COMBINED SYNOPSIS RFP W81XWH-20-R-0095 DSUVIA.pdf

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 19 August 2020 2. Close Date: 3 September 2020 10:00 AM 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 DSUVIA National Stock Number (NSN) 6505-01-678-1097 Sufentnail NanoTabs.

6. Solicitation Number: W81XWH-20-R-0095

7. Description of Requirement:

USAMMDA WPAC PMO requires Brand Name DSUVIA National Stock Number (NSN) 6505-01-678-1097

Sufentnail NanoTabs.

7.1. This is a combined synopsis/solicitation issued as a Request for Proposal (RFP) 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;

proposals are being requested.

7.2. This combined synopsis/solicitation is 100% set aside for small business and issued as Request for

Proposal (RFP) for Brand Name DSUVIA National Stock Number (NSN) 6505-01-678-1097 Sufentnail

NanoTabs products.

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 100% set aside for small business issued as brand name only. 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 Item Numbers (CLINs) numbers and items, quantities units of measure, and description are identified under the Supplies/Services Section of the RFP.

7.7. Required Delivery Date (RDD): See RFP “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. Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at 52.212-3 Offeror Representations and Certifications—Commercial Items with its proposal.

8. Point-of-Contact: The point-of-contact for this acquisition is Ms. Maribel C. Fratina, Contract

Specialist, (maribel.c.fratina.civ@mail.mil. No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Proposals.

9.1. Proposals 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

RFP.

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 RFP.

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 Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil, no later than 27 August 2020 at 10:00 AM 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. Proposals: Proposals in response to this RFP are due via e-mail no later than Thursday, 3 September

2020 at 10:00 AM EST to Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil.

9.8. The Offeror shall agree to honor proposed prices for 45 calendar days from the due date for receipt of proposals.

mailto:maribel.c.fratina.civ@mail.mil.

mailto:maribel.c.fratina.civ@mail.mil

STATEMENT OF NEED (SoN)

U.S. Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care (WPAC) Project

Management Office

Brand Name DSUVIA National Stock Number (NSN) 6505-01-678-1097 Sufentnail NanoTabs

1. PURPOSE

The USAMMDA-WPAC Project Management Office requires DSUVIA in order to conduct a comparative clinical trial to aid clinical practice guideline development. The goal of the clinical trial is gain information regarding acceptability of DSUVIA compared to

Oral Transmucosal Fentanyl Citrate (OTFC) in an Emergency Room setting in patients with moderate to severe pain requiring an opioid. The clinical trial contains several secondary endpoints including healthcare provider feedback.

2. SCOPE OF WORK

The contractor shall provide USAMMDA-WPAC Project Management Office with DSUVIA.

Contractor will provide delivery of the DSUVIA that meets the minimum essential characteristics (MECs) listed in RFP.

Contractor will store DSUVIA until shipping is requested.

Quantity: The Government intends to procure 3,200 boxes of DSUVIA (30,000 doses) immediately, with three (3) optional CLINs in order to procure three (3) separate additional 3,000 box purchases.

Place of Performance: Delivery of the DSUVIA to be determined by USAMMDA.

3. PERIOD OF PERFORMANCE/DELIVERY DATE:

Base Year 5 October 2020 through 4 October 2021: 3,200 Boxes

Option 1 5 October 2021 through 4 October 2022, Quantity: 3,000 Boxes

Option 2 5 October 2022 through 4 October 2023, Quantity: 3,000 Boxes

Option 3 5 October 2023 through 4 October 2024, Quantity: 3,000 Boxes

Salient Characteristics

DSUVIA, National Stock Number (NSN) 6505-01-678-1097.

1. DSUVIA

a. Shall be FDA approved DSUVIA tablets for oral use, indicated for use in adults in a certified medically supervised healthcare setting, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

b. Each tablet shall contain 30 mcg of Sufentanil for oral use only.

c. The recommended dosage of DSUVIA is one 30-mcg tablet administered sublingually as needed, with a minimum of 1 hour between doses. The maximum cumulative daily dose of DSUVIA is 360 mcg or 12 tablets (12 tablets x 30 mcg/dose).

d. A box of DSUVIA shall contain 10 single dose applicator packages.

e. DSUVIA can be stored at 20°C to 25°C (68°F to 77°F); with excursions permitted to 15-30°C (59-86°F).

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Contract Number:

Contract Description: The Government has a requirement for one commercial lot of 12,200 boxes (3,200 boxes), with three (3) optional Contract Line Item Number (CLINs) to procure up to 3,000 packages per CLIN of a U.S.

Food and Drug Administration (FDA) Brand name DSUVIA, National Stock Number (NSN) 6505-01-678-1097.

