AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350) RATING PAGE 1 OF PAGES 3
EXHIBIT
10.27
AWARD/CONTRACT
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1.
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THIS
CONTRACT IS A RATED ORDER
UNDER DPAS (15 CFR 350) |
RATING
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PAGE
1
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OF
PAGES
3
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2.
CONTRACT (Proc.
Inst. Ident.) NO.
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3.
EFFECTIVE DATE
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4.
REQUISITION/PURCHASE REQUEST/PROJECT NO.
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HSHQDC-10-C-00034
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01/22/2010
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RSCB-09-00141
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5.
ISSUED BY
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CODE
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DHS/OPO/S&T/CHEMBIO
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6.
ADMINISTERED BY (If
other than Block 5)
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CODE
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DHS/OPO/S&T/CHEMBIO
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U.S.
Dept. of Homeland Security
Office
of Procurement Operations
S&
T Acquisition Division
000
Xxxxxx Xxxx, XX
Xxxxxxxx
000
Xxxxxxxxxx
XX 000000
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U.S.
Dept. of Homeland Security Office of
Procurement
Operations S&T Acquisition Division
000
Xxxxxx Xxxx, XX
Xxxxxxxx
000
Xxxxxxxxxx
XX 00000
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|||
7. NAME AND ADDRESS
OF CONTRACTOR (No.,
street, city, county, State and Zip
Code)
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8.
DELIVERY
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|||
o
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FOB
ORIGIN
|
x
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OTHER
(See
Below)
|
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00
XXXX XXXXXXX XXXX XXXX
ATTN
XXXXXXX XXXXXX XX
XXXXXXXXXXXX
MD 208784021
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9.
DISCOUNT FOR PROMPT PAYMENT
Net
30
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10.
SUBMIT INVOICES
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ITEM
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|||
(4
copies unless otherwise specified)
|
||||
CODE 806729547000
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FACILITY
CODE
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TO
THE ADDRESS SHOWN IN
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||
11.
SHIP TO/MARK FOR
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CODE
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DHS
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12.
PAYMENT WILL BE MADE BY
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CODE
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DHS-S&T-INV
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Department
of Homeland Security
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DHS
ICE
|
||||
000
Xxxxxx Xxxx
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Xxxxxxxxxx
Finance Center
|
||||
Bldg.
410
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PO
Box 1000
|
||||
Washington
DC 20528
|
Attn:
S&T Division Chem Bio
|
||||
XXX.Xxxxxxx.Xxxxxxxxxxxxx@xxx.xxx
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|||||
Williston
VT 05495-1000
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|||||
13.
AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION
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14.
ACCOUNTING AND APPROPRIATION DATA
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||||
o
10 U.S.C. 2304 (c)
( ) o 41 U.S.C. 253 (c)
( )
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See
Schedule
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15A.
ITEM NO.
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15B.
SUPPLIES/SERVICES
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15C.
QUANTITY
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15D.
UNIT
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15E.
UNIT PRICE
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15F.
AMOUNT
|
Continued
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15G.
TOTAL AMOUNT OF CONTRACT
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$3,809,122.0
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16. TABLE
OF CONTENTS
(X)
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SEC
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DESCRIPTION
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PAGE(S)
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(X)
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SEC
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DESCRIPTION
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PAGE(S)
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PART
I - THE SCHEDULE
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PART
II - CONTRACT CLAUSES
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||||||
o
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A
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SOLICITATION/CONTRACT
FORM
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I
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CONTRACT
CLAUSES
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|||
o
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B
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SUPPLIES
OR SERVICES AND PRICES/COSTS
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PART
III - LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACH.
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||||
o
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C
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DESCRIPTION/SPECS/WORK
STATEMENT
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J
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LIST
OF ATTACHMENTS
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|||
o
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D
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PACKAGING
AND MARKING
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PART
IV - REPRESENTATIONS AND INSTRUCTIONS
|
||||
o
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E
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INSPECTION
AND ACCEPTANCE
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K
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REPRESENTATIONS,
CERTIFICATIONS AND
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|||
o
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F
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DELIVERIES
OR PERFORMANCE
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OTHER
STATEMENTS OF OFFERORS
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||||
o
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G
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CONTRACT
ADMINISTRATION DATA
|
L
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INSTRS.,
CONDS., AND NOTICES TO OFFERORS
|
|||
o
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H
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SPECIAL
CONTRACT REQUIREMENTS
|
M
|
EVALUATION
FACTORS FOR AWARD
|
CONTRACTING
OFFICER WILL COMPLETE 17 OR 18 AS APPLICABLE
17.
x CONTRACTOR’S
NEGOTIATED AGREEMENT (Contractor
is required to sign this
document and return
1
copies
to issuing office.) Contractor agrees to furnish and deliver
all items or perform all the services set forth or otherwise identified
above and on any continuation sheets for the consideration stated herein.
The rights and obligations of the parties to this contract shall be
subject to and governed by the following documents: (a) this
award/contract, (b) the solicitation, if and, and (c) such provisions,
representations, certifications and specifications, as are attached or
incorporated by reference herein. (Attachment
are listed herein.)
|
18. o AWARD
(Contractor
is not required to sign this document.) Your offer on Solicitation
Number _________________________________________,
including
the additions or changes made by you which additions or changes are set
forth in full above, is hereby accepted as to the items listed above and
on any condition sheets. This award consummates the contract
which consists of the following documents: (a) Government’s solicitation
and our offer, and (b) this award/contract.
No
further contractual document is
necessary.
|
19A.
Name and Title of Signer
Xxxxxxx
X. Xxxxxxx, Chief Financial Officer
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20A.
Name of Contracting Officer
Xxxxxxxx
Xxxxxxxxx
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|||
19B.
Name of Contractor
By:
/s/ Xxxxxxx
X. Xxxxxxx
(signature
of person authorized to sign)
|
19C.
Date Signed
01/28/2010
|
20B.
United States of America
By:
/s/ Xxxxxxxx
Xxxxxxxxx
(signature
of contracting officer
|
20C.
Date signed
02/12/2010
|
NSN
0000-0-000 mei
|
OPTIONAL
FORM 336 14.86]
|
SpOrtSored
In GSA
|
|
RAE
(4 El CFR) 53.110
|
* 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.
HSHQDC-10-C-00034
CONTINUATION
SHEET
|
REFERENCE
NO OF DOCUMENT BEING CONTINUED
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PAGE
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OF
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HSHOC-10-C-00034
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2
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3
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|
NAME
OF OFFEROR OR CONTRACTOR
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ITEM NO
(A)
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SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||||
DUNS
Number: 806729547+0000
|
||||||||||
Division: Chemical
& Biological
|
||||||||||
PPA: Chemical
& Biological
|
||||||||||
Thrust: Agriculture
|
||||||||||
Program: Foreign
Animal Diseases (FAD)
|
||||||||||
Project: FAD
Vaccines and Diagnostics
|
||||||||||
Performer: GenVec
|
||||||||||
Appropriation
Year: FY09 (9X Funds)
|
||||||||||
Budget
Authority: No-Year R&D Funds
|
||||||||||
ALC: 70-08-1513
|
||||||||||
APPS: 70X0800
|
||||||||||
Description:
The purpose of this Cost Plus Fixed Fee contract, which is awarded under
the Department of Homeland Security (DHS) Long Range Broad Agency
Announcement, is to provide support for research and development of a
molecular Foot-and-Mouth Disease (FMD) vaccine, in accordance with the
attached Terms and Conditions and Statement of Work.
|
||||||||||
Delivery: 365
Days After Award
|
||||||||||
Accounting
Info:
|
||||||||||
NONE000-000-9X-31-01-01-002-01-00-0000-00-00-00-00-GE-OE-25-50-000000
|
||||||||||
FOB: Destination
|
||||||||||
Period
of Performance: 01/22/2010 to 01/21/2012
|
||||||||||
0001
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Base
Year: Foreign Animal Disease Program support.
|
3,809,122.00
|
||||||||
01/22/2010
until 01/21/2011
|
||||||||||
Est
Unit Cost: $*
|
||||||||||
Fixed
Fee: $*
|
||||||||||
Total
CPFF: $3,809,122.00
|
||||||||||
Obligated
Amount: $3,809,122.00
|
||||||||||
0002
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Option
Year: Foreign Animal Disease Program support.
|
0.00
|
||||||||
01/22/2011
until 01/21/2012
|
||||||||||
Est
Unit Cost: $*
|
||||||||||
Fixed
Fee: $*
|
||||||||||
Total
CPFF: $746,766.00
|
||||||||||
Amount: $746,766.00(Option
Line Item)
|
||||||||||
|
Continued
...
|
|
|
|
|
NSN
7540-01-152-8067
|
OPTIONAL
FORM 336(4-86)
|
Sponsored
by GSA
|
|
FAR
(49CFR) 53.110
|
* 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.
