V797P-2202D-022.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 2 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C255-19-AP-1100

1. Contracting Activity: Department of Veterans Affairs, VISN 15, Colmery-O’Neil VA Medical

Center – 589-19-2-2618-0042

2. Description of Action: New Requirement

Order against: FSS Contract Number: V797P-2202D

Name of Proposed Contractor: Bayer Healthcare, LLC Street Address: 100 Bayer Blvd City, State, Zip: Whippany, NJ 07981-1544 Phone: 574-252-3311

3. Description of Supplies or Services:

The estimated value of the proposed action is

Xofigo is an alpha-paarticle emitting radioactive therqpeutic agent for the treatmen of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

4. 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:

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

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));

https://www.acquisition.gov/?q=/browse/far/8

VHAPM Part 808.405-6 Limiting Sources Page 2 of 2 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rational/explanation to support cited authority: Bayer HealthCare (Large Business) and Cardinal Health (Large Business) announced the signing of a 15 year agreement for the contract manufacturing of Xofigo (Radium Ra 223 Dichloride). Cardinal Health is the sole distributor of contract manufacturing of Xofigo in the U.S.

Xofigo is the only alpha radiation treatmen for bone pain. Xofigo is the only drug that is known to treat the bone pain and reduce bone tumor size. This is the only treatment being prescribed by VA Doctors to treat this type of illness.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the Award on FBO, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

PAUL DIXON, JR.

Contracting Officer Date: 4/2/2019 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/6