Redacted_J A.pdf

Limited Sources Justification for Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $150K)

JA: 16-009

1. Contracting Activity: Regional Health Contract Office - Pacific Bldg 339 Clark Rd Ft Shafter, HI 96858

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: DHP Total Dollar Value:

Name of Intended Contractor: INO Therapeutics LLC Street Address: Perryville III Corporate Park

53 Frontage Road, 3rd Floor, P.O. Box 9001 City, State, Zip: Hampton, NJ 08827-9001

Phone: 908-238-6668

3. Description of Supplies/Services: The item being purchased is inhaled nitric oxide INO. The period of performance is 1 January 2016 through 30 September 2016.

This is a continuation of W81K02-15-F-0017 which expires on 31 December 2015 because the VA FSS contract expires on this date and the vendor did not allow the order to extend past the expiration date. A new order is being issued because the VA FSS contract has been extended and the requesting activity still needs this product.

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): 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; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

reviewed/approved

5. Reason for Authority Cited: INO Therapeutics LLC is the only known FSS source that manufactures this highly specialized delivery system. A physician prescribed amount of nitric oxide gas is precisely administered through the state-of-the-art drug delivery system called the INOmax DS.

Nitric oxide is indicated for the treatment of hypoxic respiratory failure associated with pulmonary hypertension. There are no other sources on FSS schedule or open market.

6. Actions to Increase Competition:

Although this is an FSS requirement, the SIN 65 I B 42-2a is not supported by GSAAdvantage EBuy.

Therefore, this JA will be posted on FedBizOpp to increase competition.

7. Market Survey: Market research initially indicated that this requirement was solicited and awarded by the Southern Regional Contracting Office for Brook Army Medical Center under W81K00- 15-P-0330 to the suggested source INO Therapeutics. Based on this market research, this requirement was solicited under W81K02-15-T-0126 for a total of 42 days, however there were no quotes received by the closing. Therefore the solicitation was cancelled. Further market research was conducted, and the suggested source was contacted who stated that they would only provide a quote based on their FSS schedule.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K02-15-F-0017 or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 8.405-6(a)(1)(i)(B)

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Submitted By:

Position Title :

Email address:

Date:

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name:

Position Title:

Email address:

Date: