75A50424R00006 Multi-Antigen Diagnostic Tests RFP 9-10-24.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

ASPR-ORM-IBMSC

Washington DC 20024 Constitution Center 400 7th St SW

US DEPT OF HEALTH & HUMAN SERVICES

ASPR-ORM-IBMSC

ASPR-ORM-IBMSC CODE 16. ADMINISTERED BYCODE

X

X

X

325413

SIZE STANDARD:

100.00 % FOR:SET ASIDE:UNRESTRICTED ORASPR-ORM-IBMSC

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

09/17/2024 1600 ET

09/10/2024

CHRISTOPHER NEWELL

(No collect calls)

INFORMATION CALL:

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

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75A50424R00006

5. SOLICITATION NUMBER

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

1 70 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Washington DC 20024 Constitution Center 400 7th St SW

US DEPT OF HEALTH & HUMAN SERVICES

15. DELIVER TO

Washington DC 20024 Constitution Center 400 7th St SW

US DEPT OF HEALTH & HUMAN SERVICES

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

1,250

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

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

ASPR-ORM-IBMSC

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

DELIVER TO:

ASPR-ORM-IBMSC

US DEPT OF HEALTH & HUMAN SERVICES

INDUSTRIAL BASED MANUFACTURING AND

CONSTITUTION CENTER 400 7TH ST SW

WASHINGTON DC 20024 US

Delivery: 03/11/2026 Period of Performance: 09/30/2024 to 09/29/2025

1 This is a combined synopsis / solicitation for 1000000 EA Continued ...

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

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

TONYA W. PURCE

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

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

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

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

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

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

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

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

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

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

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

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

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

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

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

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

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

commercial services prepared in accordance with the format in Federal Acquisition Regulation

(FAR) Subpart 12.6 in conjunction with FAR Part

15, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested. This acquisition is being posted as a 100% Small Business Set-Aside.

Proposal submissions in response to the RFP are due no later than September 17, 2024, at 4:00

P.M. Eastern Time (ET). Proposal submissions must be submitted electronically by e-mail to

IBMSCC-Submissions@hhs.gov and copied to christopher.newell@hhs.gov with the subject line

RFP 75A50424R00006.

All questions regarding this RFP must be submitted electronically by e-mail to

IBMSCC-Submissions@hhs.gov September 12, 2024, by

4:00 P.M. ET.

One million multi-antigen diagnostic test kits capable of detecting SARS, CoV-2, and Influenza

A/B are to be provided in accordance with the referenced requirement description specifications.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

70 2 of

RFP 75A50424R00006 Page 1 of 68

COMBINED SYNOPSIS SOLICITATION

I. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services”, as supplemented with additional information included in this notice. The procedures from FAR Parts 12, 15, and 19 are being utilized as part of the Request for Proposal (RFP). This announcement constitutes the only solicitation;

proposals are being requested, and a written solicitation will not be issued.

II. The solicitation number is 75A50424R00006 which is a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are currently in effect through Federal Acquisition Circular 2024-06 effective August 29, 2024.

III. Contract Type will be Firm Fixed Price (FFP).

NOTICE TO Offerors: This acquisition is being posted as a 100% Small Business Set- Aside in accordance with FAR 19.502-2 Total small business set-asides.

NAICS Code: 325413 - In Vitro Diagnostic Substance Manufacturing. The size standard is 1,250 employees.

Product Service Code: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets. This includes in vitro diagnostic aids, such as test tablets, test slides, test strips, test cards, test papers, test solutions, reagents; sets and kits designated for in vitro qualitative and quantitative tests on specimens, such as blood, urine, feces, and the like, for the purposes of aiding in the medical diagnosis of disease, determining body organ dysfunction, or other abnormal conditions.

