As
filed with the Securities and Exchange Commission on March 2,
2006.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
POST-EFFECTIVE
AMENDMENT NO. 2 TO FORM SB-2
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
___________
Advaxis,
Inc.
(Name
of small business issuer in our charter)
|
Colorado
(State
or other jurisdiction
of
incorporation or organization)
|
2836
(Primary
Standard Industrial
Classification
Code Number)
|
841521955
(I.R.S.
Employer
Identification
No.)
|
|
Technology
Center of New Jersey
675
Route 1, Suite 119
North
Brunswick, NJ 08902
(201)
750-2347
(Address,
including zip code, and telephone number, including area code,
of
registrant’s principal place of business)
___________________________
Mr.
Roni Appel, Acting Chief Executive Officer
Technology
Center of New Jersey
675
Route 1, Suite 119
North
Brunswick, NJ 08902
(201)
750-2347
(Name,
address, including zip code, and telephone number, including area
code, of
registrant’s agent for service)
___________________________
Copies
to:
|
|||
|
Gary
A. Schonwald, Esq.
Reitler
Brown & Rosenblatt LLC
800
Third Avenue
21st
Floor
New
York, New York 10022
(212)
209-3050 / (212) 371-5500 (Telecopy)
|
|||
|
Approximate
date of commencement of proposed sale to the public. From
time to time after this Registration Statement becomes
effective.
If
any of the Securities being registered on this Form are to be offered
on a
delayed or continuous basis pursuant to Rule 415 under the Securities
Act
of 1933, as amended, check the following box: S
If
this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act of 1933, please
check the
following box and list the Securities Act registration statement
number of
the earlier effective registration statement for the same offering:
o
If
this Form is a post-effective amendment filed pursuant to Rule
462(d)
under the Securities Act of 1933, check the following box and list
the
Securities Act of 1933 registration statement number of the earlier
effective registration statement for the same offering: o
If
delivery of the prospectus is expected to be made pursuant to Rule
434,
please check the following box: o
|
|||
1
INFORMATION
NOT REQUIRED IN PROSPECTUS
This
Post-Effective Amendment No. 2 to Form SB-2, dated and filed with the Securities
and Exchange Commission (the “SEC”)
on
February 3, 2005, as amended by Pre-Effective Amendments on April 8, 2005,
April
28, 2005, June 1, 2005 and June 9, 2005 and as amended by Post-Effective
Amendment No. 1 on January 5, 2006 (the “Original
Filing”)
is
being filed for the purpose of amending Exhibit 10.33. Except as filed herewith,
the exhibits listed below were filed as exhibits to the Original Filing.
POST-EFFECTIVE
AMENDMENT NO. 2 TO FORM SB-2
EXHIBITS
|
EXHIBIT
NUMBER
|
DESCRIPTION
OF EXHIBIT
|
|
Exhibit
3.1
|
Amended
and Restated Articles of Incorporation. Incorporated by reference
to
Exhibit 4.2 to Report on Form S-8 filed with the SEC on December
1,
2005.
|
|
Exhibit
3.2
|
Amended
and Restated Bylaws. Incorporated by reference to Exhibit 3.1 to
Report on
Form 8K filed with the SEC on December 27, 2004.
|
|
Exhibit
4.1
|
Form
of Warrant issued to purchasers. Incorporated
by reference to Exhibit 4.1 to Report on Form 8K filed with the SEC
on
November 18, 2004.
|
|
Exhibit
4.2
|
Form
of Warrant issued to Placement Agent. Incorporated
by reference to Exhibit 4.2 to Report on Form 8K filed with the SEC
on
November 18, 2004.
|
|
Exhibit
5.1
|
Opinion
of Jody M. Walker, Esq.
|
|
Exhibit
10.1
|
Share
and Exchange Agreement, dated as of August 25, 2004, by and among
the
Company, Advaxis and the shareholders of Advaxis. Incorporated
by reference to Exhibit 10.1 to Report on Form 8K filed with the
SEC on
November 18, 2004.
|
|
Exhibit
10.2
|
Form
of Securities Purchase Agreement, by and among the Company and the
purchasers listed as signatories thereto. Incorporated
by reference to Exhibit 10.2 to Report on Form 8K filed with the
SEC on
November 18, 2004.
|
|
Exhibit
10.3
|
Form
of Registration Rights Agreement, by and among the Company and the
persons
listed as signatories thereto. Incorporated
by reference to Exhibit 10.3 to Report on Form 8K filed with the
SEC on
November 18, 2004.
|
|
Exhibit
10.4
|
Form
of Standstill Agreement, by and among the Company and persons listed
on
Schedule 1 attached thereto. Incorporated
by reference to Exhibit 10.4 to Report on Form 8K filed with the
SEC on
November 18, 2004.
|
2
|
Exhibit
10.5
|
Amended
and Restated Employment Agreement, dated December 20, 2004, by and
between
the Company and J.Todd Derbin. Incorporated by reference to Exhibit
10.1
to Report on Form 8K filed with the SEC on December 23,
2004.
|
|
Exhibit
10.6
|
2004
Stock Option Plan of the Company. Incorporated by reference to Exhibit
4.1
to Report on Form S-8 filed with the SEC on December 1,
2005.
|
|
Exhibit
10.7
|
License
Agreement, dated as of June 17, 2002, by and between Advaxis and
The
Trustees of the University of Pennsylvania*.
|
|
Exhibit
10.8
|
Non-Exclusive
License and Bailment, dated as of March 17, 2004, between The Regents
of
the University of California and Advaxis, Inc.
|
|
Exhibit
10.9
|
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP Management,
LLC. and the Company.
|
|
Exhibit
10.10
|
Government
Funding Agreement, dated as of April 5, 2004, by and between David
Carpi
and Advaxis, Inc.
|
|
Exhibit
10.11
|
Amended
and Restated Consulting and Placement Agreement, dated as of May
28, 2003,
by and between David Carpi and Advaxis, Inc., as
amended
|
|
Exhibit
10.12
|
Consultancy
Agreement, dated as of January 22, 2005, by and between Dr. Yvonne
Paterson and Advaxis, Inc.
|
|
Exhibit
10.13
|
Consultancy
Agreement, dated as of March 15, 2003, by and between Dr. Joy A.
Cavagnaro
and Advaxis, Inc.
|
|
Exhibit
10.14
|
Grant
Writing Agreement, dated June 19, 2003, by and between DNA Bridges,
Inc.
and Advaxis, Inc.
|
|
Exhibit
10.15
|
Consulting
Agreement, dated as of July 2, 2004, by and between Sentinel Consulting
Corporation and Advaxis, Inc.
|
|
Exhibit
10.16
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and
Advaxis,
Inc.*
|
|
Exhibit
10.17
|
Securities
Purchase Agreement, dated as of January 12, 2005, by and between
the
Company and Harvest Advaxis LLC. Incorporated by reference to Exhibit
10.1
to Report on Form 8K filed with the SEC on January 18,
2005.
|
|
Exhibit
10.18
|
Registration
Rights Agreement, dated as of January 12, 2005, by and between the
Company
and Harvest Advaxis LLC. Incorporated by reference to Exhibit 10.2
to
Report on Form 8K filed with the SEC on January 18,
2005.
|
|
Exhibit
10.19
|
Letter
Agreement, dated as of January 12, 2005 by and between the Company
and
Robert T. Harvey. Incorporated
by reference to Exhibit 10.3 to Report on Form 8K filed with the
SEC on
January 18, 2005.
|
|
Exhibit
10.20
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Dr. David
Filer
and the Company.
|
|
Exhibit
10.21
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the Company.
|
3
|
Exhibit
10.22
|
Agreement,
dated February 1, 2004, by and between Strategic Growth International
Inc.
and the Company.
|
|
Exhibit
10.23
|
Letter
Agreement, dated February 10, 2005, by and between Richard Berman
and the
Company.
|
|
Exhibit
10.24
|
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi and
the
Company.
|
|
Exhibit
10.25
|
Employment
Agreement, dated March 1, 2005, by and between John Rothman and the
Company.
|
|
Exhibit
10.26
|
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the Company.*
|
|
Exhibit
10.27
|
Amendment
to Consultancy Agreement, dated as of April 4, 2005, between LVEP
Management LLC and the Company.
|
|
Exhibit
10.28
|
Royalty
Agreement, dated as of May 11, 2003, by and between Cobra
Bio-Manufacturing PLC and the Company
|
|
Exhibit
10.29
|
Resignation
Agreement between J. Todd Derbin and the Company dated October 31,
2005.
Incorporation by reference to Exhibit 10.1 to report of Form 8-K
filed
with the SEC on November 9, 2005.
|
|
Exhibit
10.30
|
Second
Amendment to Consultancy Agreement between the Company and LVEP Management
LLC, dated October 31, 2005. Incorporation by reference to Exhibit
10.2 to
Report on Form 8-K filed with the SEC on November 9, 2005.
|
|
Exhibit
10.31
|
Letter
of Agreement between the Company and the Investor Relations Group
Inc.,
dated September 27, 2005.
|
|
Exhibit
10.32
|
Consulting
Agreement between the Company and Freemind Group, LLC dated October
17,
2005.
|
|
Exhibit
10.33
|
Strategic
Collaboration and Long Term Vaccine Supply Agreement between the
Company
and Cobra Bio-Manufacturing PLC date October 31, 2005*
|
|
Exhibit
14.1
|
Code
of Ethics. Incorporated
by reference to Exhibit 14.1 to Report on Form 8K filed with the
SEC on
November 18, 2004.
|
|
Exhibit
21.1
|
Advaxis,
Inc., a Delaware corporation
|
|
Exhibit
23.1
|
Consent
of Goldstein
Golub Kessler LLP
|
|
Exhibit
23.2
|
Consent
of Jody
M. Walker, Esq. (included
in Exhibit 5.1 above)
|
|
Exhibit
24.1
|
Power
of Attorney (Included on the signature
page)
|
----------------------
*
Confidential Treatment sought.
4
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the Registrant has duly
caused this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in North Brunswick, Middlesex
County, State of New Jersey, on the 2nd
day of
March, 2006.
| ADVAXIS, INC. | ||
| |
|
|
| By: | /s/ Roni Appel | |
|
Roni Appel,Chief Executive Officer |
||
POWER
OF ATTORNEY
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration
Statement has been signed by the following persons in the capacities and on
the
dates indicated:
|
SIGNATURE
|
TITLE
|
DATE
|
|
s/
Roni Appel
|
Chief
Executive Officer, Chief Financial Officer and Director (Principal
Financial and Accounting Officer)
|
March
2, 2006
|
|
*
J.
