[ebs20191231exhibit1048001.jpg]
Certain identified information has been excluded from the exhibit because it is
both (i) not material and (ii) would likely cause competitive harm to the
Company, if publicly disclosed. Double asterisks denote omissions. Exhibit 10.48
AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF UNDER DPAS (15
CFR 700) 1 26 2. CONTRACT (Proc. Inst. Ident.) NO. 3. EFFECTIVE DATE 4.
REQUISITION/PURCHASE REQUEST/PROJECT NO. 75A50119C00071 08/30/2019 OS247977 5.
ISSUED BY CODE ASPR-BARDA 6. ADMINISTERED BY (If other than Item 5) CODE
ASPR-BARDA02 ASPR-BARDA US DEPT OF HEALTH & HUMAN SERVICES 200 Independence
Ave., S.W. Room ASPR/ORM 640-G O’NEILL HOUSE OFFICE BUILDING Washington DC 20201
Washington DC 20515 8. DELIVERY 7. NAME AND ADDRESS OF CONTRACTOR (No., street,
county, State and ZIP Code) SCD-C. EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG
INC. 1365869   OTHER (See below) Attn: Mike Mann FOB ORIGIN 300 PROFESSIONAL
DRIVE 9. DISCOUNT FOR PROMPT PAYMENT SUITE 100 GAITHERSBURG MD 208793419 10.
SUBMIT INVOICES (4 copies unless otherwise specified) ITEM TO THE ADDRESS SHOWN
IN CODE 1365869 FACILITY CODE 11. SHIP TO/MARK FOR CODE OS 12. PAYMENT WILL BE
MADE BY CODE ASPR-BARDA02 Office of the Secretary ASPR-BARDA02 200 Independence
Ave. S.W. 200 C St SW Washington DC 20201 Washington DC 20201 13. AUTHORITY FOR
USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA
 10 U.S.C. 2304 (c)( )  41 U.S.C. 3304(a)( ) 2019.199SNS1.26088 15C. 15D. 15A.
ITEM NO 15B. SUPPLIES/SERVICES 15E. UNIT PRICE 15F. AMOUNT QUANTITY UNIT (Base
Year) ACAM Doses [**] $[**] $169,988,000.00 Continued 15G. TOTAL AMOUNT OF
CONTRAC $2,007,468,366.00 16. TABLE OF CONTENTS (X) SEC DESCRIPTION PAGE(S) (X)
SEC DESCRIPTION PAGE(S) PART I – THE SCHEDULE PART II – CONTRACT CLAUSES X A
SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 23 X B SUPPLIES OR SERVICES
AND 5 PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER PRICES/COSTS ATTACH. X C
DESCRIPTION/SPECS./WORK 9 X J LIST OF ATTACHMENTS 26 STATEMENT X D PACKAGING AND
MARKING 16 PART IV – REPRESENTATIONS AND INSTRUCTIONS X E INSPECTION AND
ACCEPTANCE 16 K REPRESENTATIONS, CERTIFICATIONS X F DELIVERIES OR PERFORMANCE 17
AND OTHER STATEMENTS OF OFFERORS X G CONTRACT ADMINISTRATION DATA 18 L INSTRS.,
CONDS., AND NOTICES TO OFFERORS X H SPECIAL CONTRACT REQUIREMENTS 19 M
EVALUATION FACTORS FOR AWARD CONTRACTING OFFICER WILL COMPLETE ITEM 17
(SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS
APPLICABLE 17.  Contractor’s Negotiated Agreement (Contractor is required to
sign 18.  SEALED-BID AWARD (Contractor is not required to sign this this
document and return one copy to issuing office.) Contractor agrees to document.)
Your bid on Solicitation Number ________, including the furnish and deliver all
items or perform all the services set forth or additions or changes made by you
which additions or changes are set otherwise identified above and on any
continuation sheets for the forth in full above, is hereby accepted as to the
items listed above and on consideration stated herein. The rights and
obligations of the parties to any continuation sheets. This award consummates
the contract which this contract shall be subject to and governed by the
following consists of the following documents: (a) the Government’s solicitation
and documents: (a) this award/contract, (b) the solicitation, if any, and (c)
your bid, and (b) this award/contract.

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[ebs20191231exhibit1048002.jpg]
such provisions, representation, certifications, and specifications, as are No
further contractual document is necessary. (Block 18 should be attached or
incorporated by reference herein. (Attachments are listed checked only when
awarding a sealed-bid contract.) herein.) 19A. NAME AND TITLE OF SIGNER (Type or
print) 20A. NAME OF CONTRACTING OFFICER Adam Havey, EVP Operations [**] 19B.
NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE
SIGNED 16 Dec 19 BY /s/ [**] BY /s/ Adam Havey Digitally signed by (Signature of
person authorized to sign) [**] – S Date: 2019.12.17 09:22:47-05’00’ (Signature
of the Contracting Officer) AUTHORIZED FOR LOCAL REPRODUCTION Previous edition
is NOT usable ACAM 10-Yr 75A50119C00071 Page 2 of 33

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CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
75A50119C00071 2 26 NAME OF OFFEROR OR CONTRACTOR EMERGENT PRODUCT DEVELOPMENT
GAITHERSBURG INC. 1365869 ITEM No. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE
AMOUNT (A) (B) (C) (D) (E) (F) Tax ID Number: [**] DUNS Number: [**] ACAM2000,
Smallpox (Vaccinia) Vaccine, Live (ACAM) Delivery: 12/30/2019 Appr. Yr.: 2019
CAN: 199SNS1 Object Class: 26402 Period of Performance: 08/30/2019 to 08/29/2029
- All Dollar Amounts based on Target Amounts of Products CLINs X0001 through
X0004 as stated on Page 3. 1 Base Year ACAM2000, Smallpox (Vaccinia) Vaccine,
Live (ACAM) See Section B below for further details. Obligated Amount:
$169,988,000.00 2 Option Year 1 ACAM2000, Smallpox (Vaccinia) Vaccine, Live
(ACAM) See Section B below for further details. NTE: $[**] 3 Option Year 2
ACAM2000, Smallpox (Vaccinia) Vaccine, Live (ACAM) See Section B below for
further details. NTE: $[**] 4 Option Year 3 ACAM2000, Smallpox (Vaccinia)
Vaccine, Live (ACAM) See Section B below for further details. NTE: $[**] 5
Option Year 4 ACAM2000, Smallpox (Vaccinia) Vaccine, Live (ACAM) See Section B
below for further details. NTE: $[**] 6 Option Year 5 ACAM2000, Smallpox
(Vaccinia) Vaccine, Live (ACAM) See Section B below for further details. NTE:
$[**] 7 Option Year 6 ACAM2000, Smallpox (Vaccinia) Vaccine, Live (ACAM) See
Section B below for further details. NTE: $[**] 8 Option Year 7 ACAM2000,
Smallpox (Vaccinia) Vaccine, Live (ACAM) See Section B below for further
details. NTE: $[**] 9 Option Year 8 ACAM2000, Smallpox (Vaccinia) Vaccine, Live
(ACAM) ACAM 10-Yr 75A50119C00071 Page 3 of 33

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See Section B below for further details. NTE: $[**] 10 Option Year 9 ACAM2000,
Smallpox (Vaccinia) Vaccine, Live (ACAM) See Section B below for further
details. NTE: $[**] This Contract award document finalizes the Notice of Award
Letter issued by Contracting Officer [**] on August 30, 2019, which established
an effective date of August 30, 2019. AUTHORIZED FOR LOCAL REPR OPTIONAL FORM
336 (4-86) Sponsored by GSA FAR (48 CFR) 53.11 ACAM 10-Yr 75A50119C00071 Page 4
of 33

