Temperature Monitoring Devices - RFP 75A50325R00010.pdf

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CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

ASPR/SNS

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OS CODE 16. ADMINISTERED BYCODE

X

X

334519

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORASPR/SNS

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

09/22/2025 1000 ET

09/13/2025

LEATRICE BULLS

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INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75A50325R00010

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 41 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Washington DC 20201 200 Independence Ave. S.W.

Office of the Secretary

OS

15. DELIVER TO

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

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

ISSUE DATE

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(FOB) DESTINATION UNLESS

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SEE SCHEDULEX

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

ASPR/SNS

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

ADMINISTERED BY:

ASPR/SNS

ASPR/SNS

2945 FLOWERS ROAD

ATLANTA, GA 30341

The Department of Health and Human Services (HHS), Strategic National Stockpile (SNS) issues this Request for Proposal (RFP) for the procurement of Temperature Monitoring Devices (TMD) for the Transportation of Temperature

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

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

LAMONICA R. NORWOOD

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

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

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

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

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

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Sensitive Biomedical and Pharmaceutical Products.

Statement of Work (SOW) is attached.

1 CLIN 0001 - BASE: 4800 EA

Category 1: Temperature Monitoring Device as described in Section C, SOW

Period of Performance: 09/29/2025 to 09/28/2026

2 CLIN 0002 - BASE: 2500 EA

Category 2: Temperature Monitoring Device as described in Section C, SOW

Period of Performance: 09/29/2025 to 09/28/2026

3 CLIN 1001 - Option Period: 4800 EA

Category 1: Temperature Monitoring Device as described in Section C, SOW

Period of Performance: 09/29/2026 to 09/28/2027

4 CLIN 1002 - Option Period: 2500 EA

Category 2: Temperature Monitoring Device as described in Section C, SOW

Period of Performance: 09/29/2026 to 09/28/2027

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

41 2 of

SECTION A – SOLICITATION DESCRIPTION

(i) This is a solicitation for commercial supplies or commercial services prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This solicitation will be conducted as a commercial acquisition competed on a full and open basis in accordance with the policies and procedures of Part 12 and Part 13 of the Federal Acquisition Regulation.

(ii) The solicitation number is 75A50325R00010, which is being issued as a Request for

Proposal (RFP). The United States Government (USG or Government) anticipates the award of a Firm Fixed Price (FFP) type contract as a result of this solicitation.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-05, effective August 07, 2025.

Referenced FAR clauses can be found at www.acquisition.gov.

(iv) This solicitation is issued on the basis of full and open competition and is not set aside for small businesses. The NAICS code is 334519 - Other Measuring and Controlling Device Manufacturing. The size standard is 600 (number of employees).

(v) The Center for the Strategic National Stockpile (SNS), of the U.S. Department of

Health and Human Services (HHS) Office of the Administration for Strategic Preparedness and Response (ASPR), has a requirement for Temperature Monitoring Devices (TMD) for the Transportation of Temperature Sensitive Biomedical and Pharmaceutical Products. See Section B below for line item numbers and product, quantities, and units of measure.

(vi) See Section C, Statement of Work (SOW), below for description of requirements.

(vii) The period of performance is anticipated to be a one (1) year Base Period and one

(1), one-year Option Period. See below for place(s) of delivery and acceptance and FOB point(s).

(viii) The provision at FAR 52.212-1, Instructions to Offeror-Commercial Items, applies to this acquisition. The Government intends to award without discussions (although it reserves the right to conduct discussions). Therefore, the submitted proposal should represent the offeror’s best offer.

(ix) The provision 52.212-2, Evaluation-Commercial Items, applies to this procurement.

Addenda to the provision include evaluation factors and evaluation criteria.

(x) Offeror shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer – Refer to and complete Attachment 1.

(xi) The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition.

(xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders Commercial Items, applies to this acquisition and applicable FAR clauses include 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222- 21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-5, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See Section I below for details.

(xiii) There are no special contract requirements or terms and conditions related to contract financing arrangements, and the agency has no intention of entering into any agreements for contract financing arrangements.

