11. THIS CONTRACT IS A RATED ORDER

AWARD/CONTRACT

ilo

RATINGUNDER DPAS 115 CFR 7001

PAGE OF PAGES
91
4. REQUISITION/PURCHASE REQUEST/PROJECT NO

2. CONTRACT (Proc. Inst. ?dent.) NO.

3. EFFECTIVE DATE

75A50120000092

See Block 20CSee Schedule

5. ISSUED BY

CODE

6. ADMINISTERED BY Mother den Item 5)

ASPR — BARDACODE

ASPR-BARDA

200 Independence Ave., S.W.
Room 640-G
Washington DC 20201
SCD-C
7. NAME AND ADDRESS OF CONTRACTOR (No., street, country, Stele end ZIP Code)

8. DELIVERYPHLOW CORP 1558286

9. DISCOUNT FOR PROMPT PAYMENT0FOB ORIGIN)11 OTHER (See below)

PSC NET 15P

PHLOW CORP.
737 N 5TH ST STE 6
737 N 5TH ST STE 605
RICHMOND VA 232191441

10.SUBMIT INVOICES(4 copies unless otherwise specified)
TO THE ADDRESS SHOWN IN
CODE

12

FACILITY CODE

1558286

11. SHIP TO/MARK FOR

CODE

psc

PSC
Program Support Center
7700 Wisconsin Ave
Bethesda MD 20814

14.ACCOUNTING AND APPROPRIATION DATA

13. AUTHORITY FOR USING OTHER THAN FULL AM) OPEN COIAPETMON

1

CODE

12. PAYMENT WILL BE MADE BY

Multiple Destinations

X' 10 U.S.C. 2304 (c) (

ITEM
10,

1- :41 U.S.C. 3304 fel (1

15A. ITEM NO

See Schedule)

158, SUPPUES/SERVICES

MC.
150.
QUANTITY UNIT

15E UNIT PRICE

15F. AMOUNTContinued
150. TOTAL AMOUNT OF CONTRACT$354,256,000.00

16 TABLE OF CONTENTS
DO

SEC. 1 DESCRIPTION

1 PAGE(S)(XIPART I - THE SCHEDULE

ISEC. 1 DESCRIPTIONPACE (S)PART II - CONTRACT CLAUSESXASOLICITATION1CONTRACT FORMX

B

SUPPLIES OR SERVICES AND PRICES/COSTS

6

12
24
24
24
36
41

X

C

DESCR1PTION/SPECS.ANORK STATEMENTX

D

PACKAGING AND MARKINGXE

INSPECTION AND ACCEPTANCE

XF

DELIVERIES OR PERFORMANCE

X

0

CONTRACT ADMINISTRATION DATAX

H

SPECIAL CONTRACT REQUIREMENTS

I

I

I CONTRACT CLAUSES

46

PART III- LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
X

J

53

LIST OF ATTACHMENTS

PART IV- REPRESENTATIONS AND INSTRUCTIONSK

REPRESENTATIONS CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORSL

INSTRS.. CORDS.. AND NOTICES TO OFFERORSM

EVALUATION FACTORS FOR AWARDCONTRACTING OFFICER WILL COMPLETE REM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE
17. ;.8 . CONTRACTOR S NEGOTIATED AGREEMENT (Contractor is required to sign this
18. _ SEALED-BID AWARD (Contractor is not required to sign this document.) Your bid on
document and natum
Sokitalkin Number_ _ _ copies to issuing office.) Contractor agrees tofurnish and delver al items or perform all the services set forth or otherwise identified
above and on any corendalion sheets for the consideration stated herein. The rights andinclucfing the additions or changes made by you which additions or changes are set forthn full above, is hereby accepted as to the items fisted above and on any continuation

Obligations of the parties to the contract shall be subject to and governed by the following
documents: (a) this award/contract. (b) the solicitation, if any. aria (c) such provisions,representations. certifications, and specifications, as are attached or Incorporated byreference herein. iAttachrnents are listed herein.)
19A. NAME AND TITLE OF SIGNER (Type or print)

sheets. This award consummates the contract which consists of the following
documents: (a) the Government's solicitation and your bid, and (b) this award/contract.
No (tallier contractual document is necessary. (Block 18 should be checked only whenawarding a sealed-bid contract.)
20A. NAME OF CONTRACTING OFFICER

SY4 5, relfr.).L., Js

198. NAME OF CONTRACTORJAMES HARRISC(s)19C. DATE SIGNED

208. UNITED STATES OF AMERICA

5:/f-2.43

BY.0C. DATE SIGNEDHLOW CORP 15811286

r,b)(6)T
AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is NOT usable

Digitallysigned by lames Harris -5
James Harris -S Date:
2020.05.18 09:0454 -0400'

5/18/2020

Sionature of the Contract/no Offircen.
STANDARD FORM 26 (Rev. 3/2013)
Prescneal by GSA- FAR (48 CFR) 53214(a)CONTINUATION SHEETPAGEREFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50120000092

2

OF

1 9

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO.

SUPPLIES/SERVICES

(A)

(B)

QUANTITY UNIT

(C)

(D)

UNIT PRICEAMOUNT(E)(H )Tax ID Number: 84-4910906
DUNS Number: 117445813
Reference BAA-18-100-SOL-00003
Cost Plus Fixed-Fee contract providing baseperiod funding to furnish U.S.- based advanced
manufacturing of COVID-19 essential medicines )(4)

DOL General Decision No VA20200155
as revised applies to construction work under
this contract.
Period of Performance: 05/18/2020 to 05/17/2030(b)(4)
1

Overall Project Management
1)
Cost Plus Fixed Fee (CPFF)
2) EVMS reporting NOT required3) SOW: The base award will comprise the task ofmanaging the program per the contract and toassure the program is executed completely, to USG
standards, and per proposed timelines. Scope of
this base award includes the direct labor for the
project management of the first 5 task orders to
be completed in the first 4 years of the contract.
Requisition No: 0S259204
Accounting Info:
2020.199COV2.25103 Appr. Yr.: 2020 CAN: 199COV2Object Class: 25103(b)(4)

2

Near - Term Fill Finish
4) CPFF/ Period of performance: See below (1 yea
5) EVMS reporting NOT required6) SOW: The first task is to provide BARDA
MCMs/Essential Medicines for COVID-19 Response tomeet critical market demand. l(W)

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 33614-86)
Sponsored by GSA
FAR (48 CFR) 53.110

CONTINUATION SHEETREFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50120000092

PAGE

OF

3

1

9

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO.

SUPPLIES/SERVICES

(A)

(B)

QUANTITY UNIT

(C)

(D)

UNIT PRICEAMOUNT(E)(F)

Requisition No: 0S259204
Accounting Info:
2020.199C0V2.25103 Appr. Yr.: 2020 CAN: 199C0V2
Object Class: 25103(b)(4)
3

Near-Term API Manufacture1) CPFF/ Period of performance: See Below(2 year)2) EVMS reporting NOT required3) SOW: This task will be executed in the first 2
years of the contract to ensure U.S.-Based
Production of Active Pharmaceutical Ingredients(API) for COVID-19 MCMs or Essential Medicines
currently experiencing a shortage

They will establish immediate,
U.S.- Based, development and surge capacity
ramp-up for essential active pharmaceuticalingredients (APIs) and their chemical precursor
ingredients to support COVID -19 response efforts
and national su 1 chain securit .
a)b)Ability to rapidly manufacture, provided
C)
regulatory relief is granted, additional COVID-19
MCMs/essential medicine API needed for the
COVID-19 responsed)

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 336 (4-88)
Sponsored by GSA
FAR (48 CFR) 53.110

CONTINUATION SHEETPAGEREFERENCE NO. OF DOCUMENT BEING CONTINUED

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OF

1 9

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO.

SUPPUEVSERVICES(A)QUANTITY

UNIT PRICEAMOUNT(E)(F).1':Pff€
1

Requisition No: 0S259204
Accounting Info:
2020.199C0V2.25103 Appr. Yr.: 2020 CAN: 199C0V2
Object Class: 25103

4SAPIR Build
1) CPFF/ Period of performance: See Below (4years)
2) EVMS reporting required3) SOW: This task will occur over the first 4
years of the contract to establish a BARDA
MCM/Essential Medicine Strategic Active
Pharmaceutical Ingredient Reserve (SAPIR)
Facility.

(b)(4)a) Operationalizing the Nation's First Strategic
Active Pharmaceutical Ingredient Reserve (SAPIR)
Facilityb) Design, build, and validate warehouse ODY4)c) Implement a facility maintenance and stabiliL
program, perform maintenance, calibration andupkeep for facility and continue stability
program on all API's_

Requisition No: 0S259204
Continued ...

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 33614-86)
Sponsored by GSA
FAR (48 CFR) 53.110

CONTINUATION SHEETPAGEREFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50120000092

OF

5

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO.

SUPPUEVSERVICES

(A)

(B)

QUANTITY UNIT

(C)

(D)

UNIT PRICEAMOUNT(E)(F)

Accounting Info:
2020.199C002.25103 Appr. Yr.: 2020 CAN: 199C002
Object Class: 25103

5Advanced Manufacturing Capability
1) CPFF/ Period of performance: See Below (4years)
2) EVMS reporting required3) SOW: This task will occur over the firstyears of the contract to establish a U.S. Based, End-to-End, Advanced Manufacturing
Capability for BARDA MCMs/Essential Medicines,
and their Ingredients. This involves(b)(4)

development of a U.S. - based, advanced
manufacturing infrastructure to support novel
processes that reduce waste, improve yields andreduce cost for strategic MCMs/ Essential
Medicines. Development of the U.S. - Based,
Advanced Manufacturing Infrastructure
including:a)b) Initializing continuous manufacturing processdevelopment of key MCMs/Essential Medicines inshortage131(41

d)
t-,X1

e)
Continue

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 33614-86)
Sponsored by GSA
FAR (48 CFR) 53.110

CONTINUATION SHEETPAGEREFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50120000092

6

OF

1 9

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO

SUPPLIES/SERVICES

(A)

(B)

QUANTITY UNIT

(C)

(D)

UNIT PRICEAMOUNT

(E)

( 1

_

Requisition No: 0S259204
Accounting Info:
2020.199C0V2.25103 Appr. Yr.: 2020 CAN: 199COV2Object Class: 25103

61) EVMS reporting NOT required2) 11-

7

0.0
Option Period 1
See POP below (1 year)

8

VI

0.0

Option Period 1
See POP below (1 year)

1,1
9

0.0
Option Period 2
See POP below (1 year)
ii

10

0.0
Option Period 2
See POP below (1 year)
1

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 33614-86)
Sponsored by GSA
FAR (48 CFR) 53.110

CONTINUATION SHEETREFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50120000092

PAGE

OF

7

I

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO.

SUPPLIES/SERVICES

(A)

(B)

QUANTITY UNIT

(C)

(D)

UNIT PRICEAMOUNT

(K)

(K)
..

11

Option Period 2
See POP below (1 year)

12• ption "erio.
See POP below (1 year)

13

0.0
Option Period 3
See POP below (1 year)

14

0.0

Option Period 3
See POP below (1 year)

15

0.0
,

Option Period 4
See POP below (1 year)
',I 1

16

1

1

0.0

Option Period 4
See POP below (1 year)

11
17

Continued ...

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 33614-86)
Sponsored by GSA
FAR (48 CFR) 53.110

CONTINUATION SHEETPAGEREFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50120000092

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OF

1 9

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO.

SUPPLIES/SERVICES

(A)

(B)

QUANTITY UNIT

(C)

(D)

UNIT PRICE(I )At 'CUNT)

Option Period 4
See POP below (1 year)

18

0.0
Option Period 5
See POP below (1 year)

19

0.0
Option Period 5
See POP below (1 year)

20

0.0

Option Period 5
See POP below (1 year)

H

21

0.0

Option Period 6
See POP below (1 year)

22

[I

I, 1

0.0

Option Period 6
See POP below (1 year)
—1

23

0.0

Option Period 6
See POP below (1 year)
Continued ...

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 33614-86)
Sponsored by GSA
FAR (48 CFR) 53.110

CONTINUATION SHEETPAGEREFERENCE NO. OF DOCUMENT BEING CONTINUED

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9

OF

1 9

NAME OF OFFEROR OR CONTRACTORPHLOW CORP 1558286
ITEM NO.