IV. a. The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Center for Industrial Base Expansion and Supply Chain (IBMSC) has a requirement for commercial off-the-shelf multi-antigen diagnostic tests kits, also known as multiplex tests, which are capable of detecting SARS, CoV-2, and Influenza A/B.

b. The Government intends to evaluate offers and award a single-award, Firm-Fixed Price contract without discussions.

c. Award is anticipated for a total one million commercial off-the-shelf multi-antigen diagnostic tests kits, also known as multiplex tests, which are capable of detecting SARS, CoV-2, and Influenza A/B. One award to the lowest price technically acceptable offeror (LPTA) is anticipated. This RFP does not represent the guarantee that any contract awards will be made. This requirement is a 100% small business set-aside.

d. Offerors are encouraged to provide their lowest price, best offer in response to this request for proposal. The Government is asking for any and all discounts, including spot discounts, one-time discounts, prompt payment discounts, and volume discounts. The proposed unit price shall include all shipping and delivery costs to the Government’s warehouses.

V. See Sections B and C below for description of requirements, including a list of line-item number(s), quantities, and units of measure.

RFP 75A50424R00006 Page 2 of 68

VI. The delivery period will begin 15 days after receipt of award (ARO) with a period of performance of 12 months. See Section F.1 below for additional delivery information.

VII. The FAR provision at 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include submission instructions.

VIII. The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include evaluation approach and factors.

Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services, with its offer, if not available in the System for Award Management (SAM).

IX. The Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition.

X. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (May 2024), applies to this acquisition and FAR clauses applicable include, but are not limited to: 52.219-9, 52.219-14, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See Sections D through I.

XI. There are no special contract requirements or terms and conditions related to contract financing arrangements.

XII. 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.

XIII. Proposals are due via e-mail by 4:00PM ET on Tuesday, September 17, 2024, to IBMSCC-Submissions@hhs.gov and copied to christopher.newell@hhs.gov . The proposal shall include a single point of contact (name, title, phone number, email) who is authorized to commit the company financially. The proposal shall be submitted in accordance with ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES.

FORMATTING AND PAGE LIMITATIONS

A. Formatting for proposals

• Proposals should not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

• Font size should be 11 point.

B. Page limitations:

The technical proposal should be no more than 15 pages in length. This page limit does not include cover pages, table of contents, cross reference Matrix, appendixes and attachments. If the Offeror includes appendixes with information not expressly allowed herein, the Offeror should note that such information may not be evaluated. Proposal pages should be numbered “Page 1 of 15, “Page 2 of 15” etc.

mailto:IBMSCC-Submissions@hhs.gov mailto:christopher.newell@hhs.gov

RFP 75A50424R00006 Page 3 of 68

Only Electronic submissions will be accepted and shall be submitted via email to IBMSCC-Submissions@hhs.gov and copied to christopher.newell@hhs.gov. All submissions must include the solicitation number and the word “SUBMISSION”. It is recommended that offerors limit email submissions to 2MB. If submissions are going to exceed this size, it is recommended that offerors submit them as clearly titled and numbered separate emails or as a zip file. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

All questions regarding this RFP must be submitted electronically by email to IBMSCC- Submissions@hhs.gov and copied to christopher.newell@hhs.gov no later than 4:00pm ET, Thursday, September 12, 2024. For proper submission of questions, include the solicitation number and the word “QUESTION” in the subject of the email.

The Government’s responses to questions will be posted as an amendment to the combined synopsis/solicitation posting. Please be advised that the Government reserves the right to transmit those questions and answers of a common interest to all prospective offerors. The Government also reserves the right to respond or not respond to any questions at its discretion. No calls will be accepted. All questions received by the stated deadline will be answered via a solicitation amendment and posted on the Contracting Opportunities (https://sam.gov/) website.

The point of contact for information regarding this combined synopsis/solicitation are:

Contracting Specialist:

Christopher Newell Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA) Administration for Strategic Preparedness & Response (ASPR) U.S. Department of Health and Human Services (DHHS) Email: christopher.newell@hhs.gov

Contracting Officer:

Tonya Woodford Purce Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA) Administration for Strategic Preparedness & Response (ASPR) U.S. Department of Health and Human Services (DHHS) Email: tonya.purce@hhs.gov

XIV. Vendors are required to complete all fill-in Provisions listed in the solicitation. The combined synopsis solicitation notice includes the following:

The FAR provision at 52.212-1, Instructions to Offerors -- Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include submission instructions.

The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include evaluation approach and factors.

