Other Transactions (OT) Agreement/Modification OTHER TRANSACTION FOR PROTOTYPE AGREEMENT DRAFT BETWEEN GenVec, Inc. Gaithersburg, MD 20878 AND The Department of Homeland Security Science & Technology Directorate Washington, DC 20528
EXHIBIT
10.1
Other
Transactions (OT) Agreement/Modification
OTHER
TRANSACTION FOR PROTOTYPE AGREEMENT
DRAFT
BETWEEN
GenVec,
Inc.
00
Xxxx
Xxxxxxx Xxxx Xxxx
Xxxxxxxxxxxx,
XX 00000
AND
The
Department of Homeland Security
Science
& Technology Directorate
Xxxxxxxxxx,
XX 00000
Agreement
Number:
|
HSHQDC-07-9-00004
|
Modification
Number:
|
P00001
|
Concerning:
|
Human
Adenovirus Type C, Serotype 5
|
Replication
Deficient Foot-and-Mouth Disease (FMD) Serotype-Specific Vectored Vaccines,
and
Vectored Biological Immunomodulators
Base
Period:
|
|
Total
Value of Base Period:
|
$5,976,726
|
GenVec’s
Cost Share/Contribution:
|
$0.00
|
Government’s
Cost Share/Contribution:
|
$5,976,726
|
Funds
Obligated:
|
$5,976,726
|
Option
1:
|
|
Total
Value of Option 1:
|
$5,613,815
|
GenVec’s
Cost Share/Contribution:
|
$0.00
|
Government’s
Cost Share/Contribution:
|
$5,613,815
|
Funds
Obligated:
|
$5,613,815
|
PR
Number:
|
RSCB-07-00200
|
Line
of Accounting:
|
NONE000-000-7X-31-01-0
1-002-01-00-0000-00-00-00-0 0-GE-OE-25-11-000000
|
Option
2:
|
|
Total
Value of Option 2:
|
$6,588,176
|
GenVec’s
Cost Share/Contribution:
|
$0.00
|
Government’s
Cost Share/Contribution:
|
$6,588,176
|
Funds
Obligated:
|
$0.00
|
PR
Number:
|
TBD
|
Line
of Accounting:
|
TBD
|
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
Authority: Section
831 of the Homeland Security Act of 2002, Public Law 107-296 The
Modification of the Agreement is entered into between the United States of
America, hereinafter
called the Government, represented by The Department of Homeland Security
(DHS), and GenVec, Inc., pursuant to and under US Federal law.
FOR
DHS:
|
||
/s/
Xxxxxxx X. Xxxxxxx
|
/s/
Xxxxxxx X. Xxxxx
|
|
GenVec/Date
|
OT
Agreements Officer/Date
|
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
The
following articles are revised as follows:
ARTICLE
II: TERM
is
amended to add the following:
The
period of performance of Option 2 of this agreements starts on date of award
and
ends on 28 February 2010.
ARTICLE
III: STATEMENT OF OBJECTIVES
is
revised to incorporate the following tasks for Option 2:
I.
Background
The
Department of Homeland Security (DHS) is committed to using cutting edge
technologies and scientific talent in its quest to make America safer. DHS’s
Directorate of Science & Technology (S&T) is tasked with researching and
organizing the scientific, engineering, and technological resources of the
United States and leveraging these existing resources into technological tools
to help protect the homeland. In support of this effort, the DHS S&T Plum
Island Animal Disease Center (PIADC) in Long Island, NY, is a unique research
facility and critical national asset conducting research on diseases of
livestock to protect America from terrorist threats directed against agriculture
from the intentional introduction of diseases. As defined in Homeland Security
Presidential Directive-7 (HSPD-7) and HSPD-9, the Secretary of Homeland Security
is responsible for coordinating the overall national effort to enhance the
protection of the critical infrastructure and key resources of the United
States, including the defense of agriculture and food. To fulfill these
requirements, DHS S&T supports programs at PIADC to strengthen the nation’s
ability to predict and respond to the incursion of a foreign animal disease.
DHS
S&T requires scientific, vaccine development and regulatory services from
GenVec, Inc. (GenVec). GenVec is a non-traditional contractor that has core
competencies in patent protected technology platforms for replication-defective
recombinant adenovirus serotype 5(rAd5) based-vaccines and therapeutic product
candidates. GenVec’s technology has been successfully applied to discovery,
pre-clinical, and clinical (Phase I-II) trials for human vaccines. GenVec also
has experience in Ad5 production (scale-up and downstream processing) with
an
integrated QA program.
