Execution Version


 


Note:
Certain portions of this document have been marked “[c.i.]” to indicate that confidential treatment has been requested
for this confidential information. The confidential portions have been omitted and submitted separately with the Securities and
Exchange Commission.


 


CLINICAL
TRIAL collaboration AGREEMENT


 


This
Collaboration Agreement (this “Agreement”) is entered into as July 21, 2014 (“Effective
Date”), by and among MedImmune, LLC, a limited liability company having a place of business at One MedImmune Way,
Gaithersburg, MD 20878 USA (“MedImmune”), and Advaxis, Inc., a New Jersey Limited Liability Company,
having a place of business at 305 College Road East, Princeton, New Jersey 08540 USA (“ADVAXIS”). Each
of ADVAXIS and MedImmune may be referred to in this Agreement as a “Party,” and collectively, they may
be referred to as the “Parties.”


 


WHEREAS,
MedImmune is in the business of developing therapeutic drugs for the treatment of human health conditions and has identified a
certain MedImmune Development Product that has therapeutic potential in the treatment of cancer, and wishes to collaborate with
a third party for a clinical study of such MedImmune Development Product;


 


WHEREAS,
ADVAXIS is in the business of developing Listeria monocytogenes (Lm) immunotherapy therapeutic products for the treatment
of human health conditions and has identified an ADVAXIS Development Product that has therapeutic potential in the treatment of
cancer, and wishes to collaborate with a third party for a clinical study of such ADVAXIS Development Product;


 


WHEREAS,
the Parties believe that there may be potential therapeutic benefit from the combination of the MedImmune Development Product
and the ADVAXIS Development Product in the treatment of cancer;


 




    	 



    	 



    

  


WHEREAS,
each Party has established a clinical research program to conduct clinical trials of cancer immunotherapies and wishes to
perform a clinical trial using combination of the MedImmune Development Product and ADVAXIS Development Product;


 


WHEREAS,
the Parties see a mutually beneficial opportunity to collaborate in such a combination clinical trial as more detailed herein.


 


NOW,
THEREFORE, in consideration of the mutual covenants set forth in this Agreement, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the Parties intending to be legally bound agree as follows:


 


1.
DEFINITIONS.


 


1.1
Defined Terms. Capitalized terms used in this Agreement and not otherwise defined herein shall have the meaning set forth
below.


 


“AAA”
shall have the meaning set forth in Section 2.2(c)(ii).


 


“ADVAXIS
Invention” shall have the meaning set forth in Section 4.3.


 


“ADVAXIS
Development Product” means ADXS11-001 which is a live, attenuated Listeria monocytogenes (Lm) based
vector bioengineered to secrete an antigen-adjuvant fusion (tLLO-E7) protein consisting of a truncated fragment of the listeriolysin
(tLLO) fused to human papillomavirus type 16 E7 (HPV16-E7). “ADVAXIS Representatives” shall mean ADVAXIS,
its Affiliates and each of their respective directors, managers, officers, employees and agents.


 


“Affiliate”
means any person, corporation, or other entity that controls, is controlled by, or is under common control with a Party.
A corporation or other entity shall be regarded as in control of another corporation or entity if it owns or directly or indirectly
controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or
if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation
or other entity or the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the corporation
or other entity. 


 




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“Alliance
Manager” shall have the meaning set forth in Section 2.2(g).


 


“Antibody”
means, depending on the context it is used in, a molecule or genetic material that encodes such a molecule where the binding
activity of the molecule comprises complementarity determining regions. This includes, but is not limited to, a molecule or genetic
material encoding such a molecule comprising or containing:


 


	 	●	at
                                         least one immunoglobulin variable domain;
	 	 	 
	 	●	parts
                                         of such domains or modifications thereof; or
	 	 	 
	 	●	the
                                         genetic materials that encode either one of the 1st and 2nd sub-bullets
                                         right before this 3rd bullet.



 


“Anti-bribery
and Anti-corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010 and
any other applicable anti-bribery and anti-corruption laws in any country in the Territory.


 


“Anti-Corruption
Policies” means the AstraZeneca Global Policy on Ethical Interactions, as the same may be amended, modified or supplemented
from time to time.


 


“Applicable
Law(s)” means any national, supra-national, federal, state or local laws, treaties, statutes (including but not
limited to the FD&C Act, EMA regulations, and any laws, regulations and guidelines pertaining to human subject protection
and privacy), ordinances, rules and regulations, including any rules, regulations, guidance or guidelines having the binding effect
of law, or requirements of Regulatory Authorities, national securities exchanges or securities listing organizations, government
authorities, courts, tribunals, agencies other than Regulatory Authorities, legislative bodies and commissions that are in effect
in any part of the Territory from time to time during the term of the Agreement.


 




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“Background
Intellectual Property” means, individually and collectively, all Intellectual Property Rights of any of the Parties
in existence at any time prior to the Effective Date provided to the other Party for use in, or which is necessary or useful for
performing, the Sponsored Clinical Trial. In the case of ADVAXIS, Background Intellectual Property shall include but not be limited
to, rights in and to the ADVAXIS Development Product and in and to any INDs relating to the ADVAXIS Development Product. In the
case of MedImmune, Background Intellectual Property shall include but not be limited to, rights in and to the MedImmune Development
Product and in and to any INDs relating to the MedImmune Development Product.


 


“Business
Day” means any day other than a Saturday or Sunday that is not a national holiday in the United States.


 


“CFR”
means the United States Code of Federal Regulations.


 


“Clinical
Development and Commercialization Agreement” shall have the meaning set forth in Section 3.4.1.


 


“Confidential
Information” means any confidential and proprietary scientific, technical, commercial, marketing or other information
(as hereinafter defined) furnished, directly or indirectly, and whether in writing, orally or otherwise, by one Party (“Disclosing
Party”) to the other Party (“Receiving Party”) pursuant to or in connection with this Agreement and/or
arising from the activities or transactions contemplated by this Agreement, and/or relating to Proprietary Materials (as hereinafter
defined). All information disclosed and to be protected hereunder as Confidential Information, if disclosed in writing or other
tangible form, shall be designated as confidential and proprietary at the time of delivery, or if disclosed orally or in other
intangible form, shall be identified as confidential and proprietary in writing within thirty (30) days of disclosure.


 




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“Data”
means the information, data or results arising from the activities under this Agreement, including the Study Data and
any analyses of the foregoing.


 


“Derivative(s)”
means substances created which constitute an unmodified functional subunit or product expressed by the ADVAXIS Development
Product. Some examples of Derivatives include: subclones of unmodified cell lines, purified or fractionated subsets of the ADVAXIS
Development Product, proteins expressed by DNA/RNA, or monoclonal antibodies secreted by a hybridoma cell line.


 


“Development
Products” means the ADVAXIS Development Product and/or the MedImmune Development Product.


 


“Expert”
shall have the meaning set forth in Section 2.2(c)(ii).


 


“FDA”
means the United States Food and Drug Administration, or any successor thereto.


 


“FD&C
Act” means the United States Federal Food, Drug and Cosmetic Act of 1938 and applicable regulations promulgated
thereunder, as amended from time to time.


 


“Forecast”
means a twelve (12) month written rolling forecast that is approved by the JSC that includes the best estimate of the following
information for the applicable twelve (12) months: (i) the quantity of MedImmune Development Product reasonably needed to supply
the Sponsored Clinical Trial for the applicable period; (ii) the dose; (iii) the frequency of dosing; (iv) the number of patient
subjects to be enrolled; (v) the duration of the Sponsored Clinical Trial; and (vi) the number of Study Sites to perform the Sponsored
Clinical Trial and the country in which each Study Site is based.


 




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“Good
Clinical Practices”, “Good Laboratory Practices” and “Good Manufacturing Practices”
shall have the meaning set forth in FDA rules, regulations and guidelines and any other applicable corresponding rules,
regulations and guidelines in any other Territory. 


 


“Government
Official” means any person employed by or acting on behalf of a government, government-controlled entity or public
international organization; any political party, party official or candidate; any person who holds or performs the duties of an
appointment, office or position created by custom or convention; and any person who holds him/herself out to be the authorized
intermediary of a Government Official.


 


“HIPAA”
means the United States Health Insurance Portability and Accountability Act of 1996 and its applicable regulations.


 


“HPV”
shall mean human papillomavirus.


 


“ICH
Guidelines” means the guidelines of the International Conference on Harmonization.


 


“IND”
means an investigational new drug application, as defined in the FD&C Act, filed with the FDA and necessary for beginning
clinical trials of any product in humans or any clinical trial application (CTA) or other equivalent application or other documentation
filed with any Regulatory Authority of a country other than the U.S. required to begin clinical trials of any product in humans
in that country.


 




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“Intellectual
Property Right(s)” means any and all ideas, inventions, discoveries, know-how, data, information, results,
databases, documentation, reports, materials, writings, designs, computer software, processes, principles, methods, techniques
and other information, including Patents, trade secrets, trade-marks, service marks, trade names, registered designs, design rights,
copyrights (including rights in computer software and database rights), whether registered or not, and all legal means of establishing
rights in and to and the aforesaid rights or property similar to any of the foregoing, in any part of the world, together with
the right to apply for the registration of any such rights.


 


“Investigator”
means an individual who conducts a clinical investigation (i.e., under whose immediate direction the drug is administered
or dispensed to a subject).


 


“IRB”
shall have the meaning set forth in Section 3.1(e).


 


“JSC”
shall have the meaning set forth in Section 2.1.


 


“Joint
MedImmune-ADVAXIS Invention” shall have the meaning set forth in Section 4.4.


 


“MedImmune
Clinical Representative” shall have the meaning set forth in Section 3.1(b).


 


“MedImmune
Compound Invention” shall have the meaning set forth in Section 4.2.


 


“MedImmune
Development Product” means the MEDI-4736 antibody binding to Programmed DEATH-Ligand1 (PD-L1), also known as cluster
of differentiation 274 (CD274) or B7 homolog1 (B7-H1).


 


“MedImmune
Drug Supply” means the amount of the MedImmune Development Product supplied pursuant to Section 3.3.1 which
meets the standards of Good Manufacturing Practice for use in human clinical trials in the country in the Territory.


 


“MedImmune
Representatives” shall mean MedImmune, its Affiliates and each of their respective directors, managers, officers,
employees and agents.


 




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“Negotiation
Period” means a period beginning upon the completion of the Sponsored Clinical Trial and receipt by MedImmune of
the last final report for the Sponsored Clinical Trial and, unless extended in writing by the Parties, ending one-hundred twenty
(120) days thereafter.


 


“Net
Sales” means with respect to Royalty Bearing Product the gross amount invoiced to a Third Party for Royalty Bearing
Product by ADVAXIS or its Affiliates or any of their respective licensees or sub-licensees, and in each case to extent included
in the gross amount invoiced after deducting the following related to the applicable Royalty Bearing Product:


 


(a)
trade, quantity and/or cash discounts, allowances or rebates, including promotional, service or similar discounts or rebates and
discounts or rebates to governmental or managed care organizations, to the extent actually given or allowed in connection with
Royalty Bearing Product;


 


(b)
credits or allowances actually granted with respect to Royalty Bearing Products by reason of rejection, defects, recalls or returns,
or chargebacks;


 


(c)
any tax, tariff, duty or government charge (including any Indirect Taxes, import or customs duty or similar tax or government
charge, but excluding any income tax) levied on the sale, transfer, delivery and/or transportation of the Royalty Bearing Product;
and


 


(d)
a reasonable allowance for bad debt, which allowance for bad debt for a calendar year shall be adjusted in the last Quarter of
a calendar year to reflect the amount of bad debt actually written off for sale of Royalty Bearing Product for that calendar year.


