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Exhibit 10.3.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE AGREEMENT
by and between
WYETH HOLDINGS CORPORATION
and
BIOVEX LIMITED
dated as of
April 1, 2005
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LICENSE AGREEMENT
THIS AGREEMENT is made as of April 1, 2005 (the "Effective Date")
by and between
Wyeth Holdings Corporation, having a place of business at Five
Giralda Farms,
Madison, New Jersey, 07940 ("Licensor"), and Biovex Limited,
(company number
3480520), having its registered office at 70 Milton Park, Abingdon,
Oxford OX14
4RX England ("Licensee").
Licensor is the owner of the Licensed Patents, as defined
below.
Licensee wishes to obtain a license under the Licensed Patents, to
develop,
have developed, make, have made, use, offer to sell, sell and have
sold, import
and have imported, Licensed Products and perform Licensed Services,
as defined
below.
Licensor is willing to grant such a license to Licensee on the
terms and
conditions of this Agreement.
Licensor and Licensee have therefore agreed as follows.
1. DEFINITIONS
The
following terms shall have the meanings indicated in this
Agreement:
1.1.
"Agreement" means this Agreement, including all Schedules
hereto.
1.2.
"Affiliate" means any Person controlled by, controlling, or
under
common control with either Licensee or Licensor. For this purpose,
"control"
means direct or indirect beneficial ownership of at least fifty
percent (50%)
interest in the voting stock (or the equivalent) of such Person or
having the
right to direct, appoint or remove a majority or more of the
members of its
board of directors (or their equivalent), or having the power to
control the
general management of such Person, by contract, law or
otherwise.
Notwithstanding the foregoing, the term "Affiliate" shall not
include Persons in
which a Party or its Affiliates owns a majority of the ordinary
voting power to
elect a majority of the board of directors or other governing body,
but is
restricted from electing such majority by contact or otherwise,
until such time
as such restrictions are no longer in effect.
1.3.
"Applicable Percentage" means [**] percent ([**]%).
1.4.
"Bankruptcy Event" means, with respect to a specified Person, (a)
the
filing by such Person in any court or agency, pursuant to any
statute or
regulation of any state or country, a petition in bankruptcy or
insolvency or
for reorganization or for the appointment of a receiver or trustee
of such
Person or of its assets, (b) the filing against such Person of an
involuntary
petition for any bankruptcy or insolvency proceeding which petition
is not
dismissed within ninety (90) days after filing, (c) the making by
such Person of
an assignment for the benefit of its creditors, (d) the taking of
possession of
any material part of the assets of such Person by a lien holder or
other
encumbrancer, or (e) the levy or enforcement of any distress,
execution or other
process upon or against any of the material assets of such
Person.
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1.5.
"Confidential Information" means, with respect to any Party
("Disclosing Party"), any information relating to the Licensed
Product(s) or
Improvements that is disclosed in writing or by email to the other
Party
("Receiving Party") during the term of this Agreement, but shall
not include
information that:
1.5.1. the Receiving Party or an Affiliate owned or controlled
prior
to
receipt from the Disclosing Party, or
1.5.2. is or becomes public through no breach of this Agreement by
the
Receiving Party or any Affiliate thereof, or
1.5.3. is hereafter developed by the Receiving Party or an
Affiliate
independent of any disclosure from the Disclosing Party as
evidenced by
competent written evidence, or
1.5.4. the Receiving Party or an Affiliate obtains from a third
Person
not
under a confidentiality obligation to the Disclosing Party.
1.6.
"Effective Date" has the meaning given to it in the Preamble.
1.7.
"Improvements" means any information, patentable or otherwise,
developed or acquired (by license or otherwise, provided in the
case of
acquisition that the terms of the acquisition do not prohibit
Licensee from
making the grant set forth in Section 2.1.5) by Licensee during the
term of this
Agreement and which relates to improvements to inventions disclosed
in the
Licensed Patents as follows:
"Improvements in Area A" means patentable and non-patentable [**]
to
regions of the HSV-1 and/or HSV-2 genome other than regions
represented by
the
[**] gene or between the [**] and [**] sites on the [**]
corresponding
to
[**] that result in improved [**] in and [**] neoplastic cells
conceived
under and/or reduced to practice by BioVex during the term of
this
Agreement;
"Improvements in Area B" means patentable and non-patentable
[**]
within regions of the
HSV-1 and/or HSV-2 genome represented by the [**]
gene
or between the [**] and [**] sites on the [**] corresponding to
[**]
that
result in improved [**] in and [**] neoplastic cells conceived
under
and/or reduced to practice by BioVex during the term of this
Agreement.
1.8.
"Licensed Patents" means United States patent application
Serial
Number 08/686631 filed July 24, 1996 and any divisional,
continuation or
continuation-in-part thereof or substitute therefor, any foreign
patent
applications corresponding to any such patent applications claiming
priority
from such patents and applications, and any U.S. or foreign patent
or the
equivalent thereof issuing therefrom and any reissue,
re-examination, renewal,
supplementary protection certificate or extension thereof.
