B08-W81XWH-21-R-0055_KO Rev 04 JUN 2021_COND APPR.docx

W81XWH21R0055

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 07 June 2021

2. Close Date: 07 July 2021 3:00 PM EST

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702

4. Requiring Activity: U.S. Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO).

5. Subject: Brand Name Artesunate for Injection

6. Solicitation Number: W81XWH-21-R-0055

7. Description of Requirement:

USAMMDA WPAC PMO requires Brand Name Artesunate for Injection

7.1. This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested.

7.2. This solicitation is issued as a Request for Quote (RFQ) for Brand Name Artesunate for Injection.

7.3. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-07; effective 2 July 2020.

7.4. This acquisition is a Brand Name Only Solicitation. The North American Industry Classification System (NAICS) code is 325412 - Pharmaceutical Preparation Manufacturing with a size standard of 1250 employees.

7.5. Contract award shall be made on a competitive best value basis using Lowest Price Technically Acceptable “LPTA” approach.

7.6. The Contract Line Items Number (CLINs) and item, quantities units of measure, and description are identified under the Supplier/Services Section of the RFQ.

7.7. Required Delivery Date (RDD): See RFQ “DELIVERY INFORMATION” for details. Shipping shall be Free On Board (FOB) Destination IAW FAR 52.247-34 to:

To be determined by:

U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO) 1430 Veterans Drive Fort Detrick, MD 21702-5009

7.8. FAR provision 52.212-1 Instruction to Offerors – Commercial Items-- including the Addendum (m) applies to this acquisition and the attached RFQ.

7.9. FAR provision 52.212-2 Evaluation – Commercial Items applies to this acquisition including the Addendum contacted in the RFQ

7.10. Offerors responding to this solicitation shall include a completed copy of the provision at 52.212-3 Offeror Representations and Certifications-Commercial Items with their quote.

7.11. FAR Clause 52.212-4 Contract Terms and Conditions – Commercial Items applies to this acquisition. Additional contract requirements and terms and conditions are identified in the attached RFQ.

7.12. FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statue or Executive Order – Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and market which are applicable to this acquisition.

8. Point-of-Contact: The point-of-contact for this acquisition is Mr. Ireneusz Jozwiak, Contract Specialist, (ireneusz.a.jozwiak.civ@mail.mil.) No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Quotes.

9.1. Quotes shall be prepared in accordance with this solicitation and FAR provision 52.212 -1 Instructions to Offerors- Commercial Items including the Addendum which is included with the attached RFQ.

9.2. All proposals shall be evaluated in accordance with the evaluation criteria identified in Addendum (M) to FAR 52.212-2 Evaluation—Commercial Items included with the attached RFQ.

9.3. The FAR clause 52.212-4 Contract Terms and Conditions-Commercial Items applies to this acquisition. Additional contract requirements and terms and conditions are identified in the attached RFP.

9.4. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

– Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

9.5. The Government reserves the right to reject any or all proposals, and to award no contract at all, depending on the quality of the proposal (s) submitted and the availability of funds.

9.6. Questions: Questions shall be submitted via e-mail to Mr. Ireneusz Jozwiak, Contract Specialist, ireneusz.a.jozwiak.civ@mail.mil, no later than 29 June 2021 at 3:00 PM EST. Questions received after this date will not be accepted. An Amendment to this RFP will be posted to BETA.SAM.gov with responses to the questions received. Only one set of questions per Contractor will be accepted. No telephone calls will be accepted.

9.7. Quotes: Quotes in response to this RFQ are due via e-mail no later than 07 July 2021 at 3:00 PM EST to Mr. Ireneusz Jozwiak, Contract Specialist, ireneusz.a.jozwiak.civ@mail.mil.