 


ADVAXIS
shall make periodic adjustments of the amounts described in (a) through (d) to its initial accruals of such amounts applied in
a prior calendar Quarter to reflect amounts actually incurred or taken.


 


Net
Sales shall be determined in accordance with the accounting convention used by ADVAXIS consistently applied.


 




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“Patents”
means (a) issued patents, (b) provisional patent applications filed in any jurisdiction, (b) non-provisional patent applications
filed in any jurisdiction, whether or not corresponding to or claiming priority from any other patent and/or patent applications,
(c) divisional, continuations and continuations-in-part of a patent and/or patent application, (d) all reissues, re-examination
certificates, registrations, confirmations, extensions, substitutions, renewals and supplementary protection certificates of any
patents and/or patent applications, and (e) all foreign counterparts of the patents and patent applications.


 


“PD-1”
means Programmed Death-1 receptor, also identified as CD279, and encoded by the PDCD1 gene. 


 


“PD-1
Antibody” means an antibody binding to PD-1.


 


“PD-L1”
means Programmed Death-Ligand 1, also identified as CD274 or B7-H1, and encoded
by the CD274 gene.


 


“PD-L1
Antibody” means an antibody binding to PD-L1.


 


“Person”
means any individual, corporation, association, partnership (general or limited), joint venture, trust, estate, limited
liability company, limited liability partnership, unincorporated organization, government (or any agency or political subdivision
thereof) or other legal entity or organization. 


 


“Pharmacovigilance
Agreement” shall mean that certain pharmacovigilance agreement referenced in Section 3.1(j) of this Agreement.


 




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“Principal
Investigator” means [c.i.] at Georgia Regents University, or as may be amended or changed upon written consent of
both Parties.


 


“Progeny”
means unmodified descendants from the ADVAXIS Development Product, such as virus from virus, cell from cell, or organism
from organism.


 


“Protocol
Concept Sheet” means the draft proposed protocol of the Sponsor Clinical Trial, attached to this Agreement as Attachment
A, which shall be the basis for the JSC approved final protocol.


 


“Publication”
shall have the meaning set forth in Section 5.6.


 


“Quality
Assurance Agreement” shall mean that certain quality assurance agreement(s) referenced in Section 3.1(j) of
this Agreement.


 


“Quarter”
means each period of three (3) months ending on March 31, June 30, September 30, or December 31, and “Quarterly”
shall be construed accordingly.


 


“Regulatory
Approval” means any applicable and all approvals from Regulatory Authorities in a country which are required to
market and sell Development Products in such country.


 


“Regulatory
Authority” means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity, with authority over the distribution, importation, exportation, manufacture, production,
use, storage, transport, investigational clinical testing or sale of a drug for use in humans, in the Territory, including but
not limited to the FDA.


 


“Representatives”
means, with respect to a Party, such Party’s Affiliates and its and their respective officers (including directors),
trustees, employees, agents, vendors and sub-contractors, and with respect to either Party acting as a Sponsor of a Sponsored
Clinical Trial, any other Person engaged in the conduct of the Sponsored Clinical Trials as permitted hereunder.


 




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“Royalty
Bearing Product” means any HPV immunotherapy (including, but not limited to, an ADVAXIS Development Product that
has Regulatory Approval to be used in conjunction or in combination with any PD-1 Antibody or PD-L1 Antibody.


 


“Samples”
means all biological samples, including blood, tissue, tumor biopsy tissue, cells and any other biological materials,
collected during the Sponsored Clinical Trial.


 


“Samples
Analysis/Assays Procedures” shall mean the analysis and/or assays the Parties wish to perform on the Samples pursuant
to Section 3.3.9 and listed in Attachment B of this Agreement.


 


“Secondary
Research” shall have the meaning set forth in Section 3.3.9.


 


“SEC”
shall mean the United States Securities Exchange Commission.


 


“Sponsor”
shall have the meaning set forth in Section 3.1(a).


 


“Sponsored
Clinical Trial” means a clinical trial with respect to a combination of MedImmune Development Product and ADVAXIS
Development Product in accordance with the protocol approved by the JSC or any amendment to such protocol approved by the JSC
and the budget and any amendments to such budget provided to MedImmune for review.


 


“Study
Data” means all of the data and results in the form they have been received by ADVAXIS which have been collected
by Investigators and/or Study Sites in the conduct of the Sponsored Clinical Trials and which are supplied by Investigators and/or
Study Sites to ADVAXIS .


 


“Study
Sites” means the institutions selected to participate in a Sponsored Clinical Trial pursuant to this Agreement.


 




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“Study
Subjects” shall mean any patient that has consented to and is enrolled in a Sponsored Clinical Trial.


 


“Term”
shall have the meaning set forth in Section 6.1.


 


“Territory”
means the United States of America.


 


“Third
Party” means any Person, or Affiliate thereof, that is neither a signatory to this Agreement nor an Affiliate of
a signatory to this Agreement.


 


“WMA”
shall have the meaning set forth in Section 3.1(e).


 


2.
JOINT STEERING COMMITTEE.


 


2.1
A joint steering committee (“JSC”) shall be responsible and have decision making authority for (i) approving a protocol
for the Sponsored Clinical Trial pursuant to the Protocol Concept Sheet attached to this Agreement as Appendix A; (ii) amending
any such approved protocol; (iii) approving forecast for MedImmune Drug Supply and (iv) without limiting either Party’s
rights in Section 6.2, suspending or terminating the Sponsor Clinical Trial for cause. The JSC shall also be responsible
for discussing and monitoring the progress of the Sponsored Clinical Trial. For the avoidance of doubt, the JSC shall not have
the power or authority to amend the terms and conditions of this Agreement and/or any of the rights and obligations of a Party
under this Agreement. Through the JSC and prior to the first patient screened in the Sponsored Clinical Trial, a copy of the budget
for the Sponsored Clinical Trial and any amendments thereafter shall be provided to MedImmune for review. ADVAXIS shall reasonably
consider any comments or suggestions made by MedImmune to the budget and associated amendments.


 




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2.2
(a) The JSC shall be composed of four (4) members with MedImmune appointing one half of the members and ADVAXIS one half of the
members, which number of members may be adjusted by the JSC as long as there is an even number of members.


 


(b)
The JSC shall meet at least once each calendar Quarter in person or by video conference. A quorum for the conduct of business
shall consist of at least one representative of MedImmune and at least one representative of ADVAXIS. Each of MedImmune and ADVAXIS
shall have one vote, and subject to Section 2.2(c) all decisions shall be reached by a unanimous vote. The Parties shall cause
the JSC to approve a protocol consistent with Appendix A within sixty (60) days of the signing of this Agreement.


 


(c)
If there is a tie vote in the JSC, ADVAXIS and MedImune agree to exert all reasonable efforts, including escalation to individuals
at each Party at the Vice President level or higher, to arrive at a mutually acceptable resolution. In the event that there is
a tie vote that is not resolved within thirty (30) days, then the tie vote shall be resolved by arbitration in accordance with
the following procedure:


 


(i)
either Party shall have the right to elect, upon written notice to the other, to arbitrate the tie vote dispute in accordance
with this Section 2.2(c);


 


(ii)
upon receipt of notice of the request for arbitration, the Parties shall promptly negotiate in good faith to appoint a mutually
acceptable, disinterested, conflict-free individual not affiliated with either Party, and with the scientific, technical, regulatory
and/or clinical experience with respect to the tie vote dispute necessary to resolve such dispute (an “Expert”).
If the Parties are not able to agree within seven (7) days after the receipt by a Party of the written request in the immediately
preceding sentence, the American Arbitration Association (or any successor entity) (the “AAA”), shall be responsible
for selecting an Expert within seven (7) days of being approached by a Party. The fees and costs of the Expert and the AAA (or
such other entity) shall be shared equally by the Parties;


 




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(iii)
Within fourteen (14) days after the designation of the Expert, the Parties shall each simultaneously submit to the Expert and
one another a written statement of their respective positions on such disagreement. Each Party shall have seven (7) days from
receipt of the other Party’s submission to submit a written response thereto, which shall include any scientific and technical
information in support thereof. The Expert shall have the right to meet with the Parties, either alone or together, as necessary
to make a determination; and


 


(iv)
No later than thirty (30) days after the designation of the Expert, the Expert shall make a determination by selecting the resolution
proposed by one of the Parties that as a whole is the most fair and reasonable to the Parties in light of the totality of the
circumstances and shall provide the Parties with a written statement setting forth the basis of the determination in connection
therewith. The decision of the Expert shall be final and conclusive, absent manifest error.


 


(d)
The JSC shall keep accurate minutes which shall record all decisions and all actions recommended or taken. The Parties shall alternate
responsibility for the preparation of the draft minutes on an annual basis. All records of the JSC shall at all times be available
to both Parties.


 


(e)
ADVAXIS shall provide the JSC with Quarterly written reports regarding activities performed under the Sponsored Clinical Trial
for the applicable calendar Quarter and activities to be performed in the next calendar Quarter and any other information reasonably
requested by the JSC.


 




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(f)
Each Party shall be responsible for all travel and related costs and expenses for its members to attend meetings of and otherwise
participate in the JSC.


 


(g)
Each Party shall appoint one (1) individual, who is not a member of the JSC, to take on the responsibility of alliance manager
(“Alliance Manager”) for that Party. The purpose of the Alliance Manager shall be to help facilitate the collaboration
between the Parties as contemplated by this Agreement. Responsibilities include, but are not limited to, assisting the JSC with
setting the agenda and meetings times, communicating decisions to their Party’s senior executives and being the point of
contact for communications between the Parties.


 


3
Obligations and Responsibilities of the Parties with respect to the Sponsored Clinical Trial.


 


3.1
ADVAXIS Obligations and Responsibilities with respect to the Sponsored Clinical Trial are as follows:


 


(a)
Except for MedImmune bearing the cost and expense for supplying the MedImmune Development Product (as well as the costs relating
to the proprietary assays performed by MedImmune or a third party on behalf of MedImmune on the MedImmune Development Product
or on Samples from Study Subjects (as identified in Appendix A, the Protocol Concept Sheet)) in accordance with this Agreement,
ADVAXIS shall be the sponsor of (the “Sponsor”) and shall conduct the Sponsored Clinical Trial at the cost
and expense of ADVAXIS, and shall remain responsible for the submissions of all filings to the Regulatory Authorities to support
the Sponsored Clinical Trial. ADVAXIS shall not perform the Sponsored Clinical Trial in any country other than the Territory.


