UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 8-K/A
(Amendment
No. 1)
CURRENT
REPORT
Pursuant to Section 13 or
15(d) of the Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): March 15, 2010
GENESIS
BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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000-53127
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75-3254381
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(State
or other jurisdiction
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(Commission
File Number)
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(IRS
Employer
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of
incorporation)
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Identification
No.)
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1601
N. Sepulveda Blvd., #632
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90266
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Manhattan
Beach, California
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(Zip
Code)
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(Address
of principal executive offices)
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Registrant’s
telephone number, including area code: (866) 963-2220
Not
applicable
(Former
name or former address, if changed since last report.)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
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ITEM
1.01
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ENTRY
INTO A MATERIAL DEFINITIVE
AGREEMENT.
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On March 19, 2010, Genesis Biopharma,
Inc. (“Genesis” or the “Company”) filed a Current Report on Form 8-K (the “Form
8-K”) disclosing, among other things, that it had entered into a Patent and Know
How Licence with Cancer Research Technology Limited (“Cancer Research UK”) on
March 15, 2010 (the “License Agreement”). Attached to the Form 8-K was a version
of the License Agreement from which portions had been redacted pursuant to a
request for confidential treatment (the “CTR”) submitted to the Securities and
Exchange Commission (the “Commission”). In response to comments from the
Commission on the CTR, the Company submitted a revised, redacted version of the
License Agreement to the Commission (the “Revised License Agreement”). On June
10, 2010, the Commission issued an order granting confidential treatment of the
text omitted from the Revised License Agreement. The purpose of this Amendment
No. 1 to the Form 8-K is to file publicly the Revised License Agreement, a copy
of which is attached hereto as Exhibit 10.1 and incorporated herein by
reference.
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ITEM 2.01
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COMPLETION OF ACQUISITION OR
DISPOSITION OF ASSETS.
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The information called for by this
item is contained in Item 1.01, which is incorporated herein by
reference.
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ITEM 8.01
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OTHER
EVENTS.
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Genesis entered into the License
Agreement with Cancer Research UK for the development of anti-CD55 monoclonal
antibodies.
In connection with the license,
Genesis will be managing further development of the intellectual property, with
monitoring of the process by Cancer Research UK. This includes
prosecution of the national patent applications that are derived from the
International Application No. PCT/GB2003/005163 filed November 26th, 2003 with
the title “Specific Binding Members and Uses Thereof.” When
necessary, Genesis also will be responsible for payment of any national patent
filing and maintenance fees subsequent to a patent grant.
In Europe, the Company received a
Notice of Intent to Grant from the European Patent Office for EP Patent
Application No. 1565494 to grant as of June 2nd, 2010. The Company
will determine in which countries to apply and will file formalities by
September 2nd, 2010 to apply for national patent applications, and upon
completion of patent formalities, payment of filing fees, and any necessary
translations, patents should be formally granted in the European nations
selected.
In the United States, the Company has
pending US Patent Application No. 12,559,342.
In Japan, the Company has filed
Patent Application No. 2004-554700, which has been initially
refused. The Company plans to appeal this decision and is required by
the Japan Patent Office to formally appeal the decision by October 8th,
2010.
The Company currently also has patent
applications pending in additional jurisdictions, including Canada, Hong Kong,
and Australia.
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ITEM
9.01
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FINANCIAL
STATEMENTS AND EXHIBITS.
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(d)
EXHIBITS
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EXHIBIT NO.
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DESCRIPTION
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10.1
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Patent
and Know How Licence between Cancer Research Technology Limited and
Genesis Biopharma, Inc. dated March 15, 2010
*
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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GENESIS
BIOPHARMA, INC.
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By:
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/s/ Robert Brooke
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| Robert Brooke | ||
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Dated:
July 2, 2010
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Chief Executive Officer | |
DATED 15TH MARCH
2010
(1)
CANCER RESEARCH TECHNOLOGY LIMITED
AND
(2)
GENESIS BIOPHARMA, INC.
Patent
and Know How Licence
GB 000001
THIS
AGREEMENT is made the 15th day of March 2010
BETWEEN:
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(1)
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Cancer Research Technology
Limited, a company registered in England and Wales under number
1626049 with registered office at Sardinia House, Sardinia Street, London
WC2A 3NL, England (“CRT”);
and
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(2)
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Genesis Biopharma, Inc.
(formerly known as Freight Management Corporation), a company
incorporated in the State of Nevada, United States of America whose
principal place of business is at Suite 200, 8275 Eastern Ave., Las Vegas,
Nevada, 89123 (“Genesis
Biopharma”).
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RECITALS
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(A)
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CRT
is an oncology focused technology transfer and development
company.
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(B)
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CRT
is wholly owned by Cancer Research UK, a company registered under number
4325234 and registered charity number 1089464. Cancer Research UK was
formed as a result of the merger on 4 February 2002 of two charities: the
Cancer Research Campaign (“CRC”) and Imperial
Cancer Research Fund.
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(C)
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CRC
funded research concerning the CD55 antigen in the laboratories of
Professor Lindy Durrant at the University of Nottingham (the “University”). Pursuant
to a Research Collaboration and Option Agreement dated 27th
July 2000 made between CRT (under its former name of Cancer Research
Campaign Technology Limited), Viragen (Scotland) Limited and the
University, as amended by the Novation Agreement dated 7th
September 2001 (the “Collaboration
Agreement”), the research led to a novel therapeutic use of
anti-CD55 antibodies (the “Invention”) and CRT is
the registered proprietor of the application(s) for patent(s) described in
Schedule 2 (the ”Scheduled Patents”) in
respect of the Invention. Under a letter agreement dated
11th
November 2003 between Viragen, Inc. (“Viragen”) and CRT (the
“Letter
Agreement”), CRT granted a limited licence to Viragen to certain
intellectual property in respect of the Invention. The Collaboration
Agreement and Letter Agreement expired and Viragen (the parent company of
Viragen (Scotland) Limited), entered into a patent and know how licence
agreement dated 27 April 2005 (the “2005 Licence”) under
which CRT granted Viragen an exclusive licence to the Licensed
Intellectual Property (as defined by the 2005 Licence, the “2005 Licensed Intellectual
Property”). During the term of the Letter Agreement and
2005 Licence, Viragen (either itself or through its wholly owned
subsidiary Viragen (Scotland) Limited) generated certain Viragen
Intellectual Property (defined in Clause
1).
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(D)
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In
connection with the liquidation of Viragen and Viragen (Scotland) Limited,
the 2005 Licence was terminated in accordance with its terms by CRT. In
the interests of ensuring the further development of the Invention, CRT
waived its rights to call for Viragen’s rights in the Viragen Intellectual
Property (as defined in the 2005 Licence) and the clinical data generated
by Viragen relating to the 2005 Licensed Intellectual Property to be
assigned to CRT. At the request of Viragen’s liquidators, CRT
negotiated and concluded a licence (the “Percipio Licence” as
defined below) in materially similar terms to the 2005 Licence with
Percipio Biotherapeutics, Inc. (“Percipio”) to ensure the
commercial exploitation of the Invention and anti-CD55 antibody programme
to develop Products (as defined in Clause 1). During the term
of the Percipio Licence, Percipio generated certain Percipio Intellectual
Property (defined in Clause
1).
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GB 000002
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(E)
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On
the basis of the arrangements described in paragraph D, (i) the Viragen
Intellectual Property was assigned to Hamilton Atlantic, a company
organized in the Cayman Islands (“Hamilton”), pursuant to
an Assignation executed by Hamilton on 6 May 2008;
(ii) Hamilton entered into that certain License Agreement (“Agreement I”) effective
as of August 20, 2008, by and between Hamilton and Percipio (formerly
known as Sunburst Acquisitions III, Inc., a Colorado corporation), and
that certain License Agreement (“Agreement II,”
collectively with Agreement I the “Sunburst License
Agreements”) effective as of August 21, 2008, by and between
Hamilton and Percipio, pursuant to which Hamilton agreed to license to
Percipio the Viragen Intellectual Property; and (iii) CRT and Hamilton
entered into that certain Agreement effective as of October 21, 2008,
between CRT and Hamilton (the “Hamilton Side
Agreement”), pursuant to which Hamilton agreed to grant CRT an
exclusive worldwide right and licence to the Viragen Intellectual Property
in the event that the Percipio Licence and Agreement II are
terminated.
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(F)
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It
is proposed that concurrent with this Agreement Hamilton will terminate
the Sunburst Licence Agreements by agreement with Percipio and will assign
the Viragen Intellectual Property to Genesis Biopharma pursuant to an
asset purchase agreement (the “Asset Purchase
Agreement”).
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(G)
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It
is proposed that concurrent with this Agreement CRT, Hamilton, Percipio,
and Genesis Biopharma will enter into an agreement (the “Licence Termination and Waiver
Agreement”) pursuant to which CRT and Percipio will terminate the
Percipio License and CRT will waive its rights arising from the Hamilton
Side Agreement in order to facilitate the commercial exploitation of the
Invention and anti-CD55 antibody programme, including by the grant of an
exclusive licence under the Licensed Patents (defined in Clause 1), the
Licensed Know How and the Licensed Materials upon the terms and conditions
set out in this Agreement.
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(H)
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Percipio
has assigned all rights in the Percipio Intellectual Property to Genesis
Biopharma as referred to in the Licence Termination and Waiver
Agreement.
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GB 000003
NOW
IT IS HEREBY AGREED as follows:
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1.
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DEFINITIONS
AND INTERPRETATION
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1.1
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In
this Agreement and in the Schedules to this Agreement the following words
and phrases shall have the following
meanings:
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“Affiliate”
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means,
with respect to a Party, any company, corporation, partnership or other
entity, which directly or indirectly Controls, or is controlled by, or is
under the common control with such Party including as a subsidiary, parent
or holding company of such Party; and the term “Control” means the
ownership of more than fifty per cent (50%) of the issued share capital or
the legal power to direct or cause the direction of the general management
and policies of the relevant Party.
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“Agreement”
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means
this document entitled “Patent and Know How Licence” and any and all
schedules, appendices and other addenda to it as may be varied or
otherwise altered or amended from time to time in accordance with the
provisions of Clause 13.3.
