And Development and License Agreement Relating to Nimotuzumab (TheraCIM h-R3)
(1)
CIMYM, Inc.
(2)
CIMAB S.A.
(3)
Innogene Kalbiotech Private Limited
And
(4)
P.T. Kalbe Farma Tbk
Relating
to Nimotuzumab (TheraCIM h-R3)
This Agreement dated the 31
day of October, 2005 is made
between:
(1)
CIMYM, Inc.
(company registration number 12142) ("CIMYM"), a company incorporated in
Canada, whose principal place of business is at 0000 Xxxxxxx Xxxxx, Xxxxxxxx XX,
Xxxxx 000 Xxxxxxxxxxx, Xxxxxxx X0X 0X0; and
(2)
CIMAB
S.A. (company registration number 107/92) ("CIMAB"), a company
incorporated in Cuba, whose principal place of business is at 206 Street,
No. 1926, e/ I9 y 00, Xxxxxx, Xxxxx, Xxxxxx Xxxx, Xxxx; and
(3)
Innogene
Kalbiotech Private
Limited (company registration number 200306430D) ("IGK") a company
incorporated in Singapore, whose principal place of business is at
00 Xxxxxxx Xxxxx, #00-00 Xxxxxxxx Xxxxxx, Xxxxxxxxx 000000);
and
(4)
P.T. Kalbe Farma,
Tbk, (company registration number X.X. 5/72/23) ("Kalbe"), a
company incorporated in Indonesia, whose principal place of business is at
JI. Let. Jend. Suprapto Xxx. 0, Xxxxxxx 00000, X.X. Xxx 0000 / XXX Xxxxxxx 00000,
Xxxxxxxxx.
Recitals:
A. CIMYM is
the exclusive licensee of certain Licensed Patent Rights and certain
Licensed Know-how and other rights relating to marketing and selling
Licensed Product (as defined below) in the Territory (as defined
below).
B. The
shareholders of CIMYM are YM BioSciences, Inc. and CIMAB.
C. CIMAB
enters into commercial agreements on behalf of the Center of
Molecular Immunology ("CIM", as defined below). CIM originally developed
Licensed Product (as defined below) and has the facilities to manufacture
Licensed Product. CIMAB is entering into this Agreement principally in
order to assume the manufacturing and supply obligations set out in Clause
5.
D. IGK
is a subsidiary of Kalbe and Kalbe is an Affiliate (as defined below) of
IGK.
E. IGK
is a drug development company that wishes to pursue the further development
and commercialisation of Licensed Product for the treatment of cancer in
humans in the Territory and in accordance with the provisions of this
Agreement.
F. IGK
has demonstrated evidence of economic and financial solvency sufficient to
assume the product development and conduct clinical trials of Licensed
Product in the Territory.
G. CIMYM
is willing to grant to IGK, and IGK is willing to accept, a license within the
IGK 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
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In
relation to CIMYM or IGK, means any entity or person that controls, is
controlled by, or is under common control with that Party. For the
purposes of this definition, "control" shall mean direct or indirect
beneficial ownership of 50% (or, outside a Party's home territory, such
lesser percentage as is the maximum, permitted level of foreign
investment) or more of the share capital, stock or other participating
interest carrying the right to vote or to distribution of profits of that
entity or person, as the case may be.
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Arising
Intellectual Property
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Any
and all of the Arising Patents and the Arising
Know-how.
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Arising
Know-how
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Technical,
commercial and all other information generated by any Party or its
Affiliates or sublicensees under this Agreement that relates to any of the
Licensed Intellectual Property or the Licensed Product in the Territory,
including any scientific or regulatory data (including clinical trial data
generated by IGK), product license applications and approvals, clinical
trial license applications and approvals, and development and marketing
plans and activities.
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Arising
Patents
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Any
and all patents and patent applications that may be applied for or
obtained in respect of any invention(s) made by any Party or its
Affiliates or sublicensees under this Agreement and which relate to any
Licensed Intel1ectual Property or the Licensed Product, together with any
continuations, continuations in part, extensions, reissues, divisions, and
any patents, supplementary protection certificates and similar rights that
are based on or derive priority from the foregoing.
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Calendar
Quarter
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Each
three-month period ending on 31st
March, 30th
June, 30th
September and 31st
December.
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Calendar
Year
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A
year commencing on 1st
January and ending on 31st
December (but commencing on the Commencement Date in the first year of
this Agreement and, in the final year of this Agreement, ending on the
date of the last sale of Licensed Product under this
Agreement).
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CIM
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The
Center of Molecular Immunology, a scientific research institute based in
Havana, Cuba.
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CIMAB’s
Contract Manufacturer
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Any
Person that may from time to time be contracted by CIMAB to manufacture
the Licensed Product, or any component or ingredient thereof in accordance
with the provisions of this Agreement.
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CIMYM
Field and Territory
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(a)
outside the Territory, all fields (including the Field); and
(b)
within the Territory, all fields other than the
Field.
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Claims
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All
demands, claims and liability (whether criminal or civil, in contract,
tort or otherwise) for losses, damages, legal costs and other expenses of
any nature whatsoever and all costs and expenses (including without
limitation reasonable attorneys fees) incurred in connection
therewith.
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Commencement
Date
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The
date of execution of this Agreement by the Parties (or, if they sign on
different dates, the last date of signature of this Agreement by a
Party).
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Confidential
Information
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Means
any and all trade secrets, technical and non technical and information
owned by one of the Parties, or by any Affiliates of one of the Parties.
Confidential Information includes, without limitation, all inventions,
discoveries, processes, materials, formulae, clinical development plans,
data, ideas, financial information, legal, corporate, marketing, product,
research, personnel, customer, supplier and other non-public information,
in whatever form or media, specifically identified as confidential prior
to or at the time of its disclosure or disclosed orally and confirmed in
writing as confidential within thirty (30) days of such oral
disclosure.
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Delivered
Items
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Has
the meaning given in Clause 4.2.
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Development
and Commercialisation
Plan
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Has
the meaning given in Clause 3.1.
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Development
and Commercialisation
Plan Report
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The
report described in Clause 3.4 as amended from time to
time.
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Development
Team Parties
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CIMYM
and IGK, and "Development Team Party" shall mean either of
them.
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Development
Term
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Means
the period from the Commencement Date until completion of the development
of Licensed Product to the point of first commercial sale of a Licensed
Product in the Territory in accordance with the Development and
Commercialisation Plan.
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Diligent
and Reasonable Efforts
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Exerting
such efforts and employing such resources (whether by itself or through
sub-contractors or sub-licensees) as would normal1y be exerted or employed
by a reasonable Third Party pharmaceutical company for a product of
similar market potential at a similar stage of its product life, when
utilizing sound and reasonable scientific, business and medical practice
and judgment in order to develop the product in a timely manner and
maximize the economic return from its
commercialisation.
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Expiring
Patents
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Patents
or patent applications in the Territory as defined in Clause
9.1.1.
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IGK
Field and Territory
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In
respect of any activity that is licensed to IGK under this Agreement,
shall mean that the activity must occur both within the Field and within
the Territory.
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Field
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The
treatment of cancer in humans.
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Gross
Sales Value
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Shall
mean any and all amounts invoiced and received by IGK or any of its
Affiliates or any of its sublicensees 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 between any
of IGK and its Affiliates or sublicensees shall not be considered a
sale for the purposes of this definition unless there is no subsequent
sale to a Person other than IGK and its Affiliates in an arm's length
transaction. For the purpose of this definition, a sale shall occur when
Licensed Product is transferred, shipped, or otherwise distributed to a
Third Party for valuable consideration that is greater than or equal to
the Net Sales Value.
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Initial
Development Program
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A
program of development to be conducted by IGK in accordance with the
provisions of the attached Schedule 3 Part A.
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Joint
Development Team
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A
committee to be established, and operating, in accordance with the
provisions of Clause 2.
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Know-how
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The
Licensed Know-how and the Arising Know-how.
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Licensed
Intellectual Property
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Any
and all of the Licensed Patent Rights and the Licensed
Know-how.
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Licensed
Know-how
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Technical
and scientific information in the possession of CIMYM or CIMAB in the
Field relating to (a) Licensed Product and/or (b) the inventions claimed
in the Licensed Patent Rights, including the information further described
in the attached Schedule 2, in each case to the extent that such
information is relevant, related to, derived from or useful for the
clinical development, registration, commercialisation, storage, use or
sale of Licensed Product within the Field in any country within the
Territory. Licensed Know-how specifically excludes all technology,
materials, and information related to the manufacture of Licensed
Product.
