CONFIDENTIAL TREATMENT REQUESTED. Confidential portions of this document have
been redacted and have been separately filed with the Commission.

 

Exhibit No. 10.1

 

[imagge_001.jpg] 

 

Co-Development and Commercialization Agreement

 

This Co-Development and Commercialization Agreement (this “Agreement”) is made
effective as of February 3, 2016 (the “Effective Date”) by and between Advaxis,
Inc., a corporation formed under the laws of Delaware (“Advaxis”) having its
place of business at 305 College Road East, Princeton, NJ 08540, and Especificos
Stendhal SA de CV, a corporation formed under the laws of Mexico City and with
headquartered in Av. Camino a Santa Teresa 1040, Mezannine, Jardines en la
Montana, Tlalpan, C.P. 14210 Mexico D. F. (“Stendhal”; each of Stendhal and
Advaxis are a “Party”, and together, the “Parties”).

 

RECITALS

 

WHEREAS, Stendhal has regional expertise in developing, obtaining regulatory
approvals and commercializing pharmaceutical products in Latin American
countries;

 

WHEREAS, Advaxis has expertise in developing pharmaceutical products and owns
certain information, proprietary data, know-how and other intellectual property
(i.e., patents, methods, techniques, specifications, formulae and the like)
necessary to further develop and manufacture the Product (as defined in §2.1,
below);

 

WHEREAS, Advaxis has filed an Investigational New Drug Application (IND) for its
product candidate, ADXS-HPV, with the U.S. Food and Drug Administration (“FDA”);

 

WHEREAS, Advaxis is in the process of conducting a Global Phase 3 clinical trial
of the Product, including in the Territory (the “Clinical Trial”);

 

WHEREAS, Stendhal wishes to provide assistance in the Clinical Trial of the
Product in the Territory, including providing financial support, planning and
advice, and helping to integrate and align patient sites within the Territory in
the Clinical Trial;

 

WHEREAS, Stendhal wishes to market, promote and commercialize the Product within
the Territory;

 

WHEREAS, Advaxis wishes to utilize Stendhal’s financial support and expertise in
support of the clinical trial, marketing, promotion, regulatory approval and
commercialization of the Product in the Territory;

 

 

 

 

WHEREAS, Advaxis and Stendhal wish to market, promote, and commercialize the
Product for certain Latin American countries that shall include * (collectively,
the “Territory”), for the treatment of HPV-associated cancers or any future
indications, combinations and presentations approved for the Product (the
“Field”); and

 

WHEREAS, in accordance with the terms of this Agreement Advaxis will supply the
Product to Stendhal in the Territory under a Stendhal brand in the Territory and
Stendhal will provide the funding specified in this Agreement to support the
Clinical Trial in the Territory.

 

NOW THEREFORE, in consideration of the payments and the mutual promises and
conditions set forth in this Agreement, the sufficiency and adequacy of which
are acknowledged, the Parties agree as follows:

 

1. Clinical Trial

 

1.1 Advaxis shall use Commercially Reasonable Efforts and commercially
reasonable clinical practices to conduct the Clinical Trial. Advaxis shall
include in the Clinical Trial such patient sites located in the Territory chosen
by Advaxis in its discretion with the participation and advice of Stendhal.
Advaxis shall keep Stendhal informed on a quarterly basis on the progress,
developments and results of the Clinical Trial, except as may be prohibited by
law, and shall promptly notify Stendhal upon learning of a relevant event that
could have a material impact on the Clinical Trial or the Product. Stendhal
shall advise Advaxis on and provide direction regarding relevant regulatory
authorities and/or ethics committees in the Territory with jurisdiction over the
Clinical Trial. The Parties agree that, Stendhal shall use Commercially
Reasonable Efforts to obtain, and shall file for, all regulatory approvals from
any regulatory authority with jurisdiction over the Product, in the Territory.
The Parties further agree that the responsibilities of the Parties with respect
to the clinical testing, promotion, marketing, and commercialization of the
Product, including any regulatory approval from any regulatory authorities
and/or ethics committees with jurisdiction over the sites of the Clinical Trial
in the Territory, shall be set forth in greater detail as specified in the
Project Plan as defined in §2.1, below.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  2

 

 

1.2 Advaxis shall solely control and be responsible for the protocol for the
Clinical Trial both inside and outside the Territory with consideration of
comments and input from Stendhal. For the Clinical Trial and for marketing
authorization outside the Territory, Advaxis shall be solely responsible for
obtaining necessary regulatory authorizations, registrations, licenses, or
approvals as may be necessary from the FDA or any institutional review board or
ethics committees overseeing such trial or any other U.S. development activities
to obtain marketing authorization in the U.S. (collectively, “FDA Trials”) along
with anywhere else outside the Territory. For avoidance of doubt, Advaxis shall
bear any and all costs and liability relating to or arising out of the FDA
Trials, whether conducted inside or outside of the Territory, and shall
indemnify and hold Stendhal harmless as to any and all such costs and liability.
Any clinical trials, other than the Clinical Trial of the Product, that are
conducted solely for the purpose of obtaining marketing authorization in the
Territory will be at the discretion and under the decision, control and
responsibility of Stendhal with consideration of comments and input from Advaxis
and the right of Advaxis to use any such data arising from those clinical
trials.

 

1.3 In addition to its commercialization, marketing, and promotion activities
with regard to the Clinical Trial as specified in the Project Plan (as defined
in Section 2.1 below), Stendhal shall provide up to US$* to fund the enrollment
of patients in the Territory in the Clinical Trial of the Product in the
Territory (the “Support Payments”) during the Term of this Agreement. For
purposes of computing the Support Payments, the Parties agree that, each year
during the conduct of the Clinical Trial, Advaxis shall determine in good faith
a portion of the total Clinical Trial costs that are allocable to the Clinical
Trial in the Territory (the “Allocated Portion”), which Allocated Portion shall
not exceed * (*) percent of the total Clinical Trial costs. Stendhal’s Support
Payments shall be payable to Advaxis, after the Parties have agreed in writing
that the Clinical Trial has commenced and during the conduct of the Clinical
Trial, on March 31, 2017 and each March 31st thereafter an amount not to exceed
the lesser of (i) * or (ii) US$* in any calendar year. The initial Project Plan
pertaining to the Clinical Trial shall be agreed to by the Parties on or before
March 31, 2016 and shall contain Project milestones agreed to by the Parties. In
any calendar year in which the Project Plan milestones have not been achieved,
the Stendhal Support Payment due on the following March 31st shall be suspended
and shall not be due and payable until such time thereafter as the missed
milestones for the prior calendar year shall have been achieved in accordance
with the Project Plan. In no event shall Stendhal be required to pay more than
US$* in total in support of the Clinical Trial. Stendhal’s Support Payments
shall cease on the earlier of: (x) the payment by Stendhal of US$* in total
Support Payments (including Stendhal’s internal expenses per the Project Plan)
or (y) termination of the Clinical Trial. In the event the Clinical Trial is
terminated before payment by Stendhal of the entire US$* Support Payments has
been completed, the support payment due to Advaxis in the year of termination
shall be prorated to the date of termination of the Clinical Trial. In the event
the Clinical Trial is suspended (but not terminated) before payment by Stendhal
of the entire US$* Support Payments has been completed, the Support Payments due
to Advaxis in the year of suspension shall be suspended until the Clinical Trial
recommences, and Support Payments shall recommence, on a schedule mutually
agreed between the Parties. Certain internal expenses of Stendhal, as agreed to
in the Project Plan and totaling not more than US$*, shall be counted towards
Stendhal’s Support Payments obligation.

 

1.4 Each calendar year, the Parties will meet in October to forecast projected
annual expenses for the next calendar year, with Stendhal’s annual contribution
for any calendar year payable in Q1 of the following year. Advaxis will invoice
Stendhal for its share of Clinical Trial support in accordance with Section 1.3
above. Payments will be due ninety (90) days following the date of invoice
receipt.

 

1.5 Stendhal shall recoup the US$* Support Payments as follows: Upon
commencement of sales of the Product in the Territory, Stendhal will retain *%
of the revenue shares specified in Section 4, below, i.e., Stendhal will receive
both its *% revenue share and the *% Advaxis Revenue Share until the Advaxis *%
portion equals the total Support Payments made by Stendhal under Section 1.4,
above (such total not to exceed US$*). Once the said Support Payments made by
Stendhal have been recouped by Stendhal from the Advaxis revenue share, the
revenue shares shall thereafter be *% to Stendhal and *% to Advaxis, as
specified in Section 4, below.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  3

 

 

2. Project Activity

 

2.1 For purposes of this Agreement, the “Product” shall mean the product
candidate described in BB-IND 13712, as filed on July 29, 2009 with the FDA,
entitled “Live, Attenuated Listeria monocytgones Bacteria Expressing Human
Papilloma Virus Type 16 E7 Tumor Antigen Linked to Listeriolysin O Protein
(Lm-LLO-E7) (Lovaxin-C)”. For purposes of this Agreement, the “Project” shall
mean the clinical testing, promotion, marketing, and commercialization of the
Product by the Parties in the Territory. The Parties shall carry out their
respective responsibilities related to the Project as provided in one or more
project plans agreed upon by both Parties in writing (each, a “Project Plan”).
The Project Plan shall be in such written format later agreed upon by the
Parties and shall set forth the specific tasks to be performed by each Party,
the timeline for performing the tasks, the estimated fees and expenses
associated with the tasks, the payment schedule applicable to the tasks, format
of deliverables associated with the tasks, and any other matters specified
therein. Each Project Plan, which must be in writing and make express reference
to this Agreement, shall automatically be incorporated and made a substantive
part of this Agreement upon its execution by both Parties. In the case of a
conflict between the terms of this Agreement and a Project Plan, the terms and
conditions of this Agreement will control unless Advaxis and Stendhal expressly
acknowledge in the Project Plan their intent to modify the terms and conditions
of this Agreement. In the event of a conflict between the terms of any Project
Plans, the terms of the latter Project Plan will control. Both Parties shall use
Commercially Reasonable Efforts to achieve the timelines agreed upon by the
Parties in the Project Plans. As used in this Agreement, “Commercially
Reasonable Efforts” means the carrying out of a Party’s obligations under this
Agreement with a level of effort, care and resources consistent with the
efforts, care and resources that the Party who bears the performance obligation
or a comparable third party in the industry would employ.