Todd Derbin
|
Chairman
of Board of Directors
|
March
2, 2006
|
|
*
|
Director
|
March
2, 2006
|
|
*
James
Patton
|
Director
|
March
2, 2006
|
|
*
Richard
Berman
|
Director
|
March
2, 2006
|
*
By:
/s/
Roni Appel____________________________
Roni Appel
Attorney-in-fact
5
|
Confidential
|
Page
1
|
Confidential
Treatment Request
[
* ] indicates information that has
been
omitted pursuant to a
confidential
treatment request and
this
information has been filed under
separate
cover with the Commission
DATED
OCTOBER31, 2005
(1) COBRA
BIO-MANUFACTURING PLC
(2) ADVAXIS
INC
---------------------------------------------------------------------------
STRATEGIC
COLLABORATION AND LONG TERM VACCINE SUPPLY AGREEMENT
--------------------------------------------------------------------------
DRAFT
for Discussion Only
|
Confidential
|
Page
2
|
THIS
AGREEMENT
is made
the 31 day
of
October
2005
BETWEEN
|
(1)
|
COBRA
BIOLOGICS Ltd (a
wholly owned subsidiary of Cobra Biomanufacturing Plc) whose principal
place of business is at Stephenson Building, The Science Park,
University
of Keele, Keele, Staffordshire, ST5 5SP (“Cobra”);
and
|
| (2) |
ADVAXIS
INC whose
principal place of business is 212 Carnegie Center Suite
206, Princeton, NJ 08540 USA
(“Advaxis”).
|
Suite
206, Princeton, NJ 08540 USA (“Advaxis”).
BACKGROUND
| (A) |
The
parties have agreed to enter an agreement for Cobra to manufacture
and
supply products in the field of live or dead wild type attenuated
or
recombinant Listeria based vaccines for use in cancer and other
indications to Advaxis and for Advaxis and/or its affiliates to
undertake
clinical trials and commercial sales in respect of such
vaccines.
|
| (B) |
The
parties have agreed that Cobra will have the right of first refusal
to
manufacture and supply Clinical Product and Bulk Product (as defined
hereinafter) for use in the program of research and development,
clinical
trials and commercial exploitation. If Cobra is unwilling, or unable
to
supply and manufacture either Clinical Product or Bulk Product
under the
terms herein, Cobra will transfer the necessary Vaccine Process
(as
defined hereinafter) to enable a third party to manufacture and
supply any
part of the Clinical Product and/or Bulk Product to Advaxis. The
parties
have further agreed that Cobra shall not supply, provide or manufacture
the Bulk Product to or for any third party.
|
| (C) |
In
exchange for the rights granted in (B) above Cobra will provide Advaxis
a
discount on the cost of the manufacture and supply by Cobra of all
Clinical Product required by Advaxis for clinical trial purposes.
For the
avoidance of doubt, this provision is not applicable to the supply
of Bulk
Product to Advaxis for commercial
sale.
|
| (D) |
The
parties have agreed that Advaxis will have care and conduct of the
exploitation of the Programme Deliverable (as defined
below).
|
IT
IS AGREED as
follows:
| 1 |
Definitions
|
| 1.1 |
In
this Agreement the following words have the following
meanings:
|
|
“Advaxis
IP”
|
means
any and all existing and/or future Intellectual Property Rights in
the
Programme Deliverable, Vaccine Process and the existing Intellectual
Property Rights set out in Schedule 2 but excluding any Cobra Know
How;
|
DRAFT
for Discussion Only
|
Confidential
|
Page
3
|
|
Drug
Product
|
Programme
Deliverable
|
|
“Bulk
Drug Substance ”
|
means
any bulk quantities of Drug Substance required by Advaxis for the
commercial exploitation of the Programme Deliverable;
|
|
“Bulk
Product”
|
means
any and all Bulk Drug Substance, Drug Product and/or Programme Deliverable
supplied by Cobra to Advaxis under this Agreement for commercial
use;
|
|
“Clinical
Product”
|
means
the Programme Deliverable which is to be used in the development
phase of
the Programme and/or the Clinical Trials;
|
|
“Clinical
Trials”
|
means
FDA Phase I, II and III clinical trials, or corresponding regulatory
trials in another jurisdiction to be undertaken by Advaxis (if
commercially viable) to test the safety and/or efficacy of the Programme
Deliverable;
|
|
“Cobra
Know How”
|
means
any of the Know How of Cobra and Intellectual Property Rights of
Cobra in
the same which can be demonstrated to have been in existence before
this
agreement and any preceeding agreements with Advaxis came into
force.
|
|
“Cobra
Terms and Conditions”
|
means
the standard terms and conditions of Cobra from time to time, the
current
version of which is set out in Schedule 3;
|
|
“Confidential
Information”
|
means
in relation to each party, any information about the other party’s
business and/or given by one party to the other party and/or generated
by
one party from the other party’s Confidential Information, including but
not limited to any information relating to the other party’s Intellectual
Property Rights and/or Know How;
|
|
“Cost”
|
means
the actual and direct aggregate costs and/or expenses (with no non-program
related overhead) associated with the production of Bulk Product
based on
the cost of raw materials plus the cost of project specific equipment
plus
direct costs of labour plus the Facility Occupancy Charge, or in
the
absence of agreement, as determined in accordance with section
21;
|
DRAFT
for Discussion Only
|
Confidential
|
Page
4
|
|
“Discount”
|
means
the discount granted by Cobra to Advaxis based on total sales by
Cobra of
the Clinical Product to Advaxis for [ * ] as detailed in Schedule
1. Any
Discount will be applied to orders placed by Advaxis for the Clinical
Product in the following [ * ];
|
|
“Drug
Substance”
|
means
the active component of the Drug Product as defined in the
“Field”.
|
|
“Drug
Product”
|
means
any quantities of the formulated dosage form incorporating a defined
quanitity of the “Drug Substance”required by Advaxis for the commercial
exploitation of the vaccine;
|
|
“Exploit”
|
means
any use, research, development, manufacture, production, distribution,
sale, marketing, licensing, assignment and/or import and the term
“exploitation” and “exploited” shall be interpreted
accordingly;
|
|
“Facility
Occupancy Charge”
|
means
the cost of running that part of the production line used to produce
the
Bulk Product to be supplied by Cobra under this Agreement as calculated
in
accordance with Schedule 4;
|
|
“Field”
|
means
in the field of live or dead cell based wild type or attenuated or
recombinant Listeria vaccine(s) with a therapeutic and/or preventative
effect;
|
|
“First
Commercial Sale”
|
shall
mean, in respect of any Resale Products, the first sale by Advaxis
on a
commercial basis in an arm's length transaction of any Resale Products
for
use in a country where the governing health regulatory authority
of such
country has granted regulatory approval of such Resale Products (to
the
extent such regulatory approval is required in such country). Any
Drug
Product, Drug Substance and/or Programme Deliverable distributed
or used
for clinical trial purposes shall not be considered sold, marketed
or made
publicly available for sale and shall not constitute first commercial
sale;
|
DRAFT
for Discussion Only
|
Confidential
|
Page
5
|
|
“Force
Majeure”
|
means
any event outside the reasonable control of either party affecting
its
ability to perform any of its obligations (other than payment) under
this
Agreement including act of God, fire, flood, lightning, war, revolution,
act of terrorism, riot or civil commotion, strikes, lock-outs or
other
industrial action, whether of the affected party’s own employees or
others, failure of supplies of power, fuel, transport, equipment,
raw
materials or other goods or services;
|
|
“Increased
Order Level”
|
means
any material increase required in the output levels of Bulk Product
for
commercial exploitation of the Programme Deliverable;
|
|
“Initial
Order Level”
|
means
the initial output levels required of Bulk Product for commercial
exploitation ;
|
|
“Intellectual
Property Rights”
|
means
all know how, inventions, conceptions, patents, methods, materials,
compositions, formulations, isomers, metabolites, processes, any
copyright, trade marks, design rights and any other intellectual
property
rights and/or industrial property rights (whether registered or
unregistered) anywhere in the world and (a) any applications for the
protection of any intellectual property rights; (b) any and all
corresponding foreign intellectual property rights and applications;
(c) provisionals, substitutions, divisionals, reexaminations,
reissues, renewals, extensions, term restorations, continuations,
continuations-in-part, substitute applications and inventors’
certificates, arising from, or based upon, any of such intellectual
property rights, and (d) intellectual property rights issuing from
any such patent applications;
|
|
“Know-How”
|
means
any and all data, know-how, methods, process, or experience (whether
patentable or not) including but not limited to manufacturing and/or
production techniques, operating instructions, raw material, intermediate
material, specifications, formulations, and any other technical and
commercial information relating to the research, development, testing,
manufacture and/or production of the Clinical Product, Bulk Product
and/or
the Programme Deliverable; ;
|
DRAFT
for Discussion Only
|
Confidential
|
Page
6
|
|
“Manufacture
Specifications”
|
means
the agreed specification for the manufacture of the Clinical Product
and/or the Bulk Product as set forth in the Programme;
|
|
“Mark
Up”
|
means
the mark up to be applied to the Cost in relation to production of
Bulk
Product being the greater of [
*
] or [ * ];
|
|
“Net
Sales”
|
means
in relation to any Resale Products :
(a) where
the Resale Products are sold on arm’s length terms, the amount received by
Advaxis less:
(i) taxes,
any value added tax or other sales tax duties or other governmental
tariffs (other than income taxes) and,
(ii)
any packing, freight, warehousing, carriage and insurance
charges,
(iii)
trade discounts, credits or allowances,
(iv)
credits or allowances additionally granted upon returns, rejections
or
recalls, and
(v)
government mandated rebates.
