Domestic Nitrile Exam Gloves - Solicitation - SPE2DV26R0001.pdf

SOLICITATION NO. SPE2DV-26-R-0001 Page 1 of 43

SOLICITATION NO. SPE2DV-26-R-0001 Page 2 of 43

Table of Contents Part I – The Schedule

Section A – Solicitation Form Section B – Supplies or Services and Prices/Costs Section C – Description/Specifications/Requirements Section D – Packaging and Marking Section F – Deliveries or Performance Section G – Contract Administration Data Section H – Special Contract Requirements

Part II – Contract Clauses Section I – Contract Clauses

Part III – List of Documents, Exhibits, and Other Attachments Section J – List of Attachments

Part IV – Representations and Instructions Section K – Representations, Certifications, and Other Statements of Offerors Section L – Instructions, Conditions, and Notices to Offerors Section M – Evaluation Factors for Award

SOLICITATION NO. SPE2DV-26-R-0001 Page 3 of 43

PART I -THE SCHEDULE

SECTION B

SUPPLIES OR SERVICES AND PRICES/COSTS

CONTINUATION OF SF 1449 BLOCKS 19-22

Guaranteed Minimum and Contract Maximum:

The guaranteed minimum for the one (1) year base period is $13,200,000 and $6,600,000 for each of the two

(2) six (6) month option periods, if exercised by the Government. The maximum dollar value for this procurement is $105,600,000 over the two (2) year period.

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

ESTIMATED

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

TOTAL ESTIMATED

PRICE

0001AA

0001AB

0001AC

0002AA

0002AB

0002AC

0003AA

0003AB

0003AC

0004AA

0004AB

0004AC

0005AA

0005AB

0005AC

0006AA

0006AB

0006AC

Halyard Sterling SG Nitrile Gloves – Extra Small Manufacturer Part Number __________ Base Year Option Period 1 Option Period 2

Halyard Sterling SG Nitrile Gloves – Small Manufacturer Part Number _________

Base Year Option Period 1 Option Period 2

Halyard Sterling SG Nitrile Gloves – Medium Manufacturer Part Number __________

Base Year Option Period 1 Option Period 2

Halyard Sterling SG Nitrile Gloves – Large Manufacturer Part Number __________

Base Year Option Period 1 Option Period 2

Halyard Sterling SG Nitrile Gloves – Extra Large Manufacturer Part Number __________

Base Year Option Period 1 Option Period 2

Halyard Sterling SG Nitrile Gloves – Extra Extra Large Manufacturer Part Number __________

Base Year Option Period 1 Option Period 2

*Unit = Case of 2,500 gloves

24,192 12,096 12,096

39,456 19,728 19,728

20,510 10,255 10,255

2,724 1,362 1,362

CS*

CS

SOLICITATION NO. SPE2DV-26-R-0001 Page 4 of 43

PART I - THE SCHEDULE

SECTION C

DESCRIPTION/SPECIFICATIONS/REQUIREMENTS

Statement of Work

1. Background

a. The Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel provides medical surgical products for the Department of War (DOW) to its customers through its Medical Surgical Prime Vendor (MSPV) program. A prime vendor is an independent business concern that functions as a purchaser's primary source for specified classes of products and is responsible for the delivery of goods produced by various suppliers. As a part of the Medical Surgical Prime Vendor Program, this solicitation will establish an independent Indefinite Delivery Indefinite Quantity (IDIQ) contract for the items listed in the schedule. The MSPV Program consists of separate contracts which establish the fees for the distribution of medical surgical products that are distributed through the MSPV Program. The contractor consents to allow DLA Troop Support Prime Vendors to distribute the listed products in the schedule.

2. Purpose and Objective

a. A contract resulting from this solicitation will establish a DOW supply source, in accordance with FAR

52.216-22 Indefinite Quantity, to provide the products listed in the schedule for purchase by DLA customers through the PV. The annual usage for DLA customers, served through the MSPV program, is estimated in the Schedule of Supplies. The objective of the contract is to establish a domestic manufactured source of supply to ensure availability and consistency of domestically manufactured product, and to obtain volume-based, committed use pricing.

3. Purchase Compliance

a. Ordering activities will purchase the selected contractor’s product for the items listed in the Schedule of

Supplies section of this solicitation through the DLA Med/Surg Prime Vendors.

b. The Contractor must deliver products exactly as ordered. Unilateral substitutions are prohibited.

4. Production Contingency

a. The Contractor shall ensure that DLA maintains access to sufficient stock Halyard Sterling Sensi-Guard

(SG) surgical glove product line. The estimated demand shall be established and preserved based on DLA’s 12-month historical Sterling SG usage at the time of award.

b. Upon identifying any condition that affects the domestic Sterling SG production line’s ability to meet DLA’s capacity requirements, the Contractor shall notify the Contracting Officer (KO) as soon as the issue is known, but no later than 24 hours after identification. If approved by the KO, the Contractor shall redirect Sterling SG production to Halyard-qualified alternate facilities, as necessary, to maintain required output. The Contractor shall ensure that any Halyard qualified alternative Sterling SG product manufactured through contingency production is made available for Government purchase by