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Table of Contents Section B - Supplies or Services and Cost/Price
..........................................................................8
Section C - Statement of Work (SOW)
......................................................................................12
C.1 – Background and Need
..................................................................................................12
C.2 – Purpose
.........................................................................................................................12
C.3 – Scope of Work
..............................................................................................................12
C.4 – Task 1: Manufacturing and Delivery of ACAM2000 Vaccine
...................................13 Manufacture of Bulk Vaccine
............................................................................................13
Vaccine Fill and Finish
......................................................................................................13
Requirements for Packaging & Delivery
...........................................................................13
SNS Locations
...................................................................................................................14
Warranties
..........................................................................................................................15
Historical Lots - Testing Program and Quarantine
............................................................15 Task 2: Diluent
Replacement
.............................................................................................17
Task 3: Syringe Replacement
............................................................................................17
Task 4: ACAM2000 Vaccine Limited Re-Labeling Activities
........................................17 C-5 – Reporting Requirements
(Emergent)
...........................................................................19
C.6 – Reporting Requirements (SNS)
....................................................................................19
C.7. – Delivery Notifications
.................................................................................................20
C.8 – Quality Inspections
.......................................................................................................20
Section D - Packaging And Marking
..........................................................................................20
Section E - Inspection And Acceptance
.....................................................................................20
E.1. – FAR 52.252-2 Clauses Incorporated by Reference (1998)
.....................................20 E.2. – Inspection and Acceptance
.....................................................................................21
E.3. – Shipment
Acceptance..............................................................................................21
Section F - Deliveries Or Performance
......................................................................................22
F.1. – Period of Performance
.................................................................................................22
F.2. – Delivery
Locations.......................................................................................................22
Section G - Contract Administration Data
................................................................................22
G.1. – Electronic Subcontracting Reporting System (eSRS)
.................................................22 G.2. – Invoice Submission
.....................................................................................................23
G.3. – Contracting Officer
.....................................................................................................23
G.4. – Contracting Officer’s Representative
..........................................................................24 G.5
– Contract Communications/Correspondence
................................................................24 ACAM 10-Yr
75A50119C00071 Page 5 of 33

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Section H - Special Contract Requirements
..............................................................................24
H.1. – Evaluation of Contractor Performance Utilizing CPARS (April 2015)
.....................24 H.2. – CDC37.0001 Non-Personal Services (April 2015)
.....................................................25 H.3. – Restrictions on
Disclosure of Information and Rights in Data
...................................26 H.4. – Liability Protection under the PREP
Act ....................................................................26 H.5.
– SNS Responsibilities
...................................................................................................27
H.6. – Rights of the Contractor to Market Smallpox Vaccine
...............................................27 H.7. – Expired Doses in the
SNS
...........................................................................................27
H.8 – Testing of Quarantined Product
...................................................................................27
Section I - Contract Clauses
........................................................................................................29
I.1 - Clauses Incorporated By Reference
...............................................................................29
I.1 - Clauses Incorporated By Reference
...............................................................................30
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)
.........................32 Section J - List Of Attachments
..................................................................................................33
Table 8: Kit Reference (including Shelf Life)
..........................................................................33
ACAM 10-Yr 75A50119C00071 Page 6 of 33

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Tables Table 1: Overall Price Summary
.....................................................................................................5
Table 2: Task 1 - ACAM2000 Vaccine Manufacture and Provision to the SNS
...........................6 Table 3: Task 2 - Diluent Replacement and Provision
to the SNS .................................................7 Table 4: Task 3 -
Transfer Syringe Replacement and Provision to the SNS1F
..............................7 Table 5: Task 4 - Vaccine Limited Re-Labeling
Program ..............................................................7 Table 6:
Strategy for managing expiring ACAM2000 vaccine
....................................................12 Table 7: Re-labeling of
Rockville MD Manufactured Lots with [**] expiry
...............................14 Table 8: Kit Reference (including Shelf Life)
..............................................................................26
ACAM 10-Yr 75A50119C00071 Page 7 of 33

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Section B - Supplies or Services and Cost/Price Table 1: Overall Price Summary
ITEM CLIN X001- Doses CLIN X002- Diluent CLIN X003- Syringe CLIN X004-
Replacement Replacement Re-labelling Grand Total Contract Year ACAM Doses
EXTENDED Diluent EXTENDED Transfer EXTENDE Target PRICE Vials PRICE Syringes D
PRICE 1 Base Year [**] $169,988,000 $169,988,000 100X Option Year 1 [**] [**]
[**] [**] 200X Option Year 2 [**] [**] [**] [**] 300X Option Year 3 [**] [**]
[**] 400X Option Year 4 [**] [**] [**] [**] [**] [**] [**] [**] 500X Option Year
5 [**] [**] [**] [**] [**] [**] [**] 600X Option Year 6 [**] [**] [**] [**] [**]
[**] [**] [**] 700X Option Year 7 [**] [**] [**] [**] [**] [**] [**] 800X Option
Year 8 [**] [**] [**] [**] [**] [**] [**] [**] 900X Option Year 9 [**] [**] [**]
[**] [**] [**] [**] Overall [**] [**] [**] [**] [**] [**] [**] $2,007,468,366
Note: Values based on delivery of target amounts of product and relabeling of
inventory at the time of contract preparation. ACAM 10-Yr 75A50119C00071 Page 8
of 33

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Price Summary with Tiered Pricing details Table 2: Task 1 - ACAM2000 Vaccine
Manufacture and Provision to the SNS 0001 (Base) 1001 (Option) 2001 (Option)
3001 (Option) 4001 (Option) Contract Year 08/15/19-09/30/19 10/01/19-09/30/20
10/01/20-09/30/21 10/01/21-09/30/22 10/01/22-09/30/23 Target Exercise-By
8/15/2019 [**] [**] [**] [**] Date Delivery Target 12/30/2019 [**] [**] [**]
[**] [**] Doses [**] [**] [**] [**] [**] Extended Price [**] [**] [**] [**] [**]
[**] Doses [**] [**] [**] [**] [**] Extended Price** $169,988,000 [**] [**] [**]
[**] [**] Doses [**] [**] [**] [**] [**] Extended Price [**] [**] [**] [**] [**]
[**] Doses [**] [**] [**] [**] [**] Extended Price [**] [**] [**] [**] [**] 5001
(Option) 6001 (Option) 7001 (Option) 8001 (Option) 9001 (Option) Contract Year
10/01/23–09/30/24 10/01/24–09/30/25 10/01/25–09/30/26 10/01/26–09/30/27
10/01/27–09/30/28 Target Exercise- [**] [**] [**] [**] [**] By Date Delivery
Target [**] [**] [**] [**] [**] [**] Doses [**] [**] [**] [**] [**] Extended
Price [**] [**] [**] [**] [**] [**] Doses [**] [**] [**] [**] [**] Extended
Price [**] [**] [**] [**] [**] [**] Doses [**] [**] [**] [**] [**] Extended
Price [**] [**] [**] [**] [**] [**] Doses [**] [**] [**] [**] [**] Extended
Price [**] [**] [**] [**] [**] ** Extended Price on base period 0001 is for
order quantity of [**] doses Supplies, Services, and Requirements:  ACAM2000
doses supplied as part of a palletized kit. 1 Kit includes 1 ACAM2000 vial, 1
diluent vial, 1 transfer syringe and 100 bifurcated needles. Package Insert and
Medication Guide to be supplied as digital PDF and posted on Daily Med.
(Electronic Medication Guide/Package Insert is contingent upon FDA approval).
The kit components are provided on separate pallets. Each kit supports [**]
doses.  This is a firm-fixed price line item.  The unit price listed next to
each quantity is a price per dose.  The exercise of each CLIN must be completed
prior to any obligation to perform work under that CLIN.  The Delivery Target
is expected to occur by [**] within the same contract year. Due to the
variability in order quantities, long lead times for certain raw materials, and
uncertainties related to manufacturing and release, any expected changes to the
delivery target date will be negotiated and mutually agreed upon.  Guaranteed
shelf life at time of delivery is [**] of the [**] from the date of manufacture
for vaccine.  Target Exercise-By Date: Both parties agree that the U.S.
Government will work to meet the date as closely as possible within allowable
confines of budget cycles. Emergent recognizes that in the event of a continuing
resolution or other delayed U.S. Government budgeting scenario that this may be
delayed into the next calendar year. The U.S. Government and Emergent intend to
work in good faith to clearly articulate annual production planning expectations
and the U.S. Government may provide a non-binding notice of intent to
communicate its intentions, in the event of a delayed annual budget.  The
minimum order quantity per contract year is [**] doses.  For the nine option
years, an order may be placed once per contract year in a quantity of [**]
doses. For the base year of the contract, the Government chooses to procure a
quantity between the tiers at the tier below the determined amount. For example,
in the base year the Government is procuring [**] doses at the price of $[**].
ACAM 10-Yr 75A50119C00071 Page 9 of 33

