Exhibit 10.3
DATED 15TH MARCH 2010
(1) CANCER RESEARCH TECHNOLOGY LIMITED
AND
(2) GENESIS BIOPHARMA, INC.
PATENT AND KNOW HOW LICENCE
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THIS AGREEMENT IS MADE THE 15TH DAY OF MARCH 2010
BETWEEN:
(1) CANCER RESEARCH TECHNOLOGY LIMITED, a company registered in England and
Wales under number 1626049 with registered office at Xxxxxxxx Xxxxx,
Xxxxxxxx Xxxxxx, Xxxxxx XX0X 0XX, Xxxxxxx ("CRT"); and
(2) 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 Xxxxx 000, 0000 Xxxxxxx Xxx., Xxx
Xxxxx, Xxxxxx, 00000 ("GENESIS BIOPHARMA").
RECITALS
(A) CRT is an oncology focused technology transfer and development company.
(B) 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.
(C) CRC funded research concerning the [********]in the laboratories of
[****************]at the [*******************************] (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 [**********]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).
(D) [*******************************] 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) [*******************************] with
Percipio Biotherapeutics, Inc. ("PERCIPIO") to ensure the commercial
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exploitation of the Invention and [*************] 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).
(E) [*******************************] (i) the Viragen Intellectual Property was
assigned to Xxxxxxxx Atlantic, a company organized in the Cayman Islands
("XXXXXXXX"), pursuant to an Assignation executed by Xxxxxxxx on 6 May
2008; (ii) Xxxxxxxx entered into that certain License Agreement ("AGREEMENT
I") effective as of August 20, 2008, by and between Xxxxxxxx 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 Xxxxxxxx and Percipio, pursuant to
which Xxxxxxxx agreed to license to Percipio the Viragen Intellectual
Property; and (iii) CRT and Xxxxxxxx entered into that certain Agreement
effective as of October 21, 2008, between CRT and Xxxxxxxx (the "XXXXXXXX
SIDE AGREEMENT"), pursuant to which Xxxxxxxx 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.
(F) It is proposed that concurrent with this Agreement Xxxxxxxx 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").
(G) It is proposed that concurrent with this Agreement CRT, Xxxxxxxx, Percipio,
and Genesis Biopharma will enter into an agreement (the "LICENCE
TERMINATION AND WAIVER AGREEMENT")
(H) Percipio has assigned all rights in the Percipio Intellectual Property to
Genesis Biopharma as referred to in the Licence Termination and Waiver
Agreement.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS AND INTERPRETATION
1.1 In this Agreement and in the Schedules to this Agreement the following
words and phrases shall have the following meanings:
"Affiliate" 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" 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.
"Business Day" means a day other than a Saturday,
Sunday, bank or other public holiday in
England.
"Commencement Date" means the date first above written.
"Competent Authority" 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.
"Confidential Information" 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.
"Development Plan" 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.
"European Economic Area" means those countries that are members of
the European Economic Area as constituted
at the Commencement Date.
"Field" means the field of use of [********] for
the immunotherapeutic treatment and/or
diagnosis of diseases.
"Financing Event" means the receipt by Genesis Biopharma of
at least [****************] in total,
whether in a single tranche or
cumulatively, in cash.
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"Genesis Biopharma Intellectual
Property" means any Know How, Material or Patent
Rights directly related to the development
of antibodies directed against [*****] 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.
"Force Majeure" 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.
"Indication" 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).
"In Vivo Efficacy Work" means the work so described as detailed in
Part 1 of Stage 1 of the Development Plan.
"Initial Financing" means the receipt by Genesis Biopharma of
the sum of [***********************]
pursuant to commitments made on or before
the Commencement Date.
"Know How" means technical and other information which
is not in the public domain including,
ideas, concepts, inventions, discoveries,
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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.
"Licensed Intellectual Property" means the Licensed Know How, the Licensed
Materials and the Licensed Patents.
"Licensed Know How" means any and all Know How set out in
Schedule 3 to this Agreement.
"Licensed Materials" means (i) the [***********] antibody called
[******] and (ii) the hybridoma
[*****************************] owned by
CRT.
"Licensed Patents" means (i) Patent Application Number
[***************] (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.
"Major Market" means each of the following groups of
countries:
(i) [***************]
(ii) [***************]
(iii) [***************]
"Marketing Plan" has the meaning set forth in Clause 3.5.
"Material" means any chemical or biological substance
directly related to the Licensed Materials,
including any:
(i) organic or inorganic chemical
element or compound;
(ii) nucleotide or nucleotide sequence
including DNA and RNA sequences;
(iii) gene;
(iv) vector or construct including
plasmids, phages, or viruses;
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(v) host organism including bacteria,
fungi, algae, protozoa and
hybridomas;
(vi) eukaryotic or prokaryotic cell line
or expression system or any
development strain or product of
that cell line or expression system;
(vii) protein including any peptide, amino
acid sequence, enzyme, antibody or
protein conferring targeting
properties and any fragment of a
protein, peptide, enzyme, or
antibody;
(viii) drug or pro-drug;
(ix) other genetic or biological material
or micro-organism; or
(x) assay or reagent.
"Net Sales" means [****************]
[****************************************].
"Orphan Indication" 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.
"Parties" means CRT and Genesis Biopharma and "Party"
shall be construed as any of them.
"Patent Rights" 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.
"Percipio Intellectual Property" means any Know How, Material or Patent
Rights directly related to the development
of antibodies directed against [******],
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
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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).
"Percipio Licence" means the Patent and Know How Licence dated
21 October 2008 made between (1) CRT and
(2) Percipio.
"Pivotal Registration Study" 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.
"Product" 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.