 

  4

 

 

2.2 The Parties shall form a joint development team (the “Joint Development
Committee” or “JDC”), made up of an equal number of representatives of Advaxis
and Stendhal (not to exceed three (3) each), which shall have responsibility for
coordinating all regulatory and other activities under, and pursuant to, this
Agreement. Each Party shall designate a project manager (each a “Project
Manager”) who shall be responsible for ensuring clear and responsive
communication between the Parties and the effective exchange of information,
serving as the primary point of contact for any issues arising under this
Agreement, implementing and coordinating activities, and facilitating the
exchange of information between the Parties, with respect to the co-development
and commercialization activities. Other JDC members will be agreed to in writing
by both Parties. The JDC shall meet as soon as practicable after the Effective
Date, and thereafter no less than once each calendar quarter, and more often as
reasonably necessary at the request of either Party with reasonable notice, to
provide an update on progress of the co-development, promotion, marketing, and
commercialization activities and make decisions and modifications regarding the
same. Five (5) business days prior to any such meeting, the Stendhal Project
Manager shall provide an update in writing to the Advaxis Project Manager, which
update shall contain information with regard to Stendhal’s Project
responsibilities, as well as any Stendhal comments about overall progress,
including without limitation recruitment status, interim analyses (if results
are available), final analyses, other information relevant to the conduct of the
clinical trials, marketing authorization status updates for the Territory and
projected timelines, Product launch dates, and Product sales in the Territory.
The JDC will attempt to reach decisions by consensus. When consensus is not
achieved on any matter, the matter will be escalated to the Stendhal CEO (or
his/her designee) and the Advaxis CEO (or his/her designee) for resolution, and
the matter shall be resolved by such individuals amicably within thirty (30)
days after such escalation (“Resolution Period”). If a matter relating to this
Agreement or a Project Plan does not achieve consensus and is not successfully
resolved within the Resolution Period in accordance with this Section, the
Parties agree to submit the unresolved matter to arbitration, as provided and in
accordance with Section 13.6.

 

2.3 For the commercialization activities, Advaxis shall provide Stendhal with
(i) an electronic draft of the final study report for any Project Plan, for
Stendhal to provide comments to Advaxis within thirty (30) days of Stendhal’s
receipt of the draft of the final study report and (ii) a final version of the
final study report promptly following receipt of the Stendhal comments and Study
Completion. Advaxis shall consider in good faith all comments provided by
Stendhal on the final study report. “Study Completion” shall occur upon database
lock of the Clinical Trial results.

 

  5

 

 

2.4 Advaxis undertakes to promptly supply Stendhal with any documents in
Advaxis’ possession reasonably necessary for Stendhal to file any local
regulatory application within the Territory, including without limitation the
registration dossier submitted to FDA by Advaxis for FDA regulatory approval of
the Product (the “Dossier”). Stendhal shall acknowledge in writing receipt of
the Dossier from Advaxis. If any documents or information not then available to
the Parties are required to enable Stendhal to obtain or to maintain Product
approval in the Territory, the Parties shall cooperate to obtain or to produce
the documents and information reasonably required. Any further data which might
be relevant to obtaining Product registration in the countries of the Territory
shall be provided by Advaxis to Stendhal, as and to the extent they are
available to Advaxis, according to appropriate timelines that agreed upon in the
Project Plan. Advaxis shall keep Stendhal informed, on a regular and timely
basis, of the progress of the development of the Product. Advaxis shall respond
promptly to specific reasonable requests of Stendhal for information and,
additionally, Advaxis shall inform Stendhal, within a reasonable time, of any
adverse or negative results that could affect the approval of the Product by the
FDA or in the Territory.

 

2.5 Stendhal shall (1) use Commercially Reasonable Efforts to carry out all
obligations designated in the Project Plan in furtherance of obtaining all
necessary regulatory authorizations, registrations, licenses, approvals, or as
otherwise may be necessary, including, from any regulatory authority or ethics
committee, to engage in the promotion, marketing, and commercialization
activities in the Territory and Field; and (2) use Commercially Reasonable
Efforts to promptly prepare, file and submit the relevant files and apply for
applicable regulatory approvals within the Territory. Advaxis shall, upon
reasonable request from Stendhal, use Commercially Reasonable Efforts to provide
such complementary information, including safety and pharmacovigilance
information necessary to support and maintain the regulatory approvals, it being
understood that said complementary information shall form part of the Dossier.
Within six (6) months of receiving the complete Dossier from Advaxis, Stendhal
shall complete all initial filings required to obtain regulatory approval in the
Territory. Stendhal shall diligently take appropriate actions to obtain
regulatory approvals in the Territory, within * (*) months from receipt of the
Dossier from Advaxis, or, where the competent local authorities do not accept
submission of a new application while a previously submitted application is
still under evaluation, within * (*) months of approval of such previously
submitted application, unless unforeseen circumstances may impact regulatory
timelines in which case the Parties will work together to secure the regulatory
approval as quickly as possible.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  6

 

 

2.6 Each Party shall permit representatives of the other Party, upon mutually
agreeable notice, to visit and inspect the facilities in which Project Plan
activities are being conducted and to observe the Project activities.

 

2.7 Each Party represents and warrants that, to its knowledge, no person who
will perform activities under this Agreement has been suspended, debarred or
subject to temporary denial of approval, nor is under consideration to be
suspended, debarred or subject to temporary denial of approval, by the U.S. Food
and Drug Administration or any foreign authority from working in or providing
services, directly or indirectly, to any applicant for approval of a drug
product or any pharmaceutical or biotechnology company under the Generic Drug
Enforcement Act of 1992, as amended, or any similar foreign laws. In the event
that during the Term of this Agreement, either Party becomes aware that person
who is or was involved in the performance of any activities on behalf of a Party
under this Agreement becomes disbarred, or is in the process of disbarment, or
are otherwise listed in the FDA’s Clinical Investigator Disqualification
Proceedings database or has a hearing pending for disqualification, or any
similar removal proceedings by a foreign authority, the disclosing Party will
immediately notify the other Party in writing. Each Party further represents and
warrants that, to its knowledge, no person who will perform activities under
this Agreement has been (i) convicted of an offense related to any Federal or
State healthcare program, including (but not limited to) those within the scope
of 42 U.S.C. § 1320a-7(a); (ii) excluded, suspended or is otherwise ineligible
for Federal or State healthcare program participation, including (but not
limited to) persons identified on the General Services Administration’s List of
Parties Excluded from Federal Programs or the HHS/OIG List of Excluded
Individuals/Entities; or is otherwise ineligible for Federal or State healthcare
program participation or (iii) debarred from or under any Federal or State
healthcare program (including, but not limited to debarment under Section 306 of
the Federal Food, Drug and Cosmetic Act (21 USC 335a) or applicable foreign
authority) In the event any of the foregoing occurs or is in the process of
occurring Stendhal will promptly notify Advaxis.

 

  7

 

 

2.8 Each Party agrees to maintain accurate books and records in connection with
its performance in connection with any Project Plan (“Records”). All such
Records will be held for a period of three (3) years after the expiration or
termination of this Agreement. Copies of all Records shall also be made
available by each Party for inspection by the other Party upon reasonable prior
notice and provided that such inspection shall be conducted in a manner that
does not unreasonably interfere with the normal business operation of the Party
maintaining the Records. Records shall be considered Confidential Information of
the Party that maintains the Records in question.

 

2.9 The Parties agree that the outcome of any registration efforts or regulatory
approvals in the Territory cannot be guaranteed by Stendhal.

 

2.10 Other than the clinical research organization selected by Advaxis to assist
with the Clinical Trial and the US or EU-based contract manufacturing
organization selected by Advaxis to manufacture the Product, any subcontracting
of a Party’s performance or obligations under the terms of this Agreement shall
be approved in advance by both Parties in writing. Each Party shall ensure that
each of its subcontractors is appropriately qualified and that appropriate
regulatory notification or approval is received for the activities selected.
Each Party shall further ensure that each of its subcontractors performs its
obligations pursuant to applicable law and the terms and conditions of this
Agreement, and such subcontracting Party shall be fully liable for such
subcontracted services to the same extent as if such services were performed by
that Party under this Agreement. Each Party shall verify that any subcontractors
selected have not been disqualified, debarred, or excluded under applicable law.

 

2.11 Each Party shall advise the other and the Project Managers, by written or
oral communications, on not less than a quarterly basis and, in the event of
matters that a Party reasonably considers to require urgent attention, when
requested, of the progress and status of the Project Plans, and each Party shall
advise the other and the Project Managers promptly, by written or oral
communications, of all significant developments regarding each Project Plan. The
Project Managers shall confer as promptly as possible with regard to any such
urgent or significant matters.

 

2.12 Each Party agrees to act in good faith in performing its obligations under
this Agreement and shall notify the other Party as promptly as possible in the
event of any delay that is likely to adversely affect its performance under this
Agreement.

