W911QY20D0019
Page 2 of 27
Section B - Supplies or Services and Prices

ITEM NO

SUPPLIES/SERVICESMAX
QUANTITY(b) (4)UNIT

UNIT PRICE

0001

Each
(b) (4)
SARS-CoV-2 LFI Kit
FFPLateral Flow Immunoassay kit for detection of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV-2) antigen to include nasal swab andappropriate amount of clinical buffer.
FOB: Destination
MFR PART NR: TBD
PSC CD: 6550

MAX
NET AMTMAX
QUANTITY
UNDEFINED

UNIT

UNIT PRICE

MAX AMOUNT$60,000,000.00$60,000,000.00

ITEM NO

SUPPLIES/SERVICES

MAX AMOUNT

0002

Job
UNDEFINED
Shipping
COST
Costs for shipping of SARS-Co V-2 kits should be billed against this Cost
Reimbursable Shipping CLIN. Ship To Addresses will be included on individual
Delivery Orders.
FOB: Destination
MFR PART NR: TBD
PSC CD: 8145

$100,000.00

MAX COST$100,000.00

CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE
The minimum quantity and contract value for all orders issued against this contract shall not beless than the minimum quantity and contract value stated in the following table. The maximum

W911QY20D0019
Page 3 of 27

quantity and contract value for all orders issued against this contract shall not exceed the
maximum quantity and contract value stated in the following table.
MINIMUM
QUANTITY(b) (4)MINIMUMAMOUNT$100,000.00

MAXIMUM
QUANTITY(b) (4)MAXIMUMAMOUNT$60,000,000.00

DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND ORDER VALUE
The minimum quantity and order value for each Delivery/Task Order issued shall not be less than the minimum
quantity and order value stated in the following table. The maximum quantity and order value for each
Delivery/Task Order issued shall not exceed the maximum quantity and order value stated in the following table.
MINIMUM
QUANTITY(b) (4)MINIMUMAMOUNT

MAXIMUM
QUANTITY(b) (4)MAXIMUMAMOUNT

CLIN MINIMUM/MAXIMUM QUANTITY AND CLIN VALUE
The minimum quantity(s) and CLIN value(s) for all orders issued against the CLIN(s) on this contract shall not beless than the minimum quantity(s) and CLIN value(s) stated in the following table. The maximum quantity(s) and
CLIN value(s) for all orders issued against the CLIN(s) on this contract shall not exceed the maximum quantity(s)and CLIN value(s) stated in the following table.
CLIN
0001

MINIMUM
QUANTITY(b) (4)MINIMUMAMOUNT

MAXIMUM
QUANTITY(b) (4)MAXIMUMAMOUNT

CLIN DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND CLIN ORDER VALUE
The minimum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not be less thanthe minimum quantity and order value stated in the following table. The maximum quantity and order value for the
given Delivery/Task Order issued for this CLIN shall not exceed the maximum quantity and order value stated in thefollowing table.
CLIN
0001
0002

MINIMUM
QUANTITYMINIMUMAMOUNT$$

MAXIMUM
QUANTITY

MAXIMUMAMOUNT$$W911QY20D0019
Page 4 of 27
Section C - Descriptions and Specifications

Statement of Work
Manufacture of Lateral Flow Immunoassays
for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
For Defense Biological Product Assurance Office (DBPAO)
1.0 Scope. The scope of this work includes all activities required for a
SARS-CoV-2 lateral flow immunoassay (LFI) test system, including the
optimization and production of antigen screening test and all verification,
validation, and regulatory activities required to achieve Food and Drug
Administration (FDA) Emergency Use Authorization (EUA). Although, FDA
Licensure is anticipated, it is not part of this effort. The end product shall besuitable as an in vitro diagnostic (IVD) test for the detection of SARS-CoV-2
virus in specimens from infected persons or persons suspected of exposure to
SARS-CoV-2 and shall be intended for use at the point of care. The
determination of an FDA sponsor will be reviewed during the ordering period.
2.0 Background. The DBPAO was established in 1997 by the Joint Program
Executive Office Chemical Biological Radiological Nuclear Defense (JPEOCBRND) to support the need for an integrated biological defense capability.
The DBPAO serves as the principal source of high quality validated andstandardized biological reference materials, reagents and assays that meet thetechnology development and sustainment needs of the Department of Defense(DoD) and its partners. The DBPAO facilitates the transition of newtechnologies and coordinates their advanced development, efficient production
and timely distribution.
DBPAO has been tasked by the Acting Deputy Assistant Secretary of
Defense for Health Readiness Policy and Oversight (HRP&O) to support
SARS-CoV-2 response by rapidly developing and distributing antigen
detection immunoassays that will serve as a screening test for the novel
coronavirus, SARS-CoV-2. These screening tests will be used by DoD
civilians and service members, medical healthcare workers at military healthfacilities and other health agencies.

3.0 Requirements
3.1

Manufacturing Facility

3.1.1 Have manufacturing yield sufficient to meet Government delivery order
requirements of up to 1,000,000 kits per month (250,000 per week)
specifically 5,000 kits/week by 15 May 2020, scalable to 250,000 kits/week by
15 July 2020. This quantity shall not include kits intended for third party
conformance testing and contractor’s internal testing.

W911QY20D0019
Page 5 of 27

3.1.2 Inventory management procedures to store antigens, antibodies and assays
under the appropriate storage conditions as required by the label tomaximize performance integrity and shelf life.
3.1.3 Security monitoring, temperature and humidity controlled for production
area, with appropriate BioSafety Level and storage areas for assay materials
including emergency backup power.
3.1.4 Standard Operating Procedures for all procedures associated with
manufacturing, storage, and shipping of SARS-CoV-2 kits to assurecompliance with contractual requirements and all local, state, and federal
regulations and Standards.
3.3

SARS-CoV-2 Lateral Flow Immunoassay Kit

3.3.1 Deliverables
3.3.1.1 SARS-CoV-2 LFI kits for the detection of SARS-CoV-2
virus, nasal swabs and appropriate clinical buffer labeled in accordance with
Research Only Use (ROU) or as a EUA once approved. These kits shall bedelivered while maintaining product integrity.
3.3.1.2 Certificate of Conformance that includes specifications
and results of internal conformance testing with each manufacturing lot of
SARS-CoV-2 LFI kits.
3.3.2 Reagents
3.3.2.1 The Contractor shall be responsible for the production or procurement of
the reagents required for the manufacture of this SARS-CoV-2 LFI kit suchas recombinant viral capsid proteins; capture and detector antibodies,secondary antibodies, reference standards, near neighbor panel for
specificity testing, negative controls etc. The government will not provide
these reagents as government furnished materials.
3.3.2.2 The Contractor shall assume all risks and responsibilities in connection withthe handling, storage, disposal, transfer, and use of the assay materials
including appropriate safety and handling precautions to minimize health orenvironmental risk. The Contractor shall agree that any activity undertakenwith the manufacture of this assay will be conducted in compliance with allapplicable guidelines, laws and regulations, including Department of Defense
Instruction 5210.89 (DoDI 5210.89) for DoD recipients.

W911QY20D0019
Page 6 of 27
Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS
Supplies/services will be inspected/accepted at:
CLIN
0001
0002

INSPECT AT
Destination
Destination

INSPECT BY
Government
Government

ACCEPT AT
Destination
Destination

ACCEPT BY
Government
Government

CLAUSES INCORPORATED BY REFERENCE
52.246-2
52.246-16

Inspection Of Supplies--Fixed Price
Responsibility For Supplies

AUG 1996
APR 1984

W911QY20D0019
Page 7 of 27
Section F - Deliveries or Performance

DELIVERY INFORMATION
CLIN

DELIVERY DATEQUANTITYSHIP TO ADDRESS

0001

POP 29-MAY-2020 TO
28-MAY-2021

N/A

N/A
FOB: Destination

0002

POP 29-MAY-2020 TO
28-MAY-2021

N/A

N/A
FOB: Destination

DODAAC /CAGE

CLAUSES INCORPORATED BY REFERENCE
52.242-15
52.247-34

Stop-Work Order
F.O.B. Destination

AUG 1989
NOV 1991

DELIVERY DATE INFORMATION
Delivery of CLIN 0001 end items shall be 180 days After Receipt of Order, unless a different delivery schedule isagreed to by the contractor and DBPAO.
ORDERING PERIODS
The Period of Performances cited above represent the dates which supplies can be ordered. Each Delivery Ordershall specify the delivery date and delivery location.

