1
EXHIBIT 10.24
DATED 1998
(1) IMPERIAL CANCER RESEARCH TECHNOLOGY LIMITED
(2) INTROGEN THERAPEUTICS, INC
OPTION AGREEMENT
21/05/1998
REFERENCE
DM/97 - 58598
2
CONTENTS
CLAUSE
1 INTRODUCTION ................................................ 1
2 INTERPRETATION .............................................. 1
3 GRANT OF THE FIRST OPTION ................................... 5
4 EXERCISE OF THE FIRST OPTION ................................ 7
5 THE PROJECT ................................................. 8
6 OWNERSHIP OF TECHNOLOGY AND INTELLECTUAL PROPERTY ...........11
7 CONFIDENTIALITY AND PUBLICATION .............................16
8 TERMINATION .................................................20
9 GENERAL .....................................................22
10 NOTICES AND SERVICE ........................................26
11 MISCELLANEOUS ..............................................27
SCHEDULES
SCHEDULE 1 ....................................................28
THE EXISTING PATENTS .......................................28
SCHEDULE 2 ....................................................29
THE TERMS OF THE FIRST LICENCE .............................29
SCHEDULE 3 ....................................................35
OBJECTIVES OF THE PROJECT ..................................35
SCHEDULE 4 ....................................................36
THE TERMS OF THE SECOND LICENCE ............................36
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CONTENTS AGREEMENT dated 1998
BETWEEN:
(1) IMPERIAL CANCER RESEARCH TECHNOLOGY LIMITED, incorporated in England and
Wales with registered number 1662284, whose registered office is at
Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx, Xxxxxx XX0X 0XX, Xxxxxxx ('ICRT')
(2) INTROGEN THERAPEUTICS, INC, incorporated in the State of Delaware, whose
principal office is at 000 Xxxxxxxx Xxxxxx, Xxxxx 0000, Xxxxxx, Xxxxx
00000, XXX ('INTROGEN')
1 INTRODUCTION
1.1 Imperial Cancer Research Fund ('ICRF') and ICRT have identified and carried
out a programme of research work relating to a tumour suppressor gene known
as 'PTEN' which has potential diagnostic and therapeutic uses, and in
respect of which certain patent applications have been made by ICRT,
details of which are given in Schedule 1.
1.2 Introgen wishes to acquire rights in relation to the Gene in order to
develop DNA based therapeutic products, in particular for the treatment of
cancer.
1.3 ICRT is a company wholly owned by ICRF and, by arrangement with ICRF, owns
and is responsible for the management and exploitation of ICRF technology.
2 INTERPRETATION
2.1 In this Agreement -
'AFFILIATE' means, in relation to either party, a company which controls
that party, or is controlled by that party or by a company which controls
that party; and for these
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purposes a company controls another company if, either directly or
indirectly through one or more other companies, it can -
o exercise a majority of the votes attached to the shares in the other
company; or
appoint or remove a majority of the board of directors of the other
company;
'THE EFFECTIVE DATE' means 1st June 1998;
'THE EXISTING PATENTS' means the patent applications referred to in clause
1.1, any patents issued in pursuance of any such application, any
extension, reissue, division, continuation or continuation-in-part of any
such application or patent and any patent of addition, supplementary
protection certificate or similar rights based on any such patent;
'EXISTING TECHNOLOGY' means any Technology relating to the Gene which has
been obtained, developed, found, produced or made by or for ICRF or ICRT at
any time prior to the Effective Date;
'THE FIELD' means the field of [*];
'THE FIRST LICENCE' means the licence to be granted pursuant to clause 4.1;
'THE FIRST OPTION' means the option granted by ICRT under clause 3.1;
'THE FIRST OPTION PERIOD' means the period of [*] from the Effective
Date;
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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'THE GENE' means the PTEN gene referred to in clause 1.1 including, for the
avoidance of doubt, any splice variants or other derivatives of that gene
and for the purposes of the foregoing, a "derivative" means a nucleotide
sequence derived from that gene (including fragments thereof) the product of
which has tumour suppressor activity;
'ICRF' means Imperial Cancer Research Fund;
'INTELLECTUAL PROPERTY' means any patent application or patent (including
any extension, reissue, division, continuation or continuation-in-part of
any such application or patent and any patent of addition, supplementary
protection certificate or similar rights based on any patent), copyright or
other form of protection, the right to make any application for any such
protection in any part of the world, and any right in respect of any trade
secret or other confidential information;
'THE INVENTION' means the invention(s) claimed or disclosed in the Existing
Patents;
'MATERIALS' means any model, prototype, material or substance (including,
without limitation, any living organism or genetic material), and includes
any progeny or derivative of any of the foregoing;
'THE NEGOTIATION PERIOD' means the period of [*] from the date of exercise
of the First Option or the Second Option, as the case may be, or such longer
period as the parties may agree in either case;
'THE PROJECT' means the programme of collaborative research referred to in
clause 5.1;
'PROJECT TECHNOLOGY' means any Technology obtained, developed, found,
produced or made at any time on or after the Effective Date in the course of
the Project;
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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'PROJECT PATENTS' means any patent applications claiming any Project
Technology, any patents issued in pursuance of any such application, any
extension, reissue, division, continuation or continuation-in-part of any
such application or patent and any patent of addition, supplementary
protection certificate or similar rights based on any such patent;
'THE SECOND LICENCE' means the agreement to be entered into pursuant to
clause 6.7;
'THE SECOND OPTION' and 'THE SECOND OPTION PERIOD' have the meanings given
in clause 6.6;
'TECHNOLOGY' means any methods, techniques, processes, discoveries,
inventions (whether patentable or not), formulae, results of
experimentation, statistics, data, computer software or plans, any
Materials and any records in any form relating to any of the foregoing; and
'YEAR' means a period of 365 (or, in the case of a leap year, 366) days.
