B- SSJ_SSJ_MatTek_FY22_LC220106174156.pdf

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Sole-Single Source (including Brand-Name) Justification

Identification of the Agency and Contracting Activity.

Federal Agency and Contracting Activity.

Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse

Sponsoring Organization.

National Center for Advancing Translational Sciences Division of Pre-Clinical Innovation

Early Translation Branch (ETB)

Project Officer Information.

Project Officer Name. Matthew Hall Mailing Address. 9800 Medical Center Drive, Bldg B, Rockville, MD 20850 E-mail Address. hallma@mail.nih.gov Telephone Number. 301.480.9928

Project Description.

Name of Item or Project Title.

MatTek 3D Human Tracheobronchial Tissues (Epiairway) and MatTek 3D Human Alveolar Tissues (Epialveolar) and media and MatTek 3D Small Intestinal Tissues ft

Description of the Item or Service.

In order to understand emerging variant threats from SARS-CoV-2 variants, it is necessary to characerize infection and response to antivirals in a relevant tissue model. We have optimized and shown that MatTek human alveolar and tracheobronchial and gut tissues can be used to robustly support SARS CoV2 infection and can successfully replicate antiviral findings seen in vivo (i.e.

remdesivir and interferons). Our objective is to use these tissues for rapid variant analysis and antiviral screening efforts and in order to assess emerging variant threat in a rapid fashion and identify potential disease targets for therapeutic intervention. A similar PO was placed in FY 2020 (Requisition 5708770). We were able to validate the tissues as a robust SARSCoV2/COVID19 model and screen antiviral activity by compounds in these tissues. We are continuing this work in order to identify additional COVID19 markers and potential therapeutic targets of severe viral infection.

Market Research:

Market Research was conducted and the results of market research are detailed in the attached market research document. (see FAR Part 10)

Acquisition Type:

This acquisition exceeds $5,000 and is not expected to exceed $250,000, and is conducted in accordance with FAR Part 13- Simplified Acquisition Procedures.

Acquisition Authority:

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, 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, or industrial mobilization).

Justification Rationale:

Only one source is available:

I hereby determine that the item or service listed herein is available from only one source and competition is precluded for the reasons indicated below. There are no substitutes available.

This acquisition is restricted to:

Company Name. MatTek Life Sciences Company Address. 200 Homer Ave. Ashland, MA 01721 Point of Contact. Viktor Karetksy, Manager of Business Development Contact Phone. 508-881-6771 ext 337 Contact Email Address. vkaretsky@mattek.com

The estimated cost of the required item or service is:

$225,126.00 The item or service is required to be delivered/performed on:

Within 30 days after receipt of individual requests (orders to be requested weekly/biweekly)

Brand-name or Items peculiar to one manufacturer:

The essential characteristics of the item or service that limit the availability to a sole source are:

Only this suggested source can furnish the requirements, to the exclusion of other sources, because:

Exclusive licensing, engineering, developmental or research capability, or industrial mobilization: A patent, copyright, proprietary data, or licensing agreement limits competition. The proprietary data are described as:

These tissues are only available from MatTek Life Sciences and we have been working with and fully validated/characterized infection with SARS COV2 in these tissues including infection kinetics, disease profiles, and antiviral compound treatments.

Include as appropriate:

The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed and must coordinate, connect, or interface with the existing equipment or system by:

The new items are "direct replacement" parts / components for existing equipment.

Any other facts supporting the justification:

These tissues are only available from MatTek Life Sciences. In addition, we are continuing a large body of work that is dependent on the use of these tissues for rapid variant characterization.

Project Officer Certification. The undersigned program official(s) certifies that the information in support of this justification for the proposed acquisition has been reviewed, is completed and correct to the best of my knowledge and belief and recommends approval.

Signature:

Contracting Officer Certification. The Contracting Officer certifies that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete and in accordance with FAR 13.106-1(b)(1), the facts of this acquisition preclude the use of full and open competition.

Signature:

Sole-Single Source (including Brand-Name) Justification Identification of the Agency and Contracting Activity.

Federal Agency and Contracting Activity.

Department of Health and Human ServicesNational Institutes of Health National Institute on Drug Abuse Sponsoring Organization.

National Center for Advancing Translational Sciences Division of Pre-Clinical Innovation Project Officer Information.

Project Description.

Name of Item or Project Title.

Description of the Item or Service.

Include a complete description of the item or service required. Briefly state the nature, purpose, and objective(s) of the acquisition and the overall program of which it is a part. Briefly state what is to be acquired and the benefit(s) received by the Government. Specify any background information that is important to understanding the acquisition and the need it will satisfy and indicate if the action is a new or follow-on requirement. If the project is a continuation or renewal of an ongoing purchase order, provide the current purchase order number and indicate: (i) the name of the incumbent or predecessor contractor; (ii) the period of performance; (iii) total dollar amount obligated to date; and (iv) whether the initial and any subsequent awards were competed and, for any previous awards made under the basis of an approved sole/single source justification.

Include a complete description of the item or service required. Briefly state the nature, purpose, and objective(s) of the acquisition and the overall program of which it is a part. Briefly state what is to be acquired and the benefit(s) received by the Government. Specify any background information that is important to understanding the acquisition and the need it will satisfy and indicate if the action is a new or follow-on requirement. If the project is a continuation or renewal of an ongoing purchase order, provide the current purchase order number and indicate: (i) the name of the incumbent or predecessor contractor; (ii) the period of performance; (iii) total dollar amount obligated to date; and (iv) whether the initial and any subsequent awards were competed and, for any previous awards made under the basis of an approved sole/single source justification.

Market Research:

Market Research was conducted and the results of market research are detailed in the attached market research document. (see FAR Part 10) Acquisition Type:

This acquisition exceeds $5,000 and is not expected to exceed $250,000, and is conducted in accordance with FAR Part 13- Simplified Acquisition Procedures.

Acquisition Authority:

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, 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, or industrial mobilization).

Justification Rationale:

Only one source is available:

I hereby determine that the item or service listed herein is available from only one source and competition is precluded for the reasons indicated below. There are no substitutes available.

This acquisition is restricted to:

The estimated cost of the required item or service is:

The item or service is required to be delivered/performed on:

Include as appropriate:

Any other facts supporting the justification:

Project Officer Certification. The undersigned program official(s) certifies that the information in support of this justification for the proposed acquisition has been reviewed, is completed and correct to the best of my knowledge and belief and recommends approval.

Contracting Officer Certification. The Contracting Officer certifies that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete and in accordance with FAR 13.106-1(b)(1), the facts of this acquisition preclude the use of full and open competition.

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