* CONFIDENTIAL INFORMATION
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED
BY AN [_].
Confidential
XENOVA LIMITED
AND
OXXON THERAPEUTICS LIMITED
---------------------------------------
DEVELOPMENT AND LICENCE AGREEMENT
---------------------------------------
Anderson & Company
76 Wallingford Road
Shillingford
Oxon OX10 7EU
wwww.andersonsolicitors.com
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DEVELOPMENT AND LICENCE AGREEMENT
THIS AGREEMENT dated 12th
January 2005 is made between:
(1) XENOVA LIMITED
(company registration number 01970244) ("Xenova") a
company incorporated in England and Wales whose registered office
is at
957
Buckingham Avenue, Slough, Berkshire SL1 4NL; and
(2) OXXON THERAPEUTICS
LIMITED (company registration number 03671700)
("Oxxon") a company incorporated in England and Wales whose
principal
place of business is at Florey House, 3 Robert Robinson Avenue,
The
Oxford Science Park, Oxford OX4 4GP.
RECITALS:
A. Xenova is the
beneficial owner of certain Xenova Patent Rights, and
possesses certain Xenova Know-how and Xenova Materials relating to
the
DISC-HSV Vector.
B. Oxxon has expertise in developing
immunotherapeutic products based on a
proprietary Heterologous PrimeBoost approach. Oxxon also has
expertise in
developing viral based antigen delivery vectors for the treatment
of
cancer and infectious disease.
C. Oxxon wishes to
pursue the further development and commercialisation of
the
DISC-HSV Vector in Selected Indications and Fields, in
accordance
with
the provisions of this Agreement.
D. Xenova is
willing to grant to Oxxon, and Oxxon is willing to accept,
a
licence in the Selected Indications in the Field under the Xenova
Patent
Rights 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
In relation to a Party, means any entity or person
that Controls, is Controlled by, or is under common
Control with that Party.
ARISING INTELLECTUAL
Any
and all of the Arising Patents, Arising Know-how
PROPERTY
and Arising Materials.
ARISING KNOW-HOW
Technical, commercial and all other information
generated by Oxxon during the continuation of this
Agreement that relates to any of the Xenova
Intellectual Property or any Licensed Product(s),
including any scientific or regulatory data, product
licence applications and approvals, clinical trial
licence applications and approvals, and development
and
marketing plans and activities.
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ARISING MATERIALS
Any and all materials that may be generated or
developed by Oxxon in the course of this Agreement,
including any materials based on or derived from any
Xenova Materials.
ARISING PATENTS
Any and all patents and patent applications that may
be applied for or obtained in respect of any
invention(s) made by Oxxon during the continuation
of this Agreement and which relate to any Xenova
Intellectual Property, 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.
BLA
A biologies license application (as that term is
used in Title 21 of the United States Code of Federal
Regulations) filed with the FDA seeking regulatory
approval to market and sell any Licensed Product in
the United States for a particular indication or the
non-U.S. equivalent thereof.
COMMENCEMENT DATE
The date of execution of this Agreement by the
Parties.
CONTROL
Direct or indirect beneficial ownership of 50% (or,
outside a Party's home territory, such lesser
percentage as is the maximum permitted level of
foreign investment) or more of the share capital,
stock or other
participating interest carrying the
right to vote or to distribution of profits of that
entity or person, as the case may be.
DEVELOPMENT AND
The development and commercialisation plan for
COMMERCIALISATION PLAN
Licensed Product(s), the initial programme for which
is briefly summarised in Schedule 3, to be further
defined in accordance with Clause 3.1 and as may be
amended from time to time by Oxxon.
DEVELOPMENT AND
The report described in Clause 3.4 as amended from
COMMERCIALISATION REPORT
time to
time.
DISC-GMCSF
A recombinant virus that has been developed by
Xenova and is designated dH2T, and which is a
disabled infectious single cycle herpes simplex type
2 virus that expresses the cytokine human
granulocyte macrophage colony stimulating factor
from the gH locus from which the gH gene has been
deleted.
