* 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
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DEVELOPMENT AND LICENCE AGREEMENT
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Xxxxxxxx & Company
00 Xxxxxxxxxxx Xxxx
Xxxxxxxxxxxx
Xxxx XX00 0XX
xxxx.xxxxxxxxxxxxxxxxxx.xxx
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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
000 Xxxxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxx XX0 0XX; and
(2) OXXON THERAPEUTICS LIMITED (company registration number 03671700)
("Oxxon") a company incorporated in England and Wales whose principal
place of business is at Xxxxxx House, 3 Xxxxxx Xxxxxxxx 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 Xx Xxxxx Xxxxxxxxxx and Xx Xxxxxxxxx Xxxxxxxxx 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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(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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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, prior to its receipt by the Receiving Party from the
Disclosing Party, in the possession of the Receiving Party and at
its free disposal; or
(b) is subsequently disclosed to the Receiving Party without any
obligations of confidence by a third party who has not derived it
directly or indirectly from the Disclosing Party; or
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(c) is or becomes generally available to the public through no act or
default of the Receiving Party or its agents, employees,
Affiliates or sub-licensees; or
(d) 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 5.7, provided that
the Receiving Party shall:
(i) inform the Disclosing Party as soon as is reasonably
practicable; and
(ii) at the Disclosing Party's request seek to persuade the
court, agency or authority to have the information treated
in a confidential manner, where this is possible under the
court, agency or authority's procedures.
5.8 Disclosure to employees. The Receiving Party shall procure that all of
its employees, contractors, consultants, advisers and Sub-licensees
pursuant to this Agreement (if any) who have access to any of the
Disclosing Party's information to which Clause 5.6 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 5.6 and 5.7 and which apply to the Disclosing Party's
information.
5.9 [_]
In all other cases Xenova shall be entitled to supply:
(c) master and working CR2 cell lines: master and working dH2A virus;
or master and working dH2T virus only to third party licensees
appointed by Xenova under the Xenova Intellectual Property Rights;
and
(d) all other Xenova Materials to any third party
in each case only under appropriate and binding obligations of
confidentiality which are no less onerous than those set out in this
Agreement, and in each case Xenova shall notify Oxxon of the name of the
third party to whom the supply has been made within 30 days of making
such supply.
6. PAYMENTS
6.1 Initial payment. Oxxon shall pay to Xenova a non-refundable,
non-creditable, initial licence fee of [_]. Subject to Clause 6.2, this
licence fee will be paid [_] shall be due even if this Agreement is
terminated for any reason prior to the due date of payment:
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(a) [_] forthwith upon signature of this Agreement and receipt by
Oxxon at an invoice for such amount suitable for VAT purposes; and
(b) [_] by the [_] of the Commencement Date; and
(c) [_] by the [_] of the Commencement Date.
6.2 [_]
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6.3 Milestone payments. Oxxon shall pay to Xenova the following
non-refundable, non-creditable milestone payments for the [_] Licensed
Products to achieve the following milestone events in either Field A or
Field B. For the avoidance of doubt, such payments are due: (a) on the
[_] Licensed Products to achieve each milestone event, whether or not
these were the same [_] Licensed Products that achieved an earlier
milestone event; and (b) irrespective of whether Oxxon sub-licenses any
rights under this Agreement. For the avoidance of doubt, no further
milestone payments are due other than those payable for the [_] Licensed
Products.
-------------------------------------------------------------------------------------------------------
MILESTONE EVENT LICENSED PRODUCT IN LICENSED PRODUCT IN
FIELD A (MILLION FIELD B (MILLION
POUNDS STERLING) POUNDS STERLING)
-------------------------------------------------------------------------------------------------------
[_] [_] [_]
-------------------------------------------------------------------------------------------------------
Filing of application for Marketing [_] [_]
Authorisation in USA
-------------------------------------------------------------------------------------------------------
Grant of Marketing Authorisation in USA [_] [_]
-------------------------------------------------------------------------------------------------------
Filing of application for Marketing [_] [_]
Authorisation in any part of European Union
-------------------------------------------------------------------------------------------------------
Grant of Marketing Authorisation in any part of [_] [_]
the European Union
-------------------------------------------------------------------------------------------------------
Filing of application for Marketing [_] [_]
Authorisation in Japan
-------------------------------------------------------------------------------------------------------
Grant of Marketing Authorisation in Japan [_] [_]
-------------------------------------------------------------------------------------------------------
TOTAL [_] [_]
-------------------------------------------------------------------------------------------------------
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6.4 Opt-in Fees. Oxxon shall pay to Xenova:
(a) [_] per annum, commencing on the [_] of the Commencement Date and
ending on the [_] of the Commencement Date, as an annual fee for
the continued grant of rights under Clause 4.3(d)(i); and
(b) [_] per annum for each year commencing on the [_] of the
Commencement Date that Oxxon elects to extend its opt-in rights
pursuant to Clause 4.3(d)(ii), as an annual fee for the continued
grant of the rights under Clause 4.3(d)(ii); and
(c) an opt-in fee of [_] for each Indication and Further Indication
that Oxxon selects in Field A under Clause 4.3(d), and payable at
the time of selection of such Indication or Further Indication;
and
(d) an opt-in fee of [_] for each Indication and Further Indication
that Oxxon selects in Field B under Clause 4.3(d) and payable at
the time of selection of such Indication or Further Indication.