W911QY20D0019
Page 8 of 27
Section G - Contract Administration Data

CLAUSES INCORPORATED BY REFERENCE
252.232-7003

Electronic Submission of Payment Requests and Receiving
Reports

DEC 2018

CLAUSES INCORPORATED BY FULL TEXT
252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)(a) Definitions. As used in this clause—“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit,
activity, or organization.
“Document type” means the type of payment request or receiving report available for creation in Wide Area
WorkFlow (WAWF).
“Local processing office (LPO)” is the office responsible for payment certification when payment certification isdone external to the entitlement system.
“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission ofPayment Requests and Receiving Reports.
(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests
and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.2327003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Contractor shall—(1) Have a designated electronic business point of contact in the System for Award Management at
https://www.sam.gov; and(2) Be registered to use WAWF at https://wawf.eb mil/ following the step-by-step procedures for self-registration
available at this web site.
(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training
Course and use the Practice Training Site before submitting payment requests through WAWF. Both can beaccessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.
(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data
Interchange, or File Transfer Protocol.
(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment
requests and receiving reports in WAWF for this contract or task or delivery order:(1) Document type. The Contractor shall submit payment requests using the following document type(s):W911QY20D0019
Page 10 of 27(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
(End of clause)W911QY20D0019
Page 11 of 27
Section H - Special Contract Requirements
MOST FAVORED CUSTOMER
H.1 Most Favored Customer
A.
Awardee agrees that during the term of this contract and for a period of 5 years thereafter, that it shall notoffer, sell or otherwise provide the production model of the CLIN 0001 end items (for the avoidance of doubt, CLIN
0001 end items in this clause shall mean a finished good of like material, like quality, to be used in a similar
applications, and shall not include more general products to any entity at a price lower than that offered to the DoD.
In the event that Awardee sells the production model at a lower unit price than that price sold to the DoD, Awardee
shall immediately notify the Contracting Officer in writing of the lower price. For prior purchases, the Awardee
shall reimburse the DoD, the difference between the lower price sold to the other customer(s) and the price sold to
the DoD multiplied by the number of items sold. Such reimbursement shall occur within thirty days (30) of theAwardee discovering that the lower price was given to another customer. Notwithstanding the foregoing, the Parties
may agree to apply the difference in price paid by the other customer(s) and DoD into additional quantities requiredby the DoD.
B.
If Awardee develops a like product (commercialized version or derivative of the production model) withsimilar capability and intended application, but at a lower unit price (“"Like Product”") regardless of quantity,
Awardee shall make the DoD aware of that similar product and the technical and price differences between that
product and the DoD Product. Such notification shall be made to the Contracting Officer in writing, of which email
is an acceptable form, within thirty (30) days of such offering. Awardee agrees that no entity shall receive a lower
price for any Like Product than the DoD for like purchase quantities.

W911QY20D0019
Page 12 of 27
Section I - Contract Clauses
CLAUSES INCORPORATED BY REFERENCE
52.202-1
52.203-3
52.203-5
52.203-6
52.203-7
52.203-8
52.203-10
52.203-12
52.203-13
52.204-4
52.204-10
52.204-19
52.204-23
52.204-25
52.209-6
52.209-952.209-10
52.211-5
52.215-2
52.215-8
52.215-11
52.215-12
52.215-13
52.215-14
52.215-19
52.215-23
52.216-7
52.219-8
52.219-14
52.219-28
52.222-19
52.222-20
52.222-21
52.222-35
52.222-36
52.222-37

Definitions
NOV 2013
Gratuities
APR 1984
Covenant Against Contingent Fees
MAY 2014
Restrictions On Subcontractor Sales To The Government
SEP 2006
Anti-Kickback Procedures
MAY 2014
Cancellation, Rescission, and Recovery of Funds for Illegal or MAY 2014
Improper Activity
Price Or Fee Adjustment For Illegal Or Improper Activity
MAY 2014
Limitation On Payments To Influence Certain Federal
OCT 2010
Transactions
Contractor Code of Business Ethics and Conduct
OCT 2015
Printed or Copied Double-Sided on Postconsumer Fiber
MAY 2011
Content Paper
Reporting Executive Compensation and First-TierOCT 2018
Subcontract Awards
Incorporation by Reference of Representations andDEC 2014
Certifications.
Prohibition on Contracting for Hardware, Software, andJUL 2018
Services Developed or Provided by Kaspersky Lab and Other
Covered Entities.
Prohibition on Contracting for Certain Telecommunications AUG 2019and Video Surveillance Services or Equipment.
Protecting the Government's Interest When Subcontracting OCT 2015
With Contractors Debarred, Suspended, or Proposed for
Debarment
Updates of Publicly Available Information Regarding
OCT 2018
Responsibility Matters
Prohibition on Contracting With Inverted Domestic
NOV 2015
Corporations
Material Requirements
AUG 2000
Audit and Records--Negotiation
OCT 2010
Order of Precedence--Uniform Contract Format
OCT 1997
Price Reduction for Defective Certified Cost or Pricing Data-- AUG 2011
Modifications
Subcontractor Certified Cost or Pricing Data
OCT 2010
Subcontractor Certified Cost or Pricing Data--Modifications OCT 2010
Integrity of Unit Prices
OCT 2010
OCT 1997
Notification of Ownership Changes
Limitations on Pass-Through Charges
OCT 2009
Allowable Cost And Payment
AUG 2018
Utilization of Small Business Concerns
OCT 2018
Limitations On Subcontracting
MAR 2020
Post-Award Small Business Program Rerepresentation
MAY 2020
Child Labor -- Cooperation with Authorities and Remedies JAN 2020
Contracts for Materials, Supplies, Articles, and Equipment
MAY 2014
Exceeding $15,000
Prohibition Of Segregated Facilities
APR 2015
Equal Opportunity for Veterans
OCT 2015
Equal Opportunity for Workers with Disabilities
JUL 2014
Employment Reports on Veterans
FEB 2016

W911QY20D0019
Page 13 of 27
52.222-40
52.222-50
52.222-54
52.223-6
52.223-952.223-18
52.225-13
52.227-1
52.227-11
52.229-3
52.232-8
52.232-9
52.232-11
52.232-17
52.232-20
52.232-22
52.232-25
52.232-33
52.233-1
52.233-3
52.233-4
52.242-13
52.243-1
52.244-5
52.244-6
52.245-1
52.246-23
52.249-2
52.249-8
52.253-1
252.201-7000
252.203-7000
252.203-7002
252.203-7003
252.203-7004
252.204-7000
252.204-7003
252.204-7006
252.204-7012
252.211-7003
252.222-7006
252.223-7001
252.225-7012
252.225-7048
252.226-7001
252.227-7016

Notification of Employee Rights Under the National Labor DEC 2010
Relations Act
Combating Trafficking in Persons
JAN 2019
Employment Eligibility Verification
OCT 2015
Drug-Free Workplace
MAY 2001
Estimate of Percentage of Recovered Material Content for
MAY 2008
EPA-Designated Items
Encouraging Contractor Policies To Ban Text Messaging
AUG 2011
While Driving
Restrictions on Certain Foreign Purchases
JUN 2008
Authorization and Consent
DEC 2007Patent Rights--Ownership By The Contractor
MAY 2014
Federal, State And Local Taxes
FEB 2013
Discounts For Prompt Payment
FEB 2002
Limitation On Withholding Of Payments
APR 1984
ExtrasAPR 1984
Interest
MAY 2014
Limitation Of Cost
APR 1984
Limitation Of Funds
APR 1984
Prompt Payment
JAN 2017
Payment by Electronic Funds Transfer--System for Award
OCT 2018
Management
Disputes
MAY 2014
Protest After Award
AUG 1996
Applicable Law for Breach of Contract Claim
OCT 2004
Bankruptcy
JUL 1995
Changes--Fixed PriceAUG 1987
Competition In Subcontracting
DEC 1996
Subcontracts for Commercial Items
AUG 2019
Government Property
JAN 2017
Limitation Of Liability
FEB 1997
Termination For Convenience Of The Government (Fixed- APR 2012
Price)
Default (Fixed-Price Supply & Service)
APR 1984
Computer Generated Forms
JAN 1991
Contracting Officer's Representative
DEC 1991
Requirements Relating to Compensation of Former DoD
SEP 2011
Officials
Requirement to Inform Employees of Whistleblower Rights SEP 2013
Agency Office of the Inspector General
AUG 2019
Display of Hotline Posters
AUG 2019
Disclosure Of Information
OCT 2016
Control Of Government Personnel Work Product
APR 1992
Billing Instructions
OCT 2005
Safeguarding Covered Defense Information and Cyber
DEC 2019
Incident Reporting
Item Unique Identification and Valuation
MAR 2016
Restrictions on the Use of Mandatory Arbitration Agreements DEC 2010
Hazard Warning Labels
DEC 1991
Preference For Certain Domestic Commodities
DEC 2017
Export-Controlled Items
JUN 2013
Utilization of Indian Organizations and Indian-Owned
APR 2019
Economic Enterprises, and Native Hawaiian Small Business
Concerns
Rights in Bid or Proposal Information
JAN 2011

