EXHIBIT 10.6

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

 

 

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TABLE OF CONTENTS

 

Part I – The Schedule

Page #

 

 

 

 

Section A – Contract Form

1

 

 

 

 

Section B – Supplies or Services and Price/Costs

3

 

 

 

 

Section C – Statement of Work

8

 

 

 

 

Section D – Packaging and Marking

12

 

 

 

 

Section E – Inspection and Acceptance

13

 

 

 

 

Section F – Deliveries or Performance

14

 

 

 

 

Section G – Contract Administration

17

 

 

 

 

Section H – Special Contract Requirements

22

 

 

 

 

 

 

 

Part II – Contract Clauses

 

 

 

 

 

Section I – Contract Clauses

30

 

 

 

 

 

 

 

Part III – Attachments

 

 

 

 

 

Section J – List of Attachments

36

 

 

 

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HHSO100200800091C

 

Section B – Supplies or Service and Price/Costs

 

B.1. Brief description of supplies or services

 

The Federal Response Plan of the Department of Homeland Security designates the
Department of Health and Human Services (HHS) as the lead agency for public
health and medical response to manmade or natural disasters. Within HHS, the
Division of the Strategic National Stockpile (DSNS) and the BioMedical Advanced
Research & Development Authority (BARDA) under the Office of the Assistant
Secretary for Preparedness and Response are combining their efforts to respond
to, acts of bioterrorism and other public health emergencies threatening the
civilian population. This responsibility within HHS is to contract for
large-scale manufacturing and delivery of licensed and licensable products to
the Strategic National Stockpile (SNS) in preparation for response(s) to a
public health emergency.

 

Significant changes in both the nature, regularity, and degree of the threat
posed by the use of infectious agents as weapons of biological warfare have
generated increased concern for the safety of the general American populace.
Following the deliberate exposure of citizens of the United States to Bacillus
anthracis (B. anthracis) spores in 2001, there is an urgent need to stockpile
appropriate and effective medical countermeasures to safeguard against this
potential threat. The USG has established a requirement for the procurement of
licensed Anthrax Vaccine Adsorbed (here after referred to as BioThrax() to meet
this urgent need.

 

B. 2. Project Identification and Purpose

 

The purpose of this contract is to provide up to 14.5 million doses of FDA
licensed BioThrax( in multi-dose vials with 3 year dating product stability (or
4 year if FDA approved) which shall be delivered during the contract period of
performance in appropriately packaged containers under controlled and secure
conditions to the SNS.

 

B.3.

Specific Technical Requirements

 

The Contractor shall provide the necessary qualified personnel, facilities,
material, equipment (except Government property) and services to produce, test,
bottle, package, and prepare for BioThrax ( delivery. The manufacture,
formulation, filling, and testing of BioThrax( shall be done in accordance with
the contractor’s Standard Operating Procedures, and the contractor’s Food and
Drug Administration Biologics License, and all federal statutory requirements.

 

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B.4. Base Prices:

 

The pricing for four-year dated product is set forth in each CLIN, with
alternative pricing for three-year dated product set forth in each alternative
CLIN (A*). If four-year dated lots of BioThrax® are available at the time of
delivery, Contractor shall deliver four-year dated product to the SNS. The
minimum remaining shelf-life at time of delivery for four-year dated product
will be [**] months, unless otherwise agreed in writing by the Contracting
Officer in connection with a particular delivery; the Contractor shall target a
minimum remaining shelf-life of [**] months for four-year dated product.

 

If FDA has not approved four-year dating at the time of delivery, Contractor may
instead deliver three year dated product to the SNS, at the discounted pricing
set for in each alternative CLIN (A*). Contractor shall target a minimum
remaining shelf-life of [**] months at time of delivery for three-year dated
product. If the minimum remaining shelf-life at time of delivery of a particular
lot or shipment is less than [**] months, the price of such product will be
discounted by $[**] per dose for each month below [**] months of remaining shelf
life.

 

 

 

B.4.1

Pricing for Funded Doses of BioThrax® under CLINs 0001 and 0001A

 

In consideration for the completion of the work to be performed under CLIN 0001,
for the delivery of [**] doses of four-year dated BioThrax® in accordance with
the statement of work, the Contractor shall be paid an amount not to exceed
$[**] (Firm Fixed Price). If four-year dating has not yet been approved, the
Contractor shall be paid the discounted per dose price set forth in CLIN 0001A
for any of the [**] doses that are delivered to the SNS as three-year dated
product (See Section B.4.8).

 

 

 

B.4.2

Pricing for Funded Doses of BioThrax( under CLINs 0002 and 0002A

 

 

In consideration for the completion of the work to be performed under CLIN 0002,
for the delivery of [**] doses of four-year dated BioThrax® in accordance with
the statement of work, the Contractor shall be paid an amount not to exceed
$[**] (Firm Fixed Price). If four-year dating has not yet been approved, the
Contractor shall be paid the discounted per dose price set forth in CLIN 0002A
for any of the [**] doses that are delivered to the SNS as three-year dated
product (See Section B.4.8).

 

 

 

B.4.3

Pricing for Funded Doses of BioThrax® under CLINs 0003 and 0003A

 

In consideration for the completion of the work to be performed under CLIN 0003,
for the delivery of [**] doses of four-year dated BioThrax® in accordance with
the statement of work, the Contractor shall be paid an amount not-to-exceed
$[**] (Firm Fixed Price). If four-year dating has not yet been approved, the
Contractor shall be paid the discounted per dose price set forth in CLIN 0003A
for any of the [**] doses that are delivered to the SNS as three-year dated
product (See Section B.4.8).

 

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B.4.4              Pricing for Doses of BioThrax® under CLINs 0004 and 0004A

 

In consideration for the completion of the work to be performed under CLIN 0004,
for the delivery of up to [**] doses of four-year dated BioThrax® in accordance
with the statement of work, which is subject to the availability of funding, the
Contractor shall be paid an amount not to exceed $[**] (Firm Fixed Price). If
four-year dating has not yet been approved, the Contractor shall be paid the
discounted per dose price set forth in CLIN 0004A for any of the [**] doses that
are delivered to the SNS as three-year dated product (See Section B.4.8).

 

 

 

B.4.5

Pricing for Doses of BioThrax® under CLINs 0005 and 0005A

 

In consideration for the completion of the work to be performed under CLIN 0005,
for the delivery of up to [**] doses of four-year dated BioThrax® in accordance
with the statement of work, which is subject to the availability of funding, the
Contractor shall be paid an amount not-to-exceed $[**] (Firm Fixed Price). If
four-year dating has not yet been approved, the Contractor shall be paid the
discounted per dose price set forth in CLIN 0005A for any of the [**] doses that
are delivered to the SNS as three-year dated product (See Section B.4.8).

 

 

 

B.4.6

Prices for Shipping to the SNS (CLINs 0006 - 0008)

 

In consideration for the completion of the work to be performed under CLINs
0001-0005, for the shipment of BioThrax® to the SNS sites in accordance with the
statement of work, the Contractor shall be paid an amount not-to-exceed
$1,936,512 (Firm Fixed Price).

 

B.4.7. Cancellation Ceiling Fee (CLIN 0009)

 

For consideration should the USG cancel the entire performance of work under
CLIN 0004 and/or CLIN 0005, the Contractor shall be paid the amount, or
percentage thereof, of the cancellation ceiling fee not-to-exceed $1,000,000.
(See Section B.5.d. Advanced Understanding)

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B.4.8. Contract Pricing

 

CLIN #

Type

#/range of doses

 

Price per dose

Price

1

[**]

[**]

 

$[**]

$[**]

0001A*

[**]

 

 

$[**]

$[**]

 

 

 

 

 

 

2

[**]

[**]

 

$[**]

$[**]

0002A*

[**]

 

 

$[**]

$[**]

 

 

 

 

 

 

3

[**]

[**]

 

$[**]

$[**]

0003A*

[**]

 

 

$[**]

$[**]

 

 

 

 

 

 

4

[**]

[**]

 

$[**]

$[**]

0004A*

[**]

 

 

$[**]

$[**]

 

 

 

 

 

 

5

[**]

[**]

 

$[**]

$[**]

0005A*

[**]

 

 

$[**]

$[**]

 

 

 

*

CLINs designated “A” are alternative CLINs; if Contractor has not obtained
four-year dating by the time of delivery of a particular lot, the “A” unit
prices are applicable for each three-year dated dose delivered to the SNS.

 

 

CLIN#

Type

Requirement

Delivery Date

Per Truck

Total Price

 

 

 

 

 

 

6

[**]

Shipping to SNS

[**]

$ [**]

$[**]

 

 

(CLINs 0001~0003)

[**]

 

 

 

 

 

 

 

 

7

[**]

Shipping to SNS

[**]

$[**]

$[**]

 

 

(CLIN 0004)

[**]

 

 

 

 

 

 

 

 

8

[**]

Shipping to SNS

[**]

$ [**]

$[**]

 

 

(CLIN 0005)

[**]

 

 

 

 

Total Estimated Price ([**] trucks)

$

1,936,512

 

Total Estimated Contract Value

$404,685,512

 

0009*

Fee

Cancellation Ceiling

$

1,000,000

 

(CLINs 0004/*4A and 0005/*5A)

 

B.5. Advanced Understandings:

 

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a.

Subcontracts

 

The Contractor shall provide the Contracting Officer with an annual summary of
small businesses used as subcontractors.

 

 

b.

Ranges of doses manufactured and shipped

 

The targeted delivery schedules are based on Contractor’s anticipated production
schedule, projections regarding manufacturing variables, and assumptions
regarding lot release dates. Lot numbers, quantities, and dates are not
guaranteed and may change as a result of lot failures, FDA lot release dates,
lots dedicated to BioThrax® to improvement programs, including the fill/finish
and manufacturing process improvements described in Contractor’s Technical
Proposal, and other factors. Should the projected number of doses not be
delivered on any projected delivery date, the Contractor shall adjust the
delivery schedule to make up for deficiencies in prior deliveries, so long as
the Contractor delivers up to a total of 14.5 million doses at a total contract
price of $402,749,000 (assuming 4 year dating approval) during the period of
performance. Contractor may accelerate deliveries within each CLIN of production
if production capacity permits with the prior approval of the Contracting
Officer.

 

 

c.

Data Rights

 

Data provided by or obtained from the contractor shall be solely for the
purposes of award of this contract. All such data shall be proprietary and
confidential and, except or unless required by federal law, shall not be
distributed outside of the USG without the advance written consent of the
contractor.

 

 

d.

Multi-Year Contract and Advanced Notice

 

This is a multi-year contract for the delivery of up to 14.5 million doses of
BioThrax®, with a period of performance from September 30, 2008 through
September 30, 2011.  The total not-to-exceed cancellation ceiling is applicable
to CLINs 0004/4A and 0005/0005A in the event that funds are not available for
performance of those CLINs, as referenced in FAR 52.217-2 (incorporated by
reference into this contract) is $1,000,000.

 

The Contracting Officer agrees to provide the Contractor with the advanced
notice of funds availability for CLINs 0004/*4A and/or 0005/*5A no later than
[**] months prior to the first scheduled delivery under the applicable CLIN(s).
The Contractor’s obligation to perform under CLINs 0004/*4A and/or 0005/*5A is
contingent upon receiving notice of funding in a timely manner.

 

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e.

Use of product by the USG

 

To the extent that third parties contact DSNS to obtain doses of BioThrax, DSNS
will notify such third parties that Emergent sells AVA at prices not greater
than $[**] per dose. 

Because DoD will obtain BioThrax from the SNS going forward, BARDA and DSNS
agree to work with Contractor to develop a process for notifying Contractor of
all FMS of BioThrax.

 

Section C. Statement of Work  

 

C.1 Vaccine Production and cGMP Compliance:

 

a)

The Contractor shall manufacture BioThrax( in accordance with current Good
Manufacturing Practices (cGMP) guidelines. The Contractor shall manufacture
5,700,000 doses of Final Drug Product (FDP) in 5 mL, ten dose vials in
accordance with the estimated delivery schedule under Section J Attachment 7. At
the time the Government notifies the Contractor that funds have been obligated
funds for the performance of CLINs 0004/*4A and/or 0005/*5A, the Contractor
shall manufacture those doses of Final Drug Product in 5 mL, ten dose vials in
accordance with the proposed delivery schedule applicable to those CLINs.