(xiv) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

(xv) Offeror’s proposal shall be submitted electronically to the Contract Specialist, Leatrice Bulls, via email to OSContracting@hhs.gov no later than the date and time provided herein under Section L, L.1 Proposal Submission Deadline. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). When responding to the RFP, please use the subject line: RFP Response 75A50325R00010 (TMD).

a. All questions or clarification requests regarding any aspect of this RFP shall be submitted to the contract specialist, Leatrice Bulls, via email at OSContracting@hhs.gov no later than the date and time provided below under Section L, L.2 Questions or Clarifications. Unless the Government otherwise determines that it is in its best interest to provide a response, questions received after the deadline will not be answered. When submitting questions or clarifications, please use the subject line: RFP Questions 75A50325R00010

(TMD).

(xvi) The point of contact for information regarding this solicitation is:

Contract Specialist:

Leatrice Bulls Division of Operational Contracting (DOC) Office of Head of Contracting Activity (OHCA) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: OSContracting@hhs.gov

SECTION B – CONTINUATION OF SF1449

BLOCK 20. SCHEDULE OF SUPPLIES/SERVICES

B.1 Contract Line Items

Base Period: 29 September 2025 – 28 September 2026

CLIN

SUPPLIES/SERVICES

Description Unit of

Measure Base

Quantity Unit Price

Extended Price

Base Period Category 1:

Temperature Monitoring Device as described in Section C, SOW

EA 4,800 $ ______ $ _________

Base Period Category 2:

Temperature Monitoring Device as described in Section C, SOW

EA 2,500 $ ______ $ _________

Option Period 1: 29 September 2026 – 28 September 2027

CLIN

SUPPLIES/SERVICES

Description Unit of

Measure

Option Period

Quantity

Unit Price

Extended Price

Option Period Category 1:

Temperature Monitoring Device as described in Section C, SOW

EA 4,800 $ ______ $ ________

Option Period Category 2:

Temperature Monitoring Device as described in Section C, SOW

EA 2,500 $ ______ $ ________

SECTION C - STATEMENT OF WORK

Title of Project: Temperature Monitoring Devices for the Transportation of Temperature Sensitive Biomedical and Pharmaceutical Products

C.1 Background

The Strategic National Stockpile (SNS) is responsible for federal stockpiling and deploying pharmaceuticals, equipment and medical supplies needed during a public health response. These supplies are used to treat or prevent illness and need to be distributed and dispensed to people throughout the country.

Distribution of pharmaceuticals or biologicals require strict cold chain management (CCM) logistics to ensure the stability and viability of the product. The most common product the SNS distributes are vaccines. If the cold chain is not properly maintained, vaccine potency may be lost, resulting in an unusable supply. Vaccines must be stored properly from the time they are manufactured until they are administered.

Potency is reduced every time a vaccine is exposed to an improper condition. This includes overexposure to heat, cold, or light at any step in the cold chain. Once lost, potency cannot be restored. Exposure to any inappropriate conditions can affect potency of any refrigerated vaccine, but a single exposure to freezing temperatures (0° C [32° F] or colder) can destroy potency. Liquid vaccines containing an adjuvant can permanently lose potency when exposed to freezing temperatures.

Distribution of the vaccines to end users rely on state and local health departments. However, the SNS in collaboration with the Administration for Strategic Preparedness and Response (ASPR) aims to optimize the distribution of pharmaceuticals vaccines during national emergencies. One of the main objectives is to implement a real time in-transit asset visibility (ITV) capability. This will allow the SNS to constantly monitor location and temperature of shipments. Greatly improving communication with stakeholders and reducing the time required documentation and to clear the product for use by the provider/end user.

C.2 Project Objective and Need

SNS must maintain readiness and be capable of transporting and tracking shipments of critical vaccines during a public health emergency. The objective of this procurement is to acquire a total of 7,300 temperature monitoring devices (TMDs):

4,800 Category 1 Devices 2,500 Category 2 Devices

Deliveries will be made quarterly to designated U.S. locations. The first quarterly delivery must be completed within 30 calendar days of contract award. Vendors must be able to supply both Category 1 and Category 2 devices as specified in Section C.4.

