* CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED
BY AN [_].
Final Version 12 April 2005 Confidential
LICENCE AGREEMENT
THIS AGREEMENT is made the 12th day of April, 2005 BETWEEN:
1 XENOVA LIMITED a company incorporated in England and Wales whose
registered office is at 000 Xxxxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxx XXx 0XX,
Xxxxxxx ("Xenova"); and
2 PHARMAENGINE, INC. a company incorporated in Taiwan, Republic of China
whose principal place of business is at 00X, Xx. 000 Xxxx-Xxxxxx Xxxx,
Xxxxxx 000, Xxxxxx, Xxxxxxxx of China ("PharmaEngine").
WHEREAS:
A. Xenova has a certain pharmaceutical product (defined below as the
"Licensed Product") under development for use in the therapy and
prophylaxis of brain cancers.
B. Xenova wishes to grant to PharmaEngine, and PharmaEngine wishes to
accept, an exclusive licence to develop in accordance with the
Development Plan, market, promote, distribute, sell and/or sub-license
the Licensed Product in the Indications in the People's Republic of China
and in the Republic of Korea (together defined below as the "Territory"),
upon and subject to the terms contained in this Agreement.
C. To the extent (if any) that Xenova is free to grant such rights, Xenova
is willing to grant to PharmaEngine, and PharmaEngine wishes to accept,
an option to extend the Territory to include Taiwan, upon and subject to
the terms contained in this Agreement (including Clause 2.4).
D. Xenova and PharmaEngine wish to collaborate in the further development of
the Licensed Product as may be required to obtain marketing
authorisations for the Licensed Product in the Indications in the
Territory.
NOW IT IS HEREBY AGREED as follows:
1 DEFINITIONS
1.1 In this Agreement, unless the context otherwise requires:
1.1.1 "ADVERSE EVENT" means any unfavourable and unintended sign
(including an abnormal laboratory finding), symptom or disease
associated with the administration of a medicinal product whether
or not considered related to the Licensed Product;
1.1.2 "API", OR "ACTIVE PHARMACEUTICAL INGREDIENT" shall mean CRM107
conjugated to human transferrin;
1.1.3 "AFFILIATE" means in relation to either Party any person who
directly or indirectly controls, is controlled by or is under
common control with that Party. A person shall be regarded as in
control of another person if it owns directly or indirectly more
than 40% (forty per cent) of the voting stock or other ownership
or income interest of another person or if it directly or
indirectly possesses the power to direct or cause
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the direction of the management and policies of another person by
any means whatsoever;
1.1.4 "BUSINESS DAY" means a day other than a Saturday, Sunday, Bank
Holiday or other public or national holiday in England or the
Territory;
1.1.5 "COMMERCIAL LAUNCH" shall mean the first shipping by PharmaEngine,
its Affiliate or Sub-Licensee of the Licensed Product to its
wholesalers in each country of the Territory in such commercial
quantities of the Licensed Product as may reasonably be
appropriate to establish the Licensed Product throughout the
Territory;
1.1.6 "COMMERCIALLY REASONABLE EFFORTS" shall mean exerting such effort
and employing such resources 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.
1.1.7 "COURSE" means a course of treatment of a patient with Licensed
Product that consists of two treatments, each of not more than 27
micrograms of API;
1.1.8 "CRM 107" means single point mutated diphtheria toxin;
1.1.9 "DEVELOPMENT PLAN" means a plan for the undertaking of all
appropriate activities for the development of Licensed Product in
the Territory, to be prepared in accordance with Clause 4.3, and
which shall include detailed plans covering the activities
summarised in Schedule 2;
1.1.10 "DOSSIER" means, in respect of each country, the master regulatory
dossier relating to the Licensed Product prepared by or on behalf
of either Party in connection with obtaining the Marketing
Authorisations for the Licensed Product in and outside of the
Territory, including relevant Programme Data;
1.1.11 "Effective DATE" means 12th April 2005;
1.1.12 "EU" means the European Union and each of the member states from
time to time of the European Union;
1.1.13 "FILING DATE" means the date upon which a Dossier for the Licensed
Product is submitted by or on behalf of PharmaEngine in support of
an application for the Marketing Authorisation of the Licensed
Product in any part of the Territory;
1.1.14 "FORCE MAJEURE" means in relation to either Party any
circumstances beyond the reasonable control of that Party
including without limitation any strike, lock-out or other form of
industrial action, act of God, war, riot, accident, fire, flood,
earthquake, explosion or government action;
1.1.15 "GBM" means glioblastoma multiforme;
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1.1.16 "ICH GUIDELINES" means the guidelines established from time to
time by the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use;
1.1.17 "INDICATIONS" means the Initial Indications and any Other
Indications;
1.1.18 "INITIAL INDICATIONS" means each indication within the general
area of the treatment of brain tumours in humans including the
following indications:
(a) recurrent, non-resectable GBM in adult humans;
(b) newly diagnosed GBM in adult humans;
(c) metastatic GBM in adult humans; and
(d) each of the indications referred to in paragraphs (a) to
(c) above in humans under the age of 18 years;
1.1.19 "INTELLECTUAL PROPERTY" means all patents, claims in patents,
registered designs, applications for any of the foregoing and the
right to apply for any of the foregoing in any part of the world,
copyright, design right, inventions, confidential information
(including Know how) and any other similar right (but excluding
any Trademarks) situated in any country of the world;
1.1.20 "JDCC" means a Joint Development and Commercialisation Committee
to be formed in accordance with Clause 4.2;
1.1.21 "KNOW-HOW" means all information relating to the API and/or the
Licensed Product not in the public domain of whatsoever nature,
including any such information contained in the Dossier and
including any pre-clinical and clinical data;
1.1.22 "LAUNCH DATE" means each date of Commercial Launch by PharmaEngine
of the Licensed Product in each country of the Territory after all
necessary Marketing Authorisations have been obtained by
PharmaEngine;
1.1.23 "LIBOR" means the rate per annum (rounded upwards if necessary to
the next higher 1/100th of 1%) which is the average of the inter
bank offered rates for US Dollar deposits in the London inter bank
Euro Dollar Market for a period of five consecutive Business Days
as reported in the Financial Times newspaper in its "Money Rates"
column on the relevant date or if the Financial Times does not
publish such rate for any reason, such rate as is quoted by
Reuters at 10.00 am (London time) on such date or (if the relevant
date is not a Business Day) on the first Business Day following
the relevant date;
1.1.24 "LICENSED PRODUCT" means any pharmaceutical product in finished
dosage or in finished dosage package form ready for sale to third
parties which consists of or contains the API for human use
1.1.25 "MARKETING AUTHORISATION" means such formal approvals from the
State Food and
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Drug Administration (People's Republic of China), Korean Food and
Drug Administration (Republic of Korea) or Department of Health
(Taiwan), as applicable, as are necessary for the commercial
marketing, sale and use of the Licensed Product in the Territory;
1.1.26 "MARKETING AUTHORISATION APPLICATION" means an application for
Marketing Authorisation in any country of the Territory;
1.1.27 "MARKETING PLAN" means a plan for the undertaking of all
appropriate activities for commercialisation of Licensed Product
in the Territory, including pre-launch and post-launch marketing
and sales activities, to be prepared in accordance with Clause
4.3;
1.1.28 "MEDICAL AFFAIRS LIAISON" means persons appointed by Xenova and
PharmaEngine to communicate with each other with regard to
information to be exchanged pursuant to Clause 7.1;
1.1.29 "Net SALES" means all monies invoiced to the ultimate purchaser by
PharmaEngine or its Affiliates or any Sub-Licensees or their
respective agents or distributors, in respect of the sale of the
Licensed Product less the following items to the extent that they
are actually paid or allowed and specified on any documents
related to such sale:
(a) normal discounts actually granted;
(b) credit actually allowed for any Licensed Product returned
or not accepted by customers on quality grounds;
(c) packaging, transportation and prepaid insurance charges on
shipments or deliveries to customers;
(d) cost of samples for regulatory testing, promotional and
hospital listing purposes as set out in the Marketing Plan
from time to time; and
(e) sales or value added taxes actually incurred and paid by
PharmaEngine, its Affiliates or any Sub-licensees in
connection with the sale or delivery of the Licensed
Products to customers;
Provided that the total, aggregate amount of deductions under
paragraphs (a), (b) and (c) above with respect to any unit of
Licensed Product shall not exceed 10% of the sale price.
