Exhibit 4.3
(1) CIMYM, INC.
(2) CIMAB S.A.
AND
(3) ONCOSCIENCE AG
______________________________________
DEVELOPMENT AND LICENCE AGREEMENT
RELATING TO TheraCIM h-R3
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DEVELOPMENT AND LICENCE AGREEMENT
THIS AGREEMENT dated __November 5th__ 2003 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, ▇▇▇▇▇▇, St. ▇▇▇▇▇▇▇, Barbados, West Indies; and
(2) CIMAB S.A. (company registration number 107/92) ("CIMAB"), a company
incorporated in Cuba, whose principal place of business is at 206 Street,
No. 1926, e/ ▇▇ ▇ ▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇; and
(3) ONCOSCIENCE AG (company registration number HRB 5414) ("Oncoscience") a
company incorporated in Germany, whose principal place of business is at
▇▇▇▇▇▇▇▇▇(▇▇▇▇)▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇.
RECITALS:
A. CIMYM is the exclusive licensee of certain Licensed Patent Rights and
certain Licensed Know-how (each as defined below) relating to an antibody
known as TheraCIM h-R3 (as defined below).
B. The shareholders of CIMYM are YM Biosciences, Inc. and CIMAB.
C. CIMAB enters into commercial agreements on behalf of the Center of
Molecular Immunology ("CIM", as defined below). CIM originally developed
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 0.
D. Oncoscience has expertise in cancer immunotherapy and experience in
conducting immunotherapy clinical trials in cancer patients.
E. 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.
F. 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
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In this Agreement, the following words shall have the following meanings:
AFFILIATE 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.
ARISING INTELLECTUAL Any and all of the Arising Patents and the Arising
PROPERTY Know-how.
ARISING KNOW-HOW Technical, commercial and all other information
generated by Oncoscience 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.
ARISING PATENTS 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, reissues, divisions, and any
patents, supplementary protection certificates and
similar rights that are based on or derive priority
from the foregoing.
CALENDAR QUARTER Each three-month period ending on 31st March, 30th
June, 30th September and 31st December.
CALENDAR YEAR A year commencing on 1st January and ending on 31st
December (but commencing on the Commencement Date in
the first year of this Agreement and, in the final
year of this Agreement, ending on the date of the
last sale of Licensed Product under this Agreement).
CIM The Center of Molecular Immunology, a scientific
research institute based in Havana, Cuba.
CIMAB'S CONTRACT Any Person that may from time to time be contracted
MANUFACTURER by CIMAB to manufacture the Licensed Product, or any
component or ingredient thereof, in accordance with
the provisions of this Agreement.
CIMYM FIELD AND (a) outside the Territory, all fields (including the
TERRITORY Field); and
(b) within the Territory, all fields other than the
Field.
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CLAIMS 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.
CO-EXCLUSIVE LICENCE A licence whereby:
(a) both CIMAB and Oncoscience may exercise the
licensed rights in the field and territory
of the licence in question;
(b) Oncoscience may grant sub-licences to the
extent permitted under Clause 7.4; and
(c) 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
(d) 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.
COMMENCEMENT DATE 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).
COMMERCIAL TEAM PARTIES CIMYM and Oncoscience, and "Commercial Team Party"
shall mean either of them.
DELIVERED ITEMS Has the meaning given in Clause 0.
DEVELOPMENT AND The development and commercialisation plan for
COMMERCIALISATION PLAN Licensed Product to be defined and agreed in
accordance with Clause 0, 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.
DEVELOPMENT AND The report described in clause 0 as amended from
COMMERCIALISATION time to time.
REPORT
DEVELOPMENT TEAM PARTIES CIMYM and Oncoscience, and "Development Team Party"
shall mean either of them.
DEVELOPMENT TERM 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.
DILIGENT AND REASONABLE Exerting such efforts and employing such resources
EFFORTS (whether by itself or through sub-contractors or
sub-licensees) as would normally be exerted or
employed by a reasonable third party pharmaceutical
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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.
FIELD The treatment of cancer in humans.
INITIAL DEVELOPMENT A programme of development to be conducted by
PROGRAMME Oncoscience in accordance with the provisions of
Schedule 3 Part A.
JOINT DEVELOPMENT TEAM A committee to be established, and operating, in
accordance with the provisions of Clause 0.
KNOW-HOW The Licensed Know-how and the Arising Know-how.
LICENSED INTELLECTUAL Any and all of the Licensed Patent Rights and the
PROPERTY Licensed Know-how.
LICENSED KNOW-HOW 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.