Offerors shall include a completed copy of the provision at 52.212-3, Offeror mailto:IBMSCC-Submissions@hhs.gov mailto:christopher.newell@hhs.gov mailto:IBMSCC-Submissions@hhs.gov mailto:IBMSCC-Submissions@hhs.gov mailto:christopher.newell@hhs.gov https://sam.gov/ mailto:tonya.purce@hhs.gov

RFP 75A50424R00006 Page 4 of 68

Representations and Certifications—Commercial Products and Commercial Services, with its offer, if not available in the System for Award Management (SAM).

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition and found in Section I - Contract Clauses and Provisions.

The FAR Provision found at 52.204-7(b)(1) requires that an Offeror is to be registered in SAM when submitting an offer or proposal and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. All interested Offerors must be registered in SAM prior to submitting a proposal. You may access the SAM website at https://sam.gov/content/home . All Offerors must be certified as with the appropriate NAICS code on the SAM website.

https://sam.gov/content/home

RFP 75A50424R00006 Page 5 of 68

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Contract Line Items

The requirement is to purchase 1,000,000 over-the-counter use, multi-antigen diagnostic commercial off-the-shelf (COTS) test kits. The multi-antigen diagnostic tests must have shelf lives that are within the manufacturer's Food and Drug Administration (FDA) approved expiration date, be FDA approved, 510(K)-cleared, and/or have Emergency Use Authorization (EUA) to rapidly detect SARS, CoV-2 and Influenza A/B. In order to be considered for award, the offeror must meet all terms of the solicitation. The Government will only accept multi-antigen diagnostic tests from the original equipment manufacturer (OEM). No products offered from retailers, dealers, or authorized resellers will be accepted.

The quality and quantities of supplies shall be delivered in accordance with the terms and conditions specified herein. Offerors are to submit a complete price/cost proposal for the following Contract Line Items (CLIN):

CLIN Description Estimated

QTY

Unit Price

Discount Percentage

Discount Price Per Test

Unit of Measure

Total

Multi-antigen diagnostic test capable of detecting SARS CoV-2 and Influenza A and B.

1,000,000 $ Each $

RFP 75A50424R00006 Page 6 of 68

SECTION C – PRODUCT TECHNICAL SPECIFICATIONS

C.1 BACKGROUND

The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Center for Industrial Base Expansion and Supply Chain (IBMSC) has a requirement for one million commercial off-the-shelf multi-antigen diagnostic tests kits, also known as multiplex tests, which are capable of detecting SARS, CoV-2, and Influenza A and B. There have been recent outbreaks of H5N1 in poultry and dairy cattle. These tests will be distributed to Federally Qualified Health Centers and/or transferred to established government diagnostics warehouses where they will be stored before distribution to the counties most impacted by these outbreaks. The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus. These multi-antigen diagnostic tests will be used to detect and prevent any further spread of the H5N1, CoV- 2, Influenza A and B viruses. This requirement will be used to replenish and maintain a stockpile of tests to be prepared if there is a spike in the SARS, CoV-2 and Influenza A/B impacting public health. State/tribal/local/territorial public health agencies. Testing Diagnostic Working Group was created as part of the Federal response to COVID-19 in March 2020 and its mission continues to be a high Administration priority.

C.2 PURPOSE

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to meet ASPR diagnostic stockpile requirements and deliver 1,000,000 Food and Drug Administration (FDA) approved multi-antigen diagnostic test kits to six designated government warehouse locations throughout the U.S for the future distribution.

C.3 SPECIFICATIONS

The Government will only accept multi-antigen diagnostic tests from the original equipment manufacturer (OEM) that meet all of the following requirements:

Item Description Quantity Delivery Schedule Multiplex Test Kits – Multi-antigen diagnostic tests capable of detecting SARS CoV-2 and Influenza A/B

1,000,000

EA

To begin15 days after receipt of award for a period of 12 months

1. Must be multiplex platform which are newly manufactured and shipped directly from the

OEM;

2. Must be antigen-based tests;

3. Must be manufactured within 60 days from the date of delivery;

4. Must be made for over-the-counter use and have FDA approval, be 510(k) cleared, and/or have an Emergency Use Authorization to detect SARS, CoV-2, and Influenza A and B;