(b) where
the Resale Products are not sold on arm’s length terms, but are
subsequently sold on arm’s length terms, the price charged under the first
such arm’s length sale, calculated in accordance with paragraph (a) above;
and
(c) where
the Resale Products are
not sold on arm’s length terms but are used or otherwise disposed of on a
commercial basis, the price that would have been charged on the first
arm’s length sale, calculated in accordance with paragraph (a)
above;
|
DRAFT
for Discussion Only
|
Confidential
|
Page
7
|
|
“Programme”
|
means
the interactions between Cobra and Advaxis in the planning and
implementation of the research and development work, toxicology study
and/or the manufacture, production and exploitation relating to any
Clinical Product, Drug Product, Bulk Drug Substance, Programme
Deliverable, Vaccine Process or any amendment of such collaboration
as may
be agreed in writing between the parties but excluding the conduct
of the
Clinical Trials;
|
|
“Programme
Data”
|
means
all data, records, analysis, assays, notes regulatory applications,
approvals, certificates, authorizations, letters and documents,
inventions, practices, methods, knowledge, know-how, skill, experience,
test data including pharmacological, manufacture, stability, safety,
toxicological, pre-clinical studies and clinical test data, analytical
and
quality control data, marketing, manufacturing, and compounds,
compositions of matter, assays and biological materials related thereto,
and any other information stored and/or kept in whatever media produced
during the Programme other than Cobra Know How;
|
|
“Programme
IP”
|
means
any and all Intellectual Property Rights arising under, developed
or
resulting from the Programme other than the Cobra Know How;
|
|
“Resale
Products”
|
means
any and all Drug Product, Bulk Drug Substance and/or Programme Deliverable
commercially exploited by Advaxis which is produced by any Third
Party
Product Manufacturer;
|
|
“Technology
Transfer”
|
means
the transfer by Cobra of the Cobra Know-How to a Third Party Product
Manufacturer solely as necessary to enable the Third Party Product
Manufacturer to manufacture the Bulk Product for
Advaxis;
|
DRAFT
for Discussion Only
|
Confidential
|
Page
8
|
|
“Third
Party Product Manufacturer”
|
means
any third party drug product manufacturer approved in writing by
Cobra
(such approval not to be unreasonably withheld or delayed) and Advaxis
which is to supply Bulk Product to Advaxis instead of or in addition
to
Cobra;
|
|
“Programme
Deliverable”
|
means
i) the end form vaccine made from the Drug Substance and/or the Drug
Product ; ii) the Master Cell Bank, Working Cell Bank, and Cell Bank
Characterization, any biological material made or developed under
the
Programme; and iii) Vaccine Process.
|
|
“Vaccine
Process”
|
means
the process, methods, synthesis for making, using or exploiting the
Drug
Substance to produce the Drug Product for inclusion within the Programme
Deliverable; .
|
| 1.2 |
The
headings to clauses are inserted for convenience only and shall not
affect
the interpretation or construction of this
Agreement.
|
| 1.3 |
Words
imparting the singular shall include the plural and vice versa. Words
imparting a gender include every gender and references to persons
include
an individual, company, corporation, firm or
partnership.
|
| 1.4 |
The
words and phrases “other”, “including” and “in particular” shall not limit
the generality of any preceding words or be construed as being limited
to
the same class as any preceding words where a wider construction
is
possible.
|
| 1.5 |
References
to any statute or statutory provision shall include: any subordinate
legislation made under it; any provision which it has superseded
or
re-enacted (whether with or without modification); and any provision
which
subsequently supersedes it or re-enacts it (whether with or without
modification).
|
| 2 |
Conduct
of the
Programme and Clinical
Trials
|
| 2.1 |
Cobra
and Advaxis agree that they shall conduct and undertake the Programme
on
the terms and conditions of this
Agreement.
|
| 2.2 |
Each
of Cobra and Advaxis shall perform the obligations for which they
are
responsible under this Agreement and the Programme.
|
| 2.3 |
Cobra
shall manufacture and supply Clinical Product to Advaxis in accordance
with the Manufacture Specifications. Cobra may not change the Manufacture
Specifications without the prior written approval of Advaxis unless
such
change is required in order to comply with any legislative and/or
regulatory requirements. Any such approval is not to be unreasonably
withheld and/or delayed by Advaxis.
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| 2.4 |
For
the avoidance of doubt Advaxis shall be solely responsible for the
planning and conduct of any Clinical Trials and for determining whether
to
proceed with and/or terminate any Clinical
Trials.
|
| 2.5 |
For
the duration of this Agreement Advaxis grants to Cobra, solely for
use in
the manufacture of Clinical Product and/or Bulk Product, a non-exclusive
royalty free licence in the UK (with the right to sub-licence to
any of
Cobra’s affiliates and/or sub-contractors whether inside or outside the
UK) of any Advaxis IP used in the production of the Clinical Product
and/or Bulk Product to the extent required by Cobra in order to perform
its obligations under this Agreement. Where all Bulk Product is to
be
produced by a third party under section 10, the licence to Cobra
under
this clause shall no longer be required.
|
| 2.6 |
Cobra
agrees to provide Advaxis within twenty (20) days of a written request
from Advaxis with a cross-reference letter to any Cobra regulatory
applications and approvals relating to the Clinical Product, Bulk
Product
or Vaccine Process. The cross-reference letter shall be without limitation
to clinical phase of the ongoing study. Any such cross-reference
letter
shall remain in effect and may not be revoked by Cobra unless this
Agreement is terminated.
|
| 3 |
Programme
Data
|
| 3.1 |
Cobra
shall ensure that all Programme Data created by Cobra:
|
| 3.1.1 |
is
accurate and complete; and
|
| 3.1.2 |
complies
with all legal and regulatory
requirements
|
| 3.2 |
At
the request of Advaxis from time to time, Cobra shall within twenty
days
(20) of Advaxis’ request provide to Advaxis a copy of all Programme Data
and/or Programme Data as may be requested by Advaxis . Any and all
Programme Data shall belong to Advaxis and form part of Advaxis’
Confidential Information.
|
| 4 |
Supply
of Clinical Product
|
| 4.1 |
Advaxis
will only use Clinical Product supplied by Cobra for the research
and
development stage of the Programme and any Clinical Trials. Advaxis
shall
place orders for all its requirements for the Clinical Product with
Cobra.
|
| 4.2 |
The
parties acknowledge that Advaxis has already placed orders for the
Clinical Product with Cobra as at the date of this Agreement. Repeat
orders for any further batches of Clinical Product required for the
Clinical Trials shall be placed by Advaxis with Cobra as soon as
reasonably practicable.
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| 4.3 |
Advaxis
will place further orders for the Clinical Product with Cobra at
least 3
months in advance of the date of commencement of the production slot
of
the relevant Clinical Product.
|
| 4.4 |
Advaxis
will pay a deposit [ * ] of the gross order value with each order
for
Clinical Product.
|
| 4.5 |
Cobra
shall, on accepting any further order placed by Advaxis for Clinical
Product, allocate a production slot for the production of such Clinical
Product included within the order and notify Advaxis of the allocated
production slot and anticipated delivery date. Cobra shall use all
reasonable endeavours to obtain for Advaxis the earliest production
slot
for such order of Clinical Product.
|
| 4.6 |
Cobra
will use its reasonable endeavours to deliver the Clinical Product
within
3 months of the commencement of the allocated production slot(s)
for the
Clinical Product.
|
| 4.7 |
All
Clinical Product shall be supplied to Advaxis on Cobra’s Terms and
Conditions. If there is any conflict between such terms and the terms
in
the main body of this Agreement then the terms in the main body of
this
Agreement shall prevail.
|
| 4.8 |
Cobra
warrants and represents that the Clinical Product manufactured by
Cobra,
its affiliates and/or its sub-contractors and delivered to Advaxis
or its
affiliates hereunder for clinical use shall (i) from the date of
shipment
until the end of the specified shelf-life conform to the Manufacturing
Specifications and shall also be manufactured in accordance with
U.S. FDA
Good Manufacturing Practices and Good Laboratory Practices; and (ii)
be
transferred free and clear of any security interests, liens and
encumbrances.
|
| 4.9 |
Cobra
shall furnish Advaxis with a certificate of analysis, in the form
required
by law for each batch of Clinical Product supplied hereunder with
shipment
of each such batch.
|
| 4.10 |
Advaxis
shall inspect and analyze a representative sample of the Clinical
Product
from batches supplied by Cobra within thirty days (30) after receipt.
If,
after inspection, Advaxis reasonably believes the shipment does not
meet
the Manufacturing Specifications, Advaxis shall notify Cobra in writing
within forty five (45) days after Advaxis’ receipt of any such Clinical
Product. If Advaxis does not so notify Cobra within the specified
timescales, Advaxis shall be deemed to have accepted the Clinical
Product
and waived all claims against Cobra for said Clinical Product delivered,
except for any latent defects that could not have been reasonably
discovered upon such inspection, which defects must be notified by
Advaxis
to Cobra within fourteen (14) days from discovery of same. Any claims
by
Advaxis regarding any Clinical Product delivered shall specify in
reasonable detail the nature and basis for the claim and cite relevant
Cobra lot numbers or other information to enable specific identification
of the goods involved. Advaxis shall not be required to accept Clinical
Product having a shelf-life of less than ninety percent (90%) of
the
stated expiration dating on the date of shipment by
Cobra.
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| 4.11 |
So
long as Advaxis provides Cobra with its forecast for short term and
long
term requirements for the Clinical Product in a regular and timely
fashion
(and in any event at least [once] a month), Cobra shall cooperate
to
anticipate Advaxis’ short term and long-term requirements for Clinical
Product supply and will take reasonable measures to ensure that Advaxis’
and its sublicensees requirements as set forth in Advaxis’ forecast can be
met. Cobra shall make best efforts to ensure Advaxis is given the
highest
priority for supply of the Clinical Product by Cobra or Cobra’s sub
contractor (as appropriate).
|
| 4.12 |
Cobra
shall allow Advaxis and/or representatives of the U.S. FDA and any
other
regulatory agency or authority with jurisdiction over the manufacture,
marketing and distribution of the Clinical Product, at a mutually
agreed
time and date, to tour and inspect all facilities utilized by such
party
in the manufacture, testing, packaging, storage, and shipment of
Clinical
Product sold under this Agreement, and shall co-operate with such
representatives in every reasonable manner. Each party shall also
provide
the other party with a copy of any U.S. FDA Form 483 notices of adverse
findings, regulatory letters or similar notifications it receives
from any
other governmental authority setting forth adverse findings or non
-compliance with any applicable laws, regulations or standards relating
to
the items supplied by it hereunder within five (5) days of its own
receipt
thereof. Each party shall also provide the other party with a copy
of its
proposed written response to such governmental authority before submission
and shall incorporate any changes thereto which the other party may
reasonably request.
|
| 4.13 |
Clinical
Product sales will be subject to the Discount dependent on the volume
of
orders placed by Advaxis. The level of Discount shall be determined
as set
out in Schedule
1.
Any Discount shall apply to all sales of the Clinical Product to
Advaxis
in the next 12 months.
|
| 4.14 |
The
prices for the services connected with the manufacture of Clinical
Product
are set out in Schedule 1. These prices will be subject to review
and
Cobra reserves the right to increase these price by up to 2% above
the
rate of inflation current at the time of the price review. The current
rate of inflation is defines as the UK retail price index (RPI) as
published by the UK Office of National
Statistics.
|
| 4.15 |
The
price review will take place [ * ] providing the RPI [ * ]. Under
those
circumstances where the RPI is greater than [ *
].
