Document:

Unassociated Document

  

Cobra Biomanufacturing Plc

The
Science Park,

Keele,

U.K.

ST5
5SP

 

   

   Executive
Summary

Advaxis
has developed a recombinant attenuated L.
monocytogenes for
vaccination against HPV E7 expressing tumors. Advaxis will require the
production of approximately [ * ] cfu of
L.
monocytogenes non-cGMP
preclinical material and [ * ] cfu for
clinical trial use produced following cGMP guidelines. The program will involve
the following phases:

Phase
I

	·  	
      Transfer
      of current Listeria
      culture and analysis methods 

	·  	
      Two
      month feasibility study and process development
program

	·  	
      Animal
      component free growth media recommendation

	·  	
      Analytical
      methods development and host characterization methods

Phase
II

	·  	
      cGMP
      Master Cell Bank production

	·  	
      Toxicology
      material

	·  	
      Manufacture
      of clinical material

	·  	
      Development
      of product stability tests 

	·  	
      Quality
      assurance review 

	·  	
      Bulk
      product release for fill/finish

To
achieve these goals, Advaxis will require the collaboration of a partner
with:

	·  	
      Specialized
      facilities for plasmid DNA manufacture

	·  	
      Experience
      in plasmid DNA manufacture according to cGMP 

	·  	
      Successful
      track record producing material for clinical trials in the
    USA

	·  	
      Experience
      in meeting regulatory requirements in facilities and
      documentation

Cobra
has both the expertise and the facilities available to meet the project
deliverables required by Advaxis in the timescales attached.

Cobra
Biomanufacturing Plc

Cobra is
a full
service, world class Contract Manufacturing Organization that manufactures and
supplies DNA-based therapeutics for the pharmaceutical and biotechnology
industries. Cobra provides contract services spanning pre-clinical to early
Phase III scale production and supply of biological products. These services
include the cGMP manufacture of DNA, recombinant protein, viruses, mammalian
cell products and cell banking.  

Currently,
four clinical trials in the USA are being conducted using products manufactured
at Cobra. Additionally, there are clinical trials in Europe, Africa, China, and
Australia using products manufactured at Cobra.

Cobra has
a Type II Drug Master File (DMF) lodged with the FDA covering DNA manufacture.
We were last inspected by the MCA in August 2002 and found to be cGMP compliant.
Cobra provides a comprehensive analytical and documentation package for
regulatory filing.

 

 

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Introduction

Cobra
Biomanufacturing
is a full service, world class Contract Manufacturing Organization that
manufactures and supplies DNA-based therapeutics for the pharmaceutical and
biotechnology industries. Cobra provides contract services spanning pre-clinical
to early Phase III scale production and supply of biological products. These
services include the cGMP manufacture of DNA, recombinant protein, viruses,
mammalian cell products and cell banking. The company also undertakes process
development programs for recombinant protein and gene therapy products.

Company
History

Cobra was
founded in 1992 as a start up biotechnology company specializing in gene therapy
and has been operating from facilities at the Keele Science Park for the past 8
years. The manufacturing division was originally established in order to
expedite Cobra Therapeutics own R & D programs. Investments were made in
cGMP manufacturing facilities and the development of technology for scaleable
manufacture of DNA and protein based pharmaceuticals. In 1998 the manufacturing
division began to offer cGMP manufacturing services to the pharmaceutical
industry. Cobra Therapeutics became a wholly owned subsidiary of ML Laboratories
in 2000. 

In June
2002, following a successful IPO on London’s AIM, Cobra Biomanufacturing was
established as an independent company
with an exclusive focus on custom manufacturing of bio
therapeutics.

Cobra’s
corporate objective is to continue to grow as a major contract supplier of DNA,
virus and protein based therapeutics for clinical trials and of licensed
biopharmaceutical products for commercial sale.

Manufacture
of DNA Therapeutics for Clinical Trials

Cobra has
established a worldwide reputation in the manufacture of plasmid DNA
therapeutics and is supporting clinical trials in the USA, Europe, Africa,
China, and Australia.

Every
project undergoes a technology transfer of your existing expression system to
utilize our scale-up expertise before initiating the cGMP manufacturing program.
During the evaluation stage genetic stability and relative productivity will be
determined in shake flask experiments. The fermenter productivity of the
transformed host strain will then be evaluated in a scale down (5L)
evaluation.
This
initial optimisation is to achieve the maximum productivity in the fermentation,
ensure yield and product purity throughout the purification process. It is
essential for the identification
of potential difficulties with your plasmid. The process development work is
necessary because in our experience 

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there can
often be a 5-10 fold difference in productivity between strains (even with
similar plasmid backbones) and genetic instability is observed with some
plasmids. By assessing the plasmid at the beginning of the program, we can
accurately estimate the yields of clinical material that you will
obtain.

 

Cobra has
substantial experience working with Kanamycin and Tetracycline resistant
plasmids and has also developed and been granted patents covering an
antibiotic-free plasmid DNA manufacturing process, the Operator Repressor
Titration (ORT) System. 

A Type II
DMF (Drug Master File) has been lodged with the FDA covering DNA
manufacture.