2.2 Unless the context otherwise requires, each reference in this Agreement
to -
(a) 'WRITING', and any cognate expression, includes a reference to any
communication effected by facsimile transmission or similar means (but
not electronic mail);
(b) a licence includes a sub-licence; and 'LICENSE' (as a verb) and
cognate expressions shall be construed accordingly;
(c) a statute or a provision of a statute is a reference to that statute
or provision as amended, re-enacted or extended at the relevant time,
and includes any statute or a corresponding provision in a statute
replacing that statute or provision;
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(d) 'THIS AGREEMENT' is a reference to this Agreement and each of the
Schedules, as amended or supplemented at the relevant time;
(e) a Schedule is a reference to a schedule to this Agreement;
(f) a clause or a paragraph is a reference to a clause of this Agreement
(other than the Schedules) or a paragraph of the relevant Schedule;
(g) any reference to the parties includes a reference to their respective
successors in title and permitted assignees;
(h) any reference to a person includes any body corporate, unincorporated
association, partnership or other legal entity;
(i) the singular includes the plural and vice versa; and
(j) words importing any gender include any other gender.
2.3 The headings in this Agreement are for convenience only and shall not
affect its interpretation.
3 GRANT OF THE FIRST OPTION
3.1 ICRT hereby grants to Introgen, on and subject to the terms of this
Agreement, the exclusive option to obtain an exclusive, world-wide licence
(to the extent that ICRT is able to grant such a licence under any
applicable law) in respect of the Existing Patents and any Materials or
other Existing Technology referred to in clause 5.4, on the terms referred
to in clause 4.1.
3.2 The First Option shall be exercisable by Introgen, subject to payment of
the sum referred to in clause 3.3, by giving written notice to ICRT at any
time during the First Option Period.
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3.3 In consideration of the grant of the First Option, Introgen shall pay to
ICRT the sum of [*] on the Effective Date.
3.4 The sum referred to in clause 3.3 shall not be refunded in any
circumstances.
3.5 If Introgen does not duly exercise the First Option during the First
Option Period, it shall forthwith lapse.
3.6 During the First Option Period ICRT shall diligently prosecute and maintain
the Existing Patents and keep Introgen fully informed as to the prosecution
status of the Existing Patents (including, without limitation, furnishing
to Introgen information relevant to such prosecution and maintenance) and
shall give fair consideration to suggestions made by Introgen in respect of
the prosecution strategy in so far as they relate to the Field, but if ICRT
notifies Introgen in writing that -
(a) it wishes to abandon any patent application or patent within the
Existing Patents which relates to the Field, it shall give a prompt
written notice Introgen offering to assign it to Introgen at the
expense of Introgen but otherwise free of charge, and if Introgen does
not accept the offer in writing within 30 days, ICRT shall have no
further obligation with respect to the patent or patent application;
or
(b) it does not wish to elect to proceed from PCT stage to national stage
with respect to any such application in any country, it shall give a
prompt written notice to Introgen, and ICRT shall have no further
obligation with respect to the application unless Introgen notifies
ICRT in writing within thirty (30) days that it wishes ICRT so to
proceed, in which event ICRT shall do so but at the sole expense of
Introgen, and accordingly for the purposes of -
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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(i) clause 3.7(b), that application and any Existing Patent granted
pursuant to it in the relevant country shall be treated as if
they had been assigned to Introgen; and
(ii) the provisions of the First Licence as to royalties summarised in
paragraph 9 of Schedule 2, that application and any Existing
Patent granted pursuant to it shall be deemed not to exist in the
relevant country.
3.7 During the First Option Period the out-of-pocket costs and expenses of
prosecuting and maintaining the Existing Patents shall be borne -
(a) in respect of any of the Existing Patents the claims of which relate
exclusively to any matter outside the Field, by [*];
(b) in respect of any of the Existing Patents the claims of which relate
exclusively to the Field, or which have been assigned to Introgen
pursuant to clause 3.6(a) (or are treated as if they had been so
assigned pursuant to clause 3.6(b)(i), [*];
(c) in respect of any other of the Existing Patents, by [*];
and Introgen shall accordingly pay to ICRT the [*] of those
costs and expenses incurred from time to time within 30 days after receipt
from ICRT of an account setting out the relevant information to enable its
share to be ascertained.
4 EXERCISE OF THE FIRST OPTION
4.1 If Introgen exercises the First Option in accordance with clause 3.2, ICRT
and Introgen shall forthwith use their best endeavours during the
Negotiation Period to negotiate in good faith the terms and conditions for
the grant to Introgen of the
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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licence referred to in clause 3.1 ('THE FIRST LICENCE'), which shall
include the terms and conditions set out in Schedule 2 and such other terms
and conditions (consistent with those set out in Schedule 2) as are
reasonable and customary in the biopharmaceutical industry for arrangements
of the type contemplated by the First Licence.
4.2 Upon agreement being reached between ICRT and Introgen as to the terms of
the First Licence, the parties shall forthwith execute an agreement
containing the terms so agreed between ICRT and Introgen.
4.3 If, notwithstanding their best endeavours, ICRT and Introgen do not agree
upon the terms for the grant of the First Licence to Introgen during the
Negotiation Period, Introgen shall have the right, exercisable by notifying
ICRT in writing at any time within fifteen (15) days after the expiration
of the Negotiation Period, to initiate a binding arbitration proceeding,
pursuant to which the terms and conditions of the First Licence shall be
established. Any arbitration under this provision shall be held in
accordance with clause 9.12 by a single arbitrator and the sole issue
before such arbitrator shall be to establish the terms and conditions of
the First Licence in accordance with clause 4.1, to the extent that they
have not been agreed. If Introgen does not exercise the foregoing right to
initiate arbitration within the applicable fifteen (15) day period, the
First Option shall lapse.
