HT942525Q0036.pdf

SEE ADDENDUM

(No Collect Calls)

HT942525Q0036 16-Jun-2025

b. TELEPHONE NUMBER

301-619-1013

8. OFFER DUE DATE/LOCAL TIME

11:00 AM 15 Jul 2025

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

HT94259. ISSUED BY

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

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

BRENDA I MENA

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

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

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

ARMY MED RES ACQ ACTIVITY

808 SCHREIDER ST

FORT DETRICK MD 21702

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0968 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

WALTER REED

WALTER REED

503 ROBERT GRANT AVENUE

SILVER SPRING, MD DC 20910

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

334516

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

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

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF59

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

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

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

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

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

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

HT942525Q0036

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each Equipment and Installation

FFP

Ambr 250 High Thoughput bioreactor, installation, calibration, testing and training as per the Statement of Work (SOW) and the Minimum Essential Characteristics (MECs).

FOB: Destination

PSC CD: 6640

NET AMT

0002 1 Each Service Agreement

FFP

Service and maintenance as per the SOW and MECs . This includes on-site repairs, software/hardware upgrades.

0003 1 Each Shipping

FFP

Shipping and Handling

1002 1 Each Service Agreement

FFP

Service and maintenance as per the SOW and MECs . This includes on-site repairs, software/hardware upgrades.

2002 1 Each Service Agreement

FFP

Service and maintenance as per the SOW and MECs . This includes on-site repairs, software/hardware upgrades.

3002 1 Each Service Agreement

FFP

Service and maintenance as per the SOW and MECs . This includes on-site repairs, software/hardware upgrades.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 1002 Destination Government Destination Government 2002 Destination Government Destination Government 3002 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 15-AUG-2025 TO

14-AUG-2026

N/A WALTER REED

WALTER REED

503 ROBERT GRANT AVENUE

SILVER SPRING, MD DC 20910

HT0968

0002 POP 15-AUG-2025 TO

14-AUG-2026

N/A (SAME AS PREVIOUS LOCATION)

0003 15-AUG-2025 1 (SAME AS PREVIOUS LOCATION)

1002 POP 15-AUG-2026 TO

14-AUG-2027

N/A (SAME AS PREVIOUS LOCATION)

2002 POP 15-AUG-2027 TO

14-AUG-2028

N/A (SAME AS PREVIOUS LOCATION)

3002 POP 15-AUG-2028 TO

14-AUG-2029

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions JUN 2020 52.203-3 Gratuities APR 1984 52.203-5 Covenant Against Contingent Fees MAY 2014 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(JUN 2020) -- Alternate I

NOV 2021

52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014 52.203-19 Prohibition on Requiring Certain Internal Confidentiality

Agreements or Statements

JAN 2017

52.204-7 System for Award Management NOV 2024 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011 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 Maintenance AUG 2020 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-21 Basic Safeguarding of Covered Contractor Information Systems

NOV 2021

52.207-6 Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts)

AUG 2024

52.209-7 Information Regarding Responsibility Matters OCT 2018 52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.211-6 Brand Name or Equal AUG 1999 52.217-3 Evaluation Exclusive Of Options APR 1984 52.217-5 Evaluation Of Options JUL 1990 52.222-1 Notice To The Government Of Labor Disputes FEB 1997 52.232-1 Payments APR 1984 52.232-8 Discounts For Prompt Payment FEB 2002 52.232-11 Extras APR 1984 52.232-17 Interest MAY 2014 52.232-18 Availability Of Funds APR 1984 52.232-23 Assignment Of Claims MAY 2014 52.232-25 Prompt Payment JAN 2017

52.232-33 Payment by Electronic Funds Transfer--System for Award Management

OCT 2018

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

MAR 2023

52.233-1 Disputes MAY 2014 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.239-1 Privacy or Security Safeguards AUG 1996 52.242-13 Bankruptcy JUL 1995 52.242-15 Stop-Work Order AUG 1989 52.242-17 Government Delay Of Work APR 1984 52.244-6 Subcontracts for Commercial Products and Commercial