 




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(b)
MedImmune will appoint a clinical representative for the Sponsored Clinical Trial (“MedImmune Clinical Representative”).
The MedImmune Clinical Representative will receive copies of all safety reports including without limitation adverse event reports,
minutes of dose escalation meetings, Study status reports, interim safety reports, as well as meeting minutes of all Investigator
meetings/teleconferences. The MedImmune Clinical Representative will also have access to all clinical team correspondence including
without limitation, weekly team meeting minutes, monitoring reports, site activation reports, contract status updates etc., upon
request. The MedImmune Clinical Representative may participate in all investigator meetings and any audit conducting by a Regulatory
Authority as described in section 3.3.5.


 


(c)
In addition to the Principal Investigator, ADVAXIS shall select Investigators who are qualified by their training and experience
to participate in the Sponsored Clinical Trial and who have not been debarred from conducting clinical trials in the US or in
any other jurisdiction in the world. ADVAXIS shall be responsible for reviewing any documentation required under Applicable Laws
pertaining to an Investigator’s financial interests, or any other Investigator-related requirements.


 


(d)
ADVAXIS shall be responsible for the negotiation and execution of the clinical trial agreements with each Study Site. The clinical
trial agreements shall require the Study Sites to comply with all Applicable Laws and will contain confidentiality provisions
no less stringent than those contained in this Agreement and intellectual property provisions that guarantee MedImmune rights
in MedImmune Compound Inventions as provided under this Agreement. MedImmune shall have the right to review and approve the site
template proposed by ADVAXIS. As between MedImmune and ADVAXIS, ADVAXIS shall be liable for all the acts and/or omissions of the
Investigators and the Study Sites.


 




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(e)
ADVAXIS may sub-contract certain obligations to a Third Party to perform on behalf of ADVAXIS provided that ADVAXIS shall remain
solely and fully liable for the performance of such subcontractors. ADVAXIS shall ensure that each of its subcontractors performs
its obligations pursuant to the terms of this Agreement, including the Appendixes attached hereto. ADVAXIS shall use reasonable
efforts to obtain and maintain copies of material documents relating to the obligations performed by such subcontractors that
are held by or under the control of such subcontractors to be provided to MedImmune, to the extent required under this Agreement.
The scope of the obligations that may be subcontracted by ADVAXIS to a Third Party may include, but shall not be limited to, aspects
of work relating to Study Site contracting, clinical trial monitoring and source data verification, data management and validation,
biostatistics and statistical analysis plan, and clinical study report medical writing.


 


(f)
ADVAXIS shall obtain Institutional Review Board (“IRB”) approval or other ethics approval prior to ADVAXIS
and/or any Investigators conducting any activity relating to Study Subjects (including but not limited to enrollment of Study
Subjects in the Sponsored Clinical Trial) and shall conduct the Sponsored Clinical Trial in compliance with all relevant Applicable
Laws and guidance governing the protection of human subjects including, without limitation, 45 C.F.R. Parts 160 and 164, patient
rights to know, and use of investigational drugs (as specified at 21 C.F.R Parts 50, 56 and 312). ADVAXIS shall ensure that each
Study Site has obtained from each subject prior to the commencement of any study procedures: (i) a signed informed consent form
approved by the IRB or ethics committee; and (ii) authorization to disclose individually identifiable health information necessary
in order to conduct the Sponsored Clinical Trial, and to provide the Study Data, analyses, and reports to MedImmune as required
under this Agreement. ADVAXIS shall prepare the patient informed consent form for the Sponsored Clinical Trial in consultation
with MedImmune (it being understood that the portion of the informed consent form relating to the MedImmune Development Product
will be provided by MedImmune). Any changes to such form that relate to safety information regarding the MedImmune Development
Product shall be subject to MedImmune’s written consent, which shall not be unreasonably withheld or conditioned. MedImmune
will provide such consent, or a written explanation for why such consent is being withheld or conditioned, within fifteen (15)
business days of receiving ADVAXIS’s request therefore. Upon MedImmune’s request, ADVAXIS shall provide to MedImmune
a copy of such IRB or ethics committee approval of the informed consent form and/or the master informed consent form for the Sponsored
Clinical Trial. ADVAXIS shall at all times comply with any applicable data privacy legislations, regulations and guidelines applicable
in any part of the Territory.


 




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(g)
ADVAXIS shall be responsible for, at its own cost, packaging and labeling the ADVAXIS Development Product and MedImmune Drug Supply
and shipping (including customs and taxes) the ADVAXIS Development Product and MedImmune Drug Supply (in labeled form compliant
with Applicable Law) to all Study Sites that shall be performing the Sponsored Clinical Trial.


 


(h)
ADVAXIS shall maintain complete and accurate records relating to the disposition of the Development Products, which shall include
but not be limited to: (i) details of the quantity and batch code of drug supplies delivered to each Investigator; (ii) the quantity
and vial number of the vials of Development Product administered to each Study Subject; and (iii) confirmation that the Development
Product are disposed of in accordance with policies of each Study Site’s pharmacy (which policies shall comply with all
regulatory requirements and all Applicable Laws relating to the Development Product).


 


(i)
ADVAXIS shall conduct a prompt investigation of any Study Site that ADVAXIS suspect to be involved in fraud and/or scientific
misconduct, and ADVAXIS shall notify MedImmune within forty-eight (48) hours of the initiation of such investigation and the results
of such investigation, as soon as available.


 


(j)
ADVAXIS will be responsible for compliance with all Applicable Law pertaining to safety reporting of the Sponsored Clinical Trial.
The Parties agree that provisions relating to Adverse Event Reporting shall be set out in a separate Pharmacovigilance Agreement
to ensure the exchange of relevant safety data within appropriate timeframes and in appropriate format to enable the Parties to
fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews. Both Parties shall
use commercially reasonable efforts to execute the Pharmacovigilance Agreement within sixty (60) days from the Effective Date
of this Agreement. The execution of the Pharmacovigilance Agreement by the Parties is a condition precedent of the implementation
of the Sponsored Clinical Trial hereunder.


 




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(k)
The Parties agree that provisions relating to quality assurance of the Development Products shall be set out in a separate Quality
Assurance Agreement. Both Parties shall use commercially reasonable efforts to execute the Quality Assurance Agreement within
sixty (60) days from the Effective Date of this Agreement. The execution of the Quality Assurance Agreement by the Parties is
a condition precedent of the implementation of the Sponsored Clinical Trial hereunder.


 


(l)
ADVAXIS shall ensure accurate and timely collection, recording, and submission of the Study Data. ADVAXIS and MedImmune shall
jointly own the Study Data. During the Term, neither Party shall, without the other Party’s written consent, share any Study
Data from the Sponsored Clinical Trial with any third party or exploit the Study Data, except as necessary for regulatory filings
and compliance with Applicable Laws. Notwithstanding the foregoing, ADVAXIS shall provide to MedImmune; and hereby grants MedImmune
a limited, non-exclusive, license to (i) the Study Data in raw form and/or derived SAS datasets; and (ii) a final study report;
to be used for sole purpose offor MedImmune’s internal business, patent procurement and enforcement (preparing, filing,
prosecuting, enforcing, or defending) of MedImmune Compound Inventionsand Joint MedImmune- ADVAXIS Inventions, or legal or regulatory,
or compliance purposes. On a monthly basis, no later than the 5th of each month, beginning two (2) months after first
patient screened in the Sponsored Clinical Trial, ADVAXIS shall provide the MedImmune Clinical Representative with the most current
Study Data in either raw form and/or derived SAS datasets as requested by MedImmune. This license is non-transferable and non-sublicensable
except for Study Data directly and solely related to potential biomarker and/or diagnostics for the MedImmune Development Product,
and such excepted Study Data shall be identified in writing to ADVAXIS prior to any transfer or sublicensing to a Third Party,
and such Third Party must agree to reasonable terms and conditions protecting the confidentiality of such Study Data that are
not less stringent than those set forth herein. ADVAXIS shall use commercially reasonable efforts to provide such Study Data and
draft study report for MedImmune review and MedImmune shall provide its comments to ADVAXIS within thirty (30) days of receipt
of suchdraft; provided, however, that ADVAXIS shall have the final decision as to whether incorporate any comments or changes
made by MedImmune. ADVAXIS shall provide the final version of the final study report to MedImmune as soon as practicable following
completion of the Sponsored Clinical Trial but in no event later than two (2) months following completion of the Sponsored Clinical
Trial or termination of this Agreement. ADVAXIS shall promptly provide MedImmune with copies of any minutes or memorandums containing
feedback from or communications with the FDA or any other Regulatory Authority pertaining to the MedImmune Development Product.
Notwithstanding the above, MedImmune shall not be provided with study subject names or other information, which could be used
for identification, or any other information proscribed by the provisions of HIPAA.


 




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(m)


 


	 	(i)	ADVAXIS
    shall maintain Study reports and all related documentation in good scientific manner and in compliance with Applicable Law.
    On a quarterly basis, beginning three (3) months after execution of this Agreement, ADVAXIS shall provide the MedImmune Clinical
    Representative with interim safety and clinical data activity reports and any other information as may be reasonably requested
    by MedImmune as set forth in Section 3.1(b) above.
	 	 	 
	 	(ii)	ADVAXIS
    shall, in addition, provide copies of any expedited safety reports and access to any safety data as may be required pursuant
    to the Pharmacovigilance Agreement or as may be otherwise required by MedImmune for the purpose of any submissions to or other
    communications with the FDA or to any other Regulatory Authority. ADVAXIS shall respond promptly, as set forth in the Pharmacovigilance
    Agreement, to MedImmune’s questions, comments or concerns to the safety reports and safety data provided.MedImmune acknowledges
    and agrees that ADVAXIS shall be responsible for registration of the Sponsored Clinical Trial and results posting as required
    by the FDA and by any other Regulatory Authorities, and that MedImmune shall not post or publish any Study Data, registration
    information or results without the prior written consent of ADVAXIS, unless required by Applicable Law, in which case MedImmune
    shall use reasonable efforts to provide ADVAXIS sufficient prior written notice of MedImmune’s intent to post or publish
    any such information to allow ADVAXIS sufficient time to seek confidential treatment for such information and/or to petition
    to halt such posting or publication. 


 




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	 	(iii)	In
    the event that ADVAXIS reports to MedImmune an adverse event, pursuant to the Pharmacovigilance Agreement or otherwise, or
    any other safety data related to the ADVAXIS Sponsored Clinical Trial, which relates to the MedImmune Development Product,
    MedImmune shall provide all such additional information related to such MedImmune Development Product as may be reasonably
    required by ADVAXIS to comply with Applicable Laws. Such information may include but shall not be limited to a letter from
    MedImmune expressly permitting ADVAXIS to cross-reference pertinent non-clinical, clinical and chemistry manufacturing control
    (“CMC’) information that exist under an IND in any submissions to be made by ADVAXIS to the FDA or to any other
    Regulatory Authority. For the avoidance of doubt, except as expressed otherwise in this clause or elsewhere in this Agreement,
    MedImmune shall not be required to disclose any other confidential or proprietary information related to the MedImmune Development
    Product in question.


 


(n)
In the event that the Sponsored Clinical Trial is stopped or terminated by the FDA or by any other applicable Regulatory Authority,
or by an IRB or other ethics committee due to scientific or safety reasons, ADVAXIS shall promptly (within seven (7) days) inform
MedImmune along with the reasons for such termination.


 




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3.2
MedImmune Obligations and Responsibilities with respect to the Sponsored Clinical Trial are as follows. 


