DATED OCTOBER 2008
Exhibit 10.1
DATED OCTOBER
2008
(1)
CANCER RESEARCH TECHNOLOGY LIMITED
AND
(2)
PERCIPIO BIOTHERAPEUTICS
1
THIS
AGREEMENT is made the________ day of October 2008
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 ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇
▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ (“CRT”);
and
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(2)
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Percipio Biotherapeutics, Inc.
a company incorporated in the State of Nevada, United States of
America whose principal place of business is at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇.,
▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
(“Percipio”).
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RECITALS
| (A) | 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 [********] 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. and CRT (the “Letter Agreement”), CRT
granted a limited licence to Viragen, Inc. to certain intellectual
property in respect of the Invention. The Collaboration Agreement and
Letter Agreement expired and Viragen, Inc. (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, Inc. an exclusive licence to the Scheduled
Patents, Licensed Know How (defined in Clause 1) and Licensed Materials
(defined in Clause 1). During the term of the Letter Agreement
and 2005 Licence, Viragen, Inc. (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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Following
the liquidation of Viragen, Inc. 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, Inc.’s rights in the Viragen Intellectual
Property (as defined in the 2005 Licence) to be assigned to CRT, and at
the request of Viragen Inc.’s liquidators CRT agreed to enter into
negotiations to conclude a licence in materially similar terms to the 2005
Licence with the purchasers, from the liquidators, of Viragen, Inc. and
Viragen (Scotland) Ltd.’s assets to ensure the commercial exploitation of
the Invention and [*************] antibody programme to develop Products
(as defined in Clause 1) based upon the exploitation of its rights under
the 2005 Licence by Viragen, Inc (including through the use and
development of Viragen Intellectual
Property).
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2
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(E)
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On
the basis of the arrangements described in paragraph D, (i) Viragen
Intellectual Property has been assigned to ▇▇▇▇▇▇▇▇ Atlantic (a company
organized in the Cayman Islands) pursuant to an Assignation executed by
Hamilton Atlantic on 6 May 2008; and (ii) ▇▇▇▇▇▇▇▇
Atlantic has granted Percipio (under its former name of Sunburst
Acquisitions III, Inc.) an exclusive worldwide right and licence under all
of its rights in the Viragen Intellectual Property to research, develop,
use, keep, make, have made, market, distribute, sell, offer to sell,
advertise or otherwise dispose of licensed products pursuant to a licence
agreement dated 21st
August 2008 (the “Sunburst Licence
Agreement”).
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(F)
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CRT
and ▇▇▇▇▇▇▇▇ Atlantic have entered into a separate agreement addressing
the consequences of termination of this
Agreement.
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(G)
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CRT
has agreed to grant Percipio 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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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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3
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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 Percipio 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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“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 [********] for the immunotherapeutic treatment and/or
diagnosis of diseases.
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“Financing
Event”
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means
the receipt by Percipio of at least [****************], in total, whether
in a single tranche or cumulatively, in cash.
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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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4
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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 [******] and (ii) the hybridoma
[*****************************] 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:
(i)[*****************************];
(ii)[*****************************];
and
(iii)[*****************************].
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“Marketing
Plan”
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has
the meaning set forth in Clause
3.5.
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5
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“Material”
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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;
(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.
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“Net
Sales”
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means
the invoiced amount actually received
[*********************************************].
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“Orphan
Indication”
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means
a disease 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 Percipio (as defined above) 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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6
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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 [******] or the Products,
whether as an improvement to the Licensed Intellectual Property and/or
Viragen 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 undertaken pursuant to the licence in
this Agreement.
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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.
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“Quarter”
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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”
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[**********************************************]
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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”
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means
a sub-licence of the Licensed Intellectual Property granted by Percipio to
its Affiliate or a Third Party.
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[*****************]
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[*******************************************]
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“Sub-licensee”
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means
any Third Party or Affiliate of Percipio granted a Sub-licence by Percipio
in accordance with Clause 2.4.
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“Territory”
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means
the world.
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7
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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”
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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”
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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, Inc. itself or its Affiliates or Sub-licensees or
research funded by Viragen, Inc. but undertaken by a Third Party and
whether undertaken pursuant to the 2005 Licence or pursuant to the Letter
Agreement and included within the Sunburst Licence
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
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reference
to any statute or regulation includes any modification or re-enactment of
that statute or regulation.
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8
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2.
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GRANT
OF LICENCE
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2.1
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In
consideration for the payments to be made by Percipio to CRT pursuant to
Clause 4, CRT hereby grants to Percipio 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.
Percipio 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
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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
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the
expiry of the relevant Licensed Patent in the relevant country;
or
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2.2.2
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ten
years after the date that the first therapeutic Product was placed on the
market in such country,
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whichever
is the later.
