W911QY20P0141
Page 2 of 29
Section B - Supplies or Services and Prices

ITEM NO
0001

SUPPLIES/SERVICESQUANTITY
(b)

UNIT
Each

UNIT PRICE(b) (4)AMOUNT(b) (4)Development of LFI's
FFP
The contractor shall develop (b) (4)devices for testing andevaluation in accordance with specifications at Section C and Section J. Note: (b) (4)devices to be shipped (b) (4), (b) (4) devices shipped(b) (4), remaining
devices to be held until further instruction)
FOB: Destination
MFR PART NR: TBD
PURCHASE REQUEST NUMBER: 0011477047-0001
PSC CD: 6550

NET AMT
ACRN AA
CIN: GFEBS001147704700001

ITEM NO
0002

SUPPLIES/SERVICESQUANTITYOPTION

Technical Data Package
FFP
Technical Data Package to be negotiated.
FOB: Destination
MFR PART NR: TBD
PSC CD: 6550(b) (4)(b) (4)UNIT

UNIT PRICE

NET AMTAMOUNT
NSPW911QY20P0141
Page 3 of 29
Section C - Descriptions and Specifications
STATEMENT OF WORK (SOW)

Statement of Work (SOW)
Development of COVID-19 Lateral Flow Immunoassay (LFI) Assay Kits
For the Joint Product Lead- Enabling Biotechnologies (JPL-EB) Defense Biological
Product Assurance Office (DBPAO)

Task/Deliverable 1 & 2 – LFI Formulation Development, In-house Testing and Production:
Development of a rapid, simple to use, handheld LFI for detecting SARS-CoV-2 virus in
specimens from infected or suspected viral exposed persons. Offeror plans to produce an antigen
screening test for detecting SARS-CoV-2 in nasopharyngeal swab specimens. Dendrimers andtheir corresponding conjugates with different antibodies or binding pairs will be designed andsynthesized by the ANP synthesis team. Upon testing with recombinant protein or live orinactivated COVID-19 virus preparations, fine tuning of capture and detector antibody
formulations will be needed in order to identify the final optimized assay configuration. The
scope of this effort may include a medical device that is regulated by the US FDA which requires
FDA pre-market approval or clearance before commercial marketing may begin please reference
attachment 1 (FDA Guidance In Support of Diagnostic Emergency Use Authorization) and 2(Regulatory Rights).
Specifically,
1. Dynamic range (and LOD range-finding) using both inactivated/killedvirus and recombinant surface antigen protein will be tested to determine dynamic
range. A half-log serial dilution scheme will be tested up to seven different
concentrations of virus/antigen spiked into ANP specified buffer solution.
2. Analytical sensitivity using inactivated/killed virus or recombinant surface
antigen protein in ANP-specified buffer will be tested to determine the LOD. Basedon the replicates during range finding, additional rounds will be tested at 2X the initial
LOD, if any of the starting 32 elicit a failure at the candidate LoD established during
range finding above. Each round will consist of Quality Control Blanks (QCBs)
totaling (b) (4) individual tests per LFI. Final LOD for each LFI shall be defined as
the lowest tested concentration which produces positive results for (b) (4)LFI
replicates.
3. Analytical specificity (Cross-reactivity/Exclusivity) of up (b) (4)nearneighbors and pooled human nasal wash containing various respiratory microflora
will be evaluated in triplicate totaling (b) (4) per LFI. We plan to test the following
panel of near neighbors: SARS, MERS, human coronaviruses 229E, humancoronaviruses OC43 and human coronaviruses NL63. Near neighbors will be tested
in ANP-specified buffer at the highest stock concentration reasonably allowed for. In
lieu of clinical samples, ANP will utilize contrived samples for testing.
4. Interference testing of (b) (4)interferents will be evaluated for any
false positive and/or false negative results at concentrations similar to or greater thanthat which may be present in respiratory samples. Samples tested will consist ofrecombinant antigen diluted in the ANP-specified buffer. False positives areW911QY20P0141
Page 4 of 29

determined by testing antigen-negative samples containing the potentially interfering
substance in triplicate while false negatives will be determined by running spiked
samples at 1X LOD in triplicate followed by confirmation testing at 10X LOD in theevent that a negative result is observed at 1X LOD. A PCR comparator test may also
be used under the same testing conditions to compare with the LFI performance. In
addition, assay robustness and stability testing at various temperatures for at least one
year will also be carried out during the proposed effort.
5. Specificity evaluation with contrived specimens in different media
formulations will be done as a series of specimens prepared with nasopharyngeal
swab samples collected from virus negative individuals in up to three different
formulated medias. (b) (4)swabs are collected per media and the resulting
NP media from each is to be tested in three iterations as follows:(b) (4)