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Table 3: Task 2 - Diluent Replacement and Provision to the SNS 4002 (Option)
5002 (Option) 6002 (Option) 7002 (Option) 8002 (Option) 9002 (Option) Contract
Year 10/01/22– 10/01/23– 10/01/24– 10/01/25– 10/01/26– 10/01/27– 09/30/23
09/30/24 09/30/25 09/30/26 09/30/27 09/30/28 Target Exercise-By [**] [**] [**]
[**] [**] [**] Date Delivery Target [**] [**] Vials [**] [**] [**] [**] [**]
[**] Extended Price [**] [**] [**] [**] [**] [**] [**] Vials [**] [**] [**] [**]
[**] [**] Extended Price [**] [**] [**] [**] [**] [**] [**] Vials [**] [**] [**]
[**] [**] [**] Extended Price [**] [**] [**] [**] [**] [**] [**] Vials [**] [**]
[**] [**] [**] [**] Extended Price [**] [**] [**] [**] [**] [**] Supplies,
Services, and Requirements:  Diluent replacement for ACAM2000 vaccine kits
provided under this contract.  Expiry is [**] from date of manufacture.  This
is a firm-fixed price line item.  Guaranteed shelf life from delivery is [**]
from the date of manufacture for vials of diluent.  Provision of diluent
replacement under prior contracts is available under separate contract. Table 4:
Task 3 - Transfer Syringe Replacement and Provision to the SNS1 4003 (Option)
5003 (Option) 6003 (Option) 7003 (Option) 8003 (Option) 9003 (Option) Contract
Year 10/01/22– 10/01/23– 10/01/24– 10/01/25– 10/01/26– 10/01/27– 09/30/23
09/30/24 09/30/25 09/30/26 09/30/27 09/30/28 Target Exercise-By [**] [**] [**]
[**] [**] [**] Date Delivery Target [**] [**] Transfer [**] [**] [**] [**] [**]
[**] Syringes Extended Price [**] [**] [**] [**] [**] [**] [**] Transfer [**]
[**] [**] [**] [**] [**] Syringes Extended Price [**] [**] [**] [**] [**] [**]
[**] Transfer [**] [**] [**] [**] [**] [**] Syringes Extended Price [**] [**]
[**] [**] [**] [**] [**] Transfer [**] [**] [**] [**] [**] [**] Syringes
Extended Price [**] [**] [**] [**] [**] [**] Supplies, Services, and
Requirements:  Transfer syringe replacement for ACAM2000 vaccine kits.  Expiry
is [**] from date of manufacture.  This is a firm-fixed price line item. 
Guaranteed shelf life from delivery is [**] from the date of manufacture for
transfer syringes.  Provision of transfer syringe replacement under prior
contracts is available under separate contract. ACAM 10-Yr 75A50119C00071 Page
10 of 33

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Table 5: Task 4 - Vaccine Limited Re-Labeling Program 1004 (Option) 2004
(Option) 4004 (Option) 6004 (Option) 8004 (Option) Contract Year
10/01/19–09/30/20 10/01/20–09/30/21 10/01/22–09/30/23 10/01/24–09/30/25
10/01/26–09/30/27 Target Exercise-By [**] [**] [**] [**] [**] Date Delivery
Target [**] Number of Vials [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
Unit Price (per vial) [**] [**] [**] [**] [**] Extended Price [**] [**] [**]
[**] [**] Supplies, Services, and Requirements:  This is a firm-fixed price
line item.  Complete prior to expiry at site; the number of vials is
approximate.  Annual stability testing of representative lots is incorporated
into the unit price for ACAM2000 vaccine. Notes: B.1 As shown in the chart
above, the Government agrees to purchase at least [**] doses of product in the
base year for a total amount of $169,988,000, and to purchase a minimum of [**]
doses (with a target amount of [**] doses) in each option year, if exercised.
The Government maintains the right to purchase up to [**] doses per option year.
B.2 As shown in the chart above, the pricing accounts for both annual escalation
and tiered pricing, which is based on the quantity of the Government’s order.
B.3 Delivery of product shall be FOB Destination. An updated and detailed
delivery schedule will be provided to the SNS within [**] of annual award.
Following delivery, SNS will provide Emergent written notification that it
either accepts or rejects the delivered lot(s) within [**] of receipt. If formal
acceptance or rejection is not received in the [**] period it shall be deemed to
have been accepted. ACAM 10-Yr 75A50119C00071 Page 11 of 33

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Section C - Statement of Work (SOW) Title: Warm based manufacturing and license
maintenance for ACAM2000 Vaccine C.1 – Background and Need As a direct result of
the September 11, 2001 tragedy and the increased perceived threat of bio-
terrorist activities against the United States, the Department of Health and
Human Services (DHHS) and the Assistant Secretary for Preparedness and Response
(ASPR) have a need to maintain a contract with the experienced manufacturer to
supply its Food & Drug Administration (FDA) licensed ACAM2000, Smallpox
(Vaccinia) Vaccine, Live; the only domestically- produced such vaccine, to
maintain its ability to manufacture and deliver the licensed vaccine up to [**]
doses annually. C.2 – Purpose The purpose of this project is to maintain the
ability to manufacture and deliver licensed ACAM2000, Smallpox (Vaccinia)
Vaccine, Live. The ACAM2000 vaccine shall be manufactured within the United
States (US) in accordance with current Good Manufacturing Practices (cGMP)
guidelines and palletized kits of ACAM2000 Vaccine, diluent, bifurcated needles
and transfer syringes delivered to the ASPR Strategic National Stockpile (SNS).
C.3 – Scope of Work The Contractor, as an independent organization and not as an
agent of the Government, shall furnish all labor, materials, supplies,
facilities, equipment, transportation and travel necessary to manufacture and
deliver listed doses of licensed ACAM2000 vaccine, in accordance with C.10. The
contractor shall deliver an equivalent quantity of ancillaries (ACAM2000
diluent, bifurcated needles and transfer syringes for use in the administration
of the ACAM2000 vaccine. The contractor shall comply with the following
objectives: • (Task 1) Manufacture and deliver, Food & Drug Administration (FDA)
licensed ACAM2000 under Biologic License Application (BLA) Submission Tracking
Number (STN) 125158 from approved facilities with the timeframe and quantities
in accordance with Task 1. • (Task 1) Maintain the agency-approved Stability
testing structure which assesses the long-term safety and efficacy of the
ACAM2000 Lyophilized Drug Product at the Strategic National Stockpile and
supports [**] of shelf life [**] from the time of product manufacture. • (Task
1) Perform qualified vaccinia vaccine potency assay on ACAM2000. • (Task 2)
Replace expiring ACAM2000 diluent as related to new doses supplied under this
contract • (Task 3) Replace expiring transfer syringes as related to new doses
supplied under this contract • (Task 4) Relabel vaccine to [**] shelf-life ACAM
10-Yr 75A50119C00071 Page 12 of 33