1.9.
"Licensed Product(s)" means any product which would, or the
development, manufacture, use, sale or importation of which product
would,
absent the license granted by
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Licensor to Licensee herein, infringe any Valid Claim in any
Licensed Patent in
a country where a Licensed Patent subsists.
1.10. "Licensed Service(s)" means any commercial research,
development or
manufacturing services provided to a third Person, the provision of
which
utilizes or embodies any process, product or discovery claimed by
one or more
Valid Claims of any Licensed Patent in a country where a Licensed
Patent
subsists.
1.11. "Net Sales" shall mean the actual gross amount invoiced by
Licensee
or its Affiliate or any sublicensee (as defined in Section
2.1.1(d)) for sales
or other commercial disposition of a Licensed Product, or provision
of a
Licensed Service, to a third Person customer (including any
distributor as
defined in Section 2.1.1 (b)), less the following deductions with
respect to
such sales or services:
a) any rebates, quantity, trade and cash discounts, and other
usual and customary discounts to customers;
b) compulsory payments and rebates, actually paid or deducted;
c) retroactive price reductions, credits or allowances actually
granted upon rejections or returns of Licensed Products, including
for
recalls or damaged goods;
d) freight, postage, shipping and insurance charges actually
allowed or paid for delivery of Licensed Products, to the
extent
included in the gross sales price;
e) sales taxes, excise taxes, use taxes, import/export duties
or
other governmental charges actually due or incurred with respect
to
such sales, including without limitation value-added taxes;
f) discounts and performance discounts to the extent that such
discounts
are associated with the Licensed Products together with
other products of Licensee and its Affiliates, and to the extent
that
such discounts cannot be attributed only to the Licensed
Products.
Such discounts and performance discounts will be allocated to
the
Licensed Products on a reasonable pro rata basis (based on the
amount
of the sales of products by Licensee and its Affiliates prior
to
discount); and
g) charge-back payments and rebates granted to managed health
care organizations or to federal, state and local governments,
their
respective agencies, purchasers or reimbursers;
all as incurred in the ordinary course of business in type and
amount consistent
with good industry practice and determined in accordance with
generally accepted
accounting principles on a basis consistent with Licensee's audited
consolidated
financial statements.
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For sake of clarity and avoidance of doubt, sales by Licensee, its
Affiliates or
any sublicensee defined in Section 2.1.1 (d) of a Licensed Product
to a
distributor defined in Section 2.1.1 (b) of such Licensed Product
in a given
country shall be considered a sale to a third Person customer.
Any Licensed Products used as samples or used for clinical or other
research
purposes and for donations shall not be included in Net Sales.
1.12. "Party" means each party to this Agreement and their
respective
successors and permitted assigns.
1.13. "Person" means any natural person or legal entity.
1.14. "Phase II" means any controlled clinical study involving the
use of a
Licensed Product in human patients designed primarily to obtain
preliminary data
on the effectiveness of a specific therapy involving the use of a
Licensed
Product in human patients.
1.15. "Phase III" means any Phase IIb/III clinical study involving
a
Licensed Product designed to have adequate statistical power to
meet the
requirements for regulatory approval by regulatory authorities
either in the
United States, European Union, or Japan.
1.16. "Royalty Payments" is defined in Section 3.1.4.
1.17. "Territory" means all countries in the world.
1.18
"Valid Claim" means any claim of any issued and unexpired patent
that
has not been held permanently revoked, deemed unenforceable or
invalid by a
decision of a court or other government agency of competent
jurisdiction, which
decision is unappealable or unappealed within the time allowed for
appeal.
2. LICENSE
2.1.
Grant of License. Licensor hereby grants to Licensee for the term
of
this Agreement a non-exclusive, royalty bearing license under the
Licensed
Patents, with the limited right to grant sublicenses only as set
forth in
Section 2.1.1, to develop, have developed, make, have made, use,
offer to sell,
sell, have sold, import and have imported, Licensed Products and to
provide
Licensed Services in the Territory. In addition to the other terms
and
conditions of this Agreement, the license granted hereby is subject
to the
following:
2.1.1. Sublicensing. Notwithstanding anything herein to the
contrary,
Licensee shall have the right to grant sublicenses only to (a)
Licensee's
Affiliates, (b) any distributor of Licensed Products pursuant to a
bona
fide
arm's length distribution agreement between such distributor
and
Licensee, (c) any subcontractor that performs all or a portion of
the
manufacturing of Licensed Products pursuant to a bona fide arm's
length
manufacturing agreement between such subcontractor and Licensee, or
(d) any
third Person that enters into a bona fide license agreement with
Licensee
to
make, use, sell or promote Licensed Products; provided, however,
that
Licensee shall be responsible for the operations of any
sublicensee
relevant to this Agreement as if such operations were carried out
by
Licensee itself, including
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(without limitation) the payment of any royalties or other
payments
provided for hereunder. All sublicenses granted hereunder shall
be
consistent with and subject to the terms and conditions of this
Agreement.