6.5 Royalties on Net Sales. Oxxon shall pay to Xenova a royalty that will be
a percentage of Net Sales Value of each unit of Licensed Product sold by
Oxxon or its Affiliates, as set out in the following table, depending on
whether the Licensed Product is the first, second or subsequent product
in Field A or Field B, respectively, and subject to the minimum
percentages, after any deductions are made under other provisions of this
Agreement, set out in the third column of the following table.
Notwithstanding the foregoing and subject to Clause 10.1, in any country
where there are no Xenova Patent Rights or in any country where the
Xenova Patent Rights have expired or been revoked without a right of
further appeal, all royalties and the relevant minimums set out below
shall be reduced by 50%.
------------------------------------------------------------------------------------------------------
LICENSED PRODUCTS IN FIELD A % OF NET SALES VALUE MIN. % OF NET SALES VALUE
------------------------------------------------------------------------------------------------------
First Licensed Product [_] [_]
------------------------------------------------------------------------------------------------------
Second Licensed Product [_] [_]
------------------------------------------------------------------------------------------------------
Subsequent Licensed Products [_] [_]
------------------------------------------------------------------------------------------------------
LICENSED PRODUCTS IN FIELD B
------------------------------------------------------------------------------------------------------
First Licensed Product [_] [_]
------------------------------------------------------------------------------------------------------
Second Licensed Product [_] [_]
------------------------------------------------------------------------------------------------------
Subsequent Licensed Products [_] [_]
------------------------------------------------------------------------------------------------------
6.6 Royalties on Upfront and Royalty Receipts. Oxxon shall pay to Xenova, in
respect of each Licensed Product and each Selected Indication that Oxxon
sub-licenses the following sums provided that Oxxon shall not be required
to pay sums under this Clause 6.6 in respect of sums receivable from
Sub-licensees which are also its Affiliates if Oxxon is required to pay
under Clause 6.5 in respect of such sums:
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(a) A percentage of any Upfront Receipts which shall be:
(i) [_] if the agreement, under which the Upfront Receipts are
due, is signed before completion of all Phase II Studies in
respect of that Licensed Product in that Selected
Indication; or
(ii) [_] if the agreement, under which the Upfront Receipts are
due, is signed after completion of all Phase II Studies in
respect of that Licensed Product in that Selected
Indication;
Provided that:
(iii) where any consideration that falls within the definition of
Upfront Receipts is attributable to both Licensed
Product(s) and other products licensed by Oxxon or any of
its Affiliates to any other person, the percentages
referred to above shall be calculated on a reasonable
proportion of such consideration (the "Apportionment"); and
(iv) the Parties will negotiate in good faith to determine the
Apportionment (where applicable) and (whether or not any
Apportionment is required) to arrive at a reasonable
methodology to assess any amounts that may be due under
paragraphs (b) to (e) of the definition of Upfront
Receipts, and if the Parties cannot agree on (1) the
Apportionment, or (2) the methodology, within 60 days of
commencing such negotiations, or if the Parties at any time
during the term of this Agreement cannot agree on the
amount due under this paragraph (a) based on the
Apportionment or such methodology, either Party may refer
the matter to an expert to be appointed in accordance with
the provisions of Schedule 4.
(b) A percentage of Royalty Receipts, as set out in the second column
of the following table, the percentage depending on when the
agreement under which the Royalty Receipts are due is signed (as
set out in the first column below), and subject to the conditions
that:
(i) the royalty paid to Xenova on each Licensed Product under
this paragraph (b) shall be not less than the minimum
percentages of Net Sales Value, after any deductions are
made under other provisions of this Agreement, as set out
in the third column below; and
(ii) in the case only of the [_]% royalty on Royalty Receipts
referred to in the following table, the royalty paid to
Xenova on each Licensed Product under this paragraph (b)
shall not exceed a maximum of [_] of Net Sales Value,
except that this maximum limit shall not apply to
DISC-GMCSF which has not been genetically modified by Oxxon
or its Sub-licensees).
Provided that:
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(iii) where any Royalty Receipts are attributable to any
Combination Product (as defined in Clause 6.7.1) or other
products or rights (other than Arising Intellectual
Property) licensed by Oxxon or any of its Affiliates to any
Sublicensees the percentages referred to above shall be
calculated on a reasonable proportion of such consideration
(the "Apportionment"); and
(iv) the Parties will negotiate in good faith to determine the
Apportionment (where applicable) and (whether or not any
Apportionment is required) to arrive at a reasonable
methodology to assess any amounts that may be due under
this Clause 6.6(b), and if the Parties cannot agree on (1)
the Apportionment, or (2) the methodology, within 60 days
of commencing such negotiations, or if the Parties at any
time during the term of this Agreement cannot agree on the
amount due under this paragraph (a) based on the
Apportionment or such methodology, either Party may refer
the matter to an expert to be appointed in accordance with
the provisions of Schedule.