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Licensed
Patent Rights
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The
patents and patent applications described in the attached Schedule 1
subject to the provisions of Schedule 1, together with any continuations,
continuations in part, extensions, reissues, divisions, and any patents,
supplementary protection certificates and similar rights that are based on
or derive priority from the
foregoing.
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Licensed
Product
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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 that is sold or otherwise supplied
by IGK or its Affiliates and/or which incorporates, or its development
makes use of, any of the Licensed Know-how or Licensed Patent
Rights.
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Major
Countries
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Shall
mean Indonesia, Taiwan, Malaysia, Philippines, South Africa and
Thailand.
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Milestone
Receipts
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The
amount of any payment, excluding Value Added Tax, due to CIMYM from IGK as
described in Clause 7.2.
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Net
Sales Value
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Shall
mean Gross Sales Value net of (a) normal trade, cash and quantity
discounts, allowances and credits, actually allowed and taken (including
credit given for damaged, rejected or returned Licensed Products), (b)
sales taxes, or other taxes, excluding withholding tax, duties and levies
of a similar nature actually paid on Licensed Products, (c) freight,
postage, shipping, insurance and other transportation charges; provided
always the total deductions pursuant to (a, b, and c) above shall not
exceed 10% of the Gross Sales Value.
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Orphan
Drug Status
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Refers
to the process of obtaining Orphan Drug Status in the IGK Field from the
local drug regulatory authority in any country in the
Territory.
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Parties
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CIMYM,
CIMAB, Kalbe and IGK, and "Party" shall mean any of
them.
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Person
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Includes
any individual, firm, company, corporation or other legal
entity.
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Patents
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Any
and all of the Licensed Patent Rights and the Arising
Patents.
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Providing
Parties
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Both
of CIMAB (whether on its own behalf or on behalf of CIM) and CIMYM, and
"Providing Party" shall mean either of them.
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Regulatory
Application
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Any
and all applications that are necessary and appropriate to obtain a
Regulatory Approval including, without limitation, all required documents,
data and information concerning, filed or required to be filed, otherwise
submitted by IGK or its Affiliates to a Regulatory
Authority.
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Regulatory
Approval
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Any
and all approvals, licenses, registrations or authorisations of any
Regulatory Authority that are necessary for the manufacture, use, storage,
import, export, transport, marketing, distribution or sale of the Licensed
Product in any part of the
Territory.
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Regulatory
Authority
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The
equivalents of the US Food and Drug Administration in the
Territory.
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Supply
Agreement
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Any
agreement between CIMAB, CIMYM and IGK under which CIMAB agrees to
manufacture and supply IGK with Licensed Product.
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Territory
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Shall
mean Thailand, Singapore, Indonesia, Taiwan, Myanmar, Cambodia, Laos,
Brunei, Philippines, Malaysia, African Republic of the Congo, Nigeria and
South Africa.
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TheraCIM
h-R3
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A
humanised antibody to the EGF receptor, known scientifically as h-R3 and
which has been given the INN "nimotuzumab".
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Third
Party
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A
Person other than one of the Parties.
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Valid
Claim
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A
claim of a patent or patent application that has not expired or been held
invalid or unenforceable by a court of competent jurisdiction in a final
and non-appealable
judgment.
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2 Joint
Development Team
2.1 Formation. Within thirty (30)
days after the Commencement Date, the Development Team Parties shall
establish a Joint Development Team, by each Development Team
Party designating its initial members to serve on the Joint Development
Team and notifying the other Development Team Party of its dates of
availability for the first meeting of the Joint Development Team. The
purpose of the Joint Development Team shall be to oversee the development
of Licensed Product for purposes of commercialisation in the IGK Field
and Territory. The Joint Development Team shall consist of not more than
three (3) representatives designated by each Development Team Party. Each
representative shall have relevant and appropriate expertise in order to
oversee the development of the Licensed Product.
If a representative of a Development Team Party is unable to attend a meeting of
the Joint Development Team, such Development Team Party may designate an
alternate to attend such meeting. In addition, each Development Team Party
may, at its discretion, invite a reasonable number of other employees,
consultants or scientific advisors to attend the meetings of the Joint
Development Team, provided that such invitees are bound by appropriate
confidentiality obligations. Each Development Team Party may change one or
all of its representatives to the Joint Development Team at any time upon
notice to the other Development Team Party.
2.2
Meetings. The
Joint Development Team shall meet every six months in person or
by teleconference and at such other times as the Parties may agree. The
first meeting of the Joint Development Team shall be held as soon as
reasonably practicable, but in no event later than 60 days after the
Commencement Date. Meetings shall be held at such place or places as
are mutually agreed or by teleconference or videoconference; provided,
however, that there shall be at least one face-to-face meeting per calendar
year.
2.3 Responsibilities. The Joint
Development Team shall:
(a)
Elaborate the Development and Commercialisation Plan in accordance with
Clause 3.1
(b)
review and unanimously approve (or, if the members of the Joint Development
Team are unable to reach unanimous agreement, recommend to the Parties) the
overall development strategy for Licensed Product in the IGK Field and Territory
(including, without limitation, setting criteria for progression of
Licensed Product to the next stage of development under the Development and
Commercialisation Plan);
(c)
review and recommend to the Parties modifications to the Development
and Commercialisation Plan (including the resources to be allocated and the
timelines contained in the Development and Commercialisation Plan);
(d)
facilitate the transfer of Know-How and other information between the Parties
for purposes of conducting the Development and Commercialisation
Plan;
(e)
regularly assess the progress of IGK in its conduct of the Development
and Commercialisation Plan; and
(f)
perform such other activities as are contemplated under this Clause 2. For the
avoidance of doubt the Joint Development Team shall not have any role or
responsibility in relation to determining whether IGK has complied with its
obligations to CIMYM under this Agreement.
2.4
Disputes. If
agreement cannot be reached within the Joint Development Team, IGK
shall have the right to make the final determination concerning the
resolution of the disagreement. Notwithstanding the foregoing, in the case
of a material disagreement, prior to invoking its rights under this Clause
2.4, IGK agrees to have its chief executive contact the chief executive of
CIMYM for the purpose of discussing the disagreement and attempting to
reach a consensus. It shall be the goal of the chief executives to reach a
consensus within five (5) days of the date on which contact is initiated by
the chief executive of Kalbe, it being understood that (i) in the event of
an extraordinary circumstance requiring a faster resolution (e.g., a safety
issue or extraneous timing issue), IGK shall have the right to make the
final determination prior to the end of such five (5) day period if a
consensus has not been reached by the required time for resolution and (ii)
in the event that a consensus has not been reached within ten (10) days of
the date on which contact is initiated by the chief executive officer of IGK,
IGK shall have the right to make the final determination. For the avoidance of
doubt, IGK shall not have any right, under this clause, to determine
whether it has complied with its obligations to CIMYM under this
Agreement.
3 Development
and Commercialisation
3.1
Development and
Commercialisation Plan.
3.1.1
Within 90 days of the Commencement Date, the Joint Development Team shall
prepare a written plan ("Development and Commercialisation Plan") that
expands upon the initial development plan sec out in Schedule 3 and will
describe, and provide a time line for:
(a) all
development activities for the Licensed Product in the IGK Field and
Territory, addressing each phase of development and the budget for
completion of such activities, and providing detailed information on the
activities to be conducted in the next 12-month period.
(b)
intellectual property protection strategy, including applying for Orphan Drug
Status,
patents
and supplementary protection certificates;
(c)
clinical and registration strategy, with a view to expediting Regulatory
Approval; and
(d)
commercialisation strategy.
The Joint
Development Team shall update the Development and Commercialisation Plan on a
regular basis and at least annually.
3.2 Development and Commercialisation
Activities. IGK shall be responsible for the development and
commercialisation (in accordance with the Development and Commercialisation
Plan) of the Licensed Product in the IGK Field and Territory.
Such development and commercialisation shall be carried out under the
oversight and management of the Joint Development Team and in accordance with
the provisions of this Agreement.
3.3
Development and
Commercialisation Costs. IGK shall bear all costs associated with
the development and commercialisation of Licensed Product in the IGK Field
and Territory, including costs incurred in the preparation and execution of
the Development and Commercialisation
Plan. If any Providing Party agrees with IGK to conduct work as part of the
Development and Commercialisation Plan (which may include advice given to the
Joint Development
Team), the Providing Party's costs of conducting such work shall be borne by
IGK, with
the time costs of the Providing Party's representatives being charged to IGK on
a daily rate basis. The Providing Party's daily rate for its representatives'
work referred to in the previous sentence shall be agreed between the Providing
Party and IGK or, if they are unable to agree, the rate shall be $1,000 (one
thousand US dollars) per day plus any reasonable out-of-pocket expenses and
external costs associated with such work.
