and License Agreement Relating to Nimotuzumab (TheraCIM h-R3)
(I) CIMYM
Biosciences Inc.
(2) CIMAB
S.A.
and
(3)
Daiichi Pharmaceutical Co., Ltd.
Relating
to Nimotuzumab (TheraCIM h-R3)
This
Agreement dated the 25th day of July, 2006 is made among:
(1) CIMYM Biosciences Inc.
(company registration number 12142) ("CIMYM"), a company
amalgamated
under the laws of Ontario, whose principal place of business is at 0000 Xxxxxxx
Xxxxx,
Xxxxxxxx 00, 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/19 y 00, Xxxxxx,
Xxxxx, Xxxxxx
Xxxx, Xxxx; and
(3) Daiichi Pharmaceutical Co.,
Ltd. (company registration number 0199-10-034855) ("DAIICHI") a company
incorporated in Japan, whose principal place of business is at 14-10, Xxxxxxxxxx
0-Xxxxx, Xxxx-xx, Xxxxx, 000-0000, Xxxxx.
Recitals:
A. CIMYM
has been granted by CIMAB the exclusive license, with the right to sub-license,
of certain
Licensed Patent Rights (as defined below) and certain Licensed Know-how (as
defined below)
and other rights relating to research, development, marketing and selling the
Product (as defined
below) in several territories including Japan.
B. CIMAB
is one of the shareholders of CIMYM and is entering into this Agreement
principally in order to
assume the manufacturing and supply obligations set out in Clause 8 and to
provide Product
data generated by CIMAB's licensees set out in Clause 4.4.
C.
DAIICHI is a fully integrated pharmaceutical company that wishes to evaluate the
further development
and commercialisation of the Product for the treatment of cancer in humans in
the Territory
(as defined below) and in accordance with the provisions of this
Agreement.
D.
DAIICHI expressed its desire to obtain a license to develop and commercialize
the Product in the Territory.
E. CIMYM
is willing to grant to DAIICHI, and DAIICHI is willing to accept, a license
within the DAIICHI Field and Territory (as defined below), under certain terms
and conditions and in accordance with the provisions of this
Agreement.
It
is agreed as follows:
1 Definitions
In this
Agreement, the following words shall have the following meanings:
Affiliate
|
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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Arising
Intellectual Property
|
Any
and all of the Arising Patents and the Arising
Know-how.
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Arising
Know-how
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Any
and all trade secrets, know-how and technical, scientific, commercial and
all other information generated by any Party or its Affiliates or
sub-licensees during the term of this Agreement that relates to any of the
Licensed Intellectual Property or the Product, 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 the Product. Arising Know-how includes any scientific or
regulatory data used for Regulatory
Applications and Regulatory Approvals (including clinical trial data
generated by any Party or its sub-licensees), and development and
marketing plans and activities.
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Arising
Patents
|
Any
and all patents and patent applications that may be applied for or
obtained in respect of any invention(s) made by any Party or its
Affiliates or sub-licensees during the term of this Agreement and which
relate to any Licensed Intellectual Property or the Product, together with
any continuations, continuations in part, extensions, reissues, divisions,
and any patents, supplementary protection certificates, conversion and
similar rights that are based on or derive priority from the
foregoing.
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CIMAB’s
Contract Manufacturer
|
Any
Person that may 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/CIMAB
Field
and
Territory
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(a) outside
the Territory, all fields (including the Field); and
(b) within
the Territory, all fields other than the Field.
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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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Competitive
Product
|
Any
product, which may compete with or is substantially similar to the
Licensed Product, which is comprised of:
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(a)
other anti-EGF-R antibodies, single chain, fragments and peptides derived
from antibody molecules; or
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(b)
any molecule that interacts through extracellular domain of EGF-R, except
for such molecule that interacts with intracellular or transmembrane
domain of EGF-R; or
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(c)
cancer vaccines which use any epitopes from EGF, TGF or Her
1.
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Confidential
Information
|
Know-how
and any other information owned or provided 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, manufacture,
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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DAIICHI
Field and Territory
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The
Field in the Territory.
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DAIICHI
Research and Development
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Has
the meaning given in Clause 4.2
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Diligent
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 normally 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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EGF-R
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Epidermal
growth factor receptor.
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Field
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The
treatment of cancer in humans.
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Force
Majeure Event
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Has
the meaning given in Clause 14.1.
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Generic
Drug
|
A
drug containing TheraCIM h-R3 and that is bioequivalent to the Licensed
Product with respect to pharmacokinetic and pharmacodynamic properties and
that is required to meet the same pharmacopoeial requirements as the
Licensed Product.
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Gross
Sales Value
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Any
and all amounts invoiced by DAIICHI from the sale of the Licensed Product
to a Third Party in an arm's length transaction (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 by DAIICHI to its
Affiliates or sub-licensees shall not be considered a sale for the
purposes of this definition unless there is no subsequent sale to a Person
other than DAIICHI and its Affiliates in an arm's length
transaction.
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Indication(s)
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Glioma
and other indications which shall be considered and selected by DAIICHI
for the Regulatory Applications in the Territory
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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 3.1
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Know-how
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The
licensed Know-how and 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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Any
and all trade secrets, know-how and technical, scientific, commercial and
all other information in the possession of CIMYM or CIMAB in the Field as
of the Commencement Date that relates to the Product and/or 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, packaging,
labelling, commercialisation, storage, use or sale of the Licensed Product
within the Field in the Territory.
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Licensed
Patent Rights
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Any
and all patents and patent applications applied for or obtained by CIMYM
or CIMAB in the Field and the Territory as of the Commencement Date
relating to any Licensed Intellectual Property or the Product, together
with any continuations, continuations in part, extensions, reissues,
divisions, and any patents, supplementary protection certificates,
conversion and similar rights that are based on or derive priority from
the foregoing, as described in the attached Schedule
1.
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Licensed
Product
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The
Product that is developed, commercialised or used by DAIICHI or its
Affiliate under any of the Licensed Know-how or the Licensed Patent
Rights.
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Net
Sales Value
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The
Gross Sales Value excluding (a) normal trade, cash and quantity discounts,
allowances and credits, actually allowed and taken (including credit given
for damaged, rejected or returned Licensed Product), (b) sales taxes, or
other taxes, excluding withholding tax, duties and levies of a similar
nature actually paid on the Licensed Product, (c) freight, postage,
shipping, insurance and other transportation charges; provided always the
total deductions pursuant to (a, b, and c) above shall not exceed 15% of
the Gross Sales Value.
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XXX
xxxxx
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Has
the meaning given in Clause 8.2(a).
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Parties
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CIMYM,
CIMAB and Daiichi, and “Party” shall mean any
of them.
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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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Person
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Includes
any individual, firm, company, corporation or other legal
entity.
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Product
|
Any
product containing the humanised antibody to the EGF receptor, known
scientifically as h-R3 and which has been given the INN "nimotuzumab" and
otherwise referred to as TheraCIM h-R3.
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QA
Agreement
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Any
agreement between CIMAB, CIMYM, DAIICHI and/or DAIICHI's Affiliates
relating to the quality assurance of the Licensed Product being supplied
to DAIICHI under this Agreement or a Supply Agreement.
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Re-examination
Period
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The
period of 6 years following the date of the first regulatory approval of a
pharmaceutical product in the Territory during which generic
competition is not allowed.
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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 or,
otherwise submitted by DAIICHI to a Regulatory Authority in the
Territory.
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Regulatory
Approval
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Any
and all approvals, licenses, registrations or authorisations of any
Regulatory Authority to DAIICHI that are necessary for the development,
manufacture, packaging, labelling, use, storage, import, transport,
marketing, distribution or sale of the Licensed Product in the
Territory.
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Regulatory
Authority
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The
equivalents of the Ministry of Health, Labour and Welfare
(Kosei-Rodo-Shos), the U.S. Food and Drug Administration and the
Therapeutic Products Directorate of Health Canada or any successor agency
thereto.
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Research
and Development Plan
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Has
the meaning given in Clause 4.1.
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Safety
Information Exchange Agreement
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The
agreement between the Parties stipulating necessary procedures and rules
for handling and exchanging safety information in order to fulfill
regulatory requirements appropriately at each Party and to take prompt
safety measures for the Product.
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Supply
Agreement
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Any
agreement between CIMAB, CIMYM, DAIICHI and/or DAIICHI’s Affiliates under
which CMIAB agrees to manufacture and supply CIMYM and/or DAIICHI’s
Affiliates with the Licensed Product.
