W911SR23R0005_Amendment 00001.pdf

CODE

(Hour)

PAGE(S)

until 04:00 PM local time 02 Jun 2023

X

A X B X C X D

EX

X

G F

47 - 70 H 71 - 75

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 75

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W911SR 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and 1 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and via email conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 8

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

9 - 16

J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

19 - 20

K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 21 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIONS AND INSTRUCTIONS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

22 - 45

PART II - CONTRACT CLAUSES

USA CONTRACTING CMD-APG. - W911SR

EDGEWOOD CONTRACTING DIVISION

8456 BRIGADE STREET

BLDG E4215

ABERDEEN PROVING GROUND MD 21010-5401

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

02 May 2023

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W911SR23R0005

Section B - Supplies or Services and Prices

MIN/MAX ORDERING CEILING TAB

B.1 MINIMUM AND MAXIMUM QUANTITIES

As referred to in paragraph (b) of FAR Clause 52.216-22, “Indefinite Quantity” of this contract, the contract minimum quantity is a total of $1,000,000.00 worth of order. The maximum quantity is the total “not to exceed” amount of $35,000,000.00 for the cumulative sum of all orders to be issued under this IDIQ contracting vehicle.

This maximum quantity set forth herein is the total available for all orders issued under this solicitation/contract.

The maximum quantity may only be exceeded with prior written approval of the Procuring Contracting Officer.

Minimum Quantity Minimum Amount Maximum Quantity Maximum Amount

- $1,000,000.00 - $35,000,000.00

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 559,000 Each First Article Production Lot

FFP

First Article Production Lot of LFI Strips, Agent Specific FOB: Destination

PSC CD: 6550

NET AMT

0002 32,000,000 Each LFI Strips

FFP

LFI Strips for a Specific Agent

0003 1,080,000 Each Positive/Negative LFI Strips

FFP

Positive/Negative LFI Strips (Individual positive assay strips/Individual negative assay strips).

0004 Job Travel

COST

Travel

ESTIMATED COST

0005 12 Each CDRL A001 - Status Report

FFP

A001 - Status Report

0006 1 Each CDRL A002 - General Incident Reports

FFP

A002 General Incident Reports - As Needed

0007 1 Each CDRL A003 - Inspection and Test Plan

FFP

A003 Inspection and Test Plan

0008 1 Each CDRL A004 - Request for Deviation

FFP

A004 Request for Deviation (RFD) - As Needed

0009 1 Each CDRL A005 - Specification Change Notice

FFP

A005 Specification Change Notice (SCN) - As Needed

0010 1 Each CDRL A006 - Engineering Change Proposal

FFP

A006 Engineering Change Proposal (ECP) - As Needed

0011 1 Each CDRL A007 Configuration Management Plan

FFP

A007 Configuration Management Plan (CMP)

0012 1 Each CDRL A008 Quality Assurance Program Plan

FFP

A008 Quality Assurance Program Plan (QAP)

0013 1 Each CDRL A009 First Article Qualification

FFP

A009 First Article Qualification Test Plan and Procedures

0014 1 Each CDRL A010 - FAT Inspection Report

FFP

A010 FAT Inspection Report

0015 1 Each CDRL A011 - GFP Inventory Report

FFP

A011 GFP Inventory Report

0016 1 Each CDRL A012 - Certificate of Conformance

FFP

A012 Certificate of Conformance, NSP*

0017 1 Each

CDRL A013 - GFP PMS

FFP

A013 Government Furnished Property Property Management System, NSP*

0018 1 Each

CDRL A014 - GFP PMP

FFP

A014 Government Furnished Property, Property Management Plan, NSP*

Section C - Descriptions and Specifications

STATEMENT OF WORK

Manufacture of Lateral Flow Immunoassay (LFI) Strips For Defense Biological Product Assurance Office (DBPAO)

1.0 Scope: This Statement of Work (SOW) addresses the program objectives for the manufacture of LFI strips for the DBPAO. The LFI strips are to be used in the assembly of end items for the Joint Biological Point Detection System (JBPDS), and the Joint Portal Shield (JPS) System, as well as individual Hand Held Assays (HHA) used by Department of Defense entities for domestic preparedness, Homeland Defense, counter-terrorist operations and by Other Government Agencies (OGAs). These LFI strips may also be distributed to end users of DBPAO products or supplied as Government Furnished Materials (GFM) when needed for government contracted activities. DBPAO reviews all requests for LFI strips to ensure that these strips are only delivered to qualified entities.

1.1 Background: The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), with its headquarters in Aberdeen Proving Ground, MD has cognizance over DBPAO, JBPDS and JPS programs. These programs (and others) provide the Department of Defense with equipment and materials to detect and identify biological warfare agents (BWA).

1.2 Mission Statement: The DBPAO mission is to serve as the principal resource of high quality, validated, and standardized biological detection assays and reagents that meet the requirements of the Warfighter and Joint Biological Defense Systems, and support the biological defense community by facilitating the transition of new technologies and coordinating their advanced development, efficient production, and timely distribution.