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| 4.16 |
Advaxis
is allowed to establish or contract with a third party back up
manufacturing source for any Program Deliverable provided that Advaxis
shall not manufacture more than [ * ] Program Deliverable with such
third
party in the absence of a Non Performance Event by
Cobra.
|
| 5 |
Change
in Production
Dates for Clinical Product
|
| 5.1 |
Cobra
has already allocated a production slot for the manufacture of the
first
batch of Clinical Product. Advaxis may request in writing a change
of
production slot for the Clinical Product already ordered at the date
of
this Agreement by giving written notice to Cobra not less than 2
calendar
months before the date of commencement of production under the existing
production slot allocated to the Clinical Product. Cobra will use
its
reasonable endeavours to accept any such request provided that the
requested new production slot is
available.
|
| 5.2 |
If
Advaxis requests a change or cancellation of a production slot for
Clinical Product already ordered at the date of this Agreement which
is
less than 2 calendar months’ prior to the planned date of commencement of
production under the existing production slot
then:
|
| 5.2.1 |
Cobra
shall use its reasonable endeavours to accept any such request provided
that the requested new production slot is available;
|
| 5.2.2 |
Advaxis
shall forfeit the amount of the deposit paid to Cobra and such deposit
shall be unconditionally released to Cobra and not be creditable
against
the price of that Clinical Product;
and
|
| 5.2.3 |
Advaxis
shall be obliged to pay a further deposit in relation to the rescheduled
production slot for that Clinical Product to which the provisions
of
clauses 5.1 and 5.2 shall again
apply.
|
| 5.3 |
Advaxis
may request in writing a change of production slot for any further
future
orders of Clinical Product not less than 6 calendar months before
the date
of commencement of production under the production slot allocated
to the
Clinical Product. Cobra will use its reasonable endeavours to accept
any
such request provided that the requested new production slot is
available.
|
| 5.4 |
If
Advaxis requests a change or cancellation of a production slot for
any
further future orders of Clinical Product and such request is made
fewer
than 6 calendar months’ prior to the planned date of commencement of
production under the production slot allocated to that Clinical Product
then:
|
| 5.4.1 |
Cobra
shall use its reasonable endeavours to accept any such request provided
that the requested new production slot is available;
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| 5.4.2 |
Advaxis
shall forfeit
|
| 5.4.2.1 |
20%
of the deposit where the request is made fewer than 6 months but
more than
5 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product;
|
| 5.4.2.2 |
40%
of the deposit where the request is made fewer than 5 months but
more than
4 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product;
|
| 5.4.2.3 |
60%
of the deposit where the request is made fewer than 4 months but
more than
3 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product;
|
| 5.4.2.4 |
80%
of the deposit where the request is made fewer than 3 months but
more than
2 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product; or
|
| 5.4.2.5 |
100%
of the deposit where the request is made fewer than 2 months before
the
date of commencement of production under the existing production
slot
allocated to that Clinical Product;
|
and
the
amount of the deposit paid to Cobra which is forfeited shall be unconditionally
released to Cobra and not be creditable against the price of that Clinical
Product; and
| 5.4.3 |
Advaxis
shall be obliged to pay a further deposit in relation to the rescheduled
production slot for that Clinical Product to which the provisions
of
clauses 5.3 and 5.4 shall again
apply.
|
| 6 |
Reporting
|
| 6.1 |
Cobra
shall ensure that regular written reports on the manufacture of the
Clinical Product are provided to
Advaxis.
|
| 6.2 |
Each
party will promptly notify the other party of any material developments,
progress and/or adverse events which arise in the performance of
its
aspects of the Clinical Trials and/or the
Programme.
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| 6.3 |
Each
party will promptly respond with a full and proper response to any
queries
raised by the other party from time to time in relation to the current
status of the Programme.
|
| 7 |
Cobra’s
Right of First Refusal for Bulk Drug Substance and Drug
Product
|
| 7.1 |
Advaxis
will notify Cobra in advance of the anticipated order level for Bulk
Product for each 12 calendar months (commencing each October) by
the end
of the March preceding that period.
|
| 7.2 |
Cobra
will advise Advaxis in writing within 3 calendar months following
the
determination of the anticipated order level for Bulk Product whether
Cobra will supply:
|
| 7.2.1 |
all
the Initial Order Level from Cobra’s own production
facilities;
|
| 7.2.2 |
all
the Initial Order Level from sub-contractors of
Cobra;
|
| 7.2.3 |
all
the Initial Order Level partly from Cobra’s own production facilities and
partly by sub-contractors of Cobra;
|
| 7.2.4 |
part
only of the Initial Order Level; or
|
| 7.2.5 |
none
of the Initial Order Level.
|
| 7.3 |
Advaxis
will notify Cobra as soon as reasonably practicable of any Increased
Order
Level.
|
| 7.4 |
Cobra
will confirm in writing within 3 calendar months following notification
of
the anticipated Increased Order Level whether Cobra will
supply:
|
| 7.4.1 |
all
of the Increased Order Level from Cobra’s own production
facilities;
|
| 7.4.2 |
all
of the Increased Order Level from sub-contractors of
Cobra;
|
| 7.4.3 |
all
of the Increased Order Level partly from Cobra’s own production facilities
and partly by sub-contractors of Cobra;
|
| 7.4.4 |
part
only of the Increased Order Level;
or
|
| 7.4.5 |
none
of the Increased Order Level.
|
| 7.5 |
Advaxis
shall ensure that all orders for requirements for Bulk Product are
placed
with Cobra to the extent that Cobra has indicated under clauses 7.2
and
7.4 above that it wishes to supply any Initial Order Level and/or
Increased Order Level by itself and/or in conjunction with its
subcontractors.
|
| 7.6 |
Advaxis
shall ensure that only its orders for requirements for Bulk Product
which
Cobra has indicated under clauses 7.2 and 7.4 that it does not wish
to
accept will be placed with a Third Party Product
Manufacturer.
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| 7.7 |
All
Bulk Product supplied by Cobra to Advaxis (or Advaxis’ nominee) shall be
supplied on Cobra’s Terms and Conditions. If there is any conflict between
such terms and the terms in the main body of this Agreement then
the terms
in the main body of this Agreement shall
prevail.
|
| 7.8 |
Cobra
shall use its reasonable endeavours to deliver any Bulk Product as
soon as
reasonably possible after firm orders have been placed with
Cobra.
|
| 8 |
Requirements
for Cobra’s Product
Subcontractors
|
| 8.1 |
If
Cobra wishes to sub-contract all or any part of the production of
the
Clinical Product and/or the Bulk Product for the Programme, it will
consult with Advaxis and obtain the prior written approval of Advaxis
in
respect of the identity of each sub-contractor. Advaxis shall not
unreasonably refuse and/or delay such approval. Advaxis may also
nominate
a sub-contractor but such sub-contractor shall not be appointed without
the prior written approval of Cobra, which it shall not unreasonable
refuse.
|
| 8.2 |
Cobra
will use its reasonable endeavours to conclude any sub-contracting
agreements within 9 months of receiving Advaxis’ notification of the
Initial Order Level and/or Increased Order
Level.
|
| 8.3 |
Any
sub-contract shall conform to the same terms and conditions of this
Agreement. Cobra shall forward to Advaxis any sub-contract for review
by
Advaxis that the terms and conditions of the sub-contract are compatible
with the terms of this Agreement. If material terms are not compatible
or
for other reasonable commercial reasons Advaxis objects to the
sub-contract, Advaxis may refuse approval to Cobra entering into
the
sub-contract. Cobra will ensure that adequate quality control provisions
are included within any of its contracts with sub-contractors, including
a
specification for the production of the Clinical Product and/or the
Bulk
Product (as relevant).
|
| 8.4 |
The
parties agree that, where Cobra elects to sub-contract all or part
of the
production of Bulk Product and/or Clinical Product, it is Cobra’s
intention to give preference to any eligible sub-contractor on condition
that:
|
| 8.4.1 |
such
sub-contractor has sufficient capacity, facilities and experience
to
produce the Bulk Product and can demonstrate accreditation for the
manufacture of biological licensed materials;
and
|
| 8.4.2 |
such
sub-contractor is, as far as Cobra is aware, sufficiently financially
stable, trustworthy and reputable.
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|
| 8.5 |
Cobra
shall be liable for the acts and/or omissions of its sub-contractors
as if
they were its own acts and/or omissions under this Agreement except
where
any such sub-contractor has been nominated by Advaxis as being a
suitable
sub-contractor in which case, as a condition of Cobra’s consent to the
appointment of such sub-contractor, the parties shall agree the
appropriate sharing of risk in relation to the activities of such
sub-contractor.
|
| 9 |
Price
for Bulk
Product
|
| 9.1 |
The
price Advaxis will pay Cobra for the supply of Bulk Product is an
amount
equal to the Cost for the Bulk Product plus the Mark Up plus any
freight,
shipping, insurance, packaging and other similar
costs.
|
| 9.2 |
Cobra
shall use its reasonable endeavours to minimise the Cost of any Bulk
Product which is produced by Cobra’s sub-contractors. Such Cost detailed
and itemized shall be presented to
Advaxis.
|
| 9.3 |
Sections
4.8- 4.12 above shall also apply to supply of Bulk Product as if
all
references to “Clinical Product” were references to “Bulk
Product”.
|
| 9.4 |
Recall
Notification: Each Party shall promptly notify the other Party in
writing
of any facts relating to the advisability of the recall, destruction
or
withholding from the market of the Bulk Product anywhere in the world
(collectively, "Recall").
|
| 9.5 |
Recall
Implementation: If at any time (a) any governmental or regulatory
authority issues a request, directive or order for a Recall; (b)
a court
of competent jurisdiction orders a Recall; or (c) Advaxis reasonably
determines that a Recall is necessary or advisable, Advaxis shall
take all
appropriate corrective actions to effect the Recall and Cobra shall
provide Advaxis with such cooperation in connection with the Recall
as
Advaxis may reasonably request
|
| 9.6 |
Recall
Costs and Expenses: Advaxis shall bear the costs and expenses of
any
Recall (including any costs and expenses incurred by Cobra in assisting
Advaxis under clause 9.5 above) to the extent such Recall is the
result of
any fault or omission attributable to Advaxis or its affiliates;
and Cobra
shall bear all reasonable costs and expenses of any Recall to the
extent
such Recall is the result of any fault or omission attributable to
Cobra
or its affiliates.
|
| 10 |
Technology
Transfer
|
| 10.1 |
If
Cobra:
|
| 10.1.1 |
confirms
that it will not, either itself or by using sub-contractors, supply
all of
Advaxis’s requirements for Bulk Product;
and/or
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|
| 10.1.2 |
confirms
that it will supply any and/or all of Advaxis’ requirements for Bulk
Product using sub-contractors and Cobra then fails to conclude any
sub-contracting agreement in relation to such supply of such Bulk
Product
within 9 months of the date of Advaxis’s notification in respect of the
Initial Order Requirements and/or Increased Order Requirements (as
the
case may be); and/or
|
| 10.1.3 |
has
not scaled up for commercial volume production of Bulk Product in
respect
of Advaxis ’s Initial Order Requirements and/or Increased Order
Requirements within 9 months of Advaxis notifying Cobra of Advaxis’
Initial Order Requirements and/or Increased Order Requirements (as
the
case may be);
|
then
Advaxis at its sole option may require Cobra to enter into a Technology Transfer
to a Third Party Product Manufacturer so that the Third Party Product
Manufacturer can produce the Bulk Product solely for supply to Advaxis or its
nominee for use in the Programme and/or solely in the commercial exploitation
of
the Programme Deliverable.
| 10.2 |
Cobra
and ADVAXIS shall consult in respect of the identity of any Third
Party
Product Manufacturer to which a Technology Transfer is to occur.
|
| 10.3 |
The
identity of any Third Party Product Manufacturer shall be subject
to
Cobra’s prior written consent (such consent not to be unreasonably
withheld or delayed).
|
| 10.4 |
The
Technology Transfer will:
|
| 10.4.1 |
be
negotiated by Cobra in good faith;
|
| 10.4.2 |
incorporate
such commercial terms as Cobra reasonably requires in order to protect
its
Intellectual Property Rights and/or materials in relation to Cobra
Know
How;
|
| 10.4.3 |
provide
for Cobra to train the Third Party Product Manufacturer at the then
current market rates for such training to produce Bulk Product.
|
| 10.5 |
Any
costs and expenses to Cobra associated with the Technology Transfer
shall
be borne and paid for by Advaxis except to the extent that they are
borne
and paid for by the Third Party Product
Manufacturer.
|
| 10.6 |
Advaxis
at its sole discretion may instruct Cobra to enter into a Technology
Transfer in accordance with this Section 10 as it relates to one
or
several Programme Deliverables, in one or several disease indications,
and
with one or several Third Party Product
Manufacturers.