 

 

b)

BioThrax shall be delivered on any business day, except Federal holidays, within
the scheduled month in accordance with the delivery schedule. All changes to the
delivery schedule must be approved by the Contracting Officer and/or the Project
Officer.

 

 

c)

Quantities for each scheduled delivery shall be of a specific quantity.

 

 

d)

The Contractor shall perform all requisite assays and release tests, including
but not limited to potency, identity, and stability testing in accordance with
the most current FDA approved Biologic License Application (BLA-License Number
1755, STN 103821, and/or any approved change).

 

 

e)

All BioThrax( delivered under this contract shall be labeled with an expiration
date consistent with its current product license at the time of manufacture.

 

 

f)

The Contractor shall provide primary and secondary points of contact who will be
available 24 hours per day, seven days per week to be notified in case of a
public health emergency.

 

 

 

g)

The Contractor shall report to the Government material correspondence from the
FDA regarding the quality, safety, or efficacy of BioThrax(.

 

 

 

 

h)

The Contractor shall provide the Government at least 72 hours (during normal
business hours) to review and provide comments and on material submissions to
the BLA for BioThrax (e.g., Building 55 supplement for BioThrax( BLA) prior to
the Contractor

 

 

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submitting such documents to the FDA (with confidentiality restrictions and /or
redactions as applicable). The Government reserves the right to have additional
review time for submissions greater than 10 pages.

 

 

 

i)

The Contractor shall provide the Government with access to and/or provide copies
(with confidentiality restrictions and/or redactions as applicable) of the
following documents: (1) Form 483s from FDA inspections of Contractor’s Lansing
facility, (2) Establishment Inspection Reports (EIRs) from FDA inspections of
Contractor’s Lansing facility; (3) Warning Letters relating to BioThrax(; and
Contractor’s Annual Safety Report to FDA regarding BioThrax(. These documents
will be provided to the Contracting Officer with the submission of the periodic
reports due under the Contract, with the exception of Warning Letters relating
to BioThrax(, which shall be provided within [**] business days of receipt.

 

 

 

 

j)

The Government reserves the right to be in attendance at all material regulatory
meetings between the FDA and the Contractor relating to the safety and efficacy
of BioThrax( and/or manufacturing or quality at the Lansing facility.

 

 

 

k)

The Contractor shall notify the Contracting Officer of anticipated material
meetings with the FDA relating to the safety and efficacy of BioThrax( and/or
manufacturing or quality at the Lansing facility. On request of the Contracting
Officer, the Contractor will recommend to FDA that a representative of the SNS
be invited to participate in all meetings between the FDA and the Contractor
relating to BioThrax ® Warning Letters or Notices of Intent to Revoke
Contractor’s license to manufacture BioThrax®.

 

 

l)

The Contractor may be subject to quarterly inspections by the Project Officer or
the Project Officer designee(s).

 

 

m)

If the contractor should obtain FDA approval for the manufacture and production
of BioThrax ® having 4 year expiry dating while under this contract, the USG
will accept delivery of those doses with the longer shelf life. Contractor may
invoice only for those doses actually delivered under contract.

 

 

n)

The product shall be delivered and shipped in accordance with cGMP (current Good
Manufacturing Practices). The USG shall make payment for shipping to the SNS as
set forth in CLINs 0006 (CLINs 0007 ~ 0008 are applicable only to those doses
under CLIN 0004/*4A and 0005/*5A respectively).

 

 

o)

At least [**] prior to each delivery to the SNS, the Contractor shall provide to
the Contracting Officer:

 

 

•

Certificate(s) of Analysis

 

•

FDA Lot Release(s)

 

•

Number of pallets, vials, and doses to be shipped

 

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p)

With each shipment, the Contractor will provide:

 

•

Bill of Lading

 

•

Packing Slip

 

•

Shipping directives

 

•

Completed (signed off) shipping instructions

 

•

Identification number for all trucks

 

•

Instructions given to the drivers

 

•

Diagram of product shipment pallet (how many vials per box, per pallet, and
positioning)

 

 

q)

Within [**] business days of each delivery, the Contractor shall provide to the
Contracting Officer:

 

 

•

Confirmation from the Contractor’s Quality Department that product remained
within the acceptable temperature range during shipping

 

•

The remaining ambient exposure time for each lot from the Contractor’s Quality
Department

 

•

Post transit product delivery checklist

 

 

r)

Funds provided shall be paid on a price per dose basis only on those products
delivered to the SNS inventory under contract.

 

 

s)

Under CLINs 0001, 0002, 0003, 0004 and 0005 the product shall have an expiry
period of 48 months. The Contractor shall target [**] months of the total
expiration period remaining when the USG takes delivery of the product. Under
CLIN 0001A, 0002A, 0003A, 0004A and/or 0005A, the product shall have an expiry
period of [**] months. The Contractor shall target [**] months of the total
expiration period remaining when the USG takes delivery of the product.

 

 

t)

The USG shall notify the Contractor of its security requirements applicable to
the shipping service and/or drivers for delivery of BioThrax® to the SNS. The
Contractor shall select the source of transportation to be used for the delivery
of BioThrax® to the SNS, shall notify the Contracting Officer in advance of the
shipping carrier for each delivery, and shall ensure that the services provided
meet the stated requirements.

 

C.2. Anticipated Delivery Schedule:

 

 

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CLIN

Delivery Period

# of Doses

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

 

The number under quantity shows the number of doses that the Contractor
anticipates delivering during the period shown. The Contractor shall ship
BioThrax® to the SNS in accordance with Section B.5.b (Range of Doses
Manufactured and Shipped), F.2 (Place and Method of Delivery), and the Delivery
Schedule, which will be provided to the Contracting Officer and updated
periodically. Should the projected number of doses not be delivered in a
specific period, the Contractor shall adjust the delivery schedule to make up
for deficiencies in prior deliveries, so long as the Contractor delivers a total
of 5,700,000 doses during the period of performance of CLINs 0001 through 0003.
For the anticipated number of doses under CLINs 0004/4A and 0005/5A, the
Contractor shall ship BioThrax® to the SNS in accordance with Section B.5.b
(Range of Doses Manufactured and Shipped), F.2. (Place and Method of Delivery)
and the delivery schedule upon notice from the Contracting Officer regarding the
availability of funds. Contractor may accelerate deliveries within each CLIN of
production if production capacity permits with prior approval of the Contracting
Officer.

.

C.3. Audits/Site Visits:

 

 

a)

Pre-award Site Visit: The USG reserves the right to conduct a pre-award site
visit of the manufacturing plant, if deemed necessary.

 

b)

Site Visits/Audits: The USG shall perform annual site visits/security audits as
deemed necessary by the USG throughout the period of performance of the
contract.

 

c)

Quality: The USG may visit the Lansing site for purposes of assessing quality on
an annual basis or as deemed necessary by the USG throughout the period of
performance of the contract.

 

d)

The contractor (s) shall facilitate cGMP site-visits or inspections as requested
by FDA/CBER at the time of production of product lots destined for the SNS.

 

e)

Quality Management System (QMS): Contractor(s) shall submit evidence of its QMS
to the Contracting Officer within 90 days after contract award.

 

f)

Notice: The USG shall provide at least 2 weeks advance notice to the Contractor
of all site visits and audits. The notice will include a statement concerning
the intended scope of the audit and a list of the required documents or access
to personnel.

 

g)

All audits shall be conducted between normal business hours i.e. 8 a.m. through
4 p.m., Monday through Friday.

 

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C.4 Meetings and Reports:

 

a)

The contractor shall participate in a quarterly meeting (teleconference and/or
face-to-face) to discuss performance under the contract. These meetings should
provide the status updates and discuss on-going manufacturing, clinical,
regulatory, and shipment issues as applicable. These meetings shall be
coordinated by the Project Officer and/or Contracting Officer.

 

b)

Risk Mitigation Plan. The plan should identify manufacturing, quality,
regulatory, and shipment risks and countermeasures to mitigate these risks. This
report should be updated annually or as deemed necessary by the USG.

 

c)

Additional reporting requirements:

 

 

1.

Contractor will notify DSNS in its quarterly reports if Contractor undertakes
post-marketing commitments for Phase 4 studies in the event of emergency use
authorization.

 

 

 

2.

Contractor will provide DSNS with drafts of supplements to its BLA for BioThrax(
that are material to the manufactured product and to the contract.

 

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Section D – Packaging and Marking

 

D.1 Method of Delivery

Unless otherwise specified by the Contracting Officer, delivery of items other
than BioThrax( that are to be furnished to the government under this contract
(including invoices), shall be made by first class mail, overnight carrier, or
e-mail.

D.2 Packaging

 

Packaging shall be consistent with the FDA approved labeling and packaging for
this product at the time of manufacture.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Section E – Inspection and Acceptance  

 

 

FAR Source

Title and Date

 

FAR Clause 52.243-1

Changes – Fixed Price (Aug 1987)

 

FAR Clause 52.246-1

Contractor Inspection Requirements (Apr 1984)

 

FAR Clause 52.246-2

Inspection of Supplies – Fixed Price (Aug 1996)

 

FAR Clause 52.246-16

Responsibility of Supplies (Apr 1984)

 

E.1 Inspection and Acceptance (July 1999)

 

Inspection and acceptance of the articles, services, and documentation called
for herein shall be accomplished by the Contracting Officer, or their duly
authorized representative (who for the purposes of this contract shall be the
Project Officer) at the destination of the articles, services or documentation.

 

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Section F - Deliveries or Performance  

 

 

FAR Clause

Title and Date

 

FAR 52.211-17

Delivery of Excess Quantities (Sept 1989)

 

FAR 52.242-15

Stop Work Order (Aug 1989)

 

FAR 52.242-15, Alt 1

Stop Work Order, Alternate 1 (Apr 1984)

 

FAR 52.242-17

Government Delay of Work (Apr 1984)

 

FAR 52.247-34

FOB Destination (Nov 1991)

 

F.1 Period of Performance

The period of performance of this contract shall be from September 30, 2008 to
September 30, 2011.

 

F. 2. Place and Method of Delivery

 

a.

The delivery of this BioThraxÂproduct shall be F.O.B. Destination to the SNS
site(s).

 

 

b.

The place of delivery shall be at a Strategic National Stockpile site that will
be provided to the Contractor at least [**] prior to shipping. This notification
will be provided by the Contracting Officer.

 

F.3 Contract Deliverables

 

a.

The following deliverables are applicable to CLINs 0001-0005 (and *A):

Up to 14.5 million doses of BioThrax® delivered in accordance with the statement
of work.

b.

The following deliverables are applicable to CLIN 0006 - 0008:

Invoices submitted in accordance with the shipping requirements.

 

F.4 Reporting Requirements

 

The Contractor shall submit to the Contracting Officer and to the Project
Officer quarterly progress reports covering the work accomplished during each
reporting period. These reports are subject to the technical inspection and
requests for clarification by the Project Officer. These shall be brief and
factual and prepared in accordance with the following format:

 

(1)

Quarterly Progress Reports: On the fifteenth (15th) day of each quarter, the
Contractor shall submit a quarterly progress report to the Project Officer and
the Contracting Officer. The Contractor shall submit one copy of the quarterly
progress report electronically via e-mail. Any attachments to the e-mail report
shall be submitted in Microsoft Word or WordPerfect 9 or a compatible version. A
quarterly report will not be required for the quarter where a final report is
due. Such reports shall include the following specific information:

 

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a.

The contract number and title, the period of performance being reported, the
contractor’s name and address, the author(s), and the date of submission;

 

 

b.

Section I – An introduction covering the purpose and scope of the contract
effort;

 

 

c.

Section II – The report shall detail, document, and summarize the results of
work done in performance of requirements of this contract during the period
covered, and include a summary of work planned for the next reporting period.
Production capacity assessment problems and recommendations to include:

 

 

i.

Raw material procurement status;

 

ii.

