SPE2DE21R0005 Approved JA_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

DePuy Synthes Spine, CraniMaxioFacial, Trauma Orthopedic “Procedural Packages”

Electronic Catalog (ECAT) Manufacturer Direct Program

SOURCE SELECTION INFORMATION – SEE FAR 2.101 AND 3.104

physician will likely use that manufacturer’s products consistently thereafter for the duration of their career.

At the request of the Military Medical Treatment Facilities (MTF), Johnson & Johnson Health Care Systems will have a qualified representative on site at the MTF within the timeframe specified by the facility necessary to meet their requirements. The representative provides technical advice and guidance to the physician before, during, and after implantation.

Furthermore, technical support is available twenty-four (24) hours a day, seven (7) days a week.

To facilitate the implantation process, there are ancillary accessories and instrumentation sets that are part of the “procedural package” necessary for orthopedic implant surgery. Johnson & Johnson Health Care Systems distributes these ancillary accessories and instruments since they are essential for implantation of their implantable products and needed at the scheduled time of surgery. These products are considered ancillary to the overall cost of the acquisition (less than 10%) but are an essential part of the procedural package.

Johnson & Johnson Health Care Systems DePuy Synthes Spine, CMF, and Trauma Division is the only provider of their Spine, CMF, and Trauma procedural packages. There are no known manufacturers or distributors other than Johnson & Johnson Health Care Systems DePuy Synthes Spine, CraniMaxioFacial, Trauma Division who can provide DoD hospitals with the complete procedural package under all three delivery methods and has direct control over a sales force that is knowledgeable in their products.

As technology advances or further product lines are required by the MTFs, additional orthopedic products determined to be sole source to Johnson & Johnson Health Care Systems may be added to the contract. All product lines added to the contract must be within the scope of the solicitation. All prices for new product lines will be determined fair and reasonable prior to placement on the contract.

6. A Sources Sought Notice (SSN) was issued to ensure that offers are solicited from as many sources as is practicable. The SSN was issued on February 15, 2021, via the Beta.SAM.gov website seeking sources capable of providing DePuy Synthes Spine, CMF & Trauma procedural packages, and closed on March 15, 2021. Johnson & Johnson Health Care Systems DePuy Synthes Spine, CraniMaxioFacial, Trauma Division was the only company that expressed interest in the proposed acquisition.

As required by FAR 5.2, the acquisition was synopsized on March 19, 2021 in Contract Opportunities (Beta.SAM.GOV). In addition, this justification will be published with the solicitation in accordance with FAR 6.305(c).

7. As the Contracting Officer, I hereby determine that the anticipated cost to the Government will be fair and reasonable based on a favorable comparison to commercial pricing. Negotiations will be conducted, as necessary, to obtain fair and reasonable prices and favorable discounts.

8. Market Research was conducted in March 2021 with current DLA Troop Support ECAT customers, Johnson & Johnson Health Care Systems and other orthopedic manufacturers to

I have reviewed this justification and recommend approval.

Date EILEEN MOTTA

Chief, ECAT Division

Date DANIEL KEEFE

Director, Supplier Operations Medical Supply Chain

Date ROBERT J. PANICHELLE

DLA Troop Support Competition Advocate

I have reviewed this justification for legal sufficiency.

Date

Supply Chain Counsel DLA Counsel -Troop Support

Date WILLIAM J. KENNY

Executive Director DLA Troop Support Contracting and Acquisition Management

Date ROXANNE J. BANKS

DLA Competition Advocate

I have reviewed this justification for legal sufficiency.

Date

DLA Office of General Counsel

I have reviewed and hereby approve this justification.

Date MATTHEW R. BEEBE Senior Procurement Executive