"Quarter" means any period of three consecutive
calendar months commencing on 1 January, 1
April, 1 July, or 1 October in any year.
"Revenue Share" [*****************************************]
"SPC" 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.
"Sub-licence" means a sub-licence of the Licensed
Intellectual Property granted by Genesis
Biopharma to its Affiliate or a Third
Party.
[*****************] [*****************************************]
"Sub-licensee" means any Third Party or
Affiliate of Genesis Biopharma
granted a Sub-licence by Genesis
Biopharma in accordance with
Clause 2.4.
"Territory" means the world.
"Third Party" means any entity or person other than the
Parties or an Affiliate of either of them.
"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 [****],
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
Xxxxxxxx under the terms of the Asset
Purchase Agreement.
1.2 In this Agreement:
1.2.1 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;
1.2.2 the headings are inserted for convenience only and shall be
ignored in construing this Agreement;
1.2.3 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;
1.2.4 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;
1.2.5 the words "include", "included" and "including" are to be
construed without limitation to the generality of the preceding
words; and
1.2.6 reference to any statute or regulation includes any modification
or re-enactment of that statute or regulation.
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
9
Licensed Materials and CRT is under no obligation to provide further
quantities of such Licensed Know How and Licensed Materials.
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:
2.2.1 the expiry of the relevant Licensed Patent in the relevant
country; or
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 [************************************************************]
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;
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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 [************************************************************************].
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 [*******] reports for periods ending on [*******]and each
subsequent period of [*******]months until [*******], and
thereafter [*******]reports for periods ending on , 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 [*******] US Dollars [*******]of the Initial
Financing in undertaking and completing the In Vivo Efficacy Work
on or before 30 September 2010.
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
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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[*******], 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 [*******]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.
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") [*******]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 [*************************************];
and
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4.1.2 [*************************************];
and
4.1.3 subject to the provisions of Clauses 4.2, 4.3, 10.6 and 11.4, the
following payments [********************] of the occurrence of the
relevant milestone event [********************************] set
forth in this Clause 4.1.3:
4.1.3.1 [******************************************]
4.1.3.2 [******************************************]
4.1.3.3 [******************************************]
4.1.3.4 [******************************************]
and
4.1.4 subject to the provisions of Clauses 4.2, 4.3, 10.6 and 11.4, the
following payments within [*****************]of the occurrence of
the relevant milestone event [*********************************]:
[*******************************************************];
and
4.1.5 subject to the provisions of Clauses 10.6 and
11.4[************************* ***************************];
and
4.1.6 subject to the provisions of Clauses 10.6 and 11.4,
[************************].
4.2 For the avoidance of doubt [***********************************].
4.3 Notwithstanding anything to the contrary set forth herein, (i) Genesis
Biopharma shall [***********].
4.4 [***********************************************************************].
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).
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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
[*******************] 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.
6. BOOKS AND RECORDS
6.1 Pursuant to Clause 4.4, Genesis Biopharma shall prepare [*******]Reports.
The [*******]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 [*******]of the receipt of any such
[*******]Report that it does not accept the same, that [*******]Report
shall be certified by an independent accountant appointed by agreement
between Genesis Biopharma and CRT or, in default of agreement within
[*******]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
14
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 [********************] 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 [********************]. 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
[*******]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).
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.
15
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
[*************************************] 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.
[*****************************]
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 [******], 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
[**********]. Genesis Biopharma shall provide, [********], all such
reasonable assistance as CRT may reasonably request in any such
proceedings. [*************************************************].
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, [*************], 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
16
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 [**********************************]
8.1.1 [****************************************]
8.1.2 [****************************************]
8.2 [**********************************].
8.3 [**********************************].
8.4 [**********************************].
8.5 [**********************************].
8.6 [**********************************].
8.7 [**********************************].
8.8 [**********************************].
8.9 [**********************************].
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.
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
17
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 Xxx
0000 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.
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. [*********************]
10.2 CRT may, on [*******]written notice, terminate this Agreement if:
18
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 [*******]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 [************************************************].
10.4 [************************************************].
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:
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 [******************]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 [*******] [**********************] 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
19
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 [****************************************************].
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 [********************]
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,
[*************************] 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 [*******]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
20
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 [*******]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.
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
21
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.
11.8 [***************************************************].
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.
22
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.
ADDRESS OF GENESIS BIOPHARMA
Genesis Biopharma, Inc.
Xxxxx 000
0000 Xxxxxxx Xxx.
Xxx Xxxxx, Xxxxxx
XXX
For the attention of Xxxxxx Xxxxxx
Chief Executive Officer
Fax No. x0 (000) 000-0000
ADDRESS XX XXX
Xxxxxxxx Xxxxx
Xxxxxxxx Xxxxxx
Xxxxxx
XX0X 0XX
Fax No. x00 (0) 00 0000 0000
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.
23
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:
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 [*******]the Innocent Party may
give [*******]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 [*******]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[*******], 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
24
within[*******], 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):
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 xxxx, trade device, service xxxx, 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
25
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.
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) Xxx 0000 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.
26
IN WITNESS whereof this Agreement has been executed by duly authorized officers
of the Parties on the date first above written.
Signed by: /s/ X.X. L'Huillier
--------------------------------------------
Name: X.X. L'Huillier
--------------------------------------------
Title: Director, Business Management
--------------------------------------------
For and on behalf of
CANCER RESEARCH TECHNOLOGY LIMITED
Signed by: /s/ Xxxxxx Xxxxxx
--------------------------------------------
Name: Xxxxxx Xxxxxx
--------------------------------------------
Title: Chief Executive Officer
--------------------------------------------
For and on behalf of
GENESIS BIOPHARMA, INC.
27