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TTM
Rate (Telegraphic Transfer Middle Rate)
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Mean
value of the TTS (Telegraphic Transfer Selling Rate) and the TTB
(Telegraphic Transfer Buying Rate), which are rates of exchange of
Japanese Yen for US Dollars.
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Territory
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Japan.
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TheraCIM
h-R3
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A
hurnanised antibody to the EGF receptor. known scientifically as h-R3 and
which has been given the INN "nirnotuzumab''.
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Third
Party
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A
Person other than 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 Grant
of Rights
2.1 Licensed
Intellectual Property. CIMYM hereby grants to DAIICHI,
subject to the provisions of this Agreement:
(a) an
exclusive sub-license under the Licensed Intellectual Property to sell the
Licensed Product in the DAIICHI Field and Territory; and
(b) an
exclusive sub-license, with a right to sub-sub-license to DAIICHI's Affiliates,
to use the Licensed Intellectual Property to research, develop, import, package,
label and use the Licensed Product in the DAIICHI Field and Territory;
and
(c) the
right of DAIICHI to contract with any Third Party for the purpose of this
Agreement under the Licensed Intellectual Property to conduct research on and
develop the Licensed Product in the DAIICHI Field and
Territory.
2.2 Sale of Licensed
Product. For greater certainty, nothing in Clause 2.1
grants DAIICHI the right to sub-sub-license to its Affiliates the right to sell
the Licensed Product in the DAIICHI Field and Territory.
2.3 License
to Manufacture. Notwithstanding Clause 2.1(b), in the
case where the circumstances described in Clause 8.7 occur, CIMAB grants DAIICHI
a non-exclusive sub-license for the DAIICHI Field and Territory, to manufacture
by itself or to have manufactured by its Affiliates or a manufacturer nominated
by DAIICHI ("Third Party
Manufacturer"), the Licensed Product.
2.4
Arising
Intellectual Property.
(a) Subject
to Clause 13.3(b), the Arising Know-how generated and disclosed by a Party to
the other Parties pursuant to Clause 7.1 during the term of this Agreement shall
be owned solely by the generating Party.
(b) The
Arising Patents made by a Party during the term of this Agreement shall be owned
solely by such Party. The Arising Patents that claim an invention jointly
developed by the Parties shall be jointly owned by the Parties. The Parties
hereby agree that the identity of the inventor of all Arising Patents shall be
determined in accordance with Japanese patent law (or, if the jurisdiction in
which patent or other protection is being sought does not permit the application
of Japanese Patent law to identify the inventor, then in accordance with the
applicable law in that jurisdiction),
(c) CIMYM
and CIMAB hereby grants and agrees to grant to DAIICHI, with a right to
sub-license to DAIICHI’s Affiliates, a non-exclusive, fully paid-up and
royalty-free, license under the Arising Intellectual Property, for the duration
of this Agreement (and any extension thereto) within DAIICHI Field and Territory
to research, develop, make, have made, import, use and otherwise deal in any and
all Licensed Product.
(d) DAIICHI
hereby grants and agrees to grant to CIMYM/CIMAB, with a right to sub-license to
other Third Parties, a non-exclusive, fully paid-up and royalty-free, license
under the Arising Intellectual Property, for the duration of this Agreement (and
any extension thereto) within CIMYM/CIMAB Field and Territory to research,
develop, make, have made, import, use, sell and otherwise deal in any and all
Products.
(e)
Notwithstanding Clauses 2.4(a), (c) and (d), in the event that any of the
Parties desire to be granted an exclusive license to another Party's Arising
Intellectual Property to research, develop, make, have made, import, use, sell
and otherwise deal in any and all Products, the applicable Parties will
negotiate in good faith to reach the terms and conditions for such
license.
(f) If
DAIICHI develops an improvement of the Licensed Intellectual Property and an
Arising Patent claims such improvement, DAIICHI undertakes not to assert such
Arising Patent against CIMYM/ClMAB, its Affiliates, successors, assignees or
licensees for manufacturing, using or selling the Product that otherwise would
infringe such Arising Patent.
2.5 Applicable Patent
Law. The
determination of whether Arising Intellectual Property is conceived, discovered,
developed or otherwise made by a Party for the purpose of inventorship
(including patent or other intellectual property rights), shall, for purposes of
this Agreement, be made in accordance with Japanese patent law (or, if the
jurisdiction in which patent or other protection is being sought does not permit
the application of Japanese Patent law to identify the inventor, then ill
accordance with the applicable law in that jurisdiction).
2.6 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 Japan Patent Office 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.
2.7 Reservation of
Rights within Field and Territory. For the avoidance of
doubt, CIMYM reserves the right for itself and its sub-licensees and assigns to
use the Product and the Licensed Intellectual Property in the DAIICHI Field and
Territory with the prior written consent of DAIICHI (a) for the purposes of
research; and/or (b) for the purposes of development (including clinical trials)
of the Products with a view to filing Regulatory Applications and obtaining
Regulatory Approval for such Products in the CIMYM/CIMAB Field and Territory. If
CIMYM wishes to conduct research or development activities in the DAIICHI Field
and Territory in accordance with the provisions of this Clause 2.7, CIMYM will
so inform DAIICHI and give DAIICHI a first opportunity to propose terms for an
agreement with CIMYM under which
DAIICHI
would assist CIMYM with such activities at the cost of CIMYM.
2.8 No Other
License. It is acknowledged and agreed that no license is
granted by CIMYM to DAIICHI other than the sub-license(s) expressly granted by
the provisions of this Clause 2. Without prejudice to the generality of the
foregoing, CIMYM reserves all rights under the Licensed Intellectual Property in
the CIMYM/CIMAB Field and Territory.
2.9 Acknowledgement
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 this Clause 2.
3 Join
Development Team
3.1 Formation. Within thirty (30) days
after the Commencement Date, CIMYM, CIMAB and DAIICHI shall establish a joint
development team in order to exchange worldwide development plans and
information created by each Party and their sub-licensees regarding any and all
Products ("Joint Development
Team"), by each Party designating its initial members to serve on the
Joint Development Team and notifying each other Party of its dates of
availability for the first meeting of the Joint Development Team. The Joint
Development Team shall consist of not more than three (3) representatives
designated by each Party. Each representative shall have relevant and
appropriate expertise in order to exchange development plans and information
regarding the Products. If a representative of a Party is unable to attend a
meeting of the Joint Development Team, such Party may designate an alternate to
attend such meeting. In addition, each 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 Party may change one
or all of its representatives to the Joint Development Team at any time upon
notice to the other Party. DAIICHI shall have final decision-making authority
with respect to the Licensed Product in the DAIICHI Field and Territory. DAIICHI
may attend joint development meetings between CIMYM, CIMAB and other
sub-licensees, if approved in writing by CIMYM, CIMAB and by the other
sub-licensees.
3.2 Meetings. During
the term of this Agreement, unless otherwise agreed in writing among the
Parties, the Joint Development Team shall meet quarterly 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 ninety (90) 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.
3.3 Responsibilities. The
Joint Development Team shall have the responsibility to:
(a)
review and update the Research and Development Plan in accordance with Clause
4.1;
(b)
review the overall research and development strategy for the Licensed Product in
the DAIICHI Field and Territory (including, without limitation, setting criteria
for progression of the Licensed Product to the next stage of development under
the Research and Development Plan);
(c)
review the modifications to the Research and Development Plan;
(d)
facilitate the disclosure of Arising Intellectual Property and other information
between the Parties for purposes of conducting the Research and Development
Plan;
(e)
regularly assess the progress of Parties and other sub-licensees in the conduct
of the Research and Development Plan.
For the
avoidance of doubt the Joint Development Team shall not have any role or
responsibility in relation to determining whether DAIICHI, CIMYM or CIMAB has
complied with its obligations to the other Parties under this
Agreement.
3.4 Consultation.
(a) In
the event that CIMYM objects to the action relating to DAIICHI Research and
Development activities proposed to be taken by DAIICHI, on the basis that it
would prejudice CIMYM's, CIMAB's or any of their licensees or sub-licensees'
rights to the Product, then DAIICHI agrees to negotiate in good faith with CIMYM
to cease such activity or to pursue a different avenue which would not be
prejudicial to CIMYM, CIMAB or their licensees or sub-licensees.