SUPPLIES/SERVICES

(A)

(B)

QUANTITY UNIT

(C)

(D)

UNIT PRICEAMOUNT(L)(F)

PSC: AN17 NAICS: 325412, HHS/BARDA COR is Arlene
Joyner, (202) 205-8691, arlene.joyner@hhs.g

AUTHORIZED FOR LOCAL REPRCOPTIONAL FORM 33 (4-86)
Sponsored by GSA
FAR (48 CFR) 53.110

U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Phlow Corporation, 75A50120000092

TABLE OF CONTENTSSECTION B - SUPPLIES/SERVICES AND COST/PRICE2

SECTION C - DESCRIPTION / SPECIFICATIONS / WORK STATEMENT18

SECTION D - PACKAGING AND MARKING31

SECTION E - INSPECTION AND ACCEPTANCE

32

SECTION F - DELIVERABLES / PERFORMANCE

33

SECTION G - CONTRACT ADMINISTRATION43

SECTION H - SPECIAL CONTRACT REQUIREMENTS

48

SECTION I - CONTRACT CLAUSES58

SECTION J - LIST OF ATTACHMENTS

64

Page 10 of 59

U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Ph low Corporation, 75A50120000092

SECTION B — SUPPLIES OR SERVICES AND PRICES/COSTS
B.1

BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This contract is intended to establish a program where essential medicines already on the FDA
drug shortage list, and/or have been exclusively manufactured using foreign sources, aremanufactured and immediately supplied to health care systems in urgent need due to the current
COVID-19 national pandemic. These are medicines, for example,
With the rise in hospitalizations due to COVID-19, theX)
shortages of these medicines have been further magnified and the lack of supply has become amore substantial issue and these medicines are needed even more than during non-pandemic
times. The contract is also to maintain a facility, producer, manufacturer, or other supplieravailable for furnishing supplies or services in case of a future national emergency and toachieve industrial mobilization so that at least nine years' worth of replenishments will beavailable in the United States. The Contract will establish and maintain a domestic supply chain
necessary to secure Essential Medicines, including Generic Medicines, and Active
Pharmaceutical Ingredients (API) necessary to treat COVID-19 patients in the short-term as well
as alleviate the long term risk of domestic shortages to help address future pandemic threats. This
will establish a manufacturing capability and capacity to potentially produce raw materials andactive pharmaceutical ingredients and final drug products for critical COVID-19 and otheressential medicines.
B.2

PRICE/COST

This contract contains the price/cost provisions agreed upon by the United States Government
and Plow Corporation (hereinafter, the "Contractor").
B.2.1 Contract Budget Ceiling
The contract has a cost/price ceiling that the Contractor exceeds at its own risk. The
Contractor is responsible for managing its performance in accordance with the final scopeof work and costs/prices incorporated into the contract. The Government is not obligatedto reimburse the Contractor for costs incurred in excess of costs/prices agreed upon attime of award.
Table B.1

Contract Ceiling Amount(without Option Periods)$354,256,000

Page 11 of 59

U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Ph low Corporation, 75A50120000092

B.2.2 Price/Cost Schedule
The following Cost-Plus-Fixed-Fee (CPFF) Contract Line Item Numbers (CLINs) are
included in this contract:
Table B.2

Activity

CLIN
Type

CLIN 0001
BASE

Program Management

CPFF

Base: 5/18/2020 5/17/2024

CLIN 0002
BASE

Provide BARDA MCMs/Essential
Medicines for COVID-19 Response
to Meet Critical Market Demand

CPFF

Base: 5/18/2020 5/17/2021

CLIN 0003
BASE

U.S.-Based Production of Active
Pharmaceutical Ingredients (API)for COVID-19 MCMs/Essential
Medicines in Shortage

CPFF

Base: 5/18/2020 5/17/2022

CLIN 0004
BASE

Establish MCM/Essential Medicine
Strategic Active Pharmaceutical
Ingredient Reserve (SAPIR) Facility
for USGCPFF

Base: 5/18/2020 5/17/2024

CLIN 0005
BASE

Establish a U.S.-Based, End-to End,
Advanced Manufacturing
Capability for BARDA
MCMs/Essential Medicines, andtheir Ingredients

CPFF

Base: 5/18/2020 5/17/2024

CLIN

Fee
(MO

Total Costs
Not to ExceedPOP

Total Base CLINS:$354,256,000.00

CPFF

Option year 1:
5/18/2024 -5/17/2025(b)(4)

CLIN 0007
OPTION PERIOD 1

CPFF

Option year 1:
5/18/2024 -5/17/2025

CLIN 0008
OPTION PERIOD 1

CPFF

Option year 1:
5/18/2024 - 5/17/2025

CLIN 0009
OPTION PERIOD 2

CPFF

Option year 2:
5/18/2025 - 5/17/2026

CLIN 0010
OPTION PERIOD 2

CPFF

Option year 2:
5/18/2025-5/17/2026

CLIN 0011
OPTION PERIOD 2

CPFF

Option year 2:
5/18/2025-5/17/2026

CLIN 0006
OPTION PERIOD 1(b)(4)

Page 12 of 59

U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Ph low Corporation, 75A50120000092(b)(4)
CLIN 0012
OPTION PERIOD 3

CPFF

CLIN 0013
OPTION PERIOD 3

CPFF

Option year 3:
5/18/2026 -5/17/2027

CLIN 0014
OPTION PERIOD 3

CPFF

Option year 3:
5/18/2026 -5/17/2027

CLIN 0015
OPTION PERIOD 4

CPFF

Option year 4:
5/18/2027 -5/17/2028

CLIN 0016
OPTION PERIOD 4

CPFF

Option year 4:
5/18/2027 -5/17/2028

CLIN 0017
OPTION PERIOD 4

CPFF

Option year 4:
5/18/2027 -5/17/2028

CLIN 0018
OPTION PERIOD 5

CPFF

Option year 5:
5/18/2028 -5/17/2029

CLIN 0019
OPTION PERIOD 5

CPFF

Option year 5:
5/18/2028 -5/17/2029

CLIN 0020
OPTION PERIOD 5

CPFF

Option year 5:
5/18/2028 -5/17/2029

CLIN 0021
OPTION PERIOD 6

CPFF

Option year 6:
5/18/2029 -5/17/2030

CLIN 0022
OPTION PERIOD 6

CPFF

Option year 6:
5/18/2029 -5/17/2030

CLIN 0023
OPTION PERIOD 6

CPFF

Option year 6:
5/18/2029 -5/17/2030(b)(4)

Option year 3:
5/18/2026 -5/17/2027

Total OPTION CLINs:
TOTAL CONTRACT VALUE(incl. potential options):

Page 13 of 59(b)(4)$458,174,247$812,430,247

U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Ph low Corporation, 75A50120000092

B.3

CONTRACT TYPE

This contract consists of the following contract type:•
B.4

Cost-Plus-Fixed-Fee (CPFF)ADVANCE UNDERSTANDINGSThe contract contains advance understandings between the Government and the Contractor.
Specific elements of cost, which normally require prior written approval of the Contracting
Officer before incurrence of the cost, will be included in this Section if the Contracting Officer
has granted his/her approval prior to contract award. Other provisions of this contract
notwithstanding, approval of the following items within the limits set forth is hereby granted
without further authorization from the Contracting Office.
a. Indirect Rates and Ceiling
i. Pending the establishment of final indirect cost rates, which shall be determinedbased on audit of actual costs as provided in Subpart 42.7 of the Federal Acquisition
Regulation, the Contractor shall be reimbursed for allowable indirect costs at theagreed upon provisional billing rates. The Contractor's audited final indirect costs areallowable, to the extent that they do not lead the Contractor to exceed the total
estimated costs for performance of the contract, or the Ceiling Rates establishedunder this contract. The Contractor is also directed to the requirement to provide the
USG with notice, that actual costs are expected to exceed the costs estimates, as
required by 52.232-20(b). The contractor is responsible for tracking all costs duringperformance, including indirect costs, and providing all required notices.
ii. Any costs over and above the established cost ceiling shall not be reimbursed under
this contract or any other Government contract, grant, or cooperative agreement
without prior approval of the Contracting Officer per FAR Clause 52.232-20
Limitation of Cost.
iii. The Government is not obligated to pay any additional amount, should the fmal
indirect cost rates exceed the established ceiling rates of the contract. In the event thatthe final indirect cost rates are less than the negotiated ceiling rates, the Government's
obligation shall be reduced to conform to the lower rate. The negotiated rates will beestablished and negotiated after the contract award.

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U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Phlow Corporation, 75A50120000092

b. Priority Rating
HHS may assign a priority rating to this Contract. The Contracting Officer may
unilaterally modify this contract to add FAR Clause 52.211-15, Defense Priority and
Allocation Requirements (Sep 1990) and assign a Health and Human Services priority
rating under Defense Priorities and Systems Regulation (15 CFR 700).
c. Option Year Terms
Consistent with FAR 17.207 (c)(3), before exercising an option in the "out" years 5
through 10 of the Phlow contract, a determination will be made regarding whether there
is a USG industrial mobilization need for the continuing production and storage of drugs
and drug components and whether the options and estimated costs in the Phlow contract
represent the most advantageous offer to satisfy the agency's continuing need for thoseservices.
d. Pre-Contract Costs
Within the dollar limitation set forth under SECTION B, the Contractor shall be entitled
to reimbursement for costs incurred in an amount not to exceed $15,000,000.00, per the
Advance Agreement between the USG and the Contractor, dated March 21, 2020, which
if incurred after this contract had been entered into, would have been reimbursable under
the provisions of this contract.
e. Non-Personal Services and Inherently Government Functions
1. Pursuant to FAR 37.104, no personal services shall be performed under thiscontract. All work requirements shall flow only from the Contracting Officer's
Representative (COR) to the Contractor's Project Manager. No Contractor
employee will be directly supervised by the Government. All individual employee
assignments, and daily work direction, shall be given by the applicable employeesupervisor. If the Contractor 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.
2. Pursuant to FAR 7.5, the Contractor shall not perform any inherently
governmental functions under this contract. No Contractor employee shall holdhim 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 isacting on behalf of the Government. In all communications with third parties inconnection with this contract, Contractor employees shall identify themselves asContractor employees and specify the name of the company for which they work.
In all communications with other Government contractors in connection with thiscontract, the Contractor employee shall state that they have no authority to in any
way change the contract and that if the other contractor believes thiscommunication to be a direction to change their contract, they should notify theContracting Officer for that contract and not carry out the direction until aclarification has been issued by the Contracting Officer.
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U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Phlow Corporation, 75A50120000092

3. The Contractor shall insure that all its employees working on this contract are
informed of the substance of this article. Nothing in this article shall limit theGovernment's rights in any way under the other provisions of the contract,
including those related to the Government's right to inspect and accept theservices to be performed under this contract. The substance of this article shall be
included in all subcontracts at any tier.
f. Confidential Treatment of Sensitive Information
The Contractor shall guarantee strict confidentiality of the information/data that it isprovided by the Government and designated by BARDA as confidential information
during the performance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the performance of thecontract is of a sensitive nature.
Disclosure of the information/data, in whole or in part, by the Contractor can only bemade after the Contractor receives prior written approval from the Contracting Officer.
Whenever the Contractor is uncertain with regard to the proper handling of
information/data under the contract, the Contractor shall obtain a written determinationfrom the Contracting Officer.
g. Contract Number Designation
On all correspondence submitted under this contract, the Contractor agrees to clearly
identify the contract number that appears on the face page of this contract, as follows:
Contract No. 75A50120000092
h. Manufacturing Standards
The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR 210-211) willbe the standard applied for manufacturing, processing and packing of all productmanufactured through this contract. If at any time during the life of this contract, theContractor fails to comply with cGMP in the manufacturing, processing and packaging ofthese products and such failure results in a material adverse effect on the safety, purity or
potency of these product (a material failure) as identified by CBER and CDER, theContractor 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.
i. Facility Use/AccessIn consideration for funding the proposed construction activities, and capacity andcapability expansion, the Contractor's U.S.-based facilities and entire capacity shallremain operational and accessible to the USG for six (6) years after completion of thecontract's base period. Access shall be provided for purposes of potential additional
development, manufacturing, and storage of essential medicines or APIs.
B.5

PROVISIONS APPLICABLE TO DIRECT COSTS

Page 16 of 59

U.S.-Based Advanced Manufacturing for COVID-19
Essential Medicines and Future Threats
Phlow Corporation, 75A50120000092

B.5.1 This section prohibits or restricts the use of contract funds for the following, unlessotherwise approved in advance by the Contracting Officer. However, the government shallapprove travel between the Contractor(s) site and BARDA, as required to execute thiscontract.
a. Conferences and Meetings.
b. Food for Meals, Light Refreshments, and Beverages.
c. Acquisition, by purchase or lease, of any interest in land or real property.
d. Purchase or lease of any item of general-purpose office furniture or office equipment
regardless of dollar value. (General purpose equipment is defined as any items of
personal property which are usable for purposes other than research, such as officeequipment and furnishings, pocket calculators, etc.).
e. Travel to attend general scientific meetings.
f. Foreign travel.
g. Consultant, CPA, attorney costs that are direct will be approved by the CO in
advance.
h. Patient care costs.
i. Accountable Government Property (defined as non-expendable personal property
with an acquisition cost of $1,000 or more) and "sensitive items" (defined as items of
personal property (supplies and equipment that are highly desirable and easily
converted to personal use), regardless of acquisition value.
j. Printing Costs (as defined in the Government Printing and Binding Regulations).
k. Travel Costs.
B.5.2

Contracting Officers Authorization (COA)The Contractor shall submit a Contracting Officer's Authorization (COA) approval request,
to the Contracting Officer, for subcontractors, consultants and equipment purchases proposed
during the course of this contract. COAs for subcontractors and consultant agreements shallbe submitting when the potential subcontract is expected to exceed $250,000. During an
emergency declaration, the $250,000.00 limit will increase to $750,000.00. Sufficient timeshall be provided for the Government to fully assess the transaction proposed. The supporting
documents shall include, but not be limited to:
1. Competition activities, as well as technical and cost/price evaluation activities
performed, in the selection of the subcontractor(s);2. The subcontractor's qualifications/capabilities statement as they pertain to theactivities included in the proposed subcontract;
3. The subcontractor's willingness to perform under the Contractor (i.e. commitment
letters/preliminary agreements), with a list of specific duties included in the proposed
subcontract;
4. The priority that the work will be given and how it will relate to other work;
5. The amount of time and facilities available for the subject requirement; and6. A complete subcontractor cost proposal or quote, in similar format as the Contractor's
cost proposal.