 

  8

 

 

3. Product Supply

 

3.1 During the Term of this Agreement, Advaxis shall not, directly or
indirectly, knowingly sell or supply (i) the Product, or (ii) any raw material
and technology that Advaxis knows will be used to make the Product, in each case
to any other person or entity within the Territory. Advaxis shall supply all
required Product for all clinical trials within the Territory, including the
Clinical Trial. Prior to approval of the Product in the Territory and when
approval is imminent, the Parties agree to negotiate in good faith and enter
into a separate supply agreement. Upon execution by both Parties, the supply
agreement shall be incorporated into this Agreement and shall be a substantive
part of this Agreement.

 

3.2 Advaxis agrees to manufacture and supply Stendhal’s total requirements of
the Product, agreed to by the Parties in the Supply Agreement, to Stendhal in
finished pharmaceutical form packaged for sale, unless otherwise agreed to by
the Parties in writing. Advaxis covenants and agrees that the Products shall
conform to the specifications and with the Stendhal Product labels approved in
the marketing authorization in the applicable country of sale within the
Territory, as notified in writing by Stendhal to Advaxis with sufficient advance
notice to meet the supply obligations in this Agreement (the “Specifications”),
and consistent with current GMP applicable in the country of manufacture, of
which Stendhal shall notify Advaxis, and all applicable laws and regulations.
Advaxis shall provide Stendhal with an English version of the current applicable
GMP, and shall notify Stendhal as soon as possible, of any changes to such GMP.
Advaxis shall supply the Product with at least * (*)* shelf life remaining, but
in no case shall shelf-life upon shipment by Advaxis be less than * (*) *.
Advaxis shall work with Stendhal and provide Product from multiple lots at no
charge to secure Zone II and Zone IVb stability in the Territory.

 

3.3 At such time as Product sales can be reasonably anticipated, minimum
purchase order, annual minimum purchase obligations, and a rolling Stendhal *
(*) * forecast of Product supply needed, with a * (*) month frozen period for
the Product shall be determined by the Parties and made a part of the Supply
Agreement.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  9

 

 

3.4 At any time during the Term of the Agreement if the Parties agree that
market conditions affecting the sales of the Product have materially and
adversely changed due to factors beyond their control, they will discuss in good
faith such market conditions. Examples of such factors include: significant
changes to product labeling and approved indications for Product, the
introduction of competitive products that significantly reduce market share for
the Product or changes in reimbursement for the Products. In determining whether
factors have materially and adversely affected market conditions in the Product
Territory, the Parties may consider how the factors or similar factors have
affected sales of the Products in other countries outside of the Territory.

 

3.5 Advaxis shall deliver finished Product to Stendhal as vialed product in
packaged form. Stendhal shall provide any information and reasonable advice and
assistance necessary to Advaxis in order for Advaxis to modify its manufacturing
practices as required to comply with applicable laws in the Territory. Advaxis
will be solely responsible for ensuring such finished Product is compliant with
the applicable laws in the Territory as disclosed by Stendhal to Advaxis.
Stendhal will supply Advaxis with labeling for the Product and Stendhal will be
solely responsible for ensuring such labeling is compliant with the applicable
laws, regulations, guidelines, and standards of each jurisdiction within the
Territory. Conditioned upon Stendhal’s performance of its obligations in the
previous sentence, Advaxis will supply the Product to Stendhal with such labels
as required for the specific countries in the Territory. If there is a change of
the country in which the manufacturing facility is located, Advaxis shall notify
Stendhal at least one hundred and eighty (180) days in advance of any delivery
from such country in order to permit Stendhal to change the marketing approvals,
and Advaxis shall provide Stendhal with information and documentation regarding
such change of the country in which the manufacturing facility is located; and
after receiving such notice and necessary information and documentation,
Stendhal shall file the applicable amendments required regarding the Product’s
registration. The Parties agree that the Product shall be manufactured in the US
or EU to take advantage of existing Free Trade Agreements. Advaxis will certify,
on an ongoing basis, that the Products manufacturing origin is either the US or
EU. If for any reason, the Products manufacturing origin is moved from the US or
EU, then Advaxis shall reimburse Stendhal for any additional importation taxes
or duties. Any penalties and/or fines imposed on Stendhal due to delays or
breaches with Stendhal’s clients caused by such change of country of the
manufacturing facility or due to Advaxis’ delay in providing the relevant
information in such regard, shall be reimbursed by Advaxis to Stendhal.

 

  10

 

 

3.6 All commercial Product that Advaxis provides to Stendhal shall include
package inserts based on local health-related requirements in the Territory upon
notification provided by Stendhal to Advaxis. It is understood that this may
include, by petition of the applicable governmental health authorities, medical
samples, in which case Stendhal will timely advise Advaxis with respect to any
applicable petitions.

 

3.7 Advaxis shall use Commercially Reasonable Efforts to deliver the Products on
the agreed delivery dates. Advaxis shall allocate its available inventory and
make deliveries in order to fill Stendhal’s orders and satisfy scheduled
delivery dates. In the event that Advaxis is unable to satisfy its supply
obligations for any reason, it will promptly notify Stendhal. In such case,
except where Advaxis’ inability to satisfy its supply obligations results from a
breach of this Agreement by Stendhal, Stendhal shall be relieved, to the extent
of any such non-delivery, of its obligation to purchase the minimum purchase
obligation, if any, for the pertinent calendar year. Such minimum purchase
obligation for the pertinent calendar year shall be reinstated and prorated for
the remaining calendar year upon resumption of Advaxis’ ability to meet its
supply obligations. If Stendhal is subject to penalty or fine for not delivering
Product that has already been forecast and accepted by Advaxis in writing, for
any cause other than Force Majeure, Advaxis will discount from the following
purchasing orders in full, the amounts that Stendhal was required to pay as a
penalty or fine.

 

3.8 Stendhal will handle and store all Product supplied by Advaxis in accordance
with Advaxis’ customary handling procedures for the Product and any special
handling instructions set forth in a Project Plan, and will return or destroy,
at the direction of Advaxis and in accordance with applicable local laws, all
unused Product supplied by Advaxis. All arriving packages will be opened
promptly following arrival and inspected thoroughly for correct labeling and
packaging integrity. Stendhal will contact Advaxis via phone or email promptly
about any receipt issues, including nonconformance, modifications in shipping
conditions, or conditions of the Product which may delay processing, use, sale
or distribution. Should any Product received not comply with any requirements
provided in this Agreement or any Supply Agreement applicable to the Product,
Stendhal promptly will communicate with Advaxis about the nature of the issue.
More specific handling requirements may be set forth in the Project Plan. A
certificate of analysis shall accompany each shipment of the Product to
Stendhal. Advaxis shall be responsible for any failure of the Product to meet
Specifications except that Stendhal shall be responsible to the extent any such
failure is caused by shipping, storage or handling conditions occurring after
delivery to Stendhal (and performance of the acceptance procedures). Replacement
of Product found to be nonconforming due to circumstances occurring after
delivery to Stendhal will be at Stendhal’s sole expense. Advaxis shall have the
right to investigate any nonconformance reported by Stendhal, prior to any
remedy being provided by Advaxis. Should Stendhal report any receipt issues,
including nonconformance, modifications in shipping conditions, or conditions of
the Product which may delay processing, use, sale or distribution, Advaxis shall
have the right to investigate any such report, and be provided with a reasonable
period to cure any reported nonconformance. Any reported nonconformance shall
not be deemed a breach of the Agreement and shall not trigger the provisions of
Section 3.6, except to the extent such nonconformance results in the imposition
of a penalty or fine as referred to in Section 3.6 and is not the result of a
wrongful act or omission by Stendhal.

 

  11

 

 

3.9 Stendhal shall (i) use the Product solely for purposes of performing its
obligations under this Agreement; (ii) not use the Product in any manner
inconsistent with this Agreement; and (iii) use, store, transport, handle, sell,
distribute and dispose of the Product in compliance with applicable law, as well
as all reasonable instructions of Advaxis. Stendhal shall not reverse engineer,
reverse compile, disassemble or otherwise attempt to derive the composition or
underlying information, structure or ideas of the Product, and in particular
shall not analyze the Product by physical, chemical or biochemical means except
as necessary to perform its obligations under the Agreement or as required by
applicable law.

 

3.10 Stendhal shall commercialize, market, promote, advertise, price, sell and
distribute the Product in the Territory in compliance with applicable law.

 

3.11 Recalls of commercialized Product in the Territory shall be discussed and
agreed upon by a special meeting of the JDC. The Parties will allocate the costs
and expenses of a Product recall based on each Party’s relative fault with
respect to the events giving rise to the recall; if it is determined that
neither Party is at fault, then each Party shall bear such costs and expenses
for each country within the Territory in proportion to such Party’s share of
revenue for such Product in such country.

 

  12

 

 

3.12 Stendhal shall have the right, with the prior written approval from
Advaxis, which approval shall not be unreasonably withheld, conditioned or
delayed, to establish one or more Stendhal re-packaging sites for the Product in
the Territory to permit Stendhal to facilitate handling of minimum order
quantities for smaller countries in the Territory, control inventory management
and shelf life of the Product between countries within the Territory, more
expeditiously address multiple label requirements and label updates mandated by
regulatory agencies within the Territory, and otherwise respond to the
particular needs of Product commercialization in the Territory. Any re-packaging
by Stendhal shall comply with the terms and conditions of this Agreement, and be
in full compliance with all applicable local and international laws.

