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) |
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) |
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) |
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. |
The
Parties entered into a development and licence agreement dated 17
November
2003 (the “Original Agreement”).
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B. |
The
Parties wish to enter into this Agreement for the purposes of wholly
replacing and superseding the Original
Agreement.
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C. |
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. |
The
shareholders of CIMYM are YM Biosciences, Inc. and
CIMAB.
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E. |
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. |
Oncoscience
has expertise in cancer immunotherapy and experience in conducting
immunotherapy clinical trials in cancer
patients.
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G. |
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. |
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
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(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. |
Joint
Development Team
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2.1 |
Formation.
Within fifteen (15) days after the Commencement Date, the Development
Team
Parties shall establish a Joint Development Team, by each Development
Team
Party designating its initial members to serve on the Joint Development
Team and notifying the other Development Team Party of its dates
of
availability for the first meeting of the Joint Development Team.
The
purpose of the Joint Development Team shall be to oversee the development
of Licensed Product for purposes of commercialisation in the 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 |
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 |
Responsibilities.
During the Development Term, the Joint Development Team
shall:
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(a) |
elaborate
the Development Commercialisation Plan in accordance with Clause
3.1
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(b) |
review
and unanimously approve (or, if the members of the Joint Development
Team
are unable to reach unanimous agreement, recommend to the Parties)
the
overall
development strategy for Licensed Product in the 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) |
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) |
facilitate
the transfer of Know-How between the Parties for purposes of conducting
the Development and Commercialisation
Plan;
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(e) |
regularly
assess the progress of Oncoscience in its conduct of the Development
and
Commercialisation Plan; and
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(f) |
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 |
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. |
Development
and Commercialisation
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3.1 |
Development
and Commercialisation Plan.
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3.1.1 |
Within
90 days of the Commencement Date, the Joint Development Team shall
prepare
a written plan (“Development and Commercialisation Plan”) that expands
upon the initial development plan set out in Schedule 3 and will
describe,
and provide a timeline for:
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8
(a) |
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) |
intellectual
property protection strategy, including applying for Orphan Drug
Status,
patents and supplementary protection
certificates
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(c) |
sub-licensing
strategy;
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(d) |
clinical
and registration strategy, with a view to expediting regulatory approval
for Licensed Product; and
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(e) |
commercialisation
strategy.
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3.1.2 |
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 |
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 |
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 |
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 |
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. |
Know-how
and Confidential
Information
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4.1 |
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.
|
4.2 |
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.
|
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.
|
4.4 |
Confidentiality
obligations.
Each Party (“Receiving Party”)
undertakes:
|
(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,
|
(b) |
to
use the same exclusively for the purposes of this Agreement,
and
|
(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.
|
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:
|
(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
|
(c) |
is
or becomes generally available to the public through no act or default
of
the Receiving Party or its agents, employees, Affiliates or
sub-Licensees.
|
4.6 |
Disclosure
to court, etc.
If the Receiving Party is required to disclose 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$[*] ([*] US dollars) (excluding
VAT
or other taxes or charges and excluding the amount of any payments
from
Oncoscience to CIMYM in respect of the supply of products, materials
or
services) (the “Payment Cap”), Oncoscience shall pay to CIMYM the
following amounts:
|
(a) |
[*]%
([*] percent) of all Milestone Receipts, which shall be payable within
30
(thirty) days of any such Milestone Receipt being received by Oncoscience
or its Affiliate;
|
(b) |
In
the case of sales of the Licensed Product made directly by Oncoscience
or
its Affiliates to a third party other than its
sub-licensee(s):
|
(i) |
a
royalty of [*]% ([*] percent) of Net Sales Value of all Licensed
Product;
and
|
(ii) |
an
additional royalty of US$ [*] ([*] 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$[*]
|
[*]
|
%
|
||
Greater
than US$[*] and
less
than or equal to US$[*]
|
[*]
|
%
|
||
Greater
than US$[*] and
less
than or equal to US$[*]
|
[*]
|
%
|
||
Greater
than US$[*]
|
[*]
|
%
|
Example:
If in a particular Calendar Year, cumulative Gross Sales Value amounts to
US$[*], the following royalties would be payable under this Clause:
(i)
|
[*]% on the first US$175M of Gross Sales Value = |
|
US$[*]
|
||||
(ii)
|
[*]% on the next US$175M of Gross Sales Value = |
|
US$[*]
|
||||
(iii)
|
[*]% on the remaining US$20M of Gross Sales Value= |
|
US$[*]
|
||||
(iv)
|
Total amount of royalty due in Calendar Year = |
|
US$[*]
|
; |
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