institution, Investigator, or both, shall provide all support personnel needed to conduct the Clinical Trial. In the event Investigator becomes either unwilling or unable to perform the duties required by this Agreement for any reason, Institution shall notify GOG within a reasonable time (i.e., with enough notice to mitigate the circumstances) and propose a new investigator to GOG. 
	 	 	 
	 	 	If a mutually acceptable substitute is not available, this Agreement will automatically terminate; however, Institution shall continue to provide follow-up care to Enrolled Participants per the Protocol and generally accepted standards of Good Clinical Practice. Any substitute Investigator shall be required to agree in writing to the terms and conditions of this Agreement.

 

	 	B.	IRB/Patient Informed Consent. Institution shall be responsible for obtaining and maintaining all IRB approvals required by Applicable Law for the conduct of the Clinical Trial. Institution shall keep Sponsor and/or Sponsor’s designee fully informed of the progress of IRB submissions and shall, upon request, provide Sponsor and/or Sponsor’s designee with all correspondence relating to such submissions. Institution shall use the “Informed Consent” template attached hereto as Exhibit B (the “ICF”) for the performance of this Clinical Trial. Institution shall not consent to any change in the Protocol or ICF requested by the IRB without the prior written consent of Sponsor and/or Sponsor’s designee. Institution shall obtain and maintain a signed Patient Informed Consent (as approved by the IRB) for each Enrolled Participant in the Clinical Trial at Institution, prior to performing any activities under the Protocol. Institution shall retain such consent forms for the length of time required by Applicable Law.
	 	 	 
	 	C.	Enrollment. Institution shall not enroll any Eligible Patients in the Clinical Trial until: (i) the Protocol has been approved by the IRB, and    (ii) all applicable FDA approvals have been obtained. Institution acknowledges and agrees that Sponsor and/or Sponsor’s designee may communicate directly with Investigator regarding recruitment and enrollment in the Clinical Trial.
	 	 	 
	 	D.	Conduct. Institution, under the guidance of Investigator, is responsible for the day-to-day supervision and control of the Clinical Trial and shall conduct the Clinical Trial in accordance with the Protocol, this Agreement, Applicable Law and current Good Clinical Practices. In the event of any conflict between the Protocol and the provisions of this Agreement, the Protocol shall govern with respect to clinical issues, and the provisions of this Agreement shall govern with respect to all other issues. Institution shall maintain a file of all documents pertaining to the Protocol including, but not limited to, Protocol amendments and safety reports.
	 	 	 
	 	 	Institution shall perform the following duties:

 

	 	●	Review and approve Clinical Trial Data collection forms

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	 	Institution shall promptly notify Sponsor and/or Sponsor’s designee of any adverse reactions in the course of the Clinical Trial to enable Sponsor to fulfill its drug safety reporting requirements. In the event of SAEs, Institution shall promptly and fully comply with all notification procedures, time frames, and requirements stated in the Protocol, including completion of a Sponsor Serious Event Report form. Institution shall notify Sponsor’s designee within twenty-four (24) hours of first becoming aware of an SAE via the GOG SAE Portal. Institution shall comply with all FDA reporting requirements, including without limitation, the requirement for adverse event and SAE reporting in accordance with 21 CFR 312.64, and such other reporting requirements set forth under Applicable Law. 
	 	 	 
	 	 	Institution shall submit completed CRFs to according to Protocol requirements. Federal regulations require that copies of case report forms be retained by the Institution for a period of no less than two years following either the approval of the New Drug Application or the withdrawal of the Investigational New Drug Application.
	 	 	 
	 	E.	Study Drug. Institution shall keep the Study Drug in a locked, secured area, and maintain control of the Study Drug in accordance with this Agreement, the Protocol and Applicable Law, including taking regular and ongoing inventories and reconciling the same with records of receipt and dispensing or other disposition of the Study Drug as required by Applicable Law. Any use by Institution or Investigator of the Study Drug for any purpose outside of the Protocol is prohibited by this Agreement, and any work so performed would represent a breach of this Agreement and misuse of the Study Drug. Institution shall make use of the Study Drug solely for the purpose of conducting the Clinical Trial in accordance with the Protocol and shall limit access to Institution personnel working on the Clinical Trial. All unused Study Drugs(s), and any other materials, that were furnished to Institution by or on the behalf of Sponsor shall be returned to Sponsor or destroyed by Institution at the completion or termination of the Clinical Trial, as directed by Sponsor and Sponsor’s designee.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	F.	Required Disclosures.

 

 

	 	(i)	In compliance with Applicable Law governing “Financial Disclosure by Clinical Investigators” (21 CFR Part 54), Institution shall require all Investigators proposed to work on the Clinical Trial to submit FDA financial disclosure forms to Sponsor’s designee before beginning work on the Clinical Trial, and update such information promptly if any relevant changes occur during the term of this Agreement and for one (1) year following completion of the Clinical Trial.
	 	 	 
	 	 	Notwithstanding anything to the contrary in this Agreement, Institution acknowledges and agrees that (a) GOG and/or Sponsor are permitted to publicly disclose information regarding this Agreement to comply with Applicable Law, including without limitation the Physician Payment Sunshine Act (a provision of the Patient Protection and Affordable Care Act) (collectively,“Disclosure Laws”) and (b) this information may include without limitation payments, or other transfers of value, made on behalf or at the request of GOG to physicians, hospitals, and other persons or entities that are the subject of the Disclosure Laws (each a “Disclosure Subject”). Institution agrees to promptly respond to, and cooperate with, reasonable requests of GOG and/or Sponsor regarding collection of information regarding and compliance with Disclosure Laws. Institution shall collect and, no later than January 30 of each year during the term of this Agreement, submit in a format reasonably requested by GOG the following information for each Disclosure Subject that, in connection with or as a result of performance of the Clinical Trial, received payments or other transfers of value in the calendar year prior to the year in which such submittal is to be made hereunder: (1) the amounts, dates, and description of payments made to, or other transfers of value to, each Disclosure Subject; (2) the name, address, specialty, and, if applicable, National Provider Identifier number of each Disclosure Subject; and (3) a description of the goods or services provided by each Disclosure Subject in return for such payments or transfers of value.

 

	 	G.	Biologic Materials. Institution shall (i) maintain in accordance with industry standards and Applicable Law, any biologic materials of human origin (“Materials”) collected by Institution in accordance with the Protocol; (ii) retain all right, title and interest in and to the Materials, (iii) grant Sponsor an exclusive, royalty-free, perpetual license to use such Materials in accordance with the Protocol and the Patient Informed Consent under which the Materials were obtained; (iv) use the Materials for purposes of obtaining and maintaining regulatory approval of the Study Drug; and (v) use the Materials in conjunction with the confidentiality and Publication rights set forth in this Agreement.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	III.	Duties of GOG.

 

	 	A.	Sponsor and Sponsor’s designee shall provide the Investigator’s Brochure, and any amendments and/or updates to the Investigator’s Brochure for the Study Drug. Sponsor shall provide Institution properly formulated and acceptably labeled clinical-grade Study Drug without charge, in a timely manner and in sufficient quantity to complete the Protocol.
	 	 	 
	 	B.	Amount of Payments. GOG shall pay Institution in accordance with the Exhibit “C” Site Budget attached hereto and incorporated herein by reference, provided, however, that the services have been properly performed in accordance with the Protocol and this Agreement, in a timely and satisfactory manner. Payment for partially completed cases, i.e., early withdrawals, shall be made on a pro-rata basis for services performed according to the Budget. Institution and Investigator will not be paid for any services performed that violate the Protocol or this Agreement. 
	 	 	 
	 	C.	Payments shall be sent to Institution as follows:

 

 

	 	(i)	Checks shall be made payable to: ____________ (“Payee”)
	 	 	 
	 	(ii)	Federal Tax I.D. Number: ____________
	 	 	 
	 	(iii)	Checks shall be mailed to: Attention:
	 	 	 
	 	 	___________

 

Institution and
Investigator acknowledge that the designated Payee is the sole recipient of payment under this Agreement and that no separate or
additional payment will be made by GOG to Institution, Investigator or any other person or entity for services provided in connection
with this Agreement.

 

	IV.	Confidential Information.

 

	 	A.	“ Confidential Information” means all proprietary, trade secret and/or confidential information, including Sponsor information and Study Drug, that Sponsor, Sponsor’s designee and GOG or its representatives provides to Institution, which is (i) in writing or other tangible or electronic medium and designated “confidential” or otherwise marked with indicia of its confidential nature; (ii) orally disclosed and not previously reduced to a tangible medium, provided that Sponsor, Sponsor’s designee and GOG shall use reasonable efforts to identify such information as “confidential” at the time of disclosure and thereafter summarize such information in writing or reduce it to a tangible medium within thirty (30) days of disclosure; (iii) the foregoing notwithstanding, disclosed by Sponsor, Sponsor’s designee and GOG and which a reasonable person would understand to be confidential or proprietary in nature, including, without limitation, the Protocol, Investigator’s Brochure and any regulatory documents; or (iv) any Data, records and information (excluding source medical documents), generated by Institution, Investigators and Institution Personnel as a result of the performance Study including information, Data and Clinical Trial results generated or required during this Agreement or Sponsor’s Confidential Information including un-published Data and Study results,

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	B.	Notwithstanding any designation by Sponsor, Sponsor’s designee and GOG, “Confidential Information” shall not include information which the receiving party can demonstrate that:

 

	 	(i)	is or becomes publicly known or available through no fault of Institution or Investigators or Institution Personnel;
	 	 	 
	 	(ii)	Sponsor, Sponsor’s designee and GOG has made available to third-parties without a confidentiality obligation;
	 	 	 
	 	(iii)	is already independently known to Institution or Investigator, as shown by their prior written records except for information concerning the Clinical Trial that was created in collaboration with Sponsor, Sponsor’s designee and GOG or in view of this Agreement;
	 	 	 
	 	(iv)	at such time that it is disclosed, is included in a publication produced in accordance with Section VI; or
	 	 	 
	 	(v)	publicly available information that relates to potential hazards or warnings associated with the production, handling, or use of the Study Drug.