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• (C.5.) Provide quarterly reports and update meetings by the [**] following the
end of the quarter. C.4 – Task 1: Manufacturing and Delivery of ACAM2000 Vaccine
The Contractor shall manufacture and deliver, in accordance with this Task 1,
licensed ACAM2000, including ancillary components which shall be delivered to
the SNS [**], and produced entirely in the US in accordance with this Statement
of Work. The product shall meet all requirements as specified in the approved
FDA license and any approved supplements or amendments thereto. Ancillary
components include diluent, syringe and bifurcated needle for reconstitution of
vaccine. One vial of diluent will be provided for USP for each vial of vaccine;
one syringe for reconstitution of each vial of vaccine; and one bifurcated
needle for each dose of vaccine. The vaccine and diluent will be labeled and
packaged as outlined in the BLA and subsequently approved FDA license.
Manufacture of Bulk Vaccine The contractor shall manufacture the cell cultures
required for the domestic production of ACAM2000 at its US bulk vaccine
manufacturing facility at the [**] bioreactor scale. The contractor shall
perform all Installation Qualification (IQ), Operational Qualification (OQ), and
Performance Qualification (PQ) on any equipment required to produce the vaccine.
The domestic manufacturing of the ACAM2000 vaccine in Vero cells grown on micro
carrier beads at the [**] scale shall be in accordance with the approved
ACAM2000 BLA on file with the FDA. Vaccine Fill and Finish The Contractor shall
maintain a validated filling, lyophilization, labeling and packaging of ACAM2000
at its US fill and finish facility and shall perform all IQ, OQ, and PQ on any
additional equipment required at that facility and associated process
development. Requirements for Packaging & Delivery The products shall be
delivered as follows: ACAM2000, (Smallpox (Vaccinia) Vaccine, Live), shall be
provided in a multiple dose [**]. Each vial shall contain [**]. Each vaccine box
shall contain [**]. Each case shall contain [**]. The ACAM2000 vaccine shall
have >[**] shelf life remaining at the time of delivery. ACAM2000 Diluent shall
be provided as [**]. Each diluent box shall contain [**]. Each case shall
contain [**]. The diluent shall have a [**] shelf life. The diluent should have
> [**] of shelf life remaining at the time of delivery Bifurcated needles shall
be supplied in boxes containing [**] needles each. Each case shall contain [**]
bifurcated needles with an expiry date of [**] from date of manufacture.
Transfer Syringes shall be provided as [**]needles for vaccine reconstitution.
Each box shall contain [**] syringes and [**] syringes per case. Transfer
syringes have an expiry date of [**] from the date ACAM 10-Yr 75A50119C00071
Page 13 of 33

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[ebs20191231exhibit1048014.jpg]
of manufacture. The transfer syringes should have ≥[**] of shelf life remaining
at the time of delivery. Complete, unopened cases of bifurcated needles and
syringes will be provided. The additional quantity required to provide complete
cases (rounded up quantity in excess of kit requirements) will be provided at no
additional cost to the Government). The provided kit summary should note both
the Emergent lot number and the manufacturer’s lot number for needles and
syringes. FDA-approved ACAM2000 Package Insert and Medication Guides shall be
provided per the license as a compact disk (CD). Emergent will work with the FDA
to phase-out the CDs and provide a suitable electronic solution. The contractor
shall notify the Contracting Officer’s Representative (COR) when the Package
Insert or Medication Guide are revised and will ship the current PDF version
with each delivery order. Boxes, cases and shelf cartons shall not contain mixed
lot numbers. All pallets are to have the identical TiHi stack pattern except for
the last final pallet per lot number. All ACAM2000 vaccine product shall be
delivered on standard 48" by 40" pallet, not to exceed 60” in height, stretch
wrapped and secured to pallet for safe transport. Prior to an ACAM2000 vaccine
and ancillary delivery, the Kit Component Inventory Summary Sheet which provides
the ACAM2000 Kit (vaccine, diluent, bifurcated needle and transfer syringe)
Inventory Summary, shall be provided outlining the products in each delivery;
lot numbers of each items; number of full and partial boxes, cases and pallets;
and the total quantities of each items in vials or each. The contractor shall
provide Certificates of Analysis and Certificates of Conformance for the vaccine
at least [**] prior to shipment arriving at the SNS facility. The contractor
shall also provide Certificates of Analysis and Vendor Certificate of
Manufacturing (or Conformance) for the diluent prior to shipment arriving at the
SNS facility. Driver information for each delivery truck shall be provided as
soon as available to the SNS site. After the delivery, a documented review of
the temperature data from the vaccine and diluent shipments will be provided.
SNS Locations Delivery location shall be in accordance with United States
Government (USG) instructions provided [**] prior to the shipment and are
specific exclusively to Continental US (CONUS) locations. Locations outside
CONUS may incur additional shipping/validation charges which will result in a
contract modification to be performed prior to shipment. No more than [**]
shipments [**]. Vaccine relabeling shall occur at current inventory locations
unless otherwise agreed upon. Delivery shall also include ancillary items for
reconstitution of each vial of vaccine (diluent, transfer syringe) as well as a
bifurcated needle for administration of each dose of vaccine. Packaging,
labeling and delivery shall be done according to the methodology and
specifications ACAM 10-Yr 75A50119C00071 Page 14 of 33

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outlined in the current BLA filed with the FDA and as outlined in Section C.6,
C.8. Section D, Section E. Warranties A warranty shall be provided for vaccines,
diluent, transfer syringes, and bifurcated needles delivered to the USG during
this 10-year contract. • Vaccine will have ≥ [**] of shelf-life remaining at
time of delivery • Diluent will have >[**] of shelf-life remaining at time of
delivery. • The transfer syringes should have ≥[**] of shelf life remaining at
the time of delivery. • Transfer Syringes and Needles are commercial products.
In the event of supplier and/or delivery issues that result in shelf life not
meeting minimum requirements, the parties will develop suitable alternatives in
delivery and pricing. For ACAM2000 delivered during this contract, if it is
determined that the ACAM2000 vials delivered do not meet the shelf life standard
of [**] expiry from the date of manufacture (with a minimum of [**] of shelf
life remaining at the time of delivery) and that USG has met its storage and
handling obligations for such products pursuant to a separate Quality Agreement,
then the Contractor will provide an equitable remedy based on the remaining
shelf life of the non- conforming product(s), which will include one of the
following: (a) replacement product (only during the contract period), (b) a
credit against future purchases under the contract, or (c) reimbursement.
Historical Lots-Testing Program and Quarantine Doses manufactured and
distributed prior to 2018 had labeled expiry periods of less than the current
[**] expiry. As these lots approach their labeled expiry dates, Emergent will
coordinate with SNS and the SNS sites to re-label impacted lots with [**]
expiry, per STN 103821/203 (approved 15 Dec 2017). Once lots have exceeded the
FDA approved [**] expiry, they will be quarantined by SNS and will not be
distributed for any use. Given the commitment for a long-term contract to
replace the stockpile, Emergent will agree to test representative lots of
quarantined product on an [**] basis and provide the data as For Information
Only (FIO) to SNS until replenished stockpile inventory levels meet the desired
threat assessment level. This information will be provided as soon as it is
available and following the Government placing its annual optional CLIN order
for at least [**] ACAM2000 doses. Under this Vaccine Testing Program, Emergent
understands that, in the event of an emergency, the SNS would be responsible for
seeking an appropriate regulatory mechanism to deploy for use quarantined
product. • Emergent would follow our procedures in the event of an OOS (out of
specification) result. Upon confirmation of an OOS, that information would be
shared with the SNS; • Testing would continue only with the concurrent exercise
of the option for product delivery; ACAM 10-Yr 75A50119C00071 Page 15 of 33