W911QY20D0019
Page 14 of 27
252.227-7030
252.227-7037
252.227-7039
252.231-7000
252.232-7007
252.232-7010
252.235-7010
252.243-7001
252.243-7002
252.244-7000
252.246-7001
252.247-7023

Technical Data--Withholding Of Payment
Validation of Restrictive Markings on Technical Data
Patents--Reporting Of Subject Inventions
Supplemental Cost Principles
Limitation Of Government's Obligation
Levies on Contract Payments
Acknowledgment of Support and Disclaimer
Pricing Of Contract Modifications
Requests for Equitable Adjustment
Subcontracts for Commercial Items
Warranty Of Data
Transportation of Supplies by Sea

MAR 2000
SEP 2016
APR 1990
DEC 1991
APR 2014
DEC 2006
MAY 1995
DEC 1991
DEC 2012
JUN 2013
MAR 2014
FEB 2019

CLAUSES INCORPORATED BY FULL TEXT
52.216-18

ORDERING. (OCT 1995)(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders ortask orders by the individuals or activities designated in the Schedule. Such orders may be issued from 29 May 2020
through 28 May 2021.
(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict
between a delivery order or task order and this contract, the contract shall control.
(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in themail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the
Schedule.
(End of clause)

52.216-19

ORDER LIMITATIONS (OCT 1995)(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount ofless than $10,000, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those
supplies or services under the contract.
(b) Maximum order. The Contractor is not obligated to honor (1) Any order for a single item in excess of the maximum quantities stated in Section B;(2) Any order for a combination of items in excess of the maximum quantities stated in Section B; or(3) A series of orders from the same ordering office within 60 days that together call for quantities exceeding thelimitation in paragraph (b) (1) or (2) of this section.
(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal
Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from theContractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.
(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding theW911QY20D0019
Page 15 of 27
maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for andthe reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.
(End of clause)

52.216-22

INDEFINITE QUANTITY. (OCT 1995)(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in
the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are notpurchased by this contract.
(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Orderingclause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in
the Schedule up to and including the quantity designated in the Schedule as the "maximum". The Government shallorder at least the quantity of supplies or services designated in the Schedule as the "minimum".
(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on
the number of orders that may be issued. The Government may issue orders requiring delivery to multiple
destinations or performance at multiple locations.
(d) Any order issued during the effective period of this contract and not completed within that period shall becompleted by the Contractor within the time specified in the order. The contract shall govern the Contractor's andGovernment's rights and obligations with respect to that order to the same extent as if the order were completed
during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries
under this contract after 28 May 2021.
(End of clause)

52.228-7

INSURANCE--LIABILITY TO THIRD PERSONS (MAR 1996)(a)(1) Except as provided in subparagraph (a)(2) of this clause, the Contractor shall provide and maintain workers’
compensation, employer’s liability, comprehensive general liability (bodily injury), comprehensive automobile
liability (bodily injury and property damage) insurance, and such other insurance as the Contracting Officer may
require under this contract.
(2) The Contractor may, with the approval of the Contracting Officer, maintain a self-insurance program; provided
that, with respect to workers' compensation, the Contractor is qualified pursuant to statutory authority.
(3) All insurance required by this paragraph shall be in a form and amount and for those periods as the Contracting
Officer may require or approve and with insurers approved by the Contracting Officer.
(b) The Contractor agrees to submit for the Contracting Officer's approval, to the extent and in the manner requiredby the Contracting Officer, any other insurance that is maintained by the Contractor in connection with theperformance of this contract and for which the Contractor seeks reimbursement.
(c) The Contractor shall be reimbursed—

W911QY20D0019
Page 16 of 27(1) For that portion (i) of the reasonable cost of insurance allocable to this contract, and (ii) required or approved
under this clause; and(2) For certain liabilities (and expenses incidental to such liabilities) to third persons not compensated by insurance
or otherwise without regard to and as an exception to the limitation of cost or the limitation of funds clause of thiscontract. These liabilities must arise out of the performance of this contract, whether or not caused by the negligenceof the Contractor or of the Contractor's agents, servants, or employees, and must be represented by final judgments
or settlements approved in writing by the Government. These liabilities are for-(i) Loss of or damage to property (other than property owned, occupied, or used by the Contractor, rented to theContractor, or in the care, custody, or control of the Contractor); or(ii) Death or bodily injury.
(d) The Government's liability under paragraph (c) of this clause is subject to the availability of appropriated funds
at the time a contingency occurs. Nothing in this contract shall be construed as implying that the Congress will, at alater date, appropriate funds sufficient to meet deficiencies.
(e) The Contractor shall not be reimbursed for liabilities (and expenses incidental to such liabilities)-(1) For which the Contractor is otherwise responsible under the express terms of any clause specified in the
Schedule or elsewhere in the contract;(2) For which the Contractor has failed to insure or to maintain insurance as required by the Contracting Officer; or(3) That result from willful misconduct or lack of good faith on the part of any of the Contractor's directors, officers,
managers, superintendents, or other representatives who have supervision or direction of-(i) All or substantially all of the Contractor's business;(ii) All or substantially all of the Contractor's operations at any one plant or separate location in which this contract
is being performed; or(iii) A separate and complete major industrial operation in connection with the performance of this contract.
(f) The provisions of paragraph (e) of this clause shall not restrict the right of the Contractor to be reimbursed for thecost of insurance maintained by the Contractor in connection with the performance of this contract, other thaninsurance required in accordance with this clause; provided, that such cost is allowable under the Allowable Cost
and Payment clause of this contract.
(g) If any suit or action is filed or any claim is made against the Contractor, the cost and expense of which may bereimbursable to the Contractor under this contract, and the risk of which is then uninsured or is insured for less than
the amount claimed, the Contractor shall-(1) Immediately notify the Contracting Officer and promptly furnish copies of all pertinent papers received;(2) Authorize Government representatives to collaborate with counsel for the insurance carrier in settling or
defending the claim when the amount of the liability claimed exceeds the amount of coverage; and(3) Authorize Government representatives to settle or defend the claim and to represent the Contractor in or to takecharge of any litigation, if required by the Government, when the liability is not insured or covered by bond. The
Contractor may, at its own expense, be associated with the Government representatives in any such claim or
litigation.
(End of clause)W911QY20D0019
Page 17 of 27

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 infull text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may
be accessed electronically at this/these address(es):https://www.acquisition.gov/content/regulations
https://www.acquisition.gov/(End of clause)

252.216-7006 ORDERING (SEP 2019)(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders ortask orders by the individuals or activities designated in the contract schedule. Such orders may be issued from
29 May 2020 through 28 May 2021.
(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict
between a delivery order or task order and this contract, the contract shall control.
(c)(1) If issued electronically, the order is considered ``issued'' when a copy has been posted to the Electronic Data
Access system, and notice has been sent to the Contractor.
(2) If mailed or transmitted by facsimile, a delivery order or task order is considered ``issued'' when the Government
deposits the order in the mail or transmits by facsimile. Mailing includes transmittal by U.S. mail or private delivery
services.
(3) Orders may be issued orally only if authorized in the schedule.
(End of Clause)

252.227-7013 RIGHTS IN TECHNICAL DATA--NONCOMMERCIAL ITEMS (FEB 2014)(a) Definitions. As used in this clause-(1) Computer data base means a collection of data recorded in a form capable of being processed by a computer. The
term does not include computer software.
(2) Computer program means a set of instructions, rules, or routines recorded in a form that is capable of causing acomputer to perform a specific operation or series of operations.
(3) Computer software means computer programs, source code, source code listings, object code listings, design
details, algorithms, processes, flow charts, formulae and related material that would enable the software to be
reproduced, recreated, or recompiled. Computer software does not include computer data bases or computer
software documentation.