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C.

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1

BACKGROUND AND PURPOSE

The Pandemic and All Hazards Preparedness Act (PAHPA) established BARDA as the focal
point within HHS for the advanced development and acquisition of medical countermeasures toprotect the American civilian population against Chemical, Biological Radiological and Nuclear(CBRN), Influenza and Emerging and Infectious Diseases emergent and naturally occurring
threats to public health. PAHPA was reauthorized in 2013 by the signing of Pandemic and All
Hazards Preparedness Reauthorization Act (PAHPRA). BARDA's mission is to develop andprocure needed medical countermeasures, including vaccines, therapeutics, diagnostics, and nonpharmaceutical countermeasures, against a broad array of public health threats, whether naturalor intentional in origin.
During this current era of the COVID-19 National Pandemic, there is expectation that the
number of hospitalizations will surpass the number of beds available in the US. From the
Washington Post news article on March 15, 2020,"The U.S. Department of Health and Human
Services estimates a pandemic influenza, such as the one that hit the United States in 1957,
would result in 38 million needing medical care, 1 million needing hospitalization and 200,000
needing to be in intensive care. In a severe scenario, such as in the 1918 influenza epidemic, thenumbers would go up to 9.6 million hospitalizations and 2.9 million needing intensive care. The
United States, in comparison, has only about 924,107 hospital beds and 97,776 intensive carebeds, according to a 2018 American Hospital Association survey." The impact of full hospitals
is that the gaps and concerns with national supply of essential medicines are further amplified
and have become more critical. Prolonged shortages of important medicines are increasing in the
U.S., with more than 200 drugs already in short supply. There is a substantial lack of API
manufacturing capacity and infrastructure in the U.S. focused on essential medicines, especiallycritical generics. Although the exact reliance on foreign sources for our generic medicine supply
is unknown, some estimates include greater than 95% of Generic Chemical Precursors, 80% ofGeneric Active Pharmaceutical Ingredients and 40% of Finished Generic Dosage Forms are
sourced from foreign countries, including primarily from China. This presents substantial
national health supply risks and security challenges. This has been exemplified during thepresent COVID-19 pandemic where India has already stopped the export of at least 26 APIs andmedicines and China sources have threatened to stop exports of key medicines that would be
used to treat COVID-19 patients. Countries are locking down borders, and the threat to ourglobal supply chain is real.
As the U.S. faces the threat of the novel coronavirus (COVID-19), it is essential that anuninterrupted supply of fully domestic-made generic life-saving medicines are available toensure the nation's health security.
The initial focus of the agreement will be establishing a never-done-before program where
essential medicines that are already on the FDA drug shortage list are manufactured and
immediately supplied to health care systems in urgent need of these medicines, particularly due
to the current COVED-19 national pandemic.
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1Although the proposed contract with Contractor will initially

focus on the immediate use of existing inventory of generic essential medicines, it will also allow
BARDA to review the stores of other generic medicines that may be needed to support COV1D19 hospitalized patients. Following review, those predetermined products selected in the current
Contractor's proposal to be developed may be replaced by other products that are more urgently
needed.
The next program objective will be to use the CM technology to develop continuous manufacture
process for APIs small scale and eventually large scale in sufficient quantities to store material ina government owned strategic stockpile. This will be for both APIs and other starting raw
materials that currently are only available through purchasing from suppliers outside of the US.
In order to implement this concept to bring manufacturing domestic, a new hybrid manufacturing
utilized
141111
111M111E111=111continuous manufacturing technologies will be
to manufacture additional APIs.
inally, the Contractor's program shall tech transfer their continuous
manufacturing technology to the Medicines on Demand program within (ASPR Foundry).
C.2

OVERVIEW

Activities that may be supported under this contract include:
a.
b.
c.
d.
e.
f.
8.
C.3

Evaluation, purchasing and distribution of essential medicines generic and/or on
drug shortage list;
Facility design, modification (retrofit/renovation), commissioning andqualification, and facility validation;
Product-dedicated manufacturing equipment;
Generic drug and API process development and manufacturing scale-up
development;
Product lot release assay development and process validation;
Generic medicines and API manufacturing including consistency lots;
Fill/finish capacity evaluation, expansion, and validation.

STATEMENT OF OBJECTIVES

Independently and not as an agent of the Government, the Contractor shall be required to furnish
all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise
provided by the Government, as needed to perform the Scope of Work submitted by theContractor in response the Coronavirus Pandemic and submitted as the "U.S.-Based Advanced
Manufacturing for COVID-19 Essential Medicines and Future Threats" on March 18, 2020. The
program is designed to enhance domestic manufacturing of COVID-19 Essential medicines andAPIs. The following are the overall objectives and are supported by the CLINs described
subsequently:

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a.
b.

Addresses the near term threat of generic drug shortages that are critical for
COVID-19 surge hospitalized patient treatment.
Provides domestic self-sufficiency for manufacturing critical, generic API's andfinished medicines to prevent future shortages.

CLIN structure:a.
CLIN 0001: Program Management
CLIN 0002: Provide BARDA MCMs/Essential Medicines for COVID-19b.
Response to Meet Critical Market Demandc.
CLIN 0003: U.S.-Based Production of Active Pharmaceutical Ingredients (API)for COVID-19 MCMs/Essential Medicines in Shortaged.
CLIN 0004: Establish BARDA MCM/Essential Medicine Strategic Active
Pharmaceutical Ingredient Reserve (SAPIR) Facilitye.
CLIN 0005: Establish a U.S.-Based, End-to-End, Advanced Manufacturing
Capability for BARDA MCMs/Essential Medicines, and their Ingredientsf.
CLINs 0006 through 0023: Optional CLINS1(b)(4)OM)

The following table describes in more detail the scope of these CLINS.
Table C.1

CLIN

Activity
Program Management

CLIN 0001

Key Deliverables• PM designated.
• Reports submitted to PO/CO. Example: monthly technical progress
reports, annual technical progress report, and biweekly meeting minutes.
(b)(4)

CLIN 0002

CLIN 0003

CLIN 0004

Provide BARDA
MCMs/Essential Medicines
for COVID-19 Response to
Meet Critical Market
DemandU.S.-Based Production of
Active Pharmaceutical
Ingredients (API) for
COVID19 MCMs/Essential
Medicines in Shortage

Establish MCM/Essential
Medicine Strategic Active• Immediate availability ol(b)(4)
IMCMs/Essential Medicinesw•thin 14 days of award to support the COVID-19 Response, ramping up
enough surge capacity to treat up to 1 million patients within 6 months• Availability ofl(b)(4)
r4CMs/Essential Medicines
within 4 weeks of award s, ramping up enough surge capacity to treat up
to 1 million patients within 6 months• Securi €1(b)(4)
additional MCMs/Essential Medicines as requested by the USG• Availability of a supply of 1(13 )(4)
MCMs/Essential Medicines to support the COVID-19 Response within 6months• Ability to rapidly manufacture, provided regulatory relief is granted,
additional COVID-19 MCMs/essential medicine API needed for the
COVID-19 response
Operationalizing the Nation's First Strategic Active Pharmaceutical
Ingredient Reserve (SAPIR) Facility
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Pharmaceutical IngredientReserve (SAPIR) Facility for
USG
Establish a U.S.-Based, Endto End, Advanced
Manufacturing Capability
for BARDA MCMs/Essential
Medicines, and their
Ingredients

Development of the U.S. - Based, Advanced Manufacturing Infrastructurel(b)(4)
ncluding:(WM• Initializing continuous manufacturing process development of key
MCMs/Essential Medicines in shortage Ib)(4)
IthVA%b)(4)CLIN 0005(b)(4)OPTIONPERIOD
CLINs 0006,
0009, 0012,
0015, 0018,
0021,
OPTIONPERIOD
CLINs 0007,
0010, 0013,
0016, 0019,
0022
OPTIONPERIOD
CLINs 0008,
0011, 0014,
0017, 0020,
0023

Additional detailed information and requirements for the CLINs are as follows:

I. CLIN 0001 Manage the program per USG standards.
a. Maintain a Contractor Work Plan (CWP) that describes the activities to be performedin response to the Request for Proposal (RFP) requirements and a single Gantt chart
to include all activities described in the CWP with a time-phased and task-linked
budget. The level of detail contained in the CWP and the corresponding Gantt chart
shall be sufficient to facilitate management and execution of the contract by the
successful Contractor. This CLIN will also include any program management
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activities related to the sharing of technologies with the ASPR Foundry and otherindustry entities.

2. CL1N 0002 Procure and Manufacture Essential medicines and their ingredients, including
generic medicines in shortage, used for the treatment of COVID-19 hospitalized patientsa. The essential medicines purchased, stored and distributed under this agreement shallbe manufactured under a current establishment and product licensure issued by the
Food and Drug Administration.
b. Contractor shall indicate number below:
i. Name of Medicine:ii. License Number:c. The Contractor agrees to comply with cGMP guidelines (21 CFR Parts 210-211, 600)
for manufacturing, processing and packing of drugs, chemicals, biological, andreagents.
d. The Contractor agrees to advise the HHS CO and COR immediately of any relocationof any of their manufacturing facilities or the relocation of any sub Contractor's
facility, funded under this contract. Contractor also agrees to advise the EMS CO andContracting Officer's Representative immediately if at any time during the life of thecontract, the items under this contract fail to comply with cGMP guidelines and/or thefacility receives a negative FDA Quality Assurance Evaluation (Form 483)
e. Distribution of Medicines: The government may elect to require shipment of theessential medicines, API's or precursor materials to US Government facilities or tostate and local health agencies and/or other providers.
i. The Government may direct the Consortium to destroy all quantities
remaining in storage at a charge to be negotiated between the parties. Suchcharges shall not exceed the actual costs incurred by the Consortium, andagreed to by the Government in advance of the destruction and/or disposal.
ii. The contractor cannot reclaim title to product upon acceptance.
f. MANUFACTURING STANDARDS: The Current Good Manufacturing PracticeRegulations (cGMP) (21 CFR 210-211) will be the standard applied for
manufacturing, processing and packing of this therapeutic product.
i. If at any time during the life of this contract, the Contractor fails to comply
with cGMP in the manufacturing, processing and packaging of thistherapeutic product and such failure results in a material adverse effect on thesafety, purity or potency of this therapeutic product (a material failure) as
identified by CBER and CDER, the Contractor shall have thirty (30) calendar
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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.
3. CLIN 0003 Acquisition of the process knowledge and the technical package from an existing
manufacturer of the APIs from an existing manufacturer, Technology Transfer of Process
and Process Validation to rapidly manufacture APIs for essential APIs of Strategic National
Health Security interest
a. Development of APIs: Develop API's with the objective of identifying theappropriate continuous manufacturing or batch technology to ensure successful scale
up to commercial batches. It is expected that the API maniifartnrina nrrCeSSeS will
be developed, bulk manufactured an. "4)API
manufacturing prioritization and selection may be revised based on HHS/BARDA
recommendations.
b. The Contractor specifically plans to partner with the ASPR Foundry on continuous
process technological innovations that arise from the proposed work previously
described in the technical proposal. The Contractor will provide a technology transfer
process to transfer continuous processes to ASPR Programs focused on building a
Network of Distributed Pharmacies to add Resilience and Redundancy to the Supply
Chain (e.g. The Pharmacy and Medicines on Demand Programs). Specifically,following the completion route scouting and process development activities, theContractor will provide the Foundry with all technical information that has beenobtained for the development of the continuous manufacturing processes for the drug
targets that have been identified in both CLIN0003 and CLIN0005. These efforts will
be performed at no additional cost to the USG as the work involved is already being
done through CLIN0001, CLIN0003 and CLIN0005 where the efforts are included intheir proposed funding request.

4. CLIN 0004 Build facility, store and maintain Strategic Reserve of Essential APIs, Precursor
Chemical Ingredients, and Select Finished Products for National Public Health Security. The
SAPIR will also be managed under an FDA Part 11 compliant validated Warehouse
Management System, under Current Good Manufacturing Practices (CGMP)

a. Draft Manufacturing Facility Plan
Prepare a detailed Manufacturing Facility Plan describing the design, permit
approval, retrofit/renovation, commissioning, qualification and validation of aU.S.-based facility(s) to store the Contractor's proposed SAPIR and Finishedproducts. The Plan(s) shall contain the following elements:
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i) Architectural/structural plans that include concept functional
designs, descriptions, and diagrams of space requirements,
adjacency plans, floor plans, mechanical/electrical/plumbing,equipment layouts, material, product and personnel flows, solid,
liquid contaminated and other waste flows, and an air balance
description or diagram detailing zoning, pressurization, air flows
and air quality classification.
ii) Process and building/mechanical engineering including energybalances, utility flow diagrams, automation plan, equipment lists
and a preliminary layout.
iii) A proposed retrofit/renovation schedule including permitting,installation, commissioning and installation/ operational/
performance qualification and a risk mitigation analysis.
iv) A description of the warehouse facility quality assurance andregulatory acceptance including quality systems, the validation
master plan (VMP), and regulatory milestones towards facility
approval as a cGMP storage facility.
v) Provide a comprehensive Business Continuity Plan.
5. CLIN 0005

a. Draft Manufacturing Facility Plan
Prepare a detailed Manufacturing Facility Plan describing the design, permit
approval, retrofit/renovation, commissioning, qualification and validation of aU.S.-based facility(s) to produce the Contractor's proposed APIs. The Plan(s)shall contain the following elements:i) Architectural/structural plans that include concept functional
designs, descriptions, and diagrams of space requirements,
adjacency plans, floor plans, mechanical/electrical/plumbing,equipment layouts, material, product and personnel flows, solid,
liquid contaminated and other waste flows, and an air balance
description or diagram detailing zoning, pressurization, air flows
and air quality classification.
ii) Process and building/mechanical engineering including energybalances, utility flow diagrams, automation plan, equipment lists
and a preliminary layout.
iii) A proposed retrofit/renovation schedule including permitting,installation, commissioning andinstallation/operational/performance qualification and a risk
mitigation analysis.