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• Testing would only continue until the stockpile reaches the threat assessment
level ([**] doses); • Based on the lots tested and the proposed delivery
schedule, the maximum that lots would be tested is anticipated to be no more
than [**] from the date of manufacture; The product expiration will remain at
[**]. This testing will not be used to support any further extension to the
product expiry dating. Under this agreement, the product maintained in the SNS
stockpile beyond the shelf life of [**] is no longer considered to be under our
license. Emergent is not making any representation or guarantees that the
testing will support extensions to the shelf life and the testing data is not
being provided to the SNS in support of expiry extensions. As a result, Emergent
will also no longer be performing any activities beyond the submission of the
data to the SNS. The testing data is not being provided to the SNS in support of
expiry extensions, and any discussions with the FDA regarding the use of the
stockpile in an emergency event or any use of this product will be captured
under a different regulatory mechanism outside of Emergent’ s license and will
be the responsibility of the SNS. The following table provides a summary
detailing the strategy for managing expiring ACAM2000 vaccine: Table 6: Strategy
for managing expiring ACAM2000 vaccine Category Proposed Strategy Older lots
with < [**] expiry All lots can be managed as having [**] expiry per STN
labeling and < [**] since date of 125158/203 (approved 15 Dec 2017). These lots
will be manufacture re-labeled with [**] expiry per the schedule in Section C
below. Once these lots exceed [**], the lots will be quarantined by SNS, per
below. Older lots that have ≥ [**] since These lots have, or will have, exceeded
the FDA approved date of manufacture expiry period and will be quarantined by
SNS. The lots will not be distributed by ASPR for any purpose (vaccination,
research, etc.) except under an approved appropriate regulatory mechanism. Once
SNS has achieved its inventory goal for ACAM2000 vaccine, all quarantined
expired doses should be destroyed. New lots with [**] expiry* All newly
manufactured lots under this contract will be *It is expected the U.S. labeled
with [**] expiry. Therefore, none of these lots will Government will deploy in
date expire during the 10- year period of this contract. When vaccine first and
quarantined the lots do expire in the future, the expired materials vaccine
would only be deployed should be destroyed. after all in date product is
depleted (and with the appropriate regulatory oversight). ACAM 10-Yr
75A50119C00071 Page 16 of 33

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Task 2: Diluent Replacement The contractor shall replace expiring ACAM2000
diluent related this contract (see Task 2 table). Government to provide forecast
[**] to confirm the quantity to be delivered Options may be exercised after the
base year is awarded through year 10 at the quantities also outlined herein. If
the quantity of diluent requiring replacement changes from the quantity outlined
in Section C.6, both parties shall agree to the change. Note timing listed in
C.6 are approximations as replacement timing is dependent of the manufacturing
date of shipped quantities. The contractor shall deliver [**]. The diluent shall
be packaged in [**] per case. The diluent shall have a [**] shelf life. At the
time of delivery to the SNS the diluent should have >[**] of shelf life
remaining. Task 3: Syringe Replacement • Transfer Syringe quantities will be in
increments of a full case box (divisible by [**]). • Replacement of transfer
syringes sold prior to this contract are outside the scope of this proposal and
can be quoted separately upon request. Task 4: ACAM2000 Vaccine Limited
Re-Labeling Activities The ACAM2000 vaccine currently has an expiration date of
[**]. Emergent will re-label vaccine lots located at the Strategic National
Stockpile (SNS) for lots produced by the [**] facility which have less than an
expiry of [**] as they approach their current labeled expiration. (See table
below). Quantities are estimates and will be verified prior to relabeling
efforts. ACAM 10-Yr 75A50119C00071 Page 17 of 33

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Table 7: Re-labeling of [**] Manufactured Lots with [**] expiry Over-label
Expire Lot Grand Location 2020 2021 2023 2025 2027 Year Date Number Total [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] Grand [**] [**] [**] [**] [**] [**] [**] [**]
Total ACAM 10-Yr 75A50119C00071 Page 18 of 33

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C-5 – Reporting Requirements (Emergent) The contractor shall submit a Quarterly
Progress Report, which shall include the information listed below that is
applicable for the performance period during the quarter being reported. The
contractor shall provide the Contracting Officer’s Representative (COR) with one
electronic copy of the Quarterly Progress Report via e-mail. Any attachments to
the report shall be submitted in Microsoft Word, Adobe Acrobat, or similar
files. The contractor shall meet with the COR quarterly to discuss the Quarterly
Progress Report. The contractor shall submit the Quarterly Reports and schedule
the meetings by the [**] following the end of the quarter. The following shall
be included in the quarterly report. 1. Quarterly Reporting Requirements
Manufacturing and Delivery of ACAM2000® Kits a. Procurement and Production b.
Quality Control Testing and Potency c. Quality Manufacturing Deviations (major)
2. FDA inspections, consultation results or recommendations and any files to the
FDA concerning the ACAM2000 BLA 3. Security Assessment 4. Stability Program
Assessment (Provided [**]) 5. Overall Project Assessment a. Delivery Summary b.
Projected Deliveries for next reporting period c. Plan vs. Actual and Specific
problems to address C.6 – Reporting Requirements (SNS) SNS shall provide the
following information to Emergent at the frequency described below: 1. Doses
delivered from SNS. This number is needed for safety reporting ([**]) 2.
Destruction of expired lots of ACAM Vaccine. ([**] for record retention) 3. ACAM
Vaccine lots in inventory, number of vials, and quantity in quarantine. ([**]
for over-labelling planning) 4. ACAM Diluent lots in inventory, number of vials.
([**]) ACAM 10-Yr 75A50119C00071 Page 19 of 33

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5. Note: Updated inventory on specific lots may be required as part of
investigations throughout the contract. C.7. – Delivery Notifications Emergent
shall notify the COR of the total quantity of product(s) and pallet count that
will be delivered utilizing the Kit Component Inventory Summary Sheet, which
provides the ACAM2000 Kit (vaccine, diluent, bifurcated needle and transfer
syringe) Inventory Summary to the SNS at least [**] prior to each delivery. C.8
– Quality Inspections • Site Visits/Audits: The Government shall perform [**]
site visits/security audits as deemed necessary by the Government throughout the
period of performance of the contract. • Quality: The Government reserves the
right to visit the contractor’s site for purposes of assessing quality on an
[**] basis or as deemed necessary by the Government throughout the period of
performance of the contract. • Notice: The Government will provide [**] advance
notice prior 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. Note: Facilities with live vaccine is
in use (core production/testing areas) require vaccinations or waivers prior to
entry. • All audits will be conducted between normal business hours i.e. 8 a.m.
through 4 p.m., Monday through Friday. • Report to be provided by the Government
as to any observations associated with site visits/audits. The government
reserves the right to inspect any contractor or subcontractor facility used for
the manufacture, packaging, storage, transportation or any other handling of
products ordered as a result of this solicitation without prior notice. These
inspections do not replace any required inspections conducted by the FDA but are
in addition to such inspections. The contractor will be required to respond to
any finding’s resultant from these inspections with remediation plans or an
explanation of why no remediation is required. Section D - Packaging And Marking
Packaging shall be consistent with the FDA approved labeling and packaging for
this product at the time of manufacture. Section E - Inspection And Acceptance
E.1. – FAR 52.252-2 Clauses Incorporated by Reference (1998) ACAM 10-Yr
75A50119C00071 Page 20 of 33