Services

JAN 2025

52.246-4 Inspection Of Services--Fixed Price AUG 1996 52.246-16 Responsibility For Supplies APR 1984 52.246-25 Limitation Of Liability--Services FEB 1997 52.249-8 Default (Fixed-Price Supply & Service) APR 1984 52.253-1 Computer Generated Forms JAN 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7001 Prohibition On Persons Convicted of Fraud or Other Defense- Contract-Related Felonies

JAN 2023

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

SEP 2022

252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

MAY 2024

252.204-7014 Limitations on the Use or Disclosure of Information by Litigation Support Contractors

JAN 2023

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

JAN 2023

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2023

252.204-7020 NIST SP 800-171 DoD Assessment Requirements NOV 2023 252.204-7024 Notice on the Use of the Supplier Performance Risk System MAR 2023 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7021 Trade Agreements--Basic FEB 2024 252.225-7021 Trade Agreements--Basic FEB 2024 252.225-7048 Export-Controlled Items JUN 2013 252.225-7048 Export-Controlled Items JUN 2013 252.225-7050 Disclosure of Ownership or Control by the Government of a

Country that is a State Sponsor of Terrorism

DEC 2022

252.225-7055 Representation Regarding Business Operations with the Maduro Regime

MAY 2022

252.225-7055 Representation Regarding Business Operations with the Maduro Regime

MAY 2022

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime

JAN 2023

252.225-7057 Preaward Disclosure of Employment of Individuals Who Work in the People's Republic of China

AUG 2022

252.225-7058 Postaward Disclosure of Employment of Individuals Who Work in the People's Republic of China

JAN 2023

252.225-7059 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region - Representation

JUN 2023

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region

JUN 2023

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.244-7000 Subcontracts for Commercial Products or Commercial

Services

NOV 2023

252.247-7023 Transportation of Supplies by Sea OCT 2024

CLAUSES INCORPORATED BY FULL TEXT

52.204-1 APPROVAL OF CONTRACT (DEC 1989)

This contract is subject to the written approval of the Contracting Officer and shall not be binding until so approved.

(End of clause)

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR (AUG 2020)

(a) Definitions. As used in this provision--

Commercial and Government Entity (CAGE) code means—

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

(b) The Offeror represents that it [ ___ ] has or [ ___ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (c) and if applicable, paragraph (d) of this provision for each participant in the joint venture.

(c) If the Offeror indicates ``has'' in paragraph (b) of this provision, enter the following information:

Immediate owner CAGE code:

Immediate owner legal name: ___

(Do not use a ``doing business as'' name)

Is the immediate owner owned or controlled by another entity?:

[ ___ ] Yes or [ ___ ] No.

(d) If the Offeror indicates ``yes'' in paragraph (c) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:

Highest-level owner CAGE code:

Highest-level owner legal name:

(Do not use a ``doing business as'' name)

(End of provision)

52.204-20 Predecessor of Offeror (AUG 2020)

(a) Definitions. As used in this provision--

Commercial and Government Entity (CAGE) code means--

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

(b) The Offeror represents that it [____] is or [____] is not a successor to a predecessor that held a Federal contract or grant within the last three years.

(c) If the Offeror has indicated “is” in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):

Predecessor CAGE code: ____ (or mark “Unknown”).

Predecessor legal name: ____.

(Do not use a “doing business as” name).

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--REPRESENTATION (OCT

2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” and "reasonable inquiry" have the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services”.

(c) Representations.

(1) The Offeror represents that it [ ___ ] does, [ ___ ] does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition--

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation.

(1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of Federal specifications, standards, and product descriptions can be downloaded from the ASSIST website at https://assist.dla.mil.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained from the address in paragraph (i)(1)(i) of this provision.

(2) Most unclassified Defense specifications and standards may be downloaded from the ASSIST website at https://assist.dla.mil.

(3) Defense documents not available from the ASSIST website may be requested from the Defense Standardization Program Office by--

(i) Using the ASSIST feedback module (https://assist.dla.mil/feedback); or

(ii) Contacting the Defense Standardization Program Office by telephone at 571-767-6688 or email at assisthelp@dla.mil.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers that exceed the micro-purchase threshold, and offers at or below the micro-purchase threshold if the solicitation requires the Contractor to be registered in the System for Award Management (SAM).) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) Reserved.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

ADDENDUM to 52.212-1 – INSTRUCTIONS TO OFFERORS

1.1 Point of Contact

The Contract Specialist (CS) is the point of contact for this acquisition. Any questions or concerns regarding this acquisition shall be submitted electronically via e-mail to brenda.i.mena.civ@health.mil.