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iv) A description of the manufacturing facility quality assurance andregulatory acceptance including quality systems, tech transfer plan,
the validation master plan (VMP), and regulatory milestones
towards facility approval.
v) Provide a comprehensive Business Continuity Plan.
b) Draft Facility Operation Feasibility Plani) Prepare an operational plan to manufacture the API's that includes:
1.
Detailed process descriptions, including a summaryof process data that describes the yield and purification
efficiencies of key process steps.
2.
Integration plans that outlines the addition of
new/retrofitted facility(s) within the Contractor's productfranchise.
3.
Comparison of process data that describes thesignificance of process scale-up and strain variability on
production capacity.
4.
Proposed production schedules including detailed
timelines for each production step from accessibility API
manufacturing process through development, and scale up to
full scale mfg.
5.
Detailed bulk upstream, bulk downstream,
formulation, fill, and finish manufacturing capacity analysis
for each API.
Operational cost structure for API lot production
6.
that includes the anticipated cost breakdown for a specified
quantity (ie kg or ton) of the finished product.
7.
Description of ongoing and/or anticipated processoptimization activities.
8.
Dose calculations and contingency plans to address
the need for higher dosages of the active product ingredient.
9.Pre-pandemic facility management plans including apandemic preparedness plan.
Pandemic facility management plans including
10.
change procedures to pandemic operations in a declared
emergency.
c) Draft Security Plan
i. The Contractor shall submit a Draft Security Plan addressing Security ofContract Operations. The plan shall include, at a minimum:ii. Personnel Security Policies and Procedures including, but not limited to:
Recruitment of new employees; Interview process; Personnel backgroundchecks; Suitability/adjudication policy; Access determination; Rules of
behavior/conduct; Termination procedures; Non-disclosure agreements.
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iii. Physical Security Policies and Procedures including, but not limited to:Internal/external access control; Identification/badge requirements;
Facility visitor access; Parking areas and access; Barriers/perimeter
fencing; Shipping, receiving and transport (on and off-site); Security
lighting; Restricted areas; Signage; Intrusion detection systems; Closed
circuit television; Other control measures.
iv. General Information Security Policies and Procedures including, but notlimited to: Identification of sensitive information; Access
control/determination; Secured storage infrastructure; Document control;
Retention/destruction requirements.
v. Information Technology Security Policies and Procedures including, but
not limited to: Intrusion detection and prevention systems; Encryption
systems; Identification of sensitive information/media; Passwords;
Removable media; Laptop policy; Media access control/determination;
Secure storage; System document control; System backup; System disasterrecovery.
vi. The following instruction/intent shall be incorporated in the Draft Security
Plan: Security Reporting Requirement - Violations of established security
protocols shall be reported to the Contracting Officer (CO) and Project
Officer (PO) upon discovery. The Contractor will investigate violations todetermine the cause, extent, loss or compromise of sensitive program
information, and corrective actions taken to prevent future violations.
BARDA will determine if the severity of the violation requires further
U.S. Government intervention.
d) Occupancy and Retrofit/Renovation Close-Out
i. Following the successful completion of facility commissioning andvalidation, and the product/process consistency/validation campaign,
the Contractor shall submit a certificate of occupancy and a final
retrofit/renovation technical close-out report for these activities.
e) As mentioned in CLIN0003 and repeated here, the Contractor specificallyplans to partner with the ASPR Foundry on continuous process technologicalinnovations that arise from the proposed work previously described in thetechnical proposal. The Contractor will provide a technology transfer process
to transfer continuous processes to ASPR Programs focused on building a
Network of Distributed Pharmacies to add Resilience and Redundancy to the
Supply Chain (e.g. The Pharmacy and Medicines on Demand Programs).
Specifically, following the completion route scouting and processdevelopment activities, the Contractor will provide the Foundry with alltechnical information that has been obtained for the development of the
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continuous manufacturing processes for the drug targets that have been
identified in both CLIN0003 and CLIN0005. These efforts will be performedat no additional cost to the USG as the work involved is already being done
through CLIN0001, CL1N0003 and CLIN0005 where the efforts are includedin their proposed funding request.

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C.4

RETROFIT/RENOVATION — GENERAL
C.4.1

The General Contractor/Subcontractor (GC) proposed by the Contractor, for the
retrofit portion of the anticipated contract, shall comply with the current edition of
all applicable practices, codes, methods and standards as prepared by technicalsocieties and associations, and other applicable laws, statues, ordinances, rules
and regulations. In case of conflict between codes and standards of theorganizations, the more stringent regulations shall govern.

C.4.2 The GC shall provide all labor, materials, equipment, tools, supplies, supervision,and general retrofit/renovation services for the retrofit portion of the anticipatedcontract. The GC shall accomplish the retrofit objectives as described in theContractor-proposed basis of design, as well as the detailed design plan, drawings
and specifications developed during the design stage of the contract.
C.5

EARNED VALUE MANAGEMENT (EVM) SYSTEM REQUIREMENTS

The Contractor shall use an Earned Value Management (EVM) System for all retrofit and new
construction activities of the anticipated requirement, that is consistent with the "7 Principles ofEarned Value Management Tier 2 System Implantation Intent Guide" attached to this contract.
Alternative systems may be submitted to the Contracting Officer for consideration and approval.
C.6

PERSON-IN-PLANT

With seven (7) days advance notice to the Contractor in writing from the Contracting Officer, theGovernment may place a man-in-plant in the Contractor's facility, who shall be subject to theContractor's policies and procedures regarding security and facility access at all times while in
the Contractor's facility.
C.7

SECURITY REQUIREMENTS

Provide appropriate plans that demonstrate how the Contractor will meet and adhere to thesecurity requirements outlined in attachment labeled Appendix D: BARDA Security
Requirements.
C.8

PROGRAM MANAGEMENT
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The overall management, integration and coordination of all contract activities, including atechnical and administrative infrastructure to ensure the efficient planning, initiation,
implementation, and direction of all contract activities. The Contractor shall provide for thefollowing program management activities as outlined below:a.
A listing of employees and subcontractors required to complete the objectives,
including labor categories and descriptions, hourly rates, and estimated labor hours.
Positions shall include, but are not limited to the following Program Manager, Quality
Control and Inspection staff, Support Staff.
b.
Program Director (PD)Responsible for project management, communication, tracking, monitoring and reportingon status and progress, and modification to the project requirements and timelines,
including projects undertaken by subcontractors. The contract deliverables list in Section
F identifies all contract deliverables and reporting requirements for this contract.
Project Managers (PM)c.
Responsible for monitoring and tracking day-to-day progress and timelines, coordinating
communication, project activities, costs incurred and other program management duties.
Administrative and Legald.
Will provide development of compliant subcontractors (if applicable), consulting, andother legal agreements, and ensure timely acquisition of all proprietary rights, including
IP rights, and reporting all inventions made in the performance of the project.
Additionally, administrative staff with responsibility for financial management andreporting on all activities conducted by the Contractor and any subcontractors.
C.9

REPORTING REQUIREMENTS

See Section F for specific reporting requirements.
Performance of the contract will be monitored by the Contracting Officer (C0)/Contracting
Officer's Representative (COR) on a regular basis. The CO will be responsible for inspection
and acceptance of deliverables and services. Monitoring of the contract will be based on periodic
reporting by the Contractor.
C.10 SITE VISITS AND INSPECTIONSAt the discretion of the Government and independent of activities conducted by the Contractor,
with five (5) business days' notice to the Contractor, the Government reserves the right toconduct site visits and inspections on an as needed basis. DCMA/BARDA reserves the right toconduct unannounced site visit inspections in circumstances where safety concerns are involved.

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Contractor shall accommodate periodic or ad hoc site visits by the Government. If theGovernment, the Contractor, or other parties identify any issues during an audit, the Contractor
shall capture the issues, identify potential solutions, and provide a report to the Government.

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SECTION D — PACKAGING, MARKING AND SHIPPING
Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to theGovernment under this contract (including invoices) shall be made by first class mail, overnight
carrier, or email as described in Section F.
All deliverables required under this contract shall be packaged, marked and shipped inaccordance with Government specifications. At a minimum, all deliverables shall be marked
with the contract number and Contractor name. The Contractor shall guarantee that all requiredmaterials shall be delivered in immediate usable and acceptable condition.

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SECTION E — INSPECTION AND ACCEPTANCE
1. The Contracting Officer or the duly authorized representative will perform inspection andacceptance of materials and services to be provided.
2. For the purpose of this SECTION, the Contracting Officer's Representative is theauthorized representative of the Contracting Officer.
3. Inspection and acceptance will be performed at:
Department of Health and Human Services (DHHS)
Assistant Secretary for Preparedness and Response (ASPR)
Biomedical Research and Development Authority (BARDA)
O'Neill House Office Building, 21l1 Floor
Washington, DC 20515
Acceptance may be presumed unless otherwise indicated in writing by the Contracting
Officer or the duly authorized representative within 30 days of receipt. Inspection andacceptance of drug product may be performed at the Contractor's and/or Subcontractor's
location, as approved by the Contracting officer or the Contracting Officer's
Representative.
E.1

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if
they were given in full text. Upon request, the Contracting Officer will make their full text
available. Also, the full text of a clause may be accessed electronically at this address:
http://acquisition.gov/far/
The following FAR clauses, pertinent to Section E, are hereby incorporated by reference:
Table D.1

FAR Clause
52.246-3

Title

Aml

Inspection of Supplies — Cost

Date
May 2001

Reimbursement
52.246-5

Inspection of Services — Cost Reimbursement

Apr 1984

E.2
All work under this contract may be subject to inspection and final acceptance by the COor the duly authorized representative of the Government. The Contracting Officer's
Representative (COR) is a duly authorized representative of the Government and is responsible
for the inspection and acceptance of all items/activities to be delivered and or completed under
this contract.

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SECTION F — DELIVERABLES/PERFORMANCE
F.1
Federal Acquisition Regulation Clause Incorporated by ReferenceThis 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 address:
http://acquisition.gov/far/
The following FAR clause, pertinent to Section F, is hereby incorporated by reference:
Table F.1

52.242-15

F.2

Stop-Work Order, Alternate I (Apr 1984)

Aug 1989

PERIOD OF PERFORMANCEThe base period of performance, for CLINs 0001 through 0005 of this contract, is four (4) years,
from May 18, 2020 through May 17, 2024. Each option period, if CLINS are exercised, may
extend the period of performance by one (1) year, to provide the U.S. Government full access to
the Contractor's capacity. Should all options under this contract be exercised (CLINs 0006
through 0023), the period of performance may be ultimately extended to ten (10) years with thecontract end being no later than May 17, 2030.
F.3

DELIVERABLES

The items specified below as described in the REPORTING REQUIREMENTS Article in
SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in
FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984),
and in accordance with the date(s) specified below:
Table F.2
Item

Delivery Method

Description& Addressee(1)

Reporting of Financial Conflict of Interest(2)

Invention Reporting Requirement —Electronically to COPart 94

Electronically to CO

Annually on contract
anniversary dateInvention Reporting Requirement — Final

Electronically to CO

On or before contract
expiration

invention Statement(4)

In accordance with 45 CFR& COR
Annual Utilization Report(3)

Delivery Schedule

Inventory of Government Owned

Electronically to CO

Property& COR

Per Article G.7

Successful performance of the final contract shall be deemed to occur upon performance of thework described in Section C of this RFP, and upon delivery and acceptance of the items
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described in Sections F.4 through F.6, by the Contracting Officer or their duly authorized
representative.
F.4

CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

As applicable under the aforementioned CLINS and BARDA's discretion for frequency of
meetings.
F.4.1 Submission of Contract Deliverables:
Documents shall be delivered electronically via email to the Contracting Officer (CO)and the Contracting Officer's Representative (COR), listed in Section G.1 and G.2. Whenelectronic deliverables are not preferred by the Contracting Officer, deliverables andreports furnished to the Government under the potential resultant contract (including
invoices) shall be addressed as indicated in Section G.3.
F.4.2 Reporting Requirements and Meetings:
The Contractor shall submit, to the CO and the COR, technical progress reports as
identified in the anticipated contract. These reports shall be subject to the technicalinspection and requests for clarification by the COR, and approval by the CO. These
reports shall be brief, factual, and prepared in accordance with the following:
F.4.3 Monthly Progress Reports:
The Contractor shall submit a Monthly Progress Report on the 15th of each month or
earlier, to the COR and CO/CS, summarizing all contractor work performed during theprevious month, and an overall status of the project.
These reports shall include, but shall not be limited to: Contract number and title,
Contractor's name and address, report author, date of submission, period of time being
reported on, breakdown of any/all other direct costs by line item; assessment of technicalprogress, schedule status, travel conducted; and any Contractor concern or problems
encountered and their recommended solutions. This report shall also provide an estimate
of work to be completed and billed in the subsequent invoicing period.
F.4.4 Kick-off Meeting:
The Contractor shall accommodate for a meeting with HHS personnel, to kick-off the
project. The meeting shall be scheduled within fourteen (14) calendar days after contract
award. The Contractor shall keep meeting minutes and forward a finalized copy to theContracting Officer and COR for approval, within five (5) business days of the meetingor as otherwise authorized by the Contracting Officer. Location of the kick-off meeting is
TBD.