Facilities

Cobra has
over 11,000 square feet of space used for a process development facility,
separate QA/QC laboratories, and dedicated cGMP manufacturing facilities. The
existing cGMP manufacturing facility includes 4,500 square feet of EU Grade C
Clean Room space required for key stages in the manufacture of biopharmaceutical
products. The cGMP facility has two microbial production suites. The [ * ]
fermenter suite ([ * ] working volume) is for Phase I and II clinical trial
material. There is a [ * ] fermenter ([ * ] working volume) that is used to
provide an inoculum for the larger fermenter. The [ * ]fermenter suite ([ * ]
working volume) is for Phase II and III clinical trial material. 

Additionally,
there are two virus production suites with [ * ] and [ * ] fermenters ([ * ] and
[ * ] working volume) utilising adenovirus and baculovirus expression systems
for manufacture of Phase I and II clinical trial material.

Quality

Cobra is
committed to conducting its manufacturing activities in accordance with
appropriate current Good Manufacturing Practice (cGMP) and Good Control
Laboratory Practice (GLP) regulations and/or guidelines. The latest inspection
from the UK Medicines Control Agency (MCA) was in August 2002 with a compliance
statement received several weeks later. Cobra’s QA group ensures that the
products manufactured by the division meet appropriate standards of safety,
quality, and efficacy. The QA group oversees manufacture at all stages and is
responsible for testing, release, storage, and arranges shipment of the drug
product. Overseas shipping and safe passage 

through
Customs is easily co-ordinated and sub-contracted to BioCair, Inc or World
Courier.

Key
Personnel 

Cobra’s
belief that quality individuals result in quality products is reflected in the
key personnel that will be involved in the manufacture of Advaxis’ L.
monocytogenes for
clinical trials.

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    Julian
      Hanak B.Sc.
      (Hons), MSc., Director
      of Production
      

  

After
gaining an honours degree in Biochemistry at University College London, Julian
obtained an MSc at the University College of North Wales and then trained in
cell culture and microbial fermentation at the National Institute of Medical
Research. He then moved to the Bioproducts Laboratory (Elstree) where his duties
involved the pilot scale production of human monoclonal antibodies for clinical
trials. He was also responsible for running a sterile fill operation and
supervising the commissioning of a new cGMP production suite.

In 1992,
Julian moved to Zeneca Pharmaceuticals where he was involved with the process
development of several immunotherapy products and the development of virus
expression systems for protein production. He joined Cobra in 1994 and took over
responsibility for production in 1995.

Geoff
Sharpe BSc.,
PhD., CChem, MRSC.,
Director
of Quality
Assurance 

Geoff has
over 25 years experience in pharmaceutical biotechnology with over 12 years
experience in Quality Assurance. After having gained a degree in Applied
Chemistry at Liverpool, Geoff trained as a research chemist working for ICI
Corporate Laboratory. He later worked at the ICI Corporate Bioscience Group and
went on to complete a PhD in molecular biology at Leicester University.

In 1991
he transferred to ICI Pharmaceuticals (now AstraZeneca) where he was involved
with the cloning and expression of recombinant proteins and managed the
corporate DNA sequencing laboratory. In 1993, he moved to Zeneca
Pharmaceuticals. In the pharmaceutical department Geoff managed a team involved
in the development, manufacture, and release of both small molecule and
biotechnology based therapeutics. In 1996 he joined Cobra as their Quality
Assurance Manager and has been trained as a Qualified Person under Article 23 of
Directive 75/319/EEC.

Amanda
Weiss BSc.,
MSc.,
Section
Head Fermentation

Amanda
was trained at the University of Birmingham, Centre for Biochemical Engineering
before joining Cobra in 1996 as a fermentation scientist. Amanda has expertise
in microbial and mammalian cell culture, scale-up design and large-scale

manufacture
of biopharmaceuticals. She was also involved with the exemplification and
publication of Cobra’s ORT technology. Amanda has successfully managed the
fermentation aspect of Cobra’s manufacturing operations for over 5
years.

Tony
Hitchcock BSc,
Section
Head Microbial Products

Tony has
over 19 years’ experience in the large-scale manufacture of biopharmaceuticals.
Tony has held positions in the Blood Products Laboratory (Elstree) and at Zeneca
Pharmaceuticals in the protein process development department. Tony was a
founding staff
member of Cobra and has been responsible for the development of much of Cobra’s
DNA manufacturing technology. Tony has published several papers in the field and
is an inventor on two families of Cobra’s process patents.

 

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Roy
Cowell BSc.
(Hons), CChem, MRSC,
Section
Head Quality
Control 

Roy has
16 years’ experience of analytical development and quality control of
pharmaceuticals within the associated regulatory framework. Ten years employed
by Zeneca (now AstraZeneca) Pharmaceuticals working on new chemical entities and
candidate biotherapeutics and six years employed at Cobra working on candidate
DNA products. Roy is currently undergoing training leading to eligibility for
Qualified Person status.

Joy
Manley BSc, Senior
QA Microbiologist

Joy is
currently responsible for developing, validating, and applying suitable testing
regimes that help to assure clean room suitability and equipment cleanliness.
New test methods are designed and validated for plant systems and for cleaning
as required. Both standard and novel microbiological methods are developed and
used to characterize cell banks. She has experience in working with
microorganisms from both pharmaceutical and clinical backgrounds, previously
working for Fisons and The Public Health Laboratory.