SOLICITATION NO. SPE2DV-26-R-0001 Page 5 of 43 establishing a Distribution and Pricing Agreement (DAPA) for the qualifying alternatively sourced item within 48 hours through the DLA MSPV program (see Section 13. Contingency and Implementation Plans) without reducing, reallocating, or delaying supply to the Med/Surg Prime Vendors.

c. Conditions that may result in insufficient domestically manufactured Sterling SG production capacity include, but are not limited to:

1. Quality nonconformance

2. A surge in DOW demand resulting from natural disasters, pandemics, armed conflict/war, or other emergent conditions that substantially increase DLA’s immediate requirements

3. Unplanned equipment failure or prolonged maintenance

4. Raw material shortages

5. Labor shortages, stoppages, or workforce availability disruptions

6. Facility safety or environmental incidents requiring temporary shutdown

7. Regulatory, quality-system, or certification delays affecting the Sterling SG line

8. Natural disasters or severe weather impacting the U.S. facility

9. Upstream supplier interruptions impacting Sterling SG throughput

d. All purchases made through the Halyard‑qualified alternate facilities will be applied toward fulfillment of the contract’s guaranteed minimum. In the event the unit price of the alternative Sterling SG product provided to the Government is lower than the unit price established under this contract, the contract unit price contained herein will be used for purposes of calculating satisfaction of the guaranteed minimum.

5. Extent of Obligation

a. Unless otherwise agreed, Halyard authorizes and consents to allow all Med/Surg Prime Vendors selected by DLA Troop Support Medical Supply Chain to distribute the domestically manufactured Halyard Sterling SG glove to participating Medical Treatment Facilities (MTFs) and other customers under the DLA Troop Support Medical Supply Chain's Prime Vendor Programs.

6. Chargeback Agreements

a. Chargeback arrangements shall be coordinated between the contractor and Med/Surg Prime Vendors.

7. Development of the Domestic Sterling SG Nitrile Examination Glove

a. Halyard shall execute a coordinated development effort with the manufacturer to produce a domestically manufactured version of the Sterling SG nitrile examination glove. The development period shall be no more than nine (9) months. Any extension beyond nine (9) months requires prior written approval from the KO.

b. Halyard will submit a detailed plan and timeline outlining the steps required to complete the glove development timeline stated above within ten (10) business days following contract award. This submission will include key milestones, projected completion dates, and any dependencies necessary to

SOLICITATION NO. SPE2DV-26-R-0001 Page 6 of 43 ensure timely and successful execution of the development effort. (see Section 13. Contingency and Implementation Plans).

c. During this period, Halyard agrees to supply all technical data, product specifications, and design parameters necessary for the manufacturer to establish production capability and meet the specification of the Halyard Sterling SG glove. It is Halyard’s responsibility to conduct material trials, production test runs, and process validation activities to ensure equivalency with the current Sterling SG glove used by DLA and Defense Health Agency (DHA) customers.

d. Halyard shall ensure all development and production activities comply with relevant regulatory and industry standards applicable to medical-grade nitrile examination gloves, including U.S. Food and Drug Administration (FDA) requirements, ASTM benchmarks, and applicable quality-system regulations. The effort shall culminate in delivery of pre-production glove samples and validated process documentation necessary to support government evaluation and subsequent clinical user trials.

e. Halyard shall provide written monthly progress reports to the Government on the last business day of each month during the glove development period. Each report shall summarize technical progress, schedule status, risks, mitigation actions, and upcoming milestones for the domestic Sterling SG glove development. Reports shall be submitted via email to the KO.

f. All costs associated with the development period shall be included in the product price.

8. Clinical Trial Requirements

a. Halyard, in coordination with the manufacturer, shall perform a three (3) month clinical evaluation of the Sterling medical exam glove at a minimum of three (3) hospitals designated by the KO. At a minimum, the Contractor shall:

1. Site Coordination and Preparation

i. Engage with each KO selected hospital to confirm participation, obtain necessary approvals, and coordinate timelines.

ii. Provide all required documentation, including product information, safety data, and trial protocols.

iii. Ensure the manufacturer is available to support technical questions and provide product-specific expertise.

2. Product Distribution and Training

i. Deliver an adequate quantity of Sterling gloves to each hospital prior to trial start.

ii. Provide training to hospital staff on the intended use, storage, and proper handling of the gloves.

iii. Supply any supplemental materials needed to support consistent evaluation across sites (instructions, quick-reference guides, evaluation forms).

3. Data Collection and Analysis

i. Track and document observed issues such as tears, defects, performance failures, and any operational concerns reported by users.

ii. Collect standardized feedback from healthcare professionals using Contractor-provided evaluation forms.

SOLICITATION NO. SPE2DV-26-R-0001 Page 7 of 43

iii. Capture both qualitative (user comments, satisfaction notes) and quantitative data (failure rates, frequency of defects, performance metrics).

iv. Ensure data integrity, maintain confidentiality and compliance with all applicable CUI, safety, and hospital requirements.

4. Progress Monitoring and Communication

i. Maintain ongoing communication with each hospital to monitor trial progress, resolve issues, and ensure consistent execution.

ii. Provide weekly updates to the KO no later than Friday at 3:00 PM (EST) for each week during the clinical trial period. These updates shall include trial progress, any issues encountered, data collection status, and planned activities for the following week.

