Contract
(1)
CIMYM, Inc.
(2)
CIMAB S.A.
And
(3)
Oncoscience AG
Amended
and Restated
Relating
to TheraCIM h-R3
This Amended and Restated Development
and Licence Agreement (this “Agreement”) dated 15 August 2007 is made
between:
(1)
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CIMYM,
Inc. (company
registration number 12142) (“CIMYM”), a company incorporated in Barbados,
whose principal place of business is at Sagicor Centre, Xxxxxx, St.
Xxxxxxx, Barbados, West Indies;
and
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(2)
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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/ 00 x 00,
Xxxxxx, Xxxxx, Xxxxxx Xxxx, Xxxx;
and
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(3)
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Oncoscience
AG (company
registration number HRB 5414) (“Oncoscience”) a company incorporated in
Germany, whose principal place of business is at Xxxxxxxxxxx 00, 00000
Xxxxx, Xxxxxxx.
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Recitals:
A.
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The Parties entered into a
development and licence agreement dated 17 November 2003 (the “Original
Agreement”).
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B.
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The Parties wish to enter into
this Agreement for the purposes of wholly replacing and superseding the
Original Agreement.
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C.
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CIMYM is the exclusive licensee
of certain Licensed Patent Rights, certain Licensed Know-how (each as
defined below) relating to an antibody known as TheraCIM h-R3 (as defined
below).
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D.
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The shareholders of CIMYM are YM
Biosciences, Inc. and CIMAB.
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E.
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CIMAB enters into commercial
agreements on behalf of the Center of Molecular Immunology (“CIM”, as
defined below). CIM originally developed TheraCIM h-R3 and has the
facilities to manufacture Licensed Products (as defined below). CIMAB is
entering into this Agreement principally in order to assume the
manufacturing and supply obligations set out in Clause
5.
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F.
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Oncoscience has expertise in
cancer immunotherapy and experience in conducting immunotherapy clinical
trials in cancer patients.
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G.
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Oncoscience wishes to pursue the
further development and commercialisation of TheraCIM h-R3 for the
treatment of cancer in humans, in accordance with the provisions of this
Agreement.
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H.
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CIMYM is willing to grant to
Oncoscience, and Oncoscience is willing to accept, a licence in the Field
under the Licensed Patent Rights and to use the Licensed Know-how, all in
accordance with the provisions of this
Agreement.
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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
Oncoscience, 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 Oncoscienee or its
Affiliates or sub-licensees during the continuation of this Agreement that
relates to any of the Licensed Intellectual Property or the Licensed
Product, including any scientific or regulatory data (including clinical
data), product licence applications and approvals, clinical trial licence
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 Oncoscience, its
Affiliates or sub-licensees during the continuation of this Agreement and
which relate to any Licensed Intellectual Property or the Licensed
Product, together with any continuations, continuations in part,
extensions, re-issues, 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 3lst
December.
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Calendar
Year
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A
year commencing on lst
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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2
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 legal costs) incurred in
connection therewith.
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Co-exclusive
Licence
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A licence
whereby:
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(a)
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both CIMAB and Oncoscienee may
exercise the licensed rights in the field and territory of the licence in
question
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(b)
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Oncoscience may grant
sub-licences to the extent permitted under Clause 6.4;
and
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(c)
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CIMAB may appoint a single,
further licensee from time to time in each part of such field and
territory to exercise such rights in its place,
but
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(d)
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except as described in (c) above
CIMAB may not grant further licences in such field and territory for as
long as the co-exclusive licence continues, subject to the provisions of
this Agreement and the requirements of any applicable
law.
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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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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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The development and
commercialisation plan for Licensed Product to be defined and agreed in
accordance with Clause 3.1, as amended from time to time by agreement in
writing of the Parties. An initial programme of work, which is anticipated
to form the basis of a more detailed Development and Commercialisation
Plan, is briefly summarised in the attached Schedule
3.
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Development
and Commercialisation 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 Oncoscience, and
“Development Team Party” shall mean either of
them.
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Development
Term
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In respect of each country in the
Territory, means the period from the Commencement Date until completion of
the development of TheraCIM h-R3 to the point of first commercial sale of
a Licensed Product in that country 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 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
to the Parties from its
commercialisation.
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3
Field
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The treatment of cancer in
humans.
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Gross Sales
Value
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Any and all amounts received
(including the value of any non-monetary consideration received) for the
sale of the Licensed Product by Oncoscience or its Affiliates from a third
party (including any of Oncoscience’s sub-licensees) in an arm’s length
transaction exclusively for money (or where the sale is not at arm’s
length, the price that would have been so invoiced and received if it had
been at arm’s length), after deduction of all
documented:
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(a)
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normal trade discounts actually
granted and any credits actually given (including for rejected or returned
Licensed Product),
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(b)
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rebates to customers and third
parties,
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(c)
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provided the amounts are
separately charged on the relevant invoice any costs of packaging,
insurance, carriage and
freight,
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(d)
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any value added tax or other
sales or use tax charged to the
customer
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(e)
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any import or export duties or
similar applicable government levies; provided that such deductions do not
exceed reasonable and customary amounts in the markets in which such sales
occurred;
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provided
that in no event the total of deductions referred to in paragraphs (a) to
(e) above will exceed 10% (ten percent) of the total
invoice.
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Initial
Development Programme
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A programme of development to be
conducted by Oncoscience in accordance with the provisions of 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 Licensed
Know-how.
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Licensed
Know-how
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Technical information in the
possession of CIMYM or CIMAB in the Field relating to (a) TheraCIM h-R3
and/or (b) the inventions claimed in the Licensed Patent Rights, and being
further described in the attached Schedule 2, in each case to the extent
that such information is relevant to the development and commercialisation
of the Licensed Product.
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4
Licensed
Patent Rights
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The patents and patent
applications described in the attached Schedule 1 subject to the
provisions of Schedule 1, together with any continuations, continuations
in part, extensions, reissues, divisions, and any patents, supplementary
protection certificates and similar rights that are based on or derive
priority from the foregoing.
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Licensed
Product
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TheraCIM h-R3 that is sold or
otherwise supplied by Oncoscience or its Affiliate or sub-licensee and
which (a) is within any Valid Claim of the Licensed Patent Rights and/or
(b) is the subject of any Orphan Drug Status in the Territory; and/or (c)
incorporates, or its development makes use of, any of the Licensed
Know-how.
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Major
Country
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Germany, France, Italy, Spain or
the United Kingdom.
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Milestone
Receipts
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The amount of any payment,
excluding Value Added Tax, (other than sales income on which Oncoscience
pays CIMYM a royalty under Clause 7.1 or 7.2, including any payments to
Oncoscience or its Affiliate for Licensed Product supplied directly by
Oncoscience or its Affiliate for sale or promotion by Oncoscience’s
Affiliates or sub-licensees) obtained by, or due to, Oncoscience or its
Affiliate and the value of any non-monetary receipt, in relation to the
development or sub-licensing (including the grant of any option over a
sub-licence) of any Licensed Intellectual Property (“Relevant
Transaction”), and including any of the following in relation to a
Relevant Transaction:
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(a)
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up-front, licence, milestone
(whether at the stage of development, marketing or otherwise), success,
bonus, maintenance and periodic (including annual) fees and other
payments, and minimum royalty payments (to the extent not offset against
royalties based on sales and coming within the definition of Royalty
Receipts), due under any sub-licence
agreement;
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(b)
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any receipt greater than actual
incurred cost in respect of the funding of research or development
activities related to the Licensed Product, provided that such incurred
costs shall not include any costs that were incurred prior to the date of
the agreement under which such funding was
provided;
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(c)
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where any sub-licence is to be
granted under cross-licensing arrangements, the value of any third party
licence obtained under such
arrangements;
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(d)
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any premium paid over the fair
market value of shares, options or other securities in respect of any of
the share capital of Oncoscience or its Affiliate (such fair market value
to be determined on the assumption that CIMYM had not granted, nor agreed
to grant, any rights to Oncoscience in respect of any Licensed
Intellectual Property);
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(e)
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any loan, guarantee or other
financial benefit made or given other than on normal market terms;
and
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5
(f)
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any shares, options or other
securities obtained from a third
party.