David
Thatcher, Chief Executive

David was
trained as a protein chemist at the Universities of Newcastle on Tyne and
Edinburgh. In 1981 he moved to Biogen SA in Geneva where he worked on the
isolation of recombinant cytokines. In 1985 he became Director of Process
Development of Biogen, Inc. in Cambridge, MA, where he was responsible for the
development of large-scale processes for the production of gamma interferon,
GM-CSF and several other products. 

In 1988
he left Biogen and joined Zeneca Pharmaceuticals as head of their Protein
Production Lab where he was responsible for the production of a number of
biopharmaceutical products for clinical evaluation. In 1994 he joined Cobra and
has been responsible for managing the evolution of Cobra’s manufacturing
technology and developing the contract manufacturing business into an
independent company with a successful initial public offering.

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Quotation
O422

Description        Price

Phase
I

[
* ] 

Phase
II

[
* ]

Notes:

Stage
I

	1.	Execution
      of Material Transfer Agreement. Advaxis methods for recombinant
      Listeria
      culture and analysis will be transferred to Cobra. This will include
      plasmid isolation, plasmid and host identity, plasmid and host stability,
      cryopreservation, and protocol for plasmid
isolation.

	 2.	Characterization
      and strain history of the untransformed L.
      monocytogenes
      will be addressed by Advaxis. Advaxis will also be responsible for plasmid
      sequence and/or detailed restriction maps. Host and plasmid information is
      required for the GMO risk assessment. A letter from Dr. Paterson
      addressing the mobility of L.
      monocytogenes is
      requested.

	3.	Advaxis
      will supply [ * ] vials of a transformed research cell bank (mid log
      phase) of L.
      monocytogenes
      with documentation sufficient to make the research bank suitable for
      generation of the cGMP Master Cell Bank.

	4.	A
      two-month feasibility study will be undertaken to determine the growth
      kinetics of Listeria
      (latest
      harvest point) in various growth media. The study will also involve
      bioreactor growth, analysis of log phase, determination of yield, and
      number of cell doublings in vivo before maintenance of virulence is lost.
      We suggest running Stage II at the same time as Stage I to reduce the
      timeline to cGMP manufacture. 

Stage
II

	4.	An
      animal component free growth media will be recommended following
      evaluation
      of the existing media formulations with suitable alternatives. The media
      evaluated will be from published references for media used in Listeria
      culture.

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	5.	Development
      of a cryopreservation media suitable for administration to
    patients.

	6.	Analytical
      methods will be developed to meet FDA regulatory requirements for a
       live
      attenuated bacterial vaccine. Methods developed will include:

	o  	
      host
      identity

	o  	
      plasmid
      identity (restriction mapping or sequencing)

	o  	
      culture
      purity (monosepsis)

	o  	
      viable
      count.

	7.	Host
      characterization methods will be developed for the
following:

	o  	
      phenotype
      auxotrophies and markers

	o  	
      morphology

	o  	
      specific
      media for identification

	o  	
      gram
      strain

	8.	Cobra
      will supply Dr. Paterson with [ * ] of log phase culture for a hemolysin
      assay. Additionally, Cobra will supply Dr. Paterson with three samples of
      [ * ] for a mouse tumor challenge to study maintenance of
    virulence.

	9.	The
      following documentation will be provided:

Technical
Report

	10.	Confirmation
      of price estimates for cGMP manufacture at this point, dependent upon
      successful technology transfer, feasibility study and process development.
      

Stage
III

	
      11.
	
      Cell
      banking will only proceed based upon the feasibility study achieving cell
      densities of at least [ * ] viable
      cells per litre of culture. The Master Cell Bank will be manufactured
      under cGMP in accordance with the latest CPMP guidelines and MCA guidance.
      A Type II Drug Master File has been lodged with the FDA covering these
      procedures. Cells will be cryopreserved in mid log growth at a density of
      between [ * ] to [ * ] cfu/ml. 

Pricing
for the Working Cell Bank is based on production immediately following the
Master Cell Bank. Characterization for the Working Cell Bank is free of charge
if concurrent with Master Cell Bank testing.

	
      12.
	
      A [
      * ]-vial cGMP Master Cell Bank and Working Cell Bank will be released
      according to the agreed program. 

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      13.
	
      The
      Master Cell Bank and Working Cell Bank will be characterised using the
      following range of tests:

	·  	
      Confirmation
      of species (API Listeria)

	·  	
      Confirmation
      of strain by partial genotyping 

	·  	
      Plasmid
      stability by serial sub-culture

	·  	
      Counter
      selection for monosepsis

	·  	
      Plasmid
      identity by restriction digest

	·  	
      DNA
      sequence of the plasmid (to be invoiced
separately).

	14.	The
      non-cGMP material for use in toxicology studies, stability testing, and
      quality control
      lot release will produced at the [ * ] scale with a yield of [ * ]
      based
      upon the feasibility study achieving cell densities of at least [ * ]
      viable cells per litre of culture.

