* CONFIDENTIAL INFORMATION
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED
BY AN [_].
XENOVA LIMITED
AND
XENOVA RESEARCH LIMITED
AND
CANCER RESEARCH TECHNOLOGY LIMITED
-------------------------------------------
LICENCE
AND DEVELOPMENT AGREEMENT
-------------------------------------------
Anderson & Company
76 Wallingford Road
Shillingford
Oxon OX10 7EU
www.andersonsolicitors.com
--------------------------
<PAGE>
DEVELOPMENT AND LICENCE AGREEMENT
THIS AGREEMENT dated 10
January 2005 is made between:
(1) XENOVA LIMITED ("Xenova") a
company incorporated in England and Wales
whose
registered office is at 957 Buckingham Avenue, Slough, Berkshire
SL1
4NL;
and
(2) XENOVA RESEARCH LIMITED a
company incorporated in England and Wales whose
registered
office is at 957 Buckingham Avenue, Slough, Berkshire SL1
4NL;
and
(3) CANCER RESEARCH TECHNOLOGY
LIMITED ("CRT") a company incorporated in
England
and Wales whose registered office is at Sardinia House,
Sardinia
Street,
London WC2A 3NL.
RECITALS:
A. Xenova Research
Limited (formerly known as Cantab Pharmaceuticals
Research
Limited)
and Cancer Research Campaign Technology Limited (now
Cancer
Research
Technology Limited) entered into a licence agreement dated
6
March 1996
(the "Prior Licence Agreement") in respect of certain L2
Patent
Rights.
The Prior Licence Agreement was terminated by Xenova
Research
Limited in
January 2004. Under Clause 9.1.3 of the Prior Licence
Agreement, CRT
is entitled to request a licence from Xenova Research
Limited in
respect of certain intellectual property rights that may
be
required
by CRT for the commercial exploitation of the L2 Patent
Rights.
Xenova
Research Limited and CRT intend that the licences granted to
CRT
under this
Agreement shall be in satisfaction of such obligations
as
Xenova
Research Limited may have under Clause 9.1.3 of the Prior
Licence
Agreement.
B. Xenova Research
Limited has assigned the beneficial interest in all of
its
right,
title and interest in the Xenova Intellectual Property to
Xenova,
although
certain Xenova Patents remain registered with Patent Offices
in
the name
of Xenova Research Limited (or Cantab Pharmaceuticals
Research
Limited).
Accordingly, Xenova is the beneficial owner of certain
Xenova
Patents,
and possesses certain Xenova Know-how and Xenova
Materials
relating
to TA-CIN, a recombinant fusion protein vaccine
comprising
L2/E6/E7 from
HPV 16.
C. Xenova is willing to
grant to CRT, and CRT is willing to accept, a licence
in the
Field under the Xenova Patents and to use the Xenova Know-how
and
Xenova
Materials, all in accordance with the provisions of this
Agreement.
IT IS AGREED AS
FOLLOWS:
1
DEFINITIONS
In this Agreement, the
following words shall have the following meanings:
AFFILIATE
means in relation to a Party, any entity or person
that Controls, is Controlled by, or is under common
Control with that Party.
1
<PAGE>
ARISING INTELLECTUAL
means any and all of the Arising Patents, Arising
PROPERTY
Know-how and Arising Materials.
ARISING KNOW-HOW
means technical, commercial and all other information
generated by CRT or its Affiliates or Sub-licensees
during the continuation of this Agreement which is
not publicly known that relates to any of the Xenova
Intellectual Property or any Licensed Product,
including any scientific or regulatory data, product
licence applications and approvals, clinical trial
licence applications and approvals, and development
and marketing plans and activities.
ARISING MATERIALS
means any and all materials that may be generated or
developed by CRT or its Affiliates or Sub-licensees
in the course of this Agreement, including any
materials based on or derived from any Xenova
Materials.
ARISING PATENTS
means any and all patents and patent applications
that may be applied for or obtained in respect of
any invention(s) made by CRT, its Affiliates or
Sub-licensees during the continuation of this
Agreement and which relate to any Xenova Intellectual
Property or any Licensed Product, together with any
continuations, continuations in part, extensions,
reissues, divisions, and any patents, supplementary
protection certificates and similar rights that are
based on
or derive priority from the foregoing.