Inventory report of product manufactured and delivered to the USG under this
contract;

 

iii.

Quality control testing and purity;

 

iv.

Quality control potency assessment;

 

v.

Quality manufacturing deviations – summary;

 

vi.

FDA inspections and consultation results or recommendations;

 

vii.

Security assessment, problems and recommendations;

 

viii.

Physical storage monitoring and calibration reports for manufactured products.

 

ix.

Overall project assessment, problems encountered and recommended solutions, etc.

 

 

d.

Section III – An explanation of any difference between planned progress and
actual progress,

 

why the differences have occurred, and, if behind planned progress, what
corrective steps are

 

planned. The project plan and delivery schedule will be updated in each
Quarterly Report and

 

compared to the baseline plan and delivery schedule.

 

(2)

Risk Mitigation Plan: The contractor shall submit a risk mitigation plan within
90 days after contract award and shall provide an updated plan on the
anniversary of the contract award.

 

(3)

Final Report: A final report is due 30 days prior to the end of the period of
performance of the contract.

 

The Contractor shall deliver, within the time frames specified above, an
original to the Contracting Officer and a copy to the Project Officer (See
Section G.1. for the Project Officer’s address).

 

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F.5 Excusable Delay

 

The contractor shall be liable for default unless nonperformance is caused by an
occurrence beyond the reasonable control of the Contractor and without its fault
or negligence such as, acts of God or the public enemy, acts of the Government
in either its sovereign or contractual capacity, fires, floods, epidemics,
quarantine restrictions, strikes, unusually severe weather, and delays of common
carriers. Furthermore, the Contractor will not be in default under this contract
if it is unable to deliver AVA doses in accordance with any delivery schedule
because of the action or inaction of the FDA, except to the extent that such
action or inaction is a direct consequence of the negligence or willful
misconduct of the Contractor. Additionally, the Contractor will not be in
default of this contract in the event that deliveries are delayed as a result of
another Government agency placing an order for AVA doses that is determined to
have priority over this contract under the Defense Priority Allocation System or
under any other reasonable legal justification or as a result of allocating up
to ten lots of BioThraxÒ to improvement programs, including fill/finish and
manufacturing process improvements. The Contractor shall notify the Contracting
Officer in writing as soon as it is reasonably possible after the commencement
or any excusable delay, setting forth the full particulars in connection
therewith, shall remedy such occurrence with all reasonable dispatch and shall
promptly give written notice of the Contracting Officer of the cessation of such
occurrence.

 

 

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Section G – Contract Administration  

 

G.1 Project Officer

 

The following Project Officer will represent the Government for the purpose of
this contract

 

 

CDR Jacqueline K. Thomas

 

1600 Clifton Road, NE

 

Atlanta, GA 30333

 

Email: gtv4@cdc.gov

 

Performance of the work hereunder shall be subject to the technical directions
of the designated Project Officer for this contract.

 

As used herein, technical directions are directions to the Contractor, which
fill in details, suggests possible lines of inquiry, or otherwise completes the
general scope of work set forth herein. These technical directions must be
within the general scope of work, and may not alter the scope of work or cause
changes of such a nature as to justify an adjustment in the stated contract
price/cost, or any stated limitation thereof. In the event that the Contractor
feels that full implementation of any of these directions may exceed the scope
of the contract, he or she shall notify the originator of the technical
direction and the Contracting Officer in a letter separate of any required
report(s) within two (2) weeks of the date of receipt of the technical direction
and no action shall be taken pursuant to the direction. If the Contractor fails
to provide the required notification within the said two (2) week period that
any technical direction exceeds the scope of the contract, then it shall be
deemed for purposes of this contract that the technical direction was within the
scope. No technical direction, nor its fulfillment, shall alter or abrogate the
rights and obligations fixed in this contract.

 

The Government Project Officer is not authorized to change any of the terms and
conditions of this contract. Changes shall be made only by the Contracting
Officer by properly written modification(s) to the contract. Any changes in the
Project Officer designation will be made by the Contracting Officer in writing
with a copy being furnished to the Contractor.

 

G.2 Payment by Electronic Funds Transfer – Central Contractor Registration (Oct
2003)

 

 

(a)

The Government shall use electronic funds transfer to the maximum extent
possible when making payments under this contract. FAR 52.232-34, Payment by
Electronic Funds Transfer in Section I, requires the contractor to designate in
writing a financial institution for receipt of electronic funds transfer
payments.

 

 

(b)

The contractor shall make the designation by submitting the form titled “ACH
Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below.
Note: The form may be either attached to this contract (see Section J, List of
Attachments) or may be obtained by contacting the Contracting Officer or the CDC
Financial Management Office at (404)498-4050.

 

 

(c)

In cases where the contractor has previously provided such designation, i.e.,
pursuant to a prior contract/order, and been enrolled in the program, the form
may not required.

 

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

 

(d)

The completed form shall be mailed after contract award, but no later than 14
calendar days before an invoice is submitted, to the following address:

 

Centers for Disease Control and Prevention (FMO)

PO Box 15580

Atlanta, GA 30333

(404) 498-4050 or (800) 335-2455

 

G.3. Invoice Submission

 

(a)

The Contractor shall submit an original contract invoice/voucher to the address
shown below:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

PO Box 15580

Atlanta, GA 30333

 

Alternatively, the Contractor may submit invoices electronically via email to
fmoapinv@cdc.gov. Invoices may also be faxed to (404) 638-5324. In any event, an
invoice must be submitted to the Financial Management Office in order for it to
be paid.

 

(b)

The Contractor shall submit one (1) copy of the invoice/voucher to the
Contracting Officer.

 

(c)

The Contractor agrees to include (as a minimum) the following information on
each invoice:

 

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a
defective invoice

(12) Payment Address, if different from the information in (c)(1)

(13) DUNS + 4 Number

(14) The following certification:

 

I certify that this voucher reflects (fill in Contractor’s name) request for
reimbursement of allowable and allocable costs incurred in specific performance
of work authorized under Contract (fill in contract number)/Task (fill-in task
order number, if applicable), and that these costs are true and accurate to the
best of my knowledge and belief.

 

(Original Signature of Authorized Official)

Typed Name and Title of Signatory

 

 

d.

 

 

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In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management
Office is the designated billing office for the purpose of determining the
payment due date under

FAR 32.904.

 

G.4 Evaluation of Contractor Performance (Service)

 

(a) Purpose: In accordance with FAR 42.1502, the contractor's performance will
be periodically evaluated by the government, in order to provide current
information for source selection purposes. These evaluations will therefore be
marked “Source Selection Information.”

 

(b) Performance Evaluation Period: The contractor's performance will be
evaluated at least annually.

 

(c) Evaluators: The performance evaluation will be completed jointly by the
Project officer and the Contracting officer.

 

(d) Performance Evaluation Factors: The contractor's performance will be
evaluated in accordance with the attachment listed in Section J titled
Contractor Performance Evaluation Report.

 

(e) Contractor Review: A copy of the evaluation will be provided to the
contractor as soon as practicable after completion of the evaluation. The
contractor shall submit comments, rebutting statements, or additional
information to the Contracting Officer within 30 calendar days after receipt of
the evaluation.

 

(f) Resolving Disagreements Between the Government and the Contractor:
Disagreements between the parties regarding the evaluation will be reviewed at a
level above the Contracting Officer. The ultimate conclusion on the performance
evaluation is a decision of the contracting agency. Copies of the evaluation,
contractor's response, and review comments, if any, will be retained as part of
the evaluation.

 

(g) Release of Contractor Performance Evaluation Information: The completed
evaluation will not be released to other than Government personnel and the
contractor whose performance is being evaluated. Disclosure of such information
could cause harm both to the commercial interest of the Government and to the
competitive position of the contractor being evaluated as well as impede the
efficiency of Government operations.

 

(h) Source Selection Information: Departments and agencies may share past
performance information with other Government departments and agencies when
requested to support future award decisions. The information may be provided
through interview and/or by sending the evaluation and comment document to the
requesting source selection official.

 

(i) Retention Period: The agency will retain past performance information for a
maximum period of three years after completion of contract performance for the
purpose of providing source selection information for future contract awards.

 

 

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G.5 Contracting Officer

 

(a) The Contracting Officer is the only individual who can legally commit the
Government to the expenditure of public funds. No person other than the
Contracting Officer can make any changes to the terms, conditions, general
provisions, or other stipulations of this contract.

 

(b) No information, other than that which may be contained in an authorized
modification to this contract, duly issued by the Contracting Officer, which may
be received from any person employed by the United States Government, or
otherwise, shall be considered grounds for deviation from any stipulation of
this contract.

 

G.6 Contract Communications/Correspondence

 

The contractor shall identify all correspondence, reports, and other data
pertinent to this contract by imprinting thereon the contract number from Page 1
of the contract.

 

G.7. Notice Prior to Publication

 

The contractor shall not release any reports, manuscripts, press releases, or
abstracts about the work being performed under this contract without written
notice in advance to the Contracting Officer; provided however, that no such
notice is required to comply with any law, rule, regulation, court ruling or
similar order; for submission to any government entity; for submission to any
securities exchange on which the Contractor’s (or its parent corporation’s)
securities may be listed for trading; or to 3rd parties relating to securing,
seeking, establishing or maintaining regulatory or other legal approvals or
compliance, financing and capital raising activities, or mergers, acquisitions,
or other business transactions. .

 

G.8. Press Releases

 

1.

Pursuant to Public Law(s) cited in paragraph (2), 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: the percentage of the total costs of the
program or project which will be financed with Federal money; the dollar amount
of Federal funds for the project or program; and the percentage and dollar
amount of the total costs of the project or program that will be financed by
nongovernmental sources.

 

2.

Public Law and Section No.

Fiscal Year

Period Covered

 

P.L. 108-447,

 

Title V - General Provisions, Section 506    

2007  

10/1/06 - 9/30/07

 

 

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G.9. 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 e-mail 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, D.C. 20026

 

G.10. Notification of Utilization

 

The USG agrees to notify the contractor of any ultimate use of the government
owned vaccine provided by the Contractor to the SNS with the exception of
classified information. This information is necessary for the investigation of
adverse event claims and adverse event reporting.

 

The notice shall include the recipient, intended purpose of the use, projected
date of use, number of doses, and the lot number from which the product will be
used.

 

 

 

 

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Section H – Special Contract Requirements  

 

H.1 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul
1999)

 

The contractor is hereby notified of the restrictions on the use of Department
of Health and Human Service's funding for lobbying of Federal, State and Local
legislative bodies.

 

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective
12/23/89), among other things, prohibits a recipient (and their subcontractors)
of a Federal contract, grant, loan, or cooperative agreement from using
appropriated funds (other than profits from a federal contract) to pay any
person for influencing or attempting to influence an officer or employee of any
agency, a Member of Congress, an officer or employee of Congress, or an employee
of a Member of Congress in connection with any of the following covered Federal
actions; the awarding of any Federal contract; the making of any Federal grant;
the making of any Federal loan; the entering into of any cooperative agreement;
or the modification of any Federal contract, grant, loan, or cooperative
agreement. For additional information of prohibitions against lobbying
activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

 

In addition, the current Department of Health and Human Services Appropriations
Act provides that no part of any appropriation contained in this Act shall be
used, other than for normal and recognized executive-legislative relationships,
for publicity or propaganda purposes, for the preparation, distribution, or use
of any kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support, or defeat legislation pending before the
Congress, or any State or Local legislature except in presentation to the
Congress, or any State or Local legislative body itself.

 

The current Department of Health and Human Services Appropriations Act also
provides that no part of any appropriation contained in this Act shall be used
to pay the salary or expenses of any contract or grant recipient, or agent
acting for such recipient, related to any activity designed to influence
legislation or appropriations pending before the Congress, or any State or Local
legislature.

 

(End of Clause)

 

H.2 Representations, Certifications and Other Statements of Offerors (Jul 1999)

 

The Representations, Certifications and Other Statements of Offerors submitted
by the Contractor dated on September 10, 2008 are hereby incorporated by
reference, with the same force and effect as if they were given in full text.