3.4
Reporting. Without prejudice to
the generality of IGK's obligations under Clauses 8.1 and 9.2, IGK shall
provide a report ("Development and Commercialisation Report") to CIMYM at
least once per annum. In addition, IGK shall provide to CIMYM a quarterly,
written status update on all clinical, development and commercial
activities being undertaken, and from time to time upon request, showing
all past, current and projected activities taken or to be taken by IGK to
bring Licensed Product to market and maximise the sale of Licensed Product
in the IGK Field and Territory, and including details of all Arising
Intellectual Property. CIMYM's receipt or approval or non-approval of any
such report shall not be taken to waive or qualify IGK's obligations under
Clause 8.1 or otherwise under this Agreement.
3.5
Exchange of Data.
It is CIMYM's intention to grant sub-licenses to commercialise Licensed Product
in the CIMYM Field and Territory and to facilitate the expeditious development
and commercialisation of the Licensed Product in the IGK Field and
Territory. Accordingly,
each of the Parties, or CIMYM's sub-licensee(s), may generate data in relation
to Licensed Product or Licensed Products that is useful to the other Parties in
connection with their development or commercialisation of Licensed
Products. To facilitate such commercialisation, each Party shall disclose and
provide to the other Parties all Arising, technical and clinical trial
information (including case report forms and source documentation) and all
notices and other correspondence between IGK and its Affiliates and any
Regulatory Authority on a quarterly basis in accordance with the provisions
of Clause 3.4. In addition, each Party shall use commercially reasonable efforts
to ensure that their sub-licensee(s) of Licensed Product disclose and
provide to other Party and CIMAB technical and clinical data (including
clinical trial information, case report forms and source documentation) in
respect of Licensed Product that is generated by such sub-licensee(s) that
is relevant to, related to, derived from or useful for the
development, registration, commercialisation, or use of the Licensed
Product for the other Party's Field and Territory, including but not
limited to all Licensed Patent Rights, and any Arising Patents or Arising
Know-how relevant to, related to, derived from or useful for the clinical
development,
registration, commercialisation, storage, use or sale of Licensed Product. Each
Party shall also promptly notify the other Party as soon as they come into
possession of clinical data related to or useful for the development and
commercialisation of Licensed Product
and Arising Know-how or Arising Patents generated by a sublicensee, by
furnishing full details thereof to the other Party. CIMYM will not share or
exchange data generated by the Parties under this Agreement with any of their
third party licensees, unless such third party licensee also agree to the
exchange (with IGK. either generally or specifically) of data generated by them
on terms no more favourable than those agreed to be IGK.
4 Know-how
and Confidential Information
4.1
Provision of
Know-how. Upon IGK's reasonable written request, CIMYM shall supply IGK
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
Licensed Product within the IGK Field and Territory. The Licensed Know-how shall
be subject to the confidentiality provisions of Clause 4.4.
4.2
Status of
Know-how. IGK acknowledges that the Licensed Know-how is subject to
further development. Accordingly, specific results cannot be guaranteed and
any results, materials, information or other items, including the Licensed
Know-how and inventions claimed in the Licensed Patent Rights (together
“Delivered Items”) to be provided under this Agreement are provided “as is” and
without any express or implied warranties, representations or undertakings. As
examples, but without limiting the foregoing, CIMYM does not give any warranty
that Delivered Items are of merchantable or satisfactory quality, are fit for
any particular purpose, comply with any sample or description, or are viable,
uncontaminated, safe or non-toxic.
4.3
Use of Know-how.
IGK agrees, not to use the Know-how for any purpose except as
expressly licensed hereby and strictly in accordance with the provisions of
this Agreement.
4.4
Confidentiality
Obligations. Each Party (“Receiving Party”) undertakes:
(a) to
maintain as secret and confidential all Know-how and other Confidential
Information obtained directly or indirectly from the other Party (“Disclosing
Party”) in the course of or in anticipation of this Agreement and to respect the
Disclosing Party's rights therein,
(b) to
use the same exclusively for the purposes of this Agreement,
and
(c)
subject to the provisions of Clause 4.7, to disclose the same only to those of
its employees, contractors and sub-licensees pursuant to this Agreement (if any)
to whom and to the extent that such disclosure is reasonably necessary for the
purposes of this Agreement.
4.5
Exceptions to
Obligations. The provisions of Clause 4.4 shall not apply to Know-how and
Confidential Information which the Receiving Party can demonstrate:
(a) was,
prior to its receipt by the Receiving Party from the Disclosing Party, in the
possession of the Receiving Party and at its free disposal; or
(b) is
subsequently disclosed to the Receiving Party without any obligations of
confidentiality by a Third Party who was not under a duty of confidentiality and
did not derive it directly or indirectly from the Disclosing Party;
or
(c) is
or becomes generally available to the public through no act or default of the
Receiving
Party or its agents, employees, Affiliates or sub-licensees.
4.6 Disclosure to Court, etc. If
the Receiving Party is required to disclose Know-how or other Confidential
Information to the courts of any competent jurisdiction, or to any
government regulatory agency or financial authority, such disclosure shall
not be a breach of Clause 4.4, provided that the Receiving Party shall (i)
inform the Disclosing Party as soon as is reasonably practicable and shall
only disclose Confidential Information to the extent so required, and (ii)
allow the Disclosing Party to seek to persuade the court, agency
or authority to have the information treated in a confidential manner,
where this is possible under the court, agency or authority's
procedures.
4.7
Disclosure to Employees.
The Receiving Party shall ensure that all of its
employees, contractors, consultants, advisers and sub-licensees pursuant to
this Agreement (if any) who have access to any of the Disclosing Party's
Know-how or other Confidential Information to which Clause 4.4 applies,
shall be made aware of and subject to these obligations and shall have
entered into written undertakings of confidentiality at least as restrictive as
Clauses 4.4 and 4.5 and prior to receiving Disclosing Party's Know-how or
Confidential Information.
4.8 Ownership of Confidential
Information
All
Confidential Information disclosed by the Disclosing Party shall, as between the
Parties, remain the sole and exclusive property of the Disclosing Party
including without limitation:
(a) all
ideas, concepts, information, trade secrets, know-how, business strategies
and methods relating to the Confidential Information;
(b) all
physical material containing, bearing, or embodying any Confidential
Information in human or machine readable form, including, without
limitation, all documents, agreements, diagrams, charts, graphs, computer
programs, computer diskettes, and computer files; and
(c) all
proprietary and intellectual property rights in the Confidential
Information, regardless of whether these items were created, generated,
developed, produced or prepared by
or on behalf of the Disclosing Party, and regardless of whether these items
came into being before or after the date hereof.
4.9 Return of Confidential Information
Upon the
request of a Disclosing Party, the Receiving Party will promptly return to
Disclosing Party, or at Disclosing Party's election, destroy all Confidential
Information of the Disclosing Party in its possession or in the possession
of its representatives. 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, including
all copies, notes, summaries and outlines; Provided always IGK may retain a
copy of all Confidential Information disclosed to IGK pursuant to this
Agreement for the duration of this Agreement and for archival
purposes.
5 Manufacturing
and Supply
5.1 Clinical
Supply. CIMAB shall supply to CIMYM and CIMYM shall supply to
IGK and its Affiliates, and IGK shall, subject to Clause 5.5 below, purchase
from CIMYM for its own use and that of its Affiliates, in finished form with one
hundred percent (100%) of IGK’s unit requirements of Licensed Product for all
clinical development purposes. Such clinical requirements shall be supplied to
IGK in accordance with the following terms and conditions:
(a) In
respect of IGK's requirements for clinical trials for the purposes of seeking
Regulatory Approvals in accordance with the Development and Commercialization
Plan as outlined in Schedule 3 and agreed upon by the Parties, CIMYM shall sell
Licensed Product in finished form to IGK at a supply price of US$1,000 (one
thousand US dollars) per gram of active substance in the finished form, delivery
of which will be within 90 days of written order. Payment will be made 50% in
advance for each instalment of Licensed Product that is ordered under this
paragraph (a) when it is available for delivery. The second half of payment will
be paid within 30 days after receiving the Licensed Product.
(b) For
all other supply for clinical purposes, including without limitation supply for
Phase IV studies and for studies that are not required for obtaining Regulatory
Approvals in accordance with the Development and Commercialization Plan as
outlined in Schedule 3, CIMYM shall sell Licensed Product in finished form to
IGK at a supply price equal to US$1,100 (one thousand one hundred US dollars)
per gram. Payment will be made 50% in advance for each instalment of Licensed
Product that is ordered under this paragraph (b) when it is available for
delivery. The second half of payment will be paid within 30 days after receiving
the Licensed Product.