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“Business
Day”
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means
a day other than a Saturday, Sunday, bank or other public holiday in
England.
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“Commencement
Date”
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means
the date first above written.
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“Competent
Authority”
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means
any local or national agency, authority, department, inspectorate,
minister, ministry official or public or statutory person (whether
autonomous or not) of any government or of any country having jurisdiction
over this Agreement or of any of the Parties or over the development or
marketing of medicinal products including, but not limited to, the
European Commission, the European Court of Justice and the Food and Drug
Administration of the United States of America.
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“Confidential
Information”
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means
any and all information which is identified and treated by the disclosing
Party as secret and confidential or which, by reason of its character or
the circumstances or manner of its disclosure, is evidently secret and
confidential and which the disclosing Party from time to time discloses to
the recipient Party, whether orally, in writing, in digital form, in the
form of machine readable code or any other physical medium which relates
to the disclosing Party, its business activities and including, but not
limited to Know How, financial information (except that published in
audited accounts), business strategies or intentions, marketing plans or
information, formulae, inventions or product or services
development.
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“Development
Plan”
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means
the programme for the development of Products to be undertaken by or on
behalf of Genesis Biopharma as more particularly set out in Schedule 1 and
as may be amended from time to time by agreement of the Parties in
writing.
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GB 000004
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“European
Economic Area”
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means
those countries that are members of the European Economic Area as
constituted at the Commencement Date.
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“Field”
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means
the field of use of 791T/36 for the immunotherapeutic treatment and/or
diagnosis of diseases.
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“Financing
Event”
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means
the receipt by Genesis Biopharma of at least US$1,100,000 (one million one
hundred thousand US dollars), in total, whether in a single tranche or
cumulatively, in cash.
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“Genesis
Biopharma Intellectual Property”
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means
any Know How, Material or Patent Rights directly related to the
development of antibodies directed against CD55 or the Products, whether
as an improvement to the Licensed Intellectual Property and/or Viragen
Intellectual Property and/or Percipio Intellectual Property or otherwise,
discovered, invented, developed, or manufactured as a result of research
undertaken by Genesis Biopharma itself or its Affiliates or Sub-licensees
or research funded by Genesis Biopharma but undertaken by a Third Party
and undertaken pursuant to the licence in this
Agreement.
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“Force
Majeure”
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means
in relation to either Party any event or circumstance which is beyond the
reasonable control of that Party, which that Party could not reasonably be
expected to have taken into account at the Commencement Date and which
results in or causes the failure of that Party to perform any or all of
its obligations under this Agreement including an act of God, lightning,
fire, storm, flood, earthquake, accumulation of snow or ice, lack of water
arising from weather or environmental problems, strike, lockout or other
industrial disturbance, war, terrorist act, blockade, revolution, riot
insurrection, civil commotion, public demonstration, sabotage, act of
vandalism, prevention from or hindrance in obtaining in any way materials,
energy or other supplies, explosion, fault or failure of plant or
machinery, governmental restraint, act of legislature and directive or
requirement of a Competent Authority governing any Party provided that
lack of funds shall not be interpreted as a cause beyond the reasonable
control of that Party.
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“Indication”
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means
a recognized disease or condition, a significant manifestation of a
disease or condition, or symptoms associated with a disease or condition
or a risk for a disease or condition. Notwithstanding the foregoing,
“Indication” as used in Clause 4 shall mean a specific disease indication
differentiated by tumor types (as opposed to different labels within the
same tumor type).
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GB 000005
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“In
Vivo Efficacy Work”
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means
the work so described as detailed in Part 1 of Stage 1 of the Development
Plan.
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“Initial
Financing”
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means
the receipt by Genesis Biopharma of the sum of US$400,000 (four hundred
thousand US Dollars) pursuant to commitments made on or before the
Commencement Date.
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“Know
How”
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means
technical and other information which is not in the public domain
including, ideas, concepts, inventions, discoveries, data, formulae,
specifications, information relating to Materials (including Licensed
Materials), procedures for experiments and tests and results of
experimentation and testing, results of research and development including
laboratory records and data analyses which is secret, substantial and
identifiable.
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“Licensed
Intellectual Property”
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means
the Licensed Know How, the Licensed Materials and the Licensed
Patents.
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“Licensed
Know How”
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means
any and all Know How set out in Schedule 3 to this
Agreement.
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“Licensed
Materials”
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means
(i) the mouse monoclonal antibody called 791T/36 and (ii) the hybridoma
ATCC Hybridoma Number HB9173 which produces 791T/36 owned by
CRT.
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“Licensed
Patents”
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means
(i) Patent Application Number PCT/GB2003/005163 (and all
foreign equivalents thereof); (ii) any and all other patent
application(s), patents, divisionals, continuations, continuations in part
and improvements arising therefrom; and (iii) any and all other Patent
Rights obtained in pursuance of or deriving priority from the Patent
Rights listed in items (i) and (ii) hereof. A list of Patent
Rights as of the Commencement Date is set forth in Schedule
2.
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“Major
Market”
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means
each of the following groups of countries:
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(i)
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the
European Economic Area;
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(ii)
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Japan,
Australia and New Zealand; and
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(iii)
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the
United States of America and Canada.
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“Marketing
Plan”
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has
the meaning set forth in Clause
3.5.
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GB 000006
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“Material”
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means
any chemical or biological substance directly related to the Licensed
Materials, including any:
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(i)
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organic
or inorganic chemical element or compound;
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(ii)
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nucleotide
or nucleotide sequence including DNA and RNA sequences;
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(iii)
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gene;
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(iv)
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vector
or construct including plasmids, phages, or viruses;
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(v)
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host
organism including bacteria, fungi, algae, protozoa and
hybridomas;
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(vi)
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eukaryotic
or prokaryotic cell line or expression system or any development strain or
product of that cell line or expression system;
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(vii)
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protein
including any peptide, amino acid sequence, enzyme, antibody or protein
conferring targeting properties and any fragment of a protein, peptide,
enzyme, or antibody;
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(viii)
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drug
or pro-drug;
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(ix)
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other
genetic or biological material or micro-organism; or
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(x)
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assay
or reagent.
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“Net
Sales”
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means
the invoiced amount actually received for sales of Products to a Third
Party trade purchaser (the “Customer”) by Genesis Biopharma or its
Affiliates, or, to the extent permitted in this Agreement, by
Sub-licensees or sub-sub-licensees, less the following items to the extent
they are paid or incurred or allowed and included in the invoice
price:
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(i)
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quantity,
trade and/or cash discounts or rebates actually granted or
accrued;
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(ii)
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amounts
repaid or credited and allowances including cash, credit or free goods
allowances given by reason of billing errors and rebates actually allowed
or paid or accrued;
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(iii)
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amounts
refunded or credited for Products which were rejected or damaged or
recalled; and
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GB 000007
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(iv)
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shipping
charges, taxes, tariffs, customs duties and surcharges and other
governmental charges incurred in connection with the sale, exportation or
importation of Products.
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The
transfer of Products by Genesis Biopharma, by its Affiliates or by its
Sub-licensees to another one of the foregoing shall not be considered a
sale. In such cases, Net Sales shall be determined based on the invoiced
sale price levied by Genesis Biopharma or the relevant Affiliate or
Sub-licensee on the Customer, less the aforementioned deductions set out
above to the extent they are allowed, paid or accrued.
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“Orphan
Indication”
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means
an Indication which is rare in the general population in the Territory, as
defined by the controlling Competent Authority in the country of interest,
as such definition may be amended from time to time.
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“Parties”
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means
CRT and Genesis Biopharma and “Party” shall be construed as any
of them.
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“Patent
Rights”
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means
any patent applications, patents, author certificates, inventor
certificates, utility certificates, utility models and all foreign
counterparts of them and includes all divisions, renewals, continuations,
continuations-in-part, extensions, reissues, substitutions, provisional
applications, continued prosecution applications, requests for continued
examinations, re-examinations, confirmations, registrations, revalidations
and additions of or to them, as well as any supplementary protection
certificate, or like form of protection.
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“Percipio
Intellectual Property”
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means
any Know How, Material or Patent Rights directly related to the
development of antibodies directed against CD55, whether as an improvement
to the Licensed Intellectual Property or otherwise, discovered, invented,
developed, or manufactured as a result of research undertaken by Percipio
itself or its Affiliates or Sub-licensees or research funded by Percipio
but undertaken by a Third Party and whether undertaken pursuant to the
Percipio Licence or pursuant to the Sunburst Licence Agreement, assigned
to Genesis Biopharma as referred to in Recital
(G).
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GB 000008
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“Percipio
Licence”
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means
the Patent and Know How Licence dated 21 October 2008 made between (1) CRT
and (2) Percipio.
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“Pivotal
Registration Study”
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means
a clinical study designed to provide the efficacy data required to enable
a new drug application or other like documentation to be filed in the
United States of America or any Major
Market.
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“Product”
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means
any item, thing or process that falls within the scope of a Licensed
Patent or that uses Licensed Know How, or which contains or was developed
using Licensed Materials, or any Viragen Intellectual Property or Percipio
Intellectual Property.
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“Quarter”
|
means
any period of three consecutive calendar months commencing on 1 January, 1
April, 1 July, or 1 October in any year.
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“Revenue
Share”
|
means
the revenue share to be decided based upon the arms-length, fair market
value of the intellectual property being conveyed by Genesis Biopharma to
CRT pursuant to this Agreement. In determining fair market
value, the intellectual and financial contributions of the Parties to the
entire package of intellectual property (which includes Genesis Biopharma
Intellectual Property) that is to be commercialized shall be determinative
factors.
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“SPC”
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means
a right based on the Licensed Patents or any of them pursuant to which the
holder of the right is entitled to exclude Third Parties from using,
making, having made, selling, advertising or otherwise disposing or
offering to dispose of, importing or keeping the product to which the
right relates, such as Supplementary Protection Certificates in Europe,
and any similar right anywhere in the world.
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“Sub-licence”
|
means
a sub-licence of the Licensed Intellectual Property granted by Genesis
Biopharma to its Affiliate or a Third Party.
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“Sub-licence
Fees”
|
means
all gross consideration (including upfront and milestone payments) other
than royalty payments that accrue to Genesis Biopharma under any
Sub-licence.