-----------------------------------------------------------------------------------------------------------
AGREEMENT SIGNED ON OR BEFORE THE START %OF MIN. % OF NET SALES VALUE
OF THE FOLLOWING STAGES, IN RESPECT OF ROYALTY
THE LICENSED PRODUCT AND SELECTED RECEIPTS
INDICATIONS ON WHICH ROYALTY RECEIPTS
ARE OBTAINED
-----------------------------------------------------------------------------------------------------------
Pre-Clinical Studies [_] [_] (for DISC-GMCSF which has not been
genetically modified by Oxxon or its
Sub-licensees) [_] (for all other Licensed
Products)
-----------------------------------------------------------------------------------------------------------
Phase I Studies [_] [_] (for DISC-GMCSF which has not been
genetically modified by Oxxon or its
Sub-licensees) [_] (for all other Licensed
Products in Field A) [_] (for all other
Licensed Products in Field B)
-----------------------------------------------------------------------------------------------------------
Phase II Studies or later [_] [_] (for DISC-GMCSF which has not been
genetically modified by Oxxon or its
Sub-licensees) [_] (for all other Licensed
Products in Field A) [_] (for all other
Licensed Products in Field B)
-----------------------------------------------------------------------------------------------------------
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6.7 Combination Products
6.7.1 If any Licensed Product is incorporated in or with any other product as a
single formulated product or is sold as part of a package or kit
("Combination Product") supplied by Oxxon or its Sub-licensee and the
Licensed Product is not priced independently from the Combination
Product, the Net Sales Value of such Licensed Product shall be deemed to
be [_].
6.7.1 The Parties acknowledge and agree that (a) where a Licensed Product is
supplied or used as a prime or boost as part of a Heterologous PrimeBoost
regime, Net Sales Value and Royalty Receipts shall be calculated by
reference to [_]; and (b) that this method of calculation is convenient
to both Parties and is the basis for the agreed royalty rates for
Licensed Product in Field A set out in this Agreement.
6.8 Payment dates. Royalties due under this Agreement shall be paid within 60
days of the end of each quarter ending on 31 March, 30 June, 30 September
and 31 December, in respect of sales of Licensed Product(s) made and
Upfront Receipts and Royalty Receipts received during such quarter and
within 60 days of the termination of this Agreement.
6.9 Payment terms. All sums due under this Agreement:
(a) are exclusive of Value Added Tax which where applicable will be
paid by Oxxon to Xenova in addition;
(b) shall be paid in pounds sterling and, in the case of sales or
sub-licence income received by Oxxon in a currency other than
pounds sterling, the income shall be calculated in the other
currency and then converted into equivalent pounds sterling at the
buying rate of such other currency as quoted by Barclays Bank plc
in London as at the close of business on the last business day of
the quarterly period with respect to which the payment is made;
(c) shall be made without deduction of income tax or other taxes,
charges or duties that may be imposed, except insofar as Oxxon is
required to deduct the same to comply with applicable laws. The
Parties shall cooperate and take all steps reasonably and lawfully
available to them to avoid deducting such taxes and to obtain
double taxation relief. If Oxxon is required to make any such
deduction it shall provide Xenova with such certificates or other
documents as it can reasonably obtain to enable Xenova to obtain
appropriate relief from double taxation of the payment in
question; and
(d) shall be made by the due date, failing which Xenova may charge
interest on any outstanding amount on a daily basis at a rate
equivalent to [_] above the Barclays Bank plc base lending rate
then in force.
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6.10 Exchange controls, etc. If at any time during the continuation of this
Agreement Oxxon is prohibited from making any of the payments required
hereunder by a governmental authority in any country then Oxxon will
within the prescribed period for making the said payments in the
appropriate manner use its best endeavours to secure from the proper
authority in the relevant country permission to make the said payments
and will make them within 7 days of receiving such permission. If such
permission is not received within 30 (thirty) days of Oxxon making a
request for such permission then, at the option of Xenova, Oxxon shall
deposit the royalty payments due in the currency of the relevant country
either in a bank account designated by Xenova within such country or such
royalty payments shall be made to an associated company of Xenova
designated by Xenova and having offices in the relevant country
designated by Xenova.
6.11 Royalty statements. Oxxon shall send to Xenova at the same time as each
royalty payment is made in accordance with Clause 6.8 a statement setting
out, (i) in respect of each territory or region in which Licensed
Product(s) are sold, the types of Licensed Product(s) sold, the quantity
of each type sold, and the total Net Sales Value in respect of each type,
expressed both in local currency and pounds sterling and showing the
conversion rates used, (ii) Royalty Receipts; and (iii) Upfront Receipts
during the period to which the royalty payment relates.
6.12 Records
6.12.1 Oxxon shall keep at its normal place of business detailed and up to date
records and accounts showing the quantity, description and value of
Licensed Product(s) sold by it, and the amount of sublicensing revenues
received by it in respect of Licensed Product(s), on a country by country
basis, and being sufficient to ascertain the payments due under this
Agreement.
6.12.2 Oxxon shall no more than once in any 12 month period make such records
and accounts available, on reasonable notice, for inspection during
business hours by an independent chartered accountant nominated by Xenova
for the purpose of verifying the accuracy of any statement or report
given by Oxxon to Xenova under Clause 6.11. The accountant shall be
required to keep confidential all information learnt during any such
inspection, and to disclose to Xenova only such details as may be
necessary to report on the accuracy of Oxxon's statement or report.
Xenova shall be responsible for the accountant's charges unless the
accountant certifies that there is an inaccuracy of more than 5% (five
percent) in any royalty statement, in which case Oxxon shall pay his
charges in respect of that inspection.
7 DILIGENCE
7.1 Oxxon shall use Reasonable and Diligent Efforts to develop and
commercially exploit Licensed Product(s) in the Territory.