5. Final Reporting Requirements

i. Compile results from all participating hospitals into a comprehensive Clinical Evaluation Report.

ii. Include analysis of findings, observed trends, performance assessments, and recommendations.

iii. Submit the final report to the KO in accordance with contract-specified timelines and formats.

b. All costs associated with clinical trials shall be included in the product price.

9. Contract Ramp-Up Period

a. Following the conclusion of the clinical trial period, the Contractor shall have a 30-calendar day ramp-up period to begin full contract performance. During this time, the Contractor shall ensure that sufficient inventory of contract items are available for delivery, as the Med/Surg Prime Vendors will begin placing orders to stock MSPV distribution centers located within the Continental United States (CONUS), defined as the 48 contiguous states and the District of Columbia.

b. After award, DLA will provide the contractor with the Med/Surg Prime Vendor(s) point of contact information within five (5) business days.

c. Within 15 days from receipt of award or notice of Med/Surg Prime Vendor change, the KO shall be notified by the Contractor if any business-to-business agreements cannot be reached with the Med/Surg Prime Vendors.

d. To facilitate the sale of the contractor’s product to Government ordering activities through the DLA Med/Surg Prime Vendors, the contractor shall enter into business-to-business agreements with each of the DLA Med/Surg Prime Vendors. Payment terms, time and place of delivery to MSPV distribution centers, and other relevant terms shall be agreed upon between the Med/Surg Prime Vendors and the Contractor in these agreements. The Government is not obligated to become involved in or assume any responsibility for financial or other disputes involving these agreements. Offerors may approach the Med/Surg Prime Vendors regarding establishing business-to-business agreements prior to submitting an offer in response to this solicitation.

SOLICITATION NO. SPE2DV-26-R-0001 Page 8 of 43

10. Customer Ordering Begins

a. Customers will begin ordering from the Med/Surg Prime Vendors no later than 30 days after the ramp‑up period concludes (or earlier by mutual agreement of all stakeholders).

b. The date customers begin ordering will also mark the start of the base period, and a contract modification will be issued to formally confirm these dates.

11. Transition Period

a. After customer ordering begins, a brief phase‑in period may be required to transition patients and medical centers to the awarded products. The KO, in coordination with all stakeholders, will determine the appropriate approach for managing and reducing any remaining inventory of non‑domestic gloves being held by the Med/Surg Prime Vendors.

12. Contract Duration

a. The contract resulting herein will be for a one (1) year base period and include two (2) six (6) month option periods for a maximum possible term of two (2) years. The contract will not exceed two (2) years from the date customers begin ordering, which will be solidified in accordance with the modification referenced in Section 10(b) above.

13. Contingency and Implementation Plans

a. Contingency Plan

i. In accordance with Section 4(b), the offeror will provide a detailed Contingency plan outlining the steps taken to preserve DLA’s estimated demand based on 12-month usage of the Sterling SG glove in the case of production insufficiency. The plan shall detail how alternatively manufactured Sterling SG gloves will be made available for purchase through the DLA MSPV program within 48 hours. The plan must outline how alternative manufacturing facilities meet specifications, regulatory requirements, and quality standards defined in this SOW.

b. Implementation Plan

i. In accordance with Section 7(b), the offeror will submit a detailed plan and timeline outlining the steps required to complete the glove development and clinical trial timelines within ten (10) business days following contract award. This submission will include key milestones, projected completion dates, and any dependencies necessary to ensure timely and successful execution of the development effort.

c. The KO will approve, conditionally approve, or disapprove the plans within ten (10) days. The

Government reserves the right to require additional plans if the initial submissions are not approved.

14. Ordering and Acceptance of Orders

a. The Contractor shall accept orders placed by, and provide items to, the authorized Med/Surg Prime

Vendors for use by medical treatment facilities, formularies, eligible beneficiaries, and other ordering

SOLICITATION NO. SPE2DV-26-R-0001 Page 9 of 43 activities supported by DLA contractors. Deliveries shall be coordinated with the designated Med/Surg Prime Vendors. Invoices shall be submitted to the cognizant Med/Surg Prime Vendors. The Med/Surg Prime Vendors shall remit all payments for items ordered under this contract.

b. The Government reserves the right, during the effective period of this contract, to remove ordering sites or activities that are current prime vendor customers, as well as to add new Government ordering activities. Actual quantities ordered may be higher or lower than the estimates provided.

c. The Government reserves the right to add other federally funded customers— including those not currently served by DLA Med/Surg Prime Vendors contractors—at any point during the performance period. Estimated quantities listed in the Schedule of Supplies are based on demand from DOW customers, and offerors shall base their proposals on these estimated quantities.

d. The Contractor shall not charge Med/Surg Prime Vendors more than the contract‑established prices, which support charge‑back arrangements between the agreement holder and Med/Surg Prime Vendors.

Unit-of-sale data reflect the quantity the Contractor agrees to sell to any prime vendor, and all prices are FOB Destination, inclusive of order processing, material handling, and transportation costs.