	15.	The
      following documentation will be provided to support a Regulatory
      filing:

Certificates
of Analysis
Analytical
Reports

 

Stage
IV

	16.	cGMP
      Manufacture:
      Prices are estimates without knowledge of the results of the Phase I
      Feasibility Program and may require variances to this proposal. If the
      productivity of the strain cannot be developed to achieve cell densities
      of at least [ * ] viable cells per litre of culture the delivery of [ * ]%
      of final bulk material cannot be guaranteed. The expected quantity of bulk
      and scale required will be advised as soon as it is determined during the
      Phase I Feasibility and Development Program and prior to initiation of the
      Phase II cGMP manufacturing program. If cell densities of [ *
      ] cells
      per litre are obtained in the feasibility study then a [ * ] fermentation
      should yield the requested [ * ] clinical material. If the desired cell
      densities of [ * ] cells per litre are not achieved, then the cGMP
      manufacturing program will be renegotiated.

Stage
V

	17.	Product
      Stability Testing will be required, but will be negotiated as a separate
      contract once the methods have been developed and the protocol agreed by
      Advaxis after FDA discussions. Stability tests for genetic stability; cell
      bank stability and bulk drug stability will be developed once a program is
      agreed upon. The figure provided is for budgetary
purposes.

Stage
VI

	18.	Documentation.

The
following documentation will be provided:

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Certificate
of Analysis

Technical
Summary to support regulatory filing

A copy of
the completed BMR will be provided. 

	19.	Specifications

Cobra
warrants that upon delivery of the Product to Advaxis, Inc. the Product
shall:

	·  	
      Have
      been manufactured in accordance with cGMP. 

	·  	
      Be
      in conformity with the provisional draft specifications as attached to
      this document.

	·  	
      That
      Cobra will provide Product of sufficient quality for human clinical
      use.

	·  	
      In
      the event the Product fails to meet any of the specification described
      above, the final determination as to the suitability of the product for
      human clinical use shall be determined by Advaxis, Inc., who may consult
      with the appropriate offices of the US FDA or other regulatory
      agencies.

Stage
VII

	
      20.
	
      Fill/Finish
      will be subcontracted to BioReliance. A quote cannot be provided until the
      type of container, number of vials and other variables have been
      determined. The figure provided is for budgetary purposes.
  

	20.	The
      costs of consumables have not been included in this quotation and will be
       
      billed directly to the customer without additional charge.

	21.	The
      cost of subcontracted work has not been included in this quotation and
      will be billed
      directly to the customer (plus a [ * ]% handling
charge).

	
      22.
	
      Cobra
      will take responsibility for shipment. The price of shipment of bulk,
      dosage forms and samples and insurance thereof is excluded from this
      contract. Shipping will be arranged in consultation with the customer and
      will be billed directly to the customer (plus a [ * ]% handling
      charge).

	23.	Cobra
      and/or Advaxis, Inc. may wish to issue a press release relating to this
      contract. However, prior to any information being disclosed written
      approval must be obtained from the other party.

 

	24.	The
      Customer agrees to pay reasonable travel expenses connected with Cobra
      staff attending
      meetings, other than those on Company premises and requested by the
      Customer.
      

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      25.
	
      Cobra
      Bio-Manufacturing plc’s O422 Phase I Terms and Conditions and O422 Phase
      II Terms and Conditions apply to this work and acceptance of this
      quotation implies acceptance of these Terms and Conditions.
    

How
to Proceed

Please
return a signed copy of the enclosed contract with your formal Purchase Order to
Cobra Biomanufacturing. 

Cobra
Biomanufacturing Plc

The
Science Park

Keele,
United Kingdom ST5 5SP

Phone:
011 44 1782 714181

Fax: 011
44 1782 714168

When
timing is critical a faxed version is acceptable, but an original must be signed
and returned within fourteen days. Upon receipt Cobra will notify the client of
acceptance within 72 hours.

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Advaxis,
Inc.

212
Carnegie Center, Suite 206

Princeton,
NJ 08540 USA

July 7,
2003

Contract
O422

Determination
of Manufacturing Parameters, Process Development and cGMP Manufacture
of L.
monocytogenes

  

(a)
Phase I: Two-month Feasibility Study and Development
Program

Price 

(Line
items: a + b + c):

Total:       $[
* ]

Terms
of Payment

The
following payment terms will apply: On receipt of a signed copy of the Contract,
Cobra Biomanufacturing Plc. will begin Phase I. Upon commencement of the work
program, Advaxis will be invoiced for $[ * ] net 30 days and will be invoiced
the remaining $[ * ] appropriately on a monthly basis for the length of the
program. The final invoice will be sent before [ * ]. 

This
phase of the program is governed by the Terms and Conditions set out in the
attached document “ O422 Phase I Terms and Conditions”.