LICENSED PATENT RIGHTS 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.
LICENSED PRODUCT 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.
MAJOR COUNTRY Germany, France, Italy, Spain or the United Kingdom.
MILESTONE RECEIPTS The amount of any payment, excluding Value Added
Tax, (other than sales income on which Oncoscience
pays CIMYM a royalty under Clause 0(b) or 0,
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) 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;
(b) 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;
(c) where any sub-licence is to be granted under
cross-licensing arrangements, the value of
any third party licence obtained under such
arrangements;
(d) 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);
(e) any loan, guarantee or other financial
benefit made or given other than on normal
market terms; and
(f) any shares, options or other securities
obtained from a third party.
NET SALES VALUE The amount invoiced and received for the sale of the
Licensed Product when sold by Oncoscience or any of
its Affiliates or sub-licensees or any of their
respective distributors to the ultimate purchaser in
an arm's length transaction exclusively for money
(or where the sale is not at arm's length, the price
that would have been so invoiced and received if it
had been at arm's length), after deduction of all
documented:
(a) normal trade discounts actually granted and
any credits actually given (including for
rejected or returned Licensed Product),
(b) rebates to customers and third parties,
(c) provided the amounts are separately charged
on the relevant invoice any costs of
packaging, insurance, carriage and freight,
(d) any value added tax or other sales or use
tax charged to the customer, and
(e) 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 will the total of the
deductions referred to in paragraphs (a) to (e)
above exceed 10% (ten percent) of the total invoice
price.
Sales between any of Oncoscience, its Affiliates and
sub-licensees shall not be considered for the
purposes of this definition unless there is no
subsequent sale to a person who is not Oncoscience,
its Affiliate or sub-licensee in an arm's length
transaction exclusively for money.
ONCOSCIENCE FIELD AND In respect of any activity that is licensed to
TERRITORY Oncoscience under this Agreement, shall mean that
the activity must occur both within the Field and
within the Territory.
ORPHAN DRUG STATUS 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.
PARTIES CIMYM, CIMAB and Oncoscience, and "Party" shall mean
any of them.
PERSON Includes any individual, firm, company, corporation
or other legal entity.
PATENTS Any and all of the Licensed Patent Rights and the
Arising Patents.
PROVIDING PARTIES Any and all of CIMAB (whether on its own behalf or
on behalf of CIM) and CIMYM.
REGULATORY APPLICATION Any and all applications that are necessary and
appropriate to obtain a Regulatory Approval
including, without limitation, all required
documents, data and information concerning, filed or
required to be filed, otherwise submitted by
Oncoscience, its Affiliate or licensee to a
Regulatory Authority.
REGULATORY APPROVAL 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.
REGULATORY AUTHORITY The European Medicines Evaluation Agency and other
regulatory authorities in the Territory.
SUPPLY AGREEMENT Any agreement between CIMAB and Oncoscience under
which CIMAB agrees to manufacture and supply
Oncoscience with Licensed Product.
TERRITORY 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, ▇▇▇▇▇▇▇▇▇,
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Romania, Turkey, Albania, Andorra, Belarus,
Bosnia-Herzegovina, Croatia, Former Yugoslav
Republic of Macedonia, Iceland, ▇▇▇▇▇▇▇▇▇▇▇▇▇,
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and Montenegro, Switzerland, Ukraine, and Vatican
City.
THERACIM h-R3 A humanised antibody to the EGF receptor, known
scientifically as h-R3 and which has been given the
product name TheraCIM h-R3.
THIRD PARTY MANUFACTURER Has the meaning given in Clause 0.
VALID CLAIM 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.
2 JOINT DEVELOPMENT TEAM
2.1 Formation. Within fifteen (15) days after the Commencement Date, the
Development Team Parties shall establish a Joint Development Team, by
each Development Team Party designating its initial members to serve on
the Joint Development Team and notifying the other Development Team Party
of its dates of availability for the first meeting of the Joint
Development Team. The purpose of the Joint Development Team shall be to
oversee the development of Licensed Product for purposes of
commercialisation in the 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.
2.2 Meetings. The Joint Development Team shall meet every six months 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.
2.3 Responsibilities. During the Development Term, the Joint Development
Team shall:
(a) Elaborate the Development and Commercialisation Plan in accordance
with Clause 0
(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
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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);
(c) review and recommend to the Parties modifications to the
Development and Commercialisation Plan (including the resources to
be allocated and the timelines contained in the Development and
Commercialisation Plan);
(d) facilitate the transfer of Know-How between the Parties for
purposes of conducting the Development and Commercialisation Plan;
(e) regularly assess the progress of Oncoscience in its conduct of the
Development and Commercialisation Plan; and
(f) perform such other activities as are contemplated under this
Clause 0 and Clause 0. 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 0 or 0
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 0 or
0.