5. Must be supplied and shipped directly from the OEM. No product supplied and directly shipped from retailers, dealers, or authorized resellers will be accepted; and

6. Must meet the shelf life mandated by the FDA and demonstrate approved extensions that have been granted.

RFP 75A50424R00006 Page 7 of 68

SECTION D-PACKAGING, MARKING AND SHIPPING

D1. DELIVERY REQUIREMENTS

The Contractor shall:

A. Identify a single point of contact who is authorized to commit the company to a delivery schedule for all tests.

1)Provide the COR with the name, title, email, and phone number of the single point of contact 2)The single point of contact will work with the Government to establish a schedule for the delivery of all tests.

3)The COR will provide the Contractor contact information for the Government and warehouse for scheduling discussions.

4)The schedule will be established within one week of award.

B. Deliver tests to one or more established warehouses located in Salt Lake City, Utah, Garland, Texas, Columbus, Ohio, Memphis, Tennessee, Longview, TX, and/or Bethlehem, Pennsylvania, as established by the delivery schedule.

1) Warehouse contact information will be provided to the Contractor when a delivery is scheduled.

2) It will be understood that any force majeure can impact timing of the delivery, but the Contractor will use commercially reasonable efforts to have products delivered in a reasonable timeframe.

C. Ship all items under appropriate conditions (i.e., temperature, weight limitations, etc.).

D. Call the destination warehouse for a delivery appointment a minimum of 48 hours prior to arrival and adhere to the scheduled delivery appointment day and time.

E. Deliver only tests that will pass inspection tests upon delivery to ensure established quality standards are met. Return and/or disposal of any tests not passing inspection upon delivery will be the responsibility of the Contractor.

F. Immediately inform the Contracting Officer (CO) and the Contracting Officer’s Representative (COR) of any delivery delays.

G. Within 6 hours of shipment, provide the receiving warehouse the following information electronically:

1) Manufacturer and Model Number / Part Number

2) SKU Description

3) Test Lot Number(s)

4) Test/Lot Expiration Date

5) Quantity of Tests per Kit

6) Quantity of Kits per Package

7) Quantity of Packages per Pallet

8) Quantity of Tests delivered.

9) Contract Number

RFP 75A50424R00006 Page 8 of 68

10) Condition Code (used to account for product recall, materiel complaints, etc.)

11) Note Codes (materiel subject to damage by freezing, hazardous material, etc.)

H. Provide the tests on standard pallets with dimensions of 48” L x 40” W with a height between 60” and 80”, per International Organization for Standardization (IOS), and weighing no more than 1,750 pounds per pallet.

I. OEM shall increase production and delivery rates in the event of a surge in demand for tests.

D.2 DOCUMENTATION AND REPORTING REQUIREMENT FOR DELIVERY

A. Provide confirmation of delivery to the COR and the CO by email in a format mutually agreed upon on within 24 hours of delivery. Confirmation will include:

1) Manufacturer and Model Number / Part Number

2) Test Lot Number(s)

3) Test/Lot Expiration Date(s)

4) Quantity of Tests per Kit

5) Quantity of Kits per Package

6) Quantity of Packages per Pallet

7) Quantity of Tests delivered

8) Destination warehouse

9) Condition Code (used to account for product recall, materiel complaints, etc.)

10) Note Codes (materiel subject to damage by freezing, hazardous material, etc.)

B. Notify the COR within 48 hours of a determination that inventory has been lost, damaged, stolen, or otherwise incapacitated, and the extent that this loss will make the Contractor unable to meet established delivery timetables or quantities.

C. Notify the CO and the COR within 24 hours of any delays that impact scheduled delivery times.

D. Product Recall - If a manufacturer of a test conducts a recall or market withdrawal involving a test that has been delivered to the Government after the contract is awarded, the Contractor will coordinate with the Government to respond to the recall per the applicable manufacturer direction.

This may include any shipment of recalled tests back to the applicable manufacturer.