Contractor’s name: (hereafter referred to as the contractor).

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

What will be monitored.

How monitoring will take place.

Who will conduct the monitoring.

How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the

QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the

Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: Ayi J. Ayayi

Organization or Agency: U.S. Army Medical Research Acquisition Activity (USAMRAA)

Telephone: 301-619-4018

Email: ayi.j.ayayi.civ@mail.mil

b. Technical Point of Contact (TPOC) - The TPOC is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The TPOC shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the TPOC shall provide documentation to the

KO. The TPOC is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Assigned TPOC: To Be Determined mailto:ayi.j.ayayi.civ@mail.mil

Organization or Agency: U.S. Army Medical Materiel Development Activity (USAMMDA)

Telephone: 301-619-****

Email: ***************

c. Other Key Government Personnel

Title:

Telephone:

Email:

3. CONTRACTOR REPRESENTATIVES:

The following employees of the contractor serve as representatives for this contract.

a. Senior Contractor Personnel -

b. Other Contractor Personnel -

4. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary Matrix, shown below, includes performance standards. The

Government shall use these standards to determine contractor performance.

5. QUALITY ASSURANCE:

5.1. Quality Assurance: The Government shall evaluate the Contractor’s performance under this contract IAW with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed IAW the performance standards. It defines how the performance standards shall be applied, the frequency of surveillance, and the minimum acceptable defect rate (s).

5.2. Performance Requirements Summary:

Deliverable

Indicator

Standard

Method of

Surveillance

Incentive

CLIN 0001

Brand name FDA approved DSUVIA, National Stock Number

(NSN) 6505-01-678-1097

Delivered on schedule

Meets specifications in Salient

Characteristics

100% inspection (or random testing as determined by the

TPOC)

Potential to award options, past performance rating

CLIN 0002

Storage Services for Brand name FDA approved DSUVIA, National Stock Number (NSN) 6505-01- 678-1097

Delivered on schedule

Meets specifications in Salient

Characteristics

100% inspection (or random testing as determined by the

TPOC)

Potential to award options, past performance rating

CLIN 1001

Option 1

Brand name FDA approved DSUVIA, National Stock Number

(NSN) 6505-01-678-1097

Delivered on schedule

Meets specifications in Salient

Characteristics

100% inspection

(or random testing as determined by the TPOC)

Potential to award options, past performance rating

CLIN 2001

Option 2

Brand name FDA approved DSUVIA, National Stock Number

(NSN) 6505-01-678-1097

Delivered on schedule

Meets specifications in Salient

Characteristics

100% inspection

(or random testing as determined by the TPOC)

Potential to award options, past performance rating

CLIN 3001

Option 3

Brand name FDA approved DSUVIA, National Stock Number

(NSN) 6505-01-678-1097

Delivered on schedule

Meets specifications in Salient

Characteristics

100% inspection

(or random testing as determined by the TPOC)

Past performance rating

6. INCENTIVES.

The Government shall use positive performance reporting incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

7. METHODS OF QA SURVEILLANCE.

Various methods exist to monitor performance. The TPOC shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the TPOC shall always contact the contractor's representative when a defect is identified and inform him/her of the specifics of the problem. The TPOC shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

b. 100% INSPECTION. (Evaluates all outputs. Most applicable to small quantity, but highly important services.

May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.)

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO’s actions.

8. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

EXCEPTIONAL:

Performance significantly exceeds contract requirements to the

Government’s benefit.

SATISFACTORY: Performance meets contractual requirements.

UNSATISFACTORY: Performance does not meet contractual requirements.

9. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the TPOC shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the TPOC shall document the discussion and place it in the TPOC file.

When the TPOC determines formal written communication is required, the TPOC shall prepare a Contract

Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the TPOC in writing. The TPOC will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The TPOC will also state how long after receipt the contractor has to present this corrective action plan to the TPOC. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

PERFORMANCE REPORT (PR)

1. CONTRACT NUMBER: <insert number>

2. Prepared by: (Name of TPOC) <insert name>

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.>

Prepared by: <Enter TPOC’s name>

Signature – (TPOC) Date

CONTRACT DISCREPANCY REPORT (CDR):

<This report is to be completed by the TPOC if a performance issue arises>

1. Contract Number: <insert number>

2. TO: (Program Manager or on-site representative) <insert name>

3. FROM: (Name of TPOC) <insert name>

4. Date and time observed discrepancy:

5. DISCREPANCY OR PROBLEM:

<Describe in detail. Identify any attachments.>

6. Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned not later than < 10 days after receipt of this CDR. >

Prepared by: <insert name>

Signature – Technical Point of Contact (TPOC) Date

Received by:

Signature - Program Manager or on-site representative

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 3,200 Box

Brand name FDA approved DSUVIA

FFP

The Contractor shall provide Brand name FDA approved DSUVIA, National Stock

Number (NSN) 6505-01-678-1097.

