Synopsis-Quote_Pre-Con Container RFQ.pdf

NOTE: Due to the length of this combined synopsis/solicitation, a pdf copy to help provide easier readability is attached to this posting.

COMBINED SYNOPSIS SOLICITATION

i. This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in 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 document will not be issued.

ii. The solicitation number is 75A50323Q00016 which is being issued as a Request for Proposal (RFQ). Contract Type will be Firm Fixed Price.

iii. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-04, effective June 2, 2023.

iv. This acquisition is being posted as Full and Open and is not set aside for small businesses. NAICS 332439 Shipping, Cargo, Freight and Storage Containers. The size standard is 600 employees.

v. a. The Strategic National Stockpile (SNS), of the U.S. Department of Health and Human Services (HHS)

Administration for Strategic Preparedness and Response (ASPR), has a requirement has a requirement for non-preconditioned shipping container that are 100% domestically manufactured with 100% domestic components as is required by the Infrastructure and Investment Jobs Act (IIJA)/Make PPE in America. See Section B- SUPPLIES

OR SERVICES AND PRICES/COSTS.

b. The Government intends to evaluate offers and award a contract without discussions. However, the Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government.

vi. See Sections B and C below for description of requirements.

vii. The period of performance is anticipated to be 60 months, inclusive of a base period of 12 months with four

(4) one-year option periods. See below for place(s) of delivery and acceptance and FOB point(s).

viii. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (MAR 2023), applies to this acquisition. The Government intends, but is not obligated, to award multiple contracts.

ix. The provision FAR 52.212-2, Evaluation-Commercial Products and Commercial Services (MAR 2023), applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

x. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-

Commercial Products and Commercial Services (DEC 2022), with its offer. (Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that affect in accordance with this clause).

xi. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (DEC 2022), applies to this acquisition.

xii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (JUN 2023), applies to this acquisition and FAR clauses applicable are 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 below for details.

xiii. There are no special contract requirements or terms and conditions related to 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. Offers are due no later than August 24, 2023, 5:00 PM Eastern Standard Time (EST). Officers must submit and electronic copy of the Technical Quote and Price/Business Quote via email to dsnssolications@cdc.gov with the Subject Line RFQ 75A50323Q00016, and by email to Akela Long at oga1@cdc.gov and Rebecca Washington at qvb1@cdc.gov. The offeror’s complete quote (including all information required to be submitted as part of the offeror’s Volume I -Technical Quote, and Volume II - Price/Business Quote) must be received by the date and time specified for receipt of offers. See Section l for additional details for the content of proposals.

Electronics submissions only will be accepted and shall be submitted via email to the email addresses specified above. Email submissions are limited to 10 MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

o All questions regarding this RFQ of contractual or technical nature, must be submitted electronically by email to with subject line “ QUESTIONS RFQ 75A50323Q00016”, to Akela Long at oga1@cdc.gov and Rebecca Washington at qvb1@cdc.gov. no later than 1:00 p.m. Eastern Standard Time (EST) August 14, 2023. The Government’s responses to questions will be posted as an attachment to the combined synopsis/solicitation posting. 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.

xvi. The point of contact for information regarding this Combined Synopsis/Solicitation is:

Contracting Officer Akela Long Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: oga1@cdc.gov Office: 404.498.5635 mailto:dsnssolications@cdc.gov mailto:gwg8@cdc.gov mailto:qva7@cdc.gov mailto:gwg8@cdc.gov mailto:qva7@cdc.gov mailto:gwg8@cdc.gov%7C

RFQ-75A5323Q00016

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Contract Line Items

Base Year:

CLIN Description Quantity Unit Price

Extended Price

1001 Non-preconditioned controlled temperature shipping container, Size Medium in accordance with Statement of Work (SOW) in Section C.

This is a Firm Fixed Price Line item.

650 EA

1002 Non-preconditioned controlled temperature shipping container, Size Large in accordance with Statement of

2450 EA

1003 Transportation and Freight

This is a Time and Materials Line item.

This is a severable Line Item.

