50-H6901-24-CP422_101524 Mallinckrodt Pharmaceuticals SS UNMH.pdf.PDF

UNM Proposed Sole Source Form – Rev 04/07/2021

Proposed Sole Source Purchase Form Pursuant to New Mexico Procurement law, the UNM Purchasing Department will post your completed form on the UNM Sunshine Portal and the

State of New Mexico Procurement website for 30 days prior to purchase of the goods/services.

I. GENERAL INFORMATION. PLEASE PROVIDE THE FOLLOWING:

Date of Request 10/2/2024 Requisition Number (If Applicable) Request Submitted by: April Vigil/Abby Cullen Title Director Pulmonary

Services/ Director

Medical/Cardiac ICU Department Pulmonary Services Email apvigil@salud.unm.edu Phone 505-272-6573

Proposed Vendor Mallinckrodt Pharmaceuticals Amount $950,000 Annually Vendor Address 440 Route 22 East, Suite 302, Bridgewater, NJ 08807 Term of

Purchase

2 years with up to 10 year renewal Buyer Team - See Commodity list at http://purchase.unm.edu/department-information/comm-code-listing.pdf

Provide a basic description of goods/services to be provided:

1. Inhaled nitric oxide (INO) gas option to renew for 2 years.

2. INO is used to treat patients for pulmonary hypertension and other respiratory hypoxic.

3. Delivery devices are also standard of care.

Why is this purchase needed?

INO is used to treat patients for pulmonary hypertension and other respiratory hypoxic.

II. BASIS FOR SOLE SOURCE PROCUREMENT. CHOOSE APPLICABLE BOX(ES) AND

PROVIDE ADDITIONAL INFORMATION, AS REQUESTED:

☐ Proprietary item, technology or service only available from the proposed vendor. (Check box and describe proprietary component)

☒ Compatibility requirement with existing item, technology or service. (Check box and describe compatibility requirement)

Mallinckrodt INO is the current standard of care for UNMH patients for the treatment of term and near term neonates with hypotic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.

UNMH also administers INO therapy to adults with suspected pulmonary hypertension. Other vendor options require new delivery devices/cartridges and are not compatible with UNMH systems, ☒ Renewal of support/maintenance/subscription of software, technology or other intellectual property. (Check box and describe)

Renewal agreement for 2 years. Currently in house at UNMH

☐ Other Basis for Sole Source: Please describe below:

III. SUPPLEMENTAL DETAILS. PLEASE PROVIDE ADDITIONAL INFORMATION AS

REQUESTED BELOW:

Describe in detail the unique capabilities of the proposed vendor’s goods/service and/or personnel performing the work and why this constitutes the only source. Focus on what is unique about the goods/service and why no other vendor could meet your needs.

1. Current noted vendor is standard of care at UNMH it would be a huge lift financially, staffing and time to prevent any shortages and care for the patient. Introduction of a new delivery device/system for INO administration would be a transition for our respiratory therapists requiring additional training and that department is currently short-staffed making additional training time difficult.

2. Other vendor machines are not compatible with current UNMH devices and can compromise patient care.

Describe the due diligence made to locate other possible sources including communications with other universities, communications with similar providers, web searches, yellow page searches, review of advertisements and trade publications, etc.

Spoke with similar size hospital in New Mexico end-user and found that Praxair was not able to provide the needs.

List the other vendors who were contacted. Please describe the specs/qualifications/criteria that the other vendors were unable to satisfy.

Vero Biomed. New technology with different delivery device and cartridges that produce INO.

Approved: _________________________________________________ Date: _________________________ Jeffrey Gilmore (Oct 15, 2024 10:47 MDT) Oct 15, 2024 https://secure.na2.echosign.com/verifier?tx=CBJCHBCAABAAvFPp4Oj32GCvW2oJogaq1CdJ5jbDBSfI

Sole Source Justification Form INOtherapy Final Audit Report 2024-10-15

Created: 2024-10-15

By: Shannon Rodgers (sjrodgers@salud.unm.edu)

Status: Signed

Transaction ID: CBJCHBCAABAAvFPp4Oj32GCvW2oJogaq1CdJ5jbDBSfI

"Sole Source Justification Form INOtherapy" History Document created by Shannon Rodgers (sjrodgers@salud.unm.edu) 2024-10-15 - 4:01:01 PM GMT- IP address: 206.192.168.20

Document emailed to Jeffrey Gilmore (jcgilmore@salud.unm.edu) for signature

2024-10-15 - 4:01:38 PM GMT

Email viewed by Jeffrey Gilmore (jcgilmore@salud.unm.edu) 2024-10-15 - 4:47:42 PM GMT- IP address: 206.192.168.19

Document e-signed by Jeffrey Gilmore (jcgilmore@salud.unm.edu) Signature Date: 2024-10-15 - 4:47:55 PM GMT - Time Source: server- IP address: 206.192.168.19

Agreement completed.

2024-10-15 - 4:47:55 PM GMT