15. FDA Compliance

a. By signing this solicitation, the offeror certifies that all manufacturers producing the offered nitrile gloves comply with FDA medical device regulatory requirements, including annual establishment registration, medical device listing, Quality Management System Regulation, labeling requirements, and Medical Device Reporting obligations. The offeror further certifies that any offered devices requiring FDA premarket authorization have a valid FDA marketing authorization in place at the time of the solicitation’s closing, such as an approved Premarket Approval (PMA), a cleared Premarket Notification 510(k), or a granted De Novo classification, as applicable.

b. For devices requiring premarket authorization, an offeror relying on a PMA approval, 510(k) clearance, or De Novo request that remains pending at the time of the solicitation’s closing is technically unacceptable and will not be considered for award. An offeror will remain technically unacceptable even if the PMA, 510(k), or De Novo submission is granted after the solicitation’s closing but prior to contract award. Manufacturers must maintain current annual FDA establishment registration and device listing throughout the period of performance, including updates to listing information when device or manufacturing changes occur.

16. Backorders

a. The Contractor shall immediately notify DLA Troop Support – Medical of any backordered item. Any actual or anticipated interruption in support must be reported promptly, along with an expected get-well date.

b. If the interruption is anticipated to continue for an extended period, the KO shall direct the contractor to follow the production contingency requirements outlined in Section 4 of the Statement of Work.

SOLICITATION NO. SPE2DV-26-R-0001 Page 10 of 43

17. Manufacturing Facilities

a. If at any time during the term of the contract, the Contractor’s facility or the source from which the

Contractor obtains any of the products supplied by this contract is informed in a FDA “warning letter” that it fails to meet FDA current Good Manufacturing Practices (cGMP) (21 CFR Part 210 and 211), the Contractor shall immediately communicate to the KO the facility or source’s cGMP violation(s) or failed inspection status as outlined in a FDA warning letter. Once the KO is aware that the Contractor’s facility or the source from which the Contractor obtains any of the products provided fails to meet FDA cGMP, the procedures outlined in the paragraph below will apply. These procedures will apply regardless of whether the cGMP violation(s) or failed inspection status of the Contractor’s facility or the source from which the Contractor obtains the products was brought to the KO’s attention by the Contractor or by other means.

b. The DLA Troop Support KO will review the Contractor’s (or its source’s) cGMP violation(s) or failed inspection status unacceptable cGMP status with appropriate DLA clinical staff and will either:

1. Instruct the Contractor to stop the shipment of products listed on this contract that were manufactured, packaged, and/or packed in a facility with cGMP violation(s) or failed inspection status, or

2. Authorize the Contractor to continue to supply such contract products for 90 days from the date when the cGMP violation(s) or failed inspection status was brought to the KO’s attention, provided that the products have not been subjected to a consumer-level recall. Additional periods of 90 days may be authorized at the discretion of the DLA KO.

c. Contractors are cautioned that products that were manufactured, packaged, and/or packed in a facility with cGMP violation(s) or failed inspection status and then shipped without written authorization from the DLA KO shall be returned to the Contractor at the Contractor’s risk and expense, regardless of whether the Contractor was aware of the facility’s cGMP violation(s) or failed inspection status at the time the products were shipped. The Contractor (or its source) shall have corrected all significant cGMP deficiencies or have an acceptable plan with the FDA for the correction of such deficiencies which led to cGMP violation(s) or failed inspection status by the end of the 90-day authorization period as evidenced by a Corrective Action Plan submitted to the FDA and/or issuance of a “close-out letter” by the FDA and any extensions of such period granted by the DLA KO. Additionally, the Contractor is responsible for keeping the DLA KO informed of all corrections made and shall provide the DLA KO with: 1) written documentation of the correction plan, 2) notification from FDA of acceptance of the plan, and 3) a copy of any re-inspection requests and subsequent reports, when they are available. If the FDA’s evaluation of Contractor’s (or its source’s) compliance efforts and/or re-inspection of the non-compliant facility does not result in an accepted corrective action plan (CAP) or issued a close-out letter by the FDA within 90 days from the date when cGMP violation(s) or failed inspection status unacceptable cGMP status was brought to the KO’s attention, or by the end of a DLA KO’s authorization period (whichever is the greater period of time), the contract may be terminated for cause in accordance with FAR 52.212-4(m). The Contractor’s (or its source’s) failure to correct the cGMP deficiencies in a timely manner shall not constitute or give rise to any “excusable delays” pursuant to FAR 52.212-4(f). Nothing in this clause shall be read as limiting the recognized grounds upon which a KO may terminate this contract or delete products pursuant to any clause in this contract or any other applicable law or authority.

SOLICITATION NO. SPE2DV-26-R-0001 Page 11 of 43

d. The Contractor (or its source) shall use only the FDA-inspected manufacturing facilities referenced in the contract for the duration of the contract, unless substitution of manufacturing facilities is approved by the DLA KO, however manufacturing shall be domestic. In case of any manufacturing facility relocation or substitution of manufacturing facilities, the Contractor shall notify the DLA KO of the change, and the Contractor shall request approval from the DLA KO to supply the contracted products from the new location. If the change is approved by the DLA KO after an inquiry to FDA for cGMP status of the new location, approval will be provided by means of a formal contract modification.

18. Product Liability Coverage

a. Med/Surg Prime Vendors may require up to $1 million in product liability coverage. Halyard may seek a waiver directly from the Med/Surg Prime Vendors. If a Med/Surg Prime Vendor requires indemnification documentation and Halyard cannot provide it, the Med/Surg Prime Vendors may refuse distribution.