7.2 [_]
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7.3 Without prejudice to the generality of Oxxon's obligations under Clause
7.1, Xenova may terminate this Agreement from time to time with respect
to a Selected Indication (but not with respect to other Indications):
(a) If Oxxon is in breach of its obligations under Clause 7.1 with
respect to such Selected Indication; or
(b) In any event, and without prejudice to the generality of Oxxon's
obligations under this Clause 7, if Oxxon substantially abandons
its development work with respect to such Selected Indication for
a period of two years.
7.4 If Xenova considers at any time during the period of this Agreement that
Oxxon has without legitimate reason failed to use Reasonable and Diligent
Efforts to develop and commercially exploit Licensed Product(s) in
accordance with this Clause 7, Xenova shall, prior to exercising any
right of termination under Clause 7, refer to an independent expert (or
experts) the following questions:
(a) whether Oxxon has used Reasonable and Diligent Efforts; and if not
(b) whether the proposals submitted by Oxxon to such expert are
adequate to meet Oxxon's requirement to use Reasonable and
Diligent Efforts, and if not
(c) what actions the expert proposes Oxxon should take in order to
meet the requirement to use Reasonable and Diligent Efforts.
7.5 The independent expert (or experts) shall be appointed in accordance with
the provisions of Schedule 4.
7.6 If the expert(s) determines that Oxxon has failed to comply with its
obligations under this Clause 7, and if Oxxon fails to take the actions
proposed by Oxxon pursuant to Clause 7.4(b) or suggested by the expert(s)
pursuant to Clause 7.4(c) (as appropriate) within 6 months of the
expert(s) giving his/their decision in accordance with Schedule 4, Xenova
shall be entitled, by giving, at any time within 3 months after the end
of that 6 month period, not less than 3 months' notice to terminate this
Agreement as a whole or in relation to a Selected Indication (as
appropriate).
7.7 The provisions of Clauses 7.2 to 7.6, and the exercise of the rights
under those clauses, shall be without prejudice to any rights that Xenova
may have to claim damages in the event that Oxxon is in breach of any of
its obligations under Clause 7.1. In the event of a damages claim, any
finding of the expert under Clause 7.4(a) shall not be binding on the
Parties.
8. INTELLECTUAL PROPERTY
8.1 Obtain and maintain the Xenova Patent Rights. Xenova shall:
(a) Diligently seek to obtain valid patents in the name of Xenova
pursuant to each of the patent applications listed in Schedule 1.
Xenova shall keep Oxxon informed of the progress of such patent
applications and shall take account of Oxxon's reasonable views in
relation to all major decisions affecting patent prosecution (but
shall not be
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required to delay such decisions in order to do so) and provided
that if the Parties cannot agree Xenova shall have the final say
on all matters relating to such patent prosecution; and
(b) pay all renewal fees in respect of the Xenova Patent Rights as and
when due.
Oxxon shall reimburse [_] of Xenova's costs and expenses in relation to
such activities save that if Xenova grants any licenses to third parties
under the Xenova Patent Rights it shall notify Oxxon and the patent costs
reimbursed by Oxxon shall be reduced proportionately by the number of
additional licensees. For example, if Xenova appoints one additional
licensee then Oxxon's obligation to reimburse patent costs would be
reduced to [_], if two additional licensees were appointed then
Oxxon's obligation to reimburse patent costs would be reduced to [_]. For
the avoidance of doubt Oxxon shall not be required to reimburse to Xenova
(i) any patent costs and expenses to the extent that such costs or
expenses relate solely to prosecution or other activities affecting the
Xenova Patent Rights outside the Field; and/or (ii) any of Xenova's costs
in respect of Revocation Proceedings or proceedings of a similar nature
that Xenova initiates.
(c) if Oxxon wishes to cease reimbursing its share of the costs of any
application in respect of the Xenova Patent Rights or of the
maintenance of any such Patent it shall give 3 months' prior
written notice to Xenova and on the expiry of such notice period
Oxxon shall cease to be licensed under the patent application or
patent identified in the notice. If the patent application or
patent identified in the notice is the sole remaining Xenova
Patent Right in the country or territory of that patent then Oxxon
shall cease to be licensed under any other Xenova Intellectual
Property in the country or territory of such patent application or
patent, in which case this Agreement shall terminate in respect of
such country or territory and Oxxon shall have no further
obligations under this Agreement in respect of such country or
territory.
8.2 Obtain and maintain the Arising Patents. Oxxon shall notify Xenova of any
inventions made by Oxxon or its Affiliates that relate to any of the
Xenova Intellectual Property or any Licensed Product ("Arising
Inventions") and the provisions of Clause 4.4.2 in respect of licensing
such Arising Patents to Xenova shall apply. For the avoidance of doubt
Oxxon shall be solely responsible for the costs of any patent
applications and patents that it elects to file in respect of Arising
Inventions.
8.3 Infringement of the Patents
8.3.1 Each Party shall inform the other Party promptly if it becomes aware of
any infringement or potential infringement of any of the Patents in the
Field, and the Parties shall consult with each other to decide the best
way to respond to such infringement.