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This contract incorporates one or more clauses by reference, with the same force
and effect as if they were given in full text. Upon request, the Contracting
Officer will make their full text available. Also, the full text of a clause may
be accessed electronically at this/these address (es):
https://www.acquisition.gov FAR SOURCE TITLE AND DATE 52.246-1 Contractor
Inspection Requirements (Apr 1984) 52.246-2 Inspection of Supplies – Fixed Price
(Aug 1996) 52.246-4 Inspection of Services – Fixed Price (Aug 1996) 52.246-16
Responsibility for Supplies (Apr 1984) E.2. – Inspection and Acceptance
Inspection and acceptance of the articles, services, and documentation called
for herein shall be accomplished by the Contracting Officer, or his duly
authorized representative (who for the purposes of this contract shall be the
Project Officer/COR) at the destination of the articles, services or
documentation. The Contractor shall only tender for acceptance those items that
conform to the requirements of this contract. The Government reserves the right
to inspect or test any supplies or services that have been tendered for
acceptance. The Government may require repair or replacement of nonconforming
supplies or re-performance of nonconforming services at no increase in contract
price. The Government must exercise its post-acceptance rights: • Within a
reasonable time after the defect was discovered or should have been discovered;
and • Before any substantial change occurs in the condition of the item, unless
the change is due to the defect in the item. • Goods damaged by Government
personnel during product receipt is not covered under warranty. • Note: Needles
and Syringes are provided as complete, unopened cases. As such, excess
quantities required due to rounding to the nearest whole case will be supplied
as no cost to the government. E.3. – Shipment Acceptance Shipment Acceptance is
defined by two activities: 1) Signed review of delivered materials by SNS
(FRM041013 or other written notification) • Confirmation of quantity of all kit
components • Confirmation that the materials are labeled correctly (with lot #,
date of manufacture and/or expiration date) ACAM 10-Yr 75A50119C00071 Page 21 of
33

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• Confirmation that CoAs are available for each lot • Confirmation there is no
damage, leakage or moisture, or any other defects associated with the pallets
and boxes. 2) Review of shipping temperature for the ACAM2000 vaccine and
diluent by Emergent Quality Assurance. (FRM044234) Emergent may provide staff to
assist in the delivery inspection at no additional cost to the government. This
activity is not a requirement of delivery. SNS will provide Emergent written
notification (either by signed FRM041013 or other written notification) that it
either accepts or rejects the delivered lot(s) within [**] of receipt. If formal
acceptance or rejection is not received in the [**] period, it shall be deemed
the shipment is accepted. Section F - Deliveries Or Performance FAR SOURCE TITLE
AND DATE 52.211-17 Delivery of Excess Quantities (Sept 1989) 52.242-15 Stop-Work
Order (Aug 1989) 52.242-17 Government Delay of Work (Apr 1984) 52.247-34 FOB
Destination (Nov 1991) F.1. – Period of Performance The period of performance of
this contract shall be a base period and nine 12-month option periods as
follows: 08/30/2019 – 08/29/2020 (Base) 08/30/2024 – 08/29/2025 (Option Year 5)
08/30/2020 – 08/29/2021 (Option Year 1) 08/30/2025 – 08/29/2026 (Option Year 6)
08/30/2021 – 08/29/2022 (Option Year 2) 08/30/2026 – 08/29/2027 (Option Year 7)
08/30/2022 – 08/29/2023 (Option Year 3) 08/30/2027 – 08/29/2028 (Option Year 8)
08/30/2023 – 08/29/2024 (Option Year 4) 08/30/2028 – 08/29/2029 (Option Year 9)
F.2. – Delivery Locations Finished products shall be delivered by the Contractor
to any one of the [**] current SNS sites. Site Locations to be provided [**] in
advance of delivery. Section G - Contract Administration Data G.1. – Electronic
Subcontracting Reporting System (eSRS) The Contractor shall register with the
Electronic Subcontracts Reporting System (eSRS) for the submission of its
Individual Subcontract Report (SF 294) and the Annual Summary Reports (SF 295).
Before registering in eSRS, the Contractor information must be correct in the
System for ACAM 10-Yr 75A50119C00071 Page 22 of 33

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Award Management database. The eSRS is a world wide web-based application
available at: http://www.esrs.gov. The eSRS website provides training and
instruction for data submission. G.2. – Invoice Submission Invoices should be
submitted electronically (.pdf) simultaneously to [**], Contracting Officer (CO)
at ([**]), [**], Contracting Officer’s Representative (COR) at ([**]), and the
Program Support Center (PSC) at psc_invoices@psc.hhs.gov. Invoice requirements
(from FAR 32.905) (a) General. Payment will be based on receipt of a proper
invoice and satisfactory contract performance. (b) content of invoices. (1) A
proper invoice must include the following items: (i) Name and address of the
contractor. (ii) invoice date and invoice number. (Contractors should date
invoices as close as possible to the date of mailing or transmission.) (iii)
Contract number or other authorization for supplies delivered or services
performed (including order number and line item number). (iv) Description,
quantity, unit of measure, unit price, and extended price of supplies delivered,
or services performed. (v) Shipping and payment terms (e.g., shipment number and
date of shipment, discount for prompt payment terms). Bill of lading number and
weight of shipment will be shown for shipments on government bills of lading.
(vi) Name and address of contractor official to whom payment is to be sent (must
be the same as that in the contract or in a proper notice of assignment). (vii)
Name (where practicable), title, phone number, and mailing address of person to
notify in the event of a defective invoice. (viii) Taxpayer identification
number (TIN). The contractor must include its tin on the invoice. (ix)
Electronic funds transfer (EFT) banking information. G.3. – Contracting Officer
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. No information, ACAM 10-Yr
75A50119C00071 Page 23 of 33

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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.4. –
Contracting Officer’s Representative Performance of the work hereunder shall be
subject to the technical directions of the designated Contracting Officer’s
Representative (COR) 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 [**] 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 [**]
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 COR
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. The Government will provide the Contractor with
a copy of the delegation memorandum for the COR. Any changes in COR delegation
will be made by the Contracting Officer in writing with a copy being furnished
to the Contractor. G.5 – 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
75A50119C00071. Section H - Special Contract Requirements H.1. – Evaluation of
Contractor Performance Utilizing CPARS (April 2015) In accordance with FAR
42.15, the SNS will review and evaluate contract performance. FAR 42.1502 and
42.1503 requires agencies to prepare evaluations of contractor performance and
submit them to the Past Performance Information Retrieval System (PPIRS). The
SNS utilizes the Department of Defense (DOD) web-based Contractor Performance
Assessment Reporting System (CPARS) to prepare and report these contractor
performance evaluations. All information contained in these assessments may be
used by the Government, within the limitations of FAR 42.15, for future source
selections in accordance with FAR 15.304 where past performance is an evaluation
factor. ACAM 10-Yr 75A50119C00071 Page 24 of 33

