Exhibit
10.33


 


*** Text Omitted and Filed
Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and
240.24b-2


 


SAIC FREDERICK Solicitation, Offer and Award


 


1.                    Maryland Sales
and Use Tax Direct Pay Permit No. 3


 


2.                    Subcontract
No.


23XS003


 


3.                    Solicitation
No.


S03-003


 


4.                    o  Sealed Bid (IFB)


ý  Negotiated (RFP)


 


5.                    Date Issued


4/01/03


 


6.                    Requisition/Purchase
No.


DD1069


 


7.                    Issued By:          Address Offer To:


SAIC-Frederick, Inc.

NCI-Frederick Cancer Research & Development Center

P.O. Box B

Attn:  Bldg. 244, Rm. 227, Miller Drive,
Fort Detrick

Frederick, Maryland  21702-1201


 


8.                    Delivery
Date:  Specified in resulting Delivery
Orders


 


8A.          Place of Delivery:  N/A


 


8B.             ̈
FOB Destination                                                                                                          ý
FOB Origin


 


NOTE:  In sealed bid
solicitation “offer” and “offeror” mean “bid” and “bidder”.


 


SOLICITATION


 


9.                    To be timely sealed offers in original
and        copies must be received at
the room specified in Item 7
by        local time
          .


Envelopes
shall be marked to show solicitation number and time.                                                                       (hour)             (date)


 


10.              FOR
INFORMATIONCALL:


 


A.                NAME   Jean
LaPadula


B.                  Telephone No. (Include area code) (NO COLLECT CALLS)


(301) 644-2045


 


OFFER/SUBCONTRACT CONSISTS OF:


 


Part 1 - The Schedule


 


A.                Solicitation/Contract Form


B.                  Supplies or Services and Prices/Costs


C.                  Description/Specs./Statement of Work


D.                 Packaging and Marking


E.                   Inspection and Acceptance


F.                   Deliveries or Performance


H.                 Special Contract Requirements


 


Part II - Contract Clauses


 


I.                      Contract Clauses


 


Part III - List Of Documents, Exhibits and Other Attachments


 


J.                     List of Attachments


 


Part IV - Representations and Instructions


 


K.                 Representations, Certifications and Other Statements
of Offerors


 


SCHEDULE


 


	
  ITEM

  NO.

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QTY.

  	
   

  	
  UNIT

  	
   

  	
  UNIT PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
   

  	
   

  	
  SEE
  STATEMENT OF WORK IN SECTION C.

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [...***...]

  	
   

  



 


12.              In compliance with
the above, if this offer is accepted within
             calendar
days (60 calendar days unless a
different period is inserted by the offeror) from the date for receipt
of offers specified above, to furnish any or all items upon which prices are
offered at the price set opposite each item in accordance with the terms of the
offer.  Note:  Sealed bids providing less
than         calendar days for
acceptance will be considered non-responsive and rejected.


 


	
   

  	
   

  	
  10
  Calendar Days

  	
   

  	
  20
  Calendar Days

  	
   

  	
  30
  Calendar Days

  	
   

  	
       Calendar
  Days

  	
   

  
	
  13.              DISCOUNT FOR
  PROMPT PAYMENT

  (See Section D, Clause No. 52.232-8)

  	
   

  	
  0

  	
  %

  	
  0

  	
  %

  	
  0

  	
  %

  	
  0

  	
  %

  



 


14.  ACKNOWLEDGMENT OF AMENDMENTS


 


The offeror acknowledges receipt of
amendments to the solicitation for offerors and related documents numbered and
dated:


 


	
   

  	
   

  	
  AMENDMENT
  NO.

  	
   

  	
  DATE

  	
   

  	
  AMENDMENT
  NO.

  	
   

  	
  DATE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


15A.    Name and Address of Offeror


 


Vical, Inc.

10390 Pacific Centre Court

San Diego, CA  92121


 


15B.      Telephone No. (Include
Area Code):   858-646-1100


 


15C.       ̈  Check if remittance address is different
from above.  Enter such address in
schedule.


 


16.              Name and Title of
Person Authorized to Sign Offer (Type or print)


 


Vijay B. Samant

President and CEO


 


17.              Signature


	
  /s/ Vijay B. Samant

  	
   

  



 


18.              Offer Date April 4,
2003


 


AWARD (On
this form or by other written notice)


 


19.              Accepted As To Items
Numbered:


 


20.              IDIQ – Minimum
obligation is [...***...]


 


21.              Accounting Data:


 


22.              Submit Invoices to
Address, Item 7, Attn.:  Accounts
Payable (3 copies unless other specified)


 


23.  Name/Title of Person Authorized to Sign –
SAIC


Dennis
Dougherty


Manager,
Research Contracts


 


24.  Signature of Person Authorized to Sign –
SAIC


 


	
  /s/ Dennis
  J. Dougherty

  	
   

  



 


28.  Award Date


 


5/6/03


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


	
  CONTRACT NO.

  	
   

  	
   

  
	
  23XS003

  	
   

  	
  SPECIAL
  PROVISIONS

  



 


PART I


 


SECTION A - SOLICITATION, OFFER AND
AWARD FORM


 


1

















 


TABLE
OF CONTRACT CONTENTS


 


	
  PART I

  	
   

  	
   

  
	
  SECTION A - SOLICITATION, OFFER AND AWARD FORM

  	
   

  	
   

  
	
  TABLE OF
  CONTRACT CONTENTS

  	
   

  	
   

  
	
  SECTION B - SUPPLIES OR SERVICES AND PRICES/COST

  	
   

  	
   

  
	
  SECTION C - DESCRIPTION/SPECIFICATION/STATEMENT OF WORK

  	
   

  	
   

  
	
  SECTION D - PACKAGING AND SHIPMENT

  	
   

  	
   

  
	
  SECTION E - INSPECTION AND ACCEPTANCE

  	
   

  	
   

  
	
  SECTION F - DELIVERIES OR PERFORMANCE

  	
   

  	
   

  
	
  SECTION G - CONTRACT ADMINISTRATION DATA

  	
   

  	
   

  
	
  SECTION H - SPECIAL CONTRACT REQUIREMENTS

  	
   

  	
   

  
	
  PART II

  	
   

  	
   

  
	
  SECTION I – CONTRACT CLAUSES

  	
   

  	
   

  
	
  PART
  III

  	
   

  	
   

  
	
  SECTION J – LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS

  	
   

  	
   

  
	
  PART IV—REPRESENTATIONS AND INSTRUCTIONS

  	
   

  	
   

  
	
  SECTION K–REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF
  OFFERORS

  	
   

  	
   

  



 


2

















 


SECTION B - SUPPLIES OR SERVICES AND PRICES/COST


 


ARTICLE B.1. BRIEF
DESCRIPTION OF SUPPLIES OR SERVICES


 


A.                                   SAIC Frederick, Inc. (hereafter “SAIC” or
“Government”) under its Operations and Technical Support (OTS) contract with
the National Cancer Institute – Frederick (“NCI”) requests Vical, Inc.
(“Contractor”) to produce DNA plasmids on a delivery order basis for the
Vaccine Research Center (VRC).


 


B.                                     This is an Indefinite Delivery/Indefinite
Quantity Contract for the supplies or services specified in Section C,
Description/Specifications/Statement of Work. 
The quantities of supplies and services specified in the Schedule are
estimates only and are not purchased by this contract.  Work shall proceed upon the issuance of a
Delivery Order issued by the SAIC Contracting Officer.  The Delivery Order issued shall be on a
fixed price basis.  Payment shall be
made at the unit contract price(s) established for the initial period of
performance and each option period specified in Article B.2.  The period of performance is for (1) year
after date of award with four (4) additional one-year option years to be
unilaterally exercised by the Government. The total duration of this contract
shall be for five years if all option years are exercised.


 


C.                                     Independently, and not as an agent of the
Government, the Contractor shall furnish services, qualified personnel,
materials, equipment, and facilities, not otherwise provided by the Government
under the terms of this Indefinite Delivery/Indefinite Quantity Contract, as
needed to produce DNA plasmids, or to otherwise perform the Statement of Work
(SOW) specified in Section C herein.


 


ARTICLE B.2. PRICES/COSTS


 


Delivery Orders will be placed utilizing the
following pricing for each corresponding year of performance:


 


001 – 100-Liter Small-Scale Production 


 


	
  Description

  	
   

  	
  Base Year

  	
   

  	
  Option

  Year 1

  	
   

  	
  Option

  Year 2

  	
   

  	
  Option

  Year 3

  	
   

  	
  Option

  Year 4

  	
   

  
	
  Price per week

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  



 


Note: The Contractor is responsible for
vialing, labeling, and packaging of material produced with the 100-Liter
manufacturing train. All vials [...***...] will be filled up to a concentration of [...***...] / mL and to a volume of [...***...] unless otherwise specified in resulting
Delivery Orders.  The maximum number of
vials to be filled by the Contractor cannot exceed [...***...] per two fermentation runs.


 


002 – 500-Liter Large-Scale Production


 


	
  Description

  	
   

  	
  Base Year

  	
   

  	
  Option

  Year 1

  	
   

  	
  Option

  Year 2

  	
   

  	
  Option

  Year 3

  	
   

  	
  Option

  Year 4

  	
   

  
	
  Price per week

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  



 


Note: The Contractor is not responsible for
formulating, vialing, labeling, or packaging material produced with the
500-Liter manufacturing  train.


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 


3

















 


003 – Preparation of Master Cell Bank


 


	
  Description

  	
   

  	
  Base Year

  	
   

  	
  Option

  Year 1

  	
   

  	
  Option

  Year 2

  	
   

  	
  Option

  Year 3

  	
   

  	
  Option

  Year 4

  	
   

  
	
  Price per Master Cell Bank

  	
   

  	
  [...***...]

  	
   

  	
  [...**...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  	
  [...***...]

  	
   

  



 


Note: Government is responsible for costs
associated with the procurement of adventitious agent testing and DNA
sequencing.


 


004 – Document Preparation and Shipping


 


	
  Description

  	
   

  	
  Base Year

  	
   

  	
  Option

  Year 1

  	
   

  	
  Option

  Year 2

  	
   

  	
  Option

  Year 3

  	
   

  	
  Option

  Year 4

  	
   

  
	
  Document preparation and shipping
  preparation per shipment.

  	
   

  	
  [...***...]

  	
   

  	
  [...**...]

  	
   

  	
  [...**...]

  	
   

  	
  [...**...]

  	
   

  	
  [...**...]

  	
   

  



 


005 – Stability Testing


 


	
  Description

  	
   

  	
  Base Year

  	
   

  	
  Option

  Year 1

  	
   

  	
  Option

  Year 2

  	
   

  	
  Option

  Year 3

  	
   

  	
  Option

  Year 4

  	
   

  
	
  Stability Testing per test

  	
   

  	
  [...**...]

  	
   

  	
  [...**...]

  	
   

  	
  [...**...]

  	
   

  	
  [...**...]

  	
   

  	
  [...**...]

  	
   

  



 


Note:                   The following costs are not included in the fixed prices listed in Line
Items 001-005:


1.               Sequencing of new plasmids;


2.               Post-bulk expression testing;


3.               Adventitious agent testing of Master Cell
Bank; and


4.               DNA sequencing of Master Cell Bank.


 


General Assumptions:


1.  Plasmid size is no larger than 10,000 base
pairs


 


ARTICLE
B.3.  ITEMS TO BE FURNISHED TO THE
CONTRACTOR


 


A.                                   The Government will provide the Contractor
with equipment consisting of a 500-Liter manufacturing train (Article G.3.B).  The equipment is Government property and
shall be used for this project only and shall not be used subsequently by the
Contractor for any for-profit or non-for-profit venture without explicit
written permission of SAIC-Frederick, Inc. 
Following the receipt of authorization to use the equipment, the
Contractor may use the equipment for the approved dates for a fee (Note: fee is
a percentage of purchase price calculated in accordance with FAR 52.245-9
(c)(i)).  The Government will evaluate
in good faith specific requests made by Contractor for waiver of the rental fee
on a case-by-case basis. The Government shall not unreasonably deny requests
from the Contractor for commercial use of the equipment.


 


In addition to providing
equipment, the Government will pay to install and validate the equipment in the
Contractor’s facility.  Contractor is
responsible for all costs related to facility improvements, including but not
limited to upsizing utilities, and proper maintenance and repair of the
equipment.  Contractor shall provide
equipment maintenance records to the Government on an annual basis for all
Government-


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 


4

















 


owned equipment.


 


At contract termination, the
Government and the Contractor will mutually select and pay for an independent
appraiser to appraise the current fair market value(1) of the equipment which
appraisal shall assess only the fair market value of the equipment excluding
the facilities and any facility improvements. 
The government and Contractor will negotiate a fair and reasonable price
for the equipment based on the appraised value.


 


B.                                     The Government shall provide the Contractor
plasmids suitably developed (i.e. reasonably optimized for growth, plasmid
yield and plasmid stability) for clinical trial production (as identified in
resulting Delivery Orders).  All materials
and products, provided by the Government shall be used for this project only
and shall not be used subsequently by the Contractor for any for-profit or
not-for-profit venture without explicit written permission of SAIC-Frederick,
Inc.  Following contract completion, the
DNA plasmids should be returned or disposed of as directed by the COTR.


 


C.                                     In the event items are not furnished by the
date specified, the Delivery Order will be modified, as necessary, to
accommodate the delay (FAR 52.242-17, Government Delay of Work, April 1984).


 


D.                                    The Contractor is responsible for the
Contractor’s loss or damage of Government furnished equipment, tools and
supplies.


