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MANUFACTURING

SERVICES AGREEMENT

 

THIS AGREEMENT is entered into by and between IDT and ADVAXIS, as of the date
indicated below.

 

Attached to this Agreement, incorporated by reference herein and made an
integral part hereof are the following:

 

PART I: INTRODUCTORY STATEMENT, DEFINITIONS AND VARIABLE TERMS AND CONDITIONS  
  PART II: STANDARD TERMS AND CONDITIONS     PART III: EXHIBITS

 

For and in consideration of the mutual covenants herein contained, and for other
good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged by the Parties, the Parties hereto agree to perform and to be bound
by their respective obligations and shall have the respective rights set forth
in this Agreement.

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of September 8,
2014.

 

IDT   ADVAXIS           IDT Biologika GmbH   Advaxis, Inc.          

By:

/s/ Dr. Ralf firmann   By: /s/ Daniel J O’Connor   Dr. Ralf firmann     Daniel J
O’Connor   CEO     President

 

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Table of Contents

 

PART I: INTRODUCTORY STATEMENT, DEFINITIONS AND VARIABLE TERMS AND CONDITIONS  
3       1. DEFINITIONS   3 2. PERFORMANCE OF SERVICES   10 3. DELIVERY, SHIPMENT
AND STORAGE   13       PART II: STANDARD TERMS AND CONDITIONS   14       4. FEES
AND PAYMENT   14 5. REGULATORY MATTERS   16 6. CHANGES   17 7. AMENDMENTS TO THE
AGREEMENT   18 8. NON-CONFORMING PRODUCTS AND SERVICES   20 9. CONFIDENTIALITY  
22 10. INTELLECTUAL PROPERTY RIGHTS   23 11. WARRANTIES   27 12. INDEMNITY   28
13. INSURANCE   29 14. TERM AND TERMINATION   30 15. DISPUTE RESOLUTION   31 16.
ALLIANCE MANAGERS   32 17. STEERING COMMITTEE     18. MISCELLANEOUS          
PART III: EXHIBITS   36

 

  EXHIBIT A WORK PLAN (SCOPE OF WORK) CONSISTING OF SERVICE FEES, WORK PLAN
SUMMARY, WORK PACKAGES   37   EXHIBIT B QUALITY AGREEMENT   38   EXHIBIT C
EQUIPMENT   39   EXHIBIT D ADVAXIS MATERIALS   40   EXHIBIT E STORAGE FEES   41
  EXHIBIT F FURTHER DEFINITIONS   42   EXHIBIT G: PRODUCT SCOPE   44

 

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PART I: INTRODUCTORY STATEMENT, DEFINITIONS AND VARIABLE TERMS AND CONDITIONS

 

This Agreement sets forth the understanding of the Parties with respect to
ADVAXIS’s project and describes the project-related Services to be performed by
IDT pursuant to the Work Plan, and the ordering and payment procedures for such
Services by ADVAXIS, as well as other matters, all as more specifically set
forth in the terms and provisions of this Agreement.

 

ARTICLE 1: DEFINITIONS

 

1.1 Definitions. The following terms, whether used in the singular or plural,
shall have the meanings assigned to them below for the purposes of this
Agreement. Further definitions to be used in the performance of the Services,
and between the Parties during their relationship hereunder, including but not
limited to Exhibits, Work Packages and Manufacturing Specifications, are set
forth in Exhibit F hereto.

 

  1.1.1 “ADVAXIS” means Advaxis, Inc, and its permitted successors and assigns.
        1.1.2 “ADVAXIS Arising IP” shall have the meaning set forth in Section
9.5.         1.1.3 “ADVAXIS Materials” shall mean the materials as set forth in
Exhibit D hereto and information supplied by or on behalf of ADVAXIS to IDT for
use in connection with the development of the Process and the development and
Manufacture of Product.         1.1.4 “Affiliate” means any corporation,
partnership, or other entity Controlling, Controlled by, or under common Control
with (directly or indirectly) either Party.         1.1.5 “Agreement” means this
Manufacturing Services Agreement including the signature page, Part I -
Introductory Statement, Definitions and Variable Terms and Conditions, Part II -
Standard Terms and Conditions; and Part III - Exhibits, and all amendments to
this Agreement that have been properly executed by the Parties in accordance
with the provisions of Section 6.1.4.         1.1.6 “Alliance Manager(s)” has
the meaning set forth in Section 14.1.         1.1.7 “Amendment Procedures” has
the meaning set forth in Section 6.1.

 

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  1.1.8

“Applicable Law” means: all United States of America, European Union, and German
applicable laws, rules, regulations, guidelines and standards in effect during
performance of this Agreement, including, without limitation, GMP, relating to
the Services, the Product, and the facilities where any Services occur.

        1.1.9 “Arising IP” shall have the meaning set forth in Section 9.5.    
    1.1.10 “Batch” means a lot resulting from a single run of Product
Manufactured by a single execution of the manufacturing instructions specified
in the Master Production Record.         1.1.11 “Business Day” means a day other
than a Saturday or Sunday on which banking institutions in both, Dessau-Rosslau,
Germany and Princeton, New Jersey, USA are open for business.         1.1.12
“Claim” means any claim, personal injury claim, demand, liability (including any
and all liabilities, actions, proceedings, claims and demands), product
liability claim, suits, expenses, action, proceeding, and all damages, losses,
costs and expenses (including without limitation reasonable legal and other
professional adviser’s fees).         1.1.13 “CM Agreement” means the commercial
manufacturing agreement to be negotiated and signed by the Parties in accordance
with the provisions of Section 2.11.         1.1.14 “Confidential Information”
shall have the meaning set forth in Section 8.1.         1.1.15 “Consent” means
the consent or approval, in writing, of an authorized representative of a Party
to do the act or thing for which such consent or approval is solicited, or the
act of granting such written consent or approval, as the context may require,
which consent or approval shall not be unreasonably withheld or delayed.        
1.1.16 “Control” and its derivatives, “Controlling” and “Controlled”, refer to
the possession, directly or indirectly, of the power to direct, or cause the
direction of, the management or policies of either Party, whether through the
ownership of voting securities, by contract or otherwise, including, without
limitation, the ownership of fifty percent (50%) or more of the voting stock of
such Party.         1.1.17 “Defective Product” has the meaning set forth in
Section 7.1.         1.1.18 “Deliverable” means the reports, data and other
deliverables, including Products, to be delivered by IDT to ADVAXIS pursuant to
the Work Packages.         1.1.19 “Delivery” has the meaning set forth in
Section 3.1.

 

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  1.1.20 “Development Product” has the meaning set forth in Section 2.10.      
  1.1.21 “Drug Product” means vials containing the formulated vaccine, unlabeled
and visually inspected. This definition of “Drug Product” includes, in addition
to vials, any other presentation or primary container form of the vaccine for
which ADVAXIS may seek Regulatory Approval.         1.1.22 “Drug Substance”
means the unformulated vaccine contained, for example, in bags or other forms of
primary containers.         1.1.23 “Effective Date” means the date set forth on
the signature page of this Agreement.         1.1.24 “Equipment” has the meaning
set forth in Section 2.7.1.         1.1.25 “Exhibits” mean those documents and
materials attached to this Agreement as Exhibits in Part III hereof,
incorporated in this Agreement by reference and made an integral part hereof.  
      1.1.26 “Final Drug Product” means any form of the vaccine, which can be
sold to the final market, and which may comprise, among others, primary or
secondary container or formulation forms or components, water-for-injection to
reconstitute the vaccine, user information leaflet, blister packaging, paper box
and country-specific packaging identification features.         1.1.27 “First
Regulatory Approval Date” means the date on which the first Regulatory Approval
is granted by any Regulatory Authority for the use, distribution or sale of any
Product in the respective end market, for which such Regulatory Approval has
been granted.         1.1.28 “cGMP” means (a) the current Good Manufacturing
Practice regulations as promulgated by the EU Guidelines for Good Manufacturing
Practice for medicinal products (Eudralex Vol. 4 and Annexes thereto), (b) any
other relevant EU or national legislation and guidance documents, and (c)
current Good Manufacturing Practice regulations promulgated by the FDA published
at 21 CFR Part 210 et seq., as any such above regulation may be amended from
time to time.         1.1.29 “IDT” means IDT Biologika GmbH and its permitted
successors and assigns.         1.1.30 “IDT Production Facilities” means the
Manufacturing facilities of IDT located in Dessau-RoBlau, Germany.        
1.1.31 “Intellectual Property” includes, without limitation, rights in patents,
patent applications, formulae, processes, data, know-how, trademarks, trademark
applications, trade names, Inventions, copyrights, and industrial designs, or
any rights in material derived from any of the foregoing.

 

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  1.1.32 “Invention” means any data, innovation, improvement, development,
discovery, computer program, device, trade secret, method, know-how, process,
technique or the like, whether or not written or otherwise fixed in any form or
medium, regardless of the media on which it is contained and whether or not
patentable or copyrightable, or any material derived from any of the foregoing.
        1.1.33 “Licensee” shall mean any Third Party to which ADVAXIS granted
rights and licenses in and to a Product for commercial use, sale or
distribution, including but not limited to, licensees, partners or joint
developers.         1.1.34 “Manufacture” and “Manufacturing” means all steps and
activities necessary to produce the Product, including, without limitation, the
manufacturing, processing, quality control, quality assurance, testing, release
and storage of the Product in compliance with the terms and conditions of this
Agreement. For purposes of this Agreement and subject to the provisions of
Section 2.10, the aforesaid terms may be included, as required and agreed in
writing by the Parties in such Services as are set forth in the Work Plan.      
  1.1.35 “Manufacturing Specifications” means those specifications as approved
by the Parties in writing for (i) the Manufacturing of the Products or
performance of Services relating to Manufacturing, and (ii) the quality control
of the Product/s and of the required Starting Materials. Said Manufacturing
Specifications are or will be set forth in documents relating to the performance
of the respective Work Package. For the sake of clarity, the term “Manufacturing
Specifications” includes specifications for Services other than Manufacturing.  
      1.1.36 “Master Production Record” means the IDT provided documentation
that contains the detailed description of the Process and instructions for
Product manufacture, as approved by ADVAXIS in writing and as set forth in the
Work Plan and any applicable Work Package.         1.1.37 “Notice” means a
writing containing the information required or permitted by this Agreement to be
communicated by either Party to the other Party, sent by registered or certified
mail, confirmed air courier or telefax to such Party at the address or telefax
number set forth in Section 16.1, as the case may be; the date of registry
thereof or the date of the certification or receipt thereof as evidenced by
postal or air courier records or the date of personal delivery (or refusal
thereof during normal business hours) or the date of telefax answer-back
confirmation being the date of receipt of Notice, provided, however, that any
such writing sent to, and received by, a Party shall constitute Notice for all
purposes of this Agreement. Notwithstanding the foregoing, reports and
communications related to technical aspects of the Services may be sent as
electronic mail using appropriate tools to assure the confidentiality of such
information. “Notify” means the act of giving a Notice.