 

(End of Clause)

 

H.3 Privacy Act Applicability (Apr 2000)

 

(a) Notification is hereby given that the contractor and its employees are
subject to criminal penalties for violation of the Privacy Act to the same
extent as employees of the Government. The contractor shall assure that each of
its employees knows the prescribed rules of conduct and that each is aware that
he or she can be subjected to criminal penalty for violation of the Act. A copy
of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at

 

http://www.gpoaccess.gov/cfr/index.html

 

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(b) The Project Officer is hereby designated as the official who is responsible
for monitoring contractor compliance with the Privacy Act.

 

(c) The contractor shall follow the Privacy Act guidance as contained in the
Privacy Act system notice to be provided by the Government (See Section J, List
of Attachments).

 

(End of Clause)

Note: Clinical trials cannot be initiated until the System Notice has been
published and the Contracting Officer notifies the contractor.

 

H.4 Laboratory License Requirements (May 1998)

 

The contractor shall comply with all applicable requirements of Section 353 of
the Public Health Service Act (Clinical Laboratory Improvement Act as amended).
This requirement shall also be included in any subcontract for services under
the contract.

 

(End of Clause)

 

H.5 Dissemination of Information

 

No information related to data obtained under this contract shall be released or
publicized without the prior written consent of the Project Officer, which
approval shall not be unreasonably withheld, conditioned, or delayed; provided,
however, that no such consent is required to comply with any law, rule,
regulation, court ruling or similar order; for submission to any government
entity’ for submission to any securities exchange on which the Contractor’s (or
its parent corporation’s) securities may be listed for trading; or to third
parties relating to securing, seeking, establishing or maintaining regulatory or
other legal approvals or compliance, financing and capital raising activities,
or mergers, acquisitions, or other business transactions.

 

H.6 Identification and Disposition of Data

 

The contractor shall be required to provide certain data generated under this
contract to the Department of Health and Human Services (DHHS). DHHS reserves
the right to review any other data determined by DHHS to be relevant to this
contract. The contractor shall keep copies of all data required by the Food and
Drug Administration (FDA) relevant to this contract for the time specified by
the FDA.

 

H.7 Incorporation of Technical Proposal

 

The Contractor's Technical Proposal included in its Proposal or Final Proposal
Revision if necessary dated September 10, 2008, along with subsequent change
pages, if any, dated September 25, 2008 submitted in response to RFP-BARDA-08-26
is hereby incorporated into the contract by reference. The contractor shall
perform the work substantially as set forth in the technical proposal. Any
revisions to the technical proposal that would significantly alter the technical
approach must be approved in writing by the Contracting Officer. In the event of
a conflict between Section C, Statement of Work, and the Contractor’s technical
proposal, Section C will take precedence.

 

(End of Clause)

 

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H.8 Year 2000 Compliance (Jul 1999)

 

Unless elsewhere exempted, information technology (if any) to be acquired under
this contract/purchase order, which will be required to perform date/time
processing involving dates subsequent to

December 31, 1999, shall be Year 2000 compliant as defined in Federal
Acquisition Regulation Part 39.002.

 

(End of Clause)

 

H.9 Security Plan Requirements

 

The work to be performed under this contract will involve access to sensitive
DSNS program/logistics information. Therefore, the Offeror(s) shall develop and
submit a written Security Plan that describes their procedures and policies to
defend against theft, tampering, or destruction of product-related material,
equipment, documents, information, and data. The Security Plan will include, at
a minimum:

 

a.

Personnel Security Policies and Procedures including but not limited to:

recruitment of new employees; interview process; background checks; suitability
/ adjudication policy; access determination; rules of behavior; termination
procedures; and non-disclosure agreements.

 

b.        Physical Security Policies and Procedures including but not limited
to: internal / external access control; identification policies; facility
visitors; parking areas; barriers; shipping, receiving and transport; security
lighting; restricted areas; signage; intrusion detection systems; closed circuit
television; other control measures. The plan shall include the security measures
to be used to protect the product to be stored at the Contractor’s facility
(e.g., refrigeration/freezer alarm systems, backup electrical power generator
systems, etc.), and the contingency plan to accommodate any manufacturing and
storage problems caused by natural or man-made disasters, power loss,
refrigerant loss, equipment failures, etc..

 

c.

Information Security Policies and Procedures including but not limited to:

identification of sensitive information; access control / determination; secure
storage procedures; document control; destruction procedures.

 

d.        Information Technology Security Policies and Procedures including but
not limited to: intrusion detection and prevention systems; encryption systems;
identification of sensitive information; passwords; removable media; laptop
policy; access control / determination; secure storage procedures; document
control; backup procedures; disaster recovery.

 

e.         Security Reporting Requirement - Violations of established security
protocols will be reported to the Contracting Officer upon discovery. The
Contractor will investigate violations to determine the cause, extent, loss or
compromise of sensitive program information, and corrective actions taken to
prevent future violations. DSNS will determine if the severity of the violation
requires further government intervention.

 

Performance of the work under this contract shall be in accordance with this
written Security Plan. The Contractor shall submit this plan to the Contracting
Officer within 90 days after contract award. The Contracting Officer will notify
the Contractor that the Security Plan is acceptable.

 

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H.10 Protection of Human Subjects

 

No contract involving human subjects research shall be awarded until acceptable
assurance has been given that the project or activity will be subject to initial
and continuing review by an appropriate institutional review committee(s) as
described in 45 CFR Part 46. Contracts involving human subjects will not be
awarded to an individual unless the individual is affiliated with or sponsored
by an institution that has an Office for Human Research Protections (OHRP)
approved assurance of compliance in place and will assume responsibility for
safeguarding the human subjects involved. The OHRP web site is:
http://www.hhs.gov/ohrp. The contractor further agrees to provide certification
at least annually that the institutional review board has reviewed and approved
the procedures which involve human subjects in accordance with 45 CFR Part 46
and the Assurance of Compliance.

The contractor shall bear full responsibility for the performance of all work
and services involving the use of human subjects under this contract in a proper
manner and as safely as is feasible. The parties hereto agree that the
contractor retains the right to control and direct the performance of all work
under this contract. Nothing in this contract shall be deemed to constitute the
contractor or any subcontractor, agent or employee of the contractor, or any
other person, organization, institution, or group of any kind whatsoever, as the
agent or employee of the Government. The contractor agrees that it has entered
into this contract and will discharge its obligations, duties, and undertakings
and the work pursuant thereto, whether requiring professional judgment or
otherwise, as an independent contractor without imputing liability on the part
of the Government for the acts of the contractor or its employees.

If at any time during performance of this contract, the Contracting Officer
determines, in consultation with the OHRP, that the contractor if not in
compliance with any of the requirements and/or standards stated in paragraphs
(a) and (b) above, the Contracting Officer may immediately suspend, in whole or
in part, work and further payments under this contract until the contractor
corrects such noncompliance. Notice of the suspension may be communicated by
telephone and confirmed in writing.

If the contractor fails to complete corrective action within the period of time
designated in the Contracting Officer’s written notice of suspension, the
Contracting Officer may, in consultation with OHRP, terminate this contract in
whole or in part, and the contractor name may be removed from the list of those
contractors with approved Health and Human Services Human Subject Assurances.

 

H.11 Information on Compliance with Animal Care Requirements

Registration with the U. S. Dept. of Agriculture (USDA) is required to use
regulated species of animals for biomedical purposes. The USDA office contact
information is available at http://www.aphis.usda.gov/ac/acorg.html. They are
responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et.
seq.), http://www.nal.usda.gov/awic/legislat/awa.htm.

The Public Health Service (PHS) Policy is administered by the Office of
Laboratory Animal Welfare (OLAW) http://grants2.nih.gov/grants/olaw/olaw.htm. An
essential requirement of the PHS Policy
http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every
institution using live vertebrate animals must obtain an approved assurance from
OLAW before they can receive funding from any component of the U. S. Public
Health Service.

The PHS Policy requires that Assured institutions base their programs of animal
care and use on the Guide for the Care and Use of Laboratory Animals
http://www.nap.edu/readingroom/books/labrats/ and that they comply with the
regulations (9 CFR, Subchapter A)
http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the U.S. Department
of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from
USDA regulations in some respects. Compliance with the USDA regulations is an
absolute requirement of this Policy.

 

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The Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC) http://www.aaalac.org is a professional organization that
inspects and evaluates programs of animal care for institutions at their
request. Those that meet the high standards are given the Accredited status. As
of the 2002 revision of the PHS Policy, the only accrediting body recognized by
PHS is the AAALAC. While AAALAC Accreditation is not required to conduct
biomedical research, it is highly desirable. AAALAC uses the Guide as their
primary evaluation tool. They also use the Guide for the Care and Use of
Agricultural Animals in Agricultural Research and Teaching. It is published by
the Federated of Animal Science Societies http://www.fass.org.

 

H.12 Requirements for Adequate Assurance of Protection of Vertebrate Animal
Subjects

 

The PHS Policy on Humane Care and Use of Laboratory Animals requires that
applicant organizations proposing to use vertebrate animals file a written
Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW),
establishing appropriate policies and procedures to ensure the humane care and
use of live vertebrate animals involved in research activities supported by the
PHS. The PHS Policy stipulates that an applicant organization, whether domestic
or foreign, bears responsibility for the humane care and use of animals in
PHS-supported research activities. Also, the PHS policy defines “animal” as “any
live, vertebrate animal used, or intended for use, in research, research
training, experimentation, biological testing or for related purposes.” This
Policy implements and supplements the U.S. Government Principles for the
Utilization and Care of Vertebrate Animals Used in Testing, Research, and
Training, and requires that institutions use the Guide for the Care and Use of
Laboratory Animals as a basis for developing and implementing an institutional
animal care and use program. This Policy does not affect applicable State or
local laws or regulations that impose more stringent standards for the care and
use of laboratory animals. All institutions are required to comply, as
applicable, with the Animal Welfare Act as amended (7 USC 2131 et. seq.) and
other Federal statutes and regulations relating to animals. These documents are
available from the Office of Laboratory Animal Welfare, National Institutes of
Health, Bethesda, MD 20892, (301) 496-7163. See
http://grants.nih.gov/grants/olaw/olaw.htm.

No PHS supported work for research involving vertebrate animals will be
conducted by an organization, unless that organization is operating in
accordance with an approved Animal Welfare Assurance and provides verification
that the Institutional Animal Care and Use Committee (IACUC) has reviewed and
approved the proposed activity in accordance with the PHS policy. Applications
may be referred by the PHS back to the institution for further review in the
case of apparent or potential violations of the PHS Policy. No award to an
individual will be made unless that individual is affiliated with an assured
organization that accepts responsibility for compliance with the PHS Policy.
Foreign applicant organizations applying for PHS awards for activities involving
vertebrate animals are required to comply with PHS Policy or provide evidence
that acceptable standards for the humane care and use of animals will be met.
Foreign applicant organizations are not required to submit IACUC approval.

 

H.13 Care of Live Vertebrate Animals

 

1. Before undertaking performance of any contract involving research on live,
vertebrate animals, the Contractor shall register with the Secretary of
Agriculture of the United States in accordance with 7 U.S.C. 2316 and 9 CFR
Section 2.30. The contractor shall furnish evidence of such registration to the
Contracting Officer.

 

2. The contractor shall acquire animals used in research from a dealer licensed
by the Secretary of Agriculture under 7 U.S.C. 2131-2157 and 9 CFR Sections
2.1-2.11, or from a source that is exempt from licensing under those sections.

 

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3. The contractor agrees that the care and use of any live, vertebrate animals
used or intended for use in the performance of this contract will conform with
the PHS Policy on Humane Care and Use of Laboratory Animals, the current Animal
Welfare Assurance, the Guide for the Care and Use of Laboratory Animals prepared
by the Institute of Laboratory Animal Resources, and the pertinent laws and
regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et
seq. and 9 CFR Subchapter A, Parts 1-3). In case of conflict between standards,
the more stringent standard shall be used.