 


 












(1)  Definition of fair market value: “The price a willing and
knowledgeable buyer would pay to a willing and knowledgeable seller, both free
from mistake or coercion, without regard to increases or decreases attributable
to the project for which the property is being acquired.”  Source: GAO; "Principles of Federal
Appropriations Law;" Second Addition; Volume IV; March 2001.


 


5

















 


SECTION C -
DESCRIPTION/SPECIFICATION/STATEMENT OF WORK


 


ARTICLE C.1.  STATEMENT OF WORK


 


A.                                    Background


 


The Vaccine Research
Center (VRC) has an on-going need for DNA plasmids to support clinical trials
of different vaccine products.  The
purpose of this contract is to enable the VRC to quickly fulfill requirements
for DNA plasmids through the issuance of Delivery Orders.


 


B.                                    Scope


 


The scope of this
contract is the cGMP production of DNA plasmids for use in Phase I or Phase II
human clinical trials for the specified disease targets (see below). Production
of plasmids at the 100 liter scale shall include production, formulation in
saline, vialing, labeling, packaging and storage of product.  Production of plasmids at the 500 liter
scale shall include only the production of bulk product.


 


The Contractor shall
manufacture DNA plasmids for the following disease targets for the base year
and all option years:


 


[...***...]


 


The Contractor shall
manufacture DNA plasmids for the following disease targets during the base year
of this contract (written agreement from the Contractor is required for the
manufacture of these plasmids for each option year):


 


[...***...]


 


C.                                    Tasks


 


The Contractor shall
manufacture products as specified in resulting Delivery Orders.  The
Contractor will develop and produce specified amounts (defined in resulting
delivery orders) of clinical grade lots (cGMP) of DNA plasmids in suitable
packaging and purity for clinical human vaccine trials.  In addition, the Contractor shall provide
storage required for stability testing of the plasmids.  Stability testing shall be performed in
accordance with cGMP guidelines and all of the relevant Points to Consider at
the Contractor’s facility for a maximum of two (2) years following each
production or at the first time point following last clinical use.


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 


6

















 


1.                                       The Contractor shall
complete the following tasks to produce the specified vaccine products as
directed by the COTR:


 


a.                    Where applicable, obtain starting materials from
product inventor/supplier. Complete a material transfer agreement, if needed.


 


b.                   As applicable and as requested by the Government,
prepare a Master Cell Bank including the preparation of approximately 50
glycerol stock tubes, to be stored in liquid nitrogen.  The Contractor will manage the
administration of adventitious agent testing and DNA sequencing of the Master
Cell Bank. Costs associated with the procurement of adventitious agent testing
and DNA sequencing shall be borne by the Government.


 


c.                    Develop detailed production plan and timeline for
manufacture of lots of candidate vaccine products.


 


d.                   Where applicable, purchase or otherwise acquire
products and materials necessary for production of stated vaccine product.


 


e.                    Produce vaccine product in a form suitable for
use in human clinical studies. These products shall be prepared under cGMP
conditions (Article C.1.3).


 


f.                      Prepare vaccine product for shipment as specified
in Article D.1.


 


g.                   The Contractor shall provide notification of all
deviations, Out of Specifications (OOS), and failure investigations to the COTR
(Article G.1.B) and Program Manager (Article G.1.C) within 5 business days.


 


2.                                       The Contractor shall
provide the necessary facilities, equipment and resources including:


 


a.                             Provide facilities and equipment suitable for
cGMP production of vaccine product.  All
equipment and room identification must be traceable to batch records.


 


b.                            Maintain and operate controlled storage of
samples at appropriate temperatures with appropriate monitoring for failure
(Room temperature through -70°C. Liquid nitrogen storage may be required for
some products.)


 


c.                             If necessary, receive, store and manipulate
biohazardous materials (Biosafety Level 1 Containment) and maintain their
viability in facilities, which provide aseptic and/or sterile conditions as
appropriate.


 


d.                            If necessary, provide protective garments,
equipment and sufficient monitoring to assure safe handling of potentially
hazardous materials, employed by Contractor, for the safety and protection of
workers.


 


e.                             Conduct work under the contract in accordance
with all applicable and current Federal, state, and local laws, codes,
ordinances and regulations, as well as all PHS Safety and Health provisions.


 


7

















 


3.                                       Other than Potency
Testing, the Contractor shall perform or manage as applicable the
subcontracting of vaccine lot characterization tests.


 


At
various steps during the manufacture of a vaccine the product must be
characterized.  Prior to use of a vaccine in clinical studies the
manufactured vaccine will need to undergo final lot release testing.  As described in the regulations for General
Biological Product Standards (21 CFR 610) the following tests must be performed
for each lot of vaccine.


 


a.                             Test for Potency.  A test for potency
(21 CFR 610.10) will evaluate in an in vitro or in vivo test the specific
ability of the vaccine to effect a given response, such as an immune response
in mice, which should be supportive of the efficacy of the vaccine in
humans.  In the case of DNA vaccines potency may be evidenced by the
production of the pertinent antigen in a transfected cell line.  This test will be performed by and at the
Vaccine Research Center, NIAID, NIH.


 


b.                            Test for General Safety.  The general
safety test (21 CFR 610.11) must be performed in mice and guinea pigs on each
lot of vaccine to detect extraneous toxic contaminants potentially introduced
during manufacture.


 


c.                             Test for Sterility.  A test for
sterility (21 CFR 610.12) must be performed as described in the regulations.


 


d.                            Test for Purity.  A test for purity (21
CFR 610.13) must be performed on each lot to ensure that the product is free
from extraneous material except for that which is unavoidable due to the
manufacturing process.  In addition, the test for purity includes an
evaluation of residual ethanol and the presence of pyrogenic substances in the product
as necessary.


 


e.                             Test for Identity.  The test for
identity (21 CFR 601.14) is generally a physical or chemical test performed to
establish the identity of the material in the final container.


 


f.                               Test for Quantity.  A measure of the
amount of material present is imperative for calculating the dilution of the
bulk material required for the final container fill.


 


g.                            For materials produced at the 100 liter
scale, perform stability testing at 3, 6, 9, 12, 18 and 24 months post-fill, or
at the first time point following last clinical use.  The Government shall inform Contractor of the specific stability
tests (ex: gel electrophoresis, HPLC analysis for conformers, pH as
appropriate) requested 60 days prior to initiation of such tests. Contractor
will not be responsible for developing or administering expression / potency
assays.


 


4.                                       Contractor shall provide the following
information to the VRC to aid in applicable regulatory submissions for products
produced under this contract:


 


a.                    IND/BMF
cross-reference authorization


 


b.                   CMC
documentation for finished product


 


c.                    Quality
Assurance review / certificates of analysis


 


8

















 


5.                                       Participate in discussions with the FDA
during pre-IND and IND meetings.


 


6.                                       Meet with the COTR at periodic intervals, to
be scheduled after contract award.


 


7.                                       Retain all records, samples,
histopathological slides, etc. as indicated and as applicable under GLP and
cGMP guidelines and make them available.


 


ARTICLE C.2.  DELIVERABLES


 


A.                                   The Contractor shall provide the following
deliverables at each of the designated milestones:


 


	
  Milestone

  	
   

  	
  Deliverable

  	
   

  	
  Delivery Date

  
	
  1/4 of total processing
  weeks completed

  	
   

  	
  A quality assurance
  document specifying the following:  

  	
   

  	
  One calendar month following
  achievement of milestone.

  
	
   

  	
  1)  Results of wet cell weight assay from
  completed fermentations during period.

  	
   

  
	
   

  	
   

  	
  2)  Results of crude yield estimate based on
  optical density from lysis completed during period.

  	
   

  	
   

  
	
   

  	
   

  	
  3)  Results of chromatography yield estimate
  based on optical density from chromatography completed during period.

  	
   

  	
   

  
	
   

  	
   

  	
  4)  Any final product completed during period.

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1/2 of total processing
  weeks completed

  	
   

  	
  A quality assurance
  document specifying the following:

  	
   

  	
  One calendar month following
  achievement of milestone.

  
	
   

  	
  1)  Results of wet cell weight assay from
  completed fermentations during period.

  	
   

  
	
   

  	
   

  	
  2)  Results of crude yield estimate based on
  optical density from lysis completed during period.  

  	
   

  	
   

  
	
   

  	
   

  	
  3)  Results of chromatography yield estimate
  based on optical density from chromatography completed during period.

  	
   

  	
   

  
	
   

  	
   

  	
  4)  Any final product completed during period.

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3/4 of total processing
  weeks completed

  	
   

  	
  A quality assurance
  document specifying the following:  

  	
   

  	
  One calendar month
  following achievement of milestone.

  
	
   

  	
  1)  Results of wet cell weight assay from
  completed fermentations during period.  

  	
   

  
	
   

  	
   

  	
  2)  Results of crude yield estimate based on
  optical density from lysis completed during period.  

  	
   

  	
   

  
	
   

  	
   

  	
  3)  Results of chromatography yield estimate
  based on optical density from chromatography completed during period.

  	
   

  	
   

  
	
   

  	
   

  	
  4)  Any final product completed during period.

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Completion of all
  processing weeks

  	
   

  	
  A quality assurance
  document specifying the following:  

  	
   

  	
  One calendar month
  following achievement of milestone.

  
	
   

  	
  1)  Results of wet cell weight assay from
  completed fermentations during period.  

  	
   

  
	
   

  	
   

  	
  2)  Results of crude yield estimate based on
  optical density from lysis completed during period.  

  	
   

  	
   

  
	
   

  	
   

  	
  3)  Results of chromatography yield estimate
  based on optical density from chromatography completed during period.  

  	
   

  	
   

  
	
   

  	
   

  	
  4)  Any final product completed during period.

  	
   

  	
   

  



 


B.                                     The Contractor shall provide the following
deliverables following completion of the final milestone:


 


9

















 


•                  Clinical grade lots (cGMP) of DNA plasmids in
suitable packaging and purity for clinical human vaccine trials in amount
specified in Delivery Orders.


•                  IND/BMF cross-reference authorization


•                  CMC documentation for finished product


•                  Quality assurance review / certificates of
analysis


•                  Certificate of conformance (see Attachment A
for template)


 


10

















 


ARTICLE C.3.  GUARANTEED MINIMUM
AMOUNTS


 


A.           The Contractor shall deliver the following minimum quantity of bulk
material for processing weeks purchased at either the 100-Liter or 500-Liter
scale based on the table below:


 


	
  Column A

  	
   

  	
  Column B

  	
   

  	
  Column C

  
	
  Total
  Fermentation Yield (Sum of all grams of cell paste produced during
  fermentation runs)

  	
   

  	
  Multiplication
  Factor

  	
   

  	
  Minimum
  Quantity of Bulk Material (in milligrams) be Delivered by Contractor

  
	
  [Determined
  upon completion of fermentations]

  	
   

  	
  [...***...]

  	
   

  	
  Column
  A * Column B

  



 


Example:


1)              Contractor completes two fermentation runs
and produces [...***...] grams of cell paste.


2)              Using the above table, multiply [...***...]
by [...***...] = [...***...]. 
Contractor will deliver a minimum of [...***...]
mg of bulk plasmid DNA.


 


B.                                     In addition, Contractor shall also perform a
minimum of two fermentation runs per “block” of processing time purchased at
the 100 liter scale, and a minimum of one fermentation run per “block” of
processing time purchased at the 500 liter scale.  Contractor shall also achieve a minimum cell paste of [...***...]
grams per fermentor at the 100 liter scale, and [...***...]
grams of cell paste per fermentor at the 500 liter scale.


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 


11

















 


SECTION D - PACKAGING AND SHIPMENT


 


ARTICLE D.1.  PACKAGING AND
SHIPMENT


 


Contractor shall prepare all materials for
shipment in accordance with applicable International Air Transport Association
(IATA) guidelines.


 


All deliverables shall be shipped F.O.B. –
Origin


 


ARTICLE D.2.  RELEASE OF
MATERIALS


 


The Contractor shall submit the Certificate
of Analysis and other appropriate documentation to SAIC-Frederick, Inc.
following completion of the production of plasmids.  The SAIC-Frederick, Inc. COTR will be responsible for review and
acceptance of the documentation and materials. 
Prior to release of any materials produced by Contractor, the Government
shall review applicable batch records at the Contractor’s facility.  Upon acceptance of materials, the Government
shall send written verification of its acceptance of materials.  Prior to final release of materials for
shipment, the Government shall send written notification. The Contractor shall
not release materials for shipment prior to receiving written authorization from
the SAIC-Frederick, Inc. Contracting Officer. 
Following approval, SAIC-Frederick, Inc. will coordinate and pay for the
shipment of materials.


 


The Contractor shall store complete bulk and
finished materials for a maximum of three months.


 


12

















 


SECTION E - INSPECTION AND ACCEPTANCE


 


ARTICLE E.1.  INSPECTION AND ACCEPTANCE


 


A.                                   The acceptance criteria (i.e, expression test
and pass/fail assays) for each plasmid shall be defined and documented in the
Materials Ordering Form. The acceptance criteria for all materials shall be
mutually agreed upon in writing prior to the issuance of the first Delivery
Order.


 


B.                                     The Contracting Officer or a duly authorized
representative will perform the evaluation of the research services and
acceptance of deliverables provided.


 


C.                                     For the purpose of this Article, the SAIC
Contracting Officer’s Technical Representative (COTR) is the authorized
technical representative of the Contracting Officer, unless specified otherwise
in an individual Delivery Order.


