Exhibit 10.4

 

    FINAL

 

CLINICAL TRIAL SERVICES AGREEMENT

 

  Sponsor: Advaxis, Inc.

  Protocol: GOG-0265 (DTM0622)

  Protocol Title: A Phase II Study of Lovaxin-C (IND# 13,712) in the Treatment
of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

 

This Clinical Trial Services Agreement (“Agreement”) is between Advaxis, Inc.
(“Sponsor”) , a for-profit corporation organized under the laws of Delaware, USA
and holder of IND Number 13712, and the Gynecologic Oncology Group (“GOG”) , a
not-for-profit corporation organized under the laws of the District of Columbia,
to conduct the Clinical Trial according to the Protocol attached as Exhibit A
and incorporated by reference in this Agreement. The Principal Investigator for
the GOG shall be Philip J. DiSaia, M.D. The Clinical Trial will be directed by
Warner K. Huh, M.D. (“Study Chair”), according to the Protocol.

 

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

 

  A. “ Case Report Form ” (“ CRF ”): the case history or individual research
record created and maintained for each Enrolled Participant in the Clinical
Trial, as required by FDA regulations.

 

  B. “ Clinical Investigators ”: the physicians at the Participating
Institutions participating in the conduct of the Clinical Trial.

 

  C. “ Clinical Trial ”: that certain clinical trial of the Study Drug, as
described in the Protocol.

 

  D. “ Eligible Patient ”: a patient who meets the enrollment criteria set forth
in the Protocol.

 

  E. “ Enrolled Participant ”: an Eligible Patient who has consented to
participate and has been enrolled in the Clinical Trial.

 

  F. “ FDA ”: the United States Food and Drug Administration.

 

  G. “ HHS ”: the United States Department of Health and Human Services.

 

  H. “ IND ”: an investigational new drug application submitted to the FDA.

 

  I. “ IRB ”: an Institutional Review Board constituted and operating in
accordance with FDA/HHS regulations.

 

  J. “ NCI ”: the National Cancer Institute.

 

 

 

 

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  K. “ Participating Institution ”: the locations at which the Clinical Trial
will be conducted.

 

  L. “ Patient Informed Consent ”: a form of document describing the Clinical
Trial and its reasonable risks, which addresses all matters customarily
addressed in patient informed consents appropriate to clinical trials of this
type, includes an authorization by the patient to share with Sponsor all patient
data required for performance of the Clinical Trial and the preparation of all
regulatory submissions, and complies, at a minimum, with the requirements set
forth in FDA regulations, including without limitation 21 CFR 50.20, 50.25,
50.27, and any successor provisions.

 

  M. “ Study Drug ”: Lovaxin-C, produced in compliance with good manufacturing
practices and all applicable laws and regulations, including FDA regulations, to
be supplied by Sponsor to the Clinical Investigators for the sole purpose of
conducting the Clinical Trial, as provided in the Protocol.

 

  2. Engagement to Perform Clinical Trial Services.

 

Sponsor hereby engages GOG to provide, and GOG hereby agrees to provide, the
clinical trial management and other services described herein, and in the
attached protocol, in accordance with the terms and conditions set forth in this
Agreement, with respect to the Clinical Trial.

 

  3. Duties of GOG.

 

  A. GOG shall (i) develop the Protocol for use in the Clinical Trial in
collaboration with the Sponsor, and provide the Protocol to the Participating
Institutions, (ii) prepare and provide a Patient Informed Consent, (iii) select
qualified Participating Institutions, Study Chair and Clinical Investigators to
conduct the Clinical Trial, including without limitation selecting replacement
Participating Institutions, Study Chair and Clinical Investigators in the event
of the resignation from the Clinical Trial of any such individual or
institution, (iv) arrange for the conduct of the Clinical Trial at such
Participating Institutions under the general oversight and management of the
Study Chair and the day-to- day direction and supervision of the Clinical
Investigators, as described more fully in Section 4 below, (v) arrange for
coordination of the services of the Study Chair, Clinical Investigators and the
Participating Institutions in their conduct of the Clinical Trial, (vi) require
IRB review, approval and monitoring of the Clinical Trial, including the Patient
Informed Consent, as is required by law and regulation, (vii) furnish
Participating Institutions with blank CRFs, and (viii) provide or arrange for
the provision of such other administrative support and other services as are set
forth in this Agreement.

