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EXHIBIT
10.54
*** Text omitted and Filed
Separately
with the Securities and
Exchange Commission.
CONFIDENTIAL TREATMENT
REQUESTED
UNDER 17 C.F.R.
§§200.80(b)(4) and 240.24b-2
FIRST AMENDMENT
TO
RESEARCH AND DEVELOPMENT
AGREEMENT
AND STOCK PURCHASE
AGREEMENT
T HIS F
IRST A MENDMENT TO R
ESEARCH AND D
EVELOPMENT A GREEMENT
AND S TOCK P URCHASE A
GREEMENT (the
“Amendment” ) is entered into by and
between A N G ES MG I
NC . , a Japanese corporation (
“AnGes” ), and V ICAL I
NCORPORATED , a Delaware corporation (
“Vical” ) as of September 26, 2007
(the “First Amendment Date” ).
Capitalized terms used but not otherwise defined herein shall have
the meanings provided in the Agreements.
W HEREAS
, the parties entered into the Research and Development
Agreement, dated as of May 25, 2006 (the “R&D
Agreement” ) and the Stock Purchase Agreement, dated
as of May 25, 2006 (the “Stock Purchase
Agreement” and, together with the R&D Agreement,
the “Agreements” ); and
W HEREAS
, the parties wish to amend the Agreements as set forth in this
Amendment to modify the terms regarding payment of research and
development funding under the Agreements.
N OW , T
HEREFORE , the parties agree as
follows:
1. Addition of Definition of
Allocable General Overhead to the R&D Agreement. The
following definition of Allocable General Overhead is hereby added
as Section 1.1A of the R&D Agreement:
“ 1.1A The term
“Allocable General Overhead” shall mean an
estimated amount of general overhead ratably allocated to
activities relating to the Phase 3 Clinical Trial according to
actual patient enrollment in the Phase 3 Clinical Trial. The
total of Allocable General Overhead shall be in accordance with the
budget provided by Vical to AnGes on September 26, 2007 based
upon [ *** ] per
actual patient enrolled in the Phase 3 Clinical Trial for 2006
and 2007. However, for subsequent years during the Project Term the
Allocable General Overhead can be revised based upon an annual
budget reforecast for the Project to be agreed between the parties
in each subsequent year and shall be calculated as
follows:
Allocable General Overhead
per actual patient enrolled =
[ *** ]
2. Addition of Definition of
Project Costs to the R&D Agreement. The following
definition of Project Costs is hereby added as Section 1.29A
of the R&D Agreement:
“ 1.29A The term
“Project Costs” shall mean all of the following
costs of development activities of Vical and its subcontractors in
performance of the Phase 3 Clinical Trial: (a) all actual
and documented out-of-pocket costs, including, without limitation,
direct labor costs plus a
[ *** ] thereof to
compensate for associated fringe benefits and paid time off, and
other direct expenses for the Project; and
***CONFIDENTIAL TREATMENT
REQUESTED
(b) Allocable General
Overhead.”
3. Amendment of
Sections 6.1 and 6.2 of the R&D Agreement.
Sections 6.1 and 6.2 of the R&D Agreement are hereby
amended and restated in their entirety as follows:
“ 6.1 Research and
Development Funding. As described in greater detail below,
AnGes agrees to fund Project Costs up to $22,600,000. As noted in
Article 4 and except as otherwise set forth herein, Vical will
continue to be responsible for Product manufacturing costs and all
costs incurred by Vical for development of and filing for
Regulatory Approval with respect to the Product in the United
States after completion of the Phase 3 Clinical Trial, including
BLA preparation and filing. The payments for funding of the Project
Costs will be made by AnGes as set forth in this Section 6.1
and Section 6.2.
(a) R&D Payments.
During the Phase 3 Clinical Trial term and subject to
Section 6.2, AnGes shall make non-refundable and
non-creditable (except as provided in Section 6.2(a) and
6.2(b)) payments to Vical (each, an
“Installment” and collectively, the
“R&D Payments ”), all of which shall be used
exclusively to pay for or reimburse Project Costs, in the amounts
set forth below:
(i) On the Effective
Date, $6,900,000, pursuant to the Stock Purchase
Agreement.
(ii) A second
Installment of
[ *** ] in
cash.
(iii) A third
Installment of
[ *** ] in cash and
[ *** ], pursuant to
the Stock Purchase Agreement.
(iv) A fourth
Installment of
[ *** ] in
cash.
(v) A fifth
Installment of
[ *** ] in
cash.
(vi)
[ *** ] in
cash.
(b) R&D Expenses in
Excess of R&D Payments. To the extent that the actual and
documented Project Costs exceed the estimated aggregate amount of
$22,600,000, such excess amounts will be paid by the parties as
follows:
(i) Vical will pay the
first [ &nb
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