E. Other Requirements - Under Free on Board (FOB) Destination procedures, any damages as well as any loss of material or damages of product that occur while under possession of the Contractor, including while in storage and in transit to a delivery location, is the responsibility of the Contractor and should be reported to the COR.

RFP 75A50424R00006 Page 9 of 68

SECTION E- INSPECTION AND ACCEPTANCE

The Contractor’s performance and the quality of services provided hereunder shall be subject to final inspection and acceptance by the HHS/ASPR Contracting Officer (CO), in conjunction with the Contracting Officer’s Representative (COR). The HHS/ASPR COR will accept services for the contract, unless stated otherwise. The HHS/ASPR COR and/or PM will inform the Contract Specialist (CS) and HHS/ASPR CO if the services do not conform to contract specifications.

RFP 75A50424R00006 Page 10 of 68

SECTION F- DELIVERIES AND PERFORMANCE

F.1 Delivery Schedule

Prior to shipping, a proposed delivery schedule will be provided by the Contractor which must be approved by the Contracting Officer Representative. Attachment 1 Vendor Proposed Delivery Schedule is for information purposes only and a proposed delivery schedule is not required to be submitted with the proposal. The delivery schedule as previously noted is a due out one week after receipt of award. The delivery period will begin 15 days after receipt of award with a period of performance of 12 months. This will ensure that the stockpile numbers are maintained from September 2024 and potentially through September 2025. Prior to shipping, a proposed delivery schedule will be provided by the Contractor which must be approved by the Contracting Officer Representative.

The following are federal holidays when facilities may be unavailable for delivery. When a holiday falls on a nonwork day -- Saturday or Sunday -- the holiday usually is observed on Monday (if the holiday falls on Sunday) or Friday (if the holiday falls on Saturday).

New Years Day, January 1st Martin Luther King Jr. 's Birthday, 3rd Monday of January Presidents Day, 3rd Monday of February Memorial Day, Last Monday of May Juneteenth, June 19th Independence Day, July 4th Labor Day, 1st Monday of September Columbus Day, 2nd Monday of October Veteran’s Day, November 11th Thanksgiving Day, 4th Thursday of November Christmas Day, December 25th

F.2 Place of Performance

The Contractor Shall deliver test kits to one or more established warehouses located in Salt Lake City, Utah, Garland, Texas, Columbus, Ohio, Memphis, Tennessee, Longview, TX, and/or Bethlehem, Pennsylvania, as established by the delivery schedule.

RFP 75A50424R00006 Page 11 of 68

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 ADMINISTRATION

This contract will be administered by the following ASPR personnel:

Contracting Specialist:

Christopher Newell Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA) Administration for Strategic Preparedness & Response (ASPR) U.S. Department of Health and Human Services (DHHS) Email: christopher.newell@hhs.gov

Contracting Officer:

Tonya Woodford Purce Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA) Administration for Strategic Preparedness & Response (ASPR) U.S. Department of Health and Human Services (DHHS) Email: tonya.purce@hhs.gov Contracting Officer’s Representative (COR)/Technical Point of Contact (POC)

TBD

Office of Industrial Base Management and Supply Chain (IBMSC) U.S. Department of Health and Human Services (HHS)

G.2 ELECTRONIC INVOICING AND PAYMENT REQUIREMENTS - INVOICE

PROCESSING PLATFORM (IPP)

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

All invoice submissions for goods or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). 12 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 in the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial item contracts. The IPP website address is http://www.ipp.gov .

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 a 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 IPP CustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

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.

http://www.ipp.gov/

RFP 75A50424R00006 Page 12 of 68

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

If the Contractor is unable to comply with the requirements to use IPP for submitting 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.

Additional Administration for Preparedness and Response (ASPR) requirements:

(i) The Contractor shall submit invoices in accordance with the milestone due dates in Section B.1 Services and Supplies 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.

(iii) Invoices must include the Unique Entity ID (UEI) (which replaced the Dun and Bradstreet Number (DUNS) on April 4, 2022) of the Contractor.

RFP 75A50424R00006 Page 13 of 68

SECTION H SPECIAL CONTRACT REQUIREMENTS

H.1 CONTRACTING OFFICER AUTHORITY

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 Administration 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 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. The COR is responsible for confirming the inspection/acceptance of product delivered prior to payment of invoices.