4.4 If the First Option lapses pursuant to clause 3.5 or 4.3 then, except to
the extent that clauses 5, 6 and 7 continue to operate, this Agreement
shall terminate automatically, in which case all rights and obligations of
the parties shall terminate except as provided in clause 8.4.
5 THE PROJECT
5.1 As further consideration for the grant of the First Option, Introgen shall
co-operate with ICRT on a programme of collaborative research on the
following terms.
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5.2 Subject to the following provisions, the Project shall be carried on for a
period of [*] from the Effective Date.
5.3 The overall objectives of the Project shall be as set out in Schedule 3.
Within those overall objectives, the detailed objectives and implementation
of the Project, and the work to be carried out by ICRT and Introgen
respectively as part of the Project, shall be as agreed between Xx Xxxxx
Xxxxx of ICRT and Dr Sunil Chadaof Introgen from time to time, but
initially as set out in the document attached to this Agreement as Appendix
A and initialled on behalf of the parties.
5.4 ICRT shall, as soon as practicable after the Effective Date -
(a) Supply to Introgen samples of such of the Materials relating to the
Gene and in the possession or control of ICRT as are reasonably
necessary to enable Introgen to carry its tasks in relation to the
Project or as are otherwise requested by Introgen from time to time in
connection with its evaluation of the Gene with a view to deciding
whether or not to exercise the First Option or the Second Option; and
(b) disclose to Introgen such other of the Existing Technology as is
relevant to the Project or it exercise of the First Option or the
Second Option;
and Introgen shall be entitled to use and practice the Invention, and to use
any Materials so supplied and any Existing Technology so disclosed during
the continuance of the Project, for the purposes only of carrying out its
part of the Project and planning the development and exploitation in the
Field of the Existing Technology and Project Technology or as otherwise
reasonably necessary to evaluate the Gene with a view to deciding whether or
not to exercise the First Option or the Second Option.
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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5.5 Subject as provided in clause 5.4, the resources to be applied to the
Project by each of ICRT and Introgen shall be solely at its discretion.
5.6 Introgen shall pay to ICRT, as a contribution to the work to be carried out
by ICRT as part of the Project, the sum of [*].
5.7 For the avoidance of doubt, each sum payable pursuant to clause 5.6 shall
not be refunded in any circumstances, and if Introgen exercises the First
Option before the end of that period, any such sum which is outstanding
shall continue to be payable.
5.8 If at any time Introgen in its reasonable opinion decides that all, or a
major part of, the objectives set out in Schedule 3 have been achieved, and
proposes to proceed to full pre-clinical and clinical development of the
Gene in the Field, it shall be entitled to terminate the Project by giving
to ICRT not less than one month's written notice setting out details of its
description and its proposals.
5.9 If within one year from the Effective Date Introgen has not commenced good
faith active steps with a view to carrying out its part of the Project for
any reason, ICRT shall be entitled to terminate the Project by giving to
Introgen not less than one month's written notice provided that Introgen
does not commence such steps within such one (1) month period, in which
case the parties shall forthwith take such steps as may be necessary to
terminate the Project, and subject to those steps being taken this
Agreement shall terminate automatically.
5.10 For the purposes of the Project the principal points of contact between the
parties will be as follows -
for ICRT: Xx Xxxxx Xxxxx
for Introgen: Xx Xxxxx Xxxxx
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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5.11 ICRT and Introgen shall ensure that Dr Snary and Xx Xxxxx respectively
shall communicate and meet with one another as necessary to progress the
work on the Project, and that each of them shall report their research data
at semi-annual intervals in a short written report to Introgen and ICRT
respectively.
5.12 If any employees or other representatives of ICRT are requested to visit
the premises of Introgen for the purposes of the Project, Introgen shall -
(a) at its own cost give all reasonable assistance required by any of them
for that purpose; and
(b) reimburse ICRT for their reasonable travel, accommodation and other
expenses incurred, within 30 days after receipt of an invoice for the
sum in question.
5.13 If by agreement with ICRT any employees or other representatives of
Introgen visit the premises of ICRT for the purposes of the Project -
(a) ICRT shall at the cost of Introgen give all reasonable assistance
required by any of them for that purpose, and Introgen shall reimburse
to ICRT any out-of-pocket sum incurred by ICRT for that purpose
within 30 days after receipt of an invoice for the sum in question;
and
(b) Introgen shall be responsible for their travel, accommodation and
other expenses.
6 OWNERSHIP OF TECHNOLOGY AND INTELLECTUAL PROPERTY
6.1 Subject to provisions of this Agreement, the Invention, the Existing
Patents, the Existing Technology and all Intellectual Property in respect
of any of the Existing Technology shall remain the exclusive property of
ICRT.
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6.2 Any Project Technology, and any Project Patents or other Intellectual
Property in respect of any Project Technology, shall -
(a) if made solely by ICRT staff working on the Project, belong
exclusively to ICRT;
(b) if made solely by Introgen staff working on the Project, belong
exclusively to Introgen;
(c) if made jointly by ICRT staff and Introgen staff working on the
Project, belong to ICRT and Introgen jointly in equal undivided
shares.
6.3 Except as otherwise provided in this Agreement and subject to the rights
and licences granted herein, neither party shall have any obligation to
account to the other for profits, or to obtain any approval or consent of
the other party to license or exploit any Intellectual Property, by reason
of their joint ownership of such Intellectual Property.