HSHQDC-10-C-00034
2
CONTINUATION
SHEET
|
REFERENCE
NO OF DOCUMENT BEING CONTINUED
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PAGE
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OF
|
HSHOC-10-C-00034
|
3
|
3
|
|
NAME
OF OFFEROR OR CONTRACTOR
|
ITEM NO
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||||
Product/Service
Code: AA34
|
||||||||||
The
total amount of award: $4,555,888.00. The obligation for this
award is shown in box 15G.
|
||||||||||
|
|
|
|
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NSN
7540-01-152-8067
|
OPTIONAL
FORM 336(4-86)
|
Sponsored
by GSA
|
|
FAR
(49CFR) 53.110
|
* 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.
HSHQDC-10-C-00034
3
Exhibit 10.27
B.0 SUPPLIES/SERVICES AND
PRICES/COSTS
B.1
CONTRACT TYPE AND SCHEDULE OF ITEMS
This is a
Cost Plus Fixed Fee type contract. Under this contract, GenVec will
conduct Research and Development of a molecular Foot-and-Mouth Disease vaccine
for the Department of Homeland Security, in accordance with Section C and
Section J entitled “Statement of Work” (SOW).
B.2
CONTRACT LINE ITEMS
1. The
Contractor shall provide the Contract Line Items (CL1Ns) identified below on a
Cost Plus Fixed Fee (CPFF) basis. The fixed fee for all CLINs is
listed below. The Contractor shall consider the Estimated Costs to be
Not-To-Exceed (NTE) ceilings that can be changed only through a contract
modification.
CLIN
|
Supplies /Services
|
Qty
|
Unit
|
Est Unit Cost
|
Fixed Fee
|
Total CPFF
|
0001
|
Base Year
|
1
|
LOT
|
$*
|
$*
|
$3,809,122
|
*
|
||||||
*
|
||||||
*
|
||||||
*
|
||||||
*
|
||||||
*
|
||||||
0002
|
Option
Year
|
1
|
LOT
|
$*
|
$*
|
$746,766
|
AdVector
Technology Development to Improve AdFMD Vaccine Potency - Milestone
R1, New FMD serotype vectors
|
||||||
Total
Not-To-Exceed
|
$4,031,759
|
$524,129
|
$4,555,888
|
NSN
0000-0-000 mei
|
OPTIONAL
FORM 336 14.86]
|
SpOrtSored
In GSA
|
|
RAE
(4 El CFR) 53.110
|
4
2. The
sum of funds allotted to this contract and available for payment of costs and
fee through 21 January 2011 in accordance with the clause 52.232.20 in Section I
entitled “Limitation of Cost” is $3,809.122.
3. As
provided in paragraph (a)(2), the license granted in ATTACHMENT 3 entitled “TO
BE USED AS ALTERNATE II TO THE CLAUSE AT 52.227-14, RIGHTS IN DATA-GENERAL”
shall remain in effect for the term of all patents licensed hereunder without
regard to the expiration, completion, or termination of this
contract.
C.0 DESCRIPTION /
SPECIFICATIONS / STATEMENT OF WORK
C.1
STATEMENT OF WORK
The work
and services to be performed under this contract shall conform with requirements
contained in the Statement of Work entitled Attachment 1. See Section
J.
D.0 PACKAGING AND
MARKING
D.1
PACKAGING AND MARKING
Deliverables
shall be electronically submitted to *, and/or provided in
accordance with the Statement of Work.
E.0 INSPECTION AND
ACCEPTANCE
E.1
CLAUSES INCORPORATED BY REFERENCE
The
following FAR clauses are available in full text at xxxx://xxxxxxx.xxxx.xx.xxx and
incorporated by reference into this contract:
52.246-9
Inspection of Research and Development (Short Form) (APR 1984)
E.2
INSPECTION AND ACCEPTANCE BY THE GOVERNMENT
The
Contracting Officer’s Technical Representative (COTR) identified in Section G of
this Contract is responsible for inspection and acceptance of all services,
incoming shipments, documents, and services performed specifically for the
Contract.
E.3
ACCEPTANCE CRITERIA
Certification
by the Government of satisfactory services provided is contingent upon the
Contractor performing in accordance with the terms and conditions of the
contract and all modifications.
* 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.
5
F.0 DELIVERIES OR
PERFORMANCE
F.1
CLAUSES INCORPORATED BY REFERENCE
The
following FAR clauses are available in full text at xxxx://xxxxxxx.xxxx.xx.xxx
and incorporated by reference into this contract:
52.242-15
(Alt I) Stop Work Order (April 1989) Alternate I (April 1984) 52.247-34 F.O.B.
Destination (Nov 1991)
F.2
PERIOD OF PERFORMANCE
The
period of performance of this Contract is:
Base
Year— 22 January 2010 until 21 January 2011
Option
Year — 22 January 2011 until 21 January 2012
F.3
PLACE OF PERFORMANCE
The
services shall he performed at the contractor’s facility.
F.4
DELIVERY ADDRESS
All
deliverables shall be submitted electronically to the COTR identified in
Section G
of this Contract.
F.5
METHOD OF DELIVERY
Electronic
copies shall be delivered in Microsoft Office formatted files, unless otherwise
specified by the COTR. Electronic submission shall he made via
e-mail,
unless otherwise directed by the COTR.
F.6
DELIVERABLE/DELIVERY SCHEDULE
All
deliverable schedules are contained in Section C - Statement of
Work.
G.0 CONTRACT ADMINISTRATION
DATA
G.1
CONTRACTING OFFICER (CO)
The
Contracting Officer for this Contract is identified below:
Name: *
Title: Contracting
Officer
Agency: Department
of Homeland Security
Science and Technology
Division
Office of Procurement
Operations
Address: Washington,
D.C. 20598
Voice: *
Email: *
* 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.
6
G.2
CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR)
The COTR
for this Contract is identified below:
Name: *
Title: S&T Program
Manager
Agency: Department
of Homeland Security
Science and Technology
Directorate
Chem/Bio Division
Address: Plum
Island. NY
Voice: *
Email: *
G.3
CONTRACTING OFFICER’S AUTHORITY
The
Contracting Officer (CO) assigned to this contract has responsibility for
ensuring the performance of all necessary actions for effective
contracting; ensuring compliance with the terms of the contract and safeguarding
the interests of the United States in its contractual
relationships. The CO is the only individual who has the authority to
enter into, administer, or terminate this contract and is the only person
authorized to approve changes to any of the requirements under this contract,
and notwithstanding any provision contained elsewhere in this contract, this
authority remains solely with the CO.
It is the
Contractor’s responsibility to contact the CO immediately if there is even the
appearance of any technical direction that is or may be outside the scope of the
contract. The Government will not reimburse the Contractor for any
work not authorized by the CO, including work outside the scope of the
contract.
G.4
CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (HSAR
3052.242-72) (DEC 2003)
(a) The
Contracting Officer may designate Government personnel to act as the Contracting
Officer’s Technical Representative (COTR) to perform functions under the
contract such as review or inspection and acceptance of supplies, services,
including construction, and other functions of a technical
nature. The Contracting Officer will provide a written notice of such
designation to the Contractor within five working days after contract award or
for construction, not less than five working days prior to giving the contractor
the notice to proceed. The designation letter will set forth the
authorities and limitations of the COTR under the contract.
(b) The
Contracting Officer cannot authorize the COTR or any other representative to
sign documents, such as contracts. contract modifications. etc., that require
the signature of the Contracting Officer.
(End of
clause)
* 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.
7
G.5
INTERPRETATION OR MODIFICATION
No oral
statement by any person, and no written statement by anyone other than the
Contracting Officer (CO), or his/her authorized representative acting within the
scope of his/her authority, shall be interpreted as modifying or otherwise
affecting the terms of this contract. All requests for interpretation
or modification shall be made in writing to the CO.