 

4. If at any time during performance of this contract, the Contracting Officer
determines, in consultation with the Office of Laboratory Animal Welfare (OLAW),
National Institutes of Health (NIH), that the contractor is not in compliance
with any of the requirements and/or standards stated in paragraphs (1) through
(3) above, the Contracting Officer may immediately suspend, in whole or in part,
work and further payments under this contract until the contractor corrects the
noncompliance. Notice of the suspension may be communicated by telephone and
confirmed in writing. If the Contractor fails to complete corrective action
within the period of time designated in the Contracting Officer's written notice
of suspension, the Contracting Officer may, in consultation with OLAW, NIH,
terminate this contract in whole or in part, and the contractor's name may be
removed from the list of those contractors with approved Public Health Service
Animal Welfare Assurances.

 

The contractor may request registration of its facility and a current listing of
licensed dealers from the Animal Care Sector Office of the Animal and Plant
Health Inspection Service (APHIS), USDA, for the sector in which its research
facility is located. The location of the appropriate APHIS Regional Office, as
well as information concerning this program, may be obtained by contacting:
Animal Care Staff USDA/APHIS 4700 River Road, Unit 84 Riverdale, MD 20737 (301)
734-4980. Contractors proposing research that involves live, vertebrate animals
will be contacted by OLAW and given detailed instructions on filing a written
Animal Welfare Assurance with the PHS. Contractors are encouraged to visit the
OLAW website at http://grants.nih.gov/grants/olaw/olaw.htm for additional
information. OLAW may be contacted at the National Institutes of Health at (301)
594-2289.

 

H.14 Approval of Required Assurance by OLAW

 

Under governing regulations, federal funds which are administered by the
Department of Health and Human Services, Division of the Strategic National
Stockpile (DSNS) shall not be expended by the contractor for research involving
live vertebrate animals, nor shall live vertebrate animals be involved in
research activities by the contractor under this award unless a satisfactory
assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is
submitted within 30 days of the date of this award and approved by the Office of
Laboratory Animal Welfare (OLAW). Each performance site (if any) must also
assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the
following restriction: Only activities which do not directly involve live
vertebrate animals (i.e. are clearly severable and independent from those
activities that do involve live vertebrate animals) may be conducted by the
contractor or individual performance sites pending OLAW approval of their
respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections
2.25-2.28. Additional information regarding OLAW may be obtained via the
Internet at http://grants2.nih.gov/grants/olaw/olawaddr.htm.

 

H.15 Liability Protection under the PREP Act

 

The Public Readiness & Emergency Preparedness Act (PREP Act), Pub. L. 109-148,
Division C, 119 Stat. 2818 to 2832, amended the Public Health Service Act, 42,
U.S.C. 243 et seq., to provide targeted liability protections. The Government
agrees that the medical countermeasure delivered by the contractor under this
contract will not be administered in humans, unless the Secretary executes a

 

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declaration in accordance with section 319F-3(b) of the Public Health Service
Act, 42, U.S.C. 247-d-6d, that the medical countermeasure delivered under this
contract is a covered countermeasure to which section 319-F3(a) applies subject
to the terms and conditions of the declaration.

 

H.16 Manufacturing Standards

 

The Current Good Manufacturing Practice Regulations (cGMP)(21 CFR Parts 210-211)
will be the standard to be applied for manufacturing, processing and packaging
of this product.

 

If at any time during the life of the contract, the Contractor fails to comply
with cGMP in the manufacturing, processing and packaging of this product and
such failure results in a material adverse effect on the safety, purity or
potency of the product (a material failure) as identified by CBER and CDER, the
contractor shall have thirty (30) calendar days from the time such material
failure is identified to cure such material failure. If the contractor fails to
take such an action within the thirty (30) calendar day period, then the
contract may be terminated.

 

H.17. Prohibition on Contractor Involvement with Terrorist Activities

 

The Contractor acknowledges that U.S. Executive Orders and Laws, including but
not limited to Executive Order 13224 and Public Law 107-56, prohibit
transactions with, and the provision of resources and support to, individuals
and organizations associated with terrorism. It is the legal responsibility of
the contractor to ensure compliance with these Executive Orders and Laws. This
clause must be included in all subcontracts issued under this contract.

 

H.18. HHSAR 352.270-5 Key Personnel (APR 1984)

The personnel specified in this contract are considered to be essential to the
work being performed hereunder. Prior to diverting any of the specified
individuals to other programs, the Contractor shall notify the Contracting
Officer reasonably in advance and shall submit justification (including proposed
substitutions) in sufficient detail to permit evaluation of the impact on the
program. No diversion shall be made by the contractor without the written
consent of the Contracting Officer; provided that the Contracting Officer may
ratify in writing such diversion and such ratification shall constitute the
consent of the Contracting Officer required by this clause. The contract may be
modified from time to time during the course of the contract to either add or
delete personnel as appropriate.

Contractor Key Personnel

 

Name:

Position:

 

1. [**]

[**]

 

2. [**]

[**]

H.19. Registration with the Select Agent Program for Work Involving the
Possession, Use, and/or Transfer of Select Biological Agents or Toxins

Work involving select biological agents or toxins shall not be conducted under
this contract until the contractor and any affected subcontractor(s) are granted
a certificate of registration or are authorized to work with the applicable
select agents.

For prime or subcontract awards to domestic institutions who possess, use,
and/or transfer Select Agents under this contract, the institution must complete
registration with BARDA, Department of Health and

 

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

Human Services (DHHS) or the Animal and Plant Health Inspection Services
(APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing
work involving Select Agents, in accordance with 42 CFR 73. No Government funds
can be used for work involving Select Agents, as defined in 42 CFR 73, if the
final registration certificate is denied.

 

For prime or subcontract awards to foreign institutions who possess, use, and/or
transfer Select Agents under this contract, the institution must provide
information satisfactory to the Government that a process equivalent to that
described in 42 CFR 73 (http://www.cdc.gov/od/sap/docs/42cfr73.pdf ) for U.S.
institutions is in place and will be administered on behalf of all Select Agent
work sponsored by these funds before using these funds for any work directly
involving the Select Agents. The contractor must provide information addressing
the following key elements appropriate for the foreign institution: safety,
security, training, procedures for ensuring that only approved/appropriate
individuals have access to the Select Agents, and any applicable laws,
regulations and policies equivalent to 42 CFR 73. The Government will assess the
policies and procedures for comparability to the U.S. requirements described in
42 CFR Part 73. When requested by the contracting officer, the contractor shall
provide key information delineating any laws, regulations, policies, and
procedures applicable to the foreign institution for the safe and secure
possession, use, and transfer of Select Agents. This includes summaries of
safety, security, and training plans, and applicable laws, regulations, and
policies. For the purpose of security risk assessments, the contractor must
provide the names of all individuals at the foreign institution who will have
access to the Select Agents and procedures for ensuring that only approved and
appropriate individuals have access to Select Agents under the contract.

 

Listings of HHS select agents and toxins, biologic agents and toxins, and
overlap agents or toxins as well as information about the registration process,
can be obtained on the Select Agent Program Web site at
http://www.cdc.gov/od/sap/.

 

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

PART II – CONTRACT CLAUSES

 

Section I – CONTRACT CLAUSES

 

I.1.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or
Executive Orders-Commercial Items (Jun 2008)

 

(a) The Contractor shall comply with the following Federal Acquisition
Regulation (FAR) clauses, which are incorporated in this contract by reference,
to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:

(1) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(2) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)
(Pub. L. 108-77, 108-78)

 

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that
the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to
acquisitions of commercial items:

[Contracting Officer check as appropriate.]

_X_

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006),
with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

__

(2) 52.219-3, Notice of Total HUB Zone Set-Aside (Jan 1999) (15 U.S.C. 657a).

__

(3) 52.219-4, Notice of Price Evaluation Preference for HUB Zone Small Business
Concerns (JULY 2005) (if the offeror elects to waive the preference, it shall so
indicate in its offer) (15 U.S.C. 657a).

__

(4) removed

__ (ii) Alternate I (Mar 1999) of 52.219-5.

__ (iii) Alternate II (June 2003) of 52.219-5.

__

(5) (i)  52.219-6, Notice of Total Small Business Set-Aside (June 2003)
(15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-6.

__ (iii) Alternate II (Mar 2004) of 52.219-6.

__

(6) (i)  52.219-7, Notice of Partial Small Business Set-Aside (June 2003)
(15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

_X_

(7) 52.219-8, Utilization of Small Business Concerns (May 2004)
(15 U.S.C. 637(d) (2) and (3).

_X_

(8) (i)  52.219-9, Small Business Subcontracting Plan (Apr 2008)
(15 U.S.C. 637(d) (4).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__

(9) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a) (14).

__

(10) 52.219-16 Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637
(d)(4)(f)(i)

 

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

__

(11) (i)  52.219-23, Notice of Price Evaluation Adjustment for Small
Disadvantaged Business Concerns (SEPT 2005) (Pub. L. 103-355, section 7102, and
10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so
indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__

(12) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged
Status and Reporting (Apr 2008) (Pub). L. 103-355, section 7102, and
10 U.S.C. 2323).

__

(13) 52.219-26, Small Disadvantaged Business Participation Program—Incentive
Subcontracting (Oct 2000) (Pub). L. 103-355, section 7102, and 10 U.S.C. 2323).

__

(14) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business
Set-Aside (May 2004).

__

(15) 52.219-28, Post Award Small Business Program Representative (June 2007) (15
U.S.C. 632(a)(2)

_X_

(16) 52.222-3, Convict Labor (Jun 2003) (E.O. 11755)

_X_

(17) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2008)
(E.O. 13126).

_X_

(18) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_

(19) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X_

(20) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the
Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

_X_

(21) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998)
(29 U.S.C. 793).

_X_

(22) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the
Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

__

(23) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues
or Fees (Dec 2004) (E.O. 13201).

__

(24) (i)  52.223-9, Estimate of Percentage of Recovered Material Content for
EPA-Designated Items (May 2008) (42 U.S.C. 6962(c) (3) (A) (ii)).

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i) (2) (C)).

__

(25) 52.225-1, Buy American Act—Supplies (June 2003) (41 U.S.C. 10a-10d).

__

(26) (i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act
(AUG 2007) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note,
Pub. L. 108-77, 108-78, 108-286).

__ (ii) Alternate I (Jan 2004) of 52.225-3.

__ (iii) Alternate II (Jan 2004) of 52.225-3.

__

(27) 52.225-5, Trade Agreements (NOV 2007) (19 U.S.C. 2501,et seq.,
19 U.S.C. 3301 note).

__

(28) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.o.s,
proclamations, and statutes administered by the Office of Foreign Assets Control
of the Department of the Treasury).

___

(29) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (42 U.S.C. 5150)
(Nov 2007)

___

(30) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency
Area.(Nov 2007)

___      (31) 52.232-29, Terms for Financing of Purchases of Commercial Items
(FEB 2002) (41 U.S.C. 255(f), 10 U.S.C.

 

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

 

2307 (f)

__

(32) 52.232-30, Installment Payments for Commercial Items (Oct 1995)
(41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

_X_

(33) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor
Registration (Oct 2003) (31 U.S.C. 3332).

__

(34) 52.232-34, Payment by Electronic Funds Transfer—Other than Central
Contractor Registration (May 1999) (31 U.S.C. 3332).

__

(35) 52.232-36, Payment by Third Party (May 1999) (31 U.S.C. 3332).

__

(36) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__

(37) (i)  52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels
(Feb 2006)

 

(46 U.S.C. App. 1241 and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

 

(c) The Contractor shall comply with the FAR clauses in this paragraph (c),
applicable to commercial services, that the Contracting Officer has indicated as
being incorporated in this contract by reference to implement provisions of law
or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Act of 1965, as Amended (Nov 2007)
(41 U.S.C. 351, et seq.).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989)
(29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price
Adjustment (Multiple Year and Option Contracts) (Nov 2006) (29 U.S.C. 206 and
41 U.S.C. 351, et seq.).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price
Adjustment (Feb 2002) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

 

(d) Comptroller General Examination of Record. The Contractor shall comply with
the provisions of this paragraph (d) if this contract was awarded using other
than sealed bid, is in excess of the simplified acquisition threshold, and does
not contain the clause at 52.215-2, Audit and Records—Negotiation.