Phase
II: Pre-Clinical and GMP Manufacture

Price
Estimate is based on [ * ] cGMP manufacture: 

(Line
items: d + e + f + g + i +k + l + m + n + o)

Total:       $[
* ] (excluding Fill/Finish)

Terms
of Payment

The
following payment terms will apply: On receipt of a signed copy of the Contract,
Cobra Biomanufacturing Plc. will hold a slot for Advaxis without a deposit.
Advaxis will be notified of any request for the slot and may reserve the slot
with a [ * ]% deposit. Receipt of this payment will reserve the production slots
as per the agreed program. On commencement of the work program, [ * ]% of the
cost will be appropriately invoiced on a monthly
basis for the length of the program, with the remaining [ * ]% due upon the
delivery and acceptance of the Certificate of Analysis by the Customer’s QA
Department (less
deposit if required). There is an intention by Advaxis and Cobra to agree on %
royalties of final commercial products utilizing the current Listeria
monocytogenes platform and variations thereof for various indications in
exchange for a reduction in price of the Phase II cGMP manufacturing campaign of
proposal 0422.

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This
phase of the program is governed by the Terms and Conditions set out in the
attached document “ O422 Phase II Terms and Conditions”.

Contract
O422

Determination
of Manufacturing Parameters, Process Development and cGMP Manufacture
of L.
monocytogenes

  

For
Advaxis, Inc.                For Cobra
Biomanufacturing Plc

Accepted
by: J. Todd Derbin          
David R.
Thatcher

Signature:
/s/ J. Todd Derbin   /s/ David
R. Thatcher

Date:
7/7/03  
8th July
2003

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CTL.0422.S.1.1

Provisional
Draft Specification

                      

 

	Test	 Method  Specification
	 	 
	[ * ]	 
	 	 
	
      Identity
	 
	 	 
	
      API
      Listeria
	
      Profile
      number conforms, typically >0.95

	 	 
	
      Growth
      on selective media
	
      Good
      growth

	 	 
	
      Gram
      strain
	
      Gram
      positive

	 	 
	
      Colony
      morphology
	
      Complies
      with that for L. monocytogenes

Quantity

[ *
]

Purity

[ *
]

 

 

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       July
      7, 2003EXHIBIT 10.20
                              CONSULTANCY AGREEMENT

      THIS CONSULTANCY AGREEMENT (this "Agreement") is made as of this 15th day
of January, 2005, by and between Advaxis, Inc, a Colorado corporation, having a
principal place of business at 212 Carnegie Center, Princeton, NJ ("Company"),
and David Filer, Ph.D. having an address at 165 E. 32nd St. Apt #2F, New York,
NY 10016, Phone: 212-689-1373, Fax: 212-581-7010 ("Consultant").

      WHEREAS, Consultant and Company desire to enter into an agreement for the
performance by Consultant of certain consulting services (the "Services"); and

      WHEREAS, Consultant has the specific knowledge, experience, and expertise
to perform the Services;

      NOW, THEREFORE, in consideration of the mutual covenants, terms, and
conditions hereinafter set forth, and intending to be legally bound, Company and
Consultant agree as follows:

1. SERVICES AND COMPENSATION

      1.1 Services. Consultant shall provide the Services and perform all duties
as requested by Company, as more particularly set forth in SCHEDULE A. Company
agrees that Consultant shall have reasonable access to Company's representatives
as necessary to perform the Services provided for by this Agreement.

      1.2 Reports. Consultant shall communicate the progress of each Project
Plan to Company informally on a regular basis and in written reports to be
provided to Company as specified in each Project Plan, and if not specified in a
Project Plan, then on a calendar quarterly basis within ten (10) days after the
end of such calendar quarter. Each written report shall be subject to acceptance
by Company.

      1.3 Compensation. Consultant shall be paid for performance of the Services
as specified in SCHEDULE B. Notwithstanding the foregoing, Company may suspend
payment if, in Company's reasonable opinion after review of such reports,
Consultant has not been performing the Services in the manner and in accordance
with the schedule set forth in the applicable Project Plan and pursuant to this
Agreement.

      1.4 Conflict of Interest; Non-Exclusive Arrangement.

            1.4.1 If a conflict of interest should arise during the performance
of this Agreement, Consultant shall immediately notify Company thereof and
Company shall have the option to pursue any and all remedies, equitable, legal
or otherwise, that may be available to Company in connection therewith.
Consultant shall ensure that its performance of the Services does not conflict
with Consultant's duties with other entiries.

            1.4.2 Company may from time to time (i) engage other persons and
entities to act as consultants to Company and perform services for Company,
including, without limitation, services similar to the Services, and (ii) enter
into agreements similar to this Agreement with other persons or entities, in all
cases without the necessity of obtaining any approval from Consultant.

            1.4.3 Subject to the provisions of Section 6.2, Consultant may from
time to time act as a consultant to, perform services for, or enter into
agreements similar to this Agreement with, other persons or entities without the
necessity of obtaining approval from Company; provided, however, that in no
event shall Consultant provide such other persons or entities with, or
incorporate into or provide as part of any services for such other persons or
entities, any information or know-how obtained by Consultant through its conduct
of the Services (including, without limitation, any Confidential Information (as
defined below)) and provided further that Consultant shall not provide services
to any entity engaged in the research or development or marketing of vaccines.