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“Sub-licensee”
|
means
any Third Party or Affiliate of Genesis Biopharma granted a Sub-licence by
Genesis Biopharma in accordance with Clause 2.4.
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“Territory”
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means
the world.
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GB 000009
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“Third
Party”
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means
any entity or person other than the Parties or an Affiliate of either of
them.
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“Tobacco
Party”
|
means
any corporation, company, partnership or other organisation or person with
a material interest in or links to the tobacco
industry.
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“Viragen
Intellectual Property”
|
means
any Know How, Material or Patent Rights directly related to the
development of antibodies directed against CD55, whether as an improvement
to the Licensed Intellectual Property or otherwise, discovered, invented,
developed, or manufactured as a result of research undertaken by Viragen
itself or its Affiliates or Sub-licensees or research funded by Viragen
but undertaken by a Third Party and whether undertaken pursuant to the
2005 Licence or pursuant to the Letter Agreement, assigned to Genesis
Biopharma by Hamilton under the terms of the Asset Purchase
Agreement.
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1.2
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In
this Agreement:
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1.2.1
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unless
the context otherwise requires, all references to a particular Clause or
schedule shall be a reference to that Clause or schedule in or to this
Agreement as it may be amended from time to time pursuant to this
Agreement;
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1.2.2
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the
headings are inserted for convenience only and shall be ignored in
construing this Agreement;
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1.2.3
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unless
the contrary intention appears, words importing the masculine gender shall
include the feminine and vice versa and words in the singular include the
plural and vice versa;
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1.2.4
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unless
the contrary intention appears, words denoting “persons” shall include any
individual, partnership, company, corporation, joint venture, trust
association, organisation or other entity, in each case whether or not
having separate legal personality;
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1.2.5
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the
words “include”, “included” and “including” are to be construed without
limitation to the generality of the preceding words;
and
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1.2.6
|
reference
to any statute or regulation includes any modification or re-enactment of
that statute or regulation.
|
GB 0000010
|
2.
|
GRANT
OF LICENCE
|
|
2.1
|
In
consideration for the payments to be made by Genesis Biopharma to CRT
pursuant to Clause 4, CRT hereby grants to Genesis Biopharma an exclusive
worldwide right and licence under all of its rights in the Licensed
Intellectual Property to research, develop, use, keep, make, have made,
market, distribute, sell, offer to sell, advertise or otherwise dispose of
Products in the Field. Genesis Biopharma hereby acknowledges that as of
the Commencement Date it is already in possession of the Licensed Know How
and Licensed Materials and CRT is under no obligation to provide further
quantities of such Licensed Know How and Licensed
Materials.
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2.2
|
Subject
to Clause 2.3, the licence granted in Clause 2.1 shall, in relation to a
particular country in the Territory, terminate
on:
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|
2.2.1
|
the
expiry of the relevant Licensed Patent in the relevant country;
or
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2.2.2
|
ten
years after the date that the first therapeutic Product was placed on the
market in such country,
|
whichever
is the later.
|
2.3
|
It
is acknowledged and agreed that:
|
|
|
2.3.1
|
this
Agreement shall be subject to the academic research rights granted to the
University under the Licensed Intellectual Property;
and
|
|
|
2.3.2
|
CRT
shall have the right to license the Licensed Intellectual Property to
academic and research institutions other than the University, including,
for the avoidance of doubt, Cancer Research UK, for non-commercial
research purposes only, provided that (i) such research does not involve
and does not envisage (a) the disclosure of Confidential Information, or
Licensed Intellectual Property that is not in the public domain or (b) the
licence of any of the Licensed Intellectual Property to a Third Party who
is not a not-for-profit or publicly funded organisation; and (ii) any
licence between CRT and the Third Party licensee shall be non-transferable
and shall provide that such Third Party shall have no rights to sublicense
any of its rights under the Licensed Intellectual
Property. Prior to CRT granting any licence pursuant to this
Clause 2.3.2 CRT shall first obtain from any such prospective licensee
undertakings relating to confidentiality and publication on
terms no less onerous than those set out in Clause
9.
|
GB 0000011
|
2.4
|
Genesis
Biopharma shall have the right to grant Sub-licences of any or all of the
rights granted to it pursuant to Clause 2.1 to a Third Party or an
Affiliate if, in respect of each Sub-licence, Genesis Biopharma ensures
that CRT’s rights under this Agreement are maintained and that Genesis
Biopharma meets the material terms and conditions of the
Agreement. In the case of the grant of a Sub-licence to a Third
Party only, Genesis Biopharma shall obtain the prior written consent of
CRT, such consent not to be unreasonably withheld or delayed, provided,
however, that CRT’s failure to provide written “good cause” denial of
consent within thirty (30) Business Days after Genesis Biopharma requests
consent to grant a Sub-licence shall be deemed to be consent.
Notwithstanding anything to the contrary set forth herein, (i) Genesis
Biopharma shall have the right to grant Sub-licences of any or all of the
rights granted to it pursuant to Clause 2.1 to any Affiliate of Genesis
Biopharma without obtaining CRT’s prior written consent and (ii) Genesis
Biopharma shall also have the right, without obtaining CRT’s prior written
consent, to enter into a sub-contract manufacturing, co-marketing or
distribution agreement with a Third Party under which Genesis Biopharma
appoints a Third Party as its agent to manufacture, promote or sell
Products. Within thirty (30) Business Days of the grant of any Sub-licence
to a Third Party, Genesis Biopharma shall provide CRT with a true copy of
the Sub-licence signed by Genesis Biopharma and such Third Party, at
Genesis Biopharma’s own expense. Any Sub-licence that is granted in breach
of this Clause 2.4 shall be void. Without prejudice to Genesis Biopharma’s
obligation to seek CRT’s consent to grant Sub-licences to Third Parties as
set forth under this Clause 2.4, any Sub-licence granted by Genesis
Biopharma to a Third Party shall be presumed to meet the requirements of
this Clause 2.4 if it shall:
|
|
|
2.4.1
|
be
granted on an arm’s length basis reflecting the arms length fair market
value for 100% cash consideration;
|
|
|
2.4.2
|
provide
that the Sub-licence shall terminate automatically on termination for
whatever reason of this Agreement;
|
|
|
2.4.3
|
provide
that the Third Party with whom the Sub-licence has been entered into shall
undertake to allow Genesis Biopharma access to such Third Party’s books
and records relating to the calculation of Net Sales of Products, and
Genesis Biopharma undertakes to include in its books and records or make
available to CRT all Net Sales information and records it receives from
such Third Party relating to
Products;
|
|
|
2.4.4
|
provide
that, in the event of termination of this Agreement, the Third Party
Sub-licensee shall have the right, for a period of ninety (90) Business
Days following the date of termination, to sell off stocks of Product held
by it at the date of termination;
and
|
|
|
2.4.5
|
prohibit
the assignment of the Sub-licence to any Third Party; provided, however,
that Genesis Biopharma shall be permitted to permit such Third Party
Sub-licensee to sub-license the rights granted to it under the
Sub-licence, provided that (1) Genesis Biopharma shall ensure that the
terms of such sub-sub-licence comply with the terms of this Clause 2.4
mutatis mutandis;
and (2) the terms of the sub-sub-licence prohibit the sub-licensing of the
rights granted thereunder and Genesis Biopharma shall, at its own cost,
provide a copy of each sub-sub-licence to CRT as soon as possible after
completion.
|
|
2.5
|
Any
breach of Clauses 2.3 or 2.4 shall be a material breach of this
Agreement.
|
|
2.6
|
In
the event that this Agreement is terminated by Genesis Biopharma pursuant
to Clause 10.5 hereof, CRT agrees that it will not directly or indirectly
contact or contract with any Sub-licensee or sub-sub-licensee of Genesis
Biopharma, or enter into any contractual arrangement with any
Sub-Licensee, sub-sub-licensee or competitor of Genesis Biopharma in
regard to any Licensed Intellectual Property, for a period of one (1) year
after such termination of this
Agreement.
|
GB 0000012
|
3.
|
DEVELOPMENT
AND MARKETING PLAN
|
|
3.1
|
Genesis
Biopharma shall:
|
|
|
3.1.1
|
subject
to Clause 3.3, use commercially reasonable endeavours to undertake the
Development Plan at its own cost and expense;
and
|
|
|
3.1.2
|
provide
quarterly reports for periods ending on 31 March 2010 and each subsequent
period of three months until 31 December 2012, and thereafter six-monthly
reports for periods ending on 30 June and 31 December in each year,
outlining its and its Affiliates’ and any Sub-licensee’s progress with
respect to the milestone deadlines in the Development Plan and proposing
any reasonable changes to the Development Plan it requires;
and
|
|
|
3.1.3
|
spend
no less than [**********] of the Initial Financing in
undertaking and completing the In Vivo Efficacy Work on or before
[**********].
|
|
3.2
|
In
the event that Genesis Biopharma proposes amendment of the Development
Plan pursuant to Clause 3.1.2 or otherwise, the Parties shall discuss such
amendment in good faith but no amendment to the Development Plan shall be
effective unless made in writing and signed by both
Parties.
|
|
3.3
|
In
the event that Genesis Biopharma misses any of the material milestones
highlighted in the Development Plan (as may have been amended pursuant to
Clause 3.2) by more than three (3) months, , such failure shall
be a material breach of this Agreement and the Parties shall meet to
discuss the matter with an aim to come to an agreement on the reassignment
of the milestones, but on doing so, if the Parties cannot reach agreement,
CRT shall have the right to terminate this Agreement in accordance with
the terms of Clause 10.5 below. Failure by Genesis Biopharma to
deliver to CRT any quarterly or six-monthly report as provided in Clause
3.1.2 shall be a material breach of this
Agreement.
|
|
3.4
|
Genesis
Biopharma shall, and shall procure that its Affiliates and Sub-licensees
shall, use their commercially reasonable endeavours to: (i) obtain all
necessary and desirable regulatory and other approvals to market and sell
Products (collectively, “Marketing Approval”)
from any relevant Competent Authority and, upon receipt of Marketing
Approval in a country; (ii) commercialize the Products in each such
country to the maximum extent practicable; and (iii) without limitation of
its obligations under Clause 3.4(i) and (ii) hereof, adhere to the
Marketing Plan as further set forth in Clause 3.5
hereof.