1.1.30 "OTHER INDICATIONS" means any indications in respect of tumours in
humans, other than brain tumours, that the Parties may agree from
time to time in writing shall be licensed to PharmaEngine as Other
Indications under this Agreement;
1.1.31 "PARTIES" means Xenova and PharmaEngine, and "Party" means either
of them;
1.1.32 "PERMITS" means all necessary consents, approvals and
authorizations of all regulatory and governmental authorities and
other persons in connection with the
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development, use, importation, promotion, marketing, sale and
supply of Licensed Product in each country of the Territory;
1.1.33 "PIVOTAL TRIAL" means a controlled pivotal clinical study of a
Licensed Product which is prospectively designed to demonstrate
statistically whether such Licensed Product is effective and safe
for use in a particular indication in a manner sufficient to
obtain Marketing Authorisation for such Product;
1.1.34 "PIVOTAL TRIAL INITIATION" means the first dosing of the first
patient in a Pivotal Trial;
1.1.35 "PIVOTAL TRIAL COMPLETION" means completion of the final report of
a Pivotal Trial;
1.1.36 "PLANS" means the Development Plan and the Marketing Plan;
1.1.37 "PHARMAENGINE TRADEMARK" means any Trademark proprietary to
PharmaEngine used on products marketed by PharmaEngine (in
addition to any Trademark identifying the product) to identify
PharmaEngine as the holder of a Marketing Authorisation for such
product;
1.1.38 "PRODUCT TRADEMARK" means any Trademark selected by PharmaEngine
in respect of the Licensed Product in the Territory and notified
to Xenova under the terms of Clause 9.1;
1.1.39 "PROGRAMME DATA" means the data from any Programme Trials and any
other test data related thereto and any other documentation or
correspondence relating to any Programme Trials of the Licensed
Product conducted by or on behalf of either Party and all Know-how
in respect of the same;
1.1.40 "PROGRAMME TRIALS" means such clinical testing (including
toxicological, stability, pharmacological and clinical studies in
human beings) as may be required to be carried out and/or produced
by or on behalf of either Party in connection with obtaining the
Marketing Authorisation for the Licensed Product either inside or
outside of the Territory, and which in the case of such clinical
testing inside the Territory shall be conducted in accordance with
the Development Plan from time to time;
1.1.41 "QUARTER" means each three calendar-month period in any year
during the term of this Agreement ending on 31st March, 30th June,
30th September and 31st December in each year and "QUARTERLY" has
a corresponding meaning;
1.1.42 "REGULATORY AUTHORITY" means the body with responsibility for
granting the Marketing Authorisations of the Licensed Product in
each country of the Territory;
1,1.43 "ROYALTIES" means the royalties payable to Xenova in accordance
with Clause 11.3;
1.1.44 "SERIOUS ADVERSE EVENT" means an Adverse Event that:
(a) results in death;
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(b) is life-threatening;
(c) requires prolongation of existing hospitalization;
(d) results in persistent or significant disability or
incapacity; or
(e) results in congenital anomaly or birth defect;
and/or other medically significant events that may jeopardise the
patient or may require intervention to prevent one of the outcomes
listed in the previous paragraphs of this definition;
1.1.45 "SUB-LICENCE" means any sub-licence agreement entered into by
PharmaEngine and a Sub-Licensee, pursuant to which PharmaEngine
grants such Sub-Licensee rights to co-develop, market, promote,
distribute and/or sell the Licensed Product in the Territory, or
any part thereof;
1.1.46 "SUB-LICENSEE" means any person (including distributors) to whom
PharmaEngine has directly or indirectly, granted rights to
co-develop, market, promote, distribute and/or sell the Licensed
Product in the Territory, or any part thereof;
1.1.47 "SUPPLY AGREEMENT" means the supply agreement between the Parties
to be entered into in accordance with Clause 8;
1.1.48 "TERRITORY" means the People's Republic of China and the Republic
of Korea and, if PharmaEngine validly exercises an option in
accordance with Clause 2.4, Taiwan;
1.1.49 "TRADEMARKS" means trade names, logos and marks (both registered
and unregistered) and rights in respect thereof, including rights
to prevent passing off, rights to prevent unfair competition and
similar rights in respect of goods and/or services;
1.1.50 "XENOVA INTELLECTUAL PROPERTY" means such rights as Xenova may
have (whether as owner or licensee) in the Territory at the
Effective Date or thereafter in any Intellectual Property with
respect to the API and/or the Licensed Product, and including:
(a) any patent(s) and patent application(s) that may be filed
by Xenova in the Territory during the term of this
Agreement with respect to the API and/or the Licensed
Product, including all extensions, additions and divisions
thereof; and
(b) the Know-how; and
(c) any other rights (other than Trademarks) that may protect
any aspect of the API and/or the Licensed Product or its
marketing in the Territory, including (where applicable)
property rights in materials and data exclusivity rights.
1.1.51 "Year" means a calendar year commencing from 1st January.
1.2 In this Agreement unless the context otherwise requires:
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1.2.1 references to "this Agreement" shall mean this Agreement and any
and all Schedules to it as may be varied from time to time in
accordance with its provisions;
1.2.2 all references to a particular Clause, Schedule or paragraph shall
be a reference to that Clause, Schedule or paragraph in this
Agreement;
1.2.3 words importing the singular shall include the plural and vice
versa and words importing the masculine gender shall include the
feminine gender and vice versa;
1.2.4 headings are for convenience only and shall be ignored in
interpreting this Agreement;
1.2.5 unless the contrary intention appears words denoting persons shall
include any individual, partnership, company, corporation, joint
venture, trust, association, organisation or other entity, in each
case whether or not having separate legal personality;
1.2.6 the words "include" or "including" are to be construed without
limitation to the generality of the preceding words;
1.2.7 references to a statute include any statutory modification,
extension or re-enactment of that statute; and
1.2.8 any reference to "writing" or any cognate expression includes a
reference to any communication effected by facsimile transmission,
electronic mail or similar means.
2 GRANT OF LICENCE AND OPTION
2.1 Licence. Xenova hereby grants to PharmaEngine an exclusive licence under
the Xenova Intellectual Property to develop in accordance with the
Development Plan, market, promote, distribute and sell the Licensed
Product for the Indications in the Territory during the term of this
Agreement.
2.2 Development Sub-licences. PharmaEngine may grant Sub-licences under the
licence granted in Clause 2.1. If such sub-license of the Xenova
Intellectual Property includes a sub-licence to develop and/or apply for
and hold regulatory approval(s) for the Licensed Product for the
Indications in the Territory, such sub-license shall require the prior
written agreement of Xenova. Without limiting Xenova's rights under the
previous sentence of this Clause:
2.2.1 Xenova may require that it be added as a party to any Sub-licence
and/or may require that terms be included to provide that the
Sub-licence shall survive any termination of this Agreement as an
agreement between Xenova and the Sub-licensee directly.
2.2.2 PharmaEngine shall keep Xenova fully and promptly informed of all
material discussions with potential Sub-licensees and, if so
required by Xenova, shall facilitate Xenova's involvement in such
discussions.
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2.3 Appointment of distributors.
2.3.1 PharmaEngine may appoint distributors for Licensed Products in the
Territory with Xenova's prior written agreement. Such agreement
will be deemed to be automatically given if the distribution
agreement contains the minimum obligations referred to in Clause
2.3.2.
2.3.2 Prior to the appointment of the first distributor for Licensed
Products in the Territory, Xenova will prepare, and notify
PharmaEngine of, a list of minimum obligations for distribution
agreements in the Territory, in order to protect Xenova's
interests outside the Territory.
2.4 Option. Xenova confirms that it has granted to another company an option
("Third Party Option") to acquire a licence to market the Licensed
Product in Taiwan. Xenova shall notify PharmaEngine if the Third Party
Option lapses. During the period of 60 (sixty) days from the date of such
notification by Xenova ("Option Period"), PharmaEngine may notify Xenova
in writing that it wishes to extend the Territory, under this Agreement,
to include Taiwan. If PharmaEngine so notifies Xenova within the Option
Period, the Parties shall negotiate in good faith within 60 (sixty) days
of the notification by PharmaEngine of the terms of an agreement between
them ("Amending Agreement") under which the definition of Territory set
out in Clause 1 shall be amended to include Taiwan. If PharmaEngine fails
to so notify Xenova within the Option Period, or if (having notified
Xenova within the Option Period) the Parties fail to enter into an
Amending Agreement during the Option Period, PharmaEngine's rights under
this Clause 2.4 shall lapse.
3 DISCLOSURE OF TECHNICAL INFORMATION AND OTHER KNOWHOW
3.1 Initial disclosure. Promptly after execution but within 90 (ninety) days
at the latest following the Effective Date, Xenova shall make available
for collection by PharmaEngine any and all technical information in its
possession relating to API and/or the Licensed Product, which has not yet
been disclosed to PharmaEngine, including but not limited to pre-
clinical data, Programme Data, clinical development plan, Know-how and
Dossier, if any, for API and/or the Licensed Product. It is, however,
agreed and understood that Xenova is required to disclose to PharmaEngine
any such technical information relating to the manufacture of API and the
Licensed Product only to the extent that PharmaEngine is required to
incorporate such information in its documents to be submitted to the
Regulatory Authority in the Territory for commencing the Programme Trials
of the Licensed Product or in the Dossier to be filed with the Regulatory
Authority for Marketing Authorisation in the Territory.