 

	 	C.	Institution and Investigators shall not: (i) disclose, and shall cause their respective employees and agents not to disclose, the Confidential Information to any third party without the prior written permission of GOG and/or Sponsor, as applicable, except as permitted by this Agreement; and (ii) use the Confidential Information for any purpose other than the conduct of the Clinical Trial. The Confidential Information shall remain the confidential and proprietary property of Sponsor (or GOG as the case may be) and shall be disclosed only to Investigator and the Institution Personnel or agents on a “need to know” basis. Confidential Information shall not be provided by the Institution to any parties not involved in the conduct of the Study, other than to GOG and/or Sponsor. Institution further acknowledges and understands that Sponsor is a public company traded on the NASDAQ, and accordingly, the Confidential Information may be considered as “inside information” pursuant to securities laws and regulations. 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	D.	In the event that Institution or Investigator or their employees and agents reasonably find it necessary to disclose any Confidential Information to a governmental authority to defend the research against an allegation of fraud or other misconduct, or to defend themselves in any other legal proceeding, or are required by applicable law or medical duty to disclose Confidential Information, the party may make the necessary disclosure after providing reasonable prior written notice to Sponsor and GOG, and attempting in good faith to agree upon a mutually satisfactory way to disclose only such portions of the Confidential Information as is necessary to achieve this limited purpose. In the event disclosure is required under this section, after reasonable notice has been provided to the Sponsor, Institution or Investigator with whom the request for Confidential Information has been made agrees to fully cooperate at Sponsor’s sole cost and expense with Sponsor should Sponsor seek a protective order, or other legal remedy to limit the disclosure of such Confidential Information.
	 	 	 
	 	E.	Nothing herein shall be construed as preventing Institution or Investigator from publishing or otherwise publicly disclosing any data generated from the Clinical Trial as provided in Sections VI and VII, below.
	 	 	 
	 	F.	The obligations of this Section IV shall survive the expiration or termination of this Agreement.

 

	V.	Recordkeeping; Access to Data; Inspection and Audit.

 

	 	A.	Institution shall maintain a file of all documents pertaining to the Protocol, including, but not limited to, Protocol amendments and safety reports. Institution shall obtain and maintain a signed Patient Informed Consent for each Enrolled Participant and retain such Patient Informed Consent for at least three (3) years or longer, as required by Applicable Law or Sponsor or GOG. Institution shall submit completed CRFs according to Protocol requirements.
	 	 	 
	 	B.	Institution shall require (i) Investigator to create and maintain Data, and (ii) Investigator and other research staff to maintain confidentiality of personally identifiable information concerning Enrolled Participants, and shall disclose such information to third parties only as permitted by Applicable Law. All Data provided by Institution to Sponsor and Sponsor’s designee with respect to Enrolled Participants shall be furnished without patient names.
	 	 	 
	 	C.	Institution shall provide a complete copy of all collected Data and shall grant Sponsor the exclusive right to use, reference and disclose such Data for all purposes relating to the Study Drug, including, but not limited to, independent analysis, filing of FDA applications or other regulatory submissions, preparing patent applications and related filings and any other lawful purpose.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	D.	Institution shall retain, all Clinical Trial-related records in accordance with 21 CFR §312.62, and at a minimum for a period of two (2) years following the date a marketing application is approved for the Study Drug for the indication for which it is being investigated, and if no application is to be filed or if the application is not approved for such indication, until two (2) years after the Clinical Trial is discontinued and the FDA is notified, However, prior to destroying or otherwise disposing of any such records, Institution will provide Sponsor or Sponsor’s designee a reasonable opportunity to take possession of the records at Sponsor’s own expense.
	 	 	 
	 	E.	Sponsor and GOG and authorized agents of FDA, HHS, and other federal agencies shall have the right to inspect and review Data at the Institution to the extent permitted by law and during regular business hours and upon reasonable notice.
	 	 	 
	 	F.	Institution shall permit GOG and Sponsor or its representatives to conduct periodic monitoring visits and audits, to the extent possible at mutually acceptable times during normal business hours, to (i) inspect records (both written and electronic) relating to the Clinical Trial and Clinical Trial Data at the Participating Institutions during normal business hours from time to time as reasonably requested by Sponsor, (ii) inspect and examine the Participating Institutions’ facilities at which the Clinical Trial is being conducted, and (iii) verify compliance with the Protocol and this Agreement by GOG, Study Chair, Principal Investigator, Participating Institutions, and Clinical Investigators. 

 

	VI.	Publication and Other Public Presentation of Results.

 

Sponsor and GOG recognize that, consistent
with the principles of academic freedom, Institution requires that Investigators be free to publish the results of their research
activities after Sponsor’s provision of the final study report. Investigators engaged in this Clinical Trial are permitted
to publish reports in journals and other professional publications, and to present the methods and results of this Clinical Trial
at symposia and professional meetings (each, a “Publication”), in accordance with the requirements of this Section
VI. Such publication by Institution and/or Investigator may be no earlier than after a cooperative multi-center publication has
been published with Sponsor or eighteen (18) months from the date of completion or termination of the Study after providing Sponsor
an opportunity to review and comment in accordance with the terms herein.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	A.	GOG and Sponsor shall be furnished a copy of any proposed Publication for advisory review at least sixty (60) days in advance of the submission of such proposed Publication for journals and other professional publications and thirty (30) days for any other Publication, such as a poster presentation, abstract, or other written or oral material which describes the results of the Clinical Trial. Expedited review or additional review time may be arranged by mutual written agreement. Sponsor may remove from the proposed publication any information that is Confidential Information.
	 	 	 
	 	B.	If within such review period, GOG and/or Sponsor determines and notifies Institution in writing that the proposed Publication contains disclosures of the intellectual property of Sponsor or GOG, Institution and Investigator agree to delay submission of the proposed Publication for up to an ninety (90) days in order to allow GOG or Sponsor sufficient time to take appropriate steps to preserve U.S. or foreign patent or other intellectual property rights and/or ensure compliance with securities disclosure obligations. As directed by Sponsor and/or Sponsor’s designee and/or GOG, Institution and Investigator shall provide any additional information in their possession which Sponsor deems necessary to file such patent application(s) or otherwise protect such intellectual property rights. Sponsor shall have three (3) months from its receipt of such additional information to file such patent application(s). Institution and Investigator shall not submit the proposed Publication to anyone who is not employed by Institution and under an obligation of non-disclosure and non-use at least substantially identical to that imposed on the Institution and Investigator until each such patent application has been filed by Sponsor or the conclusion of the three (3) month period of this Paragraph, whichever occurs first, or until the information on the potentially patentable invention(s) is excised from the manuscript.
	 	 	 
	 	 	Without limiting the foregoing, Institution and Investigator shall give due regard to GOG’s and Sponsor’s legitimate interests, such as manuscript authorship, coordinating and maintaining the proprietary nature of submissions to health authorities, and coordinating with other ongoing studies in the same field, and agree to consider Sponsor’s reasonable comments and suggestions with respect to such Publications. It is understood that, except to the extent required by Applicable Law or court order or for reasons of patient safety, all disclosures of Data to third parties by Institution, Investigators and their personnel shall be through Publications in accordance with this Section VI. For clarity, such parties may freely disclose the contents of a Publication made in accordance with this Section VI after such Publication has been made.
	 	 	 
	 	C. 	GOG and Sponsor shall have the right and license to reference and reproduce any such publication or presentation in connection with any regulatory filing, patent application, company presentation, investor presentation or any other lawful purpose, subject to Section VIII.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	VII.	Use of Names.

 

Neither Sponsor,
Sponsor’s designee, GOG nor Institution shall use the name, symbols and/or marks of the other in connection with the Clinical
Trial without prior written permission from the other party. Such permission is not required for disclosure of the existence of
the Agreement in reports generated in the normal course of business by Sponsor, Sponsor’s designee or GOG, or where acknowledgment
of sponsorship is required by the guidelines of a scientific publication or organization, or the fact that Institution is conducting
the Clinical Trial in disclosures made by Sponsor, Sponsor’s designee or GOG in the normal course of business, or where required
by regulatory authority, law or stock exchange rule. Neither party shall use, nor authorize others to use, the name, symbols, or
marks of the other or any affiliate thereof in any advertising or publicity material or make any form of representation or statement
in relation to the Clinical Trial that would constitute an express or implied endorsement by the other party of any commercial
product or service, without prior written approval from the other party. None of the foregoing in this Section VII shall restrict
Sponsor, Sponsor’s designee or GOG from disclosing factual information regarding their relationship with Institution, Institution’s
performance of the Clinical Trial or the terms of this Agreement to prospective investors or sublicensees in the normal course
of its business relating to the Study Drug. Notwithstanding anything to the contrary herein, the parties agree that Institution
may post the following information on its website and in its research newsletter, with prior approval of the IRB if required: name
of Institution, Sponsor, Sponsor’s designee and/or GOG and Investigator; Protocol title, area and/or description of the Clinical
Trial; Institution’s internal project number; Institution’s contact information.

 

	VIII.	Patents and Inventions.

 

Any New Inventions (whether patentable or not), innovations, suggestions,
ideas and reports arising out of or in connection with the performance of the Study by Institution, Investigator and Institution
Personnel, or the contractors of any of the foregoing, shall be promptly disclosed to Sponsor, and shall be the exclusive property
of Sponsor. Upon Sponsor’s request, and at Sponsor’s sole expense, Institution and Principal Investigator shall take
all reasonable actions necessary or appropriate to obtain patent or other proprietary protection in Sponsor’s name with respect
to any of the foregoing. Sponsor grants to Institution a limited, royalty-free, non-exclusive license (without the right to sublicense)
to use the Sponsor’s Study Drug as required to carry out the Clinical Trial in compliance with the Protocol.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	A.	“New Invention(s)” shall mean any invention or discovery conceived, reduced to practice, or otherwise discovered or developed, in whole or in part, by Institution, Investigator, Institution Personnel, GOG, Sponsor, or the contractors of any of the foregoing, based on or resulting from performance of the Clinical Trial. As used in this Article VIII, the term “conceived” shall have the same definition of “conception” as set forth in section 2138.04 of the United States Patent and Trademark Office’s Manual of Patent Examining Procedure, Eighth Edition, Latest Revision July 2010.
	 	 	 
	 	B.	“Institution Invention(s)” shall mean any New Invention that is conceived, reduced to practice or otherwise discovered or developed solely by Institution Personnel and is not, in whole or in part, (i) anticipated by the Protocol; (ii) made in violation of the Protocol or this Agreement; (iii) conceived, reduced to practice or otherwise discovered or developed by any Institution Personnel in performance of the Clinical Trial or the use of the Study drug; (iv) dependent on or derived from Sponsor’s Background IP or Confidential Information; or (v) conceived, reduced to practice or otherwise discovered or developed as a result of access to the Study Drug or Sponsor’s Background IP or Confidential Information. Institution Inventions shall be the sole property of Institution. Institution shall provide, and shall cause the Institution Personnel to provide, prompt written notice to Sponsor of any New Invention. “Institution Personnel” shall mean, separately and collectively, Institution, Investigator, or the employees, staff, or contractors of Institution or Investigator.
	 	 	 