19. Warranties

a. Standard commercial warranties apply. Non-manufacturers without commercial warranties agree to accept returns and, at the Med/Surg Prime Vendor’s discretion, issue credit, refund, or replacement for defective or damaged items. Halyard bears the cost of returns.

20. Distribution and Pricing Agreement (DAPA) System Requirement

a. To make items available for ordering through the DLA Troop Support Medical/Surgical Prime Vendor program, the items must be entered into DLA’s DAPA Management System. To facilitate this, the Contractor is required to provide all necessary product information using the “DAPA_template_Mandatory_Fields” spreadsheet. This spreadsheet is subject to change and may be updated at DLA’s discretion. An updated version shall be requested by the Contractor prior to submission to DLA Troop Support.

SECTION D

PACKAGING AND MARKING

Statement of Work (continued)

21. Commercial Specifications

a. The products on contract shall conform to the manufacturers’ standard commercial specifications.

Packaging and packing shall provide sufficient protection to prevent damage under normal shipping conditions and handling. Product labeling shall reflect the manufacturers or authorized private labelers’ standard commercial markings. It must be readily apparent to the recipient that products received conform by manufacturer name and part number to the item ordered, as represented in the contract.

Packaging, packing, and marking shall comply with applicable laws and regulations.

22. Dispenser Box Packaging and Proprietary Configuration

a. Technical Baseline: The offered domestically manufactured nitrile gloves must be packaged and dispensed utilizing O&M Halyard’s patented, commercial-off-the-shelf SmartPull® dispenser box

SOLICITATION NO. SPE2DV-26-R-0001 Page 12 of 43 design. This dispensing configuration is a mandatory clinical requirement to prevent multi-glove dispensing waste, maximize facility storage footprint efficiency by 60%, and maintain strict infection-control and sanitary protocols.

b. Physical and Visual Uniformity: The domestic dispenser box must be visually, physically, and dimensionally identical to the current non-domestic Halyard Sterling SG® Nitrile Glove SmartPull® dispenser box to ensure full compatibility with existing clinical wall-mount brackets and dispensing hardware.

c. Labeling and Origin Markings: No modifications to the box design, colors, or branding are permitted, with the sole exception of updating the manufacturer identification, physical plant address, and required domestic origin verbiage (e.g., "Made in the USA"). All revised box artwork, labeling proofs, and country-of-origin markings must be submitted to, and approved in writing by, the DLA KO during the post-award development/pre-production phase and prior to the initiation of customer ordering.

SECTION F

DELIVERIES OR PERFORMANCE

FAR 52.242-15 Stop Work Order (AUG 1998) FAR 52.247-34 F.o.B. Destination (JAN 1991)

23. Delivery

a. As stated in Section 9(a), once the contract ramp-up period concludes, the Contractor shall be prepared to accept and fulfill orders from the Med/Surg Prime Vendors prior to the price-effective date. This advance ordering period enables the Prime Vendors to stock their distribution centers and ensure readiness for next-day delivery once customer ordering begins.

b. After completion of the ramp‑up period referenced in Section 9, the Contractor and the Med/Surg Prime Vendors will jointly define all additional delivery requirements. These requirements may include, but are not limited to, product quantities, delivery schedules, designated delivery points, and the methods or modalities used for delivery.

c. All product deliveries shall be FOB Destination to CONUS locations as defined in Section 9(a).

d. Drop Shipments

i. Halyard may ship to MSPV distribution centers or drop ship directly to customers as determined by their business-to-business with the MSPV Prime Vendors. Regardless of shipping method, prices remain FOB Destination – CONUS. Halyard cannot be compelled to drop ship but may agree to do so voluntarily. Payment shall only be made for customer receipted quantities. In cases of erroneous full payment on short shipments, the MSPV Prime Vendors are entitled to a credit/rebill. Drop shipments must include a detailed packing list containing MSPV identifiers, DoDAAC (Department of Defense Activity Address Code), order information, CLIN (Contract Line Item Number), iRAPT

SOLICITATION NO. SPE2DV-26-R-0001 Page 13 of 43

(formerly known as Wide Area Work Flow (WAWF)) number, item numbers, quantities ordered and shipped, and other relevant data. Pricing shall not appear on packing slips.

SECTION G

CONTRACT ADMINISTRATION DATA

DFARS 252.232-7010 Levies on Contract Payments (DEC 2006)

24. Subcontracting Plan

a. Pursuant to the requirements of Public Law 95-507, all large business offerors must submit a subcontracting plan with their offer. All large business concerns are required to have an approved subcontracting plan for contracts valued over $900,000 before the Government can award a contract (see FAR 52.219-9 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval.

b. Instructions for submitting the subcontracting plan are included in FAR 52.212-1 Addendum 2.

Contractors are required to report progress on subcontracting goals to the electronic Subcontracting Reporting System (eSRS) twice a year. eSRS is an internet-based tool that streamlines the process of reporting on subcontracting plans and provides agencies with access to analytical data on subcontracting performance.

25. Assessments/Reports

a. As prescribed in RFO FAR 42.11, DLA Troop Support evaluates contractor performance on all contracts that exceed $350,000 and shares those evaluations with other federal government agencies.