 


(a)
MedImmune shall allow ADVAXIS to cross-reference MedImmune’s INDs or any related or corresponding regulatory filing (such
as a CTA or other foreign equivalent) in the Territory for the MedImmune Development Product required for the conduct of the Sponsored
Clinical Trial.


 


(b)
In the event that MedImmune receives adverse event information pertaining to the MedImmune Development Product, MedImmune shall
promptly provide such information to ADVAXIS pursuant to the Pharmacovigilance Agreement.


 


(c)
MedImmune shall inform ADVAXIS of any new IND or equivalent filings in the Territory within thirty (30) days of such filing.


 


3.3
Drug Supply Availability, Forecast and Delivery


 


3.3.1


 


(a)
In accordance with Section 3.3.1(b) below, MedImmune shall provide the MedImmune Drug Supply, at no cost to ADVAXIS for
the Sponsored Clinical Trial.


 


(b)
ADVAXIS shall provide MedImmune with the initial Forecast, approved by the JSC, for the Sponsored Clinical Trial at the same time
as the JSC approves the protocol for the Sponsor Clinical Trial. Thereafter, ADVAXIS shall provide MedImmune, no less frequently
than once every Quarter, within the first 10 (ten) Business Days of each Quarter, a Forecast, approved by the JSC, for the forthcoming
twelve (12) months. Following receipt of such Forecast, MedImmune shall make the MedImmune Drug Supply available to support the
Sponsored Clinical Trial based on the aforesaid Forecast provided that ADVAXIS is otherwise not in material breach of this Agreement.
ADVAXIS acknowledges and agrees that MedImmune shall not be required to provide additional quantities of MedImmune Development
Product on top of those quantities specified in a Forecast for the conduct of the Sponsored Clinical Trial; provided, however
that, MedImmune shall use commercially reasonable efforts to provide any additional MedImmune Development Product as ADVAXIS may
reasonably request to support the Sponsored Clinical Trial.


 




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(c)
MedImmune Drug Supply Shortage.


 


(i)
MedImmune shall supply the MedImmune Development Product in accordance with the timelines, Forecasts and other terms of Sections
3.3.1 (a) and (b) above, except in the case of a bona fide supply interruption or shortage of the MedImmune Development
Product, not caused by any willful acts or omissions by MedImmune (“Supply Shortage”), MedImmune shall provide ADVAXIS
with prompt written notice of such Supply Shortage and the terms of Section 3.3.1(c)(ii) below shall apply.


 


(ii)
In the case of a Supply Shortage, MedImmune shall resume delivery of the MedImmune Development Product as soon as reasonably possible
after the Supply Shortage, and the time periods set forth in this Agreement for the Sponsored Clinical Trial shall be extended
by the duration of the Supply Shortage and any additional time as reasonably necessitated by the Supply Shortage or as otherwise
agreed to by the Parties. During the duration of the Supply Shortage where MedImmune reasonably believes that it will not be able
to supply ADVAXIS’s requirements (as set forth in the Forecast) and any of its own requirements (including those of any
other MedImmune licensees’ and distributors), MedImmune shall provide ADVAXIS with prompt written notice thereof and, upon
request, the Parties shall promptly discuss such situation and what actions has MedImmune taken to address such Supply Shortage
(including but not limited to rationing, expediting, overtime, and priority transportation modes). MedImmune shall use reasonable
efforts to address and resolve the Supply Shortage, but shall not be liable to ADVAXIS for failure or inability to resolve the
Supply Shortage. MedImmune’s reasonable efforts to address and resolve the Supply Shortage in accordance with this Section
3.3.1(c) will be ADVAXIS’s exclusive remedy with respect to any Supply Shortage of the MedImmune Development Product.
Notwithstanding the foregoing, both Parties acknowledge and agree that in the event MedImmune is able, using reasonable effort,
to supply ADVAXIS with a reduced quantity of MedImmune’s Development Product, the JSC shall determine as to how to apportion
such reduced quantity within the Sponsored Clinical Trial.


 




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(d)
MedImmune Drug Supply Delivery. MedImmune shall package and ship unlabeled MedImmune Drug Supply for the Sponsored Clinical
Trial to an ADVAXIS’ location, in the timing and manner as reasonably acceptable by the Parties. MedImmune shall be responsible,
at its own cost, for such packaging and shipping (including customs and taxes) of the MedImmune Drug Supply to such ADVAXIS’
location only. All costs associated with the subsequent transportation, warehousing, distribution, packaging and labeling of the
MedImmune Development Products shall be borne by ADVAXIS. ADVAXIS will: (i) accept delivery of the MedImmune Development Products
supplied hereunder and will subsequently label, pack and promptly ship such to the Study Sites per Section 3.1(f); (ii)
provide, from time to time at the reasonable request of MedImmune, any applicable chain of custody forms, in-transport temperature
recorder(s) and records and receipt verification documentation; and (iii) provide such other transport documentation reasonably
requested by MedImmune.


 


(f)
Other Supply and Quality Assurance Items. Other supply and quality items relating to the Sponsored Clinical Trials, including
but not limited to, product testing, non-conformance, quality matters, changes to manufacturing, etc., are set forth in the Quality
Assurance Agreement.


 


3.3.2
ADVAXIS shall not and shall ensure that its respective Investigators shall not at any time during the Term or thereafter:


 


(i)
use the MedImmune Development Products for any purpose other than to conduct the Sponsored Clinical Trials in accordance with
this Agreement; except as specified in this Agreement, transfer or provide access to MedImmune Development Products or their compositions,
sequences or structural characteristics to any Third Party except as necessary to carry out any Sponsored Clinical Trial provided
that such Third Party is also subject to the limitations of this Agreement;


 


(ii)
except as specified in this Agreement, combine any MedImmune Development Products with any other materials other than the ADVAXIS
Development Products;


 




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(iii)
except as specified in this Agreement, reverse engineer or attempt to derive the sequence, composition or structure of any of
the MedImmune Development Products; or


 


(iv)
except as specified in this Agreement, copy, reproduce, clone, express, derive, transfect, modify, improve, purify, isolate or
attempt to do any of the foregoing with respect to any of the MedImmune Development Products.


 


3.3.3
Each Party retains the sole rights to sell, offer for sale, manufacture, export, import, or otherwise commercialize their
respective Development Products. The Parties shall have no obligation to advance any product indication developed from any Sponsored
Clinical Trial(s) to the relevant next phase of clinical development, regulatory approval, or commercial sale.


 


3.3.4
MedImmune may at its sole expense, upon reasonable prior written notice to ADVAXIS (but no less than fifteen (15) business
days), and on mutually agreed dates during normal business hours, review the facilities and procedures of ADVAXIS, Study Sites,
Investigators and any other Third Party sub-contractors, directly related to the performance of the Sponsored Clinical Trial to
verify compliance with Applicable Laws and with respect to any investigations carried out pursuant to Section 3.3.5 as
the case may be. ADVAXIS shall use commercially reasonable efforts to properly address any non-compliance issues reported following
such review, and inform the Non-Sponsor Party of the actions taken.


 




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3.3.5
ADVAXIS shall allow access to any Regulatory Authorities to inspect, observe and review the facilities and procedures of ADVAXIS
Study Sites and Investigators, and manufacturing sites, directly related to the performance of any Sponsored Clinical Trial as
may be required by Applicable Laws. Each Party shall allow access to any Regulatory Authorities to inspect, observe and review
their facilities and procedures and any Third Party directly involved in the development, manufacture or shipping and handling
of the their Development Products as the case may be, or as otherwise may be required by Applicable Laws. Each Party shall: (a)
promptly notify the other Party of any such inspections and audits pertaining to the Sponsored Clinical Trial and/or the Development
Products; (b) use commercially reasonable efforts to address any non-compliance issues identified by such Regulatory Authority;
and (c) inform the other Party regarding the actions taken in response to such inspection or audit.


 


3.3.6
Except with respect to the Sponsored Clinical Trial in accordance with this Agreement, ADVAXIS shall not research, develop,
or perform a clinical trial or negotiate with or grant to a third party such rights with respect to a combination regimen of both:
(i) ADVAXIS Development Product and (ii) PD-1 Antibody and/or PD- L1 Antibody (including but not limited to MedImmune Development
Product). The obligations under this Section 3.3.6 shall not survive termination or expiration of this Agreement.


 


3.3.7
The Parties agree that each Party shall be responsible for any and all taxes of whatever nature (including related fines,
penalties, surcharges of interest) (“Tax” or “Taxes”) imposed or payable to
any authority, body or official anywhere in the world imposed on such Party by virtue of their performance under this Agreement.
In addition,


 




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	 	(a)	Each
    Party shall be responsible for Taxes imposed or calculated by reference to net income or profit, employees employed by that
    party, assets in which it has an interest, gross income or its equity or share capital. Further each Party shall be responsible
    for Taxes imposed or calculated on transactions within the Party and its Affiliates, whether in respect of this Agreement
    or otherwise.
	 	 	 
	 	(b)	The
    Parties shall reasonably work together with respect to audits, disputes or requests for information with respect to Taxes
    (e.g. provision of relevant information and documents) in connection with this Agreement. 


 


3.3.8
The Parties shall cooperate to ensure that the Party responsible for shipped goods in accordance with Applicable Laws maximizes
the full benefits of available duty free or savings programs and minimizes where permissible any such duties and any related import
taxes that are not reclaimable from the relevant authorities. The shipping Party shall be responsible for any import clearance,
including payment of any import duties and similar charges, in connection with any shipped goods under this Agreement.


 


3.3.9
ADVAXIS shall ensure that each Study Site clinical trial agreement and patient consent forms signed by the Study Subjects
allows for access to and use of Samples such that the Parties are able to conduct analysis and assays on the Samples as specified
in the Protocol Concept Sheet. The initial agreement of the Parties regarding such Samples analysis is attached hereto as Appendix
B, the Samples Analysis/Assays Procedures. This analysis plan may be amended from time to time as agreed by the JSC. Subject to
JSC approval and the appropriate consent given by Study Subjects in the signed patient consent forms and Applicable Law, and only
after sufficient quantities of Samples are available to support the analysis in Appendix B, each Party shall have access to use
Samples to conduct research that exceeds or differs from the research specified in the final protocol approved by the JSC, including
genetic research (“Secondary Research”) for purposes outside the scope of this Agreement. MedImmune shall own all
Sample analysis or research results conducted by or on behalf of MedImmune and shall have no obligation to disclose or share such
results with ADVAXIS. ADVAXIS shall ensure that any collection, handling, transportation and retention of any Samples, is carried
out in accordance with the final protocol approved by the JSC, informed consent and Applicable Laws. Each party shall ensure that
the security, integrity and quality of the Samples, whether in their possession or the possession of a third party on their behalf,
are maintained at all times.


 




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3.4
Negotiation of a Clinical Development and Commercialization Agreement


 


3.4.1
During the Negotiation Period, ADVAXIS and MedImmune shall meet, discuss and negotiate in good faith in an attempt to enter
into an agreement with respect to the development, regulatory approval, and commercialization of a MedImmune Development Product
and ADVAXIS Development Product to be used in conjunction with each other for the treatment or prevention of cancer (the “Clinical
Development and Commercialization Agreement”). Neither Party shall be obligated to enter into such Clinical Development
and Commercialization Agreement, and neither Party shall be liable to the other Party for failure to enter into such Clinical
Development and Commercialization Agreement.