G.6
ACCOUNTING AND APPROPRIATION DATA
NONE000-000-9X-31-01-01-002-01-00-0000-00-00-00-00-GE-OE-25-50-000000
Amount:
$3,809.122.00
G.7
INVOICING INSTRUCTIONS
In order
to initiate payment. the Contractor shall submit proper invoices for payment in
the manner and format described herein:
(a)
GenVec will invoice monthly for all costs incurred plus the pro rata portion of
fee.
Invoices
shall be submitted electronically to:
XXX.Xxxxxxx.XxxxxxxxxxxxxxXxxxx.xxx
Invoices
can be mailed to the following address (the preferred method of invoicing
is via email):
DHS
ICE
Burlington
Finance Center
PO Box
1000
Williston,
Vermont 05495-1000
Attn:
S&T Chem/Bio Division
(b) Each
invoice shall include the following:
(1)
Contract Number
(2)
Contractor Name
(3) Date
of Invoice
(4)
Invoice/voucher Number
(5)
Material
(6)
Labor
(7)
Benefits
(8)
Overhead
(9) Other
Direct Cost (ODCs)
(10)
Travel
(11)
Total Costs
Backup
documents shall be available for audit/review to DCAA, upon
request.
* 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.
8
G.8
TRAVEL
(a)
Domestic/local travel shall take place in accordance with the Federal Travel
Regulations (FTR) and will he considered reasonable and allowable to the extent
permitted by FAR 31.205-46. Documentation will be available upon
request to DCAA.
G.9
GOVERNMENT FURNISHED EQUIPMENT/INFORMATION/MATERIALS
The
government shall provide the GFE/GFI/GFM as called out in the Statement of
Work.
H.0 SPECIAL CONTRACT
REQUIREMENTS
H.1 RIGHTS IN DATA-GENERAL
In
accordance with FAR 52.227-14. Rights in Data-General. Alternate II
(Dec 2007), see Attachment 3 in Section J.
I.0 CONTRACT
CLAUSES
I.1
CLAUSES INCORPORATED BY REFERENCE (FAR 52.252-2) (FEB 1998)
This
contract incorporates one or more clauses by reference, with the same force and
effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the
full text of a clause may be accessed electronically at this/these
address(es):
xxxx://xxxxxxx.xxxx.xx.xxx
(FAR Clauses 52.###)
xxxx://xxx.xxx.xxx/xxxxxxxxx/xxxxxxxx/xxxxxxxxxxxx/XXX_XXXX_Xxxx_Xxxxxx_00-00.xxx
(HSAR Clauses 30##.###)
(End of
Clause)
I.2
CLAUSES INCORPORATED BY REFERENCE
The
following FAR and HSAR clauses are incorporated by reference into this
contract:
* 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.
9
52.202-1
(Jul 2004)
|
Definitions
|
52.203-3
(Apr 1984)
|
Gratuities
|
52.203-5
(Apr 1984)
|
Covenant
Against Contingent Fees
|
52.203-7
(Jul 1995)
|
Anti-Kickback
Procedures
|
52.203-8
(Jan 1997)
|
Cancellation,
Recession and Recovery of Funds for Illegal or Improper
Activity
|
52.203-10
(Jan 1997)
|
Price
or Fee Adjustment for Illegal or Improper Activity
|
52.203-12
(Sep 2007)
|
Limitation
on Payments to Influence Certain Federal Transactions
|
52.204-4
(Aug 2000)
|
Printed
or Copied Double Sided on Recycled Paper
|
52.204-7
(Jul 2006)
|
Central
Contractor Registration
|
52.209-6
(Sep 2006)
|
Protecting
the Government’s interest When Subcontracting with Contractors Debarred,
Suspended, or proposed for Debarment
|
52.215-2
(Jun 1999)
|
Audit
and Records – Negotiation
|
52.215-8
(Oct 1997)
|
Order
of Precedence – Uniform Contract Format
|
52.215-10
(Oct 1997)
|
Price
Reduction for Defective Cost or Pricing Data
|
52.215-12
(Oct 1997)
|
Subcontractor
cost or Pricing
Data
|
52.215-14
(Oct 1997)
|
Integrity
of Unit Prices
|
52.215-15
(Oct 2004)
|
Pension
Adjustments and Asset Reversions
|
52.215-18
(Jul 2005)
|
Reversion
or Adjustment of Plans for Postretirement Benefits (PRB) Other Than
Pensions
|
52.215-21
(Oct 1997)
|
Requirements
for Cost or Pricing Data or Information Other Than Cost or Pricing Data –
Modifications
|
52.216-7
(Dec 2002)
|
Allowable
Cost and Payment
|
52.216-8
(Mar 1997)
|
Fixed
Fee
|
52.219-8
(May 2004)
|
Utilization
of small business concerns
|
52.222-1
(Feb 1997)
|
Notice
to the Government of Labor Disputes
|
52.222-2
(Jul 1990)
|
Payment
for Overtime Premiums
|
52.222-3
(Jun 2003)
|
Convict
Labor
|
52.222-21
(Feb 1999)
|
Prohibition
of Segregated Facilities
|
52.222-26
(Mar 2007
|
Equal
Opportunity
|
* 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.
10
52.222-35
(Sep 2006)
|
Equal
Opportunity for Disabled Veterans, Veterans of the Vietnam Era and Other
Eligible Veterans
|
||||||
52.222-36
(Jun 1998)
|
Affirmative
Action for Workers with Disabilities
|
||||||
52.222-37
(Sep 2006)
|
Employment
Reports on Special Disables Veterans, Veterans of the Vietnam Era and
Other Eligible Veterans
|
||||||
52.223-6
(May 2001)
|
Drug
Free Workplace
|
||||||
52.223-14
(Aug 2003)
|
Toxic
Chemical Release Reporting
|
||||||
52.225-13
(Feb 2006)
|
Restrictions
on Certain Foreign Purchases
|
52.227-1
(Dec 2007)
|
Alt
I (Apr. 1984)
|
Authorization
and
Consent
– Alternate 1
|
52.227-2
(Dec 2007)
|
Notice
and Assistance Regarding Patent and Copyright
Infringement
|
||||||
52.227-11
(Dec 2007)
|
Patent
Rights – Ownership by the Contractor
|
||||||
52.227-14
(Dec 2007)
|
Rights
in Data – General
|
||||||
SEE
SECTION J OF CONTRACT, ATTACHMENT 3
|
Alt
II (Dec 2007)
|
||||||
SEE
SECTION J OF CONTRACT
|
|||||||
52.227-16
(Jun 1987)
|
Additional
Data Rights
|
||||||
52.228-7
(Mar 1996)
|
Insurance
– Liability to Third Persons
|
||||||
52.230-2
(Apr 1998)
|
Cost
Accounting Standards
|
||||||
52.230-6
(Apr 2005)
|
Administration
of Cost Accounting Standards
|
||||||
52.232-9
(Apr 1984)
|
Limitation
on Withholding of Payments
|
||||||
52.232-17
(Jun 1996)
|
Interest
|
||||||
52.232-20
(Apr 1984)
|
Limitation
of Cost
|
||||||
52.232-23
(Jan 1986)
|
Assignment
of Claims
|
||||||
52.232-25
(Oct 2003)
|
Prompt
payment
|
||||||
52.232-33
(Oct 2003)
|
Payment
of Electronic Funds Transfer – Central Contractor
Registration
|
||||||
52.233-1
(Jul 2002)
|
Disputes
|
52.233-3
(Aug 1996)
|
Alt
I (June 1985)
Protest After Award
|
- Alternate
I
|
52.233-4
(Oct 2004)
|
Applicable
Law for Breach of Contract Claim
|
||||||
52.242-1
(Apr 1984)
|
Notice
of Intent to Disallow Costs
|
||||||
52.242-3
(Mar 2001)
|
Penalties
for Unallowable Costs
|
||||||
52.242-4
(Jan 1997)
|
Certification
of Final Indirect Costs.
|
||||||
52.242-13
(Jul 1995)
|
Bankruptcy
|
52.243-2
(Aug 1987)
|
Alt
V (Apr 1984)
Changes
– Cost
Reimbursement
|
-
Alternate V
|
* 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.