2.0 Requirements:

The contractor shall manufacture LFI strips, using Government furnished antibodies and inactivated antigen (testing purposes), for the detection of specific antigens (toxins, virus, and bacterial pathogens) that do not require Bio- Safety Level 2 (or higher) containment and positive / negative control strips in accordance with Government specifications (LFI Strip Drawing 5-15-19324 and LFI performance criteria listed in section 3.6 of this SOW).

Upon issuance of a delivery order, the Government will provide the contractor with a table that outlines the quantities and specific antigens needed for delivery as well as the schedule for when the GFM will be provided to ensure manufacturing and delivery can occur by the end delivery date. The contractor shall be notified as soon as practicable on changes to the antigens or individual quantities of antigen specific LFI strips required by the Government to minimize manufacturing interruptions.

Manufactured LFI shall perform in accordance with performance criteria specified in Section 3.6. The LFI strips will be produced using Government-furnished antibodies in a production environment limiting exposure to particulates and other environmental contaminants and in a manner that allows for manufacturing yield sufficient to meet Government delivery order requirements and all other requirements of the contract to include Government conformance testing and internal contractor testing without affecting quantity requirements specified in delivery orders (i.e., if delivery order is 1,000 strips and 200 strips are required for conformance and internal contractor testing then the lot size produced should be 1,200). The contractor shall provide LFI strips in single agent lot size quantity ranges from 1,000 up to and including 100,000 strips. The contractor shall provide positive / negative control strips in quantities from 50,000 up to and including 100,000 strips per lot. The contractor shall deliver LFI strips to a Government-designated end-item manufacturer1 in such a manner as to ensure product performance integrity in accordance with Government specifications (LFI Strip Drawing 5-15-19324 and LFI performance criteria listed in section 3.6 of this SOW). The LFI strip manufacturer shall send strips in such a fashion to maintain the product performance. This includes mitigating any physical damage to the strips as well as maintaining temperature at 4°C to maintain shelf-life integrity.

3.1 Manufacturing Facility

3.1.1 The LFI manufacturer shall provide manufacturing capacity sufficient to accommodate the potential maximum strip quantities required as detailed in above section 2.0. This also includes receipt of GFM and manufacture, storage, and delivery of finished products within the delivery times specified in the contract.

3.1.2 The LFI manufacturer shall follow manufacturing procedures regarding temperature, humidity and environmental production environment and limit product exposure to particulates and other environmental contaminants to ensure LFI performance integrity (see Section 3.6 of this SOW). LFI Strip performance criteria details will be provided by the Government per delivery order.

3.1.3 The LFI manufacturer shall have facility temperature, humidity, and security monitoring.

3.1.4 The LFI manufacturer shall have facility back-up power for a minimum of 72 hours to maintain required storage conditions of Government Furnished Materials and unfinished/finished product.

3.1.5 The LFI manufacturer shall deliver LFI strips to the Government-designated end-item manufacturer under appropriate temperature and packaging conditions defined under each delivery order to maximize performance integrity and shelf life (see Section 3.0 and Section 3.6 of this SOW). The contractor shall use a commercially available temperature recording device to monitor temperature throughout the shipping process.

3.2 Quality Control

3.2.1 Inspection and Test Plan. The contractor / subcontractor performing Inspection and Testing on manufactured LFIs shall do so in accordance with CDRL A003 to ensure LFI meet Government acceptance criteria. The contractor shall submit the Inspection and Test Plan with the first delivery order after contract award.

3.2.2 Stability Test Plan. The contractor / subcontractor that manufacture LFIs shall perform real time and accelerated stability testing in accordance with CDRL A003. Real time stability testing periodicity shall follow a full factorial design pattern with testing at 0, 3, 6, 9, 12, 18, 24, 36 and 48-month time points at a minimum, as required. Stability testing is required to establish/verify stability of LFI and shall be performed on the first three productions lots for each agent only. In no event will stability testing be required beyond the maximum five-year life of the contract. The contractor shall submit the Stability Test Plan with the first delivery order.

3.2.3 First Article Test Plan. The contractor / subcontractor that manufactures LFIs shall submit a First Article Test (FAT) plan in accordance with CDRL A009. The FAT Plan shall include a sampling plan based on the ANSI Z1.4 (2003) standard. The plan will describe the actual sampling technique to be used as well as lot size, calculations, tests to be executed and specifications uses for passing / failing a First Article lot. The contractor shall submit the FAT Plan with the first delivery order. The contractor shall submit a draft FAT Plan 60 days after contract start for Government comments and submit a final FAT Plan 15 days after receipt of Government comments, in accordance with CDRL A0009.

3.2.4 First Article Testing. The contractor and any subcontractor that manufactures LFIs shall perform testing on the First Article of each type of LFI strip at the delivery order level, in accordance with the Government approved First Article Test Plan (see Section 3.2.3 of this SOW). The first article lot shall be manufactured using the same methods, materials, equipment, processes, inspections, in-process tests and facilities that will be used during regular production. The FAT shall be performed on LFI strips incorporated into the HHA configuration. The contractor shall deliver a subset of each First Article lot in HHA configuration to a Government-appointed Test Facility for additional acceptance testing. If any First Article sample fails to comply with any of the applicable requirements, the First Article sample shall be rejected.