W911QY20D0019
Page 18 of 27(4) Computer software documentation means owner's manuals, user's manuals, installation instructions, operating
instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer
software or provide instructions for using the software.
(5) Covered Government support contractor means a contractor (other than a litigation support contractor covered by
252.204-7014) under a contract, the primary purpose of which is to furnish independent and impartial advice or
technical assistance directly to the Government in support of the Government's management and oversight of aprogram or effort (rather than to directly furnish an end item or service to accomplish a program or effort), provided
that the contractor-(i) Is not affiliated with the prime contractor or a first-tier subcontractor on the program or effort, or with any directcompetitor of such prime contractor or any such first-tier subcontractor in furnishing end items or services of thetype developed or produced on the program or effort; and(ii) Receives access to technical data or computer software for performance of a Government contract that contains
the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked
with Restrictive Legends.
(6) Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of
manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform aprocess.
(7) Developed means that an item, component, or process exists and is workable. Thus, the item or component musthave been constructed or the process practiced. Workability is generally established when the item, component, or
process has been analyzed or tested sufficiently to demonstrate to reasonable people skilled in the applicable art that
there is a high probability that it will operate as intended. Whether, how much, and what type of analysis or testingis required to establish workability depends on the nature of the item, component, or process, and the state of the art.
To be considered "developed," the item, component, or process need not be at the stage where it could be offered forsale or sold on the commercial market, nor must the item, component, or process be actually reduced to practicewithin the meaning of Title 35 of the United States Code.
(8) Developed exclusively at private expense means development was accomplished entirely with costs charged toindirect cost pools, costs not allocated to a government contract, or any combination thereof.
(i) Private expense determinations should be made at the lowest practicable level.
(ii) Under fixed-price contracts, when total costs are greater than the firm-fixed-price or ceiling price of the contract,
the additional development costs necessary to complete development shall not be considered when determining
whether development was at government, private, or mixed expense.
(9) Developed exclusively with government funds means development was not accomplished exclusively or
partially at private expense.
(10) Developed with mixed funding means development was accomplished partially with costs charged to indirect
cost pools and/or costs not allocated to a government contract, and partially with costs charged directly to agovernment contract.
(11) Form, fit, and function data means technical data that describes the required overall physical, functional, andperformance characteristics (along with the qualification requirements, if applicable) of an item, component, or
process to the extent necessary to permit identification of physically and functionally interchangeable items.
(12) Government purpose means any activity in which the United States Government is a party, including
cooperative agreements with international or multi-national defense organizations, or sales or transfers by the UnitedStates Government to foreign governments or international organizations. Government purposes include competitiveW911QY20D0019
Page 19 of 27
procurement, but do not include the rights to use, modify, reproduce, release, perform, display, or disclose technicaldata for commercial purposes or authorize others to do so.
(13) Government purpose rights means the rights to-(i) Use, modify, reproduce, release, perform, display, or disclose technical data within the Government without
restriction; and(ii) Release or disclose technical data outside the Government and authorize persons to whom release or disclosure
has been made to use, modify, reproduce, release, perform, display, or disclose that data for United States
government purposes.
(14) Limited rights means the rights to use, modify, reproduce, release, perform, display, or disclose technical data,in whole or in part, within the Government. The Government may not, without the written permission of the party
asserting limited rights, release or disclose the technical data outside the Government, use the technical data for
manufacture, or authorize the technical data to be used by another party, except that the Government may reproduce,
release, or disclose such data or authorize the use or reproduction of the data by persons outside the Government if-(i) The reproduction, release, disclosure, or use is-(A) Necessary for emergency repair and overhaul; or(B) A release or disclosure to-(1) A covered Government support contractor in performance of its covered Government support contract for use,
modification, reproduction, performance, display, or release or disclosure to a person authorized to receive limited
rights technical data; or(2) A foreign government, of technical data other than detailed manufacturing or process data, when use of suchdataby the foreign government is in the interest of the Government and is required for evaluational or informational
purposes;(ii) The recipient of the technical data is subject to a prohibition on the further reproduction, release, disclosure, or
use of the technical data; and(iii) The contractor or subcontractor asserting the restriction is notified of such reproduction, release, disclosure, oruse.
(15) Technical data means recorded information, regardless of the form or method of the recording, of a scientific ortechnical nature (including computer software documentation). The term does not include computer software or data
incidental to contract administration, such as financial and/or management information.
(16) Unlimited rights means rights to use, modify, reproduce, perform, display, release, or disclose technical data inwhole or in part, in any manner, and for any purpose whatsoever, and to have or authorize others to do so.
(b) Rights in technical data. The Contractor grants or shall obtain for the Government the following royalty free,world-wide, nonexclusive, irrevocable license rights in technical data other than computer software documentation(see the Rights in Noncommercial Computer Software and Noncommercial Computer Software Documentation
clause of this contract for rights in computer software documentation):(1) Unlimited rights.
The Government shall have unlimited rights in technical data that are--W911QY20D0019
Page 20 of 27(i) Data pertaining to an item, component, or process which has been or will be developed exclusively with
Government funds;(ii) Studies, analyses, test data, or similar data produced for this contract, when the study, analysis, test, or similar
work was specified as an element of performance;(iii) Created exclusively with Government funds in the performance of a contract that does not require thedevelopment, manufacture, construction, or production of items, components, or processes;(iv) Form, fit, and function data;(v) Necessary for installation, operation, maintenance, or training purposes (other than detailed manufacturing orprocess data);(vi) Corrections or changes to technical data furnished to the Contractor by the Government;(vii) Otherwise publicly available or have been released or disclosed by the Contractor or subcontractor without
restrictions on further use, release or disclosure, other than a release or disclosure resulting from the sale, transfer, orother assignment of interest in the technical data to another party or the sale or transfer of some or all of a business
entity or its assets to another party;(viii) Data in which the Government has obtained unlimited rights under another Government contract or as a resultof negotiations; or(ix) Data furnished to the Government, under this or any other Government contract or subcontract thereunder, with(A) Government purpose license rights or limited rights and the restrictive condition(s) has/have expired; or(B) Government purpose rights and the Contractor's exclusive right to use such data for commercial purposes has
expired.
(2) Government purpose rights.
(i) The Government shall have government purpose rights for a five-year period, or such other period as may benegotiated, in technical data-(A) That pertain to items, components, or processes developed with mixed funding except when the Government isentitled to unlimited rights in such data as provided in paragraphs as provided in paragraphs (b)(1)(ii) and (b)(1)(iv)
through (b)(1)(ix) of this clause; or(B) Created with mixed funding in the performance of a contract that does not require the development,
manufacture, construction, or production of items, components, or processes.
(ii) The five-year period, or such other period as may have been negotiated, shall commence upon execution of thecontract, subcontract, letter contract (or similar contractual instrument), contract modification, or option exercisethat required development of the items, components, or processes or creation of the data described in paragraph(b)(2)(i)(B) of this clause. Upon expiration of the five-year or other negotiated period, the Government shall haveunlimited rights in the technical data.
(iii) The Government shall not release or disclose technical data in which it has government purpose rights unless(A) Prior to release or disclosure, the intended recipient is subject to the non-disclosure agreement at 227.7103-7 of
the Defense Federal Acquisition Regulation Supplement (DFARS); orW911QY20D0019
Page 21 of 27(B) The recipient is a Government contractor receiving access to the data for performance of a Government contractthat contains the clause at DFARS 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished
Information Marked with Restrictive Legends.
(iv) The Contractor has the exclusive right, including the right to license others, to use technical data in which theGovernment has obtained government purpose rights under this contract for any commercial purpose during the time
period specified in the government purpose rights legend prescribed in paragraph (f)(2) of this clause.
(3) Limited rights.
(i) Except as provided in paragraphs (b)(1)(ii) and (b)(1)(iv) through (b)(1)(ix) of this clause, the Government shallhave limited rights in technical data-(A) Pertaining to items, components, or processes developed exclusively at private expense and marked with thelimited rights legend prescribed in paragraph (f) of this clause; or(B) Created exclusively at private expense in the performance of a contract that does not require the development,
manufacture, construction, or production of items, components, or processes.
(ii) The Government shall require a recipient of limited rights data for emergency repair or overhaul to destroy thedata and all copies in its possession promptly following completion of the emergency repair/overhaul and to notify
the Contractor that the data have been destroyed.
(iii) The Contractor, its subcontractors, and suppliers are not required to provide the Government additional rights touse, modify, reproduce, release, perform, display, or disclose technical data furnished to the Government withlimited rights. However, if the Government desires to obtain additional rights in technical data in which it has
limited rights, the Contractor agrees to promptly enter into negotiations with the Contracting Officer to determine
whether there are acceptable terms for transferring such rights. All technical data in which the Contractor has
granted the Government additional rights shall be listed or described in a license agreement made part of thecontract. The license shall enumerate the additional rights granted the Government in such data.
(iv) The Contractor acknowledges that-(A) Limited rights data are authorized to be released or disclosed to covered Government support contractors;(B) The Contractor will be notified of such release or disclosure;(C) The Contractor (or the party asserting restrictions as identified in the limited rights legend) may require eachsuch covered Government support contractor to enter into a non-disclosure agreement directly with the Contractor(or the party asserting restrictions) regarding the covered Government support contractor's use of such data,or alternatively, that the Contractor (or party asserting restrictions) may waive in writing the requirement for a nondisclosure agreement; and(D) Any such non-disclosure agreement shall address the restrictions on the covered Government support
contractor's use of the limited rights data as set forth in the clause at 252.227-7025, Limitations on the Use or
Disclosure of Government-Furnished Information Marked with Restrictive Legends. The non-disclosureagreement shall not include any additional terms and conditions unless mutually agreed to by the parties to the nondisclosure agreement.
(E) The Contractor shall provide a copy of any such non-disclosure agreement or waiver to the Contracting Officer,
upon request.
(4) Specifically negotiated license rights.