	 	C.	“Joint Invention(s)” shall mean any New Inventions conceived, reduced to practice or otherwise discovered or developed jointly by (i) Institution or any Institution Personnel and (ii) Sponsor, GOG, or any contractors of Sponsor or GOG. Joint Inventions shall be owned by Sponsor, Institution and GOG shall provide prompt written notice to Sponsor of any Joint Invention. Institution and Investigator hereby assign and agree to assign, to Sponsor all of their respective right, title and interest in and to any Joint Inventions, and at the request and expense of Sponsor, shall cause to be executed all documents and perform all further acts necessary to effect, evidence, or perfect such assignment and protect Sponsor’s ownership of any Joint Invention, which shall include providing reasonable assistance with the filing, prosecution, or enforcement of any patents.
	 	 	 
	 	D.	Except as expressly provided above in Articles VIII(C) and VIII(D) above, all other New Inventions, including without limitation those New Inventions (i) anticipated by the Protocol; (ii) made in violation of the Protocol; (iii) conceived, reduced to practice or otherwise discovered or developed by any Institution Personnel in performance of the Clinical Trial; (iv) dependent on or derived from Sponsor’s Background IP or Confidential Information; or (v) conceived, reduced to practice or otherwise discovered or developed as a result of access to the Study Drug or Sponsor’s Background IP or Confidential Information; shall be the sole property of Sponsor (“Sponsor Invention”). Institution shall provide prompt written notice to Sponsor of any Sponsor Invention. Institution and Investigator/s each hereby assign to Sponsor all of their respective right, title and interest in and to any Sponsor Inventions, improvements in Sponsor Inventions technology related to Sponsor Inventions, and at the request and expense of Sponsor, shall cause to be executed all documents and perform all further acts necessary to effect, evidence, or perfect such assignment and protect Sponsor’s ownership of any Sponsor Invention, which shall include providing reasonable assistance with the filing, prosecution, or enforcement of any patents at Sponsor’s sole cost and expense.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	E.	The right of publication by Institution and Investigator, as described in Section VI, shall not be affected by a license to use any New Invention.
	 	 	 
	 	F.	Existing inventions, ideas, discoveries, technologies, methodologies and other intellectual property of each party that were conceived, reduced to practice, or otherwise discovered or developed before the Effective Date (“Background IP”) are their separate property, whether protected by patent or other intellectual property rights, and except as expressly provided in Section VIII(A), are not affected by this Agreement. Neither party shall have any claims to or rights in any such inventions, ideas, discoveries or methodologies of the other party or of Sponsor.

 

	IX.	Insurance; Indemnification.

 

	 	A.	Sponsor maintains and Institution maintains and shall require Investigators to maintain a policy or program of insurance or self-insurance in amounts adequate to cover its obligations hereunder and in accordance with industry standards or otherwise as required by law. Specifically, Institution shall maintain a policy or program of insurance of self-insurance in full force and effect, throughout the performance of the Clinical Trial that covers: (a) employer’s liability; (b) general liability; (c) contractual liability; (d) premises liability; (e) professional medical and nursing indemnity in amounts adequate to cover its obligations hereunder and in accordance with industry standards or as otherwise required by law.
	 	 	 
	 	B.	 Upon request, each party shall provide the other with evidence of its insurance or self- insurance coverage, and unless self-insured, will notify the other party within three (3) business days of notice of any reduction, non-renewal or cancellation of its coverage. Institution shall maintain a policy or program of insurance of self-insurance and require Investigators to have malpractice insurance in accordance with industry standards or otherwise required by law
	 	 	 
	 	C.	Any indemnification rights afforded to the Institution for the Clinical Trial are provided exclusively by Sponsor and are contained in the Letter of Indemnification attached hereto as Exhibit D.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	X.	Term and Termination.

 

	 	A.	This Agreement shall become effective on the Effective Date and, unless terminated earlier pursuant to the termination provision below, shall continue in force until Sponsor, Sponsor’s designee and/or GOG receives all Data, questions about Data submitted have been resolved, the database has been locked, and the final study report provided to and accepted by Sponsor.
	 	 	 
	 	B.	This Agreement will terminate automatically if any of the following occur:

 

	 	(i)	if FDA imposes a permanent hold on the Study Drug;
	 	 	 
	 	(ii)	if the Clinical Trial is terminated by Sponsor or Institution for reasons of patient safety; or
	 	 	 
	 	(iii)	if a formal investigation by an authorized governmental agency finally determines that the Data have been falsified or irreparably compromised by research misconduct.

 

	 	C.	This Agreement may be terminated by either party, upon thirty (30) days prior written notice, if either party fails to materially comply with the terms of this Agreement after receipt of written notice, with reasonable opportunity to cure, from the other party.
	 	 	 
	 	D.	This Agreement may be terminated by Institution immediately upon written notice to Sponsor and GOG if Institution reasonably determines that patient safety requires termination. This Agreement may be terminated by Sponsor for any reason upon thirty (30) days prior written notice to Institution. Provided, however, Sponsor may suspend the Clinical Trial, in whole or in part, at any time for any reason. The suspension of the Clinical Trial by Sponsor for any reason shall not be deemed a material breach of this Agreement.
	 	 	 
	 	E.	Institution shall return or properly dispose of, at the option of Sponsor, any unused Study Drug, in each case prior to the effective termination date indicated in the notice of termination or the date of automatic termination, if applicable. Further, Institution shall, within thirty (30) days of the effective date of such termination or expiration, return any Confidential Information, provided, however, that one (1) archival copy of Sponsor and/or GOG’s Confidential Information may be retained solely for purposes of monitoring compliance with this Agreement. 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	F.	Upon the effective date of any termination or expiration of this Agreement, Institution shall (i) notify the Investigator that the Clinical Trial has been terminated, (ii) cease (and cause the Investigator to cease) enrolling further patients in the Clinical Trial, (iii) cease (and cause Investigator to cease) treating Enrolled Participants according to the Protocol as directed by GOG and/or Sponsor and Sponsor’s designee to the extent medically permissible and appropriate, and (iv) terminate (and cause Investigator to terminate) as soon as practicable, but in no event more than thirty (30) days after the effective date of termination, all other applicable Clinical Trial activities; provided however, that upon Sponsor, Sponsor’s designee and/or GOG’s request, Institution shall continue to collect Data and prepare and complete CRFs for Enrolled Participants treated in the terminated Clinical Trial prior to termination or expiration. Within ninety (90) days from the effective date of any termination, Institution shall provide to Sponsor, Sponsor’s designee and/or GOG all Data.
	 	 	 
	 	G.	Expiration or termination of this Agreement for any reason shall not affect the rights and obligations of the parties accrued prior to the effective date of such expiration or termination. The rights and duties as specified and any other provision that by its terms is intended to survive termination or expiration, shall survive the termination or expiration of this Agreement.
	 	 	 
	 	H.	The parties shall cooperate with each other and with Federal agencies in winding down the Clinical Trial.

 

	XI.	Miscellaneous.

 

	 	A.	Independent Contractor. Institution, Investigators and other research staff are independent contractors and are neither employees nor agents of Sponsor, Sponsor’s designee nor GOG. Sponsor, Sponsor’s designee or GOG does not intend to create any partnership, joint venture, employment or agency relationship pursuant to this Agreement. Neither party to this Agreement shall have the right to bind the other party by contract or otherwise to transact business in the other party’s name or on its behalf, unless with the specific written consent of the other party.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

Correspondence. Institution shall address
all medical/scientific communications to the Sponsor or Sponsor’s designee at the address listed in the Protocol and to GOG.

 

	 	B.	Notices. Legal notices given to the respective parties hereunder shall be in writing and sent by facsimile or by registered or certified mail to the following:

 

	 	If to Institution:	______________
	 	 	 
	 	If to Sponsor:	 
	 	 	 
	 	If to GOG:	The GOG Foundation, Inc.
	 	 	Four Penn Center, Suite 1020 1600 John F. Kennedy Boulevard
	 	 	Philadelphia, Pennsylvania 19103-2800
	 	 	[***]
	 	 	[***]
	 	 	[***]
	 	 	 
	 	With a copy to:	______________, General Counsel
	 	 	The GOG Foundation, Inc.
	 	 	1600 John F. Kennedy Boulevard, Suite 1020
	 	 	Philadelphia, PA 19103-2800

 

Notices shall be deemed given when facsimile
transmission or mail receipt is confirmed.

 

	 	D. 	Assignment/Subcontracting. Due to the specialized nature of the services provided under this Agreement, Institution shall not assign, transfer or convey this Agreement or subcontract services under this Agreement without GOG and Sponsor’s prior written consent. This Agreement shall inure to the benefit of each party and its permitted successors and assigns. Institution shall only conduct the Clinical Trial at the Institution. For the performance of its obligations under this Agreement, Institution shall only use its employees or the employees of Institution’s wholly owned affiliates that are obligated to the relevant terms of this Agreement via a separate agreement with Institution.
	 	 	 
	 	E.	Amendment. Any amendment(s) to this Agreement must be in writing and signed by both parties.
	 	 	 
	 	F. 	Alternative Dispute Resolution. The parties agree to make their best efforts to resolve any disputes regarding this Agreement through the Commercial Rules of the American Arbitration Association by one arbitrator appointed in accordance with said Rules.
	 	 	 
	 	G. 	Entirety of Agreement. This Agreement constitutes the entire agreement between the parties concerning the subject matter herein, and supersedes all prior terms or understandings, written or oral. In the event of a conflict between the terms of this Agreement and the Protocol, this Agreement shall govern all legal and financial matters and the Protocol shall govern all clinical matters. 
	 	 	 
	 	H. 	Waiver. Neither the waiver by any of the parties hereto of a breach of or a default under any of the provisions of this Agreement, nor the failure of any of the parties, on one or more occasions, to enforce any of the provisions of this Agreement or to exercise any right or privilege hereunder shall thereafter be construed as a waiver of any subsequent breach or default of a similar nature, or as a waiver of any of such provisions, rights or privileges hereunder. No waiver by a party hereto of, or consent by a party hereto to, a variation from any provision of this Agreement shall be effective unless made in a written instrument duly executed on behalf of such party.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	I.	Severability. The invalidity or unenforceability of any term or provision of this Agreement shall not affect the validity or enforceability of any other term of this Agreement.
	 	 	 
