JA Medical ZimVie 5.17.22 Final redacted_Redacted.pdf

Controlled Unclassified Information (CUI)

Page | 2 Controlled Unclassified Information (CUI)

Source Selection Information - FAR 2.101 and 3.104

5. The use of this authority is necessary because the current spinal marketplace consists of manufacturers that produce their own "Unique" or "Highly specialized" line of products. Unlike many other industries, product selection in the spinal industry is not based solely on price and is 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 products that are expected to produce a higher quality of life for their patients or achieve certain therapeutic results. ZimVie “procedural packages” products are unique and proprietary, as is the industry standard, and requires 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 ZimVie representatives are 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 Medical Treatment Facilities (MTFs), ZimVie 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 ZimVie that can provide requiring medical facilities with the complete surgical devices and instruments under all three delivery methods and have the ability to provide support with regard to ZimVie products and surgical procedures currently being used. As technology advances or further product lines are required by the MTFs, additional products determined to be sole source to ZimVie 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 amendment 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 February 28, 2022, via the SAM.gov website seeking sources capable of providing ZimVie “procedural packages” products and closed on March 28, 2022. ZimVie was the only company that expressed interest in the proposed acquisition.

As required by FAR 5.2, the acquisition was synopsized on March 29, 2022, in Contract Opportunities (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.