Task/Deliverable 3 – Deliver First Article Test Lot to Government Contracted
Conformance Testing Lab
Within (b) (4) days of verbal notification to start effort, offeror will deliver a First Article Testing(FAT) (b) (4)devices along with appropriate ANP buffer/reagents/controls andnasal swabs, deliver (b) (4) devices for testing and evaluation by a contracted third party, anddeliver(b) (4) devices for study. In addition, a final report encompassing test data and details to
informing the third party test lab and the Government program management office.
The Conformance Testing Plan for Lateral Flow Immunoassays (LFIs) for Biosurveillanceof SARS-CoV-2 (2019-nCoV) describing how the LFIsy will be evaluated by independent
conformance test laboratory is included as Attachment 3. The evaluation factors andrating criteria for LFI performance that the Defense Biological Product Assurance Office(DBPAO) will use is included as Attachment 4.
The contractor will deliver the required materials and information to independent
conformance test laboratory (b) (4)to:(b) (6)The contractor will ship (b) (4)required materials and information to Naval HealthResearch Center (NHRC) for field testing (b) (4)to:(b) (6)

W911QY20P0141
Page 5 of 29(b) (6)

In accordance with 252.227-7013 Rights in Technical Data--Noncommercial Items, theGovernment reserves the right to obtain for a technical data package which may include allapplicable technical data such as drawings, associated lists, specifications, design
descriptions, design databases, standards, performance requirements, quality assurance
provisions, manufacturing design and packaging details.
Attachment 1 FDA Guidance In Support of Diagnostic Emergency Use Authorization
Attachment 2 Regulatory Rights
Attachment 3 Conformance Test Plan
Attachment 4 Evaluation factors and rating criteria

W911QY20P0141
Page 6 of 29
Section E - Inspection and Acceptance

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

INSPECT AT
N/A
N/A

INSPECT BY
N/A
N/A

ACCEPT AT
N/A
N/A

ACCEPT BY
Government
Government

W911QY20P0141
Page 7 of 29
Section F - Deliveries or Performance

DELIVERY INFORMATIONDODAAC /
CAGE

CLIN

DELIVERY DATEQUANTITYSHIP TO ADDRESS

0001

24-APR-2020(b)

MEDICAL COUNTERMEASURE SYSTEMS W56XNH
JPL EB
110 THOMAS JOHNSON DRIVE
FORT DETRICK MD 21702
FOB: Destination

0002

N/A

N/A

N/A

N/A

W911QY20P0141
Page 8 of 29
Section G - Contract Administration Data

ACCOUNTING AND APPROPRIATION DATA
AA: 09720202021013000018170446463255
COST CODE: AHPIIAMOUNT: $766,254.00

S.0025760.7.5.1

6100.9000021001

ACRN

CLIN/SLINCINAMOUNT

AA

0001

GFEBS001147704700001$766,254.00

W911QY20P0141
Page 9 of 29
Section I - Contract Clauses
CLAUSES INCORPORATED BY REFERENCE

52.203-5
52.203-6
52.203-7
52.203-12
52.203-17
52.204-19
52.209-10
52.223-18
52.232-2
252.203-7000
252.203-7002
252.204-7012
252.209-7002
252.211-7003
252.225-7048
252.232-7010
252.235-7010
252.235-7011
252.243-7001

Covenant Against Contingent Fees
MAY 2014
Restrictions On Subcontractor Sales To The Government
SEP 2006
Anti-Kickback Procedures
MAY 2014
Limitation On Payments To Influence Certain Federal
OCT 2010
Transactions
Contractor Employee Whistleblower Rights and Requirement APR 2014
To Inform Employees of Whistleblower Rights
Incorporation by Reference of Representations andDEC 2014
Certifications.
Prohibition on Contracting With Inverted Domestic
NOV 2015
Corporations
Encouraging Contractor Policies To Ban Text Messaging
AUG 2011
While Driving
Payments Under Fixed-Price Research And Development
APR 1984
Contracts
Requirements Relating to Compensation of Former DoD
SEP 2011
Officials
Requirement to Inform Employees of Whistleblower Rights SEP 2013
Safeguarding Covered Defense Information and Cyber
DEC 2019
Incident Reporting
Disclosure Of Ownership Or Control By A Foreign
JUN 2010
Government
Item Unique Identification and Valuation
MAR 2016
Export-Controlled Items
JUN 2013
Levies on Contract Payments
DEC 2006
Acknowledgment of Support and Disclaimer
MAY 1995
Final Scientific or Technical Report
DEC 2019
Pricing Of Contract Modifications
DEC 1991

CLAUSES INCORPORATED BY FULL TEXT

52.213-4 TERMS AND CONDITIONS--SIMPLIFIED ACQUISITIONS (OTHER THAN COMMERCIALITEMS) (JAN 2020)(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses that areincorporated by reference:(1) The clauses listed below implement provisions of law or Executive order:(i) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(ii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided byKaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iii) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services orEquipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