11
52.243-7
(Apr 1984)
|
Notification
of Changes
|
||
52.244-2
(Jun 2007)
|
Alt
I (Jun 2007)
Subcontracts
|
-
Alternate I
|
|
52.244-5
(Dec 1996)
|
Competition
in Subcontracting
|
||
52.244-6
(Mar 2007)
|
Subcontracts
for Commercial
Items
|
||
52.245-1
(Jun 2007)
|
Government
Property
Alt
II (Jun 2007)
|
||
52.246-9
(Apr 1984)
|
Inspection
of Research and Development (Short Form)
|
||
52.247-
1 (Feb 2006)
|
Commercial
Bill of Lading Notations
|
||
52.247-63
(Jun 2003)
|
Preference
for U.S. Flag Air Carriers
|
||
52.249-6
(May 2004)
|
Termination
(Cost Reimbursement)
|
||
52.249-14
(Jun 2007)
|
Excusable
Delays
|
||
52.251-1
(Apr 1984)
|
Government
Supply Sources
|
||
52.253-1
(Jan 1991)
|
Computer
Generated Forms
|
||
3052.204-71
(Jun 2006
|
Contractor
Employee Access
|
1.3
NOTIFICATION OF OWNERSHIP CHANGES (FAR 52.215-19) (OCT
1997)
(a) The
Contractor shall make the following notifications in writing:
(1) When
the Contractor becomes aware that a change in its ownership has occurred, or is
certain to occur, that could result in changes in the valuation of its
capitalized assets in the accounting records, the Contractor shall notify the
Administrative Contracting Officer (ACO) within 30 days.
(2) The
Contractor shall also notify the ACO within 30 days whenever changes to asset
valuations or any other cost changes have occurred or are certain to occur as a
result of a change in ownership.
(b) The
Contractor shall —
(1)
Maintain current, accurate, and complete inventory records of assets and their
costs;
(2)
Provide the ACO or designated representative ready access to the records upon
request;
(3)
Ensure that all individual and grouped assets, their capitalized values,
accumulated depreciation or amortization, and remaining useful lives are
identified accurately before and after each of the Contractor’s ownership
changes; and
(4)
Retain and continue to maintain depreciation and amortization schedules based on
the asset records maintained before each Contractor ownership
change.
(c) The
Contractor shall include the substance of this clause in all subcontracts under
this contract that meet the applicability requirement of FAR
15.408(k).
* 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.
12
(End of
Clause)
I.4
OPTION TO EXTEND SERVICES (52.217-8) (NOV 1999)
The
Government may require continued performance of any services within the limits
and at the rates specified in the contract. These rates may be
adjusted only as a result of revisions to prevailing labor rates provided by the
Secretary of Labor. The option provision may be exercised more than
once. but the total extension of performance hereunder shall not exceed 6
months. The Contracting Officer may exercise the option by written
notice to the Contractor within 30 days before the end of the current period of
performance.
(End of
Clause)
1.5
OPTION TO EXTEND THE TERM OF THE CONTRACT (FAR
52.217-9) (MAR 2000)
(a) The
Government may extend the term of this contract by written notice to the
Contractor within 29
days of the end of the current period of performance; provided that the
Government gives the Contractor a preliminary written notice of its intent to
extend at least 30
days before the contract expires. The preliminary. notice
does not commit the Government to an extension.
(b) If
the Government exercises this option, the extended contract shall be considered
to include this option clause.
(c) The
total duration of this contract, including the exercise of any options under
this clause, shall not exceed 2 years.
(End of
Clause)
I.6
NOTIFICATION OF EMPLOYEES RIGHTS CONCERNING PAYMENT OF UNION DUES AND FEES (FAR
52.222-39) (DEC 2004)
(a)
Definition. As used in this clause-
“United
States” means the 50 States, the District of Columbia, Puerto Rico. the Northern
Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake
Island.
(b)
Except as provided in paragraph (e) of this clause, during the term of this
contract, the Contractor shall post a notice, in the form of a poster, informing
employees of their rights concerning union membership and payment of union dues
and fees, in conspicuous places in and about all its plants arid offices,
including all places where notices to employees are customarily
posted. The notice shall include the following information (except
that the information pertaining to National Labor Relations Board shall not be
included in notices posted in the plants or offices of carriers subject to the
Railway Labor Act, as amended (45 U.S.C. 151-188)).
* 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.
13
Notice to
Employees
Under
Federal law, employees cannot be required to join a union or maintain membership
in a union in order to retain their jobs. Under certain conditions,
the law permits a union and an employer to enter into a union-security agreement
requiring employees to pay uniform periodic dues and initiation
fees. However, employees who are not union members can object to the
use of their payments for certain purposes and can only be required to pay their
share of union costs relating to collective bargaining, contract administration,
and grievance adjustment. If you do not want to pay that portion of
dues or fees used to support activities not related to collective bargaining,
contract administration, or grievance adjustment, you are entitled to an
appropriate reduction in your payment. If you believe that you have
been required to pay dues or fees used in part to support activities not related
to collective bargaining, contract administration, or grievance adjustment, you
may be entitled to a refund and to an appropriate reduction in future
payments.
For
further information concerning your rights, you may wish to contact the National
Labor Relations Board (NLRB) either at one of its Regional offices or at the
following address or toll free number:
National
Labor Relations Board Division of Information
0000 00xx
Xxxxxx, X.X. Washington. DC 20570
0-000-000-0000
0-000-000-0000
(TTY)
To locate
the nearest NLRB office. see NLRB’s website at xxxx://xxx.xxxx.xxx.
(c) The
Contractor shall comply with all provisions of Executive Order 13201 of February
17. 2001, and related implementing regulations at 29 CFR Part 470, and orders of
the Secretary of Labor.
(d) In
the event that the Contractor does not comply with any of the requirements set
forth in paragraphs (b), (c), or (g), the Secretary may direct that this
contract be cancelled, terminated, or suspended in whole or in part, and declare
the Contractor ineligible for further Government contracts in accordance with
procedures at 29 CFR Part 470, Subpart B—Compliance Evaluations, Complaint
Investigations and Enforcement Procedures. Such other sanctions or
remedies may be imposed as are provided by 29 CFR Part 470, which implements
Executive Order 13201, or as are otherwise provided by law.
(e) The
requirement to post the employee notice in paragraph (b) does not apply
to-
(1)
Contractors and subcontractors that employ fewer than 15 persons:
(2)
Contractor establishments or construction work sites where no union has been
formally recognized by the Contractor or certified as the exclusive bargaining
representative of the Contractor’s employees;
* 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.
14
(3)
Contractor establishments or construction work sites located in a jurisdiction
named in the definition of the United States in which the law of that
jurisdiction forbids enforcement of union-security agreements;
(4)
Contractor facilities where upon the written request of the Contractor, the
Department of Labor Deputy Assistant Secretary for Labor-Management Programs has
waived the posting requirements with respect to any of the Contractor’s
facilities if the Deputy Assistant Secretary finds that the Contractor has
demonstrated that-
(i) The
facility is in all respects separate and distinct from activities of the
Contractor related to the performance of a contract; and
(ii) Such
a waiver will not interfere with or impede the effectuation of the Executive
order; or
(5) Work
outside the United States that does not involve the recruitment or employment of
workers within the United States.
(f) The
Department of Labor publishes the official employee notice in two variations;
one for contractors covered by the Railway Labor Act and a second for all other
contractors. The Contractor shall-
(1)
Obtain the required employee notice poster from the Division of Interpretations
and Standards, Office of Labor-Management Standards, U.S. Department of Labor,
000 Xxxxxxxxxxxx Xxxxxx, XX, Xxxx X-0000, Xxxxxxxxxx,’ XX 00000, or from any
field office of the Department’s Office of Labor-Management Standards or Office
of Federal Contract Compliance Programs:
(2)
Download a copy of the poster from the Office of Labor-Management Standards
website at xxxx://xxx.xxxx.xxx.xxx; or
(3)
Reproduce and use exact duplicate copies of the Department of Labor’s official
poster.