Not to Exceed $54,900.00

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 1001 through 1003: $

Option Year 1:

CLIN Description Quantity

/UOM

Unit Price

Extended Price

2001 Non-preconditioned controlled temperature shipping container, Size Medium in accordance with Statement of

200 EA

2002 Non-preconditioned controlled temperature shipping container, Size Large in accordance with Statement of

400 EA

2003 Transportation and Freight

This is a Time and Materials Line item.

This is a severable Line Item.

$13,000.00

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 2001 through 2003:

Option Year 2:

/UOM

Unit Price

Extended Price

3001 Non-preconditioned controlled temperature shipping container, Size Medium in accordance with Statement of

3002 Non-preconditioned controlled temperature shipping container, Size Large in accordance with Statement of

3003 Transportation and Freight

This is a Time and Material Line item.

This is a severable Line Item.

$56,000.00

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 3001 through 3003: $

Option Year 3:

/UOM

Unit Price

Extended Price

4001 Non-preconditioned controlled temperature shipping container, Size Medium in accordance with Statement of

200 EA

4002 Non-preconditioned controlled temperature shipping container, Size Large in accordance with Statement of

400 EA

4003 Transportation and Freight

This is a Time and Materials Line item.

This is a severable Line Item.

$14,000.00

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 4001 through 4002: $

Option Year 4:

/UOM

Unit Price

Extended Price

5001 Non-preconditioned controlled temperature shipping container, Size Medium in accordance with Statement of

5002 Non-preconditioned controlled temperature shipping container, Size Large in accordance with Statement of

5003 Transportation and Freight

This is a Time and Materials Line item.

This is a severable Line Item.

$60,000.00

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 5001 through 5003: $

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 1001 through 5003: $

B.2 Contract Type: This is a Firm Fixed Price (FFP) contract.

B.3 Estimated Transportation and Freight to accomplish Section C.5 -Delivery Locations and Shipping Requirements for Contract Line-Items 1003, 2003, 3003, 4003, and 5003. The total cost shall not exceed $137,000.00 total over the five (5) year contract period.

Delivery Locations and Shipping Requirements

Deliver to Qty/EA

Medium Qty/EA Large

Honolulu, HI 350 2350 Ontario, CA 200 1600 Atlanta, GA 200 700 Puyallup, WA 200 700 Salt Lake City, UT 350 700 Olive Branch, MS 350 700 Irving, TX 350 700 Brownsburg, IN 350 700

STATEMENT OF WORK (SOW)

Title of Project: Non-Preconditioned Controlled Temperature Shipping Containers

C.1 Background – The mission of the Strategic National Stockpile (SNS), of the United States (U.S.) Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) is to ensure the availability and rapid deployment of life-savings pharmaceuticals, antidotes, other medical supplies and equipment necessary to counter the effects of nerve agents, biological pathogens, and chemical agents. When state, local, tribe and territorial public health and medical systems request federal assistance to support their response efforts, SNS ensures that the right medicine and supplies get to those who need them most during emergency.

The Strategic National Stockpile (SNS) is a national repository of medicines, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. The assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.

For the SNS to accomplish its mission of supporting the US and US territories, it will need to have durable controlled temperature shipping containers to support the vaccine mission. These shipping containers will not require the use of dry ice nor require frozen or refrigerated gel packs for vaccine shipment. The shipping container must maintain an even temperature consistently and keep pharmaceuticals at their cold temperature for several days without needing electricity.

The cold chain is a temperature-controlled environment used to maintain and distribute temperature sensitive medical products like vaccines in optimal condition. The cold chain begins at the manufacturer, continues in shipment to medical logistics, then to the vaccination site, and ends at administration of the vaccine to the patient. Failure to adhere to required specifications for shipping, storing, and handling vaccines in the manufacturer’s packaging insert may reduce the vaccines potency resulting in inadequate protection against disease. A single shipment of vaccine can immunize thousands of patients but could become compromised if that shipment is exposed to temperature fluctuations or direct sunlight.

