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

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•                  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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

 

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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

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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

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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

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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

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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

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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:

 

[g32241ke2image002.gif]

 

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

 

--------------------------------------------------------------------------------

 

 

 

BUILDING

EQUIPMENT INVENTORY LIST

 

FIELD OFFICE

 

DATE

 

PREPARED BY

PM GUIDE
NUMBER

 

EQUIPMENT
NUMBER

 

LOCATION

 

DESCRIPTION AND REMARKS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GENERAL SERVICES ADMINISTRATION

 

 

 

GSA form 1736 (REV. 6-80)

 

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