|
GB 0000013
|
3.5
|
Commencing
with the first full calendar year to occur after the first grant of
Marketing Approval for a Product by a Competent Authority and for each
calendar year thereafter during the term of the Agreement, Genesis
Biopharma shall submit to CRT an annual Marketing Plan (each a “Marketing Plan”) within
forty-five (45) days after the first day of a calendar year, which shall
include a summary of the marketing, sales and distribution plans on a
country-by-country basis for such calendar year of Genesis Biopharma or
its Affiliates or Sub-licensees, as applicable. Each Marketing
Plan shall be of sufficient detail to allow CRT to determine that a highly
professional and logical plan has been devised that will support the
objective of making the Product available to as many patients as possible
as early as possible, within the applicable laws and regulations, and
thereby generating, growing and maintaining Product sales throughout the
term of this Agreement. The Marketing Plan may be subject to
changes based upon local market conditions, changes in competition,
changes in other aspects that may be expected to have an impact on local
sales results and as a result, the Marketing Plan shall be subject to
change by Genesis Biopharma upon prior written notice to CRT (provided,
further, that the foregoing shall be without limitation of the obligations
of Genesis Biopharma pursuant to Clause 3.4(i) and (ii)
hereof). All costs relating to the preparation and submission
of the Marketing Plans shall be borne by Genesis Biopharma. All
Marketing Plans shall be deemed as Confidential Information for purposes
of this Agreement and CRT shall not provide any Third Party with access to
any Marketing Plan, or any portion
thereof.
|
|
4.
|
CONSIDERATION
|
|
4.1
|
Genesis
Biopharma shall pay to CRT:
|
|
|
4.1.1
|
£30,000
(thirty thousand pounds sterling) on the Commencement
Date;
|
and
|
|
4.1.2
|
[*****************************]
within thirty (30) Business Days of the Financing
Event;
|
and
|
|
4.1.3
|
subject
to the provisions of Clauses 4.2, 4.3, 10.6 and 11.4, the following
payments within thirty (30) Business Days of the occurrence of the
relevant milestone event for a therapeutic Product (and separate
Indications with respect thereto) set forth in this Clause
4.1.3:
|
|
|
4.1.3.1
|
[*****************************]
on filing of IND or equivalent in each of the US and the European Economic
Area; and
|
|
|
4.1.3.2
|
[*****************************]
on the commencement of Phase III clinical or Pivotal Registration Studies
in each of the US and the European Economic Area;
and
|
|
|
4.1.3.3
|
[*****************************]
on the filing of a new drug application or equivalent application in each
of the US and the European Economic Area;
and
|
|
|
4.1.3.4
|
[*****************************]
on the grant of the initial Marketing Approval in each of the US and the
European Economic Area.
|
and
GB 0000014
|
|
4.1.4
|
subject
to the provisions of Clauses 4.2, 4.3, 10.6 and 11.4, the following
payments within thirty (30) Business Days of the occurrence of the
relevant milestone event for each diagnostic Product (and separate
Indications with respect thereto):
|
[*****************************]
on the grant of Marketing Approval in a Major Market;
and
|
|
4.1.5
|
subject
to the provisions of Clauses 10.6 and 11.4, royalties of [**********] of
Net Sales of therapeutic Products and royalties of [**********] of Net
Sales of diagnostic/imaging Products (together “Direct
Royalties”);
|
and
|
|
4.1.6
|
subject
to the provisions of Clauses 10.6 and 11.4, [**********] of Sub-licence
Fees (“Indirect
Royalties”).
|
|
4.2
|
For
the avoidance of doubt, if, in respect of each of the milestone events
described in Clauses 4.1.3 and 4.1.4, that milestone event is achieved in
respect of a particular Product by a Sub-licensee which is not an
Affiliate of Genesis Biopharma, Genesis Biopharma shall not be liable to
pay the payment linked in Clause 4.1.3 or Clause 4.1.4 to that particular
milestone event and the only payments to be made, if applicable, shall be
under Clauses 4.1.5 and 4.1.6.
|
|
4.3
|
Notwithstanding
anything to the contrary set forth herein, (i) Genesis Biopharma shall not
be obliged to pay the sums in respect of the milestone events in Clauses
4.1.3 or 4.1.4 if it has already made four (4) such payments in respect
thereof previously, and (ii) Genesis Biopharma shall also not be obliged
to pay the sums in respect of the milestone events in Clauses 4.1.3 or
4.1.4 which have occurred for an Orphan Indication. For the avoidance of
doubt the maximum number of milestone events that Genesis Biopharma shall
be obliged to pay sums in respect of under Clauses 4.1.3 and 4.1.4 is
twenty (20).
|
|
4.4
|
The
Direct Royalties and Indirect Royalties shall be paid Quarterly in arrears
within thirty (30) Business Days of the end of the Quarter in which the
relevant sales of Products or receipt of Sub-licence Fees (as the case may
be) has taken place. Within thirty (30) Business Days of the
end of each Quarter Genesis Biopharma shall provide to CRT a written
report setting out in respect of that Quarter the sales of Products on a
country by country basis, if any, made by Genesis Biopharma, the
calculation of the Net Sales and the royalty payable to CRT in respect of
such Net Sales together with any Sub-licence Fees received by Genesis
Biopharma. Subject to the provisions of Clauses 10.6, 11.1 and
11.8, the royalties in this Clause 4.4 shall not be reduced, limited or
diminished in any way by virtue of the fact that Genesis Biopharma is
required to seek a licence or other rights from or make payments to any
Third Party for the exploitation of any of the rights granted to it under
this Agreement.
|
GB 0000015
|
5.
|
PAYMENT
|
|
5.1
|
All
payments due to CRT under this Agreement shall be made in pounds sterling
in cleared funds to the account of
[******************************************************] (or
such other account details as CRT may from time to time notify to Genesis
Biopharma).
|
|
5.2
|
Where
sums are received by Genesis Biopharma in a currency other than pounds
sterling, conversion of such currencies to pounds sterling shall be
performed at the closing mid-spot rate for that currency published in the
Financial Times in London on the last Business Day of the Quarter in which
the sum is to be paid.
|
|
5.3
|
All
costs of transmission or currency conversion shall be borne by Genesis
Biopharma.
|
|
5.4
|
All
payments by Genesis Biopharma to CRT under this Agreement are expressed to
be exclusive of value added tax howsoever arising, and Genesis Biopharma
shall pay to CRT in addition to those payments or if earlier on receipt of
a tax invoice or invoices from CRT, all Value Added Tax for which CRT is
liable to account in relation to any supply made or deemed to be made for
Value Added Tax purposes pursuant to this
Agreement.
|
|
5.5
|
All
payments to CRT shall be made free and clear of, and without deduction or
deferment in respect of, any claims, set-off and taxes imposed or levied
by any Competent Authority including any withholding taxes. In
the event that Genesis Biopharma is obliged to deduct any withholding or
other taxes it shall pay to CRT an amount as shall result in the net
amount being received by CRT being equal to the amount which would have
been received by CRT had no deduction or withholding been made; provided
always that, if CRT is able to recover or set-off any such deduction or
withholding, it shall refund such amount to Genesis Biopharma as shall
result in the net amount being retained by CRT being equal to the amount
which would have been received by CRT had no deduction or withholding been
made.
|
|
5.6
|
The
provisions of Clause 5.5 above requiring Genesis Biopharma to pay to CRT a
sum such that the net amount received by CRT is equal to the amount that
would have been received by CRT had no deduction or withholding been made
shall not apply if, and only to the extent that, the relevant deduction
results from Genesis Biopharma being under a legal obligation under the UK
tax rules requiring Genesis Biopharma to deduct income tax at source from
royalties payable by Genesis Biopharma to CRT in respect of a UK granted
patent.
|
|
5.7
|
Where
CRT does not receive payment of any sums due to it within thirty (30)
Business Days of the relevant date set out in Clause 4 (the “Due Date”), interest
shall accrue on the sum due and owing to CRT at the rate equivalent to an
annual rate of three per cent (3%) over the then current base
rate of the Bank of England, for the UK, calculated on a daily basis,
without prejudice to CRT’s right to receive payment on the Due
Date.
|
GB 0000016
|
6.
|
BOOKS
AND RECORDS
|
|
6.1
|
Pursuant
to Clause 4.4, Genesis Biopharma shall prepare Quarterly Reports. The
Quarterly Reports shall include Net Sales by country, including the
company making the sales and the amount of Products sold. If CRT gives
notice to Genesis Biopharma within twenty (20) Business Days of the
receipt of any such Quarterly Report that it does not accept the same,
that Quarterly Report shall be certified by an independent accountant
appointed by agreement between Genesis Biopharma and CRT or, in default of
agreement within ten (10) Business Days, appointed by the President for
the time being of the Institute of Chartered Accountants of England and
Wales in London. Genesis Biopharma shall (subject to the independent
accountant agreeing to maintain the confidentiality of the books and
records save insofar as is necessary for the proper reporting to Genesis
Biopharma and CRT) make available to the independent accountant all books
and records required for the purpose of that certification and the
statements so certified shall be final and binding between the
Parties. The cost of the certification shall be the
responsibility of Genesis Biopharma if the statement is shown to have
underestimated the monies payable to CRT by more than five per cent (5%)
and the responsibility of CRT otherwise. Any outstanding
payments due to CRT which are identified as a result of carrying out the
investigation shall be paid to CRT within ten (10) Business Days. There
shall be no more than one certification by an independent accountant in
relation to any one calendar year.
|
|
6.2
|
Genesis
Biopharma shall keep true and accurate records and books of account, and
shall require in its contracts with Sub-licensees that its Sub-licensees
shall keep true and accurate records and books of account, containing all
data necessary for the calculation of the amounts payable by Genesis
Biopharma to CRT pursuant to this Agreement, including such amounts
payable pursuant to Clause 2.4.3. Such records and books of
account shall be kept for six (6) years following the end of the calendar
year to which they relate and Genesis Biopharma’s records and books of
account shall, upon reasonable notice having been given by CRT, be open at
reasonable times on Business Days for inspection under the terms of
confidentiality contained in this Agreement, by an independent firm of
accountants appointed by agreement between the Parties or, failing such
agreement within ten (10) Business Days, appointed by the President for
the time being of the Institute of Chartered Accountants of England and
Wales in London. The cost of any such examination shall be borne by CRT,
such examination to take place and be completed not later than six (6)
years following the expiration of the period to which it relates and there
shall be no more than one examination per
year.
