Contract
(1)
CIMYM, Inc.
(2)
CIMAB S.A.
And
(3)
Kuhnil Pharmaceuticals Co., Ltd.
Amended
and Restated Development and License Agreement
Relating
to TheraCIM h-R3
This Amended and Restated
Development and License Agreement dated as of the 30th day of August, 2005 is made between:
(1) CIMYM,
Inc. (company registration
number 12142) ("CIMYM"), a company incorporated in Canada, whose principal place of
business is at 0000 Xxxxxxx Xxxxx, Xxxxxxxx XX, Xxxxx 000 Xxxxxxxxxxx, Xxxxxxx X0X 0X0; and
(2) CIMAB
S.A. (company registration
number 107/92) ("CIMAB"), a company incorporated
in Cuba, whose principal place of business is at
206 Street, No. 1926, e/
I9 y 00, Xxxxxx,
Xxxxx, Xxxxxx Xxxx, Xxxx;
and
(3) Kuhnil
Pharmaceuticals Co., Ltd. (company registration number
3128106060) ("Kuhnil") a company incorporated in Korea, whose principal place of business is
at 000-00 Xxxxxxxx-xxxx,
Xxxx-xx, Xxxxx, Xxxxx (121-803).
Recitals:
A. CIMYM is the exclusive licensee of certain
Licensed Patent Rights and certain Licensed Know-how and other rights relating to
marketing and selling Licensed Product (as defined below) in the Territory (as defined
below).
B. The shareholders of CIMYM are YM BioSciences, Inc. and CIMAB.
C. CIMAB enters into commercial agreements on behalf of the
Center of Molecular Immunology ("CIM", as defined below).
CIM originally developed ThereCIM h-R3 and has the facilities to manufacture
Licensed Product. CIMAB is entering into this Agreement principally in order
to assume the manufacturing
and supply obligations set out in Clause 5.
D. Kuhnil wishes to pursue the further
development and commercialisation of TheraCIM h-R3 for the treatment of cancer
in humans, in accordance with the provisions of this
Agreement.
E. Kuhnil has demonstrated evidence of economic
and financial solvency sufficient to assume the product development and conduct clinical
trials of Licensed Product in the Territory.
F. CIMYM, CIMAB and Kuhnil entered into a
Development and License Agreement dated as of May 25, 2005 whereby CIMYM
granted to Kuhnil a license within the Kuhnil Field and under the Licensed
Patent Rights and the Licensed Know-how to develop, use and sell the Licensed
Product (the “Original
Agreement”).
G. The Parties have agreed to
enter into this Amended and
Restated Development and License Agreement, which amends and restates the
Original Agreement.
It is agreed as
follows:
1 Definitions
In this Agreement, the following words
shall have the following meanings:
Affiliate
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In relation to CIMYM or Kuhnil, means any entity or person that
controls, is controlled by, or is under
common control with
that Party. For the purposes of this definition, "control" shall mean
direct or indirect beneficial ownership of 50% (or, outside a Party's
home territory, such
lesser percentage as is the maximum, permitted level of foreign
investment) or more of the share capital, stock or other participating
interest carrying the right to vote or to distribution of profits of that
entity or person, as the case may
be.
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Agreement
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This Amended and Restated
Development and License Agreement.
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Arising Intellectual
Property
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Any and all of the Arising Patents
and the Arising Know-how.
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Arising
Know-how
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Technical, commercial and all
other information
generated by
Kuhnil or its Affiliates under this Agreement that relates
to any of the Licensed Intellectual Property or the Licensed Product, including any scientific or
regulatory data (including clinical trial data generated by Kuhnil), product license
applications and
approvals, clinical trial license applications and approvals, and
development and marketing plans and activities.
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Arising
Patents
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Any and all patents and patent
applications that may be applied for or obtained in respect of any
invention(s) made by
Kuhnil or its Affiliates under this Agreement and which
relate to any Licensed Intel1ectual Property or the Licensed Product,
together with any continuations, continuations in part, extensions,
reissues, divisions, and any patents, supplementary protection certificates and similar
rights that are based on or derive priority from the
foregoing.
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Calendar
Quarter
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Each three-month period ending on
31st
March, 30th June, 30th September and 31st
December.
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Calendar
Year
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A year commencing on 1st January and ending on 31st December (but commencing on the
Commencement Date in the first year of this Agreement and, in the final
year of this Agreement, ending on the date of the last sale of Licensed
Product under this Agreement).
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CIM
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The Center of Molecular Immunology, a scientific
research institute based in Havana, Cuba.
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CIMAB’s
Contract Manufacturer
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Any
Person that may from time to time be contracted by CIMAB to manufacture
the Licensed Product, or any component or ingredient thereof in
accordance
with the provisions of this
Agreement.
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CIMYM Field and
Territory
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(a) outside the Territory, all
fields (including the Field); and
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(b)
within the Territory, all fields other than the
Field.
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Claims
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All demands, claims and liability
(whether criminal or
civil, in contract, tort or otherwise) for losses, damages, legal costs
and other expenses of any nature whatsoever and all costs and expenses
(including without limitation reasonable attorneys fees) incurred in
connection therewith.
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Commencement Date
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The date of execution of this
Agreement by the Parties (or, if they sign on different dates, the last
date of signature of this Agreement by a Party).
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Confidential Information
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Means any and all trade secrets,
technical and non technical and information owned by one of the
Parties, or by any Affiliates of one of the Parties. Confidential
Information includes, without limitation, all inventions, discoveries,
processes, materials, formulae, clinical development plans, data, ideas,
financial information, legal, corporate, marketing,
product, research, personnel, customer, supplier and other non-public
information, in whatever form or media, specifically identified as
confidential prior to or at the time of its disclosure or disclosed orally
and confirmed in writing as confidential
within thirty (30) days of such oral disclosure.
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Delivered
Items
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Has the meaning given in Clause
4.2.
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Development and
Commercialisation
Plan
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Has the meaning given in Clause
3.1.
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Development and
Commercialisation Plan Report
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The report described in Clause 3.4
as amended from time to time.
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Development Team
Parties
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CIMYM and Kuhnil, and "Development Team Party"
shall mean either of them.
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Development
Term
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Means the period from the
Commencement Date until completion of TheraCIM h-R3 to the point of first commercial
sale of a Licensed Product in the Territory in accordance with the
Development and Commercialisation Plan.
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Diligent and Reasonable
Efforts
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Exerting such efforts and
employing such resources (whether by itself or through
sub-contractors or sub-licensees) as would normal1y be exerted or employed
by a reasonable Third Party pharmaceutical company for a product of
similar market potential at a similar stage of its product life, when
utilizing sound and reasonable scientific, business
and medical practice and judgment in order to develop the product in a
timely manner and maximize the economic return from its
commercialisation.
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Kuhnil Field and
Territory
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In respect of any activity that is
licensed to Kuhnil under this Agreement, shall mean
that the activity must occur both within the Field and within the
Territory.
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Field
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The treatment of cancer in humans
which for greater certainty excludes diagnostic or vaccine
technology.
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Gross Sales
Value
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Shall mean the medical
reimbursement price for Licensed Product, first reduced by 5% for the
wholesaler's margin and then divided by 1.1 to account for the Value Added
Tax. The amount invoiced and received for the sale of the
Licensed Product when sold by Kuhnil or any of its Affiliates or any of
their respective distributors to the ultimate purchaser in an arm's
length transaction exclusively for money (or where the sale is not at
arm's length, the price that would have been so invoiced
and received if it
had been at
arm's
length); provided that sales between any of
Kuhnil and its Affiliates shall not be considered for the purposes
of this definition unless there is no subsequent sale to a Person
other than Kuhnil and its Affiliates in an arm's length transaction exclusively for
money.
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Initial Development
Program
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A program of development to be conducted by
Kuhnil in accordance
with the provisions of the attached Schedule 3 Part
A.
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Joint Development
Team
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A committee to be established, and
operating, in
accordance with the provisions of Clause 2.