 

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  1.1.38 “Party” means IDT or ADVAXIS as the context dictates and “Parties”
means both IDT and ADVAXIS.         1.1.39 “Process” means the Manufacturing
process for the Product as provided by ADVAXIS and further developed under this
Agreement.         1.1.40 “Product” means the vaccines set forth in Exhibit G as
amended from time to time, including any variation, presentation or form (i.e.
all bulk drug substance, intermediate stage and final drug forms) of each such
vaccine (i) for use worldwide in clinical trials, or (ii) for commercial use
worldwide.         1.1.41 “Product Specifications for Development Use” means
those specifications set forth in Attachment B to the Quality Agreement, or
alternatively, as a part of Schedule 1 to any respective Work Package,
specifically for Development Products to which said Work Package relates.      
  1.1.42 “Quality Agreement” means the Quality Assurance Framework Agreement,
attached hereto as Exhibit B.         1.1.43 “Rejection Notice” has the meaning
set forth in Section 7.1.         1.1.44 “Regulatory Approval” means (i) any and
all approvals (including any applicable supplements, amendments, pre- and
post-approvals), licenses, registrations, or authorizations of any Regulatory
Authority necessary for the performance of any obligation of IDT or of ADVAXIS,
as the case may be, under this Agreement and (ii) pursuant to application of
ADVAXIS, any such Regulatory Approval for the use, sale or distribution of the
Product in any market of the world.         1.1.45 “Regulatory Authority” means
any national (such as the FDA), supra- national (such as the European Medicines
Agency/EMA and World Health Organization/WHO), or other national,
supra-national, regional, state, or local regulatory agency, department, bureau,
commission, council, or other governmental entity with authority and/or
jurisdiction over any aspect of Product, which among other matters may grant
Regulatory Approval of the Product, including precertification by WHO.        
1.1.46 “Service Fees” means the fees for Services and for all Products Delivered
under this Agreement by IDT pursuant to each Work Package set forth as part of
the Work Plan attached hereto as Exhibit A, and is synonymous with the term
“Work Package Price”.

 

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  1.1.47 “Services” means, generally, any Manufacturing and supply of Product to
ADVAXIS, or other work to be performed by IDT specified under the Work Plan.    
    1.1.48 “Specifications” means those specifications for the Product as set
forth in an appropriate attachment to the Quality Agreement, or alternatively,
as a part of Schedule 1 to any respective Work Package as part of the
Manufacturing Specifications.         1.1.49 “Starting Materials” means any
equipment, process consumables, materials or other tangible property, either
purchased by IDT or, if ADVAXIS Materials, provided by ADVAXIS free of charge,
if any, to be used by IDT in the performance of any Work Package or Manufacture
of Product. The term Starting Materials is used synonymously with the term Raw
Materials.         1.1.50 “Term” has the meaning set forth in Section 13.1 of
this Agreement.         1.1.51 “Third Party” means a person or entity other than
IDT or ADVAXIS or their respective Affiliates.         1.1.52 “Work Plan” means
the initial SOW (Scope of Work) attached hereto as Exhibit A including all
additional Work Packages Consented to by the Parties under this Agreement as the
same are firmly ordered by ADVAXIS, and are to be performed by IDT. Each Work
Package may designate certain Products as “Development Products” that are
subject to the provisions of Section 2.10. The term “Scope of Work (SOW)” is
used synonymously with the term “Work Plan”.         1.1.53 “Work Package” means
the document, Consented to by the Parties, that contains the description of the
work and Services as well as Deliverables of the Parties: With respect to IDT,
for example, but not limited to, Product quantities and Manufacturing
Instructions, Delivery date/s (i.e. release date/s), reports, data and any other
documentation or work results as set forth by the Parties in said Work Package;
and with respect to ADVAXIS, for example, but not limited to, materials,
documentation and approvals to be provided and the respective timelines related
thereto, payment terms and other relevant terms and conditions. Each such Work
Package shall contain the following sections: (i) Title and Date; (ii) Scope,
Summary of Deliverables of both ADVAXIS and IDT; (iii) Performance Timelines;
(iv) Detailed Description of Deliverables by ADVAXIS; (v) Detailed Description
of Services and Deliverables by IDT; (vi) Amendments to this Agreement as
required under and solely intended for the performance of such Work Package, if
any; (vii) Amendments to the Quality Agreement as required and solely intended
for the performance of such Work Package, if any; (viii) Service Fees or prices,
Invoicing, Payment as far as not governed by the prevailing provisions of this
Agreement; and (ix) other terms and conditions.

 

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  1.1.54 “Work Package Value” means the aggregate Service Fees or prices,
including up-charges, to be paid by ADVAXIS to IDT for Services to be performed
by IDT under any Work Package.

 

1.2 Interpretation. The interpretation and construction of this Agreement shall
be subject to the following provisions:

 

  1.2.1 the words “including” and “include” and words of similar effect shall
not be deemed to limit the general effect of the words which precede them such
that “including” means “including without limitation”;         1.2.2 where the
context requires, (i) all pronouns used herein will be deemed to refer to the
masculine, feminine or neuter gender as the context requires, and (ii) the
singular context will include the plural and vice versa;         1.2.3 reference
to any agreement, contract, document or deed shall be construed as a reference
to it as varied, supplemented or amended;         1.2.4 words importing persons
shall include firms, companies and bodies, authorities, corporate and vice
versa; words importing the singular shall include the plural and vice versa;
words importing any one gender shall include either other gender;         1.2.5
construction of this Agreement shall ignore the headings which are for reference
only;         1.2.6 references to a numbered Article, Section, Exhibit or
paragraph are references to the Article, Section, Exhibit or paragraph of or to
this Agreement so numbered;         1.2.7 any reference to any legislative
provision shall be deemed to include any subsequent re-enactment or amending
provision; and         1.2.8 In the event of a conflict between the provisions
of this Agreement and the Quality Agreement regarding any issue not related
solely to a quality practice matter, the provisions of this Agreement shall take
precedence. The provisions of the Quality Agreement will take precedence
regarding any issue solely related to a quality practice matter. For the sake of
clarity, if there is uncertainty as to whether the provisions of this Agreement
or the provisions of the Quality Agreement prevail, any such uncertainty shall
be resolved by giving precedence to the provisions in this Agreement.

 

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  1.2.9 Subject to the provisions of Section 1.2.8, in the event of a conflict
between the provisions of this Agreement and the provision of any Exhibit, the
provisions of this Agreement shall take precedence.

 

ARTICLE 2: PERFORMANCE OF SERVICES

 

2.1 IDT General. During the Term, IDT shall undertake the performance of the
Services in accordance with the Work Plan and the terms and conditions of this
Agreement and Applicable Law.     2.2 Quality Agreement. Subject to the
provisions of Sections 1.2.8 and 2.10, the Quality Agreement attached hereto as
Exhibit B shall govern all quality practice related matters pertaining to each
Party’s obligations under this Agreement.     2.3 ADVAXIS General. ADVAXIS shall
pay the Service Fees as set forth in the Work Plan and its applicable Work
Packages for the Services and perform its obligations in accordance with the
Work Plan and the terms and conditions of this Agreement and Applicable Law.    
2.4 Work Plan. The Parties have given their Consent to the Work Plan attached as
Exhibit A. Said Work Plan and the respective Work Packages included as part
thereof shall constitute a firm and binding order, and may only be amended in a
writing signed by both Parties pursuant to the provisions of Section 6.1.4.
Without prejudice to the definition of Work Package, a detailed description of
all development work required by ADVAXIS, its Affiliates, licensees, permitted
assigns and successors, to apply for and to successfully obtain marketing
registrations for the Product worldwide shall be set forth in said Work Plan,
including, without limitation, phase 3 consistency and validation Batches. The
Parties may from time to time during the Term, amend the Work Plan by mutual
agreement by adding Work Packages to the Work Plan. Each new Work Package added
to the Work Plan shall be Consented to by the Parties and shall be in the form
defined in Section 1.1.53.     2.5 Manufacture Compliance. Subject to the
provisions of Section 2.10 relating to Development Product, all of the
Manufacturing performed by IDT shall be in accordance with: (a) cGMP; (b) the
applicable Specifications; (c) this Agreement; and (d) the Quality Agreement.  
  2.6 Subcontracting. IDT will Manufacture the Product at the IDT Production
Facilities, and may not subcontract any performance of Services without
ADVAXIS’s prior Consent. In the event that, ADVAXIS Consents to any
subcontractor, IDT shall (i) identify each subcontractor in writing in advance
to ADVAXIS; (ii) require the subcontractor to agree in writing to comply with
the applicable provisions of this Agreement and the Quality Agreement, which
shall include written confidentiality obligations at least as stringent as those
set forth in Article 8; (iii) be solely responsible for such subcontractor’s
performance of any part of the Services and any non-compliance by the
subcontractor with the terms of this Agreement or the Quality Agreement; and
(iv) ensure the rights of ADVAXIS to audit such subcontractors in accordance
with this Agreement and the Quality Agreement.

 

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2.7 New Equipment. ADVAXIS and IDT agree that it is not currently contemplated
that any new capital equipment is required by IDT. In the event that, pursuant
to the Work Plan, any new capital equipment is required by IDT in order to
perform the Manufacture or the Services, both ADVAXIS and IDT will negotiate in
good faith and mutually agree upon the terms for procurement of such equipment.
For such new equipment procured, the following provisions shall apply:

 

  2.7.1 The details and costs of said new capital equipment, including the
purchase price of the equipment and ancillary costs relating to installation,
qualification and start-up of said equipment, shall be listed in Exhibit C
(hereinafter referred to as “Equipment”).         2.7.2 ADVAXIS shall be the
owner of said Equipment and reimburse IDT for the costs of said Equipment as
further specified in Exhibit C within thirty (30) days of receipt of an invoice
from IDT for said costs.         2.7.3 During such time period that said
Equipment is the property of ADVAXIS, IDT shall maintain and repair said
Equipment in accordance with said Equipment’s maintenance schedule and IDT’s
standard equipment maintenance and repair procedures. IDT shall provide to
ADVAXIS an estimate of the costs associated with the repair or maintenance of
the Equipment and obtain ADVAXIS’s Consent prior to incurring any
Equipment-related expenses. ADVAXIS shall pay the reasonable costs of such
maintenance and repair within thirty (30) days of receipt from IDT of an invoice
for the same, any such invoice being issued by IDT to ADVAXIS not more often
than quarter-annually.         2.7.4 At the expiration or termination of this
Agreement, the items of said Equipment that are installed as part of an IDT
production line shall be retained and be owned by IDT and IDT shall pay to
ADVAXIS the depreciated book value of said items of Equipment, which payment
shall be made within thirty (30) days after the expiration or termination of
this Agreement. With respect to the items of Equipment that are not so installed
at the expiration or termination of this Agreement in an IDT production line,
the Parties shall mutually agree to either (a) ship to ADVAXIS, at ADVAXIS’s
expense, said items of Equipment; (b) dispose, at ADVAXIS’s expense, of said
items of Equipment, or (c) continue to retain the items of said Equipment as
ADVAXIS property to be used for Manufacturing of the Product in commercial
quantities under the CM Agreement, or (d) pay to ADVAXIS the depreciated book
value of said items of Equipment and thereafter retain and own said items of
Equipment, which payment shall be made within thirty (30) days after the date of
the option notice referenced above.