W911QY20D0019
Page 22 of 27
The standard license rights granted to the Government under paragraphs (b)(1) through (b)(3) of this clause,
including the period during which the Government shall have government purpose rights in technical data, may be
modified by mutual agreement to provide such rights as the parties consider appropriate but shall not provide theGovernment lesser rights than are enumerated in paragraph (a)(14) of this clause. Any rights so negotiated shall beidentified in a license agreement made part of this contract.
(5) Prior government rights.
Technical data that will be delivered, furnished, or otherwise provided to the Government under this contract, inwhich the Government has previously obtained rights shall be delivered, furnished, or provided with the pre-existingrights, unless-(i) The parties have agreed otherwise; or(ii) Any restrictions on the Government's rights to use, modify, reproduce, release, perform, display, or disclose thedata have expired or no longer apply.
(6) Release from liability.
The Contractor agrees to release the Government from liability for any release or disclosure of technical data madein accordance with paragraph (a)(14) or (b)(2)(iii) of this clause, in accordance with the terms of a license negotiatedunder paragraph (b)(4) of this clause, or by others to whom the recipient has released or disclosed the data and toseek relief solely from the party who has improperly used, modified, reproduced, released, performed, displayed, ordisclosed Contractor data marked with restrictive legends.
(c) Contractor rights in technical data. All rights not granted to the Government are retained by the Contractor.
(d) Third party copyrighted data. The Contractor shall not, without the written approval of the Contracting Officer,
incorporate any copyrighted data in the technical data to be delivered under this contract unless the Contractor is the
copyright owner or has obtained for the Government the license rights necessary to perfect a license or licenses inthe deliverable data of the appropriate scope set forth in paragraph (b) of this clause, and has affixed a statement of
the license or licenses obtained on behalf of the Government and other persons to the data transmittal document.
(e) Identification and delivery of data to be furnished with restrictions on use, release, or disclosure. (1) This
paragraph does not apply to restrictions based solely on copyright.
(2) Except as provided in paragraph (e)(3) of this clause, technical data that the Contractor asserts should befurnished to the Government with restrictions on use, release, or disclosure are identified in an attachment to thiscontract (the Attachment). The Contractor shall not deliver any data with restrictive markings unless the data arelisted on the Attachment.
(3) In addition to the assertions made in the Attachment, other assertions may be identified after award when basedon new information or inadvertent omissions unless the inadvertent omissions would have materially affected thesource selection decision. Such identification and assertion shall be submitted to the Contracting Officer as soon aspracticable prior to the scheduled date for delivery of the data, in the following format, and signed by an official
authorized to contractually obligate the Contractor: Identification and Assertion of Restrictions on the Government'sUse, Release, or Disclosure of Technical Data.
The Contractor asserts for itself, or the persons identified below, that the Government's rights to use, release, ordisclose the following technical data should be restricted-Technical data
to be FurnishedWith Restrictions \1/Basis for
Assertion \2/Asserted
RightsCategory \3/Name of Person
AssertingRestrictions \4/W911QY20D0019
Page 23 of 27(LIST)(LIST)(LIST)(LIST)\1/ If the assertion is applicable to items, components or processes developed at private expense, identify both thedata and each such items, component, or process.
\2/ Generally, the development of an item, component, or process at private expense, either exclusively or partially,is the only basis for asserting restrictions on the Government's rights to use, release, or disclose technical data
pertaining to such items, components, or processes. Indicate whether development was exclusively or partially at
private expense. If development was not at private expense, enter the specific reason for asserting that theGovernment's rights should be restricted.
\3/ Enter asserted rights category (e.g., government purpose license rights from a prior contract, rights in SBIR data
generated under another contract, limited or government purpose rights under this or a prior contract, or specificallynegotiated licenses).
\4/ Corporation, individual, or other person, as appropriate.
Date ______________________________________________________________________
Printed Name and Title ________________________________________________________________________________________________________________________________
Signature __________________________________________________________________(End of identification and assertion)(4) When requested by the Contracting Officer, the Contractor shall provide sufficient information to enable theContracting Officer to evaluate the Contractor's assertions. The Contracting Officer reserves the right to add theContractor's assertions to the Attachment and validate any listed assertion, at a later date, in accordance with theprocedures of the Validation of Restrictive Markings on Technical Data clause of this contract.
(f) Marking requirements. The Contractor, and its subcontractors or suppliers, may only assert restrictions on the
Government's rights to use, modify, reproduce, release, perform, display, or disclose technical data to be delivered
under this contract by marking the deliverable data subject to restriction. Except as provided in paragraph (f)(5) of
this clause, only the following legends are authorized under this contract: the government purpose rights legend atparagraph (f)(2) of this clause; the limited rights legend at paragraph (f)(3) of this clause; or the special license rights
legend at paragraph (f)(4) of this clause; and/or a notice of copyright as prescribed under 17 U.S.C. 401 or 402.
(1) General marking instructions. The Contractor, or its subcontractors or suppliers, shall conspicuously and legibly
mark the appropriate legend on all technical data that qualify for such markings. The authorized legends shall beplaced on the transmittal document or storage container and, for printed material, each page of the printed material
containing technical data for which restrictions are asserted. When only portions of a page of printed material are
subject to the asserted restrictions, such portions shall be identified by circling, underscoring, with a note, or otherappropriate identifier. Technical data transmitted directly from one computer or computer terminal to another shallcontain a notice of asserted restrictions. Reproductions of technical data or any portions thereof subject to asserted
restrictions shall also reproduce the asserted restrictions.
(2) Government purpose rights markings. Data delivered or otherwise furnished to the Government purpose rights
shall be marked as follows:
Government Purpose Rights
Contract No. ______________________________________________________________

W911QY20D0019
Page 24 of 27
Contractor Name ____________________________________________________________
Contractor Address ____________________________________________________________________________________________________________________________________
Expiration Date ____________________________________________________________The Government's rights to use, modify, reproduce, release, perform, display, or disclose these technical data are
restricted by paragraph (b)(2) of the Rights in Technical Data--Noncommercial Items clause contained in the above
identified contract. No restrictions apply after the expiration date shown above. Any reproduction of technical dataor portions thereof marked with this legend must also reproduce the markings.
(End of legend)(3) Limited rights markings. Data delivered or otherwise furnished to the Government with limited rights shall bemarked with the following legend:
Limited Rights
Contract No. ______________________________________________________________
Contractor Name ____________________________________________________________
Contractor Address ____________________________________________________________________________________________________________________________________The Government's rights to use, modify, reproduce, release, perform, display, or disclose these technical data are
restricted by paragraph (b)(3) of the Rights in Technical Data--Noncommercial Items clause contained in the above
identified contract. Any reproduction of technical data or portions thereof marked with this legend must also
reproduce the markings. Any person, other than the Government, who has been provided access to such data must
promptly notify the above named Contractor.
(End of legend)(4) Special license rights markings. (i) Data in which the Government's rights stem from a specifically negotiatedlicense shall be marked with the following legend:
Special License Rights
The Government's rights to use, modify, reproduce, release, perform, display, or disclose these data are restricted byContract No. ________ (Insert contract number) ________, License No. ________ (Insert license identifier)________. Any reproduction of technical data or portions thereof marked with this legend must also reproduce themarkings.
(End of legend)(ii) For purposes of this clause, special licenses do not include government purpose license rights acquired under aprior contract (see paragraph (b)(5) of this clause).
(5) Pre-existing data markings. If the terms of a prior contract or license permitted the Contractor to restrict theGovernment's rights to use, modify, reproduce, release, perform, display, or disclose technical data deliverable under
this contract, and those restrictions are still applicable, the Contractor may mark such data with the appropriate