1.2 Questions Submission

Offeror's who have questions pertaining to the solicitation requirements shall submit questions no later than Monday, 30 June 2025 at 10:00 AM Eastern Time to the Contract Specialist at brenda.i.mena.civ@health.mil.

Offerors shall submit one set of questions only; multiple e-mails will not be accepted. Questions not submitted electronically will not be answered. Answers to all relevant and appropriate questions will be issued via amendment to the solicitation.

1.3 Proposal Due Date

No Later Than Tuesday 15 July 2025 at 12:00 PM Eastern Time submitted to: brenda.i.mena.civ@health.mil.

1.4 Proposal Content and Format Instructions

The Offeror’s proposal shall consist of two (2) volumes. The Volumes are:

Volume I – Technical Volume II – Past Performance Volume III – Price

1.5.1. Administrative Format Instructions:

Volume Number Page Limitation

Volume 1— Technical Approach Non-cost/price proposals are limited to 25 pages.

Volume 2 – Past Performance

Volume 3 – Price No Limit

Files shall not contain classified data. The use of hyperlinks in proposals is prohibited. Proprietary information shall be clearly marked.

Pages should be numbered consecutively throughout the document and not by sections. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation. The following sections are not subject to page limits:

(1) Table of Contents

(2) Title page

(3) Contractor POC Cover Page

Formatting: Proposal content shall be no smaller than Times New Roman font 12 point. Exhibits, graphics, charts, captions, etc., shall be no smaller than 10 point.

1.5.2. Non-Price - Content Instructions

The Offeror’s non-cost proposal shall clearly reflect the Offeror’s approach to execute and comply with the performance requirements identified in the SOW/ MECs, regardless of the Government’s estimated effort. The non-price proposal, including any supporting documentation, is to be clear and concise. The level of effort proposed must be consistent with the proposed solution outlined in the non-price proposal. The proposal must fully document and substantiate a cross mapping of the cost approach as it equates to the non-cost proposal. All items should be addressed in the evaluation criteria.

The Offeror’s non-price proposal shall contain the following:

Technical Approach Past Performance

Volume I – Technical Capability

The offeror shall provide a written narrative that effectively demonstrates and reflects how it intends to meet the Government’s requirements outlined in the SOW and the Brand Name Amber 250 Bioreactor System’s MEC, at a minimum, address how the Offeror shall:

Provide a 21 CFR Part 11 assessment at turnover.

Provide Site Acceptance Testing (SAT).

Provide an Installation / Operation Qualification Documentation Package Provide On-site Repairs and respond within 48 hours Provide documents to demonstrate offeror is an authorized reseller

Volume II: Past Performance:

Offeror’ shall provide the name and contact information for up to tow (2) recent and relevant contracts or orders completed within the last three (3) years. Include a brief description of the work preformed, period of performance, customer information,. The Government may also consider information obtained from internal records or other sources.

1.5.3 Volume III – Business and Price Proposal Content Instructions

The following documents shall be included with the cost/price proposal:

(1) Company Cover Letter

(2) Contractor POC Cover Page

(3) Acknowledgment of Solicitation Amendments

(4) Contract Administration Data

(5) Offerors responding to this RFQ shall include a completed the following Provisions /Clauses:

52.212-3 Offeror Representations and Certifications-Commercial Items 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance

Services or Equipment 52.204-26 Covered Telecommunications and Equipment or Services Representation 52.209-11 Representation by Corporation Regarding Delinquent Tax Liability or A Felony

Conviction Under Federal Law

(6) SAM Unique Entity ID (UEI), CAGE Code and Tax Identification Number (TIN).

(7) Offeror shall provide a cost/price proposal to meet the firm-fixed price nature of the contract..

Offerors’ price proposal shall include proposal price assumptions and include required information for all CLINs.

The Offeror shall provide a statement of the methodology and assumptions used as the basis for the pricing of the effort.