 

2.8 Facilities/Personnel. At all times during the Term, IDT Production
Facilities used in connection with Manufacturing under this Agreement shall
comply with all Applicable Laws. IDT shall employ such competent personnel with
sufficient knowledge and experience for the performance of Services and
Manufacturing and as are required pursuant to the Work Plan or under Applicable
Law.

 

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2.9 Audits. ADVAXIS shall have the right, upon reasonable advance Notice and
during IDT’s normal business hours, to inspect the IDT Production Facilities
including on-site audit of the facility which will cover those portions of the
IDT Production Facilities used to Manufacture or to perform Services. ADVAXIS
shall also have the right, and IDT shall ensure that ADVAXIS is permitted, to
audit any/all ADVAXIS approved non-IDT laboratories and facilities utilized for
the performance of any Services. Any work or corrective measures specific to
ADVAXIS required to be undertaken by IDT as a consequence or result of such due
diligence audits and quality assurance audits shall be covered by a proposal
from IDT and acceptance by ADVAXIS set forth in a Work Package signed by the
Parties     2.10 Development Product. Certain of the Products are designated in
the Work Plan as “Development Products”. Product resulting from Engineering Runs
shall be considered as Development Product. Notwithstanding any other provision
herein set forth, the following terms and conditions apply to Development
Products:

 

  2.10.1 The Parties acknowledge and agree that due to the nature of the Work
Plan Deliverables relating to any Development Product, IDT cannot and does not
guarantee or warrant, and shall provide no indemnity with respect to, any such
Work Plan Deliverables or any such Development Product. Notwithstanding the
foregoing, IDT warrants that any reports, comprised in the Work Plan
Deliverables, will be materially accurate and complete and not misleading.      
  2.10.2 IDT’s obligation in respect of its performance of any work or Services
in connection with any Development Product is limited to performance of such
work or Services in a diligent manner, with reasonable skill and care applying
its professional standards and using its reasonable endeavors to meet the
estimated timelines and goals set out in the applicable Work Packages.        
2.10.3 cGMP shall not apply to the development, Manufacture, or Product
Specifications for development use or any other aspect of any Development
Product or to any Work Plan Deliverables relating thereto.

 

2.11 Commercial Manufacturing Agreement. Following the execution of this
Agreement, the Parties shall enter into good faith negotiations regarding the
terms and conditions of a commercial manufacturing agreement (“CM Agreement”)
and shall work to execute said CM Agreement by no later than June 30th, 2015.
Neither Party shall have any liability if, despite their respective good faith
efforts, the Parties do not reach an agreement regarding the CM Agreement.

 

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2.12 Capacity Reservation & Advance Payment

 

  2.12.1 Capacity Reservation. IDT shall reserve the necessary resources and
capacities to perform the Services including, without limitation, meeting the
respective Deliverables and timeline obligations as are set forth in the Work
Plan as amended from time to time and in the individual Work Packages contained
therein ordered by ADVAXIS, and pursuant to the provisions of this Agreement.  
      2.12.2 Advance Payment. In consideration of IDT’s resource and capacity
reservation commitment as set forth in Section 2.12.1, ADVAXIS shall pay the
amounts set forth below to IDT pursuant to the following payment schedule:      
  2.12.3 For any additional Work Package ordered by ADVAXIS, ADVAXIS shall pay
to IDT a fee equal to fifty per cent (50%) of said Work Package value as set
forth in an invoice to be issued by IDT to ADVAXIS on the date the Parties
Consent to such Work Package.         2.12.4 The balance of amounts of Service
Fees due by ADVAXIS to IDT shall be paid in the manner and at the time set forth
in the relevant Work Package if therein so provided, or if not provided in said
Work Package, then as set forth in this Agreement.         2.12.5 In the event
that this Agreement is terminated by ADVAXIS pursuant to Sections 13.2 or 13.4,
IDT shall reimburse to ADVAXIS an amount equal to the Service Fees as paid by
ADVAXIS upon orders as set forth in the Work Packages, minus the full value of
the Services invoiced as well as to be invoiced to ADVAXIS for Deliverables
completed by IDT prior to the date of said termination.

 

ARTICLE 3: DELIVERY, SHIPMENT AND STORAGE OF PRODUCT

 

3.1 Delivery. Delivery of each Deliverable shall occur upon completion thereof
as is set forth in the applicable Work Package (“Delivery”). Risk of loss of and
title to each Deliverable shall transfer from IDT to ADVAXIS on Delivery.
Subject to the provisions of Section 2.12, on the date of Delivery, IDT shall
submit an invoice to ADVAXIS for amounts then due pursuant to the Work Package
and the provisions of this Agreement. Payment by ADVAXIS to IDT of said invoiced
amounts shall be made pursuant to the provisions of Sections 5.2 through 5.4.  
  3.2 Delays caused by IDT. If, for reasons under its control, IDT will not be
able to Deliver a Deliverable, as set forth in and being unchanged under the
Work Plan, within two (2) weeks of the date set forth in the applicable Work
Package, IDT shall Notify ADVAXIS in advance, in which event IDT and ADVAXIS,
may reschedule Delivery as soon as possible with IDT making commercially
reasonable efforts to expedite the relevant Work Package by providing a swing
shift, weekend hours, additional personnel, etc. at no charge to ADVAXIS until
the timeline is recovered.

 

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3.3 Shipment. Upon written request from ADVAXIS, IDT shall ship the Product as
specified in the Work Package and in connection therewith render such services
and provide such assistance as are set forth by ADVAXIS or, as applicable, in
accordance with the instructions for shipping and packaging specified in the
applicable Work Package. Each such shipment shall be Ex Works (EXW) IDT
Dessau-Rosslau (Incoterms 2010), unless otherwise agreed by the Parties. ADVAXIS
shall reimburse or pay directly the price as offered by IDT and accepted by
ADVAXIS for insurance, freight, and duties. A bill of lading will be furnished
to ADVAXIS with respect to each shipment of Product. In no event shall IDT’s
liability arising in connection with any shipping services rendered by IDT for
ADVAXIS under this Agreement exceed the fees paid by ADVAXIS for said shipping
services.     3.4 Storage. IDT shall, at ADVAXIS’s request, provide storage of
Product at IDT for at least sixty (60) days after Delivery at no charge to
ADVAXIS. Storage of Product longer than said time period shall be subject to
IDT’s standard storage fees as set forth in Exhibit D hereto, which ADVAXIS
shall pay on a quarter- annual basis within thirty (30) days of receipt of IDT’s
invoice for such fees. IDT shall store the Products as set forth in the
respective Specifications and sampling plans.

 

PART II: STANDARD TERMS AND CONDITIONS

 

ARTICLE 4: REGULATORY MATTERS

 

4.1 ADVAXIS Responsibility. Unless otherwise agreed in writing by the Parties,
ADVAXIS shall be entitled to and have the sole right and responsibility for
filing all documents with applicable Regulatory Authorities and taking any other
actions that may be required or necessary in order to obtain Regulatory Approval
from said Regulatory Authorities for the use of the Product in clinical trials
or in order to obtain marketing authorization for the Product. IDT shall, upon
request provide ADVAXIS with reasonable assistance and cooperation in connection
with making such filings with Regulatory Authorities, to include authoring such
parts of the filing as relate to IDT Production Facilities. IDT shall be
responsible for all communications with any Regulatory Authority or other
governmental authority or agency relating to maintaining facility licensure.    
4.2 Within three (3) Business Days of any contact with, or after receipt of any
communication from, a Regulatory Authority that relate to the Manufacture of the
Product or that portion of the IDT Production Facility used to Manufacture the
Product, each Party shall without undue delay forward to the other Party a copy
or description of the same and shall confer with the other Party with respect to
the best means to comply with any new or modified requirements of such
Regulatory Authority. IDT shall provide ADVAXIS with a copy of all draft
responses for comment as soon as possible, but within the proscribed timelines
from the Regulatory Authority, and shall consider ADVAXIS’s comments in good
faith. ADVAXIS shall submit any comments on said draft responses within five (5)
Business Days or within such longer period of time as agreed by the Parties. IDT
shall also provide ADVAXIS with a copy of all final responses for review and
approval, which shall not be unreasonably withheld or delayed, at least five (5)
Business Days prior to submission thereof, but no longer than the proscribed
timelines from the Regulatory Authority.

 

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4.3. IDT will Notify ADVAXIS of each Batch quality investigation following and
resulting from a deviation resulting from the Manufacture of Product and will
provide ADVAXIS with access to details of said investigation as more
specifically set forth in the Quality Agreement.     4.4 Documents. IDT shall
maintain records of documents, information, data and materials used or generated
in performance of the Manufacture in a professional manner so as to permit
ADVAXIS to review such records in accordance with this Section 4.4 without
disclosing to ADVAXIS any Third Party Confidential Information. Designated
representatives of ADVAXIS shall, at a mutually agreeable time not more often
than once per calendar year, except “for cause” e.g. critical deviations,
negative regulatory inspections and upon reasonable Notice to IDT, have access
to and shall be permitted to review all such records during the term of this
Agreement and during the applicable retention period specified in Section 4.5.
Upon ADVAXIS’s request, IDT will provide to ADVAXIS an inventory of records and
record types pertaining to any Work Package or Services, and upon request, a
copy of any and all such records at ADVAXIS’s expense.     4.5 Document
Retention. Subject to the provisions of Article 8, IDT may retain in its
possession copies of any and all data, documents or information related to the
performance of this Agreement solely as required for regulatory, legal or
insurance purposes. Except as expressly set forth in any SOWs, IDT shall
maintain:

 

  a. all such records that relate in any way to the Product until the latter of
(i) five (5) years after completion of the Work Package and (ii) expiration of
the minimum retention period required by applicable laws, rules and regulations;
and         b. all other records relating to the Services under any Work Package
until the latter of (i) five (5) years after completion of such Work Package;
and (ii) expiration of the minimum retention period required by laws, rules, and
regulations.