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The CPARS system requires a contractor representative to be assigned so that the
contractor has appropriate input into the performance evaluation process. The
CPARS contractor representative will be given access to CPARS and will be given
the opportunity to concur or not-concur with performance evaluations before the
evaluations are complete. The CPARS contractor representative will also have the
opportunity to add comments to performance evaluations. The assessment is not
subject to the Disputes clause of the contract, nor is it subject to appeal
beyond the review and comment procedures described in the guides on the CPARS
website. Refer to: www.cpars.gov for details and additional information related
to CPARS, CPARS user access, how contract performance assessments are conducted,
and how Contractors participate. Access and training for all persons responsible
for the preparation and review of performance assessments is also available at
the CPARS website. The contractor must provide the SNS contracting office with
the name, e-mail address, and phone number of their designated CPARS
representative who will be responsible for logging into CPARS and reviewing and
commenting on performance evaluations. The contractor must maintain a current
representative to serve as the contractor representative in CPARS. It is the
contractor’s responsibility to notify the SNS contracting office, in writing
(letter or email), when their CPARS representative information needs to be
changed or updated. Failure to maintain current CPARS contractor representative
information will result in the loss of an opportunity to review and comment on
performance evaluations. H.2. – CDC37.0001 Non-Personal Services (April 2015)
Personal services shall not be performed under this contract. Although the
Government may provide sporadic or occasional instructions within the scope of
the contract, the Contractor is responsible for control and supervision of its
employees. If the Contractor (including its employees) believes any Government
action or communication has been given that would create a personal services
relationship between the Government and any Contractor employee, the Contractor
shall promptly notify the Contracting Officer of this communication or action.
The contractor shall comply with, and ensure their employees and subcontractors
comply with, SNS Policy titled “Identification of Contractors' Employees and
Safeguarding Government Information.” No Contractor employee shall hold him or
herself out to be a Government employee, agent, or representative. No Contractor
employee shall state orally or in writing at any time that he or she is acting
on behalf of the Government. In all communications with third parties in
connection with this contract, Contractor employees shall identify themselves as
Contractor employees and specify the name of the company for which they work.
The contractor is limited to performing the services identified in the contract
statement of work and shall not interpret any communication with anyone as a
permissible change in contract scope or as authorization to perform work not
described in the contract. All contract changes will be incorporated by a
modification signed by the Contracting Officer. The Contractor shall ensure that
all of its employees and subcontractor employees working on this contract are
informed of the substance of this clause. The Contractor agrees that this is a
non-personal services contract; and that for all the purposes of the contract,
the Contractor is not, nor shall it hold itself out to be an agent or partner
of, or joint venture with, the Government. The ACAM 10-Yr 75A50119C00071 Page 25
of 33

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Contractor shall notify its employees that they shall neither supervise nor
accept supervision from Government employees. The substance of this clause shall
be included in all subcontracts at any tier. Nothing in this clause shall limit
the Government's rights in any way under any other provision of the contract,
including those related to the Government's right to inspect and accept or
reject the services performed under this contract. H.3. – Restrictions on
Disclosure of Information and Rights in Data Information made available to the
Contractor by the Government for the performance or administration of this
effort shall be used only for those purposes and shall not be used in any other
way without the written agreement of the Contracting Officer. The Contractor
agrees to assume responsibility for protecting the confidentiality of Government
records, which are not public information. Each Contractor or employee of the
Contractor to whom information may be made available or disclosed shall be
notified in writing by the Contractor that such information may be disclosed
only for a purpose and to the extent authorized herein. Contractor and/or
contractor personnel shall not divulge or release data or information developed
or obtained in performance of this effort, until made public by the Government,
except to authorize Government personnel or upon written approval of the
Contracting Officer or COR. The contractor shall not use, disclose, or reproduce
proprietary data that bears a restrictive legend, other than as required in the
performance of this effort. Nothing herein shall preclude the use of any data
independently acquired by the contractor without such limitations or prohibit an
agreement at no cost to the Government between the contractor and the data owner
which provides for greater rights to the contractor. H.4. – 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 be administered in humans, in accordance
with the declaration under the PREP Act issued by the Secretary of the
Department of Health and Human Services on December 9, 2015 pursuant to section
319F-3(b) of the Public Health Service Act, 42, U.S.C 247-d-6d regarding
Smallpox Medical Countermeasures- Amendment. The declaration provides targeted
liability protections for smallpox countermeasures based on a credible risk that
the threat of exposure to smallpox and the resulting disease constitutes a
public health emergency. For purposes of this provision, “Vaccine” means
ACAM2000 vaccine with its labeling, packaging, diluent, needles, and any other
of their respective components as well as any other deliverable under this
contract. The Vaccine may not be used outside of the United States until the
Contractor and the Government agree to reasonable liability protections for
outside the United States and the Contract has been modified to reflect that
agreement; such contract modification will be a change for which the Contractor
will be entitled to an equitable adjustment in accordance with FAR 52.243-1.
Additionally, the USG further agrees, in ACAM 10-Yr 75A50119C00071 Page 26 of 33

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accordance with Federal rules and regulations, to provide written notice to the
Contractor of any intended use of the Vaccine delivered under this contract. In
the event that a claim or suit for damages is brought against the Contractor by
a third party arising out of its performance of this contract, the USG will
provide reasonable and timely access to documents and information potentially
relevant to the Contractor’s assertion of defenses to any dispute with a third
party, including, but not limited to, a claim for bodily injury or other damages
allegedly arising out of the use of the Vaccine delivered to the USG under this
contract to the extent permitted by Federal rules and regulations. The USG will
consider any request from the Contractor to assist the Contractor in litigation,
including a request to support the Contractor’s assertion of appropriate
defenses. If and when appropriate, the USG will file papers in support of the
Contractor’s assertion of its defenses in such disputes. H.5. – SNS
Responsibilities Please refer to QUAL40041 (Quality Agreement, SNS) for Emergent
and USG responsibilities regarding the availability of the most current FDA
approved Package Insert and Medication Guide. Emergent and SNS agree that this
Quality Agreement is applicable to this contract. Note that after contract award
the Quality Agreement will be updated to reflect any changes in the SNS
organizational structure, COR and items no longer applicable to SNS. H.6. –
Rights of the Contractor to Market Smallpox Vaccine The Contractor is not
prohibited from marketing the Smallpox Vaccine being sold to SNS under this
Contract provided that such marketing does not interfere with performance under
this Contract. H.7. – Expired Doses in the SNS During the term of this contract,
any and all expired doses will be held in quarantine by SNS and will not be
distributed for any purpose (e.g., vaccination, research, etc.) except under an
appropriate regulatory mechanism. SNS will be solely responsible for obtaining
said appropriate regulatory mechanism and maintaining it as may be required.
Once SNS inventory needs are met with non-expired doses, SNS will be responsible
for the destruction of the expired doses under the appropriate regulatory
mechanism and any future expiring lots of ACAM2000 vaccine. This Provision does
not diminish any Contractor protection granted by Special Provision H.4 above
and is in addition to it. Accordingly, all protections to Emergent granted by
Special Provision H.4 are fully applicable to any and all Government use of such
expired doses held in quarantine by SNS. H.8 – Testing of Quarantined Product
Given the commitment for a long-term contract to replace the stockpile, Emergent
will agree to test representative lots of quarantined product on an [**] basis
and provide the data as “For Information Only” (FIO) to SNS until replenished
stockpile inventory levels meet the desired threat assessment level. Under this
Vaccine Testing Program, Emergent understands that, in the event of an
emergency, the SNS would be responsible for seeking an appropriate regulatory
mechanism from the FDA to deploy for use Quarantined product. ACAM 10-Yr
75A50119C00071 Page 27 of 33

