2022-65076 MatTek_SSJ redac.pdf

Rev. 1/6/14

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Centers for Disease Control and Prevention National Centers for Immunization and Respiratory Diseases Influenza Division 1600 Clifton Rd., NE Bldg. 24, 7th floor Mailstop A-20 Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch Click here to enter text.

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Provide eighty (80) 24-well plates of qualified ready-to-use human primary bronchial microtissues in a year, 160 bottles with 250mL of ALI media needed to maintain the bronchial microtissues in ALI, and 180 Hang-top 12-well plates across twenty-four (24) shipments of media and primary cells using specialized containment and immobilization.

b. Procurement Request (PR) Number (if available): 65076

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: MatTek Corporation, 200 Homer Ave., Ashland, MA 01721

b. Estimated Procurement Amount: $247,400.00

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: N/A D. Justification:

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1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☒ Brand name required ☐ Industrial mobilization ☐ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) 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; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☐ Only One Source ☐ Logical Follow Up

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

MatTek is the only commercial provider of ready-to-use 3D tissue matrixes of the human airway. These microtissues have the potential to be the best cell-based model of the human airway by maintaining a series of basal cells to mimic the backing of the airway epithelium while allowing the apical surface to remain in an air-liquid interface (ALI).

b. What other products/services were considered and why did they not meet the need?

Having primary human cells in ALI with intact cell layers is our definition of “ready-to-use” (rather than frozen or raw organ samples), and only MatTek and Epithelix offer cells prepared accordingly. Epithelix offers traditional monolayer or bilayer airway epithelium cells that have been used for many decades in viral research. MatTek’s unique tissue matrixes (3-6 layers) have the possibility to be a better model for influenza. Many rounds of experiments will need to be done to determine their suitability, all of which will also provide usable data for influenza CVV’s even should the model not prove to be superior.

Academic groups are technically able to produce similar products, but in practice have poor quality control and exhibit extreme variation in cell health and permissivity, even among single donors.

3. Program Office efforts to seek potential offerors:

MatTek is the sole supplier and vendor of their tissue matrixes, and do not operate through any other vendors.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: Charmaine McKenzie

Center/Institute/Office COR/Program Official Signature:

Certification Date: April 30, 2024

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.