3.2 Subsequent disclosure. Xenova shall also disclose to PharmaEngine within
90 (ninety) days all of such technical information which Xenova may
develop or acquire during the term of this Agreement, including all of
such technical information that Xenova will obtain from its
sub-licensee(s), if any, outside of the Territory, unless prevented by
the terms of its agreement with such sub-licensee. It is, however, agreed
and understood that Xenova is required to disclose to PharmaEngine any
such technical information relating to the manufacture of API and the
Licensed Product only to the extent that PharmaEngine is required to
incorporate such information in its documents to be submitted to the
Regulatory Authority in the Territory for commencing the Programme Trials
of the Licensed Product or in the Dossier to be filed with the Regulatory
Authority for Marketing Authorisation in the Territory.
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3.3 Use of information. PharmaEngine shall have the right to use such
technical information disclosed to it pursuant to Clauses 3.1 and 3.2 for
the purpose of this Agreement and to disclose it to its Sub-Licensees for
their use for the purpose of this Agreement, subject to Clause 13.
3.4 PharmaEngine data. All Programme Data generated by PharmaEngine hereunder
shall solely belong to PharmaEngine. PharmaEngine shall disclose to
Xenova within 90 (ninety) days all of such technical information which
PharmaEngine may develop or acquire during the term of this Agreement in
relation to the API and/or Licensed Product, including all of such
technical information that PharmaEngine will obtain from its
Sub-licensee(s). Xenova shall have the right (without payment to
PharmaEngine or any other person) to use, and (in the case of (b) below)
permit its licensees and contractors outside the Territory to use, such
technical information for the purposes of (a) performing its activities
under this Agreement, and (b) developing and obtaining regulatory
approval for Licensed Product outside the Territory.
3.5 Investigator training. Xenova shall provide PharmaEngine with the
training described in Schedule 1 Part B, subject to the provisions of
Schedule 1 Part B.
4 DEVELOPMENT AND COMMERCIALISATION
4.1 Diligence obligations generally.
4.1.1 PharmaEngine shall be responsible for funding and managing, and
shall diligently pursue, all development, registration, marketing
(both pre- and post-launch), promotion, distribution and sales
activities in respect of Licensed Product in the Indications in
the Territory. Such activities shall include:
(a) The conduct of the Programme Trials and the development and
creation of the Dossier for the Licensed Product in the
Territory, all in accordance with ICH Guidelines and all
applicable laws and regulations in the Territory;
(b) The milestones referred to in Clause 4.4;
(c) The specific activities referred to in Clauses 5 and 6;
(d) The appointment of Sub-licensees and distributors, where
applicable; and
(e) The commercialisation of the Licensed Product in the
Territory, including marketing and sales activities,
whether itself or through its Sub-licensees and
distributors.
4.1.2 If, at any time, Xenova considers that PharmaEngine has not
diligently pursued the activities described in Clause 4.1.1 or
has failed to comply with any obligations under Clauses 4.3.6
or 6.1, Xenova may refer to an independent expert the following
questions:
(a) whether PharmaEngine has met its obligations under those
clauses; and if not
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(b) what actions the expert proposes PharmaEngine should take
in order to meet its obligations under those clauses.
4.1.3 The independent expert shall be appointed in accordance with the
provisions of Schedule 4.
4.1.4 If the expert determines that PharmaEngine has failed to comply
with its obligations under this Clause 4, and if PharmaEngine
fails to take the actions proposed by the expert pursuant to
Clause 4.1.2(b) within 3 (three) months of the expert giving his
decision in accordance with Schedule 4, Xenova shall he entitled,
by giving, at any time within 3 (three) months after the end of
that 3 (three) month period, not less than 1 (one) month's notice
to terminate this Agreement.
4.1.5 The provisions of Clauses 4.1.2 to 4.1.4, and the exercise of the
rights under those clauses, shall be without prejudice to any
rights that Xenova may have to claim damages in the event that
PharmaEngine is in breach of any of its obligations under Clause
4.1, 4.3.6 or 6.1.
4.2 Joint Development and Commercialisation Committee
4.2.1 Within 15 (fifteen) days after the Effective Date, the Parties
shall establish a Joint Development and Commercialisation
Committee ("JDCC"), by each Party designating its initial members
to serve on the JDCC and notifying the other Party of its dates of
availability for the first meeting of the JDCC. The purpose of the
JDCC shall be to oversee the development and commercialisation of
Licensed Product in the Indications in the Territory in accordance
with the Plans. The JDCC shall consist of up to 3 (three)
representatives designated by each Party. Each representative
shall have relevant and appropriate expertise in order to oversee
the development of the Licensed Product, and in particular one
representative of each Party shall be that Party's project
leader/manager, one shall have clinical development experience and
one shall have commercial experience.
4.2.2 If a representative of a Party is unable to attend a meeting of
the JDCC, such Party may designate an alternate to attend such
meeting. In addition, each Party may, at its discretion, invite a
reasonable number of other employees, consultants or scientific
advisors to attend the meetings of the JDCC, provided that such
invitees are bound by appropriate confidentiality obligations.
Each Party may change one or all of its representatives to each
JDCC at any time upon notice to the other Party.
4.2.3 The JDCC shall meet not less than 3 (three) times per Year, and at
such other times as either Party may reasonably request. In
addition, the Parties shall hold a preliminary meeting of the JDCC
as soon as reasonably practicable, but in no event later than 90
(ninety) days after the Effective 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 1 (one) face-to-face meeting per Year.
4.2.4 During the term of this Agreement, the JDCC shall:
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(a) review and recommend to the Parties the overall development
and commercialisation strategy for the Licensed Product in
the Indications in the Territory;
(b) review and approve the Plans (including the resources to be
allocated and the timelines contained in the Plans);
(c) facilitate the transfer of Know-How between the Parties for
purposes of conducting the Development Plan;
(d) regularly assess the progress of PharmaEngine in its
conduct of the Plans;
(e) seek to coordinate the clinical trials to be conducted by
PharmaEngine with other clinical trials for Licensed
Product being conducted outside the Territory; and
(f) oversee such other activities as are contemplated under
this Clause 4 and Clauses 5 and 6.
4.2.5 The JDCC shall seek unanimous agreement among its members of all
matters brought before it. If all members (whether or not present
at a meeting) are not able to agree on any matter brought before
it, either Party may refer the matter to the Chief Executives (or
other nominated officers) of each Party, who shall discuss and
seek to agree the matter in dispute. If they are unable to agree
the matter:
(a) Xenova shall have the final decision on any matter, except
for the pricing of the Licensed Product within the
Territory, that in its reasonable opinion would affect the
development or commercialisation of Licensed Product
outside the Territory; and
(b) On any matter that does not fall within paragraph (a),
either Party may refer the matter for determination by an
expert in accordance with the provisions of Schedule 4.
4.3 Development Plan and Marketing Plan
4.3.1 PharmaEngine shall within 90 (ninety) days following the
Effective Date, discuss with Xenova (in the JDDC) and
determine a Development Plan and a Marketing Plan (which
shall include detailed marketing plans for pre-launch
activities and an outline of post-launch activities) for
each country of the Territory together with a timetable and
budget for all required actions and the anticipated Filing
Date for the Licensed Product in each country of the
Territory.
4.3.2 By November 30th in each Year, PharmaEngine shall submit to
the JDCC both an updated Development Plan and an updated
Marketing Plan that will include detailed activities and a
budget for the coming Year, as well as an update of all
other sections
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of the plan. From time to time Xenova may reasonably
require PharmaEngine to provide more detailed descriptions
or explanations of any matter covered by the Plans;
4.3.3 By July 20th in each Year, PharmaEngine shall submit to the
JDCC a report detailing the progress that it has made
against the activities listed in the Plans during the first
6 (six) months of that Year;
4.3.4 By January 20th in each Year, PharmaEngine shall submit to
the JDCC a report detailing the progress that it has made
against the activities listed in the Plans during the 12
(twelve) months of the previous Year;
4.3.5 Not less than 12 (twelve) months prior to the anticipated
date of Commercial Launch, as set out in the Development
Plan, PharmaEngine shall prepare a full Marketing Plan
which shall include a description of the positioning of the
Licensed Product, sales materials, trade show support and
educational campaigns for the Licensed Product in the
Territory and a sales forecast for the Year covered by such
Marketing Plan; thereafter, the updated Marketing Plan to
be provided under Clause 4.3.2 shall be a full Marketing
Plan;
4.3.6 PharmaEngine shall use Commercially Reasonable Efforts to
implement the Plans in accordance with a timetable agreed
in the Plans and also in accordance with the terms of this
Agreement;
4.4 Development Milestones. In addition to its obligations under the
Plans, PharmaEngine shall achieve the following development
milestones in any part of the Territory:
4.4.1 Submission of an IND containing a clinical trial protocol
for a Phase II trial for the Licensed Product in the
Territory to regulatory authorities within 4 (four) months
after the transfer of any such technical information that
PharmaEngine is required to incorporate in its documents to
be submitted to the Regulatory Authority in the Territory
for commencing the Programme Trials of the Licensed
Product;
4.4.2 Pivotal Trial Initiation by the 2nd (second) anniversary of
the Effective Date;
4.4.3 Pivotal Trial Completion within 2 (two) years 6 (six)
months of Pivotal Trial Initiation;
4.4.4 Filing of a Marketing Authorisation Application within 2
(two) months of Pivotal Trial Completion; and
4.4.5 Commercial Launch within 2 (two) months of obtaining
Marketing Authorisation.