W911QY20P0141
Page 10 of 29(iv) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).
(v) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vi) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).
(vii) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.s, proclamations, and statutes
administered by the Office of Foreign Assets Control of the Department of the Treasury).
(viii) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
(ix) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78 (19 U.S.C. 3805
note).
(2) Listed below are additional clauses that apply:(i) 52.232-1, Payments (APR 1984).
(ii) 52.232-8, Discounts for Prompt Payment (FEB 2002).
(iii) 52.232-11, Extras (APR 1984).
(iv) 52.232-25, Prompt Payment (JAN 2017).
(v) 52.232-39, Unenforceability of Unauthorized Obligations (JUN 2013).
(vi) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013).
(vii) 52.233-1, Disputes (MAY 2014).
(viii) 52.244-6, Subcontracts for Commercial Items (AUG 2019).
(ix) 52.222-55, Minimum Wages Under Executive Order 13658 (MAR 2016) (Applies when 52.222-6 or 52.222-41
are in the contract and performance in whole or in part is in the United States (the 50 States and the District ofColumbia)).
(b) The Contractor shall comply with the following FAR clauses, incorporated by reference, unless thecircumstances do not apply:(1) The clauses listed below implement provisions of law or Executive order:(i) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282)(31 U.S.C. 6101 note) (Applies to contracts valued at $30,000 or more).
(ii) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (Jan 2020) (E.O. 13126). (Applies tocontracts for supplies exceeding the micro-purchase threshold).
(iii) 52.222-20, Contracts for Materials, Supplies, Articles, and Equipment Exceeding $15,000 (MAY 2014) (41
U.S.C. chapter 65) (Applies to supply contracts over $15,000 in the United States, Puerto Rico, or the U.S. Virgin
Islands).
(iv) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212) (applies to contracts of $150,000 ormore).

W911QY20P0141
Page 11 of 29(v) 52.222-36, Equal Employment for Workers with Disabilities (JUL 2014) (29 U.S.C. 793) (Applies to contracts
over $15,000, unless the work is to be performed outside the United States by employees recruited outside theUnited States). (For purposes of this clause, ``United States'' includes the 50 States, the District of Columbia, Puerto
Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.)(vi) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212) (Applies to contracts of $150,000 ormore).
(vii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67) (Applies to service contracts
over $2,500 that are subject to the Service Contract Labor Standards statute and will be performed in the UnitedStates, District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S.
Virgin Islands, Johnston Island, Wake Island, or the outer Continental Shelf).
(viii)(A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627) (Applies
to all solicitations and contracts).
(B) Alternate I (MAR 2015) (Applies if the Contracting Officer has filled in the following information with regard
to applicable directives or notices: Document title(s), source for obtaining document(s), and contract performancelocation outside the United States to which the document applies).
(ix) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015) (Executive Order 13658) (Applies
when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50
States and the District of Columbia)).
(x) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706) (Applies when 52.222-6 or
52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States and theDistrict of Columbia.))(xi) 52.223-5, Pollution Prevention and Right-to-Know Information (MAY 2011) (E.O. 13423) (Applies to services
performed on Federal facilities).
(xii) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (June, 2016)(E.O. 13693)(applies to contracts for products as prescribed at FAR 23.804(a)(1)).
(xiii) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (June,2016) (E.O. 13693) (Applies to maintenance, service, repair, or disposal of refrigeration equipment and air
conditioners).
(xiv) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b) (Unless exempt
pursuant to 23.204, applies to contracts when energy-consuming products listed in the ENERGY STAR ® Programor Federal Energy Management Program (FEMP) will be-(A) Delivered;(B) Acquired by the Contractor for use in performing services at a Federally-controlled facility;(C) Furnished by the Contractor for use by the Government; or(D) Specified in the design of a building or work, or incorporated during its construction, renovation, or
maintenance).
(xv) 52.223-20, Aerosols (June, 2016) (E.O. 13693) (Applies to contracts for products that may contain high global
warming potential hydrofluorocarbons as a propellant or as a solvent; or contracts for maintenance or repair ofelectronic or mechanical devices).

W911QY20P0141
Page 12 of 29(xvi) 52.223-21, Foams (June, 2016) (E.O. 13693) (Applies to contracts for products that may contain high global
warming potential hydrofluorocarbons or refrigerant blends containing hydrofluorocarbons as a foam blowing agent;or contracts for construction of buildings or facilities.
(xvii) 52.225-1, Buy American--Supplies (MAY 2014) (41 U.S.C. chapter 67) (Applies to contracts for supplies, andto contracts for services involving the furnishing of supplies, for use in the United States or its outlying areas, if thevalue of the supply contract or supply portion of a service contract exceeds the micro-purchase threshold and theacquisition-(A) Is set aside for small business concerns; or(B) Cannot be set aside for small business concerns (see 19.502-2), and does not exceed $25,000).
(xviii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792)(Applies to contracts greater than $25,000 that provide for the provision, the service, or the sale of food in the
United States).
(xix) 52.232-33, Payment by Electronic Funds Transfer--System for Award Management (OCT 2018) (Applies
when the payment will be made by electronic funds transfer (EFT) and the payment office uses the System forAward Management (SAM) as its source of EFT information.)(xx) 52.232-34, Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013)(Applies when the payment will be made by EFT and the payment office does not use the SAM database as its
source of EFT information.)(xxi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. App. 1241)(Applies to supplies transported by ocean vessels (except for the types of subcontracts listed at 47.504(d).)(2) Listed below are additional clauses that may apply:(i) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (June, 2016) (Applies to contracts
when the contractor or a subcontractor at any tier may have Federal contract information residing in or transiting
through its information system.
(ii) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or
Proposed for Debarment (Oct 2015) (Applies to contracts over $35,000).
(iii) 52.211-17, Delivery of Excess Quantities (SEP 1989) (Applies to fixed-price supplies).
(iv) 52.247-29, F.o.b. Origin (FEB 2006) (Applies to supplies if delivery is f.o.b. origin).
(v) 52.247-34, F.o.b. Destination (NOV 1991) (Applies to supplies if delivery is f.o.b. destination).
(c) FAR 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/theseaddress(es):(Insert one or more Internet addresses)(d) Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to therequirements of this contract. The Government reserves the right to inspect or test any supplies or services that havebeen tendered for acceptance. The Government may require repair or replacement of nonconforming supplies orW911QY20P0141
Page 13 of 29
reperformance of nonconforming services at no increase in contract price. The Government must exercise its
postacceptance rights-(1) Within a reasonable period of time after the defect was discovered or should have been discovered; and(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in theitem.
(e) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence
beyond the reasonable control of the Contractor and without its fault or negligence, such as acts of God or the public
enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine
restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify theContracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay,
setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch,and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(f) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or
any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all
work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject tothe terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of
the work performed prior to the notice of termination, plus reasonable charges that the Contractor can demonstrate
to the satisfaction of the Government, using its standard record keeping system, have resulted from the termination.
The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for thispurpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor
shall not be paid for any work performed or costs incurred that reasonably could have been avoided.
(g) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event ofany default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails toprovide the Government, upon request, with adequate assurances of future performance. In the event of termination
for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it isdetermined that the Government improperly terminated this contract for default, such termination shall be deemed atermination for convenience.
(h) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for
use for the particular purpose described in this contract.
(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.