9.8. The Offeror shall agree to honor proposed prices for 60 calendar days from the due date for receipt of proposal.

Section SF 1449 - CONTINUATION SHEET

Artesunate for Injection - GERMANY

FFP

BRAND NAME ONLY ARTESUNATE FOR INJECTION - Shipping is required to: USAMMCE - Mannheimer Strasse, BLDG 2369, 67657 Kaiserslautern, Germany

FOB: Destination

PSC CD: 6505

NET AMT

Artesunate for Injection - JAPAN

BRAND NAME ONLY ARTESUNATE FOR INJECTION - Shipping is required to: PHARMACY DEPARTMENT, US Naval Hospital-Yokosuka, Hospital Yokosuka, Japan, PSC 475 Box 6, FPO AP 96350-1600; or ***Japan-via FEDEX*** to: SUPPLY OFFICER, PHARMACY DEPARTMENT, Warehouse Receiving Bldg E-18, FPO AP 96350-1600, Hon-cho, Yokosuka, Kanagawa, 238-0041 Japan

NET AMT

Artesunate for Injection - HAWAII

BRAND NAME ONLY ARTESUNATE FOR INJECTION - Shipping is required to: Tripler Army Medical Center, 1 Jarrett White Road, Room 2F116 Pharmacy, Honolulu, HI 96859

PSC CD: 6508

NET AMT

Artesunate for Injection - KOREA

BRAND NAME ONLY ARTESUNATE FOR INJECTION - Shipping is required to: USA MED MATERIEL CTR KOREA, Bldg 709, Camp Carroll, Waegman KR, South Korea, 39886

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

ADDITIONAL DELIVERY INFO

In lieu of the address listed on Block 15 of the DD1449 coversheet for this Delivery Order, please mark all deliveries as follows, which reflects the Delivery Address listed in the Delivery Order Proposal.

DELIVERY INFORMATION:

Mannheimer Strasse, Bldg 2369 67657 Kaiserslautern, Germany Attn: Michael Stricker FOB: Destination

0002 31-AUG-2021 8 PHARMACY DEPARTMENT W806YH

US Naval Hospital-Yokosuka Hospital Yokosuka, Japan PSC 475 Box 6

FPO AP 96350-1600

FOB: Destination or

***Japan-via FEDEX*** W806YH

SUPPLY OFFICER

PHARMACY DEPARTMENT

Warehouse Receiving Bldg E-18

FPO AP 96350-1600

Hon-cho, Yokosuka Kanagawa, 238-0041 Japan FOB: Destination

Bldg 709, Camp Carroll, Waegman KR, South Korea, 39886 FOB: Destination

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

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 Items. 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.

(End of 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.

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A

FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that--

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JUN 2020)

INCLUDES ADDENDUM STARTING AT SECTION (m) BELOW:

(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 which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(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 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 subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items 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 specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462.

(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 items, the make and model of the item 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 FAR 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS

M.1. Instructions to Offerors: The Offeror’s response to this RFQ shall be legible and comprehensive to enable the Government to conduct the technical evaluation. The information shall be precise, factual, and complete. Failure to submit all information concurrently and in accordance with these instructions shall render the Offeror’s quote “unacceptable”.

M.2. Price Quote Instructions: The Offeror shall provide a total price for each Contract Line Item Number (CLIN) Price (FFP). The Government anticipates award of a Firm-Fixed Price (FFP) contract and the Offeror shall propose a FFP pricing on all CLINs.

M.3. The Offeror’s quote shall include the product literature which clearly documents the offered Brand Name Artisunate for Injection Malaria Drug identified in this RFQ.

M.4. The Brand Name equipment/product offered must be new. Offerors offering used or remanufactured equipment/products shall be rated “Unacceptable”.

M.5. Shipping shall be Free On Board (FOB) Destination IAW FAR 52.247-34. The four (4) shipping locations are:

1. USAMMCE

Mannheimer Strasse, Bldg 2369 67657 Kaiserslautern, Germany Attn: Michael Stricker

2. PHARMACY DEPARTMENT

US Naval Hospital-Yokosuka Hospital Yokosuka, Japan PSC 475 Box 6

FPO AP 96350-1600

Or

***Japan-via FEDEX***

SUPPLY OFFICER

PHARMACY DEPARTMENT

Warehouse Receiving Bldg E-18

FPO AP 96350-1600

Hon-cho, Yokosuka Kanagawa, 238-0041 Japan

3. Tripler Army Medical Center 1 Jarrett White Road Room 2F116 Pharmacy Honolulu, HI 96859

4. USA MED MATERIEL CTR KOREA

Bldg 709, Camp Carroll, Waegman KR, South Korea, 39886

M.6. Offerors are encouraged to offer the Government discounts where appropriate.

M.7. North American Industry Classification System (NAICS)” of this RFQ is 325412 Pharmaceutical Preparation Manufacturing.