W911QY20D0019
Page 25 of 27
restrictive legend for which the data qualified under the prior contract or license. The marking procedures inparagraph (f)(1) of this clause shall be followed.
(g) Contractor procedures and records. Throughout performance of this contract, the Contractor and its
subcontractors or suppliersthat will deliver technical data with other than unlimited rights, shall-(1) Have, maintain, and follow written procedures sufficient to assure that restrictive markings are used only whenauthorized by the terms of this clause; and(2) Maintain records sufficient to justify the validity of any restrictive markings on technical data delivered under
this contract.
(h) Removal of unjustified and nonconforming markings. (1) Unjustified technical data markings. The rights andobligations of the parties regarding the validation of restrictive markings on technical data furnished or to be
furnished under this contract are contained in the Validation of Restrictive Markings on Technical Data clause ofthis contract. Notwithstanding any provision of this contract concerning inspection and acceptance, the Government
may ignore or, at the Contractor's expense, correct or strike a marking if, in accordance with the procedures in the
Validation of Restrictive Markings on Technical Data clause of this contract, a restrictive marking is determined to
be unjustified.
(2) Nonconforming technical data markings. A nonconforming marking is a marking placed on technical datadelivered or otherwise furnished to the Government under this contract that is not in the format authorized by thiscontract. Correction of nonconforming markings is not subject to the validation of Restrictive Markings on
Technical Data clause of this contract. If the Contracting Officer notifies the Contractor of a nonconforming
marking and the Contractor fails to remove or correct such marking within sixty (60) days, the Government may
ignore or, at the Contractor's expense, remove or correct any nonconforming marking.
(i) Relation to patents. Nothing contained in this clause shall imply a license to the Government under any patent or
be construed as affecting the scope of any license or other right otherwise granted to the Government under any
patent.
(j) Limitation on charges for rights in technical data. (1) The Contractor shall not charge to this contract any cost,
including, but not limited to, license fees, royalties, or similar charges, for rights in technical data to be delivered
under this contract when-(i) The Government has acquired, by any means, the same or greater rights in the data; or(ii) The data are available to the public without restrictions.
(2) The limitation in paragraph (j)(1) of this clause-(i) Includes costs charged by a subcontractor or supplier, at any tier, or costs incurred by the Contractor to acquire
rights in subcontractor or supplier technical data, if the subcontractor or supplier has been paid for such rights under
any other Government contract or under a license conveying the rights to the Government; and(ii) Does not include the reasonable costs of reproducing, handling, or mailing the documents or other media in
which the technical data will be delivered.
(k) Applicability to subcontractors or suppliers. (1) The Contractor shall ensure that the rights afforded its
subcontractors and suppliers under 10 U.S.C. 2320, 10 U.S.C. 2321, and the identification, assertion, and delivery
processes of paragraph (e) of this clause are recognized and protected.
(2) Whenever any technical data for noncommercial items, or for commercial items developed in any part at
Government expense, is to be obtained from a subcontractor or supplier for delivery to the Government under thiscontract, the Contractor shall use this same clause in the subcontract or other contractual instrument, includingW911QY20D0019
Page 26 of 27
subcontracts or other contractual instruments for commercial items, and requireits subcontractors or suppliers to doso, without alteration, except to identify the parties. This clause will govern the technical data pertaining tononcommercial items or to any portion of a commercial item that was developed in any part at Government expense,
and the clause at 252.227-7015 will govern the technical data pertaining to any portion of a commercial item thatwas developed exclusively at private expense. No other clause shall be used to enlarge or diminish theGovernment's, the Contractor's, or a higher-tier subcontractor's or supplier's rights in a subcontractor's or supplier's
technical data.
(3) Technical data required to be delivered by a subcontractor or supplier shall normally be delivered to the next
higher-tier contractor, subcontractor, or supplier. However, when there is a requirement in the prime contract fordata which may be submitted with other than unlimited rights by a subcontractor or supplier, then said subcontractor
or supplier may fulfill its requirement by submitting such data directly to the Government, rather than through ahigher-tier contractor, subcontractor, or supplier.
(4) The Contractor and higher-tier subcontractors or suppliers shall not use their power to award contracts as
economic leverage to obtain rights in technical data from their subcontractors or suppliers. (5) In no event shall theContractor use its obligation to recognize and protect subcontractor or supplier rights in technical data as an excuse
for failing to satisfy its contractual obligations to the Government.
(End of clause)W911QY20D0019
Page 27 of 27
Section J - List of Documents, Exhibits and Other Attachments
Attachment 1 Conformance Test Plan
Attachment 2 Evaluation factors and rating criteria

1. CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P00001

PAGE OF P AGES

J

4. REQUISITION/PURCHASE REQ. NO.

1

5

5. P ROJECT NO.(If applicable)

23-Jun-2020

6. ISSUED BY

CODE

W911QY

7. ADMINISTERED BY (If other than item 6)

W6QK ACC-APG NATICK
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

CODE

See Item 6

9A. AMENDMENT OF SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ANP TECHNOLOGIES, INC.
824 INTERCHANGE BLVDNEWARK DE 19711-3570

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY20D0019

CODE

10B. DAT ED (SEE ITEM 13)
X 29-May-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

3AVW6

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer

is extended,

is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNT ING AND APPROPRIATION DATA (If required)
13. T HIS IT EM APPLIES ONLY TO MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES T HE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT T O: (Specify authority) THE CHANGES SET FORT H IN ITEM 14 ARE MADE IN T HE
CONT RACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONT RACT /ORDER IS MODIFIED TO REFLECT T HE ADMINISTRAT IVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORT H IN IT EM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
X C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:
By mutual agreement of both parties.
D. OT HER (Specify type of modification and authority)
E. IMPORT ANT: Contractor

is not,X

is required to sign this document and return1

copies to the issuing office.

14. DESCRIPT ION OF AMENDMENT /MODIFICAT ION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)The purpose of this modification is to:1) Add Firm Fixed Price CL N 0003 valued at (b) (4), revise Section C, Statement of Work (SOW) to include additional w ork for regulatory
meetings in support of Emergency Use Authorization (EUA), see paragraph 3.3.3.
2) Update Section J, Attachment 01 by replacing it in its entirety w ith Attachment 1, Conformance Testing Plan, dated 06 June 2020.
All other terms and conditions remain the same and in full force and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND T ITLE OF CONTRACTING OFFICER (Type or print)(b) (6) / CONTRACTING OFFICERTEL:(b) (6)
15B. CONT RACT OR/OFFEROR(Signature of person authorized to sign)
EXCEPTION T O SF 30
APPROVED BY OIRM 11-84

15C. DATE SIGNEDEMAIL:(b) (6)

16B. UNIT ED ST AT ES OF AMERICA

16C. DAT E SIGNED

BY

23-Jun-2020(b) (6)(Signature of Contracting Officer)
30-105-04

ST ANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY20D0019
P00001Page 2 of 5
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION A - SOLICITATION/CONTRACT FORM

The total cost of this contract was increased by $5,096.00 from $60,100,000.00 to$60,105,096.00.

SECTION B - SUPPLIES OR SERVICES AND PRICES
CLIN 0003 is added as follows:
ITEM NO

SUPPLIES/SERVICESMAX
QUANTITY

UNIT

UNIT PRICE

0003

Each
(b) (4)
Regulatory/EUA Meetings
FFP
Meetings to discuss regulatory requirements and Emergency Use Authorization,in accordance with Section C, Statement of Work (SOW), paragraph 3.3.3.
FOB: Destination
MFR PART NR: TBD
PSC CD: 6550
(b)

MAX
NET AMTSECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:Statement of Work
Manufacture of Lateral Flow Immunoassays
for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
For Defense Biological Product Assurance Office (DBPAO)
1.0 Scope. The scope of this work includes all activities required for a
SARS-CoV-2 lateral flow immunoassay (LFI) test system, including the
optimization and production of antigen screening test and all verification,

MAX AMOUNT$5,096.00$5,096.00

W911QY20D0019
P00001Page 3 of 5

validation, and regulatory activities required to achieve Food and Drug
Administration (FDA) Emergency Use Authorization (EUA). Although, FDA
Licensure is anticipated, it is not part of this effort. The end product shall besuitable as an in vitro diagnostic (IVD) test for the detection of SARS-CoV-2
virus in specimens from infected persons or persons suspected of exposure to
SARS-CoV-2 and shall be intended for use at the point of care. The
determination of an FDA sponsor will be reviewed during the ordering period.
2.0 Background. The DBPAO was established in 1997 by the Joint Program
Executive Office Chemical Biological Radiological Nuclear Defense (JPEOCBRND) to support the need for an integrated biological defense capability.
The DBPAO serves as the principal source of high quality validated andstandardized biological reference materials, reagents and assays that meet thetechnology development and sustainment needs of the Department of Defense(DoD) and its partners. The DBPAO facilitates the transition of newtechnologies and coordinates their advanced development, efficient production
and timely distribution.
DBPAO has been tasked by the Acting Deputy Assistant Secretary of
Defense for Health Readiness Policy and Oversight (HRP&O) to support
SARS-CoV-2 response by rapidly developing and distributing antigen
detection immunoassays that will serve as a screening test for the novel
coronavirus, SARS-CoV-2. These screening tests will be used by DoD
civilians and service members, medical healthcare workers at military healthfacilities and other health agencies.
3.0 Requirements
3.1