DISC-HSV VECTOR
A disabled infectious single cycle herpes simplex
virus from which the gH gene has been deleted and/or
from which another gene that is essential for virus
replication may be deleted, and into which a
different gene(s) is or will be substituted, as a
result of which substitution the virus expresses
heterologous gene(s). The foregoing definition shall
include DISC-GMCSF which has been genetically
modified.
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For the avoidance of doubt, a DISC-HSV vector that
is "empty" (including but not limited to the vector
known as dH2A), that is to say it does not express
any heterologous gene(s) as described in the
previous sentence of this definition, is excluded
from the definition of DISC-HSV Vector for the
purposes of this Agreement.
[_] YEAR PERIOD
The period commencing on the Commencement Date and
ending on the earlier of (a) the [_] anniversary
of the Commencement Date; and (b) any termination of
this Agreement.
FDA
The United States Food and Drug Administration and
any successor agency or authority thereto.
FIELD
Field A and Field B.
FIELD A
The use of DISC-HSV Vector in Heterologous
PrimeBoost regimes (where the DISC-HSV Vector is
either the [_] or [_]) for prophylactic and
therapeutic applications for the Indications.
For the avoidance of doubt, for the purposes of this
Agreement, Field A shall not include the use of
DISC-HSV Vector in the prophylactic setting for the
prevention of herpes virus infection/disease.
FIELD A INDICATIONS
Those Indications that Oxxon selects for use in
Field A in accordance with the provisions of
Clause 4.3.
FIELD B
The use of DISC-HSV Vector or DISC-GMCSF as a
[_] for prophylactic and therapeutic
applications for the Indications.
For the avoidance of doubt, for the purposes of this
Agreement, Field B shall not include the use of
DISC-HSV Vector in the prophylactic setting for the
prevention of herpes virus infection/disease.
FIELD 8 INDICATIONS
Those Indications that Oxxon selects for use in
Field B in accordance with the provisions of
Clause 4.3.
FURTHER INDICATIONS
Those additional indications other than the
Indications and the Haematology Indications, as
defined in this Agreement that Oxxon selects in
accordance with Clause 4.3(d)(ii).
HAEMATOLOGY INDICATIONS
The
application of Licensed Product to transduce
cells
selected from the group consisting of
haematopoietic cells, malignant cells of the
haematopoietic lineage, and malignant or
non-malignant CD34+ cells.
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HETEROLOGOUS
A multi-stage heterologous regimen involving the
PRIMEBOOST
sequential delivery of an antigen to both prime and
boost an immune response. The antigen used in the
prime and boost may or may not be identical. For the
avoidance of doubt, the prime and/or boost may be
undertaken one or more times.
IND
An Investigational New Drug Application filed or to
be filed with the FDA with regard to a Licensed
Product prior to beginning clinical trials of any
Licensed Product or the non-U.S. equivalent thereof.
INDICATIONS
[_]
INITIAL INDICATIONS
Those Field A Indications and/or Field B Indications
that Oxxon selects in
accordance with Clauses 4.3(b)
and (c).
JOINT DEVELOPMENT
A committee to be established, and operating, in
FORUM
accordance with the provisions of Clause 2.
KNOW-HOW
The Xenova Know-how and the Arising Know-how.
LICENSED PRODUCT(S)
Any and all products that incorporate DISC-GMCSF or
DISC-HSV Vector and that are manufactured, sold or
otherwise supplied by Oxxon or Sub-licensees and
which (a) are within any Valid Claim of the Xenova
Patent Rights; and/or (b) incorporate, or their
development makes use of, any of the Xenova Know-how
or the Xenova Materials. References in this
Agreement to different Licensed Products (e.g., the
first and second Licensed Products) shall be
understood as referring to Licensed Products that
require, or will require, separate Marketing
Authorisations in the United States of America.
MARKETING AUTHORISATION
Regulatory
approval to market and sell a Licensed
Product in any part of the Territory and shall
include, without limitation, approval granted with
respect to any BLA, NDA or the non-US equivalent
thereof.
NDA
A new drug application (as that term is used in
Title 21 of the United States Code of Federal
Regulations) filed with the FDA seeking Regulatory
Approval to market and sell any Licensed Product(s)
in the United States for a particular indication or
the non-U.S. equivalent thereof.