The FAR requires that the contractor be provided with an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, DLA Troop Support will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at https://www.cpars.gov.

26. Contractor Code of Business Ethics

a. RFO FAR Part 3.1002 requires all Government contractors to conduct themselves with the highest degree of integrity and honesty. Contractors should have a written code of business ethics and conduct within thirty days of award. To promote compliance with such code of business ethics and conduct, contractors should have an employee business ethics and compliance training program that facilitates timely discovery and disclosure of improper conduct in connection with Government contracts and ensures corrective measures are promptly instituted and carried out. A contractor may be suspended and/or debarred for knowing failure by a principal to timely disclose to the Government, in connection with the award, performance, or closeout of a Government contract performed by the contractor or a subcontract awarded there under, credible evidence of a violation of federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in title 18 of the United States Code or a violation of the False Claims Act (31 U.S.C. 3729-3733).

https://www.cpars.gov/

SOLICITATION NO. SPE2DV-26-R-0001 Page 14 of 43

b. If this solicitation or contract includes FAR clause 52.203-13 - CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT; the contractor shall comply with the terms of the clause and have a written code of business ethics and conduct; exercise due diligence to prevent and detect criminal conduct;

promote ethical conduct and a commitment to compliance with the law within their organization; and timely report any violations of federal criminal law involving fraud, conflict of interest, bribery or gratuity violations found in title 18 of the United States Code or any violations of the False Claims Act.

(31 U.S.C. 3729-3733). When FAR 52.203-13 is included in the contract, contractors must provide a copy of its written code of business ethics and conduct to the KO upon request by the KO.

27. Recalls

a. The Contractor shall provide product recall notification regardless of level to:

1. DLA Medical MSPV Contracting Team

DLA Troop Support – Medical, email: mspvcontracting@dla.mil

2. Natalie Zagone DLA Troop Support – Medical, email: Natalie.Zagone@dla.mil

3. Jacqueline Sandoval Defense Health Agency, email: jacqueline.g.sandoval.civ@health.mil

4. Joseph Meyer Defense Health Agency, email: joseph.g.meyer2.civ@health.mil

5. DHA JB San Antonio Healthcare Ops Mailbox Prime Vendor Defense Health Agency, email: dha.jbsa.healthcare-ops.mbx.prime-vendor@health.mil

b. This notification must be made within two (2) business days of notification by the manufacturer. The

Contractor shall act on the first notification received.

PART I – THE SCHEDULE

SECTION H

SPECIAL CONTRACT REQUIREMENTS

L02 Electronic Order Transmission (JUN 2020) Offerors shall select one of the following alternatives for paperless order transmission:

( ) American National Standards Institute (ANSI) X12 Standards through a value added network (VAN) approved by DLA Transaction Services; or ( ) Electronic mail (email) award notifications containing web links to electronic copies of the Department of Defense (DD) Form 1155, Order for Supplies or Services.

Offerors must register on the DLA Internet Bid Board System (DIBBS) (https://www.dibbs.bsm.dla.mil/) to receive email notification. If the offeror elects ANSI/VAN order transmission, DLA will send Electronic Data Interchange (EDI) transaction sets at time of award. The contractor shall acknowledge receipt of transaction sets with a functional acknowledgement or order receipt message within 24 hours. If the contractor receives the award transaction set on a weekend or Federal holiday, the contractor shall acknowledge receipt on the next business day. This acknowledgement will confirm that the contractor’s interface with the system is working as needed for contract ordering. Offerors can obtain information mailto:mspvcontracting@dla.mil mailto:Natalie.Zagone@dla.mil mailto:joseph.g.meyer2.civ@health.mil mailto:dha.jbsa.healthcare-ops.mbx.prime-vendor@health.mil

SOLICITATION NO. SPE2DV-26-R-0001 Page 15 of 43 regarding EDI, ANSI X12 transactions, and VANs approved by DLA Transaction Services at Defense Automatic Addressing System (DAAS) Value Added Network List (https://www.transactionservices.dla.mil/daashome/edi-vanlist-dla.asp ). Offerors should direct questions concerning electronic ordering to the appropriate procuring organization point of contact below: DLA Land and Maritime, Helpdesk.EBS.L&M.LTCs@dla.mil DLA Troop Support, dlaedigroup@dla.mil, DLA Aviation, avnprocsysproceddiv@dla.mil, phone # 804-279-4026

L06 Agency Protests (DEC 2016) Interested parties may file an agency level protest with the KO or may request an independent review by the Chief of the Contracting Office (CCO). Independent review by the CCO is an alternative to consideration by the KO and is not available as an appellate review of a KO decision on a protest previously filed with the KO. Absent a clear indication of the intent to file an agency level protest with the CCO for independent review, protests will be presumed to be protests to the KO.

DLAD 5452.233-9001 Disputes - Agreement to Use Alternative Dispute Resolution (JUN 2020)

(a) The parties agree to negotiate with each other to try to resolve any disputes that may arise. If unassisted negotiations are unsuccessful, the parties will use alternative dispute resolution (ADR) techniques to try to resolve the dispute. Litigation will only be considered as a last resort when ADR is unsuccessful or has been documented by the party rejecting ADR to be inappropriate for resolving the dispute.