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Know-how
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The Licensed Know-how and the
Arising Know-how.
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Licensed Intellectual
Property
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Any and all of the Licensed Patent
Rights and the Licensed Know-how.
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Licensed
Know-how
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Technical and
scientific
information in the possession of CIMYM or CIMAB in the Field relating to (a) TheraCIM
h-R3 and/or (b) the
inventions claimed in the Licensed Patent Rights, including the
information further described in the attached Schedule 2, in each case to
the extent that such
information is relevant, related to, derived from or useful for the
clinical development, registration, commercialisation, storage, use or
sale of Licensed Product within the Field and Territory. Licensed Know-how
specifically excludes all technology, materials, and information
related to the manufacture of Licensed Product.
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Licensed Patent
Rights
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The patents and patent
applications described in the attached Schedule 1 subject to the
provisions of Schedule 1, together with any continuations, continuations in part, extensions,
reissues, divisions, and any patents, supplementary protection
certificates and
similar rights that are based on or derive priority from the
foregoing.
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Licensed Product
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TheraCIM
h-R3 that is sold or otherwise supplied by
Kuhnil or its Affiliates
and which (a) is within any Valid Claim of the Licensed Patent
Rights and/or
(b) is the subject of any Orphan Drug Status in the
Territory; and/or
(c) incorporates, or its development makes use of,
any of the Licensed Know-how.
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Milestone
Receipts
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The
amount of any payment, excluding Value Added Tax, due to CIMYM from
Kuhnil as
described in Clause 7.2.
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Orphan
Drug Status
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Refers
to the process of obtaining Orphan Drug Status in the from the
Korea
drug regulatory authority.
This generally requires that:
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a) Number of patients in Korea is less than 20,000 | ||
b)
There is no alternative drug in Korea
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c)
The total value of import into Korea is less than US$1,000,000
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Parties
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CIMYM,
CIMAB and
Kuhnil,
and "Party" shall mean any
of them.
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Person
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Includes
any individual, firm, company, corporation or other legal
entity.
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Patents
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Any
and all of the Licensed Patent Rights and the Arising
Patents.
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Providing
Parties
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Both
of CIMAB (whether on its own behalf or on behalf of CIM)
and CIMYM, and "Providing Party" shall mean either of
them.
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Regulatory
Application
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Any
and all applications that are necessary and appropriate to obtain a
Regulatory Approval including, without limitation, all required documents,
data and information
concerning, filed or required to be filed, otherwise submitted by
Kuhnil or
its Affiliates to a Regulatory Authority.
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Regulatory
Approval
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Any
and all approvals, licenses, registrations or authorisations of any
Regulatory Authority that are necessary for
the manufacture, use, storage, import, export, transport, marketing,
distribution or sale of the Licensed Product in any part of the
Territory.
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Regulatory
Authority
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The
Korean Food
and Drug Administration.
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Supply
Agreement
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Any
agreement between
CIMAB and
Kuhnil under
which CIMAB agrees to manufacture and supply Kuhnil with
Licensed
Product.
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Territory
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Shall mean Korea.
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TheraCIM
h-R3
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A humanised antibody to the EGF
receptor, known scientifically as h-R3 and which has been given the INN
"nimotuzumab".
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Third Party
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A Person other than one of the
Parties.
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Valid Claim
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A claim of a patent or patent
application that has not expired or been held invalid or unenforceable by
a court of competent jurisdiction in a final and non-appealable
judgment.
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2 Joint Development
Team
2.1 Formation. Within fifteen (15) days after the Commencement Date, the
Development Team Parties shall establish a Joint
Development Team, by each Development Team Party designating its initial members to serve
on the Joint Development
Team and notifying the other Development Team Party of its
dates of availability for the first meeting of the Joint Development Team. The purpose of the
Joint Development Team shall be to oversee the development of Licensed Product for
purposes of
commercialisation in the Kuhnil Field and Territory. The Joint Development Team shall
consist of not more than three (3) representatives designated by each
Development Team Party. Each representative shall have relevant and appropriate expertise
in order to oversee the
development of the Licensed Product. If a representative of a
Development Team Party is unable to attend a meeting of the Joint Development Team, such Development
Team Party may designate an alternate to attend such meeting. In addition, each Development Team Party may,
at its discretion, invite a reasonable number of other employees,
consultants or scientific advisors to attend the meetings of the Joint Development Team,
provided that such invitees are bound by appropriate confidentiality obligations. Each Development
Team Party may change one or all of its representatives to the Joint
Development Team at any time upon notice to the other Development Team
Party.
2.2 Meetings. The Joint Development Team shall meet
every six months in person
or by teleconference and at such other times
as the Parties may agree. The first meeting of the Joint Development Team shall be held as soon
as reasonably practicable, but in no event later than 60 days after the Commencement Date.
Meetings shall be held at
such place or places as are mutually agreed or by teleconference or
videoconference; provided,
however, that there shall be at least one face-to-face meeting per
calendar
year.
2.3 Responsibilities. The Joint Development Team
shall:
(a) Elaborate the Development and
Commercialisation Plan in accordance with Clause 3.1
(b) review and unanimously approve (or,
if the members of the Joint Development Team are unable to reach unanimous agreement,
recommend to the Parties)
the overall development
strategy for Licensed
Product in the Kuhnil Field and Territory
(including, without limitation, setting criteria for
progression of Licensed
Product to the next stage
of development under the Development and Commercialisation
Plan);
(c) review and recommend to the Parties modifications to the
Development and Commercialisation Plan (including the
resources to be allocated and the timelines contained in the Development and
Commercialisation Plan);
(d) facilitate the transfer of Know-How
and other information between the Parties for purposes of conducting the Development
and Commercialisation Plan;
(e) regularly assess the progress of
Kuhnil in its conduct of the Development
and Commercialisation Plan;
and
(f) perform such other activities as are
contemplated under this Clause 2. For the
avoidance of doubt the
Joint Development Team
shall not have any role or responsibility in relation to
determining whether
Kuhnil has complied with its obligations to CIMYM under this
Agreement.
2.4 Disputes. If agreement cannot be reached within the Joint
Development Team, Kuhnil shall have the right to make the final
determination concerning the resolution of the disagreement. Notwithstanding the foregoing, in the
case of a material disagreement, prior to invoking its rights under this Clause 2.4, Kuhnil agrees to have its chief executive
contact the chief executive of CIMYM for the purpose of
discussing the disagreement and attempting to reach a consensus. It shall be the goal of the
chief executives to reach a consensus within five (5) days of the date on which contact is
initiated by the chief
executive of Kuhnil, it
being understood that (i) in the event of an
extraordinary circumstance requiring a faster resolution (e.g., a safety issue or extraneous timing issue),
Kuhnil shall have the right to make the
final determination prior to the end of such
five (5) day period if a consensus has not been reached by the required time for resolution and
(ii) in the event that a consensus has not been reached within ten (10) days of the date on which contact is initiated
by the chief executive officer of Kuhnil, Kuhnil shall have the right to make the final
determination. For the avoidance of doubt, Kuhnil shall not have any right, under this
clause, to determine whether it has complied with its obligations to CIMYM under this
Agreement.
3 Development and
Commercialisation
3.1 Development and
Commercialisation Plan.
3.1.1 Within 90 days of the Commencement Date,
the Joint Development Team
shall prepare a written plan ("Development and Commercialisation Plan") that expands upon
the initial development plan sec out in Schedule 3
and will describe, and provide a time line for:
(a) all development activities for the
Licensed Product in the Kuhnil Field and Territory, addressing each phase of development and the budget for
completion of such activities, and providing detailed
information on the activities to be conducted in the next 12-month
period.
(b) intellectual property protection
strategy, including applying for Orphan Drug Status,
patents and supplementary protection
certificates;
(c) clinical and registration strategy, with
a view to expediting Regulatory Approval; and
(d) commercialisation
strategy.