 

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  IDT shall not destroy any such records without ADVAXIS’s prior Consent. At
ADVAXIS’s written request, IDT shall continue to maintain any such records
beyond the applicable period specified above, or alternatively, shall transfer
such records to ADVAXIS or its designee, at ADVAXIS’s expense.     4.6
Regulatory Inspections. IDT will permit Regulatory Authorities to conduct
inspections relating to the Services and will cooperate fully in connection with
such inspections. IDT shall Notify ADVAXIS within three (3) Business Days of
receipt from any Regulatory Authority of any notice of inspection which
specifically includes (a) the Products or Services (e.g. pre-approval
inspection); (b) IDT Production Facilities where the Products are being
Manufactured; (c) any warehouse or distribution center where the Products are
stored; or (d) any other facility handling testing, regulatory and development
activities, product complaints or other administrative activities directly
related to the Products. IDT shall allow ADVAXIS, to the extent practicable, to
participate in or observe such inspections if ADVAXIS so chooses, and shall
provide ADVAXIS with copies of all correspondence, reports, results, findings
and other material pertinent to such inspections (including all Form-FDA 483s),
whether oral or written, without undue delay (but in any event within five (5)
Business Days) after they are received, or produced, by or on behalf of IDT from
or to the FDA or any Regulatory Authority in accordance with the Quality
Agreement; provided, however, IDT reserves the right to redact correspondence,
reports, results, findings and other material with respect to other IDT products
and/or proprietary information. For all other regulatory inspections relating
specifically to the Product or Services, e.g. routine GMP inspections, IDT will
Notify ADVAXIS of the results of the inspection.

 

ARTICLE 5: FEES AND PAYMENT

 

5.1 General. Subject to the provisions of Section 2.12 and 3.1 ADVAXIS agrees to
pay to IDT the respective Service Fees/Work Package Value in the amounts and in
accordance with the provisions (i) as set forth in the applicable Work Package;
(ii) if not set forth in said Work Package, then as set forth herein below. Each
such invoice for such Service Fees shall reference this Agreement. In case a
Work Package does not provide for specific details on payments to be made, then
ADVAXIS shall pay any remaining balance of Service Fees due and not paid
earlier, upon IDT’s respective invoice after the last Delivery under such Work
Package.     5.2 VAT and Taxes. The Service Fees/Work Package prices and other
amounts to be paid by ADVAXIS do not include VAT or other taxes to be paid by
ADVAXIS, if any. Notwithstanding the foregoing, IDT agrees that it is
responsible for compliance with German federal, state and local tax requirements
relating to payments made by ADVAXIS to IDT under this Agreement.

 

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5.3 Payment Time. Subject to the provisions of Section 2.12, payment of all
invoices issued by IDT to ADVAXIS shall be made by ADVAXIS to IDT by bank wire
transfer to IDT’s bank account within thirty (30) days following the date of
ADVAXIS’s receipt of each invoice from IDT. ADVAXIS shall be entitled to a two
per cent (2%) discount on all Services Fees/Work Package Prices paid effectively
to IDT’s bank account within fourteen (14) days following the date of ADVAXIS’
receipt of such invoice from IDT.     5.4 Late Payment Fee. ADVAXIS shall have
the right to withhold payment of the portion of any invoice that is disputed in
good faith until such dispute has been resolved. IDT may charge a late fee equal
to the current base rate established by the German Federal Bank plus eight per
cent (8%) annually calculated on a daily basis, on all undisputed amounts past
due under any invoice issued by IDT to ADVAXIS under this Agreement.

 

ARTICLE 6: AMENDMENTS TO THIS AGREEMENT

 

6.1 Amendments. Set forth in this Article 6 are the procedures to be followed by
the Parties in connection with amendments to this Agreement and to its Exhibits,
including, without limitation, the Work Packages (“Amendment Procedures”),
except as may be expressly provided otherwise in this Agreement. For the sake of
clarity, any provisions set forth in other Sections of this Agreement that
modify or amend the Amendment Procedures shall prevail.

 

  6.1.1 The Party desiring an amendment shall send to the other Party a Notice
containing an amendment proposal describing in reasonable detail said amendment
and the reasons for it and including supporting documentation if appropriate or
necessary to understand said amendment (“Amendment Proposal”). Each Amendment
Proposal shall comply with any specific provisions that may be set forth in the
Section of this Agreement under which the Amendment Proposal arises.        
6.1.2 The Party receiving said Amendment Proposal shall respond to it with a
Notice within thirty (30) calendar days from the date of receipt or within such
longer period of time as the Parties mutually agree (“Proposal Response”). Said
Proposal Response shall either accept the Amendment Proposal or set forth
suggestions for changes desired by said receiving Party or reject the Amendment
Proposal, provided, however, that no rejection shall occur unless the receiving
Party has carefully considered the Amendment Proposal and discussed it with the
offering Party.         6.1.3 Each receiving Party will use commercially
reasonable efforts to comply with the request of the offering Party to make the
amendment set forth in the Amendment Proposal received from said offering Party.
Both Parties will negotiate the terms of any such Amendment Proposal in good
faith.

 

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  6.1.4 All amendments, including without limitation any amendment to the
provisions of this Section 6.1, shall be in writing and signed by both Parties
to be valid.

 

6.2 Quality Matters. Notwithstanding the provisions set forth in Section 6.1
above, amendments to the Quality Agreement relating to quality assurance or
quality control shall be made in accordance with the applicable change control
provisions set forth in the Quality Agreement.

 

 ARTICLE 7: NON-CONFORMING PRODUCTS AND SERVICES

 

7.1 Defective Product. Subject to the provisions of Section 2.10, any Product
produced by IDT under this Agreement that does not comply with Section 2.5 at
the time of Delivery of such Product (“Defective Product”) may be rejected by
ADVAXIS pursuant to a Notice sent by ADVAXIS to IDT (“Rejection Notice”) within
thirty (30) days after ADVAXIS’s receipt of the alleged Defective Product and a
copy of all such Batch documentation that is required to be submitted by ADVAXIS
under the applicable Work Package, provided, however, that if the defects are
not evident immediately to ADVAXIS at the time of Delivery, such Notice by
ADVAXIS to IDT shall be made no later than fifteen (15) Business Days after said
discovery by ADVAXIS.     7.2 Evaluation Report. The Rejection Notice shall be
accompanied by a sample of the alleged Defective Product, if feasible. Within
thirty (30) days after receipt of the Rejection Notice, IDT shall undertake an
evaluation of the Defective Product and give to ADVAXIS a written report of the
results of such evaluation. In the event that the Parties disagree upon whether
or not any Product is a Defective Product, such disagreement shall be resolved
as set forth in Section 7.5 of this Agreement.     7.3 Defects Caused by IDT. If
Product is determined to be a Defective Product solely caused by IDT, including,
without limitation, as a result of Starting Materials provided to IDT by its
suppliers for whom IDT is responsible under the applicable provisions of the
Quality Agreement, then IDT shall Manufacture and Deliver, at IDT’s expense, to
ADVAXIS, as soon as commercially reasonable replacement of said Defective
Product in accordance with an amended production plan reasonably agreed to in
writing by the Parties (and, to the extent commercially reasonable, prior to the
time ADVAXIS is obligated to deliver the Product to its customer). If the
Defective Product had already been shipped to ADVAXIS or to a Third Party
designated by ADVAXIS, the replacement of such Defective Product will be shipped
at IDT’s expense. If ADVAXIS has paid for such Defective Product, IDT shall
issue to ADVAXIS a refund or credit, at ADVAXIS’s option, in the amount of the
Service Fees so paid by ADVAXIS. IDT shall be entitled to invoice ADVAXIS for
the Service Fees of the replacement Product, provided that (i) ADVAXIS has
received a refund for the Defective Product, and (ii) the Service Fees of the
replacement Product shall not exceed the Service Fees that had been invoiced by
IDT for the Defective Product, and ADVAXIS shall pay said invoice within thirty
(30) days of receipt thereof. ADVAXIS shall supply IDT, at ADVAXIS’ expense, any
ADVAXIS Material necessary for IDT to Manufacture and Deliver the replacement
Product.

 

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7.4 Defects Caused by ADVAXIS. If Product is rejected by ADVAXIS and is
determined to be Defective Product solely caused by ADVAXIS, including without
limitation, any Product being defective due to ADVAXIS’s provision of incomplete
or inaccurate Specifications or due to improper handling of Product by ADVAXIS,
by any Affiliate of ADVAXIS or by any Third Party or due to any defect in
ADVAXIS Materials used in such Manufacture of Product, being used by IDT in the
performance of the Manufacturing IDT shall Manufacture and Deliver to ADVAXIS,
as soon as commercially reasonable, replacement Product in accordance with an
amended production plan reasonably agreed to by the Parties (and, to the extent
possible, prior to the time ADVAXIS is obligated to deliver the Product to its
customer). ADVAXIS shall be required to pay the Service Fees of the Product
determined to be Defective Product caused solely by ADVAXIS and the Service Fees
of the replacement Product. ADVAXIS shall supply IDT, free of charge, any
ADVAXIS Material necessary for IDT to Manufacture and Deliver the replacement
Product.     7.5 Expert. If the Parties cannot agree as to whether Product is
Defective Product within thirty (30) days after delivery of the aforesaid IDT
evaluation report to ADVAXIS, the Parties shall submit the relevant materials to
a mutually agreed upon independent testing laboratory or other appropriate
expert acceptable to the Parties (“Expert”) for evaluation. The Parties shall
cooperate fully and without undue delay with the Expert’s reasonable requests
for assistance or information in connection with its evaluation hereunder.
Within thirty (30) days thereafter, the Expert shall determine whether the
Products are Defective Products and, if possible, the cause of the defect as
soon as reasonably possible. The findings of the Expert shall be final, binding
and determinative on the Parties, absent manifest error. In the event the
Parties fail to agree on the choice of the Expert, the International Chamber of
Commerce in Zurich shall be asked to select an appropriate Expert, and the
decision of the ICC will be binding on the Parties. In the event the Expert is
unable to determine the cause of the defect, the matter shall be treated as a
dispute and may be referred by either Party for resolution pursuant to the
provisions of Article 15.     7.6 Expenses of Expert. The expenses of the
Expert(s) shall be borne by IDT if the Expert(s) determines that the defect in
the Product was caused by IDT. If the Expert(s) determines that ADVAXIS caused
the defect in the Product, ADVAXIS shall pay for the expenses of the Expert(s).
If the Expert is unable to determine the cause of the defect, the Parties shall
split the expenses of the Expert(s).     7.7 Defect Resolution. Both Parties
shall employ commercially reasonable efforts to resolve any issues or disputes
associated with a Defective Product.