 


D.                                    This contract incorporates the following
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 http://www.arnet.gov/far/.


 


FEDERAL ACQUISITION
REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES


 


	
  FAR Clause
  No.

  	
   

  	
  Clause
  Title

  	
   

  	
  Date

  	
   

  
	
  52.246-2

  	
   

  	
  Inspection
  of Supplies – Fixed Price

  	
   

  	
  Aug-1996

  	
   

  



 


ARTICLE
E.2. cGMP INSPECTION REQUIREMENTS


 


A.           Review of Material
Production Records.  The Contractor shall have established
procedures for regularly assessing a contract manufacturing facility’s
compliance with the applicable product and establishment standards. This may
include, but is not limited to, review of all batch records and manufacturing
deviations and defects, and periodic audits. 
Contract facilities engaged in the manufacture of a biological product
are responsible for compliance with applicable provisions of the FD&C Act
and will be subject to FDA inspection as provided for inspection 351(c) of the
PHS Act and section 704(a) of the FD&C Act. The Contractor shall ensure
that all owned and contract facilities are ready for inspection by
SAIC-Frederick, Inc. and Government staff. 
Upon 15 business days advance written notice, the Contractor shall
permit appropriately skilled representatives of SAIC-Frederick, Inc. or the
Government, at SAIC-Frederick, Inc.’s expense, to have access, as necessary,
during the Contractor’s normal business hours to inspect Contractor’s records
as may be reasonably necessary to verify that the product manufactured by the
Contractor are in accordance with Good Manufacturing Practices (GMP) and
conform to the specifications outlined in this contract


 


B.             Routine
cGMP Audits.  Upon 60 days advance written notice from
SAIC-Frederick, Inc. or Government staff (other than FDA personnel), and not
more than once per calendar year, (other than for cause) the Contractor shall
permit appropriately skilled representatives of SAIC-Frederick, Inc. or the
Government, at SAIC-Frederick, Inc.’s expense, to have access during the
Contractor’s normal business hours to inspect Contractor’s records and
facilities as may be reasonably necessary to verify that the production
facilities and Standard Operating Processes (SOPs) used by the Contractor are
in accordance


 


13

















 


with
Good Manufacturing Practices (GMP) and conform to the specifications outlined
in this contract.


 


C.             SAIC-Frederick, Inc. and the Government shall
treat all information subject to review under this Article E.2. in strict
confidence and shall cause its consultants who review such information to be
bound by confidentiality agreements. The Contractor shall provide written
documentation to the SAIC-Frederick, Inc. COTR and Sponsor of any FDA citation
of a deviation from cGMP to allow evaluation of its impact on the purity,
potency, and safety of the product.


 


D.            Examples of documents available for audit
include:


 


1.                                       Documents listing raw materials, vendors, lot
numbers, vendors’ Certificate of Analysis, and internal release documentation
(information required to trace starting materials to batch records)


2.                                       A transaction history of all filled product
inventories detailing the quantity of starting material used; quantity
produced, sampled, and rejected; and final quantity placed in inventory and all
subsequent distributions.


3.                                       Environmental Monitoring (EM) data trends for
production areas, including EM and personnel monitoring performed during
aseptic operations.  Data required to
trace equipment and room identification to batch records.


4.                                       Documentation demonstrating proper storage of
process intermediaries and final product.


5.                                       Chain of custody documentation for receipt
and QA release of material including full reconciliation of material from
release forward.


6.                                       Batch Records


 


14

















 


SECTION F - DELIVERIES OR PERFORMANCE


 


ARTICLE F.1.  PERIOD OF PERFORMANCE


 


A.                                   The initial period of performance of this
contract shall be for twelve (12) months from the date of contract award. The
Contracting Officer may extend the period of performance by exercising one or
more of the four priced twelve (12) months option years in accordance with
paragraph B below.  The total duration
of the contract shall not exceed five (5) years if all options are exercised.


 


B.                                     Execution of option years will be based upon
actual Contractor performance.


 


                                                FAR 52.217-9 Option to Extend the Term of the
Contract (Mar 1989)


 


The Government may extend
the term of this contract by written notice to the Contractor within thirty
(30) days provided, that the Government shall give the Contractor a preliminary
written notice of its intent to extend at least sixty (60) days before the
contract expires.  The preliminary
notice does not commit the Government to an extension.


 


If the Government exercises
this option, the extended contract shall be considered to include this option
provision.


 


The total duration of this
contract, including the exercise of any options under this clause, shall not
exceed 60 months.


 


C.                                     If SAIC Frederick exercises its option(s)
pursuant to Article F.1, paragraph B, the period of performance will be
increased as listed below:


 


	
  Option Year Number

  	
   

  	
  Period of
  Performance

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Option 1:

  	
   

  	
  Twelve (12
  months)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Option 2:

  	
   

  	
  Twelve (12
  months)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Option 3:

  	
   

  	
  Twelve (12
  months)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Option 4:

  	
   

  	
  Twelve (12
  months)

  	
   

  



 


15

















 


ARTICLE F.2.  PLACE OF PERFORMANCE


 


The
principle place of performance shall be at the Contractor’s facility.


 


 


ARTICLE F.3. GOVERNMENT
DELAY OF WORK


 


This contract incorporates the following
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 http://www.arnet.gov/far/.


 


FEDERAL ACQUISITION
REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES


 


	
  FAR Clause
  No.

  	
   

  	
  Clause
  Title

  	
   

  	
  Date

  	
   

  
	
  52.242-17

  	
   

  	
  Government Delay of Work

  	
   

  	
  Apr-1984

  	
   

  



 


ARTICLE F.4.  INDEFINITE
DELIVERY/INDEFINITE QUANTITY CONTRACT (IDIQ)


 


A.                                   This is an indefinite delivery/indefinite
quantity contract for the supplies or services specified and effective for the
period stated in the Schedule and any option periods. The quantities of
supplies and services specified in the Schedule are estimates only and are not
purchased by this contract. Work shall proceed upon the issuance of a Delivery
Order issued by the SAIC Contracting Officer. 
Payment shall be made at the unit contract price(s) established in
Article B.2.


 


B.                                     Delivery or performance shall be made only as
authorized by orders issued in accordance with the Ordering clause. The
Contractor shall furnish to the Government, when and if ordered, the supplies
or services specified in the Schedule up to and including the quantity
designated in the contract as the “maximum.” The Government shall order at
least the quantity of supplies or services designated in the Schedule as the
“minimum.”


 


C.                                     Except for any limitations on quantities in
the Order Limitations clause or in the Schedule, there is no limit on the
number of orders that may be issued. The Government may issue Delivery Orders
requiring delivery to multiple destinations.


 


D.                                    Any Delivery Order issued during the
effective period of this contract and not completed within that period shall be
completed by the Contractor within the time specified in the Delivery Order.
The contract shall govern the Contractor’s and Government’s rights and
obligations with respect to that Order to the same extent as if the Order were
completed during the contract’s effective period; provided, that the Contractor shall not be required to make
any deliveries under this contract after 90 days beyond the ordering period.


 


16

















 


SECTION G - CONTRACT ADMINISTRATION DATA


 


ARTICLE G.1.  CONTRACT REPRESENTATIVES


 


A.                                   The following individual is designated as
SAIC-Frederick’s Contracting Officer and is authorized to conduct business,
negotiate award and modifications.


 


Mr. Dennis Dougherty


SAIC-Frederick, Inc.


NCI-FCRDC, P.O. Box B,
Building 244


Frederick, Maryland
21702—1201


Phone:  301-846-1087


Fax:      301-846-5414


E-mail:  ddougherty@mail.ncifcrf.gov


 


B.                                     The following individual is designated as
SAIC-Frederick’s Contracting Officer’s Technical Representative (COTR) and is
authorized to provide technical guidance and otherwise represent the Government
as stated herein:


 


Dr. John W. Madsen


Vaccine Clinical Materials
Program


SAIC-Frederick, Inc.


NCI Frederick


92 Thomas Johnson Drive,
Suite 250


Frederick, MD  21702-1201


Phone:  301-644-2089


Fax:      301-694-9467


E-mail: madsenj@ncifcrf.gov


 


1.                                       The Contracting Officer’s Technical
Representative is responsible for: (1) monitoring the Contractor’s technical
progress, including the surveillance and assessment of performance and
recommending to the Contracting Officer changes in requirements; (2)
interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.


 


2.                                       The Contracting Officer is the only person
with the authority to act as an agent of the Government under this
contract.  Only the Contracting Officer
has authority to: (1) direct or negotiate any changes in the Statement of Work;
(2) modify or extend the period of performance; (3) change the delivery
schedule; (4) authorize reimbursement to the Contractor any costs incurred
during the performance of this contract; or (5) otherwise change any terms and
conditions of this contract.


 


17

















 


C.                                     The following individual is designated as the
VRC Project Manager (PM) and is authorized to provide technical guidance:


 


Dr. Phillip Gomez


Vaccine Research Center


NIAID/NIH


Building 40, Room 5502


Bethesda, MD  20892


Phone: 301-594-8485


Fax: 301-480-2788


Email: pgomez@mail.nih.gov


 


D.                                    The following individual has been designated
as SAIC’s-Frederick’s Contract Specialist for purposes of administering,
processing and handling contractual documentation:


 


Ms. Annette Bishop


SAIC Frederick


NCI-FCRDC, P.O. Box B


Frederick, Maryland
21702—1201


Phone:           301-644-2039


Fax: 301-644-2027


E-mail:
abishop@mail.ncifcrf.gov


 


E.                                      The following individuals are representatives
designated by Vical, Incorporated:


 


	
  (1)

  	
   

  	
  For contractual items:

  
	
   

  	
   

  	
  Name:

  	
   

  	
  Seth Goldblum

  
	
   

  	
   

  	
  Title:

  	
   

  	
  Exec. Director, Corporate
  Development

  
	
   

  	
   

  	
  Phone:

  	
   

  	
  (858) 646-1135

  
	
   

  	
   

  	
  Fax:

  	
   

  	
  (858) 646-1150

  
	
   

  	
   

  	
  Address:

  	
   

  	
  10390 Pacific Center Court

  
	
   

  	
   

  	
   

  	
   

  	
  San Diego, CA 92121

  
	
   

  	
   

  	
  E-mail:

  	
   

  	
  sgoldblum@vical.com

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (2)

  	
   

  	
  For technical items:

  
	
   

  	
   

  	
  Name:

  	
   

  	
  Kevin Bracken

  
	
   

  	
   

  	
  Title:

  	
   

  	
  Vice President,
  Manufacturing

  
	
   

  	
   

  	
  Phone:

  	
   

  	
  (858) 646-1302

  
	
   

  	
   

  	
  Fax:

  	
   

  	
  (858) 646-1150

  
	
   

  	
   

  	
  Address:

  	
   

  	
  10390 Pacific Center Court

  
	
   

  	
   

  	
   

  	
   

  	
  San Diego, CA 92121

  
	
   

  	
   

  	
  E-mail:

  	
   

  	
  kbracken@vical.com

  



 


18

















 


ARTICLE G.2.  INVOICE SUBMISSION


 


A.                                   Invoices shall be prepared and submitted as
follows:


 


1.  An original to the following designated
payment office:


 


NCI-Frederick Cancer
Research & Development Center


SAIC Frederick


Accounts
Payable Department, Building 244


P.
O. Box B - West 7th Street


Frederick, Maryland   21702-1201


 


2.  A copy of the invoice should be sent via mail or facsimile to
Annette Bishop (see Article G.1.D)


 


B.                                     Inquiries regarding payment of invoices
should be directed to the attention of Annette Bishop (see Article G.1.D).


 


C.                                     An invoice is a written request for payment
under the contract for items delivered, services rendered, or milestones
achieved.  In order to be proper, an
invoice must include, as applicable, the following:


 


(1)                                  Invoice date (note:  date of Contractor’s invoice shall not be earlier than
delivery/service date


(2)                                  Contractor’s name


(3)                                  Contract number (including Delivery Order number,
if applicable)


(4)                                  Description of items or services, quantity,
contract unit of measure, contract unit price, and extended total


(5)                                  Payment terms and any trade discounts or
allowances


(6)                                  Wiring instructions for which the payment is
to be made; and


(7)                                  Name, title, phone number, and mailing
address of person to be notified in event of a defective invoice.


 


E.                                      The Contractor may invoice SAIC-Frederick,
Inc. following the successful completion of milestones listed in Article
C.2.  The completion of the last
milestone is defined as the earlier of shipment or 60 days following completion
of vialing (100-Liter scale), or bulk material (500-Liter scale).  The Contractor may invoice for master cell
bank preparation, document preparation and shipping preparation, and stability
testing after services are provided.


 


F.                                      SAIC shall pay the Contractor, upon the
submission of proper invoices or vouchers, the prices stipulated in this
contract for products/services rendered and accepted, less any deductions
provided in this contract.


 


G.                                     A proper invoice will be deemed to have been
received, when it is received by the office designated in the contract, or
Delivery Order issued hereunder, for receipts of invoices and acceptance of the
items delivered or services rendered has occurred.


 


19

















 


H.                                    Payment shall be considered made on the date
on which a check for such payment is dated. 
If the Contractor opts to receive electronic funds transfer (EFT),
payment shall be considered made on the date of the transfer.


 


ARTICLE G.3   GOVERNMENT PROPERTY


 


A.                                   The parties agree that no non-expendable
property or equipment will be acquired or furnished under this contract, unless
prior written authorization is obtained from the Contracting Officer.