The Offeror shall provide to the Government the best pricing and any available discounts.

All prices shall be rounded to two decimal places.

The Offeror shall ensure mathematical computations are correct.

(a) The Offeror's proposal must stipulate that it is predicated upon all the terms and conditions of the RFQ.

(b) Offerors’ proposals shall remain valid for a minimum of 120 days from the date of submission.

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Basis for Award:

A Firm Fixed Price (FFP) contract shall be made on a Lowest Price Technically Acceptable (LPTA) Basis utilizing FAR Part 13 Simplified Acquisition Procedures.

The LPTA process is selected as appropriate for this acquisition because the best value is expected to result from selection of the technically acceptable quotation with the lowest evaluated price. An overall technical rating must be at least "ACCEPTABLE" in order to be eligible for award. An "UNACCEPTABLE" rating, results in the technical quotation being rated "UNACCEPTABLE" unless corrected through discussions. An overall technical rating of "UNACCEPTABLE" makes a quotation ineligible for award. An offeror is expected to submit sufficient information in response to the RFQ to allow for the evaluation.

The Government intends to evaluate offers and award a contract without discussions. Therefore, the Offeror’s initial offer should contain the Offeror’s best terms from a price and technical standpoint. The Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary.

To receive consideration for award, offerors must achieve an evaluation of not less than “Acceptable” for the Technical Capability and Past Performance factors.

Evaluation will be made to identify all Offerors whose proposals are technically acceptable in accordance with the Brand Name MEC nature of the requirement. The evaluation criteria set forth below. The non-cost/price evaluation factors are as follows:

Factor 1 – Technical Approach Factor 2 – Past Performance

Government evaluators will not assume that the offeror possesses any capability or knowledge unless it is specified in the proposal.

(b) Non-Price Evaluation Criteria: The following criteria will be used to evaluate the non-price aspects of the proposal.

Factor 1: Technical Capability:

The technical approach shall be evaluated to the degree that the Offeror’s technical proposal meets the minimum requirements outlined in the SOW and the Brand Name Amber 250 Bioreactor System’s MEC that demonstrate capability to:

Provide a 21 CFR Part 11 assessment at turnover.

Provide Site Acceptance Testing (SAT).

Provide an Installation / Operation Qualification Documentation Package Provide On-site Repairs and respond within 48 hours Provide documents to demonstrate offeror is an authorized reseller

Rating Standard

Rating Description Acceptable Proposal meets the Brand Name requirements of the solicitation.

Unacceptable Proposal does not meet the Brand Name requirements of the solicitation.

Factor 2 – Past Performance The past performance evaluation shall result in an assessment of the Offeror’s probability of meeting the solicitation requirements. The past performance evaluation considers each Offeror's demonstrated recent and relevant record of performance in providing services that meet the contract’s requirements. The Offeror will be evaluated based on the narrative description and type of contract work performed similar in scope and complexity to the requirements of this solicitation. Offeror shall provide a brief description of contract work and comparability to the proposed effort.

In the case of an Offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonable assigned Offeror may not be evaluated favorably or unfavorably on at performance. Therefore, the Offeror shall be determined to have an unknown past performance. In the context of acceptability/unacceptability “unknown” shall be considered “acceptable.”

Past Performance Rating:

Rating Description Acceptable Based on the offeror's performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort, or the offeror's performance record is unknown.

Unacceptable Based on the offeror's performance record, the Government has no reasonable expectation that the offeror will be able to successfully perform the required effort.

(a) Factor 3: Price Evaluation Criteria

Price will be evaluated separately from non-price factors. A price analysis will be performed in accordance with FAR Part 13 Procedures and FAR 12.209 in order to evaluate the fairness and reasonableness of the proposed price.

The Government will evaluate offers by establishing a Total Evaluated Price which will consist of the total price proposed for all base contract line items and option contract line items.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(end of provision)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEVIATION 2025-O0003/ DEVIATION 2025-O0004) (MAR 2025)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision --

"Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

"Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

"Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

"Immediate owner" means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

"Inverted domestic corporation" means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

"Manufactured end product" means any end product in product and service codes (PSCs) 1000-9999, except--

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

"Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government.