P03 LSJ.pdf

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-26-AP-0526

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C250-26-AP-0526

1. Contracting Activity: he Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Cleveland Veterans Affairs Medical Center (CLE VAMC), Network Contracting Office (NCO) 10.

Transaction: 541-26-2-703-0690

Description of Action: Network Contracting Office (NCO) 10 intends to award a new firm-fixed-price, single source, delivery order with options (DOWO) for INOmax therapy to INO Theraputics.

INOmax therapy includes continuous access to inhaled nitric oxide gas, delivery systems, and related consumables to support uninterrupted clinical operations. Equipment and gas cylinders will remain on station to meet the immediate needs of patients requiring inhaled nitric oxide therapy. The contractor will coordinate timely cylinder exchanges, equipment calibration, and replenishment of supplies in accordance with patient volume and hospital requirements. Deliveries will be scheduled to maintain sufficient inventory levels for ongoing treatment without service interruption. All deliveries shall comply with FDA regulations, manufacturer specifications, and facility safety protocols. Coordination of delivery and maintenance activities will be managed through the Contracting Officer’s Representative (COR) and the Pulmonary Service to ensure consistent availability and performance throughout the contract period.

Order against: FSS Contract Number: V797D-60737

Name of Proposed Contractor: INO Theraeutics Street Address: 1425 US Route 206 City, State, Zip: Bedminister, NJ 07921 Phone: (314) 654--410

2. Description of Supplies or Services:

The Cleveland VA Medical Center requires INOmax therapy, which provides inhaled nitric oxide (iNO) for the treatment of neonatal hypoxic respiratory failure and other approved clinical indications. The requirement includes continuous access to INOmax nitric oxide gas, the INOmax DSIR® delivery system, and all associated consumables necessary to safely administer therapy. The contractor will furnish gas cylinders, delivery devices, calibration

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4

Acquisition ID#: 36C250-26-AP-0526 materials, and replenishment supplies to ensure uninterrupted clinical availability. Vendor-managed inventory will remain on station, and the contractor will perform timely cylinder exchanges, equipment support, and supply replenishment in accordance with patient volume and hospital needs.

INOmax therapy is the only source capable of providing this product—INO Therapeutics (Mallinckrodt)—because INOmax is an FDA-approved drug-device combination that must be delivered using the manufacturer’s proprietary DSIR delivery platform. No other manufacturer’s system is compatible with INOmax cylinders, dosing algorithms, or monitoring requirements. As such, the required therapy, consumables, and delivery systems are unique to INO Therapeutics.

The estimated value of the proposed action is $ $29,506.60 base and $147,533.00 with options.

3. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(FAR 8.405-6(a)(1)(i)(B));

4. Rationale/explanation to support cited authority:

This limited sources justification is based on FAR 8.405-6(b), Items Peculiar to One Manufacturer. The requirement for inhaled nitric oxide therapy at the Cleveland VA Medical Center is specifically for INOmax, an FDA-approved drug-device combination that must be administered using the proprietary INOmax DSIR®/DSIR Plus delivery system manufactured exclusively by INO Therapeutics. The gas formulation, dosing algorithms, monitoring features, and delivery interface are engineered to operate only with the manufacturer’s equipment and consumables. As a result, cylinders, regulators, sensors, cartridges, and software used in INOmax therapy are not interoperable with any other inhaled nitric oxide system.

Alternative nitric oxide delivery systems exist in the commercial marketplace; however, they cannot be used for this requirement for the following reasons:

1. FDA-Approved Product Specificity:

INOmax is approved by the FDA as a combination product with its dedicated delivery

VHAPG Part 808.405-6 Limiting Sources Page 3 of 4

Acquisition ID#: 36C250-26-AP-0526 system. Substituting other systems (e.g., NOxBOX, other third-party devices) would not meet the FDA-mandated configuration for safe administration of INOmax gas.

2. Lack of Clinical and Operational Compatibility:

Other nitric oxide systems are not compatible with INOmax cylinders, proprietary connectors, gas concentration sensors, software, or alarm systems. They cannot interface with the INOmax DSIR platform or support the drug-specific dosing controls required for compliant therapy.

3. Patient Safety and Continuity of Care:

The Pulmonary and Neonatal Intensive Care units rely on the INOmax DSIR equipment currently in use at the VAMC. Switching to an alternate system would require staff retraining, new clinical validation, updated protocols, and transitioning patients mid-therapy, which presents significant clinical risk. The OEM’s system is the only one that guarantees uninterrupted treatment for current and future patients.

Market research was conducted by the Contracting Officer and the Service to determine if there were other vendors capable of providing the inhaled nitric oxide that meet CLE VAMC's specific requirements. The following sources were reviewed:

INO Therapeutics, the OEM, confirmed that the INOmax therapy is made in America, they only sell directly and they have a NAC Contract # V797D-60737.

A Sources Sought notice, 36C25026Q0084, was conducted from October 23, 2025 through October 30, 2025, with no responses.

An Intent to Sole Source notice, 36C25026Q0149, was conducted from December 4, 2025 through Decmeber 10, 2025, with no responses.

GSA eLibrary, ECAT, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, MSVP, BIC FDA, SAM, and MSVP:

o Keywords Used: "inhaled nitric oxide" o Results: INO Therapeutics was the only vendor found. No other vendors or results to fit CLE VAMC needs were found across the remaining databases.

SBS:

o NAICS Code Searched: 339113 (Surgical Appliance and Supplies

Manufacturing) o Keywords Used: "inhaled nitric oxide" o Results: Victor Medical Supply, LLC was the only vendor listed and they do not provide INOmax therapy products.

VHAPG Part 808.405-6 Limiting Sources Page 4 of 4

Acquisition ID#: 36C250-26-AP-0526

The NMR does apply to this procurement under NAICS 339113, and the SBA has not issued an NMR waiver. The VA and SBA Rule of Two cannot be met, there are no distributors. This will be sole sourced to INO Therapeutics, a large business.

Rachelle J. Hamer Contracting Officer

NCO 10