The Joint Development Team shall update
the Development and
Commercialisation Plan on
a regular basis and at
least annually.
3.2 Development and
Commercialisation Activities. Kuhnil shall be responsible for the development and commercialisation (in
accordance with the
Development and Commercialisation Plan) of the Licensed
Product in the Kuhnil Field and Territory. Such development and commercialisation shall
be carried out under the
oversight and management of
the Joint Development Team and in accordance with the provisions of this
Agreement.
3.3 Development and
Commercialisation
Costs. Kuhnil shall bear all costs associated with
the development and commercialisation of
Licensed Product in the Kuhnil Field and Territory, including costs incurred in the
preparation and execution of the Development and Commercialisation Plan. If any Providing Party agrees with
Kuhnil to conduct work as part of the Development and Commercialisation
Plan (which may include advice given to the Joint Development Team), the Providing Party's
costs of conducting such
work shall be borne by Kuhnil, with the time costs of the Providing
Party's representatives
being charged to Kuhnil on a daily rate basis. The Providing Party's
daily rate for its representatives' work referred to in
the previous sentence shall
be agreed between the Providing Party and Kuhnil or, if they are unable to agree, the rate shall be
$1,000 (one
thousand US dollars) per
day plus any reasonable
out-of-pocket expenses and external costs associated with such
work.
3.4 Reporting. Without prejudice to the generality of
Kuhnil 's obligations under Clauses 8.1
and 9.2, Kuhnil shall provide a report ("Development
and Commercialisation Report") to CIMYM at least once per annum. In addition,
Kuhnil shall provide to CIMYM a quarterly,
written status update on all clinical, development and
commercial activities being
undertaken, and from time to time upon request, showing all past, current and projected
activities taken or to be taken by Kuhnil to bring Licensed Product to market and
maximise the sale of Licensed Product in the Kuhnil Field and Territory, and including details of
all Arising Intellectual Property. CIMYM's receipt or approval or
non-approval of any such report shall not be taken to waive or qualify Kuhnil 's obligations under Clause 8.1 or
otherwise under this Agreement.
3.5 Exchange of
Data. It is CIMYM's intention to grant
sub-licenses to commercialise TheraCIM h-R3 in the CIMYM Field and
Territory. Accordingly, each of the Parties, or CIMYM's sub-licensee(s), may generate
data in relation to TheraCIM h-R3 or Licensed Products that is useful to the other Parties
in connection with their development or commercialisation of Licensed Products.
To facilitate such commercialisation, Kuhnil shall disclose and provide to CIMYM and
CIMAB all Arising Intellectual Property, technical and clinical trial information (including case report
forms and
source documentation) and all notices and other
correspondence between Kuhnil and its Affiliates and any Regulatory Authority
on a quarterly basis in accordance with the provisions of Clause 3.4. CIMYM and Kuhnil shall use reasonable
efforts to reach agreement with CIMYM's other
sub-licensee(s) of TheraCIM h-R3 for the disclosure to Kuhnil of clinical data in respect of
TheraCIM h-R3 that is generated by such sub-licensee(s).
4 Know-how and Confidential
Information
4.1 Provision of
Know-how. Upon Kuhnil 's reasonable written request, CIMYM shall supply Kuhnil with all Licensed Know-how in its
possession that is relevant
to the development and commercialisation of TheraCIM h-R3 within the Kuhnil Field and Territory. The Licensed
Know-how shall be subject
to the confidentiality provisions of Clause
4.4.
4.2 Status of
Know-how. Kuhnil acknowledges that the Licensed Know-how
is subject to further development. Accordingly, specific
results cannot be
guaranteed and any results,
materials, information or
other items, including the Licensed Know-how and inventions claimed in the Licensed Patent Rights (together “Delivered Items”) to be provided under this Agreement are
provided “as is” and without any express or implied warranties, representations or
undertakings. As examples,
but without limiting the foregoing, CIMYM does not give any warranty that Delivered Items are of merchantable
or satisfactory quality, are fit for any
particular purpose,
comply with any sample or
description, or are viable,
uncontaminated, safe or
non-toxic.
4.3 Use of
Know-how. Kuhnil agrees, not to use the Know-how for any purpose
except as expressly licensed hereby and strictly in
accordance with the provisions of this Agreement.
4.4 Confidentiality
Obligations. Each Party
(“Receiving
Party”)
undertakes:
(a) to maintain as secret and confidential
all Know-how and other
Confidential Information
obtained directly or indirectly from the other Party (“Disclosing Party”) in the course of or in anticipation of this
Agreement and to respect
the Disclosing Party's
rights therein,
(b) to use the same exclusively for the
purposes of this Agreement, and
(c) subject to the provisions of Clause 4.7,
to disclose the same only
to those of its
employees, contractors and
sub-licensees pursuant to
this Agreement (if any) to whom and to the extent that such
disclosure is reasonably
necessary for the purposes of this Agreement.
4.5 Exceptions to
Obligations. The provisions
of Clause 4.4 shall not apply to Know-how and
Confidential Information
which the Receiving Party can demonstrate:
(a) was, prior to its receipt by the
Receiving Party from the
Disclosing Party, in the possession of the Receiving Party and at
its free disposal; or
(b) is subsequently disclosed to the
Receiving Party without any
obligations of confidentiality by a Third Party who was
not under a duty of
confidentiality and did not
derive it directly or indirectly from the Disclosing Party;
or
(c) is or becomes generally available to the public through no act
or default of the Receiving Party or its agents,
employees, Affiliates or sub-licensees.
4.6 Disclosure to Court,
etc. If the Receiving Party
is required to disclose
Know-how or other Confidential Information to
the courts of any competent
jurisdiction, or to any government regulatory agency or financial
authority, such disclosure shall not be a breach of Clause 4.4, provided that the Receiving Party shall
(i) inform the Disclosing Party as soon as is reasonably practicable and shall only disclose
Confidential Information to the extent so required, and (ii) allow the Disclosing Party to seek to
persuade the court, agency or authority to have the information
treated in a confidential manner, where this is possible under the court, agency or authority's
procedures.
4.7 Disclosure to
Employees. The Receiving
Party shall ensure that all of its employees, contractors, consultants, advisers and
sub-licensees pursuant to this Agreement (if any) who have access to any of the Disclosing Party's Know-how or other
Confidential Information to which Clause 4.4 applies, shall be made
aware of and subject to these obligations and shall have entered into written undertakings
of confidentiality at least as restrictive as Clauses 4.4 and 4.5.
4.8 Ownership of
Confidential
Information
All Confidential Information disclosed
by the Disclosing Party
shall, as between the Parties, remain the sole and exclusive property
of the Disclosing Party including without limitation:
(a) all ideas, concepts, information, trade secrets,
know-how, business strategies and methods relating to the Confidential
Information;
(b) all physical material containing,
bearing, or embodying any
Confidential Information in human or machine readable
form, including, without limitation, all documents, agreements, diagrams, charts, graphs,
computer programs, computer diskettes, and computer files; and
(c) all proprietary and intellectual
property rights in the Confidential Information, regardless of whether these
items were created,
generated, developed, produced or prepared by or on behalf of the
Disclosing Party, and regardless of whether these items came into being before or after
the date hereof.
4.9 Return of
Confidential Information
Upon the request of a Party, the other Party will promptly
return to such Party, or at
such Party's election,
destroy all Confidential Information in its possession or in the possession of its representatives. Such
Party shall use reasonable efforts to cause its representatives and any other Party acting under its
direction or control to return all materials containing Confidential
Information, including all copies, notes, summaries and outlines.
5 Manufacturing and
Supply
5.1 Clinical Supply. CIMAB shall
supply to Kuhnil and its Affiliates, and Kuhnil shall purchase from CIMAB for
its own use and that of its Affiliates, in finished form with one hundred
percent (100%) of Kuhnil's unit requirements of TheraCIM h-R3 and Licensed
Product for all clinical development purposes. Such clinical requirements shall
be supplied to Kuhnil under the Supply Agreement as more fully described in
Clause 5.4. The Parties confirm that cost of TheraCIM h-R3 to be supplied under
this Agreement for clinical development will be paid through the royalty
payments to be paid pursuant to Clause 7.3 of this Agreement.