(g) The
Contractor shall include the substance of this clause in every subcontract or
purchase order that exceeds the simplified acquisition threshold, entered into
in connection with this contract, unless exempted by the Department of Labor
Deputy Assistant Secretary for Labor-Management Programs on account of special
circumstances in the national interest under authority of 29 CFR
470.3(c). For indefinite quantity subcontracts, the Contractor shall
include the substance of this clause if the value of orders in any calendar year
of the subcontract is expected to exceed the simplified acquisition
threshold. Pursuant to 29 CFR Part 470, Subpart B—Compliance
Evaluations, Complaint Investigations and Enforcement Procedures, the Secretary
of Labor may direct the Contractor to take such action in the enforcement of
these regulations, including the imposition of sanctions for noncompliance with
respect to any such subcontract or purchase order. If the Contractor
becomes involved in litigation with a subcontractor or vendor, or is threatened
with such involvement, as a result of such direction, the Contractor may request
the United States, through the Secretary of Labor, to enter into such litigation
to protect the interests of the United States.
* 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.
15
(End of
clause)
1.7
PROHIBITION ON CONTRACTS WITH CORPORATE EXPATRIATES
(HSAR 3052.209-70) (JUN 2006)
(a)
Prohibitions.
Section
835 of Public Law 107-296, prohibits the Department of Homeland Security from
entering into any contract with a foreign incorporated entity after November 25,
2002, which is treated as an inverted domestic corporation as defined in this
clause. The Secretary shall waive the prohibition with respect to any
specific contract if the Secretary determines that the waiver is required in the
interest of homeland security, or to prevent the loss of any jobs in the United
States or prevent the Government from incurring any additional costs that
otherwise would not occur.
(b)
Definitions. As used in this clause:
“Expanded
Affiliated Group” means an affiliated group as defined in section 1504(a) of the
Internal Revenue Code of 1986 (without regard to section 1504(b) of such Code),
except that section 1504 of such Code shall be applied by substituting ‘more
than 50 percent’ for ‘at least 80 percent’ each place it
appears. “Foreign Incorporated Entity” means any entity which is, or
but for subsection (b) of Section 835 of the Homeland Security Act, Public Law
107-296, would be, treated as a foreign corporation for purposes of the Internal
Revenue Code of 1986.
“Inverted
Domestic Corporation.” A foreign incorporated entity shall be treated
as an inverted domestic corporation if, pursuant to a plan (or a series of
related transactions)—
(1) The
entity completes after November 25. 2002. the direct or indirect acquisition of
substantially all of the properties held directly or indirectly by a domestic
corporation or substantially all of the properties constituting a trade or
business of a domestic partnership;
(2) After
the acquisition at least 80 percent of the stock (by vote or value) of the
entity is held-
(i) In
the case of an acquisition with respect to a domestic corporation, by former
shareholders of the domestic corporation by reason of holding stock in the
domestic corporation; or
(ii) In
the case of an acquisition with respect to a domestic partnership, by former
partners of the domestic partnership by reason of holding a capital or profits
interest in the domestic partnership; and
(3) The
expanded affiliated group which after the acquisition includes the entity does
not have substantial business activities in the foreign country in which or
under the law of which the entity is created or organized when compared to the
total business activities of such expanded affiliated
group. “Person”, “domestic”, and “foreign” have the meanings given
such terms by paragraphs (1), (4), and (5) of section 7701(a) of the Internal
Revenue Code of 1986, respectively.
* 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.
16
(c)
Special rules. The following definitions and special rules shall
apply when determining whether a foreign incorporated entity should be treated
as an inverted domestic corporation.
(1)
Certain Stock Disregarded. For the purpose of treating a foreign
incorporated entity as an inverted domestic corporation these shall not be taken
into account in determining ownership:
|
(i)
|
stock
held by members of the expanded affiliated group which includes the
foreign incorporated entity; or
|
|
(ii)
|
stock
of such entity which is sold in a public offering related to the
acquisition described in subsection (b)(1) of Section 835 of the Homeland
Security Act, Public Law 107-296.
|
(2) Plan
Deemed In Certain Cases. If a foreign incorporated entity acquires
directly or indirectly substantially all of the properties of a domestic
corporation or partnership during the 4-year period beginning on the date which
is after the date of enactment of this Act and which is 2 years before the
ownership requirements of subsection (b)(2) are met, such actions shall be
treated as pursuant to a plan.
(3)
Certain Transfers Disregarded. The transfer of properties or
liabilities (including by contribution or distribution) shall be disregarded if
such transfers are part of a plan a principal purpose of which is to avoid the
purposes of this section.
(d)
Special Rule for Related Partnerships.
For
purposes of applying Section 835(b) of Public Law 107-296 to the acquisition of
a domestic partnership, except as provided in regulations, all domestic
partnerships which are under common control (within the meaning of section 482
of the Internal Revenue Code of 1986) shall be treated as a
partnership.
(e)
Treatment of Certain Rights.
(1)
Certain rights shall be treated as stocks to the extent necessary to reflect the
present value of all equitable interests incident to the transaction. as
follows:
|
(i)
warrants;
|
|
(ii)
options;
|
|
(iii)
contracts to acquire stock;
|
|
(iv)
convertible debt instruments; and
|
|
(v)
others similar interests.
|
(2)
Rights labeled as stocks shall not be treated as stocks whenever it is deemed
appropriate to do so to reflect the present value of the transaction or to
disregard transactions whose recognition would defeat the purpose of Section
835.
* 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.
17
(f)
Disclosure.
By
signing and submitting its offer, an Offer under this solicitation represents
that it not a foreign incorporated entity that should he treated as an inverted
domestic corporation pursuant to the criteria of Section 835 of the Homeland
Security Act, Public Law 107-296 of November 25, 2002.
(g) If a
waiver has been granted, a copy of the approved waiver shall be attached to the
bid or proposal.
(End of
provision)
I.8
INSURANCE (HSAR 3052.228-70) (DEC 2003)
In
accordance with the clause entitled “Insurance — Liability to Third Persons” in
Section 1, insurance of the following kinds and minimum amounts shall be
provided and maintained during the period of performance of this
contract;
(a)
Worker’s compensation and employer’s liability. The contractor shall,
as a minimum, meet the requirements specified at (FAR) 48 CFR
28.307-2(a).
(b)
General liability. The contractor shall, as a minimum, meet the
requirements specified at (FAR) 48 CFR 28.307-2(b).
(c)
Automobile liability. The contractor shall, as a minimum, meet the
requirements specified at (FAR) 48 CFR 28.307-2(c).
(End of
clause)
I.9
DISSEMINATION OF CONTRACT INFORMATION (HSAR 3052.242-71)
(DEC 2003)
The
Contractor shall not publish, permit to be published. or distribute for public
consumption, any information, oral or written, concerning the results or
conclusions made pursuant to the performance of this contract, without the prior
written consent of the Contracting Officer. An electronic or printed
copy of any material proposed to be published or distributed shall be submitted
to the Contracting Officer.
(End of
clause)
I.10
USE OF DEPARTMENT OF HOMELAND SECURITY SEAL
In
accordance with DHS Management Directive 0030, 18 U.S.C. § 701, and 28 U.S.C. §
1733(b), the usage of DHS seal shall be requested by completing DHS Form 0030-1
(4/06). Request shall be submitted to the Contracting
Officer. In summation:
|
·
|
Any
use of the DHS seal must be approved by the Secretary or his/her
designee;
|
* 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.
18
|
·
|
Any
permission granted by the Secretary will apply only to the specific use
outlined on this form and should not be construed as permission for any
other use;
|
|
·
|
The
DHS Seal shall not he used in any manner that implies DHS endorsement of
commercial products or services, the user’s policies or activities, or on
any article that may discredit the seal or reflect unfavorably on the U.S.
Department of Homeland Security.
|
I.11 KICKOFF MEETING –
CONTRACTOR SHALL COMMENCE PERFORMANCE, UPON KICKOFF MEETING.
J.0
ATTACHMENTS
ATTACHMENT 1: STATEMENT OF
WORK
ATTACHMENT 2: STATEMENT OF
WORK MILESTONES, DELIVERABLES AND HMEL/NES
ATTACHMENT 3: TO BE USED AS ALTERNATE II TO
THE CLAUSE AT 52.227-14, RIGHTS IN DATA-GENERAL
ATTACHMENT
1 – STATEMENT OF WORK (SOW)
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-9
(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. HSPD-9 mandates efforts, coordinated through DHS, to “create a
new biological threat awareness capacity that will enhance detection and
characterization of an attack.” (HSPD-9, paragraph
10). HSPD-9 also mandates that DHS accelerate and enhance the
development of countermeasures (including vaccines) for Foreign Animal Diseases
(FADs). HSPD-9 also recognized the need for a federal stockpile and
mandated the creation of the National Veterinary Stockpile.