 


3.4.2
In the event that MedImmune and ADVAXIS do not enter into a Clinical Development and Commercialization Agreement during the
Negotiation Period, and ADVAXIS, its Affiliate, collaborator, licensee or sub-licensee obtains Regulatory Approval of ADVAXIS
Development Product or its Derivative or Progeny for use in combination with any PD-1 Antibody or PD-L1 Antibody, ADVAXIS
shall pay MedImmune [c.i.] within thirty (30) days after such Regulatory Approval, and a Royalty of [c.i.], which royalty shall
be payable on a Royalty Bearing Product by Royalty Bearing Product basis for a period of ten (10) years from the first commercial
sale of the applicable Royalty Bearing Product. With respect to such Royalty Bearing Product, ADVAXIS shall continue to make payments
for such period of time that MedImmune has not brought suit or a claim of action, or is assisting or participating in a third
party suit or claim of action against ADVAXIS under MedImmune’s rights in the Joint-MedImmune-ADVAXIS Inventions.


 


3.4.3
In the event MedImmune and ADVAXIS do not enter into a Clinical Development and Commercialization Agreement, upon expiration
of the Term, neither Party shall share any Study Data or results with third parties (except
as necessary for regulatory filings and compliance with Applicable Laws), including without
limitation to current collaboration partners, except in summarized form. If a Party desires to share summarized Study Data with
third parties, the summary may show that Party’s Development Product’s dose and schedule (but not the other Party’s
Development Product’s dose and schedule). Any proposed sharing shall be subject to review and approval by the other Party,
not to be unreasonably withheld, provided that the summarized form of the Study Data does not contain any Study Data specific
to the Other Party’s Development Product. The disclosing Party shall submit such summarized Study Data for review by the
other Party at least sixty (60) days prior to any proposed disclosure to third parties. 


 




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4.
INTELLECTUAL PROPERTY RIGHTS.


 


4.1
Except as expressly set forth in this Agreement, no Intellectual Property Rights of a Party shall be granted to any other
Party, by implication, estoppel or otherwise. All rights in and to a Party’s Background Intellectual Property shall be reserved
to and individually retained by the Party who owns such Background Intellectual Property. Inventorship of Inventions, whether
patentable or not, shall be determined in accordance with United States patent laws.


 


4.2
All Intellectual Property Rights (including but not limited to new patentable and non-patentable inventions) made, conceived,
reduced to practice and/or generated through the conduct of the Sponsored Clinical Trials, whether created solely by MedImmune
Representatives or solely by ADVAXIS Representatives or jointly by MedImmune Representatives and ADVAXIS Representatives, that
relate solely to one or more MedImmune Development Products (or to any Third Party product or material that MedImmune uses in
the conduct of a Sponsored Clinical Trial) shall be owned solely by MedImmune (“MedImmune Compound Invention”).
For clarity, MedImmune Compound Inventions (whether patentable or not) that relate solely to the MedImmune Development Products
shall include those that generically encompass a MedImmune Development Product (and not the ADVAXIS Development Product nor any
other Intellectual Property of ADVAXIS or its Affiliates either existing as of the Effective Date of this Agreement or are, or
have been, developed without reliance on a MedImmune Development Product) within its scope, even where such MedImmune Development
Product is not disclosed per se, as well as biomarkers. ADVAXIS shall promptly notify MedImmune upon the making, conception, reduction
to practice and/or generation of any such MedImmune Compound Invention and hereby assign all rights, title and interest in the
aforesaid to MedImmune, and agrees to execute any additional documents necessary to enable such assignment to MedImmune.


 




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4.3
All Intellectual Property Rights (including but not limited to new patentable and non-patentable inventions) made, conceived,
reduced to practice and/or generated through the conduct of the Sponsored Clinical Trials, whether created solely by MedImmune
Representatives or solely by ADVAXIS Representatives or jointly by MedImmune Representatives and ADVAXIS Representatives, which
relate solely to one or more ADVAXIS Development Products shall be owned solely by ADVAXIS (“ADVAXIS Invention”).
For clarity, ADVAXIS Inventions (whether patentable or not) that relate solely to the ADVAXIS Development Products shall include
those that generically encompass an ADVAXIS Development Product (and not the MedImmune Development Product nor any other Intellectual
Property of MedImmune or its Affiliates either existing as of the Effective Date of this Agreement or are, or have been, developed
without reliance upon a ADVAXIS Development Product) within its scope, even where such ADVAXIS Development Product is not disclosed
per se,. MedImmune shall promptly notify ADVAXIS upon the making, conception, reduction to practice and/or generation of any such
ADVAXIS Invention and hereby assign all rights, title and interest in the aforesaid to ADVAXIS, and agrees to execute any additional
documents necessary to enable such assignment to ADVAXIS.


 


4.4
Subject to Section 4.5 below, all Intellectual Property Rights (including but not limited to new patentable and non-patentable
inventions) made, conceived, reduced to practice and/or generated through the conduct of the Sponsored Clinical Trials, whether
created solely by MedImmune Representatives or solely by ADVAXIS Representatives or jointly by MedImmune Representatives and ADVAXIS
Representatives, which relate to the combination of one or more MedImmune Development Product and one or more ADVAXIS Development
Products shall be jointly owned by MedImmune and ADVAXIS (“Joint MedImmune-ADVAXIS Invention”). MedImmune or
ADVAXIS (each the “Discovering Party”), as the case may be, shall promptly notify the other Party upon the
making, conception, reduction to practice and/or generation of any Joint MedImmune- ADVAXIS Invention. 


 




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4.4.1
In the event the Parties do not enter into a Clinical Development and Commercialization Agreement, ADVAXIS covenants and agrees
not to exploit, commercialize or license the Joint MedImmune-ADVAXIS Inventions except as for the performance of obligations under
the Agreement. If ADVAXIS desires to exploit, commercialize or license the Joint MedImmune-ADVAXIS Inventions, it may negotiate
and obtain from MedImmune a license to do so. In the event that ADVAXIS desires such a license, ADVAXIS shall notify MedImmune
and MedImmune and ADVAXIS shall negotiate such a license in good faith under reasonable commercial terms; provided, however, that
MedImmune shall not be obligated to grant such a license and shall not be held liable to ADVAXIS for failure to grant such a license.


 


4.4.2
MedImmune shall not be prevented from or require prior approval from ADVAXIS to exploit, commercialize or license the Joint MedImmune-ADVAXIS
Inventions.


 


4.5



 


(a)
MedImmune shall have the sole right to prepare, file, prosecute, maintain, enforce and defend all U.S. and foreign Patents and
other forms of Intellectual Property Rights, using patent counsel of its choice, covering all MedImmune Compound Inventions.


 




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(b)
ADVAXIS shall have the sole right to prepare, file, prosecute, maintain, enforce and defend all U.S. and foreign Patents and other
forms of Intellectual Property Rights, using patent counsel of its choice, covering all ADVAXIS Compound Inventions.


 


(c)
MedImmune shall have the sole right to prepare, file, prosecute, maintain, enforce and defend all U.S. and foreign Patents and
other forms of Intellectual Property Rights, using patent counsel of its choice, covering all Joint MedImmune-ADVAXIS Inventions.
All costs associated with preparing, filing, prosecuting, maintaining, enforcing, and defending all jointly owned Joint MedImmune-ADVAXIS
Inventions shall be shared by the Parties. In the event that MedImmune does not exercise such rights, MedImmune shall notify ADVAXIS,
and in such event, ADVAXIS shall have the sole right to copy, prepare, prosecute and maintain such joint MedImmune-ADVAXIS Inventions.


 


(i)
Each Party shall contact the other as soon as possible after identifying any information,
including but not limited to a future publication, competitive intelligence, or any public disclosure, that would require filing
a Joint MedImmune-ADVAXIS Invention application.


 


(ii)
In the event MedImmune decides
not to pursue or decides to abandon any Joint MedImmune-ADVAXIS Invention application or patent, ADVAXIS shall have the right
at, its own expense, to take control of the prosecution and enforcement of such an application or patent.


 


(d)
Each Party agrees to reasonably cooperate with the other Party to execute all lawful papers and instruments, including obtaining
and executing necessary powers of attorney and assignments by the named inventors, to make all rightful oaths and declarations,
and to provide consultation and assistance as may be reasonably necessary in the prosecution, maintenance and enforcement of all
ADVAXIS Compound Inventions, Joint MedImmune- ADVAXIS Inventions, and MedImmune Compound Inventions undertaken in a manner consistent
with this Section 4. Nothing in this Section 4.5(d) with regard to cooperation shall require either Party to make
statements or take other action that could be adverse to or to the detriment of the prosecution, maintenance, enforcement or defense
of its own Compound Inventions or Background Intellectual Property.


 




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4.6
MedImmune and ADVAXIS, as the case may be, shall keep the other party reasonably informed of the status of the prosecution
of MedImmune-Advaxis Inventions by providing information relating to any substantive decisions taken by the applicable party relating
to patent examination and maintenance.


 


4.7
Each Party shall promptly notify the other Party in writing of any allegation by a Third Party that the activity of either
of the Parties pursuant to this Agreement infringes or may infringe the intellectual property rights of such Third Party. ADVAXIS
shall have the first right to control any defense of any such claim at its own expense and by counsel of its own choice if the
intellectual property rights of such Third Party concern a ADVAXIS Development Product. MedImmune shall have the right, at its
own expense, to be represented in any such action by counsel of its own choice. Likewise, MedImmune shall have the first right
to control any defense of any such claim at its own expense and by counsel of its own choice if the intellectual property rights
of such Third Party concern a MedImmune Development Product. ADVAXIS shall have the right, at its own expense, to be represented
in any such action by counsel of its own choice. Neither Party shall have the right to settle any patent infringement litigation
under this Section 4.7 in a manner that diminishes the rights or interest of the other Party without the prior written consent
of such other Party.


 




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5.
CONFIDENTIAL INFORMATION, PUBLICITY AND PUBLICATION.


 


5.1
Nondisclosure Obligations. Each Receiving Party shall use the Confidential Information of a Disclosing Party only in accordance
with the activities contemplated by this Agreement and shall not disclose to any third party such Confidential Information without
the prior written consent of the Disclosing Party or as expressly provided below. A Receiving Party shall use the same degree
of care with respect to a Disclosing Party’s Confidential Information that it uses with respect to its own Confidential
Information and shall only disclose such information on a need-to-know basis to individuals who are under a written obligation
of confidentiality, or are otherwise so obligated. Each Party’s obligations of non-disclosure and non-use shall continue
with respect to Confidential Information disclosed to it by the Disclosing Party for a period of ten (10) years from the date
of the initial disclosure to the Receiving Party of each such item of Confidential Information. These obligations shall not apply
to Confidential Information that is:


 


	 	(a)	known
    by a Receiving Party at the time of receipt and not through a prior disclosure by a Disclosing Party to the Receiving Party,
    as documented by business records;
	 	 	 
	 	(b)	at
    the time of disclosure or thereafter becomes published or otherwise part of the public domain without breach of the Agreement
    by a Receiving Party;
	 	 	 
	 	(c)	subsequently
    disclosed to a Receiving Party by a third party who Receiving Party reasonably believes has the right to make such disclosure;
	 	 	 
	 	(d)	developed
    by a Receiving Party independently of Confidential Information received from a Disclosing Party and such independent development
    can be properly demonstrated by the Receiving Party; or
	 	 	 
	 	(e)	not
    identified as proprietary information in writing and appropriately marked at the time it is disclosed by a Disclosing Party
    to a Receiving Party.