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NET SALES VALUE
The invoiced price of Licensed Product(s) sold by
Oxxon or any of its Affiliates (or, in the context
of Clause 6.6(b) its Sublicensees, or in the context
of Clause 6.7 and 6.11 Oxxon or any of its Affiliates
and/or its Sublicensees) to independent third
parties in arm's length transactions exclusively for
money or, where the sale is not at arm's length, the
price that would have been so invoiced if it had
been at
arm's length, after deduction of normal trade
discounts actually granted and any credits actually
given, and, provided the amounts are separately
charged on the relevant invoice, any costs of
packaging, insurance, carriage and freight, any
value added tax or other sales tax, and any import
duties or similar applicable government levies.
OPT-IN FEES
The fees described in Clause 6.4.
PARTIES
Xenova and Oxxon, and "Party" shall mean either of
them.
PATENTS
Any and all of the Xenova Patent Rights and the
Arising Patents.
PHASE I STUDIES
As to a specific Licensed Product, one or more
controlled and lawful studies in humans, the
principal purpose of which is a preliminary
determination of safety of the Licensed Product for
its intended use in healthy individuals or patients
to support its continued testing in similar clinical
trials prescribed by the FDA or any relevant foreign
regulatory authority.
PHASE II STUDIES
As to a specific Licensed Product, one or more
controlled and lawful studies in humans of the
safety, dose ranging and efficacy of such Licensed
Product, which is prospectively designed to generate
sufficient data (if successful) to commence Phase III
Studies of such product.
PHASE III STUDIES
As to a specific Licensed Product, one or more
controlled and lawful studies in humans of the
efficacy and safety of such 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 file a BLA or NDA to
obtain regulatory approval to market and sell that
Licensed Product in any part of the Territory for
the indication being
investigated by the study.
PRE-CLINICAL STUDIES
As
to a specific Licensed Product, in vitro or in
vivo (non-human) studies, including but not limited
to evaluation of the safety, immunogenicity,
pharmacology or toxicity profile of a therapeutic
agent.
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REASONABLE AND DILIGENT
Exerting
such efforts and employing such resources as
EFFORTS
would normally be exerted or employed by a
reasonable, [_] when utilizing sound and reasonable
scientific, business and medical practice and
judgment in order to develop the product in a timely
manner and maximise the economic return to the
Parties from its commercialisation.
REVOCATION PROCEEDINGS
Any
proceedings before a national or international
Patent Office where the validity of any of the
Xenova Patent Rights is at issue including opposition
proceedings in respect of European patents and
interference proceedings in respect of US patents,
but excluding any proceedings that form part of, or
are linked with, proceedings in which allegations of
patent infringement are made.
ROYALTY RECEIPTS
The amount of any royalties received by, or due to,
Oxxon or any of its Affiliates calculated on the
sale of Licensed Product(s) less any Value Added
Tax.
SELECTED INDICATIONS
The
Field A Indications (if any) and the Field B
Indications (if any).
SUB-LICENSEE
Any third party (including an Affiliate of Oxxon) to
whom Oxxon has sub-licensed any of Oxxon's rights
under this Agreement.
TERRITORY
The World.
UPFRONT RECEIPTS
Subject to Clause 6.6(a)(iii) and (iv), the amount of
any payment (excluding Value Added Tax), and the
value of any non-monetary receipt, obtained by, or
due to,
Oxxon or its Affiliate, by way of "upfront"
or initial consideration (whether payable in one or
more instalments) in relation to the sub-licensing
(including the grant of any option over a
sub-licence) of any Xenova Intellectual Property,
and including any of the following:
(a) up-front payments
due under any sub-licence
agreement;
(b) payments in excess
of a fair market rate for
the funding of research or development
activities related to any Licensed Product;
(c) where any
sub-licence is to be granted under
cross- licensing arrangements, the value of any
third party licence obtained under such
arrangements;
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(d) any premium paid
over the fair market value of
shares, options or other securities in respect
of any of the share capital of Oxxon 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
Oxxon 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.
VALID CLAIM
A claim of a patent or patent application that has
not expired or been held invalid or unenforceable by
a court of competent jurisdiction in a final and
non-appealable judgment.