3.2.4.1 First Article Test (FAT) and Inspection Report. The contractor shall submit First Article Test (FAT) and Inspection Report to the Government via email within 10 business days after completion of testing, in accordance with CDRL A010. The FAT report shall include raw test data, compiled and calculated data, and conclusions drawn from inspection and test results. Government approval or comments will be provided 15 days after receipt of the report. The contractor shall submit the First Article Test (FAT) and Inspection Report with every Delivery Order.

3.2.5 Production Article Test Plan. The contractor shall submit a Production Article Test Plan in accordance with CDRL A003, with the first delivery order. The Production Article Test Plan shall include a sampling plan based on the ANSI Z1.4 (2003) standard. The plan will describe the actual sampling technique to be used as well as lot size, calculations, tests to be executed and specifications used for passing / failing a production lot.

3.2.6 Production Article Testing. The contractor / subcontractor that manufactures LFIs shall perform Production Article testing on each lot of LFI in accordance with CDRL A003. In addition, the contractor shall incorporate a subset of each Production Article lot into HHA configuration and deliver to Government-appointed Test Facility for verification testing.

3.2.7 Certificate of Conformance (CoC). The contractor shall provide a CoC with each lot of LFI that will include, at a minimum, performance (sensitivity, specificity, antigen response and non-specific reactivity) and physical specifications (test / control line placement, strip length, strip thickness and strip thickness over sample pad), in accordance with CDRL A012. The contractor shall use a CoC template approved by the Government. The contractor shall provide a CoC with delivery of each production lot of LFI strips per delivery order.

3.3 Configuration Management

The contractor shall prepare and submit for Government approval a Configuration Management Plan (CMP) in accordance with CDRL A007, at the first delivery order. The CMP shall ensure that product configuration baselines are defined, and changes proposed to configuration baselines are necessary, appropriate, and acceptable to the Government to ensure the integrity of the deliverables is maintained.

3.4 Program Management

3.4.1 The contractor shall maintain an Integrated Master Schedule (in MS Project Format [Gantt]) for all contract tasks / deliverables to include timeline for First Article and Production Article testing that reflects the minimum order of production lots to be completed in the first year.

3.4.2 The contractor shall participate in meetings in accordance with the CDRLs and requests from the government technical team. The contractor shall capture meeting minutes and submit them in with the monthly status reports.

3.4.3 The contractor shall submit Monthly Status Reports seven business days after the end of each month, in accordance with CDRL A0001. Monthly status reports shall include cost data updates, status of inventory (condition, expiration dates, lot numbers, quantities), LFI strip cutting yield, out of specification or waste products associated with antibodies and antigens used to manufacture LFI, and information on existing or potential problem areas and recommendations to resolve the problems. Monthly status reports will be at the Delivery Order level.

3.5 Quality Management Systems

3.5.1 The contractor and any subcontractors that manufacture, test and / or distribute LFIs shall have and maintain a Quality Management System that is equivalent to ISO 9001:2015 standards to ensure the items are produced, stored, and distributed in accordance with the Government requirements.

3.5.2 The contractor shall prepare and submit for Government approval a Quality Assurance Plan (QAP) that includes all subcontracted efforts, if applicable, in accordance with CDRL A008. The contractor shall submit a QAP at the first delivery order. The QAP shall clearly define the quality standards that will be employed in the following areas: facilities, equipment, personnel, methods, practices, records, controls, and procedures to ensure appropriate corrective action in response to nonconforming material and in response to Government relayed customer complaint or deficiency report.

3.6 LFI Performance Criteria

The contractor shall produce LFI strips that meet the performance criteria listed below. Upon contract award, awardee will be provided performance criteria details for all the criteria listed below.

3.6.1 Dose Response Curve

Test line intensity for each antigen shall evidence significant differences when measured at three different concentrations, as provided by the Government, and shall be assessed by adding /subtracting one standard deviation (at each concentration) from the average. There shall be no overlap between each concentration. A theoretical optimized dose response curve is shown in Figure 1.

Figure 1 – Typical Dose Response Curve

3.6.2 Sensitivity

LFIs shall achieve an average control line intensity of minimally 450 scan units and test line intensity of 30±5 scan units at conventional assay sensitivity. Conventional assay sensitivity is defined as the point on the curve, starting from the lowest concentration, where the minimal response concentration of antigen would first produce a replicable value of 30 scan units.

Target levels for each agent will be provided through the LFI Conformance Test Plan.

3.6.3 Specificity (False Positives)

Specificity will be assessed against a panel of eleven (11) relevant environmental (vehicular, battlefield, non-biological contaminants) and biological entities (near neighbor organisms, suspicious powders, biological contaminants) at concentrations appropriate for DBPAO requirements in accordance with the LFI Conformance Test Plan which will provided after contract award. Any replicate that develops against signal intensity equivalent to or greater than CAMAG™TCL-3 scanner units, in the test window, will render the PDM cross reactive for that environmental/biological activity.