	 	J.	No Debarment. Institution represents and warrants that to the best of its knowledge, after due inquiry using industry standards, neither Institution nor any of its employees or agents, Principal Investigator, or any participating Investigator or any of their employees or agents, rendering activities pursuant to this Agreement is presently debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335(a), (b)(1), and (b)(2), as amended from time, or disqualified under 21 C.F.R. § 312.70 or § 812.119, as amended from time to time, or any other FDA authority. During the term of this Agreement, Institution shall notify GOG upon knowledge of Institution or any such person involved in the Clinical Trial becoming debarred or disqualified.
	 	 	 
	 	K.	Inspections. If any governmental or regulatory authority conducts or gives notice to Institution of its intent with respect to any activities under this Agreement to conduct an inspection, audit, or monitoring visit at Institution or take any other regulatory action, or if Institution or Investigator becomes aware of any such governmental inspection or other regulatory activity at Institution, Institution shall promptly give Sponsor and Sponsor’s designee and GOG notice thereof by telephone with follow-up notice provided in writing within forty-eight (48) hours of the telephonic notification, including all information pertaining to any such inspections or actions, and Institution shall allow or cause the applicable Investigator to allow Sponsor and/or Sponsor’s designee and GOG to be present at any such inspection or actions. The Institution and the Investigator shall provide Sponsor and Sponsor’s designee and GOG with a copy of any report received in connection with, or as a result of, such inspection within three (3) days of its receipt. Any required response or action by Institution shall be made within two (2) weeks of issuance of any citations or within any earlier deadline set by the issuing regulatory authority and shall make a good faith consideration to incorporate any comments provided by Sponsor and/or Sponsor’s designee and GOG on any proposed written response. Sponsor may at its discretion solicit input from GOG to provide input into the proposed response. Institution shall provide Sponsor and Sponsor’s designee and GOG with a copy of any such written response. In the event the FDA or other regulatory authority requests or requires any action to be taken to address any citations, Institution shall immediately provide Sponsor and Sponsor’s designee and GOG with written notice thereof and shall require that Investigator, after consultation with Sponsor and/or Sponsor’s designee, take such action as necessary to address and correct any such citations, and cooperate with GOG, Sponsor and/or Sponsor’s designee with respect to any such citation and/or action taken with respect thereto. Sponsor may at its discretion solicit input from and involve GOG in discussions regarding responses to any action which needs to be taken to respond to any citations or recommendation from the FDA or other regulatory authority.
	 	 	 
	 	L. 	No Sanctions. Institution hereby represents and warrants that neither Institution nor any of its personnel involved in the Clinical Trial, nor to the knowledge of Institution any Investigator, or the research staff have been or shall be involved in an investigation or in research that was terminated, as the term “termination” is used in 21 CFR 812.3(q), nor have they been subjected to any sanctions related to allegations of research or professional misconduct.

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	M.	Additional Actions and Documents. Each of the parties hereto hereby agrees to take or cause to be taken such further actions, to execute, deliver and file or cause to be executed, delivered and filed such further documents and instruments, and to obtain such consents, as may be necessary or as may be reasonably requested in order to fully effectuate the purposes, terms and conditions of this Agreement.
	 	 	 
	 	N. 	Authority of the Parties. The Parties hereby represent and warrant that they have the legal authority to enter into this Agreement and that the terms of this Agreement are not inconsistent with their other contractual arrangements.
	 	 	 
	 	O.	Counterparts. To facilitate execution, this Agreement may be executed in as many counterparts as may be required. It shall not be necessary that the signature of or on behalf of each party appears on each counterpart, but it shall be sufficient that the signature of or on behalf of each party appears on one or more of the counterparts. All counterparts shall collectively constitute a single agreement. It shall not be necessary in any proof of this Agreement to produce or account for more than a number of counterparts containing the respective signatures of or on behalf of all of the parties. Any signature provided by facsimile or electronic image transmission shall be binding to the same extent as an original signature page.
	 	 	 
	 	P. 	Headings. The headings of this Agreement are for ease of reference only and shall not limit or otherwise affect the meaning of the terms and conditions of this Agreement.
	 	 	 
	 	Q.	Nondiscrimination. Each party agrees to comply with all applicable Federal, state and local laws respecting discrimination. The parties hereby incorporate the requirements of 41 C.F.R. § 60-1.4(a), 41 C.F.R. § 60- 741.5(a), 41 C.F.R. § 60-250.5(a), 41 C.F.R. § 60-300.5(a), and 29 C.F.R. § 471 Appendix A to Subpart A (Executive Order 13496), as applicable.
	 	 	 
	 	R. 	Notification of Incidents. Each party agrees to promptly notify the other party after the discovery of any incident, occurrence, claim (either asserted or potential), lawsuit or other causes of action involving this Agreement, and both parties agree to cooperate with each other as may be necessary to resolve such matters. 
	 	 	 
	 	S.	Release of Information. The provisions of this Agreement are confidential and protected from disclosure to a third party, other than the Sponsor and either party’s agents, attorneys, consultants and designees, unless disclosure is required by law, or said third party is bound to the same level of confidentiality set forth in this Agreement.
	 	 	 
	 	T.	Unforeseen Circumstances. Neither party will be deemed in violation of this Agreement if prevented from performing any of its duties and responsibilities under this Agreement for circumstances beyond its reasonable control. In the event either party is unable to perform its duties and responsibilities due to said circumstances, the other party has the right to terminate this Agreement upon written notice to the affected party.
	 	 	 
	 	U.	Survival. Sections IV (Confidential Information), V (Record Keeping; Access to Data, Inspection and Audit) and VIII (Patents and Inventions) shall survive termination of the agreement
	 	 	 
	 	V.	Third Party Beneficiary. Sponsor shall be a third party beneficiary of this Agreement.

 

[Signature page follows]

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

The Parties hereby accept and agree to the terms
and conditions of this Agreement.

 

	(INSTITUTION) :	 	GOG Foundation, Inc.:
	 	 	 	 	 
	By:	 	 	By:	 
	 	 	 	 	 
	Name:	 	 	Name:	Larry J. Copeland,, M.D.
	 	 	 	 	 
	Title:	Authorized Signatory	 	Title:	President
	 	 	 	 	 
	Date:	 	 	Date: 	 

 

READ AND AGREED TO:

 

INVESTIGATOR

 

	By:	 	 
	 	 	 
	Name:	 	 
	 	 	 
	Date: 	 	 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

EXHIBIT A

 

PROTOCOL

 

[To be attached]

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

EXHIBIT B

 

INFORMED CONSENT TEMPLATE

 

[To be attached]

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

EXHIBIT C

 

BUDGET INFORMATION

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

EXHIBIT D

 

[Sponsor Letter of Indemnification attachment]

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

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COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.AGREEMENT

 

This AGREEMENT is made the 1st day
of June 2016

 

 

BETWEEN

 

Vascular Biogenics Ltd. registration
number 51-289976-6 a company incorporated in Israel and having its principal place of business at 6 Yonni Netanyahu St. Or-Yehuda
Israel (the “Customer”)

 

AND

 

Biopharmax Group Ltd. registration number
51-241021-8, a private company incorporated in Israel and having its principal place of business at 4 Hasadnaot St. Hertzelia
(the “Contractor”)

 

 

WHEREAS:

 

	1.	The Customer wishes to erect, commission and validate a sterile manufacturing facility, all conforming to cGMP, FDA, EMEA, MOH (as defined below) and other Israeli regulations (the “Project”) located at Hasatat 8 Modiin, Israel (the “Facility”);
	2.	The Contractor wishes to undertake the execution of all the Works, (as defined below), all subject to the terms and conditions of the Agreement as set forth herein below; 
	3.	The Contractor represents that it is an independent contractor, duly registered with the Contractor registrar, and that it has, the know-how, expertise, financial and technical means and experience required for execution and completion of the Works all in accordance with and subject to the terms and conditions set forth herein;
	4.	The Contractor, has thoroughly examined and studied Costumer’s budget, URS, necessities and requirements, the premises set forth in Section 1 to this preamble above and its surroundings, as well as the annexes attached hereto, and represents that it is capable to perform and complete the Works in compliance with the terms of this Agreement, and in accordance with the best industry standards and within the Timetable; and
	5.	On the basis of Contractor’s warranties, representations and covenants set forth herein, Customer offered to Contractor to perform the in accordance with terms herein and Contractor has agreed to perform the Work as aforesaid.

 

NOW THEREFORE, the parties declare, stipulate
and agree as follows:

 

	1.	DEFINITIONS AND INTERPRETATIONS 
	 	 	 
	 	1.1	The following terms shall have the meanings appearing alongside them:
	 	 	 
	 	 	“Agreement” - This Agreement and its Annexes and any document which has been / will be agreed upon in writing constitutes part of the Agreement even if not actually attached to the Agreement.
	 	 	 
	 	 	“Bill of Quantity” – the bill of quantity setting forth all the Means required prepared by Contractor based on the requirements of the Design, User Requirement Specifications and the Basis of Design attached hereto as Annex A.
	 	 	 
	 	 	“Detailed Design” – mean the basis of design prepared by Contractor and approved by the Customer on the basis of the URS attached hereto as Annex C2, and/or which will be attached in the future.

 

    	 1

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	 	“cGMP”- the current Good Manufacturing Practices
	 	 	 
	 	 	“Drawings” - The drawings for execution of the Work (as defined below) which are attached to the Agreement as Annex C1, and/or which will be attached in the future.
	 	 	 
	 	 	“DQ”- design qualifications
	 	 	 
	 	 	“EMA” -  the European Medicines Agency, or any successor agency
	 	 	 
	 	 	“FDA” - the United States of America Food and Drug Administration, or any successor agency.
	 	 	 
	 	 	“Means” - The equipment, supplies, tools, materials, structures, scaffolding, installations and everything else that provided by the Contractor and required for execution of the Works or which will be used for the execution thereof.
	 	 	 
	 	 	“MOH”- means the Israeli Ministry of Health, or any successor agency
	 	 	 
	 	 	“IC” – installation commission
	 	 	 
	 	 	“IQ” – installation qualifications
	 	 	 
	 	 	“OC” – operation commission
	 	 	 
	 	 	“OQ” – operation qualification
	 	 	 
	 	 	“Regulations” – means the applicable cGMP, FDA, EMA, MOH and Israeli regulations required for the construction, maintenance and operation of the Facility.
	 	 	 