(b) In
the event that DAIICHI objects to the action relating to research and
development activities proposed to be taken by CIMYM, CIMAB and/or their
licensees or sub-licensees, on the basis that it would prejudice DAIICHI's
rights to the Licensed Product in the DAIICHI Field and Territory, then CIMYM
and/or CIMAB agree to negotiate in good faith with DAIICHI to cease such
activity or to pursue a different
avenue
which would not be prejudicial to DAIICHI.
4 Research
and Development
4.1 Research and
Development Plan. Within sixty (60) days of the
Commencement Date, DAIICHI shall submit a non-binding written research and
development plan for the Licensed Product in the DAIICHI Field and Territory
("Research and Development
Plan") to the Joint Development Team, that expands upon the initial
development plan set out in Schedule
3 and that will describe and provide a timeline for:
(a) all
development activities for the Licensed Product in the DAIICHI Field and
Territory, addressing each phase of development and providing detailed
information on the activities to be conducted in the next 12-month
period;
(b)
clinical and registration strategy, with a view to expediting Regulatory
Approval; and
(c) sales
forecast of the Licensed Product for the five (5) year period after the first
commercial sale of the Licensed Product in the DAIICHI Field and
Territory.
The Joint
Development Team shall review the progress of the Research and Development Plan
at the meetings described in Clause 3.2 of this Agreement.
4.2 Research and
Development Activities. DAIICHI shall be responsible for
the research and development, including non-clinical and clinical studies ("DAIICHI Research and
Development") in accordance with the Research and Development Plan. Such
DAIICHI Research and Development shall be carried out under the oversight and
management of DAIICHI and in accordance with the provisions of this
Agreement.
4.3 Research and
Development Costs. DAIICHI shall bear all costs
associated with DAIICHI Research and Development, including costs incurred in
the preparation and execution of the Research and Development Plan. If C1MYM
and/or CIMAB agree with DAIICHI to conduct work at DAIICHI's request as part of
the Research and Development Plan (which may include advice given to the Joint
Development Team), payment of CIMYM and/or CIMAB’s costs of conducting such work
shall be discussed between the Parties in accordance with each Parties'
contribution on such work.
4.4 Exchange of
Information. It is CIMYM's intention to grant
sub-licensees of its rights to commercialise the Product in the CIMYM/CIMAB
Field and Territory, and to facilitate the expeditious DAIICHI Research and
Development of the Licensed Product in the DAIICHI Field and Territory.
Accordingly, each of the Parties, or CIMYM's and/or CIMAB's licensee(s) or
sub-licensee(s), may generate data in relation to the Product that is useful to
the other Parties in connection with their research or development of the
Product. To facilitate such research and development, each Party shall, after
appropriate confidentiality agreements are entered into and subject to
pre-existing agreements, disclose and provide from time to time to the other
Parties with information related to: (a) all Arising Intellectual Property, (b)
worldwide research and development plans for the Product carried out by each
Party and/or its licensee(s) or sub-licensee(s), (c) the summary and result of
research and development of the Product carried out by each Party and/or its
licensee(s) or sub-licensee(s), and (d) all notices and other correspondence
between the Parties, its Affiliates, its licensee(s) and/or its sub-licensee(s)
and any Regulatory Authority related to the Product. DAIICHI agrees not to use
information provided by CIMYM or CIMAB and their respective licensees for any
other purpose than the development and commercialization of the Licensed Product
under this Agreement.
4.5 Exchange of the
Safety Information. The Parties shall provide each other
with necessary information and data relating to adverse drug reactions, adverse
events and serious adverse events in accordance with the Safety Information
Exchange Agreement. Such agreement shall be concluded three (3) months prior to
the start of phase I clinical trial for the Licensed Product in the DAIICHI
Field and Territory.
4.6 Regulatory
Applications. DAIICHI will submit Regulatory
Applications for the Regulatory Approval to market the Licensed Product in the
Territory. The applications will be based on the data generated in clinical
trials undertaken by DAIICHI, CIMAB, CIMYM and/or their licensee(s) or
sub-licensee(s). DAIICHI will provide CIMYM with all notices and other
correspondence with Regulatory Authorities relating to the Regulatory
Applications in accordance with Clause 4.4.
4.7 Response to
Regulatory Authorities. DAIICHI will submit Regulatory
Applications for the Regulatory Approval to market the Licensed Product in the
Territory. The applications will be based on the data generated in clinical
trials undertaken by DAIICHI, CIMAB, CIMYM and/or their licensee(s) or
sub-licensee(s). DAIICHI will provide CIMYM with all notices and other
correspondence with Regulatory Authorities relating to the Regulatory
Applications in accordance with Clause 4.4.
4.8 Ownership of
Regulatory Approvals. Subject to Clause 13.3(b), all
Regulatory Approvals issued pursuant to the Regulatory Applications submitted by
DAIICHI in the DAIICHI Field and Territory will be owned by
DAIICHI.
5 Sales
Promotion / Marketing
5.1 Sales
Promotion. DAIICHI shall use its commercially reasonable
efforts to promote at its own costs and on its own responsibility, sales of the
Licensed Product in the DAIICHI Field and Territory.
6 Non-Competition
6.1 During
the term of this Agreement, DAIICHI shall not sell or promote any Competitive
Product in the Territory for anti-cancer treatment.
7 Know-how
and Confidential Information
7.1 Provision of
Know-how.
(a) After
the Commencement Date and from time to time during the term of this Agreement,
upon DAIICHI’s reasonable written request, CIMYM shall supply DAIICHI with all
Licensed Know-how in its possession that is relevant to, derived from or useful
for the development, registration, commercialisation, use or sale of the
Licensed Product within the DAIICHI Field and Territory. It is expressly
understood that prior to the Commencement Date, CIMYM has already disclosed to
DAIICHI and DAIICHI has received from CIMYM part of the Licensed Know-how under
the confidentiality agreement dated December 7, 2004 (the “Confidentiality Agreement”).
The Parties acknowledge that this Agreement applies to the disclosure of
Licensed Know-how that was made under the Confidentiality Agreement and prevails
over the Confidentiality Agreement. The Licensed Know-how shall be subject to
the confidentiality provisions of Clause 7.2.
(b) Each
of the Parties shall provide the other Parties with the Arising Know-how in
their possession that is relevant to, derived from or useful for the
development, registration, commercialisation, use or sale of the Product within
each Party’s field and territory, from time to time.
7.2 Confidentiality
Obligations. Each Party (“Receiving Party”)
undertakes:
(a) to
maintain as secret and confidential all 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 exclusivity for the purposes except as expressly licensed hereby
and strictly in accordance with the provisions of this Agreement,
and
(c)
subject to the provisions of Clause 7.5, to disclose the same only to those of
its Affiliates, employees, contractors, licensees 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.
7.3 Exceptions to
Obligations. The provisions of Clause
7.2 shall not apply to 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;
(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.
7.4 Disclosure to
Court, etc. If the Receiving Party or its Affiliates,
employees, contractors, licensees and sub-licensees to whom Confidential
Information is disclosed are required to disclose 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 7.2,
provided that the Receiving Party or its Affiliates, employees, contractors,
licensees and
sub-licensees to whom Confidential Information is disclosed shall (a) inform the
Disclosing Party as soon as is reasonably practicable and shall only disclose
Confidential Information to the extent so required, and (b) 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.
7.5 Disclosure to
Employees, etc. The Receiving Party
shall ensure that all of its Affiliates, employees, contractors, consultants,
advisers, licensees and sub-licensees pursuant to this Agreement (if any) who
have access to any of the Disclosing Party's Confidential Information to which
Clause 7.2 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 7.2 and 7.3 prior to receiving the Disclosing Party's
Confidential Information.
7.6 Ownership of
Confidential Information. Subject to Clause
2.4(a), 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.
7.7 Return of
Confidential Information. Upon the request of the
Disclosing Party, the Receiving Party will promptly return to the Disclosing
Party, or at the Disclosing Party's election, destroy all Confidential
Information of the Disclosing Party in its possession or in the possession of
its representatives. The Receiving 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; provided always
DAIICHI may retain a copy of all Confidential Information disclosed to DAIICHI
pursuant to this Agreement for the duration of this Agreement and for archival
purposes.