Manufacturing Facility

3.1.1 Have manufacturing yield sufficient to meet Government delivery order
requirements of up to 1,000,000 kits per month (250,000 per week)
specifically 5,000 kits/week by 15 May 2020, scalable to 250,000 kits/week by
15 July 2020. This quantity shall not include kits intended for third party
conformance testing and contractor’s internal testing.
3.1.2 Inventory management procedures to store antigens, antibodies and assays
under the appropriate storage conditions as required by the label tomaximize performance integrity and shelf life.
3.1.3 Security monitoring, temperature and humidity controlled for production
area, with appropriate BioSafety Level and storage areas for assay materials
including emergency backup power.
3.1.4 Standard Operating Procedures for all procedures associated with
manufacturing, storage, and shipping of SARS-CoV-2 kits to assureW911QY20D0019
P00001Page 4 of 5compliance with contractual requirements and all local, state, and federal
regulations and Standards.
3.3

SARS-CoV-2 Lateral Flow Immunoassay Kit

3.3.1 Deliverables
3.3.1.1 SARS-CoV-2 LFI kits for the detection of SARS-CoV-2
virus, nasal swabs and appropriate clinical buffer labeled in accordance with
Research Only Use (ROU) or as a EUA once approved. These kits shall bedelivered while maintaining product integrity.
3.3.1.2 Certificate of Conformance that includes specifications
and results of internal conformance testing with each manufacturing lot of
SARS-CoV-2 LFI kits.
3.3.2 Reagents
3.3.2.1 The Contractor shall be responsible for the production or procurement of
the reagents required for the manufacture of this SARS-CoV-2 LFI kit suchas recombinant viral capsid proteins; capture and detector antibodies,secondary antibodies, reference standards, near neighbor panel for
specificity testing, negative controls etc. The government will not provide
these reagents as government furnished materials.
3.3.2.2 The Contractor shall assume all risks and responsibilities in connection withthe handling, storage, disposal, transfer, and use of the assay materials
including appropriate safety and handling precautions to minimize health orenvironmental risk. The Contractor shall agree that any activity undertakenwith the manufacture of this assay will be conducted in compliance with allapplicable guidelines, laws and regulations, including Department of Defense
Instruction 5210.89 (DoDI 5210.89) for DoD recipients.
3.3.3 Regulatory Work/Emergency Use Authorization
3.3.3.1 Perform work delineated below from 15 June 2020 to 26 June 2020:
3.3.3.2 Four (4) hours engagement with the Program Office and Government
Regulatory Team (ONE-RAQA); Two one-hour meetings per week to analyze
the Government Furnished Information (GFI).

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for CLIN 0003:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

W911QY20D0019
P00001Page 5 of 5

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0003 has been added:
DELIVERY DATEQUANTITYSHIP TO ADDRESSPOP 23-JUN-2020 TO
26-JUN-2020

N/A

N/A
FOB: Destination(End of Summary of Changes)

DODAAC /CAGE

1. CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P00002

PAGE OF P AGES

J

4. REQUISITION/PURCHASE REQ. NO.

1

4

5. P ROJECT NO.(If applicable)

01-Jul-2020

6. ISSUED BY

CODE

W911QY

7. ADMINISTERED BY (If other than item 6)

W6QK ACC-APG NATICK
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

CODE

See Item 6

9A. AMENDMENT OF SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ANP TECHNOLOGIES, INC.
824 INTERCHANGE BLVDNEWARK DE 19711-3570

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY20D0019

CODE

10B. DAT ED (SEE ITEM 13)
X 29-May-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

3AVW6

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer

is extended,

is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNT ING AND APPROPRIATION DATA (If required)
13. T HIS IT EM APPLIES ONLY TO MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES T HE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT T O: (Specify authority) THE CHANGES SET FORT H IN ITEM 14 ARE MADE IN T HE
CONT RACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONT RACT /ORDER IS MODIFIED TO REFLECT T HE ADMINISTRAT IVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORT H IN IT EM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
X C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:
By mutual agreement of both parties.
D. OT HER (Specify type of modification and authority)
E. IMPORT ANT: Contractor

is not,X

is required to sign this document and return1

copies to the issuing office.

14. DESCRIPT ION OF AMENDMENT /MODIFICAT ION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)The purpose of this modification is to:1) Extend the delivery date for CLIN 0003 from 26 June 2020 to 10 July 2020.
2) Increase the unit price of CL N 0003 by (b) (4).
All other terms and conditions remain the same and in full force and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND T ITLE OF CONTRACTING OFFICER (Type or print)(b) (6) / CONTRACTING OFFICERTEL:(b) (6)
15B. CONT RACT OR/OFFEROR(Signature of person authorized to sign)
EXCEPTION T O SF 30
APPROVED BY OIRM 11-84

15C. DATE SIGNED

16B. UNIT ED ST AT ES OF AMERICA(b) (6)BY

EMAIL:(b) (6)
16C. DAT E SIGNED
01-Jul-2020(Signature of Contracting Officer)
30-105-04

ST ANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY20D0019
P00002
Page 2 of 4
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION A - SOLICITATION/CONTRACT FORM
The total cost of this contract was increased by $5,096.00 from $60,105,096.00 to $60,110,192.00.

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0003
The unit price amount has increased by (b) (4)The total cost of this line item has increased by (b) (4).
.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:Statement of Work
Manufacture of Lateral Flow Immunoassays
for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
For Defense Biological Product Assurance Office (DBPAO)
1.0 Scope. The scope of this work includes all activities required for a
SARS-CoV-2 lateral flow immunoassay (LFI) test system, including the
optimization and production of antigen screening test and all verification,
validation, and regulatory activities required to achieve Food and Drug
Administration (FDA) Emergency Use Authorization (EUA). Although, FDA
Licensure is anticipated, it is not part of this effort. The end product shall besuitable as an in vitro diagnostic (IVD) test for the detection of SARS-CoV-2
virus in specimens from infected persons or persons suspected of exposure to
SARS-CoV-2 and shall be intended for use at the point of care. The
determination of an FDA sponsor will be reviewed during the ordering period.
2.0 Background. The DBPAO was established in 1997 by the Joint Program
Executive Office Chemical Biological Radiological Nuclear Defense (JPEOCBRND) to support the need for an integrated biological defense capability.
The DBPAO serves as the principal source of high quality validated andstandardized biological reference materials, reagents and assays that meet thetechnology development and sustainment needs of the Department of Defense(DoD) and its partners. The DBPAO facilitates the transition of newtechnologies and coordinates their advanced development, efficient production
and timely distribution.

W911QY20D0019
P00002
Page 3 of 4

DBPAO has been tasked by the Acting Deputy Assistant Secretary of
Defense for Health Readiness Policy and Oversight (HRP&O) to support
SARS-CoV-2 response by rapidly developing and distributing antigen
detection immunoassays that will serve as a screening test for the novel
coronavirus, SARS-CoV-2. These screening tests will be used by DoD
civilians and service members, medical healthcare workers at military healthfacilities and other health agencies.
3.0 Requirements
3.1

Manufacturing Facility

3.1.1 Have manufacturing yield sufficient to meet Government delivery order
requirements of up to 1,000,000 kits per month (250,000 per week)
specifically 5,000 kits/week by 15 May 2020, scalable to 250,000 kits/week by
15 July 2020. This quantity shall not include kits intended for third party
conformance testing and contractor’s internal testing.
3.1.2 Inventory management procedures to store antigens, antibodies and assays
under the appropriate storage conditions as required by the label tomaximize performance integrity and shelf life.
3.1.3 Security monitoring, temperature and humidity controlled for production
area, with appropriate BioSafety Level and storage areas for assay materials
including emergency backup power.
3.1.4 Standard Operating Procedures for all procedures associated with
manufacturing, storage, and shipping of SARS-CoV-2 kits to assurecompliance with contractual requirements and all local, state, and federal
regulations and Standards.
3.3

SARS-CoV-2 Lateral Flow Immunoassay Kit

3.3.1 Deliverables
3.3.1.1 SARS-CoV-2 LFI kits for the detection of SARS-CoV-2
virus, nasal swabs and appropriate clinical buffer labeled in accordance with
Research Only Use (ROU) or as a EUA once approved. These kits shall bedelivered while maintaining product integrity.
3.3.1.2 Certificate of Conformance that includes specifications
and results of internal conformance testing with each manufacturing lot of
SARS-CoV-2 LFI kits.
3.3.2 Reagents