 


B.                                     The following equipment/documentation will be
provided by the Government:


 


[...***...]


 


ARTICLE G.4.  ORDERING


 


A.
                                Any services to be furnished under this
contract shall be ordered by the issuance of a Delivery Order (See Attachment C
for example) by the SAIC-Frederick, Inc. Contracting Officer.  Such Delivery Orders may be issued commencing
with the date of the contract award through the contract expiration date
(ordering period).  Prior to the
placement of a Delivery Order, the Contractor shall provide detailed comparison
data that will demonstrate to the Government the suitability of the 500-L
process given


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 


20

















 


previous 100-L performance.


 


B.                                     All Delivery Orders are subject to the terms
and conditions of this contract.  In the
event of conflict between a delivery order and this contract, the contract
shall control.


 


C.                                     The Government shall place Delivery Orders a
minimum of six (6) months in advance of the anticipated manufacturing start
date.  Delivery Orders may be issued via
facsimile, email, or the mail by the SAIC-Frederick, Inc. Contracting
Officer.  If mailed, a Delivery Order is
considered “issued” when SAIC deposits the order in the mail.  The Contractor will notify the Contract
Administrator (See ARTICLE G.1.D.) within 10 business days that the Order has
been received and work shall begin in accordance with the order.


 


D.                                    The Government shall submit rolling
utilization forecasts (see Attachment E for example) to the Contractor a
minimum of one year in advance of the anticipated manufacturing start
date.  The utilization forecast shall
project all weeks of processing time requested for each manufacturing campaign
that is anticipated to start during the one year utilization forecast period.
The rolling forecast will be provided monthly throughout the term of this
Agreement and will show production demand on a weekly basis for the next twelve
months. The first rolling forecast is due upon award of this contract.


 


E.                                      Nine months prior to the anticipated start
date of work requiring the 500-Liter manufacturing train, the Government shall
issue a Reservation Order (see Attachment B for example) reserving the
necessary manufacturing weeks.  The
Reservation Order will have a fixed dollar amount equivalent to [...***...]
of the price of the reserved manufacturing weeks (in accordance with Article
B.2).  In the event that the Government
does not issue a Delivery Order for the time which the reservation fee has been
committed, the Government will pay the Contractor the Reservation Fee.  The reservation fee will be waived if a
corresponding Delivery Order is issued.


 


F.                                      If the Government Terminates for Convenience
(FAR 52.249-2), the Contractor is released from its obligations under the
Delivery Order to find other customers to fill the abandoned production
spot.  The Contractor shall make good-faith
efforts to fill all abandoned weeks with another party.  The Contractor may submit a termination
settlement proposal to the government. If a third party is found to fill the
production time, the amounts received by Contractor for these services shall
off-set equal amounts claimed by Contractor in the termination settlement
proposal.


 


G.                                     Modification to an Order may only be
made/issued by the SAIC Contracting Officer.


 


ARTICLE G.5.  GOVERNMENT ORDER
PLACEMENT – EVENT TIMELINE


 


1.                                       Twelve to nine months prior to anticipated
work start date – Government notifies Contractor of its intention to utilize
equipment based on rolling utilization forecasts that are submitted on a
monthly basis.  


 


2.                                       Nine to six months prior to anticipated work
start date – Government continues to notify Contractor of its intention to
utilize equipment based on rolling utilization forecasts that are submitted on
a monthly


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 


21

















 


basis for the upcoming
twelve months. Nine months prior to the commencement of work at the 500-L
scale, the Government shall issue a Reservation Order (see Article G.4.E.).


 


3.                                       Six to zero months prior to anticipated work
start date – Government continues to notify Contractor of its intention to
utilize equipment based on rolling utilization forecasts that are submitted on
a  monthly basis.  Delivery Orders
for equipment usage at the 500 liter scale must be issued a minimum of six
months prior to work start date.


 


4.                                       No later than 90 days before work is
scheduled to begin, the Government shall also complete and send via FAX and
mail a Materials Ordering Form (see Attachment F for example) which shall
include material acceptance criteria to the Contractor representative specified
in Article G.E.2.


 


ARTICLE
G.6.  ORDER LIMITATIONS


 


A.                                   General Order Limitations.  The
Contractor is not obligated to honor any Delivery Orders which:


1.               fall outside the scope of work as described
in Article C.1.B; or


2.               require the manufacture of Select Agents for
which the Contractor does not hold Select Agent Registration.


3.               require the use of the 500-L prior to July 1,
2004.


 


B.                                     Minimum order. The Contractor is not obligated to honor any
single Delivery Order:


1.               not requiring Government equipment as
specified under Article G.3.B; or


2.               requiring less than [...***...]
continuous weeks processing time.


 


C.                                     Maximum order.  The
Contractor is not obligated to honor:


1.               any single Delivery Order requiring greater
than [...***...] weeks processing time; or


2.               a series of Delivery Orders,  when combined, exceed [...***...]
weeks of processing time within any one period of 12 consecutive months.


3.               Delivery Orders causing overlapping
processing time in the same equipment utilized by an existing Government
Delivery Order.


 


ARTICLE
G.7.  MINIMUM AND MAXIMUM CONTRACT
QUANTITIES


 


The Government shall purchase a minimum of [...***...] weeks of manufacturing processing at the 500
liter scale per year (including exercised option years) of this contract and a
maximum of [...***...] weeks of manufacturing processing at the 500
liter scale per year for each year of this contract.  The Government shall not be liable for purchasing the minimum
quantity order in the event orders are refused because of facility/equipment
delays experienced by the Contractor.


 


The Parties agree that the
minimum and maximum contract quantities will not be in effect during the
performance of the contract base year.


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 


22

















 


SECTION H - SPECIAL CONTRACT REQUIREMENTS


 


ARTICLE H.1.  REFERENCES TO THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES PROJECTS


 


All references to the
Secretary, Department of Health, Education and Welfare, HEW, HEWPR, HEW forms,
etc., shall be changed to Secretary, Department of Health and Human Services,
HHS, HHSAR, etc., as appropriate.


 


ARTICLE H.2.  SAFETY AND BIOSAFETY STANDARDS


 


All work performed under this contract shall
be conducted in accordance with the Publication entitled, “Biosafety in
Microbiological and Biomedical Laboratories” (HHS Publication No. (CDC)
93-8395).


 


ARTICLE H.3.  HUMAN SUBJECTS


 


Research involving human subjects shall not
be conducted under this contract.


 


ARTICLE H.4.  HUMAN MATERIALS


 


It is understood that the acquisition and supply
of all human specimen material (including fetal material) used under this
contract will be obtained by the Contractor in full compliance with applicable
State and Local laws and the provisions of the Uniform Anatomical Gift Act in
the United States and that no undue inducements, monetary or otherwise, will be
offered to any person to influence their donation of human material.


 


ARTICLE H.5.  CONTINUED BAN ON
FUNDING OF HUMAN EMBRYO RESEARCH*


 


Pursuant to Public Law(s) cited in paragraph
b., below, NIH is prohibited from using appropriated funds to support human
embryo research.  Contract funds may not
be used for (1) the creation of a human embryo or embryos for research
purposes; or (2) research in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death greater than that
allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section
498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).  The term “human embryo or embryos” includes any
organism, not protected as a human subject under 45 CFR 46 as of the date of
the enactment of this Act, that is derived by fertilization, parthenogenesis,
cloning, or any other means from one or more human gametes or human diploid
cells.


 


Additionally, in accordance with a March 4,
1997 Presidential Memorandum, Federal funds may not be used for cloning of
human beings.


 


	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
  P.L. 107-116, Section 510

  	
   

  	
  2002

  	
   

  	
  (10/1/01 - 9/30/02)

  	
   

  



 












* In full force and affect in
accordance with the Government Continuing Resolution.


 


23

















 


ARTICLE H.6.  NEEDLE EXCHANGE*


 


Pursuant to Public Law(s) cited in paragraph
b., below, contract funds shall not be used to carry out any program of
distributing sterile needles or syringes for the hypodermic injection of any
illegal drug.


 


	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
  P.L. 107-116, Section 505

  	
   

  	
  2002

  	
   

  	
  (10/1/01
  - 9/30/02)

  	
   

  



 


ARTICLE H.7.  ANIMAL WELFARE
ASSURANCE


 


The Contractor shall obtain, prior to the
start of any work utilizing laboratory animals under this contract, an approved
Animal Welfare Assurance from the Office of Extramural Research (OER), Office
of Laboratory Animal Welfare (OLAW), Office of the Director, NIH, as required
by Section I-43-30 of the Public Health Service Policy on Humane Care and Use
of Laboratory Animals.  The Contractor
shall maintain such assurance for the duration of this contract, and any subcontractors
performing work under this contract involving the use of animals shall also
obtain and maintain an approved Animal Welfare Assurance.


 


ARTICLE H.8.  RESTRICTION FROM
USE OF LIVE VERTEBRATE ANIMALS


 


Under governing policy, Federal funds
administered by the Public Health Service (PHS) shall not be expended for
research involving live vertebrate animals without prior approval by the Office
of Laboratory Animal Welfare (OLAW), of an assurance to comply with the PHS
policy on humane care and use of laboratory animals.  This restriction applies to all performance sites (e.g.
collaborating institutions, subcontractors, subgrantees) without OLAW-approved
assurances, whether domestic or foreign.


 


ARTICLE H.9.  PUBLICATION AND
PUBLICITY


 


The contractor shall acknowledge the support
of the National Institutes of Health whenever publicizing the work under this
contract in any media by including an acknowledgement substantially as follows:


 


“This
project has been funded in whole or in part with Federal funds from the
National Cancer Institute, National Institutes of Health, under Contract No.
N01-CO-12400.


 


ARTICLE H.10.  PRESS RELEASES


 


Pursuant to Public Law(s) cited
in paragraph B., below, the Contractor shall clearly state, when issuing
statements, press releases, requests for proposals, bid solicitations and other
documents describing projects or programs funded in whole or in part with
Federal money: (1) the percentage of the total costs of the program or project
which will be financed with Federal money; (2) the dollar amount of Federal
funds for the project or


 












* In full force and affect in
accordance with the Government Continuing Resolution.


 


24

















 


program; and (3) the percentage
and dollar amount of the total costs of the project or program that will be
financed by nongovernmental sources in accordance to Public Law 107-116,
Section 507.


 


ARTICLE H.11.  REPORTING MATTERS
INVOLVING FRAUD, WASTE, AND ABUSE


 


Anyone who becomes aware of the existence or
apparent existence of fraud, waste and abuse in NIH funded programs is
encouraged to report such matters to the HHS Inspector General’s Office in
writing or on the Inspector General’s Hotline. 
The toll free number is 1-800-HHS-TIPS (1-800-447-8477).  All telephone calls will be handled
confidentially.  The email address is
Htips@os.dhhs.gov and the mailing address is:


 


Office of Inspector General


Department of Health and
Human Services


TIPS HOTLINE


P.O. Box 23489


Washington, DC  20026


 


Information regarding procedural matters is
contained in the NIH Manual Chapter 1754, which is available on
(http://www1.od.nih.gov/oma/oma.htm)


 


ARTICLE H.12.  EPA ENERGY STAR
REQUIREMENTS


 


In compliance with Executive Order 12845
(requiring Agencies to purchase energy efficient computer equipment) all
microcomputers, including personal computers, monitors, and printers that are
deliverables under the procurement or are purchased by the contractor using
Government funds in performance of a contract shall be equipped with or meet
the energy efficient low-power standby feature as defined by the EPA Energy
Star program unless the equipment always meets EPA Energy Star efficiency
levels.  The microcomputer, as
configured with all components, must be Energy Star compliant.


 


This low-power feature must already be
activated when the computer equipment is delivered to the agency and be of
equivalent functionality of similar power managed models.  If the equipment will be used on a local
area network, the vendor must provide equipment that is fully compatible with
the network environment.  In addition,
the equipment will run commercial off-the-shelf software both before and after
recovery from its energy conservation mode.


 


ARTICLE H.13.  cGMP COMPLIANCE
REQUIREMENTS


 


The contractor shall be responsible for
assuring compliance with both product and establishment standards consistent
with the phase of clinical development. The product and establishment standards
and cGMPs include, but are not limited to, the following:


 


1.               Safety and effectiveness (identity, purity,
strength, quality, potency, safety, efficacy, release and in-process
specifications)


2.               Adverse event, error and accident, and
product complaint reporting systems


3.               Development of the production process


 


25

















 


4.               Annual report submission as required by 21
CFR 312.33


5.               Quality assurance oversight and change
control for master and batch production records


6.               Quality control methodology as it relates to
the production process


7.               Submission of protocols and samples for lot
release where applicable


8.               Content of the license application


9.               Labeling


10.         Contracts with the establishment(s) at which manufacturing and testing
is being performed


11.         Maintenance and proper functioning of all equipment and systems, as
well as the facility itself


12.         Environmental and other required monitoring


13.         Report applicable CMC changes to the IND, as required in 21 CFR 312.31


14.         Training of personnel


 


ARTICLE H.14. BUY AMERICAN
ACT – BALANCE OF PAYMENTS PROGRAM CERTIFICATE


 


(a)                                  The offeror certifies that each end product,
except those listed in paragraph (b) of this provision, is a domestic end
product as defined in the clause of this solicitation entitled, “Buy American
Act – Balance of Payments Program – Supplies” and that the offeror has considered
components of unknown origin to have been mined, produced, or manufactured
outside the United States.  The offeror
shall list as foreign end products those end products manufactured in the
United States that do not qualify as domestic end products.