                                                                     Page 1 of 8
<PAGE>

2. CONFIDENTIAL INFORMATION

      2.1 Confidentiality. Consultant agrees to maintain in strict confidence
all Confidential Information (as defined below) provided to, or learned or
developed by, Consultant during the course of Consultant's performance of the
Services. Consultant shall not disclose or disseminate any Confidential
Information to any person or entity, except with the prior written consent of
Company. In addition, Consultant shall not use or copy any Confidential
Information for any purpose other than in connection with performance of the
Services hereunder.

      2.2 Definition of Confidential Information. The term "Confidential
Information" shall mean all trade secrets, processes, formulae, data and
know-how, improvements, inventions, chemical or biological materials,
techniques, marketing plans, strategies, customer lists, or other information
that has been created, discovered, or developed by Company, or has otherwise
become known to Company, or which proper rights have been assigned to Company,
as well as any other information and materials that are deemed confidential or
proprietary to or by Company (including, without limitation, all information and
materials of Company's customers and any other third party and their
consultants), regardless of whether any of the foregoing are marked
"confidential" or "proprietary" or communicated to Consultant by Company in
oral, written, graphic or electronic form.

      2.3 Exceptions to Confidential Information. Notwithstanding the foregoing
paragraph, "Confidential Information" shall not include any information or
materials that: (a) are or become known to the general public through no act or
omission of Consultant or any other person with an obligation of confidentiality
to Company, or (b) are required to be disclosed pursuant to applicable law
(provided, however, that prior to any disclosure of Confidential Information as
required by applicable law, Consultant shall advise Company of such required
disclosure promptly upon learning thereof and shall cooperate with Company in
order to afford them a reasonable opportunity to contest or limit such
disclosure).

      2.4 Consultant-Restricted Information. Consultant agrees that Consultant
will not improperly use or disclose to the Company any proprietary or
confidential information or trade secrets of any person or entity with whom
Consultant has an agreement or duty to keep such information or secrets
confidential.

      2.5 Use of Third Party Information. Consultant will not use any equipment,
supplies, chemicals, molecules, organisms, biological materials, or other
physical property, facilities or trade secret information of any present or
former employee or consulting client which are not generally available to the
public, unless Consultant has obtained prior written authorization for such use
and have delivered a copy of such authorization to Company prior to such use.
Notwithstanding such authorization, Company shall have the right, at its sole
discretion, to exclude the use of any of the foregoing by Consultant.

3. INTELLECTUAL PROPERTY

      3.1 Assignment of Inventions. Consultant agrees that Consultant will
promptly make full written disclosure to Company, will hold in trust for the
sole right and benefit of Company, and hereby assigns, transfers and conveys to
Company, or its designee, all of Consultant's worldwide right, title, and
interest in and to any and all inventions, original works of authorship,
findings, conclusions, data, discoveries, developments, concepts, improvements,
trade secrets, techniques, processes and know-how, whether or not patentable or
registrable under copyright or similar laws, which Consultant may solely or
jointly conceive or develop or reduce to practice, or cause to be conceived or
developed or reduced to practice, in the performance of the Services or which
result, to any extent, from use of Company's premises or property (collectively,
the "Inventions"), including, without limitation, any and all intellectual
property rights inherent in the Inventions and appurtenant thereto including,
without limitation, all patent rights, copyrights, trademarks, know-how and
trade secrets (collectively, "Intellectual Property Rights"). Consultant
acknowledges and agrees that certain of the Inventions (whether made solely by
Consultant or jointly with others) may be "works made for hire," as that term is
defined in the United States Copyright Act, and therefore Company would be
deemed the owner of such Inventions. For purposes of clarification, to the
extent any Invention is not a "work made for hire," such Invention would be
subject to the assignment in the first sentence of this Section 3.1.

                                                                     Page 2 of 8

<PAGE>

      3.2 Further Assurances. Upon the request and at the expense of Company,
Consultant shall execute and deliver any and all instruments and documents and
take such other acts as may be necessary or desirable to document the assignment
and transfer described in Section 3.1 or to enable Company to secure its rights
in the Inventions and any patents, trademarks, copyrights or other intellectual
property rights relating thereto in any and all jurisdictions, or to apply for,
prosecute and enforce patents, trademark registrations, copyrights or other
intellectual property rights in any and all jurisdictions with respect to any
Inventions, or to obtain any extension, validation, re-issue, continuance or
renewal of any such intellectual property right.

4. REPRESENTATIONS AND WARRANTIES

      4.1 Each party represents and warrants that, to the best of its knowledge,
it has the right to enter into and to perform its obligations hereunder without
thereby breaching any of its obligations to third parties.

      4.2 Consultant represents and warrants to Company that: (i) the Services
performed by Consultant hereunder will be of professional quality, consistent
with generally-accepted industry standards and expectations for work of a
similar nature, (ii) all Services provided to Company hereunder shall conform to
the agreed-upon specifications therefor, if any, (iii) to the best of
Consultant's knowledge, all Services, Inventions, and Intellectual Property
Rights provided to Company hereunder will not infringe or misappropriate the
patent, copyright, trademark, trade secret, or other intellectual property
rights of any third party, (iv) Consultant's performance under this Agreement
and Consultant's retention as a consultant by Company does not and will not
breach any obligation or agreement by which Consultant is bound to keep in
confidence any information Consultant may acquire, or not to compete with any
other person or entity, and (v) Consultant has not entered into, and will not
enter into, any agreement, and is not affected by any policy, either written or
oral, that would interfere or be inconsistent with Consultant's performance
under this Agreement. Consultant shall indemnify, defend, and hold harmless
Company and its officers and employees from and against any and all losses,
damages, liabilities, obligations, judgments, penalties, fines, awards, costs,
expenses, and disbursements (including without limitation, the costs, expenses
and disbursements, as and when incurred, of investigating, preparing or
defending any claim, action, suit, proceeding, or investigation) suffered or
incurred by Company on account of Consultant's breach of any of the foregoing
representations and warranties.

