JA - Allergan Aesthetics Final 2.1.2022 Approved (004)_Redacted.pdf

CUI

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Allergan Aesthetics Products and Accessories Electronic Catalog (ECAT) Manufacturer Direct Program

CUI 2

overshadowed by physician /experience and highly specialized training on use of specific surgical items. A physician’s training with a particular manufacturer’s product increases their aptitude and familiarity with the technical characteristics of the implantable products that are expected to produce a higher quality of life for their patients or achieve certain therapeutic results. Allergan Aesthetics implantable products are unique and proprietary, as is the industry standard, and require highly specialized training on the part of the physician. The manufacturers’ product will consistently be used due to a physician’s experience, training , and preference.

In addition, the Allergan Aesthetics trained representatives are technical experts on the vendor’s products and are a vital part of helping to ensure that the patient is getting the necessary treatment. At the request of MTFs, Allergan Aesthetics 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. Having a representative with technical knowledge of the products provides better patient care during and after a procedure. Furthermore, technical support is available twenty-four (24) hours a day, seven (7) days a week as the facility and surgeon will have access to the representative’s direct phone number.

There are no known manufacturers or distributors other than Allergan Aesthetics that can provide requiring medical facilities with the complete surgical devices and instruments under all three delivery methods and have the ability to provide the necessary technical support with regard to Allergan Aesthetics’ products and surgical procedures. As technology advances or further product lines are required by the MTFs, additional products determined to be sole source to Allergan Aesthetics may be added to the contract. All product lines added to the contract must be within the scope of the solicitation. Separate technical certification(s) supporting an addendum to this Justification for Other Than Full and Open Competition will be prepared and approved prior to addition to the contract. All items proposed for addition to the contract will be synopsized and the prices 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 August 16, 2021, via the Beta.SAM.gov website seeking sources capable of providing Allergan Aesthetic products and closed on September 17, 2021. Allergan Aesthetics was the only company that expressed interest in the proposed acquisition.

As required by FAR 5.2, the acquisition was synopsized on November 24, 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 began in June 2021 and is currently ongoing with current DLA Troop Support ECAT customers and Allergan Aesthetics. Market research revealed that Allergan Aesthetics is one of two breast implant manufacturers in the United States. Allergan Aesthetics’ implants and the related surgical instruments are unique and proprietary to the manufacturer. Only Allergan Aesthetics can provide the necessary support for these