8 Manufacturing
and Supply
8.1 Clinical
Supply. CIMAB or CIMAB's Contract Manufacturers shall supply
to CIMYM and CIMYM shall supply to DAIICHI and/or its Affiliates, and DAIICHI
and/or its Affiliates shall purchase from CIMYM for its own use and that of its
Affiliates one hundred percent (100%) of DAIICHI’s unit requirements of the
Licensed Product in agreed form for the purpose of all non-clinical and clinical
studies ("Studies") and post-marketing clinical trials ("PMS Studies"). Such
requirements shall be supplied to DAIICHI in accordance with the following terms
and conditions:
(a) In
respect of DAIICHI’s requirements for non-clinical studies in accordance with
the Research and Development Plan, whether for the purposes of seeking
Regulatory Approvals or not, CIMYM shall provide to DAIICHI, upon request by
DAIICHI, with any quantity of the Licensed Product in agreed form that is
necessary for DAIICHI's requirements at US$* per gram of TheraCIM h-R3. Payment
will be made by DAIICHI within sixty (60) days after receiving the Licensed
Product from CIMYM.
(b) In
respect of DAIICHI's requirements for the clinical studies in accordance with
the Research and Development Plan, whether for the purposes of seeking
Regulatory Approvals or not, CIMYM shall provide to DAIICHI with such Licensed
Product in agreed format US$* per gram of TheraCIM h-R3, under the terms and
conditions of the Supply Agreement as set forth in Clause 8.5. Payment will be
made by DAIICHI within sixty (60) days after receiving the Licensed Product from
CIMYM.
(c) For
all other supply for the PMS Studies, CIMYM shall sell such Licensed Product in
agreed form to DAIICHI under the terms and conditions of the Supply Agreement as
set forth in Clause 8.5.
8.2 Commercial
Supply. CIMAB or CIMAB's Contract Manufacturers shall
supply to CIMYM and CIMYM shall supply to DAIICHI and/or its Affiliates, and
DAIICHI and/or its Affiliates shall purchase from CIMYM one hundred percent
(100%) of DAIICHI’s unit requirements of the Licensed Product in agreed form for
the purpose of all commercial sales in accordance with the terms of this
Agreement and the Supply Agreement. CIMYM shall be the exclusive supplier of the
Licensed Product to DAIICHI or its Affiliates.
CIMAB
shall prepare one or more of CIMAB's Contract Manufacturer(s), at its cost and
responsibility, as a back-up source for any quantity of the Licensed Product
that is necessary for DAIICHI's requirements, including the Licensed Product for
the Studies and PMS Studies under Clause 8.1, in the event of supply shortage by
CIMAB as set forth in Clause 8.6. To prepare CIMAB's Contract Manufacturer(s),
CIMAB shall ensure that CIMAB's Contract Manufacturer(s) implement tests
including, but not limited to, the bioequivalence test and comparability lest,
and DAIICHI shall have the right to audit CIMAB's Contract manufacturer for
compliance with applicable regulatory laws in the Territory.
The
supply price (C.I.P by air) of the Licensed Product to DAIICHI for commercial
sales in the Territory shall be as follows:
(a) In
the event that the National Health Insurance price ("XXX xxxxx") of the Licensed
Product as of the first commercial sale in the Territory is JPY * or more per
200mg of TheraCIM h-R3, the supply price shall be * percent (*%) of the Net
Sales Value of the Licensed Product in all dosage forms, during the term of the
Re-examination Period for the Licensed Product in the Territory. After the
Re-examination period, the supply price shall be reduced to * percent (*%) until
*th anniversary of the first commercial sale of the Licensed Product in the
Territory.
(b) In
the event that the XXX xxxxx of the Licensed Product as of the first commercial
sale in the Territory is JPY * or more but less than JPY * per 200mg of
TheraCIM h-R3, the supply price shall be * percent (*%) of the Net Sales Value
of the Licensed Product in all dosage forms, during the term of the
Re-examination Period for the Licensed Product in the Territory. After the
Re-examination period, the supply price shall be reduced to * percent (*%)
until * anniversary of the first commercial sale of the Licensed Product in
the Territory.
(c) The
supply price after * anniversary of the first commercial sale of the
Licensed Product in the Territory shall be separately negotiated in good faith
by the Parties prior to the expiration of the initial term of this
Agreement.
(d) In
the event that the XXX xxxxx of the Licensed Product as of the first commercial
sale in the Territory is less than JPY * per 200mg of TheraCIM h-R3, the Parties
shall separately negotiate in good faith on the supply price.
(e) In
the event that the XXX Xxxxx of the Licensed Product after launch is reduced
severely, the Parties shall separately negotiate in good faith on the supply
price.
(f) In
the event that any Generic Drug of the Licensed Product is launched in the
Territory, the Parties shall separately negotiate in good faith a reduction to
the supply price.
Re-examination
Period
|
thereafter and
until *th
anniversary
|
thereafter
|
|||||||
JPY
* <= XXX xxxxx
|
* | % | * | % | |||||
JPY
* <= XXX xxxxx < JPY *
|
* | % | * | % |
separately
discussed
|
||||
XXX
xxxxx < JPY *
|
separately
discussed
|
Payment
shall be made by DAIICHI within sixty (60) days after the date of receiving the
Licensed Product from CIMYM.
8.3 Quality. DAIICHI
shall ensure that all Licensed Product marketed by it is of satisfactory quality
and complies with all applicable laws and regulations in the
Territory.
8.4 Specifications. CIMAB
undertakes that all Licensed Product supplied to CIMYM (and thereafter to
DAIICHI) will be manufactured in accordance with mutually agreed upon
specifications (inclusive of specifications in an approved marketing
authorization), the current rules of Good Manufacturing Practices of the
relevant Regulatory Authorities in the Territory and 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 the
Licensed Product in accordance with such specifications for the purposes of
supply and use of the Licensed Product in the Territory, and will be in good
standing with all regulatory authorities.
8.5 Supply
Agreement. The Licensed Product for clinical studies,
the PMS Studies and commercial sales shall be supplied by CIMAB or CIMAB's
Contract Manufacturer(s) to CIMYM and by CIMYM to DAIICHI or its Affiliate
pursuant to the terms of a separate Supply Agreement and a QA Agreement.
DAIICHI, DAIICHI's Affiliates, CIMYM and CIMAB shall use good faith efforts to
negotiate and enter into: (a) a Supply Agreement and a QA Agreement for the
clinical studies promptly after the Commencement Date; and (b) a Supply
Agreement and a QA Agreement for the PMS Studies and commercial purposes at
least six (6) months after 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, shipping terms, 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 Agreement shall be consistent with the provisions of
this Clause 8, unless otherwise agreed in writing among the
Parties.
8.6 Supply
Shortage.
(a) CIMYM
shall notify DAIICHI immediately upon becoming aware that CIMAB or CIMAB's
Contract Manufacturer is unable to supply CIMYM the quantity of the Licensed
Product ordered by DAIICHI. In such circumstances, CIMYM and CIMAB shall use all
best endeavours to remedy such shortage.
(b) In
the event CIMAB is unable to supply CIMYM (and therefore DAIICHI's) requirements
of the Licensed Product for any reason, CIMAB shall allocate an amount of the
Product in its inventory so that DAIICHI receives at least its proportionate
shore (as between CIMYM's other licensees globally) of such available supplies,
as determined from reasonable forecasts and orders therefore as more
specifically set forth in the Supply Agreement.
8.7 Right to Manufacture for the
Territory.
(a) In
the event that (i) CIMAB or CIMAB's Contract Manufacturer is unable to
manufacture the Licensed Product which meets with the specifications accepted by
the Japanese Regulatory Authority or by the terms of any relevant Registration
Approval, or (ii) CIMAB or CIMAB's Contract Manufacturers is or are unable to
supply CIMYM and therefore CIMYM is unable to supply DAIICHI with requirements
of the Licensed Product for three consecutive months twice in any given two year
period and in such quantities in accordance with reasonable forecasts as agreed
by the Parties, DAIICHI shall have the right to manufacture by itself or its
Affiliate, or have manufactured by a Third Party Manufacturer, one hundred
percent (100%) of its own requirements for Studies, commercial sales and PMS
Studies for the Licensed Product, in accordance with the provisions of Clause
8.7(b). Detailed terms and conditions of such grant of manufacture right shall
be separately negotiated and determined among the Parties.
(b) To
enable DAIICHI to have the Licensed Product manufactured for it in accordance
with Clause 8.7(a), the Parties shall, if the events described in Clause 8.6(a)
occur, make arrangements for the transfer of Licensed Know-how relevant to or
useful for the manufacture of the Licensed Product to DAIICHI or its Affiliate,
or a Third Party Manufacturer so long as the Third Party Manufacturer executes
confidentiality agreements with the Parties on terms and conditions at least as
restrictive as those under this
Agreement. CIMAB shall fully cooperate with and shall take all commercially
reasonable actions with DAIICHI, its Affiliate or such Third Party Manufacturer,
to provide DAIICHI with such documentation, Know-how and technical assistance,
without charge to DAIICHI.