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.

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Vendor’s Authority:

a. The Contractor shall not accept any instructions issued by any person employed by the United States (U.S.) Government or otherwise, other than the Contracting Officer, or the COR acting within the limits of their authority.

b. The Contractor shall not in any way represent that it is a part of the U.S. Government or that it has the authority to contract or procure supplies for the account of the United States of America (USA).

H.4 PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds, until reviewed and approved by the Contracting Officer. For avoidance of doubt, proposals to this RFP may include projected costs to support items below as they relate to the overall scope of work; however, written approval from the Contracting Officer prior to the contractor incurring those costs and/or entering into binding agreements for such items will be required for the duration of the Period of Performance. These costs include the following:

1) Acquisition, by purchase or lease, of any interest in real property

2) Rearrangement or alteration of facilities

3) Purchase of lease of any item of general-purpose office furniture or office equipment regardless of dollar value

4) Accountable Government Property

5) Overtime

6) General scientific meetings/conferences

7) Travel costs that include foreign travel

8) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements)

9) Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00

10) Refreshments and Meal Expenditures

11) Promotional Items

12) Printing

H.5 Foreign Transfer of Assets or Technology

This clause shall remain in effect during the term of the Contract and for five (5) years thereafter.

Definitions AFFILIATES: Associated business concerns, non-profit organizations, or individuals if, directly or indirectly, (1) either one controls or can control the other; or (2) a third-party control or can control both.

ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable of being conveyed between economic or Governmental entities that is the focus/scope of development by the U.S. Government (“USG”) and Contactor in this Contract.

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ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable of being conveyed between economic or Governmental entities that is the focus/scope of development by the U.S. Government (the “USG”) and Contactor in this Contract. FOREIGN

FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of a country other than the United States of America (U.S.), its territories, or possessions. The term includes, for purposes of this Contract, any agency or instrumentality of a foreign government; and firms, institutions or business organizations which are owned or substantially controlled by foreign governments, firms, institutions, or individuals.

TECHNOLOGY: Technical Data, Computer Software, manufactured materials and Subject Inventions funded by the USG under this Contract. Technology also includes contractor know how and personnel expertise, as well as other Assets necessary to assure successful completion of this Contract.

U.S. FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of the United States, its territories, or possessions. The term includes, for purposes of this Contract, any agency or instrumentality of the USG; and firms, institutions or business organizations which are owned or substantially controlled by U.S. citizens, firms, institutions, governmental agencies or individuals.

General: The Parties agree that research findings and technological developments made under this Contract constitute an investment by the USG on behalf of its citizens in the interest of their economic and national health security. These investments are made for the primary benefit of the citizenry of the U.S. with those same benefits potentially accruing to the people of all nations.

Therefore, the USG has a fiduciary responsibility to protect the full invested value of the Assets and Technology developed under this Contract. The USG is also cognizant of the duty the Contractor has to its shareholders and other stakeholders with a vested interest in the economic success of the Contractor. At times both parties are aware their respective interests may diverge.

Therefore, in the course of conducting business though the Contract, access to technology developments under this Contract by Foreign Firms or Institutions must be carefully considered.

Export Controls Contractor agrees to comply with all applicable laws regarding export controls and not to export any Asset or Technology to any U.S. embargoed countries. Post-award Transfer of Ownership of Assets or Technology.

The Contractor shall provide notice to the Contracting Officer and COR within three (3) business days of any discussions of a proposed transfer of ownership or establishment of a licensing agreement of any Asset or Technology funded under this Contract from the Contractor to a Foreign Firm or Institution. Notice will also be given within three (3) business days of any discussions of a proposed transfer of operational, corporate, or economic control of Assets and Technology funded under this Contract to Foreign Firms or Institutions. This Article shall not apply to transfers by the Contractor to Affiliated entities of the Contractor, as well as technology transfers for the purposes of manufacturing in accordance with Section C.