5 MARKETING AUTHORISATIONS
5.1 Obtain Marketing Authorisation. PharmaEngine shall use all best
endeavours to obtain Marketing Authorisations for the Licensed Product in
each of the Indications in each country of the Territory, including
obtaining "accelerated review" of each Marketing Authorisation
Application, where applicable.
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5.2 Amending the Dossier, etc. PharmaEngine shall be solely responsible for
effecting (at its sole cost and expense) such amendments to the Dossier
as may be required after filing with the appropriate Regulatory Authority
in the Territory to procure that the Dossier complies with and satisfies
the requirements of the Regulatory Authority in connection with obtaining
Marketing Authorisations for the Licensed Product in each of the
Indications in each country of the Territory.
5.3 Copy documents to Xenova. PharmaEngine shall furnish to Xenova promptly,
and in any event on Xenova's written request, a copy of all material
correspondence and documents provided to, and received from the
Regulatory Authority in each country of the Territory, including the
Dossier and a copy of any supplemental documents submitted to the
Regulatory Authority in the Territory in respect of such Dossier.
5.4 Data exclusivity. PharmaEngine shall use all reasonable endeavours to
procure and maintain the maximum period of data exclusivity in the
Territory in respect of the Dossiers filed by PharmaEngine in connection
with any application for or the maintenance of any Marketing
Authorisation of the Licensed Product in the Territory, including
obtaining "orphan drug status", where applicable.
6 MARKETING
6.1 Marketing diligence. PharmaEngine shall during the term of this Agreement
at its own cost, use Commercially Reasonable Efforts to:
6.1.1 initiate, extend, develop, promote and maximise sales of the
Licensed Product in the Territory and not to do anything which may
hinder or interfere with such sales;
6.1.2 achieve the sales forecasts contained in the relevant annual
Marketing Plan;
6.1.3 allocate such promotional and sales resources and such technical
support for the promotion, marketing and sales of the Licensed
Product as may reasonably be required to maximise sales of the
Licensed Product in the Territory.
6.2 Compliance with laws. PharmaEngine agrees and undertakes to market, sell
and distribute the Licensed Product in the Territory entirely in
accordance with the Marketing Authorization of the Licensed Product and
any other applicable laws, restrictions and regulations.
6.3 Attendance at conferences. Xenova shall have the right at its own expense
to undertake or send one or more representatives to any exhibition,
scientific symposium and conference related to the Licensed Product in
the Territory in collaboration with PharmaEngine.
7 PRODUCT SAFETY AND LIABILITY
7.1 Medical affairs liaison. Within 60 (sixty) days of the Effective Date,
each Party shall appoint a primary liaison person ("Medical Affairs
Liaison") to communicate with each other with regard to information to be
exchanged pursuant to this Clause 7.
7.2 Central database. PharmaEngine shall be responsible for the maintenance
of the central database for the Territory regarding all adverse drug
reactions, suspected adverse drug
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reactions and other medical and technical information relevant to the
safety of the Licensed Product and shall make the central database
available to Xenova's Medical Affairs Liaison or such other Xenova
representatives as agreed upon from time to time in writing between the
Parties.
7.3 Adverse Events outside the Territory. During the term of this Agreement,
Xenova shall inform PharmaEngine of any Adverse Event (actual or
suspected) in respect of the Licensed Product anywhere in the world
outside of the Territory about which Xenova obtains information in
accordance with the following:
7.3.1 any Serious Adverse Event information obtained by Xenova
concerning drug reactions that are life-threatening or cause death
shall be reported to PharmaEngine's Medical Affairs Liaison by
telephone or in writing within 2 (two) days after initial
determination by Xenova that the Adverse Event is serious;
7.3.2 any Serious Adverse Event information obtained by Xenova and not
falling within Clause 7.3.1 shall be reported to PharmaEngine's
Medical Affairs Liaison by telephone or in writing within 5 (five)
Business Days after initial determination by Xenova that the
Adverse Event is serious; and
7.3.3 any non serious Adverse Event information obtained by Xenova shall
be reported to PharmaEngine's Medical Affairs Liaison in writing
within 90 (ninety) days after the initial receipt by Xenova of the
information;
7.3.4 Xenova's reports shall contain any relevant information reasonably
required by PharmaEngine to meet the requirements of the
Regulatory Authority in the Territory with respect to the adverse
drug reaction reports and ICH periodic drug safety updates.
7.4 Adverse Events in the Territory. During the term of this Agreement,
PharmaEngine shall inform Xenova of any Adverse Event (actual or
suspected) in respect of the Licensed Product in the Territory about
which PharmaEngine obtains information in accordance with the following:
7.4.1 any Serious Adverse Event information obtained by PharmaEngine
concerning drug reactions that are life-threatening or cause death
shall be reported to Xenova's Medical Affairs Liaison by telephone
or in writing in English within 2 (two) days after initial
determination by PharmaEngine that the Adverse Event is serious;
7.4.2 any Serious Adverse Event information obtained by PharmaEngine not
falling within Clause 7.4.1 shall be reported to Xenova's Medical
Affairs Liaison by telephone or in writing in English within 5
(five) Business Days after initial determination by PharmaEngine
that the Adverse Event is serious; and
7.4.3 any non serious Adverse Event information shall be reported to
Xenova's Medical Affairs Liaison in writing in English within 90
(ninety) days after the initial receipt by PharmaEngine of the
information;
7.4.4 PharmaEngine's reports shall contain any relevant information
reasonably required
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by Xenova to meet the requirements of CIOMS I expedited adverse
drug reaction reports and ICH periodic drug safety updates.
7.5 Notifying events, etc. PharmaEngine shall have responsibility for
investigating adverse drug reactions associated with the Licensed Product
in the Territory and for reporting them to the Regulatory Authorities in
the Territory, where appropriate, in accordance with the laws and
regulations of the Territory and for effecting any required safety
updates of the Licensed Product in the Territory. Each Party shall
promptly deliver to the other all correspondence that it receives from
any Regulatory Authorities relating to the safety of the Licensed Product
except for procedural, non-substantive communications. The Parties shall
agree in writing, and comply with, detailed written procedures for
communicating Serious Adverse Events, Adverse Events and other safety
information.
7.6 Licensed Product recall. PharmaEngine may at its discretion and will if
requested to do so by Xenova, recall any Licensed Product in the
Territory. The costs and expenses incurred by PharmaEngine and/or
Sub-Licensees in connection with such recall shall be borne by
PharmaEngine, unless such recall is both:
7.6.1 requested by Xenova or the Regulatory Authorities in the
Territory; and
7.6.2 does not arise from any material breach of this Agreement by
PharmaEngine or any material breach of the Sub-licence by the
Sub-Licensee, or any negligence or intentional misconduct on the
part of PharmaEngine or its Sub-licensee;
in which cases Xenova shall reimburse to PharmaEngine all of such costs
and expenses.
7.7 Product liability insurance. PharmaEngine shall insure the Licensed
Product against all product liability claims to be in compliance with the
laws and regulations in each country of the Territory (including both
clinical trials insurance and product liability insurance) arising in
respect of the Licensed Product supplied by PharmaEngine in the
Territory, regardless of whether or not arising as a result of the
negligence or breach of this Agreement by PharmaEngine. Such insurance
shall be with a reputable insurer to whom Xenova does not object and the
insurance coverage, in the case of clinical trials insurance shall be not
less than the amount(s) required by the laws and regulations of each
country of the Territory, and, in the case of product liability
insurance, shall not be less than US[_] or such higher amount as is
generally considered appropriate for each country of the Territory.