 


5.2
Permitted Disclosures. Notwithstanding the provisions of Section 5.1, a Receiving Party may disclose Confidential Information
to the extent required to comply with applicable law, governmental regulation, subpoena or court order, provided that notice is
promptly delivered to a Disclosing Party, where legally permitted, in order to provide it with an opportunity to seek a protective
order or other similar order with respect to such Confidential Information and the Receiving Party thereafter discloses only the
minimum information reasonably required to be disclosed in order to comply with the request, whether or not a protective order
or other similar order is obtained by the Disclosing Party.


 


5.3
Partial Disclosures. Specific aspects or details of Confidential Information shall not be deemed to be within the public domain
or in the possession of a Party merely because the Confidential Information is embraced by more general information in the public
domain or in the possession of such Party. Further, any combination of individual elements of Confidential Information shall not
be considered in the public domain or in the possession of a Party merely because one or more individual elements of such Confidential
Information are in the public domain or in the possession of such Party unless every feature of the Confidential Information that
has been disclosed in accordance with the provisions herein is disclosed in the combination.


 




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5.4
Publicity. Each Party agrees that, except as required by Applicable Laws or regulations, it shall not, without the prior written
consent of the other Party, which consent shall not be unreasonably withheld or delayed, use the name of the other Party in any
advertising, promotional or publicity material, or make any form of representation or statement in relation to the Sponsored Clinical
Trials, which would constitute an express or implied endorsement by the other Party.


 


5.5
Return or Destruction of Confidential Information. At any time after expiration or termination of this Agreement, a Disclosing
Party may notify a Receiving Party in writing that such Receiving Party must destroy or return to the Disclosing Party the Disclosing
Party’s Confidential Information. Each Receiving Party hereby agrees to, within thirty (30) days of such notification: (a)
return all documents and tangible items it or its employees or agents have received or created pursuant to this Agreement pertaining,
referring or relating to the other Party’s Confidential Information; and (b) return or certify (in a writing attested to
by a duly authorized officer of such Party) destruction of all copies, summaries, modifications or adaptations that such Party
or its employees or agents have made from the materials provided by the Disclosing Party; provided, however, that a Party is permitted
to retain one copy of such materials in its legal files to be used to verify compliance with its obligations hereunder and provided
that neither the Receiving Party nor any of its Affiliates shall be required to delete or destroy any electronic back-up tapes
or other electronic back-up files that have been created solely by their automatic or routine archiving and back-up procedures,
to the extent created and retained in a manner consistent with its or their standard archiving and back-up procedures.


 




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5.6
Publication. Both Parties acknowledge and agree that neither Party shall have the right to submit Study Data for publication
or presentation or any other dissemination, either orally or in writing (a “Publication”) prior to expiration
of the Negotiation Period, except in the event of required securities filings with the SEC (or its equivalent foreign agency)
and only after complying with the procedure for such disclosure in Section 5.2 above. Prior to Publication, the publishing
Party shall allow the other to comment on the content of the Publication to be published or presented according to the following
procedure:


 


(i)
At least sixty (60) days prior to submission for Publication of any paper, letter, abstract, poster, talk or any other presentation
or publication, the publishing Party shall provide to the other Party details of the proposed Publication in an electronic version
(cd-rom or email attachment). Upon written request from the other Party, the publishing Party agrees not to submit data for Publication
for sixty (60) days in order to allow for actions to be taken to preserve rights for patent protection.


 


(ii)
The publishing Party shall give reasonable consideration to any request by the other Party made within the periods mentioned in
clause (i) above to modify the Publication.


 


(iii)
The publishing Party shall remove all Confidential Information of the other Party before finalizing the Publication.


 


Each
such Publication shall appropriately acknowledge both Parties, as applicable, for their participation in and contribution to the
particular Sponsored Clinical Trial.


 




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6.
TERM AND TERMINATION.


 


6.1
Term. This Agreement shall take effect as of the Effective Date and shall remain in effect until the earlier of (i) permitted
termination of this Agreement (ii) the Parties entering into a Clinical Development and Commercialization Agreement pursuant to
Section 3.4 or expiration of the Negotiation Period (“Term”), unless the Parties mutually agree to an
extension of the Term, prior to the expiration of the Term by agreement, in writing; provided, however, this Agreement shall remain
in effect beyond the Term with respect to rights and obligations that survive termination of this Agreement.


 


6.2
Termination. 


 


	 	(a)	Either
    Party may terminate this Agreement upon thirty (30) days’ written notice to the other Party if the other Party commits
    a material breach of this Agreement, unless such breach is cured within the thirty (30) day notice period, or if such breach
    is not capable of being cured within thirty (30) days if, during such thirty (30) day period, the breaching Party initiates
    actions reasonably expected to cure the breach and thereafter diligently proceeds to cure the breach.
	 	 	 
	 	(b)	The
    Parties acknowledge that patient safety is of the ultimate concern and importance. Either Party may terminate this Agreement
    immediately upon written notice to the other Party if the terminating Party determines in good faith, based on a review of
    the Study Data or other Study-related information, that the Study may unreasonably affect the Study Subjects’ safety.


 




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	 	(c)	Either
    Party shall have the right to terminate this Agreement immediately upon notice in the event that it learns of any debarment
    of the other Party and/or any of its Representatives pursuant to Section 11, and/or in the event that it becomes aware of
    any fraud or scientific misconduct on the part of the other Party and/or any of their Representatives.
	 	 	 
	 	(e)	Either
    Party shall have the right to terminate this Agreement upon written notice to the other Party (i) if voluntary or involuntary
    proceedings by or against the other Party are instituted in bankruptcy or under any insolvency law, or a receiver or custodian
    is appointed for the other Party, or proceedings are instituted by or against the other Party for the dissolution or liquidation
    of the other Party under the U.S. Bankruptcy Code, which proceedings, if involuntary, shall not have been dismissed within
    ninety (90) days after the date of filing, or if the other party makes an assignment for the benefit of creditors, or substantially
    all of the assets of the other party are seized or attached and not released within ninety (90) days thereafter, or (ii) upon
    the voluntary liquidation, dissolution, winding up or cessation of business by the other Party other than in connection with
    a permitted assignment of this Agreement
	 	 	 
	 	(f)	Either
    Party may terminate this Agreement immediately upon written notice to the other Party in the event that any Regulatory Authority
    takes any action, or raises any objection, that permanently prevents the terminating Party from supplying its Development
    Product for purposes of the Sponsored Clinical Trial. If supply of the Development Product will be delayed (but not permanently
    prevented) due to such Regulatory Authority action, the Parties shall mutually agree in good faith as to the appropriate course
    of action. Additionally, either Party shall have the right to terminate this Agreement immediately upon written notice to
    the other Party in the event that it determines, in its sole discretion, to permanently discontinue development of its Development
    Product, for medical, scientific or legal reasons.
	 	 	 
	 	(g)	Either
    Party shall be entitled to terminate this Agreement immediately upon written notice to the other Party, if such other Party
    fails to perform its obligations in accordance with Section 12, and such failure to perform is not cured within ten (10) business
    days after receipt of written notice specifying the nature of such breach. The other Party shall have no claim against the
    terminating Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance
    with this Section 6.2(g). To the extent (and only to the extent) that the laws of the Territory provide for any such compensation
    to be paid to the other Party upon the termination of this Agreement, the other Party hereby expressly agrees (to the extent
    possible under the laws of the territory) to waive or to repay to the Party terminating this Agreement any such compensation
    or indemnity.


 




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6.3
Consequences of Termination. 


 


	 	(a)	Upon
    termination (including expiration) of this Agreement for any reason: (i) MedImmune and/or ADVAXIS shall terminate all tasks
    (if any) relating to the Sponsored Clinical Trial subject to this Agreement in an orderly manner, as soon as practical, and
    in accordance with a schedule to be agreed to by the Parties within thirty (30) days, subject to the rights and obligations
    of ADVAXIS or its Investigators to complete such clinical trial(s) and ensure patient safety, and in accordance with Section
    6.4; (ii) ADVAXIS shall provide to MedImmune a copy of all Study Data generated up until the date of termination or
    expiry of the Agreement; (iii) the Parties shall either return or destroy copies of all materials required to be exchanged
    pursuant to this Agreement, at the request of the Party who supplied such materials; (iv) MedImmune shall have no further
    obligations to make available its Drug Supply and any Drug Supply in the possession of ADVAXIS or Investigators shall either
    be returned to MedImmune or destroyed, at MedImmune’s request; and (v) the Parties shall pay any monies, if any, due
    and owed up to the time of termination as required by this Agreement or any other agreement.
	 	 	 
	 	(b)	Nothing
    herein shall be construed to release either Party of any obligation pursuant to this Agreement for which the principal basis
    occurred prior to the effective date of any termination.
	 	 	 
	 	(c)	The
    expiration or earlier termination of this Agreement shall not relieve the Parties from performing any obligations accrued
    prior to the date this Agreement expires or terminates. Without limitation to the foregoing, and to any other Sections of
    this Agreement which are expressly stated to survive termination or expiry of this Agreement, or which need to survive to
    accomplish the purpose of the provision, the Parties expressly agree that Sections 3.3.6, 3.4.2, 3.4.3, 4, 5, 6.3, 6.4,
    7 and 8 shall survive any termination or expiration of this Agreement. 


 




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6.4
Wind-down. MedImmune and ADVAXIS recognize that early termination of this Agreement requires both discussion and coordination
between the Parties to ensure patient safety, continuity of treatment, if appropriate, and compliance with Applicable Laws. Upon
early termination of this Agreement for any reason, the Parties shall cooperate to provide for an orderly cessation of the Sponsored
Clinical Trial, which shall take place by such time period following the date of termination as has been mutually agreed by the
Parties. Each Party further agrees to take no action or forego taking action if such action or forbearance would in any manner
jeopardize patient safety or the utility, quality or integrity of the Sponsored Clinical Trial, or the associated Study Data,
or violate or cause the other Party to violate any Applicable Laws. In addition, ADVAXIS shall conduct such activities as are
reasonably necessary in connection with the orderly wind-down of the Sponsored Clinical Trial in question. 


 


7.
REPRESENTATIONS AND WARRANTIES.


 


7.1
Authorization. Each Party hereby represents and warrants to the other Party that: (a) it duly organized, validly existing,
and in good standing under the laws of its jurisdiction of formation; (b) has all requisite power and authority to execute, deliver
and perform this Agreement and to consummate the transactions contemplated hereby; (c) this Agreement has been duly authorized,
executed and delivered by such Party, constitutes a legal, valid and binding obligation of such Party and is enforceable against
such party in accordance with its terms; and (d) it is under no contractual or other obligation or restriction that is inconsistent
with its execution or performance of this Agreement.