Prior to transferring any Asset funded by the USG under this Contract, the Contractor should carefully review the USG rights under FAR Subpart 42.12 pertaining to Novation, specifically FAR section 42.1204. That provision provides that the USG may recognize a third-party assignment only if the transfer of Assets and Technology is determined to be in the USG’s interests. The Contractor should be aware that the USG is under no obligation to recognize a successor in interest. If the Contracting Officer determines that a transfer of Assets and Technology may have adverse consequences to the economic well-being or national health security interests of the U.S., the Contractor, and the Contracting Officer shall jointly endeavor to find alternatives to the

RFP 75A50424R00006 Page 16 of 68 proposed transfer which obviate or mitigate potential adverse consequences of the transfer, but which may provide substantially equivalent benefits to the Contractor.

In addition to the USG licensing rights to subject inventions and technical data funded under this Contract, see FAR clause 52.227-11 (Patent Rights-Ownership by the Contractor) and FAR Clause 52.227-14 (Rights in Data - General), the USG shall have a first right of refusal for the purchase of the Asset and/or Technology funded under the Contract. The USG may waive this first right of refusal in writing submitted to the Contractor within ninety (90) calendar days of the initial notification to the USG of the Contractor’s intent to conduct any form of Asset or corporate.

transfer.

Except for transfers to affiliates of the Contractor, including those entities necessary to complete the Statement of Work, the Contractor shall provide written notice to the Contracting Officer and COR of the scheduled transfer to a Foreign Firm or Institution at least ninety (90) calendar days prior to the scheduled date of transfer. Such notice shall cite this Article and shall specifically identify the Asset or Technology proposed for the transfer and the general terms of the transfer. No transfer shall take place without written concurrence from the Contracting Officer.

Transfer to a Prohibited Source

In the event of a transfer of an Asset and/or Technology by the Contractor to a Foreign Firm or Institution which is identified as a Prohibited Source pursuant to Federal Acquisition Regulation Subpart 25.7: (a) the Government may terminate this contract for cause and (b) the license rights to the technical data and subject invention under the relevant FAR IP Clauses (FAR Clause 52.227-11 and FAR Clause 52-227-14) shall survive the termination. Upon request of the USG, the Contractor shall provide written confirmation of such licenses.

Lower Tier Agreements

The Contractor shall include this Article, suitably modified, to identify the Parties, in all subcontracts or lower tier agreements, regardless of tier.

H.6 CONTRACTOR’S AUTHORITY

a. The Contractor shall not accept any instructions issued by any person employed by the United States (U.S.) Government or otherwise, other than the Contracting Officer, or the COR acting within the limits of their authority.

b. The Contractor shall not in any way represent that it is a part of the U.S. Government or that it has the authority to contract or procure supplies for the account of the United States of America (USA).

H.7 SPECIAL CONTRACT REQUIREMENTS-RATED ORDER

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. Contractor agrees that the Government’s right to exercise priorities and allocations authority with respect to this contract, to include the use of directives in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System, constitutes a no-cost change to this contract.

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H.8 CORPORATE CHANGES

The contractor shall provide the Contracting Officer copies of all correspondence relating to the prime Contractor's corporate status and major corporate revisions, such as buyouts, mergers, Novation agreements, sale or dissolution, and changes in personnel policy. Potential buyout scenarios, actual buyouts, sales and dissolutions shall be disclosed in writing to the Contracting Officer as soon as possible.

H.9 INTERRELATIONSHIPS OF CONTRACTORS

The Government has entered into contractual relationships in order to obtain storage and delivery of the supplies under Section C - PRODUCT TECHNICAL SPECIFICATIONS. Further, the Government may extend these existing relationships or enter into new relationships. The Contractor may be required to coordinate with such other Contractors through the designated COR in providing suitable, non-conflicting technical interfaces and in avoidance of duplication of effort.