8 MANUFACTURING AND SUPPLY
8.1 General responsibilities. Xenova will be responsible for the manufacture,
supply and the export permit of filled Licensed Product to PharmaEngine
at the supplier's premises. PharmaEngine will be responsible, at its
cost, for obtaining the Licensed Product from Xenova's supplier (who may
be located inside or outside the Territory) and paying any costs
associated with delivery to PharmaEngine or its nominee (including the
costs of shipping and insurance, and any export and import duties), and
for Licensed Product labelling, packaging and distribution within the
Territory.
8.2 Supply of Licensed Product for Programme Trials. PharmaEngine shall
submit to Xenova
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the estimated quantities of the Licensed Product necessary for carrying
out the Programme Trials and any other tests and studies of the Licensed
Product in the Territory which PharmaEngine, its Affiliates and
Sub-Licensees require for the preparation of the Dossier to be filed with
the Regulatory Authorities for obtaining the Marketing Authorisation of
the Licensed Product in each country of the Territory, together with
timing of delivery of such quantities of the Licensed Product. Xenova
shall supply PharmaEngine with Licensed Product in such form and
quantities as shall be then agreed upon between the Parties in writing at
a price to be agreed in the Supply Agreement but that shall be not less
than the price at which Xenova obtains such supplies.
8.3 Commercial supply. The Parties will enter into a Supply Agreement, to be
negotiated in good faith and on commercial terms, under which Licensed
Product shall be sold to PharmaEngine at a price not exceeding
US[_] (Ex-Works, Incoterms 2000, at the supplier's premises,
except that Xenova shall be responsible for obtaining export permits from
the USA) per Course.
8.4 Shortage of supply. In the event that available supplies of Licensed
Product are insufficient for all of Xenova5 s licensees, Xenova will
apportion the available supplies of Licensed Product to its licensees
(including PharmaEngine) in such proportions as Xenova considers
reasonable.
9 TRADEMARKS AND PACKAGING
9.1 Product Trademark in the Territory. PharmaEngine may in its sole
discretion (subject always to the terms of this Clause 9) select the
Product Trademark for use on the Licensed Product in the Territory.
PharmaEngine shall notify Xenova of its choice of the Product Trademark
at least 12 (twelve) months prior to effecting first filing for the
Marketing Authorisation of the Licensed Product and shall notify Xenova
in the event that it is required by any Regulatory Authority to amend or
change such Product Trademark. PharmaEngine warrants that the Product
Trademark will not infringe any third party's rights and shall indemnify
Xenova if it suffers liability due to a breach of this warranty.
PharmaEngine undertakes that the Product Trademark shall not be one
confusingly similar to, or identical to (a) any Xenova proprietary xxxx
or logo, nor (b) any trade xxxx or trade name used by Xenova or its
licensees outside the Territory in relation to Licensed Product.
9.2 No other trade marks. PharmaEngine shall not use any trade xxxx or name
on or in connection with the Licensed Product other than the Product
Trademark without the prior approval of Xenova, such approval not to be
unreasonably withheld or delayed. Apart from the Product Trademark and
any PharmaEngine Trademark, no other trade xxxx or logo may be affixed to
the Licensed Product in any form whatsoever. PharmaEngine shall not use
in its business any other trade xxxx confusingly similar to the Product
Trademark and shall not use the Product Trademark as or as part of any
corporate or trading name of PharmaEngine or any PharmaEngine Affiliate.
9.3 Labelling and packaging. PharmaEngine undertakes:
9.3.1 to develop and design labelling and packaging for the Licensed
Product in the Territory at its sole cost and expense provided
always that the general quality,
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design and content of such labelling, packaging and any
information supplied with the Licensed Product by PharmaEngine
shall be submitted to Xenova for its reference and information.
PharmaEngine acknowledges that PharmaEngine shall be solely
responsible for the labelling and packaging of the Licensed
Product and compliance with its obligations under this Clause 9;
and
9.3.2 not to use any misleading statements or misrepresentations on the
Licensed Product packaging or use any defective packaging
materials and to comply in all respects with all local regulations
and laws and the Marketing Authorisations of the Licensed Product
in connection with the Licensed Product labelling, packaging and
the information provided thereon; and
9.3.3 not to use any packaging, which may adversely affect the Licensed
Product in any way whatsoever, including the Licensed Product's
approved shelf life.
10 REPRESENTATIONS BY AND AUTHORITY OF PHARMAENGINE
10.1 Undertakings. PharmaEngine undertakes:
10.1.1 not to represent itself to any third party as the legal agent of
Xenova in any manner and clearly to indicate in all correspondence
and dealings relating directly or indirectly to the sale or other
disposition of the Licensed Product under this Agreement that it
is acting as principal; and
10.1.2 not to bind or purport to bind or indicate any authority to bind
Xenova (or otherwise any Xenova Affiliate) to any contract
whatsoever, unless otherwise agreed upon between the Parties; and
10.1.3 Not to use the corporate name or logo of Xenova (or otherwise the
corporate name of any Xenova Affiliate) without Xenova's prior
written consent, not to be unreasonably withheld or delayed; and
10.1.4 not to incur any liability on behalf of Xenova or in any way
pledge or purport to pledge Xenova's credit or accept any order or
make any contract binding upon Xenova or give or make or purport
to give or make any promises representations warranties or
guarantees with reference to the Licensed Product on behalf of
Xenova except such as are expressly authorised by Xenova in
writing.
10.2 No authority. PharmaEngine hereby confirms that nothing contained in this
Agreement shall give or be deemed to give it any authority to negotiate
the sale or purchase of the Licensed Product on behalf of Xenova or to
negotiate and conclude such transactions on behalf of Xenova.
10.3 Employees, etc. PharmaEngine shall be solely responsible for the acts and
omissions of its employees and representatives in connection with the
performance of its rights and obligations under this Agreement.
11 PAYMENTS
11.1 Consideration. In consideration of the rights and licences granted
hereunder to
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PharmaEngine in respect of the Licensed Product, PharmaEngine shall pay
to Xenova the amounts described in this Clause 11.
11.2 Fixed amounts. PharmaEngine shall pay to Xenova:
11.2.1 the sum of US[_] on the Effective Date;
11.2.2 the sum of US[_] on first dosing of the first patient in the first
Programme Trial in any part of the Territory;
11.2.3 the sum of US[_] on grant of the first approval to market a
Licensed Product in any part of the Territory for any Initial
Indication; and
11.2.4 the sum of US[_] on grant of the first approval to market a
Licensed Product in any part of the Territory for any Other
Indication.
11.3 Royalties. PharmaEngine shall pay to Xenova a Royalty equal to [_] of the
Net Sales in each country of the Territory, provided, however, that:
11.3.1 in respect of Net Sales of Licensed Product in an Other
Indication, and if PharmaEngine has obtained Marketing
Authorisation for such Other Indication in such country, and if
Xenova has provided no clinical data package for that Other
Indication, the Royalty shall be [_] of Net Sales; and
11.3.2 if the cost of supply to PharmaEngine per course of treatment of
Licensed Product in an Other Indication is more than 120% (one
hundred and twenty percent) of the average cost of supply to
PharmaEngine per course of treatment of a Licensed Product in
Initial Indication(s), Xenova will consider in good faith any
proposals that PharmaEngine may make for adjustment of the royalty
rate for the Other Indication.
12 PAYMENT TERMS
12.1 Reporting and payment of milestones. PharmaEngine shall notify Xenova
promptly of any determination, filing or approval that would trigger a
payment by PharmaEngine to Xenova under Clauses 11.2.1 to 11.2.4 and the
amount of the payment required. Xenova shall, after such notification,
invoice PharmaEngine for such amount and PharmaEngine shall pay such
amount to Xenova within 10 (ten) Business Days of receipt of such
invoice.
12.2 Reporting and payment of Royalties. PharmaEngine shall, following the
first Launch Date, prepare a statement in respect of each Quarter, which
shall show for the Quarter in question the aggregate Net Sales. Such
statement shall be submitted to Xenova within 60 (sixty) days of the end
of the Quarter to which it relates together with remittance for the
Royalties in respect of such Quarter.
12.3 Records. PharmaEngine shall during the term of this Agreement following
the first Launch
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Date keep true and accurate records of all Net Sales and books of account
containing all the data necessary for the calculation of the Royalties
and other payments due under this Agreement.
12.4 Auditing. The records and books of account referred to in Clause 12.3
shall, on reasonable prior written notice not less than 5 (five) days
having been given by Xenova, be open during normal working hours on any
Business Day for inspection by a public accounting firm of Xenova's own
selection, except one to which PharmaEngine or Sub-licensee may have
reasonable objection, not more often than once each Year, for not more
than 3 (three) previous Years. Xenova may exercise such right until the
end of 1 (one) year after termination or expiration of this Agreement.