(b) Before either party determines ADR inappropriate, that party must discuss the use of ADR with the other party. The documentation rejecting ADR must be signed by an official authorized to bind the contractor (see FAR 52.233-1), or, for the Agency, by the KO, and approved at a level above the KO after consultation with the ADR Specialist and legal counsel. Contractor personnel are also encouraged to include the ADR Specialist in their discussions with the KO before determining ADR to be inappropriate.

(c) If you wish to opt out of this clause, check here . Alternate wording may be negotiated with the KO.

PART II - CONTRACT CLAUSES

SECTION I

CONTRACT CLAUSES

FAR 52.216-19 Order Limitations (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $0.01, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor --

(1) Any order for a single item in excess of $5,000.00;

(2) Any order for a combination of items in excess of $5,000,000.00; or mailto:dlaedigroup@dla.mil

SOLICITATION NO. SPE2DV-26-R-0001 Page 16 of 43

(3) A series of orders from the same ordering office within one day that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within two hours after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR 52.216-22 Indefinite Quantity (DEVIATION 2026-O0038) (FEB 2026)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order, which may include order options to be exercised after the ordering period of this contract but before the end of the period of performance of the order.

The contract shall govern the Contractor's and Government's rights and obligations with respect to that order, including options exercised, to the same extent as if the order were completed during the contract's ordering period; provided, that the Contractor shall not be required to make any deliveries under this contract after customer ordering begins. A contract modification will be issued to formally confirm these dates in accordance with SOW Section 10.

FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 60 days of expiration provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

SOLICITATION NO. SPE2DV-26-R-0001 Page 17 of 43

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed two (2) years.

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the KO will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

• FAR: https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52

• DFARS https://www.acq.osd.mil/dpap/dars/dfars_far_overhaul_class_deviations.html

• DLAD: http://www.dla.mil/HQ/Acquisition/Offers/DLAD.aspx

The following additional clauses are incorporated by reference:

CLAUSE

NUMBER TITLE DATE

FAR

52.203-13 Contractor Code of Business Ethics and Conduct. NOV 2021

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. JAN 2017

52.203-3 Gratuities. APR 1984 52.203-6 Restrictions on Subcontractor Sales to the Government. JUN 2020 52.203-6 ALT I Restrictions on Subcontractor Sales to the Government. NOV 2021

52.204-13 System for Award Management—Maintenance (DEVIATION 2026-

O0038). FEB 2026

52.204-19 Incorporation by Reference of Representations and Certifications. DEC 2014

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations

(DEVIATION 2026-O0038). FEB 2026

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (DEVIATION 2026-O0038).

FEB 2026

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters (DEVIATION 2026-O0038). FEB 2026

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (DEVIATION 2026-O0038). FEB 2026

52.215-21 Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data-Modifications (DEVIATION 2026- O0038).

FEB 2026

52.215-8 Order of Precedence-Uniform Contract Format (DEVIATION 2026-

O0038). FEB 2026

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52 https://www.ecfr.gov/cgi-bin/textidx?SID=2a65ee6d124e0949d61d01c7d637b675&mc=true&tpl=/ecfrbrowse/Title48/48tab_02.tpl https://www.ecfr.gov/cgi-bin/textidx?SID=2a65ee6d124e0949d61d01c7d637b675&mc=true&tpl=/ecfrbrowse/Title48/48tab_02.tpl https://www.ecfr.gov/cgi-bin/textidx?SID=2a65ee6d124e0949d61d01c7d637b675&mc=true&tpl=/ecfrbrowse/Title48/48tab_02.tpl http://www.dla.mil/HQ/Acquisition/Offers/DLAD.aspx

SOLICITATION NO. SPE2DV-26-R-0001 Page 18 of 43

52.217-2 Cancellation Under Multiyear Contracts. OCT 1997

52.219-16 Liquidated Damages-Subcontracting Plan (DEVIATION 2026-

O0038). FEB 2026

52.219-28 Postaward Small Business Program Re-representation (DEVIATION

2026-O0038). FEB 2026

52.219-8 Utilization of Small Business Concerns (DEVIATION 2026-O0038). FEB 2026 52.219-9 Small Business Subcontracting Plan (DEVIATION 2026-O0038). FEB 2026 52.219-9 ALT II Small Business Subcontracting Plan (DEVIATION 2026-O0038). FEB 2026 52.222-3 Convict Labor (DEVIATION 2026-O0038). FEB 2026

52.222-19 Child Labor-Cooperation with Authorities and Remedies

(DEVIATION 2026-O0038).