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Net Sales
Value
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The Gross Sales Value after
deduction of the Supply
Price.
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Oncoscience
Field and Territory
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In respect of any activity that
is licensed to Oncoscience under this Agreement, shall mean that the
activity must occur both within the Field and within the
Territory.
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Orphan Drug
Status
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The grant of “orphan designation”
by the European Commission for a medicinal product pursuant to Regulation
(EC) No. 141/2000 of 16 December 1999 or any similar designation in any
part of the Territory.
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Parties
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CIMYM, CIMAB and Oncoscience, 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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Payment
Cap
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Has the meaning given in Clause
7.1.
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Providing
Parties
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Any and all 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 Regulatory Approval including, without
limitation, all required documents, data and information concerning, filed
or required to be filed, otherwise submitted by Oncoscience, its Affiliate
or licensee to a Regulatory
Authority.
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Regulatory
Approval
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Any and all approvals, licences,
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 European Medicines Evaluation
Agency and other regulatory authorities in the
Territory.
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Supply
Agreement
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Any agreement between CIMAB and
Oncoscience under which CIMAB agrees to manufacture and supply Oncoscience
with Licensed Product.
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Supply
Price
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The commercial supply price for
the Licensed Product payable by Oncoscience to CIMAB in accordance with
Clause 5.2.
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6
Territory
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Shall mean the following
countries and territories: Austria, Belgium, Denmark, Finland, France,
Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, The
Netherlands, United Kingdom, Cyprus, Czech Republic, Estonia, Hungary,
Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, Bulgaria, Romania,
Turkey, Albania, Andorra, Belarus, Bosnia-Herzegovina, Croatia, Former
Yugoslav Republic of Macedonia, Iceland, Xxxxxxxxxxxxx, Xxxxxxx, Xxxxxx,
Xxxxxx, Xxxxxx, Xxx Xxxxxx, Xxxxxx and Montenegro, Switzerland, Ukraine
and Vatican City.
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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
product name TheraCIM h-R3.
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Third Party
Manufacturer
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Has the meaning given in Clause
5.4.
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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.
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Joint Development
Team
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2.1
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Formation. Within fifteen (15) days after
the Commencement Date, the Development Team Parties shall establish a
Joint Development Team, by each Development Team Party designating its
initial members to serve on the Joint Development Team and notifying the
other Development Team Party of its dates of availability for the first
meeting of the Joint Development Team. The purpose of the Joint
Development Team shall be to oversee the development of Licensed Product
for purposes of commercialisation in the Oncoscience 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.
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2.2
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Meetings. The Joint Development Team
shall meet quarterly 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 30 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.
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7
2.3
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Responsibilities. During the Development Term,
the Joint Development Team
shall:
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(a)
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elaborate the Development
Commercialisation Plan in accordance with Clause
3.1
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(b)
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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 Oncoscience 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);
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(c)
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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);
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(d)
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facilitate the transfer of
Know-How between the Parties for purposes of conducting the Development
and Commercialisation Plan;
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(e)
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regularly assess the progress of
Oncoscience in its conduct of the Development and Commercialisation Plan;
and
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(f)
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perform such other activities as
are contemplated under this Clause 2 and Clause 1. For the avoidance of
doubt the Joint Development Team shall not have any role or responsibility
in relation to determining whether Oncoscience has complied or will comply
with its obligations to CIMYM under Clauses 3 or
8.
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2.4
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Disputes. If agreement cannot be reached
within the Joint Development Team, Oncoscience shall have the right to
make the final determination concerning the resolution of the
disagreement. Notwithstanding the foregoing, in the case of a disagreement
involving a material matter, prior to invoking its rights under this
Clause 2.4, Oncoscience 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 Oncoscience, 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), Oncoscience 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
achieved by the required time for resolution and (ii) in the event that a
consensus has not been achieved within ten (10) days of the date on which
contact is initiated by the executive officer of Oncoscience, Oncoscience
shall have the right to make the final determination. For the avoidance of
doubt, Oncoscience shall not have any right, under this clause, to
determine whether it has complied or will comply with its obligations to
CIMYM under Clauses 2.4 or
8.
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3.
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Development and
Commercialisation
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3.1
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Development
and Commercialisation Plan.
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3.1.1
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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 set out in Schedule 3 and will describe, and provide a
timeline for:
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8
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(a)
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all development activities for
the Licensed Product in the Oncoscience 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;
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(b)
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intellectual property protection
strategy, including applying for Orphan Drug Status, patents and
supplementary protection
certificates
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(c)
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sub-licensing
strategy;
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(d)
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clinical and registration
strategy, with a view to expediting regulatory approval for Licensed
Product; and
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(e)
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commercialisation
strategy.
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3.1.2
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The Joint Development Team shall
update the Development and Commercialisation Plan on a regular basis (and
at least annually).
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3.2
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Development
and commercialisation activities. Oncoscience shall be
responsible for the development and commercialisation (in accordance with
the Development and Commercialisation Plan) of the Licensed Product in the
Oncoscience 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.
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3.3
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Development
and commercialisation costs. Oncoscience shall bear all
costs associated with the development and commercialisation of Licensed
Product in the Oncoscience Field and Territory, including costs incurred
in the Development and Commercialisation Plan. If any Providing Party
agrees with Oncoscience 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 Oncoscience, with the time costs of the Providing
Party’s representatives being charged to Oncoscience on a daily rate
basis. The Providing Party’s daily rate for its representatives in the
work referred to in the previous sentence shall be agreed between the
Parties or, if they are unable to agree, the rate shall be US$ 1,000 (one
thousand US dollars) per day plus any product-related consumable costs and
external costs associated with such
work.
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3.4
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Reporting. Without prejudice to the
generality of Oncoscience’s obligations under Clauses 8.1 and 9.2,
Oncoscience shall provide a report (“Development and Commercialisation
Report”) to CIMYM at least annually to CIMYM. In addition, Oncoscience
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 Oncoscience to bring Licensed Product to market
and maximise the sale of Licensed Product in the Oncoscience Field and
Territory, and including details of all Arising Intellectual Property.
CIMYM’s receipt or approval of any such report shall not be taken to waive
or qualify Oncoscience’s obligations under Clause
8.1.