COMMENCEMENT DATE
means the date of execution of this Agreement by the
Parties.
COMMERCIALISATION
means an agreement to be entered into between CRT
AGREEMENT
and a permitted Sub-licensee (subject to the
provisions of this Agreement, including Clause 2.3)
as contemplated by Clause 5.1.
CONFIDENTIAL INFORMATION
means (a) all
Know-How (including Arising Know-How),
(b) information relating to the Xenova Materials
and (c) information relating to the customers,
suppliers, business partners, clients, finances,
business plans, technical developments and products
(in each case actual or prospective) of a Party
which, in each case, is not publicly known and which
is acquired by the other Party pursuant to this
Agreement.
CONTROL
means direct or indirect beneficial ownership of 50%
or more of the share capital, stock or other
participating interest carrying the right to vote or
to distribution of profits of that entity or person,
as the case may be; and "Controls" and "Controlled"
shall be interpreted accordingly.
CTM
means finished product lot number 0864FP of TA-CIN
manufactured by Xenova and intended for use in
clinical trials
DEVELOPMENT AND
means the Development and Commercialisation Plan for
Licensed
2
<PAGE>
COMMERCIALISATION PLAN
Product summarised in the attached Schedule 4, as
amended from time to time by agreement in writing of
the Parties.
DEVELOPMENT AND
means the report described in Clause 5.2 as amended
COMMERCIALISATION
from time to time.
REPORT
DILIGENT AND REASONABLE
means
exerting such efforts and employing such
CRT EFFORTS
resources as would normally be exerted or employed
by a reasonable third party company of similar size
to CRT 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 appoint a
Sub-licensee in a timely manner who will undertake
to develop the product in a timely manner and
maximize the economic return to the Parties from
its commercialisation.
DILIGENT AND REASONABLE
means
exerting such efforts and employing such
SUB-LICENSEE EFFORTS
resources as would normally be exerted or employed
by a reasonable third party 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.
DIRECT COSTS
means:
(a) the Xenova
Internal Costs;
(b) the CRT
Filling Costs; and
(c) costs
incurred by CRT in prosecuting,
maintaining, enforcing and defending and
commercialising the L2 Patents and the Xenova
Intellectual Property that consist of:
(i) official
filing fees;
(ii) patent agent
costs;
(iii) travel and out-of-pocket expenses;
(iv) courier charges
and third party printing
costs;
(v) any non-recoverable taxes or
charges
including value added tax which may be
imposed; and
(vi) any other
similar, external costs and
expenses specifically associated with
commercialisation of the L2 patents
or/and the Xenova Intellectual Property,
excluding the costs of general partnering
conferences such as BIO.
FIELD
means the prevention and treatment of HPV-related
diseases (including but not limited to vulval, anal
and cervical intraepithelial neoplasias and cervical
cancer) in humans.
3
<PAGE>
GROSS RECEIPTS
means the amount of any payment (excluding Value
Added Tax), and the value of any non-monetary
receipt, obtained by, CRT or its Affiliate, in
relation to the commercialisation or sub-licensing
(including the grant of any option over a
sub-licence) of any Xenova Intellectual Property,
including any of the following:
(a) up-front,
milestone (whether at the stage of
development, marketing or otherwise), success,
bonus, maintenance and periodic (including
annual) payments, royalty and minimum royalty
payments, due under any sub-licence agreement;
(b) payments in
respect of the funding of research
or development activities related to any
Licensed Product, to the extent that such
payments exceed a fair market price for such
research or development;
(c) where any
sub-licence is to be granted under
cross-licensing arrangements, the value of any
third party licence obtained under such
arrangements;
(d) any premium
paid over the fair market value of
shares, options or other securities in respect
of any of the share capital of CRT or its
Affiliate (such fair market value to be
determined on the assumption that Xenova
had not granted, nor agreed to grant, any
rights to CRT in respect of any Xenova
Intellectual Property);
(e) any loan,
guarantee or other financial benefit
made or given other than on normal market
terms; and
(f) any shares,
options or other securities
obtained from a third party.
HPV
means Human Papilloma Virus
KNOW-HOW
means the Xenova Know-how and the Arising Know-how.