Period-of-Performance (POP) 5 October 2020 through 4 October 2021.

FOB: Destination

PSC CD: 6505

NET AMT

0002 3,200 Box Brand name FDA approved DSUVIA Storage

FFP

The Contractor shall provide Storage Service for Brand name FDA approved

DSUVIA, National Stock Number (NSN) 6505-01-678-1097, CLIN 0001:

Period-of-Performance (POP) 5 October 2020 through 4 October 2021.

1001 3,000 Box

OPTION Brand name FDA approved DSUVIA

FFP

Period-of-Performance (POP) 5 October 2021 through 4 October 2022.

2001 3,000 Box

OPTION Brand name FDA approved DSUVIA

FFP

Period-of-Performance (POP) 5 October 2022 through 4 October 2023.

3001 3,000 Box

OPTION Brand name FDA approved DSUVIA

FFP

Period-of-Performance (POP) 5 October 2023 through 4 October 2024

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

1001 Destination Government Destination Government

2001 Destination Government Destination Government

3001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 4 October 2021

3,200 ANDREA ATKINSON

ANDREW ATKINSON

1430 VETERANS ST

FT DETRICK, MD 21702

FOB: Destination

W806YH

0002 4 October 2021 3,200 (SAME AS PREVIOUS LOCATION)

W806YH

1001 4 October 2022 3,000 (SAME AS PREVIOUS LOCATION)

2001 4 October 2023 3,000 (SAME AS PREVIOUS LOCATION)

3001 4 October 2024 3,000 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions JUN 2020

52.203-3 Gratuities APR 1984

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.203-17 Contractor Employee Whistleblower Rights and Requirement

To Inform Employees of Whistleblower Rights

JUN 2020

52.203-18 Prohibition on Contracting With Entities That Require Certain

Internal Confidentiality Agreements or Statements--

Representation

JAN 2017

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2018

52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

52.204-13 System for Award Management Maintenance OCT 2018

52.204-16 Commercial and Government Entity Code Reporting JUL 2016

52.204-18 Commercial and Government Entity Code Maintenance JUL 2016

52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-20 Predecessor of Offeror JUL 2016

52.204-22 Alternative Line Item Proposal JAN 2017

52.209-11 Representation by Corporations Regarding Delinquent Tax

Liability or a Felony Conviction under any Federal Law

FEB 2016

52.214-34 Submission Of Offers In The English Language APR 1991

52.214-35 Submission Of Offers In U.S. Currency APR 1991

52.215-20 Requirements for Certified Cost or Pricing Data or

Information Other Than Certified Cost or Pricing Data

OCT 2010

52.217-5 Evaluation Of Options JUL 1990

52.219-1 Alt I Small Business Program Representations (MAR 2020)

Alternate I

SEP 2015

52.225-1 Buy American--Supplies MAY 2014

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008

52.225-25 Prohibition on Contracting with Entities Engaging in Certain

Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.227-3 Patent Indemnity APR 1984

52.227-11 Patent Rights--Ownership By The Contractor MAY 2014

52.229-3 Federal, State And Local Taxes FEB 2013

52.232-1 Payments APR 1984

52.232-23 Assignment Of Claims MAY 2014

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-1 Disputes MAY 2014

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.242-13 Bankruptcy JUL 1995

52.242-15 Stop-Work Order AUG 1989

52.243-1 Changes--Fixed Price AUG 1987

52.246-2 Inspection Of Supplies--Fixed Price AUG 1996

52.246-16 Responsibility For Supplies APR 1984

52.247-34 F.O.B. Destination NOV 1991

52.249-2 Termination For Convenience Of The Government (Fixed-

Price)

APR 2012

52.249-8 Default (Fixed-Price Supply & Service) APR 1984

52.253-1 Computer Generated Forms JAN 1991

252.201-7000 Contracting Officer's Representative DEC 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

DEC 2008

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7000 Disclosure Of Information OCT 2016

252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7006 Billing Instructions OCT 2005

252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

DEC 2019

252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.204-7016 Covered Defense Telecommunications Equipment or Services

-- Representation

DEC 2019

252.204-7018 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services

DEC 2019

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By

The Government of a Country that is a State Sponsor of

Terrorism

MAY 2019

252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010

252.219-7003 Alt I Small Business Subcontracting Plan (DoD Contracts)(DEC

2019) Alternate I

DEC 2019

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7000 Buy American--Balance Of Payments Program Certificate--

Basic (Nov 2014)