|
|
7.
|
MANAGEMENT
OF PATENT RIGHTS; OWNERSHIP OF INTELLECTUAL
PROPERTY
|
|
7.1
|
Subject
to Clauses 7.4, 7.5 and 7.6 hereof, Genesis Biopharma shall, from the
Commencement Date, undertake or procure the filing, prosecution, and
maintenance of the Licensed Intellectual Property, including the Licensed
Patents, in the name of CRT and be responsible for any enforcement
proceedings relating to them (including any interference or opposition
proceedings); provided, further, that the Parties agree that Genesis
Biopharma’s obligations hereunder shall extend only within the Field
(unless such filing, prosecution or maintenance is not separable by
Field). Genesis Biopharma or CRT shall provide copies of all relevant
correspondence to CRT or Genesis Biopharma, as the case may be, within
fourteen (14) Business Days of receipt, and the Parties shall consult in
all material respects with each other in relation to such filing,
prosecution, and maintenance. Genesis Biopharma shall also be responsible
for payment of all fees incurred by or on instructions of Percipio but
which are not paid by Percipio. Genesis Biopharma shall not
appoint or change any outside firm of Patent Attorneys appointed to
represent it in the efforts described in this Clause 7.1 without CRT’s
prior written consent (which consent CRT shall not unreasonably
withhold).
|
GB 0000017
|
7.2
|
Each
Party shall give the other immediate notice of any actual or suspected
infringement of the Licensed Patents or any actual or suspected misuse or
misapplication of the Licensed Know How and/or the Licensed Materials by a
Third Party which comes to that Party’s attention during the term of this
Agreement.
|
|
7.3
|
If
either Party receives any notice, claim, or proceedings from any Third
Party alleging infringement of that Third Party’s intellectual property by
reason of either Party’s activities in relation to this Agreement or the
use and exploitation of the Licensed Intellectual Property in the Field,
the Party receiving that notice shall forthwith (but in no event in excess
of three (3) Business Days) notify the other Party of the notice, claim or
proceeding.
|
|
7.4
|
Genesis
Biopharma may (subject to Clause 7.5), at its own cost, defend and enforce
or may procure the defence or enforcement of the rights under the Licensed
Intellectual Property in the Field, including any interference
proceedings. CRT shall, at Genesis Biopharma’s cost, render all such
reasonable assistance as Genesis Biopharma reasonably
requests. As used herein, “cost” shall mean the actual
expenditure of expenses and shall not include any consulting fee or fees
for reasonable time spent by CRT rendering assistance pursuant to this
provision. To the extent that in any proceedings the court of competent
jurisdiction does not award damages to Genesis Biopharma in respect of
lost royalties, any damages or financial settlement monies received by
Genesis Biopharma pursuant to such proceedings shall, after deduction of
any and all of the costs and expenses incurred by Genesis Biopharma in
such proceedings (to the extent such costs and expenses have not been
recovered from the other Party), be treated as Net Sales. If Genesis
Biopharma, for any reason whatsoever, decides not to defend or enforce the
Licensed Intellectual Property in the Field or any part of it pursuant to
this Clause 7.4, it shall promptly notify CRT and CRT shall have the right
to undertake proceedings on its own behalf pursuant to Clause
7.5.
|
|
7.5
|
If
Genesis Biopharma elects not to defend or enforce the relevant Licensed
Intellectual Property in the Field pursuant to Clause 7.4 and if CRT
desires the enforcement or defence of such rights it shall notify Genesis
Biopharma and Genesis Biopharma shall, at CRT’s request and cost, grant to
CRT any and all rights that would be necessary solely for the purpose of
allowing CRT to undertake such enforcement or defence. If Genesis
Biopharma is unable to grant such rights then it shall, at CRT’s request,
grant to CRT the right to conduct such an action in its name. CRT shall
defend and enforce or shall procure the defence or enforcement of the
rights under Licensed Intellectual Property in the Field pursuant to this
Clause 7.5 at its own cost. Genesis Biopharma shall provide, at CRT’s
cost, all such reasonable assistance as CRT may reasonably request in any
such proceedings. Any monies received by CRT, or any damages or
costs awarded against CRT, pursuant to any enforcement or defence of the
Licensed Intellectual Property by it under this Clause 7.5 shall be solely
for the benefit of CRT.
|
GB 0000018
|
7.6
|
In
the event that the Licensed Intellectual Property is licensed to a Third
Party outside the Field for commercial purposes the costs and expenses in
relation to the prosecution, maintenance and defence of the Licensed
Intellectual Property referred to in this Clause 7 shall no longer be
borne by Genesis Biopharma alone and CRT undertakes to ensure that such
costs and expenses shall be apportioned as between each licensee of the
Licensed Intellectual Property in shares reflecting the commercial value
of the Licensed Intellectual Property in the respective fields. However,
nothing herein, including any licence to a Third Party by CRT, shall
prevent Genesis Biopharma from exercising its rights under Clause 7.4, and
CRT agrees to take all steps necessary with said Third Parties to grant to
Genesis Biopharma any and all rights necessary to allow Genesis Biopharma
to undertake such enforcement or defence. CRT further agrees
that it will not allow any Third Party to enforce or defend the Licensed
Intellectual Property, either within or outside the Field, without the
prior express written permission of Genesis
Biopharma.
|
|
7.7
|
CRT
shall, at CRT’s cost, provide such reasonable assistance and advice to
Genesis Biopharma as Genesis Biopharma may request (including the
provision of copies of any necessary documents) which is necessary or
desirable for Genesis Biopharma to apply for an extension to the term of
protection of the Licensed Patents in the Field including any SPC or other
like form of protection anywhere in the
Territory.
|
|
7.8
|
As
between the Parties, their Affiliates and Sub-licensees: (i)
all rights, title and interest in the Genesis Biopharma Intellectual
Property shall be exclusively owned by Genesis Biopharma and (ii) all
rights, title and interest in any clinical data or regulatory filings
relating to the Products shall be exclusively owned by Genesis
Biopharma.
|
|
8.
|
WARRANTIES
AND LIABILITY
|
|
8.1
|
Each
Party represents and warrants to the other Party
that:
|
|
|
8.1.1
|
it
has legal power, authority and right to enter into this Agreement and to
perform its respective obligations hereunder and such Agreement is valid,
binding and enforceable against such Party in accordance with its terms;
and
|
|
8.1.2
|
it
is not at the Commencement Date a party to any agreement, arrangement or
understanding with any Third Party which in any significant way prevents
it from fulfilling any of its material obligations
hereunder.
|
|
8.2
|
Save
as provided in Clause 8.1, neither Party gives any representation or
warranty to the other Party that the performance of this Agreement will
not result in the infringement of any rights, including intellectual
property rights, vested in a Third
Party.
|
|
8.3
|
Neither
Party shall be liable to the other Party, its Affiliates or Sub-licensees
in contract, tort, negligence, breach of statutory duty or otherwise for
any loss, damage, cost or expense of an indirect or consequential nature
(including any economic loss or other loss of turnover, profits, business
or goodwill) arising out of or in connection with this Agreement or the
subject matter of this Agreement.
|
GB 0000019
|
8.4
|
Nothing
in this Agreement shall be construed as a representation made or warranty
given by either Party that any patent will issue based upon the Licensed
Patents, that any patent included in the Licensed Patents which issues
will be valid, or that the use of any Licensed Intellectual Property will
not infringe the patent or proprietary rights of any other
person. Furthermore, neither Party makes any representation or
warranty, express or implied, with respect to the Licensed Intellectual
Property, including without limitation, any warranty of merchantability or
fitness for a particular purpose.
|
|
8.5
|
All
Materials, including Licensed Materials, provided by or on behalf of
either Party and data generated by or on behalf of either Party under this
Agreement are provided "as is" and without any representation or warranty,
express or implied, including without limitation any implied warranty of
merchantability or fitness for any particular purpose or any warranty that
the use of the Licensed Materials will not infringe or violate any patent
or other proprietary rights of any other
person.
|
|
8.6
|
Subject
to Clause 8.3, Genesis Biopharma shall be responsible for, indemnify and
hold harmless CRT, its Affiliates and their officers, servants and agents
against any and all liability, loss, damage, cost or expense (including
reasonable attorney’s fees and court and other expenses of litigation)
(“Losses”) arising
out of or in connection with Third Party claims relating to the discovery,
research, development, manufacture, marketing, selling and disposal of
Products by Percipio, Genesis Biopharma, its Affiliates and/or any
Sub-licensees, provided always that no such Losses arise or have arisen as
a consequence of any breach of this Agreement, breach of statutory duty,
negligent act, omission or wilful misconduct of or by CRT or its
Affiliates or their officers, servants and
agents.
|
|
8.7
|
In
the event that CRT intends to seek indemnification under Clause 8.6, as
applicable, it shall promptly inform the indemnifying Party of a claim
after receiving notice of the claim and shall permit the indemnifying
Party to direct and control the defence of the claim and shall provide
such reasonable assistance as reasonably requested by the indemnifying
Party (at the indemnifying Party’s cost) in the defence of the claim. As
used herein, “cost” shall mean the actual expenditure of expenses and
shall not include any consulting fee or fees for reasonable time spent by
CRT rendering assistance pursuant to this
provision.
|
|
8.8
|
Under
no circumstances shall CRT’s liability to Genesis Biopharma under this
Agreement in total exceed the sums which are actually paid or due and
owing by Genesis Biopharma to CRT pursuant to this Agreement except in the
event Losses arise or have arisen as a consequence of any negligent act,
omission or wilful misconduct of or by CRT or its Affiliates or their
officers, servants and agents.
|
|
8.9
|
Nothing
in this Agreement shall be construed as excluding or limiting the
liability of either Party or any of their officers, employees and agents
to the other Party for death or personal injury of any person resulting
from the negligence or wilful misconduct of such
persons.