M.8. Questions: All questions pertaining to the RFQ shall be submitted via e-mail to Mr. Erik Jozwiak, Contract Specialist, ireneusz.a.jozwiak.civ@mail.mil no later than 28 June 2021 at 3:00 PM EST. The subject header of the e-mail submission of questions shall be: Artesunate for Injection and RFQ # W81XWH-21-R-0055. Questions received after this date will not be accepted.

M.9. RFQ Due Date: Response to this RFQ is due via e-mail no later than 06 July 2021 at 3:00 PM EST via e-mail to Mr. Erik Jozwiak, Contract Specialist, ireneusz.a.jozwiak.civ@mail.mil. No telephone calls will be accepted.

M.10. Required Delivery Date (RDD): 31 August 2021.

M.11. Other Administrative Instructions: System for Award Management (SAM). Contractors must be registered in SAM to be considered for award. Registration is free and can be completed on-line at http://www.sam.gov; provide DUNS number; Cage Code and TIN.

M12. Past Performance References and Evaluation Questionnaire Form

The offeror must provide a list of 3 references for the prime offeror and no more than 3 references for each subcontractor performing 30% of the effort or more, of relevant past and present contracts for Federal, State and/or City agencies and commercial customers within the past 3 years. “Relevant” is defined as like items as stated in this solicitation’s Statement of Work in terms of similar characteristics and quantities. See the SON contained within this RFP for completion of the Past Performance Questionnaire. References must include:

Name of the Organization that will be providing the reference, Name of the Point of Contact (POC), POC Telephone Number, POC Email address, Contract Number, Period of Performance, and Description of goods/services rendered.

The Government may also consider information obtained through other sources. Past performance information will be utilized to determine the quality of the contractor’s past performance as it relates to the probability of success of the required effort. Ensure that contract information is accurate and up-to-date, as references will be checked.

Past Performance Evaluation - Questionnaire Form

Contractor: Contract No.:

Subcontract No. (if applicable):

POC: Title: (Name) (e.g. CEO, Manager, etc.,)

(Agency, Telephone No., E-mail Address & Fax Number)

The following questions pertain to the contractor's record of past (within the past three years) and current performance. The information that you provide will be used in awarding of a federal contract. Therefore, it is important that our information be as factual and accurate as possible. Please provide examples and/or explanations (use additional pages if necessary). The following adjectival ratings shall be used in your response.

Outstanding: Performance meets contractual requirements and exceeds many requirements that benefit the end user. Work was accomplished with few, if any, minor problems for which corrective actions taken by the contractor were highly effective.

Good: Performance meets contractual requirements and exceeds some requirements that benefit the end user. Work was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Acceptable: Performance meets contractual requirements. Work was accomplished with some minor problems for which corrective actions taken by the contractor were satisfactory.

Marginal: Performance does not meet some contractual requirements. Serious problems with contractor performance were experienced for which the contractor has either not yet identified corrective actions or the corrective actions taken appear only marginally effective.

Unacceptable: Performance does not meet most contractual requirements. Serious problems with contractor performance were experienced for which the corrective actions were ineffective.

PART I. (To be completed by the Offeror)

A. CONTRACT IDENTIFICATION

Contractor/Company Name/Division:

Address:

Program Identification/Title:

Contract Number:

Contract Type:

Prime Contractor Name (if different from the contractor name cited above): Contract Award Date:

Forecasted or Actual Contract Completion Date: Nature of the Contractual Effort or Items Purchased:

B. IDENTIFICATION OF OFFEROR'S REPRESENTATIVE

Name:

Title:

Date:

Telephone Number: Address:

E-mail Address:

PART II. EVALUATION (To be completed by Point of Contact - Respondent)

A. Compliance of Products, Services, Documents, and Related Deliverables to Specification Requirements and Standards of Good Workmanship

|_|Outstanding (Explanation must be provided in Comments field below) |_| Good |_| Acceptable |_| Marginal (Explanation must be provided in Comments field below) |_| Unsatisfactory (Explanation must be provided in Comments field below) Comments:

B. Effectiveness of Management (to include use and control of subcontractors)

|_| Outstanding (Explanation must be provided in Comments field below) |_| Good |_| Acceptable |_| Marginal (Explanation must be provided in Comments field below) |_|Unsatisfactory (Explanation must be provided in Comments field below)