C.2 – Purpose

The purpose of this requirement is to provide the Strategic National Stockpile (SNS), containers to ship temperature-controlled products using a non-preconditioned shipping container in order to support "emergency responses". Specifically, SNS has the need for significant quantities of Non-Preconditioned Controlled Temperature Shipping Containers that does not require the use of Dry-Ice nor requires frozen or refrigerated gel packs. Shipping containers that shall be compliant with the domestic sourcing requirements established in the Make PPE in America and the Infrastructure Investment and Job Acts. See, Public Law 117-58, Subtitle C, 135 Stat. 429 (2021).

C.3 – Scope of Work

The expectation is to receive delivery of 10,500 each non-preconditioned controlled temperature shipping containers over a five-year period, to be shipped to SNS locations within the United States identified in the deliverables section.

These containers would ensure temperature consistency during the shipping process. The container shall have a life expectancy of 2 years or longer from date of delivery.

Non-Preconditioned Controlled Temperature Shipping Containers shall be 100% domestically manufactured with 100% domestic components as is required by the Infrastructure and Investment Jobs Act (IIJA)/Make PPE in America is MANDATORY REQUIREMENT.

C.3.1 The proposed non-preconditioned controlled temperature shipping container will be used in austere environments and does not require cold storage, nor being placed in a refrigerator or freezer prior to its use, nor tethered to a power-driven or other mechanical device during Cold-Chain Management (CCM) shipment. The container shall not require the use of Dry-Ice in order to maintain a temperature range of 2°C and 8°C during transit of temperature-controlled shipments.

C.3.2 The proposed non-preconditioned controlled temperature shipping container shall maintain the following temperature ranges:

• Temperature controlled packing validated to maintain contained product at a temperature range of 2°C to 8°C for at least 96 hours without preconditioning.

• Temperature range of 2°C to 8°C for approximately 96 hours during transit regardless of external temperatures experienced during transit to any populated location.

• Shall have the ability to be stored by means of stacking or palletizing in ambient temperature between 17°C and 25°C (63°F and 77°F) to maintain the container in full, ready-to-use condition.

C.3.3 The non-preconditioned controlled temperature shipping container shall meet the requirements specified below:

• Provide effective CCM shipping without the use of dry ice, or preconditioned gel packs or icepacks.

• The use of Dry Ice, power-driven, or other mechanical devices to prepare or maintain temperature requirement is not acceptable.

• Pack out time shall be less than two minutes per shipping container.

• Two different box sizes shall be required for shipping:

o Large (Outer dimensions 14.2”x12”x12”/Inner 9.5”x8.7”x4.8”) o Medium (Outer dimensions 12.1”x7.9”x8.5”/Inner 8.5”x4.7”x3.0”)

• International Safe Transit Association (ISTA) 3A, Drop Test and ISTA 7D, Winter and Summer Protocol shall be followed and documented to ensure containers can maintain the set standards.

• The cooling device and shipping/insulated box shall have a minimum shelf life of 2 years from date of delivery (longer shelf life is preferred).

• Manufacture date, manufacturer item/model number and manufacture name shall be printed on the container in a visible location when the product is stored in warehouse racking.

• Shall provide end user operation packaging protocol instructions for each model purchased.

• Shall provide web site and phone contact information for end user to contact for help assistance.

• Shall include statement on end user directions for safe disposal and any associated material risks by end user.

• Shall describe their QA/QC Validation Approach for the product.

• Shall describe their General Qualification Acceptance Criteria

• Shall describe their testing philosophy approach and methodology (Software and Hardware, Factory

Acceptance Testing)

• Shall provide Qualification verification/certification letter for all units sold.

• Passive temperature maintenance is required to activate (Non-electrical).

• Vendor to deliver requested amount of Non-preconditioned Controlled Temperature Shipping Containers

• Vendor to notify SNS Receiving Sites prior to shipping in order to make a schedule delivery appointment(s).