H.10 KEY PERSONNEL

Certain skilled/experienced professional and/or technical personnel are essential for successful Contractor accomplishment of the work to be performed under this contract. "Key Personnel" are those individuals identified below:

Contractor’s Contract Administrator

The Contractor agrees key personnel shall not be removed from the contract work or replaced without compliance with the following:

1) If one or more of the key personnel for whatever reason becomes, or is expected to become, unavailable for work under this contract for a continuous period exceeding 30-calendar days or is expected to devote substantially less effort to the work than indicated in the proposal as initially anticipated, the Contractor shall promptly notify the Government COR identified in Section G.1. Upon concurrence of the Contracting Officer or the authorized representative, the Contractor shall promptly replace such personnel with personnel of at least substantially equal ability and qualifications.

2) All requests for approval of substitutions hereunder must be in writing and provide a detailed explanation of the circumstances necessitating the proposed substitution(s). The requests must contain a complete resume for the proposed substitute, and any other information requested by the Contracting Officer to approve or disapprove the proposed substitution. The Contracting Officer or his authorized representative will evaluate such requests and promptly notify the Contractor of the approval or disapproval thereof, in writing.

H.11 ORGANIZATIONAL CONFLICT OF INTEREST

Purpose: The primary purpose of this clause is to ensure that: (1) the Contractor's objectivity and judgment are not biased because of its past, present, or currently planned interests (financial, contractual, organizational, or otherwise) which is related to work under this contract, (2) the Contractor does not obtain an unfair competitive advantage by virtue of its access to non-public information regarding the Government's program plans and actual or anticipated resources, and

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(3) by virtue of its access to proprietary information belonging to others, the Contractor does not obtain any unfair competitive advantage.

Scope: The restrictions described herein shall apply to performance or participation by the Contractor and any of its affiliates or its successors in interest (hereinafter collectively referred to as "contractor") in the activities covered by this clause as prime contractor, subcontractor, cosponsor, joint venture, consultant, or in any similar capacity.

a. Maintenance of Objectivity: The Contractor shall be ineligible to participate in any capacity in contracts, subcontracts, or proposals therefore (solicited or unsolicited) which stem directly from the Contractor's performance of work under this contract or are directly related to this contract, for example under the same Program or Project. Furthermore, unless directed in writing by the Contracting Officer, the Contractor shall not perform any services under this contract on any of its own products or services or the products or services of another firm if the Contractor is or has been substantially involved in its development or marketing. In addition, if the Contractor under this contract advises the Government on the preparation of, or prepares complete, or essentially complete, Performance Work Statement/Statements of Work or objectives for competitive acquisitions, the Contractor shall be ineligible to perform or participate in any capacity in any contractual effort which is based on such Performance Work Statement/Statement of Work or objectives. Nothing in this subparagraph shall preclude the Contractor from competing for follow-on contracts involving the same or similar services.

b. Access To and Use of Government Information: If the Contractor, in the performance of this contract, obtains access to information such as plans, policies, reports, studies, financial plans, or data which has not been released or otherwise made available to the public, the Contractor agrees that without prior written approval from the Contracting Officer, it shall not: (a) use such information for any private purpose unless the information has been released or otherwise made available to the public, (b) compete for or accept work based on such information for a period of six months after the completion of the contract, or until such information is released or otherwise made available to the public, whichever occurs first, ( c) submit an unsolicited proposal to the Government which is based on such information until one year after such information is released or otherwise made available to the public, and ( d) release such information unless such information has previously been released or otherwise made available to the public by the Government.

c. Access to and Protection of Proprietary Information: The Contractor agrees that, to the extent it receives or is given access to proprietary data, trade secrets, or other confidential or privileged technical, business, or financial information (hereinafter referred to as "proprietary data") under this contract, it shall treat such information in accordance with any restrictions imposed on such information. The Contractor further agrees to enter into a written agreement for the protection of the proprietary data of other Contractors and to exercise diligent effort to protect such proprietary data from unauthorized disclosure. In addition, the Contractor shall obtain from each employee who has access to proprietary data under this contract, a written agreement which shall in substance provide that such employee shall not, during his/her employment by the Contractor or thereafter, disclose to others or use for its benefit, proprietary data received in conjunction with the work under this contract.

Subcontracts: The Contractor shall include this clause, including this paragraph, in consulting agreements and subcontracts of any tier when directed by the Contracting Officer. The terms "contract," "contractor," and "contracting officer" will be appropriately modified to preserve the Government's rights.

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