6.4 ICRT and Introgen shall discuss and seek to agree upon the extent to which,
and the countries in which, patent protection for any Project Technology
owned by ICRT or jointly owned by ICRT and Introgen should be obtained and,
except to the extent that they otherwise agree in writing -
(a) the protection shall be applied for by ICRT in the name of ICRT, or
jointly in the names of ICRT and Introgen, as the case may be;
(b) ICRT shall diligently prosecute and maintain the Project Patents in
question and keep Introgen fully informed as to the prosecution status
of the Project Patents (including, without limitation, furnishing to
Introgen information relevant to such prosecution and maintenance) and
shall give fair consideration to suggestions made by Introgen in
respect of the prosecution
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strategy in as far as they relate to the Field, but if ICRT notifies
Introgen in writing that -
(i) it wishes to abandon any such patent application or patent, it
shall give a prompt written notice to Introgen offering to assign
it to Introgen at the expense of Introgen but otherwise free of
charge, and if Introgen does not accept the offer in writing
within 30 days, ICRT shall have no further obligation with
respect to the patent or patent application in question; or
(ii) it does not wish to elect to proceed from PCT stage to national
stage with respect to any such application in any country, it
shall give a prompt written notice to Introgen;
(c) where ICRT gives such a notice pursuant to clause 6.4(b)(ii) above,
ICRT shall have no further obligation with respect to the application
unless Introgen notifies ICRT in writing within 30 days that it
wishes ICRT so to proceed, in which event ICRT shall do so but at the
sole expense of Introgen, and accordingly for the purposes of -
(i) clause 6.4(d), that application and any Project Patent granted
pursuant to it in the relevant country shall be treated as if
they had been assigned to Introgen; and
(ii) the provisions of the First Licence as to royalties summarised in
paragraph 9 of Schedule 2 (as they apply to Project Patents
pursuant to paragraph 3 of Schedule 4), that application and any
Existing Patent granted pursuant to it shall be deemed
not to exist in the relevant country;
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(d) the out of pocket costs and expenses of prosecuting and maintaining
the Project Patents in question shall be borne, as if they were
Existing Patents, in the manner provided in clause 3.7 which shall
apply with the necessary changes (and so that the reference therein to
clause 3.6(b)(i) shall be deemed to be a reference to clause
6.4(c)(i));
(e) Introgen shall keep ICRT informed as to the prosecution status of all
patent applications within the Project Patents owned by Introgen; and
(f) each of ICRT and Introgen shall give the other such assistance as the
other may reasonably require and at the other party's expense in order
to obtain and maintain such protection.
6.5 ICRT hereby grants to Introgen the exclusive option to take an exclusive
licence under any or all of the Project Patents and Project Technology
owned exclusively by ICRT and the exclusive right to exploit any and all
Project Patents owned jointly by ICRT and Introgen.
6.6 The option granted under clause 6.5 ('THE SECOND OPTION') shall be
exercisable by Introgen by giving written notice to ICRT at any time during
the period ('THE SECOND OPTION PERIOD') of [*] after the termination of the
Project (except where this Agreement is terminated by ICRT pursuant to
clause 8.2 or 8.3).
6.7 If Introgen exercises the Second Option in accordance with clause 6.6, the
First Licence shall be modified to include such Project Patents and Project
Technology within the scope of the First Licence, in accordance with the
provisions of Schedule 4, and ICRT and Introgen shall forthwith execute an
agreement ('THE SECOND LICENCE') to effect such a modification. In the
event of any disagreement as to the terms of the Second Licence, the
provisions of clause 4.3 shall apply with the necessary changes.
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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6.8 Notwithstanding any licence or right granted by ICRT pursuant to this
Agreement, ICRT (for itself and ICRF) shall retain -
(a) the exclusive right to use any Existing Technology (and any Existing
Patents or other Intellectual Property in respect thereof) for any
purpose outside the Field;
(b) the exclusive right to use any Project Technology which belongs
exclusively to ICRT (and any Project Patents or other Intellectual
Property in respect thereof), for any purpose outside the Field;
(c) the exclusive right to use any Project Technology which belongs to
ICRT and Introgen jointly (and any Project Patents or other
Intellectual Property in respect thereof) for [*]; and
(d) the non-exclusive right to use any Project Technology which belongs to
ICRT and Introgen jointly (and any Project Patents or other
Intellectual Property in respect thereof) for research and all other
applications (except [*]) outside the Field.
6.9 Introgen hereby grants to ICRT (for itself and ICRF) an irrevocable,
perpetual non-exclusive, worldwide, royalty-free licence, with the right to
grant sublicenses, in respect of any Introgen Improvement, and any Project
Patents or other Intellectual Property in respect of any such Introgen
Improvement, for the purposes of research and the manufacture, sale and use
of products for [*] outside the Field.
For the purposes of this Agreement, 'Introgen Improvement' means any
Project Technology which belongs exclusively to Introgen and which is a
derivative (as defined in clause 2.1) of the Gene or a method of using the
Gene (including derivatives thereof); provided, however, Introgen
Improvements shall not include
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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any vector, delivery system, method, compositions or other subject matter
which is proprietary to Introgen, or any such Project Technology which
necessarily involves or includes the use of or combination of any vector,
delivery system, method, composition or other subject matter.
6.10 If Introgen does not duly exercise the Second Option during the Second
Option Period, the Second Option shall lapse, and ICRT shall have the
option, exercisable within a further [*] by giving written notice to
Introgen, to negotiate for the grant to ICRT of an exclusive licence in
respect of any Introgen Improvement, a non-exclusive licence in respect of
any other Project Technology which belongs to ICRT and Introgen jointly,
and all Project Patents or other Intellectual Property in respect thereof
(but excluding any rights in respect of any vector, delivery system,
method, compositions or other technology which is proprietary to Introgen,
or any such Project Technology which necessarily involves or includes the
use of or combination of any vector, delivery system, method), to use the
same for any purpose, on a world-wide, royalty-bearing basis, to the extent
that Introgen is able to grant such a licence or right.
6.11 If ICRT exercises the option referred to in clause 6.10, ICRT and Introgen
shall forthwith use their best endeavours to negotiate in good faith the
terms of an agreement for the grant of the licence or right within the
period of [*] from the date of exercise of the option (provided that any
such agreement shall contain the right for ICRT to grant licences (or
sub-licences) under the Project Patents and Project Technology in question
to any other person). In the event of any disagreement as to the terms of
such agreement, the provisions of clause 4.3 shall apply with the necessary
changes.