Licensee shall notify Licensor of any such sublicense and provide
Licensor
with
a copy of any such sublicense agreement within ten (10) days of
the
execution thereof.
2.1.2. Restriction on other Rights. No right or license is granted
to
Licensee in or to any right or interest of Licensor that is not
specifically set forth in this Agreement.
2.1.3. Due Diligence. Licensee shall comply with all applicable
laws
and
regulations. Licensee shall be responsible for obtaining all
regulatory
approvals required for the manufacture and sale of Licensed
Products.
Licensee shall provide Licensor (i) prompt written notice of all
regulatory
approvals for Licensed Products in the Territory, and (ii) on an
annual
basis with a summary of the development status of the Licensed
Products and
Licensed Services. Licensee shall use reasonable commercial efforts
to
research, develop and bring to market Licensed Products and
Licensed
Services; provided that Licensee shall always be free to stop
development
or
put development of any Licensed Product or Licensed Service on
hold
without termination of this Agreement. In case Licensee provides
written
notice to Licensor that the development of all Licensed Products
and
Licensed Services is stopped or put on hold, all obligations of
the
Licensee hereunder shall cease or shall be suspended respectively,
until
such
time as Licensee restarts development of a Licensed Product,
except
for
the following: Section 2.1.3 first and third sentences, Sections,
3, 5,
6, 7
and 8.
2.1.4. Licensee shall inform Licensor within ten (10) business
days
upon
achievement of any milestone described in Section 3.1.3.
2.1.5. Improvements. Licensee hereby grants to Licensor (i) a
[**]
non-exclusive, [**] license [**] to the Improvements in Area A, and
(ii) a
[**]
license [**] to the Improvements in Area B. Licensee shall keep
Licensor currently and generally advised in writing of all
Improvements,
and
shall provide Licensor with a written report thereof not less than
once
each
calendar year. Upon request of Licensor, Licensee shall finish
to
Licensor one copy of all available documents relating to such
Improvements.
3. PAYMENTS
3.1.
Payments. Licensee shall make the following payments to Licensor
as
consideration for the rights granted by Licensor hereunder:
3.1.1. Licensing Fee. Upon execution of this Agreement, Licensee
shall
pay
within ten (10) days to Licensor a non-refundable licensing fee of
[**]
U.S.
Dollars (U.S. $[**]) in immediately available funds to an
account
designated in writing by Licensor.
3.1.2. Annual Maintenance Fee. Within thirty (30) days of each
annual
anniversary of the Effective Date, Licensee shall pay to Licensor
[**] U.S.
Dollars
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(U.S. $[**]) creditable against payments under Section 3.1.4 in
the
Calendar year in which such annual maintenance fee is paid.
3.1.3. Milestone Payments. Licensee shall pay to Licensor the
following non-refundable milestone payments, to be paid only once,
at the
time
when a Licensed Product reaches a milestone described below:
(i) upon initiation of the first Phase II clinical trial by or
on
behalf of Licensee (for the purposes of this Section, initiation
shall
mean the first administration of the first Licensed Product in
a
clinical trial): [**] U.S. Dollars (U.S. $[**]);
(ii) upon initiation of the first Phase II clinical trial by or
on behalf of Licensee (for the purposes of this Section,
initiation
shall mean the first administration of the second and each
subsequent
Licensed Product
in a clinical trial): [**] U.S. Dollars (U.S. $[**]);
(iii) upon initiation of a Phase III clinical trial of each
Licensed Product by or on behalf of Licensee (for the purposes of
this
Section, initiation shall mean the first administration of each
Licensed Product in such a trial): [**] U.S. Dollars (U.S. $[**]);
and
(iv) upon receiving an approval for marketing anywhere in the
Territory of each Licensed Product: [**] U.S. Dollars (U.S.
$[**]).
Each
such milestone payment shall be due and payable to Licensor
within
thirty (30) days of the date such milestone is achieved (whether
achieved
by
or on behalf of Licensee or any of its Affiliates or
sublicensees).
Licensee shall remit to Licensor each such milestone payment in
immediately
available funds to an account designated in writing by
Licensor.
3.1.4. Royalties. Licensee shall pay or cause to be paid to
Licensor a
royalty equal to the Applicable Percentage of all Net Sales of any
Licensed
Product or Licensed Service by Licensee or any of its Affiliates,
or
permitted sublicensees ("Royalty Payments") on a country-by-country
basis.
No
multiple royalties shall be payable because a Licensed Product
or
Licensed Service, its manufacture, use or sale is or shall be
covered by
more
than one Valid Claim of a patent included in the Licensed Patents
or
more
than one patent under the Licensed Patents. Royalty shall only
be
payable once in respect of each Licensed Product. Royalty Payments
shall be
made
in accordance with Sections 3.4 and 3.5.
3.2.
Records. During the Term of this Agreement and for three (3)
years
thereafter, Licensee shall (and shall cause its Affiliates and
permitted
sublicensees to) keep complete and accura