8.3.2 If the Parties fail to agree on a joint programme of action, including
how the costs of any such action are to be borne and how any damages or
other sums received from such action are to be distributed, then Oxxon
shall have the first right, but not the obligation to take action in
respect of any infringements of the Patents in the Field, including
conducting infringement actions in its own name at Oxxon's sole expense
and Oxxon shall be entitled to all damages or other sums received from
such action, after reimbursing Xenova for any reasonable expenses
incurred in assisting it in such action, and subject to paying Xenova
royalties based on the amount of such damages or sums as if it were the
amount of Net
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Sales Value of Licensed Product(s), in accordance with Clause 6.5. If the
alleged infringement is both within and outside the Field, the Parties
shall also co-operate with Xenova's other licensee's (if any) in relation
to any such action and shall divide the costs of such action
proportionately among Oxxon and Xenova's other licensee's who participate
in such action. To the extent that patent law requires Oxxon to bring any
such action in Xenova's name or the name of a Xenova Affiliate, Oxxon may
do so subject to the conditions that it shall:
(a) before commencing any such action in Xenova's name or the name of
a Xenova Affiliate (as appropriate), provide Xenova with an
effective indemnity against any costs that may be incurred by
Xenova or awarded against Xenova as a result of being a party to
any such action;
(b) not act, nor hold itself out as acting, as an agent or with the
authority of Xenova in respect of such action; and
(c) not make any statement in relation to such action or any
settlement thereof that may reasonably be considered to be
damaging to Xenova's reputation, except with Xenova's prior
written agreement such consent not to be unreasonably withheld or
delayed.
8.4 Infringement of third party rights
8.4.1 If any warning letter or other notice of infringement is received by a
Party, or legal suit or other action is brought against a Party, alleging
infringement of third party rights in the manufacture, use or sale of any
Licensed Product or use of any Patents, that Party shall promptly provide
full details to the other Party.
8.4.2 Oxxon shall have the right but not the obligation to defend such suit in
the Field and shall have the right to settle with such third party,
provided that if any action or proposed settlement involves the making of
any statement, express or implied, concerning the validity of any Patent,
the consent of Xenova must be obtained before taking such action or
making such settlement, such consent not to be unreasonably withheld or
delayed.
8.5 Revocation Proceedings
8.5.1 Xenova shall promptly notify Oxxon of the commencement of any Revocation
Proceedings.
8.5.2 Xenova shall have the right but not the obligation to defend the
Revocation Proceedings.
8.5.3 If Xenova does not wish to defend or continue to defend Revocation
Proceedings then Xenova shall promptly notify Oxxon and Oxxon may at
Oxxon's own cost and expense defend or continue to defend the Revocation
Proceedings referred to in Xenova's notice.
8.5.4 Each party shall provide the other party with such assistance as the
other party shall reasonably request in connection with any Revocation
Proceedings. The party requesting such assistance shall pay the other
party's reasonable out-of-pocket expenses properly incurred in providing
the requested assistance.
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8.6 Third party intellectual property.
8.6.1 For the avoidance of doubt Oxxon shall be solely responsible for
obtaining and paying for any additional licences and other rights that
may be required to enable Oxxon, its Affiliates or Sub-licensees to
commercialise Licensed Product(s) in the Territory. Except as provided
for in Clause 8.6.2, no deductions may be made in respect of any such
payments when determining the amount of any payment due to Xenova under
this Agreement.
8.6.2 If, during the continuation of this Agreement, Oxxon or any Affiliate or
any Sub-licensee considers it necessary to obtain a licence from any
independent third party ("Third Party Licence") in order to avoid
infringing such third party's patent(s) in the course of manufacture or
sale of any Licensed Product, royalty amounts to be paid pursuant to
Clause 6.5 or 6.6 shall be reduced by an amount equal to [_] of the total
amount actually paid under the Third Party Licence provided that
royalties payable by Oxxon to Xenova on any unit of Licensed Product,
after applying the deduction referred to in this Clause 8.6.2 and any
other deductions provided for under this Agreement shall not be reduced
below the minimum royalty rates set out in the third column of the table
in Clause 6.5 or the third column of the table in Clause 6.6, as
applicable, assuming that no such deductions had been made when
calculating such minimum royalties.
9. WARRANTIES AND LIABILITY
9.1 Warranties by Xenova, Xenova warrants and undertakes to Oxxon that as at
the Commencement Date, and except as referred to in Schedule 5:
(a) it is the beneficial owner of the Xenova Patent Rights and the
Xenova Materials and that there are no liens, encumbrances,
options or other charges over any of them (and for the avoidance
of doubt references in this paragraph (a) to liens and
encumbrances do not refer to intellectual property other than the
Xenova Intellectual Property);
(b) Xenova Research Limited is the legal owner of the Xenova Patent
Rights;
(c) it and its Affiliates have not done, and Xenova will not do nor
agree to do and will procure that its Affiliates do not nor agree
to do during the continuation of this Agreement, any of the
following things if to do so would adversely affect Oxxon's
ability to exercise the rights granted to it under this Agreement,
namely:
(i) grant or agree to grant any rights in the Xenova
Intellectual Property in the Field; or
(ii) assign, mortgage, charge or otherwise transfer any of the
Xenova Patent Rights in the Field; and
(d) so far as the Xenova Representatives are aware, but without having
conducted any searches or investigations other than those
disclosed to Oxxon, no third party owns or claims any rights in
the Xenova Patent Rights; and
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(e) so far as the Xenova Representatives are aware, but without having
conducted any searches or investigations other than those
disclosed to Oxxon, there are no allegations or proceedings,
pending or threatened which challenge Xenova's or Xenova's
Affiliates' exclusive ownership, the validity or the
enforceability of the Xenova Patent Rights that could adversely
affect the rights granted to Oxxon under this Agreement; and
(f) Schedule 1 is a complete and accurate list of all the patents
owned or licensed to Xenova or any Affiliate of Xenova that may be
required for the full exercise of Oxxon's rights under this
Agreement. If Schedule 1 is found during the term of this
Agreement to be incomplete, with the effect that Oxxon requires a
licence of any further patents that at the Commencement Date are
owned by or licensed to Xenova or any Affiliate of Xenova in order
to exercise Oxxon's rights under this Agreement then Xenova shall
or shall procure the grant of such licence to Oxxon and the grant
of such licence shall be Oxxon's sole and exclusive remedy for any
breach by Xenova of the provisions of this Clause 9.1 (f); and
(g) Xenova has provided or made available to Oxxon all significant
test data generated by Xenova or any Affiliate of Xenova relating
to the Xenova Materials.