9 Payments
9.1 Initial
Payment. DAIICHI shall pay to CIMYM a non-refundable,
non-creditable upfront payment of US$14,500,000 within thirty (30) days of
receipt of an invoice after the Commencement Date.
9.2 Milestone
Payment. Upon the occurrence of each of the following
events, DAIICHI shall pay to CIMYM the following non-refundable, non-creditable
milestone payments, within thirty (30) days from the date of such
events:
License
Fees Payable Upon the
Achievement
of Milestones:
|
||||||
Glioma
(Adult)
|
Filing
of Glioma NDA in the Territory
|
US$ | * | |||
Approval
of Glioma NDA in the Territory
|
US$ | * | ||||
Indication
#2
|
Initiation
of Pivotal Indication #2 study in the Territory
|
US$ | * | |||
Filing
of Indication #2 NDA in the Territory
|
US$ | * | ||||
Approval
of Indication #2 NDA in the Territory
|
US$ | * | ||||
Indication
#3
|
Initiation
of Pivotal Indication #3 study in the Territory
|
US$ | * | |||
Filing
of Indication #3 NDA in the Territory
|
US$ | * | ||||
Approval
of Indication #3 NDA in the Territory
|
US$ | * | ||||
Indication
#4
|
Initiation
of Pivotal Indication #4 study in the Territory
|
US$ | * | |||
Filing
of Indication #4 NDA in the Territory
|
US$ | * | ||||
Approval
of Indication #4 NDA in the Territory
|
US$ | * | ||||
Upon
reaching JPY * of Net Sales Value in a calendar year.
|
US$ | * |
9.3 Payment
Terms. All sums due under this Agreement, including the
supply price of the Licensed Product pursuant to Clauses 8.1 and
8.2:
(a) shall
be paid in US dollars (or such other currency as CIMYM and DAIICHI may agree in
writing) and, in the case of Net Sales Value received by DAIICHI in a currency
other than US dollars, the amount shall be calculated in the other currency and
then converted into equivalent US dollars at the TTM Rate for US dollars as
quoted by Bank of Tokyo-Mitsubishi UFJ in Tokyo, as applicable, as at the close
of business on the last business day of the quarterly period with respect to
which the payment is made;
(b) shall
be paid by the due date, failing which CIMYM may charge interest on any
outstanding amount on a daily basis at a prevailing US prime rate plus eight
percent (8%) then in force published by the Wall Street Journal compounded
monthly. By way of example, if the Wall Street Journal US prime rate is five
percent (5%), CIMYM may charge thirteen percent (13%) per annual on such
outstanding amount.
9.4 Accounting
Statements. During the term of this Agreement following
the first commercial sale of the Licensed Product in the Territory, DAIICHI
shall send to CIMYM, within ninety (90) days of the end of each fiscal year, a
statement selling out, in respect of the Territory in which the Licensed Product
is sold, the types of the Licensed Product sold, the quantity of each type sold,
the Gross Sales Value itemizing deductions and allowance actually taken, and the
Net Sales Value in respect of each type, expressed both in local currency and US
Dollars and showing the conversion rates used during the period to which the
statement relates.
9.5 Records.
(a)
DAIICHI shall keep at its normal place of business detailed and up to date
records and accounts relevant to the statement described in Clause 9.4 showing
the quantity, description, Gross Sales Value and Net Sales Value of the Licensed
Product, all source documents and other records corresponding to Gross Sales
Value, Net Sales Value or any deductions from Gross Sales Value and from Net
Sales Value in respect of the Licensed Product in sufficient detail to ascertain
the payments due under this Agreement for the three (3) year period after the
relevant statement is sent to ClMYM.
(b)
During the term of this Agreement, DAIICHI and its Affiliates 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 DAIICHI to
CIMYM under this Agreement. Such inspection shall be limited to no more than one
(1) time each twelve (12) month period. 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
DAIICHI's or its Affiliates statement or report. CIMYM shall be responsible for
the accountant's fees and expenses unless the accountant certifies that there is
an inaccuracy of more than five percent (5%) in any accounting statement, in
which case DAIICHI and its Affiliates shall pay the accountant's fees and
expenses in respect of that inspection. If the inspection shows that DAIICHI or
its Affiliates owes a payment to CIMYM under this Agreement, DAIICHI shall
promptly make such payment.
(c)
DAIICHI shall ensure that CIMYM has the same rights as those set out in this
Clause 9.5 in respect of any Affiliate of DAIICHI that is participating in the
execution of DAIICHI's rights and obligations under this Agreement.
9.6 Taxes. A
Party may deduct from any amounts it is required to pay pursuant to this
Agreement an amount equal to that withheld for or due on account of any taxes
(other than taxes imposed on or measured by net income) or similar governmental
charge imposed by a jurisdiction other than the United States ("Withholding Taxes"). At the
receiving Party's request, the paying Party shall provide the receiving Party a
certificate evidencing payment of any Withholding Taxes hereunder and shall
reasonably assist the receiving Party, at the receiving Party's expense, to
obtain the benefit of any applicable tax treaty.
10 Diligence
10.1 Diligent and
Reasonable Efforts. DAIICHI shall use Diligent and
Reasonable Efforts to develop and commercially exploit the Licensed Product to
the maximum extent throughout the Territory. Without limiting DAIICHI's
obligations under the previous sentence of this Clause 10.1, DAIICHI shall
develop and commercially exploit the Licensed Product in accordance with the
Research and Development Plan.
11 Intellectual
Property
11.1 Obtain and
Maintain the Licensed Patent Rights. CIMYM/CIMAB shall
be responsible, at CIMYM/CIMAB's cost and expense, for seeking to obtain valid
patents pursuant to each of the Licensed Patent Rights in the Territory, and
shall:
(a)
diligently seek to obtain valid patents pursuant to each of the Licensed Patent
Rights in the Territory; and
(b) pay
all prosecution, maintenance, and renewal fees in respect or the Licensed Patent
Rights as and when due.
CIMYM/CIMAB
shall not abandon any Licensed Patent Rights within DAIICHI's Field and
Territory.
11.2 Obtain and
Maintain the Arising Patents. In relation to the filing
and maintenance of each Party's
Arising Patents, each Party shall, at its own cost and expenses:
(a)
diligently seek to obtain valid patents in the names of the inventing parties,
as specified in Clause 2.4(b), in the each territory: and
(b) pay
all prosecution, maintenance, and renewal fees in respect of the Arising Patents
as and when due,
provided
that if each Party ("Abandoning
Party") wishes to abandon or not maintain any such application or not to
maintain any such Party's Arising Patent (or to cease funding such application
or patent) (collectively, "Abandoned Patents") within
the DAIICHI Field and Territory, such Abandoning Party shall give three (3)
months' prior written notice to the other Party and on the expiry of such notice
period with respect to such Abandoned Patents in the DAIICHI Field and
Territory, the Abandoning Party shall promptly assign all rights and interest in
such Abandoned Patents or patent applications in question to be assigned to the
other Parry and the Abandoning Party shall have no continuing rights under such
Arising Patents in the DAIICHI Field and Territory.
In the
event that an Arising Patent is jointly owned by the Parties, responsibility and
cost of prosecuting such Arising Patent shall be allocated as
follows:
(c) Prosecution.
CIMYM/CIMAB shall prepare, file, prosecute and maintain the appropriate filings
in respect of any jointly owned Arising Patents in the United States and in such
other jurisdictions as CIMYM/CIMAB determines jointly with DAIICHI, acting
reasonably, that are necessary in order to protect CIMYM/CIMAB's and DAIICHI's
rights in such Arising Patent. CIMYM/CIMAB shall ensure that all filings are
filed in the name of CIMYM/CIMAB and DAIICHI as co-owners.
(d) Expenses. The Parties
hereby agree that all out-of-pocket costs and expenses (including attorneys'
fees and government filing fees) incurred by CIMYM/CIMAB to prepare, file,
prosecute and maintain the appropriate filings to protect the Parties' rights in
any jointly owned Arising Patent ("Patent Expenses") will be
shared equally by the Parties to be named on such Arising Patent. CIMYM/CIMAB
shall submit invoices (including all relevant receipts) for the appropriate
amount of such Patent Expenses to DAIICHI on a quarterly basis. Each invoice
shall be paid by DAI1CHI within thirty (30) days of the receipt of such invoice
from CIMYM/CIMAB.