      4.3 COMPANY MAKES NO OTHER WARRANTY RELATING TO THE CONFIDENTIAL
INFORMATION AND THE USE TO BE MADE THEREOF BY CONSULTANT AND HEREBY DISCLAIMS
ALL IMPLIED WARRANTIES.

5. TERM

      5.1 Term. The initial term of this Agreement shall be six months ("Initial
Term"). The Term may be extended upon mutual agreement of the parties in
writing.

      5.2 Termination. Each party may terminate this Agreement upon thirty (30)
days prior written notice to the other party.

      5.3 Return of Company Property. All property belonging to Company in
Consultant's possession or control, including, without limitation, all
Confidential Information (as well as all copies, summaries, or other
representations thereof) and all originals and copies of any documents, devices,
records, data, notes, reports, proposals, lists, correspondence, specifications,
drawings, blueprints, sketches, materials, and equipment shall be and remain the
sole property of Company and shall be returned promptly to Company upon the
expiration or earlier termination of this Agreement, and earlier if requested by
Company at any time. Consultant shall not remove any of Company's property from
Company's premises without prior written authorization from Company.

                                                                     Page 3 of 8

<PAGE>

      5.4 Survival. In the event this Agreement expires or is terminated for any
reason, the rights and obligations of Sections 5.3, 5.4 and Articles 2, 3, 4, 6
and 7 shall survive such expiration or termination.

6. NON-SOLICITATION AND NON-COMPETITION

      6.1 Non-solicitation. Consultant agrees that during the term of this
Agreement and for one year thereafter, Consultant shall not for any reason,
either directly or indirectly, on Consultant's own behalf or in the service or
on behalf of others, (i) solicit, recruit or attempt to persuade any person to
terminate employment or a consulting relationship with Company or (ii) interfere
in any manner with Company's relationship with, any of Company's co-venturers,
vendors, suppliers, licensors or partners.

      6.2 Non-competition. During the term of this Agreement and for one year
thereafter, Consultant shall not, either directly or indirectly, alone or as a
consultant, partner, officer, director, employee, joint venturer, lender or
stockholder of any entity, accept employment with or provide consulting services
to, any business or entity or engage in any business or activity that relates to
cancer vaccines.

7. MISCELLANEOUS

      7.1 Social Security Number. Consultant certifies that his or her correct
Social Security is listed on the first page of this Agreement. Consultant
acknowledges that Company will rely upon the foregoing certification in filing
certain documents and instruments required by law in connection with this
Agreement, including, without limitation, Form 1099 under the Internal Revenue
Code of 1986, as amended (or any successor form).

      7.2 Independent Contractor. For purposes of this Agreement and all
Services to be provided hereunder, Consultant shall not be considered a partner,
co-venturer, agent, employee or representative of Company, but shall remain in
all respects an independent contractor, and neither party shall have any right
or authority to make or undertake any promise, warranty or representation, to
execute any contract, or otherwise to assume any obligation or responsibility in
the name of or on behalf of the other party. Without limiting the generality of
the foregoing, Consultant shall not be considered an employee of Company for
purposes of any state or federal laws relating to unemployment insurance, social
security, workers compensation or any regulations which may impute an obligation
or liability to Company by reason of an employment relationship. Consultant
agrees to pay all income, FICA, and other taxes or levies imposed by any
governmental authority on any compensation that Consultant receives under this
Agreement. Consultant shall indemnify, defend and hold harmless Company and its
officers and employees from and against any and all losses, damages,
liabilities, obligations, judgments, penalties, fines, awards, costs, expenses
and disbursements (including without limitation, the costs, expenses and
disbursements, as and when incurred, of investigating, preparing or defending
any claim, action, suit, proceeding or investigation) suffered or incurred by
Company as a result of any allegation that Consultant is an employee of Company
by virtue of performing any work for or on behalf of Company hereunder or
otherwise.

      7.3 Rules and Policies. While at Company's facilities, Consultant shall
observe and follow Company's work rules, policies, and standards as the same are
communicated to Consultant from time to time, including, without limitation,
those rules, policies and standards of Company relating to security of and
access to facilities, telephone systems, electronic mail systems, and computer
systems.

                                                                     Page 4 of 8

<PAGE>

      7.4 Successors. All of the terms and provisions of this Agreement shall be
binding upon and inure to the benefit of and be enforceable by the respective
heirs, executors, administrators, legal representatives, successors and assigns
of the parties hereto, except that the duties and responsibilities of Consultant
hereunder are of a personal nature and shall not be assignable or delegable in
whole or in part by Consultant.