5.2 Commercial Supply. CIMAB
shall supply to Kuhnil, and Kuhnil shall purchase from CIMAB in finished form
one hundred percent (100%) of Kuhnil's unit requirements of Licensed Products
for all commercial purposes. CIMAB may elect to have such requirements supplied
to Kuhnil by one or more of CIMAB's Contract Manufacturer(s). Kuhnil's quantity
requirements shall include those of its Affiliates.
5.3 Specifications. CIMAB
undertakes that all Licensed Product supplied to Kuhnil will be manufactured in
accordance with mutually agreed upon specifications (inclusive of specifications
in an approved Marketing Authorization) and Good Manufacturing Practices of the
European Medicines Agency and the relevant Regulatory Authorities, and the
relevant regulatory authorities in the countries of manufacture of the Licensed
Product, and will not be adulterated or misbranded under applicable laws,
regulations or guidelines, and that the manufacturer will have in force all
necessary Regulatory Approvals for the manufacture of Licensed Product in
accordance with such specifications for the purposes of supply and use of
Licensed Products in all countries of the Territory, and will be in good
standing with all Regulatory Authorities.
5.4 Supply Agreement. Licensed
Product supplied by CIMAB or CIMAB's Contract Manufacturer(s) to Kuhnil for clinical and
commercial purposes shall be supplied to KUHNIL pursuant to the terms of
separate Supply Agreements. Kuhnil and CIMAB shall use good
faith efforts to negotiate and enter into such supply agreements for commercial
purposes, at least six (6) months prior to the submission of a Regulatory
Application for the Licensed Product in the Territory. The Supply Agreements
shall contain forecast procedures, permitted variances from forecasted amounts,
order and delivery times, quality control and quality assurance procedures,
audits, yield ratios, maintenance of inventory, procedures and remedies for
rejection of non-conforming product, record retention, compliance with laws, and
other customary provisions. The terms of the Supply Agreements shall be
consistent with the provisions of this Clause 5, unless otherwise agreed in
writing by CIMAB, CIMYM and Kuhnil. Kuhnil will purchase supplies for clinical
trials post registration at the lower of $1,000 or manufacturing
cost.
6 Grant
of Rights
6.1 Licensed Intellectual
Property
6.1.1 CIMYM
hereby grants to Kuhnil,
subject to the provisions of this Agreement:
(a) an
exclusive sub-license in the Kuhnil Field and Territory under
the Licensed Patent Rights with the right to sub-license, to develop, use and
sell Licensed Product but only in the Kuhnil Field and Territory;
and
(b) an
exclusive sub-license in the Kuhnil Field and Territory to use
the Licensed Know-how, with the right to sub-license, to develop, use and sell
Licensed Product but only in the Kuhnil Field and Territory;
and
6.2 Arising Intellectual
Property
6.2.1 Arising
Intellectual Property shall be owned by the Party (which for the purposes of
this Clause may include CIM) that invents or creates it, and if it is jointly
invented or created by two or more of the Parties it shall be owned jointly by
those Parties in equal, undivided shares, subject to the provisions of this
Agreement including the following provisions:
(a) It is
anticipated that Arising Know-how will be generated by clinicians and other
Persons in the course of, or arising from, clinical studies that have been
designed by the Joint Development Team. Accordingly, it is agreed that all
Arising Know-how developed in, or arising from, the work performed under the
Development and Commercialisation Plan shall be jointly owned by CIM, CIMYM, and
Kuhnil in equal, undivided shares, subject to the provisions of this Agreement;
and
(b)
Subject to paragraphs (a) above, where Arising Intellectual Property consists of
an improvement to, or a new application of, Licensed Intellectual Property and,
as a matter of law, is developed or created solely by employees of Kuhnil, it
shall be owned solely by Kuhnil, and Kuhnil employees shall be named as
inventors, subject to the provisions of this Agreement.
6.2.2 CIMAB
hereby grants and agrees to grant to Kuhnil an exclusive, fully paid-up and
royalty-free, license under Arising Intellectual Property in the Kuhnil Field
and Territory, with the right to sub-license, to research, develop, make, have
made, import, use, sell and otherwise deal in any and all products and processes
in the Kuhnil Field and Territory.
6.2.3 Kuhnil
hereby grants and agrees to grant to each of CIMYM and CIMAB an exclusive, fully
paid-up and royalty-free, license under Arising Intellectual Property in the
CIMYM Field and Territory, with the right to sub-license, to research, develop,
make, have made, import, use, sell and otherwise deal in any and all products
and processes in the CIMYM Field and Territory.
6.3 Formal Licenses. If requested
by any of the Parties and at the requesting Party's administrative cost, the
Parties shall execute such formal licenses as may be necessary or appropriate
for registration with Patent Offices and other relevant authorities in the
Territory. In the event of any conflict in meaning between any such license and
the provisions of this Agreement, the provisions of this Agreement shall
prevail. The Parties shall use reasonable endeavours to ensure that, to the
extent permitted by relevant authorities, this Agreement shall not form part of
any public record.
6.4 Reservation of Rights within Field
and Territory. For the avoidance of doubt, CIMYM reserves the right for
itself and its licensees and assigns to use TheraCIM h-R3 and the Licensed
Intellectual Property in the Kuhnil Field and Territory with the prior consent
of Kuhnil (a) for the purposes of research; and/or (b) for the purposes of
development (including clinical trials) of products with a view to obtaining
regulatory approval for such products in the CIMYM Field and Territory. If CIMYM
wishes to conduct research or development activities in the Kuhnil Field and
Territory in accordance with the provisions of this Clause, it will so inform
Kuhnil and give Kuhnil a first opportunity to propose terms for an agreement
with CIMYM under which Kuhnil would assist CIMYM with such activities at the
cost of CIMYM.
6.5 No Other License. It is
acknowledged and agreed that no license is granted by CIMYM to Kuhnil other than the
sub-license(s) expressly granted by the provisions of this Clause 6. Without
prejudice to the generality of the foregoing, CIMYM reserves all rights under
the Licensed Intellectual Property in the CIMYM Field and
Territory.
6.6 Quality. Kuhnil shall ensure that all
Licensed Product marketed by it is of satisfactory quality and complies with all
applicable laws and regulations in each part of the Territory.
6.7 Acknowledgment by CIMAB.
CIMAB acknowledges and agrees that CIMYM has been granted the necessary rights
and licenses to enable it to grant the licenses and sub-licenses referred to in
Clause 6.1 of this Agreement.
7 Payments
7.1 Kuhnil shall pay to CIMYM a
non-refundable, non-creditable license fee of $400,000US, within 16 days of the
Commencement Date.
7.2 Kuhnil will pay to CIMYM the
following non-refundable, non-creditable milestone payments, within 30 days from
the date of occurrence of each of the following Events:
EVENT
|
PAYMENT
|
|||
Regulatory
Approval as a treatment for Glioma
|
$ | 100,000 | ||
Regulatory
Approval as a treatment for Head and Neck Cancer
|
$ | 200,000 | ||
Regulatory
Approval as a treatment for Non-small Cell Lung Cancer
|
$ | 200,000 | ||
Regulatory
Approval as a treatment for Pancreatic Cancer
|
$ | 200,000 |
If CIMYM
chooses to develop TheraCIM for additional indications that have not been
included above, upfront and milestone payment terms will be negotiated with
Kuhnil at an appropriate
time and if agreement is reached between the Parties, will be incorporated into
an amendment to this Agreement.