XENOVA INTELLECTUAL
Any and all of the Xenova Patent Rights, Xenova
PROPERTY
Know-how and Xenova Materials.
XENOVA KNOW-HOW
Technical information in the possession of Xenova or
its Affiliates in the Field relating to (a) DISC-HSV
Vector and/or (b) the inventions claimed in the
Xenova Patent Rights, and being further described in
the attached Schedule 2.
XENOVA MATERIALS
Physical materials in the possession of Xenova or its
Affiliates in the Field relating to (a) DISC-HSV
Vector and/or (b) the inventions claimed in the
Xenova Patent Rights, being those described in the
attached Schedule 2 and such other materials in the
possession of Xenova or its Affiliates that:
(a) were developed by
Xenova or its Affiliates in
its research and development programme for
DISC-HSV prior to the Commencement Date; and
(b) fall within the
categories set out in Schedule
2; and
(c) Oxxon may
reasonably request for the development
of Licensed Product(s); and
(d) of which Xenova or
its Affiliates is the
beneficial owner; and
(e) which Xenova or
its Affiliates is not prevented
from
providing as a result of a pre-existing
agreement with a third party.
XENOVA PATENT RIGHTS
The
patents and patent applications described in the
attached Schedule 1 together with any continuations,
continuations in part, extensions, reissues,
divisions, and any patents, supplementary protection
certificates and similar rights that are based on or
derive priority from the foregoing.
XENOVA REPRESENTATIVES
Mr
Terry Stancliffe and Dr Elizabeth Rollinson and
the executive board directors of Xenova.
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2 JOINT
DEVELOPMENT FORUM
2.1 Formation, Within 90
days after the Commencement Date, the Parties shall
establish a Joint Development Forum, by each Party designating
its
initial members to serve on the Joint Development Forum and
notifying the
other Party of its dates of availability for the first meeting of
the
Joint Development Forum. At the Joint Development Forum Oxxon
shall
report to
Xenova on its progress in developing Licensed Product(s)
for
purposes of commercialization in the Field in the Territory. The
Joint
Development Forum shall consist of up to three (3)
representatives
designated by each Party. Each Oxxon representative shall have
relevant
and
appropriate development expertise in order to report on and
discuss
the
development of the Licensed Product(s). If a representative of
a
Party is unable to attend a meeting of the Joint Development Forum,
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
Joint Development Forum, provided that such invitees are bound
by
appropriate confidentiality obligations. Each Party may change one
or all
of
its representatives to each Joint Development Forum at any time
upon
notice to the other Party.
2.2 Meetings, The Joint
Development Forum shall meet every six months and at
such
other times as the Parties may agree. The first meeting of the
Joint
Development Forum shall be held as soon as reasonably practicable,
but in
no
event later than 90 days after the Commencement Date. Meetings
shall
be
held at such place or places as are mutually agreed or
by
teleconference or videoconference; provided, however, that there
shall be
at
least one face-to-face meeting per calendar year.
2.3 Responsibilities.
During the continuation of this Agreement, the Joint
Development Forum shall:
(a)
receive
reports from Oxxon on the progress of the development of
Licensed Products;
(b)
provide
Xenova with an opportunity to comment on the Development
and Commercialisation Plan;
(c)
enable
Xenova to provide information to Oxxon that it has in
its
possession or control which may facilitate Oxxon's development
of
Licensed Products; and
(d)
facilitate
the initial transfer of Xenova Know-How between the
Parties for purposes of enabling Oxxon to develop
Licensed
Products;
For the avoidance of
doubt the Joint Development Forum shall not have any
role
or responsibility in relation to determining whether Oxxon
has
complied or will comply with its obligations to Xenova under
Clauses 3 or
7.1.
2.4 Disputes. If agreement
cannot be reached within the Joint Development
Forum, Oxxon shall have the right to make the final
determination
concerning the resolution of the disagreement.