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[ebs20191231exhibit1048028.jpg]
• Emergent would follow our procedures in the event of an OOS result. Upon
confirmation of an OOS, that information would be shared with the SNS. • Testing
would continue only with the concurrent exercise of the option for product
delivery. • Testing would only continue until the stockpile reaches the threat
assessment level. • Based on the lots tested and the proposed delivery schedule,
the maximum that lots would be tested is anticipated to be no more than [**]
from the date of manufacture. • The product expiration will remain at [**]. This
testing will not be used to support any further extension to the product expiry
dating. Under this agreement, the product maintained in the SNS stockpile beyond
the shelf life of [**] is no longer considered to be under our license. Emergent
is not making any representation or guarantees that the testing will support
extensions to the shelf life and the testing data is not being provided to the
SNS in support of expiry extensions. As a result, Emergent will also no longer
be performing any activities beyond the submission of the data to the SNS. Any
discussions with the FDA regarding the use of the stockpile in an emergency
event or any use of this product will be captured under a different regulatory
mechanism outside of Emergent’ s license and will be the responsibility of the
SNS. ACAM 10-Yr 75A50119C00071 Page 28 of 33

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[ebs20191231exhibit1048029.jpg]
Section I - Contract Clauses I.1 - Clauses Incorporated By Reference FAR
REFERENCE TITLE DATE 52.202-1 Definitions Nov 2013 52.203-3 Gratuities April
1984 52.203-5 Covenant Against Contingent Fees May 2014 52.203-6 Restrictions on
Subcontractor Sales to the Sep 2006 Government 52.203-7 Anti-Kickback Procedures
May 2014 52.203-8 Cancellation, Rescission, and Recovery of Funds May 2014 for
Illegal or Improper Activity 52.203-10 Price or Fee Adjustment for Illegal or
Improper May 2014 Activity 52.203-12 Limitation on Payments to Influence Certain
Oct 2010 Federal Transactions 52.203-17 Contractor Employee Whistleblower Rights
and Apr 2014 Requirements to Inform Employees of Whistleblower Rights 52.204-4
Printed or Copied Double-Sided on Recycled May 2011 Paper 52.204-10 Reporting
Executive Compensation and First-Tier Oct 2018 Subcontract Awards 52.204-13
System for Award Management Maintenance Oct 2018 52.209-6 Protecting the
Government's Interests When Oct 2015 Subcontracting With Contractors Debarred,
Suspended, or Proposed for Debarment 52.211-5 Material Requirements Aug 2000
52.215-8 Order of Precedence - Uniform Contract Format Oct 1997 52.215-10 Price
Reduction for Defective Certified Cost or Aug 2011 Pricing Data 52.215-11 Price
Reduction for Defective Certified Cost or Aug 2011 Pricing Data Modifications
52.215-12 Subcontractor Cost or Pricing Data Oct 2010 52.215-13 Subcontractor
Cost or Pricing Data-Modifications Oct 2010 52.215-14, Alt 1 Integrity of Unit
Prices Oct 2010 52.215-15 Pension Adjustments and Asset Reversions Oct 2010
52.215-18 Reversion or Adjustment of Plans for Post- July 2005 Retirement
Benefits (PRB) other than Pensions 52.215-19 Notification of Ownership Changes
Oct 1997 52.215-21 Requirements for Certified Cost or Pricing Data Oct 2010 and
Data Other Than Certified Cost or Pricing Data - Modifications 52.222-3 Convict
Labor Jun 2003 ACAM 10-Yr 75A50119C00071 Page 29 of 33

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[ebs20191231exhibit1048030.jpg]
I.1 - Clauses Incorporated By Reference (continued) FAR REFERENCE TITLE DATE
52.222-20 Contracts for Materials, Supplies, Articles, and May 2014 Equipment
Exceeding $15,000 52.222-21 Prohibition of Segregated Facilities Apr 2015
52.222-50 Combating Trafficking in Persons Jan 2019 52.222-54 Employment
Eligibility Verification Oct 2015 52.223-3 Hazardous Material Identification and
Material Jan 1997 Safety Data 52.223-18 Encouraging Contractor Policies to Ban
Text Aug 2011 Messaging While Driving 52.225-13 Restrictions on Certain Foreign
Purchases Jun 2008 52.227-1 Authorization and Consent Dec 2007 52.227-2 Notice
and Assistance Regarding Patent and Dec 2007 Copyright Infringement 52.229-3
Federal, State and Local Taxes Feb 2013 52.232-1 Payments Apr 1984 52.232-8
Discounts for Prompt Payment Feb 2002 52.232-9 Limitation on Withholding of
Payments Apr 1984 52.232-11 Extras Apr 1984 52.232-17 Interest May 2014
52.232-23 Assignment of Claims May 2014 52.232-25 Prompt Payment Jan 2017
52.232-33 Payment by Electronic Funds Transfer—System Oct 2018 for Award
Management 52.232-39 Unenforceability of Unauthorized Obligations Jun 2013
52.232-40 Providing Accelerated Payments to Small Business Dec 2013
Subcontractors 52.233-1 Disputes May 2014 52.233-3 Protest After Award Aug 1996
52.233-4 Applicable Law for Breach of Contract Claim Oct 2004 52.242-13
Bankruptcy Jul 1995 52.243-1 Changes - Fixed-Price Aug 1987 52.244-5 Competition
in Subcontracting Dec 1996 52.244-6 Subcontracts for Commercial Items Aug 2019
52.246-25 Limitation of Liability - Services Feb 1997 52.247-34 F.O.B.
Destination Nov 1991 52.247-68 Report of Shipment (REPSHIP) Feb 2006 52.249-2
Termination for the Convenience of the Apr 2012 Government (Fixed Price)
52.249-8 Default (Fixed-Price Supply and Service) Apr 1984 52.253-1 Computer
Generated Forms Jan 1991 ACAM 10-Yr 75A50119C00071 Page 30 of 33

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[ebs20191231exhibit1048031.jpg]
HHSAR Reference TITLE DATE HHSAR 352.203-70 Anti-Lobbying Dec 2015 HHSAR
352.208-70 Printing and Duplication Dec 2015 HHSAR 352.224-71 Confidential
Information Dec 2015 HHSAR 352.239-74 Electronic and Information Technology Dec
2015 Accessibility ACAM 10-Yr 75A50119C00071 Page 31 of 33

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[ebs20191231exhibit1048032.jpg]
FAR 52.217-8 Option to Extend Services (NOV 1999) The Government may require
continued performance of any services within the limits and at the rates
specified in the contract. These rates may be adjusted only as a result of
revisions to prevailing labor rates provided by the Secretary of Labor. The
option provision may be exercised more than once, but the total extension of
performance hereunder shall not exceed [**]. The Contracting Officer may
exercise the option by written notice to the Contractor within [**]. (End of
Clause) FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a)
The Government may extend the term of this contract by written notice to the
Contractor within [**] provided that the Government gives the Contractor a
preliminary written notice of its intent to extend at least [**] before the
contract expires. The preliminary notice does not commit the Government to an
extension. (b) If the Government exercises this option, the extended contract
shall be considered to include this option clause. (c) The total duration of
this contract, including the exercise of any options under this clause, shall
not exceed [**]. (End of Clause) ACAM 10-Yr 75A50119C00071 Page 32 of 33

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[ebs20191231exhibit1048033.jpg]
Section J - List Of Attachments Table 8: Kit Reference (including Shelf Life)
Component Quantity Expiry Shelf life Part#/ Box and Case Pallet Product at time
of Supplier Location and Delivery Temperature Requirements ACAM2000 [**] [**]
[**] [**] [**] [**] [**] Vaccine [**] ACAM2000 [**] [**] [**] [**] [**] [**]
[**] Diluent [**] Bifurcated [**] [**] [**] [**] [**] [**] [**] Needle Transfer
[**] [**] [**] [**] [**] [**] [**] Syringe [**] ACAM 10-Yr 75A50119C00071 Page
33 of 33

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