 


(b)                                 Foreign End Products:


Line
Item No.:      N/A


Country
of Origin:   N/A


 


H.15.   RESEARCH INVOLVING RECOMBINANT DNA
MOLECULES


 


In the performance of any research and/or
development under this contract involving recombinant DNA molecules, the
Contractor agrees to abide by all NIH Guidelines relating to such activities,
that are now current, or as may be updated from time-to-time.  The Contracting Officer, upon request, will
provide a copy of these Guidelines to the Contractor.


 


26

















 


PART II


 


SECTION I – CONTRACT CLAUSES


 


ARTICLE
I.1.   FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEB
1998)


 


This contract incorporates the following
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
http://www.arnet.gov/far/.


 


A.                                   FEDERAL ACQUISITION REGULATION (FAR) (48 CFR
CHAPTER 1) CLAUSES


 


	
  FAR Clause

  No.

  	
   

  	
  Title

  	
   

  	
  Date

  
	
  52.202-1

  	
   

  	
  Definitions

  	
   

  	
  Dec
  2001

  
	
  52.203-3

  	
   

  	
  Gratuities (Over $100,000)

  	
   

  	
  Apr
  1984

  
	
  52.203-5

  	
   

  	
  Covenant Against
  Contingent Fees (Over $100,000)

  	
   

  	
  Apr
  1984

  
	
  52.203-6

  	
   

  	
  Restrictions on
  Subcontractor Sales to the Government (Over $100,000)

  	
   

  	
  Jul
  1995

  
	
  52.203-7

  	
   

  	
  Anti-Kickback Procedures
  (Over $100,000)

  	
   

  	
  Jul
  1995

  
	
  52.203-8

  	
   

  	
  Cancellation, Rescission,
  and Recovery of Funds for Illegal or Improper Activity (Over $100,000)

  	
   

  	
  Jan
  1997

  
	
  52.203-10

  	
   

  	
  Price or Fee Adjustment
  for Illegal or Improper Activity (Over $100,000)

  	
   

  	
  Jan
  1997

  
	
  52.203-12

  	
   

  	
  Limitation on Payments to
  Influence Certain Federal Transactions (Over $100,000)

  	
   

  	
  Jun
  1997

  
	
  52.204-4

  	
   

  	
  Printed or Copied
  Double-Sided on Recycled Paper (Over $100,000)

  	
   

  	
  Aug
  2000

  
	
  52.209-6

  	
   

  	
  Protecting the
  Government’s Interests When Subcontracting With Contractors Debarred,
  Suspended, or Proposed for Debarment (Over $25,000)

  	
   

  	
  Jul
  1995

  
	
  52.211-05

  	
   

  	
  Material Requirements

  	
   

  	
  Aug
  2000

  
	
  52.215-2

  	
   

  	
  Audit and Records –
  Negotiation (Over $100,000)

  	
   

  	
  Jun
  1999

  
	
  52.215-8

  	
   

  	
  Order of Precedence –
  Uniform Contract Format

  	
   

  	
  Oct
  1997

  
	
  52.215-14

  	
   

  	
  Integrity of Unit Prices
  (Over $100,000)

  	
   

  	
  Oct
  1997

  
	
  52.215-19

  	
   

  	
  Notification of Ownership
  Changes

  	
   

  	
  Oct
  1997

  
	
  52.215-21

  	
   

  	
  Requirements for Cost or
  Pricing Data or Information Other Than Cost or Pricing Data – Modifications

  	
   

  	
  Oct
  1997

  
	
  52.216-22

  	
   

  	
  Indefinite Quantity

  	
   

  	
  Oct 1995

  
	
  52.219-8

  	
   

  	
  Utilization of Small
  Business Concerns (Over $100,000)

  	
   

  	
  Oct
  2000

  
	
  52.219-9

  	
   

  	
  Small Business
  Subcontracting Plan (Over $500,000)

  	
   

  	
  Jan
  2002

  
	
  52.219-16

  	
   

  	
  Liquidated Damages – Subcontracting
  Plan (Over $500,000)

  	
   

  	
  Jan
  1999

  
	
  52.222-19

  	
   

  	
  Child Labor-Cooperation
  with Authorities and Remedies

  	
   

  	
  Dec
  2001

  
	
  52.222-20

  	
   

  	
  Walsh-Healey Public
  Contracts Act

  	
   

  	
  Dec
  1996

  
	
  52.222-26

  	
   

  	
  Equal Opportunity

  	
   

  	
  Apr
  2002

  
	
  52.222-35

  	
   

  	
  Equal Opportunity for
  Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
  Veterans

  	
   

  	
  Dec
  2001

  
	
  52.222-36

  	
   

  	
  Affirmative Action for
  Workers with Disabilities

  	
   

  	
  Jun
  1998

  
	
  52.222-37

  	
   

  	
  Employment Reports on
  Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
  Veterans

  	
   

  	
  Dec
  2001

  



 

















 


	
  FAR Clause

  No.

  	
   

  	
  Title

  	
   

  	
  Date

  
	
  52.223-6

  	
   

  	
  Drug-Free Workplace

  	
   

  	
  May
  2001

  
	
  52.223-14

  	
   

  	
  Toxic Chemical Release
  Reporting

  	
   

  	
  Oct
  2000

  
	
  52.225-1

  	
   

  	
  Buy American Act –
  Supplies

  	
   

  	
  May
  2002

  
	
  52.225-13

  	
   

  	
  Restrictions on Certain
  Foreign Purchases

  	
   

  	
  Jul
  2000

  
	
  52.227-1

  	
   

  	
  Authorization and Consent

  	
   

  	
  Jul
  1995

  
	
  52.227-2

  	
   

  	
  Notice and Assistance
  Regarding Patent and Copyright Infringement (Over $100,000)

  	
   

  	
  Aug
  1996

  
	
  52.227-3

  	
   

  	
  Patent Indemnity

  	
   

  	
  Apr
  1984

  
	
  52.229-3

  	
   

  	
  Federal, State and Local
  Taxes (Over $100,000)

  	
   

  	
  Jan
  1991

  
	
  52.229-5

  	
   

  	
  Taxes – Contracts
  Performed in U.S. Possessions or Puerto Rico

  	
   

  	
  Apr
  1984

  
	
  52.232-1

  	
   

  	
  Payments

  	
   

  	
  Apr
  1984

  
	
  52.232-8

  	
   

  	
  Discounts for Prompt
  Payment

  	
   

  	
  Feb
  2002

  
	
  52.232-9

  	
   

  	
  Limitation on Withholding
  of Payments

  	
   

  	
  Apr
  1984

  
	
  52.232-11

  	
   

  	
  Extras

  	
   

  	
  Apr
  1984

  
	
  52.232-17

  	
   

  	
  Interest (Over $100,000)

  	
   

  	
  Jun
  1996

  
	
  52.232-23

  	
   

  	
  Assignment of Claims

  	
   

  	
  Jan
  1986

  
	
  52.232-25

  	
   

  	
  Prompt Payment

  	
   

  	
  Feb
  2002

  
	
  52.232-34

  	
   

  	
  Payment by Electronic
  Funds Transfer-Other Than Central Contractor Registration

  	
   

  	
  May
  1999

  
	
  52.233-1

  	
   

  	
  Disputes

  	
   

  	
  Dec
  1998

  
	
  52.233-3

  	
   

  	
  Protest After Award

  	
   

  	
  Aug
  1996

  
	
  52.242-13

  	
   

  	
  Bankruptcy (Over $100,000)

  	
   

  	
  Jul
  1995

  
	
  52.243-1

  	
   

  	
  Changes – Fixed-Price

  	
   

  	
  Aug
  1987

  
	
  52.244-2

  	
   

  	
  Subcontracts *If written
  consent to subcontract is required, the identified subcontracts are listed in
  ARTICLE B, Advance Understandings.

  	
   

  	
  Aug
  1998

  
	
  52.245-2

  	
   

  	
  Government Property
  (Fixed-Price Contracts)

  	
   

  	
  Dec
  1989

  
	
  52.245-9

  	
   

  	
  Use and Charges

  	
   

  	
  Apr 1984

  
	
  52.249-2

  	
   

  	
  Termination for the
  Convenience of the Government (Fixed-Price)

  	
   

  	
  Sep
  1996

  
	
  52.249-8

  	
   

  	
  Default (Fixed-Price
  Supply and Service)(Over $100,000)

  	
   

  	
  Apr
  1984

  
	
  52.253-1

  	
   

  	
  Computer Generated Forms

  	
   

  	
  Jan
  1991

  



 



















B.                                     DEPARTMENT OF HEALTH AND HUMAN SERVICES
ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:


 


	
  HHSAR Clause No.

  	
   

  	
  Clause Title

  	
   

  	
  Date

  
	
  352.202-1

  	
   

  	
  Definitions

  	
   

  	
  Jan-2001

  
	
  352.223-70

  	
   

  	
  Safety and Health

  	
   

  	
  Jan-2001

  
	
  352.232-9

  	
   

  	
  Withholding of Contract
  Payments

  	
   

  	
  Apr-1984

  
	
  352.270-4

  	
   

  	
  Pricing
  of Adjustments

  	
   

  	
  Jan 2001

  
	
  352.270-6

  	
   

  	
  Publications and Publicity

  	
   

  	
  Jul-1991

  
	
  352.270-7

  	
   

  	
  Paperwork Reduction

  	
   

  	
  Jan-2001

  



 


C.                                     SAIC-Frederick, Inc. Terms & Conditions


 


1.                   GOVERNMENT RELATIONSHIP


 


This Order is made by SAIC-Frederick, Inc., a
Subsidiary of Science Applications International Corporation under its contract
with the National Cancer Institute at Frederick (NCI-Frederick).  The provisions and clauses contained herein
are influenced by and reflect the relationship of the parties in that contract,
which was awarded and is administered under the provision of the Federal
Acquisition Regulation (FAR).  There is
no privity of contract between the Seller and the Government.


 


2.              GENERAL RELATIONSHIP


 


The Seller is not an employee of
SAIC-Frederick, Inc. for any purpose whatsoever.  Seller agrees that in all matters relating to this Order it shall
be acting as an independent contractor and shall assume and pay all liabilities
and perform all obligations imposed with respect to the performance of this
Order.  Seller shall have no right,
power or authority to create any obligation, expressed or implied, on behalf of
Buyer and/or Buyer’s customers and shall have no authority to represent Buyer
as an agent.


 


3.              DEFINITIONS


 


Buyer – SAIC-Frederick,
Inc.


 


Seller – The party
(contractor) receiving the award from SAIC-Frederick, Inc.


 


Contracting Officer –
The SAIC-Frederick, Inc. person with the authority to enter into and administer
Orders.  The term includes authorized
representatives of the Contracting Officer acting within their delegated
authority.


 


Order – The contractual
agreement between SAIC-Frederick, Inc. and the Seller.


 


Special Definitions – See paragraph 4 for the
special definitions that apply in the use of the solicitation and award clauses
of this Order.


 


4.              SOLICITATION AND AWARD
CLAUSES – SPECIAL DEFINITIONS


 


FAR clauses included in
this Order, including any solicitation document, shall be interpreted as
follows:


 


Unless a purposeful
distinction is made clear and the context of the clause requires retention of
the original definition, the term “Contractor” shall mean Seller, the term
“Contract” shall mean this Order, the term “Subcontractor” shall mean
subcontractors of Seller at any tier, and the terms “Government”, “Contracting
Officer” and equivalent phrases shall mean SAIC-Frederick, Inc. and
SAIC-Frederick’s Contracting Officer, respectively.  It is intended that the referenced clauses shall apply to Seller
in such manner as is necessary to reflect the position of Seller as a
contractor to SAIC-Frederick, Inc. to insure Seller’s obligations to
SAIC-Frederick, Inc. and to the United States Government, and to enable
SAIC-Frederick, Inc. to meet its obligations under its Prime Contract.


 


Full text of the
referenced clauses may be found in the FAR (Code of Federal Regulation [CFR]
Title 48), obtainable from the Superintendent of Documents, Government Printing
Office (GPO), Washington, DC  20402 or
online at http://www.arnet.gov/far/. 
Copies of the clauses will be furnished by the Contracting Officer upon
request.


 


29

















 


5.              ENTIRE AGREEMENT


 


This Order, including
all attachments and/or documents incorporated by reference by Buyer, shall
constitute the entire agreement between Buyer and Seller.  No other document (including Seller’s
proposal, quotation or acknowledgement forms, etc.) shall be a part of this
order, even if referred to, unless specifically agreed to in writing by Buyer.
No right that Buyer has regarding this Order may be waived or modified except
in writing by Buyer.


 


6.                   ACCEPTANCE AND MODIFICATION
OF TERMS


 


Acceptance of this Order
by Seller may be made by signing the acknowledgement copy hereof or by partial
performance hereunder, and any such acceptance shall constitute an unqualified
agreement to all terms and conditions set forth herein unless otherwise
modified in writing by the parties.  Any
additions, deletions or differences in the terms proposed by Seller are objected
to and hereby rejected, unless Buyer agrees otherwise in writing.  No additional or different terms and
conditions proposed by the Seller in accepting this Order shall be binding upon
Buyer unless accepted in writing by Buyer and no other addition, alteration or
modification to, and no waiver of any of the provisions herein contained shall
be valid unless made in writing and executed by Buyer and Seller.  Seller shall perform in accordance with the
Description/Quantity schedule set forth in this Order and all attachments
thereto.