|
|
9.
|
CONFIDENTIALITY
|
|
9.1
|
Each
Party undertakes to keep secret and confidential and agrees not at any
time for any reason whatsoever disclose or permit to be disclosed to any
Third Party or otherwise make use of or permit use to be made of (except
as expressly permitted by this Agreement), any Confidential Information of
the disclosing Party and/or Know How of the disclosing Party and/or the
Licensed Intellectual Property which come into the recipient Party’s
possession during the term of this
Agreement.
|
GB 0000020
|
9.2
|
The
Parties shall ensure that only those of, and their Affiliates’ and/or
Sub-licensees’, their directors, officers and employees who need to have
access to Confidential Information and/or Know How and/or the Licensed
Intellectual Property for the proper performance of this Agreement and any
Sub-licence do have access and that those who are directly concerned with
the performance of this Agreement and any Sub-licence and who have access
to the Confidential Information and/or Know How of the disclosing Party
and/or the Licensed Intellectual Property are informed of its secret and
confidential nature and the recipient Party undertakes to ensure that such
of its, and its Affiliates’ and its Sub-licensees’, directors, officers
and employees to whom the Confidential Information and/or Know How and/or
the Licensed Intellectual Property is disclosed shall have, prior to such
disclosure, executed a confidentiality undertaking on terms no less
onerous than those contained in this Agreement or that such disclosure is
adequately governed by the terms of the contract of employment of such
director, officer or employee.
|
|
9.3
|
The
obligations of confidence referred to in this Clause 9 shall not extend to
any Confidential Information or Know How or the Licensed Intellectual
Property which:
|
|
|
9.3.1
|
is
at the time of disclosure, or thereafter becomes, generally available to
the public otherwise than by reason of a breach by the recipient Party of
the provisions of this Agreement;
or
|
|
|
9.3.2
|
is
known to the recipient Party without obligations of confidence prior to
its receipt from the disclosing Party, as can be shown by written record;
or
|
|
|
9.3.3
|
is
subsequently disclosed to the recipient Party without obligations of
confidence by another party owing no such obligations in respect thereof;
or
|
|
|
9.3.4
|
is
required to be disclosed by any applicable law or any Competent Authority
to which a Party is from time to time subject;
or
|
|
|
9.3.5
|
is
independently developed by a person or persons with no access to the
Confidential Information disclosed by a Party, as demonstrated by written
records; or
|
|
|
9.3.6
|
is
required to be or is necessarily disclosed through the marketing of a
Product embodying Licensed Intellectual Property or to any Competent
Authority or by the rules of any stock exchange, including for the
avoidance of doubt the United States Securities and Exchange Commission
pursuant to relevant U.S. securities regulations, and as may be required
under the National Audit Act 1983 or otherwise legally required to be
disclosed, provided always that the recipient Party shall use its best
endeavours to limit any such disclosure to a minimum and shall, if
reasonably possible, prior to such disclosure, provide the disclosing
Party with sufficient notice, in order to obtain a protective or other
order as a court of competent jurisdiction shall
award.
|
GB 0000021
|
9.4
|
The
obligations of each Party under Clauses 9.1-9.3 shall survive the
expiration or termination for whatever reason of this
Agreement.
|
|
10.
|
TERM
AND TERMINATION
|
|
10.1
|
This
Agreement shall come into effect on the Commencement Date and, unless
sooner terminated as provided hereunder, shall continue in full force and
effect until the termination of all licences granted to Genesis Biopharma
pursuant to Clause 2.1 above. Genesis Biopharma’s obligations
to make royalty payments to CRT on a country by country basis throughout
the Territory pursuant to Clause 4 shall expire with respect to a country
upon the termination of the licence in such country pursuant to Clause
2.2.
|
|
10.2
|
CRT
may, on thirty (30) Business Days written notice, terminate this Agreement
if:
|
|
|
10.2.1
|
Genesis
Biopharma takes any action, serves any notice or commences any proceedings
seeking to revoke or challenge the validity of the Licensed Patent or if
it procures or assists a Third Party to take any such action;
or
|
|
|
10.2.2
|
the
Financing Event has not occurred prior to expiry of the period of six (6)
months after the Commencement Date;
or
|
|
|
10.2.3
|
at any time prior to the listing
of shares of Genesis Biopharma on a public exchange, in the event of a
change of Control of Genesis Biopharma where the new Controlling party is
a Tobacco Party. “Control” for the purposes of this sub-clause means the
power to secure that the affairs of Percipio are conducted in accordance
with the wishes of another whether through ownership of 50% or more of the
voting securities of Genesis Biopharma or by contract or otherwise and
“Controlling” shall be construed
accordingly.
|
|
10.3
|
If
Genesis Biopharma, for bona-fide commercial reasons, decides to cease the
prosecution and/or maintenance of the Licensed Patent in a particular
country within the Territory (“Ex-country”), Genesis
Biopharma shall notify CRT and CRT may in its discretion continue to
support the Licensed Patent in the relevant Ex-country provided that
Genesis Biopharma’s licence in respect of the Licensed Patent in the
relevant Ex-country shall expire thirty (30) Business Days from receipt by
CRT of such notification from Genesis Biopharma. Any deadlines
or payments required to be made during the notice period shall be complied
with or paid by Genesis Biopharma.
|
|
10.4
|
If
for any reason Genesis Biopharma, or its Sub-licensees no longer wish to
develop, make, market, sell and/or otherwise dispose of Products in the
Territory, or in a particular country within the Territory, Genesis
Biopharma shall so notify CRT in writing and this Agreement shall
terminate in the country or Territory, as may be applicable, ninety (90)
Business Days from receipt of such
notice.
|
|
10.5
|
Either
CRT on the one hand or Genesis Biopharma on the other hand (the “Terminating Party”)
shall have the right to terminate this Agreement forthwith upon giving
written notice of termination to Genesis Biopharma on the one hand or CRT
on the other hand as the case may be (the “Defaulting Party”), upon
the occurrence of any of the following events at any time during this
Agreement:
|
GB 0000022
|
|
10.5.1
|
the
Defaulting Party commits a material breach of this Agreement which in the
case of a breach capable of remedy has not been remedied thirty (30)
Business Days after the receipt by the Defaulting Party from the
Terminating Party of written notice identifying the breach and requiring
its remedy;
|
|
|
10.5.2
|
the
Defaulting Party for a period of longer than thirty (30) Business Days
suspends payment of its debts or otherwise ceases or threatens to cease to
carry on its business or becomes bankrupt or insolvent (including without
limitation being deemed to be unable to pay its
debts);
|
|
|
10.5.3
|
a
proposal is made or a nominee or supervisor is appointed for a composition
in satisfaction of the debts of the Defaulting Party or a scheme or
arrangement of its affairs, or the Defaulting Party enters into any
composition or arrangement for the benefit of its creditors, or
proceedings are commenced in relation to the Defaulting Party under any
law, regulation or procedure relating to the re-construction or
re-adjustment of debts (including where a petition is filed or proceeding
commenced seeking any reorganisation, arrangement, composition or
re-adjustment under any applicable bankruptcy, insolvency, moratorium,
reorganisation or other similar law affecting creditor’s rights or where
the Defaulting Party consents to, or acquiesces in, the filing of such a
petition); or
|
|
|
10.5.4
|
the
Defaulting Party takes any action, or any legal proceedings are started or
other steps are taken by a Third Party, with a view
to:
|
|
|
(a)
|
the
winding up or dissolution of the Defaulting Party (other than for the
reconstruction of a solvent company for any purpose, including the
inclusion of any part of the share capital of the Defaulting Party on a
recognised public stock exchange);
or
|
|
|
(b)
|
the
appointment of a liquidator, trustee, receiver, administrative receiver,
receiver and manager, interim receiver custodian, sequestrator or similar
officer of the Defaulting Party against the Defaulting Party or a
substantial part of the assets of the Defaulting Party;
or
|
|
|
(c)
|
the
undertaking of anything analogous to any of the foregoing under the laws
of any country.
|
|
10.6
|
Notwithstanding
anything to the contrary herein, in the event that any patent, or claim
thereof, included within the Licensed Patents is held invalid in a
country, by a final decision by a court of competent jurisdiction and from
which no appeal has or can be taken, then any obligations to make
milestone payments under Clauses 4.1.3 and 4.1.4 shall cease to exist in
such country as of the date of the final decision and that all royalties
payable under Clauses 4.1.5 and 4.1.6 of this Agreement with respect to
such country shall be reduced by [**********]; provided, further that upon
the occurrence such event, Genesis Biopharma shall have a non-exclusive
licence to the Licensed Intellectual Property in such country as set forth
in Clause 11.4 hereof.
|
GB 0000023
|
11.
|
CONSEQUENCES
OF TERMINATION
|
|
11.1
|
Subject
to Clauses 10.6 and 11.4 upon termination of this
Agreement:
|
|
|
11.1.1
|
the
licence rights granted by CRT to Genesis Biopharma pursuant to Clause 2
shall terminate and any Sub-licences granted by Genesis Biopharma pursuant
to Clause 2.4 shall terminate;
|
|
|
11.1.2
|
Genesis
Biopharma shall pay to CRT within ninety (90) Business Days all sums due
to CRT hereunder which have accrued prior to the date of
termination;
|
|
|
11.1.3
|
each
recipient of Confidential Information shall promptly return to each
disclosing Party, or, at the option of the disclosing Party, destroy, all
Confidential Information held in hard copy or electronic form which has
been provided to the recipient Party save that each recipient Party shall
be permitted to retain one copy of any document containing such
Confidential Information for the purposes of ensuring its continuing
compliance with Clause 9 and for no other purpose;
and
|
|
|
11.1.4
|
upon
written request by CRT, Genesis Biopharma shall, within thirty (30)
Business Days of receipt of said notice, return to CRT, or, at CRT’s
option, destroy all Licensed Materials held by Genesis
Biopharma. Nothing herein shall require Genesis Biopharma to
return publicly available material or other materials that are the subject
of Clause 9.3, above.