(h) Xenova has the right to grant to Oxxon a licence under the Xenova
Intellectual Property in accordance with the provisions of this
Agreement and to meet its obligations under this Agreement in
respect of such Xenova Intellectual Property. In the event that
Xenova is unable to comply with its obligations under this
Agreement in respect of any of the Xenova Intellectual Property as
it is not the legal owner, it shall procure that such of its
Affiliates as is the legal owner of such Xenova Intellectual
Property complies with Xenova's obligations on Xenova's behalf.
(i) Schedule 5 Part 1 sets out a complete and accurate list of all
third parties to whom Xenova has licensed Xenova Intellectual
Property.
(j) Schedule 5 Part 2 sets out a complete and accurate list of all
third parties to whom Xenova has supplied master and working CR2
cell lines: master and working dH2A virus; or master and working
dH2T virus. Such supply has been made under appropriate and
binding obligations of confidentiality.
(k) Schedule 5 Part 3 sets out, so far as the Xenova Representatives
are aware, a complete and accurate list of all third parties to
whom Xenova has supplied any Xenova Materials other than those
referred to in Clause 9.1 (j). Such supply of the Xenova Material
has been made solely for non-commercial use under appropriate and
binding obligations of confidentiality.
(1) As far as Xx Xxxxx Xxxxxxxxxx and Xx Xxxxxxxxx Xxxxxxxxx are aware
Xenova has disclosed to Oxxon all material searches relating to
the Xenova Intellectual Property that have been carried out by or
on behalf of Xenova and they are not aware of any past disputes,
litigation, interference or opposition proceedings relating to the
Xenova Intellectual Property other than those disclosed to Oxxon.
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9.2 No other warranties
9.2.1 Each of Oxxon and Xenova acknowledges that, in entering into this
Agreement, it does not do so in reliance on any representation, warranty
or other provision except as expressly provided in this Agreement, and
any conditions, warranties or other terms implied by statute or common
law are excluded from this Agreement to the fullest extent permitted by
law.
9.2.2 Without limiting the scope of Clause 9.2.1 and subject to Clause 9.1,
Xenova does not give any warranty, representation or undertaking:
(a) as to the technical viability of any products made or processes
carried out using any of the Xenova Intellectual Property; or
(b) that any of the Xenova Patent Rights is or will be valid or
subsisting or (in the case of an application) will proceed to
grant; or
(c) as imposing any obligation on Xenova to bring or prosecute actions
or proceedings against third parties for infringement or to defend
any action or Revocation Proceedings.
9.2.3 Indemnity. Oxxon shall indemnify and hold harmless Xenova and its
Affiliates and their respective officers, employees, consultants, agents
and representatives (the "Indemnitees") against all third party claims
which may be asserted against or suffered by any of the Indemnitees
arising out of any possession or use by a third party of any Licensed
Produces) manufactured and/or supplied by Oxxon or its Sub-licensees.
9.2.4 The indemnity given by Oxxon pursuant to Clause 9.2.3 shall be subject to
the following conditions:
(a) Xenova shall notify Oxxon of any claim or action covered by the
indemnity (a "Claim") within 14 days of becoming aware of the
Claim;
(b) the Claim does not arise as a consequence of any breach of any of
Xenova's warranties as set out in Clause 9.1 of this Agreement
and/or from any negligence or wilful misconduct by Xenova;
(c) Oxxon is given sole conduct of the defence and settlement of any
Claim;
(d) Xenova does not at any time prejudice the defence of the Claim;
and
(e) Xenova provides Oxxon (at Oxxon's cost) with such assistance,
documents, authority and information as Oxxon may reasonably
require in relation to the Claim and the defence or settlement of
the Claim.
9.3 Liability. Subject to Clause 11.12, but notwithstanding any other
provision of this Agreement, no Party shall be liable to any other Party
to this Agreement in contract, tort, negligence, breach of statutory duty
or otherwise for any loss, damage, costs or expenses of any nature
whatsoever incurred or suffered by that other party or its Affiliates of
an indirect or consequential nature including without limitation any
economic loss or other loss of turnover, profits, business or goodwill.