3 [NOT USED]
4 DEVELOPMENT AND COMMERCIALISATION
4.1 Development and Commercialisation Plan.
4.1.1 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:
(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
(c) sub-licensing strategy;
(d) clinical and registration strategy, with a view to expediting
regulatory approval for Licensed Product; and
(e) commercialisation strategy.
4.1.2 The Joint Development Team shall update the Development and
Commercialisation Plan on a regular basis (and at least annually).
4.2 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.
4.3 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.
4.4 Reporting. Without prejudice to the generality of Oncoscience's
obligations under Clauses 0 and 0, 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 0.
4.5 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 0. 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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5 KNOW-HOW AND CONFIDENTIAL INFORMATION
5.1 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 0.
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.
5.2 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.
5.3 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 0, 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.
5.4 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.
5.5 Exceptions to obligations. The provisions of Clause 0 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
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(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.
5.6 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 0, 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.
5.7 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 0 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 0 and 0
and which apply to the Disclosing Party's information.
6 MANUFACTURING AND SUPPLY
6.1 Clinical supply. CIMAB shall supply to Oncoscience, its Affiliates and
sub-licensees, 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 unit 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.
6.2 Commercial Supply.
6.2.1 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 0, in finished form with one hundred percent (100%) of
Oncoscience's unit 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).
Oncoscience's quantity requirements shall include those of its Affiliates
11
and sub-licensees. The supply price that CIMAB or its Contract
Manufacturer(s) shall charge to Oncoscience under this Clause 0 shall be:
(a) In respect of Licensed Product supplied by or on behalf of CIMAB
until the third anniversary of the first commercial sale of
Licensed Product in a Major Country, 25% of the Net Sales Value of
Licensed Product in each country of the Territory; and
(b) Thereafter, 20% of the Net Sales Value of Licensed Product.
6.2.2 Notwithstanding the provisions of Clause 0, in no event shall the supply
price charged to Oncoscience exceed 100% (one hundred percent) of
competitive market rates for such supply. Competitive market rates shall
be evidenced by formal quotes obtained from other third party
manufacturers for comparable quality and quantities of supply.
6.3 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 and 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.
6.4 Right to Have Manufactured in Event of Default by CIMAB.
6.4.1 In the event that (a) 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, or (b) the supply price charged Oncoscience
exceeds the rate for supply described in Clause 0 and CIMAB or CIMAB's
Contract Manufacturer is unwilling to reduce the supply price charged
Oncoscience to meet such maximum permissible rate, 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 0. In the event that CIMAB is unable to supply
Oncoscience with its quantity requirements of Licensed Product (as
described in Clauses 0 to 0) 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 0, 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.
6.4.2 To enable Oncoscience to have Licensed Product manufactured for it in
accordance with Clause 0, 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
12
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 0 applies.
6.5 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 for commercial purposes
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 0,
unless otherwise agreed in writing by CIMAB and Oncoscience.
7 GRANT OF RIGHTS
7.1 Licensed Intellectual Property.
7.1.1 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 a
Co-Exclusive Licence in the Field) under the Licensed Patent
Rights, with the right to sub-license, subject to clause 0 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 a
Co-Exclusive Licence in the Field) to use the Licensed Know-how,
with the right to sub-license, subject to clause 0 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 a
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 0.
7.1.2 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.
7.2 Arising Intellectual Property (including clinical data).
13
7.2.1 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; and
(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.
7.2.2 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.
7.2.3 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.
7.3 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
7.4 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 obtain CIMYM's prior written consent to the
execution of each sub-licence agreement, and such consent shall
not be unreasonably withheld or delayed;
(b) the royalties and other consideration provided for in the
sub-licence shall be at an amount or rate which is not less than
the amount or rate provided for in this Agreement;
(c) 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;
(d) 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);
(e) 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;
(f) within 30 days of the grant of any sub-licence Oncoscience shall
provide to CIMYM a true copy of it; 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 Oncoscience
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.
7.5 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.
7.6 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 0. Without prejudice to the
15
generality of the foregoing CIMYM reserves all rights under the Licensed
Intellectual Property in the CIMYM Field and Territory.
7.7 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.
7.8 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 7.1 and 7.4 of this Agreement.