 

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7.8 Sole Remedy for Defective Product. Without limiting the indemnity
obligations under Article 11, the remedies for Defective Product caused by IDT
pursuant to this Article 7 shall be the sole and exclusive remedies for the
replacement of nonconforming Product available to ADVAXIS, to any Affiliate of
ADVAXIS or to any Third Party.     7.9 Recall. Each Party shall give Notice to
the other Party immediately upon learning of any event that would be expected to
give rise to a recall of Product or other corrective measure related to the
Product. ADVAXIS shall be responsible for all such recalls and actions, provided
that IDT shall fully cooperate in the same. All costs of a Product recall or
other corrective measure related to the Product shall be the sole responsibility
of ADVAXIS except to the extent such recall is due to Defective Product caused
by IDT under the provisions of Section 7.3 above, in which event IDT shall also
be liable for the direct costs of said recall. Direct costs under this Section
7.9 shall mean and are limited to costs of transport, destruction of Defective
Product, travel and communication services for the handling of the recall and
corrective measures. Product recalls shall be handled in accordance with the
provisions addressing recalls as set forth in the Quality Agreement.

 

ARTICLE 8: CONFIDENTIALITY AND NON-USE

 

8.1 Defined. As used in this Agreement, the term “Confidential Information”
shall mean all information disclosed in writing or by oral communications by
either Party to the other Party under this Agreement including any information
relating to the Product, the Manufacturing Specifications, formulations and
compositions; scientific know-how; chemical compound, biological material and
composition data; Manufacturing processes; analytical methodology; Product
applications including safety and efficacy data; current and future Product and
marketing plans and projections; and other information of a technical or
economic nature related to the Product, the Manufacture of the Product and the
matters set forth in any Work Plan. The existence and content of this Agreement
shall also be considered Confidential Information of both Parties.     8.2
Limited Disclosure. All Confidential Information disclosed hereunder shall
remain the property of the disclosing Party and shall be maintained in
confidence and not disclosed by the receiving Party to any person except to
officers, employees, and consultants to whom it is necessary to disclose the
information for the purpose specified above. Each Party shall take all steps it
would normally take to protect its own Confidential Information to ensure that
the received Confidential Information shall be maintained in confidence and not
disclosed, but not less than reasonable care.     8.3 Use. Unless otherwise
agreed in writing, all Confidential Information disclosed hereunder shall be
used by that Party only to fulfill its obligations under this Agreement.

 

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8.4 Exceptions. The obligations of the Parties under this Article 8 shall not
apply to:

 

  8.4.1 Information which, at the time of disclosure, is in the public domain or
thereafter comes into the public domain other than as a result of breach of this
Agreement; or         8.4.2 Information which the receiving Party can establish
by contemporaneous written evidence was in its possession at the time of
disclosure by the disclosing Party; or         8.4.3 Information which was
received by the receiving Party from an Affiliate or from a Third Party not
under an obligation of confidentiality towards the disclosing Party; or        
8.4.4 Information which the receiving Party can establish by contemporaneous
written evidence was independently developed without use or reference to
Confidential Information received hereunder.

 

8.5 Mandatory Disclosure. Notwithstanding the limitations above, each Party may
disclose Confidential Information belonging to the other Party to the extent
such disclosure is required by mandatory legal provisions, provided, however, in
the event a Party is required to make a disclosure of the other Party’s
Confidential Information pursuant to this Section 8.5, it will give reasonable
advance Notice to the other Party of such disclosure obligation with sufficient
time for such other Party to seek a protective order and will endeavor in good
faith to limit the extent of such disclosure and to to cooperate with the other
Party’s attempt to obtain such protective order or confidential treatment.    
8.6 Return. Upon termination of this Agreement, each Party agrees to return to
the other Party or destroy, at such other Party’s election, all written or other
physical embodiments of the other Party’s Confidential Information, except for
one (1) copy, which may be retained in a confidential manner exclusively for
legal archival purposes. The obligations under this Article 8 shall be binding
on any Affiliate, successor or assignee of IDT or ADVAXIS as if it was a Party
to the Agreement.     8.7 Duration. The obligations of confidentiality and
non-use of the Confidential Information under this Agreement shall continue
throughout the Term of this Agreement and shall survive the termination or
expiration of this Agreement for ten (10) years.

 

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ARTICLE 9: INTELLECTUAL PROPERTY RIGHTS

 

9.1 Ownership. All Intellectual Property owned or controlled by IDT which
relates to IDT’s business and not to the Products or any of ADVAXIS’s
Intellectual Property shall remain the property of IDT. All Intellectual
Property owned or controlled by ADVAXIS shall remain the property of ADVAXIS.
For the sake of clarity, the Process and the Master Production Record are hereby
the sole and exclusive property of ADVAXIS.     9.2 License to IDT. ADVAXIS
grants to IDT a non-exclusive, royalty-free, license to use such of ADVAXIS’s
Intellectual Property that ADVAXIS provides to IDT to perform the Services under
this Agreement. The duration of said license shall be for the Term of this
Agreement. In no event shall IDT be permitted to use ADVAXIS’s Intellectual
Property for any other purpose or for any other customer of IDT without the
prior Consent of ADVAXIS.     9.3 IDT Intellectual Property and Third Party
Intellectual Property. IDT shall not incorporate any of its IDT Intellectual
Property or Third Party Intellectual Property into the Process or Master
Production Record without the prior Consent of ADVAXIS.     9.4 IDT’s
Proprietary Intellectual Property. IDT hereby agrees to use such of IDT’s
Intellectual Property as is required in order to perform the Services under this
Agreement. Said use shall be on a non-exclusive, royalty-free basis and only for
the Term of this Agreement. IDT hereby grants to ADVAXIS an irrevocable, fully
paid, non-exclusive worldwide license, with the right to grant and authorize
sublicenses through multiple layers of sub-licensees, under any and all IDT
Intellectual Property including without limitation any Arising IP that IDT
incorporates pursuant to this Agreement and with the prior Consent of ADVAXIS
into the Master Production Record or into the Specifications, to make, have
made, use, have used, sell, offer for sale, have sold, import, have imported,
export, have exported, develop, have developed, commercialize, and have
commercialized any product.     9.5 Inventions. Any Intellectual Property that
shall be created or conceived by IDT as a result of, or be derived from, the
performance of the Services under this Agreement that is not ADVAXIS Arising IP
and to the extent that it relates solely to any IDT Manufacturing processes of
general applicability or to any other IDT Intellectual Property or IDT’s
Confidential Information, which can be used without reference to the Products or
ADVAXIS Confidential Information shall be owned by and be the sole and exclusive
property of IDT (“Arising IP”). Any Arising IP relating to the Product or
relating to, based on, or incorporating any other ADVAXIS Intellectual Property
or ADVAXIS Confidential Information is hereby the sole and exclusive property of
ADVAXIS (“ADVAXIS Arising IP”).     9.6 Other Acts. Each Party shall undertake
all necessary or appropriate acts, including without limitation signing
assignment, divisionalization or other documents to give effect to the
provisions of this Article 9. IDT covenants to take all reasonable actions
necessary to obtain all right, title and interest in and to any and all
Inventions related to this Agreement that are conceived or reduced to practice
by any of its employees or contractors including negotiation of any necessary
agreement and payment of all amounts advisable or required under Applicable Law.

 

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ARTICLE 10: WARRANTIES

 

10.1 IDT warrants that:

 

  10.1.1 IDT has the power, authority and legal right to enter into this
Agreement and to perform its obligations hereunder. This Agreement has been duly
executed and delivered on behalf of IDT, and constitutes a legal, valid, binding
obligation, enforceable against IDT in accordance with its terms.         10.1.2
All necessary licenses, permits, consents, approvals and authorizations of all
Regulatory Authorities required to be obtained by IDT in connection with this
Agreement have been obtained or will be obtained as required prior to
undertaking the Services. IDT shall adhere to all Applicable Laws in the
performance of the Services         10.1.3 The Intellectual Property, if any,
utilized by IDT, in connection with the performance of the Services to the
knowledge of IDT, (i) may be lawfully used in connection therewith, and (ii)
such use does not knowingly infringe any Third Party rights.         10.1.4 IDT
has the necessary facilities, equipment, know-how and personnel to carry out the
Services in accordance with this Agreement.         10.1.5 Subject to the
provisions of Section 2.10, any Product Manufactured by IDT pursuant to this
Agreement other than Development Product, at the time of Delivery conforms to
the requirements of Section 2.5.         10.1.7 Neither IDT nor any of its
officers, directors, agents, Affiliates, employees or subcontractors rendering
services under this Agreement has been or is currently under investigation by
the FDA for debarment action; or was or is presently debarred pursuant to
Section 306 of the United States Food Drug and Cosmetic Act. In addition, IDT
represents and warrants (i) that it has not been convicted of a crime related to
health care; and (ii) that it is not listed by a federal agency as debarred,
excluded or otherwise ineligible for participation in federally funded programs.
IDT shall notify ADVAXIS immediately upon any inquiry or the commencement of any
such investigation or proceeding or of any circumstance that would cause the
foregoing statements under this Section 10.1.7 to become false or inaccurate.

 

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10.2 ADVAXIS warrants that:

 

  10.2.1 ADVAXIS has the power, authority and legal right to enter into the
Agreement and to perform its obligations hereunder. This Agreement has been duly
executed and delivered on behalf of ADVAXIS, and constitutes a legal, valid,
binding obligation, enforceable against ADVAXIS in accordance with its terms.  
      10.2.2 All necessary licenses, permits, consents, approvals and
authorizations of all Regulatory Authorities required to be obtained by ADVAXIS
in connection with this Agreement have been obtained or will be obtained as
required prior to undertaking Manufacturing. ADVAXIS shall adhere to all
Applicable Laws.         10.2.3 The Intellectual Property provided by ADVAXIS,
in connection with the Manufacturing to the knowledge of ADVAXIS, (i) may be
lawfully used in connection with such Manufacture, and (ii) such use does not
infringe any Third Party rights.         10.2.4 Neither ADVAXIX nor any of its
officers, directors, agents, Affiliates, employees or subcontractors rendering
services under this Agreement has been or is currently under investigation by
the FDA for debarment action; or was or is presently debarred pursuant to
Section 306 of the United States Food Drug and Cosmetic Act. In addition,
ADVAXIS represents and warrants (i) that it has not been convicted of a crime
related to health care; and (ii) that it is not listed by a federal agency as
debarred, excluded or otherwise ineligible for participation in federally funded
programs. ADVAXIS shall notify IDT immediately upon any inquiry or the
commencement of any such investigation or proceeding or of any circumstance that
would cause the foregoing statements under this Section 10.2. to become false or
inaccurate.

 

THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 10 ABOVE AND
ELSEWHERE IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND
WARRANTIES NOT EXPRESSLY SET FORTH HEREIN AND EACH PARTY HEREBY EXPRESSLY
DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES OF ANY KIND,
EXPRESSED OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WITHOUT LIMITATION THE
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.