7 CONFIDENTIALITY AND PUBLICATION
7.1 Except as provided herein, each party shall maintain in confidence during
the term of this Agreement and for seven (7) years thereafter, and shall
not use for any
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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purpose or disclose to any third party, any Technology or other information
disclosed by the other party in writing and marked "Confidential" or that
is disclosed orally and confirmed in writing as confidential within
forty-five (45) days following such disclosure (collectively, 'CONFIDENTIAL
INFORMATION'), except to the extent that any such Confidential
Information -
(a) is at the time of being so provided or after that time through no
fault of the party to whom it was so provided becomes public
knowledge; or
(b) was lawfully available on a non-confidential basis to the party to
whom it was so provided before that time; or
(c) can be shown by the party to whom it was so provided to have been
independently produced by that party without any use of such
confidential information provided to it by the other party; or
(d) is made available to the party to whom it was so provided otherwise
than in breach of an obligation of confidentiality owed to the other
party.
7.2 The results of the Project may be made public by either party (or, in the
case of ICRT, by ICRF) except to the extent that -
(a) publication would include any Confidential Information of the other
party; or
(b) publication would prejudice the obtaining of patent protection for an
invention constituting Project Technology, or the commercial
exploitation of any unpatented or unpatentable Project Technology
which remains unpublished.
7.3 To allow time for review of any proposed disclosure of any subject matter
which may be precluded from being made public under clause 7.2, each of
ICRT and Introgen shall provide to the other -
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(a) a copy of any manuscript disclosing any results of the Project not
less than 45 days notice before submitting the manuscript for
publication; and
(b) a copy of any slides to be used in an oral presentation disclosing any
results of the Project together with an outline of the presentation
not less than 20 working days before making any such oral
presentation.
7.4 The party receiving any such material pursuant to clause 7.3 shall promptly
and in any event prior to the proposed date of submission for publication
review the proposed disclosure and notify the other party in writing of its
conclusions, failing which the other party shall be free to make the
proposed disclosure.
7.5 If in the reasonable opinion of the party receiving the material the
proposed disclosure does not include subject matter which is precluded from
being made public under clause 7.2, it shall promptly notify the other
party which shall thereupon be free to make the proposed disclosure.
7.6 If in the reasonable opinion of either party -
(a) the proposed disclosure includes subject matter which is precluded
from being made public under clause 7.2 and which is patentable,
neither party shall publish or otherwise disclose the material in
question for a period of three months from the date on which the
relevant material was received by the party in question and, if a
patent application is made within that period of three months, for a
further period as agreed but in any event not exceeding a total of 18
months from that date (including such period of three months),
following which the other party shall be free to make the proposed
disclosure; or
(b) the proposed disclosure includes unpatented (or unpatentable) Project
Technology which that party wishes to maintain as unpublished and
which
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has been identified in Project reports pursuant to clause 5.11 as
being of potential commercial significance, neither party shall
publish or otherwise disclose the material in question for a period of
18 months from that date, following which either party shall be free
to make the proposed disclosure; or
(c) the proposed disclosure includes Confidential Information of the
reviewing party, the disclosing party shall remove such Confidential
Information prior to such disclosure.
7.7 Notwithstanding the foregoing provisions of this clause 7 above, the
receiving party may use or disclose Confidential Information of the
disclosing party
(a) to the extent necessary to exercise its rights hereunder (including
providing such information to bona fide licensees or prospective
licensees as contemplated by this Agreement or otherwise and to
potential investors or partners on reasonable terms of
confidentiality) or to fulfil its obligations and/or duties hereunder;
(b) in filing for, prosecuting or maintaining any proprietary rights,
prosecuting or defending litigation; and
(c) in complying with applicable governmental regulations and/or
submitting information to tax or other governmental authorities; or as
otherwise required by law;
provided that if the receiving party is required by law to make any public
disclosures of Confidential Information of the disclosing party then, to
the extent it may legally do so, it shall give reasonable advance notice to
the disclosing party of such disclosure and shall use its reasonable
efforts to secure confidential treatment of
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Confidential Information prior to its disclosure (whether through
protective orders or otherwise).
8 TERMINATION
8.1 This Agreement shall be deemed to have come into force on the
Effective Date and, subject to the following provisions, shall
continue in force for the respective periods of time provided for in
this Agreement and otherwise without any time limit.
8.2 ICRT shall be entitled to terminate this Agreement forthwith by giving
fifteen (15) days' prior written notice to Introgen if any sum payable
under this Agreement is not paid in full within seven (7) days after
the due date for payment and Introgen falls to make such payment
within such fifteen (15) day period.
8.3 Either party shall be entitled to terminate this Agreement forthwith
by giving written notice to the other party if -
(a) the other party commits a breach of any of its obligations under
this Agreement (other than, in the case of Introgen, a breach to
which clause 8.2 applies) and, falls to remedy to breach within
thirty (30) days after receiving a written notice from the first
mentioned party specifying the breach and requiring it to be
remedied; or
(b) the other party goes into liquidation, has a receiver appointed
over any of its assets, has an administrator appointed, makes any
voluntary arrangement with any of its creditors, or ceases to
carry on business, or any similar event under the law of any
foreign jurisdiction occurs in relation to the other party.