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3.5
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Exchange of
data. It is CIMYM’s
or CIMAB’s intention to grant licences to commercialise TheraCIM h-R3 in
the CIMYM Field and Territory. Accordingly, each of the Parties or its
licensee(s), may generate data in relation to Licensed Products that is
useful to the other Parties in connection with their commercialisation of
Licensed Products. To facilitate such commercialisation, Oncoscience shall
disclose and provide to CIMYM and CIMAB all Arising Intellectual Property
in accordance with the provisions of Clause 3.4. CIMYM (or CIMAB as
applicable) and Oncoscience shall use reasonable efforts to reach
agreement with CIMYM’s (or CIMAB’s as applicable) other licensee(s) of
TheraCIM h-R3 for the disclosure to Oncoscience of clinical data in
respect of TheraCIM h-R3 that is generated by such
licensee(s).
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9
4.
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Know-how and Confidential
Information
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4.1
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Provision of
Know-how. Upon
Oncoscience’s reasonable request, CIMYM shall supply Oncoscience with all
Licensed Know-how in its possession that is specifically relevant to the
development and commercialisation of TheraCIM h-R3 and that CIMYM is at
liberty to disclose and has not previously been disclosed and which is
reasonable necessary to enable Oncoscience to undertake the further
development of Licensed Product. The Licensed Know-how shall be subject to
the confidentiality provisions of Clause 4.4. The method of any such
supply shall be as specified in Schedule 2 but shall not require CIMYM to
undertake more than 5 man-days of work, unless otherwise agreed in writing
between the Parties.
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4.2
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Status of
Know-how.
Oncoscience 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”) 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.
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4.3
|
Use of
Know-how.
Oncoscience undertakes that for a period of 10 years from the date of
first commercial sale of Licensed Product in the Territory or for so long
as any substantial part of the Know-how remains subject to the obligations
of confidence of Clause 4.4, whichever is the shorter, it will not use the
Licensed Know-how for any purpose except as expressly licensed hereby and
in accordance with the provisions of this
Agreement.
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4.4
|
Confidentiality
obligations. Each
Party (“Receiving Party”)
undertakes:
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(a)
|
to maintain as secret and
confidential all Know-how and other technical or commercial 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,
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(b)
|
to use the same exclusively for
the purposes of this Agreement,
and
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(c)
|
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.
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10
4.5
|
Exceptions to
obligations. The
provisions of Clause 4.4 shall not apply to Know-how and other information
which the Receiving Party can demonstrate by reasonable, written
evidence:
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(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 confidence by a third party who
has not derived it directly or indirectly from the Disclosing Party;
or
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(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.
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4.6
|
Disclosure to
court, etc. If the
Receiving Party is 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 4.4, provided that the Receiving Party shall (i) inform the
Disclosing Party as soon as is reasonably practicable, and (ii) at the
Disclosing Party’s request 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 procure 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 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 which
apply to the Disclosing Party’s
information.
|
5.
|
Manufacturing and
supply
|
5.1
|
Clinical
supply. CIMAB shall
supply to Oncoscience, and Oncoscience shall purchase from CIMAB, for its
own use and that of its Affiliates and sub-licensees, in finished form
with one hundred percent (100%) of Oncoscience’ s requirements of TheraCIM
h-R3 and Licensed Product for all clinical development purposes. Such
clinical requirements shall be supplied to
Oncoscience:
|
|
(a)
|
In respect of Oncoscience’s
requirements for clinical trials for the purposes of seeking Regulatory
Approvals in the Field in the Territory, at a supply price of US$ 500
(five hundred US dollars) per gram. Payment will be made 50% in advance
for each instalment of 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
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), a
supply price equal to US$1,100 (one thousand one hundred US dollars) per
gram.
|
11
5.2
|
Commercial
Supply.
|
5.2.1
|
CIMAB shall supply to
Oncoscience, and Oncoscience shall purchase from CIMAB, as active
pharmaceutical ingredient, or if the Parties mutually agree at the time of
entering into the supply agreement described in Clause 5.5, in finished
form with one hundred percent (100%) of Oncoscience’s requirements of
Licensed Products for all commercial purposes. CIMAB may elect to have
such requirements supplied to Oncoscience by one or more of CIMAB’s
Contract Manufacturer(s). In such case, the supply agreement to be entered
into shall be concluded nonetheless between Oncoscience and CIMAB and not
between Oncoscience and CIMAB’s Contract Manufacturer(s). Oncoscience’s
quantity requirements shall include those of its Affiliates and
sub-licensees. The supply price for the Licensed Product payable by
Oncoscience or its Affiliates to CIMAB (the “Supply
Price”) shall
be:
|
|
(a)
|
In the case of sales of the
Licensed Product made directly by Oncoscience or its Affiliates to a third
party other than to its sub-licensees (i) until the Payment Cap is
reached, US$ 1,250 (one thousand two hundred and fifty US dollars) per
gram of Licensed Product and (ii) after the Payment Cap is reached, as
mutually agreed to between the Parties, acting reasonably;
and
|
|
(b)
|
In the case of sales of the
Licensed Product made by Oncoscience or its Affiliates to its
sub-licensee(s), US$ 1,250 (one thousand two hundred and fifty US dollars)
per gram of Licensed
Product.
|
5.3
|
Specifications. CIMAB undertakes that all
Licensed Product supplied to Oncoscience will be manufactured in
accordance with mutually agreed upon specifications (inclusive of
specifications in an approved Marketing Authorization and Good
Manufacturing Practices of the EMEA the relevant regulatory authorities in
the other countries in the Territory, 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
|
Right to Have
Manufactured in Event of Default by
CIMAB.
|
5.4.1
|
In the event that CIMAB or
CIMAB’s Contract Manufacturer is unwilling or unable to manufacture to the
specifications required by the relevant Regulatory Authority or by the
terms of any relevant Regulatory Approval, Oncoscience 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, in accordance with the provisions of
Clause 5.4.2. In the event that CIMAB is unable to supply Oncoscience with
its quantity requirements of Licensed Product (as described in Clause 5.1
to 5.3) for a period of one or more Calendar Quarters in any given two
year period Oncoscience shall have the right to have manufactured by a
Third Party Manufacturer as defined below its own clinical and commercial
requirements of Licensed Product, in accordance with the provisions of
Clause 5.4.2, but Oncoscience shall continue to purchase at least 50% of
its quantity requirements from CIMAB or CIMAB’s Contract Manufacturer for
as long as it is willing and able to do
so.
|
12
5.4.2
|
To enable Oncoscience to have
Licensed Product manufactured for it in accordance with Clause 5.4.1, the
Parties shall, at the request of Oncoscience, make arrangements for the
transfer of relevant CIMAB manufacturing technology and know-how to a
manufacturer nominated by Oncoscience (“Third Party Manufacturer”). CIMAB
shall supply such technology and know-how free of charge but without any
obligation to bear any of Oncoscience’s costs. Prior to the transfer of
such manufacturing technology and know-how, the Third Party Manufacturer
shall be required to enter into an agreement with CIMAB, on terms
satisfactory to CIMAB, under which the Third Party Manufacturer shall
undertake to keep CIMAB’s manufacturing technology and know-how
confidential and to use it only for the supply of Licensed Product to
Oncoscience or its Affiliate or sub-licensee and only in circumstances
where Clause 5.4.1 applies. The terms of such agreement between CIMAB and
a Third Party Manufacturer shall be deemed satisfactory to CIMAB if the
terms are identical to the terms of an equivalent agreement between CIMAB
and CIMAB’s Contract
Manufacturer.
|
5.5
|
Supply
Agreement. Licensed
Product supplied by CIMAB or CIMAB’s Contract Manufacturer(s) to
Oncoscience for clinical and commercial purposes shall be supplied to
Oncoscience pursuant to the terms of a separate Supply Agreement.
