N0018926QB041.pdf

WOMEN-OWNED SMALL

BUSINESS (WOSB)

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NUMBER 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect calls)

8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

CODE

TELEPHONE NUMBER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

REQUEST

FOR QUOTE

(RFQ)

INVITATION

FOR BID

(IFB)

REQUEST

FOR

PROPOSAL

(RFP)

SEE ADDENDUM

19.

ITEM NUMBER

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Government Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

31b. NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NORTH AMERICAN

INDUSTRY CLASSIFICATION

STANDARD (NAICS):

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

THE DEFENSE PRIORITIES

AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

8(A)

ECONOMICALLY

DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

Created On:

15 Apr 2026, 12:28 PM Greenwich Mean Time

Solicitation/Contract Form Continuation

THC Reagent Kits

DELTA-9-TETRAHYDROCANNABINOL-11-CARBOXYLIC ACID IMMUNOASSAY (THC9-COOH)

REAGENT KITS

POINTS OF CONTACT

The primary points of contact (POC) for this RFQ is Nicholas Haas nicholas.a.haas10.civ@us.navy.mil, and Gerald Bowne, gerald.l.bowne.civ@us.navy.mil.

SOLICITATION QUESTIONS

Potential quoters are encouraged to carefully review all solicitation requirements and, if they have questions concerning the solicitation, should submit one consolidated list of questions in writing via e-mail to nicholas.a.haas10.civ@us.

navy.mil and gerald.l.bowne.civ@us.navy.mil no later than 12:00 AM on 15 May 2026.

ESTIMATED WORKLOAD

The below estimates are provided for informational purposes only. The contractor is required to deliver all regent kits IAW with the Statement of Work (SOW). If the actual number of kits varies in any way or by any degree from the information provided below, the contractor is not relieved from any requirments detailed in the

SOW.

Based upon historical information, the Government estimates that this effort will require the below estimated kits:

The reagent kits are required for a period of performance of five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month, creating a potential need of 30,000,000 tests.

Cancellation Ceiling Date and Description

USD 1,050,738.75 2031

N0018926QB041

Continuation of Supplies or Services and Prices/Costs

Additional Information/Notes

Item Supplies/Service Estimated Quantity

Unit Unit Price Amount

0001 Regent Kits

Pricing Arrangement: Firm Fixed Price

30,000,000 Kit

Continuation of Description

STATEMENT OF WORK

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF DELTA-9-

TETRAHYDROCANNABINOL-11-CARBOXYLIC ACID (THC9-COOH) IN URINE

NOTE: The Offeror shall be an Original Equipment Manufacturer (OEM) of reagents, authorized dealer, authorized distributor or authorized reseller for the proposed reagents such that OEM parameters, quality controls and services are provided and maintained by the OEM. All storage, shelf life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions. Offeror shall not repackage or relabel an OEM reagent product unless authorized.

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of delta-9-tetrahydrocannabinol-11-carboxylic acid (THC9- COOH) The reagent shall be compatible with the Beckman Coulter in urine when present at a concentration equal to or greater than 50 ng/mL.

AU5800 Series Clinical Chemistry Analyzers (hereafter referred to as "analyzer"), in use at the Department of Defense (DoD) Forensic Toxicology Drug Testing Laboratories (FTDTLs) to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division. The reagent shall be compatible without modification of the equipment. The immunoassay procedure is limited to a two reagent assay procedure. A vendor's reagent proposal which requires a separate pretreatment of each testing specimen prior to testing on the Beckman analyzer will not be considered acceptable. The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the contractor's reagent on the analyzer. Immunoassay kits shall have clearance from the FDA in order to meet the requirements of DoDI 1010.16 Rev. (June 15, 2020).