5.2 Commercial Supply. CIMAB
shall supply to CIMYM and CIMYM shall supply to IGK, and IGK shall, subject to
Clause 5.5 below, purchase from CIMYM in finished form one hundred percent
(100%) of IGK's unit requirements of Licensed Products for all commercial
sales or any other non-clinical purposes. CIMAB may elect to have such
requirements supplied to CIMYM by one or more of CIMAB’s Contract
Manufacturer(s). IGK's quantity requirements shall include those of its
Affiliates and sublicensees. The supply price that CIMYM shall charge to
IGK shall be in accordance with the following:
(a) For
supplies of Licensed Product to IGK until the fifth anniversary of the first
commercial sale of the Licensed Product in a Major Country the greater of (i)
25% of the Net Sales Value of the Licensed Product in the Territory and (ii)
US$1,500 (one thousand five hundred U.S. dollars) per gram of the Licensed
Product. Payment will be made $750 per gram in advance for each instalment of
Licensed Product that is ordered under this paragraph (a) when it is available
for delivery. A second payment of $750 per gram will be paid within 30 days
after receiving the Licensed Product and a final payment, applicable in the case
where the selling price exceeds US$6,000 per gram, shall be paid within 30 days
after final sale of the Licensed Product by IGK.
(b) After
the fifth anniversary, the greater of (i) 20% of the Net Sales Value of the
Licensed Product in the Territory and (ii) US$1,200 (one thousand five hundred
U.S. dollars) per gram of the Licensed Product. Payment will be made $600 per
gram in advance for each instalment of Licensed Product that is ordered under
this paragraph (a) when it is available for delivery. A second payment
of $600 per gram will be paid within 30 days after receiving the Licensed
Product and a final payment, if applicable in the case where selling price
exceeds US$6,000 per gram, shall be paid within 30 days after final sale of the
Licensed Product by IGK.
5.3 Specifications. CIMAB
undertakes that all Licensed Product supplied to CIMYM (and thereafter to IGK)
will be manufactured in accordance with mutually agreed upon specifications
(inclusive of specifications in an approved Marketing Authorization) and Good
Manufacturing Practices of the European Medicines Agency and the relevant
Regulatory Authorities, and the relevant regulatory authorities in the countries
of manufacture of the Licensed Product, and will not be adulterated or
misbranded under applicable laws, regulations or guidelines, and that the
manufacturer will have in force all necessary Regulatory Approvals for the
manufacture of Licensed Product in accordance with such specifications for the
purposes of supply and use of Licensed Product in all countries of the
Territory, and will be in good standing with all Regulatory
Authorities.
5.4 Supply Agreement. Licensed
Product supplied by CIMAB or CIMAB's Contract Manufacturer(s) to CIMYM and by
CIMYM to IGK for clinical and commercial purposes shall be supplied to IGK
pursuant to the terms of separate Supply Agreements. IGK, CIMYM and CIMAB shall
use good faith efforts to negotiate and enter into such supply agreements for
commercial purposes, at least six (6) months prior to the submission of a
Regulatory Application for the Licensed Product in the Territory. The Supply
Agreements shall contain forecast procedures, permitted variances from
forecasted amounts, order and delivery times, quality control and quality
assurance procedures, audits, yield ratios, maintenance of inventory, procedures
and remedies for rejection of non-conforming product, record retention,
compliance with laws, and other customary provisions. The terms of the Supply
Agreements shall be consistent with the provisions of this Clause 5, unless
otherwise agreed in writing by Parties.
5.5 Supply Shortage
5.5.1 CIMYM
shall notify IGK immediately upon becoming aware that CIMAB or CIMAB's Contract
Manufacturer is unable to supply CIMYM the quantity of the Licensed Product
ordered by IGK. In such circumstances, CIMYM and CIMAB shall use all
commercially reasonable endeavours to remedy such shortage.
5.5.2
In the event CIMAB is unable to supply CIMYM (and therefore IGK's) requirements
of Licensed Product for any reason, CIMAB shall allocate an amount of the
Licensed Product in its inventory so that IGK receives at least its
proportionate share of such available supplies, as determined from reasonable
forecasts and orders therefor as more specifically set forth in the Supply
Agreement.
5.6 Right to
Manufacture
5.6.1
In the event that, other than by reason of a Force Majeure Event (as
defined in Clause 12.1), that (a) CIMAB or CIMAB's Contract Manufacturer is
unwilling or unable to manufacture Licensed Product to the specifications
required by the relevant Regulatory Authority or by the terms of any relevant
Registration Approval, or b) CIMAB or CIMAB's Contract Manufacturers is or are
unwilling or unable to supply CIMYM and therefore CIMYM is unable to supply IGK
with Licensed Product for a period of more than one calendar quarter in any
given two-year period and in such quantities in accordance with reasonable
forecasts as agreed by the Parties, IGK shall have the right to have
manufactured by a Third Party Manufacturer (as defined below) one hundred
percent (100%) of its own clinical and commercial requirements of Licensed
Product and/or the Licensed Product, in accordance with the provisions of Clause
5.6.2.
5.6.2
To enable IGK to have the Licensed Product manufactured for it in accordance
with Clause 5.6.1, the Parties shall, if the events described in Clause 5.6.1
occur, make arrangements for the transfer of Licensed Know-how relevant to or
useful for the manufacture of the Licensed Product to a manufacturer nominated
by IGK ("Third Party Manufacturer"). CIMAB shall fully cooperate with CIMYM and
IGK and take all commercially reasonable actions as shall be required to qualify
and enable such Third Party Manufacturer including, without limitation,
providing the Third Party Manufacturer without charge, such documentation,
Know-How and technical assistance, with CIMAB and IGK sharing costs on a 50:50
basis.
6 Grant
of Rights
6.1 Licensed Intellectual
Property
6.1.1 CIMYM
hereby grants to IGK, subject to the provisions of this Agreement:
(a) an
exclusive sub-license in the IGK Field and Territory (except that in South
Africa it shall be a Co-Exclusive License) under the Licensed Patent Rights with
the right to sub-license, to develop, use and sell Licensed Product but only in
the IGK Field and Territory;
(b) an
exclusive sub-license in the IGK Field and Territory (except that in South
Africa it shall be a Co-Exclusive License) to use the Licensed Know-how, with
the right to sub-license, to develop, use and sell Licensed Product but only in
the IGK Field and Territory; and
(c) in
the case where the circumstances described in Clause 5.6 occur, CIMAB grants IGK
a non-exclusive sub-license in the IGK Field and Territory (except that in South
Africa it shall be a Co-Exclusive License) to manufacture or to have
manufactured for IGK and its Affiliates and sublicensees, the Licensed
Product.
6.1.2
In the event that CIMAB wishes to exercise its co-exclusive rights in
South Africa, it shall notify IGK of its intended activities in such country so
as to ensure that IGK's rights are not adversely affected.
6.2 Arising Intellectual
Property
6.2.1 Arising
Intellectual Property shall be owned by the Party (which for the purposes of
this Clause may include CIM and CIMAB) that invents or creates it, and if it is
jointly invented or created by IGK, one or more of the Parties it shall be owned
jointly by those Parties (IGK, Kalbe, CIM and CIMYM) in equal, undivided shares,
subject to the provisions of this Agreement including the following
provisions:
(a) It is
anticipated that Arising Know-how will be generated by clinicians and other
Persons in the course of, or arising from, clinical studies that have been
designed by the Joint Development Team. Accordingly, it is agreed that all
Arising Know-how developed in, or arising from, the work performed under the
Development and Commercialisation Plan shall be jointly owned by Parties in
equal, undivided shares, subject to the provisions of this
Agreement.
6.2.2
CIMAB and CIMYM hereby grants and agrees to grant to IGK an exclusive, fully
paid-up and royalty-free, license under Arising Intellectual Property in the IGK
Field and Territory, for the duration of this Agreement (and any extension
thereto) with the right to sub-license, to research, develop, make, have made,
import, use, sell and otherwise deal in any and all products and processes in
the IGK Field and Territory save and except that the grant made hereunder in
South Africa shall be a co-exclusive License, but only so long as the current
co-exclusive license (or any extension thereof) between the Government of South
Africa and CIMAB is in force.
6.2.3
IGK and its Affiliates hereby grant to CIMYM, CIMAB, and CIM an exclusive, fully
paid- up and royalty-free, perpetual license under IGK's Arising Intellectual
Property with a right to sub- license, research, develop, make, have made,
import, use, sell and otherwise deal in any and all products and processes in
the CIMYM Field and Territory.