To
fulfill these requirements, DHS S&T supports Foot-and-Mouth Disease (FMD)
vaccine R&D countermeasure programs at PIADC to strengthen the nation’s
ability to predict and respond to the incursion of a FMD. FMD is one
of the most contagious diseases known to man. It affects cattle,
swine, sheep and other cloven-hoofed animals such as goats and
deer. FMD has been identified as one of the highest potential threats
to the U.S. economy and the country’s food supply, whether outbreaks were to
occur as a result of bioterrorism or by accidental introduction. An
intentional introduction of FMD would likely involve the simultaneous infection
of susceptible animals in numerous locations, and the number of animals and
premises infected in a large multifocal outbreak would quickly overwhelm the
ability to stamp out infected and exposed animals. In such a
scenario, it would be highly desirable to use prophylactic vaccination to reduce
the rate and size of the outbreak and increase the speed of
recovery. Adequate doses of serotype or subtype-specific matching
vaccines available within 24 hours of FMD diagnosis will be required to bring
the outbreak under control as quickly as possible.
* 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.
19
Currently,
there are no CVB licensed FMD vaccines or any foreign manufactured FMD vaccines
approved for permittee importation, sale or distribution in the
U.S. Without FMD vaccines that can he safely manufactured in the US
and FMD vaccines that allow the differentiation of vaccinated from infected
animals (DIVA), options
for responding to an FMD outbreak in the US are limited. An FMD
outbreak would result in the curtailment of meat and meat products for domestic
supply as well as a stoppage of meat exports leading to severe economic
consequences. U.S. exports of cattle, sheep, hogs, and many of their
products ranges from $6 to $10 billion/annum and many of these exports would
face restrictions during an FMD outbreak. Even if a single area of
one state was affected by FMD, trade restrictions could he imposed on the nation
as a whole, at least during the initial outbreak stage and it is estimated such
an outbreak could have more than a $100 billion impact on the U.S.
economy.
The
overarching goal of the proposed DHS S&T program is to develop next
generation, molecular-based, recombinant FMD vaccines that can differentiate
infected from vaccinated animals (DIVA) for licensure approval by
CVB. Following licensing approval, FMD vaccine lots can be produced
under procurement contracts with USDA APHIS Emergency Management for the
inclusion in the National Veterinary Stockpile.
DNS
S&T requires vaccine research and development services from GenVec, Inc.
(GenVec). GenVec is a contractor that has core competencies in patent
protected vaccine and therapeutic product technology platforms using
replication-deficient recombinant adenovirus serotype 5(rAd5)
vectors. GenVec also has experience in rAd5 production (scale-up and
downstream processing) with an integrated QA program.
XxxXxx
has collaborated with the U.S. Government on next generation, recombinant FMD
vaccine R&D since 2004. Specifically, USDA .ARS and
GenVec entered into Specific Cooperative Agreements (SCAs) in 2004-2005 and
2005-2006 to use reasonable commercial efforts to construct, produce and test
rAd5 based vectors containing FMDV serotype empty capsids as part of a Plum
Island FMD vaccine 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 FMD (AdFMD) vaccine candidates
since 2005.
The
outcome of this collaboration was the identification of a AdFMD vaccine
candidate for advanced development. The lead AdFMD vaccine candidate
is the first molecular-based FMD, DIVA vaccine. The lead vaccine
utilizes GenVec’s proprietary adenovector technology and is manufactured on a
proprietary, specialized cell line that is capable of producing protective FMDV
antigens without the use of the highly contagious FMD virus. Because
the vaccine candidate is produced without live or killed virus materials, it can
be safely produced in the U.S.
* 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.
20
DHS
executed a three-year Other Transaction Agreement with GenVec (base agreement
plus two (2) one year option periods; awarded 1 February 2007) to support the
development and manufacture of novel adenovector-based vaccines against
FMD. GenVec was responsible for the development, production and
regulatory components and DHS was responsible for conducting animal studies at
PIADC. During the base agreement ($5.98M), a lead vaccine candidate
for FMD was successfully identified utilizing GenVec’s proprietary adenovector
technology and a novel production cell line capable of producing FMD
antigens.
Based on
the deliverables produced and milestones achieved in the base agreement. the
first 12-month option period was executed ($5.6M, 5 September
2007). During Option Period One the development program for the lead
vaccine candidate was successfully expanded. Based on the
deliverables produced and milestones achieved in Option Year One, the second
12-month option period was executed ($6.6M, 29 July 2008). During
Option Period Two, the development program for the lead vaccine candidate has
significantly advanced and milestones and deliverables are currently on track
for the first AdFMD vaccine license approval by the USDA Center for Veterinary
Biologics (CVB) in November 2009.
In order
to build a pipeline of next generation, molecular, recombinant DIVA FMD vaccine
candidates that can be licensed in the U.S. and manufactured through procurement
by the USDA APHIS Emergency Management National Veterinary Stockpile, additional
research is needed to identify AdFMD serotype-specific FMD vaccine
candidates. In order to develop AdFMD vaccines that can be produced
and manufactured in the most cost effective method, additional development is
needed to improve current vaccine production and downstream processing methods
that will reduce AdFMD cost of goods. The purpose of this agreement
is to utilize GenVec’s R&D services to achieve these research and
development goals.
GenVec
has more than ten years of experience in the development of manufacturing
processes for applications in compliance with regulatory
standards. GenVec has successfully scaled its vector manufacturing
process to the one hundred liter (100L) scale and is currently coordinating
validation of this scaled-up manufacturing process for a therapeutic
application. GenVec has also developed a manufacturing process for
AdA24 FMD vaccine, transferring this process to a CVB-licensed facility for
manufacture of pre-license serial lots in support of a conditional
license. GenVec process scientists have experience in the development
of unit operations using both disposable and conventional technologies. GenVec’s
process engineers have experience in conducting process development projects
such as the one described in this proposal.
GenVec
also has experience with analytical testing methods in a regulated, quality
control environment. GenVec managed the production and release of
more than 50 clinical lots of Advector covering a wide array of
applications. GenVec developed its release assays for the AdA24 FMD
vaccine in compliance with USDA-CVB requirements. GenVec’s assay
development scientists have the experience to conduct assay development projects
described in this proposal.
II. Scope of Work -
Introduction
The
overarching goals of this SOW are two-fold: (4 Identify, produce and test three
new AdFMD-serotype vaccine candidates and make Go/No Go decision for transition
into the DHS Targeted Advanced Development FMD vaccine pipeline, and (ii)
increase AdFMD vaccine potency in order to lower the USG acquisition cost for
AdFMD vaccines for the National Veterinary Stockpile.
* 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.
21
The
proposed work is divided into two categories: Research and
Manufacturing Development. The Research portion is titled “Advector
Technology Development to Improve AdFMD Vaccine and Potency,” and the
manufacturing development portion is titled “FMD AdA24 Manufacturing
Development.” Each of the sections below contains information for the
research and manufacturing efforts. Some sections are further divided into
milestones.
A. Research
The first
research goal, identified as Research Milestone 1 (RM1) *. GenVec’s
technology is based on the use of adenovectors, in which a vector is an
adenovirus that has been modified to express certain proteins which, in this
case, generate an immune response against FMD. GenVec will prepare
these improved vectors using our * cell line technology for these new
FMD-serotype candidate vaccines. Candidate vaccines will be produced
with documentation sufficient to enable transition to a pathway for vaccine
development and licensing approval.
The
second research goal * These research programs are identified as
Research Milestones 2 and 3 (RM2 and RM3, respectively). The
technical rationale for each milestone is bolstered by the fact that similar
approaches with other disease targets have yielded encouraging
results. In RM2 and RM3, GenVec expects to produce between * vectors
to target FMD-serotypes for testing by the Department of Homeland Security
(DHS). These vaccine candidates will be constructed based on GenVec
technology and will be reviewed by DHS, though GenVec will not produce
documentation sufficient to allow these vectors to
proceed to further development.
B. Manufacturing
Development
GenVec’s
manufacturing development goal is to cut costs by simplifying the current
Advector manufacturing process. Manufacturing development work
focuses on developing an FMDV production process that can provide acceptable
virus yield and serve as the basis for future process scale-up required to
deliver material for anticipated vaccine stockpile needs. A
simplified manufacturing process is proposed *.
