Jand A Signed Redacted.pdf

USE OF OTHER THAN FULL AND OPEN COMPETITION FOR AN

ACQUISITION UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

8/19/2020

Respiratory Therapy Dept.

I. BACKGROUND:

The service or material listed on N0018320RCR4002Mallinckrodt Pharmaceuticals for competition is precluded for the reasons indicated below on this justification for other than full and open competition, in accordance with:

FAR 13.106-1(b)(1)(i): states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available FAR 13.106-3(b)(3)(i): this memorandum explains the absence of competition for this acquisition, as only one source will be solicited for this requirement (or for a portion of the requirement) and the requirement is not expected to exceed the simplified acquisition threshold)

II. DESCRIPTION OF ITEM OR SERVICE:

Manufacturer Details:

Provide original manufacturer’s name (if a sole source manufacturer distributes via dealers, include dealer information as well).

Name: Mallinckrodt Pharmaceuticals

POC: Lori Donohue

Phone Number: 908-238-6668 E-mail: Lori.Donohue@mnk.com

Manufacturer’s Dealer/Rep Details (if applicable):

Name:

POC:

Phone Number: E-mail:

PROVIDE A DESCRIPTION OF THE ITEM OR SERVICE REQUIRED:

Estimated Cost: RDD/POP: 10/1/2020 to 9/30/2021 Description:

III. THE DETERMINATION FOR USE OF OTHER THAN FULL AND OPEN COMPETITION IS

BASED ON THE FOLLOWING (select all that apply):

Description: Inhalation Nitric Oxide maintaining two machines in house at NMCP, with a par level of ten Nitric Oxide tanks, estimated cost of year and required quarterly delivery date as well as when additional devices are needed.

☒ ONLY ONE RESPONSIBLE SOURCE (example: OEM technical representative)

☐ LIMITED SOURCE (example: multiple OEM authorized technical representatives)

☐ BRAND NAME SOLE SOURCE (example: OEM replacement part)

☐ BRAND NAME LIMITED SOURCE (example: multiple OEM authorized part distributors)

☐ UNUSUAL AND COMPELLING URGENCY (example: Urgent Requirement, work stoppage, mission critical)

SECTION A:

☒ RESTRICTIVE RIGHTS. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required

☐ EXCLUSIVE LICENSING AGREEMENTS. The item or service is only available from the Original Equipment Manufacturer (OEM), or there is only one authorized distributor or technical representative for the OEM.

☒ FORM, FIT AND FUNCTION. The required items are direct replacement parts/components for existing equipment and must be compatible in terms of form, fit and function with existing equipment/ configurations.

Provide the following information:

1. Make and Model Number: Nitric Oxide Therapy Service

2. Explanation of how direct replacement parts/components must be compatible with existing equipment (i.e. reagents & analyzers, electrical system of medical equipment, etc.):

☒ UNIQUE FEATURES. Similar products lack features that are necessary to meet the Government's minimum needs (i.e. Beckman WA-96 Plus analyzer vs. Becton Phoenix M50 analyzer). Provide the following information:

INO Therapeutics provide NMCP with Nitric Oxide Therapy Service, which consists of (a) the pharmaceutical drug nitric oxide for inhalation, (b) a delivery device meeting the criteria for the administration of nitric oxide set forth in the product label for nitric oxide delivery, (c) various maintenance, pick-up and delivery, and other services. Funding is based on estimated values of previous patient censors for the Neonatal, Pediatric, and Adult Intensive care units

Mandated by Public Law 102-585 for New Drugs

☒ OTHER REASONS. Other reason not identified above.

SECTION B:

☒ BRAND NAME. Item required must be a brand name product, or feature of a product, particular to one manufacturer.

SECTION C:

☐ UNUSUAL AND COMPELLING URGENCY.

The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Urgent Requirements are supplies or services that will result in a work stoppage, or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item/service is an urgent and compelling requirement is based on the following:

1. Date on which the requirement was first identified:

2. Required delivery date/period of performance:

3. Explanation of why delivery/commencement of services by the date mentioned above is required:

4. If appropriate, include any additional pertinent information.

IV. CERTIFICATIONS/APPROVALS:

INO Therapeutics is the Original Equipment Manufacturer (OEM) requires Inhaled Nitric Oxide for patient care with two machines located at Naval Medical Center Portsmouth. Only INO Therapeutics Distributor by Mallinckrodt Pharmaceuticals is the OEM can provide the required medical gas of this product directly affecting patient care.

Only one source is capable of providing the supplies, medical gas source of Nitric Oxide required at the level of quality required because the services are unique and highly specialized. Funding is based on estimated values of previous patient censors for the Neonatal, Pediatric, and Adult Intensive care units

Only one source is capable of providing the medical gas, Nitric Oxide, services required at the level of quality required because the supplies or services are unique and highly specialized.

Section 1: Department Representative / Technical Reviewer complete the following:

Requirements Certification: I certify that the facts and representation under my cognizance which are included in this justification are complete and accurate to the best of my knowledge and belief.

Signature:

Print Name

Phone Number: mail:

Date: 8/19/2020

Section 2: Contracting Officer (KO) complete the following:

Requirements Certification: I certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

KO Signature:

KO Print Name

Phone Number: E-mail:

Date:

☐ The anticipated cost to the Government will be fair and reasonable.