8 PAYMENTS
8.1 Payments prior to reaching Payment Cap. Until such time as the total
amount of payments made by Oncoscience to CIMYM under this Clause 0
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; and
(b) a royalty of [*]% ([*] percent) of Net Sales
Value of all Licensed Product.
8.2 Payments after reaching Payment Cap.
8.2.1 Royalties. After the total amount of payments made by Oncoscience to
CIMYM under Clause 0 has reached the Payment Cap, Oncoscience shall pay
to CIMYM a royalty on cumulative Net Sales Value of Licensed Product in
each Calendar Year, at the following incremental rates:
--------------------------------------------------------------------------
Incremental Net 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$[*] [*]%
--------------------------------------------------------------------------
Example: If in a particular Calendar Year, cumulative Net Sales Value
amounts to US$[*],the following royalties would be payable under this
clause:
(i) [*]% on the first US$[*] of Net Sales Value = US$[*]
(ii) [*]% on the next US$[*] of Net Sales Value = US$[*]
(iii) [*]% on the remaining US$[*] of Net Sales Value = US$[*]
----------
(iv) Total amount of royalty due in Calendar Year = US$[*]
16
8.2.2 Windfall Milestone Receipts. If the total amount of Milestone Receipts
obtained by Oncoscience and its Affiliates exceeds US$[*] ([*] US
dollars) (the "Higher Threshold"), then Oncoscience shall pay to CIMYM
20% of the amount by which Milestone Receipts exceeds the Higher
Threshold, provided that the maximum payment shall be (a) US$[*] if such
amounts are received after completion of Phase III trials of the Licensed
Product in the Territory in any indication, or (b) US$[*] if such amounts
are received prior to the completion of Phase III trials of Licensed
Product in the Territory in any indication. Such payments shall be made
within 30 (thirty) days of any such Milestone Receipt in excess of the
Higher Threshold being received by, or becoming due to, Oncoscience or
its Affiliate.
8.3 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.
8.4 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 Kreissparkase Sudholstein
▇▇▇▇▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇ 38-40 25431 Pinneburg 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;
(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.
8.5 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
17
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.
8.6 Royalty statements. Oncoscience shall send to CIMYM at the same time as
each royalty payment is made in accordance with clause 0 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 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.
8.7 Records
8.7.1 Oncoscience shall keep at its normal place of business detailed and up to
date records and accounts showing the quantity, description and Net 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.
8.7.2 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 0.
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.
8.7.3 Oncoscience shall ensure that CIMYM has the same rights as those set out
in this Clause 8.7 in respect of any Affiliate or sub-licensee of
Oncoscience that is sub-licensed under Licensed Intellectual Property
pursuant to this Agreement.
9 DILIGENCE
9.1 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 0, Oncoscience shall develop and
commercially exploit Licensed Product in accordance with the Development
and Commercialisation Plan.
9.2 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 0, 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.
18
9.3 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.
9.4 If the expert determines that Oncoscience has failed to comply with its
obligations under this Clause 0, 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 0.
10 INTELLECTUAL PROPERTY
10.1 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 to 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.
10.2 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:
(a) Diligently seek to obtain valid patents (in the name of the
relevant Parties as specified in Clause 0) 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 funding 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.
10.3 Infringement of the Patents
10.3.1 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.
19
10.3.2 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.
10.4 Infringement of third party rights
10.4.1 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.
10.4.2 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.
10.5 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 50% (fifty
percent) of the royalties or other compensation paid to the third party
in respect of sales of Licensed Product in the Territory, subject to the
following conditions:
(a) The reduction shall not exceed 1.5% (one and a half 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 15% (fifteen
percent) of Net Sales Value, the royalty following such deduction
shall not be reduced below 13.5% (thirteen and a half 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,
20
improvements or other features that Oncoscience chooses to
incorporate into the Licensed Product.
10.6 Product names. Oncoscience shall be responsible for deciding, in
consultation with CIMYM, the trade ▇▇▇▇ to be applied to the Licensed
Product in the Oncoscience Field and Territory. Oncoscience will be
responsible for applying for any such trade ▇▇▇▇ in the Territory, at its
sole cost. CIMYM acknowledges that it has no objection to the trade ▇▇▇▇
"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".
11 WARRANTIES AND LIABILITY
11.1 Warranties by CIMYM. CIMYM warrants that:
(a) subject to Clause 0, 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
(a) 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.
11.2 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.
11.3 No other warranties
11.3.1 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.