W911QY20P0141
Page 14 of 29(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W911QY20P0141
Page 15 of 29
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--W911QY20P0141
Page 16 of 29(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W911QY20P0141
Page 17 of 29(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.

W911QY20P0141
Page 18 of 29
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/W911QY20P0141
Page 19 of 29(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. ______________________________________________________________

W911QY20P0141
Page 20 of 29
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

W911QY20P0141
Page 21 of 29
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W911QY20P0141
Page 22 of 29
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)

252.227-7017 IDENTIFICATION AND ASSERTION OF USE, RELEASE, OR DISCLOSURE
RESTRICTIONS. (JAN 2011)(a) The terms used in this provision are defined in following clause or clauses contained in this solicitation-(1) If a successful offeror will be required to deliver technical data, the Rights in Technical Data--Noncommercial
Items clause, or, if this solicitation contemplates a contract under the Small Business Innovation Research Program,the Rights in Noncommercial Technical Data and Computer Software--Small Business Innovation Research (SBIR)
Program clause.
(2) If a successful offeror will not be required to deliver technical data, the Rights in Noncommercial Computer
Software and Noncommercial Computer Software Documentation clause, or, if this solicitation contemplates acontract under the Small Business Innovation Research Program, the Rights in Noncommercial Technical Data andComputer Software--Small Business Innovation Research (SBIR) Program clause.
(b) The identification and assertion requirements in this provision apply only to technical data, including computer
software documents, or computer software to be delivered with other than unlimited rights. For contracts to beawarded under the Small Business Innovation Research Program, the notification requirements do not apply totechnical data or computer software that will be generated under the resulting contract. Notification andidentification is not required for restrictions based solely on copyright.
(c) Offers submitted in response to this solicitation shall identify, to the extent known at the time an offer issubmitted to the Government, the technical data or computer software that the Offeror, its subcontractors or
suppliers, or potential subcontractors or suppliers, assert should be furnished to the Government with restrictions onuse, release, or disclosure.
(d) The Offeror's assertions, including the assertions of its subcontractors or suppliers or potential subcontractors or
suppliers shall be submitted as an attachment to its offer in the following format, dated and signed by an official
authorized to contractually obligate the Offeror:W911QY20P0141
Page 23 of 29
Identification and Assertion of Restrictions on the Government's Use, Release, or Disclosure of Technical Data or
Computer Software.
The Offeror asserts for itself, or the persons identified below, that the Government's rights to use, release, or disclose
the following technical data or computer software should be restricted:
Technical Data or Computer
Software to be FurnishedWith Restrictions * Basis for Assertion ** Asserted Rights Category ***(LIST) *****(LIST)(LIST)Name of Person
AssertingRestrictions ****

(LIST)*For technical data (other than computer software documentation) pertaining to items, components, or processes
developed at private expense, identify both the deliverable technical data and each such items, component, or
process. For computer software or computer software documentation identify the software or documentation.
**Generally, development at private expense, either exclusively or partially, is the only basis for asserting
restrictions. For technical data, other than computer software documentation, development refers to development of
the item, component, or process to which the data pertain. The Government's rights in computer software
documentation generally may not be restricted. For computer software, development refers to the software. Indicate
whether development was accomplished exclusively or partially at private expense. If development was notaccomplished at private expense, or for computer software documentation, enter the specific basis for asserting
restrictions.
***Enter asserted rights category (e.g., government purpose license rights from a prior contract, rights in SBIR data
generated under another contract, limited, restricted, or government purpose rights under this or a prior contract, or
specially negotiated licenses).
****Corporation, individual, or other person, as appropriate.
*****Enter "none" when all data or software will be submitted without restrictions.
Date __________________________________________________
Printed Name and Title ________________________________
Signature _____________________________________________(End of identification and assertion)(e) An offeror's failure to submit, complete, or sign the notification and identification required by paragraph (d) of
this provision with its offer may render the offer ineligible for award.
(f) If the Offeror is awarded a contract, the assertions identified in paragraph (d) of this provision shall be listed in
an attachment to that contract. Upon request by the Contracting Officer, the Offeror shall provide sufficient
information to enable the Contracting Officer to evaluate any listed assertion.
(End of provision)