FEB 2026

52.222-35 Equal Opportunity for Veterans (DEVIATION 2026-O0038). FEB 2026

52.222-36 Equal Opportunity for Workers with Disabilities (DEVIATION

2026-O0038). FEB 2026

52.222-37 Employment Reports on Veterans (DEVIATION 2026-O0038). FEB 2026

52.222-40 Notification of Employee Rights Under the National Labor Relations Act. (DEVIATION 2026-O0038) FEB 2026

52.222-50 Combating Trafficking in Persons (DEVIATION 2026-O0038). FEB 2026 52.223-23 Sustainable Products (DEVIATION 2026-O0038). FEB 2026

52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving. MAY 2024

52.229-12 Tax on Certain Foreign Procurements (DEVIATION 2026-O0038). FEB 2026 52.232-17 Interest. MAY 2014

52.232-33 Payment by Electronic Funds Transfer-System for Award Management. OCT 2018

52.232-36 Payment by Third Party (DEVIATION 2026-O0038). FEB 2026 52.232-39 Unenforceability of Unauthorized Obligations. JUN 2013 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. MAR 2023 52.233-3 Protest after Award (DEVIATION 2026-O0038). FEB 2026

52.233-4 Applicable Law for Breach of Contract Claim (DEVIATION 2026-

O0038). FEB 2026

52.240-91 Security Prohibitions and Exclusions (DEVIATION 2026-O0038). FEB 2026 52.242-13 Bankruptcy. JAN 1995 52.242-5 Payments to Small Business Subcontractors. JAN 2017

52.244-6 Subcontracts for Commercial Products and Commercial Services

(DEVIATION 2026-O0038) FEB 2026

52.247-64 Preference for Privately Owned U.S.-Flag Commercial Vessels

(DEVIATION 2026-O0038). FEB 2026

52.252-6 Authorized Deviations in Clauses. NOV 2020

DFARS

252.203-7000 Requirements Relating to Compensation of Former DoD Officials. SEP 2011 252.203-7002 Requirement to Inform Employees of Whistleblower Rights. DEC 2022 252.203-7003 Agency Office of the Inspector General. AUG 2019

SOLICITATION NO. SPE2DV-26-R-0001 Page 19 of 43

252.204-7003 Control of Government Personnel Work Product. (DEVIATION

2026-O0025) APR 1992

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services. JAN 2023

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

252.211-7003 Item Unique Identification and Valuation. JAN 2023

252.219-7996 Small Business Subcontracting Plan (DoD Contracts) (DEVIATION

2026-O0037) (FEB 2026) FEB 2026

252.223-7008 Prohibition of Hexavalent Chromium. JAN 2023 252.225-7001 Buy American and Balance of Payments Program. FEB 2024 252.225-7002 Qualifying Country Sources as Subcontractors. MAR 2022 252.225-7012 Preference for Certain Domestic Commodities. APR 2022

252.225-7052 Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten. MAY 2024

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime. JAN 2023

252.225-7058 Postaward Disclosure of Employment of Individuals Who Work in the People’s Republic of China. JAN 2023

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region. JAN 2023

252.225-7061 Restriction on the Acquisition of Personal Protective Equipment and Certain Other Items from Non-Allied Foreign Nations JAN 2023

252.226-7001 Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns. JAN 2023

252.232-7010 Levies on Contract Payments. DEC 2006

252.232-7011 Payments in Support of Emergencies and Contingency Operations. MAY 2013 252.243-7001 Pricing of Contract Modifications. DEC 1991 252.243-7002 Requests for Equitable Adjustment. DEC 2022

252.244-7999 Subcontracts for Commercial Products or Commercial Services.

(DEVIATION 2026-O0015) FEB 2026

252.247-7023 Transportation of Supplies by Sea. OCT 2024 252.247-7023 ALT I Transportation of Supplies by Sea ALTERNATE I OCT 2024

PART III - LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS

SECTION J

LIST OF ATTACHMENTS

• Domestic Unit Cost Breakdown Sample Spreadsheet

SOLICITATION NO. SPE2DV-26-R-0001 Page 20 of 43

PART IV – REPRESENTATIONS AND CERTIFICATIONS

SECTION K

REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS.

SOLICITATION PROVISIONS

PROVISION

NUMBER TITLE DATE

FAR

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. SEP 2024

52.209-7 Information Regarding Responsibility Matters (DEVIATION 2026-

O0038). FEB 2026

52.229-11 Tax on Certain Foreign Procurements—Notice and Representation

(DEVIATION 2026-O0038). FEB 2026

52.240-90 Security Prohibitions and Exclusions Representations and Certifications

(DEVIATION 2026-O0038). FEB 2026

DFARS

252.203-7005 Representation Relating to Compensation of Former DoD Officials. SEP 2022

252.204-7016 Covered Defense Telecommunications Equipment or Services – Representation (DEVIATION 2026-0025) DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services—Representation. (DEVIATION 2026-O0025) MAY 2021

252.204-7998 Alternate A, Annual Representations and Certifications. (DEVIATION

2026-O0043) FEB 2026

252.215-7012 Requirements for Submission of Proposals via electronic Media. JAN 2018 252.219-7000 Advancing Small Business Growth. JUN 2023 252.225-7055 Representation Regarding Business Operations with the Maduro Regime. MAY 2022

252.225-7057 Preaward Disclosure of Employment of Individuals Who Work in the People’s Republic of China. AUG 2022

DFARS 252.225-7059 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region–Representation (JUN 2023)

(a) Definitions. “Forced labor” and “XUAR”, as used in this provision, have the meaning given in the 252.225- 7060, Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region, clause of this solicitation.

(b) Prohibition. DoD may not knowingly procure any products mined, produced, or manufactured wholly or in part by forced labor from XUAR or from an entity that has used labor from within or transferred from XUAR as part of any forced labor programs, as specified in paragraph (b) of the 252.225-7060, Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region, clause of this solicitation.

SOLICITATION NO. SPE2DV-26-R-0001 Page 21…