 

4. Project Payments

 

4.1 *. Such Advaxis Finished Product Production Cost shall be *, subject to
disclosure and annual audit on a schedule to be later agreed upon in writing
between the Parties. In the case of any cost deviation of more than * percent
(*%) in such Advaxis Finished Product Production Cost as compared to the initial
agreed Advaxis Finished Product Production Cost, the Parties shall meet to
discuss and negotiate in good faith appropriate adjustments, such that each
Party’s overall profit margin with respect to sales of the Product will not be
disproportionally affected as a result of such variations. The transfer price
shall be set as an attachment to this Agreement as soon as valid finished
Product production cost data is available and shall be subject to annual review
and audit by the Parties.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  13

 

 

4.2 Stendhal will submit to Advaxis a sales report (the “Monthly Report”),
setting forth, on a country-by-country basis: (i) the country of sale; (ii) the
date of each Stendhal sales invoice; (iii) the invoice number of each Stendhal
sales invoice; (iv) the number of Units of the Product that Stendhal sold in
such country during such calendar month; (v) Stendhal’s Invoiced Unit Price for
the Product stated in local currency; (vi) Stendhal’s Total Invoice Amount for
each invoice stated in local currency; (vii) any discount or commercial terms
given to the customer and reflected on the invoice, stated in local currency;
(viii) the Initial Net Sales amount (Total Invoice Amount less discounts and
commercial terms) stated in local currency; (ix) the U.S. Dollar exchange rate
for the local currency as of the last business day of such calendar month; (x)
Stendhal’s Total Invoice Amount for each invoice stated in U.S. Dollars; (xi)
actual duties and customs expenses incurred by Stendhal on the sale of the
Product stated in U.S. Dollars; (xii) packaging, labeling, QA and manufacturing
expenses incurred by Stendhal to finish the Product stated in U.S. Dollars;
(xiii) Advaxis Finished Product Production Cost (i.e., the Product transfer
price) to be provided by Advaxis; (xiv) Profit to be shared (Total Invoice
Amount for each invoice less actual duties and customs expenses and less any
packaging, labeling, QA and manufacturing expenses incurred by Stendhal to
finish the Product stated in U.S. Dollars and less Advaxis Finished Product
Production Cost to be provided by Advaxis, all expenses subject to disclosure
and annual audit between the Parties,); (xv) Stendhal’s Revenue Share
(percentage and U.S. Dollars); (xvi) the Advaxis Revenue Share (Profit to be
Shared less Stendhal’s Revenue Share); For purposes of example only, a sample
Monthly Report is annexed to this Agreement as Schedule 4.2.

 

4.3 Revenue Share; Monthly Balance. Subject to any additional amount for
recoupment of Support Payments as specified in Section 1.5, above, the Stendhal
Revenue Share shall be *% of the Profit to be Shared and the Advaxis Revenue
Share shall be the *% of the Profit to be Shared. At the end of each quarter,
Advaxis will issue an invoice to Stendhal for such amount, which invoice shall
be due and payable within ninety (90) days from the invoice date.

 

4.4 As used in this Agreement and for purposes of the Quarterly Reports, the
following definitions shall apply:

 

  4.4.1 Initial Net Sales means Total Invoice Amount less Product returns,
customary discounts and commercial terms, stated in local currency.        
4.4.2 Profit to be Shared means *.         4.4.3 Advaxis Finished Product
Production Cost has the meaning specified in Section 4.1.         4.4.4 Stendhal
Revenue Share means *.         4.4.5 Advaxis Revenue Share means Profit to be
Shared less Stendhal’s Revenue Share.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  14

 

 

4.5 All payments made under this Agreement shall be in US Dollars (US$). The
currency exchange rate for the US$ to be used under this Agreement shall be the
exchange rate for conversion of the foreign currency into U.S. Dollars, as
published in the Wall Street Journal (U.S., Eastern Edition) as of the close of
business on the last business day of the calendar month during which sales
Product by Stendhal occurred. In the case of a cumulative increase or decrease
in the currency exchange rate of the currency of any country in the Territory to
U.S. Dollar of more than ten percent (10%) as compared to the exchange rate in
effect in such country as of the last date on which the Transfer Price was
established, the Parties shall meet to discuss and negotiate in good faith
adjustments to the Transfer Price such that each Party’s overall profit margin
with respect to sales of the Product within such country that were affected by
the rate fluctuation will not be disproportionally affected as a result of such
exchange rate fluctuation.

 

4.6 Stendhal shall pay for all marketing authorization and registration costs in
the Territory and those payments shall not be counted toward Stendhal’s overall
$* Support Payments provided pursuant to Section 1.3.

 

4.7 All payments by Stendhal to Advaxis under this Agreement shall be made in
U.S. Dollars to the following account via wire transfer:

 

Chase Bank

 

ABA #*

 

Account Name: *

 

Account Number: *

 

 

* Confidential material redacted and filed separately with the Commission.

 

  15

 

 

5. Intellectual Property Rights; Grant of License

 

5.1 Subject to the terms and conditions of this Agreement, solely within the
Field and Territory and during the Term, Advaxis grants to Stendhal and its
Affiliates (a) a non-transferable, exclusive license under the patents and
patent applications specified in Schedule 5.1, and (b) a non-transferable,
non-exclusive license to any information provided by Advaxis to Stendhal related
to the Product, trademarks and patents and patent applications specified in
Schedule 5.1 (collectively, the “Licensed Intellectual Property”), in each case
with the right to sublicense the Licensed Intellectual Property to Stendhal
subcontractors, and in each case for the sole purpose of and to the extent
required (i) to perform its obligations hereunder, and (ii) to import,
commercialize, re-package, distribute, market, promote, offer for sale and sell
the Product in the Field and in the Territory. Stendhal shall only grant
sublicenses to the Licensed Intellectual Property to its subcontractors pursuant
to a written Agreement, which shall be provided in advance, to Advaxis for prior
approval, which will not be unreasonably withheld. Upon executing such an
agreement granting a sublicense, Stendhal shall notify Advaxis and provide
copies of executed sublicenses, to Advaxis. The Parties agree to amend Schedule
5.1 from time to time (i) to add additional patent or trademark registrations as
they are granted to Advaxis and which the Product would otherwise infringe, or
(ii) as the scope of pending claims changes during prosecution of pending patent
applications. Advaxis shall maintain and keep current all Schedule 5.1 patent
and trademark registrations in the Territory during the Term of this Agreement.
The Product shall be marketed and sold in the Territory by Stendhal, its
Affiliates, and its permitted sublicensees under a Stendhal-owned brand name.
For avoidance of doubt, the license granted to Stendhal and its Affiliates in
this Agreement includes but is not limited to the right to grant sublicenses to
sublicensees that are local distributors in each country of the Territory,
permitting such sublicensees to import, commercialize, distribute, market,
promote, offer for sale and sell the Product in the Field and in the Territory,
and to disclose to such third parties such Confidential Information (as defined
in Section 6.1, below) to the extent necessary and appropriate to carry out such
third parties’ obligations; provided, however, that any such disclosure shall be
made only under a written confidentiality agreement having terms at least as
restrictive as those provided in this Agreement. The Parties agree that
wholesalers shall not require a sublicense from Stendhal to sell the Product in
the Territory on behalf of Stendhal. Local registration (i.e., regulatory,
pricing and reimbursement approval), promotion, marketing, sale and distribution
of the Product within the Territory for any present and future approved
indication, form and presentation will be the sole responsibility of Stendhal.
Advaxis grants to Stendhal and its Affiliates and sublicensees, during the Term,
a non-transferable, royalty-free, irrevocable license to use, copy, have copied,
distribute and disclose any Product data and Clinical Trial data in Advaxis’
possession or control reasonably required by Stendhal to obtain and maintain
registration of the Product in the Territory. Registration of the Product in the
Territory shall be in the name of Stendhal, its Affiliates or distributors and
Stendhal, its Affiliates or distributors shall exclusively hold any marketing
authorizations in the Territory. Subject to terms and conditions to be
negotiated in good faith by the Parties, the rights granted by Advaxis to
Stendhal under this Agreement are inclusive of any combination product developed
by Advaxis that contains the active pharmaceutical ingredient of the Product.

 

  16

 

 

5.2 Stendhal shall own the brand name and associated trademarks for the Product
in the Territory. Product packaging design shall be in Stendhal’s reasonable
discretion. Stendhal shall be solely responsible for all expenses associated
with filing and maintaining trademark registrations for the brand name owned by
Stendhal in the Territory. Stendhal shall indemnify, defend, and hold Advaxis
harmless from and against any dispute arising from the authorized use of the
Stendhal brand name and associated Stendhal trademarks for the Product in the
Territory. Stendhal hereby grants Advaxis a non-exclusive, full-paid up,
royalty-free, irrevocable license to use and refer to the brand names and
associated trademarks, for the Product, in the Territory.