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F.4.5 Monthly Meetings (Retrofit & Development):
The Contractor shall plan and execute a monthly meeting, for each, the retrofit portionand the development portion of the contract (i.e. two meetings per month, at bi-weeklyintervals during the retrofit period; once retrofit is complete, one monthly meeting forongoing development updates). The meetings shall include the onsite Program Manager,
Retrofit/Renovation Manager, COR, Contracting Officer/Specialist and any otherpertinent personnel, unless otherwise directed by the COR and CO. The Contractor shallsubmit a meeting agenda, prior to the meeting that shall include, but not be limited to, thefollowing items:•••

Contract administration and funding
Detailed current work status (retrofit and development, as applicable)
Contractor general issues/concerns

The Contractor shall keep meeting minutes and forward a finalized copy to theContracting Officer and COR for approval, within three (3) business days of the meetingor as otherwise authorized by the Contracting Officer.
F.4.6 Quarterly Site Visits:
The Contractor shall accommodate for quarterly site visits by the USG. The Contractor
shall submit a meeting agenda, at least five (5) business days prior to the meeting, for the
USG's input. The Contractor shall keep meeting minutes and forward a finalized copy to
the Contracting Officer and COR for approval within five (5) business days after eachsite visit, or as otherwise authorized by the Contracting Officer.
F.4.7 Ad hoc Site Visits / BARDA Audits:
The Contractor shall accommodate for periodic site visits by the USG on an ad hoc basis.
The Contractor shall keep meeting minutes and forward a finalized copy to theContracting Officer and COR for approval within five (5) business days after each site
visit, or as otherwise authorized by the Contracting Officer. If the Government, theContractor, or other party identifies any issues during an audit, the Contractor shalldocument the finding(s), identify potential solutions, and provide a report to the COR and
CO detailing the finding(s) and proposed corrective action(s) within 10 business days of
the audit. The COR and CO will review the report and provide a response to theContractor with 10 business days. Once corrective action is completed, the Contractor
will provide a final report to COR and CO.

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F.5

OTHER REPORTING REQUIREMENTS/DELIVERABLES
F.5.1 Risk Management Plan:
The Contractor shall develop a risk management plan within ninety (90) calendar days ofcontract award, highlighting potential problems and/or issues that may arise during thelife of the contract, their impact on cost, schedule and performance, and appropriate
remediation plans. The plan shall clearly identify the applicability of each potential risk,
and how it could directly impact the retrofit and the development portions of the contract.
This plan should reference relevant WBS elements where appropriate. Updates to thisplan shall be included every three months (quarterly) in the monthly Project Status
Report.
F.5.2 Final Retrofit/Renovation Report & Certificate of Occupancy:
The Contractor shall submit a Final Retrofit/Renovation Report, that shall include, but
not be limited to, a summary of all retrofit/renovation activities performed during thebase period of performance, details of the increased capacity and capabilities resulting
from the retrofit, and an accounting of any equipment/materials procured, operations,maintenance security, safety, insurances, and warranties under the Contract. In addition,
the Certificate of Occupancy shall be submitted within ten (10) business days after
receipt by the Contractor or with the Final Retrofit/Renovation Report, whichever comes
first.
F.5.3 Draft Final and Final Progress Report:
These reports are to include a summation of the work performed and results obtained forexecution of various studies and/or technical work packages during the entire contract
period of performance. This report shall be in sufficient detail to describe
comprehensively the results achieved. The Draft Final Progress Report shall be due fortyfive (45) calendar days prior to the expiration date of the contract and the Final Progress
Report shall be due no later than thirty (30) calendar days following the expiration date of
the contract.
F.5.4 Reporting Interactions with the FDA:
See section H for requirements on reporting/documenting interactions with the FDA
within five (5) business days of meeting with the FDA.
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F.5.5 Incident Reporting:Contractor shall document all critical programmatic concerns, risks, or potential risks, aswell as accidents and safety violations, and communicate to the COR and CO within
forty-eight (48) hours of the activity or incident (within 24 hours for a security
activity/incident). Further updates shall be due to the COR and CO within forty-eight (48)hours, if additional issues arise. The Contractor shall submit a Corrective Action Plan
within five (5) business days, if deemed necessary by either party, to address thecircumstances. If corrective action is deemed necessary, the Contractor must address its
considerations of concerns raised by the Government. All incident communications shallbe documented in writing via e-mail. Telephone notifications will be acceptable during
severe emergencies, followed by written correspondence.
F.5.6 Standard Operating Procedures:
The Contractor shall make their own internal Standard Operating Procedures (SOPs) and,to the extent possible, their Subcontractors' SOPs available for review by theGovernment, upon request from the COR or CO. SOPs within five (5) business days andmay be provided electronically.
F.5.7 Manufacturing Campaign Reports:
Contractor shall provide Manufacturing Campaign Reports to the COR and CO, forreview and comment. The Government reserves the right to request unredacted
Manufacturing Campaign Reports for distribution within the USG. The Contractor shallsubmit said reports at least fifteen (15) business days prior to any FDA submission. If
corrective action is recommended, the Contractor must address in writing, all concerns
raised by the COR and CO. The Contractor shall take the Government's concerns andrecommendations into consideration, when revising Manufacturing Campaign Reports,prior to FDA submission. Final FDA submissions shall be provided to the COR and CO
concurrently, or no later than five (5) business day after submission to the FDA.
F.5.8 Quality Assurance (QA) Audit Reports for Subcontractor Audits / Site Visits:
The Government reserves the right to participate in QA audits. The Contractor shallnotify the COR and CO, 10 days in advance of an upcoming, ongoing or recent audit/site
visit of Subcontractor(s), as part of ongoing communications. Upon completion of theaudit/site visit, the Contractor shall provide a report capturing the findings, results andnext steps in proceeding with the Subcontractor. If action is requested of a Subcontractor,
detailed concerns for addressing areas of non-conformance to FDA regulations for GLP,
GMP, or GCP guidelines, as identified in the audit report, must be provided to the COR
and CO. The Contractor shall provide responses from the Subcontractor, to addressconcerns and plans for corrective action execution. The report shall be provided to the
COR and CO within 5 business days of report completion. If corrective action isrecommended, the Contractor must address, in writing, concerns raised by the COR andCO.
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F.5.9 Raw Data or Data Analysis / Product Transition Report:
Upon request by the Government, the Contractor shall provide raw data or data analysis.
The Contractor shall provide a Product Transition Strategy to support transition of the
product(s), ninety 90 days prior to the end of the (base/option) POP.
F.5.10 Draft and Final Validation Protocols:
The Contractor shall provide all Draft and Final Validation Protocols for API
manufacturing to the Government for evaluation. The CO and COR reserve the right torequest unredacted Validation Protocols, within the period of performance, for
distribution within the USG. The Contractor shall submit all proposed Validation
protocols to the COR and CO at least ten (10) business days prior to the validation startdate. If corrective action is required before study execution, the Contractor shall addressin writing, to the satisfaction of the Government, all concerns raised by BARDA, andprovide the COR and CO a revised Validation Protocol that addresses the Government's
comments and requested changes. The Contractor shall not proceed with any Validation
protocol until the Contractor has provided BARDA with a final Validation Protocol andthe CO provides approval. Once the validation protocols have been executed, the fmal
validation reports will be made available to the USG and provided with 60 days of
execution completion.
F.5.11 Supply Chain Resiliency Plan:
The partner contractor shall have a comprehensive Supply Chain Resiliency Program thatprovides for identification and reporting of critical components associated with the securesupply of drug substance, drug product, medical device components and work-in-process
through to finished goods. A critical component is any material that is essential to the
product or the manufacturing process associated with that product. Included in thedefinition are consumables and disposables associated with manufacturing. NOT
included in the definition are facility and capital equipment.
Consideration of critical components includes the evaluation and potential impact of raw
materials, excipients, active ingredients, substances, pieces, parts, software, firmware,labeling, assembly, testing, analytical and environmental componentry, reagents, orutility materials which are used in the manufacturing of a drug, cell banks, seed stocks,
devices and key processing components and equipment. A clear example of a criticalcomponent is one where a sole supplier is utilized.
Identification of key equipment suppliers and their locations, local resources and theassociated planning and control processes at the time of award is important to the securityof the medical countermeasure supply chain. These processes shall address planning andscheduling for active pharmaceutical ingredients, upstream, downstream, component
assembly, finished drug product and delivery events as necessary for the delivery of
product. Where multi-site manufacturing is integral to the delivery of contractual
materials, it should be included as part of the planning and scheduling process.
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Communication for these requirements shall be updated as part of an annual review, or asnecessary, as part of regular contractual communications.
As part of the contractor's Supply Chain Resiliency Program, the partner, Contract
Manufacturing Organization CMO/Contract Development Manufacturing Organization(CDMO), or Third Part Logistics (3PL) shall include a production plan that demonstrates
how they will adhere to deliveries at the time of the contract award for review andapproval by BARDA.
The focus on the aspects of resiliency shall be on critical components and aspects ofcomplying with the contractual delivery schedule. Delivery methods shall be addressed,
inclusive of items that are foreign-sourced, both high and low volume, which would
significantly affect throughput and adherence to the contractually agreed deliveries.
For upstream and downstream processing, both single-use and re-usable in-place
processing equipment, and manufacturing disposables also shall be addressed. For
finished goods, the inspection, labeling, packaging, and associated machinery shall be
addressed taking into account capacity capabilities. The contractor for medical devices
shall address consumable supplies, the sourcing thereof and the ability to identify
constraining manufacturing activities and the planned timing of resolution.
The partner contractor shall communicate the methodology for inventory control,
production planning, scheduling processes and ordering mechanisms, as part of thoseagreed deliveries. For critical items these processes should provide visibility for key
items over an adequate planning horizon that ensures effective control of the establishedsupply chain for contractual deliveries. Production rates and lead times shall be
understood and communicated to the HHS/ASPR/BARDA Contracting Officer or theContracting Officer's Representative as necessary.
Production throughput critical constraints should be well understood by activity and by
design, and communicated to contractual personnel. As necessary, communication should
focus on identification, exploitation, elevation, and secondary constraints of throughput,
as appropriate.
Reports for critical items may be summarized with the following template:
CriticalMaterial
Name

Vendor

Supplier,
Manufacturing /Distribution Locationi

Supplier
Lead Time

Shelf Life

Transportation /Shipping
restrictions

F.5.12 Miscellaneous Technical Documents:
Upon request by the Contracting Officer, the Contractor and their subcontractors shallprovide the USG with deliverables from contract funded activities, including but notlimited to the following when requested by BARDA within five (5) business days fromthe request:••

Process Development Reports;
Assay Qualification Plan/Report;
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•
•
•
•
•
•
•
•
•
•
•
•
•

Assay Validation Plan/Report;
Assay Technology Transfer Report;
Batch Records;
SOPs or test method procedures;
Master Production Records;
Release testing laboratory records,
Certificate of Analysis;
Environmental monitoring tests records and results
Utility testing and maintenance records
Clinical and/or Nonclinical Studies Data/Reports;
Animal Model or Other Technology Transfer Package;
Regulatory documentation as required by HHS.
Purchasing agreements and invoices

The CO and COR reserve the right to request unredacted copies of technical documents,
during the period of performance, for distribution within the Government. Documents
shall be provided within ten (10) days after CO issues the request. The Contractor may
arrange for additional time if deemed necessary, and agreed to by the CO.
F.5.13 Publications and Presentations:
Any manuscript or scientific meeting abstract containing data generated under thiscontract must be submitted to COR for review prior to submission. Reports shall be due
within thirty (30) calendar days for manuscripts and fifteen (15) calendar days for
abstracts. The Contractor must address in writing all concerns raised by the COR and CO
in writing. Final publications shall be submitted to the COR and CO concurrently or nolater than one (1) calendar day of its submission.
F.5.14 Press Releases:
The Contractor agrees to accurately and factually represent the work conducted under thiscontract in all press releases. The Contractor shall ensure the Contracting Officer andContracting Officer's Representative have received and approved an advanced copy of
any press release no less than five (5) business days prior to the issuance of any potential
press release.

F. 6

DELIVERY SCHEDULE:
Table F.3
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No.

Deliverable

FormatDelivery Date

1

Kick-off Meeting

N/A

Within 14 calendar days after
award.

2

Risk Management Plan

Electronic copy

3Monthly Reports

Electronic copy

Within 90 calendar days after
award.
._L -th day of each month

4

Monthly Meetings

Teleconference

Within 5 days of Monthly
Report submission.

5

Quarterly Site Visits

Site visit

To be scheduled incoordination with the USG.

6

Ad hoc Site Visits

Site visit

To be scheduled incoordination with the USG.