Oncoscience and CIMAB shall use good faith efforts to negotiate and enter
into such a supply agreement at least six (6) months prior to the
submission of a Regulatory Application for such Licensed Product in the
Territory. In addition to more detailed terms regarding form of product,
supply price, specifications, shortage of supply and default manufacturing
rights as are specified in this Clause 5, each Supply Agreement 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 Agreement shall be consistent with the provisions of this Clause 5,
unless otherwise agreed in writing by CIMAB and
Oncoscience.
|
6.
|
Grant of
rights
|
6.1
|
Licensed
Intellectual Property.
|
6.1.1
|
CIMYM hereby grants to
Oncoscience, subject to the provisions of this
Agreement:
|
|
(a)
|
an exclusive licence in the
Oncoscience Field and Territory (except that in Russia, Belarus and
Ukraine it shall be Co-exclusive Licence in the Field) under the Licensed
Patent Rights, with the right to sub-license, subject to Clause 6.4 below,
to develop, use and sell Licensed Product but only in the Oncoscience
Field and Territory; and
|
|
(b)
|
an exclusive licence in the
Oncoscience Field and Territory (except that in Russia, Belarus and
Ukraine it shall be Co-exclusive Licence in the Field) to use the Licensed
Know-how, with the right to sub-license, subject to Clause 6.4 below, to
develop, use and sell Licensed Product but only in the Oncoscience Field
and Territory; and
|
|
(c)
|
an exclusive licence in the
Oncoscience Field and Territory (except that in Russia, Belarus and
Ukraine it shall be Co-exclusive Licence in the Field) to have Licensed
Product manufactured for it by a Third Party Manufacturer, but only in the
circumstances described in Clause
5.4.
|
13
6.1.2
|
In the event that CIMAB wishes to
exercise its Co-exclusive rights in Russia, Belarus or Ukraine, it shall
notify Oncoscience of its intended activities in such countries, in
particular to ensure that Oncoscience’s rights under this Agreement are
not adversely affected.
|
6.2
|
Arising
Intellectual Property (including clinical
data).
|
6.2.1
|
Arising Intellectual Property
shall be owned by the Party (which for the purposes of this clause may
include CIM) that invents or creates it, and if it is jointly invented or
created by two or more of the Parties it shall be owned jointly by those
Parties in equal, undivided shares, subject to the provisions of this
Agreement including the following
provisions:
|
|
(a)
|
Recognising the contribution that
CIM’s scientists have made, and are continuing to make, to the development
of TheraCIM h-R3 and the current stage of its development, the Parties
anticipate that, as a matter of law, CIM scientists should be named as
inventor(s) or joint inventor(s) of any new inventions made under this
Agreement. Accordingly, unless the Party filing a patent application in
respect of Arising Intellectual Property is advised by external patent
counsel that such naming would prejudice the validity of the resulting
Arising Patents, all Arising Patents shall be considered to have been
jointly invented by representatives of CIM and Oncoscience, and
accordingly shall be jointly owned by them in equal, undivided shares,
subject to the provisions of this
Agreement;
|
|
(b)
|
It is anticipated that Arising
Know-how will be generated by clinicians and other Persons in the course
of, or arising from, clinical studies that have been designed by the Joint
Development Team. Accordingly, it is agreed that all Arising know-how
developed in, or arising from, the work performed under the Development
and Commercialisation Plan shall be jointly owned by CIM and Oncoscience
in equal, undivided shares, subject to the provisions of this Agreement;
and
|
|
(c)
|
Subject to paragraphs (a) and (b)
above, where Arising Intellectual Property consists of an improvement to,
or a new application of, Licensed Intellectual Property and, as a matter
of law, is made solely by employees of Oncoscience, it shall be owned
solely by Oncoscience.
|
6.2.2
|
CIMAB hereby grants and agrees to
grant to Oncoscience an exclusive, fully paid-up and royalty-free licence
under Arising Intellectual Property in the Oncoscience Field and
Territory, with the right to sub-license, to research, develop, make, have
made, import, use, sell and otherwise deal in any and all products and
processes in the Oncoscience Field and
Territory.
|
6.2.3
|
Oncoscience hereby grants and
agrees to grant to CIMYM and CIMAB an exclusive, fully paid-up and
royalty-free licence under Arising Intellectual Property in the CIMYM
Field and Territory, with the right to sub-license, to research, develop,
make, have made, import, use, sell and otherwise deal in any and all
products and processes in the CIMYM Field and
Territory.
|
6.3
|
Formal
licences. If
requested by Oncoscience, and at Oncoscience’s administrative cost, the
Parties shall execute such formal licences 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 licence 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.
|
14
6.4
|
Sub-licensing. Oncoscience shall be entitled
to grant sub-licences (which for the purposes of this clause shall include
any option or right to acquire a sub-licence) of its rights under this
Agreement to any person (including without limitation any Affiliate of
Oncoscience), provided that:
|
|
(a)
|
Oncoscience shall first provide
written notice to CIMYM of any request to enter into a sub-license and
shall provide with such notice a copy of the proposed sub-license
agreement. CIMYM shall provide its response to any such request within
thirty (30) days of its receipt of Oncoscience’s notice, failing which, it
shall be deemed to have consented to such request. CIMYM shall have no
reason to withhold its consent to such request provided that the proposed
sub-license agreement complies with the terms of this Clause 6.4.
Oncoscience shall provide to the Parties, within thirty (30) days of its
execution, a fully executed copy of the sub-license
agreement;
|
|
(b)
|
the scope of the sub-licence
shall not exceed the scope of the licence granted under this Agreement
and, in particular, shall not include any manufacturing
rights;
|
|
(c)
|
the sub-licence shall include
obligations on the sub-licensee which are equivalent to the obligations on
Oncoscience under this Agreement (and the sub-licensee shall not have any
right to grant sub-sub-licences without CIMYM’s prior written agreement,
which consent may be withheld at CIMYM’s sole
discretion);
|
|
(d)
|
if agreed between CIMYM and the
sub-licensee, the sub-licence shall continue in force as an agreement
between CIMYM (in place of Oncoscience) and the sub-licensee or, if no
such agreement is made, the sub-licence shall terminate automatically on
the termination of this Agreement for any
reason;
|
|
(e)
|
clinical trials in the territory
of the sub-licensee shall commence not later than 18 months from the date
of the conclusion of the sub-licence agreement, failing which the
sub-licence shall automatically
terminate;
|
|
(f)
|
Oncoscience shall have no
ownership interest of any kind in the proposed sub-licensee;
and
|
|
(g)
|
Oncoscience shall be responsible
for any breach of the sub-licence by the sub-licensee, as if the breach
had been that of Oneoscience under this Agreement, and Oncoscience shall
indemnify CIMYM against any loss, damages, costs, claims or expenses which
are awarded against or suffered by CIMYM as a result of any such breach by
the sub-licensee.
|
6.5
|
Reservation
of rights within Field and Territory. For the avoidance of doubt,
CIMYM reserves the right for itself and its licensees and assigns to use
TheraCIM h-R3 and the Licensed Intellectual Property in the Oncoscience
Field and Territory with the prior consent of Oncoscience (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
Oncoscience Field and Territory in accordance with the provisions of this
clause, it will so inform Oncoscience and give Oncoscience a first
opportunity to propose terms for an agreement with CIMYM under which
Oncoscience would assist CIMYM with such activities at the cost of CIMYM.