 

5.3 Advaxis is, and shall be, the exclusive owner of all right, title and
interest, including any intellectual property rights therein, in and to the
Product and any inventions, patents, improvements, copyrights, ideas, designs,
methods, prototypes, finished product, data, data collections and databases,
information, works of authorship or expression, trade secrets, formulas,
processes, concepts, techniques, compounds, inventions, discoveries,
improvements, technology and know-how, whether or not patentable, including all
patent applications, renewals, issues, reissues, extensions, divisions and
continuations in connection with any of the foregoing and the goodwill connected
with the use of and symbolized by any of the foregoing, that is invented,
conceived, discovered, created, made, developed, reduced to practice or
otherwise perfected or exists by Stendhal, any of its Affiliates, or any of its
sublicensees or contractors, whether alone or jointly, in furtherance of the
performance of any obligations or of any rights granted or sublicensed pursuant
to this Agreement (collectively, the “Developments”). For avoidance of doubt,
Developments shall not include market authorizations, Product registrations and
applications for Product registrations, and Stendhal trademarks, which shall be
the sole and exclusive property of Stendhal, its Affiliates and distributors, as
applicable. Stendhal agrees, and shall cause its employees, Affiliates, and
contractors to agree, that with respect to any Developments that may qualify as
“work made for hire” as defined in 17 U.S.C. § 101, such Developments are hereby
deemed a “work made for hire” for Advaxis. To the extent that any of the
Developments do not constitute a “work made for hire,” Stendhal hereby
irrevocably assigns to Advaxis, and shall cause its employees, Affiliates, and
contractors to irrevocably assign to Advaxis, in each case without additional
consideration, all right, title and interest throughout the world in and to the
Developments, including all intellectual property rights therein. Upon Advaxis’
request, Stendhal shall, and shall cause its employees, Affiliates, and
contractors to, promptly take such further actions, including execution and
delivery of all appropriate instruments of conveyance, as may be necessary to
assist Advaxis to prosecute, register, perfect or record its rights in or to any
Developments. Advaxis shall have the right to incorporate the relevant data and
results in any regulatory filings and use any such data or results in filing for
additional patents. The Parties agree to and shall use reasonable care in
inventorying, handling and safeguarding all Licensed Intellectual Property and
Developments. Advaxis grants to Stendhal an exclusive license, solely within the
Field and Territory, to use the Developments for purposes in furtherance of the
Project or any Project Plan. During the Term of this Agreement and for five (5)
years after termination of the Agreement for any reason, Stendhal shall not
discard or destroy any original records or documentation, without prior written
permission from Advaxis. Pursuant to a written request from Advaxis prior to the
end of the five (5) year period, Stendhal shall return to Advaxis all original
records and documentation received from Advaxis, subject to any record retention
requirements imposed by law.

 

  17

 

 

5.4 Notwithstanding anything in this Agreement to the contrary, Stendhal
understands and agrees that it shall have no ownership rights in or to any
regulatory filing, intellectual property or approval in the United States or
outside the Territory in respect of the Product; provided, however, that Advaxis
agrees to provide Stendhal with the right to access and use any such regulatory
filing in the United States together with any associated data in Advaxis’
possession or control for the purposes of obtaining or maintaining Product
approval in the Territory while this Agreement remains in effect.

 

5.5 Stendhal acknowledges that the Licensed Intellectual Property and Product
shall be used exclusively for the Project, in the Territory and shall not be
used for the benefit of any third party, except to the extent permitted for
Stendhal Affiliates and subcontractors. Except as otherwise expressly provided
in this Agreement, under no circumstances shall a Party, as a result of this
Agreement, obtain any intellectual property rights or ownership interest or
other right, title or interest in, to or under any intellectual property or
Confidential Information of the other Party, whether by implication, estoppel or
otherwise, including any items controlled or developed by the other Party, or
delivered by the other Party, at any time pursuant to this Agreement.

 

5.6 In the event that, at any time during the Term of this Agreement, Advaxis
develops or acquires the right to distribute and license a product in the
Territory that competes with the Product in the Field (a “Competing Product”),
Advaxis shall offer to Stendhal a first negotiation right to distribute,
promote, market and sell said Competing Product in the Territory to the extent
Advaxis has the right to sublicense or distribute such Competing Product in the
Territory. Stendhal shall have sixty (60) days from notification by Advaxis to
exercise said first negotiation right and to decide, by written election to
Advaxis, whether it is interested in said Competing Product or not. If Stendhal
decides to exercise the first negotiation right, it shall do so by notifying
Advaxis in writing. Upon notification by Stendhal, the Parties shall then
discuss and seek an agreement in good faith on all terms and conditions of an
appropriate distribution and license agreement to be entered into between the
Parties in relation to the Competing Product, providing, inter alia, conditions
of supply and marketing of the Competing Product, appropriate minimum sales
obligations, launching term, and other relevant commercial terms and conditions.
If Stendhal decides not to exercise said first negotiation right or if the
Parties are unable to reach and execute an agreement on said terms and
conditions within three (3) months from the date of Stendhal’s notification of
interest to Advaxis, Advaxis shall be free to fully exploit said Competing
Product in the Territory.

 

  18

 

 

6. Confidentiality

 

6.1 Both Advaxis and Stendhal agree that, subject to the limitations set forth
in Section 6.3 hereof, all information disclosed to the other Party
(“Recipient”), whether in oral, written or graphic form, shall be deemed the
“Confidential Information” of the disclosing Party (the “Discloser”). Further,
Confidential Information shall also include any scientific, technical, trade or
business information, intellectual property, data or materials possessed by a
Party which is treated by such Party as confidential or proprietary, including
information pertaining to strains, cells, antibodies, organisms, chemical
compounds, products, formulations, technologies, techniques, methodologies,
algorithms, computer programs, computer security systems and processes, assay
systems, procedures, tests, data, documentation, reports, sources of supply,
know-how, patent positioning, results, applications, documents, processes,
compositions, inventions, trade secrets, protocols, regulatory information,
relationships with employees and consultants, business plans, business
developments, research, development, process development, manufacturing,
commercialization, and marketing, and any other confidential information about
or belonging to a Party’s Affiliates, suppliers, licensors, licensees, partners,
collaborators, customers or others, and is provided by the Discloser to the
Recipient under this Agreement.

 

6.2 Each Party agrees that, except in connection with the performance of its
obligations under this Agreement or the exercise of its rights or licenses under
this Agreement, it will not otherwise use in any way, including for its own
benefit or the benefit of any third party, nor disclose or transfer to any third
party, any Confidential Information revealed to it by the other Party; provided,
however, that Confidential Information may be disclosed pursuant to a
regulation, law, court order or rule of any applicable securities exchange, but
only to the minimum extent required to comply with such regulation, order, or
rule and with advance written notice to the Discloser; and provided further that
a Recipient may disclose Confidential Information to its subsidiaries,
Affiliates, professional advisors, consultants, agents provided that they are
under confidentiality and use limitations consistent with those in this
Agreement and such Party will be liable for breaches of the restrictions set
forth in this Agreement by all such persons. Each Party will protect and
safeguard the confidentiality of the other Party’s Confidential Information with
at least the same degree of care as such Party would protect its own
Confidential Information, but in no event with less than a commercially
reasonable degree of care.

 

6.3 Both Advaxis and Stendhal agree that, notwithstanding the foregoing
provisions of this Section 6, the obligations of confidentiality shall not be
deemed to apply to:

 

(a) Confidential Information which at the time of disclosure is or thereafter
becomes generally known or available to the public, through no wrongful act or
failure to act on the part of the Recipient.

 

  19

 

 

(b) Confidential Information that was known by or in the possession of the
Recipient at the time of receiving such information from the Discloser as
evidenced by written records.

 

(c) Confidential Information obtained by the Recipient from a third party source
who is not breaching a commitment of confidentiality to the Discloser by
revealing such information to the Recipient.

 

(d) Confidential Information that is the subject of a granted written permission
to disclose that is issued by the disclosing party to the other party.

 

(e) Confidential Information that is independently developed by the Recipient,
outside the scope of any Project under this Agreement, without the use of and/or
reference to the Discloser’s Confidential Information.

 

(f) Confidential Information that is required to be disclosed pursuant to the
law, but only to the extent required to be disclosed; provided, however, the
Discloser notifies the Recipient in writing and gives the Recipient reasonable
time to comment on the same prior to disclosure.

 

6.4 During the Term of this Agreement and for a period of five (5) years
thereafter, each Party shall maintain all Confidential Information in trust and
confidence and shall not disclose any Confidential Information to any third
party or use any such information for any unauthorized purpose, other than as
expressly authorized in and subject to Section 6.2. Each Party may use such
Confidential Information only to the extent required to accomplish the purposes
of this Agreement. Confidential Information shall not be used for any purpose or
in any manner that is not consistent with this Agreement or that would
constitute a violation of any laws or regulations including, without limitation,
the export control laws of the United States. Each Party hereby agrees that it
will not in any way attempt to obtain, either directly or indirectly, any
information regarding any Confidential Information from any third party who has
been employed by, provided consulting services to, or received in confidence
information from, the Discloser.

 

  20

 

 

6.5 Both Parties shall require that all employees, consultants, agents,
subcontractors and manufacturing contractors who may have access to Confidential
Information of the other Party, and any other third parties who might have
access to Confidential Information, use such Confidential Information only as
permitted and in a manner consistent with the terms of this Agreement, and in
accordance with the terms set forth in this Section 6. Stendhal may disclose to
its Affiliates and valid third-party sublicensees such Confidential Information,
but only as required and to the extent necessary for such third parties and
Affiliates to carry out such Affiliate or sublicensee’s obligations; provided,
however, that any such disclosure shall be made only under a written
confidentiality agreement having terms at least as restrictive as those provided
in this Agreement. In the event any Confidential Information is improperly
disclosed by a Party or such Party’s Affiliate or sublicensee, the disclosing
Party shall bear all costs and burdens involved in enforcing the confidentiality
of the disclosed information, and mitigating any damages suffered by Advaxis and
Stendhal as a result of the improper disclosure. No Confidential Information
shall be disclosed to any employees, subcontractors, agents, consultants,
Affiliates, or sublicensees who do not have a need to receive such information.