252.232-7003
2018)

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS (DEC(a) Definitions. As used in this clause--W911QY20P0141
Page 24 of 29

Contract financing payment means an authorized Government disbursement of monies to a contractor prior toacceptance of supplies or services by the Government.
(1) Contract financing payments include-(i) Advance payments;(ii) Performance-based payments;(iii) Commercial advance and interim payments;(iv) Progress payments based on cost under the clause at Federal Acquisition Regulation (FAR) 52.232-16, Progress
Payments;(v) Progress payments based on a percentage or stage of completion (see FAR 32.102(e)), except those made under
the clause at FAR 52.232-5, Payments Under Fixed-Price Construction Contracts, or the clause at FAR 52.232-10,
Payments Under Fixed-Price Architect-Engineer Contracts; and(vi) Interim payments under a cost reimbursement contract, except for a cost reimbursement contract for services
when Alternate I of the clause at FAR 52.232-25, Prompt Payment, is used.
(2) Contract financing payments do not include-(i) Invoice payments;(ii) Payments for partial deliveries; or(iii) Lease and rental payments.
Electronic form means any automated system that transmits information electronically from the initiating system toaffected systems.
Invoice payment means a Government disbursement of monies to a contractor under a contract or otherauthorization for supplies or services accepted by the Government.
(1) Invoice payments include-(i) Payments for partial deliveries that have been accepted by the Government;(ii) Final cost or fee payments where amounts owed have been settled between the Government and the contractor;(iii) For purposes of subpart 32.9 only, all payments made under the clause at 52.232-5, Payments Under FixedPrice Construction Contracts, and the clause at 52.232-10, Payments Under Fixed-Price
Architect-Engineer Contracts; and(iv) Interim payments under a cost-reimbursement contract for services when Alternate I of the clause at 52.232-25,
Prompt Payment, is used.
(2) Invoice payments do not include contract financing payments.
Payment request means any request for contract financing payment or invoice payment submitted by the Contractor
under this contract or task or delivery order.

W911QY20P0141
Page 25 of 29
Receiving report means the data prepared in the manner and to the extent required by Appendix F, Material
Inspection and Receiving Report, of the Defense Federal Acquisition Regulation Supplement.
(b) Except as provided in paragraph (d) of this clause, the Contractor shall submit payment requests and receiving
reports in electronic form using Wide Area WorkFlow (WAWF). The Contractor shall prepare and furnish to theGovernment a receiving report at the time of each delivery of supplies or services under this contract or task ordelivery order.
(c) Submit payment requests and receiving reports to WAWF in one of the following electronic formats:(1) Electronic Data Interchange.
(2) Secure File Transfer Protocol.
(3) Direct input through the WAWF website.
(d) The Contractor may submit a payment request and receiving report using methods other than WAWF only when(1) The Contractor has requested permission in writing to do so, and the Contracting Officer has provided
instructions for a temporary alternative method of submission of payment requests and receiving reports in thecontract administration data section of this contract or task or delivery order;(2) DoD makes payment for commercial transportation services provided under a Government rate tender or acontract for transportation services using a DoD-approved electronic third party payment system or other exempted
vendor payment/invoicing system (e.g., PowerTrack, Transportation Financial Management System, and Cargo andBilling System);(3) DoD makes payment on a contract or task or delivery order for rendered health care services using the
TRICARE Encounter Data System; or(4) The Governmentwide commercial purchase card is used as the method of payment, in which case submission of
only the receiving report in WAWF is required.
(e) Information regarding WAWF is available at https://wawf.eb.mil/.
(f) In addition to the requirements of this clause, the Contractor shall meet the requirements of the appropriate
payment clauses in this contract when submitting payment requests.

(End of clause)

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).

W911QY20P0141
Page 26 of 29“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):(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.
(ii) For fixed price line items—(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting
Officer.
____________________________________________________________(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that
require shipment of a deliverable.)(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets therequirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by theContracting Officer.
____________________________________________________________(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for
fixed price line items for services.)(iii) For customary progress payments based on costs incurred, submit a progress payment request.
(iv) For performance based payments, submit a performance based payment request.

W911QY20P0141
Page 27 of 29(v) For commercial item financing, submit a commercial item financing request.
(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in thecontract.
[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice andreceiving report in one step.](3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in
applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*
Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC____

Issue By DoDAAC____

Admin DoDAAC**____

Inspect By DoDAAC____

Ship To Code____

Ship From Code____Mark For Code____

Service Approver (DoDAAC)____

Service Acceptor (DoDAAC)____

Accept at Other DoDAAC____

LPO DoDAAC____

DCAA Auditor DoDAAC____

Other DoDAAC(s)____(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert“See Schedule” or “Not applicable.”)(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the
DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the typeof payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition
Regulation 52.216-7, Allowable Cost and Payment, as applicable.
(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.
(g) WAWF point of contact.
(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s
WAWF point of contact.