It is understood and agreed that CIMYM will be required under regulatory
GCP to retain archive samples of
materials.
|
15
6.6
|
No other
licence. It is
acknowledged and agreed that no licence is granted by CIMYM to Oncoscience
other than the licence(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.
|
6.7
|
Quality. Oncoscience shall ensure that
all Licensed Product marketed by it and its sub-licensees is of
satisfactory quality and complies with all applicable laws and regulations
in each part of the
Territory.
|
6.8
|
Acknowledgment
by CIMAB. CIMAB
acknowledges and agrees that CIMYM has been granted the necessary rights
and licences to enable it to grant the licences referred to in Clauses
6.1. and 6.4 of this
Agreement.
|
6.9
|
Acknowledgment
by CIMYM and CIMAB.
CIMYM and CIMAB acknowledge and agree that, subject to Clause 6.4(g),
Oncoscience is free to organize its distribution of the Licensed Product
and determine its sales price of the Licensed Product within the
Oncoscience Field and Territory at its own discretion. Oncoscience is also
free to determine its sales price vis-à-vis its sub-licensees. However,
only for the purpose of calculating the royalties pursuant to Article 7 of
this Agreement the supply price charged by Oncoscience to its
sub-licensees shall be deemed $ 2,312.50 (two thousand three hundred and
twelve US dollars and fifty cents) per gram if and as far as Oncoscience
charges a supply price to its sub-licensees which is below the threshold
of $ 2,312.50 (two thousand three hundred and twelve US dollars and fifty
cents) per gram.
|
7.
|
Payments
|
7.1
|
Payments
prior to reaching Payment Cap. Until such time as the total
amount of payments made by Oncoscience to CIMYM under this Clause 7.1
reaches US$30,000,000 (thirty million US dollars) (excluding VAT or
other taxes or charges and excluding the amount of any payments from
Oncoscience to CIMYM in respect of the supply of products, materials or
services) (the “Payment Cap”), Oncoscience shall pay to CIMYM the
following amounts:
|
|
(a)
|
*% (* percent) of all Milestone
Receipts, which shall be payable within 30 (thirty) days of any such
Milestone Receipt being received by Oncoscience or its
Affiliate;
|
|
(b)
|
In the case of sales of the
Licensed Product made directly by Oncoscience or its Affiliates to a third
party other than its
sub-licensee(s):
|
|
(i)
|
a royalty of *% (* percent) of
Net Sales Value of all Licensed Product;
and
|
|
(ii)
|
an additional royalty of US$* (*
US dollars) per gram of the Licensed Product;
and
|
16
|
(c)
|
In the case of sales of the
Licensed Product made by Oncoscience or its Affiliates to its
sub-licensee(s), a royalty of *% of Net Sales Value of all Licensed
Product.
|
7.2
|
Payments
after reaching Payment Cap.
|
7.2.1
|
Royalties. After the total amount of
payments made by Oncoscience to CIMYM under Clause 7.1 has reached the
Payment Cap, Oncoscience shall pay to CIMYM the following
amounts:
|
|
(a)
|
*% (* percent) of all Milestone
Receipts, which shall be payable within 30 (thirty) days of any such
Milestone Receipt being received by Oncoscience or its
Affiliates;
|
|
(b)
|
In the case of sales of the
Licensed Product made directly by Oncoscience or its Affiliates to a third
party other than its sub-licensee(s), a royalty on cumulative Gross Sales
Value of Licensed Product in each Calendar Year, at the following
incremental rates:
|
Incremental Gross Sales Value in Calendar Year
|
Royalty rate
|
|||
Less
than or equal to US$*M
|
*
|
%
|
||
Greater
than US$*M and less
than or equal to US$*M
|
*
|
%
|
||
Greater
than US$*M and less
than or equal to US$*M
|
*
|
%
|
||
Greater
than US$*M
|
*
|
%
|
Example: If in a particular
Calendar Year, cumulative Gross Sales Value amounts to US$*M, the following
royalties would be payable under this Clause:
(i)
|
*%
on the first US$*M of Gross Sales Value =
|
US$ |
*M
|
||
(ii)
|
*%
on the next US$*M of Gross Sales Value =
|
US$ |
*M
|
||
(iii)
|
*%
on the remaining US$*M of Gross Sales Value=
|
US$ |
*M
|
||
(iv)
|
Total
amount of royalty due in Calendar Year =
|
US$ |
*M
|
;
|
and
|
(c)
|
In the case of sales of the
Licensed Product made by Oncoscience or its Affiliates to its
sub-licensee(s), a royalty of *% of Net Sales Value of all Licensed
Product.
|
7.3
|
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 within 120 days of the termination of this
Agreement.
|
7.4
|
Payment
terms. All sums due
under this Agreement:
|
|
(a)
|
are exclusive of Value Added Tax
which where applicable will be paid by Oncoscience to CIMYM in
addition;
|
|
(b)
|
shall be paid in US dollars (or
such other currency as the Parties may agree) and, in the case of sales or
sub-license income received by Oncoscience 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 Kreissparkasse Sűdholstein, Xxxxxxxxx-Xxxxx-Xxxx 38-40 25431
Pinneberg in Germany as at the close of business on the last business day
of the quarterly period with respect to which the payment is
made;
|
17
|
(c)
|
shall be made without deduction
of income tax or other taxes charges or duties that may be imposed, except
insofar as Oncoscience is required to deduct the same to comply with
applicable laws. The Parties shall cooperate and take all steps reasonably
and lawfully available to them to avoid deducting such taxes and to obtain
double taxation relief. If Oncoscience is required to make any such
deduction it shall provide CIMYM with such certificates or other documents
as it can reasonably obtain to enable CIMYM to obtain appropriate relief
from double taxation of the payment in question;
and
|
|
(d)
|
shall be made by the due date,
failing which CIMYM may charge interest on any outstanding amount on a
daily basis at a rate equivalent to 3% above the US prime lending rate
then in force.
|
7.5
|
Exchange
controls, etc. If at
any time during the continuation of this Agreement Oncoscience is
prohibited from making any of the payments required hereunder by a
governmental authority in any country then Oncoscience 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 (thirty) days of Oncoscience making a request for such
permission then, at the option of CIMYM, Oncoscience shall deposit the
royalty payments due in the currency of the relevant country either in a
bank account designated by CIMYM within such country or such royalty
payments shall be made to an associated company of CIMYM designated by
CIMYM and having offices in the relevant country designated by
CIMYM.
|
7.6
|
Royalty
statements.