C.4 – Contract Period of Performance:

The anticipated Period of Performance (PoP) is as follows:

Base Year: September 15, 2023 – September 14, 2024 Option I Period: September 15, 2024 – September 14, 2025 Option II Period: September 15, 2025 – September 14, 2026 Option III Period: September 15, 2026 – September 14, 2027 Option IV Period: September 15, 2027 - September 14, 2028

C.5 – Delivery Locations and Shipping Requirements:

The Contractor shall make deliveries under this contract at the SNS locations listed below. SNS State Delivery Locations and quantities are as follows:

BASE YEAR, OPTION YEAR 2 AND OPTION YEAR 4:

Qty/EA Large

Honolulu, HI 100 750 Ontario, CA 50 500 Atlanta, GA 50 200 Puyallup, WA 50 200 Salt Lake City, UT 100 200 Olive Branch, MS 100 200 Irving, TX 100 200 Brownsburg, IN 100 200

Total 650 2450

OPTION YEAR 1 AND OPTION YEAR 3:

Qty/EA Large

Honolulu, HI 25 50 Ontario, CA 25 50 Atlanta, GA 25 50 Puyallup, WA 25 50 Salt Lake City, UT 25 50 Olive Branch, MS 25 50 Irving, TX 25 50 Brownsburg, IN 25 50

Total 200 400

The contractor shall ship the non-preconditioned controlled temperature shipping containers to the destination using traceable means. For each shipment, contractor shall provide the following information to the COR within 48 hours after delivery:

• All shipments will include packing slip and contract number.

• Storage Requirements shall be on all packing lists.

• Item description shall include Model Number, Device Name and Serial Number.

• All pallets are to have the identical Ty-Hi stack pattern except for the final pallet.

• All product to be delivered on-standard 48" by 40" pallet, not to exceed 60"in height, stretch wrapped and secured to pallet for safe transport.

• Contractor shall contact the COR or designated point of contact (POC) to schedule delivery appointments.

C.6 – Deliverables

Deliverable Format/Deliver to Date Delivery Documents Scan and email to COR/POC 2 Business Days Prior to Delivery

Packing Slips Scan and email to COR/POC 48 hours after delivery

Yearly Report

Email to COR/POC Yearly Summary of quantities delivered at end of each performance period.

SECTION D-PACKAGING, MARKING AND SHIPPING

D.1 PACKING

All postage and fees related to submission of information, including forms, and reports, etc., to the Contracting Officer or Contracting Officer’s Representative (COR) or other persons designated to receive shall be paid by the Contractor.

D.2 MARKINGS

All product delivered under this contract shall be packaged, marked and shipped in accordance with Government specifications and FDA regulations. This requirement intends to require vendors to adhere to the FDA’s Unique Device Identification (UDI) Policy requirements, effective as of September 24, 2022, for any product delivered under this contract. At a minimum, each deliverable shall include the following information at time of delivery:

1. Packing Slip with Contract number

2. Contractor Name and Address

3. Storage Requirements shall be on all packing lists.

4. Product Name, Model Number, Serial Number and Manufacturer

D.3 DELIVERY LOCATION & SHIPPING REQUIREMENTS

Products shall be shipped FOB Destination. The address(es) will be provided by the COR after award and will be to a government designated location within the continental United States (CONUS) and outside of the continental United States (OCONUS). The contractor shall adhere to the following shipping requirements:

a. Contractor shall contact designated COR/POC for the respective delivery location to schedule delivery appointments NLT 48 hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:30PM).

b. All pallets are to have the identical TI-HI stack pattern for all deliveries throughout this contract except for the final pallet.

c. The product/case packaging configuration shall be identical for all deliveries throughout this contract.

d. All product to be delivered on 48" by 40" pallet, not to exceed 60” in height, stretch wrapped, and secured to pallet for safe transport.

e. Product is to be stacked in such a way that no portion of the cased materials may exceed the dimensions of pallet.

f. All cases must be positioned on the pallet in a way that allows for labels to be viewable.

g. The exact delivery locations shall be provided by the COR. Delivery will be within the CONUS and OCONUS.