The cost of such inspection shall be borne by Xenova (unless the
inspection reveals an underpayment of the Royalties of more than 5% (five
percent), in which case the cost shall be borne by PharmaEngine) and, if
such inspection reveals an underpayment of the Royalties, PharmaEngine
shall pay such underpayment promptly upon receipt of an invoice in
respect of the same, together with interest in accordance with Clause
12.5. Said public accounting firm shall treat confidential, and shall not
disclose to Xenova, any information other than information which shall be
given to Xenova pursuant to any provision of this Agreement.
12.5 Interest. Without prejudice to Xenova's rights of termination under
Clause 16 of this Agreement, if any payment under Clause 11 or any part
thereof is overdue PharmaEngine shall pay interest thereon at an annual
rate (but with interest accruing on a daily basis) at 3% (three percent)
above LIB OR, such interest to run from the date upon which payment of
such sum became due until payment thereof in full together with such
interest by PharmaEngine (whether before or after any judgement).
12.6 Payment terms. All sums due to Xenova under this Agreement:
12.6.1 are, unless otherwise expressly stated, exclusive of any Value
Added Tax or equivalent sales tax which shall be payable (if
applicable) on submission by Xenova of valid Value Added Tax
invoices in respect thereof;
12.6.2 shall be paid in full without deduction of withholding taxes,
charges and other duties except insofar as Xenova shall be capable
of obtaining a full credit therefore. The Parties agree to
co-operate in all respects necessary to take advantage of such
double taxation agreements as may be available;
12.6.3 shall be paid in United States Dollars ("US$"). Where any
Royalties or other sums falling due in any period covered by the
written statements referred to in Clause 12.1 are calculated in a
currency other than US$, they shall be converted into US$ by
reference to the exchange rate applying when the monies are
actually converted into US$ if this occurs during the period
covered by the written statement referred to in Clause 12.1; or in
the event the monies are not actually converted into US$, the
exchange rate of Barclays Bank plc ruling in London on the last
day of the Quarter covered by the written statement referred to in
Clause 12.2,
13 CONFIDENTIALITY
13.1 Undertaking by PharmaEngine. PharmaEngine undertakes that in relation to
all confidential
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information which has been disclosed to PharmaEngine pursuant to any
provision of this Agreement or which it may generate during the term of
this Agreement (such confidential information to include all information
relating to the API and/or the Licensed Products and to include all
Programme Data and the Dossier) (collectively "Confidential
Information"), it will keep the same secret and confidential, will use
the same only to the extent as may reasonably be required in connection
with the performance of its obligations under this Agreement and will not
at any time for any reason whatsoever disclose or permit the same to be
disclosed to any third party (save as provided in Clause 13.4 and 13.5
below).
13.2 Undertaking by Xenova. Xenova undertakes that in relation to all
Confidential Information which has been disclosed to Xenova pursuant to
any provision of this Agreement, it will keep the same secret and
confidential, will use the same only to extent as may reasonably be
required in connection with securing the Marketing Authorization of any
products which contain or consist of the API in any countries outside of
the Territory and will not at any time for any reason whatsoever disclose
or permit the same to be disclosed to any third party (save as provided
in Clause 13.4 and 13.5 below).
13.3 Exceptions. The obligations of confidentiality contained in this Clause
13 shall not extend to any part of the Confidential Information which the
recipient of such Confidential Information can show by documentary
evidence that such Confidential Information:
13.3.1 was received prior to the date upon which it was received from the
other Party or becomes (otherwise than by reason of any default by
such recipient) freely available to the general public: or
13.3.2 was legally in the possession or control of such recipient prior
to the date upon which it was received from the other Party, free
of any obligation of confidentiality; or
13.3.3 came into its possession or control legally from a third party
free of any obligation of confidentiality and otherwise than by
reason of any breach of any obligation of confidentiality by such
third party subsequent to the date of this Agreement.
13.4 Disclosure to court, etc. In the event that either Party is required at
any time whilst it shall retain any Confidential Information received
from the other Party under this Agreement by any relevant law or
regulation to disclose all or any part of such Confidential Information:
13.4.1 it shall forthwith notify the other Party of such part of the
Confidential Information as may be required to be disclosed by
law, the extent to which such disclosure is required and the
circumstances in which such disclosure is required or effected
pursuant to any applicable law; and
13.4.2 it shall keep the other Party informed of the extent and nature of
such disclosure; and
13.4.3 it shall ensure that any party to whom all or any part of the
Confidential Information is disclosed by reason of any disclosure
required by law is made fully aware of the confidentiality
obligations attaching to the Confidential Information and shall
(insofar as is possible) procure an equivalent obligation of
confidentiality from any
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such party.
13.5 Permitted disclosures. Notwithstanding the provisions of this Clause 13,
either Party shall be entitled to disclose Confidential Information
received from the other Party hereunder to its Affiliates and
Sub-Licensees (or, in the case of Xenova, to its licensees outside the
Territory) and their agents, representatives, employees consultants,
actual and potential investors (collectively "Third Party Recipients") to
the extent necessary to facilitate the performance of its obligations
hereunder and as may be required to exercise the rights granted to it
hereunder. Provided that any such disclosure is limited only to what is
necessary to effect the same and it shall procure that any Third Party
Recipient shall be bound by obligations of confidentiality substantially
similar to the provisions of this Clause 13.
13.6 Continuing effect of CDA. The Parties undertake to continue to comply
with the provisions of the Confidentiality Agreement dated December 19th
2003. Provided that in the event of any ambiguity or discrepancy between
this Agreement and the Confidentiality Agreement the terms of this
Agreement shall prevail.
13.7 Press releases, etc. Subject to the provisions of Clause 13.8,
PharmaEngine shall not issue any press release or communication to be
published by or in the media in any manner concerning the subject matter
of this Agreement without the prior written consent of Xenova (such
consent not to be unreasonably withheld or delayed).
13.8 Regulatory disclosures. If a Party is reasonably required to make any
announcement concerning the transaction contemplated by this Agreement or
any ancillary matter:
13.8.1 by law or by the rules of any securities exchange or regulatory or
governmental body to which either Party is subject, or
13.8.2 in connection with information supplied to its shareholders from
time to time;
the announcement shall only be made after consultation with and the prior
agreement of the other Party as to the terms and timetable for
publication of any announcement (such consultation or prior agreement to
be sought within a reasonable timescale and not to be unreasonably
withheld or delayed by the other Party).
13.9 Duration. The obligations of both Parties under this Clause 13 shall
remain in force during the term of this Agreement and continue thereafter
for a period of 10 (ten) years.
14 PRODUCT LIABILITY
14.1 Indemnity by Xenova. Xenova shall indemnify and hold PharmaEngine, its
Affiliates and Sub-licensees and their employees, agents, directors,
officers and consultants harmless from any liability for costs and
damages in respect of claims made against it for death or personal injury
which has resulted from the use of the Licensed Product purchased from
Xenova and which is attributable to the nature and properties of the
Licensed Product (except that no such indemnity and hold harmless is
given to the extent that such death or personal injury has resulted from
any matter for which PharmaEngine is required to indemnify Xenova under
Clause 14.2). However, Xenova shall not be required to give the indemnity
and hold harmless referred to in the previous sentence of this clause,
if:
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14.1.1 PharmaEngine has not complied with all terms of this Agreement
relating to the Licensed Product and such non-compliance has
caused the death or personal injury;
14.1.2 PharmaEngine has not observed all reasonable instructions given by
Xenova in respect of the Licensed Product, including instructions
as to warning to be given with respect to potential and actual
adverse effects of the Licensed Product and instructions to cease
the sale of the Licensed Product because of such potential or
actual adverse effects; or
14.1.3 PharmaEngine has not immediately advised Xenova in writing of any
Adverse Event of which it may become aware in accordance with
Clause 7.4.
14.2 Indemnity by PharmaEngine. PharmaEngine shall indemnify and hold Xenova,
its Affiliates and licensees and their employees, agents, directors,
officers and consultants harmless from any liability for costs and
damages in respect of claims made against it for death or personal injury
which has resulted from any negligent act or default or omission of
PharmaEngine, its Affiliates or Sub-Licensee or their respective
employees, agents, directors, officers or consultants whether in the
labelling, packaging, sales, or promotion of the Licensed Product or
otherwise, or where any Licensed Product defect was reasonably
discoverable upon inspection by PharmaEngine, its Affiliates or
Sub-Licensee.
14.3 Conditions. The indemnities given in this Clause 14 shall be subject to
the following conditions:
14.3.1 The indemnified Party shall immediately advise the indemnifying
Party of, and permit the Indemnifying Party to have full control
of, any legal proceedings brought by any third party and will give
to the indemnifying Party all reasonable assistance (excluding
financial assistance) that the indemnifying Party may require in
connection with such proceedings; and
14.3.2 The indemnified Party shall not communicate with any third party
or make any statement or omission regarding liability in respect
of any such legal proceedings.
