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Exhibit 10.3.4
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE AGREEMENT
This License Agreement ("Agreement") is made effective this 11th
day of March,
2002 ("Effective Date"), by and between the University of Iowa
Research
Foundation, an Iowa corporation having its principal place of
business at 214
Technology Innovation Center, Iowa City, IA 52242 ("UIRF"), and
BioVex Ltd, a
company incorporated under the laws of England and Wales having a
principal
place of business at 70 Milton Park, Abingdon, Oxford, OX14 4RX,
United Kingdom
("Licensee").
WITNESSETH
WHEREAS, under the patent policy of The University of Iowa (UI),
all inventions
arising during the normal course of research and teaching at the UI
are assigned
to the UIRF to obtain patent or other appropriate intellectual
property
protection and license said technology;
WHEREAS, UIRF is owner by assignment from Prof. Mark F. Stinski of
his invention
and of U.S. Patent Nos. 5,168,062 and 5,385,839, issued December 1,
1992, and
January 31, 1995 respectively, titled TRANSFER VECTORS AND
MICROORGANISMS
CONTAINING HUMAN CYTOMEGALOVIRUS (HCMV) IMMEDIATE-EARLY
PROMOTER-REGULATORY DNA
SEQUENCE (no foreign filings have been undertaken by the UIRF);
WHEREAS, the development of this invention was sponsored by the
National
Institute of Allergy and Infectious Diseases and as a consequence
this license
is subject to overriding obligations to the Federal Government
under 35 U.S.C.
Section 200-212 and applicable regulations;
WHEREAS, Licensee desires a non-exclusive license to the above
United States
patents for their use in gene therapy applications;
WHEREAS, UIRF wishes to grant such a license in accordance with the
terms of
this Agreement.
NOW THEREFORE, the parties agree as follows:
ARTICLE I -- DEFINITIONS
1.1 Licensed Patents shall mean U.S. Patent Nos. 5,168,062 and
5,385,839 titled
TRANSFER VECTORS AND MICROORGANISMS CONTAINING HUMAN
CYTOMEGALOVIRUS (HCMV)
IMMEDIATE-EARLY PROMOTER-REGULATORY DNA SEQUENCE, by Prof. Mark F.
Stinski,
issued December 1, 1992 and January 31, 1995 respectively, or any
U.S. patents
issuing thereon, including any continuations,
continuations-in-part, divisions,
reissues, reexaminations and extensions thereof and patents
corresponding
thereto.
1.2 Licensed Products shall mean and include any and all biological
materials
and products the making, using, selling or importing of which
would, but for
this Agreement, constitute an infringement of one or more Valid
Claims of the
Licensed Patents.
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1.3 Valid Claim shall mean any claim in an unexpired patent
included within
Licensed Patents which claim has not been disclaimed or held
invalid or
unenforceable by an unappealed or unappealable decision of a
court.
1.4 Licensed Field shall mean the use and/or sale of the Licensed
Products FOR
GENE THERAPY APPLICATIONS (INCLUDING GENETIC IMMUNIZATION OR
DNA-BASED
VACCINES).
1.5 Licensed Territory shall mean any country in which the making,
using,
selling or importing of Licensed Products would, but for the
license granted in
this Agreement, infringe one or more Valid Claims of the Licensed
Patents.
1.6 Net Sales shall mean the gross amount received by Licensee
and/or its
Affiliates and/or its Partners from the sales of Licensed Products
within the
Licensed Field in the Licensed Territory to third party customers
less:
a) normal and customary rebates, cash and trade discounts actually
allowed;
b) credits allowed for returned or damaged goods;
c) insurance and transportation costs; and
d) sales, excise, value added, import and export taxes, and any
tariffs and
duties imposed on the transaction, if separately invoiced.
On sales between Licensee and/or its Affiliates and/or its Partners
for resale,
the royalty shall be paid on the resale.
1.7 Yearly Accounting Period shall mean an annual period beginning
on January 1
and ending on December 31 of the same year.
1.8 Earned Royalties shall mean royalties paid or payable by
Licensee to UIRF as
determined with respect to Net Sales.
1.9 Affiliate means any corporation or other business entity in
which Licensee
owns or controls, directly or indirectly, at least fifty percent
(50%) of the
outstanding stock or other voting rights entitled to elect
directors, or in
which Licensee is owned or controlled directly or indirectly by at
least fifty
percent (50%) of the outstanding stock or other voting rights
entitled to elect
directors.