Vendors unable to provide both categories will not be considered for award.

The goal is to acquire temperature monitoring devices (TMDs) to allow the SNS to continue support without a disruption in the supply chain. The temperature of all vaccines must be monitored throughout every delivery. The capability of the temperature monitoring devices ensures that the SNS can support national preparedness efforts by ensuring the integrity of critical medical stockpile distribution during national or local emergencies.

C.3 Scope of Work

The SNS requires the use of TMDs to monitor all cold-chain shipments. The contractor shall provide the TMDs as described in the technical requirements section of this statement of work. The total quantity of devices is detailed in the section C.10. Delivery Schedule.

The contractor shall supply commercial off-the-shelf (COTS) TMDs that meet the defined technical and performance requirements across two temperature categories.

Devices must reliably monitor pharmaceuticals and vaccines during transportation under varying environmental conditions, provide tamper-proof data, and include real-time tracking capabilities where specified.

The contractor shall provide, configure, and deliver temperature monitoring devices with the following requirements:

Each device must have a unique serial number for tracking and inventory purposes.

Configuration and Calibration o Devices must be pre-programmed to government specifications prior to delivery.

o All devices must be calibrated prior to delivery.

o Vendor must provide a certificate of configuration and calibration for each delivery batch.

o Vendor shall describe any available recalibration or replacement services.

Data Access and Remote Reporting Devices must allow staff to:

o Change and reconfigure devices after receipt.

o Remotely access data and reports (temperature history, real-time location, delivery details).

o Generate tamper-proof data logs and remote reports.

o Vendor must provide a minimum of 20 user accounts with reporting platform access.

User Interface o Devices with an integrated display screen are strongly preferred.

C.4 Technical Requirements

The required product specifications as follows:

Category 1: TMDs Operating from -20°C to +40°C

Accuracy:

±1.0°C from -30°C to -4°C and +24°C to +55°C ±0.5°C from -5°C to +25°C

Key Features:

Device shall be standalone (e.g. probe-less) Device shall be available in single-use or multi-use formats Device must have a visible alarm indicator.

At a minimum, device shall record o Last recorded temperature o Elapsed trip time (days, hours, minutes) o Temperature excursion history (including time and duration of each) o Records up to two high and two low threshold excursions

Device shall have tamper-proof and permanent memory Device shall have a configurable delayed start (minimum 30 minutes) Device shall be pre-programmed to agency specifications prior to shipment Device shall have a battery shelf life of ≥ 18 months from delivery Device shall have the expiration date printed on both device and shipping container Contractor/Vendor shall provide a certificate of configuration that must be included with each batch Devices must be validated to meet stated performance; validation documentation and quality management approach traceable to National Institute of Standards and Technology (NIST) standards

Category 2: TMDs Minimum Operating Range from -80°C to +40°C

Accuracy:

±1.0°C from -95°C to -2°C and +11°C to +50°C ±0.2°C from -1°C to +10°C

Includes all features from Category 1, plus the following:

Device shall have real-time tracking of, at a minimum, temperature and location via Bluetooth, Wi-Fi, GPS, and/or similar methods

Device and/or platform shall have the capability of providing comprehensive digital reporting, including graphical views, summaries, and full data logs

Device and/or platform shall have programmable data collection intervals (minimum of every 15 minutes for at least 150 days)

Device shall have the ability to be reprogrammed post-award in accordance with agency requirements

Device shall support multiple alarm types. Including the following:

o Single limit o Temperature range o Dual range o Duration-based o Mean Kinetic Temperature (MKT)

Device shall be serialized or uniquely identified (lot, serial, or part number) for full traceability

Device shall have a non-Lithium battery with a shelf life of ≥ 12 months from delivery

Contractor/vendor shall provide a NIST traceable calibration certificate and documented statement of accuracy

Contractor/vendor shall provide a recalibration and/or replacement program Contractor/vendor shall provide a qualification/validation study for the device demonstrating that the units meet the requirements and are operating as intended.