15 WARRANTIES
15.1 Mutual warranties. Each Party warrants that:
15.1.1 it has provided the other Party in writing with full details of
all of its shareholders that hold 5% (five percent) or more of its
share capital and of any other persons that may control or
influence its activities;
15.1.2 it is a corporation duly organized and in good standing under the
laws of England (in the case of Xenova) or Taiwan (in the case of
PharmaEngine), and it has full power and authority and the legal
right to own and operate its property and assets and to carry on
its business as it is now being conducted and as it is
contemplated to be conducted by this Agreement;
15.1.3 it has the full right, power and authority to enter into this
Agreement and to grant the rights and licences granted by it under
this Agreement;
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15.1.4 there are no existing or, to its knowledge, threatened actions,
suits or claims pending with respect to the subject matter hereof
or its right to enter into and perform its obligations under this
Agreement;
15.1.5 it has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and the performance of
its obligations under this Agreement;
15.1.6 this Agreement has been duly executed and delivered on behalf of
it, and constitutes a legal, valid, binding obligation,
enforceable against it in accordance with the terms hereof,
subject to the general principles of equity and to bankruptcy,
insolvency, moratorium and other similar laws affecting the
enforcement of creditors' rights generally and subject to any
applicable competition laws;
15.1.7 all Permits required to be obtained by it in connection with the
execution and delivery of this Agreement and the performance of
its obligations under this Agreement will be obtained and, in the
case of PharmaEngine, all Permits will be obtained in relation to
its conduct of activities in each country of the Territory; and
15.1.8 the execution and delivery of this Agreement and the performance
of its obligations hereunder do not conflict with, or constitute a
default under, any of its contractual obligations.
15.2 Third party claims. In the event that an exercise by PharmaEngine of the
rights and licences granted hereunder in the Territory would constitute
an infringement of any patent right of third party, either Party shall,
as soon as possible it becomes aware of the same, notify the other Party
thereof, giving in such notice full detail known to it of the patent
right of such third party and extent of any alleged infringement. The
Parties shall then discuss the situation and, if and to the extent
necessary to permit PharmaEngine to practise the rights and licences
granted hereunder, shall use their reasonable efforts to obtain an
appropriate licence from such third party. The Parties shall, in
negotiating such licence with such third party, make every effort to
minimize the royalties payable thereunder. Any royalties or other costs
associated with such licence shall be borne by PharmaEngine and shall not
be deducted from any payment under this Agreement
16 TERMINATION
16.1 Commencement and expiry. This Agreement shall commence on the Effective
Date and continue thereafter until expiration of 10 (ten) years following
the first Launch Date in each country in the Territory, unless terminated
earlier by either Party pursuant to any provision of this Agreement.
16.2 Termination for breach or insolvency. Without prejudice to any other
right or remedy that it may have, either Party (as the case may be) ("the
Non Defaulting Party") will be entitled to terminate this Agreement as a
whole, or in respect of one or more countries in the Territory, forthwith
by notice in writing if:
16.2.1 the other Party ("the Defaulting Party") commits a material breach
of its obligations under this Agreement which (if capable of
remedy) is not remedied within [_] of written notice requiring it
to be remedied being received by the Defaulting
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Party; or
16.2.2 the Defaulting Party becomes unable to pay its debts as they
become due in the ordinary course of business or goes into either
compulsory or voluntary liquidation (except for the purposes of
reconstruction or amalgamation previously notified to and approved
by the Non Defaulting Party (such approval not to be unreasonably
withheld or delayed)) or a receiver or administrator receiver is
appointed in respect of the whole or any part of its assets or it
is the subject of any petition for the appointment of an
administrator or if it makes or proposes any assignment or
arrangement for the benefit of its creditors generally or shall
otherwise become subject to or seek relief under any law relating
to insolvency in any jurisdiction relevant to the Defaulting
Party.
16.3 Termination by Xenova. Without prejudice to any other right or remedy
that it may have, Xenova may terminate this Agreement as a whole, or in
respect of one or more countries in the Territory, forthwith by notice in
writing to PharmaEngine given at any time:
16.3.1 if PharmaEngine fails to achieve any of the events referred to in
Clauses 4.3.1 to 4.3.5 and 4.4.1 to 4.4.5 by the date for such
achievement set out in such Clause; or
16.3.2 if PharmaEngine does not have any necessary Permits, or is
otherwise not in a position, to conduct business in any country of
the Territory
16.4 Termination without cause. PharmaEngine may terminate this Agreement as a
whole, or in respect of one or more countries of the Territory, by
service of [_] notice in writing to Xenova at any time during the term of
this Agreement.
16.5 Alternative to termination. If at any time Xenova is entitled to
terminate this Agreement under Clause 16.2 or 16.3 it may elect, as an
alternative to termination, to convert the licences granted under Clause
2 into a Co-Exclusive Licence. For the purposes of this Agreement,
"Co-Exclusive Licence" means that in addition to PharmaEngine, Xenova may
appoint one other licensee for Licensed Product in any or all parts of
the Territory, and/or develop and/or commercialise Licensed Product
itself in any or all parts of the Territory. If Xenova exercises its
rights under this Clause 16.5, PharmaEngine shall take all steps
necessary to enable Xenova or its licensee to exercise their rights under
this Clause and to facilitate the exercise of such rights, including,
where applicable:
16.5.1 Transferring any Permits obtained by PharmaEngine or its
Sub-licensee(s) into the joint names of PharmaEngine and Xenova or
its other licensee; and
16.5.2 Making available to Xenova's licensee any data generated by
PharmaEngine and/or its Sub-licensee(s) in relation to its or
their activities under this Agreement.
17 CONSEQUENCES OF TERMINATION
17.1 Termination by Xenova. Upon any termination of this Agreement,
PharmaEngine shall forthwith as at the effective date of termination:
17.1.1 return to Xenova the Dossier, all Programme Data and any other
documents, materials, data or information received from Xenova
hereunder and within its
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possession or Control containing or evidencing any Intellectual
Property of Xenova and all Confidential Information of Xenova; and
17.1.2 subject only to Clause 17.4, cease all exploitation and marketing
of the Licensed Product provided always that PharmaEngine shall be
entitled to continue to sell the Licensed Product for a period of
6 (six) calendar months thereafter in order to fulfil existing
orders only (subject always to payment of the Royalties) and
provided that PharmaEngine shall not sell such stock in a manner
detrimental to the market for the Licensed Product in the
Territory;
17.1.3 give or procure for Xenova access to all data filed in connection
with the Marketing Authorisations for the Licensed Product in the
Territory;
17.1.4 allow Xenova to cross-reference the file(s) relating to the
Licensed Product held by each Regulatory Authority and by each
other authority that has issued any Permits with respect to
Licensed Product in relation to the Territory, for the purpose of
transferring the Marketing Authorisation and Permits for the
Licensed Product in each country of the Territory to Xenova or
such other person as it may then nominate;
17.1.5 take such action and execute such agreements and instruments as
may be reasonably required by Xenova to transfer (where possible)
all Marketing Authorisations and Permits to Xenova or such other
person as it may then nominate;
17.1.6 subject to PharmaEngine's right to sell its stocks of the Licensed
Products pursuant to Clause 17.1.2, transfer the adverse event
database for the Licensed Product in the Territory to Xenova;
17.1.7 take such action and execute such agreements and instruments as
may be reasonably required by Xenova to transfer the Product
Trademark to Xenova for a nominal consideration; and
17.1.8 in the event of termination during the course of any Programme
Trials, use all Commercially Reasonable Efforts to effect an
orderly transfer to Xenova (or such other person as it may then
direct) of the management and conduct of such Programme Trials,
and continue to effect such Programme Trials for and on behalf of
Xenova until such time as such orderly transfer can be effected
and PharmaEngine acknowledges that in the event of such
termination it shall not be entitled to any reimbursement or
repayment of any sums paid to Xenova under the terms of this
Agreement prior to the effective date of termination, subject to
the provision of Clause 17.2.
17.2 Uninterrupted supply. Notwithstanding termination of this Agreement,
pending transfer of the Marketing Authorisation of the Licensed Product
to Xenova (or such other person as it may then direct), PharmaEngine
shall at Xenova's request take such action as may be reasonably required
by Xenova to ensure that supplies to patients within the Territory being
treated, or requesting treatment, with the Licensed Product are not
interrupted.
17.3 Surviving terms. Termination or expiry of this Agreement for any cause
shall not bring to an
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end:
17.3.1 PharmaEngine's obligation to pay the Royalties (whether before or
after termination) or other sums which have accrued to Xenova up
to and including the effective date of termination; or
17.3.2 Any provision of this Agreement which in order for full effect to
be given thereto needs to survive termination of this Agreement,
and (for the avoidance of doubt) the provisions of Clause 13,
shall continue in full force and effect in accordance with their
terms.