Oncoscience 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 which Licensed Product is sold, the types of Licensed
Product sold, the quantity of each type sold, and the total Gross Sales
Value and 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.
|
7.7
|
Records
|
7.7.1
|
Oncoscience shall keep at its
normal place of business detailed and up to date records and accounts
showing the quantity, description and Gross Sales Value of Licensed
Product, all the documents corresponding to the deductions, 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.
|
7.7.2
|
Oncoscience 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 Oncoscience to CIMYM under Clause 7.6. The accountant shall be
required to keep confidential all information learnt during any such
inspection, and to disclose to CIMYM only such details as may be necessary
to report on the accuracy of Oncoscience’s statement or report. CIMYM
shall be responsible for the accountant’s charges unless the accountant
certifies that there is an inaccuracy of more than 5% (five percent) in
any royalty statement, in which case Oncoscience shall pay his charges in
respect of that inspection. If the inspection shows that Oncoscience owes
a payment to CIMYM under this Agreement, Oncoscience shall promptly make
such payment.
|
18
7.7.3
|
Oncoscience shall ensure that
CIMYM has the same rights as those set out in this Clause 7.7 in respect
of any Affiliate or sub-licensee of Oncoscience that is sub-licensed under
Licensed Intellectual Property pursuant to this
Agreement.
|
8.
|
Diligence
|
8.1
|
Oncoscience shall use Diligent
and Reasonable Efforts to develop and commercially exploit Licensed
Product to the maximum extent throughout the Territory. Without limiting
Oncoscience’s obligations under the previous sentence of this Clause 8.1,
Oncoscience shall develop and commercially exploit Licensed Product in
accordance with the Development and Commercialisation
Plan.
|
8.2
|
If CIMYM considers at any time
during the period of this Agreement that Oncoscience has without
legitimate reason failed to comply with its obligations under Clause 8.1,
CIMYM shall be entitled to refer to an independent expert the following
questions:
|
|
(a)
|
whether Oncoscience has complied
with such obligations; and if
not
|
|
(b)
|
what specific action Oncoscience
should have taken (“Specific Action”) in order to have so
complied.
|
8.3
|
The independent expert shall be
appointed in accordance with the provisions of Schedule 4 and his decision
shall be final and binding on the
Parties.
|
8.4
|
If the expert determines that
Oncoscience has failed to comply with its obligations under this Clause 8,
and if Oncoscience fails to take the Specific Action within 6 months of
the expert giving his decision in accordance with Schedule 4, CIMYM shall
be entitled, by giving, at any time within 3 months after the end of that
6 month period, not less than 3 months’ notice to terminate this Agreement
and the licences granted to Oncoscience under Clause
6.
|
9.
|
Intellectual
property
|
9.1
|
Obtain and
maintain the Licensed Patent Rights. CIMYM shall, at its cost and
expense:
|
|
(a)
|
Diligently seek to obtain valid
patents in the name of CIM pursuant to each of the patent applications
listed in Schedule 1; and
|
|
(b)
|
pay all renewal fees in respect
of the Licensed Patent Rights as and when
due;
|
provided
that if CIMYM elects to abandon any such application or not to maintain any such
Licensed Patent (or cease funding such application or patent) it shall give 3
months’ prior written notice to Oncoscience and on the expiry of such notice
period CIMYM shall cause the patent or patent application in question to be
assigned to Oncoscience and CIM shall have no continuing rights under such
Licensed Patents.
9.2
|
Obtain and
maintain the Arising Patents. The Parties shall consult with
one another in relation to the filing and maintenance of any Arising
Patents in respect of any inventions made by Oncoscience, its Affiliates
or sub-licensees that relate to any of the Licensed Intellectual Property
or the Licensed Product (“Arising Inventions”). Oncoscience shall or shall
ensure that its Affiliate or sub-licensee shall, at its own cost and
expense:
|
19
|
(a)
|
Diligently seek to obtain valid
patents (in the name of the relevant Parties as specified in Clause 6.2.1)
in respect of any Arising Inventions;
and
|
|
(b)
|
pay all renewal fees in respect
of the Arising Patents as and when
due;
|
provided
that if Oncoscience its Affiliate or sub-licensee wishes to abandon any such
application or not to maintain any such Arising Patent (or to cease finding such
application or patent) Oncoscience shall give 3 months’ prior written notice to
CIMYM and on the expiry of such notice period Oncoscience shall cause the patent
or patent application in question to be assigned to CIM and Oncoscience shall
have no continuing rights under such Arising Patents.
9.3
|
Infringement
of the Patents
|
9.3.1
|
Each Party shall inform the other
Party promptly if it becomes aware of any infringement or potential
infringement of any of the Patents in the Oncoscience Field and Territory,
and the Parties shall consult with each other to decide the best way to
respond to such
infringement.
|
9.3.2
|
Oncoscience shall be responsible,
at its discretion, for taking action against infringers of the Licensed
Patents in the Oncoscience Field and Territory at its sole expense, and it
shall be entitled to retain any damages or other payments or benefits
obtained by such action in the Oncoscience Field and Territory, after
reimbursing CIMYM and CIMAB for any reasonable expenses incurred in
assisting it in such action. If Oncoscience declines to take action, then
CIMYM shall be entitled to take action against the third party at CIMYM’s
sole expense and CIMYM shall be entitled to all damages or other sums
received from such action, after reimbursing Oncoscience for any
reasonable expenses incurred in assisting it in such action. If the
alleged infringement is both within and outside the Oncoscience 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 Oncoscience and CIMYM’s and
CIMAB’s other licensees who participate in such action. The apportionment
of costs between licensees shall be decided by CIMYM, acting
reasonably.
|
9.4
|
Infringement
of third party rights
|
9.4.1
|
If any warning letter or other
notice of infringement is received by a Party, or legal suit or other
action is brought against a Party, alleging infringement of third party
rights in the manufacture, use or sale of the Licensed Product or use of
any Patents, that Party shall promptly provide full details to the other
Party, and the Parties shall discuss the best way to
respond.
|
9.4.2
|
CIMYM shall have the right but
not the obligation to defend such suit and shall have the right to settle
with such third party, provided that if any action or proposed settlement
involves the making of any statement, express or implied, concerning the
validity of any Patent, the consent of Oncoscience must be obtained before
taking such action or making such settlement, such consent not to be
unreasonably withheld or
delayed.
|
20
9.5
|
Third party
intellectual property. For the avoidance of doubt
Oncoscience shall be solely responsible for obtaining and paying for any
additional licences and other rights that may be required to enable
Oncoscience, its Affiliates or sub-licensees to commercialise Licensed
Product in the Territory. If the sale of TheraCIM h-R3 is found to
infringe the intellectual property rights of a third party, and results in
the payment of royalties or other compensation by Oncoscience (or its
Affiliate or sub-licensee) to the third party, Oncoscience may reduce its
royalty payments to CIMYM, the reduction to be in the amount of *% (*
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 reduction shall not exceed *%
(* percent) of Net Sales Value with respect to the country(ies) in the
Territory for which payments are being made to the third party. For
example, if in the absence of this Clause the royalty due from Oncoscience
to CIMYM on the sale of a Licensed Product is *% (* percent) of Net Sales
Value, the royalty following such deduction shall not be reduced below *%
(* percent).
|
|
(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 Oncoscience chooses
to incorporate into the Licensed
Product.
|
9.6
|
Product
names. Oncoscience
shall be responsible for deciding, in consultation with CIMYM, the trade
xxxx to be applied to the Licensed Product in the Oncoscience Field and
Territory. Oncoscience will be responsible for applying for any such trade
xxxx in the Territory at its sole cost. CIMYM acknowledges that it has no
objection against the trade xxxx “Theraloc”. CIMYM will be responsible for
applying for an international, non-proprietary name (“INN”) for the
Licensed Product at its sole cost. Oncoscience acknowledges that it has no
objection to the INN
“CIMAZUMAB”.
|
10.
|
Warranties and
liability
|
10.1
|
Warranties by
CIMYM. CIMYM
warrants that:
|
|
(a)
|
subject to Clause 10.4, it is the
owner or exclusive licensee of the Licensed Patent Rights;
and
|
|
(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
Oncoscience 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 Oncoscience Field and
Territory; or
|
|
(ii)
|
assign, mortgage, charge or
otherwise transfer any of the Licensed Patent Rights;
and
|
|
(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.
|
21
10.2
|
Warranty by
Oncoscience.