|
|
11.2
|
Subject
to the provisions of Clause 10.6:
|
|
|
11.2.1
|
Genesis
Biopharma shall provide to CRT within thirty (30) Business Days of
termination of this Agreement one copy of each document containing
information, together with any information held in an electronic form, in
each case in reasonably sufficient detail to enable CRT itself or through
a Third Party to further develop Products; (a) relating directly to the
Licensed Intellectual Property and/or developed or acquired by Genesis
Biopharma whilst undertaking the Development Plan; and (b)
comprised within Viragen Intellectual Property, Percipio Intellectual
Property, Genesis Biopharma Intellectual Property and/or clinical data
relating to the Licensed Intellectual Property to which Genesis Biopharma
has rights.
|
|
|
11.2.2
|
Genesis
Biopharma shall provide to CRT within sixty (60) Business Days of the
Commencement Date and on each anniversary thereof, one copy of each such
document, together with any such information held in an electronic form,
as referred to in Clause 11.2.1, which pending accrual of CRT’s
rights under Clauses 11.1 or 11.3 CRT shall hold to the order of Genesis
Biopharma.
|
GB 0000024
|
11.3
|
In
the event of termination:
|
|
|
11.3.1
|
By
Genesis Biopharma pursuant to Clauses 10.3 or 10.4 in a particular
country, then Genesis Biopharma agrees to provide CRT with an exclusive,
sub-licensable licence to use the Percipio Intellectual Property, the
Viragen Intellectual Property, the Genesis Biopharma
Intellectual Property and all clinical data relating to the Licensed
Intellectual Property to which it has rights, to research, develop, use,
keep, make, have made, market, distribute, sell, offer to sell, advertise
or otherwise dispose of Products in the Field in that country or countries
on a Revenue Share basis;
|
|
|
11.3.2
|
By
Genesis Biopharma pursuant to Clauses 10.3 or 10.4 in the entire
Territory, or by CRT pursuant to Clauses 10.2.2 or 10.5, then
Genesis Biopharma agrees to assign to CRT the Percipio Intellectual
Property, the Viragen Intellectual Property and the Genesis
Biopharma Intellectual Property and all clinical data relating to the
Licensed Intellectual Property to which it has rights, on a
Revenue Share basis.
|
|
11.4
|
In
the event of the expiry of this Agreement or the termination of this
Agreement by Genesis Biopharma pursuant to Clause 10.5, CRT shall grant to
Genesis Biopharma a non-exclusive, perpetual, fully paid up royalty-free
licence to the Licensed Intellectual Property to research, develop, use,
keep, make, have made, market, distribute, sell, offer to sell, advertise
or otherwise dispose of the Products in the Territory. In the event of (i)
a termination of a licence in a country (except pursuant to Clauses 10.3
or 10.4) or (ii) the occurrence of an event as set forth in Clause 10.6,
CRT shall grant to Genesis Biopharma a non-exclusive, perpetual, fully
paid up royalty-free licence to the Licensed Intellectual Property to
research, develop, use, keep, make, have made, market, distribute, sell,
offer to sell, advertise or otherwise dispose of the Products in such
country. Notwithstanding anything to the contrary set forth in
this Clause 11.4, if CRT shall terminate the Agreement pursuant to Clauses
10.2 or 10.5, the licence shall
terminate.
|
|
11.5
|
If
Genesis Biopharma serves notice to terminate this Agreement in the
Territory or in particular countries pursuant to Clauses 10.3 or 10.4 it
shall, without prejudice to its obligation to pay royalties during the
notice period, pay to CRT all of any milestone payment which has not been
paid and in respect of which the milestone event has been achieved prior
to the date of notification by Genesis Biopharma of its intention to
terminate.
|
|
11.6
|
Notwithstanding
anything to the contrary herein, the termination or expiry of this
Agreement for whatever reason shall not affect the accrued rights of the
Parties arising in any way out of this Agreement as at the date of
termination or expiry and in particular but without limitation the right
to recover damages and interest, and the provisions of Clauses 2.3, 2.6,
6.2, 7.7 (but only to the extent that a licence has been granted pursuant
to Clause 11.4 hereof), 7.8, 8.1-8.9, 9.1-9.4, 10.6, 11.1-11.8, 14.1-14.2,
17.1-17.3, 18.1, 18.2, 19.1, 20.1, 20.2, 21.1 and 22.1-22.3 shall remain
in full force and effect.
|
|
11.7
|
Notwithstanding
the provisions of Clause 11.1.1, termination or expiry of this Agreement
for whatever reason shall be without prejudice to the rights of Genesis
Biopharma and/or its permitted Sub-licensees to fulfill orders received
prior to the termination or expiry subject to the payment of royalties on
any Net Sales accruing in respect thereof at the rates set out in this
Agreement.
|
GB 0000025
|
11.8
|
If
pursuant to Clause 10.3, CRT should wish to proceed with commercialisation
of a Product in any Ex-country, Genesis Biopharma shall grant to CRT a
licence in such Ex-country to the relevant portion of the Genesis
Biopharma Intellectual Property on Revenue Share terms to be agreed; for
the avoidance of doubt, CRT shall not be obliged to pay a licence fee upon
signature of such licence.
|
|
12.
|
WAIVER
|
|
12.1
|
Neither
Party shall be deemed to have waived any of its rights or remedies
conferred by this Agreement unless the waiver is made in writing and
signed by a duly authorised representative of that Party. In
particular, no delay or failure of either Party in exercising or enforcing
any of its rights or remedies conferred by this Agreement shall operate as
a waiver of those rights or remedies or so as to preclude or impair the
exercise or enforcement of those rights or remedies nor shall any partial
exercise or enforcement of any right or remedy by either Party preclude or
impair any other exercise or enforcement of that right or remedy by that
Party.
|
|
13.
|
ENTIRE
AGREEMENT/VARIATIONS
|
|
13.1
|
Save
for the Licence Termination and Waiver Agreement and the Confirmatory
Waiver Agreement of even date herewith, this Agreement constitutes the
entire agreement and understanding between the Parties and supersedes all
prior oral or written understandings, arrangements, representations or
agreements between them relating to the subject matter of this
Agreement.
|
|
13.2
|
No
director, employee or agent of either Party is authorised to make any
representation or warranty to the other Party not contained in this
Agreement, and each Party acknowledges that it has not relied on any such
oral or written representations or warranties. Nothing in this Clause 13
shall operate to limit or exclude any liability for
fraud.
|
|
13.3
|
No
variation, amendments, modification or supplement to this Agreement shall
be valid unless made in writing in the English language and signed by a
duly authorised representative of both
Parties.
|
|
13.4
|
In
the event of any conflict or discrepancy between this Agreement and any
other agreement, schedule or amendment, the terms of this Agreement shall
control unless superseded by subsequent written
agreement.
|
|
14.
|
NOTICES
|
|
14.1
|
Any
notice to be given pursuant to this Agreement shall be in writing in the
English language and shall be delivered by hand, sent by overnight
registered or recorded delivery airmail post or sent by facsimile
confirmed by registered or recorded delivery post to the address or
facsimile number of the recipient set out below or such other address or
facsimile number as a Party may from time to time designate by written
notice to the other Parties.
|
GB 0000026
Address
of Genesis Biopharma
Genesis
Biopharma, Inc.
Suite
200
8275
Eastern Ave.
Las
Vegas, Nevada
USA
For the
attention of Robert Brooke
Chief
Executive Officer
Fax No.
+1 (310) 696-0334
Address
of CRT
Sardinia
House
Sardinia
Street
London
WC2A
3NL
Fax No.
+44 (0) 20 7269 3641
For the
attention of the Chief Executive.
|
14.2
|
Any
notice given pursuant to this Clause 14 shall be deemed to have been
received:
|
|
|
14.2.1
|
in
the case of delivery by hand, when delivered;
or
|
|
|
14.2.2
|
in
the case of sending by overnight registered or recorded delivery airmail
post on the second Business Day following the day of posting;
or
|
|
|
14.2.3
|
in
the case of facsimile, on acknowledgement by the recipient facsimile
receiving equipment if the acknowledgement occurs before 1700 hours local
time of the recipient on a Business Day and in any other case on the
following Business Day.
|
|
15.
|
ASSIGNMENT
|
|
15.1
|
Neither
Party shall without the prior written consent of the other Party, assign
the benefit and/or burden of this Agreement nor sub-contract any of its
obligations hereunder unless otherwise permitted by the terms
hereof.
|
|
16.
|
FORCE
MAJEURE
|
|
16.1
|
If
a Party (the “Non-Performing Party”)
is unable to carry out any of its obligations under this Agreement due to
Force Majeure this Agreement shall remain in effect but the Non-Performing
Party’s relevant obligations under this Agreement and the relevant
obligations of the other Party (the “Innocent Party”) under
this Agreement shall be suspended for a period equal to the duration of
the circumstance of Force Majeure (the “Suspension”) provided
that:
|
GB 0000027
|
|
16.1.1
|
the
Suspension is of no greater scope than is required by the Force
Majeure;
|
|
|
16.1.2
|
the
Non-Performing Party gives the Innocent Party prompt notice describing the
circumstance of Force Majeure, including the nature of the occurrence and
its expected duration, and continues to furnish regular reports during the
period of Force Majeure;
|
|
|
16.1.3
|
the
Non-Performing Party uses all reasonable efforts to remedy its inability
to perform and to mitigate the effects of the circumstance of Force
Majeure; and
|
|
|
16.1.4
|
as
soon as practicable after the event which constitutes Force Majeure the
Parties shall discuss how best to continue their operations as far as
possible in accordance with this
Agreement.
|
|
16.2
|
If
the Suspension continues for a period of six (6) calendar months the
Innocent Party may give thirty (30) Business Days written notice
thereafter to terminate this Agreement to the Non-Performing Party and
termination shall occur if the Force Majeure is continuing at the end of
that thirty (30) Business Day notice
period.
|
|
17.
|
DISPUTE
RESOLUTION
|
|
17.1
|
Any
question, difference or dispute which may arise concerning the
construction meaning or effect of this Agreement or concerning the rights
and liabilities of the Parties hereunder or any other matter arising out
of or in connection with this Agreement shall first be submitted to the
then acting Chief Executive Officer of Genesis Biopharma and the Chief
Executive of CRT who may call on others to advise them as they see
fit.