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2.3
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It
is acknowledged and agreed that:
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2.3.1
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this
Agreement shall be subject to the academic research rights granted to the
University under the Licensed Intellectual Property;
and
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2.3.2
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[******************************************************************].
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2.4
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Percipio
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, Percipio ensures that CRT’s rights under
this Agreement are maintained and that Percipio meets the material terms
and conditions of the Agreement. In the case of the grant of a
Sub-licence to a Third Party only, Percipio 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 Percipio requests
consent to grant a Sub-licence shall be deemed to be consent.
Notwithstanding anything to the contrary set forth herein, (i) Percipio
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 Percipio without
obtaining CRT’s prior written consent and (ii) Percipio 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 Percipio 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, Percipio shall provide CRT
with a true copy of the Sub-licence signed by Percipio and such Third
Party, at Percipio’s own expense. Any Sub-licence that is granted in
breach of this Clause 2.4 shall be void. Without prejudice to Percipio’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 Percipio to a
Third Party shall be presumed to meet the requirements of this Clause 2.4
if it shall:
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2.4.1
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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
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provide
that the Sub-licence shall terminate automatically on termination for
whatever reason of this Agreement;
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9
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2.4.3
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provide
that the Third Party with whom the Sub-licence has been entered into shall
undertake to allow Percipio access to such Third Party’s books and records
relating to the calculation of Net Sales of Products, and Percipio
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;
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2.4.4
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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
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2.4.5
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prohibit
the assignment of the Sub-licence to any Third Party; provided, however,
that Percipio shall be permitted to permit such Third Party Sub-licensee
to sub-licence the rights granted to it under the Sub-licence, provided
that (1) Percipio 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 Percipio shall, at its own cost, provide a
copy of each sub-sub-licence to CRT as soon as possible after
completion.
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2.5
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Any
breach of Clauses 2.3 or 2.4 shall be a material breach of this
Agreement.
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2.6
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In
the event that this Agreement is terminated by Percipio pursuant to Clause
10.5 hereof,
[*************************************************************************].
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3.
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DEVELOPMENT
AND MARKETING PLAN
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3.1
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Percipio
shall:
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3.1.1
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subject
to Clause 3.3, use commercially reasonable endeavours to undertake the
Development Plan at its own cost and expense;
and
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3.1.2
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provide
[********] reports until the [*****] anniversary of the Commencement Date,
and thereafter [*****]l reports 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.
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3.2
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In
the event that Percipio 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.
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3.3
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In
the event that Percipio misses any of the material milestones highlighted
in the Development Plan (as may have been amended pursuant to Clause 3.2)
[**********************************************************************]
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.
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10
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3.4
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Percipio
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.
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3.5
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Commencing
with the [***********************************](each a “Marketing
Plan”)[****************************], which shall include a summary
of the marketing, sales and distribution plans on a country-by-country
basis for [************] of Percipio 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 Percipio
upon prior written notice to CRT (provided, further, that the foregoing
shall be without limitation of the obligations of Percipio 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
Percipio. 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.
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4.
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CONSIDERATION
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4.1
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Percipio
shall pay to CRT:
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4.1.1
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[*************************************];
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and
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4.1.2
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[*************************************];
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and
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4.1.3
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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:
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4.1.3.1
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[******************************************]
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4.1.3.2
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[******************************************]
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11
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4.1.3.3
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[******************************************]
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4.1.3.4
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[******************************************]
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and
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4.1.4
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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
[***************************************]:
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[*******************************************************];
and
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4.1.5
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subject
to the provisions of Clauses 10.6 and 11.4, [*************************
***************************];
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and
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4.1.6
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subject
to the provisions of Clauses 10.6 and 11.4,
[************************].
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4.2
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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 Percipio,
[***********************************].
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4.3
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Notwithstanding
anything to the contrary set forth herein, (i) Percipio shall
[***********]
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4.4
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[*************************************************************************].
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5.
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PAYMENT
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5.1
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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
Percipio).
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5.2
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Where
sums are received by Percipio 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.
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5.3
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All
costs of transmission or currency conversion shall be borne by
Percipio.
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12
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5.4
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All
payments by Percipio to CRT under this Agreement are expressed to be
exclusive of value added tax howsoever arising, and Percipio 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 Percipio 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 Percipio 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 Percipio 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
Percipio being under a legal obligation under the UK tax rules requiring
Percipio to deduct income tax at source from royalties payable by Percipio
to CRT in respect of a UK granted
patent.
|
|
5.7
|
Where
CRT does not receive payment of any sums due to it
within[*******************], 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, Percipio 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 Percipio
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
Percipio 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. Percipio 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 Percipio 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 Percipio if the statement is shown to have
underestimated the monies payable to CRT by[********************] 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 [********************]. There shall be no more than
one certification by an independent accountant in relation to any one
calendar year.
|
13
|
6.2
|
Percipio
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 Percipio 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 Percipio’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, Percipio shall, from expiry of the
2005 Licence, 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 Percipio’s
obligations hereunder shall extend only within the Field (unless such
filing, prosecution or maintenance is not separable by Field). Percipio or
CRT shall provide copies of all relevant correspondence to CRT or
Percipio, 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.
|
|
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
[*************************************] notify the other Party of the
notice, claim or proceeding.
|
|
7.4
|
Percipio
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 Percipio’s cost, render all such reasonable
assistance as Percipio reasonably requests.