 

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  B. GOG shall require that the Clinical Investigators not enroll any
participants in the Clinical Trial until: (i) the Protocol has been approved by
the National Cancer Institute (NCI), (ii) the Protocol has been approved by an
IRB assigned by the Participating Institution, (iii) GOG has submitted all
regulatory documents required by Sponsor to Sponsor, and (iv) Sponsor has
submitted all regulatory documents required by FDA regulations to FDA, received
such regulatory approval of the Clinical Trial as is required by such
regulations, and provided GOG with proof of such approval.

 

  C. GOG shall maintain the Protocol master file and all IRB-approved additions
and amendments thereto, and is responsible for providing the most recently
approved version of the Protocol and Patient Informed Consent forms to Clinical
Investigators.

 

  D. GOG shall provide all proposed amendments to the Protocol to the Sponsor
for review prior to proceeding with such an amendment, but the determination of
approval of all Protocol amendments shall rest with the GOG.

 

  E. GOG shall provide periodic follow-up information and data summaries and
analyses to Sponsor for all patients enrolled and participating in the Clinical
Trial every six (6) months commencing six (6) months after activation of the
Clinical Trial.

 

  4. Duties of Study Chair and Clinical Investigators.

 

GOG shall require that:

 

  A. Study Chair is responsible for the general oversight and management of the
Clinical Trial, and that Clinical Investigators are responsible for the
day-to-day supervision and control of the Clinical Trial at their respective
Participating Institutions;

 

  B. Study Chair and Clinical Investigators conduct the Clinical Trial in
accordance with the Protocol and all applicable laws, regulations, and good
clinical and research practices;

 

  C. Clinical Investigators maintain a file of all documents pertaining to the
Protocol including, but not limited to, Protocol amendments and safety reports;

 

  D. Clinical Investigators obtain and maintain a signed Patient Informed
Consent (as approved by the IRB) for each patient enrolled in the Clinical Trial
at their Participating Institution, and retain such consent forms for at least
three (3) years or longer, as required by the Sponsor and by applicable
regulations;

 

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  E. Clinical Investigators submit completed CRFs to GOG’s Statistical and Data
Center according to Protocol requirements;

 

  F. Clinical Investigators maintain control of the Study Drug in accordance
with FDA regulations and other applicable federal and state legal requirements,
including taking monthly inventories and reconciling the same with records of
receipt and dispensing or other disposition of the Study Drug;

 

  G. Clinical Investigators and others working on the Clinical Trial under their
direction and control, or otherwise having access to the Study Drug at their
Participating Institution, make use of the Study Drug solely for the purpose of
conducting the Clinical Trial, and return outdated and unused doses to the
Sponsor at Sponsor’s expense or dispose of such product according to applicable
state and federal law;

 

  H. In compliance with FDA’s regulations governing “Financial Disclosure by
Clinical Investigators” (21 CFR Part 54), Study Chair and all Clinical
Investigators submit FDA financial disclosure forms to Sponsor before beginning
work on the Clinical Trial, and update such information promptly if any relevant
changes occur during the course of the Clinical Trial and for one (1) year
following completion of the Study; and

 

  I. Clinical Investigators and Study Chair perform such other activities as may
be required by applicable law or regulation for persons in such positions in
respect of a Clinical Trial.

 

  5. Period of Performance.

 

This Agreement shall become effective on the date last signed below (“Effective
Date”) and (unless terminated earlier pursuant to Section 13 below) shall
continue in force until Sponsor receives completed case histories for all
participants in the Clinical Trial and questions about data submitted have been
resolved.

 

  6. Duties of Sponsor; Compensation of GOG.

 

  A. Sponsor shall (i) be the regulatory Sponsor of the Clinical Trial in
accordance with FDA regulations, and meet the obligations of a Sponsor under
such regulations, except to the extent expressly delegated to GOG hereunder;
(ii) provide Participating Institutions without charge, properly formulated and
acceptably labeled clinical- grade Study Drug in a timely manner and in
sufficient quantity to complete the Protocol; and (iii) provide GOG with the
Investigator’s Brochure, and any amendments and/or updates to the Investigator’s
Brochure for the Study Drug.