Under the
current DHS Other Transaction Agreement (Option Year 2), GenVec has developed a
small scale (40L) production process for manufacturing the AdFMD
vaccine. The current 40L process involves the following
steps:
|
1.
|
A*
|
This
manufacturing process was transferred to a CVB-licensed facility (XxxXx facility
operated by Benchmark BioLabs, BBL) for manufacture of Pre-License Serial Lots
(PLS) in support of Field Safety Studies. The overarching program
goal under the current Other Transaction Agreement (Option Year 2) is contract
is to obtain a conditional license from CVB by November 2009. Since
the priority during this contract phase was to meet this milestone timeline,
effort was not specifically focused on optimizing the process for scalability or
on reducing cost of goods. The current proposal now focuses on
reducing the cost of goods by simplifying the manufacturing
process.
* 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.
22
III. Statement of
Work
RESEARCH
MILESTONES
GenVec’s
Research work is divided into three milestones:
1.
|
Research
Milestone RM1- *
|
The chart
above illustrates the material steps in the preparation of an AdFMD vaccine, and
these steps arc outlined in detail below. All steps in RM1 should be completed prior
to making a Go/No Go decision on moving a vector from preseed testing to
production of master seed (outside the scope of this SOW).
Work Plan RMI
-
*
2.
Research Milestone RM2 - *
General Approach RM2
- *
Work Plan RM2 -
*
3.
Research Milestone RM3 - *
General Approach RM3
–*
Work Plan
RM3 -
*
MANUFACTURING
DEVELOPMENT MILESTONES
GenVec’s
manufacturing development work is divided into three milestones:
1.
Manufacturing Development Milestone DM1 - *
General Approach DM1
– *.
Work plan DM1
–*
2.
Manufacturing Development Milestone DM2 — *
General Approach DM2
- *
|
a.
|
Work Plan DM2 -
*
|
3.
Manufacturing Development Milestone D3 – *
General Approach DM3
- *
* 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.
23
|
Work
Plan DM3 -
*
|
IV. Deliverables.
See
Attachment 11 for detailed list and description of technical data and
deliverables associated with each of the six milestones.
V. Other Contract
Details
A.
|
Period of
Performance. The period of performance for the Base Year
is 12 month from the contract award date, which is followed by an Option
Year of 12 months that may be exercised at the Government’s discretion and
subject to the availability of
funds.
|
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.
|
D.
|
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 subcontractors where required as identified in this
SOW.
|
E.
|
DHS-Furnished
Property. DHS property will not be provided to GenVec,
Inc. unless otherwise agreed to by the parties of the
agreement.
|
F.
|
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 Contracting Officer and as otherwise specified in this
SOW.
|
G.
|
Publications.
DISSEMINATION OF CONTRACT INFORMATION (HSAR 3052.242-71) (DEC
2003)
|
The
Contractor shall not publish, permit to be published, or distribute for public
consumption, any information, oral or written, concerning the results or
conclusions made pursuant to the performance of this contract, without the prior
written consent of the Contracting Officer. An electronic or printed
copy of any material proposed to be published or distributed shall be submitted
to the Contracting Officer.
(End of
clause)
* 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.
24
H.
|
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.
|
I.
|
Security
Requirements. All work performed under this SOW is
unclassified unless otherwise specified by DFIS. If classified work
is required under this SOW, DHS will provide specific guidance to the
contractor as to Which work will he 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.
|
J.
|
Team Meetings/Communication
Plan. DHS/GenVec research-oriented meetings will he held
bi-weekly by teleconference. DHS/GenVEc R&D meetings will
be held monthly by videoconference. DHS/PIADC program meetings
will be held quarterly by videoconference or site
visits.
|
VI. Points of
Contact
GenVec,
Inc. Points of Contact (POCs) are as follows:
|
·
|
Technical
POC(s)
|
*
00 Xxxx
Xxxxxxx Xxxx
Gaithersburg,
MD 20878 Phone : * *
· Financial
POC(s)
*
00 Xxxx
Xxxxxxx Xxxx
Gaithersburg,
MD 20878
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.
25
The DHS
POCs are as follows:
|
·
|
DHS
S&T Technical Representative -
|
*
Science
& Technology
Department
of Homeland Security
Plum
Island Animal Disease Center
P.O. Box
848
Greenport,
NY.
Voice:
*
Fax:
*
Mobile:*
Email:
*
· Resource
Manager
*
Department
of Homeland Security
ATTN:
Science and Technology Directorate/Office,*
Washington,
DC 20528
Voice:*
Email: *
* 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.
26
Thrust:
Agricultural
Program:
FAD Vaccine & Diagnostics
Project:
Foot-and-Mouth Disease Vaccine Candidate Research and Development
ATTACHMENT
2 — STATEMENT OF WORK MILESTONES, DELIVERABLES
AND
TIMELINES
Milestone*
|
Deliverables
|
Timelines
|
Cost
|
|||||||||||||
BASE
YEAR
|
||||||||||||||||
RM1
|
*
|
2) *
|
*
|
$*
|
||||||||||||
RM2
|
*
|
*
|
*
|
$*
|
||||||||||||
RM3
|
*
|
*
|
*
|
$*
|
||||||||||||
|
* 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.
27
Thrust:
Agricultural
Program:
FAD Vaccine & Diagnostics
Project:
Foot-and-Mouth Disease Vaccine Candidate Research and Development
ATTACHMENT
2 — STATEMENT OF WORK MILESTONES, DELIVERABLES
AND
TIMELINES
DM1
|
*
|
1) *
|
*
|
$*
|
||||||||||||
DM2
|
*
|
*
|
*
|
$*
|
||||||||||||
DM3
|
*
|
*assays
|
*
|
$*
|
||||||||||||
Research
Milestones 1-3 Subtotal
|
$*
|
|||||||||||||||
Development
Milestones 1-3 Subtotal
|
$*
|
|||||||||||||||
BASE
YEAR
|
Research
and Development Milestone TOTAL.
|
$3,809,122
|
||||||||||||||
OPTION
YEAR
|
*
|
Deliverables
to be spelled out before exercising Option Year.
|
To
be determined, before exercising
Option Year
|
$746,766
|
||||||||||||
TOTAL
|
$4,555,888
|
* 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.
28
ATTACHMENT
3
To
be used as Alternate II to the Clause at 52.227-14, Rights in
Data-General
Special
License Notice
(a) These
data, computer software, and Licensed Inventions are submitted with special
license rights under Government Contract No. HSHQDC-10-C-00034. These
data, computer software, and licensed inventions may be reproduced and used by
the Government with the express limitation that they will not, without written
permission of the Contractor, be used for purposes of manufacture nor disclosed
outside the Government; except that the Government may disclose these data
outside the Government for the following purposes, if any; provided-that the
Government makes such disclosure subject to prohibition against further use and
disclosure:
(1)
Purpose.
This
license is to allow DHS to fulfill the Plum-Island Animal Disease Center’s
mission in perfecting an improved Foot and Mouth ‘Disease (FMD) vaccine, which
result will be accomplished by DHS’s meeting United States Department of
Agriculture (USDA) Center for Veterinary Biologics (CVB) licensing requirements
for Adenovirus-based FMD vaccine candidates and the procurement by the USDA for
inclusion in the Animal and Plant Health and Inspection Service (APHIS)
Emergency Management National Veterinary Stockpile. This license
provides the Government with certain rights in Licensed Inventions, copyrighted
works, proprietary technical data, and computer software.
(2)
Grant.
Accordingly,
GenVec, Inc. hereby grants the Government a Special Purpose License, as defined
in Paragraph (a)(3) of this License, in Adenovirus-based FMD viruses in any form
or embodiment, including vaccines and vaccine virus seeds. This
license shall remain in effect for the term of all patents licensed hereunder
without regard to the expiration, completion, or termination of Contract
HSHQDC-10-C-00034.
(3)
Definitions.
(i) “Special Purpose License,” for the
purposes of this contract, means: (1) a nonexclusive, irrevocable, worldwide,
paid up license to use, practice and have practiced any Licensed Inventions by
or on behalf of the Government for Government purposes and (2) a nonexclusive,
nontransferable, irrevocable, worldwide, paid up license to use, duplicate,
prepare derivative works, distribute,: or disclose copyrighted information or
Proprietary Information, listed in Attachment A to this License, and any other
Proprietary Information necessary to accomplishing the Purpose of this license,
in whole or in part and in any manner, and to have or permit others to do so,
for Government Purposes.