Oncoscience warrants and undertakes (a) that it has, and will continue to
have sufficient financial and other resources to fulfil its obligations
under this Agreement, and (b) that it has obtained all necessary
authorisations from its supervisory board and investors to use such
resources and fulfil such
obligations.
|
10.3
|
No other
warranties
|
10.3.1
|
Each of Oncoscience 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 are 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
Oncoscience under or in connection with this Agreement will produce
Licensed Product of satisfactory quality or fit for the purpose for which
Oncoscience intended; or
|
|
(e)
|
as imposing any obligation on
CIMYM to bring or prosecute actions or proceedings against third parties
for infringement or to defend any action or proceedings for revocation of
any of the Licensed Patent Rights;
or
|
|
(f)
|
as imposing any liability on
CIMYM in the event that any third party supplies Licensed Product to
customers located in the
Territory.
|
10.4
|
Indemnity and
insurance.
Oncoscience shall indemnify and hold harmless CIMYM and (except as
otherwise provided in any Supply Agreement) CIMAB and their respective
Affiliates and their respective officers, 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 Oncoscience, its Affiliates or sub-licensees, or subsequently by any
third party, including without limitation claims based on product liability
laws. For the duration of this Agreement, Oncoscience shall, or shall ensure
that its sub-licensee 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 UK£5,000,000 (five million pounds sterling) per claim or series of
claims).
22
10.5
|
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 any loss, damage, costs or
expenses 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
licences granted hereunder, shall come into effect on the Commencement
Date and, unless terminated earlier in accordance with this Clause 11,
shall continue in force on a country by country basis in the Territory
until the latest of:
|
|
(a)
|
The date on which all the
Licensed Patents have expired or been revoked in that country without a
right of further appeal, and
|
|
(b)
|
The date on which any Orphan Drug
Status for Licensed Product in that country has expired;
and
|
|
(c)
|
The tenth anniversary of the date
of the first commercial sale of Licensed Product in that country by
Oncoscience, its Affiliate or sub-licensee or, if that country is part of
the European Union, the tenth anniversary of the date of the first
commercial sale of the Licensed Product in the European Union by
Oncoscience, its Affiliate or
sub-licensee;
|
and on
such date this Agreement and the licences granted hereunder shall terminate
automatically by expiry.
11.2
|
Early
termination
|
11.2.1
|
Oncoscience may terminate this
Agreement at any time on 90 days notice in writing to
CIMYM.
|
11.2.2
|
Without prejudice to any other
right or remedy, either of CIMYM or Oncoscience 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 Oncoscience shall include any Affiliate or sub-licensee of
Oncoscience) is in material breach of this Agreement and, in the case of a
breach capable of remedy within 90 days, the breach is not remedied within
90 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 Oncoscience shall include any Affiliate or sub-licensee of
Oncoscience) 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 with its creditors or takes or
suffers any similar or analogous action in consequence of debt;
or
|
23
|
(e)
|
if the first Phase II clinical
trial for the Licensed Product in the Field in the Territory has not
commenced within a period of two years after the Commencement Date;
or
|
|
(d)
|
if the first Regulatory Approval
for marketing the Licensed Product in the Field in the Territory is not
obtained within a period of five years after the Commencement
Date.
|
11.2.3
|
CIMYM may forthwith terminate
this Agreement by giving written notice to Oncoscience if Oncoscience or
its Affiliate or sub-licensee 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 Oncoscience’s remedy for any breach by CIMAB of its obligations under
Clause 5 shall be as set out in Clause 5.4 or in any Supply Agreement that
CIMAB and Oncoscience may execute pursuant to Clause 5.5. Accordingly,
breach of Clause 5 shall not entitle any Party to terminate this
Agreement.
|
11.3
|
Consequences
of termination
|
11.3.1
|
Upon termination of this
Agreement for any reason otherwise than in accordance with Clause
11.1:
|
|
(a)
|
If termination occurs afler the
first commercial sale of Licensed Product, Oncoscience and its
sub-licensees shall be entitled to sell, use or otherwise dispose of
(subject to payment of royalties under Clause 7.1 or 7.2) any unsold or
unused stocks of the Licensed Product for a period of 6 months following
the date of termination; and if termination occurs prior to the first
commercial sale of Licensed Product, Oncoscience shall forthwith return
all such stocks of Licensed Product and Licensed Know-how to CIMYM free of
charge;
|
|
(b)
|
subject to paragraph (a) above,
Oncoscience shall no longer be licensed to use or otherwise exploit in any
way, either directly or indirectly, any of the Licensed Intellectual
Property;
|
|
(c)
|
subject to paragraph (a) above,
Oncoscience shall consent to the cancellation of any formal licence
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 the following
clauses shall continue in force without limit of time, except that the
continuing obligations under Clause 4, referred to in paragraph (i) below,
shall survive for a period of 5 years from the termination of this
Agreement:
|
|
(i)
|
Clauses 4.3 (except that
Oncoscience shall not have any continuing right to use Licensed Know-how
or any other information received from CIMYM or CIMAB), 4.4(a) (subject to
Clause 4.5) (and no further disclosure may be made by Oncoscience under
Clause 4.7);
|
24
|
(ii)
|
Clause 7 (in respect of sales of
Licensed Product made prior to termination, or after termination under the
first part of Clause 11.3.1(a));
and
|
|
(iii)
|
Clause 10.3 and 12;
and
|
|
(e)
|
subject as provided in this
Clause 11.3.1 and 11.3.2, and except in respect of any accrued rights,
neither Party shall be under any further obligation to the
other.
|
11.3.2
|
Upon termination of this
Agreement for any reason otherwise than in accordance with Clause 11.1 and
at CIMYM’s request, Oncoscience shall, without charge to, or other
obligation on the part of,
CIMYM:
|
|
(a)
|
transfer to CIMYM exclusively 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
licences and pricing approvals) and other permits and applications
transferred into the name of CIMYM or its
nominee;
|
|
(c)
|
grant CIMYM an exclusive,
worldwide licence, with the rights to grant sub-licences, under all
Arising Intellectual Property and any improvements and other intellectual
property owned or controlled by Oncoscience relating to Licensed Product;
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. Neither
Party shall have any liability or be deemed to be in breach of this
Agreement for any delays or failures in performance of this Agreement
which result from circumstances beyond the reasonable control of that
Party, including without limitation labour disputes involving that Party.