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10. DURATION AND TERMINATION
10.1 Commencement and Termination by Expiry. This Agreement, and the licences
granted hereunder, shall come into effect on the Commencement Date and,
unless terminated earlier in accordance with this Clause 10, shall
continue in force on a country by country basis until the later of:
(a) the date on which all the Xenova Patent Rights in such country (or
countries) have expired or been revoked without a right of further
appeal; and
(b) the later of:
(i) the [_] anniversary of the first commercial sale of
Licensed Product(s); and
(ii) the [_] anniversary of the date of such expiry or
revocation;
provided that this Agreement shall [_] is marketed in such country;
and on such date this Agreement and the licences granted hereunder shall
terminate automatically by expiry. On expiry of this Agreement in any
country pursuant to Clause 10.1 Xenova [_].
10.2 Early termination
10.2.1 Oxxon may terminate this Agreement at any time on [_] notice in
writing to Xenova.
10.2.2 Without prejudice to any other right or remedy, either Party may
terminate this Agreement at any time by notice in writing to the other
Party ("Other Party"), such notice to take effect as specified in the
notice:
(a) if the Other Party is in material breach of this Agreement and, in
the case of a breach capable of remedy within [_], the breach
is not remedied within [_] of the Other Party receiving notice
specifying the breach and requiring its remedy; or
(b) if an order is made or a resolution passed for the winding up of
the other party (other than for the purpose of a solvent scheme of
reconstruction or amalgamation);
(c) a liquidator, administrative receiver, receiver or trustee is
appointed in respect of a material part of the other party's
assets or business;
(d) as a consequence of financial difficulties the other party makes
any voluntary arrangement with its creditors;
(e) the other party ceases to continue its business;
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(f) as a consequence of debt and/or maladministration, the other party
takes or suffers any similar or analogous action to those listed
in Clauses 10.2.2(b) to 10.2.2(e).
10.2.3 Xenova may forthwith terminate this Agreement by giving written notice to
Oxxon if Oxxon or its Affiliate or sub-licensee commences legal
proceedings, or assists any third party to commence legal proceedings, to
challenge the validity of any of the Patents.
10.3 Consequences of termination
10.3.1 Upon termination or expiry of this Agreement for any reason:
(a) if termination occurs after the first commercial sale of Licensed
Product(s), Oxxon and its Sub-licensees shall be entitled to sell,
use or otherwise dispose of (subject to payment of royalties under
Clauses 6.5 and 6.6) any unsold or unused stocks of the Licensed
Product for a period of 6 months following the date of
termination; and if termination occurs prior to the first
commercial sale of Licensed Product, Oxxon shall forthwith return
all such stocks of Licensed Product, Xenova Materials and Xenova
Know-how to Xenova free of charge. For the avoidance of doubt, in
the event of expiry of this Agreement nothing in this Agreement
shall restrict Oxxon's ability to supply Licensed Products;
(b) subject to paragraph (a) above and Clause 10.1, Oxxon shall no
longer be licensed to use or otherwise exploit in any way, either
directly or indirectly, any of the Xenova Intellectual Property;
(c) subject to paragraph (a) above, Oxxon shall consent to the
cancellation of any formal licence granted to it, or of any
registration of it in any register, in relation to any of the
Xenova Patent Rights;
(d) the provisions of Clauses 5.6 to 5.8 (except that neither Party
shall have any continuing right to use any of the other Party's
confidential information save as provided in Clause 10.1), 6 (in
respect of payments arising prior to termination or under Clause
6.1 or 6.2 or under paragraph (a) above), 9,10.1 (to the extent
such clause refers to a post termination licence) 10.3 and 11
shall continue in force; and
(e) subject as provided in this Clause 10.3.1 and 10.3.2 and 10.3.3,
and except in respect of any accrued rights, neither Party shall
be under any further obligation to the other,
10.3.2 Upon termination of this Agreement for any reason otherwise than in
accordance with Clause 10.1 and at Xenova's request, Xenova shall have
the exclusive right for a period of 90 days from the date of termination
to negotiate in good faith the terms of an agreement between the parties
on reasonable commercial terms under which Oxxon would:
(a) transfer to Xenova all clinical and other data relating to the
development of Licensed Product(s);
(b) to the extent possible, seek to have any product licences, pricing
approvals and other permits and applications transferred into the
name of Xenova or its nominee;
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(c) grant Xenova an exclusive, worldwide licence, with the right to
grant sub- licences, under all Arising Intellectual Property and
any improvements and other intellectual property owned or
controlled by Oxxon relating to the Licensed Product(s); and
(d) grant Xenova or its nominee the right to continue to use any
product name that had been applied to the Licensed Product(s)
prior to termination of this Agreement.
10.3.3 If the Parties are unable to agree the terms of an agreement as described
in Clause 10.3.2 within 90 days of the date of termination then either
party may refer the terms for settlement by an independent expert who
shall be appointed in accordance with the provisions of Schedule 4. The
Parties shall promptly execute an agreement on the terms agreed between
them or settled by the expert.
11. GENERAL
11.1 Force majeure. Neither Party shall have any liability or be deemed to be
in breach of this Agreement for any delays or failures in performance of
this Agreement which result from circumstances beyond the reasonable
control of that Party, including without limitation labour disputes
involving that Party. The Party affected by such circumstances shall
promptly notify the other Party in writing when such circumstances cause
a delay or failure in performance and when they cease to do so.
11.2 Amendment. This Agreement may only be amended in writing signed by duly
authorised representatives of Xenova and Oxxon.