6.3 Formal Licenses. If requested by
any of the Parties and at the requesting Party's administrative cost, the
Parties shall execute such formal licenses as may be necessary or appropriate
for registration with Patent Offices and other relevant authorities in the
Territory. In the event of any conflict in meaning between any such license and
the provisions of this Agreement, the provisions of this Agreement shall
prevail. The Parties shall use reasonable endeavours to ensure that, to the
extent permitted by relevant authorities, this Agreement shall not form part of
any public record.
6.4 Reservation of Rights within Field
and Territory. For the avoidance of doubt, CIMYM reserves the right
for itself and its licensees and assigns to use Licensed Product and the
Licensed Intellectual Property in the IGK Field and Territory with the prior
consent of IGK (a) for the purposes of research; and/or (b) for the purposes of
development (including clinical trials) of products with a view to obtaining
regulatory approval for such products in the CIMYM Field and Territory. If CIMYM
wishes to conduct research or development activities in the IGK Field and
Territory in accordance with the provisions of this Clause, it will so inform
IGK and give IGK a first opportunity to propose terms for an agreement with
CIMYM under which IGK would assist CIMYM with such activities at the cost
of CIMYM.
6.5 No Other License. It is
acknowledged and agreed that no license is granted by CIMYM to IGK other than
the sub-license(s) expressly granted by the provisions of this Clause 6. Without
prejudice to the generality of the foregoing, CIMYM reserves all rights under
the Licensed Intellectual Property in the CIMYM Field and
Territory.
6.6 Quality. IGK shall ensure
that all Licensed Product marketed by it is of satisfactory quality and complies
with all applicable laws and regulations in each part of the
Territory.
6.7 Acknowledgment by CIMAB.
CIMAB acknowledges and agrees that CIMYM has been granted the necessary rights
and licenses to enable it to grant the licenses and sub-licenses referred to in
Clause 6 of this Agreement.
7 Payments
7.1 IGK
shall pay to CIMYM a non-refundable, non-creditable upfront payment of
$1,000,000, within 30 days of receipt of invoice therefor after the Commencement
Date.
7.2 IGK
will pay to CIMYM the following non-refundable, non-creditable milestone
payments, within 30 days from the date of occurrence of each of the following
Events:
EVENT
|
PAYMENT
|
|||
First
Regulatory Approval within any Major Country as a treatment for
Glioma
|
$ | 500,000 | ||
First
Regulatory Approval within any Major Country as a treatment for any
indication other than Glioma (hereinafter "Indication 2'')
|
$ | 1,100,000 | ||
First
Regulatory Approval within any Major Country as a treatment for any
indication other than Indication 2 or Glioma (hereinafter "Indication
3")
|
$ | 1,100,000 | ||
First
Regulatory Approval within any Major Country as a treatment for any
indication other than Indication 2 or 3 or Glioma (hereinafter "Indication
4'')
|
$ | 1,100,000 |
If CIMYM
chooses to develop Licensed Product for additional indications that have not
been included
above,
upfront and milestone payment terms will be negotiated with IGK at an
appropriate time and if agreement is reached between the Parties, will be
incorporated into an amendment to this Agreement.
7.3 Royalties. IGK shall pay to
CIMYM a royalty of 15% (fifteen per cent) of Net Sales Value of Licensed
Product.
7.4 Payment Dates. Royalties due
under this Agreement shall be paid within 90 days of the end of each Calendar
Quarter, in respect of sales of Licensed Product made during such Calendar
Quarter, and final royalties shall be paid within 30 days of the final sale of
the Licensed Product but in any event no later than 7 months following
termination of this Agreement for any reason.
7.5 Payment Terms. All sums due
under this Agreement:
(a) shall
be paid in US dollars (or such other currency as the Parties may agree in
writing) and, in the case of sales received by IGK in a currency other than US
dollars, the income shall be calculated in the other currency and then converted
into equivalent US dollars at the purchasing rate for US dollars as quoted by
HSBC bank in Singapore, 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) all
sums payable by IGK hereunder shall be paid in full, without set-off or
counterclaim, including but not limited to any deduction or withholding taxes or
other liability imposed by any governmental authority or applicable law in the
Territory. In the case where IGK is required by applicable law in the Territory
to make any such deductions or withholding, IGK shall pay to CIMYM such
additional amount as will result in the receipt by CIMYM of the full amount
payable hereunder had such deduction or withholding not occurred or been
required;
(c) shall
be made 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 5% and
the outstanding amount is $1000, YM may charge $.42 per day interest on such
outstanding amount.
7.6 Exchange Controls, etc. If at
any time during the continuation of this Agreement IGK is prohibited from making
any of the payments required hereunder by a governmental authority in any
country then IGK will within the prescribed period for making the said payments
in the appropriate manner use its best endeavours to secure from the proper
authority in the relevant country permission to make the said payments and will
make them within 7 days of receiving such permission. If such permission is not
received within 30 days of IGK making a request for such permission then, at the
option of CIMYM, IGK shall deposit the royalty payments due in the currency of
the relevant country either in a bank account designated by CIMYM within such
country or such royalty payments shall be made to an associated company of CIMYM
designated by CIMYM and having offices in the relevant country.
7.7 Royalty Statements. IGK shall
send to CIMYM at the same time as each royalty payment is made in accordance
with Clause 7.3 a statement setting out, in respect of each country in the
Territory in which Licensed Product is sold, the types of Licensed Product sold,
the quantity of each type sold, and the total 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 royalty payment relates.
7.8 Records
7.8.1 IGK
and its Affiliates shall keep at its normal place of business detailed and up to
date records and accounts showing the quantity, description, Gross Sales Value
and Net Sales Value of 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 and the amount of Milestone Receipts
received by it in respect of Licensed Product, on a country-by-country basis,
and being sufficient to ascertain the payments due under this
Agreement.
7.8.2 IGK
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 IGK to CIMYM under this Agreement. The accountant
shall be required to keep confidential all information learned during any such
inspection, and to disclose to CIMYM only such details as may be necessary to
report on the accuracy of IGK's or its Affiliates statement or report. CIMYM
shall be responsible for the accountant's charges unless the accountant
certifies that there is an inaccuracy of more than 5% (five percent) in any
royalty statement, in which case IGK and its Affiliates shall pay his charges in
respect of that inspection. If the inspection shows that IGK or its Affiliates
owes a payment to CIMYM under this Agreement, IGK shall promptly make such
payment.
7.8.3 IGK
shall ensure that CIMYM has the same rights as those set out in this Clause 7.8
in respect of any Affiliate of IGK that is sub-licensed under Licensed
Intellectual Property pursuant to this Agreement.
8 Diligence
8.1 IGK
shall use Diligent and Reasonable Efforts to develop and commercially exploit
Licensed Product to the maximum extent throughout the Territory. Without
limiting IGK's obligations under the previous sentence of this Clause 8.1, IGK
shall develop and commercially exploit Licensed Product in accordance with the
Development and Commercialisation Plan.
9 Intellectual
Property
9.1 Obtain and Maintain the Licensed
Patent Rights
9.1.1 CIMYM
shall, at its cost and expense:
(a)
diligently seek to obtain valid patents in the name of CIM pursuant to each of
the Licensed Patent Rights; and
(b) pay
all prosecution, maintenance, and renewal fees in respect of the Licensed Patent
Rights as and when due;
provided
that if CIMYM elects to abandon any such application or not to maintain any
Licensed Patent (or to cease funding such application or patent) within IGK's
Field and Territory (collectively "Expiring Patents") it shall give 3 months'
prior written notice to IGK to permit IGK to maintain the Expiring Patents in
the name of CIM and IGK, failing which, IGK shall not have any continuing rights
under such Expiring Patents.
9.2 Obtain and Maintain the Arising
Patents
9.2.1 IGK
shall consult with CIMYM, CIM and CIMAB in relation to the filing and
maintenance of any Arising Patents ("Arising Patents"). CIMYM shall, or shall
ensure that its Affiliates or sub-licensees shall, at its own cost and
expense:
(a)
Diligently seek to obtain valid patents in the names of the inventing parties,
as specified in Clause 6.2.1, in countries agreed upon by CIMAB and CIMYM for
any Arising Inventions; and
(b) pay
all prosecution, maintenance, and renewal fees in respect of the Arising Patents
as and when due,
provided
that if CIMYM, its Affiliates or sub-licensees wish to abandon or not
maintain any such application or not to maintain any such Arising Patent (or to
cease funding such application or patent) (collectively "Abandoned Patents")
within the IGK Field and Territory, it shall give 3 months' prior written notice
to IGK and on the expiry of such notice period with respect to such Abandoned
Patents in the IGK Field and Territory, CIMYM shall assign all rights and
interest in such Abandoned Patents or patent application in question to be
assigned to IGK and CIMYM shall have no continuing rights under such Arising
Patents in the IGK Field and Territory.