 




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7.2
MedImmune Representations and Warranties. MedImmune represents and warrants that:


 


	 	(a)	MedImmune
    has not granted rights, and shall not grant rights, to any Third Party that conflict with the rights granted to ADVAXIS pursuant
    to Section 4.
	 	 	 
	 	(b)	MedImmune
    Drug Supply shall meet the standards for Good Manufacturing Practice and comply with all Applicable Laws.
	 	 	 
	 	(c)	The
    MedImmune Development Product is the property of MedImmune and the use by ADVAXIS, Study Sites or Investigators of MedImmune
    Development Products does not and will not infringe any Intellectual Property Rights of any Third Party.


 


7.3
ADVAXIS Representations and Warranties. ADVAXIS represents and warrants that:


 


	 	(a)	ADVAXIS
    has not granted rights, and shall not grant rights, to any Third Party that conflict with the rights granted to MedImmune
    pursuant to Section 4.
	 	 	 
	 	(b)	ADVAXIS
    shall perform the Sponsored Clinical Trial in accordance with Applicable Laws.
	 	 	 
	 	(c)	ADVAXIS
    has or will have the rights to conduct the Sponsored Clinical Trial and to grant the rights arising from such Sponsored Clinical
    Trials in accordance with Sections 3 and 4.
	 	 	 
	 	(d)	ADVAXIS
    has all rights in and to the ADVAXIS Development Product and the use by ADVAXIS, the Study Sites or Investigators of ADVAXIS
    Development Products does not and will not infringe any Intellectual Property Rights of any Third Party.


 




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7.4
Compliance with Laws. Each Party hereby represents and warrants that it will perform its obligations under this Agreement
in a professional manner and in accordance with Applicable Laws.


 


7.5
Warranty Disclaimer. SECTIONS 7.1 – 7.4 SET FORTH THE ONLY WARRANTIES PROVIDED BY ANY PARTY CONCERNING THIS AGREEMENT
and the transactions contemplated hereby. THESE WARRANTIES, TOGETHER WITH THE INDEMNIFICATION UNDERTAKINGS OF SECTION 8.3,
ARE MADE EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF
FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, NON-INFRINGEMENT, TITLE OR OTHERWISE.


 


8.
REMEDIES; RISK ALLOCATION.


 


8.1
Equitable Remedies. The Parties acknowledge and agree that, in the event of a breach or a threatened breach of Sections 4
and 5 of this Agreement, a Party may suffer irreparable damage (in addition to financial harm) for which it will have no adequate
remedy at law and, accordingly, a Party shall be entitled to injunctive and other equitable remedies to prevent or restrain, temporarily
or permanently, such breach or threatened breach, without the necessity of posting any bond or surety. Such remedies shall be
in addition to any other remedy that such Party may have at law or in equity.


 




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8.2
Limitation of Liability. 


 


	 	(a)	Except
    AS OTHERWISE PROVIDED IN section 8.3 WITH RESPECT TO third party claims, IN NO EVENT SHALL either party be liable TO
    THE OTHER OR TO ANY THIRD PARTY for any LOST PROFITS OR SAVINGS OR FOR ANY indirect, incidental, consequential, special, PUNITIVE
    or exemplary damages IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, however caused,
    under any theory of liability, REGARDLESS OF WHETHER THE PARTIES HAVE ADVISED OR BEEN ADVISED OF THE POSSIBILITY OF ANY SUCH
    LOSS OR DAMAGE.
	 	 	 
	 	(b)	The
    disclaimers, limitations and exclusions set forth in this Agreement were specifically negotiated by the Parties and form an
    essential basis for the terms and conditions contained in this Agreement.


 


8.3
Indemnification. 


 


	 	(a)	ADVAXIS
    shall defend, indemnify, and hold harmless MedImmune and their Affiliates, officers, directors, employees, and their successors
    and assigns (each, in such capacity, a “MedImmune Indemnitee”) from and against any claim, suit, demand, loss,
    damage, expense (including reasonable attorneys’ fees of MedImmune Indemnified Party(ies) and those that may be asserted
    by a Third Party) or liability (collectively, “Losses”) arising from any claim or proceeding against the MedImmune
    Indemnitee by a Third Party to the extent that such claim or proceeding is based on: (i) any claim of infringement of patent
    rights with respect to the ADVAXIS Development Products; (ii) breach of any ADVAXIS representations and warranties under this
    Agreement; or (iii) product liability or personal injury (including, but not limited to, actions in the form of tort, warranty,
    or strict liability) arising from or relating to the Sponsored Clinical Trial or the development, testing, manufacture, commercialization,
    use or other disposition of any ADVAXIS Development Product (except that this Section 8.3(a)(iii) shall not apply to any negligence,
    gross negligence or willful misconduct by any of the MedImmune Indemnitees or their agents; to any activities conducted by
    any of the MedImmune Indemnitees outside the scope of this Agreement; to any violation by any of the MedImmune Indemnitees
    or their agents of any Applicable Laws; or to any unauthorized representations or warranties relating to the ADVAXIS Development
    Product made by any of the MedImmune Indemnitees or their agents).


 




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	 	(b)	MedImmune
    shall defend, indemnify, and hold harmless ADVAXIS and its Affiliates, officers, directors, employees, agents, and their successors
    and assigns (each, in such capacity, an “ADVAXIS Indemnitee”) from and against any Losses
    arising from any claim or proceeding against the ADVAXIS Indemnitee by a Third Party to the extent that such claim or proceeding
    is based on: (i) any claim of infringement of patent rights with respect to the MedImmune Development Products, (ii) breach
    of any of MedImmune representations and warranties under this Agreement; or (iii) product liability or personal injury (including,
    but not limited to, actions in the form of tort, warranty, or strict liability) arising from or relating to the development,
    testing, manufacture, commercialization, use or other disposition of the MedImmune Development Product (except that this Section
    8.3(b)(iii) shall not apply to any negligence, gross negligence or willful misconduct by any of the ADVAXIS Indemnitees
    or their agents; to any activities conducted by any of the ADVAXIS Indemnitees outside the scope of this Agreement; to any
    violation by any of the ADVAXIS Indemnitees or their agents of any Applicable Laws; or to any unauthorized representations
    or warranties relating to the MedImmune Development Product made by any of the ADVAXIS Indemnitees or their agents).


 


8.4
Terms of Indemnification.
If any claim is made by a third party against a ADVAXIS Indemnitee or a MedImmune Indemnitee (“Indemnitee”), such
Party shall be defended, at the indemnifying Party’s sole expense, by counsel selected by the indemnifying Party and reasonably
acceptable to the Indemnitee, provided that the Indemnitee may, at its own expense, also be represented by counsel of its own
choosing. The indemnifying Party shall have the sole right to control the defense of any such claim or action, subject to the
terms of this Section 8.4 including:


 


	 	(a)	The
    indemnifying Party’s indemnification under Section ‎8.3 shall not apply to any claim determined by final
    judgment to be attributable to the negligence, gross negligence, intentional misconduct or unlawful act of any Indemnitee.
	 	 	 
	 	(b)	The
    indemnifying Party may settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment
    (i) with prior written notice to the Indemnitee but without the consent of the Indemnitee if the only liability of the indemnifying
    Party to the Indemnitee is the payment of money and the indemnifying Party makes such payment or (ii) in all other cases,
    only with the prior written consent of the Indemnitee, given that such consent shall not to be unreasonably withheld, delayed
    or conditioned.


 




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	 	(c)	The
    Indemnitee shall notify the indemnifying Party promptly of any claim, demand, action or other proceeding for which it seeks
    indemnification hereunder within fifteen (15) business days of receipt of any such claim, demand action or other proceeding.
    The Indemnitee shall not settle or otherwise consent to an adverse judgment in any such claim, demand action or other proceeding
    or make any admission as to liability or fault without the express written permission of the indemnifying party, unless Indemnitee
    first releases indemnifying Party from its obligations hereunder.


 


8.5
Insurance. Each Party shall have and maintain in effect insurance coverage of commercial general liability which is
adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies similarly
situated. Such insurance shall be endorsed to include commercial general liability insurance of not less than two million US dollars
(U.S. $2,000,000) per occurrence and not less than five million US dollars (U.S. $5,000,000) in aggregate. Each Party shall provide
the other Party with a certificate of insurance upon request. Each Party shall provide the other Party with at least fifteen (15)
business days prior written notice of any material change, cancellation or expiration of the above-required insurance. It is understood
that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification
obligations under this Section 8. Each Party shall have the right to satisfy this requirement through a program of self-insurance.







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9.
RECORDKEEPING; REGULATORY ASSISTANCE.


 


9.1
Recordkeeping.


 


9.1.1
ADVAXIS will prepare and maintain, and require each Investigator for the Sponsored Clinical Trial to prepare and maintain, complete,
current, accurate, organized and legible study records in a manner acceptable for the collection of data for submission to, or
review by, the FDA or other applicable Regulatory Authorities and in full compliance with any protocols and any Applicable Law.


 


9.1.2
ADVAXIS will prepare and maintain complete, current, accurate, organized and legible records pertaining to the manufacture, labeling
and shipping of the ADVAXIS Development Products for submission to, or review by, the FDA or other applicable Regulatory Authorities
and in full compliance with any protocols and any Applicable Law. MedImmune will prepare and maintain complete, current, accurate,
organized and legible records pertaining to the manufacture and shipping of the MedImmune Development Products for submission
to, or review by, the FDA or other applicable Regulatory Authorities and in full compliance with any protocols and any Applicable
Law.


 


9.2
ADVAXIS shall retain, or require Study Sites, Investigators, or other Representatives to retain, all study records during the
Sponsored Clinical Trial and thereafter until the last approval of a marketing application in an ICH region and until there are
no pending or contemplated marketing applications in an ICH region (the “Retention Period”). At the end of the Retention
Period, ADVAXIS may retain or destroy, in ADVAXIS’s sole discretion, such study records.


 




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10.
DISPUTE RESOLUTION.


 


The
Parties will attempt to settle any claim or controversy arising out of this Agreement or the subject matter hereof through consultation
and negotiation in good faith in a spirit of mutual cooperation. If the individuals who normally handle the day-to-day matters
pertaining to this Agreement are not able to resolve such dispute, such matters will be elevated to individuals of each Party
at the Vice President level or higher, who shall use reasonable efforts to attempt to resolve the dispute through good faith negotiations
by telephone or in person as may be agreed. If they fail to resolve the dispute within thirty (30) days after it is referred to
them and do not mutually agree to extend the time for negotiation, then either Party shall have the right to pursue any judicial
remedy at law or in equity. Notwithstanding the foregoing, either Party may immediately pursue judicial remedies for disputes
pertaining to potential breaches of Sections 4.1-4.5 or 5 of this Agreement in order to preserve such Party’s Intellectual
Property Rights and Confidential Information.


 


11.
DEBARMENT. 


 


Each
Party hereby certifies that neither it nor any of its Representatives has been debarred, or been convicted of a crime which could
lead to debarment, under the US Generic Drug Enforcement Act of 1992 or similar laws under any other jurisdiction. If a Party
or any of its Representatives is debarred or receives notice of an action or threat of action of debarment, such Party shall immediately
notify the other Party of same. Each Party understands that receipt of such notice may result in the immediate termination of
this Agreement.