11.3.2 Without limiting the scope of Clause 0, CIMYM does not give any warranty,
representation or undertaking:-
(a) as to the efficacy or usefulness of any of the Licensed
Intellectual Property; or
21
(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.
11.4 Indemnity and insurance. Oncoscience shall indemnify and hold harmless
CIMYM, 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(pound)5,000,000 (five million pounds sterling) per claim or
series of claims).
11.5 Liability. Subject to clause 0, 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.
12 DURATION AND TERMINATION
12.1 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 0, shall
22
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.
12.2 Early termination
12.2.1 Oncoscience may terminate this Agreement at any time on 90 days notice in
writing to CIMYM.
12.2.2 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
(c) 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.
23
12.2.3 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.
12.2.4 The Parties acknowledge and agree that Oncoscience's remedy for any
breach by CIMAB of its obligations under Clause 0 shall be as set out
in Clause 0 or in any Supply Agreement that CIMAB and Oncoscience may
execute pursuant to Clause 0. Accordingly, breach of Clause 0 shall not
entitle any Party to terminate this Agreement.
12.3 Consequences of termination
12.3.1 Upon termination of this Agreement for any reason otherwise than in
accordance with Clause 0:
(a) If termination occurs after 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 0) 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 0, referred to in paragraph (i) below, shall survive
for a period of 5 years from the termination of this Agreement:
(i) clauses 0 (except that Oncoscience shall not have any
continuing right to use Licensed Know-how or any other
information received from CIMYM or CIMAB), 00 (subject to
clause 0) (and no further disclosure may be made by
Oncoscience under clause 0);
(ii) clause 0 (in respect of sales of Licensed Product made
prior to termination, or after termination under the first
part of clause 0(a)); and
(iii) clause 0 and 0; and
(e) subject as provided in this Clause 0 and 0, and except in respect
of any accrued rights, neither Party shall be under any further
obligation to the other.
12.3.2 Upon termination of this Agreement for any reason otherwise than in
accordance with Clause 0 and at CIMYM's request, Oncoscience shall,
without charge to, or other obligation on the part of, CIMYM:
24
(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.
13 GENERAL
13.1 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.
13.2 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.
13.3 Assignment and third party rights.
13.3.1 Subject to clause 0 below, no Party shall assign, mortgage, charge or
otherwise transfer any rights or obligations under this Agreement, nor
any of the Patents or rights under the Patents, without the prior
written consent of the other Parties.
13.3.2 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.
13.4 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.
13.5 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.
25
13.6 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.
13.7 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.
13.8 Notices
13.8.1 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 0. The fax numbers of the Parties are as
follows:
Party Fax number
CIMYM 001 o
CIMAB 0053 7 33 3509
Oncoscience 0049 4103 1808 820
26
13.8.2 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).
13.9 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.
13.10 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.
13.11 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.
13.12 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.
13.13 Third party rights. Each of the persons identified as Indemnities in
Clause 0 may in his own right enforce the provisions of those respective
Clauses. Except as provided in the previous sentence of this Clause 0,
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.
13.14 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
27
(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.
AGREED by the Parties through their authorised signatories:
For and on behalf of CIMYM, INC.
"▇▇▇▇▇ ▇▇▇▇▇▇▇▇" "▇▇▇▇ ▇ ▇▇▇▇▇"
------------------------ -----------------------------
signed signed
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇ ▇▇▇▇▇"
------------------------ -----------------------------
print name print name
Director Director
------------------------ -----------------------------
title title
November 17, 2003 Nov 17, 2003
------------------------ -----------------------------
date date
For and on behalf of CIMAB S.A.
"▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇"
------------------------
signed
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------------ -----------------------------
print name signed
Vice-President
------------------------ -----------------------------
title print name
6/11/03 -----------------------------
------------------------ title
date
-----------------------------
date
28
For and on behalf of ONCOSCIENCE AG
"▇. ▇▇▇▇"
------------------------ -----------------------------
signed signed
▇. ▇▇▇▇
------------------------ -----------------------------
print name print name
President
------------------------ -----------------------------
title title
07/11/2003
------------------------ -----------------------------
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. PUBLN DATE PUBLN NO. ISSUE DATE PATENT NO.
--------------- --------------- --------------- --------------- -------------- --------------- --------------
Europe(1) 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 DATE(2) 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
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.
----------
(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 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.
31
SCHEDULE 4
Appointment of expert
1. Pursuant to Clause 0, CIMYM may serve notice on Oncoscience ("Referral
Notice") that it wishes to refer to an expert (the "Expert") the questions set
out in Clause 0.
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.
32