 

(1) The Comptroller General of the United States, or an authorized
representative of the Comptroller General, shall have access to and right to
examine any of the Contractor’s directly pertinent records involving
transactions related to this contract.

 

(2) The Contractor shall make available at its offices at all reasonable times
the records, materials, and other evidence for examination, audit, or
reproduction, until 3 years after final payment under this contract or for any
shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of
the other clauses of this contract. If this contract is completely or partially
terminated, the records relating to the work terminated shall be made available
for 3 years after any resulting final termination settlement. Records relating
to appeals under the disputes clause or to litigation or the settlement of
claims arising under or relating to this contract shall be made available until
such appeals, litigation, or claims are finally resolved.

 

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

 

(3) As used in this clause, records include books, documents, accounting
procedures and practices, and other data, regardless of type and regardless of
form. This does not require the Contractor to create or maintain any record that
the Contractor does not maintain in the ordinary course of business or pursuant
to a provision of law.

 

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b),
(c), and (d) of this clause, the Contractor is not required to flow down any FAR
clause, other than those in paragraphs (i) through (vii) of this paragraph in a
subcontract for commercial items. Unless otherwise indicated below, the extent
of the flow down shall be as required by the clause—

 

(i) 52.219-8, Utilization of Small Business Concerns (May 2004)
(15 U.S.C. 637(d) (2) and (3)), in all subcontracts that offer further
subcontracting opportunities. If the subcontract (except subcontracts to small
business concerns) exceeds $500,000 ($1,000,000 for construction of any public
facility), the subcontractor must include 52.219-8 in lower tier subcontracts
that offer subcontracting opportunities.

(ii) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of
the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

(iv) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998)
(29 U.S.C. 793).

(v) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues
or Fees (Dec 2004) (E.O. 13201).

(vi) 52.222-41, Service Contract Act of 1965, as Amended (Nov 2007), flow down
required for all subcontracts subject to the Service Contract Act of 1965
(41 U.S.C. 351, et seq.).

(vii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels
(Feb 2006) (46 U.S.C. App. 1241 and 10 U.S.C. 2631). Flow down required in
accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for
commercial items a minimal number of additional clauses necessary to satisfy its
contractual obligations.

 

Alt 1 (FEB 2000). As prescribed in 12.301(b)(4), delete paragraph (d) from the
basic clause, re-designate paragraph

(e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or
(d) of this clause in the re-designated paragraph (d) to read “paragraphs (a),
(b), and (c) of this clause”.

 

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

I.2. FAR Addenda

 

Federal Acquisition Regulation (FAR) (48 CFR CHAPTER 1) Clauses

 

 

FAR

 

Clause No.

Title

Date

 

 

1. FAR 52.202-1

Definitions

Jul 2004

 

 

2. FAR 52-212-4

Contract Terms and Conditions -

Feb 2007

 

Commercial Items

 

 

3. FAR 52.217-2

Cancellation under Multi-Year

Oct 1997

 

Contracts

 

 

3. FAR 52.243-1

Changes-Fixed Price

Aug 1987

 

 

3. FAR 52.249-2

Termination for Convenience

May 2004

 

of the Government (Fixed Price)

 

 

4. FAR 52.249-8

Default (Fixed Price Supply and

Apr 1984

 

Service) (over $100,000)

 

 

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

I.3. HHSAR Addenda

 

Department of Health & Human Services Acquisition Regulation (HHSAR)

(48 CFR CHAPTER 3) Clauses

 

 

HHSAR

 

Clause No.

Title

Date

 

 

1. HHSAR 352.202-1

Definitions

Jan 2001

 

 

2. HHSAR 352.223-70

Safety and Health

Jan 2001

 

 

3. HHSAR 352.224-70

Confidentiality of Information

Apr 1984

 

 

4. HHSAR 352.232-9

Withholding of Contractor

Apr 1984

 

Payments

 

 

5. HHSAR 352.270-4

Pricing of Adjustments

Jan 2001

 

 

6. HHSAR 352.270-5

Key Personnel

Apr 1984

 

 

7. HHSAR 352.270-6

Publication & Publicity

Jul 1991

 

 

8. HHSAR 352.270-7

Paperwork Reduction Act

Jan 2001

 

 

9. HHSAR 352.270-8

Protection of Human Subjects

Jan 2001

 

Note: The Office for Human Research Protections (OHRP), Office of the Secretary
(OS), Department of Health and Human Services (DHHS) is the office responsible
for oversight of the Protection of Human subjects and should replace Office for
Protection from Research Risks (OPRR), National Institutes of Health (NIH)
wherever it appears in this clause.

 

 

10. HHSAR 352.270-9

Care of Live Vertebrate Animals

Jan 2001

 

 

11. HHSAR 352.270-10

Anti-Lobbying

Jan 2006

 

 

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

PART III – List of Documents, Exhibits, and other attachments

 

SECTION J - LIST OF ATTACHMENTS

 

The following Attachments are provided in full text with this contract:

 

 

1.

Summary of Related Activities

 

 

2.

Protection of Human Subjects

 

 

3.

Disclosure of Lobbying Activities

 

 

4.

Contractor Performance Evaluation Report

 

 

5.

ACH Vendor/Miscellaneous Payment Enrollment Form

 

 

6.

Subcontracting Plan

 

 

7.

Forecast Delivery Schedule as of 9/29/2008

 

 

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

SUMMARY OF RELATED ACTIVITIES

 

The following specific information must be provided by the Offeror pertaining to
the Project Director, Principal Investigator, and each of any other proposed key
professional individuals designated for performance under any resulting
contract.

 

a.

Identify the total amount of all presently active federal contracts/cooperative
agreements/grants and commercial agreements citing the committed levels of
effort for those projects for each of the key individuals* in this proposal.

 

 

Professional's Name and Title/Position:

 

 

Identifying Number

Agency

Total Effort Committed

 

 

1.

 

2.

 

3.

 

4.

 

*If an individual has no obligation(s), so state.

 

b.

Provide the total number of outstanding proposals, exclusive of the instant
proposal, having been submitted by your organization, not presently accepted but
in an anticipatory stage, which will commit levels of effort by the proposed
professional individuals*.

 

 

Professional's Name and Title/Position:

 

 

Identifying Number

Agency

Total Effort Committed

 

1.

 

2.

 

3.

 

4.

 

*If no commitment of effort is intended, so state.

 

c.

Provide a statement of the level of effort to be dedicated to any resultant
contract awarded to your organization for those individuals designated and cited
in this proposal.

 

 

Name

Title/Position

Total Proposed Effort

 

 

1.

 

2.

 

3.

 

4.

 

 

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

[image3.jpg]

 

 

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

 

Authorized for local Reproduction

Sponsored by HHS

 

Public reporting burden for this collection of information is estimated to
average less than an hour per response. An agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. Send comments regarding this
burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden to: OS Reports Clearance Officer, Room 503
200 Independence Avenue, SW., Washington, DC 20201. Do not return the completed
form to this address.

 

[image4.jpg]

 

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

 

INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

 

This disclosure form shall be completed by the reporting entity, whether
subawardee of prime Federal recipient, at the initiation or receipt of a covered
Federal action, or a material change to a previous filing, pursuant to title 31
U.S.C. section 1352. The filing of a form is required for each payment or
agreement to make payment to any lobbying entity for influencing of attempting
to influence an officer or employee of any agency, a Member of Congress, an
officer or employee of Congress, or an employee of a Member of Congress in
connection with a covered Federal action. Use the SF-LLL-A Continuation Sheet
for additional information if the space on the form is inadequate. Complete all
items that apply for both the initial filing and material change report. Refer
to the implementing guidance published by the Office of Management and Budget
for additional information.

 

 

1.

Identify the type of covered Federal action for which lobbying activity is
and/or has been secured to influence the outcome of a covered Federal action.

 

 

2.

Identify the status of the covered Federal action.

 

 

3.

Identify the appropriate classification of this report. If this is a follow-up
report caused by a material change to the information previously reported, enter
the year and quarter in which the change occurred. Enter the date of the last
previously submitted report by this reporting entity for this covered Federal
action.

 

 

4.

Enter the full name, address, city, state and zip code of the reporting entity.
Include Congressional District, if known. Check the appropriate classification
of the reporting entity that designates if it is, or expects to be, a prime or
subaward recipient. Identify the tier of the subawardee, e.g., the first
subawardee of the prime is the 1st tier. Subawards include but are not limited
to subcontracts, subgrants and contract awards under grants.

 

 

5.

If the organization filing the report in item 4 checks "Subawardee," then enter
the full name, address, city, state and zip code of the prime Federal recipient.
Include Congressional District, if known.

 

 

6.

Enter the name of the Federal agency making the award or loan commitment.
Include at least one organizational level below agency name, if known. For
example, Department of Transportation, United States Coast Guard.

 

 

7.

Enter the Federal program name or description for the covered Federal action
(item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA)
number for grants, cooperative agreements, loans, and loan commitments.

 

 

8.

Enter the most appropriate Federal identifying number available for the Federal
action identified in item 1 (e.g., Request for Proposal (RFP) number, Invitation
for Bid (IFB) number, grant announcement number, the contract, grant, or loan
award number, the application/proposal control number assigned by the Federal
agency). Include prefixes, e.g., "RFP-DE-90-001."

 

 

9.

For a covered Federal action where there has been an award or loan commitment by
the Federal agency, enter the Federal amount of the award/loan commitment for
the prime entity identified in item 4 or 5.

 

 

10.

(a)      Enter the full name, address, city, state and zip code of the lobbying
entity engaged by the reporting entity identified in item 4 to influence the
covered Federal action.

 

 

(b)

Enter the full names of the individual(s) performing services, and include full
address if different from 10(a); Enter Last Name, First Name, and Middle Initial
(MI).

 

 

11.

Enter the amount of compensation paid or reasonably expected to be paid by the
reporting entity (item 4) to the lobbying entity (item 10). Indicate whether the
payment has been made (actual) or will be made (planned). Check all boxes that
apply. If this is a material charge report, enter the cumulative amount of
payment made or planned to be made.

 

 

12.

Check the appropriate box(es). Check all boxes that apply. If payment is made
through an in-kind contribution, specify the nature and value of the in-kind
payment.

 

 

13.

Check the appropriate box(es). Check all boxes that apply. If other, specify
nature.

 

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

 

14.

Provide a specific and detailed description of the services that the lobbyist
has performed, or will be expected to perform, and the date(s) of any services
rendered. Include all preparatory and related activity, not just time spent in
actual contact with Federal officials. Identify the Federal official(s) or
employee(s) contacted or the officer(s), employee(s), or Member(s) of Congress
that were contacted.

 

 

15.

Check whether or not a SF-LLL-A Continuation Sheet(s) is attached.

 

 

16.

The certifying official shall sign and date the form, print his/her name, title
and telephone number.

 

Public reporting burden for this collection of information is estimated to
average 30 minutes per response, including time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to the Office of Management and
Budget, Paperwork Reduction Project (0348-0046), Washington, D.C. 20503.

 

 

 

 

 

 

 

 

 

 

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

Standard Contractor Evaluation Performance Report

 

Evaluation Type: Interim __ Final __ (check one)

Evaluating Organization:

Reporting Period: From to

Contracting Office:

Contract Number:

Order Number:

 

Contractor Name:

Contractor Address:

 

DUNS:

City:

State:

Additional or Alternate Contractor Name:

 

Zip/Postal Code:

Country:

 

TIN:

Industrial Code (NAICS):

Commodity Code:

Contract Type:

 

Contract Award Date:

Contract Expiration Date:

Contract Value:

 

Requirement Description:

 

 

Ratings

 

Summarize contractor performance and check the number which corresponds to the
rating for each rating category (See attached Rating Guidelines).