7

Final Contractor DefinedWork Plan

Electronic copy

3 months after contract
award

8

Final Manufacturing
Facility Plan

Electronic copy

6 months after contract
initiation

9

Final Facility Operation
Feasibility Plan

Electronic copy

9 months after contract
initiation

10

Security Plan

Electronic copy

9 months after contract
initiation

11

Final Retrofit/Renovation
Report1 hard copy andelectronic copy

12

Certificate/Permit(s) of
Occupancy

1 hard copy andelectronic copy

Draft: 60 calendar days prior
to end of Option Period 1.
Final: 10 calendar days prior
to end of Option Period 1.
Within 10 business days after
receipt by the Contractor.

13

Draft Final and Final
Progress Report

1 hard copy andelectronic copy

Draft: 45 calendar days prior
to contract expiration;
Final: within 30 calendar daysof contract expiration.

15

Manufacturing Campaign
Reports for items covered
in contract CLINSElectronic copy

Draft: 15 days prior to FDA
submission.
Final: concurrently or 1
business day after submission.

16

Raw Data / Data Analysis /Product Transition ReportElectronic copy

90 days prior to contract
expiration.

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18

Draft and Final Report on
Evaluation of Fill Finish
Alternatives

Electronic copy

Draft: 30 days after
completion of analysis
Final: 30 days after receiving
BARDA comments.

19

Supply Chain Resiliency
Plan

Electronic copy

9 months after contract
initiation.

20

Commissioning andValidation Plan

Electronic copy

Draft: within 15 months ofcontract award.
Final: at least 60 days prior tofacility turnover.

21

Pandemic Readiness
Operational ReportElectronic copy

Minimum annually, maximum
quarterly, during'Sustainment' option periods,
starting with Option Pd. 1.

22

Sustainability Costs ReportElectronic copy

Annually during `Sustainment'
option periods, starting with
Option Pd. 1.

23

Final Technical Proposal
Revision

Electronic copy

24

Final Business Proposal
Revision

Electronic copy

Within 30 days of contract
award- to include all
negotiated changes andresponses to USG questions
Within 30 days of contract
award- to include all
negotiated changes andresponses to USG questions

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SECTION G — CONTRACT ADMINISTRATION DATA
G.1

CONTRACTING OFFICER

The Contracting Officer (CO) 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 anychanges to the terms, conditions, general provisions or other stipulations of this Contract.
The CO is the only individual with authority to act as agent of the Government under thisContract, with authority to (1) direct or negotiate any changes in the statement of work, (2)modify or extend the period of performance, (3) authorize reimbursement to the Contractor for
any costs incurred during the performance of this Contract and/or (5) otherwise change any terms
and conditions of this Contract.
No information, other than that which may be contained in an authorized modification to thiscontract 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.
James Harris
Chief Contracting Officer, DCMA, BARDA(202) 805-3479
james.harris2a,hhs.gov
G.2

CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) and alternate COR will represent theGovernment for the purpose of this contract:
Primary COR:
Arlene Joyner
Branch Chief, PCI Division, BARDA(202) 205-8691
arlene.joyner@hhs.gov
Alternate COR:
Tim Belski
Branch Chief, PCI Division, BARDA(202) 205-4235
Timothy.Belski@hhs.gov
The COR is responsible for: (1) monitoring the Contractor's technical progress, including thesurveillance and assessment of performance and recommending to the Contracting Officerchanges in requirements; (2) interpreting the statement of work and any other technicalperformance requirements; (3) performing technical evaluation as required; (4) performing
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technical inspections and acceptances required by this contract; and (5) assisting in the resolutionof technical problems encountered during performance.
The alternate COR is responsible for carrying out the duties of the COR only in the event that the
COR delegates his/her authority, or can no longer perform his/her duties as assigned.
The Government may unilaterally change the COR designation.
G.3

KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance.
At least 30 days prior to the contractor voluntarily diverting any of the specified individuals toother programs or contracts the Contractor shall notify the Contacting Officer and shall submit ajustification for the diversion or replacement and a request to replace the individual. The request
must identify the proposed replacement and provide an explanation of how the replacement's
skills, experience, and credentials meet or exceed the requirements of the contract (including,when applicable, Human Subjects Testing requirements). If the employee of the contractor is
terminated for cause or separates from the contractor voluntarily with less than thirty days'
notice, the Contractor shall provide the maximum notice practicable under the circumstances.
The Contractor shall not divert, replace, or announce any such change to key personnel without
the written consent of the Contracting Officer. The contract will be modified to add or delete key
personnel as necessary to reflect the agreement of the parties.
The following individual(s) is/are considered to be essential to the work being performed
hereunder:

G.4

INVOICE SUBMISSION
Invoices for payment shall be submitted to the Contracting Officer and Contracting
Officer's Representative, as one (1) hard copy and one (1) electronic copy addressed in
the format indicated below, shall follow the detailed invoicing instructions listed in
Section J, and include an SF-1034.
The electronic version of the invoice can be submitted via e-mail or uploaded throughHHS' eRoom (shared access may be provided to the Contractor after award).
The Government may request additional information (timecards, receipts, etc.) to support
costs claimed in the Contractor's invoices. Incomplete invoices may be suspended by theContracting Officer if the Contractor's claimed costs cannot be substantiated.

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G. 5

DELIVERIESAll deliveries of physical documents shall be addressed in the following format:
Table G.2

UPS/FedEVUSPS_IL

U.S. Department of Health & Human Services
Insert Recipient's Name
HHS/ASPR/BARDA
Insert Office Number — O'Neill House Office Building, 2nd Floor
Washington, DC 20515
Insert Recipient's Telephone Number
G.6

PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESSSUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall makeaccelerated payments to its small business subcontractors under this contract, to the
maximum extent practicable and prior to when such payment is otherwise required under
the applicable contract or subcontract, after receipt of a proper invoice and all otherrequired documentation from the small business subcontractor.
b. The acceleration of payments under this clause does not provide any new rights under the
prompt Payment Act.
c. Include the substance of this clause, include this paragraph c, in all subcontracts withsmall business concerns, including subcontracts with small business concerns for theacquisition of commercial items.
G.7

INDIRECT COST RATES

a. The following provisional rates are established and incorporated into the contract forinterim reimbursement of indirect costs (include specific CLINS or Base period ifneeded) pending the establishment of final indirect cost rates in accordance with FAR
52.216-7. The provisional rates may be revised during contract performance by mutual
agreement of the contracting officer and the contractor at either party's request, toprevent substantial overpayment or underpayment. Use of the provisional rates does notchange any cost ceilings or specific obligations in the contract.

b. The above indirect cost rates are also established as ceiling rates in the contract. The
Government will not be obligated to pay any additional amounts should the final indirect
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than the above established ceiling rates, the negotiated final rates will be reduced toconform to the lower rates.
c. In accordance with FAR Part 52.216-7(d), the contractor shall submit an adequate final
indirect cost rates proposal to the contracting officer within the 6-months period
following the end of its fiscal years during the period of contract performance.
G.8

GOVERNMENT PROPERTY

a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in SECTION I of this contract, the Contractor shall comply with theprovisions of HHS Publication, "HHS Contracting Guide for Contract of Government
Property," which is incorporated into this contract by reference. This document can beaccessed at:
http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf.
Among other issues, this publication provides a summary of the Contractor's
responsibilities regarding purchasing authorizations and inventory and reporting
requirements under the contract.
Requests for information regarding property under this contract should be directed to thefollowing office:Amos Moore
Property Rep.
O'Neil Federal Office Building
BETHESDA MD 20892-7670
Amos.Moore@hhs.gov
b. Notwithstanding the provisions outlined in the HHS Publication, "HHS Contracting
Guide for Contract of Government Property," which is incorporated in this contract inparagraph a. above, the Contractor shall use the form entitled, "Report of Government
Owned, Contractor Held Property" for submitting summary reports required under thiscontract, as directed by the Contracting Officer or his/her designee. This form is included
as an attachment in SECTION J of this contract.

G.9

POST AWARD EVALUATION OF CONTRACTOR PERFORMANCEa. Contractor Performance Evaluations
Interim and Final evaluations of Contractor performance will be prepared in accordancewith FAR Subpart 42.15.
Interim and Final evaluations will be provided to the Contractor as soon as practicable
after completion of the evaluation. The Contractor will be permitted fourteen days toreview the document and to submit additional information or a rebutting statement. If
agreement cannot be reached between the parties, the matter will be referred to anindividual one level above the Contracting Officer, whose decision will be final.
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Copies of the evaluations, Contractor responses, and review comments, if any, will be
retained as part of the contract file, and may be used to support future award decisions.
b. Electronic Access to Contractor Performance Evaluations
Contractors may access evaluations through a secure Web site for review and comment at
the following address: http://www.cpars.gov.

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SECTION H — SPECIAL CONTRACT REQUIREMENTS
H.1

ACKNOWLEDGMENT OF FEDERAL FUNDING

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 partwith Federal money: (1) the percentage of the total costs of the program or project which will befinanced with Federal money; (2) the dollar amount of Federal funds for the project or program;and (3) the percentage and dollar amount of the total costs of the project or program that will befinanced by nongovernmental sources.
H.2

RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unlesssuch network blocks the viewing, downloading, and exchanging of pornography.
11.3

GUN CONTROLThe Contractor shall not use contract funds in whole or in part, to advocate or promote guncontrol.
11.4

INFORMATION SECURITY

a. Baseline Security Requirements
1. Contract Documentation — The Contractor shall use provided templates,
policies, forms and other agency documents provided by the Contracting Officer
and the Contracting Officer's Representative to comply with contract deliverables
as appropriate.
2. Contractor Non-Disclosure Agreement (NDA) — Each Contractor (and/or any
subcontractor) employee having access to non-public government information
under this contract shall complete an appropriate non-disclosure agreement as
applicable. A copy of each signed and witnessed NDA shall be submitted to theContracting Officer (CO) and/or CO Representative (COR) prior to performing
any work under this acquisition.
H.5

INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATORFINANCIAL CONFLICTS OF INTEREST

The Institution (includes any contractor, public or private, excluding a Federal agency) shallcomply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which
promotes objectivity in research by establishing standards to ensure that Investigators (defined as
the program director or principal Investigator and any other person, regardless of title or position,
who is responsible for the design, conduct, or reporting of research funded under BARDA
contracts, or proposed for such funding, which may include, for example, collaborators or
consultants) will not be biased by any Investigator fmancial conflicts of interest. 45 CFR Part 94
is available at the following Web site: https://ecfrio/Title-45/pt45.1.94
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As required by 45 CFR Part 94, the Institution shall, at a minimum:
a. Maintain an up-to-date, written, enforceable policy on financial conflicts of interest thatcomplies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator'sreporting responsibilities regarding disclosure of significant financial interests, and theapplicable regulation, and make such policy available via a publicly accessible Web site,or if none currently exist, available to any requestor within five business days of arequest. A significant financial interest means a financial interest consisting of one ormore of the following interests of the Investigator (and those of the Investigator's spouseand dependent children) that reasonably appears to be related to the Investigator's
institutional responsibilities:
1. With regard to any publicly traded entity, a significant financial interest exists if
the value of any remuneration received from the entity in the twelve months
preceding the disclosure and the value of any equity interest in the entity as of thedate of disclosure, when aggregated, exceeds $5,000. Included are payments andequity interests;
2. With regard to any non-publicly traded entity, a significant financial interest
exists if the value of any remuneration received from the entity in the twelve
months preceding the disclosure, when aggregated, exceeds $5,000, or when theInvestigator (or the Investigator's spouse or dependent children) holds any equity
interest; or
3. Intellectual property rights and interests, upon receipt or income related to suchrights and interest.
Significant financial interests do not include the following:
1. Income from seminars, lectures, or teaching, and service on advisory or review
panels for government agencies, Institutions of higher education, academic
teaching hospitals, medical centers, or research institutes with an Institution ofhigher learning; and2. Income from investment vehicles, such as mutual funds and retirement accounts,
as long as the Investigator does not directly control the investment decisions madein these vehicles.
b. Require each Investigator to complete training regarding the Institution's financial
conflicts of interest policy prior to engaging in research related to any BARDA-funded
contract and at least every four years. The Institution must take reasonable steps [see Part
94.4(c)] to ensure that investigators working as collaborators, consultants or
subcontractors comply with the regulations.
c. Designate an official(s) to solicit and review disclosures of significant financial interestsfrom each Investigator who is planning to participate in, or is participating in, theBARDA-funded research.