|
|
17.2
|
If
the discussions under Clause 17.1 should fail to resolve the question,
difference or dispute within forty-five (45) Business Days, the Parties
agree to try in good faith to settle the matter by mediation, but not
arbitration, administered by the American Arbitration Association under
its Commercial Mediation Rules. Any mediation under this Clause 17.2 shall
take place in London. If mediation should fail to resolve the
question, difference or dispute within forty-five (45) Business Days, the
Parties agree that either Party may seek resolution of such question,
difference or dispute in court pursuant to Clause
22.1.
|
|
17.3
|
Notwithstanding
the foregoing, and notwithstanding Clause 22, any Party may seek immediate
injunctive or other interim relief from any court of competent
jurisdiction with respect to any matter for which monetary damages would
not adequately protect such Party’s interests or otherwise to enforce and
protect intellectual property rights owned or licensed to such
Party.
|
|
18.
|
SEVERANCE
OF TERMS
|
|
18.1
|
If
the whole or any part of this Agreement is or becomes or is declared
illegal, invalid or unenforceable in any jurisdiction for any reason
(including both by reason of the provisions of any legislation and also by
reason of any court or Competent Authority which either has jurisdiction
over this Agreement or has jurisdiction over any of the
Parties):
|
GB 0000028
|
|
18.1.1
|
in
the case of the illegality, invalidity or unenforceability of the whole of
this Agreement it shall terminate only in relation to the jurisdiction in
question; or
|
|
|
18.1.2
|
in
the case of the illegality, invalidity or unenforceability of part of this
Agreement that part shall be severed from this Agreement in the
jurisdiction in question and that illegality, invalidity or
unenforceability shall not in any way whatsoever prejudice or affect the
remaining parts of this Agreement which shall continue in full force and
effect.
|
|
18.2
|
If
in the reasonable opinion of any Party any severance under this Clause 18
materially affects the commercial basis of this Agreement, the Parties
shall discuss, in good faith, ways to eliminate the material
effect.
|
|
19.
|
THIS
AGREEMENT NOT TO CONSTITUTE A
PARTNERSHIP
|
|
19.1
|
None
of the provisions of this Agreement shall be deemed to constitute a
partnership between the Parties and neither of the Parties shall have any
authority to bind the other in any way except as provided in this
Agreement.
|
|
20.
|
PUBLIC
STATEMENTS
|
|
20.1
|
Except
as provided in Clause 20.2, neither Party shall, without the prior written
consent of the other Party:
|
|
|
20.1.1
|
use in advertising, publicly or
otherwise, any trade-name, personal name, trade mark, trade device,
service mark, symbol, or any abbreviation, contraction or simulation
thereof, owned by the other Party or its Affiliate;
or
|
|
|
20.1.2
|
represent,
either directly or indirectly, that any product or service of the other
Party or its Affiliate is a product or service of the
representing Party or its Affiliate or that it is made in accordance with
or utilises the information or documents of the other Party or its
Affiliate.
|
|
20.2
|
The
restrictions in Clause 20.1 shall not apply to the
following:
|
|
|
20.2.1
|
a
press release, in a form agreed to in writing by both Parties, publicly
announcing this Agreement; or
|
|
|
20.2.2
|
use
as required by any applicable law or governmental regulation, including,
for the avoidance of doubt, compliance with all applicable United States
Food and Drug Administration and United States federal and state
securities laws, including the United States Securities and Exchange
Commission Rules and requirements.
|
|
21.
|
COSTS
|
|
21.1
|
Each
Party shall bear its own legal costs, legal fees and other expenses
incurred in the preparation and execution of this
Agreement.
|
GB 0000029
|
22.
|
GOVERNING
LAW, JURISDICTION AND PRESUMPTIONS
|
|
22.1
|
All
matters relating to this Agreement shall be governed by the laws of
England and the Parties submit to the non-exclusive jurisdiction of the
English courts.
|
|
22.2
|
This
Agreement shall be deemed to be jointly created and drafted, and no
presumption shall arise, and no provision shall be construed, against the
drafter of a particular section or provision, when interpreting this
Agreement.
|
|
22.3
|
No
term of this Agreement shall be enforceable under the Contracts (Rights of
Third Parties) Act 1999 by a person who is not a Party, but this does not
affect any right or remedy of a third party which exists or is available
apart from under that Act.
|
GB 0000030
SCHEDULE 1 – DEVELOPMENT
PLAN
CD55
mAb Programme
STAGE 1.
|
Activity
|
Estimated
Timeline for Achievement
|
|
|
(1)
Design and complete in
vivo efficacy xenograft model
|
[**********]
|
|
|
(2)
Manufacturing process development, Contract Manufacturing Organisation
(CMO) contracting, and Contract Research Organisation (CRO)
contracting
|
[**********]
|
1. IN VIVO
EFFICACY
|
Purpose:
|
To
determine if antibody enables destruction of tumor xenografts in
appropriate animal model.
|
|
Support:
|
A
minimum of [**********] will be committed to support this
work.
|
|
Location:
|
TBD,
either by University of Nottingham, SRI International, or another Contract
Research Organisation
|
|
Timeline:
|
Completion
Date: [**********]
|
|
(including
animal application construction, approval through ethics
committee, and conduct of study)
|
|
|
|
Decision
Point:
Go: anti-tumor (ADCC) effects observed and little appreciable gross
mAb-related toxicity
No
Go: no anti-tumor (ADCC) effects observed and gross mAb-related toxicity
observed
|
|
Tasks:
|
conduct
in vitro studies to test synergy between ADCC and chemotherapy, produce
antibody for xenograft studies, conduct xenograft studies in a model with
high expression of CD55 (e.g. 791T xenograft model), and possibly in
another model that would allow assessment of Ab toxicity (e.g. C170
xenograft model), if that model is reasonably determined to be
necessary.
|
|
Deliverables:
|
data
sets on whether antibody mediates ADCC with or without chemotherapy, and
on whether antibody exhibits non-specific binding on human
tissues.
|
Note: Either
the LD79 or most likely the LD86 version of the PB102 antibody will be used,
dependent on an analysis of the current data and discussion with the University
of Nottingham.
GB 0000031
2. MANUFACTURING PROCESS
DEVELOPMENT, CONTRACT MANUFACTURING ORGANISATION CONTRACTING, and CONTRACT
RESEARCH ORGANISATION CONTRACTING
(a)
Preparation:
Basic Characterisation of mAb and production process
|
Purpose:
|
To
determine basic characteristics of mAb and production process to
facilitate transfer to Contract Manufacturing Organization
(CMO).
|
|
Deliverables:
|
Report
on basic characteristics of antibody: structural integrity of antibody and
associated carbohydrate, plus details of cell culture process and
purification.
|
|
Tasks:
|
Cell
culture process, basic purification development, characterization of
product
|
|
Timeline:
|
[**********]
following Financing Event, as defined in the Proposed
License
|
Note: A certain level of basic
product characterization and details of the cell culture and production process
is required before transfer to CMO, as this expedites their process and cuts
costs as it can easily be done while confirmatory studies are
ongoing.
(b)
Identify and
contract with CMO
|
Purpose:
|
To
identify and commission a CMO for PB102.
|
|
Tasks:
|
Contract
a group to perform manufacturing work necessary for IND filing, such as
Contract Manufacturing Process Transfer, Cell Banking, Pilot Manufacturing
Batch for Toxicology, Regulatory Filing Support
|
|
Timeline:
|
Schedule
and contracts for path to IND within [**********] from Financing
Event
|
(c)
Identify and
contract with CRO
|
Purpose:
|
To
identify and commission a CRO for PB102.
|
|
Tasks:
|
Contract
a group to perform research and regulatory support work necessary for IND
filing, such as Analytical and Bioanalytical Method Development and
Validation (ELISA), Methods Development for the Immunogenicity Analysis,
Range Finding Toxicity Study and Pharmacokinetics in Rabbits (non-GLP),
4-Week Repeat Dose Toxicity Study in Rabbits (GLP), Tissue
Cross-reactivity (TCR) of PB102 Antibodies with Rabbit, Monkey and Human
Tissues Ex Vivo, Regulatory Preparation –Pre-IND Request and Information
Packet
|
|
Timeline:
|
Schedule
and contracts for path to IND within [**********] from Financing
Event
|
STAGE 2.
Preclinical
and Clinical development: plans to be agreed in writing by the Parties upon
completion of Stage 1.
GB 0000032
SCHEDULE
2
|
PATENT/APPLICATION
NUMBER
|
COUNTRY/REGION
|
FILING
DATE
|
||
|
PCT/GB2003/005163
|
PCT
|
26th
November 2003
|
||
|
EP2003000778533
|
EP
|
26th
November 2003
|
||
|
HK05107885.8
|
HK
|
8th
September 2005
|
||
|
AU2003285536
|
AU
|
26th
November 2003
|
||
|
CN200380104471.7
|
CN
|
26th
November 2003
|
||
|
CA032507106
|
CA
|
26th
November 2003
|
||
|
US12/559,342 (Divisional
application)
|
US
|
26th
November 2003
|
||
|
JP2004-554700
|
JP
|
26th
November 2003
|
||
|
BR2003000016741
|
|
BR
|
|
26th
November 2003
|
GB 0000033
SCHEDULE
3
Licensed Know
How
Full
detail is set out below of all Know How generated and arising from the antibody
programme prior to the termination of the Collaboration Agreement and which
forms the subject matter of the licence rights relating to the Licensed Know How
pursuant to Clause 2.1 as follows:
1. [**********]
2. [**********]
3. [**********]
4. [**********]
5. [**********]
6. [**********]
GB 0000034
IN
WITNESS whereof this Agreement has been executed by duly authorized officers of
the Parties on the date first above written.
|
Signed
by:
|
/s/
P. J. L’Huillier
|
|
Name:
|
P.
J. L’Hullier
|
|
Title:
|
Director,
Business Management
|
|
For
and on behalf of
|
|
|
CANCER
RESEARCH TECHNOLOGY LIMITED
|
|
|
Signed
by:
|
/s/
Robert Brooke
|
|
Name:
|
Robert
Brooke
|
|
Title:
|
Chief
Executive Officer
|
|
For
and on behalf of
|
|
|
GENESIS
BIOPHARMA, INC.
|
GB 0000035