9.2.2 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 in
the IGK Field and Territory. The Parties shall consult each other on the best
way to respond to such infringement.
IGK shall
be responsible, at its discretion, for taking action against infringers of the
Arising Patents in the IGK Field and Territory at its sale expense, and it shall
be entitled to retain any damages or other payments or benefits obtained by such
action in the IGK Field and Territory, after reimbursing CIMYM and CIMAB for any
reasonable out-of-pocket expenses incurred in assisting it in such action. If
IGK declines to take action, then CIMYM shall be entitled to take action against
the Third Party infringer at CIMYM's sole expense and CIMYM shall be entitled to
all damages or other sums received from such action, after reimbursing IGK for
any reasonable out-of-pocket expenses incurred in assisting it in such action.
If the alleged infringement is both within and outside the IGK Field and
Territory, the Parties shall also co-operate with CIMYM's and CIMAB's other
licensees (if any) in relation to any such action and shall divide the costs of
such action proportionately among IGK and CIMYM's and CIMAB's other licensees
who participate in such action. The apportionment of costs between licensees
shall be decided by CIMYM, acting reasonably.
9.3 Infringement of Third Party
Rights
9.3.1 If
any warning letter or other notice of infringement is received by a Party, or
legal suit or other action is brought against a Party, alleging infringement of
Third Party rights in the manufacture, use or sale of the Licensed Product or
use of any Licensed Patent Rights within the IGK Field and Territory, that Party
shall promptly provide full details to the other Party, and the Parties shall
discuss the best way to respond.
9.3.2 CIMYM
shall have the right but not the obligation to defend such suit and shall have
the right to settle with such Third Party, provided that if any action or
proposed settlement involves the making of any statement, express or implied,
concerning the validity of any Licensed Patent Rights within the IGK Field and
Territory, the consent of IGK must be obtained before taking such action or
making such settlement, such consent not to be unreasonably withheld or
delayed.
9.4 Third Party Intellectual
Property. For the avoidance of doubt IGK shall be solely responsible for
obtaining and paying for any additional licenses and other rights that may be
required to enable IGK or its Affiliates to commercialise Licensed Product in
the Territory. If the sale of the Licensed Product is found to infringe the
intellectual property rights of a Third Party, and results in the payment of
royalties or other compensation by IGK (or its Affiliates) to a Third Party
including legal fees, IGK may reduce us royalty payments to CIMYM under Clause
7.3 by 50% (fifty percent) of the royalties or other compensation paid to the
Third Party in respect of sales of Licensed Product in the Territory, subject to
the following conditions:
(a) The
royalty due from IGK to CIMYM on the sale of the Licensed Product shall not be
reduced below 12%; and
(b) Such
reductions shall only be made where the Third Party liability arises from the
use of the inventions claimed in the Licensed Patents and shall not be made in
respect of any other inventions, improvements or other features that IGK chooses
to incorporate into the Licensed Product.
9.5 Product Names. IGK may use
its own trade xxxx for the Licensed Product and shall be responsible for
deciding, in consultation with CIMYM, the trade xxxx to be applied to the
Licensed Product in the IGK Field and Territory. IGK will be responsible for
applying for any such trade xxxx in the Territory, at its sale cost. CIMYM
acknowledges that it has no objection to the trade xxxx "TheraCIM". CIMYM will
be responsible for applying for an international, non-proprietary name ("INN")
for the Licensed Product at its sale cost. IGK acknowledges that it has no
objection to the INN "NIMOTUZUMAB".
10 Representations,
Warranties and Liability
10.1 Representations and Warranties by
CIMYM. CIMYM represents and warrants that:
(a) it
has all requisite corporate power and authority to enter into and perform its
obligations pursuant to this Agreement and to grant the sub-licenses herein
granted;
(b) it
has not done, and will not do nor agree to do during the continuation of this
Agreement, any of the following things if to do so would be inconsistent with
the exercise by IGK of the rights granted to it under this Agreement,
namely:
(i) grant
or agree to grant any rights in the Licensed Patent Rights in the IGK Field and
Territory; or
(ii)
assign, mortgage, charge or otherwise transfer any of the Licensed Patent Rights
in the IGK Field and Territory;
(c) it is
not aware (but without having carried out any searches or investigations) that
any Third Party (other than CIMYM's licensor(s)) owns or claims any rights in
the Licensed Patent Rights;
(d) it is
a corporation incorporated and validly existing under the laws of its
jurisdiction of incorporation; and
(e) the
execution, delivery and performance of this Agreement by it have been duly and
validly authorized by all necessary corporate action on its part and this
Agreement is a legal, valid and binding obligation enforceable against it in
accordance with its terms, except as enforceability may be subject to
bankruptcy, insolvency and other laws affecting the rights of creditors
generally and except that equitable remedies may be granted only in the
discretion of a court of competent jurisdiction.
10.2 Representations and Warranties by
IGK and Kalbe. Kalbe and IGK jointly and severally represent, warrant and
undertake:
(a) that
IGK has, and will continue to have, sufficient financial and other resources to
fulfil its obligations under this Agreement;
(b) that
IGK has obtained all necessary authorisations from its supervisory board and
investors to use such resources and fulfil such obligations;
(c) IGK
has all requisite corporate power and authority to enter into and perform its
obligations pursuant to this Agreement;
(d) IGK
is a corporation incorporated and validly existing under the laws of its
jurisdiction of incorporation; and
(e) the
execution, delivery and performance of this Agreement by IGK have been duly and
validly authorized by all necessary corporate action on its part and this
Agreement is a legal, valid and binding obligation enforceable against it in
accordance with its terms, except as enforceability may be subject to
bankruptcy, insolvency and other laws affecting the rights of creditors
generally and except that equitable remedies may be granted only in the
discretion of a court of competent jurisdiction.
10.3 No Other
Warranties
10.3.1 Each
of IGK and CIMYM acknowledges that, in entering into this Agreement, it does not
do so in reliance on any representation, warranty or other provision except as
expressly provided in this Agreement, and any conditions, warranties or other
terms implied by statute or common law arc excluded from this Agreement to the
fullest extent permitted by law.
10.3.2 Without
limiting the scope of Clause 10.3.1, CIMYM does not give any warranty,
representation or undertaking:
(a) as to
the efficacy or usefulness of any of the Licensed Intellectual Property;
or
(b) that
any of the Licensed Patent Rights is or will be valid or subsisting or (in the
case of an application) will proceed to grant; or
(c) that
the use of any of the Licensed Intellectual Property, the manufacture, sale or
use of the Licensed Product or the exercise of any of the rights granted under
this Agreement will not infringe any other intellectual property or other rights
of any other person; or
(d) that
the Licensed Know-how or any other information or materials communicated or
provided by CIMYM to IGK under or in connection with this Agreement will produce
Licensed Product of satisfactory quality or fit for the purpose for which IGK
intended; or
(e) as
imposing any liability on CIMYM in the event that any Third Party supplies
Licensed Product to customers located in the Territory.
10.4
Indemnity and
Insurance. IGK shall indemnify and hold harmless CIMYM, CIM and (except
as otherwise provided in any Supply Agreement) CIMAB and their respective
Affiliates and their respective officers, directors, employees, consultants,
agents and representatives (the "Indemnitees") against all Third Party Claims
which may be asserted against or suffered by any of the Indemnitees and which
relate to:
(a) the
use of any Delivered Items; or
(b) the
manufacture, distribution, sale, supply or use of the Licensed Product or any
other products or services which incorporate any Delivered Items,
by or on
behalf of IGK or its Affiliates, or subsequently by any Third Party under
license from IGK, including without limitation Claims based on product liability
laws. For the duration of this Agreement, IGK shall maintain clinical trials and
product liability insurance with a reputable insurer in an amount not less than
the minimum amount required by law or best industry practice in each country of
the Territory (or, in any country, if no such law or practice exists in that
country, in an amount of at least $10,000,000) per Claim or series of
Claims).