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|
| 11 |
Royalty
on Technology Transfer
|
| 11.1 |
Where
a Technology Transfer to cover production of Bulk Product takes place
(except for in a Non Performance Event as defined below), Advaxis
shall
pay to Cobra a [ * ] (three quarters of one percent) of the Net Sales.
Such Royalty shall be capped at a maximum aggregate royalty [ *
].
|
| 11.2 |
A
“Non
Performance Event”
shall be defined as any of the following: (a) Cobra is unable to
initiate
manufacture of any material required by Advaxis within 90 days due
to
scheduling issues, (b) Cobra is unable or causes unreasonable delays
in
manufacture or development of any product required by Advaxis; and/or
(c)
due to regulatory reasons Cobra cannot manufacture/supply material;
(d)
Cobra is unable to meet the quantities required by Advaxis in relation
to
orders accepted by Cobra.
|
| 12 |
General
Financial
|
| 12.1 |
The
payment of all sums payable under this Agreement shall be made in
US
Dollars based on the applicable exchange rate as published from time
to
time by the Wall Street Journal at the day of transfer, by telegraphic
transfer to a bank account nominated from time to time by Cobra.
Any
applicable banking charges on such payments shall be borne by
Advaxis.
|
| 12.2 |
Where
it is necessary to calculate the exchange rate for the purposes of
payment
of any sums due under this Agreement, the exchange rate used shall
be the
exchange rate at which any monies received by Advaxis are actually
converted to pounds sterling or if they are not so converted during
the
relevant period the exchange rate shall be the spot exchange rate
for
pounds sterling quoted by Advaxis’s bankers at close of business on the
business day preceding the due date for payment of each such
sum.
|
| 12.3 |
All
sums payable under this Agreement are exclusive of any value added
tax or
other applicable taxes or duties which shall be payable in
addition.
|
| 12.4 |
All
monies payable under this Agreement shall be paid in cleared funds
without
any set-off, deduction or withholding except any tax which Advaxis
is
required by law to deduct or withhold.
|
| 12.5 |
If
Advaxis is required by law to make any tax deduction or withholding,
Advaxis shall do all things in its power which may be necessary to
enable
or assist Cobra to claim exemption from or (if that is not possible)
a
credit for the deduction or withholding under any applicable double
taxation or similar agreement from time to time in force, and shall
from
time to time give Cobra proper evidence of the deduction or withholding
and payment over of the tax deducted or withheld.
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| 12.6 |
If
Cobra is not able to obtain a full credit under any applicable double
taxation or similar agreement for any tax deduction or withholding
made
from monies payable to Cobra by Advaxis under this Agreement then
the
amount of monies payable to Cobra shall be grossed up and increased
so
that, after the tax deduction or withholding, Cobra actually receives
the
net amount that would have been due if no tax deduction or withholding
was
being made.
|
| 12.7 |
If
any party fails to pay in full any monies payable under this Agreement
on
the date specified for payment, the amount outstanding shall bear
interest, both before and after any judgement, from that date until
that
amount is paid in full to Cobra at the rate of 2% above the 6 month
Libor
rate as published in the Wall Street
Journal.
|
| 12.8 |
Each
party shall:
|
| 12.8.1 |
keep
(and procure that third parties engaged directly and/or indirectly
by it
keep) true and accurate accounts and records in sufficient detail
to
enable the Net Sales, the Facility Occupancy Charge, the Cost of
supply of
Bulk Product, the Mark Up and the amount of any monies payable under
this
Agreement to be determined and/or verified;
and
|
| 12.8.2 |
at
the reasonable request of the other party from time to time, allow
(and
procure that third parties engaged directly and/or indirectly by
it allow)
the other party or its auditors (at its expense) to inspect such
accounts
and records referred to in clause 12.8.1 above and, to the extent
that
they relate directly or indirectly to the calculation of any monies
payable under this Agreement, to take copies of them.
|
| 12.9 |
If,
following any inspection pursuant to clause 12.8.2 above, either
party’s
auditors certify to that party and the other party that the amount
of
monies paid in respect of any period falls short of the amount of
the
monies which were properly payable in respect of that period, the
party
owing the shortfall shall within 7 days of being served with a copy
of the
certificate pay the shortfall plus interest on that sum to the other
party.
|
| 12.10 |
The
provisions of this Section 12 shall remain in full force and effect
after
the termination of this Agreement for any reason until the settlement
of
all subsisting claims between the parties under this
Agreement.
|
| 13 |
Confidentiality
|
| 13.1 |
For
the purposes of this Agreement, any Confidential Information relating
to
Programme Deliverable, Vaccine Process, Bulk Product, Programme,
Programme
Data, Programme IP, or the Clinical Trials shall be treated as Advaxis
Confidential Information.
|
DRAFT
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|
Confidential
|
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|
| 13.2 |
For
the purposes of this Agreement, any Confidential Information relating
to
the Cobra Know How shall belong to Cobra and shall be treated as
Cobra’s
Confidential Information.
|
| 13.3 |
Each
of the parties undertakes to the other, in respect of the other party’s
Confidential Information that it (and it will procure that its employees,
ex-employees, consultants, and/or sub-contractors)
shall:-
|
| 13.3.1 |
only
use the other party’s Confidential Information which is disclosed and/or
acquired by it for the direct purposes of the Programme under this
Agreement;
|
| 13.3.2 |
not
disclose Confidential Information to any third party and maintain
as
confidential all the other party’s Confidential Information which may come
into its possession in any manner;
|
| 13.3.3 |
allow
access to the other party’s Confidential Information only to such of its
employees, consultants and/or sub-contractors who need to see and
use it
for the purposes of the Programme under this
Agreement;
|
| 13.3.4 |
upon
request by the other party made at any time deliver up to the other
party
all documents, material and/or other media which is in its possession,
custody or control which comprises or contains any part of the other
party’s Confidential Information provided that it shall be entitled to
retain one copy of such Confidential Information for archive purposes;
and
|
| 13.3.5 |
not
incorporate any Confidential Information of the other party in a
patent
application, and may not submit any Confidential Information of the
other
party in any regulatory application without the express prior written
authority of the other party.
|
| 13.4 |
Confidential
Information shall not include any information
which:-
|
| 13.4.1 |
the
other party can prove by documentary evidence produced by it was
information already in its possession and at its free
disposal;
|
| 13.4.2 |
the
other party can prove by documentary evidence produced by it was
information independently developed by it without reference to
Confidential Information of the other
party;
|
| 13.4.3 |
is
after the date of this Agreement disclosed to the other party without
any
obligations of confidentiality by a third party who has not derived
it
directly or indirectly from the party whose Confidential Information
it
was;
|
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|
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|
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21
|
| 13.4.4 |
is
or becomes available to the public through no act or default on the
part
of the other party; or
|
| 13.4.5 |
is
required to be disclosed by law or the rules of any stock exchange
and/or
regulatory authority provided where possible the disclosing party
gives
not less than 7 days’ advance notice of any such disclosure to the other
party whose Confidential Information it is and discusses with them
the
form and content of such disclosure.
|
| 13.5 |
If
a party reasonably requests that any Confidential Information of
the other
party be disclosed because of regulatory purposes, the party making
the
disclosure shall seek confidential treatment of the materials proposed
to
be disclosed and shall use commercially reasonable efforts to request
confidential treatment of such information pursuant to Rule 406 of
the
Securities Act of 1933 or Rule 25b-2 of the Securities Exchange Act
of
1934, as applicable (or any other applicable regulation relating
to the
confidential treatment of information), except to the extent that
the
party making the disclosure receives advice from its legal counsel
that
such Confidential Information is required to be disclosed under applicable
laws or regulations. The party making the disclosure shall give reasonable
advance notice to the other party of such disclosure and use efforts
to
secure confidential treatment of such information at least as diligent
as
such party would use to protect its own confidential information,
but in
no event less than reasonable efforts. In any event, the parties
agree to
take all reasonable action to avoid disclosure of Confidential Information
hereunder. The parties will consult with each other on the provisions
of
this Agreement to be redacted in any filings made by the parties
with the
Securities and Exchange Commission or as otherwise required by law
and on
any disclosure to third parties.
|
| 13.6 |
Subject
to clause 13.4 and 13.5 above, either party is allowed to disclose
the
other party’s Confidential Information solely for regulatory purposes.
|
| 13.7 |
Neither
party may disclose the existence of this Agreement or the terms and
conditions of this Agreement without the prior written consent of
another,
except for regulatory purposes as set forth in Section 13. Any press
release shall be coordinated by the parties subject to final review
and
approval by both parties.
|
| 13.8 |
For
the avoidance of doubt either party shall be entitled to disclose
the
other party’s Confidential Information to any sub-contractor which is
performing all or part of the work under the Programme subject to
it
imposing duties of confidentiality and non use on the sub-contractor
which
are no less onerous than those contained in this
Agreement.
|
| 13.9 |
Each
party shall be liable to the other for the acts and/or omissions
of its
employees, ex-employees, consultants and/or sub-contractors as if
they
were its own acts and/or omissions under this Agreement.
|
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|
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|
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|
| 13.10 |
The
obligations of confidentiality and non use in this Agreement shall
continue for 10 years after the termination of this
Agreement.
|
| 13.11 |
Each
party recognizes that violation of confidentiality results in irreparable
harm and agree to injunctive relief and damages.
|
| 14 |
Intellectual
Property
|
| 14.1 |
Any
and all Programme Deliverable, Programme IP and Programme Data under
this
Agreement shall be solely owned by Advaxis. Cobra agrees to assign
and
will assign to Advaxis, the sole and exclusive ownership of the Programme
IP.
|
| 14.2 |
Prosecution
and Maintenance of Programme Intellectual Property
Rights.