11.3 Assignment and third party rights.
11.3.1 Subject to Clause 11.3.2, neither Party shall assign, mortgage, charge or
otherwise transfer any rights or obligations under this Agreement, nor
any of the Patents or rights under the Patents, without the prior written
consent of the other Party.
11.3.2 Either Party may assign all its rights and obligations under this
Agreement together with its rights in the Patents to any Affiliate of
that Party (provided that such rights and obligations shall be assigned
back to the original Party in the event that the assignee ceases to be an
Affiliate of that Party) or to any company to which it transfers all or
substantially all of its assets or business in the Field, provided that
the assignee undertakes to the other Party to be bound by and perform the
obligations of the assignor under this Agreement.
11.4 Waiver. No failure or delay on the part of either Party to exercise any
right or remedy under this Agreement shall be construed or operate as a
waiver thereof, nor shall any single or partial exercise of any right or
remedy preclude the further exercise of such right or remedy.
11.5 Invalid Clauses. If any provision or part of this Agreement is held to be
invalid, amendments to this Agreement may be made by the addition or
deletion of wording as appropriate to remove the invalid part or
provision but otherwise retain the provision and the other provisions of
this Agreement to the maximum extent permissible under applicable law.
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11.6 No Agency. Neither Party shall act or describe itself as the agent of the
other, nor shall it make or represent that it has authority to make any
commitments on the other's behalf.
11.7 Interpretation. In this Agreement:
(a) the headings are used for convenience only and shall not affect
its interpretation;
(b) references to persons shall include incorporated and
unincorporated persons; references to the singular include the
plural and vice versa; and references to the masculine include the
feminine;
(c) references to Clauses and Schedules mean Clauses of, and Schedules
to this Agreement;
(d) references to Xenova or Oxxon shall include their permitted
successors and permitted assignees;
(e) where the word "including" is used, it shall be understood as
meaning "including without limitation"; and
(f) references to the grant of "exclusive" rights shall mean that the
person granting the rights shall neither grant the same rights (in
the same Field and Territory) to any other person, nor exercise
those rights directly to the extent that and for as long as the
Licensed Product(s) are within Valid Claims of unexpired Patents
or, to the extent that the Licensed Product(s) are protected by
Know-how that has not become known to the public, for a period of
10 years from the first commercial sale of Licensed Product(s) in
any part of the Territory.
11.8 Notices
11.8.1 Any notice to be given under this Agreement shall be in writing and shall
be sent by first class mail or air mail, or by fax (confirmed by first
class mail or air mail) to the address of the relevant Party set out at
the head of this Agreement, or to the relevant fax number set out below,
or such other address or fax number as that Party may from time to time
notify to the other Party in accordance with this Clause 11.8. The fax
numbers of the Parties are as follows:
Xenova-01753 706607
Oxxon-01865 398101.
11.8.2 Notices sent as above shall be deemed to have been received three working
days after the day of posting (in the case of inland first class mail),
or seven working days after the date of posting (in the case of air
mail), or on the next working day after transmission (in the case of fax
messages, but only if a transmission report is generated by the sender's
fax machine recording a message from the recipient's fax machine,
confirming that the fax was sent to the number indicated above and
confirming that all pages were successfully transmitted).
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11.9 Law and Jurisdiction. The validity, construction and performance of this
Agreement shall be governed by English law and shall be subject to the
exclusive jurisdiction of the English courts to which the parties hereby
submit, except that a Party may seek an interim injunction in any court
of competent jurisdiction.
11.10 Further action. Each Party agrees to execute, acknowledge and deliver
such further instruments, and do all further similar acts, as may be
necessary or appropriate to carry out the purposes and intent of this
Agreement.
11.11 Announcements. Neither Party shall make any press or other public
announcement concerning any aspect of this Agreement, or make any use of
the name of the other Party in connection with or in consequence of this
Agreement, without the prior written consent of the other Party, except
as may be required by law or by the rules of any stock exchange on which
either Party is listed. The Parties shall agree a form of press release
for issue on signature of this Agreement.
11.12 Entire agreement. This Agreement, including its Schedules, sets out the
entire agreement between the Parties relating to its subject matter and
supersedes all prior oral or written agreements (including without
limitation a material transfer agreement dated 14 November 2003),
arrangements or understandings between them relating to such subject
matter. The Parties acknowledge that they are not relying on any
representation, agreement, term or condition that is not set out in this
Agreement. Nothing in this Agreement shall operate to exclude or limit
any liability, right or remedy to a greater extent than is permitted
under English law including in relation to (1) death or personal injury
caused by the negligence of a party or (2) fraudulent misrepresentation
or deceit.
11.13 Third party rights. Each of the persons identified in Clause 9.2.3 may in
his own right enforce the provisions of that Clause. Except as provided
in the previous sentence of this Clause 11.13, this Agreement is not made
for the benefit of, nor shall any of its provisions be enforceable by,
any person other than the parties to this Agreement and their respective
successors and permitted assignees
AGREED by the Parties through their authorised signatories:
For and on behalf of For and on behalf of
Xenova LIMITED OXXON THERAPEUTICS LIMITED
/s/XXXXX OXLADE /s/XXXXXXX XXXXXXXXX
_______________________________ _______________________________
signed signed
XXXXX OXLADE XXXXXXX XXXXXXXXX
_______________________________ _______________________________
print name print name
CEO PRESIDENT + CEO
_______________________________ _______________________________
title title
12.01.2005 02.02.2005
_______________________________ _______________________________
date date
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