7.3 Royalties. In addition to the
total amount of payments made by Kuhnil to ClMYM under Clauses 7.1 and 7.2,
Kuhnil shall pay to CIMYM a royalty of 40% (forty per cent) of Gross Sales Value
of Licensed Product inclusive of cost of goods sold (COGS). In the event that
during the Term, a first generic entry of the Licensed Product becomes available
in the Territory from a competitive supplier, CIMYM will reduce the royalty on
cumulative Gross Sales Value of Licensed Product to 40% of the entry price of
the first generic version of nimotuzumab to enter the Korean
market.
7.4 Payment Dates. Royalties due
under this Agreement shall be paid within 90 days of the end of each Calendar
Quarter, in respect of sales of Licensed Product made during such Calendar
Quarter, and final royalties shall be paid within 30 days of the final sale of
the Licensed Product but in any event no later than 7 months following
termination of this Agreement for any reason.
7.5 Payment Terms. All sums due
under this Agreement:
(a) are
exclusive of Value Added Tax which where applicable will be paid by Kuhnil to
CIMYM in addition;
(b) shall
be paid in Euros (or such other currency as the Parties may agree in writing)
and, in the case of sales or sub-license income received by Kuhnil in a currency
other than Euros, the income shall be calculated in the other currency and then
converted into equivalent Euros at the purchasing rate for Euros as quoted by
the Korea Exchange Bank in Korea as at the close of business on the last
business day of the quarterly period with respect to which the payment is
made;
(c) shall
be made with a 5% deduction of income tax and other taxes charges or duties that
may be imposed, except insofar as Kuhnil is required to deduct the same to
comply with applicable laws. The Parties shall cooperate and take all steps
reasonably and law fully available to them to avoid deducting such taxes and to
obtain double taxation relief. If Kuhnil is required to make any such deduction
it shall provide CIMYM with such certificates or other documents as it can
reasonably obtain to enable CIMYM to obtain appropriate relief from double
taxation of the payment in question; and
(d) shall
be made by the due date, failing which CIMYM may charge interest on any
outstanding amount on a daily basis at a rate equivalent to 3% above the US
prime lending rate then in force.
7.6 Exchange Controls, etc. If at
any time during the continuation of this Agreement Kuhnil is prohibited from making
any of the payments required hereunder by a governmental authority in any
country then Kuhnil will
within the prescribed period for making the said payments in the appropriate
manner use its best endeavours to secure from the proper authority in the
relevant country permission to make the said payments and will make them within
7 days of receiving such permission. If such permission is not received within
30 days of Kuhnil making a
request for such permission then, at the option of CIMYM, Kuhnil shall deposit the royalty
payments due in the currency of the relevant country either in a bank account
designated by CIMYM within such country or such royalty payments shall be made
to an associated company of CIMYM designated by CIMYM and having offices in the
relevant country designated by CIMYM.
7.7 Royalty Statements. Kuhnil
shall send to CIMYM at the same time as each royalty payment is made in
accordance with Clause 7.3 a statement setting out, in respect of each country
in the Territory in which Licensed Product is sold, the types of Licensed
Product sold, the quantity of each type sold, and the total Gross Sales Value in
respect of each type, expressed both in local currency and Euros and showing the
conversion rates used during the period to which the royalty payment
relates.
7.8 Records
7.8.1 Kuhnil
shall keep at its normal place of business detailed and up to date records and
accounts showing the quantity, description and Gross Sales Value of Licensed
Product, all the documents corresponding to the deductions from Gross Sales
Value and the amount of Milestone Receipts received by it in respect of Licensed
Product, on a country-by-country basis, and being sufficient to ascertain the
payments due under this Agreement.
7.8.2 Kuhnil shall make such records
and accounts available, on reasonable notice, for inspection during business
hours by an independent chartered accountant nominated by CIMYM for the purpose
of verifying the accuracy of any statement or report given by Kuhnil to CIMYM under this
Agreement. The accountant shall be required to keep confidential all information
learned during any such inspection, and to disclose to CIMYM only such details
as may be necessary to report on the accuracy of Kuhnil's statement or report.
CIMYM shall be responsible for the accountant's charges unless the accountant
certifies that there is an inaccuracy of more than 5% (five percent) in any
royalty statement, in which case Kuhnil shall pay his charges in
respect of that inspection. If the inspection shows that Kuhnil owes a payment to CIMYM
under this Agreement, Kuhnil shall promptly make such
payment.
7.8.3 Kuhnil shall ensure that CIMYM
has the same rights as those set out in this Clause 7.8 in respect of any
Affiliate of Kuhnil that is
sub-licensed under Licensed Intellectual Property pursuant to this
Agreement.
8 Diligence
8.1 Kuhnil shall use Diligent and
Reasonable Efforts to develop and commercially exploit Licensed Product to the
maximum extent throughout the Territory. Without limiting Kuhnil's obligations under the
previous sentence of this Clause 8.1, Kuhnil shall develop and
commercially exploit Licensed Product in accordance with the Development and
Commercialisation Plan.
9 Intellectual
Property
9.1 Obtain and Maintain the Licensed
Patent Rights
9.1.1 CIMYM
shall, at its cost and expense:
(a)
diligently seek to obtain valid patents in the name of CIM pursuant to each of
the Licensed Patent Rights listed in the attached Schedule 1; and
(b) pay
all prosecution, maintenance, and renewal fees in respect of the Licensed Patent
Rights as and when due;
provided
that if CIMYM elects to abandon any such application or not to maintain any such
Licensed Patent (or to cease funding such application or patent) within Kuhnil’s Field and Territory it shall
give 3 months' prior written notice to Kuhnil and on the expiry of such notice
period CIMYM shall return all rights, title, and interest in such patent or
patent application in question to CIM and neither Kuhnil nor CIMYM shall have
any continuing rights under such Licensed Patents.
9.2 Obtain and Maintain the Arising
Patents
9.2.1 The
Parties shall consult with one another in relation to the filing and maintenance
of any Arising Patents in respect of any inventions ("Arising Inventions").
CIMYM shall, or shall ensure that its Affiliates or sub-licensees shall, at its
own cost and expense:
(a)
Diligently seek to obtain valid patents (in the name of the relevant Parties as
specified in Clause 6.2.1) in countries agreed upon by CIM and CIMYM for any
Arising Inventions; and
(b) pay
all prosecution, maintenance, and renewal fees in respect of the Arising Patents
as and when due,
provided
that if CIMYM, its Affiliates or sub-licensees wish to abandon or not maintain
any such application or not to maintain any such Arising Patent (or to cease
funding such application or patent) in the Kuhnil Field and Territory, it
shall give 3 months' prior written notice to Kuhnil and on the expiry of such
notice period CIMYM shall cause the patent or patent application in question to
be assigned to Kuhnil and
CIMYM shall have no continuing rights under such Arising Patents in the Kuhnil Field and
Territory.
9.2.2 Pursuant
to paragraph 6.2.1(b), in the case where Kuhnil is the sole inventor of Arising
Intellectual Property, Kuhnil agrees to cooperate with CIMYM and promptly
execute all documents including assignment documents, required to protect such
Arising Intellectual Property as deemed necessary by ClMYM.
9.3 Infringement of Third Party
Rights
9.3.1 Each
Party shall inform the other Party promptly if it becomes aware of any
infringement or potential infringement of any of the Patents in the Kuhnil Field
and Territory, and in such case, CIMYM shall have the right, but not the
obligation, to decide the best way to respond to such infringement.
9.3.2 Kuhnil shall be responsible, at
its discretion, for taking action against infringers of the Arising Patents in
the Kuhnil Field and
Territory at its sole expense, and it shall be entitled to retain any damages or
other payments or benefits obtained by such action in the Kuhnil Field and Territory, after
reimbursing CIMYM and CIMAB for any reasonable out-of-pocket expenses incurred
in assisting it in such action. If Kuhnil declines to take action,
then CIMYM shall be entitled to take action against the Third Party infringer at
CIMYM's sole expense and CIMYM shall be entitled to all damages or other sums
received from such action, after reimbursing Kuhnil for any reasonable
out-of-pocket expenses incurred in assisting it in such action. If the alleged
infringement is both within and outside the Kuhnil Field and Territory, the
Parties shall also co-operate with CIMYM's and CIMAB's other licensees (if any)
in relation to any such action and shall divide the costs of such action
proportionately among Kuhnil and CIMYM's and CIMAB's
other licensees who participate in such action. The apportionment of costs
between licensees shall be decided by CIMYM, acting reasonably.