1.2. Sensitivity and Specificity. The drug contained in the calibrator shall be THC9-COOH. The analyzer shall be calibrated at 50 ng/mL using DoD FTDTL-prepared and DoD FTDTL-certified solutions. All controls, DoD FTDTL-prepared and DoD FTDTL-certified, will utilize the same compound as the calibrator. The reagent shall minimize cross-reactivity with structurally similar drugs/metabolites in addition to the drugs /metabolites on the current DOD drug testing panel, listed below (excluding the compound of interest). The reagent shall demonstrate calibration stability, as evaluated by frequency of control failures, and shall require calibration no more than once per 8 hour testing period. The following drug cutoffs are currently used by DOD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

Drug Class Drugs/Metabolites (IA target in )bold Initial Screen (ng /mL)

Confirmation (ng /mL)

Marijuana 11-nor-delta-9-THC-carboxylic acid & 11-nor-delta-8-THC-carboxylic acid 50 15

Cocaine Benzoylecgonine 150 100

Opioids

Morphine

Codeine

Hydrocodone

Hydromorphone

Heroin 6-Acetylmorphine 10 10

Opioids Oxycodone & Oxymorphone 100 100

Amphetamines d-Amphetamine & d-Methamphetamine 500 500

Designer Amphetamines Methylenedioxymethamphetamine & Methylenedioxyamphetamine 500 500

Benzodiazepines Nordiazepam, , Temazepam, Lorazepam, Alpha-Oxazepam hydroxyalprazolam

200 200

Synthetic Cannabinoids 4MBUT, 4MBTN, 5FADB, 5MPCA, ADBTN, ABFUB, M4PIN, MFUBN 10 1

Fentanyl Fentanyl & Norfentanyl 1 1

Lysergic Acid Diethylamide Lysergic Acid Diethylamide & 2-oxo-3-hydroxy-LSD 0.5 0.2

1.3. Compliance with Food & Drug Administration (FDA) Requirements.

1.3.1 Immunoassay kits are considered medical devices and shall have clearance from the FDA to be marketed. The registration and listing process specified by the FDA shall be followed and the manufacturer shall adhere to good manufacturing processes in the manufacture of the devices. Any mandatory recalls of the kits provided under the resulting contract and any other problems that require notification to the FDA shall be resolved as required by the FDA regulations current at the time. The contractor shall notify the Contracting Officer of any recall or FDA notification within two working days of the event.

1.3.2. Except as provided herein, the reagents supplied throughout the term of this contract shall be identical to the reagents offered by the contractor and accepted by the Government at the time of the contract award. If, during the course of this contract, the manufacturer wishes to change or improve its kit, that product modification shall be proposed in writing to the Contracting Officer for approval prior to its incorporation into the kits to be delivered to the Government sites. The contractor's proposal shall include documentation that demonstrates that the manufacturer has complied with all applicable FDA regulations, including those concerning the filing of a new 510(k) notice, if such action and subsequent FDA clearance are warranted by the nature of the modification.

1.4. Packaging. The reagents provided shall be in volumes and packaging that are convenient and applicable to the sample throughput at the FTDTLs and shall not result in the loss or unnecessary disposal of more than 3% of the working volume of reagent. The contractor shall not be required to provide calibrators/controls. The reagents shall be provided with an instruction sheet that complies with all requirements of the FDA and includes data demonstrating specific performance characteristics, such as accuracy, precision, sensitivity, specificity, cross-reactivity, and safety precautions.

The instruction sheet(s) shall include procedures and instrument parameters optimized for FTDTL operations as represented in these specifications and cutoffs as utilized by the DOD. The Government shall not develop procedures for or optimize the performance of a kit for the contractor.

1.5. Shelf Life. The minimum shelf life of any unopened component of the assay shall be a minimum of 180 days from the date of delivery to the FTDTL. Once kit container seals are broken and the components are opened, the shelf-life shall be a minimum of 14 days.

1.6. The FTDTLs intend to use the immunoassay kits in a manner consistent with the FDA approval except as otherwise stated in this statement of work. The package insert and information for the analyzer settings must contain the information necessary for the FTDTLs to use the immunoassay kits consistent with the device's FDA approval. This ensures that the FTDTLs can use the immunoassay kits properly and derive the full benefit of the FDA approval.

2. TESTING and QUALITY CONTROL PROTOCOL.

2.1. The reagents supplied shall be compatible with the calibration requirements and characteristics of the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. Verification of each calibration, at 150 ng/mL, shall be accomplished with a drug free control and open controls at target concentrations of 50-75% and 150-200% of the calibrator/cutoff. An acceptable verification will have analytical readings as follows: drug free control < 50-75% control < cutoff (calibrator) < 150-200% control. The batch may also contain blind negative and positive controls distributed throughout the batch.