 


7.                   LEGAL CONSTRUCTION AND
INTERPRETATIONS


 


This Order shall be governed by and
interpreted in accordance with the principles of Federal Contract Law, and to
the extent that Federal Contract Law is not dispositive, and the state law
becomes applicable, the law of the State of Maryland shall apply.


 


8.                   COMPLIANCE WITH LAWS AND
REGULATIONS


 


Seller shall submit all certifications
required by Buyer under this Order and shall at all times, at its own expense,
comply with all applicable Federal, State and local laws, ordinances,
administrative orders, rules or regulations.


 


9.                   GIFTS


 


Seller shall not make or offer a gratuity or
gift of any kind to Buyer’s employees or their families. Seller should note
that the providing of gifts or attempting to provide gifts under government
subcontracts might be a violation of the Anti-Kickback Act of 1986 (4 U.S.C.
51-58).


 


10.            MARYLAND SALES AND USE TAX


 


The State of Maryland has issued Direct
Payment Permit #3 to SAIC-Frederick, Inc. for all vendor purchases for the
NCI-Frederick effective August 29, 1996. 
A copy of this certificate is available to vendors upon request.  SAIC-Frederick, Inc. is authorized to make
direct payment of sales and use tax to the State of Maryland and vendors are
not to add sales tax to invoices, nor are they responsible for collection of
such taxes for purchases by SAIC-Frederick.


 


11.            BUYER FURNISHED DATA AND
MATERIALS


 


All data and materials furnished by Buyer to
Seller under this Order including drawings, specifications and written
information and Buyer-owned parts and/or Buyer-owned tools and equipment shall
be used solely for the work to be performed under this Order. Seller shall
repair and maintain all tools at its own expense unless agreed to otherwise.
Seller agrees to promptly return all such data and materials upon completion of
the work or termination of this Order. Seller agrees to return all materials in
the same condition as delivered to Seller, reasonable wear and tear excepted.


 


12.            NOTICE OF DELAY


 


Seller agrees to immediately notify Buyer in
writing of any actual or potential delay in Sellers performance under this
Order. Such notice shall, at a minimum, describe the cause, effect, duration
and corrective action proposed by Seller to address the problem. Seller shall
give prompt written notice to the Buyer of all changes to such conditions.


 


30

















 


13.            CHANGES AND SUSPENSION


 


Buyer may, by written notice to Seller at any
time, make changes within the general scope of this Order in any one or more of
the following:  (a) drawings, designs or
specifications; (b) quantity; (c) time or place of delivery; (d) method of
shipment or packing; and (e) the quantity of Buyer furnished property.  Buyer may, for any reason, direct Seller to
suspend, in whole or in part, delivery of goods or performance of services
hereunder for such period of time as may be determined by Buyer in its sole
discretion.  If any such change or
suspension causes a material increase or decrease in the cost of, or the time
required for the performance of any part of the work under this Order, an
equitable adjustment shall be made in the Order price or delivery schedule, or
both, provided Seller shall have notified Buyer in writing of any claim for
such adjustment within twenty (20) days from the date of notification of the
change or suspension from Buyer.  No
such adjustment or any other modification of the terms of this Order will be
allowed unless authorized by Buyer by means of a written modification to the
Order.  Seller shall proceed with the
work as changed without interruption and without awaiting settlement of any
such claim.


 


14.            ADVERTISING


 


Seller agrees that prior
to the issuance of any publicity or publication of any advertising that in
either case makes reference to this Order, or to Buyer, Seller will obtain the
written permission of Buyer with respect thereto.


 


Notwithstanding the
foregoing, Seller may disclose the existence of this Order and material
information related to the Order as required to fulfill its regulatory
obligations (i.e., Securities and Exchange Commission (SEC) reportings and in
its annual report.)


 


15.            CONFIDENTIAL INFORMATION


 


Seller shall not at any time, even after the
expiration or termination of this Order, use or disclose to any person for any
purpose other than to perform this Order, any information it receives, directly
or indirectly from Buyer in connection with this Order, except information that
is or becomes publicly available, or is rightfully received by Seller from a
third party without restriction. Upon request by Buyer, Seller shall return to
Buyer all documentation and other material containing such information.


 


Seller shall not
disclose to Buyer any information that it deems to be confidential or
proprietary, and it is understood that no information received by Buyer,
including manuals, drawings and documents, will be of a confidential nature or
restrict in any manner the use or disclosure of such information by Buyer.
Seller agrees that any legend or other notice on or pertaining to any information
or materials supplied by it that is inconsistent with the preceding sentence
shall create no obligation on the part of Buyer.


 


16.            INDEMNIFICATION


 


Seller shall indemnify, defend and hold Buyer,
including its officers, agents, and employees, harmless from and against any,
liability, including attorney’s fees, arising out of or in connection with
Seller’s failure to comply with the specifications provided by the Buyer under
this agreement, provided however that Seller may assume the legal defense of any
legal proceedings by a third person against SAIC-Frederick, Inc., paying all
attorney’s fees, costs, and expenses, and satisfying any judgment rendered.


 


17.            NON-WAIVER OR RIGHTS


 


The failure of Buyer to
insist upon strict performance of any of the terms and conditions in this Order
or to exercise any rights or remedies, shall not be construed as a waiver of
its rights to assert any of same or to rely on any such terms or conditions at
any time thereafter.  Any rights and
remedies specified under this Order shall be cumulative, non-exclusive and in
addition to any other rights and remedies available at law or equity.  The invalidity in whole or in part of any
term or condition of this Order shall not affect the validity of other parts
thereof.


 


18.            EXPORT OF CONTROLLED
TECHNOLOGY


 


Seller
shall not, nor shall Seller authorize or permit its employees, agents or lower
tiers to disclose, export or re-export any Buyer information, or any process,
product or service that is produced under this Order, without prior
notification to Buyer and complying with all applicable Federal, State and
local laws, regulations and ordinances, including the regulations of the U.S.
Department of Commerce and/or the U.S. Department of State.  In addition, Seller agrees to immediately
notify Buyer if Seller is listed in the Table of Denial Orders published by the
Department of Commerce, or it Seller’s export privileges are otherwise denied,
suspended or revoked in whole or in part.


 


Under its contract with
NCI-Frederick, Buyer conducts research activities that include
export-controlled technology that cannot be readily segregated.  Buyer may require Seller (including any
lower tiers) to place restrictions on their work force performing onsite at


 


31

















 


SAIC-Frederick, Inc., to
protected individuals as established under the guidelines of the Commerce
Department Export Administration Regulations (EAR) and the State Department
International Traffic in Air Regulation (ITAR).


 


Contractors (including
any lower tiers) will be required to disclose the status of personnel proposed
to perform work onsite prior to award.


 


19.            ASSIGNMENT


 


Neither this Order nor
any interest herein may be assigned, in whole or in part, without the prior
written consent of Buyer except that the Seller shall have the right to assign
this Order to any successor of such party by way of merger or consolidation or
the acquisition of substantially all of the business and assets of the Seller
relating to the subject matter of this Order. 
This right shall be retained provided that such successor shall
expressly assume all of the obligations and liabilities of the Seller under
this Order, and that the Seller shall remain liable and responsible to Buyer
for the performance and observance of all such obligations.


 


Notwithstanding the
foregoing, any amounts due the Seller may be assigned in accordance with the
provisions of the clause 52.232-


 


20.            Assignment of Claims.


 


In the event the prime
contract of SAIC-Frederick, Inc. with the Government is succeeded by a
successor contractor selected by the Government, this Order may be assigned to
the successor contractor.


 


21.            DISPUTES


 


Buyer and Seller agree
to first enter into negotiations to resolve any controversy, claim or dispute
(“dispute”) arising under or relating to this Order.  The parties agree to negotiate in good faith to reach a mutually
agreeable resolution of such dispute within a reasonable period of time.  If good faith negotiations are unsuccessful,
Buyer and Seller agree to resolve the dispute by binding and final arbitration
in accordance with the Commercial Arbitration Rules of the American Arbitration
Association then in effect.  The
arbitration shall take place in the County of Frederick, State of
Maryland.  The arbitrator(s) shall be
bound to follow the provisions of this Order in resolving the dispute, and may
not award punitive damages.  The
decision of the arbitrator(s) shall be final and binding on the parties, and
any award of the arbitrator(s) may be entered or enforced in any court of
competent jurisdiction.


 


Pending any decision, appeal or judgment
referred to in this provision or the settlement of any dispute arising under
this Subcontract, Seller shall proceed diligently with the performance of this
Subcontract.


 


22.            NOTIFICATION
DEBARMENT/SUSUPENSION


 


By acceptance of this Order either in writing
or by performance, Seller certifies that as of the date of award of this Order
neither the Seller, lower tiers, nor any of its principals, is debarred,
suspended, or proposed for debarment by the Federal Government. Further, Seller
shall provide immediate written notice to the Buyer in the event that during
performance of this Order the Seller or any of its principals is debarred,
suspended, or proposed for debarment by the Federal Government.


 


23.            QUALITY ASSURANCE


 


The Buyer, and/or personnel authorized by
Buyer, shall have the right, at all reasonable times, to visit Seller’s
facilities or such parts thereof as may be engaged in work relating to this
Order in order to verify that Seller’s performance is in accordance with all
requirements of this Order. In addition, the Buyer, and/or personnel authorized
by Buyer, shall have the right, at all reasonable times, to visit the
facilities of the Seller’s lower tiers or such parts thereof as may be engaged
in work relating to this Order. The Seller shall include a like provision in
all related lower-tier subcontracts. Nothing herein shall give the Buyer the
right to issue direct orders or instructions to Seller’s lower tiers. Seller
shall be furnished prior notice of any planned visit.


 


24.            ORDER
OF PRECEDENCE


 


In the event of an inconsistency or conflict
between these SAIC Terms and Conditions and the Order issued, the inconsistency
or conflict shall be resolved by giving precedence in the following order:


 


1) The Order and any provisions.


 


2) SAIC-Frederick, Inc. Standard Terms and
Conditions and Exhibits thereto.


 


3) Specifications and/or drawings.


 


32

















 


4) Other documents or exhibits when attached.


 


25.                               TERMINATION


 


Buyer may terminate this Order (in whole or in
part) for convenience or for cause pursuant to the Federal Acquisition
Regulation Part 49, “Terminations of Contracts” and/or the provisions of the
individual Order.


 


ARTICLE I.2.                         DATA RIGHTS


 


For the purposes of this
clause, the following data are considered “limited rights data.”


 


1.                                       Contractor’s
proprietary manufacturing process


 


2.                                       Batch Records


 


3.                                       Standard Operating Procedures (SOP) and
protocols


 


4.                                       Analytical methods


 


5.                                       Equipment specifications and qualification


 


6.                                       Material specifications


 


7.                                       Documents prepared in support of the
manufacture, test, and release of materials


 


8.                                       Master Files (DMF, BMF) and communication
file with the Federal Drug Administration related to the Master Files


 


9.                                       Data generated via rental of Government
equipment


 


In lieu of providing copies of
the proprietary manufacturing process and batch records to the Government, the
Contractor shall allow the Government to cross-reference the Biologics
Master File (BMF) and review the batch records at the Contractor’s facility.


 


FAR
52.227-14 Rights in Data-General.


 


As prescribed in 27.409(a), insert the
following clause with any appropriate alternates:


 


Rights in Data-General (June
1987)


 


(a) Definitions.
“Computer software,” as used in this clause, means computer programs, computer data
bases, and documentation thereof.


 


“Data,” as used in this clause, means
recorded information, regardless of form or the media on which it may be
recorded. The term includes technical data and computer software. The term does
not include information incidental to contract administration, such as
financial, administrative, cost or pricing, or management information.


 


“Form, fit, and function data,” as used in
this clause, means data relating to items, components, or processes that are
sufficient to enable physical and functional interchangeability, as well as
data identifying source, size, configuration, mating, and attachment
characteristics, functional characteristics,


 


33

















 


and performance requirements; except that for
computer software it means data identifying source, functional characteristics,
and performance requirements but specifically excludes the source code, algorithm,
process, formulae, and flow charts of the software.


 


“Limited rights,” as used in this clause,
means the rights of the Government in limited rights data as set forth in the
Limited Rights Notice of paragraph (g)(2) if included in this clause.


 


“Limited rights data,” as used in this
clause, means data (other than computer software) that embody trade secrets or
are commercial or financial and confidential or privileged, to the extent that
such data pertain to items, components, or processes developed at private
expense, including minor modifications thereof.


 


“Restricted computer software,” as used in
this clause, means computer software developed at private expense and that is a
trade secret; is commercial or financial and is confidential or privileged; or
is published copyrighted computer software, including minor modifications of
such computer software.


 


“Restricted rights,” as used in this clause,
means the rights of the Government in restricted computer software, as set
forth in a Restricted Rights Notice of paragraph (g)(3) if included in this
clause, or as otherwise may be provided in a collateral agreement incorporated
in and made part of this contract, including minor modifications of such
computer software.


 


“Technical data,” as used in this clause,
means data (other than computer software) which are of a scientific or
technical nature.


 


“Unlimited rights,” as used in this clause,
means the right of the Government to use, disclose, reproduce, prepare
derivative works, distribute copies to the public, and perform publicly and
display publicly, in any manner and for any purpose, and to have or permit
others to do so.


 


(b) Allocation
of rights.


(1) Except as provided in paragraph (c) of
this clause regarding copyright, the Government shall have unlimited rights in-


(i) Data first produced in the performance of
this contract;


(ii) Form, fit, and function data delivered
under this contract;


(iii) Data delivered under this contract
(except for restricted computer software) that constitute manuals or instructional
and training material for installation, operation, or routine maintenance and
repair of items, components, or processes delivered or furnished for use under
this contract; and


(iv) All other data delivered under this
contract unless provided otherwise for limited rights data or restricted
computer software in accordance with paragraph (g) of this clause.