	 	 	“Scope of Work” - the scope of work containing the implementation, manufacturing, equipment, materials and overall scope for the Project, in the form attached as Annex B.
	 	 	 
	 	 	“Specifications” - the specifications of the Facility as specified in and in accordance with  the Design, User Required Specifications, Detailed Design and the Bill of Quantity.
	 	 	 
	 	 	“Timetable” – the time table for the specific stages as set forth in Annex D.
	 	 	 
	 	 	“User Requirement Specifications” or “URS” – the specifications prepared by the Customer attached hereto as Annex I. 
	 	 	 
	 	 	“Work and/or Works” – the execution, performance and completion of the Project, inclusive of all Means and services as set forth in the Scope of Work, meeting all of the Specifications. 
	 	 	 
	 	1.2	The Preamble hereof and all Annexes attached hereto form an integral part of this Agreement. The headings of the Sections, Sub-Sections or chapters in the Agreement are for convenience only, and shall not serve in interpretation of the Agreement.
	 	 	 
	 	1.3	In any case of discrepancy or contradiction between the provisions of this Agreement or between one of its provisions and one if its Annexes, the provisions of the Agreement will prevail. In case of conflict between the Annexes, the provisions of the Annexes shall govern in accordance with the following order: Annex I, Annex B, Annex C2, Annex C1 and Annex A.

 

    	 2

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	2.	THE ESSENCE OF THE AGREEMENT
	 	 	 
	 	2.1	The Customer hereby conveys to the Contractor and the Contractor hereby takes upon itself the execution and completion of the Work, on turnkey basis, at its own expense and on its own responsibility and in exchange for the Consideration (as defined below), all in accordance with the provisions of the Agreement.
	 	 	 
	 	2.2	Except as explicitly provided in the Scope of Work as being excluded from the Work but subject to Section 4.4 below (the “Excluded Items”), the Contractor shall perform or cause to be performed all work and services required in connection with the management, procurement, construction, DQ, IC OC, IQ and OQ and testing of the Work, and provide all materials and equipment
	 	 	 
	 	2.3	, machinery, tools, labor, transportation, utilities, administration, training and other services and items required to complete the Work at the Consideration. Upon successful DQ, IC OC, IQ and OQ testing of the Work and issuance of a Certificate of Completion (as defined below), all responsibilities regarding the Facility and Work shall transfer to Customer, subject to Contractor’s warranty, all as set forth in Section 17 below.
	 	 	 
	 	2.4	The Facility shall be constructed and operable in accordance with cGMP, and, in addition, will meet the current requirements in effect as of the date of this Agreement of the FDA, EMA, MOH and other relevant authorities of Israel. 

 

	3.	ANNEXES

 

The
Annexes to this Agreement are listed below:

 

		1.1	Bill
                                         of Quantity – Annex A.
		1.2	Scope
                                         of Work – Annex B.
		1.3	Drawings
                                         – Annex C1.
		1.4	Detailed
                                         Design - Annex C 2.
		1.5	Timetable
                                         – Annex D.
		1.6	Certificate
                                         of Completion – Annex E.
		1.7	Payment
                                         Schedule- Annex F.
		1.8	Certificate
                                         of insurance by the Contractor- Annex G.
		1.9	URS-
                                         Annex I
		1.10	Conceptual
                                         design – Annex J
		1.11	Bank
                                         Guarantee – Annex K.

 

	4.	CONSTRUCTION SCHEDULE; LIQUIDATED DAMAGES; FORCE MAJEURE 
	 	 
	 	4.1	The Contractor shall carry out the work as per the Timetable. 
	 	 	 
	 	4.2	The Work shall be completed by the completion date set forth in the Timetable (“Project Completion Date”).
	 	 	 
	 	4.3	If in the opinion of the Customer and based upon the Timetable, the Contractor is behind schedule, the Customer will direct the Contractor to take appropriate action to accelerate the performance of the Work so that the Project Completion Date is not jeopardized. Such action shall include but not be limited to overtime, shift work, additional construction equipment, extra work crews, etc. (as applicable), regardless of whether this was an Excluded Item. Any extra costs associated with such action will be borne by the Contractor, unless the delay was caused by an event that entitles the Contractor to a time extension, pursuant to Section 4.5 below or caused by the Customer.
	 	 	 
	 	4.4	The Contractor shall be responsible for liquidated damages for delays in the completion of the Work by the Project Completion Date caused by the Contractor, its employees, agents, subcontractors, suppliers or any other person or entity for whose acts the Contractor is liable, including but not limited to delays caused by problems with the Design, following a grace period of 5 (five) weeks (the “Grace Period”). In the event of delays in completion of the Work beyond the Grace Period, the Customer shall be entitled, following written notice to the Contractor but without recourse to judicial proceedings or proving damage, to collect as liquidated damages (and not as a penalty) US$ 5,000 (Five Thousand US Dollars) per week for each week of delay up to maximum of US$60,000 (Sixty Thousand US Dollars) +VAT. The payment of any liquidated damages hereunder shall not affect Customer’s right to terminate the Agreement and the consequences thereof. 

 

    	 3

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	4.5	Should the Contractor be delayed by any cause constituting an event of “Force Majeure” (as defined below), then the Project Completion Date shall be extended for a period equivalent to the time lost by reasons of any event of Force Majeure in accordance with Section 22 below.
	 	 	 
	 	4.6	As guarantee of execution of the Contractor’s undertakings under this Agreement, on the date of execution of this Agreement the Contractor shall provide an unconditional, autonomic, irrevocable bank guarantee, in the sum of NIS [***] (the “Bank Guarantee”), in accordance with the format attached as Annex K, which shall be valid until 60 days following the receipt of Certificate of Completion. In the event that the Bank Guarantee has been forfeited, in full or in part, the Contractor undertakes to provide the Customer with a new Bank Guarantee or to complete the forfeited bank guarantee, all within 7 days as of the day of forfeiture.

 

	5.	SUBCONTRACTING
	 	 	 
	 	5.1	The Contractor shall be entitled to subcontract all or part of the Work .For any work that exceeds NIS 500,000 (Five Hundred Thousand New Israeli Shekels) the Contractor must obtain the prior written consent of the Customer. 
	 	 	 
	 	5.2	Contractor shall be fully responsible and liable for the acts and omissions of any subcontractors. Any breach of this Agreement by a subcontractor or supplier shall be deemed a breach by the Contractor. 
	 	 	 
	 	5.3	Nothing contained in this Agreement and/or any agreement or arrangement between the Contractor and any subcontractors or suppliers shall create any contractual obligations on the part of the Customer to any subcontractor or supplier. 

 

	6.	SUPERVISION; PROJECT MANAGER AND QUALIFIED PERSONNEL
	 	 	 
	 	6.1	The Contractor shall designate a full time project manager (the “Project Manager”), agreed by the Customer, to be responsible for the execution of the Work. The Project Manager shall have the experience, skills and capability to timely complete the Work according to this Agreement. 
	 	 	 
	 	6.2	The Project Manager shall act as single point of contact and have authority to act on behalf of the Contractor. The Project Manager will be available to attend weekly meetings with the Customer’s representatives.
	 	 	 
	 	6.3	The Customer will appoint a project coordinator (the “Project Coordinator”), to be responsible for the Customer’s obligations related to the Work. The Project Coordinator will be available to attend weekly meetings with the Project Manager. Without derogating from the Contractor’s responsibilities and obligations, the Contractor undertakes to fulfill the instructions of the Project Coordinator and obey him.

 

    	 4

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	7.	REPORTING
	 	 	 	 
	The Contractor shall submit to the Customer weekly and monthly progress reports on the Work performed, including updated Timetables showing, among other things, the relevant portion of the Work performed. The reports shall be in such form as shall be agreed upon by the parties. 
	 	 	 	 
	8.	COMPLIANCE
	 	 	 	 
	 	8.1	The Contractor shall comply with the applicable laws, rules, regulations or ordinances applicable to the performance of the Work. The Contractor shall secure and pay for all permits, governmental fees and licenses necessary for Contractor to operate in Israel and to carry out the Work in accordance with this Agreement. It is clarified that licenses, permits and fees related to the Facility and Project itself shall be Customer’s responsibility.
	 	 	 
	 	8.2	Without derogating from the foregoing: 
	 	 	 
	 	 	8.2.1	The Contractor shall comply with the laws of Israel, including, without limitation, social insurance law, labor law, tax law, safety laws and all other laws regulations and requirements that may be applicable to the performance of the Work. 
	 	 	 	 
	 	 	8.2.2	Contractor shall obtain and maintain in full effect all work permits and licenses required under the laws of Israel, including but not limited to, permit the non-resident employees of Contractor to perform their duties pursuant to this Agreement (as applicable). Without derogating from the Contractor responsibilities above, Customer shall cooperate with Contractor, as may be reasonably required, in order to obtain such permits and licenses.
	 	 	 	 
	9.	CLEARANCE OF THE SITE; NO INTERFERENCE
	 	 	 	 
	 	9.1	The Contractor shall keep the Site and adjacent roads free from unnecessary obstruction and accumulation of waste material or rubbish caused by the Work. Upon completion of the Work, the Contractor shall clean and remove all construction surplus materials and equipment and rubbish of every kind attributable to the Work and/or caused by the Contractor, its employees, agents, subcontractors, suppliers or any other person or entity on its or their behalf (if any) to an authorized waste site and leave the Site and adjacent roads clean.
	 	 	 
	 	9.2	During the course of the Work, Contractor shall not interfere with, or cause any obstructions to, the Customer and/or the daily operations of the Customer or the other persons or entities located at the Site. To this extent and without limiting its obligations hereunder, the Contractor shall coordinate the performance of the Work in advance with Customer, Mr. Darvish Shalom or a representative on his behalf (the “Landlord”), and the municipality and other authorities as applicable, including regulatory required submissions and permits (achieving of permits is under Customer or Landlord responsibility, as applicable, however the Contractor shall be responsible for the achievement of the technical aspects of the permits). Customer will be responsible to obtain all relevant approvals from the Landlord for the Work and free access to site.
	 	 	 
	10.	CONTRACTOR’S REPRESENTATIONS
	 	 	 	 
	The Contractor represents and undertakes as follows: 
	 	 	 	 
	 	10.1	Prior to signing the Agreement, the Contractor read all the Annexes and all documents connected with the performance of the Works.
	 	 	 