(ii) This “Special Purpose License” is
unconditionally binding upon any successors to GenVec, Inc.’s interests and will
remain in effect regardless of (i) the reorganization, merger, or consolidation
of GenVec, Inc. into or with another entity, corporate or otherwise, or the
liquidation or dissolution of GenVec, Inc. or the sale or other disposition of
all or substantially all of the capital stock, business, or assets of GenVec,
Inc. to any other person or party, or (ii) the institution of any bankruptcy,
reorganization, insolvency, debt agreement, or receivership proceedings by or
against GenVec, Inc., or adjudication of GenVec, Inc. as a
bankrupt.
* 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.
29
(iii)(A) “Government Purposes,” for the
purpose of this contract, include, but are not limited to, the right of the
Government to solicit competitively, to contract for, and to transfer GenVec,
Inc. made Adenovirus-based FMD vaccine candidates and master seed 293-ORF6 and
M2A cell lines to third parties for use in the production and manufacturing of
Adenovirus-based FMD vaccine candidate master seeds, working seeds, clinical
lots, and Pre-Licensing Serials for the purpose of obtaining USDA Conditional or
final license approval of the Adenovirus-based FMD vaccines owned by GenVec,
Inc. Government purposes include the competitive solicitation and
procurement of services relating to the license application to and processing of
the application with USDA. Government purposes include the right to
transfer GenVec, Inc.-made Adenovirus-based FMD vaccine candidates to third
parties to perform Adenovirus-based FMD vaccine process improvements and
Adenovirus-based FMD vaccine yield optimization services.
“Government
Purposes” also include the solicitation by, purchase by, and distribution by the
Animal and Plant Health and Inspection Service (APHIS) of the manufactured FMD
vaccine and the use by distributees and recipients of the vaccine from APHIS of
the Adenovirus-based FMD USDA CVB licensed vaccines using Adenovirus-based FMD
working seeds derived from pre-master seed Adenovirus-based FMD vaccine virus
R&D stocks and master cell stocks produced from * cell line made by GenVec,
Inc. Contractor shall not charge Third Party Licensees or the US Government a
royalty as a result or the solicitation by, manufacturing for, purchase by, and
distribution by APHIS of the manufactured FMD vaccine and the use by distributees and
recipients of the vaccine from APHIS of the Adenovirus-based FMD USDA CVB
licensed vaccines using Adenovirus-based FMD working seeds derived from
pre-master seed Adenovirus-based FMD vaccine virus R&D stocks and master cell
stocks produced from * cell line made by GenVec, Inc. and shall assure that each
Third Party License prohibits a Third Party Licensee from charging any portion
of or any entire Third Party Royalty to the US Government.
“Third
Party License” shall mean a license granted by GenVec to a Third Party Licensee
to practice the Licensed Inventions for the purpose of solicitation by, purchase
by, and distribution by APHIS of the manufactured FMD vaccine and the use by
distributees and recipients of the vaccine from APHIS of the Adenovirus-based
FMD USDA CVB licensed vaccines using Adenovirus-based FMD working seeds derived
from pre-master seed Adenovirus-based FMD vaccine virus R&D stocks and
master cell stocks produced from* cell line made by GenVec.
(B) “Government Purposes” include the
right of the Department of Homeland Security to competitively solicit and
procure:
1. Adenovirus-based FMD master seed
vaccine virus stocks derived from Adenovirus-based FMD pre-master seed vaccine
virus stocks made by GenVec, Inc.;
2. Adenovirus-based FMD master seed
derived vaccine virus working seed stocks derived from pre-master seed
Adenovirus-based FMD vaccine virus research and development (R&D) stocks
made by GenVec, Inc.:
3. Adenovirus-based FMD vaccine
candidate clinical lots made from Adenovirus-based FMD master seed vaccine virus
derived from pre-master seed Adenovirus-based FMD vaccine virus R&D stocks
made by GenVec, Inc.:
4. Adenovirus-based FMD vaccine
candidate pre-licensing serial lots made from Adenovirus-based FMD master seed
vaccine virus derived from pre-master seed Adenovirus-based FMD vaccine virus
R&D stocks and master cell stocks produced from * or * cell line made by
GenVec, Inc.;
* 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.
30
5. Animal testing of Adenovirus-based
FMD vaccine candidate clinical lots and pre-licensing serial lots made from
Adenovirus-based FMD master seed vaccine virus derived from pre-master seed
vaccine virus Adenovirus-based FMD R&D stocks and master cell stocks
produced from * or * cell line made by GenVec, Inc.;
6. U.S. veterinary regulatory services
and expertise for Adenovirus-based FMD vaccine candidates seeds derived from
pre-master seed Adenovirus-based FMD vaccine virus R&D stocks made by
GenVec, Inc.;
7. Adenovirus-based FMD vaccine
process improvement and vaccine yield optimization services using
Adenovirus-based FMD master seed derived working seed vaccine virus derived from
pre-master seed Adenovirus-based FMD vaccine virus R&D stocks and master
cell stocks produced from * or * cell line made by GenVec, Inc.;
and
(C) Except for standard USDA regulatory
safety testing of Master and Working Cell Banks (such as, for example, testing
for sterility, mycoplasma, in vivo and in vitro adventitious virus), clinical
trials. or other processes necessary to acquire USDA approval, “Government
Purposes” do not include:
1. The right of the Government or
third parties to characterize, or issue Releases or Certificates of Analysis
for, or analyze the genome of, any * or * cell, or engage in any research of *or
* cells that
concerns any safety, toxicity or tumorigenicity of * or * cells, without the
prior written agreement of GenVec, Inc., such agreement not to be unreasonably
withheld or delayed.
2. The right to have or permit others
to practice a Licensed Invention or use, duplicate, prepare derivative works,
distribute or disclose copyrighted works or Proprietary Information for
commercial purposes, including but not limited to sales of products other than
to the Government for distribution in the United States.
3. The right to have or permit third
parties to change, modify, or alter the molecular composition or genetic
structure of the Adenovirus-based FMD vaccine candidates.
(iv) “Licensed Inventions,” for the
purposes of this contract, means U.S. Patent Nos. *, and any other invention of
which a GenVec employee is an inventor or co-inventor that would aid in
accomplishing the purpose of this license.
(v) “*,” “*,” or “*,” for the purposes
of this Contract, means:
(A) Cell line composed of
*cells;
(B) Cells or cell lines derived from *
cells, based upon further modifications and/or alterations of the genome of the
* cells; and
(4) Regulatory
Consultation.
The
Department of Homeland Security agrees to use its best efforts to promptly
notify GenVec, Inc. of any and all communications to and from Regulatory
Authorities relating to the safety of * or * cells, and agrees to consult
promptly with * or* to resolve any such concerns with the CVB or such other
Regulatory Authorities. Notwithstanding any of the foregoing, the
Department of Homeland shall not be prohibited from taking any action(s) to
comply with any requirements of the CVB or other Regulatory
Authorities.
* 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.
31
(b) This
notice shall be marked on any reproduction of these data, computer software, or
Licensed Inventions, in whole or in part.
(End of
notice)
Attachment
A
Specific
copyrighted information or Proprietary Information,
All CVB
regulatory submissions associated with USDA product (unlicensed)
code
Adt.A24.11D
including, but not limited to documents and reports associated
with:
1. Master seed virus
(Adt.A24.11D)
2. Master seed stock cell line
(*)
3. Adt.A24.11D Outline of
Production
4. Adt.A24.11D Special
Outlines
5. Adt.A24.11D Potency test
development
6. Adt.A24.11D In-process
procedures
7. Adt.A24.11D Summary of Information
Format
8. Adt.A24.11D Risk
Assessment
9.
Adt.A24.11D protocols for studies of host animal immunogenicity/efficacy,
safety,backpassage, shed/spread, immunological interference
10. Adt.A24.11D Field Safety
Studies
11. Adt.A24.11D Stability
Studies
12. Adt.A24.11D Veterinary Biologics
Production (prelicensing serials) and Test Reports
GenVec
Patent Applications
09/964065
* 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.
32