C. Timeliness of Performance for Services and Product Deliverables

|_| Good |_| Acceptable |_| Marginal (Explanation must be provided in Comments field below)

D. Effectiveness in Forecasting and Controlling Estimated Costs (Use this Question on Cost Reimbursement Type Contracts Only

|_| Good |_| Acceptable |_| Marginal (Explanation must be provided in Comments field below)

E. Commitment to Customer Satisfaction and Business-like Concern for its Customers' Interest

|_| Good |_| Acceptable |_| Marginal (Explanation must be provided in Comments field below)

F. General Comments. Provide any other relevant performance information.

G. Other Information Sources. Please provide the following information:

Are you aware of other relevant past efforts by this company?

If yes, please provide the name and telephone number of a point of contact:

H. Respondent Identification. Please provide the following information:

Organization:

Name:

Title:

Date:

Telephone Number:

Address:

E-mail Address:

PART III. RETURN INFORMATION

Please return this completed Questionnaire via e-mail to the Contract Specialist, Mr. Ireneusz Jozwiak, Contract Specialist, (ireneusz.a.jozwiak.civ@mail.mil.)

Thank you for your assistance.

(End of provision)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(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:

Factor 1 Technical Capability Factor 2 Past Performance Factor 3 Price

(b) Basis for Award: Award of this contract shall be made on a competitive best value basis using “Lowest Price, Technically Acceptable (LPTA)” approach. Evaluation will be made to identify all Offerors whose quotes are technically acceptable in accordance with this RFQ and the evaluation criteria set forth below. Award will be made to the technically acceptable Offeror whose price is the lowest. The Offeror’s quote will be evaluated to ensure the Government receives a technically acceptable quote at a fair and reasonable price. Technical acceptability will be determined by evaluating Technical Capabilities/Specifications. All technical evaluation criteria must be rated Acceptable to be considered for award. The Offeror must fully document and substantiate a cross mapping of their price approach as it equates to the technical approach listed in the evaluation criteria. Please note that unsubstantiated prices that are considered unrealistic or unsupported or both may cause the overall technical evaluation to be rated Unacceptable.

The Government evaluators will not assume the Offeror possesses the product/equipment unless specified in the quote.

After the non-price factors are rated individually, an overall rating will be assigned collectively to the factor. If the non-price evaluation factor receives an individual rating of “Unacceptable”, the collective overall rating will also be “Unacceptable”. Only proposals receiving an overall rating of “Acceptable” will be considered for award.

(c) Evaluation Criteria: The Offeror’s quote for this requirement will be evaluated using the following criteria. An evaluation for technical acceptability will be made to ensure satisfactory responsiveness to the requirements set forth in this RFQ. The non-price factor will be rated “Acceptable” or “Unacceptable” using the following rating standards:

Factor 1 – Technical Capability: The Offeror’s quote shall be evaluated to the degree to which the Offeror demonstrates (1) an understanding of the requirement; (2) the Offeror is capable of providing the required brand name Artisunate for Injection malaria drug described throughout this RFQ; and (3) the Offeror is capable of delivering the brand name Artisunate for Injection malaria drug within the stated delivery date contained within this RFQ.

Factor 2 - Past Performance:

Factor 3 – Price:

The offeror will be evaluated for fairness, reasonableness and completeness.

(a) Reasonableness: The offeror’s Price will be evaluated separately to determine the degree to which the proposed prices compare to the prices a reasonable prudent person would expect to incur for the same or similar equipment.

(b) Completeness: The offeror's Price proposal will be examined to ensure that the requirements stated in the Instructions to Offerors for price proposals have been completed. The cost/price will be evaluated separately from all non-cost/price factors. The objective of price analysis is to ensure that the final agreed-to price is fair and reasonable in accordance with FAR 12.209 and FAR 15.404-1(b).

Offerors' price proposals will be evaluated to determine whether the price is complete, fair, and reasonable. The Government's determination that the proposed price is fair and reasonable will be based on price evaluation and analysis using the techniques in FAR 15.305(1), which provides that comparison of the proposed prices will usually satisfy the requirement for price analysis.

(c) 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.

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (FEB 2021)

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. 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. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

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

“Reasonable inquiry” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate--

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under…