	 	10.2	The Contractor has visited and examined, the site of the Facility (the “Site”), its environs, nature and locality including but not limited to, its layout and found them suitable for the execution of the Work as stipulated in this Agreement, except for hidden defects and damages. 

 

    	 5

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	10.3	The Site is ready for starting the execution of the Work.
	 	 	 
	 	10.4	The Contractor has the Means, the know-how and the qualifications for the execution of the Works pursuant to this Agreement.
	 	 	 
	 	10.5	The Contractor has received all the information and required explanations, as to the details and scope of the Works.

 

	11.	LIABILITY; INDEMNIFICATION; INSURANCE
	 	 	 
	 	 	 
	 	11.1	The Contractor shall be liable for any damages, demands or claims which may arise in respect of breach of the obligations or provisions applicable to the Contractor pursuant to this Agreement and under any law.
	 	 	 
	 	11.2	The Contractor shall be liable for, and shall at all times indemnify and hold harmless the Customer, its affiliates, parent company and their respective directors, officers, employees and agents from any direct harm (whether physical or mental), damages, expenses (including legal fees) and/or loss of any kind whatsoever, including without limitation, bodily injury and/or property damage arising from any negligent act, omission or breach of this Agreement by the Contractor and/or its employees and/or its subcontractors and/or all person or entities acting on their behalf, all in accordance with the applicable laws and regulations.
	 	 	 
	 	11.3	The Contractor agrees to indemnify and hold harmless and defend at its own expense the Customer, its affiliates, parent company and their respective directors, officers, employees, agents from and against any and all claims issued against the Customer as a result of faulty or inadequate performance made by the Contractor. 
	 	 	 
	 	11.4	The Contractor shall indemnify and hold harmless and defend at its own expense the Customer, its affiliates, parent company and their respective directors, officers, employees, from and against all claims, damages and expenses occurring during the performance and continuance of this Agreement as a result of faulty or inadequate performance that it is responsible to according to any applicable  law or regulation or under the Agreement.
	 	 	 
	 	11.5	It is clarified that the Contractor’s indemnification obligations hereunder shall not apply to a claim relating to any equipment provided by the Customer, unless such equipment was not used properly and in accordance with Customer’s instructions by Contractor and/or any person or entity on its behalf.   
	 	 	 
	 	11.6	The Customer undertakes that the Contractor shall be given prompt notice of any claim described in this Section 11 above that is made against the Customer, its affiliates, parent company and their respective directors, officers, employees. The Contractor shall forthwith defend any such claims and make settlements thereof at its own expense, provided, however, that any settlement or solution, reached inside or outside of the court, shall not adversely affect the Customer’s rights under this Agreement or impose any obligations on the Customer in addition to those set forth herein, unless otherwise agreed to by the Customer in writing in advance. Customer shall have the right, but not the obligation, to be represented by counsel of its own selection and at its own expense. 

 

    	 6

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	11.7	Indemnification by Contractor of all costs, expenses and damages to the Customer for any claim for which indemnification was requested shall be made promptly upon final adjudication and/or settlement of such claim whereby Contractor was held liable and/or responsible therefore.
	 	 	 
	 	11.8	Without derogating from Contractor’s liability under this Agreement and/or under any law, the Contractor hereby undertakes to take out and maintain adequate insurance cover with a reputable insurance company against liability which the Contractor or its subcontractor or its employees may incur to any other person including but not limited to the Customer in connection with performance of the Agreement in accordance with the provisions set forth in Annex G. The Contractor shall, on request, produce to the Customer a copy of such insurance certificates. The policies shall name the Customer as an additional insured. Without derogating from the Contractor’s liability pursuant to this Agreement, the Contractor undertakes, at its own expense, to maintain and keep a fully valid insurance policy.
	 	 	 
	12.	PERFORMANCE TESTING; ACCEPTANCE; TRAINING 
	 	 	 
	 	12.1	The Contractor shall perform the testing and qualifications set forth in the Scope of Work, including but not limited to those listed below, all in accordance with the schedule set forth in the Timetable: (i) DQ tests, (ii) factory acceptance tests, (iii) commissioning tests, and (iv) IQ and OQ tests (all of which tests form the acceptance tests hereunder). Customer shall avail all required personnel and manpower on its part for the IQ and OQ tests. Customer shall attend the acceptance tests at its own cost.
	 	 	 
	 	12.2	The Contractor shall perform the acceptance tests in accordance with (i) the testing criteria set forth in the Scope of Work and (ii) the provisions of the Detailed Design.
	 	 	 
	 	12.3	At such time when the Facility operates in accordance with the provisions of the Scope of Work and the Detailed Design and Customer confirms in writing the successful completion of all of the acceptance tests, then, subject to the completion of the transactions and procedures set forth in Section 12.5, Customer shall provide a certificate of completion in the form attached hereto as Annex E (the “Certificate of Completion”), at which point sign-off and hand-over of the Facility will take place.
	 	 	 
	 	12.4	In the event that the Customer, or its designated representative, shall determine, that the Facility has not successfully passed any acceptance test, Customer shall advise Contractor in 3 days ,in writing thereof, setting forth the reasons for same to the extent known to the Customer. Upon receipt of said notification, Contractor shall, at its expense, effect the required changes, repairs or replacements of parts, as shall be indicated by Customer in said notification, within 14 (fourteen) days, unless otherwise agreed to in writing by the Customer. Upon completion of such changes, repairs or replacements, Contractor shall notify Customer, and repeated acceptance tests shall be carried out. The provisions herein contained shall apply to any repeated acceptance tests in whole or in part until all of the separate portions of the Work shall have successfully passed any and all such acceptance tests. 

 

    	 7

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	12.5	Upon successful completion of the acceptance tests: (i) Contractor shall provide Customer with the updated diagrams, plans and any other updated documentation of the Facility bearing the signature “As Built” including the date of update; (ii) Contractor shall provide the Customer with a maintenance manual, inclusive of all of the documentation, instructions and protocols (including qualification protocols) and any training required at this stage according to the Scope of Work, all as required in order to operate and maintain the Facility in accordance with the Specifications, including but not limited to FDA, EMA, MOH and all other applicable Israeli regulations; (iii) Customer shall provide Contractor with a Certificate of Completion; 
	 	 	 
	 	12.6	Customer shall be entitled, at its own expense, to bring an independent expert to attend any of the acceptance tests and to advise it as to the performance of the Facility.
	 	 	 
	13.	CHANGES
	 	 	 
	 	13.1	The Customer may issue written orders to the Contractor to include changes in the Work, consisting of additions, deletions or other revisions, and completion time shall be adjusted accordingly. The Contractor, prior to the commencement of such changed or revised Work, shall submit promptly to the Customer for Customer’s approval a written proposal for (i) adjustment to the Consideration, and (ii) completion time for such revised Work. 
	 	 	 
	 	13.2	Contractor shall not make any changes or substitutions to the Work, including but not limited to the Specifications, approved subcontractors and suppliers and/or layout of the Facility without the prior written consent of the Customer.  For the avoidance of doubt, any change recommended by the Contractor and agreed to in writing by the Customer shall be deemed as a change order in terms of this Section 13.

 

	14.	CONSIDERATION & TERMS OF PAYMENT
	 	 	 	 
	 	14.1	The Customer shall pay the following price:
	 	 	 	 
	 	 	14.1.1	A Total Price of NIS [***] (Twenty Million two fifty seven thousand and five hundred New Israeli Shekels) (the “Consideration “) +VAT. Upon receipt of each payment, the Contractor shall submit to the Company a valid tax invoice and receipt.
	 	 	 	 
	 	 	14.1.2	The Customer will pay to Contractor [***] NIS in case Contractor will stand the schedule missions of 23/10/2017.
	 	 	 	 
	 	 	14.1.3	The Customer will to pay Contractor [***] NIS in case Contractor achieves Project Completion Date of December 1st, 2017. 
	 	 	 	 
	 	14.2	The payments will be remitted in accordance with the provisions set forth in Annex F. The final payment set forth therein shall be made when the Work is fully performed in accordance with the requirements of this Agreement and Customer has issued the Certificate of Completion.
	 	 	 	 
	 	14.3	Subject to Section 14.9 below, the Consideration constitutes the full consideration for the Work and includes, for the avoidance of doubt, all the Contractor’s expenses including salaries, wages and social benefits, tools, the costs of all Means, storage, or any other expenses incurred in carrying out the Work. 

 

    	 8

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	14.4	The Consideration is inclusive of all applicable taxes, with the exception of VAT, which shall be payable under applicable law. The Consideration shall be final and binding and shall not be subject to any escalation or modification, other than as specifically provided herein. The Contractor shall comply with all applicable laws and regulations in the performance of its obligations in respect of the Project and the Work. Without limiting the generality of the foregoing, the Contractor shall be responsible to pay all taxes, levies, social benefits, insurance payments and any other payments required by law in connection with the performance of the Work under this Agreement, including, without limitation, payments to the income tax authorities, the value added tax authorities, etc., applicable to the Contractor with respect to any and all payments hereunder and/or as an independent contractor and/or for any taxes applicable to payments to its subcontractors, employees or any other person or entity on its behalf.
	 	 	 
	 	14.5	Customer shall be entitled to deduct any withholding taxes or other taxes from any payment to Contractor hereunder, unless Contractor has provided Customer with a certificate of exemption from withholding or other tax.

 

	15.	OWNERSHIP
	 	 	 
	 	15.1	All designs, drawings, specifications, notes and other works developed in the performance of this Agreement shall become the property of the Customer, shall be deemed Customer’s Confidential Information (as defined below) and may be used by Customer on any other design or construction without any additional compensation to the Contractor. Contractor shall not be entitled to use any Confidential Information including without limitation any information and/or know-how of any type or nature and in any form or medium relating to Customer’s process and/or any aspect thereof and/or the layout of any part of the Facility, as may be changed pursuant hereto. All equipment that will provided to site for under the scope of project shall become the property of the Customer provided that such costs have been paid to Contractor.
	 	 	 