 

6.6 To the extent either Party discloses Confidential Information of the other
Party to an employee, consultant, subcontractor, or other third-party
(collectively “Agents”) or permits an Agent to have access to such Confidential
Information, such Party shall assign to the other Party any claims it may have
against the Agent as a result of the Agent further disclosing or misusing such
Confidential Information.

 

7. Publications and Publicity

 

7.1 Each Party may include the other Party’s name and logo on its website and
marketing materials so long as any such usage is limited to reporting factual
events or occurrences only (for example, referencing the fact that the
partnership is occurring) and does not constitute a commercial endorsement of
the products and services of the other Party. Either Party may issue a press
release announcing the relationship governed by this Agreement provided that the
form and substance of each such release must be approved in advance by both
Parties, which approval shall not be unreasonably withheld or delayed.

 

7.2 Advaxis shall have sole right to present and/or publish the results of the
Projects hereunder as they relate to the Clinical Trial or the Product. In any
such publication or presentation, Advaxis will acknowledge Stendhal’s
contribution (including authorship if appropriate under the circumstances and
customary practice). Publication regarding any other clinical trials or data
must be agreed upon in advance as between the Parties.

 

  21

 

 

8. Covenants; Representations and Warranties

 

8.1 Stendhal hereby represents, warrants and covenants to Advaxis that:

 

(a) it shall use Commercially Reasonable Efforts to perform the activities
services required to be performed by it hereunder in a professional and
competent manner and in accordance with the Project Plan;

 

(b) all activities and services rendered shall be provided in material
compliance with the applicable laws of the Territory.

 

(c) it is duly organized and validly existing under the laws of its jurisdiction
of incorporation and has full legal right, power and authority to enter into
this Agreement, and to perform its obligations hereunder.

 

(d) the execution and delivery of this Agreement and the performance of the
transactions contemplated hereby have been duly authorized by all appropriate
corporate action by Stendhal.

 

(e) it has no knowledge, after due inquiry using Commercially Reasonable
Efforts, of any third party’s rights that would preclude Stendhal from the
marketing, promotion, commercialization and sale of the Product in the Territory
on the terms and conditions of this Agreement.

 

(f) this Agreement is a legal and valid obligation binding upon Stendhal and
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by Stendhal does not violate, conflict or breach
any provisions of (i) its articles of incorporation or by-laws or similar
constituent documents, (ii) any agreement, instrument or understanding, oral or
written, to which it is a party or by which it is bound, nor (iii) any laws or
regulations of any court, governmental body or administrative or other agency
having jurisdiction over it; and all approvals, consents or licenses that are
required by any governmental authority or that must be obtained by Stendhal in
order to enable it to enter into this Agreement and to perform its current
obligations hereunder in accordance with all applicable laws and regulations,
have been or will be obtained by Stendhal.

 

  22

 

 

(g) it has not and will not intentionally withhold from Advaxis any information
or specification related to the Product that it knows could materially limit or
otherwise impede the registration, commercialization and safe use of the
Product.

 

8.2 Advaxis hereby represents, warrants and covenants to Stendhal that:

 

(a) it shall use Commercially Reasonable Efforts to perform the activities
services required to be performed by it hereunder in a professional and
competent manner and in accordance with the Project Plan.

 

(b) all activities, services, and any goods rendered shall be provided in
material compliance with the applicable laws.

 

(c) it is duly organized and validly existing under the laws of its jurisdiction
of incorporation and has full legal right, power and authority to enter into
this Agreement, to grant to Stendhal the licenses, permissions and rights
contained in this Agreement, and to perform its obligations hereunder.

 

(d) the execution and delivery of this Agreement and the performance of the
transactions contemplated hereby have been duly authorized by all appropriate
corporate action by Advaxis.

 

(e) to the best of its knowledge after reasonable inquiry, as of the Effective
Date, there is no (i) third party right that would preclude Stendhal from the
marketing, promotion, commercialization and sale of the Product in the Territory
on the terms and conditions of this Agreement, (ii) third-party infringement
inside or outside the Territory of Advaxis’s rights, intellectual property,
patent rights, and know-how, or (iii) Advaxis issued or valid patent or
intellectual property right that would preclude Stendhal from the marketing,
promotion, commercialization and sale of the Product in the Territory on the
terms and conditions of this Agreement.

 

(f) any patents owned by or licensed to Advaxis, the claims of which cover the
Product, are valid and enforceable in the Territory.

 

  23

 

 

(g) to the best of its knowledge after reasonable inquiry, as of the Effective
Date, no third party license of any intellectual property right is necessary for
the development or commercialization of the Product in the Territory.

 

(h) it will use Commercially Reasonable Efforts to maintain during the Term of
this Agreement the Licensed Intellectual Property.

 

(i) to Advaxis’s actual knowledge there is, as of the Effective Date, no claim
or proceeding pending or threatened against Advaxis alleging that the Licensed
Intellectual Property infringes the intellectual rights of any third party
inside or outside the Territory.

 

(j) this Agreement is a legal and valid obligation binding upon Advaxis and
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by Advaxis does not violate, conflict or breach
any provisions of (i) its articles of incorporation or by-laws or similar
constituent documents, (ii) any agreement, instrument or understanding, oral or
written, to which it is a party or by which it is bound, nor (iii) any laws or
regulations of any court, governmental body or administrative or other agency
having jurisdiction over it; and all approvals, consents or licenses that are
required by any governmental authority or that must be obtained by Advaxis in
order to enable it to enter into this Agreement and to perform its current
obligations hereunder in accordance with all applicable laws and regulations,
have been or will be obtained by Advaxis.

 

(k) it has not and will not withhold from Stendhal any information or
specification related to the Product that it knows could in materially limit or
otherwise impede the registration, commercialization and safe use of the
Product.

 

(l) it shall use Commercially Reasonable Efforts to provide in a timely manner
and in English version to Stendhal all documents and information which it
possesses or controls that is necessary for Stendhal to obtain and maintain the
Product approval and registration during the Term in the Territory. If any
documents or information not then available to the Parties are required to
enable Stendhal to obtain or to maintain Product Approval in the Territory, the
Parties shall cooperate to obtain or to produce the documents and information
reasonably required.

 

  24

 

 

(m) all Product that it shall manufacture, store, ship or distribute to Stendhal
shall be manufactured, stored, shipped or distributed in material compliance
with all applicable laws.

 

(n) it is free to enter into this Agreement; and it has the legal power,
authority and right to perform its obligations hereunder.

 

(o) notwithstanding anything in this Agreement to the contrary, any Product
made, stored, shipped or distributed under any license granted pursuant to this
Agreement will not infringe the intellectual property rights of any third
parties.

 

8.3 Each of Advaxis and Stendhal represents and warrants to the other that it
has the full right and authority to enter into this Agreement and to perform its
obligations hereunder.

 

8.4 In performing their respective obligations hereunder, the Parties
acknowledge that their corporate policies require that each Party’s business be
conducted within the letter and spirit of the law. By signing this Agreement,
each Party agrees to conduct the business contemplated herein in a manner which
is consistent with all applicable laws, including without limitation the U.S.
Foreign Corrupt Practices Act (or similar foreign laws as may be applicable) and
good business ethics. In addition, the Parties have provided each other with
copies of their Codes of Business Conduct, which may be updated from time to
time. Specifically, each Party agrees that it has not, and covenants that it,
its Affiliates, and its and its Affiliates’ directors, employees, officers, and
anyone acting on its behalf, will not, in connection with the performance of
this Agreement, directly or indirectly, make, promise, authorize, ratify or
offer to make, or take any action in furtherance of, any payment or transfer of
anything of value for the purpose of influencing, inducing or rewarding any act,
omission or decision to secure an improper advantage; or improperly assisting it
in obtaining or retaining business for it or the other Party, or in any way with
the purpose or effect of public or commercial bribery.

 

8.5 EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, ADVAXIS MAKES NO WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, WITH RESPECT TO THE PRODUCT.

 

  25

 

 

9. Indemnification; Limitation of Liability

 

9.1 Stendhal shall indemnify and hold Advaxis and its Affiliates and its and
their respective officers, directors, agents and employees (“Advaxis
Indemnitees”) harmless from and defend them against any and all liabilities,
losses, proceedings, suits, actions, damages, judgments, settlements, claims or
expenses of any kind, including court costs and reasonable attorneys’ fees
(collectively, “Losses”) incurred by any Advaxis Indemnitee as a result of any
third party allegations, claims, proceedings, suits or actions of any kind and
of any nature whatsoever (“Claims”) that arise out of or are based on: (a) any
grossly negligent or willful act or omission by Stendhal, its Affiliates,
subcontractors or sublicensees; (b) any material breach of this Agreement,
including any covenant, warranty or representation herein, by Stendhal; (c) any
personal injury claim arising solely from any false or unauthorized statement by
any Stendhal personnel or personnel of its Affiliates, subcontractors or
sublicensees with respect to the features of Product; except, in each case, to
the extent such Claims falls within the scope of the indemnification obligations
of Advaxis set forth in Section 9.2.

 

9.2 Advaxis shall indemnify and hold Stendhal and its Affiliates and its and
their respective officers, directors, agents and employees (“Stendhal
Indemnitees”) harmless from and defend them against any and all Losses incurred
by any Stendhal Indemnitee as a result of Claims that arise out of or are based
on: (a) any grossly negligent or willful act or omission by Advaxis, its
Affiliates, subcontractors or sublicensees; (b) any material breach of this
Agreement, including any covenant, warranty or representation herein by Advaxis;
(c) any product liability Claims relating to or arising out of the use or sale
of the Product; (d) any Claims based on the alleged invalidity or
unenforceability of any Advaxis Licensed Intellectual Property; and (e) any
Claims based on the alleged infringement of any patent by the Product; except,
in each case, to the extent such Claims falls within the scope of the
indemnification obligations of Stendhal set forth in Section 9.1.