      7.5 Equitable Relief. Consultant hereby acknowledges and agrees that
damages at law may be an inadequate remedy for any breach of Consultant's
obligations under Article 2 (Confidential Information), Article 3 (Intellectual
Property), Article 6 (Non-Solicitation and Non-Competition), and, accordingly,
Consultant agrees that Company will be entitled to such temporary, preliminary
and permanent injunctive relief as may be necessary to remedy or limit such
breach, without the necessity of proving actual damages or posting any bond or
other security, and including specific performance of such obligations and an
order enjoining Consultant from the continuation of, or from any threatened,
breach of such obligations. The rights set forth in this paragraph shall be in
addition to, and not in lieu of, any other rights which Company may have at law
or in equity.

      7.6 Publicity. Consultant shall not disclose to any third party any
information about the Services provided or to be provided by Consultant for or
on behalf of Company, except as may be required by law or as Company may
otherwise agree in writing.

      7.7 Assignment. Consultant shall not assign this Agreement or any right
hereunder, nor delegate of any Consultant's duties hereunder, without the prior
written consent of Company.

      7.8 Amendments. No change, modification, extension, termination or waiver
of this Agreement, or any of the provisions herein contained, shall be valid
unless made in writing and signed by Consultant and a duly authorized
representative of Company.

      7.9 No Waiver. No term or provision of this Agreement will be considered
waived and no breach consented to by either party unless such waiver or consent
is in writing signed on behalf of the party against whom it is asserted. No
consent to or waiver of a breach of this Agreement by either party, whether
express or implied, will constitute a consent to, waiver of, or excuse for any
other, different, or subsequent breach of this Agreement by such party.

      7.10 Severability. Any provisions of this Agreement which are determined
to be invalid or unenforceable in any jurisdiction shall be ineffective to the
extent of such invalidity or unenforceability in such jurisdiction, without
rendering invalid or unenforceable the remaining provisions of this Agreement or
affecting the validity or enforceability of such provisions in any other
jurisdiction. If a court of competent jurisdiction declares any provision of
this Agreement to be invalid or unenforceable, the parties hereto shall request
that such court reduce the scope, duration, or area of the provision, delete
specific words or phrases from the provision, or to replace the provision with a
provision that is valid and enforceable and that comes closest to expressing the
original intention of the parties hereto, and this Agreement shall be
enforceable as so modified in the jurisdiction in which the provision was
declared invalid or unenforceable.

      7.11 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of New Jersey without regard to its conflict of law
provisions.

      7.12 Entire Agreement. This Agreement represents the entire agreement
between the parties regarding the Services provided during the term of this
Agreement and shall supersede all previous communications, representations,
understandings, and agreements, whether oral or written, by or between the
parties with respect thereto, whether theretofore or hereafter disclosed to
Consultant. Without limitation, this Agreement does not supersede any
confidentiality agreement that may have been signed between Company and
Consultant.

                                                                     Page 5 of 8

<PAGE>

      7.13 Counterparts. This Agreement may be executed in two counterparts,
each of which shall be deemed to be an original as against any party whose
signature appears thereon, but both of which together shall constitute but one
and the same instrument.

                      [SIGNATURE PAGE IMMEDIATELY FOLLOWS]

                                                                     Page 6 of 8
<PAGE>

IN WITNESS HEREOF, the parties have read and agree to be bound by the above
terms and conditions and have entered into this Agreement effective as of the
date set forth above.

COMPANY                                  CONSULTANT

By: /s/ J. Todd Derbin                   By: /s/ David Filer
---------------------------------        ---------------------------------------
                     (Signature)         (Signature) Dr.

J. Todd Derbin                           David Filer
---------------------------------        ---------------------------------------
Printed Name                             Printed Name

CEO                                      Biotech Consultant
---------------------------------        ---------------------------------------
Title                                    Title

---------------------------------        ---------------------------------------
Date                                     Date

                                                                     Page 7 of 8
<PAGE>

                                   SCHEDULE A

                                  PROJECT PLAN
                                       FOR
                                  PROJECT NO. 1

I.    CONSULTING SERVICES

      Scope: for three days per month during the term of this agreement and any
      extension thereof, Consultant shall provide Company with Consulting
      services and advise the Company on the subjects and tasks detailed below:

      i.    Assisting and advising Company on its development efforts;

      ii.   Reviewing Company scientific technical and business data and
            materials;

      iii.  Introducing he Company to industry analysts, institutional investors
            collaborators and strategic partners.

II.   COMPENSATION AND PAYMENT SCHEDULE

      Cash: a monthly consulting fee of $2,000 during the Term. EQUITY
      COMPENSATION. Company is planning to adopt its 2005 option plan ("Plan").
      Pursuant to the terms of Plan, and subject to the approval and
      establishment of the Plan, Company agrees to grant stock options
      ("Options") to Consultant for 40,000 (forty thousand) Shares of Common
      Stock, vesting monthly over 12 months provided that this Agreement has not
      been terminated. The Options shall be non-qualified. Other terms and
      conditions as set forth in the Plan shall apply.

                                                                     Page 8 of 8

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