9.4 Infringement of Third Party
Rights
9.4.1 If
any warning letter or other notice of infringement is received by a Party, or
legal suit or other action is brought against a Party, alleging infringement of
Third Party rights in the manufacture, use or sale of the Licensed Product or
use of any Patents, that Party shall promptly provide full details to the other
Party, and the Parties shall discuss the best way to respond.
9.4.2 CIMYM
shall have the right but not the obligation to defend such suit and shall have
the right to settle with such Third Party, provided that if any action or
proposed settlement involves the making of any statement, express or implied,
concerning the validity of any Arising Patent, the consent of Kuhnil must be obtained before
taking such action or making such settlement such consent not to be unreasonably
withheld or delayed.
9.5 Third Party Intellectual
Property. For the avoidance of doubt Kuhnil shall be solely
responsible for obtaining and paying for any additional licenses and other
rights that may be required to enable Kuhnil or its Affiliates to
commercialise Licensed Product in the Territory. If the sale of the Licensed
Product is found to infringe the intellectual property rights of a Third Party,
and results in the payment of royalties or other compensation by Kuhnil (or its Affiliates) to a
Third Party including legal fees, Kuhnil may reduce us royalty
payments to CIMYM under Clause 7.3 by 50% (fifty percent) of the royalties or
other compensation paid to the Third Party in respect of sales of Licensed
Product in the Territory, subject to the following conditions:
(a) The
royalty due from Kuhnil to
CIMYM on the sale of the Licensed Product shall not be reduced below 38%;
and
(b) Such
reductions shall only be made where the Third Party liability arises from the
use of the inventions claimed in the Licensed Patents and shall not be made in
respect of any other inventions, improvements or other features that Kuhnil chooses to incorporate
into the Licensed Product.
9.6 Product
Names. Kuhnil shall be responsible for deciding, in
consultation with CIMYM, the trade xxxx to be applied to the Licensed Product in
the Kuhnil Field and Territory. Kuhnil will be responsible for
applying for any such trade xxxx in the Territory, at its sale cost. CIMYM
acknowledges that it has no objection to the trade xxxx "TheraCIM". CIMYM will
be responsible for applying for an international, non-proprietary name ("INN")
for the Licensed Product at its sale cost. Kuhnil acknowledges that it has
no objection to the INN "NIMOTUZUMAB".
10 Representations,
Warranties and Liability
10.1 Representations and Warranties by
CIMYM. CIMYM represents and warrants that:
(a) it
has all requisite corporate power and authority to enter into and perform its
obligations pursuant to this Agreement and to grant the sub-licenses herein
granted;
(b) it
has not done, and will not do nor agree to do during the continuation of this
Agreement, any of the following things if to do so would be inconsistent with
the exercise by Kuhnil of the rights granted to it under this Agreement,
namely:
(i)
grant or agree to grant any rights in the Licensed Patent Rights in the
Kuhnil Field and Territory;
or
(ii)
assign, mortgage, charge or otherwise transfer any of the Licensed Patent Rights
in the Kuhnil Field and
Territory;
(c) it
is not aware (but without having carried out any searches or investigations)
that any Third Party (other than CIMYM's licensor(s)) owns or claims any rights
in the Licensed Patent Rights;
(d)
it is a corporation incorporated and validly existing under the laws of
its jurisdiction of incorporation; and
(e)
the execution, delivery and performance of this Agreement by it have been
duly and validly authorized by all necessary corporate action on its part and
this Agreement is a legal, valid and binding obligation enforceable against it
in accordance with its terms, except as enforceability may be subject to
bankruptcy, insolvency and other laws affecting the rights of creditors
generally and except that equitable remedies may be granted only in the
discretion of a court of competent jurisdiction.
10.2 Representations and Warranties by
Kuhnil. Kuhnil represents, warrants and
undertakes:
(a)
that it has, and will continue to have, sufficient financial and
other resources to fulfil its obligations under this Agreement;
(b)
that it has obtained all necessary authorisations from its supervisory
board and investors to use such resources and fulfil such
obligations;
(c) it
has all requisite corporate power and authority to enter into and perform its
obligations pursuant to this Agreement; and to grant the sub-licenses herein
granted;
(d) it
is a corporation incorporated and validly existing under the laws of its
jurisdiction of incorporation; and
(e)
the execution, delivery and performance of this Agreement by it have been
duly and validly authorized by all necessary corporate action on its part and
this Agreement is a legal, valid and binding obligation enforceable against it
in accordance with its terms, except as enforceability may be subject to
bankruptcy, insolvency and other laws affecting the rights of creditors
generally and except that equitable remedies may be granted only in the
discretion of a court of competent jurisdiction.
10.3 No Other
Warranties
10.3.1 Each
of Kuhnil and CIMYM
acknowledges that, in entering into this Agreement, it does not do so in
reliance on any representation, warranty or other provision except as expressly
provided in this Agreement, and any conditions, warranties or other terms
implied by statute or common law arc excluded from this Agreement to the fullest
extent permitted by law.
10.3.2 Without
limiting the scope of Clause 10.3.1, CIMYM does not give any warranty,
representation or undertaking:
(a)
as to the efficacy or usefulness of any of the Licensed Intellectual
Property; or
(b)
that any of the Licensed Patent Rights is or will be valid or subsisting
or (in the case of an application) will proceed to grant; or
(c)
that the use of any of the Licensed Intellectual Property, the
manufacture, sale or use of the Licensed Product or the exercise of any of the
rights granted under this Agreement will not infringe any other intellectual
property or other rights of any other person; or
(d)
that the Licensed Know-how or any other information or materials
communicated or provided by CIMYM to Kuhnil under or in connection
with this Agreement will produce Licensed Product of satisfactory quality or fit
for the purpose for which Kuhnil intended; or
(e)
as imposing any obligation on CIMYM to bring or prosecute actions or
proceedings against third parties for infringement or to defend any action or
proceedings for revocation of any of the Licensed Patent Rights; or
(f)
as imposing any liability on CIMYM in the event that any Third Party supplies
Licensed Product to customers located in the Territory.
10.4
Indemnity and
Insurance. Kuhnil
shall indemnify and hold harmless CIMYM, CIM and (except as otherwise provided
in any Supply Agreement) CIMAB and their respective Affiliates and their
respective officers, directors, employees, consultants, agents and
representatives (the "Indemnitees") against all Third Party Claims which may be
asserted against or suffered by any of the Indemnitees and which relate
to:
(a) the
use of any Delivered Items; or
(b)
the manufacture, distribution, sale, supply or use of the Licensed Product
or any other products or services which incorporate any Delivered
Items,
by or on
behalf of Kuhnil or its
Affiliates, or subsequently by any Third Party under license from Kuhnil, including without
limitation Claims based on product liability laws. For the duration of this
Agreement, Kuhnil shall
maintain clinical trials and product liability insurance with a reputable
insurer in an amount not less than the minimum amount required by law or best
industry practice in each country of the Territory (or, in any country, if no
such law or practice exists in that country, in an amount of at least
$10,000,000) per Claim or series of Claims).
10.5 Limitation of Liability.
Subject to Clause 10.4, but notwithstanding any other provision of this
Agreement, no Party shall be liable to any other Party to this Agreement in
contract, tort, negligence, breach of statutory duty or otherwise for Claims of
any nature whatsoever incurred or suffered by that other party or its Affiliates
of an indirect or consequential nature including without limitation any economic
loss or other loss of turnover, profits, business or goodwill.