	16.	CONFIDENTIALITY 
	 	 
	 	16.1	During the term of this Agreement and for a period of 5 (five) years thereafter, Contractor shall protect all of Customer’s Confidential Information disclosed by Customer or a third party on its behalf or otherwise obtained by the Contractor. Other than as may be required to perform its duties hereunder, Contractor shall not disclose such Confidential Information to third parties by any means whatsoever. Contractor further agrees not to use Confidential Information disclosed or owned by Customer for any purpose other than for the purpose of this Agreement as contemplated hereby. The Confidential Information may only be disclosed to those officers, directors, employees, agents and subcontractors (“Representatives”) of the Contractor who have a need to know, and only after such Representatives have been advised of the confidential nature of such information and agree to be bound by an obligation of confidentiality to the Customer under terms substantially similar to the terms of this Agreement and provided that the Contractor agrees to be responsible for any breach of this Agreement by any of the Contractor’s Representatives.
	 	 	 
	 	16.2	The obligations under Section 16.1 above shall not apply to information which:
	 	 	 

 

	 	 	16.2.1	Is or becomes part of the public domain without breach of the provisions hereof or is generally known in the industry; and/or 
	 	 	 	 
	 	 	16.2.2	Is lawfully obtained from a third party under no obligation of confidentiality.

 

    	 9

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	16.3	If Contractor is so required to make any disclosure of Customer’s Confidential Information, in response to a valid order by a court or other governmental body, or as otherwise required by law, it will give reasonable prior written notice to the Customer of such disclosure requirement and will use reasonable efforts to secure confidential treatment of such information required to be disclosed.
	 	 	 
	 	16.4	“Confidential Information” shall include any all notes, data, sketches, drawings, manuals, documents, blueprints, memoranda, specifications, any of the items , financial reports, equipment, any information and/or know-how of any type or nature and in any form or medium relating to the Work, and this Agreement, the Facility or Customer and/or its business, technology, plans, (including without limitation to Customer’s process and/or any aspect thereof), and/or any other information of a confidential or proprietary nature, whether written or oral, disclosed by the Customer or by a third party on its behalf  (including confidential or proprietary information of third parties, subject to a duty on the Customer’s part to maintain the confidentiality of such information) or obtained by the Contractor in connection with this Agreement its provision of services during or before the term of this Agreement.
	 	 	 
	 	16.5	Upon the termination of this Agreement, for any reason, Contractor shall immediately surrender to the Customer all Confidential Information.
	 	 	 
	 	16.6	Customer shall be the sole and exclusive owner of all Confidential Information.
	 	 	 
	 	16.7	The Contractor acknowledges and understands that the Customer is a public company traded on the NASDAQ, and accordingly, this Agreement and any Confidential Information may be considered as “inside information” pursuant to securities laws and regulations.

 

	17.	WARRANTY
	 	 	 
	 	17.1	The Contractor warrants that all materials and/or equipment used or supplied under this Agreement are of the best quality, shall be free from defects due to faulty design, material and workmanship and that the Work shall conform with the Specifications and Drawings.
	 	 	 
	 	17.2	Defective materials and/or equipment shall be promptly replaced by the Contractor at its own expense. 
	 	 	 
	 	17.3	Further to the above the Contractor undertakes to repair any system operational defect at its own expense. 
	 	 	 
	 	17.4	The warranty hereunder excludes defects resulting from improper use by the Customer or defective in maintenance. 
	 	 	 
	 	17.5	The Warranty period shall be for a period of 12 (Twelve) months from the date of Certificate of Acceptance (the “Warranty Period”). However in the event that the Contractor receive a longer warranty period from a third party for any specific item, the warranty with respect to such item shall be extended for the extended period of time. The Bank Guarantee at the Warranty Period shall be equal 5% from the contract price.

 

 

	18.	TERM AND TERMINATION
	 	 	 
	 	18.1	This Agreement shall enter into force on June 15, 2016 (the “Effective Date”) and shall remain in effect until completion of the Work, unless otherwise earlier terminated in accordance with this Section 18. 
	 	 	 
	 	18.2	Any actions taken by the parties or cost incurred prior to the Effective Date in preparation or for the performance thereof are for their own account and at their cost and expense.

 

    	 10

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	18.3	In the event of a material breach of a party’s obligations hereunder, the non-breaching party may terminate this Agreement by providing the other party with a prior written notice of termination hereof no less than 14 (fourteen) days prior to such termination becoming effective; provided however, that such termination shall not enter into effect if the other party cures such breach prior to the expiration of such 14 (fourteen) day period.
	 	 	 
	 	18.4	Either party is entitled to terminate this Agreement upon the occurrence of any of the following events: (i) a request for the liquidation and/or dissolution and/or winding up is filed against the other party, which request is not dismissed or otherwise set aside within thirty (30) days thereafter; (ii) a request for the appointment of a receiver or trustee over a material asset of the other party is filed against the other party with a competent court of jurisdiction (or execution office), which request is not dismissed or otherwise set aside within thirty (30) days thereafter; or (iii) the other party makes a general assignment for the benefit of its creditors. 
	 	 	 
	 	18.5	The Customer may at any time terminate the Agreement for the convenience of the Customer for any reason and without any default. In the event of such termination, the Contractor shall receive, as its entire and sole compensation, a settlement computed in the following manner for Work that has commenced prior to notice of termination under this Section 18.5:
	 	 	 
	 	 	18.5.1	Its actual, necessary and reasonable cost for performing the Work to the date of termination, as determined by audit of the Contractor’s records, including costs for equipment for manufacturing process, provided that such costs have been remitted, are nonrefundable and other relevant cost, plus A lump sum of 200,000 (Two Hundred Thousand NIS).
	 	 	 
	 	18.6	The provisions of Sections 4.4, 4.6, 5.2, 11, 14.4, 14.5, 15, 16, 17, 18, 20, 21 and 23 shall survive termination of this Agreement, for any reason.

 

 

	19.	SUSPENSION
	 	 
	The Contractor shall upon the written notification from the Customer suspend the progress of the Work or any part thereof for such period of time and in such manner as may be determined by the Customer, and shall during such suspension properly protect and secure (at Customer’s expense) the Work so far as is necessary in the opinion of the Customer. The extra costs, including that caused by the subsequent resumption of Work incurred by the Contractor in complying with the Customer’s instructions, shall be borne and paid by the Customer against receipt of supporting documentation, unless such suspension is necessary due to the fault of the Contractor (or anyone on its behalf). Any such suspension/s shall not exceed in the aggregate, in any event, 30 (Thirty) days.

 

	20.	GOVERNING LAW AND JURISDICTION
	 	 	 
	 	20.1	This Agreement shall be governed and construed in accordance with the laws of the State of Israel. 
	 	 	 
	 	20.2	All technical disputes  which cannot be amicably resolved between the parties in 14 days shall be resolved by agreed arbitrator. All other disputes arising from this Agreement which cannot amicably resolved between the parties, shall be finally resolved by The Israeli Institute of Commercial Arbitration in accordance with its rules, by one arbitrator. Each of the parties hereby irrevocably submits to the sole and exclusive jurisdiction of such venue. 

 

    	 11

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

	 	20.3	In any event of dispute or disagreement between the Contractor and the Customer, it is agreed that the Contractor shall not slow and/or delay the progress of the Work or suspend the Work, including any Change Order, or hinder in any way the completion and/or delivery thereof. The Work will continue to be executed as scheduled in spite of any disagreement between the parties, provided that Customer has not ceased, for a period of more than 1 (one) consecutive payment milestone, payment of the Consideration when same would become due pursuant to Section 14 above.
	 	 	 
	 	20.4	The address of the parties for the purpose of service of process shall be as set forth in Section 21 below. 

 

	21.	NOTICES
	 	 	 
	 	21.1	All legal notices, requests, consents and other communications required or permitted under this Agreement shall be in writing and shall be (as elected by the person giving such notice) hand delivered by messenger or courier service, sent by facsimile or other electronic means (with confirmation received of recipient’s number or email receipt) to the number set forth below, or mailed by registered or certified mail (postage prepaid), return receipt requested, or delivered by overnight delivery service, addressed to:

 

	 	 	If to Customer:
	 	 	
        Vascular Biogenics Ltd.

        6 Yonni Netanyahu St. Or-Yehuda Israel

        Facsimile: [***]

        Email: [***]

        Attention: [***]

         

	 	 	If to Contractor:
	 	 	
        Biopharmax Group Ltd.

        4 Hasadnaot St.

        Herzelia 46728

        Israel

        Facsimile: [***]

        Email: [***]

        Attention: [***]

 

	 	21.2	Each such notice shall be deemed delivered: (a) on the date delivered if by personal delivery (including by an overnight delivery service, with proof of delivery); (b) on the date telecommunicated if by facsimile or other electronic means (with confirmation of receipt); and (c) on the date upon which the return receipt is signed or delivery is refused, as the case may be, if mailed certified, return receipt requested.

 

	22.	FORCE MAJEURE
	 	 
	 	22.1	Any delay in or failure of performance except as specified in Section 22.4 below by either party shall be excused if and to the extent that same has been caused by an event, incident or occurrence constituting Force Majeure under the terms of Section 22.3 below.
	 	 	 
	 	22.2	Each party shall not be entitled to avail itself of the provisions of Section 22.1 above and said provisions shall not apply to any event, occurrence or incident constituting Force Majeure and affecting its performance unless such party shall notify the other party in writing of the occurrence of such event no later than 5 (five) working days from its occurrence, setting forth the estimated effect thereof on the performance of its obligations and undertakings hereunder.

 

    	 12

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	22.3	For the purpose hereof, “Force Majeure” shall mean any one or more of the following events, occurrences and incidents directly creating any such delay in or failure of performance:
	 	 	 
	 	 	(a)	Floods, hurricanes and earthquakes and other natural disasters and occurrences;
	 	 	(b)	General riots and strikes (not solely by a party’s employees) and civil disturbances;
	 	 	(c)	War, blockades, sabotage, war-like and terror actions, and general mobilization of reserves;
	 	 	(d)	Epidemics and wide spread diseases.
	 	 	 	 
	 	22.4	Notwithstanding the above, it is agreed that no reason whatsoever, including without limitation, any event, incident or occurrence constituting Force Majeure in terms of this Agreement shall serve as an excuse for non-conformity of the Work to the provisions (except for timetables) of this Agreement.

 

	23.	MISCELLANEOUS
	 	 	 
	 	23.1	Each of the parties hereby represents and warrants to the other party that it has full right and authority to enter into this Agreement and to perform its obligations hereunder and that this Agreement constitutes its valid and binding obligation, enforceable against it in accordance with its terms.
	 	 	 
	 	23.2	Customer shall be entitled to assign its rights to any Affiliate upon written notice to the Contractor. Contractor shall not be entitled to assign its rights or obligations hereunder without the prior written consent of the Customer and any assignment or transfer not in accordance with the terms and conditions of this Agreement shall be null and void. 
	 	 	 