 

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10.3 LIMITATION OF LIABILITY. With respect to any damages owed by a Party to the
other Party or to any Affiliate of the other Party or to any Third Party
resulting from a breach by said Party of its obligations under this Agreement,
the following provisions shall apply:

 

  10.3.1 IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR SPECIAL, INDIRECT
(INCLUDING WITHOUT LIMITATION LOSS OF PROFIT), INCIDENTAL OR CONSEQUENTIAL
DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL
THEORY WHETHER OR NOT THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH LOSS OR DAMAGE HOWEVER CAUSED.         10.3.2 FOR ANY CLAIM BASED ON ANY
LEGAL THEORY OTHER THAN ALLEGED GROSS NEGLIGENCE, IDT’S MAXIMUM DIRECT AND
INDIRECT LIABILITY FOR ANY SINGLE CLAIM WHICH IS BEYOND AMOUNTS PAID BY ONE OR
MORE OF IDT’S INSURERS AND WHICH IS BROUGHT UNDER THIS AGREEMENT BY ADVAXIS, BY
ANY AFFILIATE OF ADVAXIS AND/OR BY ANY THIRD PARTY SHALL NOT EXCEED, DIRECTLY OR
INDIRECTLY, AN AMOUNT WHICH EQUALS FIFTY PER CENT (50%) OF THE SERVICE FEES
RECEIVED BY IDT FOR THE PERFORMANCE OF THE SERVICES UNDER THE WORK PACKAGE
RELATED TO SUCH CLAIM, PROVIDED THAT IDT’S MAXIMUM AGGREGATE LIABILITY FOR ALL
SUCH CLAIMS WHICH ARE BEYOND AMOUNTS PAID BY ONE OR MORE OF IDT’S INSURERS AND
WHICH ARE BROUGHT UNDER THIS AGREEMENT BY ADVAXIS, BY ANY AFFILIATE OF ADVAXIS
AND/OR BY ANY THIRD PARTY SHALL NOT EXCEED, DIRECTLY OR INDIRECTLY, AN AMOUNT
WHICH EQUALS FIVE PER CENT (5%) OF THE AGGREGATE SERVICE FEES FOR THE
PERFORMANCE OF THE SERVICES RECEIVED OR TO BE RECEIVED IN THE CALENDAR YEAR TO
WHICH ANY SUCH CLAIM OR GROUP OF CLAIMS UNDER THIS SECTION 10.3.2 RELATES. THE
DELIVERY DATE OF THE PRODUCT OR OTHER DELIVERABLE SHALL DETERMINE THE YEAR TO
WHICH ANY RESPECTIVE CLAIM RELATES.

 

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  10.3.3 FOR ANY CLAIM BASED ON ALLEGED GROSS NEGLIGENCE, IDT’S MAXIMUM DIRECT
AND INDIRECT LIABILITY FOR ANY SINGLE CLAIM WHICH IS BEYOND AMOUNTS PAID BY ONE
OR MORE OF IDT’S INSURERS AND WHICH IS BROUGHT UNDER THIS AGREEMENT BY ADVAXIS,
BY ANY AFFILIATE OF ADVAXIS AND/OR BY ANY THIRD PARTY SHALL NOT EXCEED, DIRECTLY
OR INDIRECTLY, AN AMOUNT WHICH EQUALS ONE HUNDRED AND FIFTY PER CENT (150%) OF
THE SERVICE FEES RECEIVED BY IDT FOR THE PERFORMANCE OF THE SERVICES UNDER THE
WORK PACKAGE RELATED TO SUCH CLAIM, PROVIDED THAT IDT’S MAXIMUM AGGREGATE
LIABILITY FOR ALL SUCH CLAIMS WHICH ARE BEYOND AMOUNTS PAID BY ONE OR MORE OF
IDT’S INSURERS AND WHICH ARE BROUGHT UNDER THIS AGREEMENT BY ADVAXIS, BY ANY
AFFILIATE OF ADVAXIS AND/OR BY ANY THIRD PARTY SHALL NOT EXCEED, DIRECTLY OR
INDIRECTLY, AN AMOUNT WHICH EQUALS FIFTEEN PER CENT (15%) OF THE AGGREGATE
SERVICE FEES FOR THE PERFORMANCE OF THE SERVICES RECEIVED OR TO BE RECEIVED BY
IDT IN THE CALENDAR YEAR TO WHICH ANY SUCH CLAIM OR GROUP OF CLAIMS UNDER THIS
SECTION 10.3.3 RELATES. THE DELIVERY DATE OF THE PRODUCT OR OTHER DELIVERABLE
SHALL DETERMINE THE YEAR TO WHICH ANY RESPECTIVE CLAIM RELATES.         10.3.4
THE LIABILITY LIMITATION PROVISIONS SET FORTH IN SECTIONS 10.3.2 AND 10.3.3
SHALL NOT APPLY TO CLAIMS BASED ON ALLEGED WILLFUL MISCONDUCT BY IDT.        
10.3.5 For avoidance of doubt, payments made by any insurance provider shall not
be included among IDT’s liability payments for purposes of determining whether
the liability limitation herein has been reached, provided, however, that IDT
shall not be liable for any part of any claim that is paid by insurance
proceeds.         10.3.6 Notwithstanding any other provision in this Agreement,
for the sake of clarity, the Parties expressly agree that any liability
limitation in this Agreement will not limit potential recovery from any insurer
of IDT for losses covered by policies issued by such insurer which are incurred
in connection with Claims. The scope and extent of liability for IDT’s insurers
shall be governed exclusively by the terms and limitations of the policies
issued by such insurers.         10.3.5 The Parties’ respective liability shall
be further limited as provided in Sections 12.3 and 12.4.         10.3.6 Except
for Claims based on IDT’s willful misconduct, ADVAXIS expressly agrees that
ADVAXIS will be liable for, and indemnify IDT against, all Claims of ADVAXIS, of
any Affiliate of ADVAXIS and of any Third Party not satisfied by IDT’s insurance
and/or by IDT’s limited liability set forth in this Section 10.3 above.

 

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ARTICLE 11: INDEMNITY

 

11.1 ADVAXIS’s Indemnity. ADVAXIS shall indemnify, defend and hold harmless IDT
(except to the extent IDT is obligated to indemnify ADVAXIS as set forth below)
from and against all Claims asserted by a Third Party to the extent arising out
of:

 

  11.1.1 the distribution, marketing, sale, and/or use of any Deliverable or any
Product, including without limitation, the use of any such Deliverable or
Product in any clinical trials; or         11.1.2 any breach by ADVAXIS of its
representations, warranties, covenants or obligations under this Agreement; or  
      11.1.4 ADVAXIS’s willful misconduct or negligence.

 

11.2 IDT’s Indemnity. Subject to the provisions of Section 2.10, IDT shall
indemnify, defend and hold harmless ADVAXIS and ADVAXIS’s Affiliates (except to
the extent ADVAXIS is obligated to indemnify IDT as set forth above) against all
Claims asserted by a Third Party to the extent arising out of:

 

  11.2.1 Any failure of Product supplied by IDT hereunder to conform to the
requirements of Section 2.5 at Delivery;         11.2.2 any breach by IDT of its
representations, warranties, covenants or obligations under this Agreement; or  
      11.2.3 IDT’s willful misconduct or negligence.

 

11.3 Procedures. The Party seeking indemnification (“Indemnified Party”)
pursuant to this Article 11 shall promptly provide Notice to the indemnifying
Party (“Indemnifying Party”) of such Claim in reasonable detail, provided that
the failure to provide such Notice shall not affect the obligations of the
Indemnifying Party unless and only to the extent said Indemnifying Party is
actually materially prejudiced thereby. The Indemnified Party shall furnish
promptly to the Indemnifying Party copies of all papers and official documents
received in respect of any Claim. Commencing within thirty (30) days after
receipt of the aforesaid Notice, the Indemnifying Party shall undertake, conduct
and control, through counsel of its own choosing (but reasonably acceptable to
the Indemnified Party) and at its own expense, the settlement or defense of the
Claim, provided that the Indemnified Party may participate in such settlement or
defense through counsel chosen by the Indemnified Party and reasonably
acceptable to the Indemnifying Party. The Indemnifying Party shall not, without
the Consent of the Indemnified Party, settle or compromise any Claim, which
requires payment or admits fault of the Indemnified Party. The Indemnifying
Party and the Indemnified Party shall cooperate fully, at the Indemnifying
Parly’s expense, in all aspects of any investigation, defense, pre- trial
activities, trial, compromise, settlement or discharge of any Claim in respect
of which indemnity is sought pursuant to this Article 11, including, but not
limited to, providing the other Party with reasonable access to employees and
officers (including as witnesses) and other information.

 

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ARTICLE 12: INSURANCE

 

12.1 ADVAXIS General. ADVAXIS will either (i) maintain, at all times during the
term of this Agreement and for three (3) years thereafter, which such three (3)
year period may be satisfied with any combination of renewal policies, policy
term extensions or an extended reporting period, a products liability insurance
policy, with a per occurrence and aggregate limit of at least Ten Million
Dollars ($10,000,000), with a reputable, internationally operating insurance
company, or alternatively, (ii) certify to IDT that ADVAXIS is self-insured.
ADVAXIS will provide IDT with at least thirty (30) days’ Notice prior to
termination of, or reduction in coverage under, such insurance.     12.2 IDT
General. IDT will maintain, at all times during the term of this Agreement and
for three (3) years thereafter, a liability insurance policy, with a per
occurrence limit of at least Ten Million Dollars US ($10,000,000) (or Euro
equivalent) and an aggregate limit of at least Twenty Ten Million US Dollars
($20,000,000) (or euro equivalent) and, upon request by ADVAXIS will provide a
certificate of insurance to ADVAXIS. IDT will provide ADVAXIS with at least
thirty (30) days’ Notice prior to termination of or reduction in coverage under
such IDT Insurance Policy. IDT’s insurance shall be primary and not excess or
contributory with ADVAXIS’ insurance.     12.3 IDT’s Obligation. IDT shall use
commercially reasonable efforts to maintain in force the insurance coverage
referenced in Section 12.2 above, provided, however, that IDT shall have no
liability in the event that its insurance provider reduces, cancels or denies
any such insurance coverage. In the event that IDT is not able to procure or
maintain the amount of insurance coverage as set forth in Section 12.2, IDT
shall inform ADVAXIS without undue delay.     12.4 ADVAXIS’s Obligation. ADVAXIS
shall use commercially reasonable efforts to maintain in force the insurance, or
alternatively, self-insurance, coverage referenced in Section 12.1 above,
provided, however, that ADVAXIS shall have no liability in the event that its
insurance provider reduces, cancels or denies any such insurance coverage. In
the event that ADVAXIS is not able to procure or maintain the amount of
insurance coverage as set forth in Section 12.1, ADVAXIS shall inform IDT
without undue delay.