 

Quality of Product or Service

_0=Unsatisfactory            _1=Poor               _2=Fair
               _3=Good             _4=Excellent                _5=Outstanding

Government Comments for Quality of Product or Service (2000 characters maximum):

 

 

Cost Control (Rating and Comments for Cost Control are not required if contract
type is Fixed-Price)

_0=Unsatisfactory            _1=Poor               _2=Fair
               _3=Good             _4=Excellent                _5=Outstanding

Government Comments for Cost Control (2000 characters maximum):

 

 

 

Timeliness of Performance

_0=Unsatisfactory            _1=Poor               _2=Fair
               _3=Good             _4=Excellent                _5=Outstanding

Government Comments for Timeliness of Performance (2000 characters maximum):

 

 

 

Business Relations

_0=Unsatisfactory            _1=Poor               _2=Fair
               _3=Good             _4=Excellent                _5=Outstanding

Government Comments for Business Relations (2000 characters maximum):

 

 

 

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

Additional Info

 

Subcontracts

 

Are subcontracts involved?

­__Yes

__No (Check one)

Government Comment on subcontracts (2000 characters maximum):

 

 

 

 

Contractor Key Personnel

 

Contractor Manager/Principal Investigator (name):

Government Comment on Contractor Manager/Principal Investigator (2000 characters
maximum):

 

 

 

Contractor Key Person (name):

Government Comment on Contractor Key Person (2000 characters maximum):

 

 

 

Contractor Key Person (name):

Government Comment on Contractor Key Person (2000 characters maximum):

 

 

 

Small Business Subcontracting Plan

 

Did the contractor make a good faith effort to comply with its subcontracting
plan consistent with the goals and objectives, reporting and other aspects of
the plan?               _Yes_No_N/A (Check one)

 

 

 

If this is a bundled contract, did the contractor meet the goals and objectives
for small business participation?

_Yes

_No

_N/A (Check one)

 

Government Comments on Small Business Subcontracting Plan (2000 characters
maximum):

 

 

Small Disadvantaged Business Goals

 

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

Did the contractor make a good faith effort to comply with its subcontracting
plan consistent with the goals and objectives, for small disadvantaged business
(SDB) participation, monetary targets for SDB participation, and required
notifications?    _Yes_No_N/A (Check one)

 

Government Comments on Small Disadvantaged Business Goals (2000 characters
maximum):

 

 

 

Customer Satisfaction

 

Is/was the contractor committed to customer satisfaction?

_Yes

_No (Check one)

 

Would you recommend the selection of this firm again?

_Yes

_No (Check one) – FINAL REPORT ONLY

 

Government Comments on Customer Satisfaction (2000 characters maximum):

 

 

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

Admin Info

 

Project Officer/COTR

Name:

Phone:

Fax:

E-mail Address:

 

Contractor Representative

Name:

Phone:

Fax:

E-mail Address:

 

Alternate Contractor Representative (Required to insure that at least one person
is notified of evaluation)

Name:

Phone:

Fax:

E-mail Address:

 

Contracting Officer:

Name:

Phone:

Fax:

E-mail Address:

 

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

Contractor Comments

 

Quality of Product of Service

 

___Contractor has elected not to comment

 

Contractor Comments for Quality of Product of Service (2000 characters maximum):

 

 

 

Cost Control

 

___Contractor has elected not to comment

 

Contractor Comments for Quality of Product of Service (2000 characters maximum):

 

 

 

Timeliness of Performance

 

___Contractor has elected not to comment

 

Contractor Comments for Timeliness of Performance (2000 characters maximum):

 

 

Business Relations

 

___Contractor has elected not to comment

 

Contractor Comments for Business Relations (2000 characters maximum):

 

 

 

 

Overall Comment

 

___Contractor has elected not to comment

 

Contractor Comments for Quality of Product of Service (2000 characters maximum):

 

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

Rating Guidelines

 

Quality of Product or Service

 

0 = Unsatisfactory

1 = Poor

2 = Fair

3 = Good

4 = Excellent

5 = Outstanding

 

Unsatisfactory

Non-conformances are jeopardizing the achievement of contract requirements,
despite use of Agency resources. Recovery is not likely. If performance cannot
be substantially corrected, it constitutes a significant impediment in
consideration for future awards containing similar requirements.

Poor

Overall compliance requires significant Agency resources to ensure achievement
of contract requirements.

Fair

Overall compliance requires minor Agency resources to ensure achievement of
contract requirements.

Good

There are no, or very minimal, quality problems, and the Contractor has met the
contract requirements.

Excellent

There are no quality issues, and the Contractor has substantially exceeded the
contract performance requirements without commensurate additional costs to the
Government.

Outstanding

The contractor has demonstrated an outstanding performance level that was
significantly in excess of anticipated achievements and is commendable as an
example for others, so that it justifies adding a point to the score. It is
expected that this rating will be used in those rare circumstances where
contractor performance clearly exceeds the performance levels described as
"Excellent".

 

Cost Control

 

0 = Unsatisfactory

1 = Poor

2 = Fair

3 = Good

4 = Excellent

5 = Outstanding

 

Unsatisfactory

Ability to manage cost issues is jeopardizing performance of contract
requirements, despite use of Agency resources. Recovery is not likely. If
performance cannot be substantially corrected, this level of ability to manage
cost issues constitutes a significant impediment in consideration for future
awards.

Poor

Ability to manage cost issues requires significant Agency resources to ensure
achievement of contract requirements.

Fair

Ability to control cost issues requires minor Agency resources to ensure
achievement of contract requirements.

Good

There are no, or very minimal, cost management issues and the Contractor has met
the contract requirements.

Excellent

There are no cost management issues and the Contractor has exceeded the contract
requirements, achieving cost savings to the Government.

Outstanding

The contractor has demonstrated an outstanding performance level that justifies
adding a point to the score. It is expected that this rating will be used in
those rare circumstances where the contractor achieved cost savings and
performance clearly exceeds the performance levels described as "Excellent".

 

 

 

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

Timeliness of Performance

 

0 = Unsatisfactory

1 = Poor

2 = Fair

3 = Good

4 = Excellent

5 = Outstanding

 

Unsatisfactory

Delays are jeopardizing the achievement of contract requirements, despite use of
Agency resources. Recovery is not likely. If performance cannot be substantially
corrected, it constitutes a significant impediment in consideration for future
awards.

Poor

Delays require significant Agency resources to ensure achievement of contract
requirements.

Fair

Delays require minor Agency resources to ensure achievement of contract
requirements.

Good

There are no, or minimal, delays that impact achievement of contract
requirements.

Excellent

There are no delays and the contractor has exceeded the agreed upon time
schedule.

Outstanding

The contractor has demonstrated an outstanding performance level that justifies
adding a point to the score. It is expected that this rating will be used in
those rare circumstances where contractor performance clearly exceeds the
performance levels described as "Excellent".

 

Business Relations

 

0 = Unsatisfactory

1 = Poor

2 = Fair

3 = Good

4 = Excellent

5 = Outstanding

 

Unsatisfactory

Response to inquiries and/or technical, service, administrative issues is not
effective. If not substantially mitigated or corrected it should constitute a
significant impediment in considerations for future awards.

Poor

Response to inquiries and/or technical, service, administrative issues is
marginally effective.

Fair

Response to inquiries and/or technical, service, administrative issues is
somewhat effective.

Good

Response to inquiries and/or technical, service, administrative issues is
consistently effective.

Excellent

Response to inquiries and/or technical, service, administrative issues exceeds
Government expectation.

Outstanding

The contractor has demonstrated an outstanding performance level that justifies
adding a point to the score. It is expected that this rating will be used in
those rare circumstances where contractor performance clearly exceeds the
performance levels described as "Excellent".

 

 

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

Department of Health and Human Services

Center for Disease Control

Payment Information Form

The information requested on this form concerns your financial institution, your
account at that institution, and personal information which needs to verified
and completed.

Privacy Act Statement

The following information is provided to comply with the Privacy Act of 1974
(P.L. 93-579). All information collected on this form is required under the
provisions of 31 USC 3322 and 31 CFR 210. This information will be used by the
Treasury Department to transmit payment data, by electronic means to your
financial institution. Failure to provide the requested information may delay or
prevent the receipt of payments through the Automated Clearing House Payment
System.

Check one of the following:

[

] Federal Employee:

[ X ] Contractor:

[

] Vendor:

Name:

Emergent BioDefense Operations Lansing, Inc.

Address:

3500 North Martin Luther King Jr. Boulevard

 

Lansing, MI 48906-9910

Remit To

(If same as above, leave blank. Must match address on invoice for internal
control purposes.)

Address

:

 

Taxpayer Identification # (TIN):

3

8

3

4

1

2

7

8  

(If you are an individual, this may be your Social Security number)

1.

Payee’s Telephone Number: (517) 327-6886

 

The following information must be completed by your financial institution
representative:

 

2.

Name of Financial

Institution: Fifth Third Bank

3.

Address of Financial

 

Institution:

2501 Coolidge Road

 

East Lansing, MI 48823

 

4.

Financial Institution’s 9-digit ABA Routing Number for

 

Transfer of Funds:

0

7

2

4

0

0

0

5

2

5.

Depositor Account Title: Emergent BioDefense Operation

6.

Depositor Account Number: [***]

7.

Type of Account: [ X ] Checking

[

] Savings

8.

Signature and Title of Authorized Official of Financial Institution:

 

Leu Tierney, Vice President

9.

Telephone Number: (517) 351-5217

Date: 9/10/08

 

*************The following must be signed by the payee*************

 

I have verified the information on this form.

 

Signature

Date

 

 

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

SUBCONTRACTING PLAN

DATE:

September 25, 2008

CONTRACTOR:

Emergent BioDefense Operations Lansing Inc.

ADDRESS:

3500 N. Martin Luther King Jr. Blvd., Lansing, MI 48906-9910

DUNN &

BRADSTREET NUMBER: [**]

SOLICITATION OR

CONTRACT NUMBER:

RFP-BARDA-08-26

ITEM/SERVICE (Description): The supply of BioThrax® (Anthrax Vaccine Adsorbed)
to meet the nation’s urgent need to stockpile countermeasures to safeguard
against the threat of a deliberate anthrax attack.

TOTAL CONTRACT AMOUNT:

$ 404,685,512.00

PERIOD OF CONTRACT PERFORMANCE: September 26, 2008 through September 30, 2011

•

Type of Plan (check one)

X          Individual plan (all elements developed specifically for this
contract and applicable for the full term of this contract).

Master plan (goals developed for this contract) all other elements standardized
and approved by a lead agency Federal Official; must be renewed every three
years and contractor must provide copy of lead agency approval.

Commercial products/service plan (goals are negotiated with the initial agency
on a company-wide basis rather than for individual contracts) this plan applies
to the entire production of commercial service or items or a portion thereof.
The contractor sells commercial products and services customarily used for
non-government purposes. The plan is effective during the offeror’s fiscal year.
The contractor must provide a copy of the initial agency approval and must enter
an annual SSR into the electronic Subcontracting Reporting System (eSRS) with a
breakout of subcontracting prorated for HHS and other Federal agencies.

•

Goals

 

a.

Total estimated dollar value of ALL planned subcontracting, i.e., with ALL types
of concerns under this contract is: $41,760,000

 

b.

Total estimated dollar value and percent of planned subcontracting with SMALL
BUSINESSES (including SDB, WOSB, HUBz and SDVOSB: $2,088,000 and 5.00%

 

c.

Total estimated dollar value and percent of planned subcontracting with SMALL
DISADVANTAGED BUSINESSES: $417,600 and 1.00%

 

d.

Total estimated dollar value and percent of planned subcontracting with
WOMAN-OWNED SMALL BUSINESSES: $1,252,800 and 3.00%

 

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

 

e.

Total estimated dollar and percent of planned subcontracting with HUBZone SMALL
BUSINESSES: $208,800 and .5%

 

f.

Total estimated dollar and percent of planned subcontracting with
SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES: $208,800 and .5%

 

g.

Total estimated dollar and percent of planned subcontracting with “OTHER THAN
SMALL BUSINESSES” $ 39,672,000 and 95%

 

h.

Description of Services and Supplies to be Subcontracted Under This Contract:

Products and/or Services

Other

Small Business

SDB

WOSB

Hubz

SDVOSB

1

Professional Services

X

X

 

X

 

 

2

Legal Expenses

X

 

 

 

 

 

3

Animal and Animal Supplies

X

X

 

 

 

 

4

Clothing and Uniforms

X

 

 

 

 

 

5

Communications

X

 

 

 

 

 

6

Insurance

X

 

 

 

 

 

7

Office Expense

X

X

 

 

 

 

8

Supplies

X

X

X

X

X

X

9

Utilities/Waste Mgmt

X

 

 

 

 

 

10

Repairs and Maintenance

X

X

 

X

 

 

11

Recruiting and Relocation

X

 

 

 

 

 

 

 

i.

