RFP 75A50324R00005 - Atropine Pralidoxime Chloride Injector.pdf

SECTION A – SOLICITATION DESCRIPTION

(i) This is a combined synopsis/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 15 of the Federal Acquisition Regulation.

(ii) The solicitation number is 75A50324R00005, 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 2024-05, effective May 22, 2024.

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

(iv) This synopsis/solicitation is issued on the basis of full and open competition and is not set aside for small businesses. The NAICS code is 325412 (Pharmaceutical Preparation Manufacturing). The size standard is 1,300 (number of employees).

(v) 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 Atropine & Pralidoxime Chloride Injector, Single Dose Auto-Injectors. 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 delivery period and two (2), one (1) year optional ordering 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 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) Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer – Refer to Attachment 2. (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).

http://www.acquisition.gov/

(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, LaMonica Norwood, 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, offerors shall include RFP number 75A50324R00005 in the subject line.

a. All questions or clarification requests regarding any aspect of this RFP shall be submitted to the contract specialist, LaMonica Norwood, via email at OSContracting@hhs.gov no later than the date and time provided below under Section L, L.2 Questions or Clarifications. Questions and answers will be issued as a solicitation amendment and available for viewing by all interested Offerors.

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, offerors shall include RFP number 75A50324R00005 in the subject line.

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

Contract Specialist:

LaMonica Norwood 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 mailto:lamonica.norwood@hhs.gov

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

Base Delivery Period: 2024-2025

CLIN SUPPLIES/SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

0001 Base Quantity

Atropine & Pralidoxime Chloride Injector, Single Dose Auto-Injectors in accordance with the SOW herein.

This is a Firm Fixed Price line item

495,960 EA

Ordering Period 1: 2025 - 2026

CLIN SUPPLIES/SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

1001 Option for Increased Quantity the SOW herein.

599,280 EA

Ordering Period 2: 2026 - 2027

CLIN SUPPLIES/SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

2001 Option for Increased Quantity the SOW herein.

599,280 EA

SECTION C – STATEMENT OF WORK

Statement of Work 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-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological pathogens, chemical agents, radiological, natural disasters, or other emerging infectious disease agents. The SNS is part of the federal medical response infrastructure and can supplement medical countermeasures needed by states, tribal nations, territories, and the largest metropolitan areas during public health emergencies. The supplies, medicines, and devices for lifesaving care contained in the stockpile can be used as a short-term, stopgap buffer when the immediate supply of these materials may not be available or sufficient. The SNS team works every day to prepare and respond to emergencies, support state and local preparedness activities, and ensure availability of critical medical assets to protect the health of Americans.

The SNS is a national repository of pharmaceuticals, vaccines, medical supplies, and 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 depletes local supplies during an emergency operation. Pharmaceuticals and Medical Supplies are strategically stored in a network of warehouses throughout the United States as well as 62 project areas that house small caches of forward placed medical countermeasures supporting the country for rapid deployment to protect the U.S. population against 21st century health security threats, such as anthrax, botulism, smallpox, plague, tularemia, and viral hemorrhagic fevers, as well as emerging infectious diseases, pandemic influenza, natural disasters, and other chemical, biological, radiological, and nuclear incidents.

C.2 Purpose/Objectives

The purpose is to procure and stockpile Atropine & Pralidoxime Chloride Injector, Single Dose Auto-Injectors that deliver 2.1mg/0.7ml of atropine and 600mg/2ml (300mg/ml) of pralidoxime chloride, to be utilized during national emergencies and staged in SNS’s forward deployed cache locations.

The stockpiling of Atropine & Pralidoxime Chloride Injector, Single Dose Auto-Injectors is essential for future readiness and response to nerve agent or organophosphate poisoning. For emergencies like chemical attacks or accidental exposures, immediate treatment is vital, emphasizing the need for readily available auto-injectors to enable swift response by emergency personnel. The goal is to replenish and stockpile product to maintain and meet the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) strategic preparedness initiatives for national security for public health, ensuring readiness to address chemical threats from various sources.

C.3 Scope of Work

The Contractor shall provide Atropine & Pralidoxime Chloride Injector, Single Dose Auto- Injectors that deliver 2.1mg/0.7ml of atropine and 600mg/2ml (300mg/ml) of pralidoxime chloride.

C.4 Technical Requirements

The Contractor, as an independent organization and not as an agent of the Government, shall procure and furnish all labor, materials, supplies, facilities, equipment, and transportation necessary to load, and deliver the acceptable Pharmaceuticals.