W911QY20D0019
P00002
Page 4 of 4

3.3.2.1 The Contractor shall be responsible for the production or procurement of
the reagents required for the manufacture of this SARS-CoV-2 LFI kit suchas recombinant viral capsid proteins; capture and detector antibodies,secondary antibodies, reference standards, near neighbor panel for
specificity testing, negative controls etc. The government will not provide
these reagents as government furnished materials.
3.3.2.2 The Contractor shall assume all risks and responsibilities in connection withthe handling, storage, disposal, transfer, and use of the assay materials
including appropriate safety and handling precautions to minimize health orenvironmental risk. The Contractor shall agree that any activity undertakenwith the manufacture of this assay will be conducted in compliance with allapplicable guidelines, laws and regulations, including Department of Defense
Instruction 5210.89 (DoDI 5210.89) for DoD recipients.
3.3.3 Regulatory Work/Emergency Use Authorization
3.3.3.1 Perform work delineated below from 15 June 2020 to 10 July 2020:
3.3.3.2 Eight (8) hours engagement with the Program Office and Government
Regulatory Team (ONE-RAQA); Two one-hour meetings per week to analyze
the Government Furnished Information (GFI).

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule item for CLIN 0003 has been changed from:
DELIVERY DATEQUANTITYSHIP TO ADDRESSPOP 23-JUN-2020 TO
26-JUN-2020

N/A

N/A
FOB: Destination

DELIVERY DATEQUANTITYSHIP TO ADDRESSPOP 23-JUN-2020 TO
10-JUL-2020

N/A

N/A
FOB: Destination

DODAAC /CAGETo:(End of Summary of Changes)

DODAAC /CAGE

1. CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P00003

PAGE OF P AGES

J

4. REQUISITION/PURCHASE REQ. NO.

1

2

5. P ROJECT NO.(If applicable)

21-Jul-2020

6. ISSUED BY

CODE

W911QY

7. ADMINISTERED BY (If other than item 6)

W6QK ACC-APG NATICK
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

CODE

See Item 6

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ANP TECHNOLOGIES, INC.
824 INTERCHANGE BLVDNEWARK DE 19711-3570

9A. AMENDMENT OF SOLICIT AT ION NO.
9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY20D0019

CODE

10B. DAT ED (SEE ITEM 13)
X 29-May-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

3AVW6

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer

is extended,

is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNT ING AND APPROPRIATION DATA (If required)
13. T HIS IT EM APPLIES ONLY TO MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES T HE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT T O: (Specify authority) THE CHANGES SET FORT H IN ITEM 14 ARE MADE IN T HE
CONT RACT ORDER NO. IN ITEM 10A.
X B. THE ABOVE NUMBERED CONT RACT /ORDER IS MODIFIED TO REFLECT T HE ADMINISTRAT IVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORT H IN IT EM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:
D. OT HER (Specify type of modification and authority)
E. IMPORT ANT: ContractorX

is not,is required to sign this document and returncopies to the issuing office.

14. DESCRIPT ION OF AMENDMENT /MODIFICAT ION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)The purpose of this modification is to change CLIN 0003 as stated below :1. The quantity is changed from(b) (4).
2. The unit price changed from(b) (4).
3. The delivery information is removed, delivery information specified in each delivery order.
All other terms and conditions remain the same and in full force and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND T ITLE OF CONTRACTING OFFICER (Type or print)(b) (6) / CONTRACTING OFFICERTEL:(b) (6)
15B. CONT RACT OR/OFFEROR(Signature of person authorized to sign)
EXCEPTION T O SF 30
APPROVED BY OIRM 11-84

15C. DATE SIGNED

16B. UNIT ED ST AT ES OF AMERICA(b) (6)BY

EMAIL:(b) (6)
16C. DAT E SIGNED
21-Jul-2020(Signature of Contracting Officer)
30-105-04

ST ANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY20D0019
P00003
Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0003
The pricing detail quantity has increased by (b) (4)The unit price amount has decreased by (b) (4).
.

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0003 has been deleted:
DELIVERY DATEQUANTITYSHIP TO ADDRESSPOP 23-JUN-2020 TO
10-JUL-2020

N/A

N/A
FOB: Destination(End of Summary of Changes)

DODAAC /CAGEAttachment 3
Conformance Testing Plan
LoD for live virus and the candidate LoD for the developer’s antigen will be identified as thelowest levels producing positive results for 3 of 3 replicates in their respective studies.
Study 2: Analytical Sensitivity (Limit of Detection)

The LoD will be determined for both live virus and the developer-provided antigen in thedeveloper-specified buffer. Initially, 32 replicates will be tested at the candidate LoD establishedduring range-finding. If there are any failures in the first round of testing, an additional 32
replicates will be performed at 2X the initial candidate LoD. Duplicate quality control blanks(QCBs) will also be tested in each round of LoD testing, so up to 68 tests will be required per
LFI. The LoD of each LFI will be defined as the lowest level tested that produced positive
results for 32 of 32 replicates.
Study 3: Analytical Specificity (Cross-reactivity/Exclusivity)

For analytical specificity testing, a minimum of five near neighbors (all coronaviruses) and apooled human nasal wash (to include diverse respiratory microflora) will be tested in triplicate.
Potential near neighbors include: SARS, MERS, human coronavirus 229E, human coronavirus
OC43, human coronavirus NL63, human coronavirus HKU1, and two SARS-like bat
coronaviruses. Final composition of the test panel will be based on stock availability at the timeof testing. Each near neighbor will be tested in developer-specified buffer at the highest level thestock concentration reasonably allows. This study will require 18-27 tests per LFI, depending on
the number of near neighbors available at the time of testing.
Study 4: Interfering Substances

Five interfering substances will be evaluated for their ability to cause false positive and/or false
negative results at concentrations comparable to or greater than levels that may be present in
respiratory samples (Table 2). All samples will consist of antigen diluted in the developerspecified buffer. Ability to cause false positive results will be determined by testing targetnegative samples containing the potentially interfering substance in triplicate. Ability to cause
false negative results will be similarly determined by testing samples spiked at 1X LoD in
triplicate, with follow-up testing at 10X LoD if any negative results are obtained at 1X LoD.
This will require 30-45 tests per LFI.

Page 2 of 4

Attachment 3
Conformance Testing Plan

Table 2. Test Scheme for Study 4
Replicateswithout
antigen

Replicateswith antigen
at 1X LoD

Replicateswith antigen
at 10X LoD(if applicable)

Total #of tests

Potentially Interfering
Substance

Concentration
to be Tested

Human whole blood

2% v/v

3

3

3

6-9

Mucin (purified salivary protein)

1 mg/mL

3

3

3

6-9

OTC Mouthwash
3 OTC nasal sprays(phenylephrine, oxymetazoline,
and fluticasone)
3 OTC throat spray (phenol,
benzocaine, and zincum)

5% v/v

3

3

3

6-9

5% v/v of each
(15% total)

3

3

3

6-9

5% v/v of each
(15% total)

3

3

3

6-9

Study 5: Evaluation with Contrived Specimens in Various Media Formulations

A series of contrived specimens will be prepared using NP swab specimens collected fromnegative donors and stored in one of three media formulations (Table 3). Five donor NP samples
will be collected per media formulation, and NP media from each sample will be tested in three
preparations: unspiked, spiked with live virus at 1X LoD, and spiked with live virus at 5X LoD.
Table 3. Test Scheme for Study 5
NP Medium# ofDonorsTests perdonor

Total #of tests

5

3

15

5

3

15

5

3

15

Developer's buffer(no intermediate transport buffer)
BD Universal Viral Transport
MediumLiquid Amies Transport Medium

Study 6: Evaluation with PCR-Positive Patient Specimens

Up to ten residual patient specimens that are PCR-positive for SARS-CoV-2 will be tested, asavailability allows. All patient specimens will consist of NP swabs in Universal Transport
Medium (UTM). LFI results will be reported alongside quantitative RT-PCR results to add
context.

Page 3 of 4

Attachment 3
Conformance Testing Plan

Materials and Information Required from Performers:
Materials to be provided by the LFI manufacturers as soon as possible: Draft Instructions for Use A list of any ancillary generic reagents/consumables that must be supplied by the user
Materials that can be provided by 24 April 2020, before initiating conformance testing: Final Instructions for Use 250 LFI tests and any test-specific reagents/consumables required to run them

Page 4 of 4