Exhibit 10.1
Other Transactions (OT) Agreement/Modification P00001
OTHER TRANSACTION FOR PROTOTYPE AGREEMENT
BETWEEN
GenVec, Inc.
65 West Watkins Mill Road
Gaithersburg, MD 20878
AND
The Department of Homeland Security
Science & Technology Directorate
Washington, DC 20528

     
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 Vectore
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
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 GenVec:
  FOR DHS:     /s/
 
GenVec/Date        /s/
 
OT Agreements Officer/Date

AUG 30 2007
 

*   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.

 

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The following articles are revised as follows:
ARTICLE II: TERM is amended to add the following:
The period of performance of Option 1 of this agreements starts on date of award
and ends on 31 January 2008.
ARTICLE III: STATEMENT OF OBJECTIVES is revised to incorporate the following
tasks for Option 1:
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 and 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 terrorists 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
 

*   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.

 

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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.
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 1
to allow uninterrupted continuation and development of the lead FMD vaccine
candidate for eventual 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 1, milestone 1*
For option year 1, * milestones 2 and 3 *
For option year 1, milestones 4 and 5 *
For option year 1, milestone 6 *
For option year 1, milestone 7 *
III. Deliverables.
 

*   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.

 

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See Attachment II for detailed list and description of technical data and
physical deliverables associated with each of the two revised milestones
(milestones 1 and 7).
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 January 31, 2008,
with the option to negotiate and award an additional one (1) one-year period.
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.

 

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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) —
*
65 West Watkins Road
Gaithersburg, MD 20878
Phone: *
*     •   Financial POC(s) —
*
65 West Watkins Road
Gaithersburg, MD 20878
Phone: *
*

The DHS POCs are as follows:

  •   DHS S&T Technical Representative —

      *
Ag Program Manager

 

*   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.

 

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      Department of Homeland Security
ATTN: Science and Technology Directorate
Washington, DC 20528
*
*

  •   Resource Manager

      *
Department of Homeland Security
ATTN: Science and Technology Directorate/Office, *
Washington, DC 20528
*
*

      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.

 

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ATTACHMENT I — STATEMENT OF WORK EXECUTION (Option Year 1)
Milestone 1: *
General Approach
*
Adenovector Construction
*
Figure 1 *
Figure 2 *
Figure 3 *
Figure 4 *
Sequencing to Confirm Construction
*
Description of FMD Adenoviral Vaccine Vectors
*
cGMP Vector * Production and Characterization
*
Table 2: *
* Development Studies (New Funding Activity Option year 1)
*
* Potency Studies (New Funding Activity Option Year 1)
*
Milestone 7 — *
Table 9: *
Key Programmatic Steps
*
 

*   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.

 

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Description of * Process
*
Description of GenVec * Program
*
Description of GenVec * Program
*
Conduct * studies in advance of full development process *. Provide material to
DHS * testing (New Funding Activity Option Year 1).
*
SOW ATTACHMENT II — LIST OF TECHNICAL AND PHYSICAL
DELIVERABLES
(OPTION YEAR ONE)
*
 

*   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.

 

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ARTICLE IV: PAYABLE EVENT SCHEDULE AND DELIVERABLES is amended to add the
following:
B. Schedule of Payments and Payable Milestones (Phase IIIa):

          Milestone   Option 1   Milestone Date     Amount     1   *   * 2   *  
* 3   *   * 4   *   * 5   *   * 6   *   * 7   *   *

All other ARTICLES in the agreement remain unchanged and remain in effect during
this Option 1 effort.
 

*   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.