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3
DEVELOPMENT
3.1 Development and
Commercialisation Plan; IND filing. Without prejudice to
the
generality of Oxxon's obligations under Clause 7.1, Oxxon
shall:
(a)
Within [_]
of Oxxon making its selection of its first Indication
pursuant to Clause 4.3(b) Oxxon shall create a Development
and
Commercialisation Plan based on the initial, summary
Development
and Commercialisation Plan set out in Schedule 3, which will
set
out Oxxon's proposed development of Licensed Product(s)
in
relation to such first Indication. The Development and
Commercialisation Plan shall describe in outline Oxxon's
development activities for the applicable Licensed Product in
the
applicable Indication. Oxxon will update the Development
and
Commercialisation Plan on a regular (and at least
six-monthly)
basis, and such updates shall address the relevant stage
of
development and commercialization of the Licensed
Product(s)
including information under the headings set out in Part 2
of
Schedule 3 as and when such information is available;
and
(b)
Oxxon
shall use Reasonable and Diligent Efforts to file,
within
[_] of selecting each Indication in accordance with Clause 4.3,
an
IND for a Licensed Product for such Indication. In the event
that
Oxxon is in breach of its obligation to use Reasonable
and
Diligent Efforts to file in accordance with this Clause
3.1(b)
then Xenova shall only be entitled to exercise any right
of
termination under Clause 10.2.2 if Oxxon is in breach of
its
obligation in respect of all Selected Indications.
3.2 Development
activities. With respect to each Licensed Product, Oxxon
shall be responsible for the development and commercialisation of
such
Licensed Product in the Field in the Territory in accordance with
the
Development and Commercialisation Plan. Such development
and
commercialisation shall be carried out in accordance with the
provisions
of
this Agreement.
3.3 Development costs.
Oxxon shall bear all costs associated with the
development of Licensed Product(s), including costs incurred
in
connection with the Development and Commercialisation Plan save
that
Xenova shall bear its own costs associated with attending
and
participating in the Joint Development Forum as set out in Clauses
2.1 to
2.4
. If Xenova agrees with Oxxon to conduct work as part of
the
Development and Commercialisation Plan, Xenova's costs of
conducting such
work
shall be borne by Oxxon, with the time costs of Xenova
representatives being charged to Oxxon on a full-time equivalent
(FTE)
basis. Xenova's FTE rate for its representatives shall be agreed
between
the
Parties but in any event it shall be not less than [_] per annum
(on
a
pro-rata basis) plus all product-related consumable costs and
external
costs associated with such work. For the avoidance of doubt, these
rates
shall not apply to any manufacturing work performed by Xenova,
which
would be the subject of separate manufacturing agreement(s) as may
be
agreed in writing by the Parties.
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3.4 Reporting. Without
prejudice to the generality of Oxxon' s obligations
under Clause 7.1, Oxxon shall provide a Development and
Commercialisation
Report to Xenova at least twice per year to Xenova (and in any
event
prior to each meeting of the Joint Development Forum), summarising
its
past, current and projected activities taken or to be taken by
Oxxon to
bring Licensed Product(s) to market and maximise the sale of
Licensed
Product(s) worldwide; and from time to time at Xenova's
reasonable
request and on reasonable notice Oxxon shall provide details of
such
activities. Xenova's receipt or approval of any such report shall
not be
taken to waive or qualify Oxxon's obligations under Clause
7.1.
4. GRANT OF
RIGHTS
4.1 Licences to Xenova
Intellectual Property. Xenova hereby grants to Oxxon,
subject to the provisions of this Agreement, the following licences
in
the
Field:
(a) an exclusive licence
under the Xenova Patent Rights, with the
right to sub-license, subject to Clause 4.6, to develop,
manufacture, have manufactured, use and sell product(s) in
the
Field in the Territory for the Selected Indications; and
(b)
an
exclusive licence to use the Xenova Know-how and the
Xenova
Materials, with the right to sub-license, subject to Clause
4.6,
to develop, manufacture, have manufactured, use and sell
product(s) in the Field in the Territory for the
Selected
Indications.
For
the avoidance of doubt, Oxxon shall only be entitled to exploit
the
rights granted to Oxxon under the licences set out in Clauses 4.1
(a) and
4.1(b) in respect of the Field A Indications in Field A, and in
respect
of
the Field B Indications in Field B.