(e) Disclaimer. Either
Party may, at any time, disclaim its interest in such jointly owned Arising
Patent and elect to cease to bear its share of the Patent Expenses in respect of
such jointly owned Arising Patent by providing notice of such election ("Disclaimer Notice") to the
other Party; provided, however, the disclaiming Party shall remain liable for
its share of all Patent Expenses incurred or committed to through the date the
non-disclaiming party receives the Disclaimer Notice. In the event that a
Disclaimer Notice is delivered by either Party: (A) the disclaiming Party shall
promptly assign its ownership interest in such Arising Patent to the
non-disclaiming Party without consideration; (B) except as set forth in Clause
11.2(d) above, as of the date of the receipt of such Disclaimer Notice by the
non-disclaiming Party, the disclaiming Party shall no longer be responsible for
its share of the Patent Expenses in respect of such Arising Patent; (C) except
as set forth in Clause 11.2(d) above, as of the date of the receipt of such
Disclaimer Notice by the non-disclaiming Party, the non-disclaiming Party shall
be solely responsible for all Patent Expenses; and (D) except as expressly set
forth in Clauses 2.4(c) and 2.4(d) above, the disclaiming Party shall have no
further rights to such Arising Patent.
11.3 Infringement of
Licensed Patent Rights. Each Party shall inform the
other Party promptly if it becomes aware of any alleged infringement or
potential infringement of any of the Licensed Patent Rights or CIMYM/CIMAB's
Arising Patents in the DAIICHI Field and Territory. The Parties shall consult
each other on the best way to respond to such infringement. CIMYM shall be
responsible for bringing any suit or action against Third Parties infringing the
Licensed Patent Rights or CIMYM/CIMAB's Arising Patents in the DAIICHI Field and
Territory at its sole expense.
11.4 Infringement of
Third Party Rights. 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, the
receiving or sued Party shall promptly provide full details to the other Party,
and the Parties shall discuss the best way to respond.
In the
case of the situation in Clauses 11.5(a), (b) and (c) of this Agreement,
CIMYM/CIMAB shall defend such suit or action and shall have the right to resolve
such matter by settlement or otherwise with such Third Party at CIMYM/CIMAB's
cost, provided that if any action or proposed settlement involves the making of
any statement, express or implied, concerning the validity of any Licensed
Patent Rights within the DAIICHI Field and Territory, the consent of DAIICHI
must be obtained before taking such action or making such settlement, such
consent not to be unreasonably withheld or delayed. CIMYM/CIMAB will request
DAIICHI's cooperation with the suit or legal action without DAIICHI joining as a
joint litigation party and DAIICHI may cooperate in the suit or action without
sharing the litigation cost.
In
the case of situations other than in Clauses 11.5(a), (b) and (c) of this
Agreement, DAIICHI shall defend such suit or action and shall have the right to
resolve such matter by settlement or otherwise with such Third Party at
DAIICHI's cost.
11.5 Third Party
Intellectual Property. CIMYM/CIMAB shall be solely
responsible for obtaining and paying for any additional licenses and other
rights that may be required to enable DAIICHI or its Affiliates to commercialise
the Licensed Product in the Territory in the following situations. If as a
result of the use of the Licensed Intellectual Property:
(a) the
Licensed Product is covered by a Third Party's patent claiming a composition of
matter, or
(b) the
Licensed Product is covered by a Third Party's patent claiming a process for
manufacturing products, or
(c) the
use of the Licensed Product is covered by a Third Party's patent claiming a
combination use of anticancer product with a radiation therapy or a
chemotherapeutic product.
In
situations other than as set out in Clauses 11.5(a), (b) and (c), DAIICHI shall
be solely responsible for obtaining such licenses at its sole expense and for
obtaining and paying for any additional licenses and other rights that may be
required to enable DAI1CHI to commercialise the Licensed Products in the
Territory.
The Third
Party's patents in the situations set out in Clauses 11.5(a), (b) and (c)
include, but are not limited to, the patents listed in Schedule
4, which are confirmed by the Parties as of the Commencement
Date.
11.6 Product
Names. DAIICHI may use its own trade xxxx for the Licensed
Product and shall be responsible for deciding the trade xxxx to be applied to
the Licensed Product in the Territory. DAIICHI will be responsible for applying
for any such trade xxxx in the Territory, at its sole cost. CIMYM will be
responsible for applying for an international, non-proprietary name ("INN") for
the Product at its sole cost. DAIICHI acknowledges that it has no objection to
the INN "NIMOTUZUMAB".
11.7 Licensed Patent
Validity. DAIICHI agrees that it will not take any action, or
cause any other Person or other entity to take any action, seeking to invalidate
any Licensed Patent Rights.
12 Representations,
Warranties and Liability
12.1 Representations
and Warranties by CIMYM and CIMAB. Each of the CIMYM and
CIMAB severally (and not jointly) represent and warrant 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 DAIICHI of the rights granted to it under this Agreement,
namely:
(i) grant
or agree to rant any Third Party any rights in the Licensed Intellectual
Property in the DAIICHI Field and Territory; or
(ii)
assign, mortgage, charge or otherwise transfer any of the Licensed Patent Rights
or rights to Arising Patents in the DAIICHI Field and Territory;
(c) to
CIMYM and CIMAB's knowledge, no Third Party (other than CIMYM's licensor(s))
owns or claims any rights in the Licensed Patent Rights as of the Commencement
Date, other than those identified as possibilities in Schedule
4;
(d) it is
a corporation incorporated and validly existing under the laws of its
jurisdiction of incorporation;
(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 or creditors
generally and except that equitable remedies may be granted only in the
discretion of a court of competent jurisdiction; and
(f) to
its knowledge, without any additional investigation or inquiry, the Licensed
Know-how can be used as part of a Regulatory Application in the
Territory.
12.2 Representations
and Warranties by CIMAB. CIMAB represents and warrants
that:
(a) it
has granted to CIMYM the rights set forth in Clause 2.1 hereof, which CIMYM is
sub-licensing to DAIICHI.
12.3 Representations
and Warranties by DAIICHI. DAIICHI represents, warrants
and undertakes that:
(a) it
has sufficient financial and other resources to fulfil its obligations under
this Agreement;
(b) it
has obtained all necessary authorisations from its supervisory board 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;
(d) it is
a corporation incorporated and validly existing under the laws of its
jurisdiction of incorporation;
(e) the
execution, delivery and performance of this Agreement by DAIICHI does not and
will not conflict with or result in a breach or violation of any of the terms or
provisions of, or constitute a default under (whether after notice or lapse of
time or both), any indenture, mortgage, deed of trust, loan agreement, license
agreement, lease or other agreement (written or oral) or instrument, including
any material contract, to which DAIICHI is a party or by which it is bound, or
to which its property or assets is subject; nor will such action conflict with
or result in any violation of the provisions of the articles of incorporation or
other documents, by-laws or resolutions of DAIICHI or any statute applicable to
DAIICHI or any order, rule or regulation of any court or governmental agency or
body having jurisdiction over DAIICHI or any of its properties;
(f) the
execution, delivery and performance of this Agreement by DAIICHI have been duly
and validly authorized by all necessary corporate action on its pan 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;
(g) to
its knowledge, as of the Commencement Date, the research, development,
importation, use and sale of the Licensed Product in the DAIICHI Field and
Territory does not infringe the rights of any Third Party, other than those
identified as possibilities in Schedule
4; and
(h) it
shall comply in all material respects with all applicable laws in connection
with the performance of its obligations hereunder.
12.4 No Other
Warranties.
(a) Each
of DAIICHI, CIMYM and CIMAB 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 are excluded from this Agreement
to the fullest extent permitted by law.
(b)
Without limiting the scope of Clause 12.4(a), neither CIMYM or CIMAB give any
warranty or representation:
(i) as to
the efficacy or usefulness of any of the Licensed Intellectual Property or
CIMYM's or CIMAB's Arising Intellectual Property; or
(ii) that
any of the Licensed Patent Rights or CIMYM's or CIMAB's Arising Patents are or
will be valid or subsisting or in the case of a Regulatory Application will
proceed to grant; or
(iii)
that the Licensed Know-how or Arising Intellectual Property or any other
information or materials communicated or provided by CIMYM to DAIICHI under or
in connection with this Agreement are sufficient for the research, development,
importation, use or sale of the Licensed Product in the DA IICHI
Field and
Territory; or
(iv) that
the research, development, importation, use or sale of the Licensed Product in
the DAIICHI Field and Territory will not infringe any rights of Third
Parties.