L2 PATENTS
means the patents and patent applications described
in the attached Schedule 2 and, in the case of the
patent applications, all patents arising therefrom
and all progeny applications arising from PCT
applications and patents arising therefrom and all
patent applications (and patents granted thereon)
which are related to those listed by the fact that
they are based on the same specification and/or
claim priority from the same fore-runner application
and/or as filed contain substantially the same
claims, together with any continuations,
continuations in part, extensions, reissues,
divisions, and any patents, supplementary protection
certificates and similar rights that are based on or
derive priority from the foregoing.
LICENSED PRODUCT
means any product for use in the Field, that is
manufactured, sold or otherwise supplied by CRT or
its Affiliate or Sub-licensee and which (a) is
within any Valid Claim of the Xenova Patents and/or
(b) incorporates, or its development makes use of,
any of the Xenova Know-how or the Xenova Materials
(whether or not in combination with any third party
technology).
4
<PAGE>
MANCHESTER PHASE II
A Phase II study meeting the description set out in
STUDY
Schedule 5.
NET RECEIPTS
means Gross Receipts less Direct Costs.
PARTIES
means Xenova and CRT, and "Party" shall mean either
of them.
PATENTS
means any and all of the Xenova Patents and the
Arising Patents.
QUARTER
means each 3 month period ending on 31 March, 30
June, 30 September and 31 December.
SUB-LICENCE
has the meaning given in Clause 2.3.
SUB-LICENSEE
means any person with whom CRT has entered into a
Sub-licence, subject to the provisions of Clause 2.3.
TA-CIN
means a recombinant protein vaccine that has been
developed by Xenova that is a fusion protein
comprising HPV 16 L2/E6/E7 proteins.
TERRITORY
means the World.
TOBACCO PARTY
means any corporation, company, partnership or other
organisation or person
with a material interest in
or links to the tobacco industry (other than
interests held by investment firms as part of a
portfolio of investments).
VALID CLAIM
means a claim of a patent or patent application that
has not expired, been withdrawn, abandoned or
surrendered or been refused, revoked or held invalid
or unenforceable by a court or other governmental
agency of competent jurisdiction in a final and
non-appealable judgment.
XENOVA INTELLECTUAL
means any and all of the Xenova Patents, Xenova
PROPERTY
Know-how and Xenova Materials.
XENOVA INTERNAL COSTS
means
internal costs incurred or to be incurred by
Xenova in relation to the filling and lot release of
CTM for the proposed Manchester Phase II Study up to
a total aggregate sum of [_].
XENOVA KNOW-HOW
means technical information which is not publicly
known (including regulatory dossiers) in the
possession of Xenova in the Field relating to (a)
TA-CIN and/or (b) the inventions claimed in the
Xenova Patents, and being further described in the
attached Schedule 3.
XENOVA MATERIALS
means physical materials (including cell banks and
CTM) in the possession of Xenova in the Field
relating to (a) TA-CIN and/or (b)
5
<PAGE>
the inventions claimed in the Xenova Patents, and
being further described in the attached Schedule 3.
XENOVA PATENTS
means the patents and patent applications described
in the attached Schedule 1 and, in the case of the
patent applications, all patents arising therefrom
and all progeny applications arising from PCT
applications and patents arising therefrom and all
patent applications (and patents granted thereon)
which are related to those listed by the fact that
they are based on the same specification and/or claim
priority from the same fore-runner application
and/or as filed contain substantially the same
claims, together with any continuations,
continuations in part, extensions, reissues,
divisions, and any patents, supplementary protection
certificates and similar rights that are based on or
derive priority from the foregoing.
2. GRANT OF
RIGHTS
2.1 Licences to Xenova
Intellectual Property. Xenova hereby grants to CRT,
subject to
the provisions of this Agreement:
(a) an exclusive licence in the
Field under the Xenova Patents, with the right
to sub-
license, subject to clause 2.3 below, to develop,
manufacture,
have manufactured, use
and sell Licensed Product in the Field in the
Territory;
and
(b) an exclusive licence in the
Field to use the Xenova Know-how and the
Xenova
Materials, with the right to sub-license, subject to clause
2.3
below, to
develop, manufacture, have manufactured, use and sell
Licensed
Product in
the Field in the Territory.