 

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  B. In consideration of and as payment in full for the services rendered under
this Agreement by GOG, Sponsor shall pay GOG on a quarterly basis a Clinical
Trial performance fee of $8,066.63 (Eight Thousand Sixty-Six Dollars and Sixty
Three Cents) per Enrolled Participant for up to an estimated 61 (Sixty-One)
participants. The translational research costs are included in the Clinical
Trial performance fee. All payments shall be made within thirty (30) days of
receipt of an invoice submitted by the GOG. In addition, Sponsor shall pay GOG
an initial nonrefundable fee of $15,000.00 (Fifteen Thousand Dollars) for the
administrative costs associated with the conduct of the Clinical Trial. This
administrative fee shall be paid within thirty (30) days of the execution of
this Agreement.

 

  C. In addition to the foregoing, Sponsor shall reimburse GOG for any and all
reasonable travel-related expenses incurred by GOG, Study Chair or Clinical
Investigators, in performance of their respective responsibilities under this
Agreement and the Protocol up to a maximum of $10,000.00. All requests for
reimbursement for travel-related expenses must be accompanied by documentation
in form and detail sufficient to meet the requirements of the Internal Revenue
Service with respect to recognition of business-related travel expenses for
federal income tax purposes.

 

  D. Payments shall be made as follows:

 

  (i) Checks shall be made Payable to: The Gynecologic Oncology Group.

 

  (ii) Federal Tax I.D. Number: 030466352

 

  (iii) Checks shall be mailed to:

 

  The Gynecologic Oncology Group   2127 Espey Court   Suite 100   Crofton, MD
21114   Attention: Mary Sharp   Phone: 410-721-7126   Fax: 301-261-3954

 

  7. Confidential Information.

 

  A. “Confidential Information” means information that Sponsor provides to the
Study Chair or the Clinical Investigators, which is in writing and designated
“confidential.”

 

  B. Notwithstanding any designation by Sponsor, “Confidential Information”
shall not include:

 

  (i) information that is or becomes publicly known or available through no
fault of GOG, Study Chair, Clinical Investigators or other research staff;

 

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

 

  (iii) information that is already independently known to GOG, Study Chair,
Clinical Investigators, or other research staff, as shown by their prior written
records;

 

  (iv) information that, at or after such time that it is disclosed, is included
in a publication produced in accordance with Section 9 ; and/or

 

  (v) information that relates to potential hazards or warnings associated with
the production, handling, or use of the Study Drug.

 

  C. GOG shall require that the Study Chair, Clinical Investigators, and their
employees and agents not disclose the Confidential Information to any third
party without the prior written permission of Sponsor except as permitted by
this Agreement or required by law; and not use the Confidential Information for
any purpose other than the conduct of the Clinical Trial.

 

  D. In the event that GOG, a Study Chair, or a Clinical Investigator or their
employees and agents reasonably find it necessary to disclose any Confidential
Information to a governmental authority to defend the research against an
allegation of fraud or other misconduct, or to defend themselves in any other
legal proceeding, the party may make the necessary disclosure after notifying
Sponsor, and attempting in good faith to agree upon a mutually satisfactory way
to disclose only such portions of the Confidential Information as is necessary
to achieve this limited purpose.

 

  E. Nothing herein shall be construed as preventing GOG, a Study Chair or a
Clinical Investigator from publishing or otherwise publicly disclosing any data
generated from the Clinical Trial as provided in Sections 8 and 9 , below.

 

  F. The obligations of this Section 7 shall survive the expiration or
termination of this Agreement.

 

  8. Recordkeeping and Access to Data.

 

  A. GOG shall require that:

 

  (i) Study Chair or Clinical Investigators complete and maintain customary
accurate and authentic records, including without limitation signed consent
forms, clinical data, case histories, notes, accounts, and adverse event reports
of the work performed under this Agreement (“Data”);

 

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  (ii) Sponsor and authorized agents of FDA, HHS, and other federal agencies
shall have the right to inspect and review such Data to the extent permitted by
law and during regular business hours and upon reasonable notice;

 

  (iii) Sponsor, GOG and Clinical Investigators maintain confidentiality of
personally identifiable information concerning research participants, and shall
disclose such information to third parties only as permitted by applicable state
and Federal privacy laws, including (but not limited to) the Health Insurance
Portability and Accountability Act of 1996 (“H I PAA”).

 

  B. All Data generated or required by the Clinical Trial, are and shall remain
the property of GOG; however, Sponsor shall have a complete copy of all
collected Data in order to run an independent analysis, file an FDA application,
prepare a patent application, or for any other lawful purpose.