	 	23.3	The provisions of this Agreement are severable and, in the event that any court of competent jurisdiction determines that any one or more of the provisions or part of a provision contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; but this Agreement shall be reformed and construed to the maximum extent possible as if such invalid, illegal or unenforceable provision, or part of a provision, had never been contained herein.
	 	 	 
	 	23.4	Nothing contained in this Agreement shall be deemed to establish any partnership, joint venture or agency relationship and the parties shall act at all times as independent contractors. Unless otherwise expressly provided herein, the employees of each party to this Agreement shall in no event be deemed employees of the other party by reason of this Agreement, and such employees shall not be entitled to participate in any benefits provided by such other party to its employees. Neither party shall have any authority to enter into any contracts, assume any obligations or make any warranties or representations on behalf of the other party.
	 	 	 
	 	23.5	This Agreement may not be amended, modified, altered, or supplemented except by a written agreement executed by both parties hereto. 
	 	 	 
	 	23.6	This Agreement and the Schedules attached hereto set forth the entire understanding between the parties hereto and supersedes all prior agreements, arrangements and communications, whether oral or written, with respect to the subject matter hereof.
	 	 	 
	 	23.7	This Agreement may be executed in counterparts (including counterparts transmitted by fax or email via PDF), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument.

 

 

	 	23.8	The Contractor will comply with the relevant sections of the Customer’s Code of Business Conduct and Ethics, a copy of which is presented at the Company’s web site (http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-govhighlights). The Contructor has not taken and shall not take any action that would cause the Customer to violate any (i) applicable laws and regulations, including the U.S. Foreign Corrupt Practices Act of 1977 and similar laws of any applicable country or other jurisdiction and (ii) the relevant sections of the Customer’s Code of Business Conduct and Ethics.

 

 

    	 13

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

IN WITNESS WHEREOF, the parties have
signed this Agreement as of the Effective Date first herein above set forth.

 

	Vascular Biogenics Ltd.	 	Biopharmax Group Ltd.
	 	 	 	 	 
	SIGNATURE: 	 	 	SIGNATURE: 	 
	 	 	 	 	 
	NAME:	 	 	NAME:	 
	 	 	 	 	 
	TITLE:	 	 	TITLE: 	 

 

 

    	 14

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

Scope
of Work- Annex B

 

	1.	General scope:
	 	1.1.	The
    GMP Facility will be constructed in existing building shell with approximate area of [***] sq.m, as detailed below:
	 	1.2.	Ground floor +0.00:
	 	 	1.2.1.	Production Clean Rooms (Grade C, B): [***] sq.m
	 	 	1.2.2.	NC: [***] sq.m
	 	 	1.2.3.	Warehouse: [***] sq.m
	 	 	1.2.4.	CNC corridor: [***] sq.m
	 	 	1.2.5.	Cell Bank Storage: [***] sq.m
	 	 	1.2.6.	Cold room: [***] sq.m
	 	 	1.2.7.	Packaging: [***] sq.m
	 	 	1.2.8.	Utilities [***] sq.m
	 	 	1.2.9.	Future area: [***] sq.m
	 	1.3.	Middle Floor +2.87:
	 	 	1.3.1.	Technical Area: [***] sq.m
	 	1.4.	First floor +5.55:
	 	 	1.4.1.	Laboratory: [***] sq.m
	 	 	1.4.2.	Offices: [***] sq.m
	 	 	1.4.3.	Future area: [***] sq.m
	 	1.5.	Work includes design, procurement, installation and commissioning/validation (including all relevant paper work- URS etc.)
	 	 	 	 
	2.	Clean rooms Construction works:
	 	2.1.	Clean room wall panels, doors, windows
	 	2.2.	Round corner floor/wall, wall/wall, wall/ceiling
	 	2.3.	Walkable Ceiling
	 	2.4.	Flooring: PVC/ Epoxy
	 	2.5.	All CR associated equipment to be installed- sinks, shelves, chairs etc.
	 	2.6.	Cold room 2-8C.

 

    	 1

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	3.	General Construction works:
	 	3.1.	General gypsum walls (fire rated when required)
	 	3.2.	Doors, windows
	 	3.3.	Glass wall in management offices
	 	3.4.	False Ceiling
	 	3.5.	Flooring: tiles/Parquet
	 	3.6.	Archive
	 	3.7.	All supporting aids to allow proper maintenance 
	 	 	 
	4.	HVAC systems:
	 	4.1.	HVAC System for the clean rooms 
	 	4.2.	HVAC System for the labs offices and warehouse
	 	4.3.	HVAC system for offices and supporting areas (maintenance workshop, servers room)
	 	4.4.	200TR chiller and piping
	 	 	 
	5.	Utilities Systems:
	 	5.1.	OFA Generation and Distribution system 
	 	5.2.	Gasses- [***] CA Distribution system (cylinders by client) 
	 	5.3.	Purified water system (pretreatment, ESR, HOD, RO and WFI generation and distribution) and optional distillation unit
	 	5.4.	Municipal Drain including connection to main building system
	 	5.5.	Process waste with storage tanks, and pH + neutralization (hypochlorite) systems+ all relevant drains.
	 	5.6.	City water/ Hot Water including connection to main building system
	 	5.7.	Process glycol chiller
	 	5.8.	Outside utilities area will be durable to weather conditions
	 	 	 
	6.	Electrical systems
	 	6.1.	Electrical distribution to all consumers (supply from grid 400V 3ph)
	 	6.2.	Electrical and Control Panels
	 	6.3.	Electrical Generator
	 	6.4.	UPS
	 	6.5.	Server for HMI 

 

    	 2

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	6.6.	Electrical, Communication and Control Sockets
	 	6.7.	Lighting system
	 	6.8.	Approval of testing electrical engineer according to Israeli law.
	 	 	 
	7.	Fire Protection and detection
	 	7.1.	Sprinklers piping, including connection to main building piping system, also for CR (per cGMP requirements)
	 	7.2.	Fire detection system, including integration with main building piping system 
	 	7.3.	O2 depletion detectors
	 	7.4.	Fire Department approval for the facility (design and execution). 
	 	 	 
	8.	Low voltage systems
	 	8.1.	Computer network (infrastructure only, excluding end sockets)
	 	8.2.	Telephone network (infrastructure only, same as electric cables 6.1, excluding end sockets)
	 	8.3.	Door interlock electric system for clean rooms
	 	8.4.	Access Control system for cleanrooms 
	 	8.5.	Access Control for non-clean area (infrastructure only)
	 	8.6.	Intercom system (4 points, additional point will be infrastructure only-for CR. Infrastructure for non CR)
	 	8.7.	Public announcement and alarm system
	 	8.8.	CCTV (infrastructure only)

 

 

    	 3

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

	9.	Instrumentation and automation
	 	9.1.	Automatic control program for the HVAC and process systems based on PLC, adjusting the temperature, humidity and pressure
	 	9.2.	Visualize and print data for process SUMs in production 2 room.
	 	9.3.	Pressure indication from the gas systems
	 	9.4.	Temperature and CO2 and humidity monitoring for Client equipment: Incubators, Freezers, refrigerators (measurement instruments inside equipment will be supplied by Client)
	 	 	 
	10.	Process equipment (second hand):
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	 	 
	11.	Furniture 
	 	11.1.	Labs:, relocation of furniture from existing lab in Or Yehuda additional Chemical Hood, working bench, Lab Sink Cabinet per layout
	 	11.2.	Clean room furniture 
	 	11.3.	Kitchenette: Lower Kitchenette Cabinet 
	 	11.4.	Coffee room
	 	11.5.	Offices & meeting rooms (by client)
	 	11.6.	Warehouse: warehouse shelves
	 	11.7.	Maintenance workshop

 

 

    	 4

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

	 	 	 
	12.	Commissioning, Qualification and Validation (writing and execution):

 

 

*DQ,
IQ, OQ refer to Validation

 

 

	
        System/

        Equipment
	 	DQ	 	IQ	 	OQ	 	PQ	 	Commissioning only (IC,OC)
	Building and rooms 
(non GMP, CNC+NC)	 	-	 	-	 	-	 	-	 	✓
	HVAC system (Including Interlock system)	 	✓	 	✓	 	✓	 	✓	 	-
	Clean Rooms	 	✓	 	✓	 	✓	 	✓	 	-
	Control and Monitoring System 
(Including HVAC system)	 	✓	 	✓	 	✓	 	✓	 	-
	Oil Free Air	 	✓	 	✓	 	✓	 	✓	 	-
	Chilled Water	 	-	 	-	 	-	 	-	 	✓
	Process Gas (N2,CO2,O2,CAS- cylinders)	 	✓	 	✓	 	✓	 	✓	 	-
	WFI	 	✓	 	✓	 	✓	 	✓	 	-
	Electricity	 	-	 	-	 	-	 	-	 	✓
	Emergency Power Generator	 	-	 	-	 	-	 	-	 	✓
	UPS power source	 	-	 	-	 	-	 	-	 	✓
	Fire Safety systems	 	-	 	-	 	-	 	-	 	(1)
	Intercom System in clean rooms	 	-	 	-	 	-	 	-	 	(2)
	Process waste system	 	-	 	-	 	-	 	-	 	✓
	Glycol System	 	✓	 	✓	 	✓	 	✓	 	-

 

*according
to VBL criticality assessment document 13-40

(1) As
per Standard Institution of Israel

(2) Function/operation
testing

 

    	 5

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

 

 

	13.	Excluded:
	 	13.1.	Computer Network and Server
	 	13.2.	Telephone Network
	 	13.3.	Offices Furniture 
	 	13.4.	Gas cylinders 
	 	13.5.	Process equipment unless specified
	 	13.6.	LN2 Dewar and cell bank 
	 	13.7.	Transformation station (civil and equipment) 
	 	13.8.	Additional work not specified in this scope of work

 

 

    	 6

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

      

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

CERTIFICATE OF ACCEPTANCE
– ANNEX E

 

The Customer confirms that all works has been
concluded to his satisfaction and in compliance with the agreement dated _____________ and its annexes, with exception to the following
remarks which shall be corrected by the Contractor within the time limits set forth hereunder:

 

	Remarks Description	 	Last Date for Correction.
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 

 

DATE: _____________

 

SIGNED BY:

 

	Contractor:	Customer:

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

Annex I

 

 

    	 

    	CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.

     

Annex J

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