Advaxis shall control, prosecute and maintain all Programme IP. Advaxis
shall be responsible for all costs, fees and expenses incurred from
and
after the Effective Date in connection with the filing, prosecution
and
maintenance of such Programme IP.
|
| 14.3 |
The
disclosure or provision to Cobra of any Confidential Information
of
Advaxis or other information or items shall not be deemed to transfer
or
grant to Cobra, or any other person or entity any right, title, interest,
or license in, to or under any patent or patent application of Advaxis
or
other intellectual property or other right of Advaxis or in or to
any
information, discoveries, knowledge, experience, processes, procedures,
devices, compositions of matter, skills, know-how, samples, trade
secrets,
designs, formulae, specifications, methods, techniques, compilations,
programs, devices, technical information, concepts, developments,
inventions or improvements, whether patentable or not, or other
technology, inventions or property of Advaxis other than any rights
and/or
licence granted under the terms of this
Agreement.
|
| 14.4 |
Cobra
agrees (and shall ensure that all employees and agents do the same)
that
all information, materials, master cell banks, regulatory reports,
discoveries, knowledge, experience, processes, procedures, devices,
compositions of matter, skills, know-how, samples, trade secrets,
designs,
formulae, specifications, methods, techniques, compilations, programs,
devices, technical information, concepts, developments, inventions
or
improvements, whether patentable or not) arising from Cobra’s performance
of its obligations under this Agreement shall promptly be made known
to
Advaxis in writing (subject to obligations of confidentiality). Cobra
willexecute any and all documents and do any and all things reasonably
requested by to vest and perfect Advaxis interest in the Programme
IP.
|
| 14.5 |
Cobra
hereby assigns, and shall cause all investigators and clinical sites
to
assign, to Advaxis all right, title and interest, including copyrights
and
other Intellectual Property Rights, in and to all Programme
Data.
|
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|
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|
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|
| 14.6 |
Enforcement
of Licensed Intellectual Property Rights and Missapropriation of
Know-How
and Programme Deliverable.
Each party shall promptly notify the other in writing of any alleged
or
threatened infringement of any Programme IP of which such party becomes
aware.
|
| 14.6.1 |
With
respect to any infringement in any territory of any Programme IP,
Advaxis
has the sole right to direct, control and bring any action or proceeding
in its own name, with respect to such infringement at its own expense
and
by counsel of its own choice, and Cobra shall have the right, at
its own
expense, to be represented in any such action by counsel of its own
choice. In the event Advaxis brings an infringement action in accordance
with this Section, Cobra shall cooperate fully, including if required
to
bring such action, the furnishing of a power of attorney provided
that
Advaxis pays Cobra’s costs of doing the same.
|
| 14.6.2 |
With
respect to any misappropriation, conversion or other federal, state,
or
local cause of action in any territory of any Programme Deliverable,
and
Programme Data, Advaxis has the sole right to direct, control and
bring
any action or proceeding in its own name, with respect to such
misappropriation at its own expense and by counsel of its own choice,
and
Cobra shall have the right, at its own expense, to be represented
in any
such action by counsel of its own choice. In the event Advaxis brings
an
misappropriation action in accordance with this Section, Cobra shall
cooperate fully, including if required to bring such action, the
furnishing of a power of attorney provided that Advaxis pays Cobra’s costs
of doing the same.
|
| 14.7 |
Third
Party Infringement Claims.
Each party shall promptly notify the other in writing of any allegation
by
a third party that the activity of either of the parties pursuant
to this
Agreement infringes or may infringe the Intellectual Property Rights
of
such third party. Advaxis shall have the sole right to control, direct
or
defend in its own name any defense, action, appeal of any such claim,
action, proceeding at its own expense and by counsel of its own choice.
Advaxis shall act in good faith in the conduct of any such third
party
claim. During the pendency of any such proceeding or any appeal thereof
where the proceedings are as a result of any default of Cobra under
this
Agreement, any payment hereunder to Cobra shall be paid by Advaxis
into an
interest-bearing escrow account pending the outcome of such proceeding.
Upon a favorable final resolution of such proceeding or any appeal
thereof
retaining the full rights, Advaxis shall resume paying Cobra the
full
royalties, and all funds in such escrow account shall be paid to
Cobra
plus any interest which has accrued on such sum. Upon an unfavorable
final
resolution of such proceeding or any appeal thereof, the funds in
such
escrow account shall be applied toward the damage award in such action,
if
any, and the balance plus interest, if any, paid to
Cobra.
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|
| 14.8 |
Cooperation
of the Parties.
Each party agrees to cooperate fully in the preparation, filing,
and
prosecution of any Programme IP under this Agreement and in the obtaining
and maintenance of any patent extensions, supplementary protection
certificates and the like with respect to any Intellectual Property
Rights
being developed or commercialized by Advaxis. Such cooperation includes,
but is not limited to, promptly informing the other party of any
matters
coming to such party’s attention that may affect the preparation, filing,
prosecution or maintenance of any Intellectual Property
Rights.
|
| 14.9 |
Cobra
shall not co-mingle any Programme Deliverable and/or Programme IP
and/or
Programme Data with any compositions, data, information, materials,
and
methods which are proprietary to a third party; and/or with any Cobra
Know- How.
|
| 15 |
Representations
and Warranties
|
| 15.1.1 |
Cobra
represents and warrants to Advaxis that:
|
(a) it
is
duly authorized to execute and deliver this Agreement and to perform its
obligations hereunder;
(b) this
Agreement is a legal and valid obligation binding upon it and enforceable in
accordance with its terms; and
(c) the
execution, delivery and performance of this Agreement do not conflict with
any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having jurisdiction over
it.
(d)
Cobra
has the ability, capacity to perform, manufacture and supply the Bulk Product
under the terms and conditions of this Agreement
| 16 |
Indemnities
|
| 16.1 |
With
respect to any indemnification obligations of either party to the
other
party under this Agreement, the following conditions must be met
for such
indemnification obligations to become applicable where a third party
is
involved: (a) the indemnified party shall notify the indemnifying
party
promptly in writing of any claim which may give rise to an obligation
on
the part of the indemnifying party hereunder; (b) the indemnifying
Party
shall be allowed to timely undertake the sole control of the defense
of
any such action and claim, including all negotiations for the settlement,
or compromise of such claim or action at its sole expense; and (c)
the
indemnified party shall render reasonable assistance, information,
co-operation and authority to permit the indemnifying Party to defend
such
action, it being agreed that any out-of-pocket expenses or other
expenses
incurred by the indemnified party in rendering the same shall be
borne or
reimbursed promptly by the indemnifying party. These conditions shall
not
apply where the claim for which a party may seek indemnification
from the
other party under this section 16 is a claim as between the two
parties.
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|
| 16.2 |
Advaxis
will indemnify and keep indemnified Cobra against any and all claims,
damages, awards, costs (including legal costs on a full indemnity
basis),
compensation, actions, expenses, proceedings and any other losses
and/or
liabilities that may be caused by and/or arise as a result of the
conduct
of the Clinical Trials by Advaxis and/or its employees, sub-contractors
and/or agents, use of the Advaxis IP and/or the Clinical Product
and Bulk
Product (apart from the Cobra Know How) and/or any of the foregoing
infringing and/or being alleged to infringe any third party Intellectual
Property Rights except to the extent that such matters are due to
i)
manufacture or supply of Clinical Product and/or Bulk Product not
in
accordance with Manufacture Specifications; ii) breach of the
representations and warranties of this Agreement; iii) a willfull
or
grossly negligent act by Cobra; or iv) an inherent defect in the
Cobra
Know How and/or a defect in the manufacture of Bulk Product supplied
by
Cobra.
|
| 16.3 |
Cobra
will indemnify and keep indemnified Advaxis from and against any
and all
claims, damages, awards, costs (including legal costs on a full indemnity
basis), compensation, actions, expenses, proceedings and any other
losses
and/or liabilities that may be caused by and/or arise as a result
of a
defect in the production of the Bulk Product provided by Cobra and/or
its
employees, sub-contractors (except to the extent that risk is agreed
not
to borne by Cobra under clause 8.5) and/or
agents.
|
| 16.4 |
If
the parties are not able to resolve which party is liable to indemnify
the
other party then the matter shall be determined by an expert in accordance
with section 21.
|
| 17 |
Force
Majeure
|
| 17.1 |
If
either party is affected by Force Majeure it shall immediately notify
the
other party of its nature and
extent.
|
| 17.2 |
Neither
party shall be deemed to be in breach of this Agreement or otherwise
be
liable to the other, by reason of any delay in the performance, or
the
non-performance, of any of its obligations under this Agreement (other
than in respect of payment), to the extent that the delay or
non-performance is due to any Force Majeure of which it has notified
the
other party, and the time for performance of that obligation shall
be
extended by a period equal to the period of the Force
Majeure.
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|
| 17.3 |
If
the Force Majeure in question prevails for a continuous period in
excess
of 6 months, the party not affected by the Force Majeure shall, for
so
long as the Force Majeure continues, have the right to immediately
terminate this Agreement by written notice served on the other
party.
|
| 18 |
Duration
and Termination
|
| 18.1 |
This
Agreement shall come into force on the date of this Agreement and
shall,
unless terminated earlier for any reason, continue in force for as
long as
the Programme continues.
|
| 18.2 |
Either
party may terminate this Agreement forthwith by giving written notice
to
the other if:
|
| 18.2.1 |
| 18.2.2 |
the
other party breaches any of its obligations under this Agreement
(and, if
the party fails to remedy it within 45 days after being given a written
notice containing full particulars of the breach and requiring it
to be
remedied); or
|
| 18.2.3 |
the
other party persistently breaches its obligations under this Agreement
and
does not cure such breaches after being provided with reasonable
notice
and an opportunity to cure such breaches;
or
|
| 18.2.4 |
an
encumbrancer takes possession, or a receiver is appointed, of any
of the
property or assets of the other party;
or
|
| 18.2.5 |
the
other party becomes subject to an administration order, a moratorium
is
declared in respect of its debts or it makes any voluntary arrangement
with its creditors (within the meaning of the Insolvency Act 1986);
or
|
| 18.2.6 |
the
other party goes into liquidation (except for the purposes of amalgamation
or reconstruction and so that the resulting company effectively agrees
to
be bound by or assume the obligations imposed on that other party
under
this Agreement); or
|
| 18.2.7 |
the
other party suffers or undergoes any procedure analogous to any event
specified in clauses 18.2.3 to 18.2.5 above or any other procedure
available in the country in which the other party is constituted
or
established against or to an insolvent debtor or available to the
creditors of such a debtor.