SECTION E- INSPECTION AND ACCEPTANCE

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):http://farsite.hill.af.mil/

(End of Clause)

FAR SOURCE TITLE AND DATE

52.212-4 Contract Terms and Conditions-Commercial Services (DEC 2022) 52.246-2 Inspection of Supplies-Fixed Prices (Aug 1996)

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or a duly authorized representative (who for the purposes of this contract shall be the Project Officer or COR) at the destination of the articles, services or documentation. Final acceptance shall be based on the completion of each delivery.

“Notwithstanding the clause at FAR 52.212-4(a), inspection and acceptance shall be governed in accordance with FAR 52.246-2”.

http://farsite.hill.af.mil/

SECTION F- DELIVERIES AND PERFORMANCE

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/

52.246-16 Responsibility for Supplies (Apr 1984) 52.247-34 F.O.B. Destination (Nov 1991) https://www.acquisition.gov/

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 ADMINISTRATION

This contract will be administered by the following ASPR/DSNS personnel:

Contract Specialist Akela Long Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: oga1@cdc.gov| Office: 404.498.5635

Contracting Officer, Team Lead Annette Wright, Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: owf8@cdc.gov| Office: 404-273- 3127

Contracting Officer’s Representative (COR)/Technical Point of Contact (POC) Waymond Hughes Strategic National Stockpile (SNS) Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: gwd6@cdc.gov Office: 770-488-2510

G.2 HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(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) mailto:gwg8@cdc.gov%7C mailto:owf8@cdc.gov%7C mailto:gwd6@cdc.gov

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. 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) will 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.

o 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.

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

d. If your company is already registered to use IPP, you will not be required to re-register.

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

G.4 Invoice Elements.

In accordance with FAR 32.905 Payment documentation and process, Contractor shall submit an electronic invoice to the email addresses designated in the contract to receive invoices. Payment will be based on receipt of a proper invoice and satisfactory contract performance.

(a) 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.

https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

(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.

(b) 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.

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

https://www.acquisition.gov/far/subpart-4.9#FAR_Subpart_4_9 https://www.acquisition.gov/far/52.232-38#FAR_52_232_38 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 https://www.acquisition.gov/far/52.232-34#FAR_52_232_34 https://www.acquisition.gov/far/52.232-5#FAR_52_232_5 https://www.acquisition.gov/far/52.232-10#FAR_52_232_10

(d) 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.

SECTION H—SPECIAL CONTRACT REQUIREMENTS

H.1– CONTRACTING OFFICER

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, 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.

H.2 – CONTRACTING OFFICER’S REPRESENTATIVE

Performance of work under this contract is subject to the technical direction of the COR identified in Section G.1, or a representative designated by the contracting officer 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 contracting officer. 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 Contracting Officer no later than the beginning of the next Government workday. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subjected the terms of the “Disputes” clause of this contract.

H.3 – CONTRACTOR PUBLICITY

The Contractor, or any entity or representative acting on behalf of the Contractor, may not refer to the equipment 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 equipment or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government will consider institution of all remedies available under the contract and applicable law.

H.4 – NON-DISCLOSURE AGREEMENT

All Contractor’s employees 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 requires contractor’s employees properly identify themselves as employees of a 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. The Federal Acquisition Regulation (FAR) 37.114(c), states “All 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 of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

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

3) Contractor employees 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 to the Contracting Officer upon request during the contract period of performance. The list should at a minimum: contract number, employee’s name, position, date of hire and NDA requirement.