12.5 Indemnity and
Insurance.
(a)
DAIICHI shall indemnify and hold CIMYM 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
"CIMYM/CIMAB
Indemnitees") harmless from and against all losses, liabilities, damages,
cost or expenses (including reasonable attorneys' fee and disbursements) ("Damages") incurred as a
result of any claim made or suit brought against or suffered by any of the
CIMYM/CIMAB lndemnitees arising out of (i) negligence, misconduct or breach by
DAIICHI of an agreement,
representation, warranty or covenant in this Agreement or (ii) the testing,
handling, storage, use, sale or other disposition of the Licensed Product by
DAIICHI or its Affiliate under this Agreement except to the extent that such
Damages are caused by or results from the failure of the Licensed Product that
is supplied to DAIICHI by CIMYM or CIMAB to meet the requirements as agreed upon
in the Supply Agreement.
(b) CIMYM
and CIMAB shall severally and not jointly indemnify and hold DAIICHI and their
respective Affiliates and their respective officers, directors, employees,
consultants, agents and representatives (the "DAIICHI lndemnitees")
harmless from and against all Damages incurred as a result of any claim made or
suit brought against or suffered by any of the DAIICHI lndemnitees arising out
of (i) negligence, misconduct or breach by CIMYM/CIMAB of an agreement,
representation, warranty or covenant in this Agreement, (ii) CIMYM/CIMAB's
manufacture, use or sale of the Licensed Product to DAIICHI or (iii) the failure
of the Licensed Product that is supplied to DAIICHI by CIMYM or CIMAB to meet
the requirements as agreed upon in the Supply Agreements.
(e) In
the event either CIMYM/CIMAB Indemnitees or DAIICHI Indemnitees (collectively
"Indemnitees") intend to
claim indemnification under this Clause 12.5, such lndemnitees shall: (i)
promptly notify the indemnifying Party in writing of any such claim with respect
to which the Indemnitees intend to claim such indemnification, (ii) give the
indemnifying Party sole control of the defence and/or settlement thereof, and
(iii) provide the indemnifying Party, at its expense, with reasonable assistance
and full information with respect to such claim. Notwithstanding the foregoing,
the indemnifying Party shall have no obligations for any claim if the
lndemnitees seeking indemnification makes any admission, settlement or other
communication regarding such claim without the prior written consent of the
indemnifying Party, which consent shall not be unreasonably
withheld.
(d)
DAIICHI shall obtain appropriate product liability insurance with respect to
Licensed Products. At CIMYM's request, DAIICHI shall provide CIMYM with a
certificate of such insurance. Such product liability insurance shall be in
effect not later than the first administration of such a Licensed Product in
humans.
13 Duration
and Termination
13.1 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 13.2, shall continue in full
force and effect for a period of ten (10) years after the first commercial sale
of the Licensed Product. Thereafter it will be automatically renewed for
subsequent periods of one (1) year, unless CIMYM or DAIICHI terminates by
written notice to the other Party at least one hundred and twenty (120) days
prior to the expiration of the initial term of this Agreement or renewed term
hereof.
13.2 Early
Termination
(a)
Without prejudice to any other right or remedy, either of CIMYM or DAIICHI may
terminate this Agreement at any time by notice in writing to the other Party
such notice to take effect as specified in the notice:
(i) if
the other Party (which in the case of DAIICHI shall include any Affiliate of
DAIICHI) is in material breach of this Agreement and, in the case of a breach
capable of remedy within sixty (60) days, the breach is not remedied within
sixty (60) days of the other Party receiving notice specifying the breach and
requiring its remedy; or
(ii) if
the other Party 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.
(b)
Without prejudice to any other right or remedy, CIMYM and/or CIMAB may terminate
this Agreement at any time by notice in writing to DAIICHI, such notice to take
effect as specified in the notice:
(i) if
the first contact with Regulatory Authorities for Phase I clinical trial for the
Licensed Product within the DAIICHI Field in the Territory has not commenced
within a period of ninety (90) days after the Commencement Date; or
(ii) if
DAIICHI does not make decision to start pivotal study within six (6) months
after the completion of Phase II clinical trial; or
(iii) if
a Change of Control takes place at DAIICHI, "Change of Control" as used
herein shall mean the acquisition of DAIICHI by a Third Party, a business
integration of DAHCHI with a Third Party by establishment of holding company, or
any other form of merger and acquisition of DAIICHI with a Third Party, in each
case as a result of which such Third Party shall directly or indirectly (i) own
fifty percent (50%) or more of the voting securities of DAIICHI, or (ii)
otherwise have the power to elect, replace or direct fifty percent (50%) or more
of the board of directors or comparable decision making body of DAIICHI;
or
(iv) if
DAIICHI 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.
Notwithstanding
the above (iii), it is understood that CIMYM and/or CIMAB shall not exercise the
above termination right by reason of DAIICHI's merger with Daiichi Sankyo Co.,
Ltd.
(c) In
the event that DAIICHI considers, acting reasonably based on recommendations
from principal investigators or key opinion leaders involved in clinical studies
for the Licensed Product, it is seriously difficult to continue such clinical
studies due to lack of medical efficacy or safety of the Licensed Product,
DAIICHI shall promptly provide CIMYM with notice in writing of same. If the
Parties are unable to come to an agreement concerning continuation or cessation
of such clinical studies after good faith negotiation within ninety (90) days
after DAIICHI's notice, DAIICHI may terminate this Agreement effective in sixty
(60) days after DAIICHI's notice of its intention to terminate.
(d)
DAIICHI may terminate this Agreement at any time by notice in writing to CIMYM,
in the event that (i) DAIICHI receives notice from the Japanese Regulatory
Authority that Regulatory Approval for the Licensed Product has been refused, or
(ii) after launch of the Licensed Product, DAIICHI receives notice from the
Japanese Regulatory Authority that the Licensed Product shall be withdrawn from
the market, and, in either case, after consultation between the Parties, in
DAIICHI's opinion, acting reasonably, there is no possibility of appealing such
refusal or withdrawal. DAIICHI undertakes to forward a copy of all relevant
notices to CIMYM promptly upon receipt.
(e) The
Parties acknowledge and agree that DAIICHI's remedy for any breach by CIMYM or
CIMAB of their obligations under Clause 8 shall be as set out in any Supply
Agreement that CIMYM, CIMAB, DAIICHI and/or Daiichi's Affiliate may execute
pursuant to Clause 8.5. Accordingly, breach of Clause 8 shall not entitle any
Party to terminate this Agreement.
13.3 Consequences of
Termination
(a) Upon
termination or expiration of this Agreement for any reason:
(i) If
termination occurs after the first commercial sale of the Licensed Product in
the Territory, DAIICHI shall be entitled to sell, use or otherwise dispose of
any unsold or unused stocks of the Product for a period of six (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 the Licensed Product in the Territory, DAIICHI shall forthwith return all
such stocks of the Licensed Product and Licensed Know-how to CIMYM at DAIICHI's
sole expense;
(ii)
subject to paragraph (i) above, DAIICHI shall no longer be sub-licensed to use
or otherwise exploit in any way, either directly or indirectly, any of the
Licensed Intellectual Property or CIMYM/CIMAB's Arising Intellectual
Property;
(iii)
subject to paragraph (i) above, DAIICHI 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;
(iv) the
provisions of Clause 7, except Clause 7.1, shall survive termination and
continue in force for a period of five (5) years after the date of termination,
where applicable. For clarification, DAIICHI and its Affiliates shall have no
further right to use Licensed Know-how following termination or expiration of
this
Agreement;
(v) the
provisions of Clauses 9, 11.4, 11.5, 12, 13,3, and 14 are intended to survive
the termination or expiration of this Agreement and shall survive the
termination or expiration of this Agreement;
(vi) 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 CIMAB and CIMYM shall have the
right to issue licenses under the License Patent Rights to any Third Party
within DAIICHI's Field and Territory;
(vii)
DAIICHI shall cease and shall cause any Third Party Manufacturer to cease
manufacture of the Licensed Product and destroy any materials used in the
production or manufacture of the Licensed Product within thirty (30) days;
and
(viii) If
termination occurs prior to the approval of the Indication for the Licensed
Product in the Territory, DAIICHI shall provide the Licensed Product
continuously to patients who participated in the clinical trials conducted by
DAIICHI, if requested by such patients, and CIMAB/CIMYM shall supply to DAIICHI
the Licensed Product for such patients. The supply price for such Licensed
Product shall be US$1,000 per gram of TheraCIM h-R3 and be shared equally by the
Parties.