1. Kick Off Meeting: A kickoff meeting shall be held no later than 7-business days after the initial award is made to discuss plans and timelines as well as clarify roles and responsibilities of the contractor. The contractor shall take written/typed notes of the meeting and provide electronic copies to all individuals present within 5-business days of the meeting.

2. The Contractor must be an authorized manufacturer, distributor, or reseller with a current FDA license to distribute this product. If not the manufacturer, contractor must furnish a signed agreement with the manufacturer, demonstrating the capacity to consistently supply the product throughout the duration of the contract.

3. Contractor shall have and maintain all capabilities required to safely pack, ship, and deliver the product throughout the performance of this requirement.

4. All products shall be Trade Agreement Act (TAA) compliant. All products are required to conform to TAA compliance standards.

5. The Contractor shall provide a delivery schedule to cover a 36-month period.

6. The contractor is tasked with demonstrating their capability and providing a comprehensive risk management plan. This plan should cover various critical aspects to include but not necessarily limited to the following:

a. The ability to maintain optimal inventory levels, especially during urgent situations, to ensure ample stock availability.

b. Showcase the ability to manage disruptions in the supply chain.

c. Highlight production flexibility and scalability to adeptly handle demand fluctuations and unforeseen disruptions in the supply chain.

7. The Contractor shall store and maintain all products in a controlled room where temperature conditions are kept within the range of 60-77°F both during storage and transport to SNS location(s).

8. Shelf life shall be no less than 90% upon delivery to any of the SNS locations.

C.5 Special Requirements

The product shall be manufactured in accordance with the conditions approved by the Food and Drug Administration (FDA) under appropriate patents for the medication. The current Good Manufacturing Practice regulations (cGMP's) (21 CFR Parts 210 and 211) will be the standard to be applied for the manufacture, processing, packing or holding of pharmaceuticals, and manufacture of finished pharmaceuticals.

C.6 Contract Period of Performance

The anticipated contract period of performance will be a one (1) year Base delivery period and two (2), one (1) year optional ordering periods.

C.7 Delivery, Packaging, and Shipping

Due to the sensitivity of the delivery location(s), the COR will furnish the precise details (delivery location(s) and schedule) after contract award. Deliveries will be made to a government-designated location within the continental United States (CONUS).

The contractor shall adhere to the following shipping requirement.

1. All shipments will include packing slips which must list the contract number, product description, National Drug Code (NDC), Lot numbers, delivery quantities, unit price, unit of measure (UOM) and DUNS number.

2. Storage Requirements shall be on all packing lists.

3. No Partial Case or Package quantities will be accepted unless approved by the

Contracting Officer Representative (COR) in advance of delivery.

4. No Mixed Lot numbers per Case, Packages, or Pallets will be accepted.

5. Shelf-life data for the finished pharmaceutical products shall be included on all packing lists, inner packaging, and outer case.

6. Product delivered to the SNS location shall have no more than 90% of shelf-life expended upon delivery.

7. Product description, NDC or Part number, Lot numbers and package quantities, shall be included on each Case, box/inner package/etc., and the packing list. Note: NDCs must use the 5+4+2 standard digit methodology (xxxxx-yyyy-zz). Leading zeros may be utilized on the 5-digit section and/or the 4-digit section and/or the 2-digit section within the NDC methodology.

8. Inner packaging shall also include the following: dosage information, expiration date, storage temperature data, and manufacturer information.

9. All shipping pallets are to have the identical TyHi stack pattern except for the final pallet.

10. Cartons shall be shipped in master cartons, which shall be palletized. All product to be delivered on standard heat-treated 48" by 40" pallets, not to exceed 60” in height.

Pallets must be stretch wrapped and secured to pallet for safe transport.

11. The contractor shall provide full case quantities only unless approved by the COR in writing in advance of delivery.

12. Final shipment may be less than full quantity.

13. Contractor shall contact the designated point of contact (POC) to schedule delivery appointments no later than (NLT) 48 hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:00 PM ET).

14. Lot number and part number shall be included on the inner packaging and outer case.

15. All [what items] must adhere to applicable FDA labeling regulations.

16. No deliveries shall be accepted on weekends without prior approval written of the COR, or other CO designated authorized individual.

17. If damages are found upon arrival, contractor shall be responsible for replacement of the damage quantities within two business days of notification from the COR.