GenVec
has held a historical contractual scientific relationship with the USDA ARS
on a
Foot-and-Mouth Disease Virus (FMDV) countermeasure R&D program.
Specifically, USDA and GenVec entered into Specific Cooperative Agreements
(SCAs) in 2004-2005 and 2005-2006 to use reasonable commercial efforts to
construct, produce and test a rAd5 based vector containing FMDV serotype empty
capsids as part of a Plum Island FMD vaccine and immunomodulator program. These
SCAs were funded through DHS-USDA interagency agreements and DHS S&T
scientists have been involved in the testing and evaluation of several rAd5
based vaccine vectors since 2005. In addition, USDA and GenVec have been
interacting through a Collaborative Research and Development Agreement (CRADA)
since 2004. The objective of the CRADA is to jointly construct and test GenVec
Advectors expressing FMD genes and livestock cytokines, and to identify
Advectors and complementing cell lines that have the potential to serve as
a
viral-vectored platform for a new generation of FMD vaccines. DHS S&T
scientists have participated in the USDA-GenVec CRADA since 2004 through a
DHS-USDA ARS interagency agreement on the joint research and development of
FMD
countermeasures, such as FMD vaccines and biological
immunomodulators.
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
Based
on
the successful technical outcome to date of the base year contract agreement
(awarded 1 February 2007) and the initiation and acceleration of pre-product
development activities at GenVec (originally targeted for option year 1) that
has resulted in the acceleration of lead FMD vaccine material for testing,
DHS
would like to move forward with GenVec and exercise option year 2 to allow
uninterrupted continuation and development of the lead FMD vaccine candidate
for
eventual conditional product licensing * by USDA Center for Veterinary
Biologics. These products would be made available for potential manufacture
and
procurement by the USDA National Center for Animal Health Emergency Management
National Veterinary Stockpile to help accomplish critical mission objectives
with regard to live FMDV and vaccine countermeasures against high consequence
Foreign Animal Diseases such as those caused by FMDV.
II.
Scope of Work
For
option year 2, no further work activities for milestone 1,*
For
option year 2, work activities for milestone 2, *
For
option year 2, work activities for milestone 3, *
For
option year 2, no further work activities for milestone 4, *
For
option year 2, milestone 5, *
For
option year 2, milestone 6 *
For
option year 2, work activities for milestones 7 *
For
option year 2, work activities for 8 from the original SOW *
For
option year 2, milestone 9 *
For
option year 2, milestone 10 *
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
For
option year 2, a new milestone 11 has been added with the following work
activities:
1.
|
*
|
2.
|
*
|
3.
|
*
|
III.
Deliverables.
See
Attachment II for detailed list and description of technical data and physical
deliverables associated with each of the four revised milestones (milestones
6,
7, 9, and 10) and the new milestone (milestones 11).
IV.
Other Contract Details
A.
|
Period
of Performance. The period of performance for this
revised SOW is a base period from the contract year one option
award date
to February 28, 2010.. DHS may give subsequent
extension notices to GenVec, Inc. in writing for further performance
in
accordance with the terms of this
SOW.
|
B.
|
Travel. All
travel must be approved by the DHS Technical Representative. All
foreign
travel must be approved in advance by the ORD Program Manager,
DHS
Programs, Plans and Budgets (PPB), and the DHS S&T Special Assistant
for International Policy.
|
C.
|
DHS-Furnished
Information.
|
i.
|
DHS
will provide certain DHS information, materials, and forms unique
to DHS
to GenVec, Inc. to support certain tasks under this SOW. Delays
in the
supply of DHS information, materials to GenVec could result in
delays to
the completion of certain
deliverables.
|
ii.
|
The
DHS S&T Technical Representative identified in this SOW will be the
point of contact (POC) for identification of any required information
to
be supplied by DHS.
|
iii.
|
GenVec,
Inc. will prepare any documentation according to the
guidelines provided by DHS.
|
E. |
Place
of Performance. GenVec,
Inc. will
perform the work under this SOW at their place of R&D business,
located in Gaithersburg, MD and through the use of sub-contractors
where
required as identified in this SOW.
|
F. |
DHS-Furnished
Property.
DHS property will not be provided to GenVec, Inc. unless
otherwise agreed to by the parties of the agreement.
|
G. |
Deliverables.
GenVec, Inc. will
provide all deliverables identified in this SOW directly to the DHS
S&T Technical Representative with a copy of the transmittal letter
to
the Other Transaction Contracting Officer and as otherwise specified
in
this SOW.
|
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
H. |
Publications.