11 Duration
and Termination
11.1 Commencement and Termination by
Expiry. This Agreement, and the rights granted hereunder, shall come into
effect on the Commencement Date and, unless terminated earlier in accordance
with this Clause 11, shall continue in force in each country in the Territory
until the latest of the fifteenth anniversary of the date of the first
commercial sale of Licensed Product in such country in the Territory by Kuhnil or its Affiliates; and on
such date this Agreement and the rights granted hereunder shall terminate
automatically by expiry.
11.2 Early
Termination
11.2.1 KUHNIL
may terminate this Agreement at any time on 180 days’ notice in
writing to CIMYM.
11.2.2 Without
prejudice to any other right or remedy, either of CIMYM or Kuhnil may terminate this
Agreement at any time by notice in writing to the other of them ("Other Party"),
such notice to take effect as specified in the notice:
(a)
if the Other Party (which in the case of KUHNIL shall include any
Affiliate of Kuhnil) is in
material breach of this Agreement and. in the case of a breach capable of remedy
within 30 days, the breach is not remedied within 30 days of the Other Party
receiving notice specifying the breach and requiring its remedy; or
(b)
if the Other Party (which in the case of Kuhnil shall include any
Affiliate of Kuhnil)
becomes insolvent, or if an order is made or a resolution is passed for the
winding up of the Other Party (other than voluntarily for the purpose of solvent
amalgamation or reconstruction), or if an administrator, administrative receiver
or receiver is appointed in respect of the whole or any part of the Other
Party's assets or business, or if the Other Party makes any composition or
proposal with its creditors or takes or suffers any similar or analogous action
in consequence of debt; or
(c)
if the first Phase II clinical trial for the Licensed Product within the
Field in the Territory has not commenced within a period of one and a half years
after the Commencement Date; or
(d)
if the first Regulatory Approval for marketing the Licensed Product within
the Field in the Territory is not obtained within a period of three years after
the Commencement Date.
11.2.3 CIMYM
may forthwith terminate this Agreement by giving written notice to Kuhnil if KUHNIL or any of its
Affiliates commences legal proceedings, or assists any Third Party to commence
legal proceedings, to challenge the validity of any of the Patents.
11.2.4 The
Parties acknowledge and agree that Kuhnil's remedy for any breach by
CIMAB of its obligations under Clause 5 shall be as set out in any Supply
Agreement that CIMYM and Kuhnil may execute pursuant to
Clause 5.4. Accordingly, breach of Clause 5 shall not entitle any Party to
terminate this Agreement.
11.3 Consequence of
Termination
11.3.1 Upon
termination or expiration of this Agreement for any reason:
(a) If
termination occurs otherwise than in accordance with Clause 11.1 and after the
first commercial sale of Licensed Product, Kuhnil shall be entitled to sell, use
or otherwise dispose of (subject to payment of royalties under Clause 7.3) any
unsold or unused stocks of the Licensed Product for a period of 6 months
following the date of termination following which it must destroy all such
Licensed Product; and if termination occurs prior to the first commercial sale
of Licensed Product, Kuhnil shall forthwith return all such stocks of Licensed
Product and Licensed Know-how to CIMYM free of charge;
(b)
subject to paragraph (a) above, Kuhnil shall no longer be
sub-licensed to use or otherwise exploit in any way, either directly or
indirectly, any of the Licensed Intellectual Property;
(c)
subject to paragraph (a) above, Kuhnil shall consent to the
cancellation of any formal sub-license granted to it, or of any registration of
it in any register, in relation to any of the Licensed Patent
Rights;
(d)
the provisions of Clause 4, except Clause 4.1 and 4.2 shall survive
termination and continue in force without limit of time. For clarification,
Kuhnil and its Affiliates
shall have no further right to use Licensed Know-how following termination or
expiration of this Agreement;
(e)
the provisions of Clauses 6.2.3, 7, 10.3, 10.4 and 12, as well as those
Clauses which by their nature are intended to survive the termination or expiry
of this Agreement shall survive the termination or expiration of this Agreement;
and
(f)
any and all rights and obligations accrued under this Agreement prior to
termination or expiration shall survive. Notwithstanding the foregoing, neither
Party shall be under any further obligation to the other and CIM and CIMYM shall
have the right to issue licenses under the License Patent Rights to any Third
Party within Kuhnil 's
Field and Territory.
11.3.2 Upon
termination of this Agreement for any reason otherwise than in accordance with
Clause 11.1 and at CIMYM's request, Kuhnil shall at its sole cost and
expense:
(a)
transfer to CIMYM all clinical and other data relating to the development
of Licensed Product;
(b)
to the extent possible, seek to have any Regulatory Approvals (including
without limitation product licenses and pricing approvals) and other permits and
applications transferred into the name of CIMYM or its nominee;
(c)
grant CIMYM an exclusive, perpetual, fully paid up, royalty free,
worldwide license, with the rights to grant sub-licenses. under all Arising
Intellectual Property and any improvements and other intellectual property owned
or controlled by Kuhnil relating to Licensed Product and Arising Intellectual
Property; and
(d) grant
CIMYM or its nominee the right to continue to use any product name that had been
applied to the Licensed Product prior to termination of this
Agreement.
12 General
12.1 Force Majeure. None of the
Parties shall be liable for any loss, injury, delay, damage or other casualty
suffered or incurred by any other Party due to strikes, lockouts, labour
disputes, riots, storms, fires, explosions, acts of God, war or any other causes
that are beyond the reasonable control of that Party (each, a "Force Majeure
Event"), and failure or delay by a Party in performance of any of its
obligations under the Agreement due to one or more Force Majeure Events shall
not be considered a breach of this Agreement.
The Party
whose performance is affected by a Force Majeure Event shall make reasonable
efforts to remedy the situation and remove, so far as possible, and with
reasonable dispatch, the cause of its inability to perform or comply, provided
however, that settlement of labour disputes, strikes, and lockouts shall be
wholly within the discretion of the Party involved.
If a
Force Majeure Event exists for more than ten (10) consecutive days, the Parties
shall meet to negotiate a mutually satisfactory solution to the problem. Nothing
herein shall relieve the Parties of their obligations to make payments when due
hereunder.
12.2 Language and Amendment. This
Agreement is made in the English language and may only be amended in the English
language in writing signed by duly authorised representatives of the Parties. In
the event of any conflict in meaning between the English language version and
any translation of this Agreement, the English language version shall
prevail.
12.3 Assignment and Third Party
Rights
12.3.1 Subject
to Clause 12.3.2 below, no Party shall assign, mortgage, charge or otherwise
transfer any rights or obligations under this Agreement, nor any of the Patents
or rights under the Patents, without the prior written consent of the other
Parties.
12.3.2 With
the prior written consent of the other Parties, a Party may assign all its
rights and obligations under this Agreement together with its rights in the
Patents to any company to which it transfers all or substantially all of its
assets or business in the Field, provided that the assignee undertakes to the
other Party to be bound by and perform the obligations of the assignor under
this Agreement.
12.4 Waiver. No failure or delay
on the part of either Party to exercise any right or remedy under this Agreement
shall be construed or operate as a waiver thereof, nor shall any single or
partial exercise of any right or remedy preclude the further exercise of such
right or remedy.
12.5 Invalid Clauses. lf any of
the within terms, conditions or provisions or the application thereof to any
Person or circumstance shall at any time or to any extent, be invalid or
unenforceable at law such term, condition, or provisions shall be severed from
the remainder hereof which shall be affected thereby, and each and every time
and in each and every circumstance in which reference is made hereto each term,
covenant, condition and provision hereof shall be valid and be enforced to the
fullest extent permitted by law.
12.6 No Agency. Neither Party
shall act or describe itself as the agent of the other, nor shall it make or
represent that it has authority to make any commitments on the other's
behalf.