8.4 On the termination of this Agreement for any reason (including, for
the avoidance of doubt, any termination or partial termination
pursuant to clause 4.4 or clause 5.9)
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23
(a) the rights and obligations of Introgen under the First Licence
(if it has been executed) and the Second Licence (if it has been
executed) or of ICRT under any agreement entered into pursuant to
clause 6.11 (if it has been executed) shall continue in force;
(b) subject to paragraph (a), Introgen shall forthwith cease all use
of the Gene, the Invention, the Existing Technology and any
Project Technology which belongs exclusively to ICRT, and destroy
all Materials in the possession or control of Introgen which have
been supplied by ICRT or produced or derived from any Materials
so supplied;
(c) except to the extent that paragraph (a) above applies (and that
accordingly this paragraph (c) does riot apply), ICRT shall be
entitled to license the Existing Patents and the Existing
Technology, any Project Patents (other than any of them which
belong exclusively to Introgen) and any unpatented (or
unpatentable) Project Technology (other than data which Introgen
reasonably considers proprietary to itself) to any other person;
(d) the provisions of clause 6.1, 6.2, 6.3, 6.8, 6.9, 6.10, 6.11, 7,
9.10, 9.11 and 9.12 shall continue in force in accordance with
their terms,
but subject to the foregoing, and except for any accrued right or
obligation of either ICRT or Introgen, neither of them shall be under
any further obligation to the other.
8.5 Notwithstanding anything herein to the contrary, if either party
disputes in good faith the other party's right to terminate this
Agreement pursuant to the foregoing provisions of this clause 8 by
reason of a breach by the other party, the other party's right to
terminate shall be stayed unless or until it has been determined in
accordance with clause 9.12 that such party has such a right and, if
it is so determined, the party in breach has failed to remedy the
breach in question within thirty (30) days after such determination.
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9 GENERAL
9.1 This Agreement and the rights granted under it are personal to each
party, which may not assign, transfer or charge to any other person
any of its rights under this Agreement, or subcontract or otherwise
transfer to any other person any of its obligations under this
Agreement.
9.2 Notwithstanding clause 9.1, either party may assign this Agreement
and its obligations hereunder to a party that is an Affiliate of the
assigning party at the time of the assignment or a party that succeeds
to all or substantially all of its business or assets relating to this
Agreement whether by sale, merger, operation of law or otherwise;
provided that in either case such assignee promptly enters into an
agreement in writing with the other party to be bound by the terms and
conditions of this Agreement.
9.3 ICRT warrants to Introgen that -
(a) except as disclosed in writing to Introgen, ICRT owns all right,
title and interest in and to the Existing Technology, the
Existing Patents and all other Intellectual Property of ICRT in
respect of the Existing Technology and, subject to clause 9.4, it
has the authority to enter into this Agreement and to grant the
rights granted by it under this Agreement;
(b) the execution by ICRT of, and the performance of its obligations
under, this Agreement require no governmental or other approvals
or, if required, all such approvals have been obtained;
(c) it has not granted and, except as otherwise provided in this
Agreement, will not during the continuance of this Agreement
grant to any third party any rights which are inconsistent with
the rights granted by it under or pursuant to this Agreement;
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25
(d) except as disclosed in writing to Introgen, it is not aware of
any third party claims or governmental restrictions (other than
legal provisions of general application) which would restrict its
ability to grant the rights agreed to be granted by it under this
Agreement; and
(e) except for the Existing Patents, as at the Effective Date ICRT
does not own or control any patents or patent applications the
claims of which would dominate the practice of the rights to be
granted to Introgen pursuant to this Agreement.
9.4 Without limiting clause 9.3, ICRT does not warrant -
(a) the efficacy or usefulness of the Existing Technology or any
Project Technology; or
(b) that the exercise of the rights granted under this Agreement will
not infringe the patent or other Intellectual Property rights of
any third party; or
(c) that any of the Existing Patents or Project Patents is or will be
valid or enforceable, or (in the case of an application) will
proceed to grant.
9.5 Introgen warrants to ICRT that -
(a) it has the authority to enter into this Agreement and to grant
the rights granted by it under this Agreement;
(b) the execution by Introgen of, and the performance of its
obligations under, this Agreement require no governmental or
other approvals or, if required, all such approvals have been
obtained;
(c) it has not granted and, except as otherwise provided in this
Agreement, will not during the continuance of this Agreement
grant to any third party any
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26
rights which are inconsistent with the rights granted by it under
or pursuant to this Agreement; and
(d) it is not aware of any third party claims or governmental
restrictions (other than legal provisions of general application)
which would restrict its ability to grant the rights agreed to be
granted by it under this Agreement.
9.6 Subject to the terms of the First Licence (if executed), the Second
Licence (if executed) or any agreement entered into pursuant to clause
6.11, if either party becomes aware of any infringement of any of the
Existing Patents or the Project Patents, or any claim is made or
threatened against either party that the exercise of any rights
granted under this Agreement infringes the patent or other
Intellectual Property rights of any third party, it shall forthwith
notify the other party, whereupon the parties shall consult and seek
to decide what steps if any to take, and each of them shall give the
other party (at the other party's expense) such assistance as the
other party may reasonably request in connection therewith.
9.7 Neither party nor its representatives or employees (or, in the case of
ICRT, those of ICRF) shall be deemed in any circumstances to be the
employees or representatives of the other party (or, in the case of
ICRT, to be those of ICRF), or shall have any authority or power to
bind the other party or to contract in its name.
9.8 This Agreement contains the entire agreement between the parties with
respect to its subject matter and may not be modified except by an
instrument in writing signed by the duly authorised representatives of
the parties, and each party 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 herein, and
any implied warranties are hereby excluded to the fullest extent
permitted by law, but nothing in this provision shall affect the
liability of either party for any fraudulent misrepresentation.
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27
9.9 Except with regard to the exercise of the First Option and the Second
Option, no failure or delay by either party in exercising any of its
rights under this Agreement shall be deemed to be a waiver of that
right, and no waiver by either party of a breach of any provision of
this Agreement shall be deemed to be a waiver of any subsequent
breach of the same or any other provision.
9.10 If any provision of this Agreement is held by any court or other
competent authority to be invalid or unenforceable in whole or in
part, the other provisions of this Agreement and the remainder of the
affected provision shall continue to be valid.