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d. Require that each Investigator who is planning to participate in the BARDA-funded
research disclose to the Institution's designated official(s) the Investigator's significant
financial interest (and those of the Investigator's spouse and dependent children) no later
than the date of submission of the Institution's proposal for BARDA-funded research.
Require that each Investigator who is participating in the BARDA-funded research tosubmit an updated disclosure of significant financial interests at least annually, in
accordance with the specific time period prescribed by the Institution during the period of
the award as well as within thirty days of discovering or acquiring a new significant
financial interest.
e. Provide guidelines consistent with the regulations for the designated official(s) todetermine whether an Investigator's significant financial interest is related to BARDAfunded research and, if so related, whether the significant financial interest is a financial
conflict of interest. An Investigator's significant financial interest is related to BARDAfunded research when the Institution, thorough its designated official(s), reasonably
determines that the significant financial interest: Could be affected by the BARDAfunded research; or is in an entity whose financial interest could be affected by the
research. A financial conflict of interest exists when the Institution, through its designatedofficial(s), reasonably determines that the significant financial interest could directly andsignificantly affect the design, conduct, or reporting of the BARDA-funded research.
f. Take such actions as necessary to manage financial conflicts of interest, including any
financial conflicts of a subcontractor Investigator. Management of an identified fmancial
conflict of interest requires development and implementation of a management plan and,if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).
g. Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part
94.5(b).
h. Maintain records relating to all Investigator disclosures of financial interests and theInstitution's review of, and response to, such disclosures, and all actions under theInstitution's policy or retrospective review, if applicable, for at least 3 years from the dateof final payment or, where applicable, for the other time periods specified in 48 CFR Part4, subpart 4.7, Contract Records Retention.
i. Establish adequate enforcement mechanisms and provide for employee sanctions or otheradministrative actions to ensure Investigator compliance as appropriate.
j. Complete the certification in Section K - Representations, Certifications, and Other
Statements of Contractors titled "Certification of Institutional Policy on Financial
Conflicts of Interest".
If the failure of an Institution to comply with an Institution's financial conflicts of interest policy
or a financial conflict of interest management plan appears to have biased the design, conduct, or
reporting of the BARDA-funded research, the Institution must promptly notify the Contracting
Officer of the corrective action taken or to be taken. The Contracting Officer will consider the
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situation and, as necessary, take appropriate action or refer the matter to the Institution forfurther action, which may include directions to the Institution on how to maintain appropriate
objectivity in the BARDA-funded research project.
The Contracting Officer and/or HHS may inquire at any time before, during, or after award into
any Investigator disclosure of financial interests, and the Institution's review of, and response to,such disclosure, regardless of whether the disclosure resulted in the Institution's determination ofa fmancial conflict of interests. The Contracting Officer may require submission of the records orreview them on site. On the basis of this review of records or other information that may beavailable, the Contracting Officer may decide that a particular financial conflict of interest will
bias the objectivity of the BARDA-funded research to such an extent that further corrective
action is needed or that the Institution has not managed the financial conflict of interest inaccordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer
may be necessary until the matter is resolved.
If the Contracting Officer determines that BARDA-funded clinical research, whose purpose is toevaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed,
conducted, or reported by an Investigator with a financial conflict of interest that was not
managed or reported by the Institution, the Institution shall require the Investigator involved todisclose the financial conflict of interest in each public presentation of the results of the researchand to request an addendum to previously published presentations.
H.6

FDA AUDITS

In the event of an FDA inspection which occurs as a result of this contract and for the product, orfor any other FDA inspection that has the reasonable potential to impact the performance of thiscontract, the Contractor shall provide the USG with an exact copy (non-redacted) of the FDA
Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the COR
and CO with copies of the plan for addressing areas of non-conformance to FDA regulations for
GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans
execution and a copy of all final responses to the FDA. The Contractor shall also provide
redacted copies of any FDA audits received from subcontractors that occur as a result of thiscontract or for this product. The Contractor shall make arrangements for BARDA
representative(s) to be present during the final debrief by the regulatory inspector.
(1)

(2)

(3)
(4)

Contractor shall notify CO and COR within 10 business days of a scheduled FDA
audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide
advanced notice.
Contractor shall provide copies of any FDA audit report received fromsubcontractors that occur as a result of this contract or for this product within 5business days of receiving correspondence from the FDA or third party.
Within 10 business days of audit report, Contractor shall provide CO and COR
with a plan for addressing areas of nonconformance, if any are identified.
The final responses to the FDA fmdings shall be submitted on time to meet the
FDA deadline. A copy will be provided to the CO and COR within 3 days ofsubmitting to the FDA.
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H. 7

PUBLICATION AND PUBLICITY

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications andPublicity incorporated by reference in SECTION I of this contract, the Contractor shallacknowledge the support of the Biomedical Advanced Research and Development Authority
whenever publicizing the work under this contract in any media by including an
acknowledgment substantially as follows:"This project has been funded in whole or in part with Federal funds from the Biomedical
Advanced Research and Development Authority (BARDA), Assistant Secretary for
Preparedness and Response (ASPR), Department of Health and Human Services(DHHS), under Contract No. 75A50120D00007"
H.8

REPORTING MATTERS OF FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
HHS 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 website to file acomplaint on-line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
US Department of Health and Human Services
Office of Inspector General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489
Washington, D.C. 20026
11.9 INTERACTIONS WITH REGULATORY AGENCIESThe obligations set forth in this paragraph shall apply to the Contractor and any subcontract at
any tier thereunder.
(a) The Contractor shall prepare and submit initial draft minutes and final accepted minutes of all
formal meetings with U.S. regulatory agencies, to include FDA, to BARDA.
(b) The Contractor shall prepare and submit initial draft minutes and the fmal accepted minutesof all informal meetings with U.S. regulatory agencies, to include FDA, to BARDA. Informal
meetings are defined as scheduled teleconferences with such U.S. regulatory agencies. Updates
from such informal meetings will be shared during monthly or quarterly meetings.
(c) The Contractor shall forward the dates and times of all scheduled meetings with U.S.
regulatory agencies, to include FDA, to BARDA and make arrangements for appropriate
BARDA staff to attend such U.S. regulatory agencies meetings.
(d) The Contractor shall provide BARDA the opportunity to review and comment upon any
documents to be submitted to U.S. regulatory agencies The Contractor shall provide BARDA
with five (5) business days, or such shorter period as may be practicable in time-sensitive
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situations, to review and provide comments to the contractor prior to its submittal to U.S.
regulatory agencies.
(e) The Contractor shall furnish all findings of U.S. regulatory agencies inspections, including
FDA form 482 and 483 inspection notice and observations and Establishment Inspection Reports(EIR) pertinent to the Contract, to BARDA within five (5) business days of receipt.
(f) The Contractor shall notify the USG of all site visits/audits by U.S. regulatory agencies toinclude FDA, within 24 hours of agency personnel's arrival.
(g) The Contractor shall include the USG in all scheduled meetings and teleconferences with
U.S. regulatory agencies.
(h) Contractor is not obligated to notify the USG of non-HHS funded project related meetings.

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11.10. SECURITY
The work to be performed under this Contract will involve access to sensitive Biomedical
Advanced Research and Development Authority [BARDA] program information. Upon contract
award, the Program Protection Officer (PPO) will review the Draft Security Plan (submitted aspart of the Contractor's Technical Proposal) in detail and submit comments within ten (10)business days to the Contracting Officer (CO) to be forwarded to the Contractor. The Contractor
shall review the Draft Security Plan comments, and if changes are required, submit a Final
Security Plan to the U.S. Government within thirty (30) calendar days after receipt of theProgram Protection Officer's (PPO) comments. The Final Security Plan shall include a timeline
for compliance of all the required security measures. Upon completion of initiating all security
measures, the Contractor shall supply to the Contracting Officer a letter certifying compliance tothe elements outlined in the Final Security Plan.
The execution of the work under this Contract shall be in accordance with the approved Final
Security Plan. As outlined above, the content of the Final Security Plan shall be a continuation of
the Draft Security Plan submitted as part of the Contractor's Technical Proposal. The Security
Plan should address facilities providing drug shortage capabilities. Therefore, at a minimum, theFinal Security Plan shall address the following items:
Personnel Security Policies and Procedures including, but not limited to: Recruitment of new
employees; Interview process; Personnel background checks; Suitability/adjudication policy;
Access determination; Rules of behavior/conduct; Termination procedures; Non-disclosureagreements.
Physical Security Policies and Procedures including but not limited to: Internal/external access
control; Identification/badge requirements; Facility visitor access; Parking areas and access;
Barriers/perimeter fencing; Shipping, receiving and transport (on and off-site); Security lighting;Restricted areas; Signage; Intrusion detection systems; Closed circuit television; Other control
measures. Information Security Policies and Procedures including but not limited to:
Identification of sensitive information; Access control/determination; Secured storage
infrastructure; Document control; Retention/destruction requirements.
Information Technology Security Policies and Procedures including but not limited to: Intrusion
detection and prevention systems; Encryption systems; Identification of sensitive
information/media; Passwords; Removable media; Laptop policy; Media access
control/determination; Secure storage; System document control; System backup; System
disaster recovery.
The following instruction/intent shall be incorporated:
Security Reporting Requirement - Violations of established security protocols shall be reported
to the Contracting Officer (CO) and Contracting Officer's Representative (COR) 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.
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Contracting Officer will determine if the severity of the violation requires further U.S.
Government (USG) intervention.
H.11. EPA ENERGY STAR REQUIREMENTS
In compliance with Executive Order 12845 (requiring Agencies to purchase energy efficientcomputer equipment) all microcomputers, including personal computers, monitors, and printersthat are purchased using Government funds in performance of a contract shall be equipped withor meet the energy efficient low-power standby feature as defmed by the EPA Energy Star
program unless the equipment always meets EPA Energy Star efficiency levels. The
microcomputer, as configured with all components, must be Energy Star compliant. This lowpower feature must already be activated when the computer equipment is delivered to the agency
and be of equivalent functionality of similar power managed models. If the equipment will be
used on a local area network, the vendor must provide equipment that is fully compatible with
the network environment. In addition, the equipment will run commercial off-the-shelf software
both before and after recovery from its energy conservation mode.
11.12. Special Clause - Intellectual Property
Execution of this contract will require that the prime contractor (Phlow) providing services to
HHS possess sufficient rights to specific Intellectual Property (IP) required for the development
effort and the services described in this contract. Phlow will be responsible for negotiating any IP
rights between Phlow and its subcontractors or teaming partners and assuring that those IP rights
are consistent with HHS's IP rights in the Federal Acquisition Regulations (FAR) clauses
contained in the prime contract and enable Phlow to perform all services described in the contact.
The contract must reflect the Parties' (HHS and Phlow) rights to all IP developed and/or IP usedin performance of this contract. Prior to execution of this contract, and or anytime throughout its
period of performance, Phlow shall provide the Contracting Officer with a written description of
all IP necessary to develop generic drugs and provide all services in the contract. The
Description must identify the basis for offering HHS less than unlimited rights to any preexisting IP identified in the Description that will be utilized in performance of this contract.
The Description shall also include written verification that Phlow will provide HHS with rights
to any and all IP utilized or developed during performance of this contract as specified under
FAR Clause 52.227-11, FAR Clause 52.227-11 as amended in any applicable subcontract and/or
teaming agreement related to performance of this contract, FAR Clause 52.227-14 (Alt. II Dec.
2007) and FAR Clause 52.227-14 (Alt. II Dec. 2007) as amended in any applicable subcontract
and/or teaming agreement (the "FAR Clauses"). Phlow and Phlow's subcontractors and /or
Phlow's teaming partners will remain free to negotiate any agreement of their own regarding
their use of any of the IP utilized or developed during performance of this contract, so long as thenegotiated agreement complies with the requirements under the FAR Clauses, and the terms
contained in the agreement do not otherwise adversely affect the performance of work under thiscontract. The agreement if applicable shall be furnished to the Contracting Officer within five (5)business days after the agreement is finalized. This contract and any subsequent modifications
will specifically incorporate the FAR Clauses and also FAR Clause 52.227-1 Authorization andConsent (DEC 2007) and FAR Clause 52.227-3 Patent Indemnity (APR 1984).
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11.13 PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYINGACTIVITIES (JUL 1999)
The contractor is hereby notified of the restrictions on the use of HHS funding for lobbying ofFederal, 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 of a Federal contract,
grant, loan, or cooperative agreement from using appropriated funds (other than profits from afederal 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 ofprohibitions against lobbying activities, see FAR Subpart 3.8 — Limitations on the Payment ofFunds to Influence Federal Transactions and FAR Clause 52.203-12 (Sep 2007). In addition, thecurrent HHS 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, forpublicity 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 HHS Appropriations
Act also provides that no part of any appropriation contained in this Act shall be used to pay thesalary or expenses of any contract or grant recipient, or agent acting for such recipient, related toany activity designed to influence legislation or appropriations pending before the Congress, or
any State or Local legislature.

11.14. DISSEMINATION OF INFORMATION
No information related to data obtained under this Contract shall be released or publicizedwithout the prior written consent of the Contracting Officer, whose approval shall not be
unreasonably withheld, conditioned, or delayed, provided that no such consent is required tocomply 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.
11.15. ACCESS AND DISPOSITION OF DATAThe Government shall have physical and electronic access to all documentation and data
generated under this contract, including: all Contractor efforts; Subcontractor efforts;
communications and correspondence with regulatory agencies and bodies to include all audit
observations, inspection reports, and all Contractor commitments and responses. Contractor shallprovide the government with an electronic copy of all correspondence with the FDA related tothis contract and discussed during any routine or adhoc call within five (5) business days ofreceipt. The Government shall have unlimited rights to all animal and human data funded under
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this Contract. The Contractor shall keep copies of all data required by the FDA relevant to thisContract for the time specified by the FDA.
H.16. INCORPORATION OF TECHNICAL PROPOSALThe Contractor's Technical Proposal included in its Proposal dated March 18, 2020 or asrevised by the Final Proposal Revision dated no later than 30 days from date of award, submitted
in response to BAA-18-100-SOL-00003 is hereby incorporated into the Contract by reference.
The Contractor shall perform the work substantially as set forth in the technical proposal. Anyrevisions to the technical proposal that would significantly alter the technical approach must be
approved in writing by the Contracting Officer. Within 30 days after contract award, theContractor is required to deliver to the Contracting Officer a consolidated copy of their fulltechnical proposal. In the event of a conflict between Section C, SOO, and the Contractor's
technical proposal, Section C will take precedence.