SECTION I- CONTRACT CLAUSES

I.1 FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer shall make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

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

52.204-7 System for Award Management (Oct 2018) 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) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance

Services or Equipment (Nov 2021) 52.209-7 Information Regarding Responsibility Matters (Oct 2018) 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services (DEC

2022) 52.212-4 Alt. I Contract Terms and Conditions-Commercial Products and Commercial Services (Nov

2021) 52.222-56 Certification Regarding Trafficking in Person Compliance Plan (Oct 2020) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

52.242-15 Stop-Work Order (Aug 1989) 52.246-16 Responsibility for Supplies (April 1984)

HHSAR

352.203-70 Anti-Lobbying (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223-70 Safety and Health (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015) 352.233-71 Litigation and Claims (Dec 2015) 352.237-74 Non-Discrimination in Service Delivery (Dec 2015) 352.239-74 Electronic and Information Technology (EIT) Acquisitions (Dec 2015) http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Clauses Incorporated in Full Text

I.2 FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services. (JUN 2023)

(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 and Other Covered Entities (Nov 2021) (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)(l)(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:

[Contracting Officer check as appropriate.]

_ (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.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020)

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

_ (5) [Reserved].

_ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X__ (8) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328).

X (9) 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).

_ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.2313).

_ (11) [Reserved].

_ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).

_ (13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct

2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

_ (14) [Reserved]

_ (15) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

_ (ii) Alternate I (Mar 2020) of 52.219-6.

_ (16) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

_ (ii) Alternate I (Mar 2020) of 52.219-7.

X (17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (15 U.S.C. 637(d)(2) and (3)).

X (18) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) (15 U.S.C. 637(d)(4)).

_ (ii) Alternate I (Nov 2016) of 52.219-9.

_ (iii) Alternate II (Nov 2016) of 52.219-9.

_ (iv) Alternate III (Jun 2020) of 52.219-9.

_ (v) Alternate IV (Sep 2021) of 52.219-9.

__ (19) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

_ (ii) Alternate I (Mar 2020) of 52.219-13.

_ (20) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

X (21) 52.219-16, Liquidated Damages-Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

(22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) (15

U.S.C 657 https://www.acquisition.gov/far/part-52#FAR_52_204_27

X (23) (i) 52.219-28, Post Award Small Business Program Representation (MAR 2023) (15 U.S.C.

632(a)(2)).

_ (ii) Alternate I (Mar 2020) of 52.219-28.

_ (24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

_ (25) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business

Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

_ (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

_ (27) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(l 7)).

X (28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

X (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEC 2022) (E.O.13126).

X (30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (31) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

_ (ii) Alternate I (Feb 1999) of 52.222-26.

X (32) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

_ (ii) Alternate I (Jul 2014) of 52.222-35.

X (33) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

_ (ii) Alternate I (Jul 2014) of 52.222-36.

X (34) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

X (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)

(E.O. 13496).

X (36) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O.

13627).

_ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

_ (37) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

_(38) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

_ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

_ (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

_X (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

_(41) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

_ (ii) Alternate I (Oct 2015) of 52.223-13.

_ (42) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

_ (ii) Alternate I (Jun2014) of 52.223-14.

_ (43) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b).

_(44) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

_ (ii) Alternate I (Jun 2014) of 52.223-16.

X (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020)

(E.O. 13513).

_ (46) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

X (47) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (48) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

_ (ii) Alternate I (Jan 2017) of 52.224-3.

_X_ (49) (i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

_ (ii) Alternate I (Oct 2022) of 52.225-1.

__ (50) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (DEC 2022) 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501- 4732), Public Law 103-182, 108-77,108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112- 41, 112-42, and 112-43.

__ (ii) Alternate I [Reserved].

_ (iii) Alternate II (DEC2022) of 52.225-3.

_ (iv) Alternate III (Jan 2021) of 52.225-3.

_ (v) Alternate IV (Oct 2022) of 52.225-3.

_ (51) 52.225-5, Trade Agreements (DEC 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (52) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

_ (53) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C.

Subtitle A, Part V, Subpart G Note).

_ (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

_ (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)

(42 U.S.C. 5150).

_ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

_ (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

_ (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021)

(41 U.S.C. 4505, 10 U.S.C. 3805).

X (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

_ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management

(Jul 2013) (31 U.S.C. 3332).

_ (61) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

_ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

X (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (64) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631).

_ (ii) Alternate I (Apr 2003) of 52.247-64.

_ (iii) Alternate II (Nov 2021) of 52.247-64.

(c ) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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.]

X_ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

_ (2)…