3. PERFORMANCE CHARACTERISTICS.

3.1. The reagent shall be capable of identifying specimens as positive for THC9-COOH when present in human urine at concentrations equal to or greater than 50 ng/mL as determined by the current immunoassay and gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS) procedures utilized in the FTDTLs (and AFMES).

3.2. The reagent shall be capable of identifying specimens as negative for THC9-COOH when present in human urine at concentrations below 50 ng /mL as determined by the current immunoassay and GC-MS or LC-MS/MS procedures utilized in the FTDTLs (and AFMES).

3.3. The reagent performance, as evaluated through the performance of controls, shall be stable over the course of the day and shall not require re-calibration within an eight hour testing period.

3.4. The reagent shall display precision and accuracy both within and between batches for concentrations ranging between 50-200% of the calibrator concentration.

3.5. The reagent shall produce non-overlapping ranges for Quality Control (QC) samples analyzed at 0%, 50%, 100%, 150%, and 200% of the calibrator concentration.

3.6 The reagent shall have minimal cross reactivity with analytes other than THC9-COOH, except THC8-COOH.

3.7. The reagent shall have cross reactivity with THC8-COOH.

4. QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS CURRENT ISO-9000 SERIES

CERTIFICATION OR INCLUDE DOCUMENTATION OF THE FOLLOWING ELEMENTS:

4.1. Chemicals and Reagents

4.1.1. Quality and Authenticity. All materials used in the preparation of reagents shall be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, GC-MS, Nuclear Magnetic Resonance (NMR), and spectrophotometric measurements.

4.1.2. Stability. The kit and each kit component shall be shown to be stable and at the correct concentration over the period of use. Components that are homogeneous solutions shall not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration).

4.2. Manufacturer's Equipment

4.2.1. Preventive maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance shall be fully documented and in accordance with recommendations of the manufacturer of the equipment.

4.2.2. Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material shall be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes pH meters, spectrometers, micropipettes, etc.

4.2.3. Temperature Checks. Water baths, refrigerators, freezers, and other equipment that is intended to maintain a given temperature shall be periodically validated for accuracy and routinely verified for correct settings.

4.2.4. Glassware and other reusable supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented.

4.3. Antibody

4.3.1. Authenticity. The prepared antibody shall be verified to be authentic and its purity established.

4.3.2. Stability. The antibody shall be documented to be stable to the expiration date and the immunoassay shall meet all contract specifications to the expiration date (a minimum of 180 days from date of delivery to the FTDTL/AFMES).

4.3.3. Specificity. Antibody specificity shall be verified for each lot and the specificity re-evaluated at routine intervals to ensure uniformity and quality of preparations. The reagent shall provide performance characteristics in terms of sensitivity and specificity for detection of THC9-COOH in urine. Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use shall be tested to characterize antibody specificity. Specificity testing may include biochemical materials produced normally in the human body.

4.4. Immunoassays

4.4.1. Technical Performance. Performance of each lot of reagent shall be verified. The verification shall establish, as a minimum, the appropriate response to the target molecule(s) and that all other parameters as specified in the contract are met. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit.

4.4.2. Manufacturer's production manual. Procedures and criteria required to validate all components (and materials) employed during the manufacture of the reagents in the test kits and the operation of the completed kit over the entire period of shelf-life of the kit shall be described in detail. All steps of each quality control (QC) procedure shall be described thoroughly.

4.4.3. Records. The production and QC records generated by each procedure performed above shall be maintained in a systematic fashion to permit the verification of the completion of all production parameters and shall be available for inspection during the term of the contract.

4.4.4. Corrective action. When a specified QC parameter is found to be out of limits, the action taken to ensure correction for existing kits (i.e., notification) shall be documented and documented action(s) shall be taken to ensure that the deficiency does not reoccur. All records shall be retained for the term of the contract. The Contracting Officer shall be notified within 2 working days of any deficiencies in existing kits and of all corrective actions for consideration (i.e., delivery of replacement kits at no cost to the Government). The FDA shall be notified according to its regulations.