The Party affected by such circumstances shall promptly notify the other
Party in writing when such circumstances cause a delay or failure in
performance and when they cease to do
so.
|
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
Parties.
|
25
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. If any
provision or part of this Agreement is held to be invalid, amendments to
this Agreement may be made by the addition or deletion of wording as
appropriate to remove the invalid part or provision but other wise retain
the provision and the other provisions of this Agreement to the maximum
extent permissible under applicable
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 licence shall
mean, where the context requires, a
sub-licence;
|
|
(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, for a period of 10
years from the first commercial sale of Licensed Product in any part of
the Territory.
|
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:
|
26
Party
|
Fax
number
|
|
CIMYM
|
001
905 629 4959
|
|
CIMAB
|
0053
7273 3509
|
|
Oncoscience
|
0049
4103 1808 820
|
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 and
Jurisdiction. 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, including any question regarding its existence, validity or
termination, 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. 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 in any court of
competent jurisdiction.
|
12.10
|
Further
action. Each Party
agrees to execute, acknowledge and deliver such further instruments, and
do all further similar acts, as may be necessary or appropriate to carry
out the purposes and intent of this
Agreement.
|
12.11
|
Announcements. Neither Party shall make any
press or other public announcement concerning any aspect of this
Agreement, or make any use of the name of the other Party in connection
with or in consequence of this Agreement, without the prior written
consent of the other Party, except as may be required by law or by the
rules of any stock exchange on which either Party is listed. The Parties
shall agree a form of press release for issue on signature of this
Agreement.
|
12.12
|
Entire
agreement. This
Agreement, including its Schedules, sets out the entire agreement between
the Parties relating to its subject matter and supersedes all prior oral
or written agreements, arrangements or understandings between them
relating to such subject matter. The Parties acknowledge that they are not
relying on any representation, agreement, term or condition that is not
set out in this Agreement. Nothing in this Agreement excludes liability
for fraud.
|
12.13
|
Third party
rights. Each of the
persons identified as Indemnitees in Clause 10.4 may in his own right
enforce the provisions of those respective Clauses. Except as provided in
the previous sentence of this Clause 12.12, 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.
|
27
12.14
|
Non-compete. Oncoscience 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 as long as this Agreement
remains in force, 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
tyrosine kinase inhibitor.
|
12.15
|
Amendment and
Restatement. The
Original Agreement is hereby terminated. This Agreement supersedes, and
amends and restates the Original
Agreement.
|
28
Agreed by the Parties through
their authorised signatories:
For and
on behalf of CIMYM,
Inc.
[ILLEGIBLE]
|
|
|
signed
|
signed
|
|
[ILLEGIBLE]
|
|
|
print
name
|
print
name
|
|
Chair
& CEO
|
|
|
title
|
title
|
|
Aug
27/2007
|
|
|
date
|
date
|
For and
on behalf of CIMAB
S.A.
[ILLEGIBLE]
|
|
|
signed
|
signed
|
|
[ILLEGIBLE]
|
|
|
print
name
|
print
name
|
|
General
Manager
|
|
|
title
|
title
|
|
14/09/2007
|
|
|
date
|
date
|
For and
on behalf of Oncoscience
AG
/s/
X. Xxxx
|
|
|
signed
|
signed
|
|
X.
XXXX
|
|
|
print
name
|
print
name
|
|
CEO
|
|
|
title
|
title
|
|
[ILLEGIBLE]
|
|
|
date
|
date
|
29
Schedule
1
Licensed
Patent Rights
The
patents and patent applications listed in this Schedule are, or may become,
relevant to this Agreement, but they also contain other rights not licensed
under this Agreement. Thus their inclusion here is limited to the extent if any
that they would protect the exploitation of Licensed Product for use within the
Field.
Monoclonal Antibodies
Recognizing the Epidermal Growth Factor Receptor, Cells and Methods for Their
Production and Compositions Containing Them (mR3)
Country
|
Filing
Date
|
Serial No.
|
PubIn
Date
|
Publn
No.
|
Issue
Date
|
Patent
No.
|
||||||
Europe1
|
18 Aug 93
|
93202428.4 |
09 Mar 94
|
586002 |
Granted
|
586002 |
[territories
of grant within Europe to be confirmed by CIMYM to Oncoscience]
Humanized
and Chimeric Antibodies for EGF Receptor Used in Diagnosis and Therapy of
Tumours (hR3)
Country
|
Filing
Date2
|
Serial No.
|
Publn
Date
|
Publn
No.
|
Issue
Date
|
Patent
No.
|
||||||
Europe*
|
15 Nov 95
|
95203126.8
|
22 May 96
|
712,863
|
Granted
|
712,863
|
*
Validated in Austria, Belgium, Switzerland, Liechtenstein, Germany, Spain,
France, United Kingdom, Italy, Ireland
1 Priority
of 18 Aug 92 based on CU 100/92, and 01 Mar 93 based on CU
17/93
2 Priority
of 18 Nov 94 based on CU 128/94
30
Schedule
2
Licensed
Know-how
All
documentation that has been submitted by YM Biosciences, Inc. to the Health
Protection and Food Branch of the Department of Health and Welfare of Canada in
connection with an application for an IND for the Licensed Product in Canada,
together with clinical trial data generated by CIMAB.
31
Schedule
3
Initial
Development and Commercialisation Plan
Part A:
Initial Development Programme
The
development programme will include:
|
1.
|
A registration study in glioma.
It is provisionally estimated that enrolment will be in the range of 80 –
100 patients.
|
|
2.
|
A pilot study in paediatric brain
tumours. It is provisionally estimated that enrolment will be in the range
of 6 – 10 patients.
|
|
3.
|
A registration study in
paediatric brain tumours. It is provisionally estimated that enrolment
will be in the range of 60 – 80
patients.
|
|
4.
|
A pilot study in metastatic
pancreatic cancer. It is provisionally estimated that enrolment will be in
the range of 14 – 20
patients.
|
|
5.
|
Application for Orphan Drug
Status for the Product with the
EMEA.
|
Subject
to availability of clinical trial materials, regulatory approvals and ethical
votum, it is
anticipated that recruitment for the above studies will commence as
follows:
Item 2
will commence on January 15, 2004. Items 1, 3 and 4 above will commence on April
1, 2004.
The date
for submission of item 5 will be assessed based on the receipt by Oncoscience of
the documentation that has been submitted to the Health Protection and Food
Branch of the Canadian Department of Health and Welfare
32
Schedule
4
Appointment
of expert
1.
Pursuant to Clause 8.3, CIMYM may serve notice on Oncoscience (“Referral
Notice”) that it wishes to refer to an expert (the “Expert”) the questions set
out in Clause 8.2.
2. CIMYM
and Oncoscience (in this Schedule, the “parties”) shall agree the identity of a
single independent, impartial Expert to determine such questions. In the absence
of such agreement within 30 days of the Referral Notice, each party shall
appoint its own expert adviser, and the two appointed expert advisers shall
together appoint an independent, impartial Expert and such Expert shall alone
resolve the questions referred to in paragraphs 1 and 2 above.
3. 60
days after the giving of a Referral Notice, both parties shall exchange
simultaneously statements of case in no more than 10,000 words, in total, and
each side shall simultaneously send a copy of its statement of case to the
Expert.
4. Each
party may, within 30 days of the date of exchange of statement of case pursuant
to paragraph 3 above, serve a reply to the other side’s statement of case of not
more than 10,000 words. A copy of any such reply shall be simultaneously sent to
the Expert.
5. The
Expert shall make his or her decision on the said questions on the basis of
written statements and supporting documentation only and there shall be no oral
hearing. The Expert shall issue his or her decision in writing within 30 days of
the date of service of the last reply pursuant to paragraph 4 above or, in the
absence of receipt of any replies, within 60 days of the date of exchange
pursuant to paragraph 3 above.
6. The
Expert’s decision shall be final and binding on the parties.
7. The
Expert’s charges shall be borne by the parties in such proportions as the Expert
shall decide.
8. All
documents referred to in this schedule shall be in the English
language.
33