C.5 Contract Line Items

Base Period: 29 September 2025 – 28 September 2026

SUPPLIES/SERVICES

Description Unit of

Measure Base

Quantity

Base Period Category 1:

Temperature Monitoring Device

EA 4,800

Base Period Category 2:

Temperature Monitoring Device

EA 2,500

Option Period: 29 September 2026 – 28 September 2027

C.6 Reporting Schedule – None

SUPPLIES/SERVICES

Description Unit of

Measure

Option Period

Quantity

Option Period Category 1:

Temperature Monitoring Device

EA 4,800

Option Period Category 2:

Temperature Monitoring Device

EA 2,500

C.7 Special Considerations

Distribution to multiple locations across the Continental United States (CONUS), per post-award delivery schedule

Contractor must accommodate surge orders and provide:

o Typical inventory levels o Manufacturing and delivery lead times o Scalability plans for emergency demand

C.8 Government Furnished Property – None

C.9 References – NIST standards https://www.nist.gov/nist-quality-system

C.10 Delivery Schedule

All shipments shall be made in accordance with the delivery schedule below.

Deliveries shall be staggered quarterly to ensure varying expiration dates. The contractor shall ensure that the temperature monitors arrive during the work week between Monday- Friday 7:00 am to 3:00 PM local time (weekend and holiday delivery will not be accepted). The contractor shall notify the COR within 1-week of the scheduled shipment date, if it cannot meet the delivery deadline set forth within this document.

All deliveries shall be optimized TI-HI stack pattern for all pallets; standard size

48" x 40", max height 60". All pallets shall be securely stretch wrapped with packing slip clearly located on one of the sides. Packing slips must include all identifying information for tracking and inventory control. Vendor shall include at least one (1) “Quick start guide” for the device(s) per shipment

All products must be properly labeled with:

o Contract number o Product description o Lot/Serial number o Expiration date

Table.1

Location Quantity Cat 1 Quantity Cat 2 Atlanta, GA 30349 600 300

Windsor, Ct 060905 600 300

Brownsburg, IN 46112 600 300

Puyallup, WA 98372 600 300

Irving, TX 75038 600 400

Atlanta, GA 300333 600 300

Olive Branch, MS 38654 600 300

Salt Lake City, UT. 84104 600 300

Total 4,800 2,500

C.11 Deliverables

The contractor shall provide delivery as per the final delivery schedule discussed at time of contract award.

Deliverable Description Form Delivery Date 001 Kick-off Meeting CO/COR/POC 2 business days after award

Validation/qualification documentation

System Access At least 20 user accounts for the reporting platform.

Secure ability for staff to remotely reconfigure and download reports.

Delivery Documents;

Calibration and configuration certificates for each batch.

Scan and email to

COR/POC

2 business days prior to delivery

003 Packing Slips Scan and email to

COR/POC

48 hours after shipping

004 Delivery Schedules Email to COR/POC 5 business days prior to the beginning of each month

005 Final Report Email to COR/POC

Within 5 business days from end of contract, or final delivery whichever comes first

Delivery Documents – Delivery documents shall include copies of the validation/qualification paperwork for each unit

Monthly Report – The monthly report shall be in excel format and contain at a minimum, the following information for each delivery that occurred in the previous month:

1. Date of Delivery

2. Location of Delivery

3. Freight Carrier

4. Quantity of unit and number of pallets

5. Manufacturer

6. Model and Serial Number

Delivery Schedules – The delivery schedules for the upcoming month shall be provided to the COR/POC 5 business days prior to the beginning of each month and include the anticipated dates, quantities, location, and truck loads for delivery of the upcoming month.

Final Report – The final report shall be a detailed summary of all deliveries under the performance of this contract.

SECTION D – PACKING, MARKING AND SHIPPING

D.1 PACKING

All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. All postage and fees related to submission of information, including forms, reports, and other relevant documents, submitted to the Contracting Officer (CO) or Contracting Officer’s Representative (COR) or other persons designated by the CO to receive such deliverables, shall be paid by the Contractor.