 

  9. Publication and Other Public Presentation of Results.

 

  A. The Sponsor recognizes that, consistent with the principles of academic
freedom, GOG requires that Study Chair and Clinical Investigators be free to
publish the results of their research activities. The Sponsor agrees that GOG,
Study Chair and Clinical Investigators engaged in this Clinical Trial shall be
permitted to publish reports in journals and other professional publications,
and to present the methods and results of this Clinical Trial at symposia and
professional meetings, in accordance with the requirements of this Section 9 .

 

  B. The Sponsor shall be furnished a copy of any proposed publication or
presentation for advisory review and comment at least thirty (30) days in
advance of the submission of such proposed publication or presentation.
Expedited review or additional review time may be arranged by mutual agreement.

 

  C. If within such thirty (30) day period, Sponsor determines and notifies GOG
in writing that the proposed publication or other disclosure contains
disclosures of the intellectual property of Sponsor, GOG shall require that the
publication or other disclosure be delayed for up to an additional sixty (60)
days in order to allow Sponsor sufficient time to take appropriate steps to
preserve U.S. or foreign patent or other intellectual property rights.

 

  D. Sponsor shall have no ownership rights or copyright in any publications
prepared by GOG in the performance of this Agreement.

 

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  10. Use of Names.

 

Neither GOG nor Sponsor shall use the name, symbols and/or marks of the other in
connection with the Clinical Trial without prior written permission. Such
permission is not required for disclosure of the existence of the Agreement in
reports generated in the normal course of business by GOG or Sponsor, or where
acknowledgment of sponsorship is required by the guidelines of a scientific
publication or organization. Neither party shall use, nor authorize others to
use, the name, symbols, or marks of the other or any affiliate thereof in any
advertising or publicity material or make any form of representation or
statement in relation to the Clinical Trial that would constitute an express or
implied endorsement by GOG of any commercial product or service, without prior
written approval from GOG.

 

  11. Patents and Inventions.

 

  A. “New Invention or Discovery” shall mean any invention or discovery
conceived or reduced to practice by a Study Chair, Clinical Investigator, or
research staff during and as a part of the Clinical Trial conducted pursuant to
this Agreement. For purposes of this Agreement, the terms “conceived” and
“reduced to practice” shall be given the meaning of those terms as they appear
in 35 U.S.C. § 102(g).

 

  B. New Inventions or Discoveries conceived or reduced to practice solely by
GOG’s Study Chair, Clinical Investigators or research staff, shall be the sole
property of GOG.

 

  C. New Inventions or Discoveries conceived or reduced to practice jointly by
GOG’s Study Chair, Clinical Investigators, or other research staff and one or
more employees of Sponsor shall be owned jointly by GOG and Sponsor.

 

  D. New Inventions or Discoveries conceived or reduced to practice solely by
the Sponsor’s employees shall be the sole property of Sponsor.

 

  E. For new Inventions or Discoveries that are the sole property of GOG, or
that are jointly owned by GOG and Sponsor, Sponsor shall have the right to first
refusal of an exclusive license agreement, which shall provide for reasonable
royalty payments and contain other customary and commercially reasonable terms
and conditions.

 

  F. The parties acknowledge that the United States Government, as a matter of
statutory right under 35 U.S.C. § 200-212, holds a nonexclusive world-wide
license and certain other rights to use inventions made as a result of research
funded in whole or in part by the United States Government. In the event such
rights are found to apply to any New Inventions or Discoveries, any license
negotiated under this Agreement, even if termed an “exclusive” license, shall be
understood to be subject to the rights of the United States Government, without
any effect on the parties’ remaining obligations, as set forth in the license or
in this Agreement.

  

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  G. The right of publication by GOG, Study Chair, and Clinical Investigators,
as described in Section 9 , shall not be affected by a license to use any New
Invention or Discovery.

 

  12. Indemnification and Insurance.

 

  A. Sponsor shall indemnify, defend and hold harmless GOG, Study Chair,
Clinical Investigators and other research staff, including their directors,
officers, employees, agents, and assigns, from any and all third party
liabilities, claims, actions or suits arising out of or in connection with the
Clinical Trial, except for loss resulting from the negligence or willful
malfeasance of GOG, a Study Chair, Clinical Investigator or other research
staff.