[*****************************].
|
|
7.5
|
If
Percipio 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 Percipio
and Percipio 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 Percipio 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 [**********]. Percipio
shall provide,[********], all such reasonable assistance as CRT may
reasonably request in any such
proceedings. [*************************************************].
|
14
|
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 Percipio 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
Percipio from exercising its rights under Clause 7.4, and CRT agrees to
take all steps necessary with said Third Parties to grant to Percipio any
and all rights necessary to allow Percipio 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 Percipio.
|
|
7.7
|
CRT
shall, [*************] provide such reasonable assistance and advice to
Percipio as Percipio may request (including the provision of copies of any
necessary documents) which is necessary or desirable for Percipio 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 Percipio Intellectual Property shall
be exclusively owned by Percipio and (ii) all rights, title and interest
in any clinical data or regulatory filings relating to the Products shall
be exclusively owned by Percipio.
|
|
8.
|
WARRANTIES
AND LIABILITY
|
|
8.1
|
[**********************************]
|
|
8.1.1
|
[**********************************]
|
|
8.1.2
|
[**********************************]
|
|
8.2
|
[**********************************]
|
|
8.3
|
[**********************************].
|
|
8.4
|
[**********************************].
|
|
8.5
|
[**********************************].
|
|
8.6
|
[**********************************].
|
15
|
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
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
|
16
|
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 ▇▇▇ ▇▇▇▇ 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 Percipio pursuant
to Clause 2.1
above. [*********************]
|
|
10.2
|
CRT
may, on thirty (30) Business Days written notice, terminate this Agreement
if:
|
|
10.2.1
|
Percipio
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 the first anniversary of the
Commencement Date; or
|
|
10.2.3
|
the
Sunburst Licence Agreement is terminated by ▇▇▇▇▇▇▇▇ Atlantic;
or
|
|
10.2.4
|
at
any time prior to the listing of shares of Percipio on a public exchange,
in the event of a change of Control of Percipio 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 Peripio are conducted in
accordance with the wishes of another whether through ownership of 50% or
more of the voting securities of Percipio or by contract or otherwise and
“Controlling” shall be construed
accordingly.
|
|
10.3
|
[************************************************].
|
|
10.4
|
[************************************************].
|
|
10.5
|
Either
CRT on the one hand or Percipio on the other hand (the “Terminating Party”)
shall have the right to terminate this Agreement forthwith upon giving
written notice of termination to Percipio 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:
|
17
|
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 for a period of longer than
[**********************]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
|
[****************************************************]
|
|
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 Percipio pursuant to Clause 2 shall
terminate and any Sub-licences granted by Percipio pursuant to Clause 2.4
shall terminate;
|
|
11.1.2
|
Percipio
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, Percipio shall, [*************************] of
receipt of said notice, return to CRT, or, at CRT’s option, destroy all
Licensed Materials held by Percipio. Nothing herein shall
require Percipio 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 Percipio 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,
relating directly to the Licensed Intellectual Property whilst undertaking
the Development Plan or comprised within Viragen Intellectual
Property.
|
|
11.3
|
In
the event of termination:
|
|
11.3.1
|
By
Percipio pursuant to Clauses 10.3 or 10.4 in a particular country, then
Percipio agrees to provide CRT with a non-exclusive sub-licensable licence
to use the Percipio Intellectual Property and Viragen Intellectual
Property on a Revenue Share basis in that country or
countries;
|
|
11.3.2
|
By
Percipio pursuant to Clauses 10.3 or 10.4 in the entire Territory, then
Percipio agrees to assign to CRT all Percipio Intellectual Property and
clinical data relating to the Licensed Intellectual Property to which it
has rights and in the event that the Sunburst Licence
Agreement:
|
|
(a)
|
remains
in force or has been terminated by ▇▇▇▇▇▇▇▇ Atlantic, Percipio agrees to
grant CRT an exclusive sub-licensable worldwide right and licence under
all of its rights in the Viragen 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, on a
Revenue Share basis; or
|
|
(b)
|
has been or is terminated by Percipio, Percipio agrees, in accordance with any agreement in place between CRT and ▇▇▇▇▇▇▇▇ Atlantic, to grant CRT an exclusive sub-licensable worldwide right and licence under all of its rights in the Viragen 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 on a Revenue Share basis. |
18
|
11.3.3
|
By
CRT pursuant to Clauses 10.2.2, 10.2.3 or 10.5, Percipio shall assign all
Percipio Intellectual Property to which it has ownership rights and any
clinical data generated by Percipio relating to the Licensed Intellectual
Property to CRT and in the event that the Sunburst Licence
Agreement:
|
|
(a)
|
remains
in force, or has been terminated by ▇▇▇▇▇▇▇▇ Atlantic, Percipio agrees to
grant CRT an exclusive worldwide right and licence under all of its rights
in the Viragen 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, on Revenue Share terms to be
agreed;
|
| (b) |
has
been or is terminated by Percipio, Percipio agrees, in accordance with any
agreement in place between CRT and ▇▇▇▇▇▇▇▇ Atlantic, to grant CRT an
exclusive worldwide right and licence under all of its rights in the
Viragen 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 on a Revenue Share
basis.