(2) The Contractor shall have the right to-


(i) Use, release to others, reproduce,
distribute, or publish any data first produced or specifically used by the
Contractor in the performance of this contract, unless provided otherwise in
paragraph (d) of this clause;


(ii) Protect from unauthorized disclosure and
use those data which are limited rights data or  restricted computer software to the extent
provided in paragraph (g) of this clause;


(iii) Substantiate use of, add or correct
limited rights, restricted rights, or copyright notices and to take other
appropriate action, in accordance with paragraphs (e) and (f) of this clause;
and


(iv) Establish claim to copyright subsisting
in data first produced in the performance of this contract to the extent
provided in paragraph (c)(1) of this clause.


(c) Copyright-


(1) Data
first produced in the performance of this contract. Unless provided
otherwise in paragraph (d) of


 


34

















 


this clause, the Contractor may establish,
without prior approval of the Contracting Officer, claim to copyright
subsisting in scientific and technical articles based on or containing data
first produced in the performance of this contract and published in academic,
technical or professional journals, symposia proceedings or similar works. The
prior, express written permission of the Contracting Officer is required to
establish claim to copyright subsisting in all other data first produced in the
performance of this contract. When claim to copyright is made, the Contractor
shall affix the applicable copyright notices of 17 U.S.C. 401 or 402 and
acknowledgment of Government sponsorship (including contract number) to the
data when such data are delivered to the Government, as well as when the data
are published or deposited for registration as a published work in the U.S.
Copyright Office. For data other than computer software the Contractor grants
to the Government, and others acting on its behalf, a paid-up, nonexclusive,
irrevocable worldwide license in such copyrighted data to reproduce, prepare
derivative works, distribute copies to the public, and perform publicly and
display publicly, by or on behalf of the Government. For computer software, the
Contractor grants to the Government and others acting in its behalf, a paid-up
nonexclusive, irrevocable worldwide license in such copyrighted computer
software to reproduce, prepare derivative works, and perform publicly and
display publicly by or on behalf of the Government.


(2) Data
not first produced in the performance of this contract. The
Contractor shall not, without prior written permission of the Contracting
Officer, incorporate in data delivered under this contract any data not first
produced in the performance of this contract and which contains the copyright
notice of 17 U.S.C. 401 or 402, unless the Contractor identifies such data
and grants to the Government, or acquires on its behalf, a license of the same
scope as set forth in paragraph (c)(1) of this clause; provided, however, that if such data are
computer software the Government shall acquire a copyright license as set forth
in paragraph (g)(3) of this clause if included in this contract or as otherwise
may be provided in a collateral agreement incorporated in or made part of this
contract.


(3) Removal
of copyright notices. The Government agrees not to remove any
copyright notices placed on data pursuant to this paragraph (c), and to include
such notices on all reproductions of the data.


(d) Release,
publication and use of data.


(1) The Contractor shall have the right to
use, release to others, reproduce, distribute, or publish any data first
produced or specifically used by the Contractor in the performance of this
contract, except to the extent such data may be subject to the Federal export
control or national security laws or regulations, or unless otherwise provided
in this paragraph of this clause or expressly set forth in this contract.


(2) The Contractor agrees that to the extent
it receives or is given access to data necessary for the performance of this
contract which contain restrictive markings, the Contractor shall treat the
data in accordance with such markings unless otherwise specifically authorized
in writing by the Contracting Officer.


(e) Unauthorized
marking of data.


(1) Notwithstanding any other provisions of
this contract concerning inspection or acceptance, if any data delivered under
this contract are marked with the notices specified in paragraph (g)(2) or
(g)(3) of this clause and use of such is not authorized by this clause, or if
such data bears any other restrictive or limiting markings not authorized by
this contract, the Contracting Officer may at any time either return the data
to the Contractor, or cancel or ignore the markings. However, the following
procedures shall apply prior to canceling or ignoring the markings.


(i) The Contracting Officer shall make
written inquiry to the Contractor affording the Contractor 30 days from receipt
of the inquiry to provide written justification to substantiate the propriety
of the markings;


(ii) If the Contractor fails to respond or
fails to provide written justification to substantiate the propriety of the
markings within the 30-day period (or a longer time not exceeding 90 days
approved in writing by the Contracting Officer for good cause shown), the
Government shall have the right to cancel or ignore the markings at any time
after said period and the data will no  longer be made subject to any disclosure


 


35

















 


prohibitions.


(iii) If the Contractor provides written
justification to substantiate the propriety of the markings within the period
set in subdivision (e)(1)(i) of this clause, the Contracting Officer shall
consider such written justification and determine whether or not the markings
are to be cancelled or ignored. If the Contracting Officer determines that the
markings are authorized, the Contractor shall be so notified in writing. If the
Contracting Officer determines, with concurrence of the head of the contracting
activity, that the markings are not authorized, the Contracting Officer shall
furnish the Contractor a written determination, which determination shall become
the final agency decision regarding the appropriateness of the markings unless
the Contractor files suit in a court of competent jurisdiction within 90 days
of receipt of the Contracting Officer’s decision. The Government shall continue
to abide by the markings under this subdivision (e)(1)(iii) until final
resolution of the matter either by the Contracting Officer’s determination
becoming final (in which instance the Government shall thereafter have the
right to cancel or ignore the markings at any time and the data will no longer
be made subject to any disclosure prohibitions), or by final disposition of the
matter by court decision if suit is filed.


(2) The time limits in the procedures set
forth in paragraph (e)(1) of this clause may be modified in accordance with
agency regulations implementing the Freedom of Information Act (5 U.S.C. 552)
if necessary to respond to a request thereunder.


(3) This paragraph (e) does not apply if this
contract is for a major system or for support of a major system by a civilian
agency other than NASA and the U.S. Coast Guard agency subject to the
provisions of Title III of the Federal Property and Administrative Services Act
of 1949.


(4) Except to the extent the Government’s
action occurs as the result of final disposition of the matter by a court of
competent jurisdiction, the Contractor is not precluded by this paragraph (e)
from bringing a claim under the Contract Disputes Act, including pursuant to
the Disputes clause of this contract, as applicable, that may arise as the
result of the Government removing or ignoring authorized markings on data
delivered under this contract.


(f) Omitted
or incorrect markings.


(1) Data delivered to the Government without
either the limited rights or restricted rights notice as authorized by
paragraph (g) of this clause, or the copyright notice required by paragraph (c)
of this clause, shall be deemed to have been furnished with unlimited rights,
and the Government assumes no liability for the disclosure, use, or
reproduction of such data. However, to the extent the data has not been
disclosed without restriction outside the Government, the Contractor may
request, within 6 months (or a longer time approved by the Contracting Officer
for good cause shown) after delivery of such data, permission to have notices
placed on qualifying data at the Contractor’s expense, and the Contracting
Officer may agree to do so if the Contractor-


(i) Identifies the data to which the omitted
notice is to be applied;


(ii) Demonstrates that the omission of the
notice was inadvertent;


(iii) Establishes that the use of the
proposed notice is authorized; and


(iv) Acknowledges that the Government has no
liability with respect to the disclosure, use, or reproduction of any such data
made prior to the addition of the notice or resulting from the omission of the
notice.


(2) The Contracting Officer may also (i)
permit correction at the Contractor’s expense of incorrect notices if the
Contractor identifies the data on which correction of the notice is to be made,
and demonstrates that the correct notice is authorized, or (ii) correct any
incorrect notices.


(g) Protection
of limited rights data and restricted computer software.


(1) When data other than that listed in
subdivisions (b)(1)(i), (ii), and (iii) of this clause are specified to be
delivered under this contract and qualify as either limited rights data or
restricted computer software, if the Contractor desires to continue protection
of such data, the Contractor


 


36

















 


shall withhold such data and not furnish them
to the Government under this contract. As a condition to this withholding, the
Contractor shall identify the data being withheld and furnish form, fit, and
function data in lieu thereof. Limited rights data that are formatted as a
computer data base for delivery to the Government are to be treated as limited
rights data and not restricted computer software.


(2) [Reserved]


(3) [Reserved]


(h) Subcontracting.
The Contractor has the responsibility to obtain from its subcontractors all
data and rights therein necessary to fulfill the Contractor’s obligations to
the Government under this contract. If a subcontractor refuses to accept terms
affording the Government such rights, the Contractor shall promptly bring such
refusal to the attention of the Contracting Officer and not proceed with
subcontract award without further authorization.


(i) Relationship
to patents. Nothing contained in this clause shall imply a license
to the Government under any patent or be construed as affecting the scope of
any license or other right otherwise granted to the Government.


(End of clause)


 


37

















 


PART III


 


SECTION J – LIST OF DOCUMENTS, EXHIBITS, AND OTHER
ATTACHMENTS


 


ARTICLE
J.1.  ATTACHMENTS


 


Attachment A - Certificate of Conformance
Template


 


Attachment B – Sample Reservation Order


 


Attachment C – Sample Delivery Order


 


Attachment D – Utilization Forecast - 500-L
scale


 


Attachment E – Utilization Forecast - 100-L
scale


 


Attachment F – Materials Ordering Form


 


38

















 


PART
IV—REPRESENTATIONS AND INSTRUCTIONS


 


SECTION
K—REPRESENTATIONS, CERTIFICATIONS AND OTHER
STATEMENTS OF OFFERORS


 


The following document(s) are incorporated by reference in this
contract:


 


Representations
and Certifications, dated March 26, 2003.


 


39

















 


Attachement A


Certificate of Conformance Template


 


Certificate of Conformance


 


Final Lot Number


Part Number


Description


Date of Manufacture


Unit Quantity (number of vials
filled and fill volume)


 


•                  Batch
Records have been reviewed per SOP and all issues/observations have been
resolved


•                  All
deviations have been identified and resolved per SOP and approved by QA


•                  OOS
and Process related investigations are closed per SOP and approved by QA


•                  EM
and WFI test data is within specified limits. 
All excursions have been identified and assessed for potential product
impact


•                  All
materials used in the manufacture of this lot have been QA released and used
within established expiry period


•                  All
equipment used in the manufacture of this lot were used within the specified
calibration cycle


•                  Certificate
of analysis is attached (CofA lists all tests, method, specification and
result)


 


Material has been manufactured
under cGMP and is acceptable


 


 


Auditor: compiled by / date
                                      


 


QA Manager: approval / date
                                      


 


40

















 


Attachment B


Sample Reservation Order


 


RESERVATION ORDER – SUBCONTRACT No. 23XS003


 


	
  CONTRACT NO.
23XS003

  	
  RESERVATION ORDER NO.

  001

  	
  DATE OF ORDER

  TBD

  	
  REQUISITION PURCH. REQUEST
  NO.

  TBD

  



 


ISSUED BY:


SAIC Frederick


NCI-FREDERICK


P.O. BOX B


FREDERICK, MARYLAND 21702-1201


 


 


SUBCONTRACTOR NAME AND ADDRESS:


Vical, Inc.


10390 Pacific Center Court


San Diego, CA 92121


 


PAYMENT TERMS


Payment shall be made to the Contractor
pursuant to Subcontract #23XS003, Articles C.2. Deliverables and G.2. Invoice
Submission.


 


	
  ACCOUNTING AND APPROPRIATION
  DATA

  Cost Center No.20048075311

  	
  RESERVATION FEE  

  
	
   

  	
  [...***...]

  



 


DELIVERY ORDER TERMS AND CONDITIONS


In accordance with Articles G.4. and G.5. of
Subcontract#23XS003, this Reservation Order shall reserve manufacturing time
requiring the use of the 500-L manufacturing train.  A Delivery Order will be issued, six months prior to the
commencement of work, delineating a contract for cGMP production of DNA
plasmids.  The terms and conditions of
Subcontract #23XS003 shall be made part of this Reservation Order in full force
and effect.


 


This
Reservation Order reserves the 500-Liter manufacturing training for [...***...] weeks, from date to date.  During this time, the Contractor shall
manufacture DNA plasmids (to be specified in the resulting Delivery Order) in
accordance with Government specifications. 
Pursuant to the conditions of the contract, a Delivery Order for
manufacture during this period will be issued six months prior to the
commencement of work.


 


In the event
that the Government does not issue a Delivery Order for the time reserved by
this Reservation Order, the Contractor may invoice and the Government will pay
the Reservation Fee of [...***...].  If a Delivery Order
is issued for the time reserved by this order, the reservation fee shall be waived.


 


THE
CONTRACTOR HEREBY ACCEPTS THE OFFER REPRESENTED BY THE NUMBERED DELIVERY ORDER
AS IT IS NOW/MODIFIED, SUBJECT TO ALL OF THE TERMS AND CONDITIONS SET FORTH,
AND AGREES TO PERFORM THE SAME.


 


	
  Vical, Inc.

  	
  SAIC-Frederick,
  Inc.

  
	
  Vijay Samant

  	
  Dennis J.
  Dougherty, Manager, Research Contracts

  
	
   

  	
   

  
	
   

  	
   

  
	
  Signature

  	
  DATE:

  	
  Signature

  	
  DATE:

  
				



 


	
   

  	
   

  	
  * CONFIDENTIAL

  
	
   

  	
   

  	
  TREATMENT

  
	
   

  	
   

  	
  REQUESTED

  



 

















 


Attachment C


Sample Delivery Order


 


DELIVERY ORDER – SUBCONTRACT No. 23XS003


 


	
  CONTRACT/DELIVERY ORDER NO.
23XS003

  	
  DELIVERY ORDER NO.