W911QY20P0141
Page 28 of 29_________________________________________________________________(Contracting Officer: Insert applicable information or “Not applicable.”)(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
(End of clause)W911QY20P0141
Page 29 of 29
Section J - List of Documents, Exhibits and Other Attachments
ATTACHMENTS
Attachment No.
12
3
4

Description
FDA Guidance In Support of Diagnostic Emergency Use
Authorization
Regulatory Rights
Conformance Testing Plan
Evaluation Factors and Rating Criteria

Number of Pages
33
43

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

3 EFFECTIVE DATE

P000014 REQUISITION/PURCHASE REQ NO

CODE

1

2

5 P ROJECT NO (If applicable)

0011477047-0001

24-Apr-2020

6 ISSUED BY

PAGE OF P AGESJ

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 TECHNOLOG ES, INC.
824 NTERCHANGE BLVDNEWARK DE 19711-3570

9A. AMENDMENT OF SOLICIT AT ION NO.
9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY20P0141

CODE

10B. DAT ED (SEE ITEM 13)
X 17-Apr-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 T O MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES THE 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 THE
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 FORTH IN ITEM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT T O 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 add a delivery date of 31 May 2020 to unexcercised option CLIN 0002. 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 TITLE OF CONTRACTING OFFICER (Type or print)(b) (6)TEL:(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 SIGNEDEMA L:(b) (6)

16B UNIT ED ST AT ES OF AMERICA

16C. DAT E SIGNED

BY

24-Apr-2020(Signature of Contracting Officer)
30-105-04

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

W911QY20P0141
P00001Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0002
The pricing detail quantity
has been added.
The unit of issue Each has been added.
SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0002 has been added:
DELIVERY DATE
31-MAY-2020(End of Summary of Changes)

QUANTITYSHIP TO ADDRESSDODAAC /CAGE

MEDICAL COUNTERMEASURE SYSTEMS W56XNH
JPL EB
110 THOMAS JOHNSON DRIVE
FORT DETRICK MD 21702
FOB: Destination

Attachment 1
FDA Guidance In Support of Diagnostic Emergency Use Authorization
Surveillance assay status from Food and Drug Administration (FDA)
The government is intending to use these LFI tests on human clinical samples but not as an
Emergency Use Authorization (EUA) approved assay. Hence, it is seeking FDA’s advice andguidance on how to treat these assays as an intermediate between Laboratory Developed Test
(LDT) and a EUA test. Based on the outcomes of these discussion, the labeling and shipping
requirements for the final assay kits will be determined prior to shipping to the conformance testlab. It is recommended that the offeror initiate discussions with FDA on the following aspects: a)request a template for FDA submission; b) declare their intention to submit an EUA application;c) participate/attend FDA conference calls/meetings/town halls to familiarize with therequirements for submission. The EUA submission for COVID diagnostics has different
requirements and templates. The intention is to initiate the process in case the Government
desires to take an LFI assay through the process to obtain an EUA. Information from the FDA
and frequently asked questions for manufacturers can be found at:https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emergingthreats/coronavirus-disease-2019-covid-19. The FDA Division of Microbiology Devices can bereached at (301) 348-1778, or via e-mail at CDRH-EUA-Templates@fda.hhs.gov to obtain an
antigen EUA template. The manufactures will need to have quality compliance andorganizational accountability to support EUA for eventual diagnostic approval beyond initial
screening use.
FDA recommends that the following validation studies be conducted for a SARS-CoV-2 antigen
test – which the 3rd party test evaluation aligns with:····

Limit of Detection/Analytical Sensitivity
Cross-reactivity/Analytical Specificity
Microbial Interference
Clinical Agreement Study (JPEO is drafting agreement with the Naval Health ResearchCenter (NHRC) to support this with select performers during production phase)

Due to the pandemic, the FDA has allowed for a reasonable period of time after the manufacturer
validates the test to the submission of an Emergency Authorization (EUA) request. The FDA
believes that 15 business days is a reasonable period of time to prepare an EUA submission for atest whose performance characteristics have already been validated.
The following table contains the FDA recommendations and requirements for antigen based tests
from a manufacturer (not italicized). It has been laid out in a table to demonstrate/provide
additional guidance on activities (in italics) that can be done in parallel to ensure a rapidtransition from development to distribution.
Phase 1: Development and Validation Phase
Validation: All clinical tests should be
Activities that can be done concurrently withvalidated prior to use. In the context of adevelopment and validation activities:
public health emergency, it is especially Request an EUA Template from CDRHimportant that tests are validated as false
EUA-Templates@fda.hhs.gov
Page 1 of 3

Attachment 1
FDA Guidance In Support of Diagnostic Emergency Use Authorization
Surveillance assay status from Food and Drug Administration (FDA)
results can have broad public health impact
beyond that to the individual patient. FDA has
provided recommendations regarding theminimum testing that should be performed toensure analytical and clinical validity insection V below. FDA encourages
laboratories to discuss any alternative testingwith FDA that they would like to conduct.