9.11 This Agreement (and any licence to be entered into pursuant to this
Agreement) shall be governed and construed in all respects in
accordance with the laws of England, and the parties agree to submit
to the non-exclusive jurisdiction of the English Courts.
9.12 Any dispute or arising out of, in relation to, or in connection with
this Agreement, or the validity, enforceability, construction,
performance or breach hereof, shall be settled by binding arbitration
in London, England, under the then-current Rules of Arbitration of
the International Chamber of Commerce Court of Arbitration by a single
arbitrator appointed in accordance with such rules, provided that if
either party so requests (and unless otherwise provided hereunder) the
arbitration shall be conducted by a panel of three (3) arbitrators
appointed in accordance with the Rules. The decision and/or award
rendered by the arbitrator(s) shall be written, final and
non-appealable and may be entered in any court of competent
jurisdiction. Accordingly, the parties hereby waive any and all rights
of appeal to the Court under the Arbitration Xxx 0000. The parties
agree that, any provision of applicable law notwithstanding, they will
not request, and the arbitrator shall have no authority to award,
punitive or exemplary damages against any party. The costs of any
arbitration, including administrative fees and fees of the
arbitrator(s), shall be shared equally by the parties, unless
otherwise determined by the arbitrator(s). Each
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28
party shall bear the cost of its own legal and expert fees; provided
that the arbitrator(s) may in his or their discretion award to the
prevailing party the costs and expenses incurred by the prevailing
party in connection with the arbitration proceeding.
10 NOTICES AND SERVICE
10.1 Any notice or other information required or authorized by this
Agreement to be given by either party to the other shall be given by -
(a) delivering it by hand;
(b) sending it by pre-paid registered post; or
(c) sending it by facsimile transmission or similar means of
communication (but not electronic mail);
to the other party at the address given in clause 10.4.
10.2 Any notice or information sent by post in the manner provided by
clause 10.1(b) which is not returned to the sender as undelivered
shall be deemed to have been given on the seventh day after the
envelope containing it was so posted; and proof that the envelope
containing any such notice or information was properly addressed,
pre-paid, registered and posted, and that it has not been so returned
to the sender, shall be sufficient evidence that the notice or
information has been duly given.
10.3 Any notice or information sent by facsimile transmission or similar
means of communication (but not electronic mail) shall be deemed to
have been duly given on the date of transmission, provided that a
confirming copy is sent as provided in clause 10.1(b) to the other
party at the address given in clause 10.4 within 24 hours after
transmission.
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29
10.4 The address of either party for service of any legal proceedings
concerning or arising out of this Agreement, or for the purposes of
clause 10.1, shall be that of its registered or principal office, or
such other address as it may last have notified to the other party in
writing from time to time.
11 MISCELLANEOUS
11.1 Each sum payable pursuant to this Agreement is exclusive of any
applicable Value Added Tax or other taxes or duties (other than taxes
on profits or income), which shall be additionally payable by Introgen
together with the relevant sum.
11.2 Each party shall from time to time do all such acts and execute all
such documents as may be reasonably necessary in order to give effect
to the provisions of this Agreement.
11.3 The parties shall bear their own costs of and incidental to the
preparation, execution and implementation of this Agreement.
11.4 Except as required by law, neither party shall make any press or other
public announcement concerning any aspect of this Agreement or use
the name of the other (including, in the case of ICRT, that of ICRF)
without first obtaining the agreement in writing of an authorised
representative of the other party.
11.5 This Agreement may be executed in more than one counterpart and shall
come into force once each party has executed such a counterpart in
identical form and exchanged it with the other party.
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30
SCHEDULE 1
THE EXISTING PATENTS
TITLE COUNTRY APPLICATION
NUMBER DATE
[*]
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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31
SCHEDULE 2
THE TERMS OF THE FIRST LICENCE
1 Parties: ICRT (the Licensor) and Introgen (the Licensee).
2 Definitions: 'LICENSED PRODUCT' will mean any product (i) which
incorporates the Gene, or (ii) the manufacture, use or sale
of which would in the absence of the licence granted to
Introgen infringe a valid claim within any of the Existing
Patents in the country for which the product is sold.
A "valid claim" will include the claims of issued patents
(including patents of addition, supplementary protection
certificates or similar rights based on any such patent) and
patent applications; provided that in the case of a patent
application which has not been issued, not more than [*]
have elapsed from the earliest priority filing date to which
the claim is entitled.
'LICENSED SUBJECT MATTER' will mean the Existing Technology,
the Existing Patents and any other Intellectual Property of
ICRT in respect of the Existing Technology.
Subject as provided above, the provisions of clause 2 shall
apply.
3 Licence: ICRT will grant to Introgen an exclusive, worldwide licence,
with the right to grant and authorise sublicences, under the
Licensed Subject Matter to make, have made, use and sell
Licensed Products, practice any method, process or procedure
and otherwise exploit the Licensed Subject Matter, in each
case within the Field. For the avoidance of
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
PAGE 29
32
doubt, Introgen will not have any rights in respect of any
[*] or in respect of any [*] outside the Field.
4 Retained Notwithstanding the foregoing, ICRT (for itself and ICRF)
Rights: will retain the rights under the Licensed Subject Matter
referred to in clause 6.8.
5 Clinical Introgen will be responsible for conducting, directly or
Development: through third parties, clinical development with respect to
Licensed Products. Such clinical development shall include
carrying out clinical trials sufficient to market a Licensed
Product in all Major Markets. Without limiting the
foregoing, Introgen will use the same diligent efforts to
initiate and complete such clinical trials as it expends for
its other products being developed with similar market
potential. The detailed plans and budgets for clinical
development will be determined by Introgen in consultation
with ICRT (and in default of agreement settled by
arbitration pursuant to clause 4.3) and set forth in the
Agreement. Introgen will consult with and keep ICRT
reasonably informed relating to the scope and progress of
such clinical development and will provide semi-annual
reports to ICRT on each stage of product development.