1.10 For purposes of this Agreement, Partner shall mean any third
party company
or legal entity which is not controlled by or under common control
with
Licensee, with which Licensee has a joint venture or collaboration
or
marketing/distribution or such other formal arrangement providing
the third
party company the right to co-manufacture, co-develop, co-promote
or co-market
Licensed Products in the Licensed Field in conjunction with
Licensee.
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ARTICLE II -- THE GRANT
2.1 UIRF hereby grants to Licensee and its Affiliates, subject to
the terms and
conditions hereof, a non-exclusive license under Licensed Patents
to make, have
made, use, import, sell, offer to sell and have sold the Licensed
Products
within the Licensed Field in the Licensed Territory.
2.2 The license granted in Section 2.1 above extends to a Partner
as defined in
Section 1.10 only to the extent that said license is limited to the
Partner's
right to manufacture, use, sell and import Licensed Products within
the Licensed
Field in conjunction with Licensee. Within thirty (30) days of the
execution of
this Agreement, or in the case of Licensee's new Partner
Agreements, within
thirty (30) days of the execution of the Partner Agreement,
Licensee shall
notify its Partner(s) that this License grants to the Partner only
limited
rights under the Licensed Patent for the Licensed Field and that
the Partner
will need a separate license from the UIRF for the Partner's use,
manufacture or
sale of any additional products which are not made in conjunction
with Licensee.
Licensee shall promptly send copies to UIRF of all such
notifications sent to
such Partners, specifying the Licensed Products that are the
subject of the
agreement between Licensee and the Partner.
Since (a) the UIRF has granted a number of non-exclusive licenses
to the
Licensed Patents and (b) there exist several inter-relationships
among UIRF's
licensees and licensees' affiliates, the Partners of Licensee may
already have
enabling licenses for the Licensed Patents within the Licensed
Field.
Additionally, since UIRF will get delayed notification of the
nature of the
relationship between Licensee and its Partner, UIRF cannot be the
party
determining whether any of Licensee's Partners have such enabling
licenses
already. The UIRF will not intentionally collect any double
payments; however,
all payments made to UIRF are non-refundable and UIRF shall not be
held
responsible for any double payments that are made by Licensee
and/or its
Partners.
ARTICLE III -- PAYMENTS, REPORTS, RECORD-KEEPING
3.1 In consideration of the rights granted to Licensee pursuant to
Article II of
this Agreement, Licensee agrees to make the following payments to
the UIRF :
(a) A non-refundable payment ("License Fee") of [**] dollars
($[**]) immediately
upon execution of this Agreement.
(b) Earned Royalties in an amount equal to [**] percent ([**]%) of
the Net Sales
of Licensed Products to be paid on a quarterly basis.
(c) A payment of [**] dollars ($[**]) for each of the first four
Licensed
Products to successfully complete Phase I FDA trials. Such payment
shall accrue
for each Licensed Product upon approval by FDA for the product to
proceed to
Phase II FDA trials and shall be payable within thirty (30) days of
accrual.
This payment would accrue and be payable regardless of the date of
execution of
this Agreement. If such milestone event has occurred and associated
payment has
accrued prior to the execution of this Agreement, Licensee shall
pay such
amount(s) immediately to UIRF upon execution of this Agreement
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(d) A payment of [**] dollars ($[**]) for each of the first four
Licensed
Products to successfully complete Phase II FDA trials. Such payment
for each
Licensed Product shall accrue upon approval by FDA for the product
to proceed to
Phase III FDA trials and shall be payable within thirty (30) days
of accrual.
This payment would accrue and be payable regardless of the date of
execution of
this Agreement. If such milestone event has occurred and associated
payment has
accrued prior to the execution of this Agreement, Licensee shall
pay such
amount(s) immediately to UIRF upon execution of this Agreement.
(e) A payment of [**] dollars ($[**]) for each of the first four
(4) Licensed
Products to receive FDA approval for marketing in the United
States. Such a
payment for each Licensed Product shall accrue upon receipt of FDA
approval for
the product and shall be payable within thirty (30) days of
accrual. This
payment would accrue and be payable regardless of the date of
execution of this
Agreement. If such milestone event has occurred and associated
payment has
accrued prior to the execution of this Agreement, Licensee shall
pay such
amount(s) immediately to UIRF upon execution of this Agreement.
(f) An annual payment ("License Maintenance Fee") of [**] dollars
($[**]),
beginning on the one-year anniversary of the Effective Date and
continuing
annually on