D.2 MARKINGS

All deliverables required and submitted to the CO or the COR or other SNS personnel designated to receive deliverables under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name and clearly indicate the following information:

1) Contract Number

2) Product description of information/data being submitted

3) Lot/Serial Number

4) Expiration Date

The Contractor shall guarantee and comply with deliverable table in the SOW, Section C.11 – Deliverables, which is listed in the table above.

D.3 DELIVERY LOCATION & SHIPPING REQUIREMENTS

The contractor shall refer to SOW, Section C.10 – Delivery Schedule, which is listed above for details regarding delivery location and shipping requirements.

SECTION E – INSPECTION AND ACCEPTANCE

The CO or the duly authorized representative will perform inspection and acceptance of materials and services to be provided under this contract within 24 hours once product is delivered and validated.

For the purpose of this SECTION, the designated Contracting Officer's Representative (COR) is the authorized representative of the CO.

CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the CO will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/far.

SECTION F – DELIVERIES OR PERFORMANCE

CLAUSES INCORPORATED BY REFERENCE (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far.

FAR SOURCE TITLE AND DATE

52.242-15 Stop-Work Order (Aug 1989) 52.242-17 Government Delay of Work (Apr 1984) 52.246-16 Responsibility for Supplies (April 1984) 52.247-34 F.o.b. Destination (Jan 1991)

F.1 PERIOD OF PERFORMANCE

a. The anticipated period of performance will begin on 09/29/2025:

1. Base Period: 29 September 2025 – 28 September 2026

2. Option Period 1: 29 September 2026 – 28 September 2027

b. The performance of this contract shall be in accordance Statement of Work in SECTION

C.

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 GOVERNMENT REPRESENTATIVES

G.1.1 Contracting Officer (CO)

To Be Determined (TBD) at Time of Award Contracting Officer xxxxx.xxxxx@hhs.gov

a. The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions, or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

b. The CO is the only person with authority to act as agent of the Government under this contract. Only the CO has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract;(5) obligate or de-obligate funds into the contract;

or (6) otherwise change any terms and conditions of this contract.

c. No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

NOTE: An unauthorized commitment is an agreement that is not binding solely because the Government representative who made it lacked the authority to enter into that agreement on behalf of the Government. An unauthorized commitment (UC) usually results in the receipt of goods or services on behalf of the Government by someone with apparent authority, but that lacks the authority to obligate the Government; it can be intentional or unintentional. Only a warranted contracting officer has authority to obligate government funds and contractually bind the government for supplies and services within their warrant authority.

G.1.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

To Be Determined (TBD) at Time of Award Contracting Officer’s Representative HHS/ASPR/SNS xxx.xxxx@hhs.gov

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements.

The Government may unilaterally change its COR designation. Any changes in COR delegation will be made by the CO in writing with a copy being furnished to the Contractor.

G.2 HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022) See also section H.3 below.

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

G.3 Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

a) All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services included in commercial items contracts.

The IPP website address is: https://www.ipp.gov.

c) All Contractors shall enroll in IPP if not previously enrolled The Agency will enroll the

Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment.

The Contractor Government Business Point of Contact (as listed in SAM) should receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone

(866) 973-3131.

The Contractor POC should receive two emails from IPP Customer Support. The first email typically contains the initial administrative IPP User ID. The second email, usually sent within 24 hours of receipt of the first email, contains a temporary password. The Contractor must log in with the temporary password within 30 days.

• If The Contractor is already registered to use IPP, it will not be required to re-register.

• If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the CO to explain the circumstances that require the authorization of alternate payment procedures.

Invoice Elements.

In accordance with FAR 32.905 Payment documentation and process, the Contractor shall submit an electronic invoice to the email addresses designated in the contract to receive invoices.

(a) Payment will be based on receipt of a proper invoice and satisfactory contract performance.

(b) Content of invoices.