 

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  ARTICLE 13: TERM AND TERMINATION

 

13.1 Term. This Agreement shall commence on the Effective Date and shall remain
in full force and effect for an initial period of (i) eighty four (84) months
after the First Regulatory Approval (“Initial Term”), provided, however, that at
the end of each consecutive twelve (12) month period after said First Regulatory
Approval Date, the term of this Agreement shall be automatically extended by
another rolling twelve (12) month period (“Renewal Term”), unless either Party
shall have given at least thirty-six (36) months advance Notice to the other
Party of termination of this Agreement at the expiration of the Initial Term or
of the latest Renewal Term. The Initial Term and the Renewal Terms are herein
called the “Term”. The Term may be terminated early as provided in Sections
13.2, 13.3 and 13.4. Notwithstanding the foregoing, in the event that no First
Regulatory Approval Date occurs within thirty-six (36) months after the
Effective Date, this Agreement shall terminate automatically at the end of said
thirty-six (36) months period.   13.2 Early Termination by ADVAXIS. ADVAXIS may
terminate this Agreement or a Work Plan in whole or in part at any time with a
prior Notice of termination in the event that:

 

  13.2.1 Termination for Default. IDT defaults in the performance of any
material obligation set forth in this Agreement and fails to cure said default
within sixty (60) days (unless extended by ADVAXIS in its sole discretion) after
IDT receives a Notice from ADVAXIS specifying the basis for default.        
13.2.2 Insolvency. In the event IDT enters into bankruptcy proceedings (whether
voluntary or involuntary) or proceedings leading to bankruptcy, IDT agrees to
send to ADVAXIS a Notice setting forth the details of such event. This Notice
shall be furnished within ten (10) days of the initiation of the proceedings
relating to the bankruptcy. This obligation remains in effect until final
payment under this Agreement. Bankruptcy or insolvency is deemed to be a
material breach of this Agreement and may, at the sole discretion of ADVAXIS,
constitute the basis for a termination for default without further Notice.

 

13.3 Early Termination by IDT. IDT may terminate this Agreement in whole or in
part at any time with a prior Notice of termination, in the event that:

 

  13.3.1 Termination for Default. ADVAXIS defaults in the performance of any
material obligation set forth in this Agreement and fails to cure said default
within sixty (60) days (unless extended by IDT in its sole discretion) after
ADVAXIS receives a Notice from IDT specifying the basis for default.        
13.3.2 Insolvency. In the event ADVAXIS enters into bankruptcy proceedings
(whether voluntary or involuntary) or proceedings leading to bankruptcy, ADVAXIS
agrees to send to IDT a Notice setting forth the details of such event. This
Notice shall be furnished within ten (10) days of the initiation of the
proceedings relating to the bankruptcy. This obligation remains in effect until
final payment under this Agreement. Bankruptcy or insolvency is deemed to be a
material breach of this Agreement and may, at the sole discretion of IDT
constitute the basis for a termination for default without further Notice.

 

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  Execution Counterpart     13.4 Other Termination. Either Party may terminate
this Agreement upon Notice to the other Party, if either Party is not able to
procure or maintain its respective amount of insurance coverage as set forth in
Sections 12.3 or 12.4 or 16.10.5, as the case may be.

 

13.5 Effects of Termination

 

  13.5.1 Accrued Rights. Termination of this Agreement for any reason will be
without prejudice to any rights that have accrued to the benefit of a Party
prior to such termination. Such termination will not relieve a Party of
obligations that are expressly indicated to survive the termination of this
Agreement.         13.5.2 Disposition of Remaining ADVAXIS Materials and
Confidential Information. Upon termination or expiration of this Agreement, IDT
will store any remaining ADVAXIS Materials and, at ADVAXIS’s option, return or
destroy any ADVAXIS Confidential Information in the possession or control of
IDT. Likewise, ADVAXIS will, at IDT’s option, return or destroy any IDT
Confidential Information in the possession or control of ADVAXIS.

 

13.6 No Liability. Neither Party shall incur any liability whatsoever for any
damage, loss or expense of any kind suffered or incurred by the other (or for
any compensation to the other) arising from or incident to any termination of
this Agreement which complies with the terms of this Agreement whether or not
such Party is aware of any such damage, loss or expense.     13.7 Survival of
Certain Provisions. Termination or expiration this Agreement for any reason
shall not affect the rights, obligations and responsibilities of the Parties
pursuant to Sections 2.10 and 2.12 and Articles 7, 8, 9, 10, 11, 12, 13, 15 and
16 all of which survive any termination, along with any additional terms in this
Agreement necessary to give effect to such provisions.

 

ARTICLE 14: ALLIANCE MANAGER(S)

    

14.1 Alliance Managers. Each Party shall, in writing, appoint one or more
managers (“Alliance Manager(s)”) to serve as its point of contact for
communications between the Parties on matters arising under this Agreement.    
14.2 Responsibility. Each Party’s Alliance Manager(s) shall be primarily
responsible for reporting to the other Party’s Alliance Manager(s) on the
progress of the activities for which said Party is responsible as set forth in
the Work Plan and each Alliance Manager shall in general provide the opportunity
to exchange views and to discuss issues in relation to IDT’s and ADVAXIS’s
obligations under this Agreement.

 

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  Execution Counterpart     14.3 Meetings. The Alliance Managers from IDT and
ADVAXIS shall meet in person or by video or telephone conference not less than
once every calendar month during the Term of this Agreement. Written minutes
shall be kept of each meeting between the Alliance Managers from IDT and
ADVAXIS.     ARTICLE 15: DISPUTE RESOLUTION     15.1 Dispute Resolution
Procedures. All disputes arising under or related to this Agreement shall be
asserted pursuant to a Notice. The Notice must thoroughly describe the basis for
the claim.

 

  15.1.1 Senior Executives. The Parties, through appropriately appointed
representatives, who are authorized to resolve the dispute on behalf of their
respective companies, shall first meet and attempt to resolve the dispute in
face-to-face or telephonic negotiations. This first attempt at resolution shall
occur within thirty (30) days of the time that one Party gives Notice of such
dispute. If no resolution is reached through the representatives within thirty
(30) days of the first attempt to resolve the dispute, each Party is entitled to
have the dispute be resolved by binding arbitration before a panel of three (3)
arbitrators (one arbitrator chosen by each of the Parties and the third
arbitrator chosen by the first two). The Parties agree that the Arbitration
shall take place only before the International Chamber of Commerce (and no other
tribunal) and shall be under the rules of procedure of the ICC in conjunction
with the Convention on the Recognition and Enforcement of Foreign Arbitral
Awards (the “New York Convention”). The Arbitration shall be conducted under the
ICC Rules of Arbitration then in effect.         15.1.2 Venue. The venue for any
arbitration under this Article shall be New York, New York and the language of
the proceedings (including all documentation) shall be in English.        
15.1.3

Damages. Damages shall be governed by the limitation of liability

clause in Section 10.3.

        15.1.4 Discovery. In any arbitration hereunder, subject to contrary
direction by the arbitrator if, in his, her, or their judgment particular
circumstances require broader pre-hearing disclosures and investigation,
discovery prior to hearing shall presumptively be limited to one institutional
deposition per side and to advance disclosure of witnesses that each side
expects to call at the hearing and of all documents and other tangible things
that each side expects to offer in evidence at the hearing, excluding only those
materials that are expected to be used solely for purposes of impeachment.

 

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  15.1.5 Final Judgment. The Parties irrevocably agree that a final judgment in
any arbitration proceeding relating to this Agreement shall be conclusive
(except for manifest error) and shall be enforceable in any court having
jurisdiction thereof, provided, however, that the arbitrators shall not have
authority to alter any explicit provision of this Agreement.       ARTICLE 16:
MISCELLANEOUS

 

16.1 Notices. Notices shall be sent:      

If to IDT:

 

IDT Biologika GmbH

Attn: CEO

Am Pharmapark

D-06861 Dessau-Rosslau

Germany

Fax: +49 (0) 34901 885 323

     

If to ADVAXIS:

 

ADVAXIS Inc.

Attn.: Daniel J. O’Connor, President & CEO

305 College Road East

Princeton, NJ 08540

Phone: 609-452-9813

Fax: 609-452-9818

 

or to such other address as the addressee shall have last furnished in writing
to the addressor.

 

16.2 Severability. In the event that any provision of this Agreement is
judicially determined to be void or unenforceable, and such provision is
construed to be severable from the other provisions of this Agreement, the other
provisions of this Agreement shall remain in full force and effect.
Notwithstanding the foregoing, if a provision is judicially determined to be
void or unenforceable and that provision is essential to the purpose of the
Agreement such that separating that provision from the Agreement would frustrate
the original purpose of the Agreement, then there shall be no separation and the
entirety of the Agreement shall be deemed void and unenforceable.

 

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16.3 Special Transactions.

 

  16.3.1 For purposes of this Section 16.3, (a) the assignment, by either Party
of its rights and obligations under this Agreement to an Affiliate or, as part
of a merger, consolidation, or a sale of all or substantially all of such
Party’s assets, to a Third Party, (b) the sale by ADVAXIS to a Third Party of
all of its business and/or all of its assets to which this Agreement relates,
(c) the sale by ADVAXIS to a Third Party of all of its business and/or assets
related to the Product, (d) the acquisition of Control, directly or indirectly,
of either Party by a Third Party, and (e) the grant by ADVAXIS to any Licensee
of a license or right to manufacture Product, are all referred to herein as
“Special Transactions”.         16.3.2 Neither Party shall have a right,
directly or indirectly, to assign this Agreement without the Consent of the
other Party, provided, however, that each Party may engage in any Special
Transaction, without the other Party’s Consent, subject to the provisions of
Sections 16.3.3 and 16.3.4.         16.3.3 As part of any such Special
Transaction, the Party engaged in such Special Transaction shall cause this
Agreement in its entirety, without alteration, modification or amendment of any
kind whatsoever (other than minor changes that are necessary to account for the
assignment in connection with the Special Transaction), to be assigned or
transferred or otherwise made part of the Special Transaction. Within ten (10)
Business Days after the occurrence of any such Special Transaction, said Party
engaged therein shall send to the other Party a Notice, signed by an officer of
said Party, that: (a) informs the other Party of the date of the Special
Transaction; (b) identifies the Third Party or the Affiliate involved in said
Special Transaction, as applicable; and (c) certifies that this Agreement in its
entirety, without alteration, modification or amendment of any kind whatsoever,
has been assigned or transferred or otherwise made part of the Special
Transaction, or that this Agreement has in no material manner been affected by
said Special Transaction, as the case may be, and remains in full force and
effect in accordance with its terms.         16.3.4 The assigning Party shall be
liable for all damages incurred by the other Party for failure to comply with
the provisions of Section 16.3.2 and Section 16.3.3 above or in the event that,
for any reason, the assignee or acquiring or purchasing Third Party or Affiliate
in any such Special Transaction shall not be liable for, or refuse to assume,
all the obligations of the assigning Party under this Agreement by reason of, or
after, said Special Transaction or for any other reason whatsoever. The
limitation of liability provisions set forth in Section 10.3 shall not apply to
damages arising under the provisions of this Section 16.3.4.