 

  B. Sponsor shall provide a diligent defense against or settlement of any
claims brought or actions filed with respect to the subject of the indemnity
contained in this Agreement, whether such claims or actions are rightfully or
wrongfully brought or filed; provided, however, that Sponsor must obtain GOG’s
written approval before settling any claim.

 

  C. GOG shall reasonably cooperate, and shall require that Study Chair,
Clinical Investigators and other research staff reasonably cooperate, with
Sponsor and its legal representatives in the investigation and defense of any
claim or suit covered under this Section 12 . In the event a claim or action is
or may be asserted, GOG shall have the right to select and to obtain
representation by separate legal counsel.

 

  D. Upon request, each party shall provide evidence of its insurance or self-
insurance coverage and unless self-insured, will notify the other party within
three (3) business days of notice of any reduction, non-renewal or cancellation
of its coverage.

 

  13. Termination.

 

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

 

  (i) if FDA imposes a permanent hold on the Study Drug;

 

  (ii) if the Clinical Trial is terminated by GOG for reasons of patient safety,
or by NCI; or

 

  (iii) if a formal investigation by an authorized governmental agency
determines that the Data have been falsified or irreparably compromised by
research misconduct.

 

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  (iv) if the GOG’s Data Monitoring Committee (DMC) is convened for this study
and the DMC recommends study termination as part of its chartered
responsibilities, and the Group Chair agrees with the DMC’s recommendation.

 

  B. This Agreement may be terminated by either party, upon ten (10) days prior
written notice, if any of the following conditions occur:

 

  (i) if either party fails to comply with the terms of this Agreement after
receipt of written notice, with reasonable opportunity to cure, from the other
party;

 

  (ii) if no Study Chair is willing or able to continue to serve and a successor
acceptable to both the GOG and the Sponsor is not available.

 

  C. This Agreement may be terminated by either party for any reason, upon sixty
(60) days prior written notice.

 

  D. Upon the effective date of termination, there shall begin an accounting
conducted by GOG. Within thirty (30) days after receipt of adequate
documentation, Sponsor shall make payment to GOG, on a pro rata basis, for:

 

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

 

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

 

  E. GOG shall credit or return to the Sponsor any funds not expended or
obligated by GOG, a Study Chair or Clinical Investigator in connection with the
Clinical Trial, and return or properly dispose of, at the option of the Sponsor,
any unused Study Drug, prior to the effective termination date indicated in the
notice of termination.

 

  F. Termination of this Agreement by either party shall not affect the rights
and obligations of the parties accrued prior to the effective date of
termination. The rights and duties as specified under Sections 4 (G, H, I), 6,
7, 8, 9, 10, 11, 12, 13 and 14, or any other provision that by its terms is
intended to survive termination or expiration, shall survive the termination or
expiration of this Agreement.

 

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

 

  14. Miscellaneous.

 

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

 

  B. Correspondence. Sponsor shall address all medical/scientific communications
to the Study Chair at the address listed in the Protocol and GOG, as follows:

 

  The Gynecologic Oncology Group   Four Penn Center, Suite 1020   1600 John F.
Kennedy Boulevard   Philadelphia, Pennsylvania 19103-2800   Phone: 215-854-0770
  Fax: 215-854-0309   Attention: Kia Neff

 

All such information directed to Sponsor shall be addressed to:

 

  Dr. John Rothman   |Executive Vice President: Science & Operations   Advaxis
Inc.   675 US Route 1   North Brunswick, NJ 08902

 

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

 

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If to Sponsor:     Dr. John Rothman   Executive Vice President: Science &
Operations   Advaxis Inc.   675 US Route 1   North Brunswick, NJ 08902  
Phone:(732) 545-1590   Fax: :(732) 545-1084   Attention: Legal Affairs     If to
GOG: The Gynecologic Oncology Group   Four Penn Center, Suite 1020   1600 John
F. Kennedy Boulevard   Philadelphia, Pennsylvania 1910-2800   Phone:
215-854-0770   Fax: 215-854-0309   Attention: Laura L. Reese

 

  With a copy, which shall not constitute notice, to:   Ann E. Allen, Esq.  
1111 E. Capitol St. S.E.   Washington, DC 20003

 

  D. Assignment . Due to the specialized nature of the services provided under
this Agreement, neither party shall assign, transfer or convey this Agreement
without the other party’s prior written consent. This Agreement shall enure to
the benefit of each party and its permitted successors and assigns. This
Section 14.D shall not be deemed to preclude GOG from contracting with Study
Chair, Clinical Investigators and Participating Institutions to perform the
Clinical Trial hereunder, or to require Sponsor to consent to such contracts,
except as otherwise specifically set forth above.

