solesource justification -Envigo stage 3-redacted_signed.pdf

SOLE SOURCE JUSTIFICATION

MANDATORY TEMPLATE FOR FEDERAL PROCUREMENTS UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

1. Estimated Dollar Value:

2. Anticipated Period of Performance: 6/1/2023 – 11/30/2023

3. Does the anticipated Period of Performance include option years? If no, explain.

No

4. Sources Sought Notice posted to Contract Opportunities and attached to this document?

Yes No

5. Market Research conducted and attached to this document? If not, explain.

This is a continuation of an existing project that is being done in stages.

6. Is this a new requirement or a follow on to an expiring award?

New requirement Follow on to an expiring award

7. Describe the requirement. Please note that the requirement is the minimum acceptable specification or capability, and is not necessarily the best in the industry. Please note whether any additional follow on work is anticipated in response to the current proposed effort.

The requirement is for sub cloning of an existing hybridoma cell line in order to obtain monoclonal products (monoclonal cell lines). Further, a requirement is for antibody production using a maximum of 10 of the monoclonal cell lines, and shipment of the products to USDA.

8. List the proposed vendor and contact information.

Envigo contact: Shannon Snodgrass, 1 800 972 4362

9. Describe why the proposed vendor is the only vendor from which the requirement can be obtained. Examples of acceptable justifications include but are not limited to: sole manufacturer and seller, adherence to warranty provisions, urgency, etc. If other vendors can provide similar products or services, describe why they cannot meet our particular requirement.

Envigo was selected for this project because they allow work to be contracted in stages rather than all at once. This is advantageous to the government, because it allows us to test many materials in early stages and then select which materials will continue to later stages. Because we do not know the effectiveness of the materials beforehand, there is no guarantee that when we start a project it will successfully make it through all stages. Currently we have a project at Stage 2 (hybridoma production) with Envigo. If we were to switch to another company, we would need to repeat stages 1 and 2, which would cost roughly to (excluding costs at NCAUR to re evaluate the products). Furthermore, repeating the effort would not guarantee a material useful for further development.

Freezing the products at Stage 2 and shipping them to another company for Stage 3 would likely cause many of the hybridoma fusion products to either lose the ability to produce antibody or lose the ability to grow in culture. Sole source is requested to save on the costs associated with reproducing the research and because Envigo is the only vendor that has the hybridoma fusion products obtained in Stage 2. That is, they are the only vendor that has the starting materials in hand to meet our particular requirement.

10. Certification:

I hereby certify that the information provided above is accurate and complete to the best of my knowledge and belief.

X Technical Representative

11. CO Certification:

I hereby determine that the circumstances of this procurement action deem only one source reasonably available. Also, the quoted price is determined to be fair and reasonable as documented on the SAP e File Checklist and Award Summary.

Contracting Officer Date

12. Level Above the CO Approval:

I hereby determine that the circumstances of this procurement action deem only one source reasonably available. Also, the quoted price is determined to be fair and reasonable as documented on the SAP e File Checklist and Award Summary.

Supervisory Contracting Officer Date

CHRIS MARAGOS

Digitally signed by CHRIS

MARAGOS

Date: 2023.05.04 08:08:53 -05'00'

Zachary E.

Schuler

Digitally signed by Zachary E.

Schuler Date: 2023.05.05 12:56:32 -05'00'