2.2 Formal licences. If
requested by CRT, and at CRT's administrative cost,
the
Parties shall execute such formal licences as may be necessary
or
appropriate for registration with Patent Offices and other
relevant
authorities in particular jurisdictions. In the event of any
conflict in
meaning
between any such licence and the provisions of this Agreement,
the
provisions
of this Agreement shall prevail. The Parties shall use
reasonable
endeavours to ensure that, to the extent permitted by
relevant
authorities, this Agreement shall not form part of any public
record. To
the extent
that Xenova Research Limited retains any right, title or
interest
in the Xenova Patents it joins with Xenova in granting the
rights
referred
to in Clause 2.1 and undertakes to execute the formal
licences
referred
to in this Clause 2.2.
2.3 Sub-licensing. CRT shall be
entitled to grant sub-licences (which for the
purposes
of this clause shall include any option or right to acquire
a
sub-licence) of its rights under this Agreement to any person
(including
without
limitation any Affiliate of CRT) ("Sub- licences), provided
that:
(a)
CRT shall (i)
obtain Xenova's prior written consent (such consent
not to be unreasonably withheld or delayed) to the execution of
a
term sheet, letter of intent or
6
<PAGE>
similar document ("Term Sheet") with the Sub-licensee, (ii)
keep
Xenova regularly informed of the progress of negotiations with
each
sub-licensee who has agreed a Term Sheet with CRT, and (iii) if
it
is proposed that the sub-licence agreement shall survive
termination
of this Agreement, obtain Xenova's prior written consent to
the
terms of the sub-licence agreement and to CRT's execution of
the
sub-licence agreement;
(b)
the Sub-licence
shall include obligations on the Sub-licensee which
are equivalent to the obligations on CRT under Clauses 3, 5.2,
6.6,
9.3 and 10 of this Agreement, as well as obligations on
the
sub-licensee to use at least Diligent and Reasonable
Sublicensee
Efforts to develop and commercialise Licensed Products, and
CRT
shall ensure that the Sub-licence agreement provides that
Xenova
may, in its own right, enforce all such obligations against
the
Sub-licensee;
(c)
the Sub-licence
shall include obligations on the Sub-licensee that
all Licensed Products marketed by it are of satisfactory quality
and
comply with all
applicable laws and regulations in each part of the
Territory relevant to such Sub-licence.
(d)
the Sub-licence
shall terminate automatically on the termination of
this Agreement for any reason (unless Xenova has given consent
under
clause 2.3(a)(iii)); and
(e)
within 30 days
of the grant of any Sub-licence CRT shall provide to
Xenova a true copy of it.
2.4 Reservation of rights. For
the avoidance of doubt, Xenova reserves the
right to
use Xenova Intellectual Property in the Field for the purposes
of
its own
internal research only. It is understood and agreed that
Xenova
will be
required under regulatory GCP to retain archive samples of
Xenova
Materials.
2.5 No other licence. It is
acknowledged and agreed that except for the
licence(s)
expressly granted by the provisions of this clause 2,
Xenova
reserves
all its rights. Without prejudice to the generality of
the
foregoing
Xenova reserves all rights under the Xenova Intellectual
Property
outside the Field.
3 KNOW-HOW AND
CONFIDENTIAL INFORMATION
3.1 Provision of Know-how.
Within 30 days of the Commencement Date, Xenova
shall
supply CRT or its Sub-licensee (if any) with the Xenova Know-how.
In
addition,
Xenova shall supply, in confidence, information in respect
of
the Xenova
Intellectual Property, as available and to the extent Xenova
is
free to
disclose it, to Sub-licensees or potential Sub-licensees of CRT
as
CRT shall
reasonably request and as is required by such Sub-licensees
or
potential
sub-licensees to decide whether to enter into or terminate
any
Sub-licence. The Xenova Know-how shall be subject to the
confidentiality
provisions of Clause 3.4.