 

  E. Amendment. Any amendment(s) to this Agreement must be in writing and signed
by both parties.

 

  F. Applicable Law. This Agreement shall be construed under and governed by the
laws of the Commonwealth of Pennsylvania, exclusive of choice of law provisions.
The parties hereby irrevocably consent to the jurisdiction and placing of venue
of any action between the parties in the local, state, or federal courts located
in the city of Philadelphia, Pennsylvania.

 

  G. Alternative Dispute Resolution: The parties agree to make their best
efforts to resolve any disputes regarding this Agreement through mediation or
non-binding arbitration, using the services of the American Arbitration
Association.

 

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  H. Entirety of Agreement. This Agreement constitutes the entire agreement
between the parties concerning the subject matter herein, and supersedes all
prior terms or understandings, written or oral.

 

  I. Waiver. Neither the waiver by any of the parties hereto of a breach of or a
default under any of the provisions of this Agreement, nor the failure of any of
the parties, on one or more occasions, to enforce any of the provisions of this
Agreement or to exercise any right or privilege hereunder shall thereafter be
construed as a waiver of any subsequent breach or default of a similar nature,
or as a waiver of any of such provisions, rights or privileges hereunder. No
waiver by a party hereto of, or consent by a party hereto to, a variation from
any provision of this Agreement shall be effective unless made in a written
instrument duly executed on behalf of such party.

 

  J. Severability. The invalidity or unenforceability of any term or provision
of this Agreement shall not affect the validity or enforceability of any other
term of this Agreement.

 

  K. No Debarment. Neither GOG nor any of its employees or agents, or any
Participating Institution or Clinical Investigator or any of their employees or
agents, rendering activities pursuant to this Agreement is under investigation
by the FDA for debarment action or is presently debarred pursuant to the Generic
Drug Enforcement Act of 1992, 21 U.S.C. § 335a, or any other FDA authority. GOG
shall notify Sponsor immediately upon any inquiry concerning or the commencement
of any such proceeding concerning GOG or any such person or entity.

 

  L. Inspections. If any governmental or regulatory authority conducts or gives
notice to GOG of its intent with respect to any activities under this Agreement
to conduct an inspection at any Participating Institution or take any other
regulatory action, or if GOG becomes aware of any such governmental inspection
or other regulatory activity at one of the Participating Institutions, GOG shall
promptly give Sponsor notice thereof, including all information pertaining to
any such inspections or actions.

 

  M. No Sanctions. Neither GOG nor any of its personnel, nor to the knowledge of
GOG any Study Chair, Clinical Investigator, or Participating Institution or the
research staff of any have been or shall be involved in an investigation or in
research that was terminated, as the term “termination” is used in 21 CFR
812.3(8), nor have they been subjected to any sanctions related to allegations
of research or professional misconduct.

 

  N. Additional Actions and Documents. Each of the parties hereto hereby agrees
to take or cause to be taken such further actions, to execute, deliver and file
or cause to be executed, delivered and filed such further documents and
instruments, and to obtain such consents, as may be necessary or as may be
reasonably requested in order to fully effectuate the purposes, terms and
conditions of this Agreement.

 

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  O. Counterparts. To facilitate execution, this Agreement may be executed in as
many counterparts as may be required. It shall not be necessary that the
signature of or on behalf of each party appears on each counterpart, but it
shall be sufficient that the signature of or on behalf of each party appears on
one or more of the counterparts. All counterparts shall collectively constitute
a single agreement. It shall not be necessary in any proof of this Agreement to
produce or account for more than a number of counterparts containing the
respective signatures of or on behalf of all of the parties.

 

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

 

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

 

 

ADVAXIS, INC.:   THE GYNECOLOGIC ONCOLOGY GROUP:       By:   /s/ John Rothman  
By:  /s/ Philip J. DiSaia, M.D.       Name:  Dr. John Rothman   Name:  Philip J.
DiSaia, M.D.       Title:  EVP:  Science & Operations   Title:  President and
Group Chair       Date:  12/13/09   Date:  12/11/09

 

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