(1) A proper invoice must include the following items (except for interim payments on cost reimbursement contracts for services):

i. Name and address of the contractor.

ii. Invoice date and invoice number. (Contractors should date invoices as close as possible to the date of mailing or transmission.)

iii. Contract number or other authorization for supplies delivered or services performed (including order number and line-item number).

iv. Description, quantity, unit of measure, unit price, and extended price of supplies delivered, or services performed.

v. Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading.

vi. Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).

vii. Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

viii. Taxpayer Identification Number (TIN). The contractor must include its TIN on the invoice only if required by agency procedures. (See 4.9 TIN requirements.)

ix. Electronic funds transfer (EFT) banking information.

A. The contractor must include EFT banking information on the invoice only if required by agency procedures.

B. If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the contractor must have submitted correct

EFT banking information in accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

C. EFT banking information is not required if the Government waived the requirement to pay by EFT.

x. Any other information or documentation required by the contract (e.g., evidence of shipment).

(2) An interim payment request under a cost-reimbursement contract for services constitutes a proper invoice for purposes of this subsection if it includes all of the information required by the contract.

(3) If the invoice does not comply with these requirements, the designated billing office must return it within 7 days after receipt (3 days on contracts for meat, meat food products, or fish; 5 days on contracts for perishable agricultural commodities, dairy products, edible fats or oils, and food products prepared from edible fats or oils), with the reasons why it is not a proper invoice. If such notice is not timely, then the designated billing office must adjust the due date for the purpose of determining an interest penalty, if any.

(c) Authorization to pay. All invoice payments, with the exception of interim payments on cost-reimbursement contracts for services, must be supported by a receiving report or other Government documentation authorizing payment (e.g., Government certified voucher). The agency receiving official should forward the receiving report or other Government documentation to the designated payment office by the 5th working day after Government acceptance or approval, unless other arrangements have been made. This period of time does not extend the due dates prescribed in this section. Acceptance should be completed as expeditiously as possible. The receiving report or other Government documentation authorizing payment must, as a minimum, include the following:

(1) Contract number or other authorization for supplies delivered or services performed.

(2) Description of supplies delivered, or services performed.

(3) Quantities of supplies received and accepted, or services performed, if applicable.

(4) Date supplies delivered, or services performed.

(5) Date that the designated Government official-

(i) Accepted the supplies or services; or

(ii) Approved the progress payment request, if the request is being made under the clause at 52.232-5, Payments Under Fixed-Price Construction Contracts, or the clause at 52.232-10, Payments Under Fixed-Price Architect-Engineer Contracts.

(6) Signature, printed name, title, mailing address, and telephone number of the designated Government official responsible for acceptance or approval functions.

(d) Billing office. The designated billing office must immediately annotate each invoice with the actual date it receives the invoice.

(e) Payment office. The designated payment office will annotate each invoice and receiving report with the actual date it receives the invoice.

The Administration for Strategic Preparedness and Response (ASPR) additional requirements:

(i) The contractor shall submit monthly invoices under this contract unless otherwise agreed upon by all parties. For indefinite delivery and blanket purchase agreement vehicles, separate invoices must be submitted for each order.

(ii) Invoices must break-out price/cost by contract line-item number (CLIN) as specified in the pricing section of the contract.

G.4 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a) Contractor Performance Evaluations Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at or around the time of the completion of work. In addition to the final evaluation, interim evaluation will be prepared after completion of one year of performance. Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the CO, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b) Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 – CONTRACTOR PUBLICITY

The Contractor, or any entity or representative acting on behalf of the Contractor, shall not refer to the supplies or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the Contracting Officer.

Should any reference to such supplies or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government shall consider institution of all rights and remedies available under applicable law, including 31 U.S.C. 333, and this contract, including the recovery of damages. Further, any violation of this requirement may be considered as part of the evaluation of past performance.

H.2 – NON-DISCLOSURE AGREEMENT

All of the Contractor’s employees (and subcontractors) that will have access to non-public and procurement-sensitive information (photos, drawings, specifications, statements of work requirements, location data, etc.) or access to non-public ASPR facilities must sign a Non- Disclosure Agreement (NDA). The NDA will be made part of the contract file. The NDA shall require that the Contractor’s employees (or subcontractors) properly identify themselves as employees (or subcontractors) of the Contractor when communicating or interacting with ASPR employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with ASPR/SNS), and members of the public.