H.17. ACKNOWLEDGEMENT OF FEDERAL FUNDING
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 partwith Federal money: (1) the percentage of the total costs of the program or project which will befinanced with Federal money; (2) the dollar amount of Federal funds for the project or program;and (3) the percentage and dollar amount of the total costs of the project or program that will befinanced by non-governmental sources.
H.18. MANUFACTURING STANDARDSThe Current Good Manufacturing Practice (cGMP) regulations (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, and purity of the product (a material failure) as identified by the
FDA, then the Contractor shall have thirty (30) calendar days from the time such material failure
is identified to institute a comprehensive plan and obtain approval by the Contracting Officer tocure such material failure.
H.19. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORISTACTIVITIESThe 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.20. CONTRACTOR PUBLICITY

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Phlow, or any entity or representative acting on behalf of Phlow, may not refer to this contract
or the services furnished pursuant to the provisions of this contract in any news release orcommercial advertising, or in connection with any news release or commercial advertising,
without first obtaining explicit written consent to do so from the Contracting Officer or the
HHS Press Office.
At the time of signature on this contract, Phlow shall provide the name and contact information
for a point of contact for a representative from its Press Office.
Should any reference to this contract be included in any news release or commercial
advertising issued by or on behalf of Phlow without the required written consent, theGovernment will consider the institution of all remedies available under applicable law.

SECTION 1— CONTRACT CLAUSES
I.1

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if
they were given in full text. Upon request, the Contracting Officer will make their full text
available. Also, the full text of a clause may be accessed electronically at this address:
http://acquisition.gov/far/

The following FAR clauses, pertinent to Section I, are hereby incorporated by reference:
Table 1.1

FAR Clause

Title

Date

52.202-1

Definitions

Nov 2013

52.203-3

Gratuities

Apr 1984

52.203-5

Covenant Against Contingent Fees

May 2014

52.203-6

Restrictions on Subcontractor Sales to the Government

Sep 2006

52.203-7

Anti-Kickback Procedures

May 2014

52.203-8

Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

May 2014

52.203-10

Price or Fee Adjustment for Illegal or Improper Activity

May 2014

52.203-12

Limitation on Payments to Influence Certain Federal Transactions

Oct 2010

52.203-13

Contractor Code of Business Ethics and Conduct

Oct 2015

52.203-14

Display of Hotline Poster(s)Oct 2015

52.203-17

Contractor Employee Whistleblower Rights and Requirement To Inform
Employees of Whistle blower Rights
Prohibition on Requiring Certain Internal Confidentiality Agreements orStatements
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

Apr 2014
Jan 2017

52.204-10

Reporting Executive Compensation and First-Tier Subcontract Awards

Oct 2018

52.204-13

System for Award Management MaintenanceOct 2018

52.203-19
52.204-4

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52.204-18

Commercial and Government Entity Code MaintenanceJul 2016

52.204-19

Incorporation by Reference of Representations and Certifications

Dec 2014

52.204-23

Jul 2018

52.209-9

Prohibition on Contracting for Hardware, Software, and Services Developed orProvided by Kaspersky Lab and Other Covered Entities
Protecting the Government's Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment
Updates of Publicly Available Information Regarding Responsibility Matters52.209-10

Prohibition on Contracting with Inverted Domestic Corporations

Nov 2015

52.210-1

Market ResearchApr 2011

52.215-2

Audit and Records-Negotiation

Oct 2010

52.215-8

Order of Precedence - Uniform Contract Format

Oct 1997

52.215-10

Price Reduction for Defective Cost or Pricing Data

Aug 2011

52.215-11

Price Reduction for Defective Certified Cost or Pricing Data-Modifications.

Aug 2011

52.215-12

Subcontractor Certified Cost or Pricing Data

Oct 2010

52.215-13

Subcontractor Certified Cost or Pricing Data-Modifications

Oct 2010

52.215-15

Pension Adjustments and Asset Reversions

Oct 2010

52.215-18

Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other thanPensions
Notification of Ownership Changes

Jul 2005

Oct 2010

52.215-23

Requirements for Certified Cost or Pricing Data and Data Other Than Certified
Cost or Pricing Data -Modifications
Limitations on Pass-Through Charges

52.216-7

Allowable Cost and Payment

Aug 2018

52.216-7

Allowable Cost and Payment, Alternate I (Feb 1997)

Aug 2018

52.216-8

Fixed FeeJun 2011

52.219-8

Utilization of Small Business Concerns

Oct 2018

52.219-9

Small Business Subcontracting Plan

Aug 2018

52.219-16

Liquidated Damages -- Subcontracting Plan

Jan 1999

52.219-28

Post-Award Small Business Program Representation

July 201352.222-1

Notice to the Government of Labor Disputes

Feb 1997

52.222-2

Payment for Overtime Premiums [*$0.00]

July 1990

52.222-3

Convict Labor

Jun200352.222-4

Contract Work Hours and Safety Standards -- Overtime Compensation

May 2018

52.222-6

Construction Wage Rate Requirements

Aug 2018

52.222-7

Withholding of Funds

May 2014

52.222-8

Payrolls and Basic Records

Aug 2018

52.222-9

Apprentices and Trainees

Jul 2005

52.209-6

52.215-19
52.215-21

Oct 2015
Oct 2018

Oct 1997

Oct 2009

52.222-10

Compliance with Copeland Act Requirements

Feb 1988

52.222-11

Subcontracts (Labor Standards)

May 2014

52.222-12

Contract Termination-Debarment

May 2014

52.222-13

Compliance with Construction Wage Rate Requirements and Related
Regulations
Disputes Concerning Labor Standards

May 2014

52.222-14

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52.222-15

Certification of Eligibility

May 2014

52.222-16

Approval of Wage Rates

May 2014

52.222-21

Prohibition of Segregated Facilities

Apr 2015

52.222-26

Equal Opportunity

Sept 201652.222-29

Notification of Visa Denial.

Apr 2015

52.222-37

Employment Reports on VeteransFeb 2016

52.222-40

Notification of Employee Rights Under the National Labor Relations Act

Dec 2010

52.222-50

Combating Trafficking in Persons

Jan 2019

52.222-54

Employment Eligibility Verification

Oct 2015

52.222-55

Minimum Wages Under Executive Order 13658

Dec 2015

52.222-62

Paid Sick Leave Under Executive order 13706

Jan 2017

52.223-6

Drug-Free Workplace

May 2001

52.223-12

Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners

Jun 2016

52.223-18

Encouraging Contractor Policy to Ban Text Messaging While Driving

Aug 2011

52.224-1

Privacy Act Notification

April 1984

52.224-2

Privacy Act

April 1984

52.224-3

Privacy Training

Jan 2017

52.225-1

Buy American - Supplies

May 2014

52.225-13

Restrictions on Certain Foreign Purchases

Jun 2008

52.227-11

Patent Rights-Ownership by the Contractor

May 2014

52.227-14

Rights in Data - General

May 2014

52.227-14

Rights in Data - General, Alternate ll (Dec 2007)

May 2014

52.228-7

Insurance - Liability to Third Persons

Mar 1996

52.228-15

Performance and Payment Bonds -- Construction

Oct 2010

52.230-2

Cost Accounting Standards

Oct 2015

52.230-6

Administration of Cost Accounting Standards

June 201052.232-9

Limitation on Withholding of Payments

Apr 1984

52.232-17

Interest

May 2014

52.232-20

Limitation of Cost

Apr 1984

52.232-23

Assignment of Claims

May 2014

52.232-25

Prompt Payment

Jan 2017

52.232-27

Prompt Payment for Construction Contracts

Jan 2017

52.232-33

Payment by Electronic Funds Transfer--System for Award Management

Oct 2018

52.232-39

Unenforceability of Unauthorized Obligations

Jun 2013

52.232-40

Providing Accelerated Payments to Small Business Subcontractors

Dec 2013

52.233-1

Disputes

May 2014

52.233-3

Protest After Award, Alternate I (Jun 1985)

Aug 1996

52.233-4

Applicable Law for Breach of Contract Claim

Oct 2004

52.236-5

Material and WorkmanshipApr 1984

52.236-7

Permits and Responsibilities

Nov 1991

52.236-18

Work Oversight in Cost-Reimbursement Construction Contracts

Apr 1984

52.236-19

Organization and Direction of the WordApr 1984

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52.242-1

Notice of Intent to Disallow Costs

Apr 1984

52.242-2

Production of Progress Reports

Apr 1991

52.242-3

Penalties for Unallowable Costs

May 2014

52.242-4

Certification of Final Indirect Costs

Jan 1997

52.242-5

Payments to Small Business Subcontractors

Jan 2017

52.242-13

Bankruptcy

Jul 1995

52.243-2

Changes-Cost-Reimbursement, Alternate ll (Apr 1984)

Aug 1987

52.243-2

Changes-Cost-Reimbursement, Alternate III (Apr 1984)

Aug 1987

52.243-2

Changes-Cost-Reimbursement, Alternate V (Apr 1984)

Aug 1987

52.243-6

Change Order Accounting

Apr 1984

52.243-7

Notification of Changes

Jan 2017

52.244-2

Subcontracts, Alternate I (Jun 2007)

Oct 2010

52.244-5Competition in Subcontracting

Dec 1996

52.244-6

Subcontracts for Commercial Items

Jan 2019

52.245-1

Government Property

Jan 2017

52.245-9

Use and Charges

Apr 2012

52.246-3

Cost-Reimbursement Supply Contract

May 2001

52.246-25

Limitation of Liability-Services

Feb 1997

52.248-3

Value Engineering-Construction

Oct 2015

52.249-6

Termination (Cost-Reimbursement)

May 2004

52.249-6

Termination (Cost-Reimbursement), Alternate I (Sep 1996)

May 2004

52.249-14

Excusable Delays

Apr 1984

52.253-1

Computer Generated Forms

Jan 1991

1.2

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)
CLAUSES

Full text of HHSAR clauses may be accessed electronically at this address:
http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar
Table I.Z
HHSAR
ClauseTitle

352.203-70

Anti-Lobbying

Dec 2015

352.208-70

Printing and Duplication

Dec 2015

352.222-70

Contractor Cooperation in Equal Employment Opportunity Investigations

Dec 2015

352.223-70

Safety and HealthDec 2015

352.227-70

Publications and Publicity

Dec 2015

352.231-70

Salary Rate Limitation

Dec 2015

352.233-71

Litigation and Claims

Dec 2015

352.237-75

Key Personnel

Dec 2015

1.3

ADDITIONAL CONTRACT CLAUSES
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1.3.1 Additional Federal Acquisition Regulation (FAR) Clauses in Full Text
52.217-8 Option to Extend Services (Nov 1999)
The Government may require continued performance of any services within thelimits 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 ofLabor. The option provision may be exercised more than once, but the total
extension of performance hereunder shall not exceed 6 months. The Contracting
Officer may exercise the option by written notice to the Contractor within 30
days.
(End of Clause)
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 thirty (30) calendar days; provided that the Government
gives the Contractor a preliminary written notice of its intent to extend at least
thirty (30) days before the contract expires. The preliminary notice does notcommit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall beconsidered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under
this clause, shall not exceed 10 years.
(End of clause)
52.222-35 Equal Opportunity Veterans (Oct 2015)a) Definitions. As used in this clause—"Active duty wartime or campaign badge veteran," "Armed Forces service
medal veteran," "disabled veteran," "protected veteran," "qualified disabled
veteran,' and "recently separated veteran" have the meanings given at FAR
22.1301.
b) Equal opportunity clause. The Contractor shall abide by the requirements ofthe equal opportunity clause at 41 CFR 60-300.5(a), as of March 24, 2014.
This clause prohibits discrimination against qualified protected veterans, andrequires affirmative action by the Contractor to employ and advance in
employment qualified protected veterans.
c) Subcontracts. The Contractor shall insert the terms of this clause insubcontracts of $150,000 or more unless exempted by rules, regulations, ororders of the Secretary of Labor. The Contractor shall act as specified by the
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terms, including action for noncompliance. Such necessary changes inlanguage may be made as shall be appropriate of identify properly theparties and their undertakings.
(End of Clause)
52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014)a) Equal opportunity clause. The Contractor shall abide by the requirements ofthe equal opportunity clause at 41 CFR 60.741.5(a), as of March 24, 2014.
This clause prohibits discrimination against qualified individuals on the basisof disability, and requires affirmative action by the Contractor to employ andadvance in employment qualified individuals with disabilities.
b) Subcontracts. The Contractor shall include the terms of this clause in every
subcontract or purchase order in excess of $15,000 unless exempted byrules, regulations, or orders of the Secretary, so that such provisions will bebinding upon each subcontractor or vendor. The Contractor shall act as
specified by the Director, Office of Federal Contract Compliance Programs of
the U.S. Department of Labor, to enforce the terms, including action fornoncompliance. Such necessary changes in language may be made as shall beappropriate to identify properly the parties and their undertakings.
(End of Clause)

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SECTION J — LIST OF ATTACHMENTS
Attachment A: Standard Form 1034 — Public Voucher for Purchases and Services Other
Than Personal
Attachment B: Invoicing Instructions for Cost Reimbursement Contracts
Attachment C: BARDA Security Requirements
Attachment D: 7 Principles of Earned Value Management Tier 2 System Implementation
Intent Guide

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