 

9.3 Any indemnitee seeking to be indemnified hereunder (“Indemnified Party”)
shall notify promptly in writing the other Party (“Indemnifying Party”) of any
actual or potential claim in respect of which indemnification may be sought as
soon as possible but in any event no later than thirty (30) days after becoming
aware (or after the day the Indemnified Party ought to be aware), by registered
letter with acknowledgement of receipt, together with any relevant documentation
supporting the claim as well as the estimated amount of the claim.

 

  26

 

 

9.4 Upon receipt of notice the Indemnifying Party shall have the right, but not
the obligation, to defend against, control the defense of, and settle any such
claim. If the Indemnifying Party elects to assume the defense of any claim, the
Indemnifying Party shall no longer be liable for any legal or other expense
subsequently incurred by the Indemnified Party in connection with the defense.
The Indemnified Party shall co-operate with the Indemnifying Party in the
defense of any Claim and shall be entitled to participate in the defense of such
action; provided, however, the decisions of counsel for the Indemnifying Party
shall be controlling and the Indemnified Party shall be responsible for the
expenses of its own counsel, if any. There shall be no settlements, whether
agreed to in court or out of court, without the prior written consent of the
Indemnifying Party, and the Parties agree to cooperate fully and in good faith
with each other in connection with the defense, negotiation or settlement of any
such claims. In the event that the Indemnifying Party does not undertake the
defense, compromise or settlement of any claim, the Indemnified Party shall have
the right to control the defense or settlement of such claim with counsel of its
choosing, and the Indemnifying Party shall pay the reasonable expenses of
defense including reasonable attorneys’ fees incurred by the Indemnified Party
in such defense.

 

9.5 Any common or joint liability of the Parties contemplated by this Agreement
which is not indemnifiable under Section 9 shall be shared equally by the
Parties.

 

9.6 IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES OR SUBCONTRACTORS)
BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR
CONSEQUENTIAL DAMAGES OF THE OTHER PARTY (INCLUDING CONSEQUENTIAL LOST PROFITS
OR DAMAGES FOR LOST OPPORTUNITIES), WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE,
TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF THE COMMERCIALIZATION,
DEVELOPMENT OR SUPPLY OF PRODUCT OR ANY BREACH OF OR FAILURE TO PERFORM ANY OF
THE PROVISIONS OF THIS AGREEMENT OR ANY REPRESENTATION, WARRANTY OR COVENANT
CONTAINED IN OR MADE PURSUANT TO THIS AGREEMENT, EXCEPT THAT SUCH LIMITATION
SHALL NOT APPLY TO DAMAGES PAID OR PAYABLE TO A THIRD PARTY BY AN INDEMNIFIED
PARTY FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION HEREUNDER.
ThE LIMITATIONS OF THIS SECTION 9.6 SHALL however not be applicable (except with
regard to any punitive damages which are in any case excluded), with respect to
(A) breach by either Party of the confidentiality obligations set forth in this
Agreement, or (b)termination DUE TO A breach OF THIS AGREEMENT by advaxis,
provided, however, that in the event of such a termination total damage payments
to stendhal shall not exceed the total amount of support payments received by
advaxis less the amount of support payments recouped by stendhal under section
1.5.

 

  27

 

 

10. Term and Termination

 

10.1 This Agreement will commence on the Effective Date and shall continue for a
period of * (*) years (the “Term”); provided, however, that if one or more
Project Plans remain outstanding and active at the end of such * period, the
expiration date shall be automatically extended until the scheduled completion
date of the last such Project Plan.

 

10.2 If either Party commits a breach or defaults on any terms or conditions of
this Agreement or a Project Plan, and that Party fails to remedy such breach or
default within sixty (60) days after receiving written notice, in accordance
with Section 12, of the breach or default from the other Party, then the Party
giving notice may, at its option, immediately terminate this Agreement at the
end of the 60-day notice period by providing written notice to the other Party
of such termination in accordance with Section 12.

 

10.3 This Agreement may be terminated by Advaxis with or without cause during
the conduct of the Clinical Trial by providing notice of such termination in
accordance with Section 12. The effective date of such termination by Advaxis
shall be thirty (30) days from the date the notice of termination is given,
unless a later date is specified in the notice. Such termination shall be
subject to the provisions of Sections 10.45 and 10.56. If the Agreement is
terminated by Advaxis for cause during the conduct of the Clinical Trial, any
Support Payments owed by Stendhal to Advaxis shall be prorated to the effective
date of termination. If the Agreement is terminated by Advaxis without cause
during the conduct of the Clinical Trial, any Support Payments paid by Stendhal
to Advaxis prior to the effective date of termination shall be refunded by
Advaxis to Stendhal within sixty (60) days from the effective date of
termination.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  28

 

 

10.4 This Agreement may be terminated by Stendhal with or without cause by
providing noticed notice of such termination in accordance with Section 12, and
the effective date of any termination by Stendhal pursuant to this Section 10.4
shall be thirty (30) days from the date the notice of termination is received by
Advaxis, unless a later date is specified in the notice provided by Stendhal.
Such termination shall be subject to the provisions of Sections 10.5 and 10.6.
If the Agreement is terminated by Stendhal without cause during the conduct of
the Clinical Trial, any Support Payments owed by Stendhal to Advaxis shall be
prorated to the effective date of termination. If the Agreement is terminated by
Stendhal with cause before it has fully recovered the $* Support Payments
pursuant to Section 1.5, above, any Support Payments paid by Stendhal to Advaxis
prior to the effective date of termination that have not been recovered by
Stendhal pursuant to Section 1.5, shall be refunded by Advaxis to Stendhal
within sixty (60) days from the effective date of termination.

 

10.5 Termination of this Agreement pursuant to Section 10.2, Section 10.3, or
Section 10.4 will simultaneously terminate all Project Plans then outstanding as
of the effective date of termination. In the event of termination, the Parties
shall adjust between them all fees and expenses accrued and owing to the
effective date of termination. In the event of termination of this Agreement,
Stendhal shall return all Product according to Advaxis’ instructions. With
respect to any Product orders from Stendhal that were previously accepted by
Advaxis prior to notice of termination and that are outstanding at the effective
date of termination pursuant to Section 10.3 or Section 10.4, Advaxis shall, at
Stendhal’s written request, fulfill such Product orders in accordance with the
terms and conditions of this Agreement and the Supply Agreement notwithstanding
any termination of this Agreement pursuant to Section 10.3 or Section 10.4.

 

10.6 Upon expiration or termination of this Agreement for any reason, each Party
shall, and procures that its Affiliates shall, promptly terminate using any and
all Confidential Information received from the other Party and, subject to any
law or regulation or any order of court or arbitration tribunal, Stendhal shall
deliver to Advaxis all data and results in its possession that resulted from the
conduct of the Project Plans prior to the effective date of termination, and
Stendhal shall deliver to Advaxis a copy of the complete records (including,
without limitation, laboratory records and case report forms) regarding the
Project Plans. Upon termination of this Agreement, all licenses granted under
this Agreement shall automatically terminate together with the Agreement.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  29

 

 

10.7 Notwithstanding anything in this Agreement to the contrary, upon
termination of this Agreement, Advaxis and Stendhal shall cooperate to: (a)
terminate the Project in a manner which recognizes the best interests and
welfare of any subjects in any clinical trials and is designed to be safe for
subjects enrolled in such clinical trials in accordance and compliance with all
applicable laws and regulations.

 

11 Insurance

 

11.1 Each Party, at its own expense, represents, warrants and covenants that it
shall maintain in full force and effect during the Term of this Agreement,
insurance to include:

 

(a) General liability insurance including products liability and completed
operations with limits of liability not less than $* per occurrence and $* in
the aggregate. Such limit requirements may be satisfied by excess or umbrella
coverage; and

 

(b) If applicable, any insurance required by state or local jurisdiction law for
employees and employer’s liability insurance with limits not less than $*.

 

(c) Provided that a Party maintains not less than the amount of insurance
coverage required by this Section 11.1, the amount of such insurance carried by
each Party shall constitute the limit of such Party’s liability to the other
Party under this Agreement, except for product liability claims for which
liability shall not be so limited. Certificates evidencing the required
insurance or self-insurance shall be provided to the other Party as reasonably
requested. Each Party shall endeavor to provide the other Party with thirty (30)
days prior written notice of any cancellation or material reduction of required
coverage. All insurance policies shall be written by a company with an A.M. Best
rating of at least A-, VIII, or equivalent rate and shall provide coverage that
includes the Territory.

 

 

* Confidential material redacted and filed separately with the Commission.

 

  30

 

 

12. Notices

 

12.1 Any and all notices provided hereunder shall be sent to the other Party by
facsimile transmission, or mailed postage prepaid by first-class certified or
registered mail, or sent by a nationally recognized express courier service, or
hand-delivered to the following addressees:

 

If to Advaxis: Attention: Daniel J. O’Connor

305 College Road East

Princeton, NJ 08540

Phone: 609-452-9813

Fax: 609-452-9818

 

If to Stendhal: Attention: Carlos Arenas Wiedfeldt, CEO with copy to Fabiola
Quezada Nieto, General Counsel

 

Especificos Stendhal S.A. de C.V.

Camino a Santa Teresa 1040, mezzanine,

Col. Jardines en la Montaña, C.P. 14210

México, D.F.