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|
| 18.2.8 |
In
the event Advaxis determines that patient safety considerations or
due to
regulatory considerations that the supply/manufacture of the Bulk
Product
or Programme Deliverable should immediately cease and the Bulk Product
or
Programme Deliverable withdrawn from the market, Advaxis shall promptly
inform Cobra of such determination and the reasons therefore and
the
Supply/Manufacture shall terminate.
|
| 18.3 |
For
the purposes of clause 18.2.2 above, a breach shall be considered
capable
of remedy if the party in breach can comply with the provision in
question
in all respects other than as to the time of performance (provided
that
the time of performance is not of the
essence).
|
| 18.4 |
Advaxis
shall have the option to terminate this agreement by providing Cobra
a 45
day prior notice on 12.31.2007 and every 2 years
thereafter.
|
| 19 |
Effects
of Termination
|
| 19.1 |
If
this Agreement is terminated by Cobra under clauses 18.2.1 to 18.2.7,
Cobra shall transfer to Advaxis any and all Programme Deliverable,
Vaccine
Process, Programme IP, Programme Data, and Know-How and any information
and materials reasonably requested by Advaxis so as to allow them
to
continue with the Programme and the development, trials and/or
exploitation of the Programme
Deliverable.
|
| 19.2 |
The
termination of this Agreement by Advaxis shall not affect any existing
contracts for the supply of Clinical Product and/or Bulk Product
which
shall remain in force unless Advaxis also terminates such contracts
in
accordance with their terms. On termination of this Agreement by
Advaxis ,
Cobra may at its option terminate any outstanding orders for Clinical
Product and/or Bulk Product without any liability to
Cobra.
|
| 19.3 |
Upon
the termination of this Agreement for any reason any provisions which
expressly and/or impliedly survive the such termination shall continue
in
full force and effect including sections 4 to 14, 16, 17, 18, 19
and
20.
|
| 19.4 |
Termination
of this Agreement shall not affect any pre-existing claims and/or
rights
of the parties arising and/or in force prior to such
termination.
|
| 19.5 |
Any
and all payments due as at the date of termination shall immediately
become due and payable.
|
| 20 |
General
|
| 20.1 |
Relationship
Between the Parties.
The parties’ relationship, as established by this Agreement, is solely
that of independent contractors. This Agreement does not create any
partnership, joint venture or similar business relationship between
the
parties. Neither party is a legal representative of the other party,
and
neither
party can assume or create any obligation, representation, warranty
or
guarantee, express or implied, on behalf of the other party for any
purpose whatsoever.
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|
| 20.2 |
Any
notice required or provided for by the terms of this Agreement shall
be in
writing, addressed to the address at the head of this Agreement or
such
other address as may be notified in writing, and sent by registered
or
certified mail, return receipt requested, postage prepaid, or by
express
courier service providing evidence of delivery or by facsimile
transmission. The effective date of any notice shall be the date
of
receipt by the Cobra.
|
| 20.3 |
This
Agreement may be executed in two counterparts, each of which shall
be
deemed an original and both of which together shall constitute one
and the
same instrument.
|
| 20.4 |
All
rights of any third party to enforce the terms of this Agreement
are
excluded. This shall not apply to members of each party’s group in
relation to which it gives its consent who shall be entitled to enforce
the terms of this Agreement in addition to that party. All rights
of third
parties to enforce the terms of this Agreement may be varied and/or
extinguished by the agreement of the parties to this Agreement without
the
consent of any such third party.
|
| 20.5 |
This
Agreement shall take effect from the date of the last party to sign
this
Agreement or date upon which signed copies are exchanged by the
parties.
|
| 20.6 |
Nothing
in this Agreement is intended or will be construed as constituting
a
partnership, agency or joint venture relationship between the parties.
All
activities by the parties under this Agreement will be performed
by them
as independently.
|
| 20.7 |
Waiver
by either party of a breach of, or failure to comply with, this Agreement
by the other party is of no effect unless it is in writing and signed
by
or on behalf of the first mentioned
party.
|
| 20.8 |
If
any term or provision of this Agreement can sustain two or more
interpretations, one of which results in the terms or provision being
valid, legal or enforceable, that term or provision will be given
that
interpretation rather than an interpretation which would or be likely
to
result in the term or provision being invalid, illegal or
unenforceable.
|
| 20.9 |
If
any term or provision of this Agreement is to any extent held to
be
invalid, illegal or unenforceable, the validity, legality, and
enforceability of the remaining terms or provisions (and any application
of the said terms or provisions) will not in any way be affected
or
impaired.
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|
| 20.10 |
If
any term or provision of this Agreement is to any extent held to
be
invalid, illegal or unenforceable, the parties will negotiate in
good
faith and, if legally possible, will agree on an alternate term or
provision having regard to the original intention of the
parties.
|
| 20.11 |
Advaxis
has the right to assign its rights in this Agreement. Cobra does
not have
the right to assign its right in this
agreement.
|
| 20.12 |
This
Agreement represents the entire understanding between the parties
and
supersedes any and all previous understandings both written and oral
with
respect to the subject matter of this Agreement with the exception
of the
discount and royalty terms applied to contracts agreed before January
2005.
|
| 20.13 |
This
Agreement may not be amended, varied, supplemented or otherwise modified
except by an instrument in writing signed by both
parties.
|
| 20.14 |
Cobra
shall ensure that, in addition to this Agreement between Cobra and
Advaxis, any successor to Cobra is bound by an agreement with Advaxis
on
the same terms as this Agreement as if such successor were Cobra
under
this Agreement
|
| 20.15 |
Each
party shall from time to time do all such acts and execute all such
documents as may be reasonably necessary in order to give effect
to the
provisions of this Agreement.
|
| 20.16 |
Except
as otherwise provided in this Agreement, the parties shall bear their
own
costs of and incidental to the preparation, execution and implementation
of this Agreement
|
| 21 |
Experts
|
| 21.1 |
If
the parties are unable to agree on the calculation of Cost in relation
to
any matter and/or the calculation of Net Sales from exploitation
of the
Resale Products within 30 days then the calculation shall be determined
by
an independent chartered accountant selected by the agreement of
the
parties. If the parties have not agreed upon the identity of such
accountant within 14 days then, upon the application of either party,
he
shall be selected by the President of the Institute of Chartered
Accountants of England and Wales at the relevant time. Such accountant
shall be appointed on behalf of the parties jointly and each party
shall
initially pay half his professional fees. In determining the relevant
Cost
and/or division of Net Sales such accountant shall act as an expert
and
not as an arbitrator and may make any award as to costs as he sees
fit in
his absolute discretion. His decision shall be final and binding
on the
parties save in the case of manifest
error.
|
| 21.2 |
If
the parties are unable to agree on the cause of any defect in the
Programme Deliverable for the purposes of the indemnities in section
16
within 30 days then the cause shall be determined by an independent
biological engineering expert selected by the agreement of the parties.
If
the parties have not agreed upon the identity of such expert within
14
days then, upon the application of either party, he shall be selected
by
the President of the Institute of Chemical Engineers in England and
Wales
at the relevant time. Such expert shall be appointed on behalf of
the
parties jointly and each party shall initially pay half his professional
fees. In determining the relevant cause such expert shall act as
an expert
and not as an arbitrator and may make any award as to costs as he
sees fit
in his absolute discretion. His decision shall be final and binding
on the
parties save in the case of manifest
error.
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|
| 22 |
Disputes
|
| 22.1 |
English
law shall apply to the whole of this Agreement, and each party agrees
to
submit to the non-exclusive jurisdiction of the English
courts.
|
| 23 |
Intellectual
Property
|
| 23.1 |
The
terms as agreed in the existing Phase I and II agreements between
Cobra
and Advaxis shall apply and remain in full force and effect. If there
is
any conflict between the terms of this Agreement and the terms of
the
existing Phase I and II agreements, the terms of this Agreement shall
prevail.
|
| 24 |
Exclusive
supply
|
| 24.1 |
Cobra
shall not provide, supply, license, transfer, convey, or disclose,
Programme Deliverable, Vaccine Process, Programme Data, Programme
IP, to
any third party for research or development pre-clinical or clinical
trials, importing, distribution, sales or any other commercial purpose,
or
any other purpose, without the prior written consent of Advaxis.
This
section shall survive termination of this Agreement for any reason.
Cobra
shall not manufacture or supply any live or dead, or recombinant
Listeria
product to any third party for any commercial purpose without the
prior
written consent of Advaxis. This section shall survive the termination
of
this agreement for any reason.
|
IN
WITNESS OF THE ABOVE the
parties have signed this Agreement on the date written at the head of this
Agreement.
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SCHEDULE
1
Price
for Clinical Product and Retrospective Discount
[
*
]
[
*
]
[
*
]
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SCHEDULE
2
ADVAXIS
Intellectual Property
To
be added by Advaxis
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SCHEDULE
3
Cobra’s
Terms and Conditions
Any
order
given to Cobra to conduct contract manufacturing services shall be deemed to
constitute an acceptance of the following terms and conditions of
business.
The
terms
and conditions of business detailed below shall be automatically incorporated
into any contract between Cobra and the Customer and shall override and exclude
any conditions of purchase which are in any way in conflict with same
notwithstanding, the date or dates of any purchase order incorporating any
conflicting conditions of purchase, and an acceptance by Cobra of a purchase
order from the Customer shall not be deemed to be an acceptance of any such
conflicting conditions of purchase.
| 1. |
CONFIDENTIALITY
|
Cobra
undertakes as follows:
| 1.1 |
to
regard the material, information and results as confidential and
the
property of the Customer;
|
| 1.2 |
to
take all practical steps possible to ensure that the work, material,
information and results are kept secure and not subject to unauthorised
disclosure;
|
| 1.3 |
to
disclose the material, information and results only to those of its
employees who need to know the same and Cobra shall take all steps
reasonably practicable to ensure that such employees will comply
with the
requirements and restrictions herein
contained.
|
The
foregoing provisions shall not apply to that part of information or the results
which Cobra can clearly demonstrate:
| 1.1 |
was
known to it from its own activities prior to disclosure by the Customer
as
evidenced by written records of Cobra predating the date of such
disclosure by the Customer; or
|
| 1.2 |
was
part of the public domain or the subject to public knowledge at the
date
of disclosure by the Customer; or
|
| 1.3 |
becomes
part of the public domain or the subject of public knowledge after
the
date of disclosure by the Customer without breach of any obligation
owed
by Cobra to the Customer; or
|
| 1.4 |
are
furnished to Cobra by a third party without breach of any obligation
of
confidentiality owed by that third party to the Customer;
or
|
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| 1.5 |
.
|
| 2. |
SUB-CONTRACTING
|
Cobra
shall have the authority to sub-contract all or any part of the work to be
carried out in terms of its contract with a Customer, with consent of the
Customer, not to be unreasonably withheld, subject to the sub-contractor
entering into a confidentiality agreement with Cobra on standard terms. (TO
BE
AMENDED AS ABOVE )
| 3. |
QUALITY
ASSURANCE
|
| 3.1 |
Cobra
undertakes that it shall conduct the work with all reasonable skill
and
care and where applicable under the prevailing norms for Good
Manufacturing Practice and Good Laboratory Practice as applied to
the
manufacture of biotherapeutic products for Phase I/II clinical trial
purposes.
|
| 3.2 |
Subject
to clause 3.1 above, Cobra does not give any guarantee or assurance
that
the product in question shall be successfully
produced.
|
| 4. |
HEALTH
AND SAFETY
|
To
allow
Cobra to comply with the Health and Safety at Work Act (1974) or any subsequent
or amending legislation the Customer shall provide Cobra with all available
information regarding known or potential hazards associated with the use of
any
materials supplied to Cobra by the Customer.
| 5. |
VARIATIONS
|
It
is
recognised that during the work minor variations from intended methodology
may
become advisable because of results observed, and at the Customer’s request. Any
change in the contract price resulting therefrom will be incorporated in the
final account.