 

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16.4 Headings. All headings, titles, and captions in this Agreement are for
convenience purposes only and shall not be of any force or substance.     16.5
Waiver. Failure by either Party to enforce any rights under this Agreement shall
not be construed as a waiver of such rights nor shall a waiver by either Party
in one or more instances be construed as constituting a continuing waiver or as
a waiver in other instances. No waiver by any Party of any term, provision or
condition contained in this Agreement (including any exhibit hereto), whether by
conduct or otherwise, in any one or more instances, shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition or of any other term, provision or condition of this Agreement
(including any exhibit hereto).     16.6 Public Disclosure. No Party shall
disclose to any Third Party or originate any publicity, news release or public
announcement, written or oral, whether to the public or the press, or otherwise,
referring to the terms of this Agreement, the performance under it or any of its
specific terms and conditions, except by such announcements as are: (i) mutually
agreed upon by the Parties in writing; or (ii) required by law or regulation. If
a Party believes a public announcement to be required by law or regulation with
respect to this Agreement, it will give the other Party such notice as is
reasonably practicable and an opportunity to comment upon the announcement.    
16.7 Independent Contractor. Each Party is acting under this Agreement as an
independent contractor and not as the partner, joint venturer, agent, or
employee of the other Party. Each Party understands and agrees that it has no
authority to assume any obligation on behalf of the other Parties and that it
shall not hold out to Third Parties that it has any authority to act on any
other Party’s behalf except as expressly permitted herein.     16.8 Performance
by Affiliates. Each Party may have one or more Affiliates perform or otherwise
act on its behalf under this Agreement (including Exhibits). Each Party shall be
responsible for the compliance by its Affiliates performing or otherwise acting
under this Agreement on its behalf with the terms and conditions of this
Agreement.     16.9 Entire Agreement. This Agreement (including, without
limitation, the Exhibits hereto) constitutes the entire Agreement between the
Parties concerning the subject matter of said Agreement, and supersedes all
written or oral Agreements or understandings with respect thereto.

 

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16.10 Force Majeure.

 

  16.10.1 Force Majeure. Any delay in the performance of any of the duties or
obligations of either Party (except the payment of money hereunder) shall not be
considered a breach of this Agreement; provided that such delay has been caused
by or is the result of circumstances beyond the reasonable control of the
relevant Party which may include acts of God, acts of the public enemy, war,
civil commotion, terrorism, epidemic disease, quarantine restrictions, freight
embargoes, unusually severe weather, insurrections, riots, embargoes, general
labor disputes or strikes, fires, explosions, shortages of energy, accident,
fire, flood, storm, earthquake, government action or inaction in its sovereign
capacity (including acts of any country to which Product is supplied by ADVAXIS
or Germany, and/or an act by any political subdivision thereof), or other
unforeseen causes, in each case provided that such delay is beyond the
reasonable control and without the fault or negligence of the Party so affected
(each a “Force Majeure Event”). Notwithstanding the foregoing, in the event of a
complete or partial regulatory shutdown of a facility or service or other act by
a Regulatory Authority that (a) specifically impacts a Party’s operations (i.e.,
without shutting down facilities owned by Third Parties) and (b) is due to a
Party’s gross negligence, willful misconduct or noncompliance with Applicable
Laws, such shutdown shall not constitute a “Force Majeure Event”.        
16.10.2 Notice. If either Party is affected by a Force Majeure Event, the
affected Party shall Notify the other Party within five (5) days of the Force
Majeure Event which caused, threatens to cause or will cause a delay in
performance under this Agreement. The affected Party shall take reasonable
actions to avoid, mitigate or remove the cause of the affected Party’s
non-performance.         16.10.3 No Breach. Neither Party shall be in breach of
this Agreement, nor otherwise be liable to the other Party by reason of any
delay in performance, or non-performance, of any of its obligations hereunder to
the extent that such delay or non-performance is due to any Force Majeure Event
of which it has notified the other Party and the time for performance of that
obligation shall be extended accordingly.         16.10.3 Cooperation. The
Parties shall cooperate in good faith to reschedule any Manufacture of Product
that has been delayed or postponed by reason of a Force Majeure Event.        
16.10.4 Termination. In the event that a Force Majeure Event continues for more
than three (3) months, the Parties will use good faith efforts to work out a
mutually agreeable solution. Should no mutually agreeable solution be found
within a further period of three (3) months, either Party may terminate this
Agreement upon Notice to the other Party.

 

16.11 Counterparts. This Agreement shall be signed in two (2) counterparts each
of which shall be deemed to be an original and both of which taken together
shall constitute one and the same instrument. Facsimile or e-mail transmission
of executed counterparts of this Agreement shall constitute evidence of the
execution of this Agreement by the Parties.

 

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16.12 Governing Law. The arbitration undertaking provided for in Section 15.1 of
this Agreement, above, shall be governed by and construed and interpreted in
accordance with the New York Convention and the implementing U.S. legislation, 9
U.S.C. sections 101 et seq. All other provisions of this Agreement shall be
governed by and construed and interpreted in accordance with the internal laws
of the State of New York, USA. The 1980 U.N. Convention on the International
Sale of Goods shall not apply. EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT IT
MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY
DISPUTE HEREUNDER IT BEING AGREED THAT ALL DISPUTES WILL BE RESOLVED PURSUANT TO
THE DISPUTE RESOLUTION PROCEDURES SET FORTH IN ARTICLE 15 OF THIS AGREEMENT.    
16.13 Exhibits. All exhibits referred to herein form an integral part of this
Agreement and are incorporated into this Agreement by such reference.     16.14
No Presumption Against Drafter. For purposes of this Agreement, the Parties
hereby waive any rule of construction that requires that ambiguities in this
Agreement (including any exhibit hereto) be construed against the drafter.    
PART III: EXHIBITS

 

EXHIBIT A WORK PLAN AND SERVICE FEES EXHIBIT B QUALITY AGREEMENT EXHIBIT C
EQUIPMENT EXHIBIT D ADVAXIS MATERIALS EXHIBIT E STORAGE FEES EXHIBIT F FURTHER
DEFINITIONS EXHIBIT G: PRODUCT SCOPE

 

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Exhibit A WORK PLAN

 

to be added by the parties

 

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Exhibit B: Quality Agreement

 

to be added by the parties

 

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Exhibit C: Equipment

 

At the Effective Date, there is no Equipment within the meaning set forth in
this Agreement.

 

to be added by the parties

 

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Exhibit D: ADVAXIS Materials

 

The specific materials set forth in the respective Work Packages for the Product
referenced in Exhibit G, No. 1, ADXS-HPV. Said ADVAXIS Materials may include,
without limitation, cell banks, virus seeds and bulk drug substance.

 

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Exhibit E: Storage Fees

 

No.   Type of Storage   Price   Unit   Further Conditions                   1  
Standard
Storage: 15- 25°C   31,50   €/pallet/month                       2  

Cold

Storage A: 2-8°C

  45,85   €/pallet/month                       3  

Cold

Storage B: - 45 -15°C

  70,35  

€/DS

batch/month

  Up to 50 batch storage spaces available per deep freezing room.              
    4  

Cold

Storage C: ab -65 - 85°C

  137,85  

€/Storage Shelf

Space/month

  Up to 40 shelf spaces available per deep freezing room.

 

Storage fees apply to all storage except as otherwise specifically provided in
any Work Package or in the Agreement. Storage in IDT capacities as existing on
the Effective Date.

  No. 3/4 type storage: For any storage beyond existing IDT capacities the
storage fees apply, plus additional capital equipment.   For Product released by
IDT for Delivery to ADVAXIS as ordered by ADVAXIS, the applicable fees are
doubled after 120 days.

 

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Exhibit F: Further Definitions

 

a.   “Bill of Materials” means a document generated by IDT and provided to
ADVAXIS referencing all materials and supplies, including Raw Materials and
process consumables, to be used by IDT in the performance of Manufacturing as
outlined in an applicable Work Package. The Bill of Materials will indicate the
Party responsible for the acquisition and delivery of such materials and
supplies to IDT for use in the performance of the Services.       b.  
“Engineering Run” means a non-cGMP Manufacturing run utilizing Master Production
Records and intended to execute the series of unit operations in the specified
order to evaluate whether or not the Manufacturing Process meets draft Product
Specifications. For Engineering Runs raw materials and equipment will be used as
for intended later cGMP manufacturing. Raw Materials for non-cGMP purpose do not
require incoming goods controls, but QA release based on supplier certificates.
Suppliers do not need to be audited at this stage. The Engineering runs are
performed in the same cGMP clean rooms facilities and by the same trained
personnel as for the intended later cGMP manufacturing. Engineering runs will
not include deviations or OOS reporting in IDT’s Quality System. Engineering
runs will include review by Production Record review team, QC record review team
and QA, but no QP release. Product from Engineering Runs shall be considered as
Development Product pursuant to Section 2.10.       c.   “Protocol” means a
document outlining and describing in detail the approach, steps and experimental
procedure to be undertaken for an applicable process. Protocols will not be
considered final until mutually agreed in writing by the Parties.       d.  
“Technical Summary Report” means a detailed report provided upon completion of
various Services as further detailed in each individual Work Package. Technical
Summary Reports will describe the experimental methods and justification for the
Manufacturing Processes, including all data from experiments and analytical
results. Technical Summary Reports will also outline any additional work that
needs to be performed to complete Product or Process characterization and, if
applicable, recommendations for the next steps.       e.   “Validation Master
Plan” means a document detailing the equipment, systems or Processes to be
qualified or validated, defining the Services to be performed, the approach to
be used, the responsibility Party for such Services, and a timeline for the
Services.

 

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Acronyms       f. BDP Bulk Drug Product       g. BOM Bill of Materials       h.
CofA Certificate of Analysis       i. CofC Certificate of Compliance       j.
cGMP Current Good Manufacturing Practices       k. DS Drug Substance       1. DP
Drug Product       m. IPC In-Process Control       n. MCB Master Cell Bank      
o. MVS Master Virus Stock       P. OOS Out of Specification       q. QA Quality
Assurance       r. QP Qualified Person according to article 49, directive
2001/83/EG       s. QC Quality Control       t. SOP Standard Operating Procedure
      u. VMP Validation Master Plan       V. WCB Working Cell Bank       w. WVS
Working Virus Stock

 

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EXHIBIT G: Product Scope

 

1. ADXS-HPV

 

to be added by the parties

 

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