Test line results shall be ≥ 30 scan units.

3.6.4 Cross Reactivity (Non-Specific Binding)

Table 1 Cross Reactant Panel

DBPAO# Organism Stock

Concentration Test Concentration

DBPAO07 BSA 1 mg/ml 3 ug/ml in PBST DBPAO08 Burning diesel 1:10 in H2O 1:10 in H2O (as received) DBPAO09 Burning vegetation 1:10 in H2O 1:1 in PBST DBPAO14 Francisella tularensis 2.5E8 1.5E6 cfu/ml in PBST DBPAO16 Loamy soil 1% in PBS 0.1% in PBST DBPAO17 Malathion 5 mg/ml 1 mg/ml in PBST DBPAO19 Ovalbumin/Albumin 1 mg/ml 3 ug/ml in PBST DBPAO22 Sage Pollen 4 mg/ml 3 ug/ml in PBST DBPAO23 Antigen 2 1.0 mg/ml 3 ug/ml DBPAO27 Water N/A straight DBPAO28 Antigen 1 4.9E7 4.9E5 cfu/ml

The results from test exposure to the Cross-reactive panel, provided by the Government, shall be < 30 scan units.

The above cross reactant panel will be used, unless otherwise notified by USG in writing.

3.6.5 Physical Specifications / Tolerances

3.6.5.1 Manufactured LFI strips shall adhere to the tolerances for test line placement, control line placement, strip length, strip thickness and strip thickness over sample pad listed in Table 3. The Assay Dimensional drawing 5-15- 19324 is referenced.

Table 2 – Performance Criteria – LFI Strip Physical Tolerances

PARAMETER TOLERANCE RANGES (INCHES)

Test Line Placement 1.045 ± 0.02 Control Line Placement 1.435 ± 0.02 Strip Length 2.311 ± 0.01 Strip Thickness 0.052 ± 0.01 Strip Thickness over Sample Pad 0.060 ± 0.01

3.7 Testing

3.7.1 Testing will incorporate contractor requirements set forth in above.

3.7.2 The Government will perform conformance testing to verify contractor results. The contractor shall provide sample lot sizes to the US Government conformance test lab in accordance with the approved first article and production test plans submitted by the contractor.

4.0 Change Requests

4.1 The contractor shall submit a Request for Deviation (RFD) (CDRL A004) for deviations from Contractor-owned and Government-owned technical documents such as performance specifications and/or engineering drawings, in accordance with CDRL A004, on the delivery order level. Examples of deviations would be if a component or part of the LFI strip were no longer available (or different version/model), the contractor would submit a request for deviation for replacement of component or part. The Government will provide approval or comments 15 days after receipt of RFD.

4.2 The contractor shall submit a Specification Change Notice (SCN) (CDRL A005) if permanent changes are needed to existing Government-owned technical documents that include LFI performance specifications and engineering drawings. Examples of these permanent changes that need SCNs would be changes to production lot release specifications or other sensor programs change their performance criteria. Government approval or comments will be provided 15 days after receipt of SCN.

4.3 The contractor shall submit an Engineering Change Proposal (ECP) (CDR: A006) for any substantive and permanent changes to existing Government-owned technical documentation such as LFI performance specifications and engineering drawings. Examples of these substantive and permanent changes would be changes to antibodies, major labeling, OBE material changes, or packaging changes. Government approval or comments will be provided 15 days after receipt of ECP.

4.4 The Contractor shall not implement engineering changes or deviations which affect Government-owned technical documents without prior Government approval. The Government will maintain formal configuration control of all Government-furnished technical data.

4.5 The contractor shall submit General Incident Report (CDRL A002), at the delivery order level, for incidents that could result in a program, production, or delivery delay. Report incident to the Government telephonically within one day of incident occurrence. Submit a written report describing the incident to the Government via email within three business days of incident occurrence.

5.0 Meetings

5.1 The contractor shall participate in one Start of Work Meeting with the Government 30 business days after contract start. This can be a virtual or in-person meeting, depending on the status of COVID-19 restrictions on the day the meeting is scheduled. Include the start of work meeting minutes in the first status report (CDRL A001).

The Start of Work Meeting is only for the first year.

5.2 The contractor shall participate in monthly meetings with the Government to discuss contract status and any existing or potential issues/problems. Monthly meetings can be virtual or in-person, depending on the status of COVID-19 restrictions on the day the meeting is scheduled. Monthly meetings will be at the Delivery Order level.

6.0 Travel

6.1 The contractor shall travel as requested to support the DBPAO requirements: unforeseen technical issues requiring travel to the DBPAO Headquarters, End Item Assembler Conference Test Laboratory, and be able to participate in teleconferences. The Government will provide funding for travel. The Government will include Travel at the Delivery Order level.

6.2 The contractor shall submit and receive approval by US Government Contracting Officer before any reimbursable travel requirements are executed. Travel shall be cost reimbursable for approved reimbursable travel.

7.0 CDRLs

The contractor shall provide the data items requested in the Department of Defense 1423 (Contract Data Request List; CDRLs):

A001 – Monthly Status Report A002 – General incident Report A003 – Inspection and Test Plan A004 – Request for Deviation (RFD) A005 – Specification Change Notices (SCN) A006 – Engineering Change Proposals (ECP) A007 – Configuration Management Plan A008 – Quality Assurance Plan (QAP) A009 – First Article Test Plan (FAT) A010 – FAT/Inspection Test Report A011 – Government Property (GP) Inventory Report A012 – Certificate of Conformance (CoC) A013 – Property Management System Procedures A014 – Property Management Plan

8.0 Government Furnished Property

8.1 Equipment – The Government is currently using a CAMAG™ TCL-3, # 160224 scanner at the Government appointed Conference Test Laboratory to perform tests of the LFI strips. The contractor shall receive a CAMAG™ TCL-3 from government or be given access to use the CAMAG™ TCL-3 scanner. The contractor shall return the CAMAG™ TCL-3 scanner at the end of the contract.

8.2 Materials– The Government will provide materials (antibodies and antigens) to be used in the manufacture of LFI strips. A complete list of these materials will be provided upon award of contract. The contractor shall follow local, state and government regulations in the disposal of expired GFM.

8.3 The contractor shall provide monthly an updated government property (GP) inventory report, in accordance with CDRL A011. The GP inventory report shall be submitted at the delivery order level. The Government will provide the GP inventory report template. Instructions on how to fill out the report will be included with the template.

8.4 Both the requiring activity and Contractor shall utilize GFP Property Transfer to document shipment and receipt of GFP per DoDI 4161.02 and DFARS 252.211-7007.

8.5 All GFP provided not consumed will be returned to the customer unless notification in writing is provided by the customer to submit specific items in Plant Clearance function of the GFP Module in Procurement Integrated Enterprise Environment (PIEE). Any remaining Government property not reutilized, transferred, or otherwise disposed of at contract closeout, shall be submitted in the Plant Clearance function of the GFP Module in PIEE. If applicable, Contractor is responsible for demilitarization. If applicable, Contractor is responsible for transportation or shipping to Defense Logistics Agency Disposition Services (DLA DS).

8.6 Government property will be inventoried at least every 3 years at a minimum and classified or sensitive property must be inventoried at least annually.

8.7 The Contractor shall prepare and submit a Property Management System procedures, in accordance with FAR 52.245-1(f), within 60 days of award of contract (CDRL A013).

The Contractor shall prepare and submit a Property Management Plan (CDRL A014) to describe its approach to managing Government property (GP), Government-furnished property (GFP) and/or contractor-acquired property (CAP), throughout the performance of this contract, per FAR 45.202(b). This plan shall address each of the following ten outcomes per FAR 52.245-1(f)(i)-(x) and provide a brief overview of how it is addressed within the Contractor’s written Property Management System Procedures:

Acquisition – Contractor shall describe how property acquisitions, Government-furnished property (GFP) and/or contractor-acquired property (CAP), are documented, per FAR 52.245-1(f)(1)(i).

Receipt – Contractor shall describe how property receipt of all GP is documented, recorded, and identified, per FAR 52.245-1(f)(1)(ii) and DFARS 252.211-7007(f).

Records – Contractor shall describe how property records are created and maintained, per FAR 52.245- 1(f)(1)(iii).

Physical Inventory – Contractor shall describe a method to perform, record, and disclose physical inventory results, per FAR 52.245-1(f)(1)(iv). Contractor shall also disclose frequency of inventories.

Subcontractor Control – Contractor shall describe whether contractual terms and conditions are flowed down to subcontractors, per FAR 52.245-1(f)(1)(v)(A). Contractor shall outline how subcontracts are properly administered and when reviews of subcontractor Property Management Systems are performed, per FAR 52.245-1(f)(1)(v)(B).

Reports – Contractor shall describe a process to create and provide property-related reports, per FAR 52.245- 1(f)(1)(vi).

Relief of Stewardship Responsibility and Liability – Contractor shall describe a process to recognize, investigate, and report losses of Government property, per FAR 52.245-1(f)(1)(vii) and DFARS 252.245-7002.

Utilization – Contractor shall describe how Government property is to be used, consumed, moved, and stored, per FAR 52.245-1(f)(1)(viii).

Maintenance – Contractor shall describe how Government property is to be maintained, and when property requiring replacement and/or capital rehabilitation is to be reported to the Property Administrator, per FAR 52.245-1(f)(1)(ix).

Property Closeout – Contractor shall outline how property closeout is performed and when it is reported to the Property Administrator, per FAR 52.245-1(f)(1)(x) and 252.245-7004 (Deviation).

The Contractor shall address the use of the GFP Module in Procurement Integrated Enterprise Environment (PIEE) for Property Loss in accordance with DFARS 252.245-7002, Plant Clearance in accordance with DFARS 252.245- 7004 (Class Deviation) and Property Transfer in accordance with DFARS 252.211-7007(f).

The Contractor shall describe the use of the CAP Pre-Screening of the GFP Module in PIEE for any Contractor inventory (as defined in FAR 52.245-1) during the performance of the contract and for contract closeout.

Contractor submission shall also include a description of the Property Management System and any customary commercial practices, voluntary consensus standards, or industry-leading practices and standards to be used in managing Government property.

It is recommended that Contractor’s incorporate specific Statement of Work requirements into their GP Property Management Plan. For example, GP deliverables (e.g., CDRL) would be included in Reports.

The Property Management Plan is not part of the evaluation but will be reviewed for adequacy and to determine that it meets the requirements of FAR 52.245-1, and is appropriately tailored to complexity, sensitivity, and value of the property proposed to be provided and/or acquired.

9.0 Security

9.1 The contractor shall protect and secure all Government furnished properties (GFP and GFI).

9.2 The Contractor shall keep Government Furnished Information (GFI) (documents or other media) in the strictest confidence and restrict access to GFI only to contractor's employees who need such information to perform the work under this SOW.

9.3 The Contractor shall execute security requirements outlined in the Department of Defense Chemical, Biological, and Radiological Defense Research, Development and Acquisition Security Classification Guide, dated September 7, 2018, as well as any other applicable Security Classification Guides. The applicable Security Classification Guide(s) will be transmitted to the Contractor by the Contracting Officer Representative and will be available for download at the Defense Technical Information Center website (https://dtic.mil).

9.4 Per AR 530‐1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

9.5 The Contractor will have access to and be required to store Controlled Unclassified Information (CUI).

Contractor must comply with NIST 800-171 (Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations) in accordance with DFARS clause 252.204-7012.

Section D - Packaging and Marking

PACKING

Package end items in accordance with the Statement of Work for delivery of LFI strips to a government-designated end-item manufacturer in such a manner as to best maintain product integrity, maintenance of temperature and humidity requirements.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government N/A Government 0002 Destination Government N/A Government 0003 Destination Government N/A Government 0004 Destination Government N/A Government 0005 Destination Government N/A Government 0006 Destination Government N/A Government 0007 Destination Government N/A Government 0008 Destination Government N/A Government 0009 Destination Government N/A Government 0010 Destination Government N/A Government 0011 Destination Government N/A Government 0012 Destination Government N/A Government 0013 Destination Government N/A Government 0014 Destination Government N/A Government 0015 Destination Government N/A Government 0016 Destination Government N/A Government 0017 Destination Government N/A Government 0018 Destination Government N/A Government

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 5 yrs. ADC 559,000 JPEO-CBRND

SEE DELIVERY SCHEDULE FOR

LOCATIONS

APG MD 21010

W56XNH

0002 5 yrs. ADC 32,000,000 (SAME AS PREVIOUS LOCATION)

0003 5 yrs. ADC 1,080,000 (SAME AS PREVIOUS LOCATION)

0004 N/A N/A N/A N/A

0005 5 yrs. ADC 12 JPEO-CBRND

SEE DELIVERY SCHEDULE FOR

LOCATIONS

APG MD 21010

0006 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0007 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0008 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0009 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0010 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0011 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0012 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0013 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0014 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0015 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0016 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0017 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

0018 5 yrs. ADC 1 (SAME AS PREVIOUS LOCATION)

Section G - Contract Administration Data

CONTRACT ADMINISTRATION DATA

Contracting Officer (KO) Susan E. Ruzicka ACC-APG-Edgewood Division, Fort Detrick Branch 110 Thomas Johnson Dr.

Frederick, MD 21702 301.619.8802 susan.e.ruzicka2.civ@army.mil

Contract Specialist (CS) Ursela C. Jackson ACC-APG-Edgewood Division, Fort Detrick Branch 110 Thomas Johnson Dr.

Frederick, MD 21702 301.619.8401 ursela.c.jackson.civ@army.mil

Contracting Officer Representative (COR) Brady W. Redmond, Ph.D.

Defense Biological Product Assurance Office Joint Project Lead, CBRND Enabling Biotechnologies (JPL CBRND EB) Bldg. E5101, Rm. 185

APG-EA, MD 21010

410.417.0121 brady.w.redmond.civ@army.mil

Section I - Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-5 Covenant Against Contingent Fees MAY 2014 52.203-6 Restrictions On Subcontractor Sales To The Government JUN 2020 52.203-7 Anti-Kickback Procedures JUN 2020 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014 52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.203-13 Contractor Code of Business Ethics and Conduct NOV 2021 52.203-17 Contractor Employee Whistleblower Rights and Requirement

To Inform Employees of Whistleblower Rights

JUN 2020

52.203-18 Prohibition on Contracting With Entities That Require Certain Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

JAN 2017

52.204-2 Security Requirements MAR 2021 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2018 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-21 Basic Safeguarding of Covered Contractor Information Systems

NOV 2021

52.204-22 Alternative Line Item Proposal JAN 2017 52.204-23 Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities

NOV 2021

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

NOV 2021

52.209-7 Information Regarding Responsibility Matters OCT 2018 52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.210-1 Market Research NOV 2021 52.211-5 Material Requirements AUG 2000 52.215-1 Instructions to Offerors--Competitive Acquisition NOV 2021 52.215-2 Audit and Records--Negotiation JUN 2020 52.215-8 Order of Precedence--Uniform Contract Format OCT 1997 52.215-10 Price Reduction for Defective Certified Cost or Pricing Data AUG 2011 52.215-11 Price Reduction for Defective Certified Cost or Pricing Data--

Modifications

JUN 2020

52.215-12 Subcontractor Certified Cost or Pricing Data JUN 2020 52.215-13 Subcontractor Certified Cost or Pricing Data--Modifications JUN 2020 52.215-14 Integrity of Unit Prices NOV 2021 52.215-18 Reversion or Adjustment of Plans for Postretirement Benefits

(PRB) Other than Pensions

JUL 2005

52.215-19 Notification of Ownership Changes OCT 1997 52.215-21 Requirements for Certified Cost or Pricing Data and Data

Other Than Certified Cost or Pricing Data -- Modifications

NOV 2021

52.215-23 Limitations on Pass-Through Charges JUN 2020 52.216-11 Cost Contract--No Fee APR 1984 52.219-8 Utilization of Small Business Concerns OCT 2022 52.219-14 Limitations On Subcontracting OCT 2022 52.222-3 Convict Labor JUN 2003 52.222-19 Child Labor -- Cooperation with Authorities and Remedies DEC 2022 52.222-20 Contracts for Materials, Supplies, Articles, and Equipment JUN 2020 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-24 Preaward On-Site Equal Opportunity Compliance Evaluation FEB 1999 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans JUN 2020 52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020 52.222-37 Employment Reports on Veterans JUN 2020 52.222-38 Compliance With Veterans' Employment Reporting

Requirements

FEB 2016

52.222-40 Notification of Employee Rights Under the National Labor Relations Act

DEC 2010

52.222-50 Combating Trafficking in Persons NOV 2021 52.222-54 Employment Eligibility Verification MAY 2022 52.223-6 Drug-Free Workplace MAY 2001 52.223-11 Ozone-Depleting Substances and High Global Warming

Potential Hydrofluorocarbons.

JUN 2016

52.223-18 Encouraging Contractor Policies To Ban Text Messaging While Driving

JUN 2020

52.224-3 Privacy Training JAN 2017 52.225-13 Restrictions on Certain Foreign Purchases FEB 2021 52.225-18 Place of Manufacture AUG 2018 52.225-20 Prohibition on Conducting Restricted Business Operations in

Sudan--Certification

AUG 2009

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.227-1 Authorization and Consent JUN 2020 52.227-2 Notice And Assistance Regarding Patent And Copyright

Infringement

JUN 2020

52.227-3 Patent Indemnity APR 1984 52.227-3 Alt II Patent Indemnity (Apr 1984) - Alternate II APR 1984 52.228-7 Insurance--Liability To Third Persons MAR 1996 52.229-3 Federal, State And Local Taxes FEB 2013 52.232-1 Payments APR 1984 52.232-8 Discounts For Prompt Payment FEB 2002 52.232-11 Extras APR 1984 52.232-17 Interest MAY 2014 52.232-20 Limitation Of Cost APR 1984 52.232-22 Limitation Of Funds APR 1984 52.232-23 Assignment Of Claims MAY 2014 52.232-25 Prompt Payment JAN 2017

52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

OCT 2018

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

NOV 2021

52.233-1 Disputes MAY 2014 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.234-1 Industrial Resources Developed Under Title III, Defense

Production Act

SEP 2016

52.242-1 Notice of Intent to Disallow Costs APR 1984 52.242-2 Production Progress Reports APR 1991 52.242-3 Penalties for Unallowable Costs DEC 2022 52.242-4 Certification of Final Indirect Costs JAN 1997 52.242-5 Payments to Small Business Subcontractors JAN 2017 52.242-13 Bankruptcy JUL 1995 52.242-15 Stop-Work Order AUG 1989 52.242-17 Government Delay Of Work APR 1984 52.243-1 Changes--Fixed Price AUG 1987 52.244-5 Competition In Subcontracting DEC 1996 52.244-6 Subcontracts for Commercial Products and Commercial

Services

DEC 2022

52.245-1 Government Property SEP 2021 52.245-9 Use And Charges APR 2012 52.246-2 Inspection Of Supplies--Fixed Price AUG 1996 52.246-16 Responsibility For Supplies APR 1984 52.246-24 Limitation Of Liability--High-Value Items FEB 1997 52.246-25 Limitation Of Liability--Services FEB 1997 52.247-34 F.O.B. Destination NOV 1991 52.247-35 F.O.B. Destination, Within Consignee's Premises APR 1984 52.247-48 F.O.B. Destination--Evidence Of Shipment FEB 1999 52.249-2 Termination For Convenience Of The Government (Fixed-

Price)

APR 2012

52.249-14 Excusable Delays APR 1984 52.253-1 Computer Generated Forms JAN 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7001 Prohibition On Persons Convicted of Fraud or Other Defense- Contract-Related Felonies

JAN 2023

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.203-7003 Agency Office of the Inspector General AUG 2019 252.203-7004 Display of Hotline Posters JAN 2023 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

SEP 2022

252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7004 Antiterrorism Awareness Training for Contractors JAN 2023 252.204-7007 Alternate A, Annual Representations and Certifications MAY 2021 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7009 Limitations on the Use or Disclosure of Third-Party Contractor Reported Cyber Incident Information

JAN 2023

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

JAN 2023

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

JAN 2023

252.204-7018 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services

JAN 2023

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991 252.211-7007 Reporting of Government-Furnished Property MAR 2022 252.215-7002 Cost Estimating System Requirements DEC 2012 252.215-7013 Supplies and Services Provided by Nontraditional Defense

Contractors

JAN 2023

252.222-7006 Restrictions on the Use of Mandatory Arbitration Agreements JAN 2023 252.223-7004 Drug Free Work Force SEP 1988 252.225-7001 Buy American And Balance Of Payments Program--Basic JAN 2023 252.225-7002 Qualifying Country Sources As Subcontractors MAR 2022 252.225-7003 Report of Intended Performance Outside the United States and Canada--Submission with Offer

OCT 2020

252.225-7004 Report of Intended Performance Outside the United States and Canada--Submission after Award

OCT 2020

252.225-7036 Buy American--Free Trade Agreements--Balance of Payments Program--Basic

JAN 2023

252.225-7048 Export-Controlled Items JUN 2013 252.226-7001 Utilization of Indian Organizations, Indian-Owned Economic

Enterprises, and Native Hawaiian Small Business Concerns

JAN 2023

252.227-7013 Rights in Technical Data--Other Than Commercial Products and Commercial Services

JAN 2023

252.227-7014 Rights in Other Than Commercial Computer Software and Other Than Commercial Computer Software Documentation

JAN 2023

252.227-7015 Technical Data--Commercial Products and Commercial Services

JAN 2023

252.227-7016 Rights in Bid or Proposal Information JAN 2023 252.227-7017 Identification and Assertion of Use, Release, or Disclosure

Restrictions

JAN 2023

252.227-7019 Validation of Asserted Restrictions--Computer Software JAN 2023 252.227-7020 Rights In Special Works JUN 1995 252.227-7025 Limitations on the Use or Disclosure of Government-

Furnished Information Marked with Restrictive Legends

JAN 2023

252.227-7027 Deferred Ordering Of Technical Data Or Computer Software APR 1988 252.227-7030 Technical Data--Withholding Of Payment MAR 2000 252.227-7037 Validation of Restrictive Markings on Technical Data JAN 2023 252.231-7000 Supplemental Cost Principles DEC 1991 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7004 DOD Progress Payment Rates OCT 2014 252.232-7010 Levies on Contract Payments DEC 2006 252.242-7005 Contractor Business Systems FEB 2012 252.242-7006 Accounting System Administration FEB 2012 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2022 252.244-7000 Subcontracts for Commercial Products or Commercial

Services

JAN 2023

252.244-7001 Contractor Purchasing System Administration MAY 2014 252.245-7001 Tagging, Labeling, and Marking of Government-Furnished

Property

APR 2012

252.245-7002 Reporting Loss of Government Property JAN 2021 252.245-7003 Contractor Property Management System Administration APR 2012 252.245-7004 (Dev) Reporting, Reutilization, and Disposal (DEVIATION 2022-

O0006)

NOV 2021

252.247-7023 Transportation of Supplies by Sea JAN 2023

CLAUSES INCORPORATED BY FULL TEXT

52.202-1 DEFINITIONS (JUN 2020)

When a solicitation provision or contract clause uses a word or term that is defined in the Federal Acquisition Regulation (FAR), the word or term has the same meaning as the definition in FAR 2.101 in effect at the time the solicitation was issued, unless--

(a) The solicitation, or amended solicitation, provides a different definition;

(b) The contracting parties agree to a different definition;

(c) The part, subpart, or section of the FAR where the provision or clause is prescribed provides a different meaning;

(d) The word or term is defined in FAR part 31, for use in the cost principles and procedures; or

(e) The word or term defines an acquisition-related threshold, and if the threshold is adjusted for inflation as set forth in FAR 1.109(a), then the changed threshold applies throughout the remaining term of the contract, unless there is a subsequent threshold adjustment; see FAR 1.109(d).

(End of clause)

52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (DEC 2022)

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is 334516.

(2) The small business size standard is 1,000.

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition--

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b)(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

( ) Paragraph (d) applies.

( ) Paragraph (d) does not apply and the offeror has…