10.4.1 At
the option of IGK, CIMYM will either (a) use commercially reasonable efforts to
seek extension of its (or its Affiliate, YM BioSciences, Inc.'s) current
clinical trial and product liability insurance to cover claims against IGK in
the amount of at least $10,000,000 aggregate limit or such higher amount as may
be required by law within the Territory, as IGK may be required to obtain
pursuant to Clause 10.4 ("Insurance Coverage"), at the best commercially
available policy premium; and in such a case, IGK will bear the premium for such
extension; or (b) use commercially reasonable efforts to assist IGK to obtain
Insurance Coverage on the best commercially reasonable terms.
10.5 Limitation of Liability.
Subject to Clause 10.4, but notwithstanding any other provision of this
Agreement, no Party shall be liable to any other Party to this Agreement in
contract, tort, negligence, breach of statutory duty or otherwise for Claims of
any nature whatsoever incurred or suffered by that other party or its Affiliates
of an indirect or consequential nature including without limitation any economic
loss or other loss of turnover, profits, business or goodwill.
11 Duration
and Termination
11.1 Commencement and Termination by
Expiry. This Agreement, and the rights granted hereunder, shall come into
effect on the Commencement Date and, unless terminated earlier in accordance
with this Clause 11, shall continue in force in each country in the Territory
until the latest of the fifteenth anniversary of the date of the first
commercial sale of Licensed Product in such country in the Territory by IGK or
its Affiliates or the date when all Licensed Patent Rights have expired or been
abandoned in accordance with the provisions of this Agreement, whichever is
later; and on such date this Agreement and the rights granted hereunder shall
terminate automatically by expiry.
11.2 Early
Termination
11.2.1 IGK
may terminate this Agreement at any time on 120 days’ notice in
writing to CIMYM.
11.2.2 Without
prejudice to any other right or remedy, either of CIMYM or IGK may terminate
this Agreement at any time by notice in writing to the other of them ("Other
Party"), such notice to take effect as specified in the notice:
(a) if
the Other Party (which in the case of IGK shall include any Affiliate of IGK) is
in material breach of this Agreement and. in the case of a breach capable of
remedy within 60 days, the breach is not remedied within 60 days of the Other
Party receiving notice specifying the breach and requiring its remedy;
or
(b) if
the Other Party (which in the case of IGK shall include any Affiliate of IGK)
becomes insolvent, or if an order is made or a resolution is passed for the
winding up of the Other Party (other than voluntarily for the purpose of solvent
amalgamation or reconstruction), or if an administrator, administrative receiver
or receiver is appointed in respect of the whole or any part of the Other
Party's assets or business, or if the Other Party makes any composition or
proposal with its creditors or takes or suffers any similar or analogous action
in consequence of debt; or
(c) if
the first Phase II clinical trial for the Licensed Product within the Field in
the Territory has not commenced within a period of one and a half years after
the Commencement Date; or
(d) if
the first Regulatory Approval for marketing the Licensed Product within the
Field in the Territory is not obtained within a period of four (4) years after
the Commencement Date while all the required documentation has been supplied by
CIMYIM and CIMAB to IGK in a timely manner.
11.2.3 CIMYM
may forthwith terminate this Agreement by giving written notice to IGK if IGK or
any of its Affiliates commences legal proceedings, or assists any Third Party to
commence legal proceedings, to challenge the validity of any of the
Patents.
11.2.4 The
Parties acknowledge and agree that IGK's remedy for any breach by CIMAB of its
obligations under Clause 5 shall be as set out in any Supply Agreement that
CIMYM and IGK may execute pursuant to Clause 5.4. Accordingly, breach of Clause
5 shall not entitle any Party to terminate this Agreement.
11.3 Consequence of
Termination
11.3.1 Upon
termination or expiration of this Agreement for any reason:
(a) If
termination occurs after the first commercial sale of Licensed Product, IGK
shall be entitled to sell, use or otherwise dispose of (subject to payment of
royalties under Clause 7.3) any unsold or unused stocks of the Licensed Product
for a period of 6 months following the date of termination following which it
must destroy al1 such Licensed Product; and if termination occurs prior to the
first commercial sale of Licensed Product, IGK shall forthwith return all such
stocks of Licensed Product and Licensed Know-how to CIMYM at IGK's sale
expense;
(b)
subject to paragraph (a) above, IGK 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 Arising Intellectual Property;
(c)
subject to paragraph (a) above, IGK shall consent to the cancellation of any
formal sub-license granted to it, or of any registration of it in any register,
in relation to any of the Licensed Patent Rights;
(d) the
provisions of Clause 4, except Clause 4.1 and 4.2 shall survive termination and
continue in force for a period of five years after the effective date of
termination, where applicable. For clarification, IGK and its Affiliates shall
have no further right to use Licensed Know-how following termination or
expiration of this Agreement;
(e) the
provisions of Clauses 4, 6.2.3, 7, 10, and 12 are intended to survive the
termination or expiry of this Agreement and shall survive the termination or
expiration of this Agreement; and
(f) any
and all rights and obligations accrued under this Agreement prior to termination
or expiration shall survive. Notwithstanding the foregoing, neither Party shall
be under any further obligation to the other and CIM and CIMYM shall have the
right to issue licenses under the License Patent Rights to any Third Party
within IGK's Field and Territory.
(g) IGK
shall cease and shall cause any Third Party Manufacturer to cease manufacture of
Licensed Product and destroy any materials used in the production or manufacture
of Licensed Product within thirty (30) days.
11.3.2 Upon
termination of this Agreement for any reason otherwise than (i) in accordance
with Clause 11.1 or (ii) because or due to the breach of this Agreement by
CIMYM, at CIMYM's request, IGK shall:
(a)
transfer to CIMYM all clinical and other data relating to the development of
Licensed Product;
(b) to
the extent possible, seek to have any Regulatory Approvals (including without
limitation product licenses and pricing approvals) and other permits and
applications transferred into the name of CIMYM or its nominee;
(c) grant
CIMYM an exclusive, perpetual, fully paid up, royalty free, worldwide license,
with the rights to grant sub-licenses without the consent of IGK, under all
Arising Intellectual Property jointly owned by the Parties; and
(d) grant
CIMYM or its nominee the right to continue to use any product name that had been
applied to the Licensed Product prior to termination of this
Agreement.
12 General
12.1 Force Majeure. None of the
Parties shall be liable for any loss, injury, delay, damage or other casualty
suffered or incurred by any other Party due to strikes, lockouts, labour
disputes, riots, storms, fires, explosions, acts of God, war or any other causes
that are beyond the reasonable control of that Party (each, a "Force Majeure
Event"), and failure or delay by a Party in performance of any of its
obligations under the Agreement due to one or more Force Majeure Events shall
not be considered a breach of this Agreement.
The Party
whose performance is affected by a Force Majeure Event shall make reasonable
efforts to remedy the situation and remove, so far as possible, and with
reasonable dispatch, the cause of its inability to perform or comply, provided
however, that settlement of labour disputes, strikes, and lockouts shall be
wholly within the discretion of the Party involved.
If a
Force Majeure Event exists for more than ten (10) consecutive days, the Parties
shall meet to negotiate a mutually satisfactory solution to the problem. Nothing
herein shall relieve the Parties of their obligations to make payments when due
hereunder.
12.2 Language and Amendment. This
Agreement is made in the English language and may only be amended in the English
language in writing signed by duly authorised representatives of the Parties. In
the event of any conflict in meaning between the English language version and
any translation of this Agreement, the English language version shall
prevail.
12.3 Assignment and Third Party
Rights
12.3.1 Subject
to Clause 12.3.2 below, no Party shall assign, mortgage, charge or otherwise
transfer any rights or obligations under this Agreement, nor any of the Patents
or rights under the Patents, without the prior written consent of the other
Parties.
12.3.2 With
the prior written consent of the other Parties, a Party may assign all its
rights and obligations under this Agreement together with its rights in the
Patents to any company to which it transfers all or substantially all of its
assets or business in the Field, provided that the assignee undertakes to the
other Party to be bound by and perform the obligations of the assignor under
this Agreement.
12.4 Waiver. No failure or delay
on the part of either Party to exercise any right or remedy under this Agreement
shall be construed or operate as a waiver thereof, nor shall any single or
partial exercise of any right or remedy preclude the further exercise of such
right or remedy.
12.5 Invalid Clauses. lf any of
the within terms, conditions or provisions or the application thereof to any
Person or circumstance shall at any time or to any extent, be invalid or
unenforceable at law such term, condition, or provisions shall be severed from
the remainder hereof which shall be affected thereby, and each and every time
and in each and every circumstance in which reference is made hereto each term,
covenant, condition and provision hereof shall be valid and be enforced to the
fullest extent permitted by law.
12.6 No Agency. Neither Party
shall act or describe itself as the agent of the other, nor shall it make or
represent that it has authority to make any commitments on the other's
behalf.