Major
changes to the intended methodology required by the Customer must be made in
writing to Cobra and will be the subject of a mutually agreed price which will
be substituted for or charged in addition to the original contract price. Any
dispute as to price will be resolved by written mutual agreement between
authorised representatives/directors of Cobra and the Customer. HOW DO WE TEST
THIS?
| 6. |
REPORTS
|
Cobra
will provide a Final Report on completion of the work. Additional copies of
Reports will be provided at the Customer’s request and expense.
Cobra
shall publish any Report or data prepared for the Customer by Cobra without
the
prior written consent of Advaxis .
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The
name
of Cobra or the names of any of its staff shall not be used for any advertising,
promotional or other public purposes without the prior written consent of
Cobra.
All
results arising from the work shall be provided to the Customer and shall be
the
property of the Customer. Cobra shall make no use of the results without
obtaining the Customer’s written permission; such permission not to be
unreasonably withheld.
| 7. |
PROTOCOLS
AND CONTRACTS
|
The
Customer shall not make any use of this contract, the protocols or any related
documents for negotiations or discussions with third parties other than
Regulatory Authorities, Licensees, associate companies or members of the
Customer’s consortium funding the work without the prior written approval of
Cobra. The Customer has a duty of confidentiality to Cobra in relation to such
documentation.
| 8. |
PAYMENT
|
All
invoices are payable within 30 days of the invoice date or as stated in the
quotation for the work to be performed. After due notice Cobra reserves the
right to cease or suspend all work on a project on which payment remains in
arrears, and to hold the Customer in breach of contract. Cobra shall have the
right to dispose of any saleable stock or other items employed in connection
with the project and to set off the proceeds of such disposal against unpaid
accounts.
| 9. |
INTEREST
|
If
the
Customer fails to pay any sum due under these terms and conditions, then,
subject to this clause, interest shall be charged thereon from the due date
until the date payment is made at the rate of [two] per cent per annum over
the
base rate of HSBC Bank from time to time in force.
| 10. |
PRICES
|
The
contract price excludes the cost of importation of samples or specimens and
freight charges associated with their return shipment.
Prices
are exclusive of VAT which will be charged, where appropriate, at the prevailing
rate.
| 11. |
INTELLECTUAL
PROPERTY RIGHTS AND
INVENTIONS
|
All
discoveries and patentable inventions excepting methodological innovation
arising during the project shall be the property of the Customer.
| 12. |
OWNERSHIP
OF MATERIALS
|
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|
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|
Where
the
contract involves the use by Cobra of material provided to it by the Customer
or
on the Customer’s behalf, whether for the purposes of evaluation, validation,
testing or manufacture, the Customer shall be deemed to have provided to Cobra
either (1) the necessary authority of the Customer as a proprietor of such
material or (2) the necessary authority of the proprietor of such material,
to
enable and authorise Cobra to use such material for the purposes of the
contract. The onus shall be on the Customer to take all steps reasonably
necessary to satisfy itself that the appropriate authority is in place, and
the
Customer shall indemnify Cobra in respect of any claims made against Cobra
by
any third party as a result of the Customers breach of its obligations herein
contained.
Such
material shall be used by Cobra solely for the purposes of evaluation,
validation, testing or manufacture whichever is applicable as agreed with the
Customer and for no other purpose.
| 13. |
CUSTOMERS
CONFIDENTIALITY
OBLIGATIONS
|
In
that
the Customer (which shall include their employees and representatives) may
come
into possession of information relating to Cobra’s development and research
activities or their manufacturing or commercial interests in general terms,
or
more particularly details of Cobra’s study Protocols or testing methods or
related information either through discussions or correspondence with Cobra
or
during visits to Cobra’s premises the Customer hereby undertakes to regard such
information as confidential and the property of Cobra, to take all practical
steps to ensure that the said information is kept secure and not subject to
unauthorised disclosure, and to disclose the said information only to those
of
its employees who need to know the same and who are bound by similar
confidentiality obligations.
Section
1, subsection 2 shall apply mutatis mutandis.
| 14. |
ARCHIVAL
STORAGE
|
At
the
conclusion of the work and within thirty (30) days of the receipt by Cobra
of a
written request from the Customer to do so, Cobra shall arrange for the
destruction or return to the Customer of any remaining material or any sub-units
or derivatives thereof, together with any information and Results relating
thereto, but subject always to Cobra being entitled to retain such material,
or
copies of information and Results, as will enable it to comply with GLP, GMP
or
any other relevant regulations. In the event of no such request from the
Customer, Cobra shall retain in its archive for a period of ten years following
the date of the Final Report all slides, blocks, original data and other
materials arising out of the project, or for such shorter period as, in the
opinion of Cobra, the quality of the material affords evaluation. Cobra reserves
the right to make a charge for such storage or for the transport of materials.
At the end of the ten years referred to above, Cobra shall contact the Customer
for instructions on the transfer, retention or disposal of
materials.
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| 15. |
TERMINATION
|
| 15.1 |
Subject
to clause 15.2 below, either the Customer or Cobra shall be entitled
to
terminate the contract by giving the other three months written notice.
In
the event of termination by the Customer, for any reason not the
fault of
Cobra, Cobra reserves the right to charge for all costs associated
with
the termination.
|
| 15.2 |
Either
party may terminate these terms and conditions forthwith by written
notice
to the other party if:
|
| 15.2.1 |
the
other party shall commit a material breach of any of its obligations
under
these terms and conditions and shall not have remedied such a breach
within thirty days of receiving written notice of the breach;
or
|
| 15.2.2 |
the
other party shall become bankrupt or enter into liquidation (other
than
the reconstruction of amalgamation) or have a receiver appointed
of its
assets or any part thereof or any administrative order is served
upon
it.
|
| 15.2.3 |
In
the event Advaxis determines that patient safety considerations or
due to
regulatory considerations that the supply/manufacture should cease,
Advaxis shall promptly inform Cobra of such determination and the
reasons
therefore and the Supply/Manufacture shall terminate.
|
| 15.3 |
Termination
shall not prejudice or affect any right of action or remedy which
shall
have accrued or shall thereafter accrue to either
party.
|
| 15.4 |
For
the avoidance of doubt, termination shall not affect any property
or
intellectual property rights vested in the Customer under these terms
and
conditions.
|
| 16. |
FORCE
MAJEURE
|
| 16.1 |
Cobra
shall not be liable for any delay in meeting or for failure to meet
any of
its obligations under these terms and conditions due to any cause
outside
of its reasonable control, including without limitation, strikes
and
lock-outs (but excluding strikes and lock-outs of the affected party
and
its subcontractors), acts of God, war, riot, malicious acts of damage
(but
excluding malicious damage involving the employees of the affected
party
or its subcontractors), fire, acts of any government authority or
failure
of the public electricity supply. [The exception being a decision
by the
Medicines Control Agency, which indicates that the material provided,
has
been produced without appropriate GMP or GLP
controls/documentation].
|
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| 16.2 |
If
Cobra is prevented from meeting any of its obligations due to an
event
described in 16.1, it shall promptly notify the Customer in writing
of the
circumstances and if Cobra shall have been so prevented from meeting
its
obligations for more than thirty days following the date of giving
such
notice, then either party may terminate these terms and conditions
forthwith upon written notice.
|
| 16.3 |
In
the event of termination by either party by reason of Cobra suffering
an
event described in clause 16.1 which prevents Cobra from meeting
its
obligations for more than thirty days from the date which Cobra gave
notice of the event to the Customer, then subject to clause 15.3,
the
Customer shall be under no obligation to pay Cobra any
sum.
|
| 17. |
LIMITATION
OF LIABILITY AND INDEMNITY - same as Section 16
above
|
| 18. |
CONTINUING
OBLIGATIONS
|
Notwithstanding
termination of the contract or completion of the work these Terms and Conditions
shall remain in full force and effect and may be founded upon by either Cobra
or
the Customer and that for a period of ten years after such termination or
completion.
| 19. |
NOTICES
|
| 19.1 |
Any
notice, which expression includes any other communication whatsoever
which
is made in accordance with these terms and conditions, should reference
the Cobra contract shown at the head of these terms and conditions
and
shall, without prejudice to any other method of giving it, be sufficiently
given if it is sent by registered or recorded delivery first class
post to
the other party to the address stated on the signature page of these
terms
and conditions or to such other address as the respective party may
advise
by notice in writing from time to
time.
|
| 19.2 |
Notices
shall be deemed to have been properly given after three working days
in
the case of notices posted in the United Kingdom to a destination
therein
and eight working days in the case of all other notices posted
internationally.
|
| 19.3 |
Any
written notices or instructions to make variations under clause 5
shall be
sent to each party’s project
manager.
|
| 20. |
WAIVER
|
No
delay
or failure of either party in enforcing against the other party any term or
condition hereunder and no partial exercise by either party any right hereunder,
shall be deemed to be a waiver of any right of that party under these terms
and
conditions.
| 21. |
CONSTRUCTION
OF THESE TERMS AND
CONDITIONS
|
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|
| 21.1 |
If
the scope of any of the provisions of these terms and conditions
is too
broad in any respects to permit enforcement to its full extent, then
the
parties agree that such a provision shall be enforced to the maximum
extent permitted by law and that such provision shall be deemed to
be
varied accordingly.
|
| 21.2 |
No
purported variations of these terms and conditions shall take effect
unless made in writing and signed by an authorised representative
of each
party.
|
| 22. |
PROPER
LAW OF CONTRACT
|
These
terms and conditions shall be governed by and construed in accordance with
English law.
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|
SCHEDULE
4
Facility
Occupancy Charge
The
Facility Occupancy Charge (“FCC”) will be calculated as follows:
FCC
=
Total
Annual Facility Cost x Programme Area x number of weeks of
occupancy
Total
area of production facility x 46
Where:
Total
Annual Facility Cost equals the total annual cost of operating and maintaining
the relevant production facility (including depreciation and any interest
payments paid on debts incurred after investment in Product specific facility
and or equipment modifications required by any regulatory authority); and
Programme
Area is the area of the relevant production facility used in the production
of
Product for the Programme.
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|
……………………………..............
for
and
on behalf of
COBRA
BIOLOGICS LTD
Name: …………………………….
Title: ……………………………...
……………………………..............
for
and
on behalf of
ADVAXIS
INC
Name: …………………………….
Title: ……………………………...
DRAFT
for Discussion Only