All manuscripts must be approved prior to submission by the DHS S&T
Technical Representative at PIADC and by the GenVec Technical
Representative with approval not to be unreasonably withheld by either
party.
|
I. |
Program
Status Report. GenVec,
Inc. will
deliver a quarterly program status reports to the DHS S&T Technical
Representative and DHS S&T Resource Manager containing the following
metrics: (1) monthly scientific reports will be delivered to the
DHS
S&T Technical Representative according to mutually agreed upon format
and content requirements; and (2) a monthly report, including financial,
schedule, and scope information, risk information and an assessment
of
performance will be delivered to the DHS S&T Technical Representative
and the DHS S&T Resource Manager. Financial data should include
monthly expenditures for labor, travel and
equipment.
|
J. |
Security
Requirements.
All work performed under this SOW is unclassified unless otherwise
specified by DHS. If classified work is required under this SOW,
DHS will
provide specific guidance to the contractor as to which work will
be
conducted in a classified manner and at which classification level.
GenVec, Inc. participants
will also adhere to applicable government orders, guides, and directives
while performing the work hereunder.
|
V.
Points of Contact
GenVec,
Inc. Points
of
Contact (POCs) are as follows:
·
|
Technical
POC(s) –
|
*
00
Xxxx
Xxxxxxx Xxxx
Xxxxxxxxxxxx,
XX 00000
Phone
:
*
·
|
Financial
POC(s) –
|
*
00
Xxxx
Xxxxxxx Xxxx
Xxxxxxxxxxxx,
XX 00000
Phone:
*
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
The
DHS
POCs are as follows:
·
|
DHS
S&T Technical Representative –
|
*
Branch
Chief for Agricultural Security
Director
for Joint Agro Defense Office (JADO)
Science
& Technology
Department
of Homeland Security
Xxxxxxxxxx,
XX 00000
Voice:
*
Fax:
*
Mobile:
*
Email:
*
·
|
Resource
Manager
|
*
Department
of Homeland Security
ATTN:
Science and Technology Directorate/Office,
*
Xxxxxxxxxx,
XX 00000
*
*
Either
party may change its representatives named in this Statement of Work by written
notification to the other Party. The Government will effect the change as stated
in subparagraph C.4 of Article IV of the Other Transaction Agreement.
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
ATTACHMENT
I – STATEMENT OF WORK EXECUTION (Option Year 2 Funded
Milestones)
Milestone
2: *
General
Approach
*
Milestone
3: *
General
Approach
*
Milestone
6: *
General
Approach
*
Milestone
7: *
General
Approach
*
Milestone
9: *
General
Approach
*
Milestone
11: *
General
Approach
*
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
LIST
OF
TECHNICAL DELIVERABLES
(BASE
AGEEMENT, OPTION YEAR ONE, AND OPTION YEAR TWO)
Milestone
|
Deliverables
|
*
|
*
|
*
|
Timeline
|
|||||
Milestone
1
|
*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
Milestone
1 - continued
|
*
|
*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
|
*
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||||||
Milestone
2
|
*
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*
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*
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*
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*
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|||||
*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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*
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||||||
*
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*
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*
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*
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*
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||||||
*
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*
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*
|
*
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*
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||||||
*
|
*
|
*
|
*
|
*
|
||||||
Milestone
3
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
Milestone
4
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
||||||
Milestone
5
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
||||||
Milestone
6
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
||||||
Milestone
7
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
||||||
*
|
*
|
*
|
*
|
*
|
||||||
Milestone
8
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
||||||
Milestone
9
*
|
*
|
*
|
*
|
*
|
*
|
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
Milestone
10
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
||||||
Milestone
11
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
|
|||||
*
|
*
|
*
|
*
|
*
|
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
OPTION
YEAR 2 – MILESTONE DELIVERABLES, BUDGET and PAYMENT SCHEDULE
Milestone
|
Budget
|
|
Payment Schedule
|
|
|||
2-
*
|
*
|
*
|
|||||
3-
*
|
*
|
*
|
|||||
6-
*
|
*
|
*
|
|||||
7-
*
|
*
|
*
|
|||||
8-
*
|
*
|
*
|
|||||
9- *
|
*
|
*
|
|||||
10-
*
|
*
|
*
|
|||||
11-
*
|
*
|
*
|
|||||
TOTAL
OPTION YEAR 2
|
6,588,176
|
6,588,176
|
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.