12.7 Interpretation. In this
Agreement:
(a) the
headings are used for convenience only and shall not affect its
interpretation;
(b)
references to persons shall include incorporated and unincorporated persons;
references to the singular include the plural and vice versa; and references to
the masculine include the feminine;
(c)
references to Clauses and Schedules mean clauses of, and schedules to, this
Agreement;
(d)
references to any Party shall include their permitted successors and permitted
assignees;
(e)
references to any license shall mean, where the context requires, a
sub-license;
(f) where
the word "including" is used, it shall be understood as meaning "including
without limitation"; and
(g)
references to the grant of "exclusive" rights shall mean that the person
granting the rights shall neither grant the same rights (in the same Field and
Territory and in respect of the same Licensed Product) to any other person, nor
exercise those rights directly to the extent that and for as long as the
Licensed Product is within Valid Claims of unexpired Licensed Patent Rights or,
to the extent that the Licensed Product is protected by Licensed Know-how that
have not become known and available to the public.
12.8 Notices
12.8.1 Any
notice to be given under this Agreement shall be in writing and shall be sent by
first class mail, air mail or by courier, or by fax (confirmed by first class
mail or air mail) to the address of the relevant Party set out at the head of
this Agreement, or to the relevant fax number set out below, or such other
address or fax number as that Party may from time to time notify to the other
Party in accordance with this Clause 12.8. The fax numbers of the Parties are as
follows:
Party
|
Fax
number
|
CIMYM
|
000
000 000 0000
|
CIMAB
|
0053
7 273 3509
|
IGK
|
x000000000000
|
12.8.2 Notices
sent as above shall be deemed to have been received three working days after the
day of posting (in the case of inland first class mail or national courier), or
seven working days after the date of posting (in the case of air mail or
international courier), or on the next working day after transmission (in the
case of fax messages, but only if a transmission report is generated by the
sender's fax machine recording a message from the recipient's fax machine,
confirming that the fax was sent to the number indicated above and confirming
that all pages were successfully transmitted).
12.9 Law, Dispute Resolution. The
validity, construction and performance of this Agreement shall be governed by
English law. Any dispute arising out of or in connection with this Agreement
shall first be referred to the Joint Development Team for resolution. If the
Joint Development Team is unable or unwilling to resolve such dispute within 30
days of the dispute being referred to it, the dispute shall be referred to the
Chief Executive Officers of the Parties in dispute for resolution. If the Chief
Executive Officers of the Parties in dispute are unable or unwilling to resolve
such dispute within 28 days of the dispute being referred to them, either
Development Team Party may refer the dispute to mediation in accordance with the
Model Mediation Procedure of the Centre for Effective Dispute Resolution
("CEDR") in London. Unless otherwise agreed by the Development Team Parties, the
mediator will be nominated by CEDR. To initiate the mediation procedure, a
Development Team Party must give notice in writing (“ADR Notice”) to the other
parties to the dispute, requesting mediation. A copy of the request should also
be sent to CEDR. The mediation will start not later than 28 days after the date
of the ADR Notice. If the Parties are unable to resolve the dispute through
mediation, or none of the Parties refers the dispute to mediation, the dispute
shall be referred to and finally resolved by arbitration by a single arbitrator
in London under the Rules of the London Court of International Arbitration (the
"Rules"), which Rules are deemed to be incorporated by reference into this
Clause. The language to be used in the arbitral proceedings shall be English and
the place of arbitration shall be London, UK. The arbitrator shall be chosen by
the Parties or, failing agreement as to the choice of arbitrator within 28 days
of one Party requesting that an arbitrator by chosen, appointed in accordance
with the Rules. However, nothing in this Agreement shall prevent a Party from
seeking an interim injunction or other equitable remedy in any court of
competent jurisdiction.
12.10 Further Action. Each Party
agrees to execute, acknowledge and deliver such further instruments, and do all
further similar acts, as may be necessary or appropriate to carry out the
purposes and intent of this Agreement.
12.11 Announcements. Neither Party
shall make any press or other public announcement concerning any aspect of this
Agreement, or make any use of the name of the other Party in connection with or
in consequence of this Agreement, without the prior written consent of the other
Party, except as may be required by law or by the rules of any stock exchange on
which either Party is listed. The Parties shall agree a form of press release
for issue on signature of this Agreement.
12.12 Entire Agreement. This
Agreement, including its Schedules, sets out the entire agreement between the
Parties relating to its subject matter and supersedes all prior oral or written
agreements, arrangements or understandings between them relating to such subject
matter. The Parties acknowledge that they are not relying on any representation,
agreement, term or condition that is not set out in this Agreement. Nothing in
this Agreement excludes liability for fraud.
12.13 Third Party Rights. This
Agreement is not made for the benefit of, nor shall any of its provisions be
enforceable by, any person other than the parties to this Agreement and their
respective successors and permitted assignees.
12.14 Non-compete. IGK and its
Affiliates warrants, represents, acknowledges and agrees, in respect of it and
its Affiliates, that:
(a) they
do not have any interest in any technology that competes with the Licensed
Intellectual Property, nor is any of them engaged in any research or development
activities with respect to any product that would compete with the Licensed
Products; and
(b) for
so long as this Agreement remains in force and for a period of one (1) year
thereafter, they will not enter into any agreement with any Person other than
CIMAB or CIMYM for the development or marketing of any product that is, or
contains, (i) any other anti-EGF-receptor inhibitor, (ii) any product or
component or sequence of EGF-R, EGF-R ligands, or any small molecule tyrosine
kinase inhibitor, or (iii) covered under the scope of any Licensed Patent Rights
or Licensed Know-how, unless specifically authorized by each of/all of CIMAB,
CIMYM and Affiliates if applicable.
Agreed by the Parties through
their authorised signatories:
For and
on behalf of CIMYM,
Inc.
signed
|
signed
|
Xxxxx
G.P. Xxxxx
|
Xxxx
E.L. Xxxxxxxx
|
Director
|
Director,
Corporation Development
|
date
31-Oct -05
|
date
31-Oct-05
|
For
and on behalf of CIMAB
S.A.
|
|
signed
|
signed
|
Xxxxxx
Xxxxxxx Xxxxxxx
|
Nornando
Xxxxxx-Xxxxxxx
|
General
Manager
|
Head,
Division of Business and Development
|
date
|
date
19-Dec-05
|
For
and on behalf of
|
For
and on behalf of
|
Innogene
Kalbiotech Private Limited
|
P.T.
Kalbe Farma, Tbk
|
signed
|
signed
|
Rikrik
IIyas
|
Xxxxxxxx
Xxxxxxxx
|
Director
|
President
Director
|
date
11-Nov-05
|
date
11-Nov-05
|
Schedule
I
Licensed
Patent Rights
The
patents and patent applications listed in this Schedule are, or may become,
relevant to this Agreement, but they also contain other rights not licensed
under this Agreement. Thus their inclusion here is limited to the extent if any
that they would protect the exploitation of Licensed Product for use within the
IGK Field and in the Territory.
PCT/CU2003/000012.
Patent
Numbers:
Thailand:
|
To
Be Determined
|
Malaysia:
|
To
Be Determined
|
Singapore:
|
200502422-9
|
Indonesia:
|
200501212
|
Philippines:
|
To
Be Determined
|
Taiwan:
|
To
Be Determined
|
South
Africa:
|
To
Be Determined
|
Myanmar:
|
To
Be Determined
|
Laos:
|
To
Be Determined
|
Cambodia:
|
To
Be Determined
|
Brunei:
|
To
Be Determined
|
Republic
of Congo
|
To
Be Determined
|
Nigeria
|
To
Be Determined
|
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 YM BioSciences, Inc. to the Health
Protection and Food Branch of Health Canada in connection with an application
for an Investigational New Drug Submission for the Licensed Product in
Canada.
2. All
preclinical, clinical trial and manufacturing data generated by
CIMAB.
3. Any
additional data submitted to Korean FDA.
4. Any
additional data submitted to EMEA.
5. Any
additional data submitted to the Indian regulatory authority.
6. Any
additional data submitted to the Chinese regulatory authority.
7. Any
other data submitted to any regulatory authority by current and future sub-
licensees of the Licensed Product, subject to any confidentiality obligations to
Third Parties if applicable.
Schedule
3
Initial
Development and Commercialisation Plan
Part
A: Initial Development Program
The
development program will include:
1. IGK
will run a study in Head & Neck cancer in the local population. It is
provisionally estimated that the study will be a non-randomized study combining
radiation with TheraCIM in 40 patients.
2. New
indications to be determined.