In accordance with FAR 37.114(c), “[a]ll contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

1) The Contractor shall inform employees (and subcontractors) of the identification requirements by which they must abide and monitor employee (and subcontractor) compliance with the identification requirements.

2) During the contract performance period, the Contractor shall ensure that all additional or replacement contractors’ employees (and subcontractors) sign an NDA, and it is submitted to the CO prior to commencement of their work with ASPR/SNS.

3) The Contractor shall ensure that Contractor employees (or subcontractors) in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed.

4) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit the list (and any updates) to the CO upon request during the contract period of performance. The list shall at a minimum include the following information:

contract number, employee’s (or subcontractor’s) name, position, date of hire (or contracted), and the NDA requirement.

H.3 – CONTRACTING OFFICER’S REPRESENTATIVE (COR) APPOINTMENT AND

AUTHORITY

Performance of work under this contract is subject to the technical direction of the COR identified in Section G, or a representative designated by the CO in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily. Technical direction must be within the scope of the contract specification(s)/work statement. The COR does not have authority to issue technical direction that:

i. Constitutes additional work outside the contract specification(s)/work statement;

ii. Constitutes a change as defined in the “Changes” clause of this contract;

iii. Causes an increase or decrease in the contract price, or the time required for contract performance;

iv. Interferes with the contractor’s right to perform under the terms and conditions of the contract; or

v. Directs, supervises, or otherwise controls the actions of the contractor’s employees.

Technical direction may be oral or in writing. The COR must confirm oral direction in writing within five workdays, with a copy to the CO. The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If in the opinion of the contractor, any direction of the COR or the designated representative falls within the limitations above, the Contractor shall immediately notify the CO no later than the beginning of the next Government workday. Failure of the Contractor and the CO to agree that technical direction is within the scope of the contract shall be subjected the terms of the “Disputes” clause of this contract.

SECTION I – RFP PROVISIONS AND CONTRACT CLAUSES

I.1. 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far

I.2. 52.252-2 Clauses Incorporated by Reference (Feb 1998)

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

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.204-7 System for Award Management (Nov 2024) 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 (Aug 2020) 52.204-19 Incorporation by Reference of Representations and Certifications (Dec

2014) 52.204-24 Representation Regarding Certain Telecommunications and Video

Surveillance Services or Equipment (Nov 2021) 52.204-26 Covered Telecommunications Equipment or Services-Representation

(Nov 2021) 52.204-29 Federal Acquisition Supply Chain Security Act Orders, Representation and Disclosures (Oct 2020) 52.209-5 Certification Regarding Responsibility Matters (Aug 2020) 52.209-7 Information Regarding Responsibility Matters (Oct 2018) 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial

Services (Nov 2023) 52.222-56 Certification Regarding Trafficking in Person Compliance Plan (Oct 2020) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

HHSAR

SOURCE

352.203-70 Anti-Lobbying (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015)

I.3. Provisions and Clauses Incorporated in Full Text

52.212-3 Offeror Representations and Certifications—Commercial Products and Commercial Services (May 2024) – Refer to and complete Attachment 1, Offeror Representations and Certifications herein.

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders — Commercial Products and Commercial Services (Jan 2025)

(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 (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

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

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(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 (Mar 2023)

(31 U.S.C. 3903 and 10 U.S.C. 3801).

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

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

(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:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with

Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

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

3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment

Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun

2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts

(Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of

Division R of Pub. L. 117-328).

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply

Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) (Pub. L. 115–390, title II).

__ (11) (i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec

2023) (Pub. L. 115–390, title II).

__ (ii) Alternate I (Dec 2023) of 52.204-30.

_X_ (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) (31 U.S.C. 6101 note).

__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(Oct 2018) (41 U.S.C. 2313).

__ (14) [Reserved].

__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C.

657a).

__ (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns

(Oct…