|
|
11.4
|
In
the event of the expiry of this Agreement or the termination of this
Agreement by Percipio pursuant to Clause 10.5, CRT shall grant to Percipio
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 Percipio 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
Percipio 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 Percipio 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.
|
19
|
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 Percipio
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
|
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.
|
20
Address
of Percipio
▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇., ▇▇▇▇▇ ▇▇▇▇
▇▇▇
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇
▇▇▇
For the
attention of ▇▇▇▇▇▇ ▇▇▇▇▇▇
Chief
Executive Officer
Fax No.
▇▇ (▇▇▇) ▇▇▇-▇▇▇▇
Address
of CRT
▇▇▇▇▇▇▇▇
▇▇▇▇▇
▇▇▇▇▇▇▇▇
▇▇▇▇▇▇
▇▇▇▇▇▇
▇▇▇▇
▇▇▇
Fax No.
▇▇▇ (▇) ▇▇ ▇▇▇▇ ▇▇▇▇
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;
provided always that CRT or Percipio may assign the benefit of this
Agreement, or sub-contract any of its obligations hereunder, in whole or
in part to any Affiliate or to a successor to or purchaser of all or
substantially all of the business of the assigning Party relating to this
Agreement (whether in a merger, sale of stock, sale of assets or
otherwise), on the conditions that (i) the assigning Party gives prior
written notice to the non-assigning Party and (ii) that the assignee is
not a Tobacco Party; however, nothing herein shall permit an assignment to
any competitor of any Party.
|
|
16.
|
FORCE
MAJEURE
|
21
|
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 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 Percipio 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):
|
22
|
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 ▇▇▇▇, trade device, service ▇▇▇▇, symbol, or any abbreviation,
contraction or simulation thereof, owned by the other Party;
or
|
|
20.1.2
|
represent,
either directly or indirectly, that any product or service of the other
Party is a product or service of the representing Party or that it is made
in accordance with or utilises the information or documents of the other
Party.
|
|
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.
|
23
|
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) ▇▇▇ ▇▇▇▇ 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.
|
24
SCHEDULE 1 – DEVELOPMENT
PLAN
[***************************]
STAGE 1.
|
Activity
|
Estimated
Timeline for Achievement
|
|
[***********************************]
|
[************]
|
|
[***********************************]
|
[************]
|
|
[***********************************]
|
[************]
|
|
[***********************************]
|
[************]
|
[********************************************************************]
STAGE 2.
[***************************************************************************]
25
SCHEDULE
2
|
PATENT/APPLICATION
NUMBER
|
COUNTRY/REGION
|
FILING
DATE
|
|
[****************************]
|
[***********]
|
[***********]
|
|
[****************************]
|
[***********]
|
[***********]
|
|
[****************************]
|
[***********]
|
[***********]
|
|
[****************************]
|
[***********]
|
[***********]
|
|
[****************************]
|
[***********]
|
[***********]
|
|
[****************************]
|
[***********]
|
[***********]
|
|
[****************************]6
|
[***********]
|
[***********]
|
|
[****************************]
|
[***********]
|
[***********]
|
|
[****************************]
|
[***********]
|
[***********]
|
26
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. C3b
deposition assay
2. Complement
lysis assay
3. Antibody
dependent cellular cytotoxicity assay
4. Anaphylatoxin
assay
5. Monocyte
stimulation assay
6. T
cell co-stimulation assay
27
IN
WITNESS whereof this Agreement has been executed by duly authorized officers of
the Parties on the date first above written.
| Signed by: | |||
| Name: | |||
| Title: | |||
| For and on behalf of | |||
| CANCER RESEARCH TECHNOLOGY LIMITED | |||
| Signed by: | ▇▇▇▇▇▇ ▇▇▇▇▇▇ | ||
| Name: |
| Title: | Chief Executive Officer | ||
| For and on behalf of | |||
| PERCIPIO BIOTHERAPEUTICS, INC. |
28