The subcontracting goals for small, HUBZone, small disadvantaged, women-owned
small business concerns and service disabled veteran-owned small businesses were
derived from current spending patterns by product and service area as of August
2007 and estimate of supplier diversity program impact. The product and service
areas correspond to with the major expense categories in EBOL’s accounting
software. Products and services exclude: salaries and benefits, depreciation,
license fees, taxes, interest, FAR non-allowable costs, capital costs, cGMP raw
materials, travel, meals and entertainment . EBOL’s procurement department seeks
to obtain the lowest responsible and responsive bid for all goods and services.
Competitive quotes from any sources must meet the business’ specifications for
all such requirements including quality, capability, service, competitive cost,
performance expectations, and other relevant criteria. Because BioThrax© is an
FDA-regulated biopharmaceutical product, the available service providers and
suppliers are limited. Thus, specific goals for small business subcontracting
may not be achievable.

 

j.

Indirect costs have have not X been included in the dollar and percentage
subcontracting goals above (check one)

 

k.

If indirect costs have been included, explain the method used to determine the
proportionate share of such costs to be allocated as subcontracts to SB, SDB,
WOSB, HUBZone and SDVOSB concerns: N/A

•

Program Administrator:

 

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

[**]

Emergent BioDefense Operations Lansing Inc.

3500 N. Martin Luther King Jr. Blvd., Lansing, MI 48906-9910

Telephone: [**]

E-Mail: [**]

 

Duties: Does the individual named above have general overall responsibility for
the company’s subcontracting program, i.e., developing, preparing, and executing
subcontracting plans and monitoring performance relative to the requirements of
those subcontracting plans and perform the following duties? (If NO is checked,
please indicate who in the company performs those duties, or indicate why the
duties are not performed in your company on a separate sheet of paper and submit
with the proposed subcontracting plan.)

 

a.

Developing and promoting company-wide policy initiatives that demonstrate the
company’s support for awarding contracts and subcontracts to SB, SDB, WOSB,
HUBZone and SDVOSB concerns; and for assuring that these concerns are included
on the source lists for solicitations for products and services they are capable
of providing. X yes ___ no

 

b.

Developing and maintaining bidder source lists of SB, SDB, WOSB, HUBZone and
SDVOSB concerns from all possible sources x yes  _ no

 

c.

Ensuring periodic rotation of potential subcontractors on bidder’s lists; ___x__
yes

 

__ no

 

d.

Assuring that SB, SDB, WOSB, HUBZONE and SDVOSB businesses are included on the
bidders’ list for every subcontract solicitation for products and services that
they are capable of providing, ___x__ yes        __no

 

e.

Ensuring that requests for proposals (RFPs) are designed to permit the maximum
practicable participation of SB, SDB, WOSB, HUBZone and SDVOSB concerns. ___x___
yes       no

 

f.

Reviewing subcontract solicitations to remove statements, clauses, etc., which
might tend to restrict or prohibit small, 8(a), SDB, WOSB, Hubz and SDVOSB small
business participation ___x___yes            no

 

g.

Accessing various sources for the identification of SB, SDB, WOSB, HUBZone and
SDVOSB concerns to include the Central Contractor Registration
(http://www.ccr,gov/), local small business and minority associations, local
chambers of commerce and Federal agencies’ Small Business Offices; __x__ yes
     no

 

h.

Establishing and maintaining contract and subcontract award records; ___x___ yes
__ no

 

i.

Participating in Business Opportunity Workshops, Minority Business Enterprise
Seminars, Trade Fairs, Procurement Conferences, etc; ___x__yes           __ no

 

j.

Ensuring that SB, SDB, WOSB, HUBZone and SDVOSB concerns are made aware of
subcontracting opportunities and assisting concerns in preparing responsive bids
to the company ___x__ yes   __ no

 

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

 

k.

Conducting or arranging for the conduct of training for purchasing personnel
regarding the intent and impact of Section 8(d) of the Small Business Act, as
amended; ___x___ yes ____ no

 

l.

Monitoring the company’s subcontracting program performance and making any
adjustments necessary to achieve the subcontract plan goals; ___x___ yes
        __ no

 

m.

Preparing and submitting timely, required subcontract reports; ___x___ yes

no

 

n.

Conducting or arranging training for purchasing personnel regarding the intent
and impact of 8(d) of the Small Business Act on purchasing procedures; ___x___
yes         __ no

 

o.

Coordinating the company’s activities during the conduct of compliance reviews
by Federal agencies; and ___x___ yes            __ no

•

Equitable Opportunity

Describe efforts the offeror will undertake to ensure that SB, SDB, WOSB,
HUBZone and SDVOSB concerns will have an equitable opportunity to compete for
subcontracts. These efforts include, but are not limited to, the following
activities:

 

a.

Outreach efforts to obtain sources:

1.        Contact minority and small business trade associations; 2) contact
business development organizations and local chambers of commerce; 3) attend SB,
SDB, WOSB, HUBZone and SDVOSB procurement conferences and trade fairs; 4) review
sources from the Central Contractor Registration (http://www.ccr.gov/); 5)
review sources from the Small Business Administration (SBA), Central Contractor
Registration (CCR); 6) Consider using other sources such as the National
Institutes of Health (NIH) e-Portals in Commerce, (e-PIC),.
(http://epic.od.nih.qov/). The NIH e-PIC is not a mandatory source; however, it
may be used at the offeror’s discretion; and 7) Utilize newspaper and magazine
ads to encourage new sources.

 

b.

Internal efforts to guide and encourage purchasing personnel:

 

1.

Conduct workshops, seminars and training programs;

 

2.

Establish, maintain, and utilize SB, SDB, WOSB, HUBZone and SDVOSB source lists,
guides, and other data for soliciting subcontractors; and

 

3.

Monitor activities to evaluate compliance with the subcontracting plan.

•

Flow Down Clause

The contractor agrees to include the provisions under FAR 52.219-8, “Utilization
of Small Business Concerns,” in all acquisitions exceeding the simplified
acquisition threshold that offers further subcontracting opportunities. All
subcontractors, except small business concerns, that receive subcontracts in
excess of $550,000 ($1,000,000 for construction) must adopt and comply with a
plan similar to the plan required by FAR 52.219-9, “Small Business
Subcontracting Plan.” Note: In accordance with FAR 52.212-5(e) and 52.244-6(c)
the contractor is not required to include flow-down clause FAR 52.219.-9 if it
is subcontracting commercial items.

 

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

•

Reporting and Cooperation

The contractor gives assurance of (1) cooperation in any studies or surveys that
may be required; (2) submission of periodic reports which show compliance with
the subcontracting plan; (3) submission of its Individual Subcontracting Report
(ISR) and Summary Subcontract Report (SSR); and (4) ensuring that subcontractors
agree to submit ISRs and SSRs. The ISR and SSR shall be submitted via the
Electronic Subcontracting Reporting System (eSRS) website
https://esrs.svmplicitv.com/index? tab=siqnin&cck=l

Reporting Period

Report Due

Due Date

Oct 1 - Mar 31

ISR

30-Apr

Apr 1 - Sept 30

ISR

30-Oct

Oct 1 - Sept 30

SSR

30-Oct

Contract Completion

OF 312

30 days after completion

See FAR 19.7 for instruction concerning the submission of a Commercial Plan: SSR
is due on 10/30 each year for the previous fiscal year ending 9/30.

 

a.

Submit ISR (bi-annually) for the cognizant awarding Contracting Officer’s review
and acceptance via the eSRS website https://esrs.symplicity.com/index?
tab=siqnjn&cck=l.

 

b.

Currently, SSR (annually) must be submitted for the HHS eSRS Agency Coordinator
review and acceptance via the eSRS website https://esrs.symphclty.com/lndex?
tab=slanln&cck=l. (Note: Log onto the OSDBU website to view the HHS Agency
Coordinator contact information (http://www.hhs.qov/osdbu/staff.html).

 

c.

Contractors that do not use the eSRS to submit its reports must also submit a
paper copy of the SSR to the appropriate Commercial Market Representative
(contact the contracting official (CO) or the CO’s eSRS Point of Contact).

•

Record keeping

FAR 19.704(a) (11) requires a list of the types of records your company will
maintain to demonstrate the procedures adopted to comply with the requirements
and goals in the subcontracting plan. The following is a recitation of the types
of records the contractor will maintain to demonstrate the procedures adopted to
comply with the requirements and goals in the subcontracting plan. These records
will include, but not be limited to, the following:

 

a.

SB, SDB, WOSB, HUBZone and SDVOSB source lists, guides and other data
identifying such vendors;

 

b.

Organizations contacted in an attempt to locate SB, SDB, WOSB, HUBZone and
SDVOSB sources;

 

c.

On a contract-by-contract basis, records on all subcontract solicitations over
$100,000, which indicate for each solicitation (1) whether SB, SDB, WOSB,
HUBZone and/or SDVOSB concerns were solicited, if not, why not and the reasons
solicited concerns did not receive subcontract awards;

 

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

 

d.

Records to support other outreach efforts, e.g., contacts with minority and
small business trade associations, attendance at small and minority business
procurement conferences and trade fairs;

 

e.

Records to support internal guidance and encouragement provided to buyers
through (1) workshops, seminars, training programs, incentive awards; and (2)
monitoring performance to evaluate compliance with the program and requirements;
and

 

f.

On a contract-by-contract basis, records to support subcontract award data
including the name, address, and business type and size of each subcontractor.
(This item is not required on a contract - by - contract basis for company or
division-wide commercial plans.)

•

Timely Payments to Subcontractors

FAR 19.702 requires your company to establish and use procedures to ensure the
timely payment of amounts due pursuant to the terms of your subcontracts with
small business concerns, 8(a), SDB, women-owned small business, HubZone and
service disabled veteran-owned small business concerns.

Your company has established and used such procedures: ___x___ yes

__ no

•

Description of Good Faith Effort

Maximum practicable utilization of small, 8(a), small disadvantaged,
woman-owned, HubZone small and service disabled veteran owned concerns as
subcontractors in Government contracts is a matter of national interest with
both social and economic benefits. When a contractor fails to make a good faith
effort to comply with a subcontracting plan, these objectives are not achieved,
and 15 U.S.C. 637(d) (4) (F) directs that liquidated damages shall be paid by
the contractor. In order to demonstrate your compliance with a good faith effort
to achieve the small, SDB, WOSB, HubZone and SDVOSB small business
subcontracting goals, outline the steps your company plans to take. These steps
will be negotiated with the contracting official prior to approval of the plan.

1) Develop and implement a supplier diversity program, 2) enhance current vendor
system software to allow for improved measurement of small business activities,
3) attend small business seminars to identify qualified candidates, 4) review
contracts to ensure terms support the small business subcontracting goals.

 

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

SIGNATURE PAGE

Signatures Required:

This subcontracting plan was submitted by:

Signature:

/s/ R. Don Elsey

Typed Name:

R. Don Elsey

Title:

CFO

Date:

9/25/2008

This plan was reviewed by:

Signature:

Typed Name:

Title:

Contracting Officer

Date:

This plan was reviewed by:

Signature:

Typed Name:

Title:

Small Business Specialist (SBS)

Date:

This plan was reviewed by:

Signature:

Typed Name:

Title:

Small Business Administration Procurement Center Representative (PCR)

Date:

Is Accepted By:

OPDIV:

Typed Name:

Title:

Date:

 

 

 

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

Response to RFP-BARDA-08-26 BioThrax® (Anthrax Vaccine Adsorbed)

Emergent BioDefense Operations Lansing Inc.

 

Appendix A - Delivery Schedule

CLIN

Delivery
#

Lot

Ship Date

Expiry
Date

Remaining
Expiry
(Days)

Remaining
Expiry
(Months)

Doses

Cum Doses

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

Confidential materials omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment. A total of
2 pages have been omitted.