  001

  	
  DATE OF ORDER

  TBD

  	
  REQUISITION PURCH. REQUEST
  NO.

  TBD

  



 


ISSUED BY:


SAIC Frederick


NCI-FREDERICK


P.O. BOX B


FREDERICK, MARYLAND 21702-1201


 


 


SUBCONTRACTOR NAME AND ADDRESS:


Vical, Inc.


10390 Pacific Center Court


San Diego, CA 92121


 


PAYMENT TERMS


Payment shall be made to the Contractor
pursuant to Subcontract #23XS003, Articles C.2. Deliverables and G.2. Invoice
Submission.


 


	
  ACCOUNTING AND
  APPROPRIATION DATA

  Cost Center No.   20048075311

  	
  AMOUNT

  $TBD

  



 


DELIVERY ORDER TERMS AND CONDITIONS


Pursuant to Subcontract#23XS003A, Section C,
“Specifications/Work Statement”, this delivery order shall delineate a contract
for cGMP production of DNA plasmids. 
The terms and conditions of Subcontract #23XS003A shall be made part of
this delivery order in full force and effect.


 


1.                                       DESCRIPTION
OF WORK:


 


The Contractor
shall provide [...***...]
weeks of manufacturing, in accordance with Section C of the contract, using the
500-Liter manufacturing train.


 


2.                                       DATES
OF MANUFACTURE:


 


The dates of
manufacture are date to date.


 


3.                                       DELIVERABLES:


 


a)                                      The
Contractor shall deliver all DNA plasmid material manufactured under this
Delivery Order.  The minimum amount of
material the Contractor is responsible for delivering is specified in Article
C.3. of the contract.


b)                                     Documents/information
specified in Articles C.1.C.4. and C.2.


 


4.                                       ACCEPTANCE
CRITERIA:


 


a)                                      The
manufacture and documentation must be in accordance with cGMP requirements.


b)                                     The
DNA plasmids must meet Government specifications (attached).


c)                                      The
material must meet the acceptance criteria detailed on the Materials Ordering
Form which shall be sent to Contractor as specified under Article G.5.4.


 


CONFIDENTIAL


 


	
   

  	
   

  	
  * CONFIDENTIAL

  
	
   

  	
   

  	
  TREATMENT

  
	
   

  	
   

  	
  REQUESTED

  



 

















 


5.                                       GOVERNMENT
FURNISHED MATERIAL:


 


The Government
shall provide:


 


a)                                      Plasmid(s)


 


b)                                     Sequencing
information, if available.


 


In the event
items are not furnished by the date specified, the Delivery Order will be
modified, as necessary, to accommodate the delay.


 


6.                                       PRICE:  The total price for the materials/services
is [...***...] in
accordance with base year pricing outlined in Article B.2. of the contract, as
follows::


 


Manufacturing:  [...***...]
per week [...***...] weeks = [...***...]


Document
preparation and shipping:  [...***...]
per shipment [...***...]
shipments = [...***...]


Stability testing:
[...***...]
per stability test [...***...]
= [...***...]


 


 


THE
CONTRACTOR HEREBY ACCEPTS THE OFFER REPRESENTED BY THE NUMBERED DELIVERY ORDER
AS IT IS NOW/MODIFIED, SUBJECT TO ALL OF THE TERMS AND CONDITIONS SET FORTH,
AND AGREES TO PERFORM THE SAME.


 


	
  Vical, Inc.

  	
  SAIC-Frederick,
  Inc.

  
	
  Vijay Samant

  	
  Dennis J.
  Dougherty, Manager, Research Contracts

  
	
   

  	
   

  
	
   

  	
   

  
	
  Signature

  	
  DATE:

  	
  Signature

  	
  DATE:

  
				



 


CONFIDENTIAL


 


	
   

  	
   

  	
  * CONFIDENTIAL

  
	
   

  	
   

  	
  TREATMENT

  
	
   

  	
   

  	
  REQUESTED

  



 


2

















 


CONFIDENTIAL


 


Attachment D


Utilization
Forecast- 500 L Scale- Any order
placed must be shown through completion.


 


[...***...]


 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


CONFIDENTIAL


 


[...***...]


 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


CONFIDENTIAL


 


[...***...]


 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


CONFIDENTIAL


 


Attachment E


Utilization Forecast- 100 L Scale- Any
order placed must be shown through completion.


 


[...***...]


 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


CONFIDENTIAL


 


[...***...]


 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


CONFIDENTIAL


 


[...***...]


 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


Attachment F


 


Materials Ordering Form 


 


	
  Client:

  	
   

  	
  

  
	
   

  
	
  Contact:

  
	
   

  
	
  Product
  name:

  
	
   

  
	
  Contract: (VICAL USE)

  
	
   

  
	
  Date:

  
	
   

  
	
  Order #: (VICAL USE)

  



 


1.                                      MATERIAL
REQUIREMENTS:


 


	
  DNA
  requested for:

  	
  o  Clinical study

  
	
   

  	
  o  Pre-clinical studies

  
	
   

  	
  (check all
  that apply):

  
	
   

  	
  o  Safety
  study

  
	
   

  	
  o  PK

  
	
   

  	
  o  Biodistribution

  
	
   

  	
  o  Material
  for use TBD

  
	
   

  	
   

  
	
   

  	
  o  Single plasmid                                                 o  Cocktail

  
	
   

  	
   

  
	
  Plasmid
  designation(s):

  	
   

  
	
  Configuration:

  	
   

  
	
   

  	
  Vector Name

  	
   

  	
  Concentration

  (mg/ml)

  	
   

  	
  Vehicle

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Product
  Configuration: 

  	
  o   Bulk

  	
   

  	
  o   Filled

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Plasmid
  provided to Vical: 

  	
  o   DNA

  	
   

  	
  o   MCB

  	
   

  	
  o   None provided

  



 


CONFIDENTIAL


 

















 


2.                                      EXPERIMENTAL
PROTOCOL:


 


	
  Experimental
  Protocol Attached:

  	
  o Yes

  	
  o No

  



 


3.              SAFETY STUDY DESIGN/
FILL SCOPE:


 


	
  Date
  material required:

  	
   

  
	
   

  	
   

  
	
  Experimental
  design: 

  	
  Number of
  Groups:

  	
              

  
	
   

  	
  Number of
  Animals:

  	
   

  
	
   

  	
  Vial
  dose/volume (μg/mL pDNA):

  	
   

  
	
   

  	
  Number
  injections/subject:

  	
   

  
	
   

  	
   

  	
   

  
	
  Container:

  	
  o   Vials

  	
  o   Tubes

  
	
   

  	
   

  	
   

  
	
   

  	
  Size-      ml.

  	
  Size-       ml.

  
	
   

  	
   

  	
   

  
	
  Shipping
  Information:

  	
  Contact-

  	
  Address-

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Packaging
  configuration:

            containers per
  box

  	
  Ph #

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  o   Single shipment

  	
  Fax #

  	
   

  
	
   

  	
   

  	
   

  
	
  # of
  containers-

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  o   Split shipment

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  (1st
  set)  # of containers-

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  (2nd
  set) # of containers-

  	
   

  	
   

  



 


CONFIDENTIAL


 

















 


4.              CLINICAL STUDY
DESIGN/ FILL SCOPE: 


 


	
  Date
  material required:

  	
   

  
	
   

  	
   

  
	
  Clinical
  design:

  	
   

  
	
  (Needed if
  no protocol

  attached or to clarify the

  protocol)

  	
   

  
	
   

  	
   

  	
  Cohort 1

  	
   

  	
  Cohort 2

  	
   

  	
  Cohort 3

  
	
   

  	
  Number of
  subjects

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Product
  concentration (ug/mL pDNA)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Vial fill
  volume (uL)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Total no. of
  vials

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Number
  injections/subject

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  
	
  Clinical
  Protocol Attached:

  	
  o   Yes

  	
  o   No

  
	
   

  	
   

  	
  If no,
  please supply title of protocol-

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Container:

  	
  o   Vials

  	
  Please
  specify if needed-

  
	
   

  	
  Size-

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Shipping
  Information:

  	
  Contact-

  	
  Address-

  
	
  Packaging
  configuration:

          vials/ box

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  o   Single shipment

  	
  Ph #

  	
   

  
	
  # of vials-

  	
   

  	
   

  
	
  o    Split shipment

  	
  Fax #

  	
   

  
	
  (1st
  set)  # of vials-  

  	
   

  	
   

  
	
  (2nd
  set)  # of vials-

  	
   

  	
   

  
								



 

















 


5.              PLASMID DNA TEST
REQUIREMENTS AND RESULTS:


 


	
  Check as

  Required

  	
   

  	
  Test

  	
   

  	
  Standard  

  Specification

  	
   

  	
  Other Specification

  
	
  o

  	
   

  	
  Appearance

  	
   

  	
  o Clear, colorless solution  Other:

  	
   

  	
   

  
	
  o

  	
   

  	
  DNA
  concentration

  	
   

  	
             ±             mg/mL

  	
   

  	
   

  
	
  o

  	
   

  	
  Circular
  plasmid DNA

  	
   

  	
  o > [...***...] of visualized DNA 
  Other:

  	
   

  	
   

  
	
  o

  	
   

  	
  Total
  Size  (Please attach plasmid map)

  	
   

  	
  Number of
  base pairs:        

  	
   

  	
   

  
	
  o

  	
   

  	
  Restriction
  sites

  	
   

  	
  Enzyme(s):

             

             

  	
  Size(s)
  (bp’s):

             

             

  	
   

  	
   

  
	
  o

  	
   

  	
   

  	
   

  	
  Enzyme(s):

             

             

  	
  Size(s)  (bp’s):

             

             

  	
   

  	
   

  
	
  o

  	
   

  	
   

  	
   

  	
  Enzyme(s):

             

             

  	
  Size(s)  (bp’s):

             

             

  	
   

  	
   

  
	
  o

  	
   

  	
   

  	
   

  	
  Enzyme(s):

             

             

  	
  Size(s)  (bp’s):

             

             

  	
   

  	
   

  
	
  o

  	
   

  	
   

  	
   

  	
  Enzyme(s):

             

             

  	
  Size(s)  (bp’s):

             

             

  	
   

  	
   

  
	
  o

  	
   

  	
   

  	
   

  	
  Enzyme(s):

             

             

  	
  Size(s)  (bp’s):

             

             

  	
   

  	
   

  
	
  o

  	
   

  	
  %
  Supercoiled pDNA

  	
   

  	
              %

  	
   

  	
   

  
	
  o

  	
   

  	
  Endotoxin

  	
   

  	
  o < [...***...] EU/vial  Value:

  	
   

  	
   

  
	
  o

  	
   

  	
  E. coli DNA

  	
   

  	
  o  £[...***...]ug/ug 
  Value:

  	
   

  	
   

  



 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


	
  o

  	
   

  	
  RNA

  	
   

  	
  o None by ethidium bromide  Other:

  	
   

  	
   

  
	
  o

  	
   

  	
  Expression
  testing

  	
   

  	
  To be
  determined by customer unless otherwise states  Result:

  	
   

  	
   

  
	
  o

  	
   

  	
  Residual
  amino acid analysis

  	
   

  	
  o  £  [...***...] ug/mg
  of pDNA  Other:

  	
   

  	
   

  
	
  o

  	
   

  	
  Residual
  ethanol

  	
   

  	
  o  £  [...***...]ppm 
  Other:

  	
   

  	
   

  
	
  o

  	
   

  	
  Sterility;
  Bulk

  	
   

  	
  o No Growth through 14 days  Other:

  	
   

  	
   

  
	
  o

  	
   

  	
  Sterility;
  Filled vials

  	
   

  	
  o No Growth through 14 days  Other:

  	
   

  	
   

  
	
  o

  	
   

  	
  pH

  	
   

  	
  Specific for
  vehicle.  Value:

  	
   

  	
   

  
	
  o

  	
   

  	
  Stability
  testing  If checked, please
  specify:  1. Duration of testing

  	
   

  	
  Performed at
  every 3 months for the first yeatr, then at 6 month intervals.  Last test one timepoint after last
  clinical use.

  	
   

  	
   

  



 


	
  o
  Certificate of Analysis

  	
  Send to:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  



 


	
  Assay Development Required?

  	
  o
  Yes

  	
  o
  No

  



 


Other
information:


 


CONFIDENTIAL


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


	
   

   

  	
   

  	
   

  
	
  VICAL USE ONLY BELOW:

  	
   

  
	
  Date Order Received by Vical:

  	
       

  
	
  Estimated Fill Date:

  	
       

  
				



 




	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Kevin Bracken-Vice President, Manufacturing

  	
  Date

  
	
   

  	
   

  
	
  Vical Incorporated

  	
   

  
			






 


 




	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Name of authorized signature-

  	
  Date

  
	
   

  	
   

  
	
  Vaccine Research Center

  	
   

  
			






 


CONFIDENTIAL


 

















 


Materials Ordering Form


 


[...***...]


 


	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


[...***...]


	
   

  	
   

  
	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


[...***...]


	
   

  	
   

  
	
   

  	
  * CONFIDENTIAL

  
	
   

  	
  TREATMENT

  
	
   

  	
  REQUESTED

  



 

















 


	
   

  	
   

  	
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  GENERAL SERVICES ADMINISTRATION

  	
   

  	
   

  	
   

  	
  GSA form
  1736 (REV. 6-80)