(b)
Except in the case of a material breach by CIMYM as set out in Clause
13.2(a)(i), upon termination of this Agreement for any reason, at CIMYM’s
request, DAIICHI shall:
(i)
transfer to CIMYM all clinical and other data relating to the development of the
Licensed Product;
(ii) 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; and
(iii)
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.
14 General
14.1 Force
Majeure.
(a) 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.
(b) 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.
(c) 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.
14.2 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. The provision of the
Licensed Intellectual Property and the Arising Intellectual Property shall be in
the English language.
14.3 Assignment and
Third Party Rights
(a)
Subject to Clause 14.3(b), 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.
(b) 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 be
bound by and perform the obligations of the assignor under this Agreement.
Notwithstanding the foregoing, no written consent will be required if a Party
transfers all or substantially all of its assets or business in the Field to a
wholly-owned Affiliate and the assignee undertakes to be bound by and perform
the obligations of the assignor under this Agreement.
14.4 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.
14.5 Invalid
Clauses. If any of the within terms, conditions or provisions
or the application of this Agreement 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.
14.6 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.
14.7 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 Product) to any other person, nor exercise
those rights directly to the extent that and for as long as the Product is
within Valid Claims of unexpired Licensed Patent Rights or, to the extent that
the Product is protected by Licensed Know-how that have not become known and
available to the public.
14.8 Notices
(a) 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 14.8. The fax numbers of the Parties are as
follows:
Party
|
Fax Number
|
|
CIMYM: Chief Executive Officer
|
001 905 629 4959
|
|
CIMAB: General Manager
|
0053 7 273 3509
|
|
DAIICHI: General Manager of Licensing Department
|
|
x00 0 0000 0000
|
(b)
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 (7) business 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).
14.9 Law, Dispute
Resolution. The validity, construction and performance
of this Agreement shall be governed by the laws of England. Any dispute arising
out of or in connection with this Agreement shall first be discussed among the
Parties in good faith. If the Parties are unable or unwilling to resolve such
dispute within ninety (90) days of the dispute being referred to it, the dispute
shall be finally settled by arbitration in London, England pursuant to the Rules
of Arbitration of the International Chamber of Commerce, by which each Party
hereto agrees to be bound. Notwithstanding the foregoing, in the event of an
urgent issue that requires emergency action (such as a response to a Regulatory
Authority imposing a product recall, response to a product safety issue or other
similar urgent regulatory requirement), and there has been no timely resolution
using the process described above, DAIICHI will be entitled to make the decision
unilaterally. Nothing in this Agreement shall prevent a Party from seeking an
interim injunction or other equitable remedy in any court of competent
jurisdiction. Furthermore, in the event that a dispute involves a claim with
respect to the validity, enforceability, and/or alleged infringement of any of
the Licensed Patent Rights or Arising Patents owned by CIMYM or CIMAB,
CIMYM/CIMAB may have such matter resolved by a court of competent
jurisdiction.
14.10 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.
14.11 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 on a form of
press release for issue on signature of this Agreement.
14.12 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.
14.13 Third Party
Rights. 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.
Agreed by the Parties through
their authorised signatories:
For and
on behalf of CIMYM Biosciences
Inc.
|
|
|
Xxxxx
G.P. Xxxxx
|
Xxxx
E.L. Xxxxxxxx
|
|
CEO
and Director
|
Director,
Corporate Development
|
|
Date
|
|
Date
|
For an on
behalf of CIMAB
S.A.
|
|
|
Xxxxxx
Xxxxxxx Xxxxxxx
|
Xxxxxxxx
Xxxxxx-Xxxxxxx
|
|
General
Manager
|
Head,
Division of Business and Development
|
|
Date
|
Date
|
For an on
behalf of
DAIICHI
Pharmaceutical Co., Ltd.
Xxxxxxx
Xxxxxx
President
& CEO
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 the Licensed Product for
use
within
the DAIICHI Field and in the Territory.
PCT/CU2003/000012.
Patent
Numbers:
Japan:
545689/04
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 and Confidential Information
1. All
documentation that has been submitted by CIMYM or its Affiliates to the
Therapeutic Products Directorate of Health Canada in connection with an
application for an Investigational New Drug Submission for the Product in
Canada.
2. All
documentation that has been submitted by CIMYM or its Affiliates to the United
States Food and Drug Administration in connection with an application for an
Investigational New Drug Submission for the Product in the USA.
3. All
preclinical, clinical trial and manufacturing data generated by
CIMAB/CIMYM.
4.
Summary and result of any data submitted to Korean FDA.
5.
Summary and result of any data submitted to EMEA.
6.
Summary and result of any data submitted to the Indian regulatory
authority.
7.
Summary and result of any data submitted to the Chinese regulatory
authority.
8. Any
other data submitted to any Regulatory Authority by current and future
sub-licensees of CIMYM of the Product, subject to any confidentiality
obligations to Third Parties if applicable.
Schedule
3
Initial
Development Plan
Part
A: Initial Development Program
DAIICHI
will conduct the following studies:
Phase I
study: 2007.1Q - 2007.3Q
|
·
|
Glioma:
adult: (Depend on Global Development
Program)
|
Study
period: 2008. 1Q – 2009.2Q
Registration:
2009. 4Q, Approval: 2010. 3Q
|
·
|
NSCLC:
(Depend on Global Development
Program)
|
Study
period: 2008 1Q - 2011. 1Q
Registration:
2011. 3Q, Approval: 2012. 3Q
|
·
|
Esophageal:
(Depend on Global Development
Program)
|
Study
period: 2008. 1Q - 2011. 1Q
Registration:
2011. 3Q, Approval: 2012. 3Q
|
·
|
Fourth
indication to be decided
|
Schedule
4
Third
Party's Patents
Japanese
Laid-Open Application No. 2002-114710
Title:
|
Treating
Agent To Use Monoclonal Antibody Together With Antitumor
Agent
|
Assignee:
|
Xxxxx
International Overseas Inc.
|
Filed:
|
September
14, 1989
|
Status:
|
Final
Rejection November 16, 2004, Appeal filed November 16,
2004
|
Japanese
Laid-Open Application No. 2005-47934
Title:
|
Treating
Agent To Use Monoclonal Antibody Together With Antitumor
Agent
|
Assignee:
|
Xxxxx
International Overseas Inc.
|
Filed:
|
September
14, 1989
|
Status:
|
Pending
|
Japanese
Laid-Open Application No.11-335297
Title:
|
Method
of Treating Tumor Cells by Inhibiting Growth Factor Receptor
Function
|
Assignee:
|
Genentech
Inc.
|
Filed:
|
January
5, 1989
|
Status:
|
Pending
|
Japanese
Laid-Open Application No. 2002-515511
Title:
|
Treatment
of Human Turners With Radiation and Inhibitors of Growth Factor Receptor
Tyrosine Kinases
|
Assignee:
|
lmclone
|
Filed:
|
May
14, 1999
|
Status:
|
Pending
|
Japanese
Laid-Open Application No.2003-520195
Title:
|
Treatment
of Refractory Human Tumors with Epidermal Growth Factor
Receptor
|
Antagonists | |
Assignee:
|
Imclone
|
Filed:
|
May
1, 2000
|
Status:
|
Pending
|
PCT/US01/46179
no application filed in Japan
Title:
|
Combination
Radiation Therapy and Chemotherapy In Conjunction With Administration Of
Growth Factor Receptor Antibody
|
Assignee:
|
UAB
Research Foundation
|
Filed:
|
December
7, 2001
|
Status:
|
Pending
|
Japanese
Laid-Open Application No. 2003-245091
Title:
|
Chimera
Immunoglobulin Specific to P55TAC Protein of IL-2
Receptor
|
Assignee:
|
Protein
Design Labs Inc.
|
Filed:
|
December
28, 1989
|
Status:
|
Pending
|
Japanese
Patent No. 0000000
Title:
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Recombinant
DNA Product And Its Production
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Assignee:
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Medical
Research Council
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Filed:
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March
27, 1987
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Status:
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Issued
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