17.4 Sub-licences. In the event of any termination of this Agreement by
Xenova, Xenova may at its option confirm the continuation of any
Sub-licences in order that such Sub-licences may continue in accordance
with their terms provided always that Xenova shall not be under any
continuing liability to perform any obligations of PharmaEngine contained
in any such Sub-licence to the extent that the performance of any such
obligations might require the provision of personnel or otherwise
expenditure by Xenova.
18 GENERAL
18.1 Entire agreement. Save for the Confidentiality Agreement dated 19th
December 2003 between the Parties, this Agreement shall constitute the
entire agreement between the Parties in relation to its subject matter.
Each Party acknowledges that in entering into this Agreement it does not
do so on the basis of and does not rely on any representation, warranty,
or other provision except as expressly provided in this Agreement and all
conditions, warranties and other terms implied by statute or common law
are hereby excluded to the fullest extent permitted by law; provided that
nothing in this Agreement should be construed as limiting or excluding
liability for fraud.
18.2 Assignment. Neither Party shall assign, charge or transfer this Agreement
to a third party without the written consent of the other, which consent
shall not unreasonably be withheld or delayed provided always that:
18.2.1 either Party may assign and transfer its rights and obligations
under this Agreement (in whole but not in part) to any Affiliate
without obtaining the prior consent of the other Party provided
that the performance by its Affiliate of its obligations hereunder
is guaranteed by the assignor and the assignor gives prior written
notice to the other of such assignment; and
18.2.2 Xenova may assign and transfer its rights and obligations under
this Agreement (in whole but not in part) to any person to whom it
transfers all or substantially all of its assets or business
relating to API and/or Licensed Product.
18.3 No agency etc. Neither Party is authorised to act as the agent of the
other for any purpose whatsoever and neither Party shall on behalf of the
other enter into, or make, or purport to enter into or make or represent
that it has any authority to enter into or make any representation or
warranty. Nothing in this Agreement shall be deemed to constitute a
partnership or joint venture between the Parties and neither of the
Parties shall do or suffer to be done anything whereby it might be
represented as a partner of the other Party.
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18.4 Costs. Each of the Parties shall bear its own cost and expenses
incidental to the preparation, negotiation and execution of this
Agreement.
18.5 Amendment and waiver. Any agreement to amend, vary or modify the terms of
this Agreement in any manner shall be valid only if the amendment,
variation or modification is effected in writing and signed by duly
authorised representatives of each of the Parties. No delay by either
Party in enforcing any of the provisions of this Agreement shall be
deemed a waiver of that Party's right subsequently to enforce such
provision.
18.6 Severance. If any term or provision of any part thereof contained herein
shall be declared or become unenforceable invalid or illegal in any
respect under the law of any relevant jurisdiction, such term or
provision or part thereof shall be deemed to have been severed from the
remaining terms of this Agreement and the terms and conditions hereof
shall remain in full force and effect as if this Agreement had been
executed without the offending provision appearing herein; and the
Parties shall endeavour to agree an amendment which to the fullest extent
possible will give lawful effect to their intentions as expressed in any
term or provision severed under this Clause.
18.7 Notices.
18.7.1 Any notice required to be given under this Agreement shall be in
writing and delivered by hand and/or sent by an international
courier company ("courier") or facsimile (in the case of facsimile
to be confirmed in writing and delivered by hand and/or sent by
courier within four Business Days of being sent by facsimile) to
the addresses set out at the head of this Agreement and marked for
the attention of the Chief Executive Officer.
18.7.2 The fax numbers of each Party are as follows: Xenova - +44 1753
706 615; PharmaEngine - + 886-2 2515 7558.
18.7.3 A notice shall be deemed to have been served as follows:
(a) if delivered by hand, at the time of delivery;
(b) If delivered by courier, the expiration of 4 (four)
Business Days after the envelope containing the same was
delivered into the custody of the courier service;
(c) if sent by facsimile and transmission is automatically
acknowledged, at the expiration of 2 (two) hours after the
same was despatched;
except that if a notice or other communication would be deemed to
be delivered under the above provisions on a day that is not a
Business Day in the country of receipt or after 5.00 pm in that
country, then it shall be deemed instead to have been delivered at
9.00 am on the next Business Day in that country.
18.7.4 In proving service of any notice, it shall be sufficient to show
that delivery by hand was made, or in the case of courier
delivery, that the envelope containing the communication was
properly addressed and delivered into the custody of the courier
as a prepaid courier package or, in the case of a facsimile, by
production of a
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confirmatory transmission report.
18.8 Force majeure. In the event that the performance of the obligations of
either Party is prevented, restricted or hindered by any event of Force
Majeure, such Party:
18.8.1 shall not be liable to the other Party for any damages arising
from any breach of the terms of this Agreement caused by Force
Majeure; and
18.8.2 shall immediately serve notice in writing on the other Party
specifying the nature of the Force Majeure, their effect upon its
performance of this Agreement and the period of time in which they
are anticipated to apply; and
18.8.3 shall use its reasonable endeavours to overcome the Force Majeure
and resume its proper performance of its obligations under this
Agreement; and
18.8.4 If the circumstances referred to in this Clause prevail for a
continuous period in excess of 3 (three) months, the Party
notified of such circumstances may, without prejudice to any other
rights or remedies which may be available to it, terminate this
Agreement with immediate effect by giving written notice of
termination to the other. In the event of any such termination by
either Party the provisions of Clause 17.1 shall apply.
18.9 Third party rights. A person who is not a Party to this Agreement has no
right under the (UK) Contracts (Rights of Third Parties) Xxx 0000 to
enforce any term of this Agreement but this does not affect any right or
remedy of a third party which exists or is available apart from that Act.
18.10 Dispute resolution.
18.10.1 Within 7 (seven) Business Days of either Party becoming aware of
any dispute relating in any manner to this Agreement or the terms
hereof (but subject to Clause 18.10.4) it shall prepare and submit
to the Chief Executive Officer or such other senior manager as may
be nominated from time to time for such purpose ("Senior
Representatives") of each of the Parties a memorandum or statement
setting out its position in respect of the matter in dispute and
its reasons for adopting that position. The other Party shall
within 7 (seven) Business Days of receipt of the memorandum or
statement prepare and submit to the other Party a memorandum or
statement setting out like particulars on its own behalf and the
Senior Representatives shall consider the dispute in the light of
those statements.
18.10.2 If the Senior Representatives agree upon the resolution of the
dispute they shall issue a joint statement setting out the agreed
terms and shall exercise powers available to them to procure that
the agreed terms are fully and promptly carried into effect.
18.10.3 If the dispute is not resolved or disposed of in accordance with
this Clause 18.10, within 30 (thirty) days of compliance with the
terms of Clause 18.10.1; or if either Party shall fail to comply
with the terms of Clause 18.10.2, either Party may by notice in
writing propose terms for the mediation of the dispute, and the
other Party
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shall consider any such proposal in good faith but shall not be
bound to agree to the proposal or delay for more than 30 days the
initiation of legal proceedings under Clause 18.11.
18.10.4 The provisions of this Clause 18.10 shall not apply to any
dispute arising in relation to any matter brought before the JDCC,
where the provisions of Clause 4.2.5 shall apply.
18.11 Law and jurisdiction. Any controversy or claim of whatsoever nature
arising out of or relating in any manner whatsoever to this Agreement or
any breach of any terms of this Agreement shall be governed by and
construed in all respects in accordance with the laws of England, Any
dispute arising out of or in connection with this Agreement, including
any dispute regarding its existing, validity or termination, shall be
referred to and finally resolved by arbitration in Singapore in
accordance with the Arbitration Rules of the Singapore International
Arbitration Centre ("SIAC") for the time being in force, which rules are
deemed to be incorporated by reference in this clause. The Tribunal shall
consist of 3 (three) arbitrators. Unless otherwise required by SIAC, each
of the Parties shall be entitled to appoint 1 (one) arbitrator, and those
2 (two) arbitrators shall together appoint a 3rd (third) arbitrator, or
in the absence of any such appointment, the Chairman of SIAC shall
appoint the arbitrators). The language of the arbitration shall be
English.
AGREED BY THE PARTIES THROUGH THEIR AUTHORISED SIGNATORIES:
FOR AND ON BEHALF OF PHARMAENGINE, INC. FOR AND ON BEHALF OF XENOVA LIMITED
/s/XXXXX XXX /s/XXXXX OXLADE
---------------------------- ----------------------
signed signed
GRACE XXX XXXXX OXLADE
---------------------------- ----------------------
name name
CHIEF EXECUTIVE OFFICER CHIEF EXECUTIVE OFFICER
---------------------------- ----------------------
title title
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