Phone: 55 2000 66 30

 

Any notice, if sent properly addressed, postage prepaid, shall be deemed made
three (3) days after the date of mailing as indicated on the certified or
registered mail receipt, or on the next business day if sent by express courier
service or on the date of delivery or transmission if hand-delivered,
electronically delivered or sent by facsimile transmission.

 

  31

 

 

13. General Provisions

 

13.1 This Agreement shall not be assignable by either Party without the prior
express written consent of the other Party. Any assignment or attempt at same in
the absence of such prior written consent shall be void and without effect. For
purposes of this Agreement, a transfer by either Party of all or substantially
all of its stock or assets shall be deemed an assignment. As used in this
Agreement, the term “Affiliate” means any person, corporation, partnership or
other business entity, and the employees and agents thereof, which, directly or
indirectly, is controlled by, controls, or is under common control with Advaxis
or Stendhal. For purposes of the previous sentence, the term “control” means to
possess, directly or indirectly, the power to affirmatively direct the
management and policies of such person, corporation, partnership, or other
business entity, whether through ownership of voting securities or by contract
relating to voting rights or corporate governance.

 

13.2 This Agreement shall be binding upon and inure to the benefit of and be
enforceable by the Parties hereto and their respective successors and permitted
assigns.

 

13.3 No delay or omission by either Party to exercise any right under this
Agreement shall impair any such right or power or be construed to be a waiver
thereof. A waiver by either of the Parties hereto of any of the covenants,
conditions or agreements to be performed by the other shall not be construed to
be a waiver of any succeeding breach thereof or of any covenant, condition or
agreement herein contained. No waiver or discharge of any provisions of this
Agreement shall be valid unless it is in writing and is executed by the Party
against whom such change or discharge is sought to be enforced.

 

13.4 If a judicial determination is made that any of the provisions contained in
this Agreement constitute an unreasonable restriction against either Party or
are otherwise unenforceable, such provision or provisions shall be rendered void
or invalid only to the extent that such judicial determination finds such
provisions to be unreasonable or otherwise unenforceable, and the remainder of
this Agreement shall remain operative and in full force and effect.

 

13.5 This Agreement shall be governed by, and construed in accordance with, the
laws of the State of New York as though made and to be fully performed in said
State.

 

  32

 

 

13.6 Any controversy or claim arising out of or relating to this Agreement, or
the breach thereof, shall be determined by arbitration administered by the
International Centre for Dispute Resolution in accordance with its International
Arbitration Rules, before a single arbitrator, and judgment on the award
rendered by the arbitrator may be entered in any court having jurisdiction
thereof. The place of the arbitration shall be New York, New York, and the
language of the arbitration shall be English. The arbitrator shall have the
authority to issue interim and injunctive relief during the pendency of the
arbitration. Except by order of the arbitrator upon a showing of good cause,
there shall be no requests for admission and no depositions. If disputes arise
concerning discovery requests, the arbitrator shall have sole and complete
discretion to determine the disputes. The confidentiality provisions of this
Agreement shall not apply to the disclosure of Confidential Information to the
arbitrator, but the arbitrator may take such precautions as deemed necessary to
protect the confidentiality of the proprietary information of the Parties.

 

13.7 No provision of this Article 13 shall limit the right of a Party to seek
provisional or ancillary injunctive remedies from a court of competent
jurisdiction before, after, or during the pendency of any arbitration. The
exercise of a remedy does not waive the right of either Party to resort to
arbitration. The institution and maintenance of an action for judicial relief
through a provisional or ancillary remedy shall not constitute a waiver of the
right of either Party to submit the controversy or claim to arbitration if the
other Party contests such action for judicial relief.

 

13.8 If either Party commences legal or arbitral proceedings to enforce the
provisions of this Agreement, any arbitration award or the collection of any
judgment, the substantially prevailing Party, as determined by the court or
arbitrator, shall be entitled to recover, in addition to any damages from the
other Party, the reasonable costs incurred in connection with such enforcement
including, but not limited to, attorneys’ fees, expenses and costs of
investigation and litigation or arbitration, as well as the enforcement of any
award or judgment.

 

13.9 Headings. The headings contained in this Agreement do not form a
substantive part of this Agreement and shall not be construed to limit or
otherwise modify its provisions.

 

  33

 

 

13.10 This Agreement constitutes the entire Agreement between the Parties with
respect to the subject matter hereof, and there are no related understandings or
agreements other than those that are expressed herein, and no change of any
provision of this Agreement shall be valid unless it is in writing and is
executed by the Party against whom such change is sought to be enforced. The
Parties recognize that, during the Term of this Agreement, a purchase order,
acknowledgement form or similar routine document (collectively “Forms”) may be
used to implement or administer provisions of this Agreement. Therefore, the
Parties agree that the terms of this Agreement prevail in the event of any
conflict between this Agreement and the printed provisions of such Forms, or
typed provisions of Forms that add to, vary, modify or are at conflict with the
provisions of this Agreement with respect to a Project Plan performed during the
Term of this Agreement. No amendments, changes, additions, deletions or
modifications to or of this Agreement shall be valid unless reduced to writing
and signed by the Parties hereto.

 

13.11 Except where the context otherwise requires, wherever used, the singular
will include the plural, the plural the singular, the use of any gender will be
applicable to all genders, and the word “or” is used in the inclusive sense
(and/or). Whenever this Agreement refers to a number of days, unless otherwise
specified, such number refers to calendar days. The term “including” as used
herein shall be deemed to be followed by the phrase “without limitation” or like
expression. The term “will” as used herein means shall. References to “Section”
and “Schedule” are references to the numbered sections of this Agreement and any
schedules or appendices attached to this Agreement, unless expressly stated
otherwise. Except where the context otherwise requires, references to this
Agreement shall include the schedules and appendices attached to this Agreement
and any later executed Project Plans under this Agreement. The language of this
Agreement shall be deemed to be the language mutually chosen by the Parties and
no rule of strict construction will be applied against either Party hereto.

 

Signatures appear on the following page

 

  34

 

 

IN WITNESS WHEREOF, the respective representatives of the Parties have executed
this Agreement as of the Effective Date.

 

ESPECIFICOS STENDHAL SA DE CV   ADVAXIS, INC.             Carlos Arenas
Wiedfeldt   Daniel J. O’Connor, Esq. CEO   CEO Date:     Date:  

 

  35

 

 

Schedule 4.2

 

MONTHLY REPORT (EXAMPLE)

 

Monthly Report                        

Prompt
Payment
Discount

              Actual
Duties &
Customs
Expenses
in USD  

Packaging
and
Labeling
Cost

  Advaxis
Finished
Product
Production
Cost  

Profit to
be Shared

 

Stendhal’s
Revenue
Share

 

Advaxis
Revenue
Share

Step 1   Step 2   Step 3   Step 4   Step 5   Step 6   Step 7   Step 8   Step 9  
Step 10   Step 11   Step 12   Step 13   Step 14   Step 15   Step 16

Country

 

Date of
Invoice

 

Stendhal’s
Invoice
Number

 

Units
Sold

 

Stendhal’s
Invoice
Unit Price
in LC

 

Total
Invoice
Value
in LC

 

5%
Discounts/

Commercial
Terms

 

Initial Net
Sales

 

Exchange
Rate @
End of the
Month

 

Total
Invoice
Value in
USD

  Actual
Duties &
Customs
Expenses
in USD  

Packaging,
Labeling

 

Finished
Product
Production
Cost

 

Profit to
be Shared

 

75%
Stendhal’s Revenue Share

 

25%
Advaxis
Revenue
Share

*   *   *   *   *   *   *   *   *   *   *   *   *   *   *   * *   *   *   *   *
  *   *   *   *   *   *   *   *   *   *   * *   *   *   *   *   *   *   *   *  
*   *   *   *   *   *   * *   *   *   *   *   *   *   *   *   *   *   *   *   *
  *   * *   *   *   *   *   *   *   *   *   *   *   *   *   *   *   *          
                                      *   *  

*

  *                                                

Result

1

  Result
2   Result
3   Result
4

 

 

* Confidential material redacted and filed separately with the Commission.

 

  36

 

 

Step       1 Country where the sale was performed     2 Date when the invoice
was issued     3 Number of the invoice     4 Number of units sold on the invoice
    5 Unit selling price in local currency     6 Total value of the invoice
without taxes (VAT or similar) in local currency (STEP 4 x STEP 5)     7 Amount
of any Commercial Discount / Terms in local currency     8 Deduct the Commercial
Discount / Terms from the total value of the invoice in local currency (STEP 6
minus STEP 7)     9 Exchange Rate @ the end of the month, last working day of
the month     10 Local currency conversion into USD (STEP 8 divided by STEP 9)  
  11 Total of importation duties, expenses and taxes of the batch imported
divided by the total amount of the batch and times product units sold per
invoice     12 STEP 4 x Stendhal’s Packaging and Labeling Cost     13 Advaxis
Finished Product Production Cost (i.e., the Product transfer price)     14
Profit to be Shared (STEP 10 minus STEP 11, STEP 12 and STEP 13)     15
Stendhal’s Revenue Share     16 Advaxis Revenue Share     Result 1 Total
Finished Production Cost     Result 2 Total Profit to be Shared     Result 3
Total Stendhal Revenue Share     Result 4 Total Advaxis Revenue Share

 

  37

 

 

Schedule 5.1

 

LICENSED PATENTS AND TRADEMARKS

 

Type   Location   Status   App. No.   Publ. No.   Reg. No.   Filing Date   Title
*   *   *   *   *   *   *   * *   *   *   *   *   *   *   *

 

 

* Confidential material redacted and filed separately with the Commission.

 

  38