'MAJOR MARKET' will mean the [*], [*] and the [*].
6 Data Access: During the term of the Agreement, Introgen will have access
to copies of data, reports, analyses and other information
in ICRT's possession or control, which are reasonably
necessary for Introgen's exercise of its rights under the
Licensed Subject Matter. In addition, ICRT will provide
Introgen with reasonable quantities of the Gene from time to
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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33
time.
7 Licence Fee: Introgen shall pay to ICRT on the execution of the First
Licence [*], which shall be non-refundable and
non-creditable against royalties.
8 Milestone Upon the occurrence of the events set forth below for the
Payments: first Licensed Product, Introgen will make the corresponding
payment below to ICRT -
MILESTONE AMOUNT
--------- ------
Completion of [*] trials [*]
Completion of [*] trials [*]
First approval for [*] [*]
First approval for [*] [*]
First year where Net Sales of a [*]
Licensed Product exceeds [*]
TOTAL [*]
9 Royalties: Introgen will pay to ICRT as royalties the following
percentages of Net Sales by Introgen and its sublicensees,
based upon the aggregate Net Sales of all Licensed
Products -
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
PAGE 31
34
Annual Net Sales Royalties on Incremental
---------------- ------------------------
Amount
------
[*] [*]
[*] [*]
The foregoing royalties will be reduced by [*] in countries
where no valid claim of any of the Existing Patents covers a
Licensed Product.
In the event that Licensed Products are sold in combination
with one or more other registered products for which a
royalty would not otherwise be due, it is understood that
Net Sales from the combination product will be reasonably
allocated as to be set forth in the First Licence.
In the event Introgen, its affiliate or sublicensee becomes
obligated to pay a royalty to a third party in respect of
patent rights covering the Gene or use thereof such that the
total royalty burden on the Gene or use thereof (prior to
reductions) is in excess of [*] Introgen may deduct [*] of
such excess royalty from the royalty owing to ICRT on the
applicable net sales; provided, however, the royalty rate
payable on applicable net sales to such third party after
adjustments will not exceed the royalty rate payable (after
adjustments) to ICRT on such net sales (except with the
consent of ICRT, which consent will not be unreasonably
withheld) and in no case will the amount paid to ICRT be so
reduced to less than [*] of the amount that would otherwise
be due to ICRT on such net sales.
Each royalty payment will be accompanied by a proper
statement and will be made without deduction. Introgen will
keep proper accounts
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
PAGE 32
35
to enable the accuracy of royalty payments to be confirmed,
and will allow ICRT access to inspect and take copies.
10 Marketing: Introgen will be responsible for the establishment, control
and implementation of the promotion and marketing strategy,
plans and budgets for Licensed Products. Introgen will use
the same diligent efforts with respect to the marketing,
sale and promotion of Licensed Products for each Major
Market as Introgen expends for its own products being
developed with similar market potential.
11 Patent The provisions of clauses 3.6 and 3.7 above will apply
Prosecution: throughout the term of the First Licence as they apply
during the First Option Period.
12 Miscellaneous: Each party will keep Confidential Information of the other
confidential on the same terms as under clause 7 above.
The First Licence will be subject to termination on the
same terms as under clause 8 above. On termination all
rights will revert to ICRT.
Introgen will assume responsibility for the exploitation of
the Licensed Subject Matter and will indemnify ICRT (and
ICRF) accordingly. ICRT (or ICRF) will have no liability
howsoever arising under or in connection with the First
Licence for loss of profit or indirect or consequential loss
or for sums exceeding the amount of royalties paid by
Introgen.
Clauses 9, 10 and 11 above will apply to the First Licence.
The First Licence will include other reasonable and
customary terms and conditions contained in similar
agreements of this type, in so far
PAGE 33
36
as they are consistent with the above.
PAGE 34
37
SCHEDULE 3
OBJECTIVES OF THE PROJECT
[*]
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
PAGE 35
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SCHEDULE 4
THE TERMS OF THE SECOND LICENCE
1 'LICENSED SUBJECT MATTER' will include, in addition to the Existing
Patents and Existing Technology, any Project Technology and Project
Patent owned exclusively by ICRT or owned jointly by ICRT and
Introgen.
2 'LICENSED PRODUCT' will mean any product (i) which incorporates the
Gene, or (ii) the manufacture, use or sale of which would in the
absence of the licence granted to Introgen infringe a valid claim
within any of the Existing Patents or the Project Patents owned
exclusively by ICRT or owned jointly by ICRT and Introgen (or, in the
latter case, would do so if the Project Patent in question was owned
exclusively by ICRT) in the country for which the product is sold.
3 Royalties will be payable, at the rates specified in Schedule 2, on
Net Sales of Licensed Products (as defined above), where the product
(i) incorporates the Gene or (ii) is covered by a valid claim of an
Existing Patent or a Project Patent owned exclusively by ICRT. The
foregoing royalties will be reduced by [*] in countries where no valid
claim of an Existing Patent or a Project Patent owned exclusively by
ICRT covers a Licensed Product.
4 Clauses 6.3, 6.4, 6.8 and 6.9 shall apply throughout the term of the
Second Licence.
5 Subject to paragraphs 1 to 4 above, the provisions of Schedule 2 shall
apply with the necessary changes (and so that references to Existing
Technology and Existing Patents shall be construed as references to
Existing Technology and Existing Patents and/or Project Technology and
Project Patents owned exclusively by ICRT or owned jointly by ICRT and
Introgen).
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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For IMPERIAL CANCER RESEARCH TECHNOLOGY LIMITED
/s/ XXXX X. XXXX
--------------------------------
Director
For INTROGEN THERAPEUTICS, INC.
/s/ XXXXXXXX X. XXXX
--------------------------------
Director
PAGE 37