4.2 [_]
4.3 Selection of
Indications. The licences granted under Clause 4.1 are
limited to the Indications that Oxxon selects in accordance with
the
provisions of this Clause 4.3, as follows:
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(a)
Oxxon
shall have the exclusive right to select one or more of
the
Indications, in Field A and/or in Field B, subject to
the
provisions of the following paragraphs of this Clause 4.3.
In
respect of each Indication, Oxxon shall exercise this right
from
time to time by giving written notice to Xenova, within
the
relevant time-limit referred to in this Clause, stating
the
Indication and whether it is selected for Field A or Field
B.
(b)
Within [_]
of the Commencement Date, Oxxon will select [_]
Indications in Field A.
(c)
Within [_]
of the Commencement Date, Oxxon will select [_]
Indications in Field B.
(d)
Provided
that Oxxon has selected [_] Indications in Field A and
[_] Indications in Field B in accordance with the time
limits
stated in paragraphs (b) and (c) above:
(i) during
the [_], Oxxon may select [_] further Indications in
Field A and/or in Field B, subject to payment of the
Opt-in
Fees in respect of each Indication that is selected in
either of Field A or Field B.
(ii) Provided
that Oxxon has [_] develop such Further
Indications in accordance with this Agreement, during
the
[_] Oxxon may notify Xenova of Further Indications in
Field
A and/or in Field B that it wishes to select.
(iii) On receipt of a
valid notice pursuant to Clause 4.3(d)(ii)
Oxxon shall, subject to Clause 4.3(d)(iv) be entitled to
a
licence to such Further Indication in accordance with
Clause 4.1.
(iv) In the
event that Xenova has granted prior rights to any
third party and as a result is not able to grant a
licence
to Oxxon in accordance with Clause 4.3(d)(iii) or such
grant would result in Xenova being in breach of its
obligations under any agreement with a third party,
Xenova
shall offer to Oxxon a licence to the Further Indication
to
the extent available. Such licence shall, to the extent
possible, reflect the terms of the licence granted to
Oxxon
under Clause 4.1 and the other provisions of this
Agreement
(including its financial provisions) save that, if the
rights granted are less than those provided for under
Clause 4.1, the Parties will negotiate in good faith to
agree the appropriate royalty rate payable in respect of
such licence and for the avoidance of doubt no such
licence
shall be granted until all of the terms of the licence
agreement have been agreed in writing.
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(v)
Oxxon's right of selection under this paragraph (d)
shall
continue during the [_], except that this right shall
[_]
of the Commencement Date if Oxxon [_], on or before the
due
date, the annual fee that is due on that [_] under
Clause
6.4(a) ("Payment Default"). Except where Oxxon's rights
have expired due to [_], Oxxon may extend its right of
selection under Clause 4.3(d)(ii) beyond the [_] for
successive periods of [_] by [_] on or before the [_] of
the Commencement Date and on [_] of the Commencement
Date
the annual fee due under Clause 6.4(b).
4.4 Arising Intellectual
Property.
4.4.1 Oxxon shall own all Arising
Intellectual Property.
4.4.2 Oxxon agrees to grant to Xenova an
exclusive, worldwide licence under
Arising Intellectual Property outside the Field on reasonable
commercial
terms, to research, develop, make, have made, import, use, sell
and
otherwise deal in any and all products and processes outside the
Field.
If
the Parties are unable to agree such terms within 90 days of
either
Party requesting the negotiation of such terms ("Exclusivity
Period")
then
Oxxon shall not be obliged to grant a licence to Xenova and shall
be
free
to discuss and conclude with third parties licensing
agreements
relating to the Arising Intellectual Property.
4.5 Formal licences. If
requested by Oxxon, and at Oxxon'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 territories. 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.
4.6 Sub-licensing. Oxxon
shall be entitled to grant sub-licences (which for
the
purposes of this Clause 4.6 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 Oxxon), provided
that:
(a)
Oxxon
enters into a written agreement with each Sub-licensee;
(b)
the
sub-licence shall impose appropriate obligations on the
Sub-licensee which are equivalent to the obligations on
Oxxon
under Clauses 3.4,4.4, 5.5 to 5.8, 6.12, 7 and 10 of
this
Agreement; and
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Confidential
(c)
[_]
(d)
within [_]
following the grant of any sub-licence Oxxon shall
notify Xenova that a sub-licence has been entered into and
provide
a true copy of the sub-licence agreement to Xenova; and
(e)
for as
long as Oxxon remains a party to the sub-licence
agreement,
Oxxon shall be [_] of the sub-licence agreement by the
sub-licensee, as if [_] had been that of Oxxon under
this
Agreement.