NOV 2014

252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017

252.225-7002 Qualifying Country Sources As Subcontractors DEC 2017

252.225-7012 Preference For Certain Domestic Commodities DEC 2017

252.225-7021 Trade Agreements--Basic SEP 2019

252.225-7035 Buy American--Free Trade Agreement--Balance Of Payments

Program Certificate--Basic

NOV 2014

252.225-7048 Export-Controlled Items JUN 2013

252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business

Concerns

APR 2019

252.227-7038 Patent Rights--Ownership by the Contractor (Large Business) JUN 2012

252.227-7039 Patents--Reporting Of Subject Inventions APR 1990

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7001 Pricing Of Contract Modifications DEC 1991

252.243-7002 Requests for Equitable Adjustment DEC 2012

252.244-7000 Subcontracts for Commercial Items JUN 2013

252.246-7003 Notification of Potential Safety Issues JUN 2013

252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR (JUL 2016)

(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; 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)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT (DEC 2019)

The Offeror shall not complete the representation in 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 the provision at 52.204-26, Covered Telecommunications Equipment or

Services--Representation, or in paragraph (v) of the provision at 52.212-3, Offeror Representations and Certifications--Commercial

Items.

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

Covered telecommunications equipment or services, critical technology, and substantial or essential component have the meanings provided in clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment.

(b) Prohibition. 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. Contractors are not prohibited from providing--

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or 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) Representation. The Offeror represents that 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.

(e) Disclosures. If the Offeror has represented in paragraph (d) of this provision that it “will'' provide covered telecommunications equipment or services”, the Offeror shall provide the following information as part of the offer-

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

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

(3) For services, the entity providing the covered telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known); and

(4) For equipment, 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).

52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT (AUG 2019)

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

Covered foreign country means The People's Republic of China.

Covered telecommunications equipment or services means--https://www.sam.gov/

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera

Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3) Telecommunications or video surveillance services provided by such entities or using such equipment; or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means--

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms

Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled--

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part

810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C.

4817).

Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

(b) Prohibition. 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. The Contractor is prohibited from providing to the Government 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, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in Federal Acquisition Regulation 4.2104.

(c) Exceptions. This clause does not prohibit contractors from providing--

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

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

(d) Reporting requirement.

(1) In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, or the

Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are established procedures for reporting the information; in the case of the Department of Defense, the

Contractor shall report to the website at https://dibnet.dod.mil. For indefinite delivery contracts, the Contractor shall report to the

Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in the case of the

Department of Defense, identify both the indefinite delivery contract and any affected orders in the report provided at https://dibnet.dod.mil.

(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause:

(i) Within one business day from the date of such identification or notification: The contract number; the order number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial and Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number, manufacturer part number, or wholesaler number); item description; and any readily available information about mitigation actions undertaken or recommended.

(ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: Any further available information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of covered telecommunications equipment or services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.

(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial items.

(End of clause)

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

2019)

(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.

(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) Representation. 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.

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

INCLUDES ADDENDUM STARTING AT SECTION (M) BELOW:

https://dibnet.dod.mil/ https://dibnet.dod.mil/

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in paragraph 7.4., “North American Industry Classification System (NAICS)” of the Combined Synopsis/Solicitation Instructions. 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).

https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ 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.

(M) Addendum

M.1. Instructions to Offerors: The Offerors response to this RFP 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 proposal “unacceptable”.

M.2. Price Proposal Instructions: The Offeror shall provide a total price for each Contract Line Item Number (CLIN). The

Government anticipates award of a Firm-Fixed Price (FFP) contract and the Offeror shall propose a FFP pricing on all CLIN items.

M.3. The Offeror’s proposal shall include the product literature which clearly documents the offered DSUVIA must be Brand Name

DSUVIA National Stock Number (NSN) 6505-01-678-1097 product identified in this RFP.

M.4. The Brand Name product offered must be new. Offerors offering used or remanufactured products shall be rated

“Unacceptable”.

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

https://assist.dla.mil/wizard/index.cfm http://www.sam.gov/

To be determined by:

U.S. Army Medical Materiel Development Activity (USAMMDA)

Warfighter Protection and Acute Care (WPAC) Project Management Office

1430 Veterans Drive

Fort Detrick, MD 21702-5009

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

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

M.8. Questions: All questions pertaining to the RFP shall be submitted via e-mail to Ms. Maribel C. Fratina, Contract Specialist, maribel.c.fratina.civ@mail.mil no later than 27August 2020 at 10:00 AM EST. The subject header of the e-mail submission of questions shall be: Brand Name DSUVIA National Stock Number (NSN) 6505-01-678-1097 products and RFP # W81XWH-20-R-

0095. Questions received after this date will not be accepted.

M.9. RFP Due Date: Response…