C01 Award Notice 36C24621D0018_1.docx

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7M under FAR13.5

Contract Opportunity Award Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

BASE NOTICE TYPE

ARCHIVE

DAYS

AFTER THE AWARD DATE

RECOVERY ACT FUNDS

NAICS CODE

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CONTRACTING OFFICE

ADDRESS

DESCRIPTION

See Attachment

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

AWARD NUMBER

AWARD AMOUNT

LINE ITEM NUMBER

AWARD DATE (MM-DD-YYYY)

AWARDEE NAME

CONTRACTOR'S DUNS NUMBER

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AWARDEE

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AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

AWARD INFORMATION

ADDITIONAL INFORMATION

GENERAL INFORMATION

Required Field Contract Opportunity Award Notice

GA 68 DOTATE (NETSPOT)

23667 36C24620Q1075 S N 325412 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 Contract Specialist Cole J Culley cole.culley@va.gov 757-728-7014 36C24621D0018 483,000.00 10-28-2020

ADVANCED ACCELERATOR APPLICATIONS USA, INC.

051714355

57 E WILLOW ST

MILLBURN

NJ

07041 http://va.gov va.gov cole.culley@va.gov va.gov

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-20-AP-3979

1. Contracting Activity: Department of Veterans Affairs, NCO 6, VISN 6, Durham VA Medical Center

2. Nature and/or Description of the Action Being Processed: This procurement is for the supply of Ga68 Dotatate (NETSPOT™) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The Durham VAMC requires a new sole sourced firm-fixed-price Indefinite Delivery Indefinite Quantity (ID-IQ) Contract for one base year and four option years.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Durham VAMC requires Cardinal Health, the large business radiopharmaceutical distributor, to provide Ga68 NETSPOT™ injections, which is indicated for positron emission tomography (PET) imaging in patients with suspected neuroendocrine cancer. This is needed for a period of performance of 10/01/2020-09/30/2025. The estimated cost for the total life of the contract is as follows:

NetspotTM (Dotatate) requirements per FY

Required

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Ga68 Dotatate (NETSPOT™) is the only PET imaging radiopharmaceutical that can directly identify neuroendocrine cancer cells. This product is manufactured by Advanced Accelerator Applications USA, Inc. and Cardinal Health is the only authorized distributor in the Raliegh-Durham area that is capable of supplying the required radiopharmaceuticals to the Durham VAMC. Furthermore, the radiopharmaceuticals are covered under proprietary patents and are only available through the manufacture’s authorized distributor.

Patent # 9,375,498, expiration date, August 10, 2032

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Sources Sought Synopsis: Sources sought notice 36C24620Q0750 was posted on 07/16/2020 and closed on 07/21/2020. The notice stated that the Durham VAMC was seeking “qualified Businesses within 50 miles of 508 Fulton Street, Durham, NC 27705, registered under NAICS code 325412 Pharmaceutical Preparation Manufacturing, capable of providing Ga68 Dotatate. Zero responses were received as a result of this notice.

Other Actions: Prior to award, the Contracting Officer will post an intent to sole source on Contract Opportunities.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: All prices offered will be compared to the independent government estimate and historical costs that the station has paid in the past to determine price reasonableness. If deemed necessary, the CO will request other than certified cost and pricing data as well as request additional quantity discounts.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted to identify available sources and to evaluate the availability of the marketplace to meet the requirement. None of these efforts have yielded additional potential sources. Per PPM 2016-05, Implementation of the Veterans First Contracting Program as a Result of the U.S. Supreme Court Decision: §8127, the COs reviewed the Vendor Information Pages (VIP) database in accordance with VAAR Class Deviation 810.001-70 to determine if two or more service-disabled veteran-owned businesses (SDVOSBs) and veteran-owned small businesses (VOSBs), under NAICS code 325412 Pharmaceutical Preparation Manufacturing, and keyword “radiopharmaceuticals”.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by a sources sought synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from capable parties.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: U.S. Patent # 9375498, issued June 28, 2016, expires August 10, 2032.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: *REDACTED*.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: In order to overcome barriers to competition, the VA will continue survey the market for future acquisitions in an attempt to locate other Ga68 Dotae suppliers. This requirement is being sole sourced for more than one year in order to achieve guaranteed pricing for the next five years.

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 4 Original Date: 08/30/17 Revision 02 Date: 08/04/2020