4.4.5. Lot numbers. Lot numbers shall be used to identify reagents to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent shall be described. A single lot number for a kit shall suffice if all materials used in that lot number can be tracked to identify the materials and procedures used in the preparation of that kit.

5. PACKAGING AND MARKING

5.1. Thermal Protection for Biologic Reagents. The contractor shall ship biologic reagent items used in the reagent kits in insulated thermal containers to ensure protection of the reagents against thermal (heat and cold) damage which would affect reagent performance contained in the Statement of Work of this contract.

5.2. Marking of Shipments (Commercially-Packaged Items). Marking shall be in accordance with ASTM D 3951 15, "Standard Practice for Commercial Packaging."

5.2.1. Additional markings include: Contract Number & Government Delivery Order Number.

5.3. Deteriorative Material Marking. The contractor shall include as part of the marking, the following information: (a) Expiration date; (b) Required storage conditions for each kit component; and (c) Type I or Type II shelf life date as specified in MIL-STD-129 for each unit of material, issue, package, intermediate container and exterior shipping container.

6. SOW COMPLIANCE

6.1. The Offeror shall attest to compliance with the entire SOW the Offeror shall attest that their proposed reagent kit complies with the entire and

SOW.

Requirements The Department of War (DOW) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality Management Documented THC9-COOH immunoassay reagent kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting THC9-COOH in human urine samples.

Continuation of Packaging and Marking

Continuation of Inspection and Acceptance The following requiring activities and their ordering office are hereby named to place delivery orders.

Requiring Activity Ordering Activity

Navy Drug Screening Laboratory

2500 Rodgers Street, Bldg 5501

Great Lakes, IL 60088-2952

Same as Requiring Activity

Navy Drug Screening Laboratory

Building H-2033 Adams Avenue

Naval Air Station

Jacksonville, FL 32212-5000

Same as Requiring Activity

Headquarters Air Force Drug Testing Laboratory

Wilford Hall Medical Center

Building 3750, Ladd Street

Lackland Air Force Base, TX 78236

Same as Requiring Activity

Army Forensic Toxicology Drug Testing Laboratory

2490 Wilson Street

Fort Meade, MD 20755-5235

Same as Requiring Activity

Army Forensic Toxicology Drug Testing Laboratory

160 Takata Road

Fort Shafter Flats, HI 96858

Pacific Contracting Center

ATTN: MCAA-PC

Tripler AMC, HI 96859

Armed Forces Medical Examiner System (AFMES)

115 Purple Heart Drive

Dover Air Force Base, DE 19902

Same as Requiring Activity

Continuation of Deliveries or Performance

Overall Contract Delivery Period

Period of Performance From 01 Jul 2026 to 30 Jun 2031

The ordering period above may include unexercised options

Line Item Delivery Schedule Estimated Quantity

Address and POC

Period of Performance From 01 Jul 2026 To 30 Jun 2031

30,000,000 Kit

Continuation of Accounting and Appropriation Data

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.204-13 System for Award Management Maintenance. Oct 2018 52.204-18 Commercial and Government Entity Code Maintenance. Aug 2020 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services. Nov 2023

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region. Jun 2023 252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime. Jan 2023 252.203-7000 Requirements Relating to Compensation of Former DoD Officials. Sep 2011 252.203-7002 Requirement to Inform Employees of Whistleblower Rights. Dec 2022 252.204-7004 Antiterrorism Awareness Training for Contractors. 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

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports. Dec 2018 252.232-7010 Levies on Contract Payments. Dec 2006 252.243-7002 Requests for Equitable Adjustment. Dec 2022 252.244-7000 Subcontracts for Commercial Products or Commercial Services. Nov 2023 252.247-7023 Transportation of Supplies by Sea. Oct 2024 252.204-7022 Expediting Contract Closeout. May 2021

252.209-7004 Subcontracting with Firms that are Owned or Controlled by the Government of a Country that is a State Sponsor of Terrorism.

May 2019

252.204-7020 NIST SP 800-171 DoD Assessment Requirements. Nov 2023

DFARS Clauses Incorporated by Full Text

252.211-7003 Item Unique Identification and Valuation. (Jan 2023)

ITEM UNIQUE IDENTIFICATION AND VALUATION (JAN 2023)

(a) . As used in this clause- Definitions

"Automatic identification device" means a device, such as a reader or interrogator, used to retrieve data encoded on machine-readable media.

"Concatenated unique item identifier" means-

(1) For items that are serialized within the enterprise identifier, the linking together of the unique identifier data elements in order of the issuing agency code, enterprise identifier, and unique serial number within the enterprise identifier; or

(2) For items that are serialized within the original part, lot, or batch number, the linking together of the unique identifier data elements in order of the issuing agency code; enterprise identifier; original part, lot, or batch number; and serial number within the original part, lot, or batch number.

"Data matrix" means a two-dimensional matrix symbology, which is made up of square or, in some cases, round modules arranged within a perimeter finder pattern and uses the Error Checking and Correction 200 (ECC200) specification found within International Standards Organization (ISO)/International Electrotechnical Commission (IEC) 16022.

"Data qualifier" means a specified character (or string of characters) that immediately precedes a data field that defines the general category or intended use of the data that follows.

"DoD recognized unique identification equivalent" means a unique identification method that is in commercial use and has been recognized by DoD. All DoD recognized unique identification equivalents are listed at . https://www.acq.osd.mil/asda/dpc/ce/ds/unique-id.html

"DoD item unique identification" means a system of marking items delivered to DoD with unique item identifiers that have machine-readable data elements to distinguish an item from all other like and unlike items. For items that are serialized within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier and a unique serial number. For items that are serialized within the part, lot, or batch number within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier; the original part, lot, or batch number; and the serial number.

" Enterprise " means the entity (e.g., a manufacturer or vendor) responsible for assigning unique item identifiers to items.

" Enterprise identifier" means a code that is uniquely assigned to an enterprise by an issuing agency.

"Government's unit acquisition cost" means-

(1) For fixed-price type line, subline, or exhibit line items, the unit price identified in the contract at the time of delivery;

(2) For cost-type or undefinitized line, subline, or exhibit line items, the Contractor's estimated fully burdened unit cost to the Government at the time of delivery; and

(3) For items produced under a time-and-materials contract, the Contractor's estimated fully burdened unit cost to the Government at the time of delivery.

"Issuing agency" means an organization responsible for assigning a globally unique identifier to an enterprise, as indicated in the Register of Issuing Agency Codes for ISO/IEC 15459, located at http://www.aimglobal.org/?Reg_Authority15459.

"Issuing agency code" means a code that designates the registration (or controlling) authority for the enterprise identifier.

"Item" means a single hardware article or a single unit formed by a grouping of subassemblies, components, or constituent parts.

" Lot or batch number" means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.

"Machine-readable" means an automatic identification technology media, such as bar codes, contact memory buttons, radio frequency identification, or optical memory cards.

"Original part number" means a combination of numbers or letters assigned by the enterprise at item creation to a class of items with the same form, fit, function, and interface.

"Parent item" means the item assembly, intermediate component, or subassembly that has an embedded item with a unique item identifier or DoD recognized unique identification equivalent.

"Serial number within the enterprise identifier" means a combination of numbers, letters, or symbols assigned by the enterprise to an item that provides for the differentiation of that item from any other like and unlike item and is never used again within the enterprise.

"Serial number within the part, lot, or batch number" means a combination of numbers or letters assigned by the enterprise to an item that provides for the differentiation of that item from any other like item within a part, lot, or batch number assignment.

"Serialization within the enterprise identifier" means each item produced is assigned a serial number that is unique among all the tangible items produced by the enterprise and is never used again. The enterprise is responsible for ensuring unique serialization within the enterprise identifier.

"Serialization within the part, lot, or batch number" means each item of a particular part, lot, or batch number is assigned a unique serial number within that part, lot, or batch number assignment. The enterprise is responsible for ensuring unique serialization within the part, lot, or batch number within the enterprise identifier.

"Type designation" means a combination of letters and numerals assigned by the Government to a major end item, assembly or subassembly, as appropriate, to provide a convenient means of differentiating between items having the same basic name and to indicate modifications and changes thereto.

"Unique item identifier" means a set of data elements marked on items that is globally unique and unambiguous. The term includes a concatenated unique item identifier or a DoD recognized unique identification equivalent.

"Unique item identifier type" means a designator to indicate which method of uniquely identifying a part has been used. The current list of accepted unique item identifier types is maintained at .https://www.acq.osd.mil/asda/dpc/ce/ds/unique-id.html

(b) The Contractor shall deliver all items under a contract line, subline, or exhibit line item.

(c) Unique item identifier.

(1) The Contractor shall provide a unique item identifier for the following:

(i) Delivered items for which the Government's unit acquisition cost is $5,000 or more, except for the following line items:

Contract Line, Subline, or

Exhibit Line Item Number Item Description

(ii) Items for which the Government's unit acquisition cost is less than $5,000 that are identified in the Schedule or the following table:

Contract Line, Subline, or

Exhibit Line Item Number Item Description

(If items are identified in the Schedule, insert "See Schedule in this table.)

(iii) Subassemblies, components, and parts embedded within delivered items, items with warranty requirements, DoD serially managed reparables and DoD serially managed nonreparables as specified in Attachment Number .____

(iv) Any item of special tooling or special test equipment as defined in FAR 2.101 that have been designated for preservation and storage for a Major Defense Acquisition Program as specified in Attachment Number .____

(v) Any item not included in (i), (ii), (iii), or (iv) for which the contractor creates and marks a unique item identifier for traceability.

(2) The unique item identifier assignment and its component data element combination shall not be duplicated on any other item marked or registered in the DoD Item Unique Identification Registry by the contractor.

(3) The unique item identifier component data elements shall be marked on an item using two dimensional data matrix symbology that complies with ISO/IEC International Standard 16022, Information technology - International symbology specification - Data matrix; ECC200 data matrix specification.

(4) The Contractor shall ensure that- Data syntax and semantics of unique item identifiers.

(i) The data elements (except issuing agency code) of the unique item identifier are encoded within the data matrix symbol that is marked on the item using one of the following three types of data qualifiers, as determined by the Contractor:

(A) Application Identifiers (AIs) (Format Indicator 05 of ISO/IEC International Standard 15434), in accordance with ISO/IEC International Standard 15418, Information Technology - EAN/UCC Application Identifiers and Fact Data Identifiers and Maintenance and ANSI MH

10.8.2 Data Identifier and Application Identifier Standard.

(B) Data Identifiers (DIs) (Format Indicator 06 of ISO/IEC International Standard 15434), in accordance with ISO/IEC International Standard 15418, Information Technology - EAN/UCC Application Identifiers and Fact Data Identifiers and Maintenance and ANSI MH

10.8.2 Data Identifier and Application Identifier Standard.

(C) Text Element Identifiers (TEIs) (Format Indicator 12 of ISO/IEC International Standard 15434), in accordance with the Air Transport Association Common Support Data Dictionary; and

(ii) The encoded data elements of the unique item identifier conform to the transfer structure, syntax, and coding of messages and data formats specified for Format Indicators 05, 06, and 12 in ISO/IEC International Standard 15434, Information Technology - Transfer Syntax for High Capacity Automatic Data Capture Media.

(5) . Unique item identifier

(i) The Contractor shall-

(A) Determine whether to-

Serialize within the enterprise identifier; (1)

Serialize within the part, lot, or batch number; or (2)

Use a DoD recognized unique identification equivalent (e.g. Vehicle Identification Number); and (3)

(B) Place the data elements of the unique item identifier (enterprise identifier; serial number; DoD recognized unique identification equivalent; and for serialization within the part, lot, or batch number only: original part, lot, or batch number) on items requiring marking by paragraph (c)(1) of this clause, based on the criteria provided in MIL-STD-130, Identification Marking of U.S. Military Property, latest version;

(C) Label shipments, storage containers and packages that contain uniquely identified items in accordance with the requirements of MIL-STD-129, Military Marking for Shipment and Storage, latest version; and

(D) Verify that the marks on items and labels on shipments, storage containers, and packages are machine readable and conform to the applicable standards. The contractor shall use an automatic identification technology device for this verification that has been programmed to the requirements of Appendix A, MIL-STD-130, latest version.