If you need additional information forcompleting the EUA template, would liketo know how to submit your PreEUA/EUA submission to FDA, or wish toconsider use an alternative specimen type,please contact the Division of
Microbiology Devices at (301) 348-1778or the above email address

FDA defines SARS-CoV-2 antigen diagnostic
tests as those that detect SARS-CoV-2
antigens directly from clinical specimens.
FDA recommends that the following
validation studies be conducted for a SARSCoV-2 antigen test:· Limit of Detection/Analytical Sensitivity· Cross-reactivity/Analytical Specificity· Microbial Interference· Clinical Agreement Study

Information you begin to consider, or
activities you can complete prior to/for thetemplate, includes but is not limited to: The intended use of the product andwhether it is a qualitative or quantitative
type of procedure, e.g., screening,
physician's office, etc.
 You should have a system or procedure inplace to collect or track and processreports of nonconforming product oradverse events and report them to FDA
The clinical agreement study is intended toper 21 CFR 803.
establish the performance characteristics (e.g.,  You should have a website available forsensitivity/PPA, specificity/NPA) of the test.
users to report adverse events, obtain
FDA believes that clinical agreement should
product support, download productbe established on human specimens,
documentationpreferably leftover specimens from patients Product Documentation: you will need towith or without SARS-CoV-2 infection. If
create an Instructions For Use, a Fact
SARS-CoV-2 positive clinical specimens
Sheet for Health Care Providers, and acannot be obtained, it is acceptable to spike
Fact Sheet for Patientsleftover specimens with SARS-CoV-2
 You will need to provide your current
materials. For devices claiming multiple
manufacturing capabilities, including theclinical matrices, the most challenging matrix
approximate number of units/products
should be used in your validation studies.
that can currently be manufactured per
week, the number that could bemanufacturing in the event of a surge indemand, etc.
 FDA recommends that you consider
registration and listing your EUA productonce you have been issued an EUA.
Please see FDA’s website for process
here
Phase 2: Post-Validation Initial Distribution Phase
Notify: Following completion of assay
validation, manufacturers should notify FDA

Reporting of Results

Page 2 of 3

Attachment 1
FDA Guidance In Support of Diagnostic Emergency Use Authorization
Surveillance assay status from Food and Drug Administration (FDA)(e.g., e-mail to CDRH-EUATemplates@FDA.HHS.GOV) that their assay
has been validated and they intend to begin
distribution. This notification should include
the name of the manufacturer, address,
contact person, and a copy of the instructions
for use including summary of assay
performance. FDA will acknowledge receiptof this notification via auto-reply.
As noted above, FDA recommends that
manufacturers submit a completed EUA
request within 15 business days of the initialcommunication to FDA that the assay has
been successfully validated.
Manufacturers should provide information on
testing capacity, as well as the number oflaboratories in the U.S. with the required
platforms installed (if necessary). This
information will help the Agency andDepartment monitor the landscape as wework to ensure adequate testing capacity
across the country.

While awaiting FDA determination on the
EUA request, and in order to provide
transparency, FDA recommends that test
reports include a general statement that thetest has been validated but FDA’s
independent review of this validation ispending.
Labeling
While awaiting FDA determination on the
EUA request, FDA recommends that
manufacturers make publicly available on
their website the instructions for use,
including a summary of assay performance.
See (https://www.fda.gov/medicaldevices/device-labeling/vitro-diagnosticdevice-labeling-requirements#inserts) for
standard IVD labeling guidance re: IFU andperformance.

Phase 3: Request an EUA (Occurs in parallel with data generation; FDA interactive review)

FDA has made available, through download from their website, a template for test kit
manufacturers that is intended to facilitate the preparation, submission and authorization of an
EUA. Manufacturers can use alternative approaches. Manufacturers who intend to use
alternative approaches should consider seeking FDA’s feedback or advice to help themthrough the pre-EUA and EUA process. FDA encourages manufacturers to discuss any
alternative technological approaches with FDA through CDRH-EUATemplates@FDA.HHS.GOV.
FDA will communicate any questions or concerns regarding the completed EUA request or
EUA template to the manufacturer. FDA will also work collaboratively to address any
potential concerns or safety considerations raised in the request and will contact the
manufacturer regarding a final determination on the EUA request.
If FDA is not able to authorize an EUA, FDA intends to notify the manufacturer. FDA would
expect the manufacturer to suspend distribution and conduct a recall of the test.
Modifications to a manufacturer’s EUA-authorized test are submitted as an amendment to the
EUA. Where validation data supporting the modification has been submitted in theamendment, FDA does not intend to object to implementation of the modification while FDA
conducts its review.