18. The Contractor shall have a geographically diverse network with the capabilities of delivering Atropine & Pralidoxime Chloride Injector, Single Dose Auto-Injectors to the final delivery CONUS locations within schedules that will be defined at time of award.

19. Contractor shall inform all delivery personnel in advance of shipment that all contracted personnel will be required to provide personal U.S. government issued photo identification and have all vehicles inspected before they will be allowed entry at each SNS location. The Contractor shall be responsible for delays caused by delivery personnel arriving without required government identification.

C.8 RETURNS & RECALLS:

Once Contractor has delivered the products to the ASPR-provided delivery location(s), the products shall not be eligible for returns to the Contractor. The Contractor shall coordinate the recall of any distributed product per the applicable manufacturer’s direction. Any shipment of recalled GFP back to the applicable manufacturer or ASPR is subject to the Freight and Transportation Pricing Schedule provided by ASPR, if the cost is not covered by the manufacturer.

C.9 DELIVERABLES:

In addition to the Atropine & Pralidoxime Chloride Injector, Single Dose Auto-Injectors identified as CLINs and described in the above SOW, the Contractor shall also provide the following contract deliverables in the format specified, to the individual(s), and by the due dates identified below.

Deliverable Format/Deliver to Due Date Kick-Off Meeting Notes Should contain a detailed overview of the discussion.

Electronic copy of Kick-Off Meeting Notes – COR

Within 5 days of meeting being held

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 Final Report Email to COR/POC - Summary of all deliveries and product warehoused under performance of this contract.

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

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) Agency/Requiring LOC Service Unit and MAIL STOP/Room Number

2) Description of information/data being submitted

3) Contract Number

4) Contract Name and Address

The Contractor shall guarantee and comply with deliverable table in the SOW, Section C.9 – Deliverables, which is listed in the table above.

D.3 DELIVERY LOCATION & SHIPPING REQUIREMENTS

The contractor shall refer to SOW, Section C.7 - Delivery, Packaging, and Shipping, 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 into a temperature-controlled facility 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.

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) 52.246-16 Responsibility for Supplies (April 1984)

F.1 PERIOD OF PERFORMANCE

a. The anticipated period of performance will begin on or before 9/30/2024:

1. Base Delivery Period – Period 1: September 2024 – September 2025

2. Ordering Period 2: September 2025 – September 2026

3. Ordering Period 3: September 2026 – September 2027

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

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

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) and alternate 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.

https://www.ipp.gov/

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 mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov https://www.acquisition.gov/far/subpart-4.9#FAR_Subpart_4_9

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.

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

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.

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

FAR SOURCE TITLE AND DATE

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) 52.204-19 Incorporation by Reference of Representations and Certifications (Dec

2014) 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) 52.209-7 Information Regarding Responsibility Matters (Oct 2018) 52.209-12 Certification Regarding Tax Matters (Oct 2020) 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) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving

(May 2024) 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) 352.223-70 Safety and Health (Dec 2015) 352.224-70 Privacy Act (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015) https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

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 Attachment 3, Offeror Representations and Certifications herein.

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders — Commercial Products and Commercial Services (May 2024)

(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.)

352.233-71 Litigation and Claims (Dec 2015) 352.237-74 Non-Discrimination in Service Delivery (Dec 2015)

__ (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

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

__ (17) [Reserved]

__ (18) (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.

__ (19) (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.

__ (20) 52.219-8, Utilization of Small Business Concerns (Feb 2024) (15 U.S.C. 637(d)(2) and (3)).

_X_ (21) (i) 52.219-9, Small Business Subcontracting Plan (Sep 2023) (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 2023) of 52.219-9.

__ (22) (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.

__ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

_X_ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C.

637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-

Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) (15 U.S.C. 657f).

_X_ (26) (i) 52.219-28, Post Award Small Business Program Representation (Feb 2024) (15 U.S.C. 632(a)(2)).

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

__ (27) 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)).

__ (28) 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)).

__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(17)).

_X_ (31) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2024).

_X_ (33) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (34) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

_X_ (35) (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__ (36) (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.

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

_X_ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X__ (39) (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).

__ (40) 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.)

__ (41) (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.)

__ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) (42 U.S.C. 7671, et seq.).

__ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) (42 U.S.C. 7671, et seq.).

__ (44) 52.223-20, Aerosols (May 2024) (42 U.S.C. 7671, et seq.).

__ (45) 52.223-21, Foams (May 2024) (42 U.S.C. 7671, et seq.).

__ (46) 52.223-23, Sustainable Products and Services (May 2024) (E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C.