(ii) The issuing agency code-

(A) Shall not be placed on the item; and

(B) Shall be derived from the data qualifier for the enterprise identifier.

(d) For each item that requires item unique identification under paragraph (c)(1)(i), (ii), or (iv) of this clause or when item unique identification is provided under paragraph (c)(1)(v), in addition to the information provided as part of the Material Inspection and Receiving Report specified elsewhere in this contract, the Contractor shall report at the time of delivery, as part of the Material Inspection and Receiving Report, the following information:

(1) Unique item identifier.

(2) Unique item identifier type.

(3) Issuing agency code (if concatenated unique item identifier is used).

(4) Enterprise identifier (if concatenated unique item identifier is used).

(5) Original part number (if there is serialization within the original part number).

(6) Lot or batch number (if there is serialization within the lot or batch number).

(7) Current part number (optional and only if not the same as the original part number).

(8) Current part number effective date (optional and only if current part number is used).

(9) Serial number (if concatenated unique item identifier is used).

(10) Government's unit acquisition cost.

(11) Unit of measure.

(12) Type designation of the item as specified in the contract schedule, if any.

(13) Whether the item is an item of Special Tooling or Special Test Equipment.

(14) Whether the item is covered by a warranty.

(e) For embedded subassemblies, components, and parts that require DoD item unique identification under paragraph (c)(1)(iii) of this clause or when item unique identification is provided under paragraph (c)(1)(v), the Contractor shall report as part of the Material Inspection and Receiving Report specified elsewhere in this contract, the following information:

(1) Unique item identifier of the parent item under paragraph (c)(1) of this clause that contains the embedded subassembly, component, or part.

(2) Unique item identifier of the embedded subassembly, component, or part.

(3) Unique item identifier type.**

(4) Issuing agency code (if concatenated unique item identifier is used).**

(5) Enterprise identifier (if concatenated unique item identifier is used).**

(6) Original part number (if there is serialization within the original part number).**

(7) Lot or batch number (if there is serialization within the lot or batch number).**

(8) Current part number (optional and only if not the same as the original part number).**

(9) Current part number effective date (optional and only if current part number is used).**

(10) Serial number (if concatenated unique item identifier is used).**

(11) Description.

** Once per item.

(f) The Contractor shall submit the information required by paragraphs (d) and (e) of this clause as follows:

(1) End items shall be reported using the receiving report capability in Wide Area WorkFlow (WAWF) in accordance with the clause at 252.232-7003. If WAWF is not required by this contract, and the contractor is not using WAWF, follow the procedures at http://dodprocurementtoolbox.com/site/uidregistry/.

(2) Embedded items shall be reported by one of the following methods-

(i) Use of the embedded items capability in WAWF;

(ii) Direct data submission to the IUID Registry following the procedures and formats at http://dodprocurementtoolbox.com/site /uidregistry/; or

(iii) Via WAWF as a deliverable attachment for exhibit line item number (fill in) , Unique Item Identifier Report for Embedded ____ Items, Contract Data Requirements List, DD Form 1423.

(g) . If the Contractor acquires by subcontract, any item(s) for which item unique identification is required in accordance with Subcontracts paragraph (c)(1) of this clause, the Contractor shall include this clause, including this paragraph (g), in the applicable subcontract(s), including subcontracts for commercial products or commercial services.

(End of clause)

252.232-7006 Wide Area WorkFlow Payment Instructions. (Jan 2023)

WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JAN 2023)

(a) As used in this clause- Definitions.

"Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely identifies a unit, activity, or organization.

"Document type" means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

"Local processing office (LPO)" is the office responsible for payment certification when payment certification is done external to the entitlement system.

"Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as Electronic invoicing.

authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) To access WAWF, the Contractor shall- WAWF access.

(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) The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice WAWF training.

Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the "Web Based Training" link on the WAWF home page at https://wawf.eb.mil/

(e) Document submissions may be via web entry, Electronic Data Interchange, or File Transfer WAWF methods of document submission.

Protocol.

(f) The Contractor shall use the following information when submitting payment requests and receiving reports WAWF payment instructions.

in WAWF for this contract or task or delivery order:

(1) The Contractor shall submit payment requests using the following document type(s): Document type.

(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 the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting 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.

(v) For commercial financing, submit a commercial financing request.

(2) ) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF "combo" document type to create some combinations of invoice and receiving report in one step.]

(3) The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in Document routing.

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) The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in Payment request.

accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F. Receiving report.

(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.

(Contracting Officer: Insert applicable information or "Not applicable.")

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Addendum to 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services

Contract Terms and Conditions Required To Implement Statutes or Executive Orders — Commercial Products and Commercial Services

Addendum to Contract Clauses

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations. Nov 2015 52.232-39 Unenforceability of Unauthorized Obligations. Jun 2013 52.232-18 Availability of Funds. Apr 1984 52.203-12 Limitation on Payments to Influence Certain Federal Transactions. Jun 2020 52.242-13 Bankruptcy. Jul 1995 52.247-34 F.o.b. Destination. Jan 1991

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.225-7001 Buy American and Balance of Payments Program. Feb 2024 252.225-7002 Qualifying Country Sources as Subcontractors. Mar 2022 252.225-7012 Preference for Certain Domestic Commodities. Apr 2022 252.204-7003 Control of Government Personnel Work Product. Apr 1992 252.237-7010 Prohibition on Interrogation of Detainees by Contractor Personnel. Jan 2023

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting.

(DEVIATION 2024-O0013 REVISION 1)

May 2024 Deviation 2024-O0013 May 2024

252.219-7003 Small Business Subcontracting Plan (DoD Contracts). Dec 2019 252.225-7048 Export-Controlled Items. Jun 2013

FAR Clauses Incorporated by Full Text

52.216-18 Ordering. (Aug 2020)

ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from through [insert dates].____ ____

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when-

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either-

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

52.216-19 Order Limitations. (Oct 1995)

ORDER LIMITATIONS (OCT 1995)

(a) . When the Government requires supplies or services covered by this contract in an amount of less than [insert dollar figure Minimum order ____ or quantity], the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) . The Contractor is not obligated to honor-Maximum order

(1) Any order for a single item in excess of [insert dollar figure or quantity];____

(2) Any order for a combination of items in excess of [insert dollar figure or quantity]; or____

(3) A series of orders from the same ordering office within days that together call for quantities exceeding the limitation in paragraph (b)(1) ____ or (2) of this section.

(c) If this is a requirements contract ( includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), i.e., the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within days after issuance, with written notice stating the ____ Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

52.216-22 Indefinite Quantity. (Oct 1995)

INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; , that the Contractor shall not be required to make any provided deliveries under this contract after [insert date].____

(End of clause)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services.

(DEVIATION 2025-O0003 and 2025-O0004)

(Oct 2025) Deviation 2025-O0004 (Mar 2025)

Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Products and Commercial Services (MAR 2025) (DEVIATION 2025-O0003 and 2025-O0004)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (section 743 of Division E, Title VII, (Jan 2017) 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)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec (Section 1634 of Pub. L. 115-91).2023)

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Section 889(Nov 2021) (a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations .(Nov 2015)

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (31 U.S.C. 3903 and 10 U.S.C. 3801).(Mar 2023)

(6) 52.233-3, Protest After Award (31 U.S.C. 3553).(Aug 1996)

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).(Oct 2004)

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[ .]Contracting Officer check as appropriate

[ ] 52.203-6, Restrictions on Subcontractor Sales to the Government with (41 U.S.C. 4704 and 10 U.S.C. 4655).(1) (Jun 2020), Alternate I (Nov 2021)

[ ] 52.203-13, Contractor Code of Business Ethics and Conduct (41 U.S.C. 3509)).(2) (Nov 2021)

[ ] 52.203-15, Whistleblower Protections under the…