12.7 Interpretation. In this
Agreement:
(a)
the headings are used for convenience only and shall not affect its
interpretation;
(b)
references to persons shall include incorporated and unincorporated
persons; references to the singular include the plural and vice versa; and
references to the masculine include the feminine;
(c)
references to Clauses and Schedules mean clauses of, and schedules to,
this Agreement;
(d)
references to any Party shall include their permitted successors and
permitted assignees;
(e)
references to any license shall mean, where the context requires, a
sub-license;
(f)
where the word "including" is used, it shall be understood as meaning
"including without limitation"; and
(g)
references to the grant of "exclusive" rights shall mean that the person
granting the rights shall neither grant the same rights (in the same Field and
Territory and in respect of the same Licensed Product) to any other person, nor
exercise those rights directly to the extent that and for as long as the
Licensed Product is within Valid Claims of unexpired Licensed Patent Rights or,
to the extent that the Licensed Product is protected by Licensed Know-how that
have not become known and available to the public.
12.8 Notices
12.8.1 Any
notice to be given under this Agreement shall be in writing and shall be sent by
first class mail, air mail or by courier, or by fax (confirmed by first class
mail or air mail) to the address of the relevant Party set out at the head of
this Agreement, or to the relevant fax number set out below, or such other
address or fax number as that Party may from time to time notify to the other
Party in accordance with this Clause 12.8. The fax numbers of the Parties are as
follows:
Party
|
Fax
number
|
CIMYM
|
000
000 000 0000
|
CIMAB
|
0053
7 33 3509
|
Kuhnil
|
00-0-000-0000
|
12.8.2 Notices
sent as above shall be deemed to have been received three working days after the
day of posting (in the case of inland first class mail or national courier), or
seven working days after the date of posting (in the case of air mail or
international courier), or on the next working day after transmission (in the
case of fax messages, but only if a transmission report is generated by the
sender's fax machine recording a message from the recipient's fax machine,
confirming that the fax was sent to the number indicated above and confirming
that all pages were successfully transmitted).
12.9 Law, Dispute Resolution. The
validity, construction and performance of this Agreement shall be governed by
English law. Any dispute arising out of or in connection with this Agreement
shall first be referred to the Joint Development Team for resolution. If the
Joint Development Team is unable or unwilling to resolve such dispute within 30
days of the dispute being referred to it, the dispute shall be referred to the
Chief Executive Officers of the Parties in dispute for resolution. If the Chief
Executive Officers of the Parties in dispute are unable or unwilling to resolve
such dispute within 28 days of the dispute being referred to them, either
Development Team Party may refer the dispute to mediation in accordance with the
Model Mediation Procedure of the Centre for Effective Dispute Resolution
("CEDR") in London. Unless otherwise agreed by the Development Team Parties, the
mediator will be nominated by CEDR. To initiate the mediation procedure, a
Development Team Party must give notice in writing (“ADR Notice”) to the other
parties to the dispute, requesting mediation. A copy of the request should also
be sent to CEDR. The mediation will start not later than 28 days after the date
of the ADR Notice. If the Parties are unable to resolve the dispute through
mediation, or none of the Parties refers the dispute to mediation, the dispute
shall be referred to and finally resolved by arbitration by a single arbitrator
in London under the Rules of the London Court of International Arbitration (the
"Rules"), which Rules are deemed to be incorporated by reference into this
Clause. The language to be used in the arbitral proceedings shall be English and
the place of arbitration shall be London, UK. The arbitrator shall be chosen by
the Parties or, failing agreement as to the choice of arbitrator within 28 days
of one Party requesting that an arbitrator by chosen, appointed in accordance
with the Rules. However, nothing in this Agreement shall prevent a Party from
seeking an interim injunction or other equitable remedy in any court of
competent jurisdiction.
12.10 Further Action. Each Party
agrees to execute, acknowledge and deliver such further instruments, and do all
further similar acts, as may be necessary or appropriate to carry out the
purposes and intent of this Agreement.
12.11 Announcements. Neither Party
shall make any press or other public announcement concerning any aspect of this
Agreement, or make any use of the name of the other Party in connection with or
in consequence of this Agreement, without the prior written consent of the other
Party, except as may be required by law or by the rules of any stock exchange on
which either Party is listed. The Parties shall agree a form of press release
for issue on signature of this Agreement.
12.12 Entire Agreement. This
Agreement, including its Schedules, sets out the entire agreement between the
Parties relating to its subject matter and supersedes all prior oral or written
agreements, arrangements or understandings between them relating to such subject
matter. The Parties acknowledge that they are not relying on any representation,
agreement, term or condition that is not set out in this Agreement. Nothing in
this Agreement excludes liability for fraud.
12.13 Third Party Rights. Each of
the persons identified as Indemnitees in Clause l0.4 may in his own right
enforce the provisions of those respective Clauses. Except as provided in the
previous sentence of this Clause, this Agreement is not made for the benefit of,
nor shall any of its provisions be enforceable by, any person other than the
parties to this Agreement and their respective successors and permitted
assignees.
12.14 Non-compete. KUHNIL and its
Affiliates warrants, represents, acknowledges and agrees, in respect of it and
its Affiliates, that:
(a) they
do not have any interest in any technology that competes with the Licensed
Intellectual Property, nor is any of them engaged in any research or development
activities with respect to any product that would compete with the Licensed
Products; and
(b) for
so long as this Agreement remains in force and for a period of two (2) year
thereafter, they will not enter into any agreement with any Person other than
CIMAB or CIMYM for the development or marketing of any product that is, or
contains, (i) any other anti-EGF-receptor inhibitor, (ii) any product or
component or sequence of EGF-R, EGF-R ligands, or any small molecule tyrosine
kinase inhibitor, or (iii) covered under the scope of any Licensed Patent Rights
or Licensed Know-how unless specifically authorized by CIMYM.
12.15 Agreed by the
Parties through their authorised signatories:
For and
on behalf of CIMYM,
Inc.
signed
|
signed
|
Xxxxx
G.P. Xxxxx
|
Xxxx
E.L. Xxxxxxxx
|
Chairman
and CEO
|
Director,
Corporation Development
|
date
9-Sept-05
|
date
9-Sept-05
|
For and
on behalf of CIMAB
S.A.
signed
|
signed
|
Xxxxxxxx
Xxxxxx
|
Xxxxxx
Xxxxxxx
|
President
|
General
Counsel
|
date
|
date
|
For and
on behalf of KUHNIL
PHARMACEUTICALS CO., LTD.
signed
|
signed
|
Y.O.
Xxx
|
Xxxxx
X. Xxx
|
Chairman
|
President,
CEO
|
date
|
date
|
Schedule
I
Licensed
Patent Rights
The
patents and patent applications listed in this Schedule are, or may become,
relevant to this Agreement, but they also contain other rights not licensed
under this Agreement. Thus their inclusion here is limited to the extent if any
that they would protect the exploitation of Licensed Product for use within the
Field and in the Territory.
PCT/CU2003/000012
Korean
Patent Number: 00-0000-000 6995
International
Filing Date: 22 October 2003 (22.10.2003)
Title:
|
METHOD
OF OBTAINING CELL LINES IN A PROTEIN- FREE MEDIUM AND CELL LINES THUS
OBTAINED
|
Applicant:
|
CENTRO
DE INMUNOLOGIA MOLECULAR
|
Schedule
2
Licensed
Know-how
All
documentation that has been submitted by YM BioSciences, Inc. to the Health
Protection and Food Branch of Health Canada in connection with an application
for an Investigational New Drug Submission for the Licensed Product in Canada,
together with clinical trial data generated by CIMAB.
All
additional and Know How generated by other licensees to the
product.
Schedule
3
Initial
Development and Commercialisation Plan
Part
A: Initial Development Program
The
development program will include:
1.
Participation in a multinational randomized study in Non-small Cell Lung Cancer
unfit patients stage II, IIIA and IIIB in combination with radiotherapy. It is
provisionally estimated that Kuhnil will contribute 40 of the 120
patients.
2. Kuhnil
will run a study in Head & Neck cancer in the local population. It is
provisionally estimated that the study will be a non-randomized study combining
radiation with TheraCIM in 40 patients.
3. New
indications to be determined.