 




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12.
ANTI-BRIBERY AND ANTI-CORRUPTION.


 


Each
Party agrees, on behalf of itself and its officers, directors, employees, Affiliates, agents and Representatives, that, in connection
with the matters that are the subject of this Agreement, and the performance of its obligations hereunder:


 


	 	(a)	it
    will comply with the Anti-bribery and Anti-corruption Laws and the Anti-Corruption Policies, and will not take any action
    that will cause the other Party or its Affiliates to be in violation of any such laws or policies.
	 	 	 
	 	(b)	it
    will not, directly or indirectly, pay, offer or promise to pay, or authorize the payment of any money, or give, offer or promise
    to give or authorize the giving of anything of value to:
	 	 	 	 
	 	 	(i)	any
    Government Official in order to influence official action;
	 	 	 	 
	 	 	(ii)	any
    person (whether or not a Government Official) (A) to influence that person to act in breach of a duty of good faith, impartiality
    or trust (“acting improperly”), (B) to reward the person for acting improperly, or (C) where that person would
    be acting improperly by receiving the thing of value; or
	 	 	 	 
	 	 	(iii)	any
    other person while knowing or having reason to know that all or any portion of the money or thing of value will be offered,
    promised or given to a Government Official in order to influence official action or to any person to influence that person
    to act improperly.
	 	 	 	 
	 	(c)	It
    will not directly or indirectly solicit, receive or agree to accept any payment or anything else of value in violation of
    the Anti-Corruption Laws or the Anti-Corruption Policies.


 




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13.
GENERAL.


 


13.1
Independent Contractors. This Agreement and the relations hereby established by and among ADVAXIS and MedImmune does not constitute
a partnership, joint venture, franchise, agency or contract of employment. Neither Party is granted, and neither Party shall exercise,
the right or authority to assume or create any obligation or responsibility on behalf of or in the name of any other Party or
such Party’s Affiliates.


 


13.2
Force Majeure. Except as otherwise provided in this Agreement, in the event that a delay or failure of a Party to comply with
any obligation created by this Agreement is caused by acts of God, wars, revolution, civil commotion, acts of public enemy, labor
strikes (other than employees of the affected party), terrorism, embargo or acts of government in its sovereign capacity (“Force
Majeure”), the “affected Party” will, after giving prompt notice to the “disadvantaged Party(ies),”
be excused from such performance on a day-to-day basis during the continuance of such prevention, restriction, or interference
(and the disadvantaged Party(ies) will likewise be excused from performance of its obligations on a day-to-day basis during the
same period), provided, however, that the affected Party will use its best efforts to avoid or remove the causes of nonperformance
and all Parties will proceed immediately with the performance of their obligations under this Agreement whenever the causes are
removed or cease.


 


13.3
This Agreement and the rights and obligations under this Agreement may not be assigned by operation of law or otherwise by
either Party without the consent of the other Party, provided, however, that either Party may assign this Agreement
without the consent of the other Party to an Affiliate or to a successor by virtue of a sale of all or substantially all of its
assets related to this Agreement, merger, consolidation or similar transaction provided, further, that the assigning Party shall
deliver written notice of any such permitted assignment to the other Party, and the assignee shall agree to be bound to the non-assigning
Party under the terms and conditions of this Agreement. Subject to the restriction on assignment of this Section 13.3, this Agreement
shall be binding upon and inure to the benefit of the successors and assigns of the Parties. Any purported assignment that is
not in compliance with this Section 13.3 shall be null and void.


 




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13.4
Notices.


 


	 	(a)	Each notice
    required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by a nationally recognized
    overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, as follows:
	 	 	 
	 	 	If to MedImmune:
	 	 	 
	 	 	MedImmune,
    LLC
	 	 	One MedImmune
    Way
	 	 	Gaithersburg,
    MD 20878, USA
	 	 	Attention:
    Edward Bradley, Senior Vice President - Oncology
	 	 	 
	 	 	With a copy
    to:
	 	 	 
	 	 	MedImmune
    LLC
	 	 	One MedImmune
    Way
	 	 	Gaithersburg,
    MD 20878, USA
	 	 	Attention:
    General Counsel


 




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	 	 	If to ADVAXIS:
	 	 	 
	 	 	Advaxis,
    Inc.
	 	 	305 College
    Road East
	 	 	Princeton,
    New Jersey 08540
	 	 	Attention:
    Chief Executive Officer
	 	 	 
	 	 	With a copy
    to (but not for Notice purposes):
	 	 	 
	 	 	Pearl Cohen
    Zedek Latzer Baratz, LLP
	 	 	1500 Broadway,
    12th Floor
	 	 	New York,
    New York 10036
	 	 	Attention:
    Mark Cohen


 


	 	(b)	Such
    notice shall be deemed to have been received by the other Party (i) when delivered if personally delivered on a business day;
    (ii) on the business day after dispatch if sent by nationally-recognized overnight courier; or (iii) on the fifth (5th) business
    day following the date of mailing if sent by mail. A Party may change its address by giving written notice delivered in accordance
    with this Section.


 


13.5
Applicable Law and Jurisdiction. This Agreement shall be governed by, subject to, and construed in accordance with the substantive
laws of Delaware, without regard for any choice or conflict of laws rule or provision that would result in the application of
the substantive law of any other jurisdiction.


 




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13.6
Waivers. The waiver by a Party of a breach or default under any provision under this Agreement or the failure of such party
to exercise its rights under this Agreement in any instance shall not operate or be construed as a continuing waiver or a waiver
of any subsequent breach or default. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute
a waiver of any other provision hereof (whether or not similar).


 


13.7
Entire Agreement. The terms and provisions contained in this Agreement (including the Appendixes) constitute the entire understanding
of the Parties with respect to the transactions and matters contemplated hereby and supersede all previous communications, representations,
agreements and understandings relating to the subject matter hereof. No agreement or understanding extending this Agreement or
varying its terms shall be binding upon either party unless it is in a writing specifically referring to this Agreement and signed
by a duly authorized representative of the applicable Party.


 


13.8
Severability. In the event that any one or more of the provisions 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 of this Agreement and such invalid or unenforceable provision shall be construed by limiting it so as to be valid and
enforceable to the maximum extent compatible with, and possible under, Applicable Laws.


 


13.9
Binding Effect; Benefits. This Agreement shall inure to the benefit of and be binding upon the Parties and their respective
successors and permitted assigns; nothing in this Agreement, expressed or implied, is intended to confer on any person or entity
other than the Parties hereto or, as applicable, their respective successors and permitted assigns, any rights, remedies, obligations
or liabilities under or by reason of this Agreement.


 




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13.10
Headings. The section numbers and headings are inserted for convenience of reference only and are not intended to be a part
of or to affect the meaning or interpretation of this Agreement.


 


13.11
Further Assurances. Each Party covenants and agrees that, subsequent to the execution and delivery of this Agreement and without
any additional consideration, it will execute and deliver any further legal instruments and perform any acts which are or may
become reasonably necessary to effectuate the purposes of this Agreement.


 


13.12
Rules of Construction. The Parties agree that they have participated equally in the formation of this Agreement and that the
language and terms of this Agreement shall not be construed against a Party by reason of the extent to which such Party or its
professional advisors participated in the preparation of this Agreement.


 


13.13
Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument. Facsimile or Portable Document Format signatures shall be accepted
as original signatures and may be transmitted electronically and any document created pursuant to this Agreement may be maintained
in an electronic document storage and retrieval system, a copy of which shall be considered an original.


 




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IN
WITNESS WHEREOF the Parties have caused this Agreement to be executed on their behalf by their duly authorized representatives
as of the Effective Date.


 


	MEDIMMUNE,
    LLC	 	ADVAXIS,
    INC.
	 	 	 	 	 
	By:	/s/ Edward Bradley	 	By:	/s/ Daniel J. O’Connor 
	 	 	 	 	 
	Name:	Edward Bradley	 	Name:	Daniel J.
    O’Connor
	 	 	 	 	 
	Title:	SVP, R&D Oncology iMED Head	 	Title:	President and Chief Executive Officer
	 	 	 	 	 
	Date:	July 21,
    2014	 	Date:	July 21, 2014


 




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Execution
Version


 


Appendix
A


 


Protocol
Concept Sheet


 


Synopsis


 


	Sponsor:	 	Name
    of Finished Product:	 	Type
    of Treatment:
	Advaxis,
                                         Inc.
	 	ADXS11-001

        MEDI-4736
	 	ADXS11-001
                                         is a live, attenuated Listeria monocytogenes (Lm) based vector bioengineered
                                         to secrete a fusion peptide of tLLO-HPV (human papillomavirus) E7.

         

        MEDI-4736
        Programmed death-ligand 1 (PD-L1) also known as cluster of differentiation 274 (CD274) or B7 homolog 1 (B7-H1).

	Study
                                         Title:


 


Phase 1-2
Study of ADXS11-001 or MEDI-4376 Alone or Combination In Previously Treated Locally Advanced or Metastatic HPV+ Cervical or Head
& Neck Cancer



	Type
                                         of Study:


 


Randomized
open-label Phase 1 with Phase 2 expansion cohort



	Study
                                         Centers:


 


Multicenter:
1. Georgia Reagents University Cancer Center, [c.i.] 2. Others to be determined.



	Objectives:


 


Primary
objective: Phase 1


 


●
To evaluate the safety and tolerability of ADXS11-001 or MEDI-4736 alone and in combination (ADXS11-001 + MEDI-4736)
administered in repeating cycles in previously treated locally advanced or metastatic HPV+ head & neck cancer




 


●
Select a regimen for Phase 2 expansion based on safety, tolerability, evidence of clinical activity and correlative studies




 


Primary
Objective: Phase 2 expansion


 


●
To develop an estimate of clinical activity including: tumor responses, progression-free survival (PFS) by immune-related response
evaluation criteria (irRECIST) and overall survival for a Phase 2 efficacy estimate.




 


Secondary
Objectives


 


●
Describe and evaluate data from correlative immunologic and pathologic studies, along with other exploratory investigations to
patient outcomes.




 



	Methodology:
                                         [c.i.]


 



	The
                                         Number of Patients Planned:


 


[c.i]



	Diagnosis
                                         and Main Criteria for Eligibility:


 


[c.i.]



	Test
                                         Product, Dose, Mode of Administration:

                                                                                                                 

                                                                                                                [c.i.]



	Reference
                                         Therapy:


 


[c.i.]



	Study
                                         Duration:


 


[c.i.]



	Criteria
                                         for Evaluation:


 


[c.i.]



	Statistical
                                         Methods:


 


[c.i.]





 






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Schema


 


	[c.i.]
	 
	 	 
	Table
    1	Schedule
    of Dosing and Efficacy Assessments–ADXS11-001 Monotherapy
	 	 
	[c.i.]	 
	 	 
	Table
    2	Schedule
    of Dosing and Efficacy Assessments–MEDI-4736 Monotherapy
	 	 
	[c.i.]	 
	 	 
	Table
    3	Schedule
    of Dosing and Efficacy Assessments–ADXS11-001 + MEDI-4736 Combination Therapy
	 	 
	[c.i.]	 


 




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Appendix
B


 


Samples
Analysis/Assays Procedures


 


[c.i.]


 




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