Page 3 of 3

Attachment 2
Regulatory Rights
This Agreement may include research with an investigational drug, biologic or medical device
that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA premarket approval or clearance before commercial marketing may begin. Subject to further
negotiation between the parties, the Contractor or the Government may serve as the Sponsorof the Regulatory Application (an Investigational New Drug Application (IND),
Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License
Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market
Notification Filing (510(k)) or another regulatory filing submitted to FDA) that controls
research under this agreement. The Sponsor of the Regulatory Application to FDA (as theterms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t),812.2(b), 812 Subpart C, or 814.20) has certain standing before the FDA that entitles it to
exclusive communications related to the Regulatory Application.
a. With respect to any products regulated by the FDA for which the Contractor serves as
Sponsor, the Contractor agrees to the following:i. The Contractor shall provide to the Government all data, including top-line
summaries and key conclusions from all studies, supporting the regulatory filingand commercial approval to the extent that such data, summaries, and conclusions
are funded under this Agreement. In addition, the Contractor will offer theGovernment the opportunity to review and provide comments on a final draft ofregulatory submissions which include data funded under this Agreement. The
Government will review any such submissions promptly upon receipt. The
Contractor shall reasonably consider any comments provided by the Government,
and prior to submission shall provide notification to the Government of any
additional edits or revisions. The Contractor shall keep the Government reasonably
apprised of planned FDA meetings and post-meeting outcomes relating toactivities funded under this Agreement.
ii. Communications. The Contractor shall provide the Government with allcommunications and summaries thereof, both formal and informal, to or from
FDA regarding the regulatory submissions subject to this Agreement and ensurethat the Government representatives are invited to participate in any formal
Sponsor meetings with the FDA. The Contractor shall use its best efforts to ensurethat the Government representatives are invited to participate in any informal
Sponsor meetings with the FDA so long as the Contractor has 48 hour advancenotice of such Sponsor meeting from the FDA prior to the scheduled meeting time.
iii. Non-compliance with section (a)(ii) may result in termination of the agreement.
b. Product Development Failure. Certain product development failures may trigger
certain remedies in Section (c) below for the Government advanced developer funding
the development of the work in this Agreement. This remedy is not available to theGovernment for any cause outside of the following:i. if this agreement is terminated for nonperformance; orii. the Contractor gives notice, required to be submitted to the Government no later
than 30 business days, of any formal management decision to terminate thisPage 1 of 2

Attachment 2
Regulatory Rights
product development effort pre-market or to file for Federal bankruptcy
protection.
c. If any of the product development failures listed in section (b) occur, the Contractor,
upon the request of the Government:i. shall transfer possession, ownership and sponsorship or holdership of any
Regulatory Application (including any associated expedited review designation,priority review voucher, or marketing exclusivity eligibility or award), regulatory
correspondence, and supporting regulatory information related to the Technology
to the Government or its designee;
ii. shall inform FDA of the transfer of sponsorship or holdership of the Regulatory
Application transferred under section (c)(i) above; andiii. shall negotiate in good faith a non-exclusive license, at customary industry rates
and under reasonable terms and conditions, to any patent, copyright or otherintellectual property owned or controlled by the Contractor, developed prior to or
outside the scope of this agreement, or any technical data that is necessary for theGovernment to pursue commercialization of this technology with a third party forsale to the Government or otherwise.
d. This agreement will survive the acquisition or merger of the Contractor by or with athird party. This agreement will also be included in any subcontracts/sub agreements
relating to the development of the Technology. This agreement will survive theexpiration of the contracted agreements.

Page 2 of 2

Attachment 3
Conformance Testing Plan

Conformance Testing of Lateral Flow Immunoassays (LFIs)
for Biosurveillance of SARS-CoV-2 (2019-nCoV)
Overview of Planned Testing:
Six studies will be performed for each LFI:
1) Dynamic range (and LoD Range-finding)2) Analytical sensitivity (Limit of detection)3) Analytical specificity (Cross-reactivity/Exclusivity)
4) Interfering Substances
5) Evaluation with Contrived Specimens in Various Media Formulations
6) Evaluation with PCR-Positive Patient Specimens
For comparison, similar studies will also be performed using an Emergency Use Authorization(EUA) assay if available in for testing, otherwise an RUO version of the CDC’s 2019-nCoV
Real-time RT-PCR Diagnostic Panel and associated methods.
Study 1: Dynamic Range Testing and Limit of Detection (LoD) Range-Finding

Dynamic range testing will be determined for both live virus and the developer-provided antigen
in the developer-specified buffer. To test the dynamic range with virus and antigen, a half-log(~3.16-fold) dilution series will be prepared for both, consisting of up to seven different levels ofvirus/antigen tested in triplicate (Table 1).
Table 1. Example Test Scheme for Study 1, which will be performed with both live virus
and a developer-provided antigen preparation
Test level

Log/mL

Units/mL

Replicates

QCB

N/A

0

3

1

6.0

1,000,000

3

2

5.5

316,22833

5.0

100,000

3

4

4.5

31,623

3

5
6
7

4.0
3.5
3.0

10,000
3,162
1,000

3
3
3

Note: Actual levels tested may vary based on stock concentrations, anticipated LoDs, and results obtained during
the course of testing (e.g., lower levels will not be tested if negative results are obtained at higher levels).

Results interpretation will be performed both visually and with a CAMAG TLC Scanner 4.
Visual interpretation will be performed independently by two analysts, and a test will beconsidered visually inconclusive if the analysts’ interpretations do not match. The candidate

Page 1 of 4

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