4.7 No other licence. It
is acknowledged and agreed that except for the
licence(s) expressly granted by the provisions of this Clause 4,
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. It is understood and agreed that under
regulatory GCP Xenova will be required to retain archive samples
of
Xenova Materials and archive originals or copies of Xenova
Know-how. For
the
avoidance of doubt, no rights are granted under this Agreement in
the
Haematology Indications.
4.8 Quality. Oxxon shall
be responsible for ensuring that all Licensed
Product(s) marketed by it or its Sub-licensees are of
satisfactory
quality and comply with all applicable laws and regulations in each
part
of
the Territory. Oxxon's liability in respect of such
responsibilities
shall be in accordance with the provisions of Clause
9.2.3.
5. KNOW-HOW AND
CONFIDENTIAL INFORMATION
5.1 Provision of Know-how.
Upon Oxxon's reasonable request, Xenova shall free
of
charge supply Oxxon with all Xenova Know-how in existence at
the
Commencement Date that Xenova is at liberty to disclose and that
has not
previously been disclosed to Oxxon and which is reasonably
necessary to
enable Oxxon to undertake the further development of the
Licensed
Product(s). In addition, Xenova shall free of charge supply to
Oxxon all
information which Xenova or its Affiliates receives from any
regulatory
body
after the Commencement Date in response to filings made before
the
Commencement Date to the extent that such information relates to
the
Xenova Intellectual Property and would assist Oxxon in the
development of
Licensed Products. The Xenova Know-how shall be subject to
the
confidentiality provisions of Clause 5.6. If Oxxon requires any
technical
support or training to enable it to develop Licensed Products then
the
parties will discuss such requirements and negotiate in good faith
to
agree the terms under which such support or training will be
provided.
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Confidential
5.2 Transfer of Materials.
Xenova shall supply to Oxxon the Xenova Materials
in
accordance with the provisions of Schedule 2 and in such manner as
the
Parties may agree with a view to ensuring the stability and safe
delivery
of the
samples of the Xenova Materials.
5.3 Status of Know-how and
Materials. Oxxon acknowledges that the Xenova
Know-how and Xenova Materials are at an early stage of
development.
Subject to Clause 9, 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
Patent
Rights provided under this Agreement are provided "as is" and
without any
express or
implied warranties, representations or undertakings.
5.4 Responsibility for
development of Licensed Product(s). Oxxon shall be
exclusively responsible for the technical and commercial
development and
manufacture of Licensed Product(s) and for incorporating
any
modifications or developments thereto that may be necessary or
desirable
and
for all Licensed Product(s) sold or supplied, and accordingly
Oxxon
shall indemnify Xenova in the terms of Clause 9.2.3.
5.5 Use of Know-how. Oxxon
undertakes that for a period of [_] from the
date
of first commercial sale of Licensed Product(s) hi the Territory
or
for
so long as any substantial part of the Know-how remains subject
to
the
obligations of confidence of Clause 5.6, whichever is the shorter,
it
will
not use the Xenova Know-how for any purpose except [_].
5.6 Confidentiality
obligations. Each Party ("Receiving Party") undertakes:
(a)
to
maintain as secret and confidential all Know-how and
other
technical or commercial information obtained directly or
indirectly from the other Party ("Disclosing Party") in the
course
of or in anticipation of this Agreement and to respect
the
Disclosing Party's rights therein;
(b)
to use the
same exclusively for the purposes of this Agreement;
and
(c)
to
disclose the same only to those of its employees,
contractors
and Sub-licensees pursuant to this Agreement (if any) to whom
and
to the extent that such disclosure is reasonably necessary for
the
purposes of this Agreement.
5.7 Exceptions to
obligations. The provisions of Clause 5.6 shall not
apply
to Know-how and
other information which the Receiving Party can
demonstrate by reasonable, written evidence;
(a)
was,
pr