The method of such supply shall be as specified
in the
Schedule 3, but shall not require Xenova to undertake more than
5
man-days
work in respect of the obligation under this Clause 3.1
to
provide
the Xenova Know-How to the University of Manchester and
potential
Sub-licensees and more than 5 man-days work in respect of the
obligation
under this
Clause 3.1 to provide the Xenova Know-How to actual
Sub-licensees (ie a total
7
<PAGE>
maximum of
10 man-days) free of charge, unless otherwise agreed in
writing
between
the Parties
3.2 Status of Know-how and
Materials. CRT acknowledges that the Xenova
Know-how
and Xenova Materials are at an early stage of
development.
Accordingly, specific results cannot be guaranteed and any
results,
materials,
information or other items, including the Xenova Know-how
and
Xenova
Materials and inventions claimed in the Xenova Patents
provided
under this
Agreement are provided "as is" and without any express
or
implied
warranties, representations or undertakings. As examples,
but
without
limiting the foregoing, Xenova does not give any warranty
that
Xenova
Materials are of merchantable or satisfactory quality, are fit
for
any
particular purpose, comply with any sample or description, or
are
viable,
uncontaminated, safe or non-toxic.
3.3 Use of Know-how. CRT
undertakes that for a period of 10 years from the
date of
first commercial sale of Licensed Product in the Territory or
for
so long as
any substantial part of the Xenova Know-how remains subject
to
the
obligations of confidence of Clause 3.4, whichever is the shorter,
it
will not
use the Xenova Know-how for any purpose except as
expressly
licensed
hereby and in accordance with the provisions of this
Agreement,
including,
but not limited to clause 8 hereof.
3.4 Confidentiality obligations.
Each Party ("Receiving Party") undertakes:
(a)
save as
permitted by this Agreement to maintain as secret and
confidential Confidential Information obtained directly
or
indirectly from the other Party ("Disclosing Party") in the
course
of or in anticipation of this Agreement and to respect
the
Disclosing Party's rights therein,
(b)
to use the same
exclusively for the purposes of this Agreement, and
(c)
to disclose the
same only to those of its employees, contractors,
customers, potential customers, potential Sub-licensees
and
Sub-licensees pursuant to this Agreement (if any) to whom and to
the
extent that such disclosure is reasonably necessary for the
purposes
of this Agreement.
3.5 Exceptions to obligations.
The provisions of Clause 3.4 shall not apply to
Confidential Information which the Receiving Party can demonstrate
by
reasonable, written evidence:
(a)
was, prior to
its receipt by the Receiving Party from the Disclosing
Party, in the possession of the Receiving Party and at its
free
disposal;
(b)
is subsequently
disclosed to the Receiving Party without any
obligations of confidence by a third party who has not derived
it
directly or indirectly from the Disclosing Party;
(c)
is or becomes
generally available to the public through no act or
default of the Receiving Party or its agents, employees,
Affiliates
or
sub-licencees; or
(d)
in the case of
Know-how, it has independently developed
8
<PAGE>
3.6 Disclosure to court, etc. If
the Receiving Party is required to disclose
Confidential Information to the courts of any competent
jurisdiction, or
to any
government regulatory agency or financial authority,
such
disclosure
shall not be a breach of this clause 3, provided that
the
Receiving
Party shall (i) inform the Disclosing Party as soon as
is
reasonably
practicable, and (ii) at the Disclosing Party's request seek
to
persuade
the court, agency or authority to have the information treated
in
a
confidential manner, where this is possible under the court, agency
or
authority's
procedures.
3.7 Disclosure to employees. The
Receiving Party shall procure that all of its
employees,
contractors, consultants, advisers, customers, potential
customers,
potential sub-licensees and sub-licensees pursuant to
this
Agreement
(if any) who have access to any of the Disclosing
Party's
Confidential Information to which Clause 3.4 applies, shall be made
aware
of and
subject to these obligations and shall have entered into
written
undertakings of confidentiality at least as restrictive as Clauses
3.4 and
which
apply to the Disclosing Party's information.
4
MATERIALS
4.1 Supply of materials. Xenova
shall supply the Xenova Materials or any of
them,
including CTM, to CRT (or CRT's nominee) in such quantities as
CRT
may
reasonably request, within 30 days of such request. All such
CTM
supplied
by Xenova under or in connection with this Agreement shall
remain
the
absolute property of Xenova. For the avoidance of doubt, where
Xenova
Materials
ot